Fonterra Co-operative Group Limited v Arla Foods amba
[2022] APO 53
•15 July 2022
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Fonterra Co-operative Group Limited v Arla Foods amba [2022] APO 53
Patent Application: 2015344999
Title:Whey protein-based, high protein, yoghurt-like product, ingredient suitable for its production, and method of production
Patent Applicant: Arla Foods amba
Opponent: Fonterra Co-operative Group Limited
Delegate: Cathy Douglas
Decision Date: 15 July 2022
Hearing Date: 3 May 2022 by video conference
Catchwords: PATENTS – section 59 – regulation 5.23 – evidence in reply -common general knowledge – is the problem part of common general knowledge? – lack of inventive step on common general knowledge alone – opportunity to amend
Representation: Counsel for the applicant: David Larish
Patent attorney for the applicant: Charles Tansey, Spruson & Ferguson
Counsel for the opponent: Claire Cunliffe
Patent attorney for the opponent: Helen Bellchambers, AJ Park Australia
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2015344999
Title:Whey protein-based, high protein, yoghurt-like product, ingredient suitable for its production, and method of production
Patent Applicant: Arla Foods amba
Date of Decision: 15 July 2022
DECISION
The opposition is successful. Claims 1-4, 6, 7, 16 and 17 lack an inventive step in view of the common general knowledge in the art. Claims 1-4, 6, 7, 16 and 17 also lack an inventive step in view of D3 (WO 2010/120199) and the common general knowledge in the art, and, separately, in view of D4 (WO 2006/068521) and the common general knowledge in the art. The applicant has two (2) months from the date of this decision to file amendments to overcome the deficiencies.
I award costs according to Schedule 8 against the applicant.
REASONS FOR DECISION
Background
Arla Foods amba (the applicant) filed patent application 2015344999 (the application) as an international application under the Patent Cooperation Treaty (PCT) on 16 Nov 2015, claiming priority from EP application 14193363.0 filed on 14 November 2014. The application was advertised accepted on 26 September 2019.
Fonterra Co-operative Group Limited (the opponent) filed a Notice of Opposition under section 59 of the Patents Act 1990 (the Act) on 23 December 2019. A statement of grounds and particulars (SGP) was filed on 23 March 2020. Subsequently a request to amend the SGP was filed on 24 December 2020, and this request was allowed on 20 January 2021. The amended SGP identified the following grounds: Manner of manufacture, lack of novelty, lack of inventive step, lack of utility, lack of support, lack of clarity, lack of sufficiency.
The applicant proposed post-acceptance amendments to the specification on 19 January 2021 which were allowed unopposed on 5 May 2021 and this decision is in relation to the specification as amended.
The evidence filed during the evidentiary periods is summarised in the table below.
Evidence Declarant Exhibits Date of declaration Reference In Support Edward Allen Foegeding EF-1 – EF-10 20 June 2020 Foegeding 1 Annigje Dentener AD-1 – AD-2 22 June 2020 Dentener 1 Edward Allen Foegeding EF-11 – EF-17 2 July 2020 Foegeding 2 Annigje Dentener AD-3 – AD-4 7 July 2020 Dentener 2 In Answer Torben Jensen TJ-1 – TJ-3 18 September 2020 Jensen Richard Ipsen RI-1 – RI-2 18 September 2020 Ipsen 1 Milena Corredig MC-1 – MC-2 19 September 2020 Corredig 1 Richard Ipsen RI-3 – RI-4 30 September 2020 Ipsen 2 Milena Corredig 10 October 2020 Corredig 2 In Reply Edward Allen Foegeding EAF-18 – EAF-20 20 December 2020 Foegeding 3 Annigje Dentener 22 December 2020 Dentener 3 Samuel Zhi Yi Ting ST-1 – ST-4 24 December 2020 Ting
The opponent also opposed the related European patent 3217801 (EP 3217801). The declaration of Mr Ting relates to the submissions made in relation to that patent before the European Patent Office (EPO). The opponent commented in their letter to the Delegate of 18 February 2021 that the applicant’s submissions to the EPO only became available to the opponent on 10 July 2020.
After filing of the reply evidence, the opponent filed a further request to amend the statement of grounds and particulars dated 18 February 2021 (the second amendment to SGP) which was to become effective if the Delegate decided that the Ting evidence was not properly in reply. This request along with several other matters was discussed in correspondence between the parties and a Delegate of the Commissioner after the filing of the evidence as summarised below.
Challenge by applicant to the evidence in reply and the second amendment to SGP: Applicant’s letter dated 19 January 2021 and Delegate’s letter of 2 March 2021
The applicant challenged parts of Foegeding 3 and all of Ting as not being properly evidence in reply. In response, the Delegate issued a letter directing that the Ting declaration dated 24 December 2020 and accompanying exhibits ST-1 to ST-4 are not properly in reply to the evidence in answer and would therefore not form part of the evidence in determining the opposition. In that letter, the Delegate acknowledged the request for second amendment to SGP as filed on the 18 February 2021. However, the Delegate advised that this second amendment was unlikely to be allowed.
The same letter from the Delegate also proposed the direction that the following parts of Foegeding 3 are not properly in reply to the evidence in answer:
(a) paragraphs 17 to 21 of the third declaration by Dr Edward Allen Foegeding dated 20 December 2020;
(b) The words “or European” from the first sentence of paragraph 22 of the third declaration by Dr Edward Allen Foegeding dated 20 December 2020; and
(c) exhibit EAF-19.
In a further letter dated 23 March 2021, the opponent requested to be heard in relation to the proposed direction regarding Foegeding 3, the second amendment to SGP, and foreshadowed a request under Regulation 5.23 regarding the Ting declaration should the Delegate not allow it as evidence in reply.
Delegate’s letter of 31 March 2021
In this letter the Delegate confirmed his previous direction striking Ting from the evidence in reply. He also provided a lengthy response to the opponent’s comments regarding Foegeding 3 and the second amendment to SGP. However, he concluded that whether the impugned material from Foegeding 3 is properly in reply and whether the second amendment to SGP should be allowed would be determined as part of hearing and deciding the substantiative opposition. I will discuss these matters under the heading of “Impugned parts of Foegeding 3” below.
Request under Regulation 5.23 dated 18 February 2021 by applicant
This request was to introduce the preliminary opinion of the Opposition Division of the EPO dated 4 November 2020 into evidence. In the letter dated 31 March 2021, the Delegate of the Commissioner declined to exercise the Commissioner’s discretion regarding this material.
The hearing was held on 3 May 2022 by video conference. At the hearing, the following grounds were pressed: Lack of inventive step, Best method and Lack of support. Additionally, the opponent requested that the Ting declaration be brought into the evidence by an exercise of the discretion permitted under Regulation 5.23. Before turning to the consideration of the status of the evidence and opponent’s request, it is helpful to understand the nature of the invention.
The specification
In relation to construction, I note the comments of Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd:[1]
“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.”
The invention as described
[1] [2013] FCA 214; 100 IPR 451 at [139].
The description explains that it is challenging to prepare high protein, whey proteinbased yoghurt products. High concentrations of whey protein have a strong tendency to form gel during the heat-treatment step. This can result in the heat-treatment equipment clogging up. Production must then be stopped, and the equipment cleaned before the production can start again. Gel formation may also reduce the sensory quality of the yoghurt-like product.[2]
[2] Description page 1 line 25-page 2 line 5.
The specification indicates that these problems can be solved by using a combination of two types of whey protein particles of different particle size as a protein source, reducing gel formation during the production of yoghurt-like products.
The invention is therefore directed to a food ingredient that comprises a combination of two types of whey protein particles of different particle size, having different properties, termed Type A and Type B particles. Type A particles are insoluble whey protein particles having a particle size in the range of 1-10 microns. Type B particles are acid gellable whey protein aggregates having a particle size in the range of 0.02-0.5 microns.[3] Particle size is defined in the description as referring to the hydrodynamic diameter of the particles.[4] Professor Foegeding notes that “it is not easy to measure particles smaller than 0.5 microns” and “it is difficult to both prepare samples and discern the true particle properties from artefacts.”[5]
[3] Description page 2 lines 10-40.
[4] Description page 5 lines 39-40.
[5] Foegeding 1 [49].
The description indicates that the two particle types are made by separate processes. The Type A particles are typically produced by heating a solution of whey protein at an appropriate pH with a high degree of shear. The Type B particles are aggregates of denatured whey protein, often produced by heat-denaturation of demineralised whey protein at relatively low concentration. The aggregates can form strong gels, and typically have linear, worm-like, branched or chain-like shapes.[6] The description refers to and incorporates by reference several patent documents to provide more details on the production of Type A and B particles.[7]
[6] Description page 5 lines 20-29, page 6 lines 1-9.
[7] Description page 13 lines 12-22.
Example 1 has the title “Methods of analysis”. Example 1.1 relates to quantification of Type A particles. Example 1.10 relates to quantification of Type B particles. Methods for the determination of various other properties of samples are also provided in this example. There are no examples of preparation methods of Type A or Type B particles. Example 2 refers to the use of sources of Type A and B particles. The protein make-up of these sources is briefly discussed but no further information on preparation is provided.[8]
[8] Description page 38 lines 5-18.
The specification also relates to the use of the food ingredient in acidified dairy products and whey protein-based yoghurt-like products. Examples 2 and 3 relate to methods of producing whey protein-based yoghurt products. I consider that the characterisation of the Type A or Type B particles, and their use in yoghurt production are two aspects of the invention as described.
Person skilled in the art
It is well established that many of the issues in an opposition are answered by reference to the person skilled in the art:
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”[9]
[9] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70].
The hypothetical skilled person works in the field with which the invention is connected and is a non-inventive person or team likely to have a practical interest in the subject matter of the invention.[10] In other words, thepatent is directed to “a person interested in making, constructing, compounding or usingthe invention...”[11]
[10] Ibid at [70]-[72].
[11] Ibid at [71] as per Finkelstein J.
Given that the specification is directed to two aspects -- mixtures of very specific types of whey proteins, and their use in acidified/yoghurt-like products -- I consider that the hypothetical skilled addressee is best characterised as a team, made up of a protein scientist with specialist knowledge of food protein manufacture and properties, and a dairy technologist having experience in formulation of products and the machinery used in their production.
I have reviewed the CVs and declarations by each of the declarants and I am satisfied that each is able to adequately represent aspects of the knowledge of the skilled addressee as I have defined this hypothetical composite person.
Professor Edward Allen Foegeding is a Professor of Food Science and Editor in Chief for the Institute of Food Technologists Scientific Journals. His research includes studying how food biopolymers function in foods, and includes numerous papers related to whey protein. His academic career spans nearly forty years.[12]
[12] EF-1.
Ms Annigje Dentener is a consulting food technologist and a Fellow of the New Zealand Institute of Food Science and Technology, with an honours degree in Dairy Science and Technology and Food Process Engineering. She has worked in food technology since 1981, with expertise in dairy products.[13]
[13] AD-1.
Mr Torben Jensen has more than 30 years’ experience in the dairy industry and works in dairy product development. He is named as an inventor on the application.[14]
[14] TJ-1.
Professor Richard Ipsen is a retired Professor of Food Structure Engineering. His scientific focus area is structure engineering of dairy products – how macromolecular interactions influence and determine final product structure and quality. His research is focused on milk protein functionality, especially gelation and interfacial properties, as well as the rheology and microstructure of dairy products, mainly acid milk gels.[15]
[15] RI-2.
Professor Milena Corredig is a Professor in Food Science. Since 1998, the focus of her research has been on the effect of processing on the physical chemistry of foods. In particular, she has studied molecular interactions, ingredients manufacturing, and functional properties of food components. She has worked in the area of colloidal properties of food products, protein functionality and interactions of proteins with other ingredients in foods, and the structure of soft food materials.[16]
The claimed invention
[16] MC-1.
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd:[17]
“…the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear. Words used in a specification are to be given the meaning which the person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification … This applies to words used in the claims. … the construction of a specification, including the claims, is ultimately a question of law …
…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 ...”
[17] [2009] FCAFC 70; 81 IPR 228 at [118]- [120].
The specification concludes with 18 claims including 4 independent claims reproduced below. The full claim set is attached as Annex 1.
Claim 1:
A dry food ingredient comprising:
- a total amount of protein of at least 30% (w/w),
- a combination of:- insoluble whey protein particles having a particle size in the range of 1-10 micron (referred to as type A particles) in an amount of at least 20% (w/w) relative to the total amount of protein, and
- acid-gellable whey protein aggregates having a particle size in the range of 0.02 - 0.5 micron (referred to as type B particles) in an amount of at least 10% (w/w) relative to the total amount of protein,
- optionally, carbohydrate, and
- optionally, fat
and wherein at least 90% of the protein is whey protein.
Claim 8:
A method of producing a whey protein-based yoghurt-like product comprising
a) providing a liquid premix comprising:
- a total amount of protein of at least 7% (w/w),
- a combination of:
- type A particles in an amount of at least 20% (w/w) relative to the total amount of protein,
- type B particles in an amount of at least 10% (w/w) relative to the total amount of protein,
- water,
- optionally, carbohydrateand wherein at least 90% (w/w) of the protein of the premix is whey protein
b) optionally, homogenising the premix,
c) heating the premix to a temperature of least 72 degrees C for a duration of at least 15 seconds and subsequently cooling the premix to a temperature below 50 degrees C,
d) contacting the cooled premix with an acidifying agent and allowing the acidifying agent to acidify the premix to a pH of at most 5.0,
e) packaging a yoghurt-like product derived from the acidified premix.
Claim 13:
A whey protein-based yoghurt-like product comprising:
- a total content of protein of at least 7% (w/w), and
- a combination of:
- type A particles in an amount of at least 20% (w/w) relative to the total amount of protein
- type B particles in an amount of at least 10% (w/w) relative to the total amount of protein,and wherein at least 90% (w/w) of the protein is whey protein.
Claim 16:
Use of a combination of type A particles and type B particles as ingredient in the production of an acidified dairy product, wherein the type A particles are used in an amount of at least 20% (w/w) relative to the total amount of protein of the acidified dairy product, and the type B particles are used in an amount of at least 10% (w/w) relative to the total amount of protein of the acidified dairy product.
Type A particles and Type B particles
Independent claim 1 contains the phrases “referred to as type A particles” and “referred to as type B particles”. I consider that these phrases mean that for the purposes of the all the claims, Type A particles are those whey protein particles that are insoluble and having a particle size in the range of 1-10 micron, and Type B particles are acid-gellable whey protein aggregates having a particle size in the range of 0.02-0.5 micron. I consider that the Type A and B particles referred to in the other claims have the same physical features.
Regarding Type A particles, the above construction is consistent with the section of the description where these particles are defined.[18] This portion of the description, which I construe to be a dictionary, additionally refers to the insoluble particles being “denatured”. However, based upon what the experts have said about the Type A particles, I consider that it is uncontroversial that Type A particles would have been subjected to a heating process to denature them,[19] and that this feature is inherent to all Type A particles.
[18] Description page 5 lines 20-24.
[19] Dentener 1 at [46]; Corredig 1 at [18].
Regarding Type B particles, the description states the following:
“In the context of the present invention, the term "acid-gellable whey protein aggregates having a particle size in the range of 0.02-0.5 micron", also referred to herein as type B particles, relates to aggregates of denatured whey proteins which aggregates are capable of forming strong gels (much stronger than native whey protein) during acidification and which aggregates typically have linear, worm-like, branched or chain-like shapes.”[20]
[20] Description at page 6 lines 1-6.
This definition includes further information about the Type B particles, namely that they “typically have linear, worm-like, branched or chain-like shapes.” The experts consider that type B particles are “not typically spherical, but rather more linear and unfolded”[21], or in the form of “fibrils”,[22] which accords with this explanation in the description. Therefore, I construe the “Type B particles” in the claims to refer to particles having linear, worm-like, branched or chain-like shapes, even though the word “typically” used in the definitions section is more usually given a non-limiting meaning.
Yoghurt-like
[21] Ipsen 2 at [10];
[22] Foegeding 1 at [43], [50].
Professor Foegeding explains that a product made from all whey protein cannot be called yoghurt because the product doesn’t use a milk base.[23] “Yoghurt-like” is defined in the description as follows:
“… a product which has at least the visual appearance and sensory profile similar to that of a yoghurt, be it set-type yoghurt or stirred yoghurt. The term yoghurt-like products also cover yoghurt-like products which are casein-free. It should furthermore be noted that the yoghurt-like product may have been produced by bacterial and/or chemical acidification.”[24]
Whey protein-based
[23] Foegeding 2 [70].
[24] Description page 14 lines 26-32.
This term is not categorically defined in the description. However, from the stated aim of the invention, it is clear that the intention is to create products which contain mostly whey protein with only limited amounts of casein.
“The present inventors have discovered that preparation of high protein, whey protein-based yoghurt products is challenging, and especially the production of stirred-type or set-type high protein, whey protein-based yoghurt products. The inventors have found that without significant amounts of casein, high concentrations of whey protein has a strong tendency to form gel during the heat-treatment step that is used in yoghurt processes.”[25]
[25] Description page 1 lines 25-30.
This concept is found throughout the specification. For example:
“It has been shown that whey protein is a nutritionally advantageous protein source which is quickly absorbed by the human digestion system and it is therefore preferred that most of the protein of the premix is whey protein.”[26]
[26] Description page 15 lines 11-14.
The description also suggests the protein content of a whey protein-based product, but in this case I construe “typically” to indicate that the product is preferred to have but is not limited to the stated protein range.
“Typically, the whey protein-based yoghurt-like product has a total amount of protein in the range of 7-25% (w/w)”.[27]
[27] Description page 25 lines 36-37.
Therefore, reading the specification as a whole, and applying a plain meaning, I understand “whey protein-based” to mean that most of the protein in the product to which the term is applied is whey rather than casein. However, I cannot find an indication in the specification that the term of itself limits a product to having at least 90% of the protein content being whey protein. Neither do I find that the term limits the product to a particular overall protein range.
Comprising
The meaning of “comprising” is determined according to the context of its use. The construction of this word is important in claim 8, which recites in the preamble “a method of producing a whey protein-based yoghurt-like product comprising…”, followed by five method steps. The word “comprising” also occurs in step a) of the method. The use of the word “comprising” is usually construed to mean that the process or composition includes the recited features but is not limited to them. This is how I understand the word in this claim.
The first step of the method is “providing a liquid premix comprising…”. I construe this to mean that the premix may contain other components, such as fat. However, at least 90% (w/w) of the protein of the pre-mix is whey protein. This claim therefore clearly sets out the high whey content of the premix. A small amount of the protein in the premix – 10% or less – could be protein other than whey protein.
The preamble to the claim indicates that the claim is directed to a process “comprising” a series of steps, indicating that additional method steps may be included. The components of the premix are specified in step a). Treatment steps that are applied to the premix are specified in the steps that follow. Thus, based on the structure of the claim, I consider it is logical to construe “comprising” in the preamble as indicating that additional treatment steps may be included, but I do not consider it means that further key ingredients (like protein) can be added beyond the premix. Only after a yoghurt-like product is produced by the acidifying step d) does the wording of step e) change to recite packaging of the product “derived from the acidified premix”. This phrase is defined in the description to mean that at least the water-insoluble solids of the acidified premix are included, however other ingredients may be added at this point. The intention as I understand it as indicated in the description is that only minor ingredients, such as sweeteners, flavouring agents, stabilisers, emulsifiers and vitamins, are added at this point.[28] Overall, then, I construe claim 8 to be directed to a method of producing a whey protein-based yoghurt-like product, wherein the final product, like the premix, is limited to products wherein at least 90% (w/w) of the protein is whey protein.
[28] Description page 21 lines 26-37.
In claim 13, the stipulation that “at least 90% (w/w) of the protein is whey protein” clearly applies to the whole claim. In this claim, there still may be a small amount of other protein such as casein present. This construction of claims 8 and 13 is consistent with the disclosure of the description, which states that the claim “covers” yoghurt-like products which are casein free.[29] However, there is clearly no intention to limit to casein-free products given that the samples of example 2, and the mixture of example 3 all contain small amounts (1-2% w/w) cream which contains casein.
Composite particles
[29] Description page 14 line 30.
This term is defined in the description to mean larger particles or granulates which are obtained, for example, by spray-drying of a suspension containing the solids of the food ingredient or by wet-granulation.[30] In claim 5 the food ingredient is said to “comprise dry composite particles comprising both type A particles and type B particles”. I construe this to mean that the composite is made up of both Type A and Type B particles dried together into the composite particle. In claim 6, the food ingredient is said to comprise two groups of particles, one made up of Type A and one made up of Type B particles as separate dry composites.
[30] Description page 12 lines 25-28.
Professor Foegeding considers composite particles to be inherently formed when a whey ingredient is spray dried.[31] The scope of claim 6, then, encompasses spray drying Type A and Type B particles separately for addition to the food ingredient.
Acidified dairy product
[31] Foegeding 2 [64].
Considering the plain meaning, an “acidified” dairy product must be one to which acid is added or in which acid is produced. The description mentions the production of an acidified dairy product as another aspect of the invention without clearly defining what is meant by this term. Several times the description refers to “an acidified dairy product, such as e.g. a whey protein-based yoghurt-like product”[32] or “the acidified dairy product, e.g. the yoghurt-like product”.[33] The description doesn’t appear to contemplate the manufacture of other types of acidified dairy products. However, if a term in a claim is clear on its face, I cannot by reference to the description, import a limitation or “gloss” to vary or qualify that meaning. On its face, the term “acidified dairy product” is broader than just yoghurt. I consider that an “acidified” dairy product is a dairy product to which acid is added or in which acid is produced.
Scope of independent claims
[32] Description page 29 lines 32-33.
[33] Description page 30 lines 2, 4.
At this point, I will note the varying scope of the independent claims in terms of the protein content of products they encompass.
·Claim 1 is directed to a food ingredient wherein at least 90% of the food ingredient protein is whey; this claim is not directed to a yoghurt-like product. This food ingredient could be used to make a yoghurt (or other food products) by adding the food ingredient to milk containing casein protein.
·Claim 8 is directed to a method of producing a whey protein-based yoghurt-like product, wherein the final product is limited to products wherein at least 90% (w/w) of the protein is whey protein.
·Claim 13 is directed to a whey protein-based yoghurt-like product wherein at least 90% (w/w) of the protein is whey protein.
·Claim 16 is directed to the use of a combination of type A particles in an amount of at least 20% (w/w) based on total protein, and type B particles in an amount of at least 10% (w/w) based on total protein, as an ingredient in the production of an acidified dairy product. I construe “use of” to limit the claim to a method. The product of the method contains a combination of Type A and Type B particles but is not limited to a specific protein or whey concentration. It is also not limited to a yoghurt product.
·Claim 17 is appended to claim 16, and further limits the acidified dairy product to only whey protein-based yoghurt-like products. As above, I understand this product is limited to products wherein most of the protein in the product is whey protein.
·Claim 18 is appended to claim 16 or 17, and further limits the product of the method to be one having a total protein content of at least 7% (w/w).
Regulation 5.23
Regulation 5.23 of the Patents Regulations provides as follows:
(1)For the purposes of deciding an opposition, the Commissioner may consult a document that:
(a) is relevant to the opposition; and
(b) has not been filed under this Chapter; and
(c) is available in the Patent Office.
(2) If the Commissioner proposes to rely on the document, the Commissioner must give the parties:
(a) notice of the Commissioner’s intention to do so; and
(b) a copy of, or access to, the document; and
(c) an opportunity to give evidence or make representations about the document.
Noting that Regulation 5.23 is a discretionary provision, the Delegate in Reflex InstrumentsAsia Pacific Pty Ltd v Minnovare Limited[34] listed a number of factors relevant to whether this regulation should be invoked:
a) the circumstances leading up to the evidence not being filed earlier;
b) what the evidence shows and whether the information is likely to be crucial to the delegate’s decision;
c) the public interest; and
d) the balance of convenience of the parties if the information is considered.
[34] [2017] APO 8 at [52].
I return to the opponent’s request to bring the Ting declaration into evidence, I will consider each of these factors, whilst keeping in mind that a weighty consideration, as stated in Merial Limited v Bayer Intellectual Property GmbH,[35] is whether the information is likely, if not certain, to change the outcome of the opposition in a significant way.
The circumstances leading up to the evidence not being filed earlier
[35] [2015] APO 16 at [24].
The opponent submitted that the evidence of Ting was not filed earlier because it was not available when the opponent filed its evidence in support. It only became available when the applicant filed its submissions in Europe on 10 July 2020. Furthermore, although a request for consideration of the material under Regulation 5.23 was presented on the day of the hearing, I note in the opponent’s letter of 23 March 2021 that this request was foreshadowed. I consider that the circumstances as to why the Ting evidence was not filed earlier weigh in favour of allowing the Regulation 5.23 request.
What the evidence shows
The opponent’s submission is that the applicant disclosed, in opposition proceedings before the EPO relating to the equivalent European patent, methods of making the Type A and B particles used in examples 2 and 3 of the application. According to the Ting declaration, these methods are found in PCT/EP2014/072788 and PCT/EP2017/067829.[36] However, these methods are not referenced in the application. The opponent says that examples 2 and 3 of the equivalent European patent are identical to examples 2 and 3 in the application. At the hearing, the opponent submitted that these methods were the methods used by the applicant to make Type A and B particles, and that the applicant’s choice of these methods indicate that they are the best methods. As I understand the submission, the opponent is drawing the inference that these methods must have been the best methods of making Type A and B particles since they were the ones chosen by the applicant.[37]
[36] Ting [11].
[37] Opponent submission [135].
There is no dispute as to the law requiring that the applicant give “the best information in their power as to how to carry out their invention.”[38] However, the ground must be made out on the evidence.[39] As stated by Bennett J in Expo-Net Danmark A/S v Buono-Net Australia Pty Ltd (No 2):
“Fourth, as a factual matter, it must be established that there was a better method known to the applicant as at the date of filing of the patent than the one described in the specification. This is clearly a subjective question.”[40]
[38] Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27 at [104].
[39]EMD Millipore Corporation v Asahi Kasei Medical Co., Ltd. [2022] APO 6 at [83].
[40] [2011] FCA 710 at [15].
The opponent has not led any expert evidence regarding the content of the methods disclosed in the documents referenced in the EPO prosecution, nor is there evidence from experts as to how these methods compare with the methods disclosed in the application for making Type A and B particles. Rather, the opponent’s argument is based on inference – the applicant knew of several ways to produce Type A and B particles, the applicant chose a particular way to produce the particles, therefore the method they chose must have been the best method since it would be illogical for them to use a “sub-standard method”.
I am not satisfied that this line of reasoning can possibly make out the case on the balance of probabilities. At best it shows that it is a possibility that the applicant knew of a better method. However, the evidence has not laid out the facts relating to the conduct of the methods and what the experts thought about their relative effectiveness. As to what the applicant knew at the filing date, the opponent’s case is based on an inference only. Therefore, I do not consider that “as a factual matter”, the opponent has established on the evidence that there is any significant possibility that a better method known. It follows that I do not consider that the evidence of Ting is likely to be crucial to my decision.
The public interest
The opponent submitted at the hearing that there is plainly a public interest in not allowing bad patents going to grant. The ground of best method may then be raised later in an appeal, which would be inefficient, expensive, and unnecessary since the evidence is available now.
The public interest lies in the efficient resolution of matters before the Commissioner, as well as in assuring the validity of granted patents. Introducing further material via Regulation 5.23 will undoubtably delay resolution of the opposition and such delay encroaches on the public interest. Furthermore, the nature of the material as discussed above does not appear to justify the delay so introduced. Overall, I am of the view that the public interest weighs against allowing the opponent’s Regulation 5.23 request.
The balance of convenience
In relation to this factor, the opponent submitted that if the evidence is not considered the opponent would be unfairly penalised. The opponent reiterated that they were not aware of this material at the time of filing their evidence in support. They also submitted that this evidence was already known to the applicant. Nevertheless, at least some inconvenience to the applicant would result due to the necessity of providing further submissions and/or evidence, and in delaying determination of the opposition. On balance I consider that this factor weighs in favour of allowing the opponent’s Regulation 5.23 request.
Conclusion on Regulation 5.23
I have considered the opponent’s concerns and reasons for this request. However, there is no basis to conclude that the material would change the outcome of the opposition. Taking into account all the above factors, I decline to invoke Regulation 5.23 regarding the Ting declaration.
Impugned parts of Foegeding 3
At the hearing, I gave opportunity to the opponent to provide submissions on the impugned evidence of Foegeding 3. The opponent indicated that this evidence the covers the same ground as the evidence discussed above under Regulation 5.23.
The opponent submitted that the link to the evidence in answer that makes this evidence properly in reply is the evidence of Mr Jensen. Mr Jensen refers to an experiment his staff conducted related to Type B particles, filed as TJ-3. Exhibit EAF-19 to Foegeding 3 include the documents D22, D23 and D24 from the European proceeding mentioned above; Professor Foegeding says that D23 and D24 appear to be the same as Exhibits TJ-3 and TJ-2 respectively of Mr Jensen’s evidence[41]. In the opponent’s submission, TJ-3 in the evidence in answer justifies the inclusion of Professor Foegeding’s comments as being properly in reply. Professor Foegeding then states:
“However, there is no information in Arla’s Australian or European submissions that describe how the type B particles used in the experiment TJ-3 were made. For the purposes of my comments, I have assumed they were made the same as those used for making samples 1 and 4 in the opposed patent (see Example 2), and that solutions and conditions were similar to those of the yoghurt mix. On this basis, the experiment in TJ-3 shows that at 10% protein the type B particles form a heat-induced gel. Also, a gel is formed without heating.”[42]
[41] Foegeding 3 [19]-[20].
[42] Foegeding 3 [22].
In the Delegate’s letter of 31 March 2021, the Delegate commented that in this paragraph Professor Foegeding “…seems to have simply ignored a significant point for which the Opponent contends 17 to 21 and EAF-19 to be relevant as reply evidence.” At the hearing, the opponent submitted that in the quoted paragraph Professor Foegeding is drawing the inference that the method used in examples 2 (samples 1 and 4) is the same as the European method.
However, previous to the quoted paragraph, Professor Foegeding stated that D22 is “a description of how the sources of type A and type B particles used in Examples 2 and 3 of the granted patent have been produced”[43] (emphasis added). By the “granted patent” he means the European equivalent of the present application. His subsequent statement quoted above in paragraph 22 that there is “no information in… [the] submissions that describe how the type B particles used in the experiment TJ-3 were made” do not suggest to me a clear inference, suggested by the opponent, that the methods referred to in D22 are the methods used in TJ-3 experiment. Rather, the Professor only links TJ-3 to the methods in the present application (that he refers to as “the opposed patent”) in Example 2.
[43] Foegeding 3 [18].
Mr Jensen’s declaration simply states the following in relation to TJ-3:
“Also attached herewith as exhibit TJ-3 is a document showing experiments that were conducted by technical staff at Arla under my supervision. These experiments were conducted to demonstrate the heat induced gelation properties of Type B particles.”[44]
[44] Jensen [6].
In their letter of 23 March 2021 (reply to the Delegate’s letter), to support their contention that a link between evidence in answer and evidence in reply justifies the reply evidence, the opponent quoted from the decision in Sonus Pharmaceuticals, Inc v Alliance Pharmaceutical Corp and Schering Aktiengesellschaft (Sonus):[45]
“Inax Corp v Caroma Industries Ltd [1994] APO 48: evidence that had no link to statements or opinions in the evidence in answer was not evidence in reply.”
[45] [2001] APO 13 (16 March 2001) at page 8.
I accept that there is a link of sorts between exhibit EAF-19 and Mr Jensen’s exhibit TJ-3, in that Professor Foegeding says that D23 appears to be the same as TJ-3. However, the Delegate in Sonus understood the link in the quoted reference as material that “responds to some matter raised by the evidence in answer”.[46] I characterise the documents D22, D23 and D24 within EAF-19 as relating to the circumstances surrounding the corresponding EPO opposition, rather than being a responsive link to Mr Jensen’s evidence. I am not satisfied that the particular way the Type A and Type B particles were made as discussed by documents filed in the European prosecution actually responds to anything Mr Jensen has said in his declaration. Rather, this material has the character of new evidence. I therefore agree with the applicant that EAF-19 and the related comments by Professor Foegeding are not properly evidence in reply.
[46] Ibid at page 8.
That is, the following are not properly in reply to the evidence in answer and will therefore not form part of the evidence in determining the opposition under s59 of the Act:
(a) paragraphs 17 to 21 of the third declaration by Dr Edward Allen Foegeding dated 20 December 2020;
(b) The words “or European” from the first sentence of paragraph 22 of the third declaration by Dr Edward Allen Foegeding dated 20 December 2020; and
(c) exhibit EAF-19.
The Ting declaration and the above parts of Foegeding 3 which I have decided are not in evidence both relate to the opponent’s ground of Best Method. The opponent seeks to bring into the opposition additional documents and particulars related to Best Method by the second amendment to the SGP. Since I have decided not to allow the above evidence into the opposition, it follows that there would be no useful purpose in allowing the proposed second amendment to the Statement of Grounds and Particulars dated 18 February 2021. I therefore refuse the amendment.
Standard of proof and Onus
The present opposition is governed by the Act as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act) as the opposed application was filed after 14 April 2013. Therefore, the Commissioner may, under section 60(3A), refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. The opponent bears the onus of establishing the facts supporting the grounds of opposition.
Inventive Step
Common General Knowledge
The Full Federal Court summarised the relevant principles in Idenix Pharmaceuticals LLC v Gilead Sciences Pty Ltd:
“…common general knowledge is background knowledge and experience which is available to all in the trade. It must be generally accepted and assimilated by persons skilled in the art and known and accepted without question by the bulk of those who are engaged in the particular art. Information is not common general knowledge merely because it might be found in a journal, even if widely read.”[47]
[47] [2017] FCAFC 196 at [192].
The applicant referred to the recent decision in SNF (Australia) Pty Limited v BASF Australia Ltd (SNF), [48] in which Beach J recently endorsed Luxmoore J’s comments in British Acoustic Films v Nettlefold Productions:
“A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less because it is widely circulated. Such a piece of knowledge only becomes general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.”[49]
[48] [2019] FCA 425 at [523].
[49] (1936) 53 RPC 221 at page 250 per Luxmoore J.
Common general knowledge was also considered by Emmett J in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc:
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·standard texts and handbooks;
·standard English dictionaries;
·technical dictionaries relevant to the field;
·magazines and other publications specific to the field.”[50]
[50] [1999] FCA 345; 45 IPR 577 at [112].
It is common ground between the parties that the following material is common general knowledge.
The main proteins in milk are casein and whey. About 80% of the protein is casein and about 20% is whey.[51] Whey is made up of mainly beta-lactoglobulin, and alpha-lactalbumin.[52] Whey proteins can be isolated by removing the non-protein materials from liquid whey, and the isolated whey product is typically provided as a dry powdered product.[53]
[51] Foegeding 1 [22]; Ipsen 1 [8].
[52] Foegeding 1 [25]; Ipsen 1 [16].
[53] Foegeding 1 [25]; Ipsen 1 [20].
Whey protein has been used by body builders since the 1980s with an emphasis on nutritional value.[54] Subsequently, there was a move towards making products with added whey more generally desirable by improving flavour and texture. The elderly, for example, often need additional protein that has good palatability and is easy to digest.[55] Since the early 2000s the market for whey products has expanded. Consumers like a natural, healthy product. Whey protein has a “health halo” associated with its content of branched chain amino acids.[56]
[54] Foegeding 1 [26]; Dentener 1 [17].
[55] Ipsen 1[31].
[56] Foegeding 1 [27]-[28]; Ipsen 1 [22], [34].
Whey protein can be concentrated and used directly in powdered form. A concentrated product feed is spray dried to form powdered whey protein particles.[57] Professor Foegeding additionally notes that spray dried whey protein is a “composite” particle in that in addition to protein it would contain some lipids and minerals.[58]
[57] Ipsen 1 [20]; Foegeding 2 [63].
[58] Foegeding 2 [64].
The proprietary product “Simplesse” was well known at the priority date. Simplesse was the starting point for a range of particulated whey products that were produced by applying heat and shear to whey protein; it was known that shear and heat control could change the properties of Simplesse type particles. Also known was that particulated whey protein having a spherical particle shape and a particle size about 0.5-2.5 microns produced a creamy mouthfeel.[59] The parties agree that Simplesse is an example of Type A whey particles. These particles are typically inert, or of low reactivity.[60]
Aspects of the problem in the prior art
[59] Foegeding 1 [39]; Ipsen 1 [21]-[23], [26], [29]; Corredig 1 [17]-[18].
[60] Foegeding 1 [38]; Ipsen 2 [7]-[9].
Professor Ipsen states that if he were asked to make a high protein product in 2014, he would make a fermented product. He notes the high growth rate of fermented products due to their perceived health value. In the same paragraph he comments that whey protein, known for its fitness and muscle building benefits, was known as an additive in 2014.[61]
[61] Ipsen 1 [33]-[34].
Professor Foegeding reports that products fortified with protein were known by 2014; however, increasing protein can make a product too chewy. Advantageously, relatively inert whey protein particles can “fit” into existing space in the food, reducing unwanted textural effects. He expects that maintaining the conventional yoghurt texture would be the main technical challenge when making a high protein yoghurt in 2014.[62]
[62] Foegeding 1[35]; [84].
Professor Ipsen notes the problem of increased graininess caused by the addition of whey proteins to fermented products.[63] He says that for a very high protein yoghurt, there would be “serious issues to control such as graininess, astringency, and a dry feeling to the product…”.[64] Professor Corredig further elaborates on these textural challenges:
“The biggest problem with whey protein products is their "graininess" or "sandiness". This was known in 2014. It was also known at that time that that if a dairy product had a higher fat content, then a higher graininess could be tolerated. Increasing the fat in a dairy product can therefore hide the graininess. A low fat, high protein yoghurt would be expected to be quite grainy.
As well as the sensory perception of graininess or sandiness, high protein yoghurts also exhibit syneresis, which is separation of the serum fraction. The type of gel that has formed will affect the water holding capacity, but generally higher protein yoghurts tend to be brittle and cut badly and they also appear shiny.”[65]
[63] Ipsen 1 [36].
[64] Ipsen 1 [47].
[65] Corredig 1 [30]-[31].
I take from these expert statements that whey protein, including the product Simplesse, was known as an additive in products having a health focus in 2014, that fermented products were also favoured from a health perspective at this time, and that high whey fermented products would be expected to have problems with texture.
Type B particles
There is a divergence of opinion between the experts as to whether the Type B particles used in the application formed part of the common general knowledge at the priority date.
Professor Foegeding refers to “whey protein microgels” as smaller particles of whey protein (in the nanometer range) that form at a certain pH, which are spherical in shape. Professor Ipsen says that “whey protein microgels” and “whey protein microparticles” refer to the same thing. However, both agree that the size of the particles affects the organoleptic properties of the final product.[66]
[66] Foegeding 1 [40]-[41]; Ipsen 1 [27]-[28].
Professor Foegeding goes on to say that if the “microgels” are heated they can form aggregates, and if the aggregation is stopped at the right time, the microgels can remain dispersed. He says this is an advantageous property when making yoghurts to help provide texture. He says for a yoghurt, these microparticles can be caused to aggregate by lowering pH.[67] He also says that fibrils rather than spherical particles may be formed if heating is conducted at low pH.[68]
[67] Foegeding 1 [42].
[68] Foegeding 1 [43].
In his first declaration, Professor Foegeding lists seven documents that discuss various whey particles that were known before the priority date, saying these are “examples” of documents available. In his second declaration he states that of those documents, the documents attached as EF-4 and EF-10 disclose acid-gellable Type B particles.[69]. He goes on to state:
“Type B particles are more nuanced, but scientists/product developers who followed protein ingredient functionality could have heard about it from various sources.”[70]
[69] Foegeding 1 [45]; Foegeding 2 [46].
[70] Foegeding 2 [45].
I read the statement “could have heard about it” above as meaning that there was more than one source of information about Type B particles available, making it likely that the skilled person would be aware of them, rather than a statement that the skilled person might or might not have heard about the particles. This reading is consistent with Professor Foegeding’s following statement:
“As I discussed in my first declaration, the properties and potential uses of both microparticulated whey protein and acid gellable whey protein were well known before the priority date.”[71]
[71] Foegeding 2 [47].
Professor Foegeding refers to a third document, EF-16, at this point in his second declaration, titled “Characterization of a Cold-Gelling Whey Protein concentrate”. I understand from the introduction in this article that cold gelation may be induced by either addition of salts or acid.[72] The article mentions that “a cold-gelling whey protein concentrate in dried form is now commercially available,”[73] but states that this particle gels upon redispersion in a salt, so I understand that this commercial product is not an “acid gellable” particle. However, I consider it significant that well before the priority date, in 1997, this article acknowledges acid gellable whey protein aggregates in the order of 30-50 nanometers in diameter as a subset of cold-gelation particles. On the other hand, I understand an earlier publication on cold gelation, EF-18 referred to in Professor Foegeding’s third declaration, only refers to salt-induced gelation.
[72] EF-16 Abstract, page 602 bottom of second paragraph.
[73] EF-16 page 602 top of fourth paragraph.
EF-4 is titled “β-Lactoglobulin and WPI aggregates: Formation, structure and applications” and is dated 2011. Professor Foegeding states it is a well-known, frequently cited paper in the field.[74] The paper reviews the formation, structure, properties, and applications of aggregates formed by heating of β-lactoglobulin (b-lg) and whey protein isolate (WPI). The paper notes that the structure of aggregates depends on pH and illustrates that either strands or spheres are formed of less than 500 nanometers in diameter, with some particles having hydrodynamic radius of 27-60 nanometers.[75]
[74] Foegeding 1 [47].
[75] EF-4 Section 3.1 first two paragraphs, Figure 4.
The applicant submitted at the hearing that when Professor Foegeding refers to “acid gellable whey protein” he is not specifically referring to the Type B particles referred to in the claims which are specifically of the size 0.02-0.5 microns (20-500 nanometers). I am not persuaded by this submission. Professor Foegeding refers to EF-4 as disclosing acid gellable particles which are Type B particles; EF-4 discloses specifically the size of these as being less than 500 nanometers in size. EF-10 also confirms that acid gellable particles are in the nanometer size range, as opposed to microns.[76] I conclude that when Professor Foegeding refers to “acid gellable whey particles” at other points in his evidence, such as at [89] of his first declaration, it is these sub-micron particles that he is referring to.
[76] EF-10 Introduction second paragraph.
Under the heading “Cold gelation”, EF-4 discusses at length acid-induced gelation. The article states that the reactivity of whey protein soluble aggregates in acidic environment can contribute to the structure development in fermented food like yoghurt. In one study, the apparent viscosity of yoghurt was increased and syneresis was reduced by inclusion of these particles that Professor Foegeding classifies as Type B particles.[77]
[77] EF-4 paragraph bridging page1953-1954.
EF-10 dated in 2013 relates to the two different aggregate types of globular proteins - spherical aggregates and flexible strands. Professor Foegeding says that the spherical aggregates are in the same category as Simplesse particles, and the flexible strands are like the “cold gelation particles” he has previously described.[78] I understand him to be referring to the cold gelation particles described in EF-4 which describe acid-gellable particles as a sub-set. Professor Foegeding says that EF-10 shows the ability of the flexible strands to form a smooth gel by lowering the pH.[79] He also points to the conclusion in the article that spherical particles are most useful for protein enrichment, whereas the stranded aggregates are most useful for forming cold-set gels.[80]
[78] Foegeding 1 [74].
[79] Foegeding 1 [76].
[80] Foegeding 1 [78].
I recognise that a particular piece of knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read. Professor Foegeding says that EF-4 is “well known to people in my field and is frequently cited by others”.[81] I do not consider that this statement alone would be enough to conclude that Type B particles are common general knowledge. However, Professor Foegeding says of the papers he cites that these are only examples of documents available at the time, and also that EF-4 is “a review paper and provides a good idea of the knowledge in this field in 2011”.[82] He follows his discussion in his first declaration with the stronger statement in the second declaration that “the properties and potential uses of … acid gellable whey protein were well known before the priority date”.[83]
[81] Foegeding 1 [47].
[82] Foegeding 1 [46].
[83] Foegeding 2 [47].
Professor Ipsen agrees with Professor Foegeding that Type B particles were known in 2014, although he qualifies this by saying they were “somewhat less known”.[84] The only explanation he gives for his clarification is that Type B particles were not sold commercially,[85] however commercial supply is not a requirement for a product to be considered common general knowledge. He confirms the information provided by Professor Foegeding in EF-4 about Type B particles regarding their reactivity, cold-gelling ability, size and morphology.[86] He also clarifies Professor Foegeding’s comment that Type B particles are “more nuanced” by explaining that the conditions for aggregate formation determine the functionality of the cold-gelling whey proteins.[87] Other than on these points, he does not say he disagrees with Professor Foegeding regarding the degree to which these particles were known.
[84] Ipsen 2 [10].
[85] Also see Applicant submission [48a].
[86] Ipsen 2 [10].
[87] Ipsen 2 [60].
Professor Corredig also confirms that Type B particles were known in 2014, but considers they were “more or less experimental” and so “would not have been used in routine adjustment.”[88] She states:
“They were known, but mostly at an academic level and a lot of work had been put into exploring how they form, their structure, size, their behaviour in the presence of ions, etc. They were thought to be highly reactive during acidification, cooling or in the presence of ions or other polymers, and were typically made at very low concentrations in very dilute systems. While they were of interest to academia, they were not widely in use in industry as far as I am aware, and I am not aware of them being blended into any formulation.”[89]
[88] Corredig 2 [45].
[89] Corredig 2 [19].
Professor Corredig seeks to distinguish what was known by “academia” and what was known by people in industry in relation to Type B particles. She says that whilst a lot of work was put into understanding these particles at the academic level, they were not widely used in industry. For example, Ms Dentener, according to the applicant’s submission, did not know about Type B particles in 2014.[90] Counsel for the opponent did not dispute this conclusion at the hearing, but submitted that a finding of common general knowledge requires that the “bulk of people in the field” accept the subject matter concerned to be well known, not that every person in the field is aware of it. In this case, the opponent submitted that three out of the four experts knew of Type B particles, and that in any case, consultation within the industry was common.[91] Professor Foegeding states that from his experience, food companies “reach out to people in academia for our expertise”, and in his view, the knowledge of Type B particles would have been shared by others working with dairy proteins. [92]
[90] Applicant submission [48b].
[91] Dentener 1 [25].
[92] Foegeding 3 [42].
Significantly, common general knowledge is the technical background of the hypothetical skilled worker in the relevant art. Due to the dual nature of the present application that I have discussed previously, I have found that the hypothetical skilled worker in this case is a team of people made up of a protein scientist with specialist knowledge of food protein manufacture and properties, and a dairy technologist having experience in formulation of products and the machinery used in their production. This hypothetical skilled worker therefore has the knowledge of both protein scientists and industry workers.
On balance, I accept the opponent’s submission that Type B particles were common general knowledge at the priority date. Professor Foegeding’s statements are quite definitive – he says the properties and uses of acid gellable whey protein were well known before the priority date and states his knowledge of Type B particles would have been shared by others. The other experts accept that Type B particles were known. Furthermore, Professor Foegeding backs up his opinions with evidence in the form of exemplary, well-read documents that include a paper from 1997 and a paper reviewing the knowledge in the field dated 2011. Even if Type B particles were not known to all dairy technologists in the field, I am satisfied on the evidence that they would be well known technical background to protein scientists. It follows that this knowledge can be imputed to the hypothetical skilled worker.
I therefore conclude that Type B particles formed part of the common general knowledge of the hypothetical skilled worker at the priority date.
Inventive step consideration in view of common general knowledge
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art (subsection 7(3)).
In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd[93] (Wellcome) Aickin J stated:
"The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."
[93] [1981] HCA 12 at [45]; (1981) 1A IPR 268 at 281.
In Aktiebolaget Hassle v Alphapharm Pty Ltd (Alphapharm)[94] the High Court endorsed the use of the reformulated "Cripps question":
"Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and the facts … directly be led as a matter of course to try [the invention as claimed] in the expectation that it might well produce a useful alternative…”[95]
[94] [2002] HCA 59; (2002) 56 IPR 129.
[95] Ibid at [53].
Also in that decision, I note the statements about claims that relate to combinations of integers.
“It is the selection of the integers out of "perhaps many possibilities" which must be shown by Alphapharm 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.”[96]
[96] Ibid at [41].
Further elaboration is found in the Full Federal Court’s decision Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft (Generic Health):
“We do not think that the plurality in Alphapharm were saying that the reformulated Cripps question was the test to be applied in every case. Rather, it is a formulation of the test which will be of assistance in cases, particularly those of a similar nature to Alphapharm. The plurality did not reject as an alternative expression of the test the question whether experiments were of a routine character to be tried as a matter of course (The Wellcome Foundation Limited v VR Laboratories (Aust) Proprietary Limited [1981] HCA 12; (1981) 148 CLR 262, at 280, 281, 286, per Aickin J). We do not think there is a divide here in terms of whether an expectation of success is relevant between a test which refers to routine steps to be tried as a matter of course and the reformulated Cripps question. It is difficult to think of a case where an expectation that an experiment might well succeed is not implicit in the characterisation of steps as routine and to be tried as a matter of course.”[97]
[97] [2014] FCAFC 73 at [71].
In AstraZeneca AB v Apotex Pty Ltd (AstraZeneca)[98] the Full Federal Court states the following points in relation to making out a case for obviousness:
“By no means were their Honours proposing that, in order to sustain an obviousness case, a party had to lead evidence which, in terms, echoed the formula. Indeed, there is a sense in which the recitation of the formula by an expert witness might be regarded as tendentious, if not objectionable.”[99]
“That he or she would need to work towards the invention is not inconsistent with the conclusion that the invention was obvious, in the sense of falling within the range of destinations that he or she would expect to reach after the investigations, tests, trials and the like that would be carried out as a matter of course.”[100]
The problem.
[98] [2014] FCAFC 99.
[99] Ibid at [543].
[100] Ibid at [547].
As to the problem for the obviousness consideration, the applicant refers[101] to the following statement in the AstraZeneca decision:
“If the problem addressed by a patent specification is itself common general knowledge, or if knowledge of the problem is s 7(3) information, then such knowledge or information will be attributed to the hypothetical person skilled in the art for the purpose of assessing obviousness. But if the problem cannot be attributed to the hypothetical person skilled in the art in either of these ways then it is not permissible to attribute a knowledge of the problem on the basis of the inventor’s “starting point” such as might be gleaned from a reading of the complete specification as a whole.” [102]
[101] Applicant submission [66]-[68].
[102] [2014] FCAFC 99 at [202]-[203].
In other words, when formulating the problem, it is not permissible to incorporate information that is not available to the person skilled in the art as either common general knowledge or information available under section 7(3).
The applicant submitted that the problem to be addressed in the present case is the problem of making a high protein yoghurt, and that this formulation of the problem is part of the common general knowledge.[103] The opponent characterises the problem more narrowly, as the problem of making a high protein yoghurt, especially one that was whey based rather than casein based, or the problem of making a high whey protein yoghurt to target a sports market.[104]
[103] Applicant submission [61].
[104] Opponent submission [83]-[84].
At the hearing, I commented that it would seem to follow logically that the problem of making a high whey protein yoghurt to target the sports market would have been known, given that the problem of making a high protein yoghurt was known, and given that sports people were known to prefer high whey products. Counsel for the applicant responded by saying that it depended on what “high whey” means. Applicant’s Counsel acknowledged that it was common general knowledge that people were pursuing whey-based yoghurts, but the goal of 90% was not being pursued.
The distinction between “high whey” or “whey based”, and “90% whey” may appear arbitrary, and indeed the opponent submitted at the hearing that there is no difference. However, given that the protein content of milk is about 80% casein and about 20% whey, to my mind increasing the whey content of a milk-based product, and creating a product having 90% of its protein being whey are significantly different undertakings. I agree with the applicant that it is reasonable to characterise separately products wherein at least 90% of the protein is whey protein.
On balance, I conclude that the problem for the inventive step consideration is the problem of formulating high whey protein fermented products such as yoghurts, and that this problem was known in the common general knowledge at the priority date. I understand “high whey” in this context to mean a product that would appeal to sports people due to its significant content of whey. The opponent pointed me to Professor Foegeding’s statement that when making a protein fortified product, the aim is to “get the protein content as high as possible while still producing a product that is acceptable…”.[105] However, this statement does not identify any specific percentage, and I do not consider that “as high as possible” is synonymous with 90%. He also mentions increasing the concentrations of the various proteins at the end of the first declaration but again does not suggest a particular percentage.[106] The opponent submitted that in any case, not all the claims are directed to a product containing 90% or more whey. I agree with this point and have discussed the different scope of the independent claims above.
[105] Foegeding 1 [82].
[106] Foegeding 1 [94].
To solve the problem of making a high whey protein yoghurt (targeting sports people), Professor Foegeding says that he would work through a series of options and assess those options for success, starting from the assumption that an all-dairy label is desired.[107] Firstly, he says he would try adding WPC or WPI to the milk before fermentation but expects that this product would be too firm. He says a second option would be to include particulated whey protein, like the ones he has described in the literature, in the milk before fermentation. He would look for a “small and unreactive” particle to avoid more problems with texture, noting that depending on the particle type “the whey particles could also contribute to gel firmness and viscosity”.[108] He acknowledges the challenges of formulation, saying that viscosity, smoothness, slipperiness and creaminess are all different sensations that would need to be balanced, and each additional ingredient creates a different overall mouthfeel.[109]
[107] Foegeding 1 [85].
[108] Foegeding 1 [86]-[87].
[109] Foegeding 1 [88].
In key evidence provided before he saw the application, Professor Foegeding says that the desired product qualities need not come from one type of particle. He considers that a combination of two particles would be advantageous. In the context of adding whey particles to milk,[110] he states:
“One option that would be worth trying for a full dairy solution would be to use a cold gelation particle. For example, I could add an acid gellable whey particle and the product would gel as the pH dropped during fermentation. This type of particle may contribute a different kind of mouthfeel that is undesirable. If the mouthfeel still needed to be improved I would look at adding a particle that doesn’t form a gel and determine the particle size distribution need for the appropriate mouthfeel. For example, building on the Simplesse concept for adding a creamy texture, the goal would be to keep the particles at approximately 0.5 to 2.5 micrometers in diameter.” [111]
[110] Foegeding [91]-[92].
[111] Foegeding 1 [89].
The applicant questions the uncertain language of Professor Foegeding’s statements, such as his comment that a cold gelation product would be “worth trying” and that he “could add” acid gellable whey, saying that this language of “worthwhile to try” is not sufficient to make out a lack of inventive step[112] as per Alphapharm.[113] The applicant also characterises Professor Foegeding’s evidence as “conditional”, such as in the above paragraph where he states “if the mouthfeel still needed to be improved” he would proceed a certain way. [114] The applicant says this indicates the Professor would move to the next step only if a particular effect were encountered, and therefore it cannot be said that the skilled person would be “directly led” to the solution.
[112] Applicant submission [80(2)-(3)].
[113] Applicant submission [55]; Alphapharm at [66]-[76].
[114] Applicant submission [115].
However, as stated in AstraZeneca, a party is not required to lead evidence that “echoed the formula” in order to sustain an obviousness case. I consider that the principle to be drawn from this statement is that it is not the form of the words used in the evidence that should determine the outcome. Rather, the real question is whether the steps discussed by Professor Foegeding can be said to be experiments of a routine character to be tried as a matter of course.
I do not read Professor Foegeding’s language as indicating an uncertainty about how he would proceed, nor that he is simply sketching out possibilities that he might try in a research programme. He is addressing the specific question of what he would do if he asked to make a high protein yoghurt targeting sports people at the priority date. His answer is in terms of a limited selection of experiments he would conduct. After discussing the marketing goals, several options for ingredients, and the need to balance the range of sensations in the final product, Professor Foegeding states that he would try acid gellable whey particles, then he would look at adding non-gelling particles. I understand he is saying he would use the two types of particle together as one of the experiments he would conduct to improve mouthfeel, as acid gellable particles alone may contribute an undesirable mouthfeel. I read his statements as concrete intentions of how he would proceed, meaning he would conduct these experiments to work towards the solution. I characterise these statements as being in the nature of working toward the invention using “tests, trials and the like that would be carried out as a matter of course”[115].
[115] AstraZeneca at [547].
Professor Foegeding goes on to say that the additional ingredients, such as the mixture of proteins, could be added to milk in dry form.[116] He explains what he would do if faced with phase separation.[117] All these steps are presented by Professor Foegeding as routine steps that the skilled person would undertake as a matter of course when faced with the problem of making a high whey protein yoghurt.[118] Whilst he implies that some evaluation would be required since each ingredient creates a different overall mouthfeel, to my mind evaluation is within the meaning of routine trials. Professor Corredig confirms that to make any new dairy product a trial-and-error approach will necessarily be required.[119] I further note that he is addressing the combination of ingredients here and is not simply considering whether each integer would separately be considered a routine option.
[116] Foegeding 1 [92].
[117] Foegeding 1 [94].
[118] Foegeding 1 [95].
[119] Corredig 1 [35].
Ms Dentener’s evidence corroborates Professor Foegeding’s evidence at least on the point that it would be routine to combine two types of whey particle when faced with the problem of making a high protein yoghurt. The prior art document D4 was shown to Ms Dentener before she saw the application. This document is an example of Type B particles.[120] She was then asked how she would make a high protein yoghurt with this product. She states that if the gel produced by the product was too strong, she would add an additional protein source that does not contribute to gelling, such as the microparticles she previously discussed (Type A particles).[121]
[120] Corredig 2 [30].
[121] Dentener 2[10]; Dentener 1 [45]-[47].
The applicant further challenges Professor Foegeding’s statements as not providing evidence that the skilled person would have a reasonable expectation of success of producing a yoghurt having desirable properties when the two particle types are combined.[122] However, as stated in Generic Health, a routine step is one that is tried implicitly with an expectation that the experiment might well succeed. Thus, as further discussed in the decision of Nichia Corporation v Arrow Electronics Australia Pty Ltd (Nichia), care must be taken in evaluating the character of the expectation separately from the steps the skilled addressee would have taken.[123] Routine steps are those which are taken in an expectation that they might well produce the invention or a useful result, rather than an expectation based on predictive capacity.[124] However, the expectation of finding “some other useful result” is not enough; the expectation of the skilled person in the context of obviousness must be an expectation of producing the claimed invention.[125]
[122] Applicant submission [80(4)].
[123] [2019] FCAFC 2 at [88].
[124] Ibid at [89].
[125] Ibid at [77].
I consider that the necessary expectation of generating a “useful result” in the case of making high whey protein yoghurt is achieved if the skilled person expects that the experiments might well produce a product that has a satisfactory texture like that of conventional yoghurt. All the experts agree that texture is the key difficulty to overcome. Professor Foegeding’s steps specifically address this, in that he expects the creamy texture generated by the micrometre size microparticle (Type A) would balance any undesirable mouthfeel generated by the acid-gellable particle (Type B particle). I am therefore confident that the way Professor Foegeding describes the steps he would undertake indicates that he considers that carrying out these steps are a matter of routine, and that they “might well” produce a useful result when the particles are added together to a milk base.
Professor Ipsen, when asked to comment, does not challenge the steps that Professor Foegeding presents as not being routine; rather, he says the declaration is “well thought through, logical and highly relevant”.[126] Professor Ipsen notes that different processes for making whey microparticles will impact upon their properties, which makes predicting ingredient behaviour difficult. However, the relevant expectation is not based on predictive capacity as stated above. Further, he agrees that particles like Simplesse will mostly be inert,[127] and that acid gelling whey protein will be able to form a gelled network.[128] He goes on to say that there is interaction between Type A and Type B particles in the application but does not say this would impact on whether the skilled person would use them together in routine tests. He says he disagrees that acid-gellable whey protein can by itself replace casein, however Professor Foegeding says this is a misinterpretation of his statement.[129] Overall, I do not find a clear indication that Professor Ipsen is questioning whether the skilled person would conduct the steps that Professor Foegeding presents.
[126] Ipsen 2 [49].
[127] Ipsen 2 [55].
[128] Ipsen 2 [58].
[129] Foegeding 3 [33].
I have addressed Professor Corredig’s comments about how well-known Type B particles were in 2014 under the section above on common general knowledge. On Professor Foegeding’s declaration, she states that she agrees that Type A particles are well-known and would be a good option for texture modification, but then states:
“No-one thought to add Type A and Type B particles, much less doing so in the context of making high protein products.”[130]
[130] Corredig 2 [35].
However, she appears to qualify this statement in the paragraphs immediately following:
“At [21] in his second declaration, Foegeding says that he thinks the skilled person would take this approach because by 2014 there was a range of literature available about the structure that needs to be set up in milk to get a good yoghurt. There was also a range of literature available about different types of particles and their mechanisms. Foegeding concludes that in view of this literature, it would be routine to look at whey protein ingredients to see if they have the required function.
In a general sense I agree, but not in the case where a high whey protein is involved. The previous approaches in the literature relied upon the presence of significant amounts of casein, with the whey protein being added to “help” the casein gel. However, the current yogurt type gel with 90% of protein being whey protein would be surprising. It was well known in 2014 that using high amounts of whey protein resulted in a brittle, easily ruptured, non-creamy product, especially in low fat formulations.” [131]
[131] Corredig 2 [36]-[37].
I understand her evidence to be that she generally agrees with Professor Foegeding’s statement that it would be routine to investigate whey protein ingredients to see if they have the required function, “but not in the case where a high whey protein is involved”. The reason she gives is that previous approaches “relied upon the presence of significant amounts of casein”, but a yoghurt “with 90% of protein being whey protein would be surprising”. Also, although she questions whether “someone involved in routine tinkering”[132] would have come up with the product of the application, again this is followed by comments suggesting this is in the context of moving from a casein-based product to one containing little casein.
“I would note that at high concentrations, the interactions between proteins can be particularly challenging. It is the interaction between type A and type B particles that give the present result, and this cannot be controlled with casein-based material. Making an acid whey gel with the same consistency as a casein containing milk gel is quite challenging.”[133]
[132] Corredig 2 [44].
[133] Corredig 2 [47].
I understand Professor Corredig’s comments, then, as questioning the assertion that the skilled person would use Type A and B particles together when high whey gelled products having 90% or greater whey as a percentage of protein are concerned. I note here that claim 1 states that at least 90% of the protein is whey protein in the claimed dry food ingredient, but this does not limit any product formed from the claimed ingredient. The food ingredient is merely a mixture of Type A and B whey particles which could have a variety of end uses. The claimed ingredient could be added to milk containing casein, as suggested by Professor Foegeding, to generate a yoghurt having less than 90% of the protein being whey.
Professor Corredig also says she believes that in the application, a synergy between the Type A and B particles is shown which had not previously been identified. However, to my mind this observation does not address the question of what the skilled person would do when faced with the problem of making high whey protein yoghurt. If the skilled person was seeking to use more than one particle type to balance the viscosity and texture requirements as Professor Foegeding states, any effects of interaction would presumably be managed by altering the concentrations of the components as per the method suggested by the Professor at the end of his first declaration.[134] Also, the range of proportions of Type A and B particles in the claimed compositions are very broad, and encompass far more than the proportions of components found in the examples where the alleged synergy occurs. For these reasons, I do not find it necessary to enter the debate between the parties as to the degree of interaction shown in the examples of the application.
[134] Foegeding 1 [94].
The applicant submitted that none of the experts suggested combining Type A and Type B particles before seeing the application, pointing to passages in Professor Foegeding’s second and third declaration about combining Type A and B particles.[135] However, on the contrary, I cannot discount the clear statement made by Professor Foegeding in his first declaration, before he saw the application, which cannot be said to be tainted by hindsight. In that declaration, Professor Foegeding has provided evidence that it would be a matter of routine for the skilled person to combine Type A and Type B particles, (forming a “food ingredient”), and add them in dry form to a milk base, as quoted above. The comments of the other declarants do not persuade me that I should not give weight to this statement.
[135] Applicant submission [71]-[78].
Professor Foegeding does not comment specifically on the relative proportions of Type A and B particles that would be required in a mixture in his first declaration, but he does explain how he would vary the relative amounts of proteins in combination if there were problems with phase separation. He also makes clear that the purpose of the different whey particles is to balance the mouthfeel of the product, which would determine the proportions required. This is consistent with the further statement made in his second declaration that optimising to select the relative amount of each particle type would be routine for a manufacturer.[136] Ms Dentener corroborates the Professor’s evidence at this point, explaining how a food technologist would go about selecting proportions of ingredients by testing two components in various ratios (including 50:50) to get to the optimal combination.[137] Although this evidence was provided after the declarants had seen the application, the comments are linked to or consistent with what had been said in the earlier declaration, and further reasoning is provided to justify the comments. For these reasons I am prepared to give weight to these comments.
[136] Foegeding 2 [59].
[137] Dentener 2 [29].
Professor Foegeding states that all the additional dry ingredients should be added to the milk at the start of the yoghurt making process.[138] The only “additional” ingredients he refers to other than the two types of whey particles are flavourings or fruit which he mentions only in passing, (or gums/starch in the case of products that are not all-dairy)[139] - it is clear that the majority of the dry ingredients he refers to are proteins. I am therefore satisfied that when the Professor is referring to adding an ingredient mix to milk, the mix would comprise a total amount of protein of at least 30%. I also note his discussion is about adding a whey particle mix to milk – he is not suggesting adding any other kind of protein. It follows that at least 95% of the protein in the ingredient is whey.
[138] Foegeding 1 [91].
[139] Foegeding 1 [81], [88].
To summarise, I am satisfied that the skilled person, faced with the problem of making a high whey protein fermented product such as yoghurt, would:
·combine acid gellable whey particles (Type B particles) with particulated whey (Type A particles) as a matter of routine to obtain a “food ingredient” containing mostly these whey particles as the protein source.
·routinely test the relative amounts of those particles, and on balance would achieve proportions within the scope at least 20% (w/w) Type A particles and at least 10% (w/w) Type B particles relative to total protein.
·provide the mixture to milk either as a liquid or as a dry mixture.
·use the mixture added to milk to make a high whey protein (whey based) fermented product suitable for the sports market.
In following these routine steps, the skilled person would arrive at the proportions of ingredients specified in claim 1, noting that the proportions encompassed by claim 1 cover a very large range, including a 50:50 mixture. It follows that claims 1 and 2 lack an inventive step based on common general knowledge alone.
Claims 3 and 4 relate to further optimisations of the proportions of Type A and B particles in the food ingredient - at least 30% (w/w) Type A particles (claim 3) and at least 15% (w/w) Type B particles (claim 4) relative to total protein. These proportions still cover a very wide range, including a 50:50 mixture. It follows that these claims also lack an inventive step.
Claims 5 and 6 refer to composite particles. Claim 6 encompasses spray drying Type A and Type B particles separately and mixing then to form the food ingredient. I have noted previously that Professor Ipsen considers spray drying whey to be common general knowledge, and that Professor Foegeding considers composite particles to be inherently formed when a whey ingredient is spray dried. Professor Foegeding also states that additional ingredients (like whey proteins) may be used in dry form and that most dairy ingredients are sold in powdered form.[140] Given that the steps for forming the claimed mixtures of separately spray dried Type A and Type B particles are all well known, it follows that claim 6 lacks an inventive step.
[140] Foegeding 1 [92].
Claim 5 defines composite particles comprising both Type A and Type B particles. Professor Foegeding considers this to be a routine step (after he saw the claim), and also points to D1 where whey protein is co-dried with further ingredients.[141] However, I cannot find evidence before the declarants saw the application that the skilled person would routinely spray dry the two different types of whey particles together to form a composite particle. I find that this claim is not obvious.
[141] Foegeding 2 [63], [90].
Claim 7 defines a method of producing the food ingredient of claim 1 by the steps of combining sources of Type A and Type B particles and packaging the mixture. I have already found that the skilled person would routinely combine these two types of particle. The additional step of packaging cannot confer an inventive step.
Claim 16 is directed to a method of using Type A and B particles, in the same ratios as defined in claim 1, to produce an acidified dairy product. Claim 17, appended to claim 16, further specifies that the product is a whey protein-based yoghurt-like product. I have found that it would be a matter of routine for the skilled person to use Type A and B particles to make acidified dairy products or whey-based yoghurt-like products by adding a dry food ingredient containing both particle types to a milk base. Therefore, claims 16 and 17 also lack an inventive step.
Claim 18 is directed to a whey protein-based product. I have found above that “whey protein-based” means a product wherein most of the protein is whey, but the claim is not limited to a product wherein at least 90% of the protein is whey. However, the claim 18 product is further limited to a product having a total protein content of at least 7%. The declarants note examples of high protein content yoghurts in the prior art wherein the protein content is 7% or higher, including Greek yoghurt and the products in D3,[142] however these examples alone do not show that 7% protein content is routine in the art. After seeing the application, Professor Foegeding comments in relation to D1 that increasing the protein from 4.6% to 7% would be “routine product development”, but does not include further details about how to achieve this level.[143] On the other hand, Professor Corredig says that making “a high whey protein product (i.e. 7% protein) would be challenging”.[144] In his first declaration, Professor Foegeding states that in making a protein fortified product the aim is to get the protein as high as possible. However, I consider his evidence at this point to fall short of asserting that making a whey protein-based yoghurt like product with a total protein content of at least 7% (w/w) is routine, and I give less weight to the evidence he provides after seeing the application. On balance, I find that claim 18 is not obvious.
[142] Ipsen 2 [35]; Dentener 2 [46]; Dentener 3 [21].
[143] Foegeding 2 [87].
[144] Corredig 2 [17].
Claim 8 is a method of making a whey protein-based yoghurt-like product which requires in step a) providing a liquid premix, wherein at least 90% (w/w) of the protein of the pre-mix is whey protein. This claim clearly sets out the high whey content of the premix which forms the protein content of the yoghurt-like product, as I have explained above. Claim 8 also states that the premix has a total protein content of at least 7%. Claim 13 stipulates that “at least 90% (w/w) of the protein of the claimed yoghurt-like product is whey protein and that the product contains a total protein content of at least 7%.
Professor Corredig’s evidence is that she does not believe the skilled person would have routinely worked towards a 90% whey protein yoghurt at the priority date. I have also noted above that Professor Foegeding’s evidence in his first declaration is focussed on adding the whey particles to milk,[145] therefore casein would be present in the final product that he envisages. Further, although his first declaration states that the aim is to get the protein as high as possible, he does not quantify this aim in terms of the desired amount of whey protein. It is only after seeing D1 (a whey based fermented dairy product) and the opposed application does the Professor address the particular challenge of making an “all-whey” product[146] - mindful of the dangers of hindsight analysis, I am inclined to give less weight to these paragraphs.[147] I have noted previously the experts’ statements about the textural challenges of making high whey products; these challenges increase with increasing whey content. Therefore, I am not satisfied that it is a matter of routine to make a whey protein-based yoghurt like product wherein at least 90% (w/w) of the protein is whey protein, (as distinct from merely a mixture of whey proteins for any end use as in claim 1).
[145] Foegeding 1 [87], [91], [92].
[146] Foegeding 2 [10], [35], [70], [72], [86], [95].
[147] Applicant submission [58]-[59].
Since I do not consider on the evidence that it would be a matter of routine to produce a product wherein at least 90% (w/w) of the protein is whey protein, claims 8 and 13, and appended claims 9-12 and 14-15 are not obvious on common general knowledge alone.
In summary, I have found that claims 1-4, 6, 7, 16 and 17 lack an inventive step in view of the common general knowledge in the art.
Lack of Inventive step based on D1 (WO 2007/110411) and common general knowledge
D1 relates to whey protein “micelles” of particle size in the nanometre range, which may be spherical or linear. The document is cited in the application as a resource for providing more details on making Type A and Type B particles. Professor Foegeding says that he does not consider D1 describes Type A particles as the particle size is too small.[148] Both Professors Ipsen and Corredig say the fermented product of example 8 only uses one type of particle.[149]
[148] Foegeding 2 [41].
[149] Ipsen 2 [24]; Corredig 2[21].
Example 8 of D1 is titled “Whey based fermented dairy product”. Professor Foegeding says that “there is little information about texture” in the example. He goes on to say that “assuming” that one or more of the samples had a suitable consistency he would then consider whether other properties such as mouthfeel needed to be altered. If they did, he says additional ingredients “such as starch or microparticulated whey protein could be used to improve the mouthfeel”, but the choice of ingredient would depend on the marketing aims.[150] He says that he would try using a microparticulated whey “if an all whey solution was required”. After he has seen the application, he repeats this reasoning based on the goal of trying to make an all whey product, when he returns to a discussion of D1.[151] Also after he has seen the claims of the application, Professor Foegeding notes that the protein content of this product is 4.6% compared with 7% in claim 8, but states that increasing the protein content would be a “routine product development step for a food technician.” [152] Finally, he comments on the disclosure of a dry food ingredient in D1.[153]
[150] Foegeding 2 [10].
[151] Foegeding 2 [10], [86].
[152] Foegeding 2 [87].
[153] Foegeding 2 [83]-[84].
The opponent submits that all the claims are obvious in view of D1. I have difficulty accepting the reasoning here on several counts. Firstly, I have found that the problem for the inventive step consideration is the problem of formulating high whey protein fermented products, and that this problem was known in the common general knowledge at the priority date. This is distinct from the problem of formulating an all-whey product discussed by Professor Foegeding here, which incorporates part of the solution in the reasoning process.
Secondly, there is no information as to the texture of the product of Example 8 in D1, so to my mind there is no motivation in D1 for the skilled person to consider textural adjustments to the disclosed product. Here, Professor Foegeding seems to be repeating his previous reasoning regarding how he would make a product from basic ingredients (which I have found compelling), rather than what he would do faced with D1, which to my mind would involve a different reasoning process. Also, I agree with the applicant that I should give less weight to evidence provided after the application has been viewed due to hindsight concerns. I am not satisfied that the skilled person, armed with D1 and in view of the problem, would find the motivation to add Type A particles to the dry food ingredient or the product of example 8 as a matter of routine.
I am therefore not satisfied that the skilled person, armed with D1, would arrive at the food ingredient of claim 1 or the food products of claims 16 or 17 by routine steps. Further, I refer to my previous comments on increasing the protein content of a yoghurt product; I am not satisfied that it would be a matter of routine to increase the protein content to the levels required by claims 8, 13 and 18. None of claims 1-18 are obvious in view of D1 and common general knowledge.
Lack of inventive step based on D2 (CN 102550669B) and common general knowledge
This document relates to a high-protein low-fat yoghurt and a method for preparing it. Example 2 discloses an increased whey protein fermented product made from skim milk, sugar, microparticulated whey protein, a gel-type whey protein concentrate, chocolate essence, yoghurt starter and water. The gel-type whey protein concentrate enhances the gel performance of yogurt, and the microparticulated protein improves the texture of yogurt.[154] Professor Foegeding says it is not clear that the gel-type whey protein is a modified cold-gellable particle.[155] Mr Jensen has calculated the amount of protein in the product of Example 2 to be 3.8%.[156] Professor Ipsen says the calculations appear correct[157] and Professor Foegeding does not dispute them.
[154] D2 translation paragraph [0008].
[155] Foegeding 2 [17].
[156] TJ-2.
[157] Ipsen 2 [33].
Professor Foegeding was asked if he would make any changes to Example 2 if he was to make a high whey protein yoghurt at the priority date. He says that he would remove the non-whey components of the whey ingredients which may affect the yoghurt properties. He says that if thickness or firmness of the product were a concern, he would consider using acid gellable particles instead of the gel-type why used. He also says that it would be possible to make a yoghurt with more or less protein than that the product of example 2.[158] After he has viewed the application, he says that an acid gellable whey particle would be preferrable for avoiding processing issues.[159]
[158] Foegeding 2 [19], [20], [24].
[159] Foegeding 2 [36].
Professor Corredig considers the protein content of 3.8% calculated for the prior art product of D2 to be low.[160] She says that testing and modifying the conditions and amounts in D2 “would not ever get the protein content to 7% or more in an acceptable product…”.[161] In response, Professor Foegeding says that he was discussing a yoghurt that contained casein, and he does not disagree that there was a concern with viscosity build up. He does not elaborate here on how he would increase the protein content of D2 to the levels claimed. He says, after he has seen the application, that for an all-whey product, the approach would be different.[162]
[160] Corredig 2 [26].
[161] Corredig 2 [38].
[162] Foegeding 3 [49].
Regarding claim 1, D2 does not specifically disclose a dry food ingredient comprising a combination of Type A and B particles. The opponent has not pointed to any evidence showing that, armed with D2, the skilled person would arrive at such an ingredient by routine steps. Claims 1-7 are not obvious in view of D2.
Claim 8 is a method of producing a whey protein-based yoghurt-like product having specific levels of protein and whey. The opponent has not pointed to evidence providing a clear indication that it would be a matter of routine to alter the D2 process to use a premix that contained at least 7% protein and at least 90% of the protein being whey. I am therefore not satisfied that the opponent has discharged their onus in relation to showing a lack of inventive step for claim 8 and dependant claims 9-12. Similar reasoning applies to claim 13 (and dependant claims 14-15) which also requires the product to contain at least 7% protein and at least 90% of the protein is whey. Therefore, claims 8-15 are not obvious in view of D2. For similar reasons claim 18, claiming a method of making a product with protein content at least 7%, is also not obvious.
Claim 16 is directed to a method of using Type A and Type B particles as an ingredient in the production of an acidified dairy product. This claim has no limitation as to the total amount of protein in the mixture. The question in relation to this claims then becomes whether the skilled person would use acid gellable particles in place of the gel-type particles that are disclosed. Professor Foegeding says that the skilled person would use an acid-gellable whey particle instead if there was a need to modify thickness or firmness. He presents this as a routine alteration. However, as for D1, I cannot see a clear motivation in D2 for doing so. Professor Foegeding only mentions the advantage of avoiding processing issues after he has seen the present application. I am not satisfied that the skilled person, armed with D2 and in view of the problem, would consider substituting Type B particles for the gel-type whey particles as a matter of routine.
Claims 1-18 are not obvious in view of D2 and common general knowledge.
Lack of inventive step based on D3 (WO 2010/120199) and common general knowledge
This document discloses a microparticulated whey protein and its use in making yoghurts to increase protein concentration and impart a creamy mouthfeel. D3 is referred to in the application as providing production methods and information on Type A particles. The opponent submits that it would be obvious for the skilled person to add an acid gellable particle (Type B) to the Type A particle disclosed in D3, thus arriving at the present claims.[163]
[163] Opponent submission [111].
I acknowledge the applicant’s submission that Professor Foegeding provides very limited comments on D3.[164] However, he has previously provided extensive statements regarding how he would go about making a high whey protein yoghurt product, and that the steps he would take include combining Type A and Type B particles. I have accepted these statements as being routine steps that the skilled person would take at the priority date. Therefore, given these steps and given that D3 discloses Type A particles, it follows that the skilled person would add Type B particles from their common general knowledge to the Type A particles of D3 as a matter of routine. Also, as I have previously stated, the skilled person would optimise the amounts of the Type A and B particles, thus arriving at the matter claimed in claim 1. It follows that claim 1 lacks an inventive step in view of D3 and the common general knowledge in the art.
[164] Foegeding 2 [25]-[28].
The same reasoning above under lack of inventive step based on common general knowledge alone also applies here to claims 2-4, 6, 7, 16 and 17; these claims lack an inventive step in view of D3 and the common general knowledge in the art. Also, for the same reasons, claims 5, 8-15 and 18 are not obvious in view of D3 and common general knowledge.
Lack of inventive step based on common general knowledge and D4 (WO 2006/068521)
I note that D4 was referred to by the wrong number in the original SGP and in the evidence in support, but this was corrected in the amended SGP. The opponent provided an explanation of how the error occurred and stated that the correct document was exhibited to the declarants in their letter of 21 September 2020. Both Professor Foegeding and Ms Dentener confirm that they have seen and commented on WO 2006/068521, and I accept this. [165]
[165] Foegeding 3 [2]; Dentener 3 [2].
D4 discloses a cold gelation whey protein particle, a Type B particle, and method for making it. The document states the particle is useful for making yoghurt, but no example is provided.[166] The opponent submits that the skilled person would add Type A particles to modify the texture of a yoghurt produced using the particle of D4, thus arriving at the present claims.[167]
[166] Applicant submission [146]; Opponent submission [113]; Foegeding 2 [31].
[167] Opponent submission [115]-[122].
Again, I acknowledge the applicant’s submission that Professor Foegeding has provided very limited comments on D4.[168] Professor Foegeding notes that there is no data on sensory properties such a mouthfeel in this document, and he only mentions in passing the use of microparticulated whey as a possible additional ingredient.[169] However, as I have discussed in my comments on D3, Professor Foegeding’s evidence is that it is a matter of routine to combine Type A and Type B particles. D4 discloses Type B particles. It therefore follows that for the same reasons that claims 1-4, 6, 7, 16 and 17 lack an inventive step in view of D4 and the common general knowledge.
[168] Applicant submission [150].
[169] Foegeding 2 [32].
For completeness, I will also consider Ms Dentener’s evidence regarding D4. She says that there is no example of a yoghurt made with the particle in the document, but she expects that the texture it produces “might be quite nice”. She goes on to say what she would do if asked to make a yoghurt with this product, stating that she would consider using an additional non-gelling microparticle.[170] I have referred to her comments previously on this point, as I consider this evidence to be relevant to the question of whether the skilled person would routinely use two different types of whey particle together. However, I consider her evidence to be less compelling on the question of what the skilled person would do when armed with D4. Ms Dentener states that “if a client had suggested I use this ingredient to make a high protein yoghurt…” she would have taken it into consideration. I agree with the applicant that this evidence falls short of indicating what the skilled person would do (apart from the suggestions of others) armed with D4.
[170] Dentener 2 [8]-[10].
I further note that Ms Dentener’s comments here relate to a process wherein whey ingredients are added to base yoghurt milk,[171] and she does not specify any percentage protein content for the product she envisages. Only when she is asked how she would make an “all whey” yoghurt does she mention replacing the functionality of casein.[172] However, in being asked this question, she is being presented with part of the solution of the application, rather than the problem found in the prior art. For this reason, I give her evidence at this point little weight.
[171] Dentener [11].
[172] Dentener 2 [13].
However, I consider that based on Professor Foegeding’s evidence, the case for lack of inventive step in view of D4 together with the common general knowledge has been made out for claims 1-4, 6, 7, 16 and 17. However, claims 5, 8-15 and 18 are not obvious in view of D4 and the common general knowledge in the art.
Best Method
The opponent relies upon the Ting declaration, and Foegeding 3 [17]-[21] to argue this ground. However, as I have indicated above, this declaration and the above paragraphs of Foegeding 3 do not form part of the evidence. It follows that this ground has not been made out.
Support
As indicated above, I have refused the proposed second amendment to the Statement of Grounds and Particulars dated 18 February 2021 which sought to introduce particulars related to the Best Method ground. Separate from this issue, another issue related to the SGP arose at the Hearing. The amended SGP (that is, the SGP for which the amendment was allowed on 20 January 2021) particularised lack of support regarding claims 16-18, but this was not pressed at the Hearing. Instead, the opponent sought to press new particulars under this ground not particularised in the amended SGP. This new issue is articulated in the opponent’s submissions as follows:
“Because the claims extend to all type A and type B particles (as defined), and do not impose any limitations based on process or morphology, the patentee has not enabled the invention to be performed across its scope. It is apparent from the evidence of the Applicants’ experts that the Application does not disclose a principle of general application, which might reasonably be expected to work with everything covered by the claim.”[173]
[173] Opponent submission [146].
I agree with the applicant that grounds not particularised by the opponent in their SGP usually stand outside the scope of the opposition.[174] At the hearing, I asked Counsel for the opponent if they were willing to again amend the SGP if I decided to consider the new arguments - Counsel said that the opponent would be willing to do so. Counsel for the applicant responded that such a course would necessitate the applicant being given the opportunity to properly consider the newly particularized issue. I am sympathetic to the applicant’s concerns. However, as the opponent has made submissions in relation to this issue and some comments have been provided by the applicant, in the interests of resolving this issue as expeditiously as possible, I will consider the issue in view of the material before me, then decide whether it is appropriate to invite the opponent to amend their SGP.
[174]Garford Pty Ltd v DYWIDAG-Systems International Pty Ltd [2014] APO 37 at [46].
The opponent refers to the decision in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)[175], where Burley J stated that “the claim support obligation is based on a requirement that the technical contribution to the art disclosed by the specification justifies the breadth of the monopoly claimed.” He also referred to the principle articulated by Lord Hoffman that if the invention disclosed in the specification is “a principle of general application, the claims may be in correspondingly broad terms”.[176]
[175] [2020] FCA 1477 at [533].
[176] Ibid at [532].
The opponent submits that the claims extend to all Type A and B particles without any limitation based on morphology. However, previously I have construed the “Type B particles” in the claims to refer to particles having linear, worm-like, branched or chain-like shapes. Both Type A and Type B particles are also claimed in terms of their particle size. Both these limitations relate to morphology. The opponent further submits that the claims of the application fail to place any limitation on the way the Type A and B particles are made. This comment I accept. The claims therefore are directed to combinations of these Type A and Type B particles in a food ingredient, a yoghurt-like product/acidified dairy product, and associated methods, having the claimed size ranges, claimed functionality (insoluble and acid-gellable respectively) and in the case of the Type B particles, the morphology stated above.
As previously stated, the description does not provide any specific method for producing Type A and Type B particles. Rather, it refers to several patent documents where production methods may be found. Professor Foegeding states that from this information, the skilled person “would be able to understand what types of particles to use.”[177] He also states that since the description refers to a number of patents with varying processing conditions as sources for Type A and B particles, this suggests that “processing conditions are not critical.”[178] I agree that the description presents the Type A and Type B particles, as defined, as generally useful in the products and processes claimed, irrespective of their method of production.
[177] Foegeding 2 [43].
[178] Foegeding 3 [32].
The opponent refers to the evidence of Professors Ipsen and Corredig to question whether this combination of particles can validly represent a principle of general application. Professor Corredig states that the particular Type B particles in D4 are “extremely reactive”, so it is necessary to quickly spray dry them to prevent gelation on cooling.[179] Professor Ipsen considers that “the process for making a given microparticulated whey protein ingredient is known to influence its performance...including the resulting perception of creaminess”. He goes on to state:
“I have to state that the complex interplay between the applied process and the properties of the added microparticulated ingredient resulting from how it, in turn, was manufactured makes a prediction of ingredient behaviour very difficult unless a standard defined ingredient is used.”[180]
[179] Corredig 2 [31].
[180] Ipsen 2 [55].
Professor Foegeding agrees that different processing conditions will impart different properties. However, he does not believe from the description that processing conditions are critical. In other words, he thinks it is reasonable to expect that the use of a combination of Type A and Type B particles generally will work in the products and processes of the application, and that the skilled person would understand what types of particles to use.
On balance, I consider that the technical contribution of the application is the use of the combination of Type A and Type B particles generally in the products and processes of the application. The experts recognise that the way the A and B particles are produced will vary the properties of the products to some extent, and that care may need to be taken in working with more reactive particles. However, I am not satisfied on the evidence that the impact of the particle production processes on the resultant properties is such that the claimed invention cannot reasonably be expected to work over substantially the full scope claimed. I consider the technical contribution to the art disclosed by the specification justifies the breadth of the monopoly claimed.
The opponent has not discharged their onus for the support ground based upon the evidence they have provided. I see no value in inviting a further amendment to the SGP to include the particulars related to this ground.
Conclusion
The opposition is successful. Claims 1-4, 6, 7, 16 and 17 lack an inventive step in view of the common general knowledge in the art. These claims also lack an inventive step in view of each of D3 and D4, each combined with common general knowledge. I believe it is possible to overcome my finding with appropriate amendments. I will allow the applicant two (2) months from the date of this decision to file amendments to overcome the deficiencies.
Costs
Costs normally follow the event and see no reason to depart from this. Therefore, I award costs against the applicant according to Schedule 8 of the Regulations.
Cathy Douglas
Delegate of the Commissioner of PatentsAnnex 1
1. A dry food ingredient comprising:
- a total amount of protein of at least 30% (w/w),
- a combination of:
- insoluble whey protein particles having a particle size in the range of 1-10 micron (referred to as type A particles) in an amount of at least 20% (w/w) relative to the total amount of
protein, and
- acid-gellable whey protein aggregates having a particle size in the range of 0.02-0.5 micron (referred to as type B particles) in an amount of at least 10% (w/w) relative to the total amount of protein,
- optionally, carbohydrate, and
- optionally, fat
and wherein at least 90% of the protein is whey protein.2. The food ingredient according to claim 1, wherein at least 95% of the protein is whey protein.
3. The food ingredient according to claim 1 or 2, comprising type A particles in an amount of at least 30% (w/w) relative to the total amount of protein.
4. The food ingredient according to any one of the preceding claims, comprising type B particles in an amount of at least 15% (w/w) relative to the total amount of protein.
5. The food ingredient according to any one of the preceding claims, comprising dry composite particles comprising both type A particles and type B particles.
6. The food ingredient according to any one of the preceding claims, comprising:
- a first dry composite particle population comprising type A particles but substantially no type B particles, and
- a second dry composite particle population comprising type B particles but substantially no type A particles.7. A method of producing the food ingredient according to any one of the claims 1-6, the method comprising the steps of:
1) providing a source A comprising type A particles,
2) providing a source B comprising type B particles,
3) optionally, providing one or more additional ingredients,
4) combining source A, source B and optionally also the one or more additional ingredients to obtain the food ingredient, and
5) packaging the food ingredient.8. A method of producing a whey protein-based yoghurt-like product comprising
a) providing a liquid premix comprising:
- a total amount of protein of at least 7% (w/w),
- a combination of:
- type A particles in an amount of at least 20% (w/w) relative to the total amount of protein
- type B particles in an amount of at least 10% (w/w) relative to the total amount of protein,
- water,
- optionally, carbohydrate
and wherein at least 90% (w/w) of the protein of the premix is whey protein
b) optionally, homogenising the premix,
c) heating the premix to a temperature of least 72 degrees C for a duration of at least 15 seconds and subsequently cooling the premix to a temperature below 50 degrees C,
d) contacting the cooled premix with an acidifying agent and allowing the acidifying
agent to acidify the premix to a pH of at most 5.0,
e) packaging a yoghurt-like product derived from the acidified premix.9. The method according to claim 8, wherein the source of the type A particles and the
type B particles is a dry food ingredient according to any of the claims 1-6.10. The method according to claim 8, wherein the source of the type A particles and the
type B particles are provided by two different sources.11. The method according to any one of the claims 8-10, wherein the premix comprises type A particles in an amount of at least 30% (w/w) relative to the total amount of protein.
12. The method according to any one of the claims 8-11, wherein the premix comprises type B particles in an amount of at least 15% (w/w) relative to the total amount of protein.
13. A whey protein-based yoghurt-like product comprising:
- a total content of protein of at least 7% (w/w), and
- a combination of:
- type A particles in an amount of at least 20% (w/w) relative to the total amount of protein
- type B particles in an amount of at least 10% (w/w) relative to the total amount of protein,
and wherein at least 90% (w/w) of the protein is whey protein.14. A whey protein-based yoghurt-like product according to claim 13, wherein the yoghurt-like product is a stirred-type yoghurt-like product or a set-type yoghurt-like product.
15. The whey protein-based yoghurt-like product according to claim 13 or 14, wherein
the whey protein-based yoghurt-like product is a heat-treated whey protein-based yoghurt-like product.16. Use of a combination of type A particles and type B particles as ingredient in the production of an acidified dairy product, wherein the type A particles are used in an amount of at least 20% (w/w) relative to the total amount of protein of the acidified dairy product, and the type B particles are used in an amount of at least 10% (w/w) relative to the total amount of protein of the acidified dairy product.
17. Use according to claim 16, wherein the acidified dairy product is a whey protein-based yoghurt-like product.
18. Use according to claim 16 or 17, wherein the whey protein-based yoghurt-like product
has a total protein content of at least 7% (w/w), and preferably of at least 10%
(w/w).
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