MGP Ingredients, Inc v Manildra Milling Corporation
[2023] APO 32
•31 May 2023
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
MGP Ingredients, Inc v Manildra Milling Corporation [2023] APO 32
Patent Application: 2019204224
Title:Gluten-free starch and methods of producing same
Patent Applicant: Manildra Milling Corporation
Opponent:MGP Ingredients, Inc
Delegate:Dr S. J. Smith
Decision Date: 31 May 2023
Hearing Date: 1 June 2022, by videoconference
Catchwords: PATENTS – opposition to the grant of a patent – grounds of clarity, inventive step, support – inclusion of a trade mark in claims – lack of clarity not made out – essential aspects of technical contribution to the art based on examples – lack of support not made out – combinations of documents – parameteritis – lack of inventive step not made out – opposition unsuccessful – costs awarded against the opponent
Representation: Solicitor for the applicant: Duncan Longstaff, Spruson & Ferguson Lawyers
Patent attorney for the applicant: Elizabeth Barrett and Ken Johnstone, Spruson & Ferguson
Patent attorney for the opponent: Paul Whenman, Sarah Glasson and Jeremy Dobbin, FB Rice
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2019204224
Title:Gluten-free starch and methods of producing same
Patent Applicant: Manildra Milling Corporation
Date of Decision: 31 May 2023
DECISION
The opposition is unsuccessful. Subject to appeal, I direct the application proceed to grant.
I award costs according to Schedule 8 against MGP Ingredients, Inc.
REASONS FOR DECISION
Background
Patent application 2019204224 (the application) was filed by Manildra Milling Corporation (the applicant) on 17 June 2019 as a divisional application of application 2016283411 (the parent application). The parent application was filed on 27 June 2016 under the provisions of the PCT claiming priority from US 62/184,316 (the priority document) which was filed on 25 June 2015.
Acceptance of the application was advertised on 26 November 2020. MGP Ingredients, Inc (the opponent) filed a notice of opposition under section 59 of the Patents Act 1990 (the Act) on 26 February 2021.
The statement of grounds and particulars was filed on 26 May 2021 identifying as grounds of opposition manner of manufacture, inventive step, utility, clear enough and complete enough disclosure, support, and clarity. At the hearing grounds of clarity, inventive step and support were pressed.
The applicant proposed post-acceptance amendments to the specification on 29 October 2021 which were allowed unopposed on 11 February 2022 and this decision is in relation to the specification as amended.
Evidence
The evidence filed during the evidentiary periods is summarised in the table below:
Evidence Declarant Exhibits Declaration Date Reference In Support
Jeremy Dobbin[1]
P1-P4, D1-D10 and D10A
25 May 2021
Dobbin
Melissa Anne Fitzgerald
MAF-1 to MAF-14
26 August 2021
Fitzgerald #1
In Answer
Les Copeland AM
LC1 to LC6
29 November 2021
Copeland
In Reply
Melissa Anne Fitzgerald
MAF-15 to MAF-27
1 February 2022
Fitzgerald #2
[1] Mr Dobbin is a patent attorney and his declaration exhibits various documents relevant to this proceeding.
Onus
Because the application was filed after 15 April 2013 the amendments to the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act) apply to it. This includes section 60(3A) of the Act, which provides that the Commissioner may refuse an application if satisfied on the balance of probabilities that a ground of opposition exists. It is the opponent who carries the onus of proof.
The specification
The specification is directed to methods of producing gluten-free starch. The specification ends with one figure and 19 claims.
Before construing the specification, I note the comments of Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd:
“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.” [2]
[2] [2013] FCA 214; 100 IPR 451 at [139].
The 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.”[3]
[3] 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.[4]
[4] Ibid at [70]-[72].
Professor Fitzgerald is a Professor and Australian Food and Grocery Council Chair in the School of Agriculture and Food Science at the University of Queensland.[5] Professor Fitzgerald has worked extensively in food science, and particularly grain science.[6] As noted by the applicant, before the priority date (and the filing date) Professor Fitzgerald’s industrial research experience was limited to rice and her research publications primarily related to rice, which does not contain gluten.[7]
[5] Fitzgerald #1 at [2].
[6] Fitzgerald #1 at [5], [16]-[18].
[7] Applicant’s written submissions at [41]; Fitzgerald #1 at [10]-[14], Exhibit MAF-1.
Professor Copeland is an Emeritus Professor of Agriculture at the University of Sydney.[8] Before the priority date (and the filing date) he had research and teaching experience in the field of starch and starch processing.[9]
[8] Copeland at [5].
[9] Copeland at [6], [9]-[12].
I consider that both these declarants have backgrounds that enable them to understand the specification and provide evidence in relation to what a person knew or would have done at the relevant date. Where there is conflicting evidence I will, in the usual manner, decide which evidence should be given greater weight.
The invention as described
The specification indicates that the “disclosure is broadly concerned with gluten-free starch and methods of producing such starch.”[10] In particular, the invention is said to relate to starch containing less than 20 parts per million (ppm) gluten, which starch is derived either from a source naturally containing gluten, or from a naturally gluten-free starch contaminated with a gluten source.
[10] Specification, [0002].
By way of background, the specification states awareness of intolerance to gluten has increased,[11] and that the popularity of gluten-free foods is increasing “because of a health halo effect and because of millions of people afflicted with celiac disease”.[12] A gluten-free diet is the most effective way of treating celiac disease, and is also a treatment for persons afflicted by gluten intolerance or gluten sensitivity.[13]
[11] Specification, [0003].
[12] Specification, [0006].
[13] Specification, [0006].
In recognition of the need for gluten-free products, international and American standards for “gluten-free” labelling have been promulgated. Both the Codex Alimentarius Commission (the Codex) and the US Food and Drug Administration provide such standards:
“The Codex defines ‘gluten’ as a protein fraction of wheat, rye, barley, or oats or their crossbred varieties and derivatives thereof, to which some persons are intolerant and that is insoluble in water and 0.5 M NaCl. ‘Gluten-free’ food is defined as dietary food consisting of or made from one or more ingredients which do not contain wheat (i.e., all Triticum species, such as durum wheat, kamut, spelt), rye, barley, oats, or their crossbred varieties, and which contain less than 20 mg/kg (or 20 parts per million (ppm) or 0.0020%) in total of gluten, based on the food as sold or distributed to the consumer, and/or consisting of one or more ingredients from wheat (i.e., all Tritcum species), rye, barley, oats or their crossbred varieties, which have been specially processed to remove gluten, and the gluten level is less than 20 mg/kg in total, based on the food as sold or distributed to the consumer.
The U.S. Food and Drug Administration (FDA) similarly defines ‘gluten free’ to mean less than 20 parts per million (ppm) of gluten. The FDA also allows manufacturers to label a food as ‘gluten-free’ if it inherently does not contain gluten and if the food does not contain an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains, or an ingredient derived from these grains that has been processed to remove gluten, if it results in the food containing less than 20 ppm of gluten.”[14]
[14] Specification, [0004]-[0005].
The specification goes on to explain the need to commercially develop gluten-free wheat starch for use in the production of gluten-free foods:
“Wheat starch and wheat gluten are important ingredients in the food industry. Bakery products remain the predominant application for wheat starch because its properties closely match those of endogenous starch in wheat flour. The multi-functionality of wheat starch in yeast-leavened bread is summarized as follows: it dilutes the wheat gluten to an appropriate consistency, provides maltose for fermentation through the action of amylase, provides a surface for strong bonding with wheat gluten, provides flexibility for loaf expansion during partial gelatinization while baking, sets the loaf structure by providing a rigid network to prevent the loaf collapsing when cooling, gives structural and textural properties to the baked product, holds or retains water by acting as a temperature-triggered water sink, and contributes to staling. Fractionation and reconstitution studies revealed that rye and barley starches can substitute for wheat starch in producing bread of satisfactory volume. Starches from com, sorghum, oat, rice, and potato produced inferior bread. Most gluten-free foods, however, are not formulated with wheat starch because of the perceived presence of gluten. People who are intolerant to gluten typically avoid anything with ‘wheat’ in its name. Thus, there is a need to commercially develop gluten-free wheat starch for safe and widespread use in the production of gluten-free foods.”[15]
[15] Specification, [0007].
Several methods of producing wheat starch (i.e. separating wheat starch and gluten from wheat flour) used in the industry are introduced in the background,[16] but the specification states that “a majority of the production processes and technologies for wheat starch and wheat gluten do not report the protein content of the final wheat starch product” and “those that do report a range of 0.04-1.03% protein without assurance of having less than 20 ppm of gluten to meet the gluten-free labeling standard.”[17]
[16] Specification, [0008].
[17] Specification, [0009].
Against this background, the specification identifies that the present invention:
“provides a method of quantitatively solubilizing gluten proteins from a starch from a plant belonging to the tribe Triticeae (e.g., wheat, rye, barley, triticale) and extracting the dissolved proteins to product a gluten-free (i.e., less than 20 ppm of gluten) starch that is independently confirmed.”[18]
[18] Specification, [0010].
In a first aspect of the invention, the method is said to comprise the steps of: obtaining a slurry of an initial starch containing gluten protein at 600 ppm or less; treating the slurry with Alcalase at a pH of 5.5 to 6.5 and agitating for 2 hours to dissolve or degrade the gluten protein; washing the slurry; removing the dissolved or degraded gluten protein to give a slurry of purified starch; adjusting the pH of the slurry of purified starch to 5.0 to 6.5; washing the pH adjusted slurry of purified starch; and drying the washed and pH adjusted slurry of purified starch to give a purified starch with less than 20 ppm of gluten protein.[19]
[19] Specification, [0010a].
I note that this first aspect of the invention is in terms that echo claim 1. The specification provides additional detail on each of the steps of the method, some of which I outline below.
The specification states that the initial starch may be derived from a source naturally containing gluten or a source contaminated with gluten (e.g. oats, corn or other sources often treated in plants that process wheat). The initial starch may have about 600 ppm gluten or less, about 470 ppm gluten protein or about 36 ppm gluten protein or less.[20]
[20] Specification, [0013].
The specification describes the use of various agents (acids, bases, alcohols, surfactants, proteases, chaotropic agents, reducing agents, and combinations thereof) to degrade the gluten protein,[21] but I will focus on the use of Alcalase, identified in the specification as a protease, when discussing the remainder of the specification since it is the agent employed in the claimed method. In this regard I note that the specification states that:
“In some embodiments, the agent comprises a protease selected from the group consisting of endo-proteases, exo-proteases, and combinations thereof. In some embodiments, the agent comprises alcalase.”[22]
“Exemplary proteases that may be used with the present methods include endoproteases, exoproteases, or mixtures of endo/exoproteases. In particular embodiments, the protease may be alcalase or a proline specific protease such as MaxiPro PSP, from DSM Food Specialties. Proteases generally are capable of solubilizing wheat proteins by virtue of their ability to hydrolyze the proteins into low-molecular weight, water soluble peptides or oligopeptides and even down to amino acids.”[23]
[21] Specification, [0017].
[22] Specification, [0023].
[23] Specification, [0043].
It is said that the step of removing the dissolved or degraded gluten proteins includes, in some embodiments, washing the treated slurry with water and filtering the washed slurry. In some embodiments, the drying step includes drying the slurry in a flash drier, spray drier, or rotating drum drier. Some embodiments also include a step of testing the purified starch using a test selected from R5 sandwich ELISA, R5 competitive ELISA and G12 Romer ELISA to confirm that the purified starch contains less than 20 ppm of gluten protein.[24]
[24] Specification, [0026]-[0028].
An exemplary implementation of the invention is described as follows:
“…a wheat starch slurry (approximately 15,000 gallons, 21 Baumé, 100°F) may be transferred to a tank equipped with an agitator. Alcalase (approximately 0.02% based on starch solids), which is a protease, may be slowly added to the slurry. The slurry may then be allowed to stir for approximately one hour at approximately pH 5-6 to hydrolyze any residual gluten proteins. The slurry may then be washed with fresh water and centrifuged to remove the solubilized/degraded proteins and residual alcalase. The purified starch slurry may then be adjusted to approximately pH 5.0-6.5, and then dried in a flash or spray drier, resulting in the purified starch. The purified starch may then be tested.”[25]
Examples
[25] Specification, [0049].
The description concludes with a range of examples carried out on various wheat starches: Organic Wheat Starch HORG 080315, Native Wheat Starch H100215 and Australian Wheat Starch N091815, having gluten contents of 470 ppm, 600 ppm and 36 ppm, respectively, and viscosities of 351 B.U., 343 B.U. and 329 B.U., respectively.[26] The specification notes that “[i]nitial gluten concentration and viscosity emerged as important guides to determine success in making the product gluten free without damaging the functionality of the starch.”[27]
[26] Specification, [0064].
[27] Specification, [0066].
A first trial with Alcalase is reported:
“The first trial with Alcalase (a protease) was performed using both the native wheat starch (60 grams) and organic wheat starch (60 grams) slurried with 90 grams of water, to be combined with 0.022% of Alcalase, and was allowed to react for two hours under stirring at 104°F at 5.5-6.5 pH. This treated slurry was then washed three times with water and centrifuged, to mimic plant conditions, to rid the sample of enzyme and the destroyed gluten.”[28]
[28] Specification, [0069].
The results for both starches indicate a gluten concentration below the limit of quantization and no residual enzyme activity.
A second trial including three experiments with the following modifications is then reported: two times the amount of starch, two washings rather than three, and 50% reduction of Alcalase with twice the amount of starch. The results are reported as follows:[29]
[29] Specification, [0073].
Data from a third trial using lower amounts of Alcalase with 120 grams of organic wheat starch is then reported:[30]
[30] Specification, [0076].
The specification then states:
“The Protease treatment, particularly when using alcalase, works best when using 0.0022%-0.022% Alcalase, based on dried starch weight, and washed three times to ensure that the enzyme and protein is washed out of the starch, using a starch with an initial ppm of 470 or less.”[31]
[31] Specification, [0077].
Trials with various agents (sodium hydroxide, hydrochloric acid, sodium dodecyl sulfate, sodium metabisulfite, urea) are reported and the specification states that:
“Treatments using MaxiPro PSP, Urea and Sodium Metabisulfite were unable to reduce the gluten content to desired levels. Further testing is required to establish whether these agents could be useful under different reaction conditions. The unsuccessful nature of the tests employing these agents demonstrates that finding an appropriate agent, and reaction conditions are unpredictable.”[32]
[32] Specification, [0127].
The specification goes on to describe plant trials using Alcalase and reports that:
“The plant trial results were in direct comparison with laboratory results that we had obtained previously. When the Alcalase enzyme was introduced to the starch slurry, allowed to react for two hours, and then triple washed before drying, we were able to make a product that tested gluten free (below 20 ppm) and that was free of any residual enzyme after the third wash. Part 2 of the trial, using Sodium Hydroxide to deactivate the enzyme, still produced a gluten free starch with no enzyme activity.”[33]
[33] Specification, [0140].
The specification concludes that the methods are applicable to any starch (i.e. including non-wheat starches) potentially contaminated with wheat gluten, resulting in “substantially gluten-free starches without introducing functional defects”.[34]
[34] Specification, [0144].
The claims
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd:
“the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear. … While the claims define the monopoly claimed in the words of the patentee’s choosing, the specification should be read as a whole … It is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification.” [35]
[35] [2009] FCAFC 70; 81 IPR 228 at [118]-[120].
The entire claim set is reproduced at Annex A. Claim 1 is the only independent claim:
A method of producing a purified starch having less than 20 parts per million of gluten protein, the method comprising the steps of:
obtaining a slurry of an initial starch containing gluten protein at 600 ppm or less;
treating the slurry of the starch with alcalase at a pH of 5.5 to 6.5 and agitating for 2 hours to dissolve or degrade the gluten protein;
washing the resultant slurry;
removing the dissolved or degraded gluten protein, resulting in a slurry of the purified starch;
adjusting pH of slurry of the purified starch to 5.0 to 6.5;
washing the pH adjusted slurry of purified starch, and
drying the washed, pH adjusted slurry of the purified starch, resulting in the purified starch having less than 20 ppm of gluten protein.
It is clear that the steps must be carried out in the order in which they are recited in the claim and the specificity of the steps mean that, as the applicant observed, the scope of the claim is relatively narrow. The claim is in large measure self-explanatory, however, a number of aspects require some consideration.
Purified starch
In the context of the specification as a whole, and the claims, I understand purified starch to mean a starch having less than 20 ppm of gluten protein.[36] It follows to my mind that the initial starch which is to be purified should have 20 ppm gluten protein or more (and less than 600 ppm gluten protein), and as noted above the starch may be one that naturally contains gluten protein, or one that has been contaminated by gluten.
Gluten
[36] See also Copeland at [107], [166].
The specification refers to gluten as a protein “from a starch belonging to the tribe Triticeae”, which substantially accords with the definition for gluten the specification recites as being given by the Codex as recited previously: “a protein fraction of wheat, rye, barley, or oats or their crossbred varieties and derivatives thereof, to which some persons are intolerant and that is insoluble in water and 0.5 M NaCl”.
Professor Copeland provides further detail regarding gluten proteins:
“Gluten functions as a storage protein in wheat grains. There are four main types of proteins in wheat grains: albumins and globulins, which are water-soluble proteins that include enzymes and other functional proteins that occur in all cells; and glutenins and gliadins which are insoluble in water. It is the glutenins and gliadins that together are the gluten proteins, although albumins and globulins can be associated in the gluten mass.”[37]
[37] Copeland at [28].
Professor Fitzgerald notes that “[t]he allergenic components of gluten are the gliadins, which are rich in proline and glutamine.”[38]
[38] Fitzgerald #1 at [42].
Some of the documents raised in the opposition refer to the treatment of starch derived from corn/maize. Notably, while sometimes referred to as gluten, the storage proteins found in maize are zein proteins which have a different amino acid sequence to the gliadins from wheat and do not have the same allergic effects.[39] I do not understand references to gluten in the claims to encompass zein proteins from maize.
Alcalase
[39] Copeland at [58].
The specification indicates that Alcalase is a protease. Professor Copeland comments that “Alcalase is a well-known bacterial protease that would be available from a commercial supplier in high quality.”[40] He also indicates that “[r]egardless of which supplier the Alcalase has been sourced from it would include the same protease.”[41] In response, Professor Fitzgerald observes that “Alcalase” is a proprietary name applied to a range of Novozymes’ products.[42]
[40] Copeland at [59].
[41] Copeland at [108].
[42] Fitzgerald #2 at [36].
It is clear from the evidence that Novozymes is the supplier of Alcalase containing products (including both food grade and non-food grade products), and Alcalase is a proprietary name.[43] The Product Sheet for Alcalase® Food Grade describes the product as follows:
“Alcalase is a proteolytic enzyme produced by submerged fermentation of a selected strain of Bacillus licheniformis. The main enzyme component, Subtilisin A (= Subtilisin Carlsberg), is an endoproteinase extensively described in the literature. … The optimal conditions for Alcalase are temperatures between 55°C (131°F) and 70°C (158°F), depending on the type of substrate, and pH values between 6.5 and 8.5.”[44]
[43] Exhibits MAF-23: Alcalase® Product Sheet [2002] (‘D19’); MAF-24: Alcalase® Food Grade Product Sheet [2002] (‘D20’).
[44] D20.
Multiple documents referencing Alcalase are included in the evidence, and in these documents alcalase is variously described as follows:
“Alcalase is a protease preparation of bacterium Bacillus licheniformis, which contains subtilisin as the dominating protease … papain and alcalase are endopeptidases …”[45]
“Alcalase: serineprotease from Bacillus licheniformis”[46]
“…Alcalase 2.4L FG and Alcalase 2.5L DX are commercial crude preparations produced by Bacillus licheniformis strain, with the main enzyme being Subtilisin A (an alkaline serine protease)”[47]
[45] Exhibit MAF-3: Li, Y. et al. (2016) ‘The potential of papain and alcalase enzymes and process optimizations to reduce allergenic gliadins in wheat flour’, Food Chemistry, vol. 196, pages 1338-1345 at page 1339, (‘D4’).
[46] Exhibit MAF-10: Hong, Y.S. et al. (2001) ‘Molecular weight distribution of protein hydrolysate by the enzymic hydrolysis of weakly acid-treated wheat gluten’, Food Science and Technology Research, vol. 7, pages 126-130 at page 126 (‘D8’).
[47] Exhibit MAF-25: Corîci, L.N. et al. (2011) ‘Synthesis of peptide amides using sol-gel immobilized alcalase in batch and continuous reaction system’, World Academy of Science, Engineering and Technology, vol. 76, pages 361-366 at page 364 (‘D21’).
In suggesting that the reference to Alcalase is problematic due to the inclusion of multiple components (i.e. being a crude protease preparation) and variability in activity, the opponent drew my attention to the observation in D21 relating to the use of Alcalase 2.4L FG that:
“Different batches of enzymes may vary in quality and each new batch of enzyme should be tested prior to routine use. Therefore, the variations in the composition and properties of the batches of crude Alcalase … has been investigated.”[48]
However, the conclusion of that investigation was that “[d]ifferences in the SDS-PAGE were not observed between the Alcalase batches, revealing a good reproducibility in protein composition.”[49] In any event, I do not understand a possible variability in batch quality of a protein product, which may be ascertained prior to use thereof, to lead to any issue with construction or clarity, subject to an ability to understand the nature of the protein product. To the contrary, I take this to be a routine approach undertaken by the authors of D21.
[48] D21 at page 364.
[49] D21 at page 364.
In written submissions the applicant stated that:
“‘alcalase’ as used in the claims of the Opposed Application refers specifically and unambiguously to the food grade Alcalase: the 2.4 L FG (Food Grade) – a particular product containing a particular protease enzyme, which is food grade as required for producing a gluten-free starch for human consumption (the end to which the Opposed Application is directed).”[50]
[50] Applicant’s written submissions at [85] (emphasis in original).
In circumstances where the intention is to limit the scope of the claims to a specific commercial product, the use of the general term “alcalase” seems unusual. Accordingly, at the hearing I queried whether the applicant considered the claims would encompass some other food grade Alcalase (i.e. Bacillus licheniformis protease preparation) product, were it to come into existence, and I understood the applicant’s submission to be that the claims would encompass any food grade Alcalase product.
I will discuss the opponent’s objection that the use of a trade mark in the claim gives rise to a lack of clarity below, but in view of the above evidence, I understand Alcalase as used in the claims to refer to a crude protease (specifically, serine protease) preparation derived from Bacillus licheniformis being suitable to the intended use of the resulting purified starch.
Appended claims
Appended claims 2-19 further define the method of claim 1.
Claims 2-6 define features of the initial starch and claim 8 requires that the slurry of the initial starch has a specific gravity from 18° to 25° Baumé. Claims 7 and 14-17 define aspects of the treatment of the slurry with Alcalase.
Claims 9 and 10 relate to the removal of the dissolved or degraded gluten protein via filtering and centrifuging the washed slurry, respectively, and claim 11 defines that the drying step includes drying the slurry of purified starch in a flash drier, spray drier, or rotating drum drier.
Claim 12 defines the method of the preceding claims further including the step of testing to confirm that the purified starch contains less than 20 ppm of the gluten protein and claim 13 specifies that the test is selected from R5 sandwich ELISA, R5 competitive ELISA and G12 Romer ELISA.
Claim 18 defines the method of the preceding claims further comprising an additional washing step, and claim 19 specifies that this step is performed prior to adjusting the pH of the slurry of purified starch to 5.0 to 6.5.
Clarity
It is a requirement of subsection 40(3) of the Act that the claims be clear. This requirement is satisfied if a person could ascertain “whether or not what he proposes to do falls within the ambit of the claim”.[51] However, the terms used in claims need not be precise and absolute, as set out in Flexible Steel Lacing Company v Beltreco Ltd:
“Lack of precise definition in claims is not fatal to their validity, so long as they provide a workable standard suitable to the intended use. The consideration is whether, on any reasonable view, the claim has meaning. In determining this, the expressions in question must be understood in a practical, commonsense manner. Absurd constructions should be avoided and mere technicalities should not defeat the grant of protection.” [52]
[51] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59 at 60.
[52] [2000] FCA 890; (2001) 49 IPR 331 at [81] (cited with approval in Austal Ships Sales Pty Ltd v Stena Rederi Aktiebolag [2008] FCAFC 121; (2008) 77 IPR 229) (citations omitted).
The only basis on which the opponent asserts that the claims lack clarity is the recitation of the term Alcalase, which is a proprietary name.[53] Essentially, the concern is that a feature defined by a trade mark is indeterminate over time given that the manufacturer may change the product sold under the trade mark, creating a movable target such that the scope of the claim cannot be determined. For its part, the applicant submitted that “any suggestion that Novozymes would change its Alcalase product over time in a manner where, for example, the product includes a different protease, is mere conjecture and inconceivable”.[54]
[53] See, e.g., Fitzgerald #2 at [36], D19.
[54] Applicant’s written submissions at [80].
The parties have not referred me to any Australian decisions on this issue, but the opponent cited the Commissioner’s practice as set out in the Patent Manual of Practice and Procedure:
“A trade mark or proprietary name is used to identify the source of a good… A claim that uses a trade mark to identify an element of an invention may not be clear through an inability to establish the precise scope of the claim. Where the scope of the claim is uncertain or ambiguous as the result of the use of a trade mark, examiners should object that the claim lacks clarity.”[55]
[55] Patent Manual of Practice and Procedure at 2.11.5.7A (published 10 December 2020).
The opponent also referred to the practice of the European Patent Office and the UK Intellectual Property Office, noting recent decisions of the Federal Court that confirm the relevance of UK and European law to the section 40 requirements as amended by the Raising the Bar Act.[56] Of course, these decisions relate to support and sufficiency, rather than clarity, which was not amended. Without accepting the opponent’s submission that the lack of amendment to the clarity provision when the Raising the BarAct amendments were made is in itself evidence of an existing alignment with the law in Europe and the UK, I observe that the EPO Technical Board of Appeal noted in T 3037/19 that “the use of trade designations such as trade marks in a claim is not excluded under the EPC in principle” and whether such a designation is allowable is a question of fact to be answered on a case-by-case basis:
“it at least needs to be established that the marketed product defined by a given trade designation has a precise meaning and that this meaning cannot change in the course of time in a way that would impact the definition of the claimed subject-matter. If these facts cannot be established, a claim for the subject-matter defined by reference to such a trade designation is not clear and does not meet the requirements of Article 84 EPC.” [57]
[56] Opponent’s written submissions at [55]-[57].
[57] T 3037/19 at [3] (citations omitted).
The situation appears to be similar in Australia – there is no specific exclusion covering the use of trade designations within claims, but if the meaning of a term can change over time in a way that would impact the scope of the claim, it is unlikely to provide a workable standard. As such, during examination the inclusion of trade designations in claims will typically give rise to an objection. In contrast, during an opposition, the onus is on the opponent to establish that the claims are not clear.
In this case, neither the claims nor the description refer explicitly to a specific product (e.g. Alcalase 2.4L FG), but the specification refers to Alcalase in a more general manner as a protease. It appears based on the contemporaneous evidence that there has been, over an extended period, an understanding that the term Alcalase refers to a commercially available protease preparation from Bacillus licheniformis[58] and there was no evidence before me that this has ever been otherwise. The opponent noted that the apparent generic use of ‘alcalase’ in the specification and in other documents does not mean that the term has in fact become generic. Such a conclusion is clearly outside the scope of this decision, but it is necessary to understand how the skilled person would understand the term Alcalase. The use of this term, particularly in contemporaneous documents, is necessarily indicative of how the skilled person would understand it, and I consider the use in the specification to be part of the context within which the understanding arises. In the context of this application and based on the evidence of the experts and other documents discussed previously, I consider that the skilled person would understand Alcalase to refer to a protease preparation (specifically, serine protease) derived from Bacillus licheniformis.
[58] See, e.g., D4, D8, D21.
On balance, I consider that the reference to Alcalase in the claim provides a sufficiently certain meaning and workable standard such that the opponent has not made out its case that the inclusion of a proprietary name in the claims has resulted in a lack of clarity.
Support
Subsection 40(3) as amended by the Raising the Bar Act requires that the claims must be supported by matter disclosed in the specification. The requirement of support can be summarised as requiring that the scope of the claims “should correspond to the technical contribution to the art”.[59] In Merck Sharp & Dohme Corporation v Wyeth LLC (No 3)[60] Burley J confirmed that the summary provided by Aldous J in Schering Biotech Corp’s Application, and often followed in the United Kingdom, encapsulates broadly the approach in Australia:
“…to decide whether the claims are supported by the description it is necessary to ascertain what is the invention which is specified in the claims and then compare that with the invention which has been described in the specification. Thereafter the court’s task is to decide whether the invention in the claims is supported by the description. I do not believe that the mere mention in the specification of features appearing in the claim will necessarily be a sufficient support. The word ‘support’ means more than that and requires the description to be the base which can fairly entitle the patentee to a monopoly of the width claimed.”[61]
[59] Fuel Oils/EXXON (T 409/91) [1994] OJ EPO 653 at 659 (‘Exxon’).
[60] [2020] FCA 1477 at [546] (‘Merck’).
[61] [1993] RPC 249 at 252-253.
In CSR Building Products Limited v United States Gypsum Company[62] the delegate summarised the approach to determining whether the requirements of support are satisfied as follows, which remains relevant in view of subsequent Federal Court decisions:[63]
i. construe the claims to determine the scope of the invention as claimed,
ii. construe the description to determine the technical contribution to the art, andiii. decide whether the claims are supported by the technical contribution to the art.[62] [2015] APO 72 at [115].
[63] See, e.g., Merck at [546]-[547], Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2022] FCA 540 at [481] (‘Jusand’).
Claims will exceed the technical contribution to the art when they claim products that the specification does not enable[64] or cover ways of achieving the desired result which owe nothing to the patent or any principle disclosed therein.[65]
Opponent’s submissions
[64] Merck at [553], TCT Group Pty Ltd v Polaris IP Pty Ltd [2022] FCA 1493 at [243]-[244].
[65] Jusand at [483].
The opponent submitted that the claims lack support because they omit features identified in the description as essential to how the invention works and achieves its stated benefits, namely:
·the viscosity of the initial starch (said to be essential to achieving a gluten-free starch without damaging the functionality of the starch);
·initial gluten concentration of less than 470 ppm;
·concentration of Alcalase enzyme at 0.022% or more of starch dry weight; and
·three washings of the purified starch.
In support of the essentiality of these features the opponent pointed to the following passages of the specification at [0066] and [0122], respectively:
“Initial gluten concentration and viscosity emerged as important guides to determine success in making the product gluten free without damaging the functionality of the starch. Maintaining starch functionality is vital to the final starch product.”
“Alcalase enzyme was successful using any starting material with 470 ppm of gluten or less, along with the Alcalase enzyme at 0.0022% (of starting dry weight) or more and washed three times.”[66]
[66] I note that this passage refers to 0.0022% rather than 0.022% Alcalase and is therefore inconsistent with the opponent’s asserted essential concentration. However, the question of whether there is an error in the specification or the opponent’s submissions is immaterial.
The opponent also noted the presence in the specification of ineffective examples: as set out above, duplicate trials using 0.0055% Alcalase resulted in gluten concentrations of 20 and 46 ppm, outside of the requirement of less than 20 ppm defined in the claims.[67]
[67] Specification, [0076].
I understand the opponent’s position to be that to the extent the claims do not include the features asserted to be essential they exceed the applicant’s contribution to the art.
Applicant’s submissions
The applicant submitted that the invention disclosed involves “a principle of general application” to the effect that an initial starch (already extracted from flour, and having a gluten concentration of less than 600 ppm) can be rendered gluten-free by following the steps of the claimed method.
The applicant disputed the opponent’s interpretation of the specification with respect to the significance of the starting viscosity of the starch:
“MGP has based its argument on an incorrect reading of [0066]. It is the initial gluten concentration that is key to determining success in making the product gluten free, which is why claim 1 includes a limitation as to the starting starch gluten concentration. The initial viscosity does not affect whether or not the product will be gluten free, but instead can be compared to the final viscosity as a guide to whether the starch has maintained its visco-functionality.”[68]
[68] Applicant’s written submissions at [236] (citations omitted).
In addition, the applicant noted that the specification discloses example methods according to claim 1 using an initial starch with 600 ppm gluten protein, using less than three washing steps and/or less than 0.022% Alcalase resulting in a starch product having less than 20 ppm gluten protein. The applicant submitted that these aspects are therefore not essential to the working of the invention.
With respect to the ineffective examples highlighted by the opponent, the applicant suggested, with reference to Professor Copeland’s evidence, that these appear to be outliers, and inconsistent with the rest of the data in the specification,[69] but submitted that the overall disclosure of the specification is quite clear.
Consideration
[69] Copeland at [102].
I will say at the outset that I do not find consideration of whether claim 1 as a whole, entailing various steps and parameters, represents a principle of general application to be a particularly useful line of analysis in this case. Typically, a principle of general application will be found where an element of a claim is stated in general terms;[70] here the claims are quite specific in relation to the parameters associated with particular steps. In ascertaining whether the claims exceed the technical contribution to the art I think it is more helpful to simply consider whether the features identified as essential by the opponent are actually essential to working the invention, and accordingly whether their omission from the claims gives rise to the claims extending to subject-matter that is not enabled by the specification (i.e. to which the applicant is not fairly entitled).
[70] Kirin-Amgen Inc v Hoechst Marion Roussel Limited [2004] UKHL 46 at [112]-[113].
Turning first to the question of viscosity and initial gluten concentration, I am inclined to accept the applicant’s submissions. While the opponent identified a passage referring to 470 ppm gluten in the starting material, the specification clearly envisages (and demonstrates) the process including starting gluten concentrations up to 600 ppm,[71] and it is not apparent that viscosity substantially impacts the achievement of a gluten-free product (as opposed to its functionality). Moreover, I take Professor Copeland to understand that it is the use of the method described in the application that enables visco-functionality to be retained,[72] consistent with the statement in the specification that the described methods achieve their results “without introducing functional defects”.[73]
[71] Specification, [0070]-[0071].
[72] Copeland at [151].
[73] Specification, [0144].
In response to Professor Copeland’s evidence to the effect that the viscosity is indicative of the quality of the starch (i.e. damaged starch will have a low viscosity value),[74] Professor Fitzgerald refers to the lack of information concerning what degree of viscosity change would determine a process of the application unsuccessful, and states that:
“Nor does [the application] appear to draw any conclusion as to the success of reducing the gluten content below 20 ppm being related to initial starch viscosity. The initial gluten content appears more relevant in this regard as would be expected.”[75]
She goes on to comment that it would appear, based on the examples, that at least a 31% reduction in starch viscosity is acceptable and falls within the bounds of “maintaining starch functionality”.[76] There is no indication of an unacceptable viscosity outcome in the application, but identifying such a result would appear to be within the skillset of the skilled person[77] and given the silence of the specification on this point, beyond that retention of viscosity is a feature of the described method, I do not consider that this, as opposed to the achievement of a gluten-free starch product per se via the specified steps, can be characterised as essential to how the invention works or the ability of the skilled person to perform the invention, or otherwise a distinct aspect of the technical contribution to the art.
[74] Copeland at [96].
[75] Fitzgerald #2 at [27].
[76] Fitzgerald #2 at [28].
[77] See, e.g., Fitzgerald #2 at [59].
It is also apparent that a range of Alcalase concentrations are used in the examples in the specification, from 0.022% to 0.0022%, and a wider range is alluded to:
“The Protease treatment, particularly when using alcalase, works best when using 0.0022%-0.022% Alcalase, based on dried starch weight, and washed three times to ensure that the enzyme and protein is washed out of the starch, using a starch with an initial ppm of 470 or less. In some embodiments, alcalase may be introduced at about 0.001% to about 0.05% by weight, or about 0.002% to about 0.02% by weight.”[78]
[78] Specification, [0077].
Professor Copeland stated that “the specification as a whole provides a number of experimental and pilot scale experiments that show the amount of Alcalase that can be used”[79] and Professor Fitzgerald noted that “varying the amount of protease would be a routine step when treating a starch with a protease to remove protein/gluten”[80] but that she “would not expect that less than 20 ppm [gluten] would not [sic] be achievable using any quantity of Alcalase (e.g. very small amounts).”[81] Noting that the requirement that the claims correspond to the technical contribution is one of substance, and de minimis exceptions are to be put aside,[82] and the evidence that variation of concentration of a protease would be a matter essentially of routine trial and error (rather than further invention), I am not persuaded that any specific Alcalase concentration forms part of the technical contribution to the art.
[79] Copeland at [168].
[80] Fitzgerald #2 at [65].
[81] Fitzgerald #2 at [60].
[82] Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477 at [556].
Similarly, while the specification notes that the Alcalase treatment “works best” with three washings to ensure the enzyme and protein are washed out of the starch, it is apparent that washing twice is also effective.[83] There is no evidence to support a view that the presence of three washing steps, rather than two, is essential to the working of the invention or that this aspect of the claims is not enabled. Accordingly, I do not consider that the claims exceed the technical contribution in this respect.
[83] Specification, [0072]-[0073].
In relation to the ineffective examples using 0.0055% Alcalase referenced above, both declarants agreed that there are operating factors, such as degree of mixing, that could impact the efficiency of the enzymatic reaction and consequent final gluten concentration.[84] Noting this, and the examples showing efficacy of Alcalase concentrations both above and below 0.0055%,[85] I do not consider the presence of ineffective examples in the present circumstances to be indicative of the claim defining results it does not enable and consequently exceeding the contribution to the art. I note that the applicant raised the prospect of further submissions regarding these examples, and any potential sufficiency deficiency arising therefrom, following the hearing. However, in view of the evidence filed in the opposition and my conclusions above, I do not consider this necessary.
[84] Fitzgerald #2 at [31]; Copeland at [102].
[85] Examples corresponding to those using 0.0055% Alcalase but using 0.0022% Alcalase did show reduction of gluten concentration to less than 20 ppm.
Having regard to the specification as a whole, and in particular the examples, together with the evidence, I consider that the technical contribution to the art is the use of Alcalase to produce starch with less than 20 ppm gluten and the described reaction conditions associated therewith. The opponent has not established that the claims exceed the technical contribution to the art and accordingly the ground of lack support is not made out.
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 light of the common general knowledge (whether in or out of the patent area) before the priority date of the relevant claim when considered alone or together with the information mentioned in subsection 7(3).
Subsection 7(3) defines the relevant information as:
The information for the purposes of subsection (2) is:
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.
Nicholas J provided a succinct statement of principles relevant to assessing inventive step in Hood v Bush Pharmacy Pty Ltd:
“Section 7(2) of the Act uses the word ‘obvious’ in the course of describing what must be established before an invention can be held not involve an inventive step. Something may be ‘obvious’ in light of the common general knowledge, or the common general knowledge coupled with the relevant s 7(3) information, if it is ‘plain or open to the eye or mind, something which is perfectly evident to the person thinking on the subject’ or something which ‘would at once occur to anyone acquainted with the subject and desirous of accomplishing the end’.
An invention may also be obvious in light of the common general knowledge if the person skilled in the art faced with the same problem as the inventor 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 or (using the language of the ‘modified Cripps question’) if the person skilled in the art would be directly led as a matter of course to take such steps in the expectation that doing so might well produce a useful or better alternative to the prior art. However, a claimed invention is not obvious merely because the person skilled in the art would consider that it was ‘worthwhile to try’.”[86]
[86] [2020] FCA 1686 at [116]-[117] (citations omitted).
It is important to note the requirement for a reasonable expectation of success. This is explicit in the expectation that an approach “might well” succeed, and implicit in the characterisation of steps as those to be taken as a matter of routine.[87] However, success need not be guaranteed: “the relevant test is not knowing that steps will or would or even may well work, but merely expecting that the steps may well work.”[88] Further, it is possible that the skilled person might be directly led to try more than one alternative expecting that each may well produce a useful or desired result.[89]
[87] Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73; 314 ALR 91 at [71].
[88] Nichia Corporation v Arrow Electronics Australia Pty Ltd [2019] FCAFC 2 at [99].
[89] Nichia Corporation v Arrow Electronics Australia Pty Ltd [2019] FCAFC 2 at [91]-[93].
However, being led to try more than one alternative should be distinguished from a wide-reaching variation of parameters or exploration of a field; the plurality in Aktiebolaget Hässle v Alphapharm Pty Ltd referred with approval[90] to the observations of Judge Rich in In re O’Farrell[91] in rejecting such an “obvious to try” approach to inventive step:
“The admonition that ‘obvious to try’ is not the standard under §103 has been directed mainly at two kinds of error. In some cases, what would have been ‘obvious to try’ would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful. … In others, what was ‘obvious to try’ was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.”[92]
[90] [2002] HCA 59; 212 CLR 411 at 442-443, [76].
[91] (1988) 853 F 2d 894.
[92] (1988) 853 F 2d 894 at 903 (citations omitted).
In addition, principles identified by the High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) as of “continuing relevance” in relation to inventive step include:
“…obviousness and inventiveness are antitheses and the question is always ‘is the step taken over the prior art an “obvious step” or “an inventive step”’? An inventive step is often an issue ‘borne out by the evidence of the experts’. There is no distinction between obviousness and lack of inventive step. A ‘scintilla of invention’ remains sufficient in Australian law to support the validity of a patent. In R D Werner Lockhart J stated that there must be ‘some difficulty overcome, some barrier crossed’. This is consonant with older authorities in the United Kingdom which recognised that some inventiveness was required to distinguish patentable advances over the prior art from advances which ‘any fool’ could devise. It also accords with the requirement in the United States that for an invention to be ‘non-obvious’ it must be ‘beyond the skill of the calling’.”[93]
[93] [2007] HCA 21; 235 CLR 173 at [52] (‘Lockwood (No 2)’).
Importantly, where a claim is directed to a combination of known integers obviousness is not established merely by identifying each of those features in the prior art or the common general knowledge – the question is whether the combination of those features is obvious.[94] This is highlighted in Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd:
“An allegation of want of inventive step is not made out by saying you may take one or two, or twenty-one or twenty-two, prior publications and then select from them appropriate extracts or pieces of information, which will add up to the invention claimed and so demonstrate that it was obvious. So to proceed is to mistake the nature of an invention and the nature of the objection of obviousness. The question is, is the invention itself obvious, not whether a diligent searcher might find pieces from which there might have been selected the elements which make up the patent. If this were not so, there could never be a valid patent for a new combination of old integers. The proper question is not whether it would have been obvious to the hypothetical addressee who was presented with an ex post facto selection of prior specifications that elements from them could be combined to produce a new product or process. It is rather whether it would have been obvious to a non-inventive skilled worker in the field to select from a possibly very large range of publications the particular combination subsequently chosen by the opponent in the glare of hindsight and also whether it would have been obvious to that worker to select the particular combination of integers from those selected publications. In the case of a combination patent the invention will lie in the selection of integers, a process which will necessarily involve rejection of other possible integers. The prior existence of publications revealing those integers, as separate items, and other possible integers does not of itself make an alleged invention obvious. It is the selection of the integers out of, perhaps many possibilities, which must be shown to be obvious.
It is in relation to this process that the misuse of hindsight is most common. When once an idea or an object or a process or a combination, admittedly novel, has been published, it is very easy to say after perhaps months of search and study in the Patent Office and the public libraries that the integers into which the patent might be dissected could be found scattered amongst the prior documents by a person who already knew the solution to the problem and therefore knew what to look for and what to discard. But that process does not demonstrate lack of an inventive step. The opening of a safe is easy when the combination has been already provided.” [95]
[94] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9; 144 CLR 253 at 293, Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 at 429, [41].
[95] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9; 144 CLR 253 at 293.
In a similar vein, the High Court in Lockwood (No. 2) said that the question of whether it would be obvious to add one integer to a combination of other integers:
“…will turn on what a person skilled in the relevant art, possessed with that person’s knowledge would have regarded, at the time, as technically possible in terms of mechanics, and also as practical. … Even if an idea of combining integers, which individually may be considered mere design choices, is simple, its simplicity does not necessarily make it obvious.”[96]
The relevant date
[96] Lockwood (No 2) at [111].
At the hearing the opponent challenged the validity of the priority date on the basis that the priority document is silent with respect to the gluten concentration in the initial starch, and in particular the specific value of 600 ppm or less recited in claim 1. I indicated a preliminary view that additional features of the claim were lacking from the priority document that might impact the validity of the priority claim and invited the applicant’s comment in that regard. Noting that there is no suggestion that the common general knowledge differs between the filing date and the claimed priority date, and that only one document (D4) was published in the intervening period, the applicant suggested that the consideration of priority date be undertaken only if necessary (that is, if the case for inventive step in light of D4 would be made out if claims were not entitled to the claimed priority date). In view of this, the opponent agreed with an approach of proceeding with the decision on the assumption that the priority date is the filing date and accordingly the assumption that D4 forms part of the prior art base.
As will become apparent, I have not found the claims obvious in view of the disclosure of D4, and it is therefore not necessary for me to make any finding as to whether the claims are entitled to the earliest claimed priority date.
Parameteritis
I will address at the outset the opponent’s argument that certain of the parameters in the claims (specifically, the initial gluten protein concentration of 600 ppm or less, the treatment of the slurry at a pH of 5.5 to 6.5, and the adjustment of the pH of the starch to 5.0 to 6.5) merely represent parameteritis and cannot confer inventive step.
Parameteritis was discussed by Laddie J in Raychem Corp.’s Patents:
“This is the practice of seeking to repatent the prior art by limiting claims by reference to a series of parameters which were not mentioned in the prior art. Sometimes it includes reference to parameters measured on test equipment which did not exist at the time of the prior art. The attraction of this to a patentee is that it may be impossible to prove now that the prior art inevitably exhibited the parameters and therefore it is impossible for an opponent to prove anticipation. Even if that is what has happened here, it does not alter the task of the court. It must decide whether the opponent has proved anticipation or some other statutory ground of invalidity. Parametritis may make the court’s task more difficult, but at the end of the day the test of invalidity must be the same, whatever the form of the claims.”[97]
[97] [1998] RPC 31 at 37.
Laddie J then stated in relation to the parameter S/D volume ratio in question:
“It is essentially arbitrary and has little technical significance. The selection of a group of compositions by reference to such a parameter does not involve any inventive step. Although it may not be obvious, in the common use of that word, to limit a claim by reference to this particular meaningless and arbitrary parameter, that has nothing to do with patentability. Patents are not given for skill in inventing technically meaningless parameters.”[98]
[98] Ibid at 46-47.
I think it is clear the present case is not on all fours with the scenario described by Laddie J. The parameters referred to by the opponent are not meaningless and/or absent from the prior art, but what is put is that they are arbitrarily selected (rather than leading to a particular advantage) and therefore what is provided in the claims is no more than an alternative process arrived at through routine experimentation.[99]
[99] Opponent’s written submissions at [134]-[136].
However, I understand the question with respect to parameteritis to relate to technical significance rather than selection to achieve an advantage, and it is clear that parameters defining the conditions, such as the pH, under which an enzymatic reaction is carried out are, irrespective of how they are arrived at, technically significant – there will be values that lead to more or less efficient reaction progress. It is also apparent that the pH impacts upon the starch that is being treated.[100] It follows that I am not satisfied that the pH parameters defined in the claimed process are arbitrary or technically meaningless parameters. In addition, while I accept that, as the opponent submitted,[101] the upper limit of gluten protein in the initial starch has not been shown to be associated with any particular advantage it is nevertheless a limiting feature of the claim and defines a starch which has undergone an initial separation process from gluten.[102] Again, this is not a technically meaningless parameter.
[100] Fitzgerald #1 at [54].
[101] Opponent’s written submissions at [134].
[102] Fitzgerald #1 at [112].
In any event, I am mindful of the comments of Beach J in Meat & Livestock Australia Limited v Cargill, Inc to which the applicant referred:
“…there is no need for any particular scientific or technical justification to be given in the specification for what is a limiting feature of the claim. And even if a feature was included so as to narrow the claim and avoid an argument about the prior art, that does not of itself defeat a patent.”[103]
[103] [2018] FCA 51 at [322].
It follows that I consider that for inventive step to be made out in relation to the present claims, each feature of the claims (in combination) must be arrived at without invention.
Common general knowledge
Common general knowledge is the background knowledge and experience available to all those working in the relevant art:
“The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”[104]
[104] Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9; 144 CLR 253 at 293.
However, it is not enough that information is recorded in a document, even if that document is widely circulated – it is only part of the common general knowledge when it is generally known and accepted:
“…information does not constitute common general knowledge merely because it might be found, for example, in a journal, even if widely read by persons in the art … Reference in this regard is made to the words of Luxmoore J in British Acoustic Films (1936) 53 RPC 221 at 250, cited by Lehane J in Aktiebolaget Hässle v Alphapharm Pty Ltd (1999) 44 IPR 593; [1999] FCA 628 at 605 [39]:
In my judgment it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. 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.”[105]
[105] Ranbaxy Laboratories Limited v AstraZeneca AB [2013] FCA 368; 101 IPR 11 at [217].
The evidence establishes that the relevant common general knowledge at the priority date included the knowledge that:
·wheat endosperm, from which flour is milled, contains starch and protein granules[106]
·wheat flour typically comprises about 9-15% protein and 70-80% starch[107]
·the protein portion of wheat flour is made up of gluten proteins (glutenins and gliadins) as well as albumins and globulins[108]
·the starch and gluten protein components of gluten protein-containing flour may be separated by the ‘water method’: mixing the flour in water to produce a dispersion of starch suspended in water and an insoluble agglomeration of gluten proteins[109]
·in order to be identified as gluten-free (and suitable for consumption by persons with gluten intolerance or allergy), a food must contain less than 20 ppm gluten and separation of flour into starch and protein by washing with water does not lead to a sufficiently low level of gluten[110]
·various protease enzymes are capable of hydrolysing proteins with varying specificity and reaction conditions[111]
[106] Copeland at [33]-[34].
[107] Copeland at [34].
[108] Copeland at [28]; Fitzgerald #1 at [42].
[109] Fitzgerald #1 at [29]; Copeland at [40].
[110] Fitzgerald #1 at [152]; Copeland at [42].
[111] Fitzgerald at [62], [152]; Copeland at [72], [108], [127], [154]; D4 at page 1339.
I note that Professor Fitzgerald referred to a number of studies relating to the use of peptidases to degrade gluten under her evidence concerning common general knowledge,[112] identifying D4, discussed below, as a “document that I identified and referenced in my initial summary”[113] and referring to “the enzymic methods I reviewed”.[114] This language is not particularly suggestive of information widely known to, or part of the background knowledge of, the skilled person, as opposed to the products of a search, and Professor Copeland indicated that he did not consider the information in D4 in particular would have been widely known in the area at the claimed priority date.[115] On balance, I am not satisfied that the evidence establishes that these studies form part of the common general knowledge.
[112] Fitzgerald #1 at [45]-[49]; Fitzgerald 2 at [56].
[113] Fitzgerald #1 at [48].
[114] Fitzgerald #1 at [50].
[115] Copeland at [156]-[158].
I accept the applicant’s submission that while the existence of Alcalase was common general knowledge,[116] its specific applicability to degradation of gluten was not. Professor Fitzgerald provides no evidence to that effect prior to considering prior art documents (which as above have not been established to be part of the common general knowledge), nor is there any evidence indicating that the properties or specificity of Alcalase were known to either declarant. Moreover, contemporaneous evidence in the form of the reference in D4 to Alcalase as an enzyme among those “tested to select effective enzymes to hydrolyze the allergenic proteins, gliadins, in wheat flour”[117] supports a view that the capacity of Alcalase to effectively hydrolyse gluten proteins was not “generally known and accepted without question by the bulk of those who are engaged in the particular art.” Consistent with Professor Copeland’s view that not all enzymes would be effective,[118] the authors of D4 also state that:
“Enzymatic treatment has the potential to destroy allergenic epitopes and reduce the antigenicity of many food products by hydrolyzing proteins into small peptides. … The reduction in antigenicity of protein depends on both the specificity of proteolytic enzymes used and the degree of hydrolysis. Different enzymes have different specific cleavage sites of protein. Therefore, they reduce the allergenicity of a protein to different extents.”[119]
[116] Copeland at [59].
[117] D4 at page 1341.
[118] Copeland at [127].
[119] D4 at page 1339.
I note that evidence concerning the existence of a range of wheat starches having less than 20 ppm gluten content has been provided[120] but it is not apparent from this evidence that processes for their production form part of the common general knowledge.
[120] Fitzgerald #2 at [7]-[18].
While the opponent submitted that knowledge of “pre-treatment and post-treatment steps such as washing, separating, pH adjustment and drying to provide a final starch product” are common general knowledge,[121] the most significant evidence of this was furnished after Professor Fitzgerald had reviewed the specification and is quite general in nature.[122] The evidence of the declarants does not clearly establish what degree of experimentation in these aspects (for example, with respect to multiple washing steps or pH variation) would be undertaken by a skilled person as a matter of routine. I note, however, that D1, discussed below, discloses a protease treatment of wheat starch and reports washing and drying steps (including use of heat to deactivate remaining protease), but no pH adjustment;[123] D2, also discussed below, discloses treatment of corn starch with Alcalase, followed by pH reduction (to pH 3) to deactivate the protease, then filtering the starch slurry, washing and drying.[124] Given the evidence of the declarants and the contemporaneous documents, I am satisfied that washing and drying of a protease treated starch would be undertaken as a matter of routine, as would strategies, including pH adjustment, to deactivate residual protease. Relevantly, I have not identified or been directed by the parties to any evidence regarding the use of pH adjustment between washing steps for a purpose other than protease deactivation, and as such it is not apparent that this was commonplace or routine in the art, despite being something that clearly could be easily undertaken by a skilled person.
The problem
[121] Opponent’s written submissions at [73].
[122] Fitzgerald #1 at [120], [153].
[123] D1A at [0016], [0025]-[0026]; Fitzgerald #1 at [154]; Copeland at [129].
[124] D2, page 14, lines 18-31, page 16, line 26 – page 17, line 5.
The opponent submitted that the problem addressed by the specification is the provision of an alternative process to prepare a gluten-free starch. I do not take the applicant’s position to substantially differ from this: “[t]he problem to be solved… is the production of starch containing less than 20 ppm of gluten, and methods of removing gluten from starch and testing for gluten content to confirm such gluten-free starch”.[125] I accept this characterisation of the problem, and I consider it consistent with the question put to Professor Fitzgerald:
“Before being provided with any specific documents, I was first asked to provide an account of how I (prior to the relevant date) would approach reducing the gluten content of starch containing gluten (from wheat, or any other relevant gluten containing cereal), and in particular with a view to reducing levels of gluten to less than 20 ppm.”[126]
[125] Applicant’s written submissions at [46].
[126] Fitzgerald #1 at [28].
While section 7 as amended by the Raising the Bar Act does not require inventive step documents to be ascertained, understood and regarded as relevant, the problem to be solved remains relevant to the inventive step consideration. The Explanatory Memorandum makes clear that the question remains whether a skilled person faced with the same problem would have taken routine steps to arrive at the claimed invention:
“While a skilled person is essentially deemed to be aware of and to have carefully read the publically available information, the inventive step tests are otherwise applied in the context of what the skilled person would have known and done before the priority date of the claims in question. The tests will therefore continue to take account of factors such as whether the skilled person would have understood and appreciated the relevance of the prior art to the problem the invention was seeking to solve and whether it would be considered a worthy starting point for further investigation or development.”[127]
Inventive step in light of common general knowledge alone
[127] Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth) at page 43.
I understand the broad strokes of the opponent’s case on obviousness in light of the common general knowledge alone to be along the following lines:
·wheat starch includes gluten and removal of gluten to below 20 ppm is desirable
·use of proteases to remove gluten protein is well known
·proteases form a large class, some of which are suitable for use in food
·identification and use of a food grade protease to remove gluten from wheat starch (and the relevant conditions) is routine
In this regard, the opponent pointed to Professor Fitzgerald’s early comments (made before reviewing the specification) that the water method (to separate gluten and starch) could be followed by digestion with a protease to remove residual gluten:
“Another approach for removing gluten from starch is enzyme digestion of the proteins with peptidases. Enzyme digestion could be used in combination with the above described water method, with the water method used to initially bring down the gluten content followed by digestion with peptidase to remove any residual protein in the starch.”[128]
[128] Fitzgerald #1 at [32].
When asked to provide more detail in this regard Professor Fitzgerald said:
“My conclusion from reading many publications is that separating flour into starch and protein by washing with water, and then using a range of technologies such as pumps, hydrocyclone and centrifugation to dry the starch does not lead to a low enough level of gluten in the starch to meet the requirements of the less than 20 ppm claim. The allergenic components of gluten are the gliadins, which are rich in proline and glutamine. By using an endopeptidase that is able to digest the proline-rich short motifs, gluten levels below 20 ppm can be obtained.
Prior to 2015, a number of endopeptidases for digesting protein had been identified, from bacteria, fungi, bran from germinated cereals and animals. Fermentation with particular bacteria, with particular conditions also led to gluten below 20 ppm.”[129]
[129] Fitzgerald #1 at [42]-[43].
Professor Fitzgerald went on to discuss various studies not shown to form part of the common general knowledge, but clearly, even the more specific information regarding the use of proteases is at a very general level relative to the specific features of claim 1. Additionally, while Professor Fitzgerald refers to D4 which demonstrates the use of Alcalase to degrade gluten, I have discussed above that it does not form part of the common general knowledge. In terms of selection of a suitable protease, albeit in relation to prior art document D1 referenced below, Professor Fitzgerald comments:
“Two example proteases are used in the examples [of D1], however other proteases could be used. In selecting proteases to use, I would look at what was available, look at the conditions they work in (acidic, alkali), look at temperatures they work in (for wheat starch I would want it to work at temperatures below 55°C), would want it to be food grade, and would want to easily deactivate it (preferably by varying temperature, but could also be chemically).”[130]
[130] Fitzgerald #1 at [65].
Even accepting that it is routine to use a protease to degrade residual gluten in starch, in the absence of any common general knowledge regarding the use of Alcalase specifically to degrade gluten, lack of inventive step in light of the common general knowledge alone cannot be made out. This is, to my mind, a situation in which Alcalase and appropriate conditions for its use could be characterised at best as “obvious to try” when seeking to provide a suitably gluten-free starch product in the sense described by Judge Rich and set out above – that is, one of numerous possible choices (of protease, and appropriate reaction conditions) with a lack of direction as to which of those many choices is likely to be successful. Noting the evidence as to the variability in efficacy between proteases,[131] I am not satisfied that the opponent has made out a case that a skilled person would consider that any protease (or any class of proteases of which Alcalase is known to be a member) “might well” work as required to result in a gluten-free starch such that Alcalase is merely one of many obvious pathways available to the skilled person. It follows that the claims do not lack inventive step in light of the common general knowledge alone.
Inventive step in light of prior art documents
[131] D4 at pages 1339, 1341; Copeland at [127], [154].
At the hearing, the opponent relied on the following prior art documents:
·D1/D1A: JP 2005 034046 A[132]
·D2: GB 2 506 695 B
·D3: GB 182 829 A
·D4: Li, Y. et al. (2016) ‘The potential of papain and alcalase enzymes and process optimizations to reduce allergenic gliadins in wheat flour’, Food Chemistry, vol. 196, pages 1338-1345
·D8: Hong, Y.-S. et al. (2001) ‘Molecular weight distribution of protein hydrolysate by the enzymic hydrolysis of weakly acid-treated wheat gluten’, Food Science and Technology Research, vol. 7, pages 126-130
[132] D1A is a machine English translation of JP 2005 034046.
I understand the opponent’s case in relation to the prior art documents to be that the claims lack inventive step in light of the common general knowledge and each of D1A-D4 alone, and each of D1A and D3 in combination with any one of D2, D4 or D8.
I will consider first inventive step in light of each of the D1A-D4 alone, and then in light of the combinations of documents.
D1A is a patent document directed to the removal of gluten from wheat starch. Specifically, D1A describes generally the addition of a protease (of any sort[133]) to a wheat starch solution for reaction at the optimum temperature and pH conditions of said protease.[134] Washing and drying steps are also described. Examples describing the treatment of wheat starch with an endopeptidase (Orientase ONS or Orientase 20A, at pHs 7.0 and 2.5, the respective optimum pHs), and yielding wheat starch with 0 ppm gluten after reaction times of each of 1, 3 and 5 hours are provided.[135]
[133] D1A at [0013].
[134] D1A at [0015].
[135] D1A at [0022]-[0027]. I note that while Professor Copeland was unconvinced that the limit of detection in D1A was sufficient to demonstrate a less than 20 ppm result (Copeland at [124]), in other examples the residual protein content was 2 ppm or 3 ppm, suggesting that the measurement method was capable of detecting to at least this level.
Similarly, D3 discloses a method for the production of starch with low levels of gluten comprising treatment of wheat flour with a proteolytic enzyme, such as pepsin or trypsin. The specification states:
“…I have found a dilute solution of pepsin in an aqueous solution of hydrochloric acid effective. In my experiments I employed not more than 0.04% of pepsin to the weight of flour. I heated the mixture of water, acid and pepsin to a temperature of 40° to 50° C., then added the flour, and maintained the mixture between those limits of temperature until the action of the enzyme, promoted by gentle agitation, was complete, as indicated by the constancy of the density of the liquor. The time occupied ranged from about 1½ to 2½ hours. The liquor was separated from the starchy matter in a centrifuge, the solid being intermittently washed with water till free from acid, when it was removed and dried.
Where trypsin is the enzyme employed the dilute solution is alkaline in lieu of an acid one, using sodium carbonate or bicarbonate.”
D3 further discloses that the small residue of gluten remaining after the enzyme treatment can be removed by treatment of the starch with a dilute sodium hydroxide solution.
In the opponent’s submission it would be a matter of routine for a skilled person to apply the methods of D1A and D3 using different proteases, and adaptation of the process parameters is also a matter of routine.[136]
[136] Opponent’s written submissions at [127].
Neither D1A nor D3 mention Alcalase, and as above it has not been established that the use of Alcalase to degrade gluten in order to provide a gluten-free product forms part of the common general knowledge. As such, and for the reasons given in relation to inventive step in light of the common general knowledge alone, I am not satisfied that the claims lack inventive step in light of either of D1A or D3 and the common general knowledge.
D2 is a patent document titled “Process for preparing an inhibited starch”. The background to the invention explains:
“Many attempts have been made to improve the properties of native starch such that it is able to provide the viscosity stability, shear tolerance and acid tolerance required in many food applications. Starch whose properties have been improved in this way is often referred to as ‘inhibited starch’ or ‘stabilised starch’. Generally, the inhibition or stabilisation of starch is attributed to the formation of cross-links and/or intermolecular bridges between the polysaccharides.”[137]
“It has now been found that a highly inhibited starch can be produced using bleaching agents, with advantageous properties in terms of viscosity stability, shear tolerance and acid tolerance.”[138]
[137] D2 at page 1, lines 25-30.
[138] D2 at page 2, lines 19-21.
Relevantly, D2 discloses treating an inhibited starch, having a residual protein content on a dry starch basis of more than 0.4% (i.e. 4000 ppm) and less than 8.0% (i.e. 80000 ppm) by weight, with a protease to remove residual protein.[139] This protease treatment “may be used to improve the organoleptic properties of the final inhibited starch product, such as palatability, odour and colour.”[140]
[139] D2 at page 2, line 25 – page 3, line 5.
[140] D2 at page 11, lines 1-3.
D2 explains that the most commonly used native source for starch is corn/maize, and while the specification refers to the “wet-milling” approach to recover corn starch from corn as resulting in separation of starch and gluten, corn, as noted previously, contains zein proteins rather than gluten.[141] It is said that any native source of starch can be used, including wheat.[142] The enzyme for use in the protease treatment is preferably a food grade protein, and D2 refers to Alcalase as an example of such a protein. The pH is preferably adjusted to about 8 prior to the addition of the protease, and treatment is preferably carried out for a period of from around 30-90 minutes. Following protease treatment the pH is lowered to around 3, to deactivate the protease, subsequent to which protease-treated inhibited starch may be recovered by filtering the slurry to obtain a starch cake, washing and then drying the starch cake.[143]
[141] D2 at page 5, line 16 – page 6, line 5.
[142] D2 at page 8, lines 30-34.
[143] D2 at page 11, line 15 – page 12, line 9.
Example 1(b) of D2 describes preparation of protease-treated inhibited starch comprising treatment of corn starch with 0.66% protein with Alcalase at pH 8.0 for one hour, followed by lowering the pH to 3 to deactivate the enzyme (with a deactivation reaction time of 45 minutes), filtering the slurry, and washing the starch cake with water before drying it.[144] The residual protein following this treatment was 0.15% (1500 ppm).[145]
[144] D2 at page 14, lines 21-31.
[145] D2 at page 15, lines 20-22; Copeland at [60].
The opponent submitted that there is no barrier to adapting the process of D2 to wheat starch, identified as an appropriate starch in the document itself, and that additional processing steps form part of the common general knowledge in the art.[146]
[146] Opponent’s written submissions at [129]-[130].
In accordance with the opponent’s submissions, Professor Fitzgerald says:
“The described protease method of forming a slurry of the starch, treating the starch with a suitable protease such as Alcalase at a temperature below the gelatinisation temperature for wheat starch (<55°C) and at a pH of 8 for a period of time up to 1.5 hours, deactivating the Alcalase by lowering the pH, filtering, washing and drying the protease starch for removing residual protein could be applied to wheat starch (as is stated in D2 at page 8, lines 30-34) to reduce protein levels. The method could be further refined through routine experimentation (e.g. varying parameters such as the pH, treatment time, amount of Alcalase used).”[147]
“At page 8, lines 30-34, it is noted that any native starch could be used with the process including wheat. Where wheat was used, it is expected that most of the protein associated with the starch would be gluten.”[148]
[147] Fitzgerald #2 at [20].
[148] Fitzgerald #2 at [43].
Professor Fitzgerald acknowledges that “the aim was not really about gluten in this patent”, but says that she “would have tried this on a range of other cereals”.[149]
[149] Fitzgerald #1 at [74].
Professor Copeland noted that the objective of D2 was not production of a gluten-free product, and only a total residual protein content of 1500 ppm was achieved, such that he would not consider D2 relevant if developing a method to purify starch to less than 20 ppm gluten.[150] He was not confident that the method of D2 could be straightforwardly applied to produce a gluten-free starch from a gluten-containing starch:
“Waxy maize starch is a speciality starch which contains a low amount of, or no amylase. Maize starch is different to wheat starch in that it does not have the two different populations of granule sizes.”[151]
“Whether the conditions described in D2 would work for wheat is not clear, although the patent does say it could be used with other starch sources. However, I expect it would not be straight forward to adapt the described method to wheat, and would in my opinion require further scientific research to do so. Further, the inhibited starch used in D2 clearly has different properties to native starch, and accordingly any method described in D2 for treating the inhibited starch, such as the protease treatment, would be expected to have a different outcome if applied to the treatment of a native (i.e. non-inhibited) starch.”[152]
[150] Copeland at [131]-[132].
[151] Copeland at [58].
[152] Copeland at [61].
Professor Fitzgerald referred to a document[153] identifying that the first 0.25% of protein contained in wheat starch contains very little gluten, concluding from this that “a wheat starch sample having less than 0.23% total protein content can be considered gluten-free.”[154] However, as noted by the applicant, this document has not been established to be part of the common general knowledge[155] and it is not apparent to me that its information would have been known and appreciated by a skilled person reading D2 – neither declarant made any suggestion to that effect prior to Professor Fitzgerald’s reference to the document.[156]
[153] Exhibit MAF-20: Skerritt, J.H. and Hill, A.S. (1992) ‘How “free” is “gluten free”? Relationship between Kjeldahl nitrogen values and gluten protein content for wheat starches’, Cereal Chemistry, vol. 69, pages 110-112 (‘D16’).
[154] Fitzgerald #2 at [43].
[155] Applicant’s written submissions at [162].
[156] Fitzgerald #1 at [72]; Copeland at [131].
On balance, I am inclined to agree with the applicant that D2, in failing to demonstrate the use of Alcalase on a gluten-containing starch, would not afford the skilled person a reasonable expectation of success when seeking a method to reduce gluten in starch to produce gluten-free starch and accordingly the claims do not lack inventive step in light of D2 and the common general knowledge.
D4 discloses methods of reducing the amount of gliadins in wheat flour. I understand the wheat flour used in D4 to contain well over 600 ppm gluten (Table 1 indicates that a control sample has 17,086 μg/g gliadin). Six proteases, Alcalase, papain, flavourzyme, pepsin, trypsin and α-chymotrypsin, were tested for their ability to hydrolyse gliadins in wheat flour. Papain was the most effective, followed by Alcalase and these enzymes were selected for process optimisation. The optimal hydrolysis conditions for gliadin reduction by Alcalase were reported in D4 to be: enzyme to substrate ratio of 0.17% at pH 8.0, treatment time of 62 minutes and temperature of 53°C.[157] It is noted in D4 that the optimized pH and temperature determined for gliadin hydrolysis are within the optimal pH and temperature range of Alcalase.[158] D4 demonstrates Alcalase treatment leading to reduction of gliadin concentration to less than 20 ppm.[159]
[157] D4 at page 1341.
[158] D4 at page 1342.
[159] D4 at Table 1, Fitzgerald #2 at [22].
It is concluded in D4 that a sequential alcalase-papain treatment was more cost-effective than single enzyme treatment for gliadin reduction, and that this treatment was most effective in reducing allergen content in wheat.[160]
[160] D4 at page 1344.
In the opponent’s submission, in view of D4 it would be obvious to the skilled person to “revise certain operating parameters for a wheat starch as compared to a wheat flour” based on the “usual steps of changing one variable at a time”.[161] In particular, with respect to the use of Alcalase at pH 5.5 to 6.5, the opponent notes that this pH range falls within the active range for Alcalase, that such information would be readily available to the person skilled in the art, and that it is routine during process optimisation to vary process parameters such as pH.[162]
[161] Opponent’s written submissions at [114].
[162] Opponent’s written submissions at [116].
When asked to comment on the reaction conditions in the methods she reviewed (including D4), Professor Fitzgerald stated:
“Different enzymes like different conditions. Enzymes have active ranges, and you can work anywhere in this range.
Operating at the ends of an enzyme’s active range may be slower but you might do this, e.g. lower temperature is better for starch functionality but then the reaction would be slower. Wheat starch should be kept below 55°C to keep it as a powder and avoid gelatinisation.
pH is another factor that could be varied. At higher (alkaline) pH, some of the starch will dissolve into solution, at lower (acidic) pH the starch remains dispersed. Extending from this, as well as different pH values, I would consider different acids.”[163]
[163] Fitzgerald #1 at [52]-[54].
Professor Fitzgerald also comments that:
“Determining the conditions under which a less than 20 ppm gluten content could be achieved using a wheat starch of lower initial gluten values [than the flour of D4] would be a matter of routine experimentation.”[164]
[164] Fitzgerald #2 at [22].
In terms of “routine experimentation”, I understand Professor Fitzgerald to be referring to variation of “conditions such as pH, temperature, time and amount of protease” [165] and that routine variation might be achieved by “changing one variable at a time, and testing of the final product.”[166] I take Professor Fitzgerald’s view to be that various surrounding research would also be undertaken as a matter of routine:
“During the course of any method development, it is routine to research the matter thoroughly. This would include general methods targeting the reduction of protein, which would include the use of proteases being enzymes that break down protein. With regard to specific proteases, documents providing information that would assist in determining the suitability of the protease for a process (e.g. pH and temperature ranges in which it is active, whether the protease is food grade) would be routinely consulted.”[167]
[165] Fitzgerald #1 at [62].
[166] Fitzgerald #2 at [44].
[167] Fitzgerald #2 at [57].
Regarding the steps of claim 1 specifically, Professor Fitzgerald states:
“The steps are routine for a method for treating a starch to remove gluten, particularly using a protease such as alcalase. Conditions such as pH and treatment time would be routinely varied to determine reaction conditions in which the desired result (in this case less than 20 ppm gluten) is achieved.”[168]
“Treating the slurry of the starch with alcalase occurs at a pH of 5.5 to 6.5 to dissolve or degrade the gluten protein. At this pH, the starch doesn’t dissolve but the protein will. Washing removes the dissolved (due to pH) and degraded (digested by alcalase) gluten protein.”[169]
“Obtaining a slurry of the starch to be treated is a standard first step to enable the enzyme to access the protein for digestion. Agitating the slurry during treatment is a known step. Once the reaction is complete, it is routine to undertake various washing, separation, pH variation, and drying steps to arrive at the final starch product.”[170]
[168] Fitzgerald #1 at [140].
[169] Fitzgerald #1 at [143].
[170] Fitzgerald #1 at [153].
It must be noted again, however, that Professor Fitzgerald’s evidence regarding the specific claim steps was not provided until after she had reviewed the specification.
Professor Copeland notes that while D4 describes conditions that result in wheat flour with less than 20 ppm gliadin, those conditions are different to those defined in present claim 1. For example, D4 uses pH 8 for Alcalase treatments, which is close to the pH optimum for Alcalase, and does not describe using Alcalase at pH 5.5 to 6.5.[171] He states that D4 would be unlikely to be looked to by a food scientist or technologist seeking to develop a commercial method for treating starch to reduce gluten content to less than 20 ppm[172] and that the reaction temperatures and incubation times for the method of D4 would be very different if starting with wheat starch rather than flour.[173] Notably, Professor Copeland does not indicate an expectation that the appropriate pH would need to be varied, and commented, albeit in relation to D1A, that he would use the optimum pH for a given enzyme.[174]
[171] Copeland at [136].
[172] Copeland at [177].
[173] Copeland at [67].
[174] Copeland at [128].
I will note here that the opponent characterised Professor Copeland as approaching his evidence with a view to certainty of outcome.[175] I agree this appears to be the case and I am mindful of it. However, I consider he is nevertheless able to provide useful evidence as to what parameters he would expect might be varied as a matter of routine or how he would approach a given task.
[175] See, e.g., Copeland at [124], [125].
I recognise that with knowledge of the claimed invention it is possible to identify within the evidence reasons why the skilled person might be led to adapt the method of D4 to arrive at the claimed invention, particularly:
·use of Alcalase at a lower pH of 5.5 to 6.5 in order to avoid dissolution of starch[176]
·extending the duration of Alcalase treatment (optimally 62 minutes in D4) in view of the use of non-optimal Alcalase conditions[177]
·after the first washing step adjusting the pH to 5.0 to 6.5 in order to achieve a more food grade appropriate pH, drop out any solubilised starch, solubilise residual protein[178] or improve the quality of the washing[179]
[176] Fitzgerald #1 at [54].
[177] Fitzgerald #1 at [53].
[178] Fitzgerald #1 at [122].
[179] Copeland at [105].
The evidence regarding pH and duration of protease treatment was given prior to reviewing the application, albeit in general terms, but while in hindsight the claimed parameters are explicable, I am not persuaded that they would be arrived at, absent hindsight, from D4 as a matter of routine – this seems to me akin to opening the safe with the combination already in hand. In particular, Professor Fitzgerald’s evidence regarding routine experiments set out above strikes me as troublingly consonant with the description of obvious to try provided by Judge Rich. Moreover, D4 characterises the parameters therein as optimal, and, as set out above, Professor Copeland’s evidence suggests that a skilled person would not be motivated to vary the (optimal) pH of the process in D4.
In addition, the evidence that it is routine to undertake “pH variation” following protease treatment and concerning specific the basis for the pH adjustment between washing steps was not provided until after review of the specification,[180] and, as noted above, I have not identified or been directed by the parties to any contemporaneous evidence regarding the use of pH adjustment between washing steps for a purpose other than protease deactivation (which I understand would require a lower pH than that in claim 1[181]). While neither declarant seems particularly surprised by the presence of such a step in the claimed method, given the varied possible explanations offered for why a pH variation step might be undertaken between those steps (i.e. to achieve a more food grade appropriate pH, drop out solubilised starch, solubilise residual protein[182] or improve the quality of washing[183]) which have emerged only in hindsight, I am not satisfied that the evidence establishes that a skilled person would be directly led to adjust the pH to 5.0 to 6.5 between washing steps in view of D4 and the common general knowledge.
[180] Fitzgerald #1 at [122], [153].
[181] D20 indicates that Alcalase can be inactivated in 30 minutes at 50°C or higher at pH 4.
[182] Fitzgerald #1 at [122]: “An additional step of adjusting the purified starch to a level of from about 5.0 to 6.5 is described at [0029] [of the specification]. This could be to adjust the pH from a high or low pH to a more food grade friendly pH, to drop out solubilised starch (from alkaline conditions) or solubilise residual protein.”
[183] Copeland at [105]: “I assume that the pH adjustment would be to improve the quality of the washing, which would be more critical on a larger scale.”
It follows that the opponent has not discharged its onus of demonstrating, on the balance of probabilities, that the claimed invention lacks inventive step of D4.
D8, relied on by the opponent only in combination with other documents, is directed to the production of highly soluble hydrolysed vegetable protein and discloses enzymatic hydrolysis of acid-pretreated wheat gluten via treatment with Alcalase followed by flavourzyme. In particular, D8 discloses acid treatment of a wheat gluten suspension, followed by neutralisation to pH 5.7, sterilisation, and treatment with Alcalase for three hours at 50°C, followed by addition of flavourzyme for a further 21 hours. Molecular weights of peptide molecules in the hydrolysate decreased over time, with three hour hydrolysis by Alcalase said to yield molecules with a molecular weight range of 20,000 to 800 Dalton.[184] It is apparent that significant degradation continued after the introduction of flavourzyme as illustrated in Table 1 reproduced below:[185]
[184] D8 at pages 127-129.
[185] D8 at page 129.
For completeness, I note that Exhibit MAF-11: Apar, D. K. and Özbek, B. (2010) ‘Corn Gluten Hydrolysis by Alcalase: Kinetics of Hydrolysis’, Chemical Engineering Communications, vol. 197, pages 963-973 (‘D9’) is mentioned in the Opponent’s written submissions as, similar to D8, demonstrating the activity of Alcalase hydrolysing protein at a pH within the scope the claims – pH 6.5.[186] Notably, D9 relates to hydrolysis of “corn gluten”, where the reference to gluten is “non-technical” and does not refer to the allergenic protein found in wheat.[187] I did not take the opponent to press inventive step in light of combinations comprising D9 at the hearing.
[186] Opponent’s written submissions at [118].
[187] Copeland at [146].
Turning to the question of the combinations of documents, I understand the opponent’s submission to essentially be that D1A (or D3) discloses the use of a protease to degrade gluten in starch, and D2, D4 and D8 teach that a similar result would be expected with Alcalase, as each teach its ability to degrade gluten. This is consistent with Professor Fitzgerald’s evidence:
“From D2, D4 …, we can see that alcalase is a suitable and known candidate for digesting gluten. In D2, the alcalase treats a starch slurry to digest protein at pH 8, and in D4 alcalase treats a wheat flour slurry to digest at pH 8. In these documents, pH 8 is selected as the optimal pH for alcalase, however from D8, D6 … and D9 we can see alcalase is active at lower pH values.
D8 in particular demonstrates the value of operating at a pH value below the isoelectric point for gluten protein.
In D8, acid pretreatment was adopted to enhance the solubility of initial wheat gluten suspension, which could prevent the aggregation and gelation of the protein substrate, and thus accelerate the following enzymic hydrolysis process.
Protein absorbs water (see for example the water method), adding acid and reducing the pH below the isoelectric point enhances the solubility of the protein. When treating starches, if the protein is tightly bound to the starch, it is harder for the enzyme to access the protein. Acidic conditions soften the proteins and reduce the gelling, increasing the ability of the protease to access the protein for hydrolysis.”[188]
“The process of purifying starch using Alcalase involves hydrolysing of proteins into peptides and amino acids. As such, D8 which analyses this very process, would be of relevance when developing a method of removing gluten protein from starch. D8 also demonstrates that Alcalase digests proteins at a pH of 5.7 and that some of the functionality of the gluten is retained.”[189]
[188] Fitzgerald #1 at [158]-[161].
[189] Fitzgerald #2 at [62].
The applicant emphasised that the invention lies in the selection and combination of features in a particular way and characterised Professor Fitzgerald’s obtention of features from various documents as an impermissible “overt exercise in selecting features from unrelated non-CGK prior art documents to create a mosaic of features”.[190] The applicant submitted that the skilled person would not have been motivated to combine documents in the manner asserted by the opponent, noting Professor Copeland’s comment:
“I would not refer to any of documents D2, D3, … D8, … if looking to produce a purified starch having a gluten content of less than 20 ppm. Further, none of the remaining documents (i.e. D1(D1A), D4, …) describe each of the conditions set out in the claims of [the specification].”[191]
[190] Applicant’s written submissions at [220].
[191] Copeland at [150].
D1A expressly refers to use of proteases generally to degrade gluten in starch, and as such I am satisfied that in seeking an alternative method to produce a gluten-free starch a skilled person would be motivated by D1A on its face to look to the use of other proteases. However, I do not consider the general reference to proteases in D1A to supersede the understanding that proteases have variable activities, and I consider a skilled person would be motivated (with the requisite expectation of success) to use suitable (i.e. known to satisfactorily degrade gluten) proteases.[192] Given that D1A relates to treatment of wheat starch (that is, substantially separated from gluten[193]), and the evidence indicates that a level of gluten of 600 ppm, 420 ppm or 36 ppm would be unsurprising in starch that had undergone an initial separation process from gluten,[194] I consider it would be routine to apply a method as described in D1A to a starch having the properties defined in the claims, despite D1A not expressly reciting the defined starting gluten concentrations.
[192] See also Fitzgerald #1 at [65].
[193] D1A at [0003]. I note that D1A reports a total protein concentration of “0.2% or more protein (mainly gluten) is contained in the wheat starch which is distribute|circulating in the present market.”
[194] Fitzgerald #1 at [112].
However, I am not satisfied that any of the pressed combinations of documents would directly lead the skilled person to the claimed inventions. For substantially the same reasons as given above in relation to D2 alone, I do not consider that D2 is a disclosure of such a suitable protease that a skilled person would be motivated to use in the method of D1A – that is, it does not demonstrate the use of Alcalase to degrade gluten. While D4 does disclose the use of Alcalase to degrade gluten, as set out above D4 (and the common general knowledge) do not directly lead the skilled person to the specific method set out in claim 1, and nothing in D1A bridges this gap. Similarly, while D8 discloses the ability of Alcalase to degrade gluten at a pH within the range defined in the present claims, it illustrates a total hydrolysis time of 24 hours, including the use of an additional protease. While I accept that some degree of experimentation is routine and some changes would be expected upon adjusting from treatment of gluten protein per se to starch containing small amounts of gluten protein, on balance I am not persuaded that it extends here to the omission of use of the second protease used in the method disclosed in D8 accompanied by a 10-fold reduction in hydrolysis time, or that success would be reasonably expected with such a variation, noting Professor Fitzgerald’s comment early in her evidence that “[e]nzymic digestion must reduce the gluten molecules to fragments <9 amino acids, for toxicity to be lost”[195] and the high presence (79.7%) of proteins with a molecular weight of greater than 2000 Da in the gluten hydrolysate after three hours of alcalase treatment in D8.[196] There also remains a gap with respect to the specific washing process which is not filled by D1A or the common general knowledge.
[195] Fitzgerald #1 at [44].
[196] D8 at page 129.
Accordingly, obviousness in light of combination of D1A with any of D2, D4 or D8 is not made out. The same reasoning leads to a conclusion that combination of D3 with D2, D4 or D8 would also not deprive the claims of inventive step.
Conclusion
The opponent has not established that the claims lack inventive step in light of the common general knowledge or the identified prior art documents.
Conclusion
The opposition to grant is unsuccessful.
Costs
It is usual in matter before the Commissioner that costs should follow the event and I see no reason to depart from this approach. The applicant has been successful in this matter, and therefore I will award costs according to Schedule 8 against the opponent.
Dr S. J. Smith
Delegate of the Commissioner of Patents
Annex A: Claims
1. A method of producing a purified starch having less than 20 parts per million of gluten
protein, the method comprising the steps of:obtaining a slurry of an initial starch containing gluten protein at 600 ppm or less;
treating the slurry of the starch with alcalase at a pH of 5.5 to 6.5 and agitating for 2
hours to dissolve or degrade the gluten protein;
washing the resultant slurry;
removing the dissolved or degraded gluten protein, resulting in a slurry of the purified starch;
adjusting pH of slurry of the purified starch to 5.0 to 6.5;
washing the pH adjusted slurry of purified starch, and
drying the washed, pH adjusted slurry of the purified starch, resulting in the purified starch having less than 20 ppm of gluten protein.
2. The method as set forth in claim 1, wherein the initial starch is derived from a source naturally containing gluten protein.
3. The method as set forth in claim 1, wherein the initial starch is derived from a source contaminated with gluten protein.
4. The method as set forth in claim 1, wherein the initial starch is selected from the group consisting of wheat starch, rye starch, barley starch, and triticale starch.
5. The method as set forth in any one of claims 1 to 4, wherein the initial starch has 470 ppm gluten protein or less.
6. The method as set forth in any one of claims 1 to 5, wherein the initial starch has 36 ppm gluten protein or less.
7. The method as set forth in any one of claims 1 to 6, wherein the treating step occurs at a temperature of from 80ºF (26.7ºC) to 120ºF (48.9ºC).
8. The method as set forth in any one of claims 1 to 7, wherein the slurry of the starch has a specific gravity of from 18º Baume to 25º Baume.
9. The method as set forth in any one of claims 1 to 8, wherein the step of removing the dissolved or degraded gluten protein includes centrifuging the washed slurry.
10. The method as set forth in any one of claims 1 to 8, wherein the step of removing the dissolved or degraded gluten protein includes filtering the washed slurry.
11. The method as set forth in any one of claims 1 to 10, wherein the step of drying includes drying the slurry of the purified starch in a flash drier, a spray drier, or a rotating drum drier.
12. The method as set forth in any one of claims 1 to 11, further including the step of testing the purified starch to confirm that the purified starch contains less than 20 parts per million of the gluten protein.
13. The method as set forth in claim 12, wherein the step of testing the purified starch includes using a test selected from the group consisting of R5 sandwich ELISA, R5 competitive ELISA, and G12 Romer ELISA.
14. The method of any one of claims 1 to 13, wherein the slurry of the starch is treated with alcalase at a pH of 5.5 to 6.
15. The method of any one of claims 1 to 14, wherein the alcalase is added to the starch slurry in an amount of from about 0.01% to about 0.1% by weight based on the amount of starch solids contained in the slurry.
16. The method of any one of claims 1 to 15, wherein the alcalase is added to the starch slurry in an amount of from about 0.011% to about 0.022% by weight based on the amount of starch solids contained in the slurry.
17. The method of any one of claims 1 to 16, wherein the alcalase is added to the starch slurry in an amount of about 0.011%, about 0.0165%, or about 0.022% by weight based on the amount of starch solids contained in the slurry.
18. The method of any one of claims 1 to 17, further comprising an additional washing step.
19. The method of claim 18, wherein the additional washing step is performed prior to adjusting pH of slurry of the purified starch to 5.0 to 6.5.
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