Merial Limited v Novartis AG

[2015] APO 9

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Merial Limited v Novartis AG [2015] APO 9

Patent Application:                2010206029

Title:Palatable ductile chewable veterinary composition

Patent Applicant:                   Novartis AG

Opponent:  Merial Limited

Delegate:  R Subbarayan

Decision Date:  11 March 2015

Hearing Date:  13 October 2014 at Melbourne

Catchwords:  PATENTS – section 59 - opposition to the grant of a patent – chewable veterinary composition - claimed invention novel, inventive, clear, fairly based - opposition unsuccessful - costs awarded against opponent

Representation:  Patent applicant: Michael J Caine and Grant Barry of Davies Collison Cave

Opponent:Dr Marcus Caulfield and Dr Marianne Seter of FB Rice

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                2010206029

Title:Palatable ductile chewable veterinary composition

Patent Applicant:                   Novartis AG

Date of Decision:                   11 March 2015

DECISION

The opposition is unsuccessful. The claimed invention is novel, inventive, clear, fairly based, sufficient, useful and a manner of manufacture. Subject to appeal, I direct that the application proceed to grant.

I award costs according to Schedule 8 against Merial Limited.

REASONS FOR DECISION

BACKGROUND

1. Patent application 2010206029 in the name of Novartis AG was filed on 29 July 2010. It is a divisional application of AU 2008201605 which in turn is a divisional application of AU 2004262492 and through this grandparent application the present application claims an earlier priority date of 30 July 2003. The application was advertised as accepted on 9 August 2012. Merial Limited filed a Notice of Opposition to the grant of the patent under s59 of the Patents Act on 9 November 2012. The matter was heard in Melbourne on 13 October 2014.

   GROUNDS OF OPPOSITION

2. The Statement of Grounds and Particulars (SGP) stated that the application is being opposed under the grounds of Novelty, Inventive Step, Manner of Manufacture, Clarity, Fair Basis, Sufficiency, Utility and Secret Use. 

   EVIDENCE

3. Evidence filed for the proceedings comprises the following:

   • Evidence in support consists of a declaration from Mr Robert Simon Marov, an independent expert, dated 25 April 2013 (with exhibits RSM-1 to RSM-7).
   • Evidence in answer consists of six declarations from Dr James S. Rowe, an independent expert, dated 9 July 2013, 18 October 2013 (with exhibits JSR-3 to JSR-5), 18 October 2013 (with exhibit JSR-6), 18 October 2013 (with exhibit JSR-7), 15 November 2013 (with exhibits JSR-8 to JSR-23), 15 November 2013 and 26 November 2013.
   • Evidence in reply consists of a declaration from Mr Robert Simon Marov dated 22 May 2014 (with exhibits RSM-8 to RSM-20)

   SPECIFICATION

4. The present invention relates to an easy to use, safe, efficacious and stable veterinary formulation.

5. Under the heading “Field and Background of the Invention”, it identifies a number of modes of administering veterinary products to animals including topically as pour-on or spot-on formulations, in form of shampoos, showers, as a dip, bath or spray, in form of a collar, or systemically such as orally, parenterally and transdermally. Examples of systemic administration forms include injection, tablets, capsules, bolus, drink and feed additive.

6. It states that while oral treatment for humans is very convenient and easy to manage, oral treatment of animals can be a real challenge because of the natural behaviour of the animal. Most active pharmaceutical ingredients (API) have a taste that is unpleasant to the animal and they may therefore refuse to take it orally. Attempts to administer pharmaceutical preparations in the form of capsules and coated tablets are also generally unsuitable since “in the case of herd animals, they can only be used in a controlled manner with considerable effort on a daily basis and in the case of pets, such as dogs and cats, lead to particular acceptance problems”.  Cats for example are very fastidious in their eating habits and generally tend to bite the food, with the result they will damage the protective coating of any tablet or capsule mixed with their food and release the unpleasant tasting active ingredient and end up rejecting the food.

7. The specification then states that the present inventors have “recognized that in the field of animal health the dosage form and especially the palatability of the dosage form i.e. the natural acceptance of the drug plays the decisive role”. For an animal to willingly take a medicinal preparation orally, the preparation must taste well and be palatable to the animal. While the animals could be forced to take it orally, this may be difficult or even impossible for large scale animal operations or even for single animals which because of their natural tendency could bite or scratch. Consequently, administering a pharmaceutical preparation to animals can be “very labour-intensive or can require the intervention of a veterinarian and this ultimately leads to increase of costs”.

8. It then states “Therefore, for pets but equally for animals that are kept on a large scale, simple and safe oral application forms are required, which can be easily administered by the animal keeper, which leads to reliable results, and which are affordable”.

9. Then under the heading “Summary of the Invention”, it states that the present invention overcomes the shortcomings of the prior art by providing an “easy-to-use, safe, powerful and stable veterinary formulation consisting of a highly palatable ductile chewable veterinary composition which is produced by an extrusion process wherein the product is extruded at or near room temperature and wherein the extruder is cooled down below room temperature”. The veterinary formulation contains “(A) an effective amount of one or more ingredients that are active against animal pests, pathogens or animal diseases; (B) meat flavouring; (C) partially gelatinized starch; (D) a softener; and (E) optionally up to 9% (w/w) water”.

10. The specification states that the active pharmaceutical ingredient (API) is not limited to any particular ingredient and includes each and any active ingredient that is at the administered dose physiologically acceptable to the animal, does not display unacceptable side effects and most importantly exhibits systemic activity after oral uptake. 

11. The specification then discusses the function and benefits of the excipients or carriers that are mixed with the active ingredient.

12. The meat flavouring is stated to play a major role in the veterinary composition as the desired high palatability strictly “depends on the amount of meat flavouring in the final composition”.  The fat content of the meat flavouring is also important in achieving the desired softness of the final product. The meat flavouring can be either natural flavouring or artificial flavouring.

13. The partially gelatinized starch is stated to be important for achieving the desired ductility of the final product. Partially gelatinized starch is a mixture of non-gelatinized and pre-gelatinized starch with the pre-gelatinized starch being in the ratio 10-20% (w/w). The specification states that completely non-gelatinized starch or completely pre-gelatinized starch do not result in the desired ductility.

14. The softener is stated to be an important component which enhances the flexibility of the product and retains the moisture within the composition and allows the product to be stored for a long time without becoming dry and hard.

15. The moisture content is again stated to be important to the flexibility of the final product and if the other ingredients do not contain sufficient moisture, water should be added during the extrusion process so that the final product contains water at a concentration of equal to or less than 9%.

16. The specification then states that the invention further includes a process for the production of the veterinary formulation comprising, feeding the hopper of an extruder with the active ingredient and carriers of the formulation, cooling the extruder so that the temperature of the extrudate that leaves the extruder does not exceed 40°C, pressing the extrudate though a die of the required shape and cutting the extrudate into equal pieces. This production process is stated to have a substantial influence on the final product. While extrusion is a very common thermoforming process for the production of feed pellets, high extrusion temperatures transforms the molecular structure of the starch and leads to a product that is hard and crunchy rather than ductile and soft. Furthermore the high temperatures generated within the extruder can partially degrade the active ingredients. Therefore in order to achieve the required ductility of the chewable product without loss of active ingredient it is important to ensure that the extrudate is not heated during the extrusion process. In a preferred form the extruder is a co-rotating twin screw extruder which is cooled down below room temperature, preferably to 5-10°C.

17. The specification states that the ductility of the final product is somewhere in between that of a cornflake and a marshmallow.

18. The specification then ends with 22 claims. Claim 1 is the only independent claim and reads as follows:

    1. Process for the production of a highly palatable ductile chewable-veterinary composition, comprising (i) feeding the hopper of an extruder with an effective amount of one or more ingredients that are active against animal pests, pathogens or animal diseases; meat flavoring; partially gelatinized starch; a softener; and up to 9% (w/w) of water, (ii) cooling constantly down the mixture of active ingredients and carriers so that the temperature of the extrudate that leaves the tip of the extruder does during the whole extrusion process at no time exceed 40°C, (iii) pressing the extrudate through a die that is decisive for the shape of the chewable product, and (iv) cutting the extrudate that leaves the extruder into equal pieces.

    ONUS OF PROOF

19. The examination request for this patent application was filed on 14 February 2011. As a consequence, substantive amendments of the Patents Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act2012 do not apply to the present application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists.

20. Consequently the former standard for opposition proceedings applies and the opponent must establish that it is clear or practically certain that the patent is invalid (F Hoffman La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29], [67]; [2000] FCA 283; 50 IPR 305 at 311, 319; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; [2008] FCAFC 182; 79 IPR 426; Genetics Institute Inc v Kirin-Amgen Inc [1999] FCA 742; [1999] 92 FCR 106 at [17]).

    CLARITY

21. The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228 at [118] – [120]:

    “the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear ... while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole ... it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification ... terms in the claim which are unclear may be defined or clarified by reference to the body of the specification.”

22. The opponent submitted that claims lack clarity due to the use of the term “partially gelatinized starch” which is ambiguous in that it could be understood as meaning that the composition has in it gelatinized starch and non-gelatinized starch, or where gelatinization of the entire starch has proceeded to a certain amount but not to a complete gelatinization.

23. I beg to differ. This is clearly an instance where it is legitimate to refer to the specification to clarify the term. The specification on page 30, lines 17 to 19 explains that partially gelatinized starch contains 10-20% (w/w), preferably about 13-17% (w/w) most preferably 13-17% (w/w) pre-gelatinized starch. In my view this clearly indicates that the term indicates that the starch includes both gelatinized and non-gelatinized starch. This construction is also supported by both the experts. This term is therefore clear.

24. The opponent also submitted that the term “highly palatable” is unclear as palatability is a subjective assessment and changes between species.

25. While I accept that what is palatable to one animal may not be palatable to another animal, I agree with Dr Rowe when he explains that “a palatable oral veterinary composition may be thought of as being one which has an acceptable taste to the target animal”. This term is therefore clear.

26. The opponent also submitted that omnibus claim 22 which makes reference to the examples lacks clarity because all the examples only specify the excipients as including pre-gelatinized, rather than partially gelatinized starch.

27. Claim 22 reads “Process according to claim 1, substantially as hereinbefore described with reference to any one of the examples”. Claim 1 clearly defines the use of partially gelatinized starch, but as pointed out by the opponent each of the examples only mentions pre-gelatinized starch. Clearly there is some ambiguity here.

28. The applicant argued that the examples in the specification need to be construed in light of the teaching of the invention including the claims and I agree. The specification clearly asserts the use of partially gelatinized starch as being an essential integer of the invention and this is further reflected in claim 1. Claim 22 clearly states that it defines a “process according to claim 1” which is then to be further qualified with reference to any one of the examples. The only sensible construction in my view is that the reference to pre-gelatinized starch in each of the examples is to be read as a reference to partially gelatinized starch which as discussed earlier is a mixture of non-gelatinized starch and pre-gelatinized starch. Claim 22 is clear.  

    FAIR BASIS

29. The opponent argued that the claims 1-20 lack fair basis because they includes within their scope, embodiments which contain 0% water and such embodiments were not fairly based on the body of the specification which repeatedly recites the presence/need of water in the ductile chewable compositions.

30. I do not find this argument persuasive. While it is true that the specification does talk about the impact of moisture on the flexibility of the final product, as the applicant pointed out it is clear on reading the description that the additional water is required only if the other ingredients of the composition do not contain sufficient moisture. In my view there is basis in the body of the specification for not feeding any additional water into the hopper of the extruder. The claims are fairly based.

31. Although the SGP included some other particulars on this ground, none of these were pressed at the hearing. I have considered these and do not consider that any of these is well founded. This ground of the opposition has therefore not been made out.

    NOVELTY

32. It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 at [20]; 137 CLR 228 at 235:

    “The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement”.

33. This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40; (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must "contain clear and unmistakeable directions to do what the patentee claims to have invented" (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486).

34. In AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99, the full Federal Court held:

    “Sufficiency of disclosure is a cardinal anterior requirement in the analysis of whether a prior art document anticipates a claimed invention. It is only after the stage of assessing the sufficiency of disclosure – which involves a determination about whether a prior document has “planted the flag” as opposed to having provided merely “a signpost, however clear, upon the road” or, perhaps, something less – that the notion of reverse infringement comes into play as the final and resolving step of the required analysis. It is not the first step of the required analysis; nor is it the only step”.

35. In relation to the specificity required in order for a prior art document to anticipate the claimed invention, the full court in AstraZeneca (supra) also quoted with approval the following quote from Gyles J in Apotex Pty Ltd and Another v Sanofi-Aventisand Another (2008) 78 IPR 485:

    “anticipation is deadly but requires the accuracy of a sniper, not the firing of a 12 gauge shotgun”.

    D3: US 6500463

36. Document D3 is the only document relied on by the opponent in relation to the ground of Novelty. D3 relates to a process for producing shelf stable, controlled release, solid particles comprising a matrix material and an encapsulated pharmaceutically, biologically or nutritionally active component. The active component is admixed with the matrix material under low temperature conditions and then extruded in an extruder die, cut into pieces and then dried to form encapsulated pellets.  The final product could be edible compositions and be incorporated into various foods for human or animal consumption, or it could also be non-edible compositions such as detergents, herbicides, fungicides or pesticides.

37. The pharmaceutically active component may include antibiotics, vaccines, and anti-viral agents. The matrix material includes a plasticizable component, a liquid plasticizer such as water or oil and a non-plasticizable component such as partially gelatinized starch.

38. All the ingredients are admixed together in a co-rotating twin screw extruder at a temperature which does not substantially destroy the encapsulant or substantially gelatinize the starch, such as less than 35°C. While not explicitly disclosed, the requirement for the extrusion temperature to be less than 35°C would necessarily involve cooling down of the extruder. This was also not disputed by the applicant. This integer of claim 1 is therefore disclosed. 

39. The applicant argued that D3 does not anticipate claim 1 as it fails to disclose the following integers:

    ·The final product is highly palatable, ductile and chewable

    ·Meat flavouring

    ·Softener

    ·Water up to 9%

    ·Pressing the extrudate through a die that is decisive for the shape of the chewable product

40. D3 discloses that the final product “may possess a substantially non-chewable texture, which is perceived as being glassy or fracturable, but is between the chewable texture of streusel or chewable vitamin pills, and the dense hard glassy texture of uncooked pasta”, but then also states that it is “easy to swallow with or without chewing”.

41. While the opponent relied on this reference to the product being chewed before swallowing as indicating that the product is ductile, in my view this reference appears to reflect the fact that chewing is sometimes unavoidable rather than a teaching of the product being chewable and ductile. Also I do not accept that something that can be chewed before swallowing has to be necessarily ductile. The meaning of the term ductile is “flexible, pliant; capable of being moulded or shaped” (Oxford Dictionary) and in my view this is the meaning that should be ascribed to this term in the context of the claimed invention. I can find no indication in D3 to suggest that the final product is flexible or pliant and in fact the reference to the product being glassy or fracturable would suggest the opposite. In my view D3 lacks the teaching of the final product being ductile and chewable.

1. Although the applicant argued that the product of D3 is intended to be mixed with other foods for consumption and that the product is therefore not highly palatable, I do not find this persuasive. D3 does mention the inclusion of flavouring in the extruded product and this would clearly for the purpose of increasing the taste and palatability. Even if it is only meant to be served mixed with other food, it would certainly need to be palatable if it is not to be rejected by the animal. This integer is disclosed.

2. While the opponent admitted that there is no specific teaching of the inclusion of a meat flavouring, they argued that it does mention the inclusion of flavouring and that their expert Mr Marov has stated that “in the context of compositions for animal consumption, such as dogs and cats, I usually associate the term flavouring to include meat or fish flavouring” and also “essentially all (or at least 99.99%) products designed for consumption by cats and dogs would contain some form of meat or fish flavouring”.

3. Whilst I accept that meat flavouring is one of many flavourings that are commonly used in products for animal consumption, the fact remains that there is no clear teaching of the use of meat flavouring in D3. The only reference to the types of flavouring in D3 is in column 12 where it teaches the use of “fruit juice to adjust pH and to obtain a pleasant flavour in the final product”. I am not satisfied that the reference to flavouring in D3 is a clear and unmistakeable teaching to use meat flavouring. This integer of claim 1 is not disclosed.

4. The opponent submitted that D3 discloses that the liquid plasticizer can be glycerol, polyethylene glycol or polypropylene glycol and that these are clearly softeners that are contemplated in the opposed specification.

5. I agree. While D3 uses these chemical compounds as plasticizers and not specifically as softeners, the fact remains that these compounds are clearly considered as softeners in the context of the claimed invention. Claim 7 of the opposed application clearly states that the softener is selected from the group consisting of glycerol, polyethylene glycol or polypropylene glycol. I can see no reason why these compounds would also not act as softeners in the product of D3. This integer of claim 1 is disclosed.

6. In relation to the water content, D3 teaches the need to adjust the total water content of the dough as a moisture content above 50% would result in a thin, low viscosity dough and a moisture content below 5% may result in a dry fragile product. Examples of percentages are 10% to 50% and 15% to 25% by weight. While neither of these examples encompass the claimed percentage of 9% or less, I am satisfied that there is a teaching in D3 that the water content can go as low as 5%. The integer of water content up to 9% is taught in D3.

7. In relation to the feature of pressing the extrudate through a die, this is clearly disclosed in D3 at column 21, lines 38-48.

8. In summary D3 does not teach the features of meat flavouring and the final product being ductile. It follows that it does not anticipate the claimed invention.

   INVENTIVE STEP

9. Under the provisions of subsections 7(2) and 7 (3) of the Patents Act 1990, an invention is taken to involve an inventive step when compared with the prior art base unless it would have been obvious to a person skilled in the art.  The invention must be obvious in the light of the common general knowledge as it existed in the patent area before the priority date, either on its own or together with information in a document, or combination of documents, that the person skilled in the art could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant and, where necessary, combined.  ‘Obvious’ means ‘very plain’ (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21 at [ 51] - [52]; (2007) 72 IPR 447 at 461 [51] - [52]).

10. The test for obviousness was provided by Justice Aicken in Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12 at [45]; 148 CLR 262 at 286 as follows:

    "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."

11. More recently, in Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59 at [53]; 212 CLR 411 at [53] the High Court approved the approach taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at 187 in which Graham J had posed the reformulated Cripp's question:

    "Would the notional research group at the relevant date, in all the circumstances,  directly be led as a matter of course to try [the claimed combination of integers] in the expectation that it might well produce a [useful or desired result]?"

12. Where the invention lies in a combination of features, the question is whether the combination, not each individual feature, is obvious when compared to the prior art base:

    "The claim is for a combination, the interaction between the integers of which is the essential requirement for the presence of an inventive step.  It is the selection of the integers out of "perhaps many possibilities" which must be shown to be obvious, bearing in mind that the selection of the integers in which the invention lies can be expected to be a process necessarily involving rejection of other possible integers." (Alphapharm (supra) at [41])

13. An important consideration is also the impermissible use of hindsight.  The High Court in Alphapharm (supra) also warned against the misuse of hindsight noting that the danger of such misuse will be "particularly acute where what is claimed is a new and inventive combination for the interaction of integers, some or all of which are known". In that regard, the court referred with approval to Lord Diplock's comments in Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1972] RPC 346 (at 362):

    "Once an invention has been made it is generally possible to postulate a combination of steps by which the inventor might have arrived at the invention that he claims in his specification if he started from something that was already known. But it is only because the invention has been made and has proved successful that it is possible to postulate from what starting point and by what particular combination of steps the inventor could have arrived at his invention. It may be that taken in isolation none of the steps which it is now possible to postulate, if taken in isolation, appears to call for any inventive ingenuity. It is improbable that this reconstruction a posteriori represents the mental process by which the inventor in fact arrived at his invention, but, even if it were, inventive ingenuity lay in perceiving that the final result which it was the object of the inventor to achieve was attainable from the particular starting point and in his selection of the particular combination of steps which would lead to that result."

14. The usual approach to obviousness is the problem-solution approach.  Once the problem has been formulated, and the common general knowledge or prior art base have been determined, the question of whether the claimed solution is obvious must be addressed.

    The Problem to be Solved

15. The opponent submitted that the problem to be addressed is the production of highly palatable ductile chewable veterinary compositions which contain a temperature sensitive active ingredient. The applicant on the other hand argued that the problem is the preparation of an oral veterinary composition that would be highly palatable and hence readily accepted by animals.

16. The specification mentions various approaches to administer veterinary formulations to animals including topical and systemic and how the method of administration will vary depending on the type of animal. It also states that while oral administration is a convenient and easy way to administer medication to humans and would also be desirable for animals; oral administration can be a real challenge for animals because of their natural behaviour to reject medications which do not have an acceptable taste. It then states that the dosage form and palatability of the dosage form play a decisive role in the animal’s acceptance of the drug and that “Therefore, for pets but equally for animals that are kept on a large scale, simple and safe oral application forms are required, which can be easily administered by the animal keeper, which leads to reliable results, and which are affordable”.

17. It also then acknowledges that one of the problems that arise in the context of production of medicated animal feed is the stability of the active ingredient. Conventional extrusion processes for forming feed pellets involve elevated temperatures and pressures and these can result in considerable loss of active ingredients.

18. In my view it is clear from reading the specification that the problem to be addressed is twofold; firstly to come up with a veterinary formulation for oral administration that is highly palatable and therefore readily accepted by the animal and secondly to ensure that active ingredients that are thermally sensitive are not degraded during the production process.

19. It is clear from the evidence of Mr Marov and Dr Rowe, that both these problems are common general knowledge in the art and therefore my formulation of the problem is also consistent with the Full Court’s decision in AstraZeneca (supra).

20. It is also my view that the problem does not require that the final product have any particular form. The only requirement is that it should be capable of oral administration. It could be either a solid or a liquid.

21. In my view the problem as stated by the opponent is too narrow and appears to be influenced by the solution provided in the opposed application.

    Person Skilled in the Art (PSA)

22. Both parties submitted that their respective expert declarant was the more suitably qualified to provide expert opinion in this matter and that I should give more weight to the opinion of their expert.

23. Mr Marov, the opponent’s expert, is currently a consultant specialising in the area of manufacturing food products for companion animals such as cats and dogs. His qualifications include Bachelor of Science in Food Technology, Qualified Cannery Person and Safe Quality Food Systems Implementation.

24. Since 1988 he has worked for various companies in the pet food industry including Uncle Ben’s, Pet Foods Pty Ltd, Effem Foods Ltd and in various roles such as New Product Scientist, Applied Research Scientist and Technical & Product Development Manager. While with Uncle Ben’s he was part of a team that developed many pet food products including “Dine” brand cat food.  Later on in his role as Technical & Product Development Manager he was involved in the research and development activities for canned pet foods, soft chew treats and refrigerated pet food products. He states that he also has good knowledge of the equipment used to prepare these products and these include extruders, dryers, cooling equipment and packaging systems.

25. He has been a member of the technical committee of the Pet Food Industry Association of Australia (PFIAA) and in this role he states that he regularly interacted with the Australian Pesticides and Veterinary Medicines Authority (APVMA). However it is unclear as to what kind of interaction this was and whether it involved discussions on the use of active ingredients in pet foods.

26. Based on his experience, it was his view that when developing and bringing a new product to market in the pet food industry, a team of people would be involved including people from business development, research and development, quality control and manufacturing.

27. Dr Rowe, the applicant’s expert, is currently an independent consultant for the pharmaceutical, personal care and veterinary industries. His educational qualifications include Bachelor of Pharmacy, Master of Science (Biopharmaceuticals) and PhD (Pharmaceutics), and Pharmaceutical Compounding.

28. Since 1967 he has worked in a number of roles dealing with the development of new formulations of known active ingredients for both pharmaceutical and veterinary products in companies such as Abbot Laboratories, Technical Consultancy Services (TCS) and CoPharm Pty Ltd. He states that during his time with TCS he has formulated hundreds of products for veterinary administration including oral tablets for cats and dogs, oral pastes, chewable tablets, sheep drenches, pour-on liquids and oral suspensions. He also is named as inventor in a number of patents for veterinary formulations.

29. The opponent argued that the field of the present invention is that of production of palatable ductile chewable veterinary products using extrusion techniques and that Mr Marov’s experience in the development of soft chews for pets makes him eminently qualified to provide opinion on the common general knowledge in the art. They further submitted that Dr Rowe’s experience however on the other hand is in the field of veterinary compositions and their formulations and not in their processing or production using extruders and that the evidence of Mr Marov is therefore to be preferred to that of Dr Rowe.

30. As I have found earlier the problem to be addressed is to produce a veterinary formulation for oral administration that is highly palatable and readily accepted by the animal and is produced in such a manner that the active ingredients are not degraded. Clearly in my view the PSA for this problem would include a person working in the field of veterinary formulations, someone such as Dr Rowe. If the formulation developed by such a person requires to be administered as a pet food or along with pet food, that PSA may also need to work with a PSA in the art of pet food manufacture such as Mr Marov for any assistance in coming up with a suitable process to manufacture the formulation so that the final product will have the necessary attributes such as texture, palatability, potency, stability, and shelf life. 

31. It is well established law that the notional skilled worker can include a team of workers and that one person does not need to provide all the requisite skills in such a team (see, for example Minnesota Mining & Manufacturing Company v Tyco Electronics Pty Ltd (2002) AIPC 91-823 and ICI v Lubrizol 45 IPR 577). In my view both Mr Marov and Dr Rowe can be considered to be a PSA in their respective areas of expertise and I will therefore weigh their evidence accordingly.

    Common general knowledge

32. From reading the evidence of both Mr Marov and Dr Rowe, it is clear that the following were common general knowledge in the art at the priority date of 30 July 2003.

    • The palatability of any veterinary formulation for oral administration is key to the animal’s acceptance of the formulation.
    • Veterinary formulation for oral administration can be manufactured in a number of forms including pellets, granules, tablets, chewable tablets, soft chews, suspensions, pastes, powders, bolus, drink and feed additive.
    • Use of starch as an excipient in pet foods and veterinary formulations.
    • Forming and extrusion are well known processes for manufacturing pellets and chewable treats.
    • Extrusion can be either hot extrusion or cold extrusion.
    • During extrusion significant amount of heat is generated and this heat can advantageously allow the starch to undergo gelatinization which in turn assists in providing the required mechanical properties for the final product.
    • The stability of active ingredients in veterinary formulations can be affected by factors such as the excipients it is mixed with, heat, moisture, pressure and light.
    • Soft chews for pets generally included a binding agent such as starch, a humectant, flavouring and optionally water and/or oil.
    • Meat flavouring is one of the common flavourings used in pet foods and veterinary formulations.

    Ascertained Requirement

33. S7(3) requires that for a document to be part of the prior art information that can be used for assessing inventive step, it must be a document that a PSA could have ascertained.

34. Mr Marov states that his research group “conducted regular patent searches based on keywords” and that he “would regularly review the abstracts of the identified patent documents”. Dr Rowe also states that when he was tasked with developing a veterinary composition he would conduct an online keyword search on various databases such as “International Pharmaceutical Abstracts, Medline/Index Medicus and Chemical Abstracts”. Some of these databases clearly include patent abstracts and the 39 records retrieved in a prior art search done by Dr Rowe also include a number of patent documents.

35. I am therefore satisfied that the PSA in the field of veterinary formulations would normally have regard to prior patents in the art when tasked with developing a new formulation.

36. The applicant as part of their brief to Dr Rowe had asked him to conduct an online search to find information that would assist him in devising a single oral veterinary composition containing one or more active ingredients that is palatable to animals such as cats and dogs. Dr Rowe conducted an online search using a professional searcher and came up with 39 records. The final search strategy used was as follows:

    [(veterinary or oral) and palatab?)] AND (dog or dogs or cat or cats)

37. The applicant submitted that most of the documents relied on by the opponent in the present opposition did not feature in these 39 records and therefore those documents could not have been ascertained for the purposes of s7(3). The opponent on the other hand argued that the search strategy used by Dr Rowe was inadequate and therefore this could not be used to establish whether these documents could have been ascertained.

38. I agree with the opponent. A number of important search terms like “animal”, “pet”, “taste” and “orally” have not been included and Dr Rowe has given no explanation as to why such terms were not used. The highly restricted search strategy used by Dr Rowe probably explains why only 39 records were identified when one would have expected to have found a lot more. Quite a few of the documents that are relied upon by the opponent are clearly directed to improving the palatability of oral veterinary compositions and I have no doubt that a comprehensive search strategy would have identified some of these documents.

39. Therefore I am not prepared to accept the applicant’s submission that the fact that these documents were not in the 39 records identified by Dr Rowe’s search means that these documents could not have been ascertained. I will assess each document based on its disclosure.

    D1: EP 1247456

40. Document D1 was not pressed by the opponent at the hearing. D1 is directed to a palatable pharmaceutical composition for companion animals and is therefore directed to a similar problem. It is therefore a document that the PSA would have ascertained, understood and regarded as relevant.

41. D1 teaches that the active ingredients be mixed with a palatability improving agent that is non-meat and non-fish derived and a binding agent such as pre-gelatinized starch. The non-meat and non-fish derived flavouring can be artificial meat flavouring. The formulation is made into a dosage form such as granules by wet granulation or into a tablet or chewable tablet in a tablet press.

42. There is no teaching in D1 of the inclusion of partially gelatinized starch, the use of a cold extrusion process to form the final product or that the final product is ductile. Even if the use of partially gelatinized starch and the use of cold extrusion to form pet foods were common general knowledge in the art there is no evidence from Mr Marov as to why the PSA would have been motivated to use partially gelatinized starch and employ a cold extrusion process to form a ductile chew when the teaching in D1 is to form granules or tablets using different processes.

1. The claimed invention is inventive over D1.

   D2: GB 2300103

2. D2 is directed to a dog biscuit containing creatine and a method of making them. As creatine can be substantially destroyed at temperatures conventionally used in the extrusion process, the invention teaches that the extrusion should be carried out at temperatures below 130°C. It also states that the biscuit will include other standard ingredients including cereals, meat and animal products and flavours.

3. The opponent submitted that creatine could be considered a pharmaceutically active ingredient as it used to treat inflammation and therefore D2 is directed to a veterinary composition. They further argued that as D2 is directed to solving the problem of temperature sensitivity of creatine it is clearly a document that the PSA would have ascertained, understood and regarded as relevant.

4. While I am prepared to accept that creatine could be considered to be an active ingredient and that D2 recognises and seeks to overcome the problem of temperature sensitivity of creatine, D2 does not talk about the palatability of the product or the general problem of acceptance of pet foods containing active ingredients. While D2 may mention the inclusion of meat products and flavours, there is nothing to suggest that the palatability of the biscuit is a problem. In my view it is not directed to the problem of making veterinary formulations more palatable and hence could not have been regarded as relevant. Therefore D2 is not part of the prior art information under s7(3) of the Act for the purposes of assessing inventive step.

5. Even if I am wrong on this point and D2 could have been ascertained and regarded as relevant, I am not satisfied that it would make the claimed invention obvious. D2 does not disclose the extrusion temperature to be less than 40°C and that the final product is ductile. D2 teaches that the extrusion is carried out at less than 130°C but also states that the starch that is used in the biscuit will need to be gelatinized during the extrusion process to an extent that will not upset the dog’s digestive system. Dr Rowe states that if the temperature was reduced to 40°C, then the partial gelatinization of the starch that is required would not occur. I am therefore not satisfied that it would have been a matter of routine to use an extrusion temperature of 40°C as required by the claimed invention. Also as discussed earlier with reference to D3, I do not accept that just because something can be chewed before swallowing it has to be necessarily ductile. There is no teaching in D2 to produce a ductile product as required.  

6. The claimed invention is inventive over D2.   

   D3: US 6500463

7. The applicant argued that D3 would not have been regarded as relevant by the person skilled in the art and I am inclined to agree. While it states that the product of the described process can be used for making oral veterinary compositions, this is only one amongst various other uses including compositions for non-edible use. The focus of D3 is in the encapsulation of active ingredients in a matrix. There is no discussion in D3 about the difficulty in oral administration of veterinary formulations in animals or the importance of taste and palatability in this oral administration. In my view this document would not have been ascertained by the person skilled in the art and even if it had been ascertained, they would not have regarded it as relevant to solving the stated problem.

8. D3 is not part of the prior art information under s7(3) of the Act for the purposes of assessing inventive step.

9. Again even if I am wrong on this point and D3 could have been ascertained and regarded as relevant, I am not convinced that D3 would make the claimed invention obvious. As discussed earlier under Novelty, D3 does not disclose the inclusion of meat flavouring and that the product is ductile.

10. While D3 teaches that flavourings can be included in the product for animal consumption, it does not specifically mention meat flavouring or any other flavouring for that matter.

11. It is not in dispute that the use of different flavouring in pet foods to improve palatability and acceptability was well known and that the different flavours used include meat, fish and fruit flavouring. The type of flavouring employed could vary depending on the target animal. Is it then obvious to use a meat flavouring with the teaching of D3?

12. Prima facie it would appear to be so, but I note that the opposed specification states that the inclusion of meat flavouring and other animal matter may affect the stability of the active ingredients. For example it states “It is a matter of fact that many potent active compounds are somewhat unstable (temperature-sensitive), above all when in contact with feed material, especially close contact to vegetable and animal materials, during conventional extrusion of feed pellets, result in considerable losses of active ingredient’ (page 5) and “it is highly surprising and was absolutely unpredictable that even so the chewable veterinary composition of the present invention contains a relatively high amount of meat material, this has obviously when combined with the appropriate amount of partially gelatinized starch, no adverse effect on the stability of the active ingredient” (page 7). These statements would appear to suggest that the inclusion of meat flavouring in veterinary formulations may not be so obvious after all. However assertions in the specification such as these needs to be treated with caution if they are not supported by expert evidence.

13. Mr Marov does not talk about any stability problems arising out of use of meat flavours. Dr Rowe does appear to suggest that aroma and flavours can affect stability when he states: 

    “When formulating a product for voluntary administration the addition of attractants such as aromas and flavours has the potential to decrease the stability of the final product. This lack of stability in these more palatable forms may be the result of a chemical reaction occurring between the API and the excipients used in the chewable tablet, pellet, crumble, powder, granule or paste”.

14. However I note that this is a reference to aromas and flavours in general and not specific to meat flavouring. In fact when he was asked by the applicant as to what would he do if he was asked to devise a highly palatable oral veterinary composition that would be suitable for a wide range of active ingredients and be palatable for a range of animals, he states in paragraph 55 of his first declaration:

    “If it would be cost effective to prepare a voluntarily accepted dosage forms, two options that were available prior to 30 July 2003 that I would have favoured would have been to incorporate various flavours such as meat or fish and fragrances into a unitary composition so that the composition is palatable and readily accepted by the animal voluntarily, again ensuring that the product is stable and the API is bioavailable. Such compositions are likely to be more expensive to produce than standard pelleted materials that are mixed with feed. The composition may have taken the form of:

    a. a larger, hard, extruded starch-based pellet; or
    b. a chewable tablet.”

15. He also states in paragraph 36 of the same declaration:

    “Veterinary compositions were able to be made palatable to enhance animal compliance in a number of ways. Before 30 July 2003 these included the use of an aroma or other ingredient to lure the animal which is attracted to the smell and/ or taste of the composition. In this respect, dogs are known to prefer products having a flavour such as beef, chicken, liver, raspberry and strawberry while cats prefer tuna, chicken and cheddar cheese.”

16. It is therefore clear from the evidence presented to me that the use of meat flavouring was common general in the art of veterinary compositions. While D3 does not specify any particular flavouring, I am satisfied on the evidence that the inclusion of meat flavouring with the teaching of D8 would have been a matter of routine where the product is for animal consumption.

100. While I accept that soft chews for pets was common general knowledge in the art at the priority date, that is not sufficient to establish that making the product of D3 ductile would have been an obvious thing to do. The ductility of the final product is a result of the selection of the appropriate ingredients and the processing method for producing the final product. Therefore to make the product of D3 ductile would necessarily involve modifications to either the ingredients of the mixture or the extrusion process or even both. I have been provided with no evidence to satisfy me that the hypothetical skilled addressee would have as a matter of routine made these modifications when the teaching in D3 is to produce a product that is glassy or fracturable. Furthermore it must be the combination claimed that must be shown to be obvious and not just individual integers. I am not satisfied that the evidence establishes that the claimed combination of the ingredients of the mixture and the extrusion process with constant cooling is obvious in light of the teaching of D3.

D7: US 2004/0043925

101. D7 is directed to a veterinary formulation for oral administration that is readily accepted by animals. Similar to the opposed application it talks about the difficulty in getting animals to voluntarily take oral medicaments and the importance of the palatability of the medicament. It is clearly directed to a similar problem and is therefore a document that the PSA would have ascertained, understood and regarded as relevant.

102. The solution proposed by D7 is to incorporate the active ingredient in a starch based extruded article along with meat flavours, humectants and other additives including water with the extrusion carried out at 120°C. The Shore A hardness of the final product is stated to be preferably in the range 15-25 and this clearly is in the soft or ductile range and therefore the integer of the product being ductile and chewable is disclosed. Dr Rowe for the applicant also agrees that D7 discloses the integer of inclusion of up to 9% water.   

103. Among the various starches that can be used D7 also mentions pre-gelatinized or chemically modified starches. While the opponent accepted that D7 does not mention “partially gelatinized starch”, they submitted that this was implicit as Mr Marov has stated that “It’s common terminology in the art to use the term “pre-gelatinized” starch when discussing partially gelatinized starch”. They also referred me to the examples in the opposed specification all of which only list the starch component as “pre-gelatinized starch” and not as “partially gelatinized starch” in support of this contention.

104. I have already discussed the issue of the examples referring to pre-gelatinized starch under “Clarity” and found that this should be read as a reference to “partially gelatinized starch” only because the rest of the specification clearly asserts the importance of using partially gelatinized starch. No such assertion is made in D7 and therefore I am not prepared to accept that the teaching of pre-gelatinized starch in D7 includes also the use of partially gelatinized starch. Mr Marov’s view on this is not supported by Dr Rowe. There is no clear and unmistakable teaching of the integer of partially gelatinized starch in D7. 

105. The opponent accepted that D7 does not disclose the feature of cooling the mixture so that the temperature of the extrudate does not exceed 40°C, but submitted that that the opposed specification admits that it is common general knowledge that active ingredients are “somewhat unstable (temperature-sensitive)” and result in losses of active ingredient during conventional extrusion. They argued that the use of cold extrusion to form soft chews for pets was common general knowledge in the art and that in light of this common general knowledge it would have been obvious to the person skilled in the art to reduce the production temperature to a temperature at which the temperature sensitive components are stable and this is an obvious and routine adjustment of the production parameters.

106. While I accept that temperature sensitivity of active ingredients is a known problem and that cold extrusion as a method of forming pet foods is well known in the art, I am not convinced that lowering the extrusion temperature to less than 40°C would have been the obvious thing to do when presented with the teaching of D7. Although D7 states that its teaching is suitable for all active ingredients which are suitable for use in veterinary medicine, it still only teaches an extrusion temperature of 120°C which is three times higher than what is required in the claimed invention. There is no discussion in D7 of the temperature sensitivity of the active ingredients or the need to keep the temperature as low as possible.

107. The opposed specification states that much effort has been directed at stabilizing temperature sensitive active ingredients so that they withstand elevated temperatures and pressures during pellet preparation and some of these unsuccessful attempts include reduction of the active ingredient surface area, sealing of the active ingredient in one or more protective layers, enclosure of the active ingredients within porous materials and chemical modification of the structure of the active ingredients. 

108. Dr Rowe also admits that the temperature sensitivity of active ingredients was a known problem but states that the heat generated during the extrusion process is also important as it advantageously allows the starch to undergo a number of important chemical modifications in the presence of water. The gelatinization of the starch allows the product to puff and release steam during the extrusion process and this combination of the action of heat, pressure and water on the mass provides the final product with the mechanical properties necessary to retain its shape. He also states that if he was asked to devise an oral palatable veterinary composition comprising an active ingredient that is sensitive to the process steps during extrusion he would favour a tablet, chewable tablet or capsule that could be enveloped in food to improve palatability. He does not suggest the use of cold extrusion.

109. It is therefore clear that there are a range of options available to the PSA when confronted with the problem of active ingredients that are sensitive to the heat generated during conventional extrusion processes. It is also clear from the declarations of both Mr Marov and Dr Rowe that the properties of the final product such as hardness and texture will be affected by whether it is produced by hot extrusion or cold extrusion.

110. As discussed earlier the invention of the opposed application resides not only in the choice of cold extrusion but also in the choice of the other ingredients that make up the composition including the use of partially gelatinized starch, the softener and water to a specified content as these all play a major role in achieving the required ductility and texture of the final product.

111. The opponent’s evidence does not satisfy me that faced with the stated problem, the PSA would have as a matter of routine modified the teaching of D7 to include partially gelatinized starch and to lower the extrusion temperature to be less than 40°C.  

112. The claimed invention is inventive over D7.

D8: US 2001/0036464

113. This document is titled “Semi-moist Oral Delivery System” and states that it is directed to a soft chewable oral composition for delivery of pharmaceuticals to mammals including pets and other animals. The use of such soft chewable delivery systems is stated to be limited by the reaction of the active ingredient to the water in the system and the invention seeks to control the water activity in such systems using a polyhydric alcohol. While D8 does not specifically address the issue of palatability of oral delivery systems the fact that it is directed to oral delivery system of an active ingredient in the form of a soft chew would naturally suggest that this system is palatable and therefore the PSA is likely to regard this document as being relevant to the problem being addressed by the claimed invention. D8 also mentions the problem of temperature sensitivity of the active ingredient and the need to avoid high cooking temperatures if required and therefore addresses this aspect of the stated problem as well. Therefore in my view D8 is a document that the PSA would have ascertained, understood and regarded as relevant.

114. D8 discloses a composition in which the active ingredients is mixed with starch, a fat or oil, a sugar component, a polyhydric alcohol, water and other minor ingredients such as flavourings and then extruded to form chewable tablets. It is not in dispute that it discloses the use of partially gelatinized starch, a softener, and up to 9% water, but what is however in dispute is the teaching in D8 of the inclusion of meat flavouring and the cooling of the mixture to below 40°C.

115. While D8 teaches that minor ingredients like flavourings can be included, it does not specifically mention meat flavouring. The only flavouring specifically identified is cherry flavouring in example 5. Mr Marov was of the view that as the composition of D8 includes fats and oils such as fish oil, chicken fat, tallow and lard, these animal fats or oils could be considered as meat flavourings and therefore this feature was disclosed by D8. Dr Rowe did not share the same view. 

116. The animal fats or oils mentioned in D8 are not stated to be for the purpose of flavouring the product. They appear to have been included for providing the texture and softness of the product and not for any flavouring as D8 also states that the fat or oil can also be of vegetable origin. Also the fact that it does mentions the use of flavourings as an additional ingredient in my view further indicates that that the fats or oils are not for flavouring purposes. So while D8 does disclose the inclusion of flavouring, it does not explicitly teach the inclusion of meat flavouring.

117. However I have earlier found, when discussing D3, that the use of meat flavouring was common general in the art of veterinary compositions. While the example given in D8 may only be cherry flavouring, I am satisfied on the evidence that the inclusion of meat flavouring with the teaching of D8 would have been a matter of routine.

118. In relation to the integer of the extrusion temperature, as mentioned earlier there is a clear recognition in D8 of the temperature sensitivity of some active ingredients and the need to avoid high cooking temperatures during the extrusion process. D8 teaches that this can be addressed by the use of pre-gelatinized starches. For example it states in paragraph [0009] that “if gelatinized starch is used, it may be possible to prepare the product of the subject invention or perform the method of the subject invention without heating or cooking of any sort”. D8 includes six examples of various compositions that were tried including the temperatures at which these extrusions were carried out. Example 1 was performed at an extrusion temperature of 52°C and the remaining examples were performed at a temperature of 46°C.

119. The opponent submitted that while they accept that D8 does not explicitly teach that the extrusion temperature should not exceed 40°C, their expert Mr Marov is clearly of the view that there is a clear teaching in D8 that the extrusion can be performed without heating and this would therefore include temperatures 40°C and lower. 

120. In relation to the extrusion temperature, while I accept that D8 does teach that the extrusion can be carried out without cooking if pre-gelatinized starch is used, the claimed invention calls for a mixture of gelatinized and non-gelatinized starch. D8 states that if non-gelatinized starch is used the matrix must be cooked sufficiently to gel or cook the starch. There is a no clear teaching in D8 that the mixture need not be cooked if the starch used is a partially gelatinized starch. The lowest temperature used in the examples when using partially gelatinized starch is 46°C and there is no suggestion that this can be lowered to 40°C. Also what is required by claim 1 is a constant cooling of the mixture in the extruder so that the temperature of the extrudate leaving the tip of the extruder at no time exceeds 40°C. Even if I were to accept that D8 teaches performing the extrusion of the mixture comprising partially gelatinized starch without heating, I have not been presented with evidence to satisfy me that this would necessarily involve a constant cooling of the extruder. In my view this integer of claim 1 is not taught by D8.

121. I am not satisfied that the PSA having the teaching of D8 would have as a matter of course been led to extrude the mixture containing partially gelatinized starch with constant cooling such that the temperature of the extrudate does not exceed 40°C.

122. The claimed invention is therefore inventive over the disclosure of D8. 

D9: US 4284652

123. D9 is also by the applicant of D8 and therefore it has some similarities to the disclosure of D8. It is directed to a matrix comprising a starch, a fat, a polyhydric alcohol and water for producing extruded dry pet food that is soft and palatable. The matrix can include flavouring and other nutritional ingredients such as a protein, vitamins and minerals. It is not in dispute that it discloses the use of partially gelatinized starch, a softener, and up to 9% water.

124. The opponent argued that the vitamins are active ingredients that are used to treat animal diseases such as vitamin deficiency and therefore the product of D9 can be considered a veterinary composition and that D9 is therefore a document that the PSA would have been ascertained, understood and regarded as relevant to solving the stated problem.

125. While D9 does suggest the inclusion of vitamins to make the food more nutritious and I accept that vitamins are used to treat certain diseases caused by vitamin deficiency and could arguably come within the scope of the term “ingredients that are active against pests, pathogens or animal diseases”, that is not the focus of D9 which is all about producing a dry pet food that is soft and palatable and which retains its softness for long periods of time. It does not talk about active ingredients or the difficulty in getting animals to voluntarily accept oral veterinary formulations comprising such active ingredients. The vitamins are stated to be included for the purpose of improving the nutritional value of the pet food and not for the purpose of any activity against pests, pathogens or diseases. Dr Rowe who is clearly a skilled addressee in the field of veterinary formulations is of the view that D9 is directed to a pet food and not a veterinary composition. Although Mr Marov has an opposing view on this, I note that his expertise is in the field of pet food production and not veterinary formulations. In this regard, I would therefore give more weight to the views of Dr Rowe. In my view D9 is not a document that a PSA would have regarded as relevant when faced the problem of improving the palatability of oral veterinary compositions. D9 does not form part of the prior art information under s7(3) of the Act for the purposes of assessing inventive step. 

126. Even if I am wrong on this point, D9 similar to D8 lacks explicit disclosure of a meat flavouring and the cooling down of the mixture so that the temperature of the extrudate does not exceed 40°C. While it does mention that the extrusion can be done without cooking and example 12 uses cold extrusion, this example uses pre-gelatinized starch and not partially gelatinized starch. Another example, namely example 5, is extruded at 55°C. It clearly states that if ungelatinized starch is used, the mixture has to be cooked to gelatinize the starch during the extrusion process. Therefore for similar reasons as for D8, I would still not be satisfied that the PSA would have as a matter of routine been led to extrude the mixture containing partially gelatinized starch at a temperature of 40°C or lower with constant cooling.

127. The claimed invention would therefore be inventive over the disclosure of D9.   

D10: US 5637313

128. D10 is directed to the preparation of soft chewable dosage forms for oral delivery of an active ingredient. While the teaching of this document appears to be primarily for human use, it does mention that it can also be used in veterinary applications. Therefore in my view D10 is a document that the PSA would have ascertained, understood and regarded as relevant.

129. The active ingredients in D10 are mixed with a hydrogenated starch, a bulking agent and optionally flavourings and colourants in a sigma-bladed mixer at room temperature.

130. D10 does not however teach the integers of partially gelatinized starch, meat flavouring, water content to be no more than 9%, the use of an extruder to mix the ingredients and that the extruder is constantly cooled down. Although the opponent submitted that each of these missing integers is common general knowledge in the art, the evidence they have provided does not establish to the level of practical certainty that the combination of all these integers with the teachings of D10 is obvious.

131. The claimed invention is inventive over the disclosure of D10. 

D15: WO 99/48372

132. This document is titled “Encapsulation of Components into Edible Products” and is stated to relate to a process for the production of an edible product that is chewable, has a pleasant taste and contains encapsulated active pharmaceutical ingredients. The process can be used to make edible products for human and animal consumption. Therefore in my view D15 is a document that the PSA would have ascertained, understood and regarded as relevant to solving the stated problem.

133. The matrix composition that is used to encapsulate the active ingredient, comprises a free flowing mixture of at least one starch and one sugar that has been pre-processed, a plasticizer and optionally additional components like flavourings, dry milk, corn syrup and leavening agents.

134. The starch is required to be in a substantially non-gelatinized state so that the texture of the product is granular and crumbly rather than hard and glassy. The degree of gelatinization of the starch is stated to be preferably less than 15%. It also mentions that plasticizable matrix components which form a glassy matrix such as gelatinized starches may be included provided they do not adversely affect the chewable texture of the composition. The integer of partially gelatinized starch is therefore disclosed. A preferred example of the pre-processed starch and sugar mixture is finely ground-up cookies.

135. Exemplary plasticizers that may be used include water, alcohol, glycerol, oils, fats and mixtures thereof. Glycerol is one of the softeners used in the opposed application and therefore the inclusion of softeners is inherently disclosed.

136. In relation to the water content, D15 teaches the need to adjust the total water content of the dough as a moisture content above 50% would result in a thin, low viscosity dough and a moisture content below 5% may result in a dry fragile product. Examples of percentages are 10% to 50% and 15% to 25% by weight. I am satisfied that the integer of water content up to 9% is taught in D15.

137. All the ingredients are mixed and extruded in a twin screw extruder at a temperature of 5°C to 50°C with preferred temperatures of 30°C and 20°C and D15 also states that temperatures above 50°C could destroy heat sensitive ingredients. While there is no specific disclosure of the integer of constantly cooling down the extruder, the fact that the extrusion is carried out at temperatures of 20°C and lower would necessarily require cooling down of the extruder.

138. D15 mentions that aromas and flavours may be added to the mixture but does not identify any specific flavouring. I have already found that the inclusion of meat flavouring in veterinary compositions was common general knowledge in the art and therefore the addition of meat flavouring to the teachings of D15 would be a matter of routine as there is nothing in D15 that would teach away from its inclusion.

139. The final product is stated to be chewable and exhibit a granular, crumbly structure. The opponent submitted that while D15 does not explicitly state that the final product is ductile, the fact that the product is chewable inherently means that the product is also ductile. The applicant on the other hand submitted that Dr Rowe was of the view that the product was not ductile and I am inclined to agree. As discussed with reference to document D3, I do not accept that something that can be chewed before swallowing has to be necessarily ductile. I would not consider a product that is stated to be granular and crumbly as being ductile. This feature of the claimed invention is therefore not disclosed.

140. While I accept that soft chews for pets was common general knowledge in the art at the priority date, that is not sufficient to establish that making the product of D15 ductile would have been an obvious thing to do. The ductility of the final product is a result of the selection of the appropriate ingredients and the processing method for producing the final product. Therefore to make the product of D15 ductile would necessarily involve modifications to either the ingredients of the mixture or the extrusion process or even both. I have been provided with no evidence to satisfy me that the hypothetical skilled addressee would have as a matter of routine made these modifications when the teaching in D15 is to produce a product with a granular crumbly texture. Furthermore it must be the combination claimed that must be shown to be obvious and not just individual integers. I am not satisfied that the evidence establishes that the claimed combination of the ingredients of the mixture and the extrusion process with constant cooling to produce a ductile product is obvious.

141. The claimed invention is inventive over the disclosure of D15. 

D16: WO 2004/016252

142. This document is directed to a palatable chewable veterinary formulation and is therefore a document that the PSA would have ascertained, understood and regarded as relevant.

143. The focus of this document appears to be to make the formulation palatable without the use of animal products or flavours derived from animal sources. It teaches the use of artificial flavouring including artificial meat flavouring. The active ingredients are mixed with a filler, a disintegrant, a binder, a humectant, artificial flavouring and a granulating solvent and extruded to form chewable products.

144. There is no teaching in D16, of the use of partially gelatinized starch. While Mr Marov was of the view that example 3 discloses partially gelatinized starch, I am not convinced. Example 3 only states pre-gelatinized starch sourced from the company Colorcon. While the evidence filed by the opponent establishes that Colorcon also manufacture partially gelatinized starches that is not sufficient to depart from the express teaching of pre-gelatinized starch in this example.

145. There is also no teaching of cooling the extruder so that the temperature of the extrudate does not exceed 40°C. In fact it teaches that the extruded product should be dried at 50°C.

146. Two of the key integers of the claimed invention are lacking in D16 and I am not satisfied that the inclusion of these integers would have been obvious.

147. The claimed invention is inventive over the disclosure of D16.

OTHER GROUNDS

148. While the SGP included other grounds such as manner of manufacture, sufficiency and utility these grounds were not pressed at the hearing. The opponent’s evidence also does not address any of these grounds. These grounds of the opposition have therefore not been made out.

CONCLUSION

149. The opposition fails. The claimed invention is novel, inventive, clear, fairly based, sufficient, useful and a manner of manufacture. Subject to appeal, I direct that the application proceed to grant.

COSTS 

150. In proceedings such as these it is usually the case that costs follow the event. The opposition has been unsuccessful. I therefore award costs according to Schedule 8 against Merial Limited.

R Subbarayan
Delegate of the Commissioner of Patents