EIS Gmbh v LELO Oceania Pty Ltd

(1) the claims do not comply with ss 40(2)(a), 40(2)(b) and 40(3) of the Patents Act. It follows that the Patent is invalid and should be revoked;

(2) the cross-claims should otherwise be dismissed;

(3) none of the LELO Products infringes the relevant claims. This has the consequence that the application should be dismissed.

1. The Patent is entitled "Pressure Wave Massager".
2. The Abstract states as follows:

A compression wave massage device for body parts is described, particularly for erogenous zones such as the clitoris, comprising a pressure field generation device and a drive device. The pressure field generation device has at least one cavity with a first end and a second end, located opposite the first end and distanced from said first end, with the first end being provided with at least one opening for placement on a body part. The drive device causes a change of the volume of at least one cavity between a minimal volume and a maximal volume such that in at least one opening a stimulating pressure field is generated. The cavity is formed by a single chamber, and the ratio of the volume change to the minimal volume is not below 1/10, preferably not below 1/8.

A device of the type mentioned at the outset is particularly known from DE 10 2013 110 501 Al. In this known device the cavity is formed by a first chamber and a second chamber. The second chamber shows an opening for placement on a body part or on an erogenous zone. The two chambers are connected to each other via a narrow connection channel. The drive device is embodied such that it only changes the volume of the first chamber, namely such that via the connection channel a stimulating pressure field is generated in the second chamber. This construction of prior art shows considerable disadvantages, though. The use with gliding gel or under water is impossible, since the lubricant or the water increases the throttle effect in the narrow connection channel to such an extent that the drive device is choked off. Additionally, the device of prior art fails to comply with the strict requirements of hygiene required here, since the connection channel due to its very narrow cross-section prevents any cleaning of the first chamber located at the inside so that contaminants and bacteria can accumulate there, which then cannot be removed.

The objective of the present invention is to provide a compression wave massage device of the type mentioned at the outset which shows a simple and simultaneously effective design, and additionally meets the strict requirements for hygiene.

1. Under the Summary, there is further discussion of the objective:

This objective is attained in a pressure field generation device, which comprises at least one cavity with a first end and an opposite second end, located at a distance from the first end, with the first end comprising at least one opening for placement on a body part and a drive device, which is embodied to change the volume of at least one cavity between a minimal volume and a maximal volume such that a stimulating pressure field is generated in at least one opening, characterized in that the cavity is formed by a single chamber and the ratio of volume change to minimal volume is not below 1/10, preferably not below 1/8.

Accordingly, the invention is characterized in a single-chamber solution, which shows the advantages of a simpler construction, improved hygiene, particularly due to the ability of easier rinsing of the cavity according to the invention, formed by only a single chamber, and the easy handling with lubricant or under water.

Furthermore, according to the invention the ratio of the minimal volume to the volume change shall not exceed 10, particularly not exceed 8, since it was found that otherwise the suction effect becomes too low. Here, the volume change refers to the difference between the maximal volume and the minimal volume. The volume of the cavity is defined as the volume of a chamber which ends in the proximity of the opening in a virtually planar area, which virtually closes the opening.

1. Accordingly, the invention is characterised in the Patent as a _"_single-chamber solution". Furthermore, the above passage discloses that the volume of the cavity "is defined as the volume of a chamber which ends in the proximity of the opening in a virtually planar area, which virtually closes the opening".
2. The drawings depict a preferred exemplary embodiment of the invention. Under the Brief Description of the Drawings, it is stated that the embodiment is greater detail based on the drawings.
3. It is stated that Figure 1 is a perspective side view of the compression wave massage device according to the invention in a preferred embodiment. Figure 1 is shown below:

1. Figure 2 (reproduced below) is a front view of the compression wave massage device of Figure 1.

1. Figure 3 (reproduced below) is a longitudinal section through the compression wave massage device of Figure 1.

1. Figure 4 (reproduced below) is an enlarged detail of the longitudinal section of Figure 3 in the head section of the compression wave massage device of Figure 1.

1. The Detailed Description provides detailed information about the preferred embodiment as depicted in the Figures, but also refers to other possible designs and preferments.
2. Other aspects of the specification will be addressed later in these reasons.
3. The relevant claims, with integers identified, are as follows:

A compression wave massage device when used on the clitoris, comprising:

a pressure field generation device comprising at least one cavity with a first end and a second end, located opposite the first end and distanced from the first end,

with the first end being provided with an opening for placement over the clitoris; and

a drive device configured to generate a change of the volume of at least one cavity between a minimal volume and a maximum volume such that in at least one opening a stimulating pressure field is generated,

and the ratio of the volume change to the minimal volume is not below 1/10 and not greater than 1.

wherein the cavity is formed by a single continuous chamber.

wherein the cavity is limited by a continuous lateral wall connecting the first end with the second end of the cavity.

wherein the cross-section of the cavity of the chamber defined perpendicular to its length between the two ends is essentially unchanged or at least almost consistent over the entire length between the two ends

such that the air flow is essentially unchanged or at least almost consistent over the entire length of the cavity of the chamber.

wherein the cavity of the chamber essentially shows the form of a rotary body with a circular or elliptic cross-section.

wherein the lateral wall of the chamber limiting the cavity and connecting its two ends to each other is free from discontinuations.

wherein the cavity of the chamber shows the form of a continuous tube.

wherein the ratio of the width of the cavity of the chamber, defined perpendicular to its longitudinal extension, to the length of the cavity of the chamber, defined in the direction of its longitudinal extension, ranges from 0.1 to 1.0.

wherein the cavity of the chamber is closed at its second end with a flexible membrane,

which essentially extends over the entire cross-section of the cavity and

which is moved by the drive device alternating in the direction towards the opening and in the opposite direction thereto.

wherein the stimulating pressure field shows a pattern of relative vacuum and overpressure stages, which are modulated on a reference pressure.

wherein the stimulating pressure field shows an essentially sinusoidal periodic pressure progression.

further comprising a control device which controls the drive device and

comprises at least one control means by which the respective modulation of the stimulating pressure field can be changed.

wherein the ratio of the volume change to the minimal volume is not below 1/8.

1. Ms Margaux Hayes is a mechanical engineer and product designer, with over 10 years' experience in the design and development of consumer products, medical instruments, sexual stimulation devices and percussion devices.
2. Ms Hayes affirmed six affidavits in the proceedings, dated 6 March 2024 (Hayes 1), 15 May 2024 (Hayes 2), 12 September 2024 (Hayes 3), 15 November 2024 (Hayes 4), 15 November 2024 (Hayes 5) and 7 February 2025 (Hayes 6).
3. Between 2014 and 2016, Ms Hayes worked as a sessional lecturer at the Royal Melbourne Institute of Technology (RMIT), and her work included teaching classes on the design and manufacture of sex toys. During that period, she visited sex toy shops, including for the purposes of her teaching. In 2015 and 2016, she taught undergraduate students at RMIT's "Future Sex" design studio about product solutions including for the improvement of sexual pleasure. As part of this, Ms Hayes assisted students with the detailed design of a clitoral stimulator.
4. A Sydney Morning Herald Article published in December 2015 entitled "Melbourne's RMIT University runs design course on how to make sex toys" is in evidence. According to that article, RMIT's Future Sex design studio was the first university course of its kind which involved industrial design and development of sex toys. Based on that article, Dr Judith Glover, with whom Ms Hayes and Ms Lauren Rigbye worked, believed she was the only person in the world who had a PhD in sex toy design at that time.
5. In 2018, Ms Hayes worked as an assistant researcher for Handii (now called Bump'n) on the design and manufacture of sexual stimulation products for people with disabilities, particularly those with cerebral palsy. As part of that project, she designed and developed prototype clitoral stimulation devices with vibrating components.
6. LELO is critical of the evidence of Ms Hayes and submits that she was biased towards EIS, that she had issues recalling salient facts and that she had withheld relevant and important information when writing Hayes 1 in order to aid EIS's infringement position. In particular, LELO submits that Ms Hayes was selective in the choice of photographs of the LELO Products which were included in her evidence, and that the ones she chose to include were advantageous to EIS. I do not accept these criticisms as, although I consider that there were some issues with the evidence of Ms Hayes which I address below, I do not consider that Ms Hayes lacked independence or was biased. This is especially as the explanations given by Ms Hayes for why she chose particular photographs (for example) were not unreasonable.
7. LELO also submits that Ms Hayes was incapable of being impartial in respect of the testing performed by Cobalt Design (Cobalt). Ms Hayes worked as a product engineer for Cobalt from 2017 until 2020. Furthermore, in late 2024, Ms Hayes corresponded with Cobalt about a potential employment position. Ms Hayes stated that she ceased all communication with Cobalt once she was informed by the lawyers for EIS that Cobalt had been appointed to undertake the experiments in the proceeding, and that it was inappropriate for her to continue to correspond with Cobalt. Although Ms Hayes was cross-examined about this association by counsel for LELO, it failed to demonstrate that Ms Hayes was biased.
8. Although Ms Hayes appeared to take her role as an expert witness seriously and was independent, much of her written evidence and many of her answers during the hearing lacked precision, were at times vague and confusing and, on occasion, appeared to be based on her own personal experience and knowledge of devices of the kind claimed in the Patent acquired post the priority date, rather than based on the extent of the disclosure, and the terms used, in the Patent and the common general knowledge.
9. Mr Brody Payne is a mechanical design manager and senior mechanical engineer employed by Outerspace Design (Outerspace). Mr Payne was engaged as an independent witness. He affirmed two affidavits addressing the conduct of certain experiments by Outerspace.
10. EIS also relied on various affidavits from its solicitors, including Mr John Lee, Ms Irini Lantis, Mr Connor Jarvis and Ms Vanessa Farago-Diener from Gilbert + Tobin. Their evidence addressed various issues, including the conduct of the experiments, various inspections of prior art products, Wayback Machine searches, and various overseas decisions. None of these witnesses was required for cross-examination.

1. Ms Rigbye is a mechanical engineer. Ms Rigbye affirmed two affidavits on 6 March 2025 (Rigbye 1) and 15 November 2024 (Rigbye 2).
2. Ms Rigbye described her qualifications and experience in relation to sex toys as follows:

From 2014 - 2017, I worked under Dr Judith Glover as a sessional academic, teaching the subject "Engineering for Industrial Design". Dr Glover's research work was focussed on sex toy design, and she developed a course on sex toy design (the "Future Sex design studio"), which was delivered to students in 2015. We frequently discussed her work in this field of sex toy design, which is how I became familiar with the industry before 4th April 2016, prior to working with Dr Glover later in 2017 on the first sex toy-based project mentioned above. We discussed some sex toys on the market before April 2016, for example, We-Vibe, Lelo and Iroha devices.

1. Like Ms Hayes, Ms Rigbye was mentored by Dr Glover, and worked for Dr Glover after earning her Bachelor degree. Ms Rigbye also had a practical interest in, and possessed for her own use, sex toys before 4 April 2016 but had not been involved in sex toy design before April 2016.
2. Between 2017 and 2018, Ms Rigbye was involved in two projects which included stimulation devices, albeit that the project in 2017, which involved the insertion of a clitoral stimulator above the male pubic bone, was not considered to be feasible. The other project involved the Handii product (being the same project in which Ms Hayes was also involved).
3. Ms Rigbye's affidavit evidence and her evidence in the joint expert reports contained detailed, logical and cogent explanations for her opinions. Her oral evidence during the hearing was clear and generally consistent with her written evidence, which evidence was not undermined by the answers given under cross-examination in any significant way. Ms Rigbye made appropriate concessions during the hearing, and was an exemplary expert witness. For these reasons, where the evidence of Ms Rigbye differed from that of the other experts, I prefer the evidence of Ms Rigbye unless indicated otherwise.
4. Mr Michael Duff is an electrical engineer, who affirmed ten affidavits in the proceedings, dated 5 December 2023 (Duff 1), 12 December 2023 (Duff 2), 6 March 2024 (Duff 3), 28 March 2024 (Duff 4), 29 April 2024 (Duff 5), 7 June 2024 (Duff 6), 13 June 2024 (Duff 7), 12 September 2024 (Duff 8), 15 November 2024 (Duff 9) and 18 November 2024 (Duff 10).
5. Mr Duff graduated with a Bachelor of Electronic and Electrical Engineering from the University of Northumbria in 1989. Since 2010, he has worked as an engineer for Armocon Technology (Armocon), in Suzhou, China. LELO has been a customer of Armocon for more than 14 years. Armocon is the Chinese manufacturing partner for LELO, and in particular in relation to the LELO Products.
6. Mr Duff was initially called as a factual witness. The first four affidavits affirmed by Mr Duff did not contain the expert declaration required by r 23.13(1)(b), or the acknowledgement required by r 23.13(ga), of the Federal Court Rules 2011 (Cth). It was not until Mr Duff's fifth affidavit filed in April 2024 that he was provided with the Expert Witnesses Guidelines.
7. In the circumstances, it is difficult to understand how Mr Duff could describe himself as being an independent expert witness in his fifth and later affidavits in light of the connection between his employer and LELO. Further, at times during the hearing, Mr Duff acted in a manner which was demonstrably partisan because he appeared to be taking steps to give evidence which he considered would assist LELO. For example, Mr Duff would interject frequently and ask to comment on a topic despite not being asked to do so. He also tended to give very elaborate answers that were not responsive to the question being asked.
8. Indeed, Mr Duff appeared to appreciate the position that he was in when he gave these answers:

MS COCHRANE: Yes, but also your role in this proceeding was to assist LELO and Armacon to avoid a finding of infringement of the EIS patent.

MR DUFF: It's - because LELO is a good client of ours, it was of interest to help, yes.

MS COCHRANE: Yes, and it's of interest to Armacon to avoid a finding that the LELO products infringe the EIS patent, because then they can keep on making them, can't they?

MR DUFF: That's correct.

MS COCHRANE: Yes.

MR DUFF: That's correct.

MS COCHRANE: And it's very difficult, isn't it, Mr Duff, for you to apply an open mind to this case, given that you're employed by Armacon, and it has an interest in ensuring that the LELO products are found not to infringe the EIS patent.

MR DUFF: I'm here as an expert because I've been involved in the design with the LELO team in Shanghai on pressure wave devices, and LELO is a good client of Armacon, so it is of my interest to assist and give my expert advise.

MS COCHRANE: Yes. And in particular, you're conscious that it's in Armacon's interest to make sure that the LELO products are found not to infringe the EIS patent.

MR DUFF: I think it's in the interest of LELO and Armacon.

MS COCHRANE: Yes.

MR DUFF: Is that - it's in the interest of both, because LELO is a client to Armacon.

1. LELO submits that its justification for calling Mr Duff is that finding an expert working in the field of clitoral pressure wave massage devices in Australia "proved impossible". LELO also submits that, "[d]ue to these difficulties, Mr Duff was asked by LELO and agreed to share his expertise in the area". However, no evidence was adduced in support of these difficulties.
2. In any event, Mr Duff's knowledge exceeded the common general knowledge as at the priority date in relation to compression wave massagers. That is because, while working at Armocon, Mr Duff had experience in building and testing prototypes of designs for "pressure wave vibrators" and assembling the final products from component parts. Mr Duff also attended weekly "New Product Development" meetings hosted by LELO, which were also attended by Mr Filip Sedic (being the named inventor on patents and patent applications in the name of LELO, such as, for example, the patent which is contained in Annexure MD-5 of Duff 1). By these meetings, Mr Duff had extensive exposure to the design of these devices by someone who is inventive. This peculiar knowledge which was derived by Mr Duff through his role at Armocon is therefore not representative of the knowledge of the hypothetical person skilled in the art.
3. For these reasons and unless stated otherwise, I place less weight on Mr Duff's opinion evidence where it conflicts with that of Ms Hayes and Ms Rigbye. However, I do not accept that Mr Duff gave false evidence when it came to factual matters, as EIS contends. While it is the case that Mr Duff gave inconsistent factual evidence at times, this affected his reliability as a witness (in terms of his recollection) rather than demonstrating his dishonesty.
4. Mr Barry Schoonenberg is a retailer and the owner of the Playhouse Adult Stores, based on the Gold Coast, Queensland (Playhouse). Mr Schoonenberg affirmed two affidavits on 6 December 2023 (Schoonenberg 1) and 15 November 2024 (Schoonenberg 2).
5. Ms Michelle Temminghoff is a retailer and the owner of the shop called "Passionfruit, The Sensuality Shop Pty Ltd" (Passionfruit Shop). Ms Temminghoff affirmed three affidavits on 6 March 2024 (Temminghoff 1), 7 June 2024 (Temminghoff 2) and 15 November 2024 (Temminghoff 3). Ms Temminghoff was not required for cross-examination.
6. Mr Roger Sheldon-Collins is the Managing Director of Calvista. Mr Sheldon-Collins affirmed three affidavits on 6 March 2024 (Sheldon-Collins 1), 2 April 2024 (Sheldon-Collins 2) and 15 November 2024 (Sheldon-Collins 3). Mr Sheldon-Collins' evidence addressed the introduction of the Womanizer devices into the Australian market and his sale of those devices.
7. Mr Viktor Pilčik is the Global Head of Marketplaces for LELO Adria. Mr Pilčik affirmed one affidavit on 14 November 2024. His evidence addressed the provenance of the Womanizer W100 devices supplied to Mr Duff for the purposes of certain experiments.
8. Mr Dejan Lukac is the director of LELO Oceania Pty Ltd. Mr Lukac swore and affirmed (respectively) two affidavits in the proceeding on 4 December 2023 and 5 June 2024. His evidence addressed the issue of the claimed threats.
9. LELO also relied on affidavits from its solicitor, Mr Peter Douros. Mr Douros swore or, in one instance, affirmed seven affidavits on 9 June 2023 (Douros 1), 29 November 2023 (Douros 2), 6 March 2024 (Douros 3), 6 May 2024 (Douros 4), 13 September 2024 (Douros 5), 2 October 2024 (Douros 6) and 18 November 2024 (Douros 7).

1. On 14 October 2024, I made orders facilitating further experiments to be conducted by a court-appointed, independent testing facility in Australia.
2. On 21 October 2024, I appointed Cobalt to undertake this testing, with the experiments conducted under the supervision of Mr Kynan Taylor, Associate Principal of Cobalt.
3. Cobalt is an engineering and design firm with over 25 years' engineering and design expertise.
4. Mr Taylor is a registered engineer with over 18 years' experience. He affirmed one affidavit dated 8 November 2024 annexing a report regarding the conduct of the experiments that were undertaken by Cobalt and a copy of the experimental report prepared by Mr Taylor and Mr Marcus Krigsman, who is a lead engineer at Cobalt and who conducted the testing under the supervision of Mr Taylor.

1. Three joint expert reports were prepared being:

(a) a report addressing the topics of the person skilled in the art (PSA), the common general knowledge (CGK) and construction of the Patent was prepared following a conclave attended by Ms Hayes, Ms Rigbye and Mr Duff (JER 1);

(b) a report addressing the topics of novelty and inventive step was prepared following a conclave attended by Ms Hayes and Ms Rigbye (JER 2);

(c) a report addressing the topics of infringement, utility, s 40 grounds and the experimental evidence was prepared following a conclave attended by Ms Hayes and Mr Duff (JER 3).

1. During the hearing, certain evidence was the subject of objections. The reasons for admitting or excluding that evidence are contained in Annexure A to these reasons. In Annexure A, I do not address objections where an agreement was reached between the parties about the outcome of an objection or where a party did not press the evidence following an objection being made.
2. In addition, for the reasons explained in EIS GmbH v LELO Oceania Pty Ltd (Expert Evidence) [2024] FCA 1334 (Downes J), the question of whether LELO was entitled to rely upon [14]-[49] of Duff 9 at trial was reserved to the trial. That topic is also addressed in Annexure A.

1. In December 2023, Outerspace, a design and engineering firm in Melbourne, was engaged by the parties, with leave of the Court, to carry out experimental tests (Outerspace experiments). LELO provided unopened samples of the LELO Products to be tested. The Outerspace experiments were carried out between 31 January and 2 February, and 28 February 2024. Representatives from both parties were present.

1. In late February and early March 2024, the respondents carried out further experiments on alleged prior art devices at Armocon in Suzhou, China (China experiments). The circumstances relating to the China experiments are described in EIS GmbH v LELO Oceania Pty Ltd (Evidence of Experiments) [2024] FCA 713 (Downes J).

1. Further testing was conducted by Cobalt (Cobalt experiments) where LELO provided unopened samples of the LELO Products to be tested. The Cobalt experiments were carried out between 30 October to 1 November 2024. Representatives from both parties were present.

1. The experimental protocols followed in the Outerspace experiments and Cobalt experiments (only) are in evidence. In respect of each LELO Product and at a high level, the protocols involved three tests, as follows.

1. These tests were designed to measure whether the ratio of the volume change of the cavity to the minimal volume (i) is not below 1/10 and/or (ii) is not below 1/8. These tests were relevant to integer 1.6 and integer 22.2.

1. These tests were designed to measure whether the ratio of the width of the cavity of the chamber, defined perpendicular to its longitudinal extension, to the length of the cavity of the chamber, defined in the direction of its longitudinal extension, ranged from 0.1 to 1.0. This is relevant to claim 9.

1. These tests involved bisecting each LELO Product, leaving the cross-section of the cavity unaffected, and taking photographs. This is relevant to various integers, insofar as they relate to the shape or structure of the cavity and single chamber.

1. Mr Payne gave evidence about the conduct and reliability of the Outerspace experiments and Mr Taylor gave evidence about the conduct and reliability of the Cobalt experiments.
2. Insofar as Mr Duff sought to impugn the conduct and reliability of the Outerspace and Cobalt experiments, I do not accept his criticisms in circumstances where (a) neither Mr Payne nor Mr Taylor were cross-examined and (b) Mr Duff is not independent. In any event, during the trial, Mr Duff accepted that all of his criticisms about the experiments were immaterial.
3. For these reasons and subject to their relevance to the issues raised concerning the construction of the claims and infringement, I accept the veracity of the results of the Outerspace and Cobalt experiments.

1. The PSA is the hypothetical person to whom the patent specification is addressed and who, generally speaking, works in the art or science with which the invention is connected. It is a notional person who may have an interest in (inter alia) using the products or methods of the invention: see e.g., Aristocrat Technologies Australia Pty Ltd v Konami Australia Pty Ltd (2015) 114 IPR 28; [2015] FCA 735 at [26] (Nicholas J); Hanwha Solutions Corporation v REC Solar Pte Ltd (2023) 180 IPR 315; [2023] FCA 1017 at [86] (Burley J).
2. The first step in identifying the PSA is to identify the field of knowledge to which the invention relates: see e.g., Neurim Pharmaceuticals (1991) Ltd v Generic Partners Pty Ltd (No 5) [2024] FCA 360 at [72]-[74] (Nicholas J). The "subject matter of the invention" is the area "in which the invention is intended to be used": Neurim at [74]. The "patent specification is directed to those with a real, not a peripheral, interest in its subject matter": Novartis AG v Pharmacor Pty Limited (No 3) [2024] FCA 1307 at [157] (Yates J).
3. If the field is defined too narrowly, this would fall into the error identified by Birss J in Illumina Cambridge Ltd v Latvia MGI Tech SIA [2021] EWHC 57 (Pat) at [62], citing Peter Prescott QC in Folding Attic Stairs v The Loft Stairs Company Ltd [2009] EWHC 1221 (Pat) at [33]:

... It is unfair to define an art too narrowly, or else you could imagine absurd cases e.g. "the art of designing two-hole blue Venezuelan razor blades", to paraphrase the late Mr T.A. Blanco White. Then you could attribute the "common general knowledge" to that small band of persons who made those products and say that their knowledge was "common general knowledge" in "the art". That would have the impermissible result that any prior user no matter how obscure could be deemed to be common general knowledge, which is certainly not the law.

1. The PSA is the "non-inventive worker in the field": Wellcome Foundation Limited v V.R. Laboratories (Aust.) Proprietary Limited (1981) 148 CLR 262 at 270 (Aickin J, with whom Gibbs ACJ and Stephen, Mason and Wilson JJ agreed); Minnesota Mining and Manufacturing Company v Beiersdorf (Australia) Ltd [1980] HCA 9; (1980) 144 CLR 253 at 293 (Aickin J, with whom Barwick CJ, Stephen, Mason and Wilson JJ agreed).
2. Further, the notional PSA may be a team. As observed by Yates J in Novartis at [148]-[151]:

The "person skilled in the art" is a construct that is used to analyse questions that arise in patent law.

It is well-recognised that this construct can be understood as a "team", particularly if the art is one having a highly developed technology. As such, the construct combines and deploys the knowledge and skills of the members of the "team". This means that, in real life, the knowledge and skills of some members of the "team" may not be known or shared by others in the "team". There is, however, but one construct. The person skilled in the art thinks with one mind, speaks with one voice, and draws, when and to the extent necessary, on the disparate knowledge and skills of all the members of the "team". The person skilled in the art is indivisible.

Depending on the relevant art, the members of the "team" may be highly skilled with research capabilities...

This does not mean, however, that the person skilled in the art, understood as a highly skilled team or a notional research group, exhibits the capacity for invention. The person skilled in the art, even when understood as a highly skilled team or a notional research group, is taken to have no inventive capacity whatsoever, and is constrained to act only with knowledge that is publicly known, and commonly accepted, by those within the calling of the art in question.

(Citations omitted.)

1. The Court may focus on particular characteristics of the PSA depending on the legal issue involved: see e.g., Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd (No 4) (2015) 113 IPR 191; [2015] FCA 634 at [127] (Yates J); Axent Holdings Pty Ltd (t/as Axent Global) v Compusign Australia Pty Ltd (2020) 154 IPR 431; [2020] FCA 1373 at [251] (Kenny J).

1. The Abstract of the Patent describes the invention as, "[a] compression wave massage device for body parts is described, particularly for erogenous zones such as the clitoris, comprising a pressure field generation device and a drive device. The pressure field generation device has at least one cavity with a first end and a second end, located opposite the first end and distanced from said first end, with the first end being provided with at least one opening for placement on a body part. The drive device causes a change of the volume of at least one cavity between a minimal volume and a maximal volume such that in at least one opening a stimulating pressure field is generated. The cavity is formed by a single chamber, and the ratio of the volume change to the minimal volume is not below 1/10, preferably not below 1/8".
2. Similarly, the section entitled "Technical Field" states that, "the invention relates to a compression wave massage device for body parts, particularly erogenous zones such as the clitoris, comprising a device generating a pressure field which shows at least one cavity with a first end and a second end, located opposite thereto and distanced from the first end, with the first end comprising at least one opening for placement on a body part and a drive device, which is embodied to generate a change of the volume of at least one cavity between a minimal volume and a maximal volume such that a stimulating pressure field is generated in at least one opening".
3. The specification also states that, "[t]he objective of the present invention is to provide a compression wave massage device of the type mentioned at the outset which shows a simple and simultaneously effective design, and additionally meets the strict requirements for hygiene".
4. Claim 1, which is the only independent claim, claims "[a] compression wave massage device when used on the clitoris..." comprising a pressure field generation device with certain features and which is configured to generate a stimulating pressure field.
5. Thus, the relevant subject matter of the invention relates to a compression wave massage device which has particular characteristics when used on the clitoris.
6. LELO submits that the PSA would be a person working in the field of clitoral pressure wave massage devices. However, I disagree as this would define the field too narrowly in the manner described in Illumina.
7. This conclusion finds support by the agreement reached between the experts as recorded in the JER 1, being that the person or team to whom the Patent is directed or addressed has (at least):

(1) experience designing battery powered handheld therapeutic devices;

(2) knowledge of materials, waterproofing, relevant levels of power output, knowledge of drive systems and battery capacity;

(3) knowledge and experience of the product design process, including reverse engineering;

(4) enough knowledge of manufacturing methods (e.g. injection moulding) and quality control processes to engage with manufacturers;

(5) knowledge of general engineering principles including common mechanisms and basic fluid mechanics;

(6) a degree in mechanical engineering or product design or similar;

(7) exposure to or understanding of sexual stimulation devices through industry or research experience;

(8) industry experience working as a product designer with hands-on experience designing consumer products, including work on therapeutic or medical devices, and using tools such as CAD (computer aided design) programs for detailed design and documentation;

(9) knowledge of anatomy of the clitoris, vulva and perineum;

(10) knowledge of the history and current state of the art in sex toy design - which given the lack of formal published and academic resources on the subject, would have involved discussions with manufacturers, retailers and users of sex toys.

1. Nowhere in the agreement reached by the experts (including Mr Duff) was it stated that the PSA needed to have knowledge of and experience with the design or manufacture of clitoral pressure wave massage devices, or even sexual stimulation devices to be used on the clitoris per se (whether pressure wave or otherwise).
2. For these reasons, the field of knowledge to which the invention relates is the design and manufacture of sex toys or, to put it another way, the design and manufacture of devices for sexual pleasure. Those who work in this field would have a real interest in the subject matter of the Patent irrespective of whether they had any prior knowledge or experience of clitoral pressure wave massage devices.
3. Considering the evidence of Mr Duff concerning his "real life" involvement in meetings at which the development of the design of potential sex toys (and specifically clitoral stimulators) was discussed, I consider that, in this case, the hypothetical PSA would be a team of people who have, as a team, the skills and knowledge identified by the experts. As the experts themselves acknowledged, the PSA would have knowledge of the history and current state of the art in sex toy design, acquired through discussions with manufacturers, retailers and users of sex toys.
4. During the trial, both Ms Rigbye and Ms Hayes gave evidence that retailers of the devices would be consulted by the PSA team, at the least, if not (in the case of Ms Rigbye) being members of the team either "formally or informally". Ms Hayes said that it was "very common to consult retail experts, among other people, for inputs". Ms Rigbye explained that "anyone who's looking at developing a device in any field is going to look at what's already out there". Ms Hayes agreed with this, saying that "whenever you get given a brief or a project, if there are any gaps, then go and fill them. And so you would have [the] skills to go and ask the questions...".
5. Ms Hayes also gave evidence that it was "common practice [to] start consulting with manufacturing experts when you get to the detail design phase. So you might have some crude prototypes already that you've put together yourselves to explore - well, to answer questions, whatever they are. I think it's best practice to engage manufacturing experts earlier, but I think it's actually uncommon, in my experience of the design industry, to engage them at the concept phase. It usually happens at a detail design phase."
6. On that basis and having regard to their respective qualifications and work experience as at the priority date, Ms Hayes, Mr Duff and Ms Rigbye each qualified as members of the notional PSA team. That is so even though neither Ms Hayes nor Ms Rigbye was aware of clitoral pressure wave massage devices before the priority date, and Mr Duff's engineering degree was in electrical engineering rather than mechanical engineering.

1. The kinds of information that form part of the CGK differ from industry to industry and from one technical field to another. The qualifications of the skilled addressee, the setting in which and the resources with which he or she operates, and the practices and techniques that he or she regards as commonplace and known are important considerations in determining the CGK in any case: Aktiebolaget Hässle v Alphapharm Pty Ltd (2002) 212 CLR 411; [2002] HCA 59 at [153] (Kirby J).
2. The fact that a witness, or even a number of witnesses, had particular knowledge at the priority date does not of itself establish that such knowledge was CGK. The witness may be an expert who has specialised expertise and knowledge. At the same time, evidence that an expert, or number of experts, were not aware of certain information may be evidence, depending on the circumstances, that the information was not CGK.
3. Further, material or information cannot be regarded as CGK based upon the personal knowledge of a witness by reason of their individual experiences in the absence of evidence of its general acceptance and assimilation by the bulk of those in the relevant field: see Aktiebolaget at [31]. It follows that, research or other work carried out by witnesses in the course of their employment or matters which became known to them by reason of that employment or individual experiences is not, for that reason alone, knowledge and experience which is available to all in the trade, and nor is it probative of CGK.

1. In the JER 1, Ms Rigbye, Ms Hayes and Mr Duff provided an agreed statement of the CGK at the priority date as including:

(1) understanding of needs of sex toys: hygiene, pleasure, ease to use, ergonomics, safety;

(2) familiarity with common sex toy architecture (rotary motor, battery, housing, soft touch areas);

(3) understanding of technical needs (e.g., how to specify the motors and batteries in drive systems);

(4) general understanding that there are different waterproofing levels and different ways you might achieve each;

(5) understanding of existing market and how to check that your design is unique, for example a patent search;

(6) familiarity with user testing methods.

1. Ms Hayes and Ms Rigbye generally agreed with the descriptions of the state of the CGK in Hayes 3 ([33]-[47]) and [2.2.1] (Basic engineering principles) of Rigbye 1, Annexure LR-1. The latter concerned evidence which was related primarily to pressure fields, and is aligned with LELO's Second Further Amended Particulars of Invalidity (invalidity particulars) at [2(c)(i)]. This evidence included:

(1) obtaining reciprocating straight-line motion from a drive engine rotating shaft using an eccentric or con-rod;

(2) creating a pressure field from a piston system or membrane system. As to this, the relationship between pressure and volume is given by Boyle's law. The piston is often given as a basic example to study change in pressure due to a change in volume. It is widely known that the mechanism of operation of loudspeakers is a membrane system which creates varying changes in air pressure;

(3) a pressure field can be constant or modulating;

(4) a pressure field can be modulating and always positive (pushing);

(5) a pressure field can be modulating and always negative (sucking);

(6) a pressure field can be modulating between positive and negative.

1. The evidence of Ms Hayes was that, based on her reading of the Patent, she understands that the field of the invention is the field of sexual stimulation devices, which she defines as "Field": Hayes 3 [13]. Ms Hayes was instructed that the PSA was a "skilled but not particularly inventive or imaginative worker in the field, with qualifications, experience, and knowledge of practices and techniques regarded as commonplace and known in the field" and that the CGK was "the general body of knowledge and experience which is available to all in the relevant Field at the relevant time".
2. With those instructions in mind, Ms Hayes gave evidence of what she considered to be the CGK of a PSA as at the priority date. I have set this out below with a cross-reference to the invalidity particulars, and noting Ms Rigbye's general agreement to this evidence:

At the Relevant Date, I had a sound understanding of the female sexual anatomy, including the labia majora, labia minora and clitoris, including through the work I performed. In particular, the size and shape of the female sexual anatomy, and the way that stimulation (being direct or indirect) would cause arousal, being the body's response to sexual stimulation. This information is important in the design of sexual stimulation devices and affects the size and dimensions of the device.

At the Relevant Date, sexual stimulation devices were essentially of two types, that is, devices designed to be used to create stimulation through; (i) insertion into bodily orifices (which were typically phallic in nature and described in the industry as "dildos"); or (ii) vibration on the relevant body area, that is, externally (described in the industry as "vibrators"). At the Relevant Date, some products had both of these functions. [[2(c)(ii)a] invalidity particulars]

Insertable products, before the Relevant Date, typically sought to reflect the male anatomy but the product design of products in the sexual stimulation device market was beginning to shift. At the Relevant Date some new, higher end sexual stimulation devices were being created with user centred design in mind, with more playful shapes and colours, greater focus on ergonomics, and a wider market of end user, not being limited to heterosexual men and women. ...

Vibration-type products typically used an electric motor with an off centre weight attached to the driveshaft of the motor to create vibration when the driveshaft spins the attached weight. At the Relevant Date, vibration-type devices were used as external genital massagers. A vibration-type product that I was aware of at the Relevant Date was the Hitachi Magic Wand, which based on my review of industry publications and discussions with industry colleagues before the Relevant Date, I regarded as widely known in the Field, before the Relevant Date. [[2(c)(ii)b], [2(c)(ii)c] and [2(c)(ii)f] invalidity particulars]

At the Relevant Date, there were some sexual stimulation devices that created stimulation through bodily insertion, and through external genital stimulation through vibration. The "rabbit" vibrator was a device that I was aware of at the Relevant Date, which, based on my review of industry publications and discussions with industry colleagues before the Relevant Date, I regarded as known in the Field at the Relevant Date. It comprised both an insertable appendage and a second external appendage for use as a clitoral stimulator, with an electric motor to create vibration in the device. [[2(c)(ii)d] invalidity particulars]

At the Relevant Date, sexual stimulation devices comprised hard plastic ABS was the most common plastic used in this kind of consumer product due to its impact resistance, its stability over time, and its low cost). Only some sexual stimulation devices were covered with silicone, and only on the contact surfaces of the devices. These devices were typically higher end and were more expensive. [[2(c)(ii)h] invalidity particulars]

... At the Relevant Date, I was not aware of sexual stimulation devices that created positive and negative pressure waves for stimulation of erogenous zones (pressure wave stimulation devices). Specifically, at the Relevant Date, I had not seen and had no experience with the Womanizer W100, Womanizer W500, or Satisfyer Pro devices. [[2(c)(ii)e], [2(c)(ii)g] and [2(c)(iii)] invalidity particulars]

For all sexual stimulation devices, it is of paramount importance that the device functions to provide sexual stimulation. The shape, construction and, in the case of powered devices the electronic components, must be optimised to provide stimulation to the intended erogenous zone, such as the clitoris. The development of a sexual stimulation device will involve testing, optimisation, and iteration to obtain a functional final product.

At the Relevant Date, I was aware of product design principles relevant to the design of consumer products, such as sexual stimulation devices. Relevant consumer products typically comprised electromechanical components such as electric motors (including crankshafts and camshafts, used to convert linear motion (up and down or back and forth) to rotational motion, and vice versa), basic electrical circuitry, and the use of printed circuit boards and batteries.

At the Relevant Date, I was aware of general engineering principles relevant to the design and manufacture of consumer products. This included the use of design tools such as CAD and geometrical dimensioning and tolerancing as used in geometric drawings. One application of geometrical dimensioning and tolerancing is to define virtual references called datums. Datums are theoretically exact lines, points, axes, or planes. A datum will often have an associated edge or surface on the part, but the virtual plane itself will extend beyond that edge or surface and is treated as infinite. This is used to define geometry of parts and assemblies.

At the Relevant Date, I was aware of general fluid dynamic principles. That is, what a wave is, and how waves behave in air or liquid fluids.

At the Relevant Date, I was aware of speakers and had a high-level understanding of how they functioned. Speakers were, and are today, typically comprised of a fixed, permanent magnet, a voice coil connected to a power source, a speaker cone, and a flexible material which connects the speaker cone to the assembly. Speakers generate sound waves (which are pressure or compression waves in air) through the movement of the speaker cone backwards and forwards.

At the Relevant Date, and today, I was not aware of any sexual stimulation devices that utilised speaker technology. That is, I was not aware of any sexual stimulation devices that had a mechanism to generate compression waves comprising a magnet, voice coil connected to a power source, and a speaker cone.

As I noted [above], in the Field at the Relevant Date, user-centred design had started to become a more central consideration when designing a sexual stimulation device. User-centred design required that the product be suitable for use on genital areas. This would have required that the shape of the product would be easy to use for consumers and would simply fit into the hand and other bodily areas. Sexual stimulation devices are used on sensitive areas of the body, and body safe silicone was known to be a useful material for the external body contact surfaces of sexual stimulation devices. As gels or lubricants could be used with sexual stimulation devices, the materials comprising these products should be resistant to, or not be damaged by use with, gels or lubricants.

1. While Ms Hayes and Ms Rigbye were familiar with commercially available clitoral stimulation devices, they stated in their respective affidavit evidence that they were not aware of any clitoral stimulation device which used positive and negative airwave pressure to stimulate the clitoris: Hayes 3 [35]-[40], [50], [58]; Rigbye 1, Annexure LR-1 at [2.2.2.7]. They also stated in the JER 2 that, "[o]ur understanding of CGK at the time did not include knowledge of pressure wave massagers". However, that Ms Hayes and Ms Rigbye were not personally aware of such devices is not definitive, as they were each relatively new entrants to the industry and had limited experience as at the priority date.
2. Nor did the evidence of Ms Hayes and Ms Rigbye support a finding that "suction type stimulation devices that use suction to stimulate the clitoris" were CGK as alleged by LELO: [2(c)(ii)e] invalidity particulars.
3. Mr Duff added some comments in the JER 1 about matters which he considered formed part of the CGK. However, in relation to many of the matters identified by him in the JER 1, Mr Duff described them as matters that would "need to be known", which indicates that he did not have a proper understanding of the meaning of CGK. Further, in Duff 1 and Duff 9, Mr Duff refers to information of which he became aware in his role at Armocon. However, because of his employment with Armocon and his interactions with LELO, his peculiar or specialised knowledge exceeds that of the notional PSA in relation to the design and manufacture of clitoral devices for sexual stimulation.
4. None of the experts in the JER 1 (including Mr Duff) identified compression wave massager devices as forming part of the CGK at the priority date.
5. However, LELO relies upon the position taken by EIS in opposition proceedings to an application filed by Novoluto GmbH, being EIS GMBH v Novoluto GMBH (2021) 162 IPR 342; [2021] APO 1, as constituting an admission that compression wave massage devices for clitoral stimulation were CGK as at the priority date.
6. In that case, EIS contended, through the evidence of Mr Florian Witt, that "sexual stimulation devices which use alternating positive and negative pressure to stimulate erogenous zones (pressure wave massagers) were [CGK] in the art at the priority date [being 13 March 2015 in that case]": see [77]. Mr Witt "refers to the Womanizer W100 and its availability before the priority date to support his contention". Mr Witt also stated that "a Womanizer W100 device was sent to him for analysis before March 2015": see [95].
7. The delegate did not accept that such devices were CGK having regard to the evidence, including the evidence of the expert called by Novoluto GmbH: see [79]. However, I am not, of course, bound by such a finding, and EIS did not submit that I was.
8. The real question is whether, by the position taken by it in the opposition proceedings, EIS has admitted that compression wave massage devices for clitoral stimulation were CGK as at the priority date in this case (being a date which post-dates the date in those proceedings).
9. No evidence was adduced by EIS to explain the circumstances around the position taken by it in those opposition proceedings, and it is notable that Mr Witt is the named inventor on the Patent. That is, it is not the case that EIS called an independent witness who was not associated with it - rather, it called its own man, as it were. This was no doubt done for the purpose of defending the Patent, and its case on CGK was a central contention advanced by EIS in that proceeding for the purposes of obviousness: see e.g., [81].
10. Nor did EIS contend that the reasons given by the delegate as reported were inaccurate or incorrect.
11. To be an admission under the Evidence Act 1995 (Cth), there must be a previous representation that is made by a person who is or becomes a party to a proceeding and is adverse to the person's interest in the outcome of the proceeding. "Previous representation" (also a defined term) means a representation made otherwise than in the course of giving evidence in the proceeding in which evidence of the representation is sought to be adduced. "Representation" (also a defined term) includes an express or implied representation (whether oral or in writing) and a representation to be inferred from conduct.
12. In this case and by its conduct in the opposition proceedings (including the case which it advanced to the delegate and the evidence which it adduced through Mr Witt), EIS admitted that compression wave massage devices for clitoral stimulation were CGK as at the priority date of the Patent including, in particular, the Womanizer W100. Such an admission is admissible evidence as exceptions to both the hearsay and opinion rules: see s 81 of the Evidence Act.
13. The position taken by EIS in the opposition proceedings accords with the evidence of Mr Sheldon-Collins who gave evidence about the promotion, distribution and sale of the Womanizer products in Australia and New Zealand from February 2015. This timing is consistent with the reported evidence of Mr Witt in the opposition proceedings that "a Womanizer W100 device was sent to him for analysis before March 2015".
14. By Sheldon-Collins 1, Mr Sheldon-Collins said that "[t]he Womanizer was a gamechanger because it was the first of its kind using pulsed air waves in the adult products market". He also called it an "instant best seller" and said during the hearing that there was a "90-second club coming out of the States through social media, and that women will climax in under 90 seconds. So that's how impressive the product was". He also gave evidence during the trial to the effect that the Womanizer achieved a significant number of sales in 2015 and early 2016 for a product that was being launched and which was brand new. His evidence was to the effect that the promotion by Calvista of the Womanizer prior to the priority date included press releases, electronic direct mail marketing, flyers, magazine advertising, advertising on websites, social media, catalogues, posters and banners.
15. Mr Sheldon-Collins stated that, as at 4 April 2016 and as a result of the matters set out in his affidavit, he believed that all those working in the industry knew about the Womanizer. I accept this evidence. Having regard to his evidence as a whole, I do not accept the submission by EIS that the Womanizer had a "fledgling reputation amongst retailers". Notably, even if Mr Sheldon-Collins would not have been a member of the PSA team, someone like him would have been consulted by the notional PSA team to ascertain the current state of the art in sex toy design, and the existence of the Womanizer would have been disclosed to the team, if they were not already aware of it.
16. Another person who could have been consulted by the PSA team is a retailer like Ms Temminghoff, who has sold sex toys since 1998. She said that her knowledge "is at the coalface of the sex toy industry" and that, in her view, it was commonly known in Australia in the sex toy industry before 4 April 2016 that sex toys using air pressure waves to stimulate the clitoris were introduced in "about 2014" and the main product was the Womanizer W100. Ms Temminghoff recalls being shown the first Womanizer in 2015 and did not believe it would work; but said that she tried the product and was proved wrong. Included in her evidence is an invoice dated 18 January 2016 showing the purchase by her business of three Womanizer products.
17. Similarly, Mr Schoonenberg could have been consulted by the PSA team. His evidence was that Playhouse was the first importer, retailer and distributor of the Womanizer in Australia, and that it had commenced selling the Womanizer in Australia in January 2015. He said that the Womanizer was "widely publicised" and had "mainstream promotion in Australia"; and that there were also online reviews and online discussion about the Womanizer. Mr Schoonenberg sold the Womanizer through Playhouse and also online, and he saw that the Womanizer won awards internationally in 2015 and January 2016 (which information he saw on the internet at the time).
18. EIS seeks to downplay the evidence of these lay witnesses by, first, pointing to what it says are the low numbers of sales of the Womanizer products before the priority date (which I do not accept having regard to the evidence of Mr Sheldon-Collins referred to above) and, secondly, submitting that public availability for sale, and knowledge by retailers, does not establish that the Womanizer was CGK - that is, it does not establish that there was general acceptance and assimilation by the PSA. While I accept the latter submission, I observe that, even if the Womanizer was not CGK, people like distributors and retailers would have been consulted by the notional PSA team and so (at the least) the Womanizer devices (and the existence of air pressure based clitoral stimulators) would have become known to the notional PSA team asked to design a new sexual stimulation device for women. In any event, the submissions by EIS do not overcome its admission in the opposition proceedings including in relation to the Womanizer W100.
19. For these reasons, the following was CGK at the priority date of the Patent in the art of sexual stimulation devices:

(1) sexual stimulation devices which use alternating positive and negative pressure to stimulate erogenous zones (pressure wave massagers);

(2) the Womanizer W100.

1. The evidence was insufficient to establish that the Womanizer W500 was CGK as at the priority date, especially as this version of the Womanizer device was not the subject of admission by EIS in the opposition proceedings. However, the evidence did establish that sales of the Womanizer W500 occurred in Australia, and so was publicly available, before the priority date: see e.g., Temminghoff 1 [24], Sheldon-Collins 1 [13].
2. Nor did the evidence establish that the Satisfyer Pro was CGK as at the priority date. However, the evidence did establish that it was being sold in Australia in early 2016, and so was publicly available before the priority date.

7.1 "compression wave massage device when used on the clitoris"

1. The first construction debate relates to the meaning of "compression wave massage device when used on the clitoris" in integer 1.1.
2. Claim 1 was amended on 22 December 2017 in order to overcome the Patent Examiner's objections of lack of novelty and lack of inventive step over the prior art:

A compression wave massage device for when used on body parts, particularly erogenous zones such as the clitoris, comprising...

1. The form of claim 1 prior to its amendment may be taken into account when construing the current wording of claim 1: see s 116 of the Patents Act.
2. LELO submits that the amendment changed the claim from a "for" claim, indicating suitability for a particular use, to a "when used" claim, which it says limits the scope of the claim to the device "when used on the clitoris".
3. The words used in claim 1 are ordinary English words. Further, by the JER 1, the experts agreed that the phrase is a description of the device, and its function in situ.
4. EIS accepts the construction of the experts and accepts that the phrase "compression wave massage device when used on the clitoris" describes the function of the device. EIS also submits that it is a "compression wave massage device when it's used on the clitoris" but it submits that, as a matter of construction, the features which are described in the subsequent integers of claim 1 are not referable to its use on the clitoris.
5. However, in my view, on the proper construction of "compression wave massage device when used on the clitoris" in integer 1.1, the device is (that is, it functions as) a compression wave massage device when used on the clitoris and which has certain identified features when it is used on the clitoris. It follows that the words "when used on the clitoris" in integer 1.1 limits the scope of claim 1 to a device "when used on the clitoris" comprising the features identified in integers 1.2 to 1.6. Thus, the words "when used on the clitoris" govern all of the features of the device that follow those words, such that each of those features must be present when the device is used on the clitoris when it is performing its function as a compression wave massage device.
6. This conclusion is supported by the reference in integer 1.3 to the first end being provided with an opening for placement over the clitoris, and the reference in integer 1.4 to the generation of a "stimulating pressure field". It is difficult to conceive of how such a pressure field can be generated, and how it could be adjudged to be stimulating, other than when using the device on the clitoris.
7. To understand how to generate a "stimulating pressure field", one has particular regard to the interplay between integers 1.4 and 1.6. Integer 1.4 refers to (inter alia) the generation of a change of volume between a minimal volume and a maximal volume such that in at least one opening a stimulating pressure field is generated. Integer 1.6 refers to what the parties and experts called the volume change ratio or VCR. That is, integer 1.6 requires that "the ratio of the volume change to the minimal volume is not below 1/10 and not greater than 1".
8. The experts agreed in the JER 1 that the VCR is the ratio of minimal volume to volume change, where:

(1) the minimal volume is the smallest volume of the cavity allowed by the device, when the drive device is in its forward-most position;

(2) the maximal volume is the largest volume allowed by the device, when the drive device is in its backward-most position;

(3) the volume change is the difference between minimal volume and maximal volume.

1. The specification also contains statements which describe VCR as being a measure of the strength of the stimulating pressure field when used on the clitoris.
2. In the Patent at page 2 lines 10-12, which forms part of the Summary, it is stated that:

...according to the invention the ratio of the minimal volume to the volume change shall not exceed 10, particularly not exceed 8, since it was found that otherwise the suction effect becomes too low...

1. In context, the reference to the "suction effect" becoming "too low" means that the pressure field is no longer "stimulating", which can only be a reference to the pressure generated by the device when used on the clitoris.
2. In the Patent at page 2 lines 19-23, which forms part of the Summary, it is also stated that:

Preferably the ratio of minimal volume to volume change should not be below 1, and preferably not below 2, since according to the invention it was found that otherwise the required power of the drive device becomes excessive and on the other hand the vacuum at the opening becomes too strong and perhaps even painful.

1. The reference to the vacuum becoming "too strong" and "perhaps even painful" as a consequence of the VCR can only be a reference to the pressure generated by the device when used on the clitoris.
2. EIS advances a number of specific arguments against a construction that the features of claim 1 must be present when the device is used on the clitoris. These arguments tend to focus upon the practical inability to measure the VCR when the device is being used on the clitoris. However, the fact that the PSA could face difficulty in measuring the VCR when the device is being used on the clitoris (if that is the case) does not alter the language chosen by the patentee to formulate its claim. The phrase "when used" was chosen by the patentee, with such words indicating that the device has certain identified features when it is being used (such as, that the VCR falls within a particular range as identified in integer 1.6).
3. To read the claim in the way that EIS posits has the consequence that the device when used on the clitoris does not have the features contained in integers 1.2 to 1.6, but that it has those features as a standalone device. However, such a construction would rewrite the claim and replace the words "when used" with words such as "able to be used on the clitoris", or "for use on the clitoris". However, the latter style of wording was removed by the amendment and changed to "when used".
4. The words "when used" mean something different to "for use" and have a narrowing effect on the scope of the claim. That a particular feature stated in integer 1.6 might be unable to be discerned when the device is being used as claimed does not have the result that the claim should be recast. Rather, the claim is for a device which, when used on the clitoris, functions as a compression wave massager device with the features identified in integers 1.2 to 1.6. That is the claimed invention.
5. Ms Rigbye agreed with this construction: see e.g., Rigbye 1, Annexure LR-1 at [4.1.1.1].
6. I turn then to the particular arguments advanced by EIS.
7. First, EIS submits that there are no express words or requirements in the claims that the VCR of the cavity be measured when the clitoris is inside the cavity. It submits that the particular requirements for determining VCR in the claims - namely integers 1.4 to 1.6 - do not contain any requirement that the VCR of the cavity must be between 1 and 1/10 when the clitoris is inside the cavity.
8. However, this submission ignores the ordinary meaning of the words used in integer 1.1, which words serve as the chapeaux to the list of features which follow that integer. That is, the words refer to a device which acts as a compression wave massage device when used on the clitoris comprising the subsequent integers. The word comprising, according to page 8 of the Patent, implies the inclusion of the stated integers. Those integers form part of the device when used as described in integer 1.1.
9. Secondly, EIS submits that "the specification makes it clear that the VCR of the cavity, from its maximum to minimum positions, is measured using a virtual planar surface, and not in the manner for which the respondents contend".
10. However, that the specification explains the manner of measuring the volume of the cavity by reference to something other than the clitoris does not have the consequence that the plain language of the words used in claim 1 should be modified. To do so would be to "expand the boundaries of monopoly as fixed by the words of [the] claim by adding to those words glosses drawn from other parts of the specification", which is not legitimate: Welch Perrin & Co Pty Ltd v Worrel [1961] HCA 91; (1961) 106 CLR 588 at 610 (Dixon CJ, Kitto and Windeyer JJ). As also observed in Welch Perrin, "if a claim be clear it is not to be made obscure simply because obscurities can be found in particular sentences in other parts of the document".
11. As Nicholas J observed in Caffitaly System SpA v One Collective Group Pty Ltd (2020) 154 IPR 1; [2020] FCA 803 at [29]-[30]:

Plain language must be given its plain meaning, and clear words in a claim must not be given an unnatural meaning by imposing glosses drawn from the body of the specification. However, the context in which the relevant language is used is of crucial significance to the ascertainment of its meaning. When construing a patent specification the Court seeks to give the document a purposive construction by reading the document as it would be understood by a person skilled in the art and without engaging in overly meticulous verbal analysis...

There is a danger that in seeking to give a claim a purposive construction, or in seeking to read it in context, an impermissible gloss might be imposed upon the language used based on material found in the body of the specification: ... Purposive construction does not justify departing from clear and unambiguous language used in the claim.

(Citations omitted.)

...the construction advanced by the respondents involves measurement by reference to an object which varies (i.e. "the clitoris"). The relative size of a clitoris can vary between person to person. The construction advanced by EIS, by contrast, involves construing the claims in a "practical commonsense manner" whereby the VCR is measured, consistent with the teachings in the specification, by reference to a "virtual planar surface" which "virtually closes" the opening of the cavity, and not by reference to an arbitrary and indeterminate object within the cavity.

1. This submission assumes that claim 1 is ambiguous, such that it bears two possible meanings and that the meaning proffered by EIS is to be preferred because it is the practical and commonsense one. This submission is consistent with the expert evidence of Ms Hayes.
2. In particular, in the JER 1, Ms Hayes stated that:

"A compression wave massage device when used on the clitoris" describes the function and intended application of the product, and does not describe the conditions in which the min/max volumes should be specified. The patent defines the minimal and maximal volumes (used to calculate the VCR) using a virtual plane at the opening. In my view it is obvious that the inventors would have optimised the design for use, and then looked for a way to describe the invention in simple, measurable, reproducible ways. I believe this abstraction - a virtual plane rather than a clitoris - is appropriate...

1. However, this evidence does not address the construction of the claim through the eyes of the PSA as at the priority date. Rather, Ms Hayes appears to be making assumptions about what the inventors intended which she considers to be "obvious" and then refers to the words used in the specification (being the virtual plane) rather than the claim (being the clitoris) as being the appropriate way to describe the invention in "simple, measurable, reproducible ways".
2. However, the plain words used in claim one, being words chosen by the patentee, refer to a device which functions as a compression wave massager device when used on the clitoris comprising certain identified features when it is so used.
3. For these reasons, the construction advanced by LELO is the correct one.

7.2 "wherein the cavity is formed by a single chamber"

1. The word cavity is used in integers 1.2, 1.4 and 1.5. It is not a term of art. The term "single chamber" appears in integer 1.5, and is also not a term of art.
2. According to the Oxford English Dictionary (online), "cavity" means "a hollow place; a void or empty space within a solid body".
3. This definition fits the concept of cavity in integer 1.2, being a device comprising (or including) at least one cavity.
4. As to the cavity being "formed by a single chamber", the word "chamber" is defined as "an enclosed space or cavity" by the Oxford English Dictionary (online) (emphasis added). It is also defined as a "room or suite of rooms in a house", but this definition is not apposite in the context of the claim which is referring to a cavity in a device.
5. The reference to "enclosed" in the dictionary definition encompasses the surrounding structure or walls of the negative space of the cavity and the cavity itself. For this reason, I agree with Ms Rigbye's evidence in the JER 1 that chamber means "union of the negative space of the cavity and the structure/walls which delineate this space". The reference to a single chamber is, as Ms Rigbye and Ms Hayes agreed, where there are no separate delineated areas in the cavity.
6. LELO pressed a construction of "single chamber" as being an open space that has no narrowing or constriction, thus allowing unobstructed air flow. In doing so, it places reliance on statements in the specification concerning the stated advantages of the invention of improved hygiene and the generation of "a homogenous, unhindered and thus effective airflow" on page 2 line 39. However, the latter statement is part of a sentence which relates to a preferment, rather than the invention, as follows:

Additionally, for generating a homogenous, unhindered and thus effective airflow it is advantageous when preferably the side wall of the camber [sic], limiting the cavity and connecting its two ends to each other, is free from discontinuous sections.

1. LELO also refers to the citation of German patent no. DE 10 2013 110 501 (Novoluto) in the Background section, being a "known device" in which "the cavity is formed by a first chamber and a second chamber" which are "connected to each other via a narrow connection channel". It cites Ms Hayes' evidence in the JER 1 (out of context, as it relates to integer 4.3) that "[t]he patent is distinguishing itself from prior art, by specifying that there will be no narrow channels for accelerated air flow".
2. However, the Background makes plain that "strict requirements of hygiene" are not met by Novoluto since the connection channel prevents "any cleaning of the first chamber". When the invention is distinguished from Novoluto, no mention is made of airflow.
3. This can also be seen on page 2 at lines 5-8 of the Patent, which states:

Accordingly, the invention is characterized in a single-chamber solution, which shows the advantages of a simpler construction, improved hygiene, particularly due to the ability of easier rinsing of the cavity according to the invention, formed by only a single chamber, and the easy handling with lubricant and water.

1. The Patent does not identify that an objective of the invention is to provide improved airflow.
2. That the preferred embodiment depicted in Figure 4 includes a cavity with walls that are relatively straight but flare open slightly does not mean that the reference to "single chamber" in claim 1 should be read down to only include a cavity which has no narrowing or constriction.
3. For these reasons, not only is LELO's construction impermissible because it seeks to add a gloss to the clear words of the claim by reference to other parts of the specification, but the arguments advanced by it are not supported by the specification in any event.
4. To the extent that LELO otherwise advanced an argument that the reference to a "single chamber" lacked definition and was not clear, this is rejected for the same reasons.

1. LELO contends that claim 1, and therefore all of the claims of the Patent, do not satisfy s 40(3) and/or s 40(2)(b) of the Patents Act because the "VCR feature" is not clear and is not defined. Integer 1.6 and integer 22.2 refer to the VCR, and I will call them the VCR integers for convenience.
2. All of the claims of the Patent depend on claim 1, either directly or indirectly. It was common ground by the time of closing submissions that claim 1 is a claim limited by result (with the result being a device which generates a change of volume of at least one cavity with the claimed VCR). I agree.
3. LELO also contends that claims 2, 3 and 6 do not satisfy s 40(3) and/or s 40(2)(b) of the Patents Act because the references to "continuous" in claims 2 and 3, and "free from discontinuations" in claim 6, is not clear and is not defined.
4. Finally, LELO contends that claims 4 and 9 do not satisfy s 40(3) and/or s 40(2)(b) of the Patents Act because the reference to width of the cavity in claim 9, and the reference to length of the cavity in claims 4 and 9, is not clear and is not defined.

1. As to s 40(3) of the Patents Act, the requirement that claims be clear exists because "readers should be able to ascertain the precise extent of monopoly claimed": Nesbit Evans Group Australia Pty Ltd v Impro Ltd [1997] FCA 1092; (1997) 39 IPR 56 at 94 (Lindgren J, with whom Hill J agreed). Thus, the requirement for clarity is not satisfied where the person skilled in the art cannot objectively ascertain whether what he proposes to do falls within the claim's ambit: BlueScope Steel Ltd v Dongkuk Steel Mill Co, Ltd (No 2) (2019) 152 IPR 195; [2019] FCA 2117 at [705] and [710] (Beach J).
2. In Austal Ships Sales Pty Ltd v Stena Rederi Aktiebolag (2008) 77 IPR 229; [2008] FCAFC 121 at [13]-[14] (Heerey, Finn and Dowsett JJ), the Full Court cited the decision of Hely J in Flexible Steel Lacing Company v Beltreco Ltd (2000) 49 IPR 331; [2000] FCA 890 with approval. In the latter decision at [80], Hely J quoted Mr Blanco White QC in Patents for Inventions and the Protection of Industrial Designs (5th ed, The Law Book Company, 1983) at 4-701 (which appears at [14] of Austal Ships):

Thus a claim is bad if no reasonably certain construction can be given to it, or it is fairly and equally open to diverse meanings. But the rule goes further than this. A court is not bound to find a meaning for a claim, nor to approach a claim with the "conviction that its language is capable of a reasonable construction when carefully examined" that is the due of an Act of Parliament. Thus a claim may be bad for uncertainty although the court could find its true meaning (and would do so if the words concerned appeared in a commercial contract) if it is so obscure that "its proper construction must always remain a matter of doubt". On the other hand, what matters is not the grammar of the claim, but whether a reader would be left in doubt whether any given apparatus or method fell within the claim or not; the purpose of the rule is to enable the public to rely upon the words of the claim as defining the rights of the patentee. Accordingly, a mere grammatical ambiguity, not affecting the scope of the monopoly, will not invalidate...

(Emphasis added.)

1. To similar effect, Besanko J stated in Vehicle Monitoring Systems Pty Limited v SARB Management Group Pty Ltd trading as Database Consultants Australia (No 8) [2023] FCA 182 at [666] that "lack of clarity is concerned with the certainty surrounding the scope of the monopoly claimed" and "a claim will not fail for lack of clarity if it identifies a workable standard suitable to the intended use".
2. Section 40(2)(b) requires that, for a standard patent, a complete specification must "end with a claim or claims defining the invention". Claims must "mark out the monopoly operating to disclaim what is not specifically and definitely claimed... to ensure that the public and specifically a manufacturer will not have difficulty being satisfied that a claim is not infringed": see Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2005) 66 IPR 84; [2005] FCA 1078 at [29] (Crennan J).
3. In BlueScope at [715], Beach J cited General Tire & Rubber Company v Firestone Tyre and Rubber Company Ltd (1971) 1A IPR 121 and stated:

...[In that case, the] Court also observed that allowances should be made for any difficulties of the case, so that an alleged issue of want of definition should always be considered in relation to the particular facts. It concluded (at IPR 167- 8; RPC 513-4):

It is clear in our judgment that the question whether the patentee has sufficiently defined the scope of his claims is to be considered in relation to the facts of each case, that allowance is to be made for any difficulties to which the circumstances give rise, and that all that is required of the patentee is to give as clear a definition as the subject matter admits of. It is also clear in our judgment that, while the court is to have regard to all the relevant facts, the issue of definition is to be considered as a practical matter and little weight is to be given to puzzles set out at the edge of the claim which would not as a practical matter cause difficulty to a manufacturer wishing to satisfy himself that he is not infringing the patent. We accept also that definition of the scope of a claim is not necessarily insufficient because cases may arise in which it is difficult to decide whether there has been infringement or not provided the question can be formulated which the court has to answer in the issue of infringement.

1. In Albany Molecular Research Inc v Alphapharm Pty Ltd (2011) 90 IPR 457; [2011] FCA 120 at [174], Jessup J observed that "[a] claim which is a model of verbal or grammatical clarity may none the less fail the test of this requirement if it leaves the definition of the boundaries of the invention uncertain or variable". To similar effect, Beach J stated in Meat & Livestock Australia Ltd v Cargill, Inc (2018) 129 IPR 278; [2018] FCA 51 at [940]: "[a] claim will be bad if it fails to define the monopoly claimed so that the skilled addressee of the patent can know the exact boundaries of the area within which they will be trespassers".
2. Particular issues arise in the case of claims which are limited by result.
3. In Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 25 IPR 119 at 125-126, Gummow J quoted Patents for Inventions and the Protection of Industrial Designs (op. cit.) at 4-413:

To amount to a limitation by result, what is in the claim must at least be a limitation: something that draws a line between two classes of things that would otherwise fall within the claim: with the implication that conditions of the manufacture can be adjusted, by the reader of the specification, to secure the specified result. It is, of course, a matter of construction to determine whether words in the claim effect a limitation or merely assert that complying with the claim will secure a certain result...

See also BlueScope at [718]; Axent Holdings at [262]-[263]), which was cited with approval in Vald Pty Ltd v KangaTech Pty Ltd (No 5) [2024] FCA 333 at [148] (Downes J).

1. In Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth (2011) 119 IPR 194; [2011] FCAFC 132, Yates J (with whom Nicholas J agreed) referred at [259] to a contention that a claim lacks clarity as a "criticism that can be made of many claims limited by result" but that such claims "do not fail for lack of clarity simply because further steps must be taken by the person skilled in the art, in the nature of trial and error or routine testing not involving invention, in order to understand when the result will be achieved...The necessity for, or extent of, the work required in that regard may point to the possibility of insufficient description...".
2. In BlueScope at [719], Beach J quoted Patents for Inventions and the Protection of Industrial Designs (op. cit.) at 4-703:

...particular care must be taken when claims [limited by result] are adopted to give in the specification all possible assistance in determining what does, and what does not, give the useful result concerned: clarity of claim and sufficiency of description go together here. Thus a claim limited by result has been held bad for ambiguity where the instructions for attaining the result were meaningless to those in the art. In addition, it must not be forgotten that there is no authority for putting upon the reader of the specification the burden of making any but "simple" experiments...

1. Further, in GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Ltd v Apotex Pty Ltd (2016) 119 IPR 1; [2016] FCA 608, referring at [700] to Interlego AG v Toltoys Pty Ltd [1973] HCA 1; (1973) 130 CLR 461 at 480, Beach J said in relation to claims which were "akin to a limitation by result claim" (emphasis original):

... [i]n such a case, it is said that the specification must not only enable the addressee to carry out the invention claimed in the form of any particular embodiment but also enable the addressee of the Patent to ascertain whether the particular result concerned is or is not secured by forms of the invention lying near the boundaries of the claim. It is said that such a limitation is permissible only if it is sufficient to characterise the construction of the article claimed...

1. Claim 1 claims a compression wave massage device which, amongst other things, has at least one opening in which a stimulating pressure field is generated (integer 1.4).
2. In Annexure LR-1 of Rigbye 1, the evidence of Ms Rigbye concerning the VCR was as follows:

It is specified that the drive device creates a "stimulating pressure field" by means of varying the volume of a cavity, and then specifies that the ratio of the volume change to the minimum volume must fall between 1/10 and 1, but the purpose or effect of this specification on the use of the device is not clear outside of arbitrarily constraining the relative dimensions of the device.

The ratio of volume change to minimum volume appears to be an attempt at specification of the range of pressures achievable with such a device, as suggested by paragraph 5, page 2 of the patent:

"Preferably the ratio of minimal volume to volume change should not be below 1, and preferably not below 2, since according to the invention it was found that otherwise the required power of the drive device becomes excessive and on the other hand the vacuum at the opening becomes too strong and perhaps even painful".

...

Here they have chosen to describe this ratio as the reciprocal of the ratio specified in the claim:

Therefore, paragraph 5, page 2 is specifying an upper limit for this ratio, stating that otherwise "the vacuum at the opening becomes too strong and perhaps even painful" (p2, paragraph 4) which is intended to specify an upper limit to the vacuum pressure achievable with the device.

Similarly, paragraph 2, page 2 specifies a lower limit for the ratio, stating that "otherwise the suction effect becomes too low".

There is nothing in the specification which explains how these limits were arrived at. For example, no data are given for tests on users, or the definition of what is considered to be "stimulating" - for example whether this is purely subjective, or whether it refers to some kind of physiological effect.

1. None of the evidence above was contradicted by Ms Hayes, and it accords with the content of the Patent.
2. Ms Rigbye then opined that, if the intention is to specify pressure limits, it would have been much more straightforward to specify these in terms of actual pressures - in units such as atmospheres, pascals, mmHG, inHG, or Torr. Ms Rigbye reiterated during the concurrent evidence session that using the VCR is "an odd and imprecise way to specify pressures".
3. This criticism of the approach taken by the patentee has force, especially as the concept of VCR was not known by the PSA at the priority date and there was no standard or known method of measurement of, or testing for, VCR. That pressure might be more difficult to measure than volume change, as Ms Hayes states, is not to the point.
4. Further, by Rigbye 1, it appears that Ms Rigbye also considered VCR to be an invalid means for specifying pressure limits in this context.
5. In this context, Ms Rigbye explained that the relationship between volume change and pressure is given by Boyle's law. That relationship is shown as follows:

1. Ms Rigbye explained that, assuming that the starting volume (v1) is the minimum volume and on the assumption that the starting pressure (p1) is atmospheric pressure (which is a reasonable assumption, especially as the Patent did not state otherwise), and taking v2 to be the maximum volume, obtained by adding the volume change to the minimum volume (which is logical), it would be possible to calculate the value of p2 (representing the maximum vacuum pressure achievable with the device) as:

1. This equation is correct as a matter of mathematics, and it was also not challenged by Ms Hayes. I accept this evidence.
2. Ms Rigbye then explained that:

However, there is no specification that the device will always start in the configuration where the membrane is in the position that creates the minimum volume in the cavity - there is no specification that v1 is equal to the minimum volume.

If the device started with the membrane in the position with the greatest distance from the opening (definition of the maximum volume, according to paragraph 6, page 2), at the time the device was placed over the clitoris, then the motion of the drive device could only move the membrane towards the opening, reducing the volume of the cavity. This means that the air inside the cavity would be compressed, resulting in a higher pressure than atmospheric pressure. In this scenario, the lower limit of pressure would be atmospheric pressure, and the upper limit would be greater than this, therefore no vacuum pressure would be produced.

Similarly, if the membrane was in a position in between the positions of minimum and maximum volumes, the maximum vacuum pressure achievable with the device would be less than if the device was placed while the membrane was in the minimum volume configuration.

Therefore, a volume change ratio is not a definitive indication of the range of pressures, given that the resulting pressure variation in use is determined by both the volume change ratio and the position of the membrane when the device is placed over the clitoris and the airtight seal is created...

1. In summary, then, Ms Rigbye's evidence was that the pressure generated by the device is impacted by the starting position of the membrane and the VCR. As such, VCR alone will not provide a definitive indication of the range of pressures.
2. In her responsive affidavit, Ms Hayes stated at [27] of Hayes 3:

In my view, identifying the VCR as a method of quantifying the amount of stimulating pressure produced by a device is a useful and innovative approach. In my experience, measuring pressure directly is more difficult than measuring the volume of the cavity. One can measure volume change relatively accurately with basic equipment such as that found in the average kitchen. Directly measuring pressure change would require more sophisticated equipment and would be more difficult to implement. It would require a pressure gauge; a means to connect it to the chamber in question; and a means of sealing that chamber and pressure gauge system to isolate it from the surrounding environment, which must occur without affecting the minimum and maximum volumes of the chamber. That is, none of the internal surfaces should be affected and all of these parts should form the perfect virtual plane at the open end of the device. It is much simpler and more reliable to measure the volume change and volume change is a direct indicator of a change in pressure: as a matter of physics, increased volume change in the cavity would correlate with a greater amplitude of generated pressure wave because a greater volume is displaced. Accordingly, in my view, the VCR is a convenient measure of the strength of the stimulating pressure field of the device.

(Emphasis added.)

The inventor ultimately cares about the stimulating pressure field but is looking for a tangible way to describe the invention. The stimulating pressure field is created by changing the volume of the cavity.

There is a direct relationship between the change in volume (Volume Change Ratio or VCR) and the stimulating pressure field. The VCR is a clear, repeatable way to constrain the design to achieve the stimulating field desired.

...

Rigbye also points out that during use it's difficult to control for the starting position of the membrane, which would affect the experienced pressure field. The inventors are aware of how the membrane start position effects the pressure field and in my view the VCR accommodates that variability. This is demonstrated in the Patent, page 3 lines 35 - 43 where they describe circumstances in which the reference pressure could be something other than 1atm.

The VCR gives enough information for a PSA to create the invention disclosed and does not depend on uncontrollable variables. As such I believe the VCR is appropriate.

1. However, notwithstanding that Ms Hayes appeared to disagree with Ms Rigbye concerning whether VCR alone provided sufficient information to the PSA to be able to measure the change in pressure in the cavity, Ms Rigbye explained during the trial (and Ms Hayes agreed) that the "starting position" of the membrane will affect the pressure generated. Ms Hayes also accepted that the Patent does not state what the starting position is (which is the case). Thus, the disclosure in the Patent does not provide adequate information to the PSA to measure the pressure in the cavity of the device.
2. By Rigbye 2, Ms Rigbye emphasised that the VCR alone is ambiguous and does not directly dictate the operating pressure. She further explained that, unless the system is modelled as a constant mass system, where no air is added to or removed from the volume in use, the VCR has no bearing on the pressure created and is simply a matter of the arbitrary dimensions of the device. She said that if air is moving into or out of the cavity, any measure of the change of volume will not allow the calculation of a change of pressure.
3. As to this, Ms Hayes appeared to agree with Ms Rigbye when she stated in Hayes 3 [24] that, "for the device to generate the stimulating pressure field, it must be being used on the body part such that the cavity is essentially closed to prevent air (or another fluid) entering or escaping the cavity". This was repeated at Hayes 3 [329(b)] when Ms Hayes stated that, "when the device is used on the clitoris, contact with the body essentially closes the cavity". During the concurrent evidence session, Ms Hayes gave evidence as to measuring the pressure in the chamber by reference to the volume "assuming [the device is] sealed against the body".
4. However, Ms Hayes also gave this evidence in Hayes 3:

... When a device is in operation in the real world, a perfect airtight seal is not possible and air is likely to escape during periods of overpressure. This is particularly the case for this device as it is being applied to an irregular surface, that is, the clitoris. In addition, the device could be moving over that surface. In these circumstances, the seal is essentially airtight, but would permit a limited exchange of air between the cavity and the outer environment. In my view, during use an equilibrium pressure field will be generated by the device, depending on the pressure pattern generated by the device, which will create vacuum, and overpressure stages...

1. So, according to Ms Hayes, while the device is essentially closed to prevent air entering or escaping the cavity (see e.g., Hayes 3 [24]), there is still a limited exchange of air between the cavity and the outside environment when the device is used on the clitoris. However, if, as the Patent teaches, the VCR is measured using a virtual planar surface but without replicating the limited exchange of air when the device is used on the clitoris (about which there is no mention in the Patent), such a method of measurement will be meaningless to the PSA who is trying to ascertain whether a device has the claimed VCR when used on the clitoris. That is because, as the cavity is not airtight when used on the clitoris, a change in volume in the cavity alone is not a sufficient proxy to enable the measurement of the pressure in the cavity, when that pressure in use will be affected by the entry or exit of at least some of the air molecules in the cavity.
2. The invention claimed in the Patent is not a device which blows air onto the clitoris at different speeds; that is, it does not work as a fan, for example. Rather, it is a compression wave massager device which generates a "stimulating pressure field" through the compression of the air molecules in the cavity. During the hearing, Ms Hayes agreed with Ms Rigbye that "pressure is really, really important". I also agree.
3. Thus, the only method of measurement of the VCR which is described in the Patent is to an artificial situation where the cavity is airtight (using a virtual planar surface) rather than a method of measurement of the VCR of the device when used on the clitoris, being a situation where there will be a limited exchange of air between the cavity and the outside environment. For this additional reason, the disclosure in the Patent does not provide adequate information to the PSA to measure the pressure in the cavity of the device.
4. A further variable which will affect the volume of the cavity, and therefore the pressure generated, is the presence of the clitoris which will protrude in the cavity when the device is used.
5. In Rigbye 1, Ms Rigbye explained that:

...Claim 1 specifies that the device is "A compression wave massage device when used on the clitoris:", with the specification of volume ratio range following this. This is problematic as "when used on the clitoris" means when the opening is placed over the clitoris. The clitoris is not a planar structure, therefore the content of claim 1 is at odds with the definition of the cavity volume given in paragraph 3, page 2 - "The volume of the cavity is defined as the volume of a chamber which ends in the proximity of the opening in a virtually planar area".

The clitoris will protrude into the cavity, thus reducing the volume of the space and reducing the "minimum volume", resulting in higher vacuum pressures in use. Given the substantial anatomical variation in clitorises, the resulting minimum volume will vary accordingly. Therefore, the limitation of the volume ratio as defined when the cavity is delineated by a planar area is meaningless in determining the limits of pressure produced in use, despite this apparently being given as the justification for the ratio limits in paragraphs 3 and 5 of page 2 of the patent.

(Emphasis added.)

1. Ms Rigbye gave further evidence in the JER 1 that:

The critical quantity here is the strength of the pressure field, not the volume of the cavity. The ratio of the volume change to the minimal volume can dictate pressure created, but only if a set of specific conditions is met as outlined in Rigbye-1 4.1.1.1 and Rigbye-2 10-14. I believe it is reasonable to assume the state of some of these conditions - such as constant mass, constant temperature and the starting pressure being equal to ambient atmospheric pressure. However there are two other factors which are critical in determining the strength of the pressure field - being the starting position of the membrane, and the presence of the clitoris in the cavity. Shown below is the range of pressures achievable in the device depending on the starting position of the membrane:

1. By reference to this diagram, Ms Rigbye explained that:

This is to illustrate that varying the VCR can change the range of pressure achievable, however the actual resulting pressure is heavily dependent on the starting position of the membrane. If it starts in the forward-most position (green), then only negative pressures will be produced, and if it starts in the rearward-most position (red), then only positive pressures will be produced, regardless of the value of the VCR.

(Emphasis original.)

Secondly, the presence of the clitoris in the cavity strongly affects the pressures produced. Taking only the case where the membrane is assumed to be starting in the centre position, the below plot demonstrates how the operating pressures change for cases where the clitoris takes up 20% and 50% of the minimum volume. Dashed lines show pressures for a VCR of 1, and solid lines show the result for a VCR of 0.1.

This demonstrates that for a given VCR, the operating pressure can vary significantly depending on the presence and size of the clitoris in the cavity. These differences are even more pronounced for the other membrane starting positions mentioned above, but omitted here for clarity.

Therefore, since the VCR alone is not a good predictor of the operating pressure of the device, I believe it is an inappropriate proxy for specifying the limits for the stimulating pressure field. A pressure range specified in pressure units, (such as atmospheres, pascals etc) is more appropriate, as this will directly dictate whether the pressure is strong enough for efficacy, and low enough to avoid pain, avoiding the ambiguity of the starting position and the presence of the clitoris. In practice, the VCR dictates only device proportions.

1. Ms Rigbye also stated in the JER 1 that the product does not need to be measured on an actual clitoris, "however specification during use (i.e. pressure generated in a volume when closed by skin) is important. Calculation of operating pressures (as a direct analogue of strength of sensation) through use of volumes should take into account the range of potential volumes of clitorises that will decrease the volume of the minimum volume" (emphasis original). In Rigbye 2, Ms Rigbye explained that this could be done by reference to the expected bell curve of clitoris sizes. Mr Duff observed in the JER 1 that, for example, an "imitation clitoris could have been used".
2. In the JER 1, Ms Hayes stated the following on this topic:

As it is impossible to control for the size, shape and position of the clitoris, it is inappropriate to use an indicator that depends on them. The patent would be more vague if it tried to define the VCR in terms of a clitoris. The patent defines the minimal and maximal volumes (used to calculate the VCR) using a virtual plane at the opening. This is unambiguous and can be quickly and effectively used to guide both the design and verification of the product.

1. I do not accept the evidence of Ms Hayes. The "stimulating pressure field" is created by changing the volume of the cavity, and that volume will be reduced by the placement of the device on the clitoris. This in turn affects the pressure field which is generated. The Patent could teach that the VCR can be measured in a way which takes account of the clitoris being in the cavity, such as by the expected bell curve of clitoris sizes (for example). Many medical devices (patented or otherwise) take account of the range of physical differences between prospective users, and it is not apparent why the device claimed in the Patent would be any different from such devices.
2. That the Patent teaches a method of measurement which does not take account of the clitoris in the cavity is a further reason that the PSA would understand that the method of measurement of the VCR taught by the Patent is insufficient to determine the VCR of the device when used on the clitoris.
3. A further complication arises when the device is used underwater, which use is contemplated in the Patent. As to this, Ms Rigbye stated in Rigbye 1:

Volume change ratio does not correspond to pressures produced if the fluid being used in the device is water or gel. Water is an incompressible substance, therefore it is not physically possible to change the volume of a constant quantity of water. If the device's cavity is full of water when it's placed against the clitoris, the change in the volume of the cavity will be kept constant by the deflection of the clitoris into and away from the opening. In this case, the water or gel acts only to transmit the force of the movement of the membrane to the clitoris. Therefore, as there is no effective volume change in use (as per claim 1 "when used on the clitoris") when the device is used with water, specifying a range for the volume change ratio is meaningless beyond constraining the dimensions of the device.

(Emphasis added.)

1. In response, Ms Hayes stated in Hayes 3 at [329(h)]:

Ms Rigbye also notes that water is an incompressible substance, and so there can be no effective volume change in use when the fluid in the cavity is a liquid (Rigbye Report, page 30, paragraph 4.1.1.1.4). 1 agree that water is effectively incompressible, however the result of this fact is not that the device will not function. Force from the movement of the membrane is transmitted through the water onto the clitoris. And so, I agree with Ms Rigbye that the device will deflect "the clitoris into and away from the opening", and in my view, this could be a more pronounced effect than when used with air. Also, one could also reasonably expect that if the device is used underwater, the flexible membrane would push some water out of the cavity during overpressure stages. But being incompressible does not prevent the device from forming a relative vacuum, and when the device drives from minimum to maximum volume in the cavity, a relative vacuum will be generated in the cavity, creating a suction effect. Accordingly, even when used underwater, the VCR remains a useful indicator of the pressure field experienced.

1. Once again, Ms Hayes relies upon the escape of the medium in the cavity (in this case, water) when the device is being used on the clitoris to justify her opinion. Further, Ms Hayes identifies VCR in this scenario as no more than a "useful indicator" of the "pressure field experienced". However, in circumstances where the invention as claimed is not limited in terms of use above or below water (and the Patent itself discloses it can be used in either scenario), the question is whether claim 1 (with the VCR integer) identifies a workable standard suitable to the intended use of the device below water. That something is a "useful indicator" of the pressure field achieved falls far short of enabling the PSA to ascertain whether the particular result concerned is or is not secured by forms of the invention lying near the boundaries of the claim.
2. In conclusion, the Patent does not identify the starting position for the membrane or account for the presence of the clitoris in the cavity. This is a critical deficiency as these variables affect the VCR. Further, the method of measurement of the VCR of the device which is taught by the Patent (using a virtual planar surface) is not a method of measurement of the device when used on the clitoris because (a) the cavity will be airtight in the laboratory but not when the device is so used and (b) the volume of the cavity will be larger in the laboratory than when the device is so used due to the presence of the clitoris. Finally, specifying the VCR is meaningless when the device is used on the clitoris underwater and the cavity is full of water as there will be no effective volume change.
3. For these reasons, there is insufficient information in the Patent to enable the PSA to achieve the claimed stimulating pressure field, and the PSA cannot objectively ascertain whether what they propose to do falls within the ambit of the claims of the Patent as they do not identify a workable standard suitable to the intended use.
4. As a consequence, claims 1 and 22 (which contain the VCR integers) are unclear and do not define the invention.
5. Claim 1 is therefore invalid and should be revoked, as it fails to comply with ss 40(2)(b) and 40(3) of the Patents Act. As all of the claims of the Patent depend on claim 1, or on other claims which depend on claim 1, it follows that the Patent is invalid and should be revoked for the same reason.
6. Further and in any event, claim 22 is also invalid and should be revoked, as it fails to comply with ss 40(2)(b) and 40(3) of the Patents Act.

1. Integer 1.5 refers to the cavity being formed by a "single chamber". However, claim 2 claims a device according to claim 1 wherein the cavity is formed by a "single continuous chamber" (integer 2.2) (emphasis added). Claim 3 claims a device according to claim 1 with the cavity being limited by a "continuous lateral wall connecting the first end with the second end of the cavity" (integer 3.2) (emphasis added) whereas claim 6 claims a device according to claim 1 "wherein the lateral wall of the chamber limiting the cavity and connecting its two ends to each other is free from discontinuations" (integer 6.2) (emphasis added).
2. It is difficult to understand how claims 3 and 6 differ from each other as a "continuous lateral wall" which limits the cavity in claim 3 appears no different in substance to "the lateral wall of the chamber limiting the cavity" in claim 6 being "free from discontinuations". Further, if "single continuous chamber" in claim 2 is a reference to the walls of the chamber being continuous, then the differences between claim 2, claim 3 and claim 6 appear to be semantic, rather than real. Alternatively, if the word "continuous" in claim 2 is not intended to be a reference to the walls of the chamber, but to identify that there is only one chamber, and not two or more chambers, then it is unclear what the word "continuous" (integer 2.2) adds to the word "single" (integer 1.5).
3. The word "continuous" is not a term of art. It is defined as "characterized by continuity; extending in space without interruption of substance; having no interstices or breaks; having its parts in immediate connection; connected, unbroken": Oxford English Dictionary (online).
4. However, even considering this dictionary meaning, the real question is whether the reference to continuity is to continuity of shape or cross-section of the chamber, or continuity in the walls of the chamber (i.e. no breaks in the wall), or continuity in the materials used in the wall, or something else. Further, if it means continuity in the walls of the chamber (i.e. no breaks in the wall), a further question is whether it also encompasses a wall which is made of separate parts which are aligned so that they are flush, or only a wall made from a single piece of material or both or something else.
5. Other parts of the Patent appear to distinguish between continuity of the shape or cross-section of the chamber (using terms such as "unchanged" or "constant" rather than "continuous") and continuity in the walls of the chamber (described as "free from discontinuous sections", for example, or the avoidance of "any points of discontinuation"). However, the reference to "the form of a continuous tube" tends to indicate that the word "continuous" in this context is referring to the shape of the chamber, rather than its walls.
6. This is shown in the Patent specification at pages 2-3:

When using a flexible membrane, to be set into a reciprocal motion by the drive device, for the alternating generation of vacuum and pressure... In order for the air flow to remain essentially unchanged over the entire length of the cavity of the chamber or to be at least almost consistent, preferably the cross-section of the cavity of the chamber, defined perpendicular to the length between its two ends, should be unchanged or at least almost constant over the entire length between its two ends.

The cavity of the chamber can preferably show essentially the form of a rotary body with a circular or elliptic cross-section.

Additionally, for generating a homogenous, unhindered and thus effective airflow it is advantageous when preferably the side wall of the camber [sic], limiting the cavity and connecting its two ends to each other, is free from discontinuous sections.

Beneficially the cavity of the chamber may show the form of a continuous tube.

Preferably the cross-section of the opening is essentially equivalent to the cross-section of the cavity of the chamber.

It has proven particularly advantageous to size the ratio of the width of the cavity of the chamber, defined perpendicular to its longitudinal extension, to the length of the cavity of the chamber, defined in the direction of its longitudinal extension, from 0.1 to 1.0, preferably from 0.2 to 0.6, particularly preferred from 0.38 to 0.4.

Preferably the cavity of the chamber is closed at its inner, second end with a flexible membrane which extends essentially over the entire cross-section of the cavity and is moved by the drive device alternating in the direction towards the opening and the direction opposite thereto. With such a construction the stimulating pressure field can be generated in a particularly simple and simultaneously effective fashion in the cavity of the single chamber provided according to the invention.

For reasons of hygiene, it is further advantageous if particularly the section of the chamber showing the opening is provided as an interchangeable socket, with its inner lateral wall forming a section of the lateral wall of the cavity leading towards the opening. Beneficially the socket should be made from a flexible material, preferably silicon.

In a further development of the preferred embodiment stated above the inner lateral wall of the socket should essentially be aligned to the other section of the lateral wall of the cavity such that any points of discontinuation between the socket and the inner section of the cavity of the chamber is avoided.

In an alternative further development of the above-stated preferred embodiment the inner lateral wall of the socket forms an essentially continuous lateral wall of the cavity, connecting the first end with the second end, and thus a lateral wall of the cavity connecting the opening of the socket with the membrane, and the socket together with the membrane form a one-piece component. Such a preferred further development offers, based on the one-piece connection of the socket and the membrane, a particularly easily produced design and additionally has advantages with regards to hygiene, because the entire component comprising membrane and socket can be exchanged, which is possible only with the one-chamber solution realized according to the invention.

(Emphasis added.)

1. In the Detailed Description, the preferred embodiment of the device is addressed by reference to the Figures. Figure 4 is reproduced here for convenience.

1. According to page 5, the "cavity 12 is formed by a single continuous chamber 14 and is limited by an inner or lateral wall 12c connecting its two ends 12a, 12b to each other" (emphasis added).
2. Both Figures 3 and 4 depict the chamber 14 as being made up of three sections. Based on the specification, the walls of the chamber are made up of 12c1, 12c2 and 6c (although, confusingly, 6c is not shown in the Figures). These sections are addressed as follows:

In the head of the compression wave massage device 1, formed by the first end section 2a of the housing 2 and the projection 4, a compression wave generation device 10 is located, by which a stimulating pressure field is generated with the help of the opening 8. As particularly discernible in detail from Fig. 4, the pressure field generation device 10 comprises a cavity 12 with an exterior first end 12a and an inner second end 4b, opposite the first end 12a and located distanced from the first end 12a, with the first end 4a simultaneously also forming the opening 8 in the socket 6. The cavity 12 is formed by a single continuous chamber 14 and is limited by an inner or lateral wall 12c connecting its two ends 12a, 12b to each other. As discernible from Figs. 3 and 4, the socket shows an exterior section 6a by which it can be detachably fastened to the projection 4, and an inner section 6b, with the exterior section 6a and the inner section 6b of the socket 6 being connected to each other in the proximity of the opening 8. The inner section 6b of the socket 6 is formed like a sheath and limits an exterior section of the cavity 12 leading to an exterior first end 12a. This way, the inner wall of the sheath-shaped inner section 6b of the socket 6 forms simultaneously an exterior section 12c1 of the inner or lateral wall 12c of the cavity 12, leading to the opening 8. Further, in the exemplary embodiment shown the cavity 12 is limited by an interior annular element 16, with its inner wall simultaneously forming the other inner section 12c2 of the lateral wall 12c of the cavity 12. Accordingly, in the exemplary embodiment shown the continuous single chamber 14 is composed of the sheath-shaped inner section 6c of the socket 6 and the annular element 16.

1. That the walls of the chamber can be formed by sections is also referred to at page 3 lines 16-19 of the Patent.
2. Taking into account the change in the shape of the chamber at each of the ends in Figure 4 (denoted by 12a which flares, and 12b which depicts an end with two significant curves), the reference to "single continuous chamber" does not appear to be a refence to a constant or unchanged shape of the walls of the chamber.
3. Ms Rigbye's evidence about the meaning of "continuous chamber" in claim 2 in Rigbye 1, Annexure LR-1 at [4.2.1.1] supports my view, as follows:

It is not clear what "continuous" means in this context. Further to 4.1.1.2 above, it is not clear whether "chamber" refers to a wall, a space or the combination of a wall and a space. If taken to mean a space, then specifying that the cavity is "formed by a single continuous chamber" is redundant. However, if "chamber" refers to the wall of a space, then this claim does not match up with other descriptions of the device. Figure 4 shows the wall being made up of three separate parts, and paragraph 4 of page 3 describes an interchangeable socket "forming a section of the lateral wall of the cavity", thus the wall of the cavity being in sections. If the structure shown in figure 4 is to be considered to be a "continuous chamber", then this term could refer to a space of any given shape, made up of any number of different sections. My comments below are based on this interpretation.

(Emphasis added.)

1. As to claim 2, Ms Hayes appears to take the position that a single "continuous" chamber is one which does not have a connecting element between two chambers: Hayes 3 [101]. Ms Hayes stated in the JER 1 that a "single continuous chamber" is "[a]ny enclosure of a contiguous space, without significant change in cross section". However, her evidence begs the question - what does it mean to say that there is, or is not, a significant change? By what metric is this assessed? These questions are not answered by the disclosures in the Patent.
2. By contrast, Ms Rigbye gave evidence in the JER 1 that the meaning of "single continuous chamber" is "quite difficult to precisely define" and that she did not know where to draw the line "between when a single chamber becomes multiple chambers, based on variations to the shape of that space". Mr Duff agreed with Ms Rigbye and added additional comments.
3. In my view and giving preference to the views of Ms Rigbye, with which I agree based on my own analysis of the Patent, the meaning of "continuous" in integer 2.2 is unclear with the consequence that the invention is not defined. If the word is intended to add something to the meaning of "single", then it is not clear what that is intended to be. Claim 2 is therefore invalid and should be revoked, as it fails to comply with ss 40(2)(b) and 40(3) of the Patents Act.
4. As to the meaning of "continuous" in claim 3, it was Ms Hayes' and Mr Duff's position in the JER 1 that the Patent allows two materials joined together to comprise a continuous lateral wall, while Ms Rigbye regarded the phrase as ambiguous. In my view, it is sufficiently clear that the reference in integer 3.2 to a "continuous lateral wall" is to the walls of the chamber, being a wall made of a single piece of material or one which is made of more than one section joined flush with each other such that there is no break or discontinuation in the wall. Each of these types of walls would fall within this integer. In this regard, I prefer the evidence of Ms Hayes and Mr Duff over that of Ms Rigbye. It follows that claim 3 satisfies ss 40(2)(b) and 40(3) of the Patents Act.
5. As to claim 6, Ms Rigbye stated in Rigbye 1, Annexure LR-1 at [4.6.1.1]:

I am unsure how [claim 6] differs from claim 3, as it is unclear how being "free from discontinuations" is distinct from being "continuous", and it is not clear what defines being "free from discontinuations". As in 4.2.1.1, this appears to be at odds with the drawings and descriptions of the device.

(1) Ms Rigbye stated in the JER 1 that it was context dependent such that for bacterial growth, any change in part of material is a discontinuation;

(2) Ms Hayes stated in the JER 1 that it meant no narrow sections, no significant steps and no grooves or notches.

1. In my view and giving preference to the views of Ms Rigbye, with which I agree based on my own analysis of the Patent, the reference in claim 6 to the lateral wall of the chamber being "free from discontinuations" is unclear. If it is intended to claim something different to claim 3, then it is uncertain what that difference is intended to be, as there are many possibilities. The consequence is that the invention is not defined. Claim 6 is therefore invalid and should be revoked, as it fails to comply with ss 40(2)(b) and 40(3) of the Patents Act.

1. Claim 4 claims a device according to claim 1 wherein the cross-section of the cavity of the chamber defined perpendicular to its length between the two ends is essentially unchanged or at least almost consistent over the entire length between the two ends (integer 4.2) such that the air flow is essentially unchanged or at least almost consistent over the entire length of the cavity of the chamber (integer 4.3).
2. Claim 9 claims a device according to claim 1 wherein the ratio of the width of the cavity of the chamber, defined perpendicular to its longitudinal extension, to the length of the cavity of the chamber, defined in the direction of its longitudinal extension, ranges from 0.1 to 1.0.
3. The cavity of the chamber in these claims is not defined as being any particular shape. On that premise, the opposing walls of the chamber could be angled or otherwise not parallel such that the cross-section of the cavity has different widths depending on where the measurement is taken. Further, the cavity of the chamber has a different shape depending on whether the drive shaft is retracted. In the JER 1 topic 1(s), Ms Rigbye considered that the reference to the width of the cavity was a measurement taken across the largest dimension of the cross-section, although that was not specified. Ms Hayes agreed but said that while the definition was clear for circular cross-sections, it was not clear for elliptical or otherwise. During the concurrent evidence session, Ms Hayes agreed that the Patent does not tell you where to measure width, and that different people might choose different places if the width varies.
4. Further, while Ms Rigbye and Ms Hayes agreed in the JER 1 topic 1(t) that the length of the cavity is the measurement taken between the two ends, it appeared to be common ground that this measurement would differ depending on the position of the drive system, which could be in the minimum or maximum position, the starting position, or some other position.
5. During the hearing, Ms Hayes said that she would measure length in the minimum position but agreed that the Patent does not tell you whether to measure it in the minimum or maximum position.
6. Ms Rigbye said she would probably take it in "the middle position for the membrane", which view is consistent with the statement in the Patent at pages 6-7 (by reference to the exemplary embodiment) that volume is defined when the membrane is in the "normal and/or middle position".
7. EIS submits that the "preferred form of this feature is in its 'minimum volume position' as illustrated by 'L' in figure 4" in reliance upon the oral evidence of Ms Hayes. As to this, Ms Hayes gave this evidence at the hearing by reference to Figure 4:

MS HAYES: No. I think it's around 22A points to the drive shaft of the motor. And around that, it has got a part which is a little offset cam that moves the back of the membrane. And that's in its most - I guess in terms of the orientation of this picture, it's in its furthest down position, which I think would put this in the minimum position of the volume of that cavity.

...

MS HAYES: Yes. So I think 22A is pointing to the shaft of the actual motor. And there's a piece that I don't think actually has a number on it, unless it's a part of 22A that's around that. It has got the cross-hatching. And you can see that it fits over the shaft of the motor. And on the bottom side of that, it's longer. And so you kind of infer from this that the shaft is spinning that part. And at the point that we see it in this diagram, it's at its lowest point, which pushes the membrane down the furthest, which puts it in its minimum position.

MS RIGBYE: I can definitely see what Ms Hayes is saying but I don't think that that follows directly from this diagram, particularly because this other part that's cross-hatched that looks like it's around the driveshaft isn't labelled. And it isn't actually sort of explicitly described, I guess, in this. So I think if you've got an idea already of what it probably should look like, so if you had seen the device or something, then you would assume that that's probably what was going on. But I don't think you can say conclusively from that that that's the case.

If we're going to say that this part is attached to it there and that this - so the membrane part wraps around it, and that it doesn't extend further out of plane because that could change things again then yes. But that's making a lot of assumptions. And also it looks like that membrane could be pushed further forward just based on the fact that we know it's flexible, and there's a little bit of a radius there that looks like it could be pushed.

1. Ms Rigbye also disagreed with senior counsel for EIS that claim 9 provided "a workable standard".
2. To support her opinion that Figure 4 showed the minimum volume (about which she also accepted that there was "some ambiguity"), Ms Hayes relied upon her view that the Patent uses the minimum position as the baseline for the VCR and "a bunch of other things". Specifically, Ms Hayes referred to the VCR as being measured by reference to the minimal volume, such as at page 2 lines 2-3. However, the Patent refers in many places to both the maximal volume and the minimal volume: see e.g., page 1 line 40, page 2 lines 12-13, page 2 lines 24-30, page 6 lines 25-27 and page 7 lines 1-8. This is not surprising as the VCR relates to the change in volume of the cavity between those two extremes. For that reason and when it is read as a whole, I do not agree that the Patent uses the minimal volume as the "reference volume" or "baseline". Rather, it is used as one of the two measures for the purposes of the VCR.
3. Notwithstanding its reliance on Figure 4, the submissions by EIS did not overcome the reference at pages 6-7 of the Patent which identified the volume of the cavity as follows:

The volume of the cavity 12 is defined as the volume of the chamber 14 which ends in the proximity of the opening 8 at a virtual planar area, which virtually closes the opening 8 when the membrane 18 is in its normal and/or middle position.

(Emphasis added.)

1. The Patent then goes on to define the minimal volume and maximal volume of the cavity by reference to Figures 3 and 4. These descriptions do not commence with the words "[a]s further discernible from Figs. 3 and 4", which are the commencing words of the subsequent paragraphs on page 7 of the specification. If Figure 4 was intended to depict the minimal volume (or, indeed, any particular volume), one would have expected this to be stated, whether using such words or similar words, but it is not. This is telling, in my view.
2. As I prefer the evidence of Ms Rigbye, which accord with my own analysis of the Patent, I am not persuaded that Figure 4 depicts the cavity in its minimum volume position. Nor am I persuaded that the length of the cavity as referred to in claims 4 and 9 is a reference to the measurement between the two ends when the cavity is in its minimal volume position.
3. For these reasons, the meaning of "the ratio of the width of the cavity of the chamber...to the length of the cavity of the chamber" in claim 9 is unclear, as is the reference to length in claim 4. The consequence is that the invention is not defined in claims 4 and 9.
4. It follows that claims 4 and 9 are invalid and should be revoked, as they do not comply with ss 40(2)(b) and 40(3) of the Patents Act.

1. Sections 40(2) and 40(3) of the Patents Act relevantly provide:

Requirements relating to complete specifications

(2) A complete specification must:

(a) disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art; and

(3) The claim or claims must be clear and succinct and supported by matter disclosed in the specification.

1. On the proper construction of claim 1, the invention claimed in the Patent is for a compression wave massager device which has particular features when used on the clitoris. The technical contribution to the art is the device's "simple and simultaneously effective" design which is embodied to change the volume of at least one cavity formed by a single chamber between a minimal volume and maximal volume such that a stimulating pressure field is generated in at least one opening, and the VCR is not below 1/10 (claim 1) or 1/8 (claim 22).
2. For the same reasons given in section 8.3 above, the Patent does not enable the PSA to make the claimed compression wave massage device without undue burden, with the consequence that the Patent fails to comply s 40(2)(a) of the Patents Act.
3. As to the ranges of each VCR and as noted above, Ms Rigbye observed (correctly) in Rigbye 1 that:

It is specified that the drive device creates a "stimulating pressure field" by means of varying the volume of a cavity, and then specifies that the ratio of the volume change to the minimum volume must fall between 1/10 and 1, but the purpose or effect of this specification on the use of the device is not clear outside of arbitrarily constraining the relative dimensions of the device.

...

There is nothing in the specification which explains how these limits were arrived at. For example, no data are given for tests on users, or the definition of what is considered to be "stimulating" - for example whether this is purely subjective, or whether it refers to some kind of physiological effect.

1. As there is no experimental or other data in the Patent which justifies the VCR which is claimed in the VCR integers, the patentee has claimed a monopoly over a device which includes changes in the range of volume of at least one cavity that are not the product of the technical contribution to the art provided by the specification.
2. As a consequence, the claims are invalid for want of support.
3. For these reasons, the Patent should be revoked.
4. Although LELO advanced other arguments based on ss 40(2)(a) and 40(3) of the Patents Act, it is unnecessary to address those other arguments in light of the conclusions which I have reached.

1. Section 18(1)(b)(i) of the Patents Act requires that an invention, so far as claimed in any claim, when compared to the prior art base, be novel. The touchstone for lack of novelty is whether a prior publication anticipates a claimed invention: see CPC Patent Technologies Pty Ltd v Apple Pty Limited [2025] FCA 489 at [526] (Burley J).
2. By the invalidity particulars, LELO alleges that the invention was not novel when compared with "JP 2011-083423 A in the name of Panasonic Electric Works Co" published on 28 April 2011 (Panasonic). It states that "Panasonic renders each of the Claims not novel except claim 9". Panasonic is a patent application filed in the Japanese Patents Office and published on 28 April 2011.
3. The invalidity particulars also state that the VCR of not below 1/10, or not below 1/8, and not greater than 1 was merely arbitrary and/or the result of mere routine optimisation and should be disregarded for the purposes of novelty.

10.2 The manner in which the proceeding was conducted

1. In evidence were two versions of Panasonic, one in Japanese and one in English.
2. On 15 September 2023, LELO's lawyers served a Notice to Admit on EIS which sought admission of the publication date of (inter alia) Panasonic. Included in the DropBox of documents which accompanied the Notice to Admit was a copy of the English version of Panasonic.
3. On 29 September 2023, EIS by its lawyers served a Notice of Dispute which (inter alia) admitted that "patent number JP 2011-083423 A (annexed to this Notice of Dispute and marked "F"), referred to at sub-paragraph (v), was published on 28 April 2011". The authenticity of the same document was also admitted. EIS submits that in error, there was no annexure "F" to the Notice of Dispute, and that EIS had intended to only admit that the Japanese version of Panasonic was authentic and published on 28 April 2011.
4. Ms Rigbye and Ms Hayes were called by LELO and EIS respectively to give evidence about Panasonic, and they did so by reference to the English version. Relevantly, the lawyers for EIS briefed Ms Hayes with a copy of the English version of Panasonic.
5. Panasonic was also one of the topics addressed by Ms Rigbye and Ms Hayes in the JER 2.
6. By its written opening submissions on invalidity, EIS addressed Panasonic by reference to what it disclosed, citing pages of the Court Book which contained the English version of Panasonic.
7. By its closing submissions, EIS raised for the first time a dispute about the English version of Panasonic. It submits that:

There is no certified English translation of Panasonic in evidence. It is not clear how the English version provided to Ms Rigbye as part of her letter of instructions was created, when or by whom. Mr Duff was unable to explain how the same document came to be annexed to Duff #1. There is no evidence that what is before the Court reflects what was in the public domain before the Priority Date...

(Footnotes omitted.)

1. However, EIS will not be permitted to advance such a contention after the evidence has closed and the case has been run by the parties, including through the expert evidence and the joint expert conclave, on the premise that the English version of Panasonic was published on 28 April 2011 or, at the least, that it was an accurate translation of Panasonic which was published on 28 April 2011. Had EIS wished to dispute the English version of Panasonic, then that should have been made plain by its Notice of Dispute, including by annexing the Japanese version of Panasonic as annexure "F".

1. LELO submits that the VCR integers are merely an arbitrary parameter and should be disregarded for the purposes of novelty and inventive step. It submits that the question is whether the parameters have been chosen to achieve a technical effect, or whether they are an arbitrary convenience.
2. While LELO accepts that the change in volume in the cavity is one factor which will affect the pressure field, it submits that there is nothing in the Patent that justifies the VCR range. However, some limited justification for the VCR range appears at page 2 (lines 10-12, 19-22) of the Patent.
3. LELO further relies on the fact that EIS did not produce any document that showed a basis for the VCR range despite being ordered to produce the experimental protocol used to determine the VCR range on 18 December 2023 and to discover all documents relating to research and experimental work up to the priority date on 11 March 2024.
4. LELO submits that, based on this fact, on the content of the letter sent by the patent attorneys to the Commissioner of Patents dated 22 December 2017 and the absence of any example or data in the Patent that supports the VCR range, it can be inferred that the VCR integer was added to the claims solely in an attempt to provide novelty and inventive step over Novoluto.
5. However, as the Full Court in AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324; [2014] FCAFC 99 at [205] (Besanko, Foster, Nicholas and Yates JJ) (AstraZeneca FC) stated "although the complete specification must describe the invention fully...it does not follow that the inventor must explain how he or she arrived at the invention. It is the invention itself that must be fully described, not the route that was travelled by the inventor to arrive at it".
6. Further, the evidence of Ms Lantis in her affidavit dated 5 February 2025 is that, based on information provided to her by EIS's German counsel, under German law, business records need only be retained for six years and that EIS does not generally retain records for more than six years. This provides a cogent explanation for the failure by EIS to produce the documents, which explanation does not support the contention that the VCR integers were arbitrary.
7. The letter to the Commissioner of Patents relies on the VCR to distinguish the claimed invention from the prior art - however, that also does not support the contention that the VCR integers were arbitrary.
8. For these reasons, I am not prepared to draw the inference which LELO seeks.
9. LELO also relies on evidence given by the experts during the trial, submitting that:

During trial, Ms Hayes repeatedly confirmed that VCR is a totally arbitrary parameter. At various points, she stated or agreed that VCR: (i) "is a post-hoc tool to try to describe the invention"; (ii) was not something she was aware of prior to reading the EIS Patent; (iii) is a subjective experience that does not indicate whether a particular pressure is pleasurable or painful to a user; (iv) is a later construction to describe the invention; (v) is not supported by any data of which she is aware; (vi) is an "abstract measurement"; (vii) was only created after a working, useful device was created as a later way to describe a parameter of the device; and (viii) was "made up". This list is not exhaustive.

Without prompting, Ms Hayes even said that VCR is a construction "by whoever wrote the patent." She references the idea that the writer of the Patent created VCR multiple times - in fact, she alleges that the Patent writer "made it up." Ms Hayes even agrees that VCR "could have just been plucked out of thin air." This is consistent with the documents discovered by EIS.

Ms Rigbye agreed with Ms Hayes that VCR was an arbitrary parameter, stating that "using the VCR is an odd and imprecise way to specify pressures" and had little to do with the stimulation a user would feel.

(Footnotes omitted.)

1. However, when the oral evidence of Ms Hayes cited by LELO is read in context, her evidence was that she was not aware of VCR at the priority date, and VCR was something that she believed was devised to attempt to describe the invention in a way that could be reproduced. Such evidence does not support a submission that the VCR integers are arbitrary.
2. Ms Rigbye gave evidence at the hearing that the VCR is "an odd and imprecise way to specify pressures, because pressure is obviously the important quantity at play here". However, while it is the case that Ms Rigbye had many criticisms of the Patent (as addressed above), this does not mean that she considered the VCR integers to be arbitrary, in the non-pejorative sense of depending on the will or discretion of EIS rather than reflecting any discovery or new scientific insight: see NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1992] FCA 493; (1992) 24 IPR 1 at 35 (Wilcox J); see also Williams Advanced Materials Inc v Target Technology Co LLC (2004) 63 IPR 645; [2004] FCA 1405 at [48] (Bennett J).
3. For these reasons, the VCR integers are not arbitrary. They are part of the invention and are related to a claimed advantage according to the Patent itself.

1. The following is extracted from the first page of Panasonic:

(54) STIMULATION IMPARTING DEVICE FOR LIVING BODY

(57) Abstract:

PROBLEM TO BE SOLVED: To provide a stimulation imparting device capable of giving various stimulations to the object part of a living body.

SOLUTION: A massage device 1 as the stimulation imparting device for the living body includes a stimulation imparting part 20 for giving stimulations to the skin 100. The stimulation imparting part 20 includes a cylinder 21 which is provided with a cylinder chamber 25 in the inside and is brought into contact with the skin 100, and a speaker 40 which changes the density of air in the cylinder chamber 25.

1. The following also appears on the first page, which is Figure 4:

[Claim 1] A stimulus imparting device for a living body including a stimulus imparting part for applying a stimulus to a target site of a living body, wherein

the stimulus imparting part includes a contact part for contacting the target site, the contact part having a space provided therein, and a vibration part for changing a density of a medium in the space.

[Claim 2] The stimulus imparting device for a living body according to claim 1, wherein changes in density of the medium apply a massage to the target site of the living body.

...

[Claim 4] The stimulus imparting device for a living body accordingly to any one of claims 1 to 3, wherein the vibration part vibrates at a frequency lower than an audible region frequency.

[Detailed Description of Invention] [Technical Field]

[0001] The present invention relates to a stimulus imparting device for a living body which applies a stimulus to a target site of a living body.

[Background Art]

[0002] A massager is known as the foregoing stimulus imparting device.

For example, the massager taught in patent document 1 is configured to impart a stimulus to the skin by repeating an impact action on a target site of a human body. Furthermore, the massager taught in patent document 2 is configured to impart a stimulus by bringing an attachment into contact with the skin and suctioning.

[Problem to be Solved by Invention]

[0004] Incidentally, although in recent years massagers have been anticipated to apply stimuli to target sites of living bodies at various levels of strength and at various intervals, conventional stimulus imparting devices can only impart simple stimuli such as impact or suction.

[0005] The present invention has been made in light of such circumstances, and an object thereof is to provide a stimulus imparting device that can apply various stimuli to a target site of a living body.

[Means for Solving Problem]

[0006] Means for achieving the foregoing object and the operational effect thereof are described below.

(1) The essence of the invention according to claim 1 is a stimulus imparting device for a living body including a stimulus imparting part for applying a stimulus to a target site of a living body, wherein the stimulus imparting part for changing a density of a medium in the space.

[0007] According to the present invention, when the vibration part vibrates while the contact part is in contact with the target site of the living body, the density of the medium in the contact part changes in conjunction therewith. Also, the vibration part operates in a direction of reducing the space within the contact part to make the medium more dense, whereby the target site is pressed, and when the vibration part operates in a direction of expanding the space within the contact part to make the medium less dense, the target site is suctioned. That is, the target site of the living body is pressed and suctioned according to the operation of the vibration part. Accordingly, various stimuli can be imparted to the target site.

[0008] (2) The essence of the invention according to claim 2 is the stimulus imparting device for a living body according to claim 1, wherein changes in density of the medium apply a massage sensation to the target site of the living body.

[0009] In the present invention, because a massage sensation is applied to the target site of the living body by changes in the density of the medium, that is, a massage sensation is applied by the suction and pressing of the target site by the stimulus imparting part, a massage with a soft touch can be applied to the living body.

...

[0012] (4) The essence of the invention according to claim 4 is the stimulus imparting device for a living body according to any one of claims 1 to 3, wherein the vibration part vibrates at a frequency lower than an audible region frequency.

[0013] In the present invention, because the frequency of the vibration of the vibration part is lower than the audible region frequency, the user's perception of the operating sound of the vibrating part can be suppressed when changing the density of the medium in the space within the contact part due to the vibration of the vibration part.

1. The first embodiment is described on pages 7-12. On page 19, reference is made to other embodiments, and the following statements are made:

(1) In the foregoing embodiments, a plate-shaped paper cone 42 is used, but the shape and material of the paper cone are not limited thereto, and for example, a conical paper cone may be adopted.

(2) In the foregoing embodiments, the density of air is changed by the speaker 40, but this may also be changed to an actuator other than a speaker. Examples include linear actuators such as a solenoid coil, crank piston structures, and working fluid actuators such as a diaphragm pump.

(3) The foregoing embodiments are configured to impart stimuli to the skin 100, but even if the target site is something other than the skin 100, it may be any site on the living body insofar as it is the location which is desired to be massaged. For example, the massager may be applied to medical devices such as oral massaging devices and the like with the oral cavity as the target site.

(4) In the foregoing embodiments, the medium is air, but another fluid may be used as the medium. For example, a liquid such as water may be used as a medium, at which time, the user can perform a massage even in water, such as in a bath.

1. Having reviewed Panasonic, I agree with and accept the evidence of Ms Hayes and Ms Rigbye that the VCR integers are not disclosed. LELO did not submit that their evidence in this regard should not be accepted. It follows that the novelty attack on the validity of the Patent must fail.
2. In addition, I agree with and accept the evidence of Ms Hayes and Ms Rigbye that Panasonic does not disclose "[a] compression wave massage device when used on the clitoris" (integer 1.1) "with the first end being provided with an opening for placement over the clitoris" (integer 1.3). That is because Panasonic does not contain "clear and unmistakable directions" to use the device in this way, and it is not the case that use of the disclosed device on the clitoris is implicit in what is described in Panasonic: see, generally, AstraZeneca FC at [299]-[301]. That the clitoris is part of the human body, and that the device in Panasonic can be used to massage skin, is insufficient to constitute anticipation in circumstances where the clitoris is not mentioned in Panasonic at all, and the skin (100) in Panasonic is not illustrated or described as a clitoris. It follows that the novelty attack on the validity of the Patent must fail for this additional reason.
3. In light of these conclusions, it is unnecessary to consider other integers which the experts agreed were not disclosed in Panasonic.

1. LELO contends that the invention does not involve an inventive step. This ground arises under ss 138(3)(b) and 18(1)(b) of the Patents Act, and the assessment of inventive step is conducted in accordance with ss 7(2) and 7(3) of the Patents Act.
2. In support of this ground, LELO relies on the following pieces of prior art together with the CGK:

(1) Panasonic;

(2) Novoluto;

(a) alleged disclosures through each of the following acts:

(i) sale of the Womanizer W100 by Corva Technology (based in Hong Kong) to Playhouse from January 2015 and by Calvista from March 2015;

(ii) sale of the Womanizer W500 by Calvista from January 2016, including to Passionfruit Shop on 18 January 2016;

(iii) sale of the Satisfyer Pro by EIS GmBH before April 2016;

(b) the following combinations:

(i) Novoluto with Womanizer W100 and/or Womanizer W500;

(ii) Womanizer W100 and/or Womanizer W500 with either or both of the Womanizer YouTube Videos;

(iii) Novoluto with Womanizer W100 and/or Womanizer W500 and with one or both of the Womanizer YouTube Videos;

1. The onus is on LELO to establish that the claimed invention lacks an inventive step, in circumstances where the Patents Act deems there to be an inventive step unless proven otherwise.

1. LELO relies upon the evidence of Ms Rigbye in support of this aspect of its invalidity case. Ms Rigbye was provided with the Patent along with a letter of instructions dated 8 December 2023. She was asked to read through it and, in addition to other questions, was given the following instructions:

Having established the CGK, your expert opinion must be given in respect of whether:

• the CGK established as at 4 April 2016 alone; or

• the CGK established as at 4 April 2016 combined with any single prior publication (whether a document or device); or

• the CGK established as at 4 April 2016 combined with any two or more prior publications (whether documents, devices, or a document and a device) (but only where a person skilled in the relevant art would be reasonably expected to have combined them);

shows that the subject of each claim of the EIS patent specification was non-inventive, in the sense that for EIS to have arrived at the claimed invention would have involved nothing more than routine steps rather than an inventive step. There is no inventive step if the claimed invention only varies from prior art information in ways that, to a person skilled in the relevant art in the light of CGK before the priority date, was obvious.

Another way to test whether an invention is obvious is to ask whether a skilled addressee would, in light of the CGK, have been directly led as a matter of course to the claimed "invention" in the expectation that it might provide a useful alternative to clitoral stimulators on the market.

(Emphasis in original.)

1. Additional questions were also asked about whether particular aspects of the claims of the Patent were "non-inventive (obvious)" or achievable by a PSA by taking routine steps.
2. These instructions beg the question - what problem is the hypothetical PSA grappling with as at the priority date (if any)? What is the context? Is it to design and develop a sex toy? For women? A clitoral stimulator? Using pressure waves? It appears that the answers to all of these questions is "yes" but without any basis established in the evidence as to why that would be the starting point for the hypothetical PSA as at the priority date.
3. The vice in such an approach was explained by the Full Court in AstraZeneca FC at [202]-[204]:

Accordingly, whether a claim of a patent is invalid for lack of inventive step is to be determined by comparing the invention, so far as claimed, against the common general knowledge and any s 7(3) information. The question is then whether the invention would have been obvious to the hypothetical person skilled in the art in light of that knowledge considered separately from, or together with, the s 7(3) information. So understood, it is apparent that the relevant provisions of the Act do not expressly or impliedly contemplate that the body of knowledge and information against which the question whether or not an invention, so far as claimed, involves an inventive step is to be determined may be enlarged by reference to the inventor's (or patent applicant's) description in the complete specification of the invention including, in particular, any problem that the invention is explicitly or implicitly directed at solving.

If the problem addressed by a patent specification is itself common general knowledge, or if knowledge of the problem is s 7(3) information, then such knowledge or information will be attributed to the hypothetical person skilled in the art for the purpose of assessing obviousness. But if the problem cannot be attributed to the hypothetical person skilled in the art in either of these ways then it is not permissible to attribute a knowledge of the problem on the basis of the inventor's "starting point" such as might be gleaned from a reading of the complete specification as a whole...

[The] inventor's "starting point" as ascertained from the complete specification might not be one that would suggest itself to the hypothetical person skilled in the art who, for the purpose of assessing inventiveness, is taken to be in possession of the common general knowledge and any s 7(3) information but who lacks the capacity for invention. It is true the contents of the complete specification may have an evidentiary significance, for example, as an admission (see Doric No 2 at [105]-[111]), which might lead to a finding that a piece of information referred to is common general knowledge or s 7(3) information. But that is quite different to supplementing the knowledge and information available for the purposes of s 7(2) with any knowledge or information that is, ex hypothesi, not common general knowledge and not s 7(3) information.

1. A further problem with the manner in which Ms Rigbye was instructed is that Ms Rigbye was supplied with the Patent and asked to read it before being asked questions concerning inventive step. Ms Rigbye was also asked whether there was any relevant prior art available at the priority date of the Patent which would be treated by that skilled person as "relevant to the aim of the 'invention', being to provide a compression wave massage device for use on the clitoris which generates a stimulating pressure field". That is, Ms Rigbye was not only provided with the Patent, but she was asked to consider the "aim of the invention" expressly for the purposes of her evidence on inventive step.
2. In Rigbye 1, Annexure LR-1 she states at [4.1.3.2] that Novoluto and Panasonic "would have been located and treated as relevant to the aim of a person or team designing a device for stimulation of the clitoris, in particular, one using pressure waves...". She also states that the Womanizer and Satisfyer Pro devices "would each have been located and treated as relevant to the aim of a person or team designing a device for stimulation of the clitoris, in particular, using pressure waves".
3. When it was suggested to Ms Rigbye during the hearing that a lot of her analysis was undertaken "knowing what the ultimate solution is", she conceded with admirable candour:

Look, there probably would have been some element of that. I think it's impossible to not have, you know, some kind of priming based on, like, what I know that this case is about. But I tried, to the best of my ability, to put it out of my mind.

1. In the JER 2, Ms Rigbye and Ms Hayes appear to have been asked a different question to that considered by Ms Rigbye - namely, "the problem the experts are faced with is to produce a useful alternative or better sexual stimulation device than those devices that formed part of the common general knowledge before 4 April 2016".
2. Notwithstanding this, Ms Rigbye refers in the JER 2 to "the scenario where a PSA is tasked with the development of an air pressure based sex toy" (emphasis added). This reinforces my view that Ms Rigbye's understanding of this topic has been tainted by being instructed to adopt a particular starting point which is suggestive of the solution rather than any problem forming part of the CGK as at the priority date, and by being given the Patent before being asked to express her views on this topic.
3. For these reasons, I place little weight on Ms Rigbye's opinions concerning inventive step. For this reason and had it been necessary, I would have preferred the evidence of Ms Hayes on this topic where these experts disagreed; however, as matters transpired, the experts reached agreement.

1. Through the JER 2, the experts reached agreement about a number of matters. I am not persuaded by other evidence given during the trial that this agreement was overtaken, or that I should not accept this evidence.
2. As to Panasonic, the experts agreed that:

(1) the VCR integers are not obvious, which has the consequence that none of the claims are obvious;

(2) integer 9.2 is not obvious.

(1) the VCR integers are not obvious, which has the consequence that none of the claims are obvious;

(2) integer 9.2 is not obvious.

1. As to the Womanizer videos, the experts agreed that integers 1.2, 1.4, 1.5 and 1.6 are not obvious, which has the consequence that none of the claims are obvious. They also agreed that claims 2, 3, 4, 5, 6, 7, 8, 9 and 10 are not obvious, as well as integer 22.2.
2. As to the Alleged Prior Uses (as defined), EIS did not dispute that there was (at least a) version of Womanizer W100, Womanizer W500 and Satisfyer Pro in existence and sold before April 2016. The experts agreed, however, that in relation to each of the devices:

(1) the VCR integers are not obvious, which has the consequence that none of the claims are obvious;

(2) integer 9.2 is not obvious.

1. They also reached the same conclusions concerning the combinations.
2. For these reasons, LELO failed to establish that the invention lacks an inventive step.

1. Section 40(2)(aa) of the Patents Act requires that a specification must "disclose the best method known to the applicant of performing the invention".
2. LELO contends that the requirements of s 40(2)(aa) have not been met because EIS knew of a method that would not be useful (i.e. a geared motor with high torque) and it did not disclose this in the Patent. It relies on a series of emails dated between 1 March 2016 and 14 March 2016. In those emails, Mr Thomas Milewski (EIS's Chief Design Officer) and Mr Witt (Indeed Innovation, Head of Engineering and the named inventor) discuss various motor options for incorporation in a prototype version of a new pressure wave device. In one of his emails to Mr Milewski, Mr Witt referred to the fact that a motor with "gears" is "noticeably louder" and that "[t]he operating noise is not satisfactory". A few days later, Mr Witt sent to Mr Milewski photographs of alternative motor options and the dimensions for those options.
3. There was no dispute about the legal principles concerning the requirement to disclose the best method, and the question is essentially one of fact in that it depends on the facts and circumstances of the particular case: Zoetis Services LLC v Boehringer Ingelheim Animal Health USA Inc (2024) 306 FCR 19; [2024] FCAFC 145 at [26] (Perram, Nicholas and Downes JJ).
4. The answers to the following questions have been regarded as relevant when deciding whether the best method requirement is satisfied. Each of these questions will be considered and answered in turn.

(1) What is the invention (being the embodiment which is described and around which the claims are drawn)? Zoetis at [15]; SARB Management Group Pty Ltd (t/as Database Consultants Australia) v Vehicle Monitoring Systems Pty Ltd (2024) 176 IPR 391; [2024] FCAFC 6 at [122]-[123] (Burley, Jackson and Downes JJ); Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd (2017) 126 IPR 427; [2017] FCAFC 138 at [94], [115] (Greenwood, Rares and Moshinsky JJ); Les Laboratoires Servier v Apotex Pty Ltd (2016) 247 FCR 61; [2016] FCAFC 27 at [59] (Bennett, Besanko and Beach JJ). The nature of the invention is to be discerned from the invention as described in the whole of the specification: Zoetis at [15], [25].

The invention is a compression wave massage device when used on the clitoris which is comprised of at least one cavity and which generates a stimulating pressure field in an opening which is placed over the clitoris, which pressure field is generated by changing the volume of the cavity at a prescribed ratio.

(2) What is the promise or nature of the invention as described in the whole of the specification? Servier at [124], [129]. For example, does the specification claim that the invention has any advantages?

The promise of the invention is that it provides a compression wave massage device for use on the clitoris which is a simple and simultaneously effective design, and is hygienic. It makes no promise about how much noise it makes.

(3) What information is not disclosed in the specification? Is that information required to perform the invention? Servier at [126].

According to LELO, the missing information is that the motor (drive system) should be one which does not have gears. However, such information is not required to perform the invention.

(4) How material or important is the omitted information to the advantages it is claimed the invention brings? Zoetis at [16]; GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Ltd v Generic Partners Pty Ltd (2018) 264 FCR 474; [2018] FCAFC 71 at [187], [194] (Middleton, Nicholas and Burley JJ) (Glaxo FC); Sandvik at [126]. Does the information relate to a real issue which needs to be overcome? Sandvik at [118], [125].

While the motor (drive system) is essential for the device to operate, the issue of whether or not it has gears is not material or important to the claimed advantages of the invention, and nor does it relate to a real issue which needs to be overcome.

(5) Does the omitted information take the methodology to a more satisfactory stage or provide more certainty so that the public may more quickly and easily utilise the invention for which a monopoly is granted? Servier at [64].

Whether the motor used in an embodiment of the invention has gears is a design choice; however, as gears would render the use of the device noisy, and as the device is a sex toy, it is questionable whether the PSA would need be informed that the motor in the device should not have gears.

(6) Was the omitted information CGK? What is the burden on the PSA arising from the non-disclosure of the information? Would the disclosure save the PSA the possible dead ends and false starts (or difficulties and uncertainties) that would otherwise have been risked? Servier at [173]-[174]. Does the omission of the information leave the PSA at risk of failure? Servier at [173]. Was it information which would have been discovered by routine experimentation by the PSA? What are the qualifications, knowledge and capabilities attributed to the PSA, and will the required experimentation be time consuming and expensive? Glaxo FC at [190]-[191].

The PSA would know that gears might render the use of the device noisy, and, even if the PSA decided to attempt to construct a device with a geared motor, the PSA's decision whether or not to use a geared motor would be routine.

(7) What is the practicality of disclosing the omitted information? What is the burden imposed on the patent applicant by requiring its disclosure? Glaxo FC at [191]-[192].

The burden of including information telling against the use of a geared motor would not have been significant. However, what is disclosed is a motor without gears. This means that if the best method known to EIS was to include a motor without gears in the invention, then this was disclosed. During the hearing, Mr Duff accepted that Figure 4 did not depict the rotary motor as having a gearbox, and there was no gearbox shown between drive engine 22 and output shaft 22A.

(8) Is the omitted information required to perform or carry out the invention in the best manner known to the patent applicant at the relevant time? Servier at [101].

The evidence did not establish this.

(9) Did the patent applicant know the embodiment to be the "best" embodiment of the invention (being a method which is better than the method described in the specification)? Servier at [99]; see also [106].

The evidence did not establish this.

1. In summary, EIS is not required to disclose idiosyncratic features of the motor which it has decided not to use in relation to its commercial embodiment of the invention. The selection of an appropriate motor depends on the particular commercial product being built, and is a routine decision which would be taken by the PSA. However, on the assumption that the best method of performing the invention is to include a motor without gears, such a motor was disclosed.
2. For these reasons, LELO failed to establish that the Patent did not comply with s 40(2)(aa) of the Patents Act.

1. Section 18(1)(c) of the Patents Act requires a patentable invention to be useful.
2. The first step is to ask: what is the promise of the invention, derived from the whole of the specification?
3. By the invalidity particulars, LELO contends that the Patent makes one or more of the following promises:

(1) the device has "a simple and simultaneously effective design" (p. 1, second paragraph under Background);

(2) the device has "a simpler construction" than the prior art (p. 2, second paragraph);

(3) the device meets "the strict requirements for hygiene" (p. 1, second paragraph under Background) and/or has "improved hygiene" over the prior art due to easier rinsing of the cavity (p. 2, second paragraph);

(4) the device has the advantage of "easy handling with lubricant or under water" (p. 2, second paragraph);

(5) the device provides uninterrupted air flow to the opening:

(a) air flow in the cavity of the chamber is "essentially unchanging" or "constant" between the two ends of the cavity (p 2, sixth paragraph);

(b) the device generates "a homogenous, unhindered and thus effective airflow" (p. 2, second last paragraph).

1. As to (5), LELO also relied upon the evidence of Ms Hayes that the Patent promises homogenous, unhindered and effective airflow.
2. As to this list, I agree with (1)-(4), but disagree with (5) and do not accept the evidence of Ms Hayes. When the Patent is read as a whole, the promise of the invention does not include the promise that the "device provides uninterrupted air flow to the opening". Further, the parts of the specification cited by LELO relate to particular claims, and not the invention per se.
3. The relevant passage on page 2, sixth paragraph (which is cited in the invalidity particulars) states:

In order for the air flow to remain essentially unchanged over the entire length of the cavity of the chamber or to be at least almost consistent, preferably the cross-section of the cavity of the chamber, defined perpendicular to the length between its two ends, should be unchanged or at least almost constant over the entire length between its two ends.

(Emphasis added.)

1. In other words, in order to achieve the described outcome, the cavity of the chamber should have particular features, which also appear in claim 4.
2. The other relevant passage on page 2, second last paragraph (which is cited in the invalidity particulars) reads:

Additionally, for generating a homogenous, unhindered and thus effective airflow it is advantageous when preferably the side wall of the camber [sic], limiting the cavity and connecting its two ends to each other, is free from discontinuous sections.

(Emphasis added.)

1. In other words, in order to achieve the described outcome which is stated to be advantageous, the side wall of the chamber should be free from discontinuous sections, which feature also appears in claim 6.
2. By the JER 3, the experts (Mr Duff and Ms Hayes) also agreed that the promises made in the Patent are that the device can be used with gel or under water, and that it generates stimulation that is effective but not painful. I agree with this based on what is stated in the Patent at page 2 lines 7-8 and 18-22.
3. Although LELO referred in passing to this agreement of the experts, it did not make any additional submissions as to the promise relating to the generation of stimulation (which was not pleaded in any event), and so I will not address it as it appears not to be pressed.
4. The second step is to ask: by following the teaching of the specification, does the invention as claimed attain the result promised for it?
5. In this regard, Mr Duff accepted at the hearing that the claimed device:

(1) meets the objective of providing "a simple and simultaneously effective design". In the JER 3, Ms Hayes agreed about this;

(2) has "a simpler construction" than the prior art;

(3) meets the "strict requirements for hygiene" and/or has "improved hygiene" over the prior art due to easier rinsing of the cavity. Ms Hayes agreed with this in the JER 3;

(4) has the advantage of easy handling with lubricant or under water.

1. As to the promise concerning use with gel or under water, Mr Duff's position in the JER 3 concerned gel rather than water on the basis that it would "throttle the womanizer". However, even if that is accepted, that does not mean that gel cannot be used at all, which Mr Duff accepted during the hearing.
2. No mention was made by Mr Duff in the JER 3 concerning issues relating to using the device underwater.
3. By its closing submissions, LELO advanced two further submissions which fell outside the scope of the invalidity particulars, which I will address as there was no objection by EIS.
4. The first was that:

The discovered documents establish inutility, given EIS determined that a device within the Claims (with a geared motor) was not useful and had no practical application.

1. This argument is rejected - the emails between Mr Milewski and Mr Witt did not determine that a device within the claims of the Patent "was not useful and had no practical application".
2. The second was that the device can be used underwater, and therefore must be waterproof. This was advanced by LELO even though Mr Duff did not mention that this promise was not met in the JER 3.
3. LELO relies upon Ms Temminghoff's evidence of rust in one Satisfyer Pro many years ago. However, the cause of the rust is unknown in that one product as it is no longer available for inspection.
4. LELO also relies upon Mr Duff's evidence that he saw the Satisfyer Pro 2 leak during the China experiments, and submits that the video appears to show a droplet of water falling from the Satisfyer Pro 2. However, Mr Duff agreed that the photographs and reports in Duff 3 and the videos that he provided of the China experiments did not demonstrably show any fluid leakage from the Satisfyer Pro 2 device that was tested. Mr Duff also conceded that he did not refer to any such leakage in his reports of the China Experiments. Further, Mr Duff accepted that the Cobalt experiments did not reveal leaking of the Satisfyer Pro 2 device.
5. On the whole, the evidence relied upon by LELO is wholly inadequate to discharge LELO's burden of proving that the "waterproof promise" (as it calls it) has not been met.
6. For these reasons, this aspect of LELO's invalidity attack on the Patent must fail.

1. There are eight LELO Products in issue. The four models - Sona, Sona 2, Enigma and Sila - each include a sub-variant denoted by the term "Cruise" in their name. The "Cruise" function in these sub-variants is not material for the purposes of the infringement analysis.
2. The LELO Products are depicted in Annexure B to these reasons, including with the cross-section depicted with the cavity in minimal volume and maximum volume position.
3. In relation to the issue of infringement, EIS called Ms Hayes, and LELO relied upon the evidence of Mr Duff. For the reasons given above in relation to Mr Duff's lack of independence, I generally prefer the evidence of Ms Hayes to that of Mr Duff where they disagree. Ms Hayes and Mr Duff addressed infringement in the JER 3.
4. In reliance on the evidence of Ms Hayes, EIS submits that, in general terms, the LELO Products all operate in broadly the same manner. Each of them has an internal drive device, which has a motor (powered by a battery) and a drive shaft which is connected to a flexible membrane of silicone which (according to Ms Hayes) forms the second end of the cavity (although this is disputed by LELO). EIS contends that the oscillation of the flexible membrane changes the volume in the cavity from a maximum volume, to a minimum volume, back to a maximum volume. It says that this, in turn, generates a stimulating pressure field within the chamber which oscillates between vacuum (negative) and overpressure (positive) in the cavity's chamber and opening.
5. A material difference, for the purposes of some (but not all) of the claims, is between the Sila models and other LELO Products. This is because the Sila models have a different shaped chamber from the shape adopted by the other LELO Products. This can be seen in the photographs which are found in Annexure B.

14.2 The manner in which the proceeding was conducted

1. As against LELO Australia and LELO Sweden, EIS alleges that the LELO Products include each of the essential integers of the relevant claims of the Patent. In the Statement of Claim in the proceeding brought against Calvista, the same allegation is made in relation to the same products with the omission of "Sila Cruise". However, the "Sila Cruise" is addressed in the Agreed Statement of Issues filed in the proceeding against Calvista, and the parties proceeded on the basis that the infringement claims related to all of the LELO Products as against all of the respondents.
2. LELO filed and relied upon a document entitled "Second Further Amended Position Statement on Infringement" which was filed after the trial commenced and which contained detailed reasons for its denial of infringement of the relevant claims.
3. The experts addressed all of the claims in issue in the JER 3, which was filed on 5 December 2024.
4. On 24 January 2025, being about two weeks before the commencement of the trial, LELO's solicitors wrote to the lawyers for EIS asking whether EIS was "narrowing the claims relied on for infringement". Apparently, no response was received.
5. By its opening submissions, LELO submitted that:

EIS has only addressed claim 1 in [its opening submissions] - it has not addressed each of the features of the other 14 claims asserted against LELO (except lateral walls in claims 3 and 6). Accordingly, LELO will not address the other features of the dependent claims until EIS indicates whether it is pressing infringement of all of the Claims, and explains how it puts its case on those claims (LELO relies on its Position Statement on Infringement, and MD-25, except the points identified in Annexure A).

EIS addresses three non-infringement arguments: (a) no ends (or walls) (AOS 52); (b) no cavity formed by a single chamber (AOS 53); and (c) no VCR in range (AOS 54-55).

(Footnotes omitted.)

1. That EIS did not respond to the letter of 24 January or address all of the claims alleged to be infringed in its opening submissions did not mean that any of these claims had been abandoned by it. By its pleadings and Agreed Statements of Issues, EIS had notified the case which it intended to advance at trial. At trial, it relied on evidence in relation to all of the relevant claims, and the parties also relied upon the JER 3.
2. By its closing submissions, EIS submits that, "There are a number of dependent claims that have not been addressed by the respondents". However, the same might be said of EIS, including by its closing submissions. Remembering that EIS bears the onus on infringement, it was upon EIS to submit why each of the essential integers of the relevant claims had been taken by the LELO Products, and to identify the evidence which supported a finding to that effect.
3. Similarly, by its closing submissions, LELO has also only addressed some of the relevant claims, and did not make submissions concerning all of the matters in its Second Further Amended Position Statement on Infringement.
4. For these reasons, I have addressed the matters raised by the parties in their closing submissions but not otherwise.

14.3.1 Integer 1.2 "a pressure field generation device comprising at least one cavity with a first end and a second end, located opposite the first end and distanced from the first end"

1. LELO contends that the LELO Products do not have "ends" within the meaning of integer 1.2 because the cavity is made from a single piece of silicon.
2. For the following reasons, that argument fails.
3. There is no requirement in claim 1 that the ends (or walls) of the cavity be constructed from any particular piece of material, singular or otherwise. The claims are thus not limited in the manner contended by LELO.
4. Further, as is apparent from Annexure B to these reasons, it is clear where the walls and the ends of the cavity of the LELO Products are located. For example, in the photographs of the Sona, the photograph showing the cavity in minimum volume position shows the floor of the cavity pushed up into what is almost a lip shape, which doubles over part of the walls, whereas the photograph showing the cavity in maximum volume position shows the floor of the cavity as a slightly curved base.
5. Similarly, in Annexure MSH-10 to Hayes 4, which is reproduced here, the ends of the cavities are shown by the additional lines added to the photographs of the cavities as follows:

1. In any event, the Patent discloses that one preferred form of the cavity includes a socket which extends to and is connected to the flexible membrane as a "one-piece component" such that the inner walls of the socket form the entire lateral walls of the cavity: see page 3 lines 26-29 and page 5 lines 32-35.
2. For these reasons, the same argument which is made by LELO in relation to the "lateral walls" required by claims 3 and 6 and the form of the "second end" required by claim 10 also fails.

14.3.2 Integer 1.5 "wherein the cavity is formed by a single chamber"

1. In summary, LELO contends that the LELO Products do not include a cavity "formed by a single chamber" because the cavity has a round or "honeypot" shape and a narrowing towards the opening or "nozzle" that impedes airflow. The same argument is repeated in respect of claims 2 and 4.
2. Because of these features, LELO submits that the LELO Products falls outside the claims.
3. However, I have not accepted LELO's construction of this integer, for the reasons explained above. Further, as EIS submits and with which submissions I agree:

(1) there are no words in any of claims 1 to 4, 6 or 8 to 31 that limit the single chamber to any particular shape. The words of these claims are instead expressed generally and not so limited. In this regard, even Mr Duff was prepared to accept that "[g]enerally a cavity can have any shape" and that a chamber is "[a] defined space within the cavity in this case one chamber";

(2) the invention, even in its preferred form, includes, at its first end, a section that extends outwardly towards the opening and an irregularly shaped flexible membrane: see Figures 3 and 4. These illustrations are consistent with the single chamber in the claims not being required to adopt uniform or straight walls or ends;

(3) the LELO Products are single-chamber devices which do not adopt the two-chamber architecture and narrow connection element referred to in the Background in the Patent.

14.3.3 Integer 1.6 "and the ratio of the volume change to the minimal volume is not below 1/10 and not greater than 1"

1. LELO submits that the VCR in integer 1.6 has not been established because the LELO Products have not been tested, and the required VCR has not been shown to be present, when the LELO Products were used on the clitoris. The same argument is made in relation to the VCR in integer 22.2.
2. However, Ms Hayes and Ms Rigbye agreed in the JER 1 that the device does not need to be measured on the clitoris, which evidence I accept. Notwithstanding this, the onus remained on EIS to establish that the LELO Products, when used on the clitoris, take the integers of each of the claims relied upon by it. Based on my findings that there is insufficient information in the Patent as to the measurement of the VCR of a device when used on the clitoris, I cannot be satisfied that the testing of the LELO Products established that they each generated a change of volume of at least one cavity which fell within the VCR claimed in integer 1.6.
3. That there is insufficient information in the Patent as to how to measure the VCR was borne out by the disputes between the parties concerning the protocols for the Outerspace experiments and Cobalt experiments, and the differences between those protocols. Such debates and differences establish the practical reality, and fortifies my view, that the Patent does not enable the PSA to make the claimed compression wave massage device without undue burden, and that the definition of the boundaries of the invention are uncertain.
4. For these reasons, the evidence did not establish that the LELO Products take integers 1.6 and 22.2. As all of the claims of the Patent depend on claim 1, or on other claims which depend on claim 1, this has the consequence that the LELO Products do not infringe any of the relevant claims.

1. For these reasons, none of the LELO Products infringes the relevant claims of the Patent.

1. By the cross-claims, LELO alleges that various letters, emails and press releases made by EIS were unjustified threats pursuant to s 128 of the Patents Act and misleading and deceptive conduct pursuant to s 18(1) of the ACL. LELO also alleges that EIS breached the December 2023 undertaking.
2. LELO's closing submissions appeared to present a different (and expanded) case to that which had been pleaded, including submitting that a range of specific representations had been made. It also did not address many of the facts pleaded by it, and nor did it identify the evidence relied upon to establish the pleaded fact. This has caused difficulties in understanding the case being advanced by LELO and identifying which aspects of its pleaded case were being pressed.
3. The submissions by EIS (including through documents handed up during oral closing submissions) address LELO's pleaded case, including by reference to the affidavit of Ms Farago-Diener dated 9 October 2024.

15.1 Relevant legal principles - unjustified threats

1. Section 128(1) of the Patents Act provides as follows:

128 Application for relief from unjustified threats

(1) Where a person, by means of circulars, advertisements or otherwise, threatens a person with infringement proceedings, or other similar proceedings, a person aggrieved may apply to a prescribed court, or to another court having jurisdiction to hear and determine the application, for:

(a) a declaration that the threats are unjustifiable; and

(b) an injunction against the continuance of the threats; and

(c) the recovery of any damages sustained by the applicant as a result of the threats.

1. In Rakman International Pty Limited v Boss Fire & Safety Pty Ltd (2023) 178 IPR 20; [2023] FCAFC 202 at [79]-[82] (Nicholas, Burley and Rofe JJ), the Full Court identified the following principles:

(1) Whether a communication amounts to a threat to commence infringement proceedings against the person said to be threatened for the purposes of s 128 is determined objectively.

(2) A threat arises where the language, by direct words or implication, conveys to a reasonable person in the position of the recipient that the author of the letter intends to bring infringement proceedings against the person said to be threatened: U & I Global Trading (Australia) Pty Ltd v Tasman-Warajay Pty Ltd (1995) 60 FCR 26 at 31-32 (Cooper J).

(3) The conclusion of whether a document amounts to a threat of patent infringement proceedings is essentially one of fact: Occupational and Medical Innovations Limited v Retractable Technologies Inc (2007) 73 IPR 312; [2007] FCA 1364 at [9] (Dowsett J).

(4) A threat may arise without a direct reference to infringement proceedings: Lido Manufacturing Co Pty Ltd v Meyers & Leslie Pty Ltd (1964) 5 FLR 443; [1964- 5] NSWR 889 at 450-451(McLelland CJ).

(5) Once a threat has been established, it is prima facie unjustifiable unless the person making the threat establishes that it was justified. The court may grant the relief applied for unless the person threatening infringement proceedings establishes that the relevant conduct infringes or would infringe a valid claim of a patent: s 129.

(6) A threat can be made by means of a letter from a legal representative: Sydney Cellulose Pty Ltd v Ceil Comfort Home Insulation Pty Ltd (2001) 53 IPR 359; [2001] FCA 1350 at [36] (Conti J).

1. To this statement of principles I would add that, while this Court has typically taken the approach that a finding that there has been no infringement means that the threats were unjustified, it is not the case that such a finding will necessarily result in a finding that a threat was unjustified. Rather, it depends on the circumstances.

15.2 Relevant legal principles - misleading or deceptive conduct

1. Section 18(1) of the ACL provides that:

(1) A person must not, in trade or commerce, engage in conduct that is misleading or deceptive or is likely to mislead or deceive.

1. Section 4(1) of the Competition and Consumer Act defines "trade or commerce" to mean "trade or commerce within Australia or between Australia and places outside Australia."
2. Sections 5(1)(c) and (g) of the Competition and Consumer Act extend the ACL (other than Part 5-3) to the engaging in conduct outside Australia by (relevantly) bodies corporate carrying on business within Australia.
3. There was no pleaded case by LELO which articulated the factual basis for the contention that all of the alleged conduct engaged in by EIS, a German company, was in trade or commerce within the meaning of the ACL or to identify the facts relied upon which had the consequence that the ACL applied to its conduct, which conduct included acts undertaken overseas. This undermines the entire case brought by LELO under the ACL.
4. There was also insufficient differentiation between, and identification of, the relevant person or class of persons to whom each pleaded representation was published which identification was supported by the evidence.
5. Such matters are necessary to make good a claim for breach of s 18 of the ACL.
6. Relevantly, in Self Care IP Holdings Pty Ltd v Allergan Australia Pty Ltd (2023) 277 CLR 186; [2023] HCA 8, Kiefel CJ, Gageler, Gordon, Edelman and Gleeson JJ stated these principles at [80]-[83]:

The principles are well established. Determining whether a person has breached s 18 of the ACL involves four steps: first, identifying with precision the "conduct" said to contravene s 18; second, considering whether the identified conduct was conduct "in trade or commerce"; third, considering what meaning that conduct conveyed; and fourth, determining whether that conduct in light of that meaning was "misleading or deceptive or ... likely to mislead or deceive".

The first step requires asking: "what is the alleged conduct?" and "does the evidence establish that the person engaged in the conduct?". The third step considers what meaning that conduct conveyed to its intended audience. As in this case, where the pleaded conduct is said to amount to a representation, it is necessary to determine whether the alleged representation is established by the evidence. The fourth step is to ask whether the conduct in light of that meaning meets the statutory description of "misleading or deceptive or ... likely to mislead or deceive"; that is, whether it has the tendency to lead into error. Each of those steps involves "quintessential question[s] of fact".

The third and fourth steps require the court to characterise, as an objective matter, the conduct viewed as a whole and its notional effects, judged by reference to its context, on the state of mind of the relevant person or class of persons. That context includes the immediate context - relevantly, all the words in the document or other communication and the manner in which those words are conveyed, not just a word or phrase in isolation - and the broader context of the relevant surrounding facts and circumstances. It has been said that "[m]uch more often than not, the simpler the description of the conduct that is said to be misleading or deceptive or likely to be so, the easier it will be to focus upon whether that conduct has the requisite character". That said, the description of the conduct alleged and identified at the first step should be sufficiently comprehensive to expose the complaint, because it is that conduct that will ultimately, as a whole, be determined to be or not to be misleading or deceptive.

Where the conduct was directed to the public or part of the public, the third and fourth steps must be undertaken by reference to the effect or likely effect of the conduct on the ordinary and reasonable members of the relevant class of persons. The relevant class of persons may be defined according to the nature of the conduct, by geographical distribution, age or some other common attribute, habit or interest. It is necessary to isolate an ordinary and reasonable "representative member" (or members) of that class, to objectively attribute characteristics and knowledge to that hypothetical person (or persons), and to consider the effect or likely effect of the conduct on their state of mind. This hypothetical construct "avoids using the very ignorant or the very knowledgeable to assess effect or likely effect; it also avoids using those credited with habitual caution or exceptional carelessness; it also avoids considering the assumptions of persons which are extreme or fanciful". The construct allows for a range of reasonable reactions to the conduct by the ordinary and reasonable member (or members) of the class.

(Citations omitted.)

1. It is also necessary to view the impugned words in context, and to determine whether the statements would be construed by the ordinary or reasonable reader as an expression of belief or opinion rather than a statement of fact. In Australian Competition & Consumer Commission v Dateline Imports Pty Ltd [2015] FCAFC 114 (Gilmour, McKerracher and Gleeson JJ), the Full Court cited the principles in Australian Competition and Consumer Commission v Dukemaster Pty Ltd [2009] FCA 682 at [10] (Gordon J) as being the "correct approach concerning representations of different types" in relation to s 52 of the Trade Practices Act 1974 (Cth), stating relevantly at [179]:
   1. ... it would be wrong to select particular words or acts which although misleading in isolation do not have that character when viewed in context ...

...

1. Precisely the same principles control the operation of s 52(1) to statements involving the state of mind of the maker when the statement was made (e.g. promises, predictions and opinions). A statement which involves the state of mind of the maker ordinarily conveys the meaning (expressly or impliedly) that the maker of the statement had a particular state of mind when the statement was made and, commonly, that there was a basis for that state of mind: ...

2. A statement of opinion will not be misleading or deceptive or likely to mislead or deceive merely because it turns out to be incorrect, misinforms or is likely to do so: ... An incorrect opinion does not of itself establish that the opinion was not held by the person who expressed it or that it lacked any or any adequate foundation: ... An expression of an opinion which is identifiable as an expression of opinion conveys no more than that the opinion is held and perhaps that there is a basis for the opinion. If that is so, an expression of opinion however erroneous misrepresents nothing: ...

(Emphasis and citations omitted.)

15.3 Conduct occurring before the commencement of proceedings

1. LELO claims that by letter dated 4 May 2023, EIS by its lawyers has alleged that (amongst other actions) the supply of the LELO Products constitutes an infringement of the Patent by LELO. In its Amended Defence, EIS admits that by letter dated 4 May 2023, it, by its lawyers, served LELO with the Originating Application and Statement of Claim filed in proceeding NSD 376 of 2023 on 3 May 2023.
2. By its closing submissions, LELO did not refer to the letter dated 4 May 2023, and nor did it take me to the letter. For these reasons, I treat this allegation as not pressed by LELO.

1. LELO claims that "on a date unknown and since about 4 May 2023" EIS or its agent has notified online retail platforms Amazon and eBay to take-down or cease to advertise the LELO products for sale, alleging that the sale of the LELO Products by LELO or other retailers including JouJou constitutes infringement of the Patent in Australia.
2. EIS admits that on or after 4 May 2023, agents for EIS have sent take-down requests via amazon.com.au and ebay.com concerning isolated listings for LELO products and the Patent. However, it relies on the content of the documents, does not admit that the conduct occurred in Australia and states that the documents included statements of opinion or belief which were genuinely and reasonably held by EIS and its agents.
3. By its closing submissions, LELO cites [14] of Lukac 1, which states as follows:

Previous threats of patent infringement were made by EIS on about 4 May 2023 to online retail platforms Amazon and EBay, requesting them to take-down or cease to advertise the LELO Products for sale, alleging that the sale of the LELO Products by LELO Oceania or other retailers including JouJou, constitutes infringement of the Patent in Australia.

1. This affidavit does not annex the notices or contain the text of the notices, and the evidence given by Mr Lukac is hearsay and also opinion evidence in that he expresses the opinion that the notices were "threats of patent infringement". Little weight can be given to this evidence for these reasons, especially as it is not known the basis upon which Mr Lukac is able to attest to these matters. Without the notices themselves being in evidence and without knowing the circumstances in which these notices were sent, I cannot be satisfied to the required standard that EIS has engaged in either misleading or deceptive conduct or has made unjustified threats as alleged.

1. By its closing submissions, LELO submits that a letter alleging patent infringement was sent from EIS's lawyers to Calvista on 9 November 2023. The evidence reference (Lukac 1 at [3]) which is cited in LELO's closing submissions makes no reference to any such letter, and the letter does not appear to be in evidence. I am therefore unable to be satisfied to the required standard that EIS has engaged in either misleading or deceptive conduct or has made unjustified threats by way of this letter as alleged.

On about 9 November 2023, the Cross-respondent or its agent has notified Calvista Australia Pty Ltd ("Calvista") to cease to advertise the LELO Products for sale on the Calvista website and to destroy LELO Products that are in stock, alleging that "our patent is also valid in Australia" and that the LELO Products were "dupes" and that sale of the LELO Products by the Cross-claimants or other retailers including Calvista constitutes infringement of the Patent in Australia.

1. The notification was contained in an email dated 9 November 2023 which stated:

I wanted to discuss with you, the issue of the air pressure wave products available on your website.

Please note that we have a patent regarding air pressure wave products, and any product that uses our patent is referred to as a "dupe". I have attached the patent for your reference and ask that you remove any products utilizing our patent from your website. Please see the attached documents for additional information. Our patent is also valid in Australia. We are currently checking the markets worldwide.

Our patent applies to all products except for Womanizer, as they have their own patent. The easy way would be to delete all our pressure wave products from the website and then I would connect to our legal department for signing the settlement agreement.

Let's schedule a call to discuss the details. Could you give me your feedback as soon as possible?

Since Kerrie is out of office, I am more than happy to jump in.

Looking forward to your feedback.

1. The attached patent is a copy of a European patent (EU 297 Patent).
2. The email does not say that Calvista should "destroy all LELO Products that are in stock" and nor does it make any reference to LELO products. However, the settlement agreement which was attached to the email included proposed terms to this effect, and so there is an implicit representation to this effect. Further, the email does not say in terms that "sale of the LELO Products by the Cross-claimants or other retailers including Calvista constitutes infringement of the Patent in Australia", but that is also the implicit representation including when one has regard to the terms of the attached settlement agreement. Accordingly, when the communication is regarded as a whole (including the attachments to the email), the notification was made as alleged by LELO.
3. EIS contends that the documents included statements of opinion or belief which were genuinely and reasonably held by EIS and its agents. I agree with this characterisation of the notification dated 9 November 2023. Leaving aside the social niceties in the email, the express or implied representations about which complaint is made in LELO's pleading are statements of opinion or belief. That is, they are representations that the maker of the statements holds those opinions, and I consider that they would have been perceived as such by Calvista. As to this, although Mr Sheldon-Collins (the recipient of the email) was called as a witness, he did not give evidence on this topic. That it transpired that the opinions were incorrect does not make them misleading or deceptive, and the reasonable reader of this email and its attachment would regard them as allegations: see e.g., GM Global Technology Operations LLC v SSS Auto Parts Pty Ltd (2019) IPR 199; [2019] FCA 97 at [592] (Burley J).
4. However, having regard to the content of the email and its attachments, the notification of 9 November 2023 to Calvista was a threat within the meaning of s 128 of the Patents Act. That is because, determined objectively, the communication as a whole (with the attached settlement agreement), would convey to a reasonable person in the position of Calvista that EIS intends to bring infringement proceedings against it. This is especially as:

(1) the email refers to "the issue of the air pressure wave products available on [Calvista's] website";

(2) the email refers to the EIS patent "regarding air pressure wave products" and states that any product "that uses our patent" is referred to as a "dupe";

(3) the email asks that Calvista remove any products "utilizing our patent from your website". That the products should be taken down is repeated as part of what is said to be the "easy way" (and thereby implying that there is a "hard way");

(4) the email asserts that the patent is "also valid in Australia" and "applies to all products except for Womanizer";

(5) the email refers to connecting "to our legal departments for signing the settlement agreement";

(6) the attached settlement agreement refers to the distribution of the LELO Products in the Preamble and contains a proposed undertaking by Calvista to refrain from offering, putting into circulation or selling the LELO Products, to destroy any such products which are in stock, to provide certain information "and to render account". In return, EIS defers its rights for compensation against Calvista "including the profit made... insofar as it is based on the patent infringement" but if the information provided to EIS turns out to be incorrect, the deferral ends and the rights of EIS for compensation of damages is revived and immediately due, along with an agreed contractual penalty.

1. Notwithstanding that it was a threat of infringement proceedings, the conduct by EIS in sending correspondence directly to an alleged infringer to attempt to resolve the dispute before issuing proceedings was consistent with its obligations under s 6 of the Civil Dispute Resolution Act 2011 (Cth). That is not the conduct sought to be addressed by s 128 of the Patents Act: see Nine Network Australia Pty Ltd v Ice TV Pty Ltd (2007) 73 IPR 99; [2007] FCA 1172 at [232] (Bennett J) in relation to the analogous provision in the Copyright Act 1968 (Cth), but cited and applied in relation to the Patents Act in Damorgold Pty Ltd v Blindware Pty Ltd (2017) 130 IPR 1; [2017] FCA 1552 at [420] (Middleton J).
2. Further, EIS had good grounds for asserting the rights that it did. The EU 297 Patent is in the same patent family as the Patent, both being derived from the same parent application. The specification and claims of the Patent and EU 297 Patent are broadly the same. LELO had opposed the EU 297 Patent before the European Patent Office (EPO). On 18 October 2022, being just over one year prior to the First Calvista Email, the EPO had rejected the opposition brought against the EU 297 Patent (EPO decision).
3. Further, the contentions by EIS in this proceeding as to the construction of the claims, and its infringement case against Calvista, were not unarguable (and LELO did not submit that they were).
4. For these reasons, the threat in the First Calvista Email was not objectively groundless or unjustifiable: JMVB Enterprises Pty Ltd v Camoflag Pty Ltd (2005) 67 IPR 68; [2005] FCA 1472 at [212]-[213] (Crennan J). It was therefore not an unjustified threat.

15.4 Conduct occurring after the commencement of proceedings

1. LELO alleges that, on 25 January 2024, EIS or its agent sent a report to Amazon stating that the LELO products listed on Amazon's website (including the Australian website) infringe the Patent. EIS relies on the content of the document for its full terms and effect.
2. By its closing submissions, LELO did not direct me to the alleged report, and it does not appear to be in evidence. What is in evidence is an email from Amazon dated 25 January 2024 stating that it had "received a report from a rights owner that one or more of your listings may be infringing on the intellectual property rights of others" and it refers to the Patent.
3. Without being able to consider the report itself and without knowing the circumstances in which it was sent to Amazon, I cannot be satisfied to the required standard on the evidence that EIS has engaged in misleading or deceptive conduct, has made unjustified threats or has breached the December 2023 undertaking.

1. On about 6 August 2024, EIS sent an email to Mr Sheldon-Collins of Calvista which stated:

Dear Roger,

I hope you are having a smooth start to the week

Please find attached the latest Press release outlining a significant success against LELO, with the court confirming and fully supporting our position, emphasizing the validity of Satisfyer Patents regarding LELO x Satisfyer.

I hope you can use this to confirm any queries that may arise from your customers.

Please don't hesitate to let me know if you have questions!

Kindest regards,

Kerrie

1. The attached press release bore the Satisfyer logo as a header. The stated location is Bielefeld, Germany and the date is 07/31/2024. The press release states:

Court Convicts LELO of Patent Infringements

This is a significant victory against LELO, fully supporting our position and emphasizes the validity of our patents:

The court confirms that products from LELOi AB and LELO Europe GmbH infringe on the patents of EIS GmbH.

On July 25, 2024, the Düsseldorf District Court ruled that LELO products Sona, Sila, and Enigma infringe on the patents of EIS GmbH. EIS primarily utilizes these patents in Satisfyer's pressure wave vibrators. As a result of this ruling, LELO is required to cease distributing the infringing products within the jurisdiction of the court's decision, provide EIS with information about all distributed products and their recipients, and pay damages for the distribution of patent-infringing products.

Previously, on October 18, 2022, the European Patent Office had rejected the opposition filed by LELO Europe GmbH against our patent. Both decisions provide strong support for our ongoing legal proceedings against LELOi AB, which are pending in Sweden, Australia, Canada, and other European countries.

LELO has appealed both the decision of the European Patent Office and the Düsseldorf District Court. However, our patent and legal attorneys remain confident that the clear decisions already issued will be upheld on appeal.

We feel more than validated by the Düsseldorf District Court's decision and are now offering former dealers of our competitor LELO, and other providers who refrain from infringing our patents, the opportunity to cooperate with us regarding our Satisfyer products.

1. LELO alleges and EIS admits that they published this press release on LinkedIn, and communicated this press release to Calvista, Checkright Pty Ltd, LonBrook Pty Ltd, PHE International Pty Ltd, Sexyland Australia P/L, Synergy Magazine and Windsor Wholesale Australasia Pty Limited. Other than Calvista and Synergy Magazine, no submission was made or evidence identified which showed the status of these other companies (such as whether they were actual or potential distributors, and even if they were all located in Australia). Nor is there any evidence that the named companies were "clients or potential clients of LELO" as LELO submits.
2. For that reason, I will proceed on the generous assumption that the reader of the press release is a person within Australia who is interested in sexual products, particularly those for women.
3. LELO alleges that, by this conduct, EIS made representations "well knowing" of facts which had the consequence that they were misleading and deceptive. However, LELO's case seeks to select particular sentences from the press release, rather than reading the press release in context and in its entirety, which is the wrong approach.
4. In any event, each of LELO's allegations will be addressed in turn.
5. LELO submits that:

(1) In circumstances where the German court decision is a civil matter and not a criminal matter, the use of the word "convicts" in the press release is said to be misleading because it suggests a criminal hearing and decision and/ or a criminal penalty.

I disagree. When the press release is read as a whole, it is plain that it is referring to a civil case and not a criminal one. This is especially because of the reference to LELO being required to cease distributing the infringing products and pay damages, which are not typical outcomes of criminal proceedings. For these reasons, the pleaded representation is not conveyed by the conduct.

(2) The statement in the press release that the "Düsseldorf District Court" decision and EPO decision are a "significant victory against LELO fully supporting [EIS's] position and [which] emphasizes the validity of [EIS's] patents" is said to be misleading because the "Düsseldorf District Court" decision only relates to construction and infringement and the issue of validity has not been heard; the claims of the German patent are different to the claims of the equivalent Australian patent; there are grounds of objection to the validity of the Australian patent which are not available in Germany; and the questions of construction and infringement and validity will be determined on the basis of different evidence.

By its closing submissions, LELO did not direct me to any evidence on this topic, including evidence from an appropriately qualified German lawyer to attest that there are grounds of objection to the validity of the Australian patent which are not available in Germany (for example). In any event, I consider that the statement in the press release is one of opinion or belief, and it would be perceived as such. That is, it is a representation that the maker of the statement holds this opinion. That the opinion is incorrect (if that is the case) does not make it misleading or deceptive.

(3) Complaint is also made about the statement in the press release that the Düsseldorf District Court's decision, alongside the EPO decision, "provide strong support for [EIS's] ongoing legal proceedings against LELOi AB, which are pending in Sweden, Australia, Canada, and other European countries".

Again, I consider that this statement is one of opinion or belief. That is, it is a representation that the maker of the statement holds this opinion, and it would be perceived as such. That the opinion is incorrect (if that is the case) does not make it misleading or deceptive.

(4) The press release invites LELO dealers and "other providers who refrain from infringing our patents" to provide EIS's Satisfyer products which is said by LELO to imply that providers must refrain from infringing EIS's patents (including any Australian patent). This is said to be misleading because it is not confined to the German patent (it is couched in the plural, i.e., "our patents").

In my view, the statement contains an implicit expression of an opinion that LELO products infringe the Patent, and it would be perceived as such. This opinion has turned out to be incorrect (having regard to my findings) but that does not make it misleading in and of itself for the reasons explained above.

(5) The statement in the email that the press-release outlines "... a significant success against LELO, with the court confirming and fully supporting our position, emphasizing the validity of Satisfyer Patents regarding LELO x Satisfyer" is said to be misleading for the same reasons as (2) above.

Again, I consider that this statement is one of opinion or belief. That is, it is a representation that the maker of the statement holds this opinion, and it would be perceived as such. That the opinion is incorrect (if that is the case) does not make it misleading or deceptive.

(6) The statement in the email to "use this [press-release] to confirm any queries that may arise from your customers" is said to be misleading in that it implies that the press-release relates to the [Australian] Patent and is relevant to Australian customers.

I disagree that it conveys this representation but if it does, it is a statement of opinion or belief. That is, it is a representation that the maker of the statement holds this opinion, and it would be perceived as such. That the opinion is incorrect (if that is the case) does not make it misleading or deceptive.

1. By the time of the Second Calvista Email, EIS had commenced infringement proceedings against Calvista. For this reason, a threat within the meaning of s 128 was not made in such circumstances.
2. Nor do I consider that the text of the press release itself conveys a threat to bring infringement proceedings in respect of the Patent against the other recipients of the press release or the readers of the press release published on LinkedIn.
3. As there has been no relevant threat established, there has been no breach of the December 2023 undertaking.
4. The press release referred to a decision dated 25 July 2024 of the Dusseldorf Regional Court which found in favour of EIS against LELO, and which found that the LELO Products (being the same ones as in issue in this proceeding) infringed the EU 297 Patent (Dusseldorf Decision). The Düsseldorf Decision also reviewed the EPO decision and confirmed the validity of the EU 297 Patent.
5. In the affidavit of Ms Farago-Diener, the following evidence is given:

I am informed by EIS' representatives and verily believe, that in light of the history of proceedings between EIS Gmbh and LELOi AB in the German Courts and European Patent Office that EIS believes that the LELO products are infringing EIS' patent rights in Germany and Australia, as well as in other jurisdictions and that the favourable outcomes EIS has achieved in Germany may also be achieved in Australia and in other jurisdictions. In addition, I am informed by EIS' representatives and verily believe, that EIS honestly holds the opinions and beliefs expressed in its Press Releases, including the Press Releases published in Sign and Synergy Online Magazines.

I am further informed by EIS' representatives and verily believe, that, since the Dusseldorf Decision, EIS has decided and offered former suppliers and distributors the opportunity to re-supply and distribute EIS' Satisfyer products.

1. Considering this evidence, as well as the matters relied upon in relation to the First Calvista Email, I consider that, had a threat within the meaning of s 128 been made, it was not objectively groundless or unjustifiable.
2. For these reasons, the claims in relation to the Second Calvista Email fail.

1. The next complaint by LELO relates to a press release in or to Sign Magazine on or about 15 August 2024 (First Sign Press Release) and a press release in or to Sign Magazine on or about 17 September 2024 (Second Sign Press Release).
2. The First Sign Press Release stated as follows:

15.08.2024 | Bielefeld, Germany - The Düsseldorf Regional Court ruled on 25 July 2024 that the Sona, Sila and Enigma products of the LELO brand infringe the patents of EIS GmbH/Satisfyer.

These patents are used in particular in the pressure wave vibrators of the Satisfyer brand. As a result of this judgement, LELO is obliged to refrain from distributing the infringing products within the scope of the decision, to provide EIS with information about all distributed products and their recipients and to pay damages.

The European Patent Office had already previously rejected LELO Europe GmbH's opposition to the patent in a decision dated 18 October 2022. Both decisions provide EIS GmbH with a tailwind in further proceedings against LELOi AB, which are pending in Sweden, Australia, Canada and other countries in Europe, LELO has appealed against both the decision of the European Patent Office and the judgement of the Düsseldorf Regional Court.

However, EIS GmbH/Satisfyer and its patent attorneys and attorneys-at-law remain convinced that the clear decisions already made will be further confirmed by the appellate courts. EIS GmbH/Satisfyer sees the decision of the Düsseldorf Regional Court as confirmation of its decision to offer former dealers of the market companion LELO and other patent-infringing providers who refrain from infringing the patent a co-operation with regard to the Satisfyer products.

1. The Second Sign Press Release stated as follows:

German court has ruled that LELO made false and misleading statements in an ongoing patent dispute

17.09.2024 | Bielefeld, Germany - On 9 September 2024, the Hildesheim Regional Court ruled in favour of EIS in preliminary injunction proceedings and confirmed that LELO had made false and misleading statements about the status of the infringement proceedings against LELO products in a press release.

As previously reported, the Düsseldorf Regional Court ruled on 25 July 2024 that LELO'S products - Sona, Sita and Enigma - infringe EIS GmbH's patents. As a result, LELO is obliged to cease distribution of the infringing products in the court's jurisdiction, provide EIS with information about all distributed products and their recipients and pay damages for the distribution of the infringing products. Previously, on 18 October 2022, the European Patent Office had rejected LELO Europe GmbH's opposition to EIS's patent. LELO has appealed against both the decision of the European Patent Office and that of the Düsseldorf Regional Court.

Disregarding the status of the proceedings, LELO made false and misleading statements in a press release including the following:

"Importantly, the German court did not review the patent for validity, LELO will challenge the patent on these grounds shortly."

"Accordingly, LELO's customers and clients outside of Germany will not be affected in any way by this judgement."

Regarding the false statements: Firstly, the Opposition Division of the European Patent Office confirmed the validity of the relevant patent EP '297 on 18 October 2022. Secondly, it is not unlikely that the courts in other countries will follow the German judgement; LELO had not presented any counter-arguments.

LELO has the right to lodge an immediate appeal against the interim injunction of the Hildesheim court.

EIS is encouraged by the recent decision of the Hildesheim District Court to offer former distributors of our competitor LELO as well as other companies that respect our patent rights in the future, the opportunity to co-operate in the distribution of our Satisfyer products.

1. LELO alleges that Sign Magazine is a trade magazine for the adult industry published in Germany and Europe (German language) and in the United Kingdom (English language) and online. While EIS admits that it or its agent issued the First and Second Sign Press Releases, the allegations are otherwise denied.
2. In Douros 6, Mr Douros describes the publication as the "online Sign weekly newsletter", which is some evidence that Sign Magazine is published online. However, I was not taken to the evidence to support the balance of the pleaded allegation about Sign Magazine, and it does not appear to have been adduced. Importantly, I was not taken to any evidence which identified the class of persons who read Sign Magazine at the relevant time (including online) with the consequence that I am unable to form a view as to the effect of the statements made in these press releases on the state of mind of the relevant person or class of persons.
3. On 9 September 2024, the Regional Court of Hildesheim made findings that LELOi AB and LELO Europe GmbH were prohibited from making certain statements in business dealings with sex toys (Hildesheim Decision). Taking into account the EPO decision, the Dusseldorf Decision and the Hildesheim Decision (including the evidence of Ms Farago-Diener about those decisions and the evidence about the state of mind of EIS in light of the decisions), the pleaded case concerning the First and Second Sign Press Releases brought under s 18 of the ACL would fail for this additional reason.
4. It follows that the case brought by LELO for breach of s 18 of the ACL in relation to the First and Second Sign Press Releases must fail.
5. As to publication of the press releases in Sign Magazine, LELO did not explain how this would constitute an unjustified threat. In particular, LELO did not explain how publication of these press releases in a magazine which is published overseas (including in German) to an unidentified class of persons constitutes an unjustified threat of infringement proceedings in relation to the Patent against those persons within the meaning of s 128 of the Patents Act (i.e. Australian legislation). This claim appears to be misconceived.
6. Taking into account the EPO decision, the Dusseldorf Decision and the Hildesheim Decision (including the evidence of Ms Farago-Diener about those decisions and the evidence about the state of mind of EIS in light of the decisions), as well as the matters relied upon in relation to the First Calvista Email, I would not have found that, had a threat within the meaning of s 128 been made, it was objectively groundless or unjustifiable.
7. Finally, as there has been no relevant threat established, there has been no breach of the December 2023 undertaking by EIS.

15.4.4 First and Second Synergy Press Releases

1. The next pleaded complaint relates to a press release in or to Synergy Magazine on or about 20 August 2024 (First Synergy Press Release) and a press release in or to Synergy Magazine on or about 18 September 2024 (Second Synergy Press Release).
2. LELO alleges that Synergy Magazine is a trade magazine for the adult industry published in Australia and online and which publishes a regular newsletter to its subscribers in Australia. The particulars state that the newsletter was sent to Ms Temminghoff (Passionfruit Shop) on 19 September 2024. While EIS admits that it or its agent issued the First and Second Synergy Press Releases, the allegations are otherwise denied.
3. In Douros 6, Mr Douros describes the Synergy Magazine as an "Australian magazine", and that there are "Australian readers of the magazine, whether as subscribers or otherwise". However, I was not taken to the evidence to support the balance of the pleaded allegation about Synergy Magazine, including the characteristics of these "Australian readers", and it does not appear to have been adduced.
4. The newsletter was sent by email to Ms Temminghoff (who operates a business in Australia and is in the trade) on 19 September 2024 from Synergy, which is stated to have an address in Victoria. The email itself states that, "Synergy is an adult retail trade publisher catering for adult pleasure product personnel to keep them abreast of industry news, new and existing products and brands".
5. However, other than the evidence that the newsletter was sent to Ms Temminghoff (a retailer) and the statement in the newsletter itself, I was not taken to any evidence which identified the class of persons who read Synergy Magazine at the relevant time (including online) such that I am able to form a view as to the effect of the statements made in these press releases on the state of mind of the relevant person or class of persons. In particular, LELO submits that the class of persons would be likely to be unaware of the jurisdictional limits of patent rights and the courts that determine them. Based on the evidence, however, I cannot accept that submission. This is especially as Ms Temminghoff did not give evidence about the views which she formed when she received the newsletter, or about her understanding of patent rights.
6. The First Synergy Press Release stated:

New York, NY - This is a significant victory against LELO, fully supporting our position and emphasizes the validity of our patents:

The court confirms that products from LELOi AB and LELO Europe GmbH infringe on the patents of EIS GmbH.

On July 25, 2024, the Düsseldorf District Court ruled that LELO products Sona, Sila, and Enigma infringe on the patents of EIS GmbH. EIS primarily utilizes these patents in Satisfyer's pressure wave vibrators. As a result of this ruling, LELO is required to cease distributing the infringing products within the jurisdiction of the court's decision, provide EIS with information about all distributed products and their recipients, and pay damages for the distribution of patent-infringing products.

Previously, on October 18, 2022, the European Patent Office had rejected the opposition filed by LELO Europa GmbH against our patent. Both decisions provide strong support for our ongoing legal proceedings against LELOi AB, which are pending in Sweden. Australia, Canada, and other European countries.

LELO has appealed both the decision of the European Patent Office and the Düsseldorf District Court.

However, our patent and legal attorneys remain confident that the clear decisions already issued will be upheld on appeal.

We feel more than validated by the Düsseldorf District Court's decision and are now offering former dealers of our competitor LELO, and other providers who retain from infringing our patents, the opportunity to cooperate with us regarding our Satisfyer products.

1. The particular statements in the First Synergy Press Release about which complaint is made by LELO are:

(1) Court Convicts LELO of Patent Infringements;

(2) This is a significant victory against LELO, fully supporting our position and emphasizes the validity of our patents;

(3) Both decisions provide strong support for our ongoing legal proceedings against LELOi AB, which are pending in Sweden, Australia, Canada and other European countries;

(4) We feel more than validated by the Düsseldorf District Court's decision and are now offering former dealers of our competitor LELO, and other providers who refrain from infringing our patents, the opportunity to co-operate with us regarding our Satisfyer products.

1. As to statement (1), LELO contends that, in circumstances where the German court decision is in a civil matter and not a criminal matter, the use of the word "convicts" in the press release is said to be misleading because it suggests a criminal hearing and decision and/ or a criminal penalty. However, I disagree. When the press release is read as a whole, it is plain that it is referring to a civil case and not a criminal one, and I would be surprised if it was read in any different way.
2. As to statements (2) and (3), these are statements of opinion or belief. That is, they are a representation that the maker of the statement holds this opinion, and (doing the best I can) I consider that it would be perceived as such. That each opinion is incorrect (if that is the case) does not make it misleading or deceptive.
3. As to statement (4), this is alleged to be misleading because it implies that providers must refrain from infringing EIS's patents (including any Australian patent) because it is not confined to the German patent (it is couched in the plural, i.e., "our patents") and the statement is made in the context of earlier statements in the press release that the decisions support EIS's pending case in Australia, which constitutes a threat of patent infringement. However, in the absence of evidence as to the class of persons who read Synergy Magazine at the relevant time, I am unable to accept that this submission.
4. It follows that the case brought by LELO for breach of s 18 of the ACL in relation to the First Synergy Press Release must fail.
5. As to publication of the First Synergy Press Release, LELO did not explain in any satisfactory way how this would constitute an unjustified threat, and why that was so (including why it was a threat of infringement proceedings).
6. In any event, taking into account the EPO decision, the Dusseldorf Decision and the Hildesheim Decision (including the evidence of Ms Farago-Diener about those decisions and the evidence about the state of mind of EIS in light of the decisions), as well as the matters relied upon in relation to the First Calvista Email, I would not have found that, had a threat within the meaning of s 128 been made, it was objectively groundless or unjustifiable.
7. Nor do I consider that the text of the press release itself conveys a threat to bring infringement proceedings in respect of the Patent. As there has been no relevant threat established, there has been no breach of the December 2023 undertaking by EIS.
8. For these reasons, the pleaded case in relation to the First Synergy Press Release fails.
9. The Second Synergy Press Release stated:

New York, NY - On September 9, 2024, in preliminary injunction proceedings, the District Court of Hildesheim ruled in favour of EIS, confirming that LELO had included incorrect and misleading statements in a press release about the status of the infringement proceedings against LELO products.

As reported previously, on July 25,2024, the Düsseldorf District Court ruled that the LELO's products - Sona, Sila, and Enigma - violate the patents of EIS GmbH. As a result, LELO is required to cease distributing the infringing products within the court's jurisdiction, provide EIS with information about all distributed products and their recipients, and pay damages for the distribution of patent-infringing products.

Previously, on October 18, 2022, the European Patent Office had rejected the opposition filed by LELO Europe GmbH against EIS's patent. LELO has appealed both the decision of the European Patent Office and the Düsseldorf District Court.

Ignoring the status of the proceedings, in a press release LELO provided incorrect and misleading statements, including the following:

"Importantly, the German court did not review the patent with regard to its validity; LELO will challenge the patent on these grounds shortly."

"Accordingly, LELO customers and clients outside of Germany will not be impacted by this ruling in any manner whatsoever."

In regard to the incorrect statements, firstly on October 18, 2022, the European Patent Office Opposition Division confirmed the validity of the patent EP '297 in question. Secondly, it is not unlikely that the courts in other jurisdictions will follow the German court ruling: LELO had not brought forward any counter-argument for this.

LELO has the right to file an immediate appeal against the Hildesheim court's preliminary injunction.

EIS is encouraged by the recent decision of the Hildesheim court to offer former distributors of our competitor LELO, as well as other companies that will respect our patent rights, the opportunity to collaborate with us in promoting and distributing our Satisfyer products.

1. The particular statements in the Second Synergy Press Release about which complaint is made are:

(1) Court Rules that LELO Provided Incorrect and Misleading Information;

(2) Ignoring the status of the proceedings, in a press release LELO provided incorrect and misleading statements, including the following:

"Importantly, the German court did not review the patent with regard to its validity; LELO will challenge the patent on these grounds shortly."

"Accordingly, LELO customers and clients outside of Germany will not be impacted by this ruling in any manner whatsoever."

(3) In regard to the incorrect statements, firstly on October 18, 2022, the European Patent Office Opposition Division confirmed the validity of the patent EP '297 in question. Secondly, it is not unlikely that the courts in other jurisdictions will follow the German court ruling; LELO had not brought forward any counter-argument for this.

(4) EIS is encouraged by the recent decision of the Hildesheim court to offer former distributors of our competitor LELO, as well as other companies that will respect our patent rights, the opportunity to collaborate with us in promoting and distributing our Satisfyer products.

1. As to statements (1) and (2), these are alleged to be misleading because the reasons given in the relevant court decision do not state that LELO made any "false or misleading statements" at all and, at the time of publishing these statements (and seeking the preliminary injunction), the statements made by LELO were not "false and misleading" but were in fact true, including because "the German court decision only relates to construction and infringement because the issue of validity has not been heard; the claims of the German patent are different to the claims of the equivalent Australian patent; there are grounds of objection to the validity of the Australian patent which are not available in Germany; and the questions of construction and infringement and validity will be determined on the basis of different evidence". However, again, I was not taken to the evidence to support these various propositions, and it does not appear to have been adduced.
2. As to statement (3), this is alleged to be misleading because at the time of publishing these statements (and seeking the preliminary injunction), the statements made by LELO were not "false and misleading" but were in fact true, including because "the German court decision only relates to construction and infringement because the issue of validity has not been heard; the claims of the German patent are different to the claims of the equivalent Australian patent; there are grounds of objection to the validity of the Australian patent which are not available in Germany; and the questions of construction and infringement and validity will be determined on the basis of different evidence". However, I was not taken to the evidence to support these various propositions, and no submissions were made by LELO, and so I regard this allegation as not pressed.
3. As to statement (4), this is alleged to be misleading because it implies that LELO's distributors ("former distributors of our competitor LELO") and other companies ("that respect our patent rights in the future") can no longer distribute LELO products because that would be in contravention of the EIS's "patent rights". LELO says that, in the context of the previous paragraphs in the press release, this implication is not confined to Germany, but extends to any country where there are equivalent patents. It is also said that this constitutes a threat to providers of LELO products in Australia that they will infringe the Australian patent by selling LELO products in Australia.
4. However, I do not accept that statement (4) conveys these representations, as it reads too much into what is, in effect, no more than an invitation to promote and distribute EIS products on a certain basis (such basis being that LELO products are not also distributed).
5. Nor am I persuaded that the readers of the Second Synergy Press Release had the attributes which LELO submits that they had. As there appears to be very limited evidence about the general status and identity of these readers, it is difficult (if not impossible) to assess.
6. Further, LELO did not explain in any satisfactory way how the Second Synergy Press Release contained or would constitute an unjustified threat, and why that was so (including why it was a threat of infringement proceedings).
7. In any event, taking into account the EPO decision, the Dusseldorf Decision and the Hildesheim Decision (including the evidence of Ms Farago-Diener about those decisions and the evidence about the state of mind of EIS in light of the decisions), as well as the matters relied upon in relation to the First Calvista Email, I would not have found that, had a threat within the meaning of s 128 been made, it was objectively groundless or unjustifiable.
8. Nor do I consider that the text of the press release itself conveys a threat to bring infringement proceedings in respect of the Patent. As there has been no relevant threat established, there has been no breach of the December 2023 undertaking by EIS.
9. For these reasons, the pleaded case in relation to the Second Synergy Press Release fails.

1. On 19 September 2024, an email was sent to Calvista as follows:

Hi Roger,

Just keeping you updated on the preliminary injunction proceedings regarding EIS vs LELO. Please find the latest press release attached.

If you have any questions or queries please don't hesitate to ask!

Have a wonderful rest of the week!

Kindest regards,

Kerrie Mckinnon

Sales Manager Australia & New Zealand

1. The attached press release bore the dateline "Germany, September 2024" and stated as follows:

A German court has ruled that LELO provided incorrect and misleading information in an ongoing patent dispute

On September 9, 2024, in preliminary injunction proceedings, the District Court of Hildesheim ruled in favour of EIS, confirming that LELO had included incorrect and misleading statements in a press release about the status of the infringement proceedings against LELO products.

As reported previously, on July 25, 2024, the Düsseldorf District Court ruled that the LELO's products - Sona, Sila, and Enigma - violate the patents of EIS GmbH. As a result, LELO is required to cease distributing the infringing products within the court's jurisdiction, provide EIS with information about all distributed products and their recipients, and pay damages for the distribution of patent-infringing products. Previously, on October 18, 2022, the European Patent Office had rejected the opposition filed by LELO Europe GmbH against EIS's patent. LELO has appealed both the decision of the European Patent Office and the Düsseldorf District Court.

Ignoring the status of the proceedings, in a press release LELO provided incorrect and misleading statements, including the following:

"Importantly, the German court did not review the patent with regard to its validity; LELO will challenge the patent on these grounds shortly."

"Accordingly, LELO customers and clients outside of Germany will not be impacted by this ruling in any manner whatsoever."

In regard to the incorrect statements, firstly on October 18, 2022, the European Patent Office Opposition Division confirmed the validity of the patent EP '297 in question. Secondly, it is not unlikely that the courts in other jurisdictions will follow the German court ruling: LELO had not brought forward any counter-argument for this.

LELO has the right to file an immediate appeal against the Hildesheim court's preliminary injunction.

EIS is encouraged by the recent decision of the Hildesheim court to offer former distributors of our competitor LELO, as well as other companies that will respect our patent rights, the opportunity to collaborate with us in promoting and distributing our Satisfyer products.

1. EIS admits sending the Third Calvista Email but otherwise denies the allegations (described as the Second Calvista email in the pleadings).
2. By its pleading, LELO complains about the following statement in this email:

Just keeping you updated on the preliminary injunction proceedings regarding EIS v LELO. Please find the latest press release attached.

1. This statement is neither misleading nor does it contain a threat, let alone an unjustified threat, within the meaning of s 128 of the Patents Act. This is especially as proceedings had been commenced against Calvista by this time.
2. As there was no threat, there was no breach of the December 2023 undertaking.
3. For these reasons, the pleaded case in relation to the Third Calvista Email fails.

1. The causes of action and complaints concerning the statements made by EIS, as advanced in the cross-claims, were not established on the evidence.

1. The application brought by EIS should be dismissed, declaratory relief should be granted and the Patent should be revoked. The cross-claims should otherwise be dismissed. Orders will be made accordingly. Further, these orders should be stayed for 28 days or the determination of any appeal.

I certify that the preceding four hundred and sixty (460) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Downes.

1. During the hearing, certain rulings were made, with reasons to be provided in this judgment. These are my reasons for those rulings.

1. EIS objected to certain words in the first sentence as well as the penultimate and final sentences of [11] of Duff 1 on the basis that Mr Duff cannot give evidence about what was in the mind of the design team when designing the LELO Products. As to this, there was no dispute that Mr Duff was not part of the design team: Duff 6 [16], [42].
2. For this reason, I made an order pursuant to s 136 of the Evidence Act that the penultimate and final sentence of [11] should be limited to what Mr Duff recognised based upon his personal experience. In my view, this met the complaint raised by EIS. I did not consider that the impugned words in the first sentence of [11] should be excluded as they are a statement of fact.
3. The following paragraphs of Duff 1 were also objected to by EIS, with the following consequences:

(1) paragraph [13] was excluded because it purports to give evidence about the state of mind of Mr Sedic;

(2) the first, second and last sentences of [14] were excluded as they related to the state of mind of Mr Sedic. The balance of [14] are factual statements based on Mr Duff's observations and were admitted into evidence for that reason;

(3) paragraphs [23], [26]-[29] were excluded because they constitute inadmissible hearsay evidence about the development process of the design team.

1. Paragraph 24 was excluded because, as Mr Duff was not a member of the design team, it is inadmissible hearsay evidence.

1. EIS objected to the words "and was being discussed by everybody in the industry, as well as users" in [9] of Duff 9. I excluded that evidence on the basis that it is inadmissible hearsay evidence_._
2. EIS also objected to the final sentence of [9], which reads:

See e.g. the EAN Magazine article dated 8 August 2016, with extracts from an interview with the inventor of the Womanizer, Michael Lenke. Annexed and marked "MD- 26" is a copy of the EAN Magazine article. (See also paragraphs 16-17 below).

1. However, I allowed this sentence on the grounds that the article contained in Annexure MD-26 is relied upon for Mr Duff's understanding, and not for the truth of its contents.

1. Paragraphs 14-33 of Duff 9 related to the Womanizer promotional videos. The Womanizer videos had been considered by the other independent expert witnesses in the JER 2.
2. In [14]-[33] of Duff 9, Mr Duff gave evidence by reference to specific screenshots taken from both Womanizer videos. If his evidence had been admitted, it would have expanded the evidence to be addressed in the concurrent evidence at trial in circumstances where Mr Duff had not attended the relevant joint expert conclave.
3. For this reason, I excluded [14]-[33] of Duff 9 and LELO was not permitted to rely on this evidence.

1. Paragraphs 34-46 suffered from the same vice, being that they sought to add Mr Duff's evidence on a topic which had been addressed by the other experts, and which would have rendered the joint expert conclave a wasted exercise. For that reason, I excluded [34]-[46] of Duff 9 and LELO was not permitted to rely on this evidence.

1. Paragraphs 47-49 were admitted because they were responsive to the evidence of Ms Hayes in Hayes 3 and I considered that they would not lead to the issues at trial being expanded unduly.

1. EIS objected to [5]-[7] of Schoonenberg 2, which read:

Further, I have been asked about the effectiveness of the Womanizer. I asked customers to post their feedback on my websites. Annexed and marked "BS-9" is a copy of the "Reviews" page from my website www.thewomanizer.com.au downloaded from the WayBack Machine website, which contains some of the feedback as at 5 November 2015.

I published the statistics arising from extensive use by women aged between 20 and 60 on my website, stating that:

63% experienced an entirely new sexual experience;

73% experienced a multiple orgasm

76% experienced an exceptionally intense orgasm

99% wanted to own a womanizer

100% evaluated the womanizer to be absolutely unique.

Annexed and marked "BS-10" is a copy of the statistics page from my website from my website www.thewomanizer.com.au as at 5 November 2015, which has been downloaded from the WayBack Machine website.

I was so confident in the effectiveness of the Womanizer that I offered an "orgasm guarantee". Annexed and marked "BS-11" is a copy of the "Orgasm Guarantee" page from my website www.thewomanizer.com.au as at 5 November 2015, which has been downloaded from the WayBack Machine website. I did not have any calls on the guarantee. I did not offer the guarantee for the Swarovski Edition because that was a small run product and I could not return the product to my supplier nor promise a Swarovski replacement.

1. LELO submitted that these paragraphs should be admitted as they reflect actions taken by Mr Schoonenberg in relation to his website. However, as submitted by EIS, back-in-time captures of Mr Schoonenberg's website are irrelevant. Furthermore, the paragraph about the "orgasm guarantee" was irrelevant.
2. I therefore ruled that [5]-[7] be excluded, except to the extent that they identify Annexures BS-9, BS-10 and BS-11.

1. EIS objected to the first sentence of [45] of Sheldon-Collins 1 on the basis that it is hearsay and a conclusory statement of opinion because it did not disclose how Mr Sheldon-Collins knew a particular fact. I allowed this paragraph of Sheldon-Collins 1 as it was neither hearsay nor a statement of opinion. As to how Mr Sheldon-Collins knew the stated fact, this could be a subject of a submission as to weight at the conclusion of the trial.
2. EIS also objected to the second sentence of [48]. As EIS submitted, this evidence was an inadmissible opinion because it is based on hearsay evidence, and for that reason, I disallowed the sentence.

1. EIS objected to [30] of Temminghoff 1, which reads:

It was generally regarded by me and others in the industry that Satisfyer was the company "ripping-off" the original Womanizer. Everyone in the industry was talking about it in 2016. More recently, everyone in the industry has been talking about the recent decision in the USA, where the company Wowtech that makes the Womanizer had successfully sued the Satisfyer company in the USA and had a large payout in excess of 12 million dollars. Annexed and marked "MT-6" is a copy of a news story summarising the case and with a link to the case, that I found on the internet.

1. LELO submitted that this paragraph should be allowed because it is relevant to the conduct of the parties. However, Ms Temminghoff's speculation about whether the Satisfyer was a "rip-off" of the Womanizer, and the litigation in the USA concerning the Satisfyer and the Womanizer, was irrelevant, and so I excluded it.

1. LELO objected to [22(e)], [22(i)] and [22(k)] of Hayes 1 on the basis that it should be limited pursuant to s 136 of the Evidence Act to Ms Hayes' understanding of Figure 4 of the Patent. However, I did not impose this limitation as I consider that Ms Hayes was entitled to give evidence in her role as an expert, including by reference to the Figures, and that, as she is an expert, she was (in this situation) only giving evidence of her own understanding in any event.

1. LELO objected to the last sentence of [259(e)] of Hayes 3 on the basis that it was a general statement of opinion. I allowed the paragraph as I considered that it was admissible opinion evidence.

LELO also objected to paragraph [284(c)] of Hayes 3 on the basis that it was speculative and that Ms Hayes had no basis for making statements about the Panasonic device when she was not an expert in speakers. However, I allowed this paragraph as I considered that it was opinion evidence admissible under s 80 of the Evidence Act and that Ms Hayes was qualified to express that opinion.

1. LELO objected to the words "it was an error that required correction" in [41] of Payne 2 on the basis that Mr Payne was not qualified to give an opinion that the severed crankshafts affected the shape of the cavity and needed correction. I upheld the objection on that basis and the words "an error" were not admitted in [41].

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