Deb Worldwide Healthcare, Inc v Gojo Industries Inc. [2015] APO 20

1. They also highlight that the language used by Dr Richardt is vague pointing to "some embodiments" without indicating which embodiments have the requisite viscosity. They argue that there are no directions within Asmus to prepare the requisite composition such that the person skilled in the art would inevitably (in all cases) be guided to prepare a composition with a viscosity of less than 100 mPas.

1. The examples referred to in Asmus which have the low viscosity ignore other integers in the claims (submissions [42]). They state at [44] that it would be open for the person skilled in the art to produce a composition with a viscosity of greater than 100 mPas (or 100cPs). It is also pointed out in paragraph 38 of the applicant's submissions that page 9 of Asmus teaches that:

"It will also be appreciated that the addition of an emollient and/or other optional ingredients (discussed herein) can also have an affect (sic) on viscosity (either positively or negatively)."

1. I consider that because there is no specific example in Asmus in which the viscosity is measured that is said to be within the scope of claims 1-10 and 17, and that clearly each ingredient in the composition will affect viscosity, I cannot conclude that there are clear and unmistakable directions to claims 1-10 and 17 of '144 without further evidence in which examples are made and shown to have the requisite viscosity.

1. Claim 11 only requires a foamable alcoholic composition with at least 40% alcohol, which is not in dispute, and a particular foaming surfactant.

1. Richardt #3 at [133] makes the following statement:

"My understanding from Asmus is that all dimethicone surfactants, including those listed in claim 11, can be used in a foamable alcoholic composition. Moreover, Asmus expressly discloses that dimethicone copolymers -that is, polymers of dimethylsiloxane with polyoxyethylene (PEO) and/or polyoxyproylene (PPO) side chains can be used in the compositions (at page 5 line 26 to 31). That is, Asmus suggests that some of the surfactants disclosed in claim 11 (including PEG-20/PPG-23 dimethicone, bis-PEG/PPG-20/20 dimethicone, PEG 23/PPG 6 dimethicone, PEG 20/PPG 23 dimethicone, PEG5/PPG3 methicone, bis-PEG 20 dimethicone) are suitable for use in a foamable alcohol composition."

1. In responding submissions the applicant relied on their submissions in respect of claim 1 of '144.

1. It is clear that dimethicone surfactants are used in Asmus, however, there is no reference provided to those listed in claim 11. While I agree with Dr Richardt that Asmus suggests the use of dimethicones, I do not consider a "suggestion" to be clear and unmistakable directions to the specific dimethicones listed in claim 11. As a result, I do not find that claim 11 lacks novelty over Asmus and it follows that dependent claims 12-16 are also novel.

1. Koivisto was published on 7 April 2005 and was raised as a particular against '144 for the ground of novelty.

1. Koivisto is directed towards high alcohol gel like and foaming compositions with viscosities less than 4000 cPs (see title and abstract). The alcohol content of the gels is approximately 52% by weight (see page 1). Koivisto utilises fluorosurfactants as the foaming surfactant (see page 15) and further additives to achieve a commercially suitable formulation including foam stabilizers (see pages 16-17).

Claims 1, 2, 3, 4, 8, 9, 10 are alleged to lack novelty over Koivisto

1. The opponent submitted that Koivisto discloses foamable compositions from 60% to about 70% for disinfecting purposes (submissions paragraph 131, Richardt#3 paragraph 44). This is disclosed in Koivisto at page 1 lines 15-16 and page? 8 lines 15-16.

1. As pointed out by Richardt#3 at [45] and in the submissions at [131] a fluorosurfactant is also disclosed and these include amphoteric (zwitterionic), non-ionic and anionic fluorosurfactants (page 1 lines 11 to 12, page 7 lines 21 to 22, page 8 lines 17 to 18, page 15 line 17 to page 16 line 6). The use of a fluorosurfactant was not in dispute.

1. Koivisto mentions foam stabilizers on page 16 lines 1-13. The disclosure is on page 19 as follows:

"Examples of compatible foam stabilizers that can optionally be employed include lactic acid esters of monoglycerides, cationic emulsifiers, triquaternized stearic phospholipid complex, hydroxystearamide propyltriamine salts, lactic acid monoglycerides, food emulsifiers such as glyceryl monostearate, propylene glycol monostearate, sodium stearoyl lactylate, silicone wax, an encapsulated oil, Microcapsule Mineral Oil.

A preferred foam stabilizer used in the present foamable composition is cetyl betaine. A preferred combination of foam stabilizers is that of butyleneglycol, butoxyethanol and n-propanol."

1. The reference to cationic emulsifiers is relied on by the opponent to anticipate the claims. In Richardt#4 at paragraph 23 he states that he understands "cationic emulsifiers" in Koivisto to include polymeric foam stabilizers such as polyquaterniums (which are also cationic). Dr Nearn's view is that cationic emulsifiers do not include cationic polymers and Dr Richardt believes they do.

1. Based on the general nature of the disclosure and on looking at the reference in Koivisto above I do not feel that a broad reference to cationic emulsifiers in a list of other foam stabilizers and then followed by preferred foam stabilizers which are not cationic emulsifiers amounts to clear and unmistakable directions.

1. Koivisto does not identify the viscosity of the foamable alcoholic composition and Dr Richardt is of the opinion that it is likely that the compositions would have a viscosity between about 20 to 50 cPs (Richardt #3 [60] and [61]).

1. Dr Nearn's view is that experiments would be necessary (Nearn #1 [24]).

Because it appears each ingredient can have an effect on viscosity and as it follows with my logic with Asmus. I favour the opinion of Dr Nearn and believe that without evidence to show that the viscosity of the compositions of Koivisto are within the scope of claim 1, I do not find that it is novelty destroying and thus the dependent claims are also novel. Therefore I find that claims 1, 2, 3, 4, 8, 9, and 10 are novel over Koivisto.

1. I find that in view of the evidence presented that this ground of opposition fails and that '070 and '144 are both novel over Asmus and Koivisto.

1. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art. A document is prior art for this purpose if "a skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded [the document] as relevant" (subsection 7(3)).

1. The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12 at [45]; 148 CLR 262 at 286 Aickin J stated:

"The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."

1. The High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 approved this approach.

The opponent alleged a lack of inventive step against claims 1, 2, 3, 4, 8, 9 and 10 in light of Koivisto and BASF Technical Information for Luviquat PQ11(Luviquat)

1. Koivisto is directed towards foamable alcoholic compositions and it was clear from the declarants of both parties that the person skilled in the art would read patent specifications. There was no dispute that Koivisto would be ascertained, understood and regarded as relevant.

1. Luviquat was published in May 1997 and the opponent submitted that it was part of the common general knowledge at the priority date of the opposed applications. Luviquat is a technical document about a product available from BASF.

1. Luviquat discusses polyquaternium-11 and says it can be used in alcoholic foams but only gives limited examples of them. They include a shaving foam with only a minor amount of stearyl alcohol; a mousse with 10% ethanol and 10% Luviquat; and a face cleansing lotion with 20% alcohol and 0.5% Luviquat.

1. As pointed out by the applicant, the Luviquat document has no disclosure of high alcohol content foams.

1. The next question is whether or not Luviquat can be considered to be part of the common general knowledge.

1. There is no evidence that BASF was contacted by the opponent and it is not clear how widely distributed this document was in Australia. Dr Richardt mentioned he would contact producers, such as BASF, before seeing the Luviquat document (paragraph 14 in Richardt #1).

"If I had been trying to develop a foamable alcohol composition in accordance with Koivisto before 28 December 2005, I would as a matter of course have approached technical suppliers, including BASF, to ask them to provide me with ingredients that could be used as cationic emulsifiers in a foam system. Further, I would expect a supplier such as BASF would have recommended polyquaterniums for this purpose."

1. The applicant's own declarant had the Luviquat document on his shelf so I am confident it was readily available to the person skilled in the art. Staton #1 at [48] he says:

"Whilst reviewing the Luviquat PQ-11 document it struck me as though I had seen this before and I referred to my own reference library and retrieved our own copy of Luviquat PQ-11 document that we had obtained from the Australian distributor of the product and was in my possession prior to 28 December 2005."

1. The question is then would the person skilled in the art as a matter of routine be directly led from the prior art to the invention. Dr Richardt has stated that he would of, as a matter of routine, when developing foams, contact suppliers such as BASF which would have meant he would have been given the Luviquat document. The issue is would it have been routine on reading Koivisto for a person skilled in the art to combine it with Luviquat. The process of developing foams discussed by Dr Richardt might be that he was merely trying to avoid infringement or it might be that he was conducting genuine inventive research. I do not feel that Dr Richardt was thinking of genuine research but rather, if he was looking for an alternative composition to that in Koivisto he would have contacted BASF.

1. However, there remains no evidence from BASF as to whether or not this document would have been definitively provided to anyone enquiring or the nature of the enquiry that would have been made. Though, given that Mr Staton was aware of it, I am confident it was distributed and the person skilled in the art had access to it.

1. Would the person skilled in the art combine the Luviquat document with Koivisto?

1. Very little evidence has been put forward on whether or not it would be obvious to combine these two documents. It could be that the person skilled in the art was merely trying to avoid infringing the Koivisto patent. Then they would have to choose to combine it with the Luviquat document. Koivisto only makes reference to cationic surfactants and before listing preferred foam stabilizers. This disclosure is on page 19 and mentioned above for novelty.

"I agree with Mr Staton's observation at paragraph 18 of the Staton declaration that alcohol is generally a foam suppressant. For this reason, if I was asked to design a foaming alcohol product at 28 December 2005, I would pay particular attention to any competing products, technical literature (e.g. data sheets) or patent literature I could identify in which a foaming product using alcohol was disclosed, since these products and/or literature would provide a good basis for my development efforts. Where I am aware of a particular technical difficulty (such as the defoaming effects of alcohol), I will pay particular attention to the composition disclosed in any literature (including any patents or patent literature and any technical documents, such as data sheets from suppliers) where the technical difficulty has been overcome."

"I agree with Mr Staton's observation at paragraph 19 that if I was designing a foaming hand hygiene wash, I would include a surfactant, a foam booster and/or stabiliser (noting that the same ingredient may perform both functions), and a diluent as a matter of course."

1. He then agrees that humectants, emollients and thickeners could also be added.

1. I agree with the submission that polyquaterniums are broadly cationic surfactants. However, the list on page 19 includes other broad terms which do not lead to the claimed invention.

1. It appears that any number of ingredients could have been added to Koivisto without resulting in the claims of '144.

1. There is no evidence that the person skilled in the art would be directly led as a matter of routine to combine the Luviquat document with Koivisto. Without this issue being resolved, I cannot say that the '144 clearly lacks an inventive step in the light of these two documents.

1. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be useful. The issue of utility was considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228. Emmett J at 247 [81] stated:

"A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid. That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility."

Utility of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14, 15 and 16 of '144 and claims 1-7 of '070

1. The Stern declaration annexed SMS2 which introduced into evidence information from the US prosecution of the US family member of the opposed applications. In the US application a ratio of foaming surfactant to foam stabilizer has been introduced into the claims to overcome objections there. The US attorney states the following on page 11 of SMS2. This was used to support a lack of utility ground, the issue being that the invention only works when the stabilizer and foam are in certain ratios and that this must be followed in order to achieve the promise of the invention.

"Moreover, even if the ratio of foaming surfactant to the foam stabilizer can be considered to be a result-effective variable, the results of optimizing this variable were unexpectedly good. In this regard, the attached Declaration of Amanda J. Copeland shows that the claimed ratios produce unexpectedly good stabilized foam, while compositions outside of the claimed ratios do not. These results could not have been predicted based upon Barger.

In addition, the attached Declaration of Copeland demonstrates that the claimed ratio of foaming surfactant is key to obtaining a stabilized foamable composition." My emphasis

1. It is this last sentence that formed the basis of this ground. However, I think that in the context of the preceding paragraph it is clear that it is saying that the foams work very well within this ratio but it is not clear and unequivocal evidence of the foam not working at all outside of this ratio.

1. The Copeland declaration was introduced by Stern as SMS3 and shows detailed experiments where a fluorosurfactant and a polyquaternium were used. These experiments did show that a certain ratio is required when using a fluorosurfactant. This is relevant only to the claims in which a fluorosurfactant is used. It is therefore not relevant to the '070 claims.

1. The experiments conducted in the Copeland declaration show that the foam stabilizer taught by Koivisto, such as glycerin or cetyl betaine, do not work. However the cationic polymers such as polyquaternium-11 do work, but only in specific ratios when a fluorosurfactant is used.

1. The experiments showed that a ratio of 15:1 foaming surfactant to foam stabilizer yielded a stabilized foam, however, ratios of 600:1, 0.025:1 and 1:1 did not. As mentioned above, paragraph [0013] of both specifications makes it clear that the promise of the invention is that the foam produced is stable.

1. It therefore is necessary for the a foam made with a fluorosurfactant and polyquaternium-11 to be present in the ratio worked out by the experiments undertaken in SMS3 and in line with those claimed in the US. I therefore conclude that claims 1, 2, 3, 4, 7, 8, 9, 10, 11, 14, 15 and 16 of '144 lack utility because everything within the scope of the claims, which includes ratios outside the range worked out in SMS3, is not useful and will not form foams. I see no reason why the '070 claims are not useful.

Sufficiency and the claims fail to define the invention for both '070 and '144

1. It is a requirement of subsection 40(2) of the Act that the specification must describe the invention fully. The High Court in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at [25]; [2001] HCA 8; 207 CLR 1 at 17 explained this requirement as:

"The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?"

1. The opponent argued that because the foaming surfactant to foam stabilizer ratio is essential to the working of the invention when fluorosurfactants are used, this should be reflected in the patent. This follows from the utility argument. However, there are examples in the specification which enable the person skilled in the art to put the invention into practice. Some trial and error is permitted and as a result I find that the specifications are sufficient.

1. The opponent purported that the '144 does not disclose a method of how to measure viscosity nor is the viscosity of the actual examples of the '144 provided. However, both declarants were quickly able to discuss the standard techniques of measuring viscosity and the applicant put forward in the hearing that it was like measuring temperature to the skilled addressee; you do not need to tell them to use a thermometer or how to use it. I accept this argument given the ease of discussion the declarants had on the topic and the disclosures of Asmus on viscosity also supported this view. Therefore I find that this ground of opposition fails for the '144.

1. The opposition fails on the grounds of novelty, inventive step, sufficiency and that the claims fail to define the invention. However, the opposition succeeds on the ground that claims 1, 2, 3, 4, 7, 8, 9, 10, 11, 14, 15 and 16 of '144 lack utility. I am of the view that this matter may be overcome by amendment and consequently the applicant is allowed 2 months from the date of this decision to propose suitable amendments.

1. Subject to appeal, I direct that '070 proceed to grant.

1. The parties submitted that costs should follow the event. I see no reason to depart from that result. The opposition has been successful against '144, I therefore award costs according to Schedule 8 against the applicant.