The common general knowledge and s 7(3) information
159 The five witnesses who gave evidence relevant or potentially relevant to these issues were Dr Pougnas, Ms Linfoot, Mr Walsh, Mr Surawski and Mr Cruise. I will discuss their expertise and experience before addressing what matters formed part of the common general knowledge and the question whether Christensen constitutes information as described in s 7(3)(a) of the Patents Act.
160 Dr Pougnas is the Chief Executive Officer of a speciality drug delivery company based in the Bordeaux area of France. He has qualifications in pharmaceutical science and more than 20 years' experience in the area of pharmaceutical formulation for animals and humans. In 1992, he joined the Virbac group (Virbac). Virbac was (and remains) an international veterinary pharmaceutical group which develops and markets vaccines and medicines for the prevention and treatment of the main pathologies for companion and food-producing animals. He was employed by Virbac until 2002. From 1994 to 2002, Dr Pougnas was the head of Virbac's formulation unit. In the course of his work with Virbac, Dr Pougnas acquired and developed considerable experience in relation to veterinary formulations for oral, parenteral and topical applications. In the oral area, these included solid, liquid and semi-solid dosage forms. During Dr Pougnas's time at Virbac, Virbac had operations in many countries around the world, including Australia. Dr Pougnas interacted with Virbac's research and development (R&D) teams in other countries, including Australia. There was collaboration on international R&D projects; there was at least one international R&D meeting per year, when the R&D teams from the subsidiaries of Virbac with R&D activities (including the Australian R&D team) visited Virbac's headquarters in France to share knowledge and discuss projects. Dr Pougnas worked on the development of soft chew medicaments for animals before 13 August 2002, but much of that work remains confidential to Virbac and he was unable to detail it in his evidence.
161 During evidence-in-chief, Dr Pougnas said that he collaborated with the Australian R&D group on a project for oral paste formulation which contained parasiticides; there was at least one meeting of the research teams each year; there was some interaction during the year during which technical aspects, such as ingredients, were discussed. He stated that in the pharmaceutical industry, the driver for development was the regulatory regime, which tended to be harmonised across Europe and the US; as a result, each team followed more or less the same rules and the same procedures for developing drug formulations. He said in cross-examination that the Australian team came to France; he never went to Australia. I accept the evidence that Dr Pougnas gave during the hearing as set out in this paragraph.
162 It may be accepted that the field of pharmaceutical formulation is, and was by 13 August 2002, one in which information was exchanged internationally such that there is (and was) likely to be substantial overlap in the knowledge of those working in the field in developed countries. On this basis, although Dr Pougnas was based in France and had never been to Australia, his evidence may be of assistance in identifying matters that constituted the common general knowledge in Australia. Dr Pougnas stated in his first affidavit that he had been asked to assume that he had been asked to develop a soft chew medicament for animals using only knowledge that he had before 13 August 2002. In the course of describing how he would have gone about this task, Dr Pougnas made a number of statements pertaining to pharmaceutical formulation. In some cases, it may be appropriate to treat these as forming part of the common general knowledge. However, in some cases his evidence did not describe what was, or was not, commonly known by pharmaceutical formulators generally; it cannot be assumed that just because something was within Dr Pougnas's knowledge, it was part of the common general knowledge.
163 Ms Linfoot has expertise and experience in the compounding of pharmaceuticals. She stated in her affidavit that compounding "allows a pharmacist to customise or tailor make a medication to meet a patient's specific needs". In 1999, she attended a Professional Compounding Centre of America (PCCA) course in Houston, United States, which included various courses on how to make troches, capsules, creams and other forms of product. The folder from that course included two chewable troche formulas. One of these included polyglycol 1450 which Ms Linfoot stated was a reference to polyethylene glycol (or PEG) 1450. She stated that PEG is a wax base and its purpose in such a formulation is to bind all of the components together. She stated that, through her use of the PCCA folder in the compounding of pharmaceuticals from 1999 onwards, she was familiar with PEG 1450 as a component that could be used in the preparation of chewable and hard troches as a binder. She said during cross-examination that she recalled making veterinary chewable troches before August 2002, but was unable to produce records of such products as the records did not go back that far. She also said that she made chewable troches with PEG as described in the PCCA course materials from 1996 onwards. (It may be that Ms Linfoot meant from 1999 onwards, as that was the year she attended the course.) I accept Ms Linfoot's evidence as set out in this paragraph. However, as her knowledge of PEG seemed to be based on the particular PCCA folder, and her evidence did not describe what was known by compounding chemists (or pharmaceutical formulators) generally, I do not think her evidence assists in identifying the common general knowledge.
164 Mr Walsh has qualifications and experience in the field of food science and technology with particular expertise in animal food products. He has more than 30 years' experience in the field in Australia. In 1987, he moved to Mars, a business which at the time was known as Uncle Ben's of Australia Pty Ltd. He remained with Mars in different roles and different locations until 2012. When Mr Walsh commenced at Mars in 1987, he worked on the Danny's meatballs project (reporting to Mr Surawski). That product (which was not ultimately fully released) was a palatable, semi-moist meat-based product formed through a Koppens forming machine. While at Mars, Mr Walsh worked on a product called Schmackos, which is a semi-moist chew product for dogs that was (and still is) made by Mars in Australia. Schmackos was a relatively new product when Mr Walsh joined Mars in 1987. Another product that Mr Walsh worked on at Mars was the Exelpet Arthricare product. This was an edible semi-moist chew product that contained an active ingredient (green lip mussel powder) to maintain the health of joints and help reduce the symptoms of arthritis in animals. The active ingredient in Arthricare was not an anti-parasitic drug. This product was released in around 1997. It was formed in chewy bars.
165 Mr Surawski has qualifications in food technology including a Bachelor of Technology (Food Technology). Following completion of his studies in food technology in 1976, he commenced employment with Uncle Ben's of Australia, now called Mars Petcare, and was employed in a number of roles there until his retirement in 2005. From 1982 to 1986 he was Research and Development Manager at the Uncle Ben's facility in Bathurst, New South Wales. He was responsible for developing a number of new products, new varieties of existing products, and recipe variations. From 1987 to 1988, he was Project Manager for the Danny's meatballs project. From 1989 to 1996, he was Quality Manager for the Bathurst production facility. From 1997 to 2005 he worked in China, Thailand and India to assist with the operation of new pet food production facilities for Effem Foods (part of Mars Petcare). These factories produced dry pet foods. Mr Surawski said during concurrent evidence that from about the mid-1990s he was no longer involved with semi-moist products. Mr Surawski also said during concurrent evidence that his experience as at 13 August 2002 was focused on pet food products; he had not worked on a veterinary health product; nor had he worked on a product containing an active pharmaceutical ingredient (being an ingredient that would require regulatory approval) for delivery to an animal.
166 It is apparent that, because of the way their career paths diverged, Mr Walsh had (as at 13 August 2002) experience in the development of an oral formulation for delivery of an active ingredient to animals, while Mr Surawski did not. In relation to some matters discussed later in these reasons, it may be that greater weight is to be attached to Mr Walsh's evidence due to the difference in his experience compared with that of Mr Surawski. In relation to the common general knowledge, as I have concluded, above, that the person skilled in the relevant art for present purposes is a person or notional research team combining expertise in pet food development and pharmaceutical formulation, both Mr Walsh's and Mr Surawski's evidence is of assistance in identifying the common general knowledge pertaining to pet food development. Mr Walsh's evidence may additionally shed some light on the common general knowledge pertaining to pharmaceutical formulation.
167 In Mr Walsh's first affidavit, he stated that he had been asked to explain how he would have gone about developing a soft chew formulation for delivery of an active ingredient to animals before 13 August 2002. In his affidavit, Mr Surawski stated that he had been asked to consider how he would have gone about producing a semi-moist product if it were being used for the purpose of delivering a veterinary active ingredient to an animal, had he been asked to do so before August 2002. (It may be noted that the question asked of Mr Surawski was framed in terms of "semi-moist" rather than "soft chew". This may have been because, as he explained in his evidence, he was not familiar with the term "soft chew" as at 13 August 2002.) In the course of responding to these hypothetical development tasks, each of Mr Walsh and Mr Surawski made observations about matters that may be considered part of the common general knowledge. (As discussed below, because Mr Surawski had a view as to the water content of a "semi-moist" product, he would have targeted that level of water content had he been undertaking the hypothetical development task. This needs to be borne in mind in considering his evidence.) Further, in their joint report, the first question Mr Walsh and Mr Surawski addressed was: "What considerations would be relevant in developing a soft chew formulation for delivering an antiparasitic drug to an animal (Soft Chew Medicament)?" Their responses to this question, both in the joint report and during the concurrent evidence session, included statements which assist in identifying the common general knowledge.
168 Mr Cruise was not cross-examined and the evidence in his affidavits is therefore to be accepted. He holds the position of Manager in an intellectual property research company; he is also a partner of an intellectual property firm. He has more than 25 years' experience in conducting intellectual property research in the areas of patents, trade marks and designs. He described in his first affidavit instructions he was given to undertake searches for patents and applications published before 13 August 2002 and the process he undertook following receipt of those instructions (including the narrowing of the search terms and interactions with Mr Walsh in that regard). His evidence is of assistance in relation to s 7(3) information.
169 Before addressing the common general knowledge specifically, I note the following. Mr Walsh stated in his first affidavit that, when he joined Mars in 1987, Mars had for some time been selling worming products for pets, such as tablets and patches, under the Exelpet brand; in about 1996 or 1997, Mr Walsh became aware of an alternative heart worming dosage form called Heartgard, which was a semi-moist chew. He said during cross-examination that his understanding was that Heartgard was a palatable soft chew product for heartworm which delivered active ingredients. It appears that it was produced by Merial. Mr Walsh stated in his first affidavit that Mars then developed a semi-moist chew product for delivering intestinal worming active ingredients; this was released under the Exelpet brand, as Exelpet Ezy-dose intestinal all wormer, in about 1997; this was developed with cooperation from Pfizer, which supplied the active ingredients. On the basis of this evidence, it may be accepted that soft chew formulations for the delivery of an active ingredient to animals were already on the market as at 13 August 2002.
170 Having regard to the evidence of Mr Walsh, Mr Surawski and Dr Pougnas, I make the following findings as to the common general knowledge in Australia as at 13 August 2002.
(a) Mr Walsh stated in his first affidavit that the word "soft" in the expression "soft chew" could include formulations from something that can be flattened with gentle pressure from a person's finger, to something which is firmer, like a hard jube (such as a Marella jube); the softness of the chew can affect the acceptance of a product; if the chew is too soft, some pets will find it hard to eat, as it could stick to the roof of their mouth; additionally, it might be more difficult to form the product in the manufacturing equipment if it is too soft and sticky, as very soft products may not reliably form and then release from the forming machine. Mr Surawski said during the hearing that the term "soft chew" was not on his radar at August 2002. But, apart from the terminology used, I did not take Mr Surawski to disagree with the substance of Mr Walsh's statements. I consider Mr Walsh's statements, set out in this paragraph, as to the considerations relevant to formulating a soft chew medicament for animals, to have been part of the common general knowledge.
(b) Mr Walsh and Mr Surawski agreed in their affidavits that "semi-moist" did not have a precise meaning in the field of pet food manufacturing. Mr Surawski stated in his affidavit that he used "semi-moist" to refer to a particular texture of pet food, such that the product has a degree of softness and compressibility, with a moist, rather than dry, mouth feel. Mr Walsh said in his second affidavit that he considered the term to refer principally to the water content. He said in his affidavit and oral evidence that, in his experience in the pet food field, a "semi-moist" product would usually have a water content of between 15% and 30%. Mr Surawski stated in his affidavit that he would not expect a semi-moist product to have a water content much lower than 18%. On the basis of this evidence, I find that there was no precise meaning for the expression "semi-moist" in relation to pet food and such a product would usually have a water content of between 15% and 30%.
(c) Dr Pougnas said during cross-examination that usually the water content for a product such as this (that is, a soft chew medicament) is below 10 per cent. He said that this was general knowledge. I accept that this formed part of the common general knowledge.
(d) Mr Walsh said during concurrent evidence that, in developing a soft chew formulation for delivering an anti-parasite drug to an animal, it would be necessary to understand as much as possible about the drug itself - the drug is likely to have some negative taste implications and the sensitivity of the drug to its environment would need to be considered. Mr Walsh also said that, in developing a soft chew formulation for delivering an anti-parasite drug to an animal, the reaction of the drug to moisture was one of the things that the person developing the formulation would need to understand. Mr Surawski did not disagree with this evidence, but emphasised the importance of considering palatability. I accept the evidence of Mr Walsh set out in this paragraph and consider that it formed part of the common general knowledge.
(e) Dr Pougnas said during cross-examination that when one develops any kind of oral formulation, one has in mind that the product would be palatable; the context of soft chew is "more related to the texture"; nevertheless, "palatability is a general - I would say a preoccupation". He accepted that the concept of palatability includes the texture, taste and mouth feel. Mr Surawski gave evidence to similar effect. I accept that these matters formed part of the common general knowledge.
(f) Mr Surawski said during concurrent evidence that, in developing a soft chew formulation for delivering an antiparasitic drug to an animal, the question of palatability could be affected by the properties of the drug; one example is where the antiparasitic drug has negative taste implications; palatability depends on the animal species that the product is targeted at. Mr Walsh agreed with these propositions. I accept the evidence of Mr Surawski set out in this paragraph and consider that it formed part of the common general knowledge.
(g) Mr Walsh said during concurrent evidence that water activity and water content are two terms that are used quite widely in the pet food industry; water content is the absolute amount of water that is in a product; water activity is a measure of how well the water is bound - there are a lot of ingredients that will bind water and the purpose of binding water is to make it unavailable to microorganisms; water activity is a measure of the bound water. Mr Surawski agreed with this summary. I accept this evidence and find that these matters formed part of the common general knowledge.
(h) Mr Surawski accepted during concurrent evidence that, if he was dealing with a water-sensitive active ingredient, one way of addressing this was to reduce the water content. Mr Walsh's evidence generally was to similar effect. Mr Surawski said during concurrent evidence that the risk of microbial growth as a general proposition is something that one wants to avoid in a product of this kind (a soft chew medicament), as it affects the shelf life; for this reason, one tries to target a particular level of water activity. He accepted that, as a general proposition, the lower the amount of unbound water, the lower the risk of microbial growth. Mr Walsh agreed with these statements. I find that these matters formed part of the common general knowledge.
(i) Mr Surawski said that the use of humectants to reduce water activity was something he was familiar with before August 2002. He said that this can potentially have a negative impact on palatability. I accept this evidence and find that it formed part of the common general knowledge.
(j) Mr Walsh stated in his first affidavit that, if lower water content is used in a formulation, which would tend to make the product less soft, a higher fat or oil content could be used to provide the desired softness. Mr Walsh stated in his second affidavit that it is possible to produce food products that are soft and compressible without the use of a significant amount of water. Mr Walsh also stated in his second affidavit that a soft formulation does not necessarily need a high water content - other ingredients can achieve a soft texture; such a product would not necessarily be "semi-moist" but would be soft and chewy. Mr Surawski said during concurrent evidence that fat aided the soft texture of the product; this was something he was aware of at August 2002. Mr Surawski said during cross-examination that he did not disagree with the proposition that fats and oils provide softness if they are used. In relation to the role of moisture content in the formulation of a soft chew, Mr Surawski emphasised during the concurrent evidence that it imparts softness to the product and acts as a binding agent. Mr Walsh said he agreed with this if the product was water-based. On the basis of this evidence, I find that the common general knowledge included that fat or oil can be used to provide softness to a formulation; it is possible to produce food products that are soft and compressible without the use of a significant amount of water; in a water-based product, moisture imparts softness to the product and acts as a binding agent.
(k) Mr Walsh stated in his second affidavit that a soft chew product could be aqueous or non-aqueous based (although he had not worked on projects that involved non-aqueous matrices for chews). Mr Surawski said during concurrent evidence that before August 2002 he was not aware of non-aqueous matrices. Notwithstanding Mr Surawski's evidence, I find that the common general knowledge included that a soft chew product could be aqueous or non-aqueous based. Although Mr Surawski was not familiar with non-aqueous bases, his experience, unlike Mr Walsh's, did not extend to the development of an oral formulation for delivery of an active ingredient.
(l) Mr Walsh stated in his second affidavit that in a non-aqueous system, binders that do not require water could be used; in such instances, meltable binders, such as fats, may be used. Mr Walsh also stated in his second affidavit that the non-aqueous system can achieve a soft texture without the need to add water; this will not only reduce the need for water activity management (such as by using humectants) to prevent microbial activity, but will also reduce the risk of an active ingredient that is water-sensitive reacting or breaking down once mixed with the soft chew base. I accept the evidence of Mr Walsh as set out in this paragraph and find that it formed part of the common general knowledge. (I note that Mr Walsh said during concurrent evidence that he had not worked on projects that involved non-aqueous matrices for chews; nor had he worked on any product that used added oil for soft chews or semi-moist products. Nevertheless, I accept that the matters set out in this paragraph formed part of the common general knowledge.)
(m) Dr Pougnas identified the following manufacturing processes that could be used to produce soft chew formulations: (a) an extrusion process; (b) a moulding process; and (c) a tabletting process. Mr Walsh and Mr Surawski gave evidence to similar effect. (The terms "moulding" and "forming" were generally used interchangeably.) I accept that these matters formed part of the common general knowledge.
(n) Mr Walsh stated in his first affidavit that in his field of pet food, "extrusion" typically refers to a process involving heat, pressure and mixing, where the substance is then pushed through a nozzle. Mr Walsh and Mr Surawski agreed in their affidavits that heat in an extrusion process may compromise some active ingredients. I find that these matters formed part of the common general knowledge.
(o) Dr Pougnas said during cross-examination that a moulding process involved mixing, melting and putting the substance into moulds. Mr Walsh and Mr Surawski gave evidence to similar effect. Mr Surawski stated in his affidavit that a forming process is one where the material or formulation is forced by different means (for example, piston or screw pressure) into a shaped die and then removed by positive or negative pressure; a forming process would generally not include any heat generation or significant pressure. I find that these matters formed part of the common general knowledge.
(p) Dr Pougnas referred in his first affidavit to the use of PEG in connection with a moulding process. He stated:
The API can be mixed with components such as gelatine, glycerine and water. Alternatively a semi-solid heated mass can be prepared without the addition of water using meltable materials such as: (i) solid polyethylene glycols (PEGs) (macrogols), such hydrophilic polymers having relatively low melting points (from 45 degrees Celsius to 65 degrees Celsius depending upon the number of monomer units), or alternatively (ii) using hydrophobic polymers combined with fats (see AU 693). This moulding process is commonly used in the pharmaceutical industry, for example in the preparation of suppositories or gynaecological ovules. Prior to 13 August 2002, solid PEGs having relatively low melting points were commonly known and used as meltable materials for the preparation of suppository mass combined with other ingredients. Such polymers were also commonly known and used as meltable materials in melt granulation processes.
Dr Pougnas stated in his second affidavit that, based on his experience in pharmaceutical formulation, including veterinary pharmaceutical formulation, PEG is and was before 13 August 2002 commonly used in many different kinds of formulations including oral and injectable medicaments. He did not provide any examples. In cross-examination, it was put to Dr Pougnas that he had referred in his first affidavit to the use of PEGs in the preparation of suppositories and gynaecological ovules, and that this was far removed from oral administration. He responded that these statements were "more in reference with the moulding process". It was put to him that it was not something that one would ordinarily think to look to for a tablet that would be swallowed. He responded that "we are talking more about the manufacturing process and not about the destination of a final product". In response to further questioning as to whether he would have selected PEG, he said that he and his team had conducted some experimental works at the time he was at Virbac, but he could not disclose more. He also said:
But PEG are used and commonly used for oral application, for example, for melt granulation, there are plenty of scientific publications. So - but it is not in reference with a pure moulding process. Usually when you use PEG as a melt for a melt granulation purpose, for example, then it is - the microparticle you obtain or the mass you obtain is then put into a tablet.
Mr Walsh did not refer to PEG in his first affidavit. In his second affidavit, Mr Walsh stated that PEG was not commonplace in pet food products before 13 August 2002; however, he had been aware of PEG and its function as an emulsifier for many years before 13 August 2002; for example, in his work at Devro (1984-1987) he was involved in a project which sought to develop a collagen product for use in cosmetics and investigated the use of PEG in that context. Mr Surawski stated in his affidavit that, as at August 2002, he had heard the name of polyethylene glycol (that is, PEG), but it was not an ingredient that he had used, and he had not heard of it being used in any particular food product; he did not know what its properties were, or what it was used for, before August 2002. Mr Walsh accepted during concurrent evidence that: none of the food products that he knew about before August 2002 had PEG in it; and the one example of a product with PEG that he knew of at the time was a collagen product for cosmetics. Mr Surawski said that he knew of the product but had never had any cause to use it or even to look at it as a product in pet foods. Having regard to the evidence of Dr Pougnas, Mr Walsh and Mr Surawski, I find that the common general knowledge (pertaining to pharmaceutical formulation) included knowledge of PEG and its properties, but not knowledge of its use in a moulding process for an oral formulation.
(q) Mr Surawski said during concurrent evidence that an emulsifier is a material that allows two immiscible materials to be held together in a colloidal form (that is, where the two immiscible materials are held together in a situation where they do not separate); if you do not have a situation where you need to bind these two things, the emulsifying portion of the ingredient is not necessary, and it is just a forming agent. Mr Walsh agreed. I find that these matters formed part of the common general knowledge.
171 I now turn to consider what information, if any, fell within s 7(3) of the Patents Act. It was contended by Merial that Christensen fell within s 7(3)(a) as a "single piece of prior art information" being "information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, [and] regarded as relevant". Christensen constituted "prior art information" as it was information that was part of the "prior art base", being information in a document that was publicly available (in or out of the patent area) as at 13 August 2002. The question, then, is whether it was information that the skilled person could, as at 13 August 2002, be reasonably expected to have ascertained, understood and regarded as relevant. I have concluded, above, that the person skilled in the relevant art is a person or notional research team combining expertise in pet food development and pharmaceutical formulation. Mr Walsh stated in his first affidavit that (if he had been carrying out the development task described in his affidavit) he would have had access to the current pet technology in the field; as a matter of course, he would have had patent searches done for products that were similar to the product he had been asked to create; he would look at the patents and patent applications revealed in those searches and would see what could be used from them, and also see whether there might be any formulations or processes that would need to be avoided; he would have asked a specialist patent searcher to conduct patent searches. Mr Walsh also stated in his first affidavit that he was asked to describe the patent searches that he would have undertaken before 13 August 2002 as part of the development process described in his affidavit. He set out the search terms he would have used for initial searches. These included "semi-moist". He described his interactions with Mr Cruise (who conducted the searches) and the abstracts he reviewed. Mr Walsh stated that, after he reviewed the abstracts, he identified the results which he thought were relevant to formulating a soft chew product. The annexed list of such abstracts included the patent referred to in these reasons as Christensen (the title of which is "semi-moist oral delivery system"). Mr Walsh stated that he found Christensen to be of particular interest; and that this patent provides a formulation for a soft chew for delivering active ingredients. It is apparent from Christensen that it describes a soft chew formulation for delivery of an active ingredient: see column 1, line 51 ("soft chewable oral delivery system"); column 5, last line ("in a chewable form") and claims 1 and 23 ("soft and chewy texture").
172 Mr Surawski said during cross-examination that conducting searches of literature was something that he had done before August 2002; it was something that a scientist would do on a regular basis, in order to seek out information needed. He said that, quite often, he would not actually carry out the search himself but would ask a specialist to do so. He accepted that scientific publications and patents were potentially useful sources of information on matters of the kind discussed in his affidavit. He accepted that he would have used the term "semi-moist" as a search term. In relation to Christensen, Mr Surawski said that he would reasonably expect Christensen to have turned up in a search if he was searching patent literature before August 2002. Mr Surawski stated in his affidavit, in relation to Christensen, that while he may have initially identified this document to be relevant had it been in a list of search results, on reading the document more completely it did not provide anything new or outside of what he already knew, and he would not have considered it further as a result. In particular, he stated that it does not say anything about animal palatability, which in his view would be a major concern. He said during cross-examination: "I guess my reaction to this would have been I know all this and I know how to do it better; that's the way I would - having read that".
173 On the basis of the evidence of Mr Walsh and Mr Cruise, I find that Christensen is a document that the skilled person could, before the priority date, be reasonably expected to have ascertained, understood, and regarded as relevant. I accept the evidence of Mr Walsh and Mr Cruise, summarised in [171] above, as regards searches. It is likely that Christensen would have been ascertained had those searches been carried out. I accept Mr Walsh's evidence, set out in [171] above, that he would have considered Christensen to be of particular interest to the development task described in his affidavit. Notwithstanding Mr Surawski's evidence that he would not have considered it to be telling him anything he did not already know, I conclude that the skilled person would have regarded Christensen as relevant, as it describes a soft chew formulation for delivery of an active ingredient. I note that the Delegate reached the same conclusion.