Mars Incorporated v Nestec S.A - [2016] APO 10

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Mars Incorporated v Nestec S.A. [2016] APO 10

Patent Application: 2008271478

Title:Extruded food products and methods for making extruded food products

Patent Applicant:  Nestec S.A.
Opponent:  Mars Incorporated
Delegate:  R Subbarayan
Decision Date:  23 February 2016
Hearing Date:  2 December 2015, in Sydney

Catchwords: PATENTS – section 59 – opposition to grant of patent – extruded pet food product – claim construction – whether claims suffer from parameteritis - whether claims are clear and fairly based – whether claims are novel and inventive –whether claims are useful – whether claims are to a collocation – none of the grounds succeed – costs awarded

Representation: Patent applicant: Mr Paul Harrison of Shelston IP
Opponent:Dr Aaron Olsen of Spruson and Ferguson

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2008271478

Title:Extruded food products and methods for making extruded food products

Patent Applicant: Nestec S.A.
Date of Decision: 23 February 2016
DECISION
The opposition is unsuccessful. The claimed invention is clear, fairly based, novel, inventive, useful and a manner of manufacture.
Costs according to Schedule 8 awarded against the opponent Mars Incorporated.
REASONS FOR DECISION
BACKGROUND

Patent application 2008271478 in the name of Nestec S.A. (the applicant) was filed on 4 July 2008 as a PCT application (PCT/EP2008/005507) and claims an earlier priority date of 4 July 2007. Following examination it was advertised as accepted on 30 January 2014. The grant of the patent has been opposed under section 59 of the Patents Act 1990 by Mars Incorporated (the opponent). The matter was heard on 2 December 2015 in Sydney.
EVIDENCE
The evidence in support from the Opponent comprises:
- Declaration of Aaron Heath Olsen dated 30 October 2014 with exhibits AAO-1 to AAO-17 (Olsen);
- Declaration of Dennis Forte dated 30 October 2014 with exhibits DF-1 to DF-6 (Forte #1).
The evidence in answer from the Applicant comprises:
- Declaration of Dr John Kenyon Leonard Russell-Maynard dated 2 February 2015 with exhibits JRM-1 to JRM-4 (Russell-Maynard).
The evidence in reply from the Opponent comprises:
- Declaration of Dennis Forte dated 7 April 2015 with exhibits DF-7 to DF-32 (Forte #2).
Mr Forte is a chemical engineer presently working as an independent Engineering Consultant to the food industry. He has worked in the food industry in Australia since 1985 including in the pet food industry from 1988 to 1994 with Uncle Bens, a subsidiary of Mars Incorporated and from 2001 to 2014 as an independent consultant. From 1994 to 2000 he worked with Uncle Tobys and was involved in the extrusion processing of breakfast cereals and snacks. Through these roles, he states that he has acquired extensive knowledge of extrusion processes, particularly in relation to pet food products, extrusion equipment and pet food formulations. In his capacity as a consultant he has been engaged intermittently by both Mars Incorporated and Nestle Australia Ltd.
Dr Russell-Maynard is currently employed as a Senior Research Scientist and Technical Expert with Nestle Purina Pet Care Pty Ltd. He states that he has worked in the food industry in Australia and overseas since 1987. From 1989 onwards he has been involved with the Nestle group of companies in various capacities including product development, scientist and R&D technologist. Through these roles he states that he has gained significant experience in extrusion of pet foods and pet food formulations.
ONUS OF PROOF
The examination request for this patent application was filed prior to 15 April 2013. As a consequence, substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 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.
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]; 50 IPR 305 at 311, 319; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18] , [22]; 79 IPR 426; Genetics Institute Inc v Kirin-Amgen Inc [1999] FCA 742; [1999] 92 FCR 106 at [17] ).
THE SPECIFICATION
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214, 100 IPR 451 at [139]:
"It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date."
Field of the invention
The specification states that the present invention relates to extruded food products and particularly to extruded food products that are meat analog products made from meat and vegetable protein and to methods useful for producing such products. The term "meat analog" is defined in the specification as “a product having a plurality of strands of interwoven fibers that are linearly arranged in cohesive, layered bundles” and having “a texture resembling the texture of meat”.
Background of the invention
As part of the background of the invention, the specification states that textured edible products are conventionally produced using extrusion machines or extruders. The process involves kneading a mixture of the ingredients to obtain an edible paste and using the extruder to successively heat, gel and shape the paste into the product. The extruder will typically have at least one screw that rotates within a barrel, a means for heating the product and a die for extruding the product. Rotation of the screw kneads and compresses the mixture and forces it through the barrel. The mixture is heated in the barrel before being forced through the die.
The specification then briefly discusses some prior art documents directed to producing meat analog products using extrusion processes and concludes “current methods for producing meat analog products use complicated processes that produce product with undesirable fiber structure. Similarly, current methods are not applicable to all types of food products”.
Object of the invention
The object of the invention is stated to be “to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative” and to “provide novel extruded food products and methods for making such products, particularly meat analog products”.
The nature of the invention
Under the heading “The Invention” at paragraph [0029], the specification states as follows:
“In one aspect, the invention provides methods for producing extruded food products comprising from about 25% to about 77% meat and vegetable protein. In one embodiment, the methods further comprise adding water. The methods comprise (1) continuously introducing components of the product to an extruder wherein the components comprise meat and/or vegetable protein (ie protein from meat and/or vegetable sources); (2) mixing the components to produce a mixture in the extruder; (2) (sic) heating the mixture in the extruder to produce the product; (4) extruding the product from the extruder through the extruder die; and (5) cooling the product. The meat and/or vegetable protein may comprise meat protein or vegetable protein or a mixture thereof. The vegetable protein is preferably in the form of wheat gluten, but may comprise other vegetable proteins including proteins from one or more of wheat gluten, soy, rice, mushrooms or legumes.”
Also under the heading “Summary of the Invention”, the specification includes a number of consistory clauses which basically mirror the independent claims. These consistory clauses fall into three categories, namely a wet pet food product, a semi-moist pet food product and a dry pet food product. The product of each of these categories of pet food primarily contains the same ingredients, namely meat, vegetable protein in the form of wheat gluten, starch and water and these ingredients are subjected to mixing, heating, gelling and shaping to produce a product having a total meat and vegetable protein content of about 25% to about 77%. Each of these consistory clauses also defines a specific “water activity” range and a concentration range for each of the these primary ingredients in the final product.
Detailed description of the invention
In addition to the term “meat analog”, the specification also provides definitions for certain other terms used in the specification. The ones that are relevant for the purposes of this decision are as follows:
- "about" means plus or minus 20%.
- "meat" means meat and meat by-products including carcass, bones, skin, offal and muscle.
- "water activity" means "relative water activity" and has this term's accepted meaning in the art, i.e., the proportional availability of the water molecules present to react relative to the availability of water molecules in pure liquid water.
The detailed description of the invention describes methods of producing an extruded wet pet food product, an extruded semi-moist pet food product and an extruded dry pet food product.
The methods for producing each of these types of food products are very similar and basically involve the steps of (a) introducing ingredients including meat, vegetable protein in the form of wheat gluten, starch, water and optionally plasticisers and cross-linking compounds to an extruder, (b) mixing the ingredients to produce a mixture, (c) heating the mixture inside the extruder to produce the product, (d) extruding the product through the extruder die and finally (e) cooling the product. The extruded food product thus produced is stated to comprise from about 25% to about 77% meat and vegetable protein. It is clear from the description that heating of the mixture in the extruder is important to achieving the desired fibrous texture.
A typical extruder used in the extrusion methods is stated to include 10 barrels wherein each of the barrels can be heated to different temperatures. Each barrel has a length to diameter ratio of about 4 and the entire extruder has a length to diameter ratio of about 36 to 48. Each barrel is also provided with twin screws that rotate around parallel axes. The heating of the barrels is carried out using heaters positioned on each of the barrels and the temperature inside each barrel is adjusted depending on whether the product is a wet, semi-moist or dry pet food product. Some embodiments specify a minimum temperature of 150°C and others a minimum temperature of 130°C.
The die of the extruder is also described as having a cooling section to cool the product. The cooling section is in the form of a tube having a plurality of sub-sections that are regulated by temperature and pressure conditions.
The specification also provides typical processing conditions of the extrusion process for each of the types of products including the speed of rotation of the extruder screws, the temperatures of the barrels, the pressure inside the extruder and the temperature gradient of the cooling section.
The quantity of water and the water activity of the final product are also different depending on whether the product is a wet, semi-moist, or dry pet food product.
Examples
The detailed description ends with three examples directed to each of these three categories of pet food products that have been produced by the method of the invention.
Example 1 is a wet pet food product that comprises from about 25% to about 75% meat, from about 15% to about 35% vegetable protein in the form of wheat gluten, about 3% starch, and about 30% to about 90% water, wherein the water activity of the product is from about 0.8 to about 1.0.
Example 2 is a semi-moist pet food product that comprises from about 25% to about 55% meat, from about 15% to about 35% vegetable protein in the form of wheat gluten, about 3% starch, about 14% to about 30% water and about 5% to about 50% plasticiser, wherein the water activity of the product is from about 0.3 to about 0.8.
Example 3 is a dry pet food product that comprises from about 25% to about 77% meat, from about 15% to about 35% vegetable protein in the form of wheat gluten, about 3% starch, and about 4% to about 14% water, wherein the water activity of the product is from about 0.3 to about 0.7.
Claims
The specification ends with 19 claims of which the independent claims are set out below:
1. A product of a method for producing an extruded food product for producing an extruded wet pet food product comprising meat and vegetable proteins in a combined amount of from about 25% to about 77%, comprising:
continuously introducing components of the food product to an extruder wherein the components include meat and vegetable protein;
mixing the components to produce a mixture in the extruder;
heating the mixture in the extruder to produce the food product;
extruding the food product from the extruder through the extruder die; and cooling the food product,
wherein the product comprises from about 30% to about 90% water, from about 25% to about 75% meat, from about 15% to about 35% vegetable protein in the form of wheat gluten and about 3% starch, wherein the water activity of the product is from about 0.8 to about 1.0.
2. An extruded wet pet food product comprising:
meat and vegetable proteins in a combined amount of from about 25% to about 77%;
from about 30% to about 90% water;
from about 25% to about 75% meat;
from about 15% to about 35% vegetable protein in the form of wheat gluten;
and about 3% starch,
wherein the water activity of the product is from about 0.8 to about 1.0.
5. An extruded semi-moist pet food product comprising:
meat and vegetable proteins in a combined amount of from about 25% to about 77%;
from about 14% to about 30% water;
from about 25% to about 55% meat;
from about 5% to about 50% of one or more plasticisers;
from about 15% to about 35% vegetable protein in the form of wheat gluten;
and about 3% starch,
wherein the water activity of the product is from about 0.3 to about 0.8.
11. An extruded dry pet food product comprising:
meat and vegetable proteins in a combined amount of from about 25% to about 77%;
from about 4% to about 14% water;
from about 25% to about 77% meat;
from about 15% to about 35% vegetable protein in the form of wheat gluten;
and about 3% starch,
wherein the water activity of the product is from about 0.3 to about 0.7.
18. A product of a method for producing an extruded food product for producing an extruded semi-moist pet food product comprising meat and vegetable proteins in a combined amount of from about 25% to about 77%, comprising:
continuously introducing components of the food product to an extruder wherein the components include meat and vegetable protein;
mixing the components to produce a mixture in the extruder;
heating the mixture in the extruder to produce the food product;
extruding the food product from the extruder through the extruder die; and cooling the food product,
wherein the product comprises;
from about 14% to about 30% water,
from about 25% to about 55% meat,
from about 5% to about 50% of one or more plasticisers,
from about 15% to about 35% vegetable protein in the form of wheat gluten and
about 3% starch,
wherein the water activity of the product is from about 0.3 to about 0.8.
19. A product of a method for producing an extruded food product for producing an extruded dry pet food product comprising meat and vegetable proteins in a combined amount of from about 25% to about 77%, comprising:
continuously introducing components of the food product to an extruder wherein the components include meat and vegetable protein;
mixing the components to produce a mixture in the extruder;
heating the mixture in the extruder to produce the food product;
extruding the food product from the extruder through the extruder die;
and cooling the food product,
wherein the product comprises
from about 4% to about 14% water,
from about 25% to about 77% meat,
from about 15% to about 35% vegetable protein in the form of wheat gluten and
about 3% starch,
wherein the water activity of the product is from about 0.3 to about 0.7.
CLARITY AND CLAIM CONSTRUCTION
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."
I will now construe the following terms in the claims.
Water Activity
The opponent argued that the insofar as claims 1, 2, 5, 11, 18 and 19 (and their dependent claims) specify a range of “water activity” values they suffer from “parameteritis” as the opposed specification does not suggest that the water activity ranges “are in any way part of a discovery or new scientific insight” and that the only disclosure of a water activity range in the opposed specification other than in the claims and consistory statements is in paragraph [0044] which merely states that “Preferably, the water activity of the product is from about 0.3 to about 1.0 depending on whether the product is a wet, semi-moist, or dry product”. They therefore submitted that the integer of the water activity values is a non-essential integer of the claimed invention and could therefore be ignored for the purposes of establishing anticipation.
Parameteritis was discussed by Laddie J in Raychem Corp’s Patents [1998] RPC 31. At page 37, he defines the concept:
“This is the practice of seeking to repatent the prior art by limiting claims by reference to a series of parameters which were not mentioned in the prior art. Sometimes it includes reference to parameters measured on test equipment which did not exist at the time of the prior art. The attraction of this to a patentee is that it may be impossible to prove now that the prior art inevitably exhibited the parameters and therefore it is impossible for an opponent to prove anticipation. Even if that is what has happened here, it does not alter the task of the court. It must decide whether the opponent has proved anticipation or some other statutory ground of invalidity. Parametritis may make the court’s task more difficult, but at the end of the day the test of invalidity must be the same, whatever the form of the claims.”
In Williams Advanced Materials Inc v Target Technology Co LLC [2004] FCA 1405 at [48], 63 IPR 645 at 654, Bennett J considered claims to an optical storage medium having a reflective layer including a silver–palladium alloy. Her Honour noted that the parameters were selected without a purpose:
“there is nothing in the specification that suggests that the proportions or the ranges of the metals in the alloys are in any way part of the invention, other than the mere reference to them. It is a case of ‘parameteritis’.”
Her Honour then found that certain of the claims were not novel.
In Austal Ships Pty Ltd v Stena Rederi Aktiebolag [2005] FCA 805 at [108], 66 IPR 420 at 437, Bennett J referred to the Williams(supra) case, and distinguished it because:
“there is reference in the patent specification and evidence which supports the fact that the parameters have been carefully chosen, are part of the invention and are related to a claimed advantage as part of the combination of the design.”

In Euroceltique S. A. [2009] APO 21, the delegate having reviewed these decisions, noted that “parameteritis is not objectionable per se. However, it may give rise to grounds of opposition, depending on the merits of the case” and that the critical question is whether the parameters “have been chosen to achieve a technical effect, or whether they are an arbitrary convenience”.
As I noted earlier, the opposed specification states that “water activity" refers to the proportional availability of the water molecules present to react. Water activity is a well-known parameter which is related to the products susceptibility to microbial growth and is therefore an important factor in determining its shelf life and the type of packaging to be used. The specification defines three different ranges of water activity for the final products depending on whether it is a wet, semi-moist or dry pet food product.
Mr Forte in his evidence in support (Forte #1), discusses water activity and states:
“In simplistic terms, this parameter may be considered as a measure of the amount of available water within a material. Thus, the water activity of a product will increase as the water content of the product increases, all other things being equal” (at 1.51).
“Water activity is also an indicator as to whether or not a product is susceptible to microbial growth, such as yeast and mould. A product does not support microbial growth if it has a water activity of around 0.63 or below. This is important where product is not hermetically sealed or not refrigerated once its packaging is opened, such as most dry and semi-moist pet foods” (at 1.54).
Similarly Dr Russell-Maynard also discusses water activity in his evidence in answer. He states:
“Water activity is the amount of free water i.e. water that is not bound, and is a relevant factor in determining whether in fact bacteria or mould will grow” (at 49).
“The amount of water that is available to assist with the plasticisation, and the amount of non-bound i.e. free water, are very important in respect of plasticisation as far as the entire extrusion process is concerned” (at 55).
“there is a delicate interplay between the amount of free water and the plasticisation of the product” (at 56).
Although Mr Forte disagrees that the amount of free water plays an important role in the rheological properties of the mixture during the extrusion process, it is clear that both experts agree that water activity does play an important role in the stability of the final product. In that respect, it clearly provides a technical effect and is not a parameter chosen for arbitrary convenience.
However as submitted by the opponent, it is true that there is absolutely no discussion in the body of the specification as to how the water activity of each of the three types of extruded products is regulated. At the hearing when I queried Mr Harrison on this, he was not able to provide any further explanation other than to state that is what is specified in the specification and that the applicant does not rely on the claimed water activity levels to distinguish the claimed invention from the prior art. As water activity is a well-known parameter in the art, I am satisfied that the skilled addressee would know how to regulate the water activity levels using their common general knowledge without the need for further invention.
I am therefore satisfied that the water activity is an essential integer of the claimed invention and that the claims do not suffer from parameteritis on account of this integer.
Ingredient Ranges
The opponent further submitted that the “Insofar as claims 1, 2, 5, 11, 18 and 19 (and their dependent claims) specify a concentration range in the final product of “water”, “vegetable protein” in the form of wheat gluten, “meat”, “starch” and in the case of claims 5 and 18, “plasticisers” they suffer from “parameteritis”” as the opposed specification does not suggest that the particular claimed concentration ranges are in any way part of a discovery or new scientific insight, nor does it suggest a relationship between these concentration ranges and the provision of a fibrous meat analog.
Where a product is made up of a number of ingredients naturally the properties of that product will vary depending on the concentrations of these ingredients. In the opposed application, the applicant has sought to produce a pet food product that is a meat analog and includes as its ingredients meat, vegetable protein in the form of wheat gluten, water and starch each of which is present in certain concentration ranges depending on whether the product is a wet, semi-moist or dry pet food product. While the claims do not explicitly define these products as a meat analog, it is clear from the description that the products produced by the described methods were meat analog products some of which had these ingredients in the claimed concentration ranges. There is no evidence from the opponent to suggest that the products produced by following the method of the opposed specification and having these ingredients in the specified concentration ranges would not have the fibrous texture resembling meat.
In my view, the claimed concentration ranges for each of the ingredients provides a technical effect in that they contribute to achieving the fibrous texture of a meat analog food product. I am not convinced that they are merely specified as an arbitrary convenience. The claims do not suffer from parameteritis in relation to the specified concentration ranges for the different ingredients of the pet food products.
Wheat gluten
Wheat gluten is a food product made from gluten, the main protein of wheat. It is made by washing wheat flour dough to remove all the starch leaving the sticky insoluble gluten as an elastic mass. The gluten is then dried and ground into a powder which is generally called vital wheat gluten. It is used as an additive in baking and also to make meat substitute products. All of this is well known in the art.
The opposed specification specifies the vegetable protein as wheat gluten. There was difference of opinion between the parties as to whether this is the same as vital wheat gluten, the powdered form of wheat gluten. Mr Forte has submitted that where the opposed application states “wheat gluten” it means “vital wheat gluten” and in support he has provided a copy of the Codex Alimantarius “Standard for Wheat Protein Products Including Wheat Gluten” (Exhibit DF-29).
Codex Alimantarius is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety. The following are some of the relevant passages from this Exhibit:
2.1     Definitions
Wheat Protein Products (WPP) covered by this standard are food products produced by separation from wheat or wheat flour of certain non-protein constituents (starch, other carbohydrates).
-Vital wheat gluten is characterized by its property of high viscoelasticity as hydrated.
-Devitalized wheat gluten is characterized by its reduced property of viscoelasticity as hydrated due to denaturation.
-Solubilized wheat proteins are characterized by their reduced property of viscoelasticity as hydrated due to partial hydrolysis of wheat gluten.
8.        LABELLING
In addition to the requirements of the General Standard for the Labelling of Prepackaged Foods (CODEX STAN 1-1985, Rev 1-1991) the following specific provisions apply:
8.1      Name of the food
8.1.1    Vital wheat gluten
The name of the food shall be "vital wheat gluten" or "wheat gluten".
8.1.2    Devitalized wheat gluten
The name of the food shall be "devitalized wheat gluten" or "devital wheat gluten".
8.1.3    Solubilized wheat proteins
The name of the food shall be "solubilized wheat protein" or “soluble wheat protein”.
Dr Russell-Maynard on the other hand states that “vital wheat gluten is a specific category of wheat gluten and in many countries, non-vital wheat gluten is also available i.e. wheat gluten that is not guaranteed to bind ingredients well”. While Dr Russell-Maynard attempts to support his view by referring to a product description of a particular modified wheat gluten product produced by Manildra Limited, he has not filed this online product information as evidence. This was however provided by Mr Forte and I am not satisfied that the information in this product description supports Dr Russell-Maynard’s contention.
Codex Alimantarius is clearly a standard reference in the food industry and I am therefore prepared to accept what it states in relation to the terms “vital wheat gluten” and “wheat gluten”. I am therefore satisfied that these terms can be used interchangeably and therefore the term wheat gluten as it appears in the opposed specification can be treated as a reference to vital wheat gluten.
While vital wheat gluten is prepared by washing the starch from wheat flour, it is clear from the evidence of Mr Forte and from some of the exhibits attached to his evidence that anywhere up to 10% residual starch will still be present in vital wheat gluten and this is again consistent with the opposed application where it states that there is about 5% to 10% starch naturally present in wheat gluten.
Starch content of about 3%
The opponent submitted that the specified concentration of starch of “about 3%” should be interpreted as about 0.075% to about 3.5% on the basis of the following statement in the opposed specification:
“The wet pet food comprises from about 15% to about 35% vegetable protein in the form of wheat gluten. There is from about 5% to about 10% starch naturally present in the gluten. In view of this, the product has about 3% starch content”. [0049]
They submitted that it is clear from this passage that the starch in the final product is solely from the wheat gluten present and therefore using the specified concentration range for the wheat gluten of about 15% to about 35%, it follows that the starch can be present in the range of about 0.075% to about 3.5% and not just about 3% as claimed.
The plain meaning of the term “about 3%” is that the value need not be exactly 3% but can include minor deviations both above and below 3%. This meaning is also consistent with the opposed specification where it specifically defines that the term “about” is to be interpreted to mean “plus or minus 20%”. Applying this “dictionary” definition of the opposed specification, the term “about 3%” would be interpreted as a range of 2.4 to 3.6%.
However what the opponent is suggesting is that I should adopt a different interpretation for this term based on the aforementioned passage in the specification. While I agree that there is a strong suggestion from this passage that the starch in the final product is solely derived from the starch naturally present in wheat gluten, I am not convinced that the interpretation suggested by the opponent should override the plain meaning of this term as further qualified by the specification. The applicant has chosen to deliberately specify the starch content in the final product to be about 3%. Starch is a common ingredient in extruded food products and although not specifically mentioned in the specification, it is quite possible that the specification envisages adding additional starch to bring it a concentration of around 3% in the final product. I am not therefore convinced that I should interpret the term much more broadly than 3% plus or minus 20%.
Clarity and Succinctness
The opponent submitted claims 1, 18 and 19 lack clarity and/or succinctness because the preamble “A product of a method for producing an extruded food product for producing an extruded …..pet food product comprising meat and vegetable proteins in a combined amount of from about 25% to about 77%....” is unnecessarily lengthy and results in confusion to the reader as to its meaning.
While the applicant admitted that there is a typographical error in the additional inclusion of the words “for producing an extruded food product”, the claims are not obscure by this minor error.
I agree. As the Court noted in Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331; [2000] FCA 890 at [81]:
“Lack of precise definition in claims is not fatal to their validity, so long as they provide a workable standard suited to the intended use ... the consideration is whether, on any reasonable view, the claim has meaning ... In determining this, the expressions in question must be understood in a practical, common sense manner ... Absurd constructions should be avoided ... and mere technicalities should not defeat the grant of protection ...”
While these claims may repeat the phrase “for producing an extruded food product”, that does not in my view deter from a clear understanding of the preamble. Both Dr Russell-Maynard and Mr Forte had no problem in understanding the scope of this term and while Mr Forte states that he had to read it several times to make sense of it, he did correctly interpret this term as “any product prepared by the technique outlined below”. I also do not consider that the repetition of this phrase makes the claim unnecessarily lengthy for it to be considered to lack succinctness.
The opponent also submitted that claim 4 lacks clarity as it is of identical scope to claim 2 to which it is appended.
I disagree. Claim 4 further defines that the meat defined in claim 2 can comprise both wet meat and meat meal. While the range of wet meat is the same as the range of meat in claim 2, that does not make the scopes of the two claims identical. If the quantity of wet meat is 75% naturally the product cannot include meat meal, but however if the quantity of wet meat is less than 75%, then it could also include meat meal as long as the total meat content is not greater than 75%. There is no redundancy and claim 4 is clear.
Claim 14 was also submitted to lack clarity as the claimed range of “0% to about 50%” plasticiser, would encompasses embodiments that do not comprise one or more plasticisers and this would be contrary to claim 13 to which it is appended, which clearly requires that there be one or more plasticisers.
I fail to see any serious clarity issue with this. The authorities have clearly noted that absurd constructions should be avoided. It would therefore be clear to the skilled addressee that the claim seeks to define that the product includes up to about 50% plasticiser.
The claims do not suffer from lack of clarity or succinctness.
NOVELTY
A claimed invention is deprived of novelty if it has been given to the public before the priority date, either by prior use of a product or process, or by publication of information that equates to the claimed invention (Novozymes A/S v Danisco A/S [2013] FCAFC 6; 99 IPR 417 at [147]). It is well settled that the general test for anticipation or want of novelty is the reverse infringement test (Meyers Taylor Pty Ltd v Vicarr Industries Ltd ([1977] HCA 19; 137 CLR 228 at [19]), and this test is satisfied if the alleged anticipation discloses all of the essential features of the invention as claimed (Nicaro Holdings Pty Ltd v Martin Engineering Co ([1990] FCA 40; 16 IPR 545 at [19]).
To meet this requirement, the prior art must contain “clear and unmistakable directions” to produce the invention as claimed (Pfizer Overseas Pharmaceuticals v Eli Lilley and Company [2005] FCAFC 224; 68 IPR 1 at [314]). However, if the prior publication contains a direction which is capable of being carried out in a manner which would infringe the claimed invention, but would at least as likely be carried out in such a way that would not do so, the invention as claimed will not be anticipated (General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457 at 485-486; 1A IPR 121 at 138, Novozymes A/S v Danisco A/S [2013] FCAFC 6; 99 IPR 417 at [177]).
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".
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-Aventis and Another [2008] FCA 1194; (2008) 78 IPR 485:
"anticipation is deadly but requires the accuracy of a sniper, not the firing of a 12 gauge shotgun".
The opponent relied on the following two documents in support of their contention that the claimed invention is not novel.
D1: WO 03/007729
This prior art document relates to a method for the preparation of a retextured food product that exhibits a three-dimensional fibrous texture with the “fibers being readily individualizable when this product is torn”. It is therefore clearly a meat analog within the definition of this term in the opposed application. To produce this product, proteins of animal and/or vegetable origin, water, and where appropriate, fatty substances and additives such as flavouring and colouring agents are introduced into an extruder where these ingredients are mixed to form a paste and this paste is then subjected to heating, gelling and shaping to form the edible product. While the document does not explicitly mention that the food product is a pet food product, the teaching of this document is to extruded food products in general without any specific limitation as to the target audience. I am satisfied that the product of D1 can include food for human or animal consumption and would therefore encompass pet foods.
The opponent relied on Example B which is directed to a food product containing proteins of vegetable and animal origin and as part of their written submissions provided a Table comparing the integers of claim 1 with Example B of D1. Mr Forte has also construed this document and provided his analysis of the disclosure of D1 in his evidence. Example B reads as follows:
“The composition of the mass on leaving the extruder is as follows:
- 70.5% chicken drumstick meat without bone and without skin,
- 9.0% soybean concentrate,
- 9.0% wheat gluten,
- 10.5% water
- 1.0% flavoring.
The composition of the product which is obtained is as follows:
- 66.0% water (based on total material),
- 78.8% proteins (based on dry material),
- 11.5% lipids (based on dry material),
- 1.1% fibers (based on dry material)
- 8.1% starch (based on dry material).
The origins of the constituents are as follows:
- proteins: . chicken drumstick meat without bone and without skin,
. soybean concentrate,
. wheat gluten;
- starches: . starch contained in the wheat gluten,
. starch contained in the soybean concentrate;
- fibers: . fibers contained in the soybean concentrate.
51.1% of the proteins are of animal origin (chicken).
The extrusion output is 45 kg/h.
The product has the appearance of a homogeneous, smooth, flexible and cohesive strip which exhibits a fibration of the longitudinal type (Fig. 7B). Its color is light beige and its taste is of the “cooked chicken” type.”
The total water content is 66% and therefore falls within the scope of claim 1 which specifies about 30% to about 90% water.
While the total proteins is stated as 78.8% based on dry material, this is equivalent to 26.79% based on total material (Forte #1 at 1.123) and therefore falls within the scope of claim 1 which specifies meat and vegetable proteins in a combined amount of from about 25% to about 77%.
The chicken meat content is 70.5% and therefore this falls within the scope of from about 25% to about 75% meat as specified in claim 1.

Mr Forte has calculated that the stated figure of 8.1% starch based on dry material equates to 2.75% based on total material. This is within the range of 2.4% to 3.6% defined in claim 1.
There was disagreement between the parties as to what is the wheat gluten content of Example B. Mr Forte is of the view that it is 9% based on the first table in Example B, while Dr Russell-Maynard is of the view that the 9% is based on dry ingredients only and that therefore wheat gluten content would only be 2.4%. I am not convinced that the 9% is based on dry material. As Mr Forte notes, if all the ingredients in the first table are added up, you arrive at a figure of 100%. Therefore I am satisfied that the 9% is based on total material. But I note that this table is the composition of the mass on leaving the extruder and it is unclear whether this is the composition of the final product. At the hearing the applicant submitted that as the final product comprises 26.79% protein of which 51.1% is of animal origin (or in other words only 48.9% is of vegetable origin with both soybean concentrate and wheat gluten being of equal concentration) the wheat gluten content would only amount to 6.5% of the product. I agree that there is clearly some inconsistency in the data provided in Example B. Irrespective of whether the wheat gluten content is 9% or 6.5%, it is well below the specified minimum value of 12% (15% less 20%).
There is no disclosure in D1 of the water activity of its product. However Mr Forte has stated that the water content of 66% in Example B is consistent with the water content of a wet food product and on that basis he would expect the water activity of Example B to be about 0.8 or above (Forte #1 at 1.122). Although Dr Russell-Maynard states that there is “no recognition of the complex interplay between water activity, plasticisers and extrusion of a wet food product” in D1, he does not dispute that Example B would inherently have a water activity of 0.8 to 1.0 limiting his argument only to the water content of the dry food product. I am therefore satisfied that the product of Example B being a wet pet food product would inherently have a water activity of about 0.8 to about 1.0 as specified in claims 1 and 2.
The wheat gluten content of claims 1 and 2 is different to that of Example B. These claims are therefore novel.
Each of the other independent claims 5, 11, 18 and 19 also require wheat gluten in the range of 15-35%. Furthermore independent claims 5 and 18 which are directed to a semi-moist food product require water in the range 14-30% water and independent claims 11 and 19 which are directed to a dry pet food product require water in the range 4-14% and these low water ranges are clearly not disclosed in Example B. Claims 5, 11, 18 and 19 are also therefore novel over Example B. It follows that all of the dependent claims are also novel.
General Disclosure
The opponent further argued that claims 1 and 2 lack novelty over the general disclosure of D1 based on the following statement of Mr Forte which they submitted was not contested by Dr Russell-Maynard:
“For example, it is stated at page 5, lines 4 to 9 of D1 that “the product is made from a raw material which is rich in proteins of animal and/or vegetable origin”. It is further stated at page 6, lines 3 to 8 of D1 that “[t]he proteins of vegetable origin are derived, for example, from leguminous plants, cereals and proteinaceous plants (soybean, wheat, pea, corn, chickpea, lentils, etc.) and the proteins of animal origin are derived, for example, from fish, meat, poultry, game, milk and eggs”. There appears to be no reason to exclude any particular combination of protein sources or any relative concentrations of protein sources (provided the above protein requirement is met). Thus, on my reading of D1, the protein content of the products may be provided by a combination of meat and wheat gluten in the concentration ranges defined in the opposed claims”. (Forte #1 at 1.119)
I fail to see how such a broad statement in the disclosure of D1 can constitute a disclosure of specific concentrations of animal and vegetable protein. To establish lack of novelty 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). The broad disclosure in D1 does not satisfy this requirement.
The claimed invention is not anticipated by the general disclosure of D1.
D3: US 6635301
D3 relates to a method of producing a fibrous meat analog product using cooking extrusion technology and a meat analog product obtained by such method.
In its broadest form the method includes subjecting, in a food-extruder, a mixture containing: about 40 to 95% by weight edible proteinaceous materials selected from the group consisting of predetermined mixtures of defatted soy flour, soy meal, soy concentrate, cereal gluten in vital or starch-containing form and egg white; and up to about 7% by weight of edible mineral binding and cross-linking compounds to mechanical pressure and added heat to convert the mixture into a hot protein lava and extruding the lava through a temperature controlled die to obtain a cohesive extrudate slab which is then subjected to mechanical shredding in a hammer mill to obtain a plurality of extruded shreds that resemble in consistency and texture shredded fish, chicken or meat. In a preferred method, some real meat is added to the mixture prior to or during the extrusion process.
A typical product formulation may have the following composition in the finished mixture:
Ingredient                  % Weight
defatted soy flour         40-55
Vital wheat gluten        35-45
Nutritional Cellulose      0-5
Vitamins   0.1-0.3
Minerals   0.1-7.0
Sulphur   0.08-0.3%
Flavourings                  0-3.0
Colourings                   0.01-3.0
The specification ends with three examples. Examples 1 and 2 are meat analog products made using vegetable proteinaceous mixtures of defatted soy flour and vital wheat gluten while Example 3 which is relied on by the opponent relates to a meat analog product made using vegetable proteinaceous mixtures of defatted soy flour and vital wheat gluten and real meat in the form of beef liver.
Example 3 reads as follows:
“Meat analogue chunk having a fibrous striated structural matrix and resembling beef muscle meat was prepared using the method and apparatus generally described above as follows:

The ingredients listed in Table 6 were weighed out as indicated there, milled through a hammer mill fitted with a screen of size 1.2-2 mm and pre-blended in a ribbon blender for 4 minutes.

TABLE 6
Ingredient   % by weight
Vital wheat gluten                    42
Soy concentrate   41.6
Fibre   10.0
Di-calcium phosphate               5
Colouring agents   0.6
Salt   0.5
Vitamins   0.2
Sulphur   0.1

The blended mixture was then fed into the hopper and metered into the extruder (Werner & Pfleiderer C58, fitted with 5 barrel sections) at a rate of 40 kg/hr. Emulsified beef liver was added at the barrel section adjacent to the feed section at a rate of 50 kg/hr. The extruder screw rpm set at 280. Temperatures of the barrels were regulated to the values listed in Table 7.

TABLE 7
Barrel number           Temp °C.
1   25
2   95-105
3   125-135
4   130-140
5   125-135

The dry precursor materials and meat are plasticised and molten into a viscous extrudate as they are conveyed through the extruder barrel sections. The hot melt is extruded through the breaker plate (20 holes with a diameter of 3.5 mm and land length of 10 mm). The extrudate leaving the breaker plate enters the cooling die channel member (cross-sectional dimensions of 50 mm by 7 mm and a length of 400 mm), cooling water inlet temperature being set at about 5°C.

Extrudate product exiting the cooling die as a continuous slab was analysed and shown to have a moisture level of 48-52% by weight and a density in a range between 0.90-1.1 kg/l. The slab was then conveyed directly to the modified hammer mill under water spraying at a temperature of about 15°C. The product slab was cut and shredded into pieces of torn, non-uniform appearance, quite similar to canned white tuna pieces. The rotational speed of the hammer discs was set to 1800-200 rpm, whilst a screen with holes of a size of 50 mm by 7 mm was employed”.
It is not in dispute that the method of producing the food product in D3 is similar to the method of the claimed invention and that the extruded food product comprises meat protein and vegetable proteins in the form of wheat gluten, water and starch that would be naturally present in wheat gluten. What the applicant disputes however is that these ingredients and the water activity are within the ranges as specified in the claims.
Based on the ingredients of Example 3 and his understanding of typical protein content in vital wheat gluten, soy concentrate and beef liver (Forte #1 at 1.159), Mr Forte has calculated the concentration of these ingredients in the product of Example 3 to be as follows:
Meat in the form of emulsified beef liver 44.4%
Meat protein  6.67 – 6.94%
Moisture  48-52%
Vital wheat gluten  18.7%
Wheat protein  14.93%
Soy protein  12.02 – 12.94%
Total protein content  33.62 – 34.81%
Starch  0.93 – 1.86%
While Dr Russell-Maynard did not agree with some of these calculations, at the hearing the applicant did not dispute the revised calculations submitted by Mr Forte. It is clear from these calculations that the percentages of total protein, wheat gluten, water and meat fall within the ranges specified in claims 1 and 2.
In relation to the starch content the opponent again submitted that the range of inherent starch in the vital wheat gluten of Example 3 as calculated by Mr Forte falls within the extended range of 0.075% to about 3.5% of the claims. The applicant on the other hand argued that the vital wheat gluten does not have any starch and that this is supported by the fact that D3 states that the cereal gluten can be in vital or starch-containing form. Mr Forte counters this by stating that the starch-containing cereal gluten mentioned in D3 refers to high starch content devitalised wheat gluten, in which extra starch is required to bind the product as the wheat gluten is denatured.
The relevant extract from Codex Alimantarius that I reproduced earler, clearly distinguish vital wheat gluten and devitalised wheat gluten and states that devitalised wheat gluten is denatured and has reduced viscoelastic properties. In my view, this lends support to Mr Forte’s view that the starch containing gluten referred to in D3 is a reference to denatured wheat gluten. I will therefore adopt this interpretation in relation to the disclosure of D3.
As discussed earlier, I am satisfied that the evidence establishes that vital wheat gluten will still have anywhere up to 10% residual starch and therefore the opponent’s calculation that the vital wheat gluten of Example 3 will inherently provide 0.93 – 1.86% starch is a fair inference. However I have already found that I can only interpret “about 3%” as 2.4 to 3.6%. Hence the starch content of Example 3 does not fall within the scope of the starch content defined in claims 1 and 2.
Similar to D1, D3 is silent on the water activity of its food products. However Mr Forte makes some inferences regarding the water activity based on the moisture content of the product of
Example 3. He states as follows:
“Wet pet food is typically hermetically sealed (e.g., in a can) and refrigerated once exposed to the air. Consequently, microbial growth during normal storage conditions is not a significant concern and there is no need to adjust the water activity to below 0.63. Thus, as the water content of wet pet foods is high, they typically have a water activity of around 0.8 or higher. However, this is merely a typical range and wet pet food products having a water activity outside this range are known.” (Forte #1 at 1.66)
“The extruded product of Example 3 has a moisture level of 48-52% (column 13, lines 17 to 19), consistent with the moisture content of a wet food product and within the range defined for the wet pet food products of opposed claims 1 and 2. I would therefore expect the water activity of the products of Example 3 to be about 0.8 or above.” (Forte #1 at 1.154)
Dr Russell-Maynard contests Mr Forte’s inferences stating:
“I also again question Mr Forte's assertion at paragraph 1.154 wherein he states there is a direct correlation between a moisture level content and water activity. There is no disclosure of water activity in citation D3 and a person skilled in the art is aware that there is no direct or inherent relationship between moisture content and water activity. Water activity can fluctuate between 1 and 0, even if its moisture content is the same.” (Russell-Maynard at 91)
Mr Forte responds to this in his evidence in reply and states:
“With regard to Example 3 of D3, I would expect a moisture content of about 48-52% to result in a water activity of about 0.8 or higher. It is difficult to accurately predict the exact water activity of a product based on its in ingredients and concentrations alone. However, certain assumptions can be made on the basis that water activity is roughly equal to the relative sum of the water binding ability (humectancy) of each of the various ingredients of a composition (see page 376, last paragraph to page 381, 1st full paragraph of Exhibit DF-9). This relationship is described by the Salwin equation, shown as Fig. 15.5 in Exhibit DF-9.” (Forte #2 at 1.242)
“That is not to say that water activity will necessarily change as total moisture content changes. At a given temperature, water activity is a function of total moisture content and a function of humectant concentration. If total moisture content increases and humectant concentration remains the same, water activity will increase (as mentioned in paragraph 1.83 above). Likewise, if humectant concentration increases and moisture content remains the same, water activity will decrease. Thus, in principle, it is possible to maintain a constant water activity if moisture content and humectant concentration are both increased.” (Forte #2 at 1.246)
“My assumptions in relation to the water activity of the products of D3 are based on the typical end use of such products, their normal water activity ranges and the need (or not) for the presence of humectants.” (Forte #2 at 1.250)
At the hearing, the applicant did not contest Mr Forte’s responding statements in his second declaration. I find Mr Forte’s statements more persuasive than those of Dr Russell-Maynard. I am therefore satisfied that the moisture content of 48-52% in D3 indicates a wet food product and that such a wet food product will typically have a water activity of 0.8 or more. I am satisfied that this integer of claims 1 and 2 is therefore inherently disclosed in D3.
However as the starch content of D3 does not fall within the range of claims 1 and 2, it follows that these claims are novel over D3.
Each of the other independent claims 5, 11, 18 and 19 also require the same levels of starch. These claims are also therefore novel.
INVENTIVE STEP
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; (2007) 72 IPR 447 at 461 [51] - [52]).
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."

100. More recently, in Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59 at [53]; 212 CLR 411 at [53] the High Court also 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]?"

101. 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])

102. 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."

103. The opponent submitted that certain claims lacked an inventive step in view of documents D1 and D3 that I have earlier discussed under Novelty and also in view of document D2: US 6379738.
Problem to be solved
104. I have earlier noted that the object of the invention is to overcome or ameliorate at least one of the disadvantages of the prior art extrusion methods for producing meat analogs and to provide novel extruded meat analog food products and methods for making such meat analog products. As neither party has provided a different view on what is the problem that the invention seeks to solve, I am satisfied that this object of the invention is the problem that is to be solved.
Common General Knowledge in the art (CGK)
105. Mr Forte in his first declaration provides in Section C his comments on the pet food industry in Australia at the priority date of 4 July 2007 and in Section D his comments and opinions on what was commonly known in relation to pet food technology in Australia at the priority date. From these passages, it would appear that some of the CGK that are relevant to the present opposition include the following:

A typical pet food formulation incorporated a broad range of ingredients, the most common ones being vegetable proteins, animal proteins and starch, each of which contributes to the product as a nutritional component and may also contribute to the product as a structure forming component.

Animal proteins were provided in the form of fresh meat, meat meal or a combination of the two.

Vegetable proteins were typically provided in the form of oilseeds (e.g., soybeans) or cereal grains (e.g., wheat, rice or corn), or they may be provided in pure form (e.g., wheat gluten or corn gluten).

Starch acts as the main structure forming component and was typically provided by inclusion of cereal grains, such as wheat, corn or rice. Wheat was by far the most commonly used starch source as it was relatively inexpensive and readily available in Australia. Wheat flour typically includes about 68 to 72% starch. It also includes about 9 to 14% vegetable protein, namely wheat gluten, which also functions as a structure forming component.

Typically, the starch source would have made up about 40-70% of the pet food product.
·Other commonly added ingredients in pet foods included fats, humectants, plasticisers, acidifying agents, fibre, vitamins, minerals and emulsifiers.

·Water is an important ingredient of pet foods and the moisture content is a determining factor in its appearance and texture. Water also plays a role in determining the water activity of the product.

·Water activity is an indicator as to whether a product is susceptible to microbial growth, such as mould. A product does not support microbial growth if it has a water activity of around 0.63 or below.

·The water activity of pet food products could be lowered by addition of humectants. Commonly used humectants were sugars (e.g., sucrose, glucose and dextrose), polyols (e.g., glycerol and propylene glycol) and salt. Such ingredients also act as a plasticiser and may result in a simultaneous improvement in the palatability of the product.

·Pet food products can be broadly categorised based on their moisture content as either “wet pet food”, “semi-moist pet food” or “dry pet food”.

·Dry pet food is typically characterised by a final moisture content of around 8 to 10% and a water activity range of about 0.57 to 0.61.
·Semi-moist pet food is typically characterised by a final moisture content of around 15 to 20%. Humectants were generally added to lower the water activity to a range of about 0.57 to 0.61.

·Wet pet food is typically characterised by a final moisture content of around 70 to 80% and a water activity range of 0.8 or higher. It is therefore typically hermetically sealed such as in a can.

·Wet pet food was typically made by extrusion either (i) at a high moisture content or (ii) at a lower moisture content and subsequently hydrating the extruded product.

·The most commonly used method for preparing pet food in Australia was extrusion cooking (or “extrusion”).

·High moisture extrusion cooking (HMEC) was commonly used to manufacture meat analog food products. It was common to use less starch and more functional proteins in a meat analog compared to other pet food formulations as the starch does not align as well as the functional proteins.

·By controlling the parameters of the HMEC, it was possible to create a pet food product having a fibrous, meat-like texture based on one or more types of vegetable proteins either on its own or in combination with meat proteins.
·Target temperature for HMEC is typically in the range of 130 - 170°C.

106. Dr Russell-Maynard does not provide a contrary view on any of the above, except in relation to water activity. He states that while water activity is a relevant factor in determining whether bacteria will grow, there are also other factors such as packaging, pH, whether cooked or sterilised, and inclusion of certain ingredients such as plasticisers that will determine whether bacterial growth will occur. In particular he states that the inclusion of plasticisers such as glycerol perform a dual role in that they provide plasticity to allow the mixture to be forced through the die and also have a direct impact on bacterial growth. According to him, “there is a delicate interplay between the amount of free water and the plasticisation of the product” and that the opposed application “provides, among other things, a delicate balance between water activity and other plasticisers to provide the desired extruded product”.
107. Mr Forte disputes this in his evidence in reply and states that the agent that binds water is known as a humectant and not a plasticiser and that humectants may directly or indirectly act as plasticisers in that they can bind water in the product, thus enabling a food product to have a higher total moisture content without compromising its shelf stability. He further states “Once it is realised that: (i) water activity is a measure of free water and is therefore an indicator of susceptibility to microbial growth; and (ii) that water activity is proportional to total moisture content and inversely proportional to humectant concentration, it is relatively simple to see how moisture and humectant concentrations can be used to achieve a shelf-stable product. Specifically, a shelf-stable product can be provided by decreasing the total water content, by increasing the humectant content, or both”. (Forte #2 at 1.86)
108. While Dr Russell-Maynard appears to be stating that the water activity is a key factor in the rheology of the final extruded product and not just in the product stability, I am unable to find any disclosure in the opposed specification that directly relates water activity to the rheology of the mixture in the extruder. I agree with Mr Forte that the “more appropriate parameter when considering viscosity of a material is the total moisture content of the material (which includes both free and bound water), not the water activity (which considers only free water).” I am satisfied that the water activity mentioned in the opposed specification is primarily in relation to the stability of the product. This is also consistent with the statement in the specification that water activity is “the proportional availability of the water molecules present to react”.
Ascertained, understood and regarded as relevant
109. Mr Forte states that it was common at 4 July 2007 for research and development personnel to consult patents as a way of keeping up to date with new developments and that he regularly consulted patents relating to food and extrusion technology. Dr Russell-Maynard does not refute this in his evidence. I am satisfied that the skilled worker in this field would have regard to patent documents.
110. Documents D1 and D3 as discussed under Novelty, relate to extruded food products and extrusion methods for producing such products that are meat analog products that contain a mix of proteins from both animal and vegetable sources. Although the applicant submitted that Mr Forte did not locate the specific documents himself but was rather provided with those documents by the attorneys for the opponent, that is not to say that those documents could not have been found by a diligent searcher looking for a solution to the problem of forming an extruded food product that has the texture and fibrous structure of meat. I am satisfied that these are documents that would have been ascertained, understood and regarded as relevant.
111. Document D2 relates to the production of a meat emulsion product having a meat-like appearance and texture. The method involves comminuting a mix of meat particles under conditions which emulsify the meat material to form an emulsion to which various additives may be incorporated and then heated to form a firm emulsion product which is then cut into pieces as desired. There is no extrusion involved in the method. As the problem that I have identified is to overcome the problems with prior art extrusion methods for producing meat analog products, I am not satisfied that the skilled addressee would look for a solution in non-extrusion methods of producing a meat analog. In my view D2 is not a document that would have been ascertained, understood and regarded as relevant. Hence it does not form part of the prior art base for determining inventive step. I will therefore have no further regard to this document.
D1 combined with CGK
112. As discussed earlier, the invention defined in claims 1 and 2 only differs from Example B of D1 in that it specifies wheat gluten to be in the range of 12% to 42% (taking into account the definition of “about”) whereas in Example B, the amount of wheat gluten is 9% or 6.7% depending on which interpretation is correct.
113. The opponent submitted that Mr Forte’s evidence establishes that the skilled addressee would have as a matter of course replaced the soybean concentrate in Example B with an equal amount of wheat gluten to bring the total wheat gluten content to 18%, thereby falling within the range specified in claims 1 and 2 and that these claims therefore lack an inventive step.
114. Mr Forte’s reasons as to why the skilled addressee would have been led to replace the soybean concentrate with wheat gluten can be summarised as follows:

D1 does not place any importance on the exact source of the vegetable protein as it states “The proteins of vegetable origin are derived, for example, from leguminous plants, cereals and proteinaceous plants (soybean, wheat, pea, corn, chickpea, lentils, etc).

The key requirement in D1 is that there is some form of functional protein present to be texturized during extrusion.

Wheat gluten is cheaper than soybean concentrate.

Wheat gluten provides improved texture over soybean concentrate and soy protein isolates alone.

Wheat gluten provides improves palatability over soybean concentrate.

The skilled addressee would therefore have been motivated to replace the soybean concentrate with wheat gluten in Example B.

115. The applicant on the other hand submitted that Mr Forte’s evidence is tainted by hindsight and that although he makes bold assertions regarding what is “well known”, “conventional” and “commonplace”, there is no evidence provided by Mr Forte in this regard.
116. There is no evidence to suggest that Example B of D1 does not produce a meat analog product. In other words, it provides a solution to the stated problem. So the question that needs to be answered is why the skilled addressee would be motivated to replace the soybean concentrate with wheat gluten.
117. Mr Forte states that the motivation would be that wheat gluten is cheaper, provides improved texture and improved palatability. While he also selectively refers to one or more prior art documents to back up his claims in relation to these qualities of wheat gluten, I have been presented with no evidence to suggest that these documents were part of the CGK in the art. The applicant on the other hand argued that some of the documents being relied on by the opponent would appear to suggest that wheat gluten may not be a suitable replacement for soybean concentrate. In particular they referred to the following passages from document D3:
“Some of the ingredients listed in Table 2 may be substituted with other ingredients having similar properties. For example, Table 3 lists substituents that have been successfully tested in the manufacture of a shredded TPP that satisfies the above mentioned criteria and desired characteristics in relation to mimicking tuna fish flakes.

TABLE 3

Ingredient                  Substituent
Defatted soy flour        soy meal
Defatted soy flour        soy concentrate
Vital wheat gluten        egg white powder
Vital wheat gluten        Vital wheat gluten/maize gluten
Vital wheat gluten        Vital wheat gluten/wheat flour

The substituents listed above are generally preferred, although the object of the invention may still be achieved by using other functional, high protein sources (eg. cereal or meat fractions)”.

118. From looking at the various prior art filed in evidence by the opponent, it is quite clear that the ingredients and their relative quantities in the food product play an important role in the extrusion process and the properties of the extruded product, including its texture, colour, palatability and nutritional value. For example:
“In a normal recipe all the ingredients will interact with one another to affect the transformations taking place. Therefore, it is important to understand the role of each individual material in the recipe and the effect of any variation in an individual ingredient on the overall processing performance of the extruder.” (Exhibit DF-11 at page 6)

“The properties of the feed material have an important influence on the texture and colour of the product; the most important factors are:
• the type of feed materials
• their moisture content
• the physical state of the materials
• their chemical composition, particularly the amounts and types of starches, proteins, fats and sugars
• the pH of the moistened material.” (Exhibit DF-23 at page 296)

119. In fact even document D1 specifically states:
“The fibration state of the resulting product is a function of the nature of the raw material which was introduced into the extruder, of the temperature of the mass in the extruder and of the temperature gradient profile during the cooling of said mass in the die.” (page 14, lines 31-35)

120. Furthermore D1 also suggests when discussing prior art WO 99/13735 that the use of gluten may reduce “the variety of texture and products which can be obtained” (page 2, lines 9-14).
121. It is also plainly evident that the choice of vegetable proteins is not just limited to wheat gluten and soybean concentrate and can include protein from other sources such as rice and legumes.
122. While I accept that it was well known that one or more vegetable proteins either on their own or in combination with meat proteins could be extruded using a HMEC process to form a meat analog product, it is clear from the evidence that the properties of the extruded meat analog product including texture, colour, palatability and consistency will vary depending on the type of proteins used and their relative concentrations. Hence it is not simply a matter of arbitrarily choosing whatever protein is readily available.
123. Based on the evidence and the disclosure of D1, I am not satisfied that it is clear or practically certain that the skilled addressee would have as a matter of routine be led to replace the soybean concentrate with another source of vegetable protein and in particular wheat gluten in the expectation that it would produce an improved meat analog product.
124. Claims 1 and 2 do not lack an inventive step over D1.
125. All of the other independent claims also require the same concentration of wheat gluten. In addition as noted earlier, the water content and water activity of these claims are not disclosed in D1. It therefore follows that these claims also do not lack an inventive step over D1.
D3 combined with CGK
126. I have earlier found that Example 3 of D3 discloses all of the integers of claims 1 and 2 except for the starch content. Based on the amount of vital wheat gluten in Example 3, Mr Forte has calculated that the product will inherently have a starch content of 0.93 – 1.86% which is below the claimed range of 2.4 to 3.6%.
127. In order to establish lack of inventive step over D3, I need to be satisfied that the skilled addressee would have as a matter of course be led to increase the quantity of vital wheat gluten to levels wherein the inherent starch content would fall within the claimed range, in the expectation that it could provide an improved meat analog product.
128. The opponent did not file any submissions in relation to this instead relying on their construction that about 3% should be construed as 0.93 – 1.86% which I have already rejected. In the absence of any submissions or evidence in this regard, it is difficult for me to be practically certain that the claimed invention lacks an inventive step. Nevertheless I will consider all of the evidence filed in order to make a finding in relation to lack of inventive step.
129. As there is no added starch in Example 3, any increased starch content has to necessarily come from increased levels of vital wheat gluten. While I initially thought that the general disclosure of D3 that the mixture should contain about 40% to 95% edible proteinaceous materials may suggest that the wheat gluten content can be increased to more than the 42% used in Example 3, I note that this general disclosure is further qualified by the teaching that this range of proteinaceous material should be selected from the group consisting of “predetermined mixtures of defatted soy flour, soy meal, soy concentrate, cereal gluten in vital or starch-containing form and egg white; and up to about 7% by weight of edible mineral binding and cross-linking compounds”. In my view the reference to “predetermined mixtures” clearly implies that the choice of the ingredients and their relative concentrations is important and it is not a mere matter of arbitrarily choosing any one or more of the proteinaceous matter from the listed group and their relative quantities. Hence I am not satisfied that the skilled addressee would have as matter of routine increased the quantity of vital wheat gluten while reducing the quantity of meat protein and/or soy concentrate.
130. As noted earlier, although Example 3 uses vital wheat gluten, D3 does state that the cereal gluten can be in vital or starch-containing form and based on the evidence I have interpreted the reference to starch-containing wheat gluten as meaning devitalised wheat gluten. Another question that I therefore need to ask is whether it would have been a matter of routine to replace the vital wheat gluten of Example 3 with starch-containing devitalised wheat gluten. However in the absence of any submissions or evidence on this point from the opponent, I cannot answer this question in the affirmative. Even if I had done so, I have no evidence as to what would be the inherent starch content of such gluten. It is also unclear whether the protein content of such devitalised wheat gluten would be different to that of vital wheat gluten and if so that could affect the vegetable and total protein content of the product. Furthermore as denatured devitalised wheat gluten has reduced viscoelastic properties to vital wheat gluten, its use would also have an effect on the rheology of the mixture and the properties of the extruded product. Hence I am not satisfied that it would have been obvious to replace the vital wheat gluten with starch containing devitalised wheat gluten.
131. The evidence does not establish that the skilled addressee would have as a matter of routine increased the starch content to bring it within the range specified in each of the independent claims. The claimed invention does not therefore lack an inventive step over D3.
CGK alone
132. The opponent also submitted that the claimed invention is merely an obvious combination of the CGK. This argument is primarily based on their contention that the disclosure of document D1 and the technology it describes were CGK at the priority date.
133. In relation to D1, Mr Forte states as follows:
“D1 and the technology it describes were both very well-known to persons working in the pet food industry in Australia at 4 July 2007 and, in some situations, was being used for manufacturing pet food products. One reason for this is that Clextral advocated the technology directly to pet food manufacturers throughout Australia, including both Mars and Nestle, even before the document was published. Clextral also promoted the technology at various food manufacturing conferences in Australia and internationally and in articles published in industry magazines (see, e.g., Swientek, B. “Extrusion Yields Fibrous, Meat -like Products”, Prepared Foods (2000), Vol. 169 Issue 1, page 53; Exhibit DF-6 annexed hereto)”. (Forte #1 at 1.112)

134. While I am prepared to accept that the high moisture extrusion cooking technology described in D1 to form meat analog food products was well-known at the priority date and that it was also well-known that this technology could be used with various functional proteins or combinations thereof to produce meat analog products with cohesive aligned fibres, I can find no basis to conclude that the specific examples or the ingredient ranges described in this document were also CGK as contended by the applicant.
135. The claimed invention requires meat proteins, vegetable proteins in the form of wheat gluten and water all in specified quantities. I have already found that based on the evidence the ingredients used and their relative quantities does have an impact on the properties of the extruded product, including its texture, colour and palatability. Hence while high moisture extrusion cooking could be used with various functional proteins to form meat analogs, there is bound to be differences in these properties of the extruded product depending on the ingredients and their relative quantities. Hence I cannot be certain that the skilled addressee would have as a matter of routine chosen a mix of animal proteins and wheat gluten in the quantities specified in the claims in the expectation that it would produce an improved meat analog pet food product.
136. The claimed invention does not lack an inventive step in light of the CGK.
FAIR BASIS
137. The opponent submitted that claims 1-19 lack fair basis insofar as they encompass products that do not have the fibrous texture of meat analog products. It was their contention that the specification makes it clear, particularly at paragraphs [0032] and [0034], that extrusion at a temperature of at least about 150°C is essential for producing the fibrous texture and as none of the claims specify this temperature they would encompass products having a non-fibrous texture which are not meat analog products and in that respect travel beyond the what the specification as a whole asserts as the invention.
138. The relevant disclosures in paragraphs [0032] and [0034] are as follows:
[0032] In one embodiment, the extruder comprises heaters positioned on the barrels of the extruder. During the process, the temperature of the barrels reaches at least about 150°C. This temperature is required to produce the desired texture. More preferably, the temperature of the barrels reaches from about 160°C to about 180°C. The temperature inside each barrel of the extruder is adjusted depending on whether the product is a wet, semi-moist, or dry pet food product.

[0034] The cooling section has a plurality of sub-sections that are regulated by temperature and pressure conditions and these conditions have an effect on the food product. This effect produces the desired fibrous textures. During the process, the temperature of the barrels reaches at least about 150°C. This temperature is required to produce the desired texture. More preferably, the temperature of the barrels reaches from about 160°C to about 180°C. The temperature inside each barrel of the extruder is adjusted depending on whether the product is a wet, semi-moist, or dry pet food product.

139. I note that neither the consistory clauses under “Summary of the Invention” or “The Invention” specify any minimum temperature for the extrusion process. But as noted by the High Court an assertion in the consistory clause “does not compel the conclusion by the Court that the claims are fairly based” and that the “consistory clause is to be considered by the Court with the rest of the specification” (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd, [2004] HCA 58; 217 CLR 274).
140. While I accept that the cited passages suggest that the temperature of the barrel during the extrusion process plays an important role in the formation of the fibrous texture, I note that in paragraph [0040], the specification states “Preferably, the temperature in the extruder reaches at least about 130°C. More preferably the temperature in the extruder reaches from about 130°C to about 200°C. Comparative tests have revealed that if the maximum temperature is below 130°C an inferior fibrous texture is achieved. Without wishing to be bound by theory, it is believed that the inferior texture is because gluten protein is not melted and does not align through the extruder die into a fibrous texture”. This passage clearly indicates that a minimum barrel temperature of 150°C is not as critical to the invention as the opponent submits. While processing parameters including temperature of extrusion, the speed of rotation of the extruder screws, the pressure inside the extruder are all mentioned in the specification and would appear to contribute to obtaining the desired fibrous texture, I am not satisfied that when the specification is read as whole, it asserts that the claimed invention lies in a minimum extrusion temperature.
141. All the claims are fairly based.
UTILITY
142. The opponent also submitted that “claims 1-19 are inutile as they encompass products that are not the fibrous “meat analogs” promised by the opposed application” because they are not limited to products produced by extrusion methods involving an extrusion temperature of at least about 150°C nor are they explicitly limited to meat analog products.
143. I have already found that the claims are fairly based despite not being limited by any specific extrusion temperature. However I agree that none of the claims explicitly states that the product is a meat analog product which is the promise of the invention. However that does not necessarily lead to the conclusion that the claims are not useful.
144. Independent claims 1, 18 and 19 are limited to extruded food products having certain ingredients in specific quantities which are produced by an extrusion cooking process involving certain steps including heating of the mixture in the extruder. The specification asserts that products produced by such a method will be meat analog products that exhibit cohesive, aligned fibres resembling the texture of meat and there is no evidence to suggest otherwise. Therefore despite these claims not explicitly mentioning the product to be a meat analog product, I am satisfied that they would meet the promise of the invention and are therefore useful.
145. Independent claims 2, 5 and 11 on the other hand, although limited to having similar ingredients in similar quantities are not limited to having been produced by an extrusion cooking process. They could very well have been extruded by a cold extrusion process that does not involve heating of the mixture in the extruder. While I accept that the specification and evidence strongly suggest that heating of the mixture is critical to forming the cohesive aligned fibres of a meat analog, I cannot be certain that cold extrusion would necessarily not produce such a fibrous texture without further evidence on this point. Therefore despite some concerns, I am not satisfied that these claims lack utility.
MANNER OF MANUFACTURE
146. The opponent submitted that claims 1-19 are not for a manner of manufacture as they are a mere collocation of well-known integers with no interworking relationship, potential or otherwise.
147. Firstly they argued that the integer of “water activity” in each of the independent claims does not interact with the other integers to provide the desired result of a fibrous meat analog, but instead performs its own separate well-known function of determining product stability. They relied on the Full Court’s decision in Smith & Nephew Pty Ltd v Wake Forest University Health Sciences [2009] FCAFC 142, where it was found that a claim was found not to be a manner of manufacture on the basis that one of the integers did not have a working relationship with the other integers in bringing about the desired result.
148. I think the present claims can be distinguished from Smith & Nephew (supra) in that unlike in that case there is no assertion in the opposed specification that the water activity is an essential integer of the combination that provides the desired result of the meat analog. In my view, the integer of water activity appears to have been included merely to limit the scope of the claimed combination and the Full Court made it clear that such a situation is not objectionable in line with authorities such as British United Shoe 25 RPC 631 and Pugh 31 RPC 266. Hence the inclusion of the integer of water activity in the claims does not make it a mere non-patentable collocation.
149. The opponent also made a similar attack on the patentability of independent claims 11 and 19 based on the integer “about 4% to about 14% water” on the basis that they are unrelated to the provision of a fibrous meat analog. For similar reasons this argument does not succeed.
150. It was also argued that all of the integers of the independent claims apart from the water activity are explicitly disclosed in D1 and as D1 and the technology it describes were well-known in the art according to the evidence of Mr Forte, it follows that the each of these claims is directed to a mere collocation of well-known integers. I have already found that the claimed invention is novel and inventive over D1 and hence this argument also fails.
151. This ground of the opposition has not been made out.
CONCLUSION
152. The opposition does not succeed. The claimed invention is clear, fairly based, novel, inventive, useful and a manner of manufacture.
153. Subject to any appeal, I direct that the application proceed to grant.
COSTS
154. The opposition is unsuccessful. There is no reason to vary the normal practice of costs following the event. I award costs according to Schedule 8 against the opponent Mars Incorporated.
R Subbarayan
Delegate of the Commissioner of Patents