Ingredion Incorporated v Tate & Lyle Solutions USA LLC and Tate & Lyle Technology Limited
[2023] APO 63
•11 December 2023
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Ingredion Incorporated v Tate & Lyle Solutions USA LLC and Tate & Lyle Technology Limited [2023] APO 63
Patent Application: 2016225278
Title:Allulose syrups
Patent Applicant: Tate & Lyle Technology Limited and Tate & Lyle Solutions USA LCC
Opponent: Ingredion Incorporated
Delegate: K. Wagg
Decision Date: 11 December 2023
Hearing Date: 31 March 2023
Catchwords: PATENTS – All grounds of opposition fail—
—costs awarded against the Opponent—Reg 5.23 material has not been consulted—inventive step—common general knowledge—inventive step not made out—costs awarded against the Opponent.
Representation: Counsel for the Applicant: Clare Cunliffe
Patent attorney for the Applicant: Corrine Porter and Marcus Caulfield of FB Rice
Counsel for the Opponent: Phoebe Arcus
Patent attorney for the Opponent: Michael Zammit of Spruson & Ferguson
Lawyer for the Opponent: Duncan Longstaff of Spruson & Ferguson
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2016225278
Title:Allulose syrups
Patent Applicant: Tate & Lyle Technology Limited and Tate & Lyle Solutions USA LLC
Date of Decision: 11 December 2023
DECISION
The Opposition has been unsuccessful on all grounds. Regulation 5.23 material has not been consulted. I award costs outlined in Schedule 8 against the Opponent, Ingredion Incorporated.
REASONS FOR DECISION
Background
Patent application number 2016225278 (the opposed application or the specification) was filed on 19 February 2016 by Tate & Lyle Technology Limited and Tate & Lyle Ingredients Americas LLC, the latter is now known as Tate & Lyle Solutions USA LLC. Tate & Lyle Technology Limited and Tate & Lyle Solutions USA LLC are together the Applicant.As a result of the filing date and subsequent request for examination, the substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar) apply to the opposed application. Any subsequent references to sections of the Patents Act relate to the Patents Act 1990 as amended by the Raising the Bar Act. A similar qualification applies to references to the Patents Regulations 1991.
The opposed application was examined and advertised as accepted by the Commissioner on 12 March 2020. On 12 June 2020 Ingredion Incorporated (the Opponent) filed a notice of opposition to grant under section 59 of the Act. Two other parties, Samyang Corporation and Archer Daniels Midland Company also filed separate notices of opposition. The hearing on the opposition by both Samyang Corporation and Archer Daniels Midland Company (the first opposition) was held on 30 March 2023, one day before this opposition. That opposition is the subject of a separate decision that is currently not open to public inspection, though I do note that this has been appealed in the Federal Court.
The Grounds of Opposition
The Statement of Grounds and Particulars was filed on 11 September 2020. At the hearing the following grounds were pressed under paragraph 59 (b):
·Lack of Manner of Manufacture under subparagraph 18(1)(a).
·Lack of Novelty under subparagraph 18 (1)(b)(i)
·Lack of Inventive Step under subparagraph 18 (1)(b)(ii)
The grounds of lack of entitlement, utility and the internal grounds of sufficiency, support and clarity, whilst raised in the statement of grounds and particulars, were not pressed in the current opposition.
Onus and Standard of Proof
The onus lies with the Opponent to satisfy me that a ground of opposition exists on the balance of probabilities.[1] If I am satisfied, then I may refuse the opposed application.[2]
[1] Section 60(3A).
[2] Ibid.
Evidence
The evidence in support filed by the Opponent is set out below:
Declarant Date Reference Exhibits Sam Himstedt 16 November 2020 Himstedt #1 SH-1 to SH-4 Bradley M. Johnson 8 February 2021 Johnson#1 BJ-1 to BJ-2 Sam Himstedt 4 February 2021 Himstedt #2 SH-5 to SH-12
The evidence in answer filed by the Applicant is set out below:
Declarant Date Reference Exhibits Abigail Storms 15 October 2021 Storms #1 AS-1 to AS-8 Brian Timothy Pohrte 25 October 2021 Pohrte #1 BTP-1 to BTP-5 John S. White 30 October 2021 White #1 JSW-1 to JSW-19 Marcus J. Caulfield 9 December 2021 Caulfield #1 MJC-1 to MJC-5
The evidence in reply filed by the Opponent is set out below:
Declarant Date Reference Bradley M. Johnson 30 March 2022 Johnson #2 Sam Himstedt 30 March 2022 Himstedt #3
Regulation 5.23 Material
The Opponent sought to incorporate information from the first opposition into this opposition. I have decided that case and the opposition was unsuccessful. The Opponent made submissions in view of Reflex Instruments Asia Pacific Pty Ltd v Minnovare Limited[3]. I note that regulation 5.23 is discretionary and the questions raised in Reflex reflect those of when discretion should be exercised. However, I also note that in Merial Limited v Bayer Intellectual Property GmbH[4] the Deputy Commissioner concluded that:
“I conclude that a decision under regulation 5.23 must have regard to the nature of the information and whether the information is likely, if not certain, to change the outcome of the opposition in a significant way.”[5]
[3] [2017] APO 8.
[4] [2015] APO 16
[5] Ibid at [24]
In the current case the Opponent sought to rely on evidence from the declarants in the first opposition in relation to allulose and introduce a further prior art document, D25, discussed below. Given I have already made conclusions on D25 in the first opposition, which I discuss further below, I do not any reason to consult it in the present opposition. Furthermore, the passages of evidence cited in the Opponent’s submissions do not appear to add any weight to any of the grounds pressed in this opposition. I therefore will not consult the 5.23 material in this opposition.
The Opposed Application
Before commencing to construe the specification, I note what Middleton J said about approaching patent specifications in Eli Lilly 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 patent's subject matter. 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.”[6]
[6] Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214, 100 IPR 451 at [139].
To properly construe the specification, it is essential to obtain an idea of the technology the invention relates to and obtain a picture of the person skilled in the art.
Background
The Opposed Application is entitled “Allulose Syrups” and begins by outlining the field of the invention. It states that:
“The present invention relates to allulose syrups, use of allulose syrups in the manufacture of food or beverage products, and food and beverage products made using the allulose syrups.”[7]
[7] Page 1 lines 5-7.
The specification then sets out the background of the invention and states:
“Many food and beverage products contain nutritive sweeteners such as sucrose (generally referred to as ‘sugar’ or ‘table sugar’), glucose, fructose, corn syrup, high fructose corn syrup and the like. Although desirable in terms of taste and functional properties, excess intake of nutritive sweeteners, such as sucrose, has long been associated with an increase in diet-related health issues, such as obesity, heart disease, metabolic disorders and dental problems. This worrying trend has caused consumers to become increasingly aware of the importance of adopting a healthier lifestyle and reducing the level of nutritive sweeteners in their diet.”[8]
[8] Page 1 lines 11-18.
The specification then goes to state:
“One proposed alternative to nutritive sweeteners is allulose (also known as D-psicose). Allulose is referred to as a “rare sugar,” since it occurs in nature in only very small amounts. It provides around 70% of the sweetness of sucrose, but only around 5% of the calories (approximately 0.2 kcal/g). It may therefore essentially be considered to be a “zero calorie” sweetener.”[9]
[9] Page 1 lines 22-26.
From the above passages, the reader is told that the field relates to allulose syrups for use in food and beverages as a sweetener. Allulose itself being a type of sugar that is rare in nature but low in calories. The specification further explains that:
“Allulose is present in processed cane and beet molasses, steam treated coffee, wheat plant products and high fructose corn syrup. D-allulose is the C-3 epimer of D-fructose and the structural differences between allulose and fructose result in allulose not being metabolized by the human body to any significant extent, and thus having “zero” calories. Thus, allulose is thought to be a promising candidate as a replacement for nutritive sweeteners and as a sweet bulking agent, as it has essentially no calories and is reported to be sweet while maintaining similar properties to sucrose.”[10]
[10] Page 2 lines 18-24.
Noting that allulose is known, I understand the invention relates to its use in syrups as a zero calorie sweetener or an alternative to nutritive sweeteners.
The Person Skilled in the Art
The concept of the person skilled in the art (“PSA”) has long been considered by the courts when construing patent specifications. Finkelstein J described the PSA as follows:
“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.” [11]
[11] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; 49 IPR 225 at [70].
The PSA is not a real person, but an artificial construct used as a tool of analysis by the court, and in this case, the Commissioner. This concept was explained in AstraZeneca[12]:
“The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.”[13]
[12] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30.
[13] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23].
The characteristics of the PSA in relationship to the art itself has been given by Lord Diplock who stated that the PSA is likely to have a practical interest in the subject matter:
“My Lords, a patent specification is a unilateral statement by the patentee, in words of his own choosing, addressed to those likely to have a practical interest in the subject matter of his invention (i.e., ‘skilled in the art’)”[14]
[14] Catnic Industries Inc. v Hill & Smith Limited [1982] RPC 183 at 243.
In Australia, the Full Federal Court approved this approach with Heerey, Emmett and Dowsett JJ stating:
“The uninventive but skilled worker is likely to have a practical interest in the subject matter of the claimed invention.”[15]
[15] Minnesota Mining & Manufacturing Co v Tyco Electronics Pty Ltd [2002] FCAFC 315; 56 IPR 248 at [39], 257.
The field of the invention relates to allulose syrups and their use in food and beverage products and from the background set out in the specification it is clear that allulose is a sugar, structurally related to fructose, but not metabolised in the same way and thus yielding fewer calories. Therefore, the PSA would have a practical interest in nutritive sweetener alternatives and the manufacture of syrups for use in food and beverage products.
The Opponent submitted that the skilled person is a team, made up of scientists with backgrounds in sugar chemistry and food technology with experience in sugar syrups and their use in food and beverage products, and accepts that both Dr White and Mr Pohrte are skilled persons. However, the Opponent noted that Mr Pohrte has worked for the Applicant since 2006.
Dr Himstedt holds a PhD in Food Science from the University of Queensland and has worked in the food industry for a number of years, being the Director of Queen Fine Foods Pty Ltd from 2000-2015.[16] This work included syrups, such as pure and sugar free maple syrups, and sweetened vanilla and coffee syrups as well as glucose syrup.[17] Currently he is general manager R&D, Innovation and Export Development at Rd. Oetker Queen Australia Pty. Ltd.[18]
[16] Himstedt at [1.3] and SH-1.
[17] SH-1 and SH-2.
[18] SH-1.
Mr Johnson holds a bachelor’s degree in Chemical Engineering from Iowa State University.[19] He is Senior Manager of Process Engineering for the Opponent, and prior to 2011 worked in refinery operations in the manufacture of starch-based sweeteners, being one of the lead engineers involved with the startup of their allulose facility in San Juan del Rio, Querétaro, Mexico.[20] Mr Johnson also worked for Archer Daniels Midland Co. from 1995-1997 in refinery operations for high fructose corn syrups, dextrose (glucose) and polyols before working in glucose refinery and maltodextrin processes for Cerester (now Cargill, Inc.).
[19] Johnson #1 at [1.3].
[20] Johnson #1 at [1.1] and [1.5].
Dr White states that he founded White Technical Research in 1994[21] and before that he worked at A.E. Staley (now Tate and Lyle, that is, the Applicant) from 1981[22] where he was responsible for technical developments leading to 100% replacement of sucrose with HFCS-55 in carbonated beverages. A lot of his experience relates to the use of high fructose corn syrups (HFCS).[23] There is no evidence that his company has or has not had affiliations with the Applicant since the 1990s. The Applicant noted that he had read and confirmed his compliance with the Expert Evidence Practice Note[24] in his declaration for this opposition.[25]
[21] White #1 at [9].
[22] White #1 at [8], in his CV he notes this work in 1984, see JSW-2 page 1.
[23] JSW-2.
[24] JSW-1.
[25] White #1 at [4]
Mr Pohrte is employed by the Applicant and has worked on stevia products, Monk Fruit extracts and the Dolcia Prima Allulose syrup. Mr Pohrte also stated that he read the Expert Evidence Practice Note[26] and complied with it when preparing his declaration.[27]
[26] BTP-1.
[27] Pohrte #1 at [3].
Ms Storms is the Global Head of Sweeteners for the Applicant and also read and understood the Expert Evidence Practice Note and declared that she complied with it.[28]
[28] Storms #1 at [3].
The Applicant said that Dr Himstedt’s evidence would be of dubious assistance because of the manner in which it was prepared. I note that initially he stated that, although he had not read the opposed application nor had he been told what it describes or claims, he was aware it concerned allulose syrups.[29] He was also told to assume allulose syrups were first described by the Applicant in an earlier related priority application that was filed on 24 February 2015.[30] He was shown the first two pages and the first sentence of page 3 of the opposed application before giving evidence on common general knowledge.[31] These pages only provide the field of the invention and background portion of the opposed application. Dr Himstedt was provided with the Expert Evidence Practice Note and stated that he had read it and complied with it.[32]
[29] Himstedt #1 at [2.2].
[30] Himstedt #1 at [2.3]
[31] Himstedt #1 at [3.1] and SH-4.
[32] Himstedt #1 at [2.6].
The Applicant’s criticism of the process in which Dr Himstedt’s declaration was collected relates to the fact that with the knowledge of the allulose syrups in mind, Dr Himstedt’s evidence would be tainted with hindsight. Dr Himstedt provides information on the syrups he had worked on and then does indeed go straight to discussing allulose. I will be mindful of this hindsight bias through the usual weighing of evidence which is part of the role of the Commissioner in patent oppositions. Similarly, the impartiality of the experts—there are experts on both sides who are employees of the parties—may also affect their weight.
The Alleged Invention
As outlined above the specification states what allulose is, in that it is a low calorie sugar, and that the invention relates to allulose syrups. Syrups are said to be a convenient product:
“A convenient product form for allulose is an allulose syrup, i.e., a syrup comprising allulose and water.”[33]
[33] Page 2, line 26-27.
The specification then goes on to state that:
“It has been found that allulose syrups may be susceptible to degradation over time (i.e., gradual reduction in allulose content), to color formation, to the formation of impurities (such as hydroxymethylfurfural—HMF), to crystallisation and/or to inadequate microbial stability.”[34]
[34] Page 2, lines 27-30.
At the hearing there was some discussion of the above paragraph particularly as it starts with the words “it has been found.” I note that this paragraph is under the heading “background of the invention” and the following section is called “summary of the invention.” I will discuss this paragraph later in relation to inventive step.
The summary of the invention is then given starting on page 3, line 15. This summary is essentially a consistory clause of the claims, but importantly it starts with:
“According to a first aspect, the present invention provides an allulose syrup having a total dry solids content of from 50% to 80% by weight, and comprising allulose in an amount of at least 80% by weight on a dry solids basis, wherein the pH of the syrup is from 2.5 to 6.0”[35]
[35] Page 3 lines 16-19.
The following paragraphs further specify embodiments with various levels of dry solids and pH, with the embodiment at the end of page 3 stating that the pH of the syrup is from 3.5 to 5.0. Further embodiments specify the amounts of impurities such as HMF, sulfur dioxide, isovaleraldehyde and 2-aminoacetophenone.[36] Additives are also outlined and shelf life of 3, 6, 9 or more than 12 months given.[37] Processes for preparing the allulose syrup are then outlined.[38]
[36] Pages 3a-Page 4.
[37] Page 4 lines 13-30.
[38] Page 5 lines 5-page 5a line 10.
Then under the title of “detailed description” the specification states:
“The present invention is based on the finding that allulose syrups with improved storage stability can be prepared by careful control of certain parameters.”[39]
[39] Page 10 lines 6-7.
The specification states narrowing ranges in embodiments from pH 3.0 to 5[40] and goes on with:
“It has been found that allulose degradation and HMF formation can be minimized by increasing the pH, but that undesirable color formation is also promoted by increasing the pH. It has been found that the pH according to the present invention is optimal both in terms of minimizing allulose degradation and HMF formation and minimizing undesirable color formation.”
“It is surprising that allulose syrups have been found to be most stable in the above range of pH, since monosaccharide syrups have previously been found to be most stable at lower pH, e.g., between 2.2 and 3.0 (Smirnov V, Geispits K; Stability of Monosaccharides in Solutions of Different pH; Biochem. Moscow. 1957, 22:849-854).”[41]
[40] Page 11 line 28 to page 12 line 4.
[41] Page 12 lines 6-15.
There was some discussion in the evidence about whether the pH range was surprising. I will leave that discussion to inventive step.
The Specification ends with 7 examples and 34 figures. Examples 1-4 are summarised as:
“It was determined from stability experiments that allulose syrup produced at one set of conditions has a more rapid purity degradation than allulose syrup produced at another set of conditions (Example 1). The main difference between these syrups was initial pH. An accelerated stability study (Example 2) was carried out with pH values around the narrow range of predicted stability and also with additives and at different % dry solids. It was determined that 71-77% dry solids and a pH of around 3.8 to 4.2 provided optimum storage stability. Microbial stability was also investigated (Example 2). The allulose syrup was very stable at 77% dry solids and less stable at 71%. The results could be used to predict a low limit on microstability of 60% DS. Another stability study was carried out at ambient storage temperature with pH values and dry solid content around the ranges of predicted stability (Example 3). Finally, a more detailed study of additives with respect to two different dry solids levels and optimal pH was carried out (Example 4). Some of the additives reduced the change in color, composition and HMF.”[42]
[42] Page 19 lines 9-21.
In Example 1 the pH was set at 3.4 and the syrup decomposition was measured over 2 months at different temperatures (25℃, 30℃ and 35℃). A decrease in purity and increase in colour was seen in all samples (Figures 1 and 2). HMF increased in all samples as well but was more marked in the 35℃ sample (Figure 3) and the pH dropped from 3.4 to 3.2 over the two months in all samples (Figure 4). The effect of pH was further investigated and when pH remained above 3.5 the change over time was slower (Figures 5-8).[43]
[43] Page 21 Lines 15-19.
The effect of pH on stability can be seen when Figure 1, which started at a pH of 3.4 is compared to Figure 8 which started at a pH of 4. As shown below, when the time in months is compared the decrease in purity is greater in Figure 1 at pH 3.4 than Figure 8 at pH 4.
In example 2 the effect was tested with a dissolved solids content of 71% and 77% and the additives of sodium metabisulfide and sodium citrate. This is shown below in Figure 12, with pH 4.7 showing the least decomposition.
The effect of pH and dry solids content at 25℃ is shown below in Figure 19.
The specification ends with 20 claims, with claim 1 being the only independent claim.
The Claims
The 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” [44]
[44] [2009] FCAFC 70, 81 IPR 228 at [118] – [120].
This approach of reading the specification as whole through the PSA's eyes with the common general knowledge (CGK) in mind provides context and the intention behind what is meant[45] and is commonly referred to as a purposive construction.[46] The lack of a precise definition in claims may not be fatal to validity so long as they provide a workable standard suitable to the intended use.[47]
[45] Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183 (HC).
[46] Technip France S.A.’s Patent [2004] RPC 46.
[47] Minnesota Mining and Manufacturing Co. v Beiersdorf (Australia) Ltd. (1980) 144 CLR 253 at (46).
Claim 1 reads:
“An allulose syrup having a dry solids content of from 70% to 80% by weight and comprising allulose in an amount of at least 90% by weight on a dry solids basis, wherein the pH of the syrup is from 3.5 to 5.0.”
Allulose
I have outlined what the specification defines as allulose above and this is supported in the evidence. Allulose is considered a rare sugar because it is rare in nature[48] and is sometimes referred to as psicose or D-psicose. It is a monosaccharide, meaning it has a single sugar molecule (c.f. sucrose being a disaccharide) with 6 carbons. It is an epimer of fructose and can be manufactured by treating fructose with the enzyme D-psicose-3-epimerase to give a crude product which can then be purified to give allulose.[49] Dr White describes allulose as having:
“…a clean, sweet taste that is quite similar to sucrose in terms of taste, performance and mouth feel. Allulose is what I would call a reduced calorie or low digestibility sweetener. These sweeteners are carbohydrates that are only partially digested or are not digested at all. They are typically excreted from the body largely unchanged. Most carbohydrates such as sucrose, fructose and glucose have a caloric value of 4 kilocalories per gram but allulose has a caloric value of about 0.2-0.4 kcal/g — about 10% of the caloric value of these carbohydrates. Allulose also has a very low glycaemic index and has been shown to have beneficial physiological effects. Allulose is about 70% as sweet as sucrose.”[50]
Sugar syrups
[48] White 1 at [26].
[49] White 1 at [27].
[50] White 1 at [28].
Dr White explained that sugar syrups are:
“Aqueous solutions of carbohydrates. Some of the more well-known sugar syrups include corn syrup, high fructose corn syrup (hereinafter “HFCS”), inverted sugar, molasses, honey and maple syrup. One of the simplest ways to make a sugar syrup is to dissolve a dry powder or crystalline carbohydrate in water and then dilute or concentrate the solution to the desired concentration (dry solids).”[51]
[51] White #1 at [33].
Dr White also stated that:
“Most end users of sugar syrups do not want a colored syrup. There are several different sources of color in a sugar syrup. Colored compounds can form as a result of the Maillard reaction or caramelization, both of which are non-enzymatic browning reactions. The Maillard reaction is a chemical reaction between reducing sugars and amino acids, peptides and proteins. The Maillard reaction creates colored compounds which can cause the sugar syrup to have a yellow, golden or even brown color. One product of the Maillard reaction is 5-hydroxymethylfurfural (“HMF”)” … “HMF forms as a result of a dehydration reaction under acidic conditions. HMF formation increases at lower pH. HMF itself is not colored but it is often used as an indicator of the quality or age of sugar syrup. Caramelization is the browning of a sugar with heat.”[52]
[52] White #1 at [39].
Dr Himstedt made similar comments about browning and the Maillard reaction.[53] Dr Himstedt also stated that syrups offer advantages in manufacturing because they are easy to handle. They can be easily pumped from tank to tank and mix faster and they do not have the disadvantages that crystal solids have such as hygroscopicity—which can lead to rock hard clumps of the sugar in humid climates.[54]
Dry solids
[53] Himstedt #1 at [3.14].
[54] Himstedt #1 at [3.7].
Dry solids are the amount of the dry sugar material in the final sugar syrup. For example, if 5 grams of a solid material are dissolved in a liquid to give 100 grams of solution, that solid material is present as only 5% by weight in the solution, and that is the “dry solids content” of the solution.
pH
pH is a measure of acidity with lower pH being more acidic and high pH being basic, a pH of 7 is generally regarded as neutral.
The Opponent’s case regarding both manner of manufacture and inventive step rely on common general knowledge. I will therefore consider the common general knowledge as shown in the evidence of this opposition now.
Common General Knowledge
The CGK forms part of the background knowledge and experience which is available to all skilled persons in the field.[55] It is the technical background of the skilled worker but does not need to be memorised or front of mind but can include material in the field which the worker knows exists and would refer to as a matter of course.[56]
Allulose
[55] Minnesota Mining & Manufacturing Co. Pty Ltd v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 at 292
[56] ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc [1999] FCA 345 at [112].
The Opponent’s declarant, Dr Himstedt, was aware that the current opposition related to allulose syrups and did not provide any naïve background evidence of it being CGK.[57] Similarly, Mr Johnson’s declaration is more to confirm that Dr Himstedt and he was were shown the Opposed specification initially.[58] Dr White, however, was aware of allulose when he was discussing his background on sweeteners and mentioned it when discussing reduced calorie sweeteners.[59] Dr White was then asked to expand on it and he did so.[60] I accept that allulose and its properties--so far as chemical structure, sweetness and calorific yield--was CGK.
Allulose syrups
[57] Himstedt #1 at [2.2].
[58] Johnson #1 at [2.2].
[59] White #1 at [24]
[60] White #1 at [25]-[30].
The Opponent submitted that allulose syrups were commercially available before the priority date and therefore were CGK. However, when asked about allulose syrups that were available before the priority date Dr White stated that he was not aware of any.[61] He then conducted an online search and found that only Rare Sugar Sweet by Matsutani was available.[62] The Rare Sugar Sweet he described as a fairly impure sugar preparation with a mix of rare sugars as well as glucose and fructose. A rare sugar means a monosaccharide that exists in small quantities in nature, allulose being just one example of a rare sugar.[63] He said allulose only appears to be comprise about 5% of the Rare Sugar Sweet.[64]
[61] White #1 at [31]
[62] White #1 at table 1.
[63] White #1 at [26].
[64] White #1 at [32].
Based on the evidence I am not satisfied that allulose syrups were CGK before the priority date.
Sugar syrups
Sugar syrups include corn syrup, high fructose corn syrup, molasses, honey and maple syrup.[65] There is no debate that sugar syrups are CGK. Dr White did discuss formulating sugar syrups in detail and stated:
“I was asked to explain what factors and issues I would have considered when formulating a sugar syrup before the priority date. Consumers are typically looking for sugar syrups with no color, no off flavor, no off taste and that won’t detract from their product. Factors that I would consider when developing a sugar syrup include purity, both in terms of sugar composition and in terms of other components (e.g., ions, organic compounds, ash), cost, sweetness, taste, color, stability (including chemical, physical and microbial stability), flavor profile, availability of commercial quantities and cost. The sugar syrup would also need to be stable enough to be transported and stored by the end user for a defined period of time. A number of these factors are dictated by the end user. For example, the end user may specify that preservatives cannot be used or the degree of color that is acceptable.”[66]
[65] White #1 at [33].
[66] White #1 at [34].
Dr White was then asked to expand on the chemical, physical and microbial stability. He said that he would also alter pH and temperature in the manufacture and storage:
“When formulating a sugar syrup I would try to avoid conditions which cause degradation of the sugar. To do this I may alter parameters such as the pH of the syrup and the temperature used during manufacture and storage.”[67]
[67] White #1 at [36]
He was then asked to expand on this and said:
“I was also aware that sugars can degrade under alkaline conditions. Chemical stability also depends on the nature of the sugar. Some sugars are more reactive than others and will degrade more rapidly. For example, reducing sugars such as fructose are more reactive than non-reducing sugars like sucrose; however, some reducing sugars like fructose are more reactive than other reducing sugars like glucose. I would also consider the purity of the syrup; for example, other compounds present in the syrup can impact the rate of degradation.”[68]
[68] White #1 at [37].
Here Dr White does say that different sugars have different chemistry, such as being reducing sugars, and the reactivity of sugars is different. This difference in the chemistry of sugars means their chemical stability is also different.
On physical stability Dr White states:
“By physical stability I am referring to the ability of the sugar syrup to form sugar crystals. Ideally, this is something to be avoided as it can reduce the concentration of sugar in solution or cause problems during transportation and delivery. I would attempt to lower the concentration of the sugar in solution to avoid concentrations which approach the solubility limit of the sugar. The solubility limit of a sugar will depend on the physical and functional properties of the sugar, and is commonly known to vary from sugar to sugar. I would also consider the recommended storage temperature for the sugar, as the solubility of a sugar will typically decrease as temperature decreases. For example, fructose is more soluble than glucose and can therefore be transported at lower temperatures without crystallisation.”[69]
[69] White #1 at [37]
Again there is variation from sugar to sugar in terms of solubility limit which affects the final concentration of the sugar syrup.
When asked to expand on microbial stability, Dr White, like with chemical stability for storage, noted a lower pH is likely to give lower microbial growth, however, the pH range of the problem microorganism will be considered as well as the properties of the sugar itself:
“By microbial stability I am referring to the ability of microbial species, such as yeasts and bacteria, to survive or grow in a sugar syrup. Some microbial species are more resilient and can survive under more extreme conditions. Microbial species are able to survive and grow under specific conditions of temperature, pH and sugar concentration and osmotic pressure. When formulating a sugar syrup I would try to avoid conditions under which microbial species can survive and/or grow by manipulating these properties of the syrup. In general, the lower the pH, the lower the microbial growth. However, each microbial species will have a pH range in which they are able to survive and/or grow and I would consider the preferred pH range of microbial species commonly encountered in sugar syrups, food or beverages and try to avoid formulating the syrup with a pH in the optimal growth range. For sugar syrups, the osmotic pressure is dictated by the concentration of the sugar in solution and by the colligative properties of the sugar. Generally, microbial species will not grow and/or survive when the sugar concentration is above a certain value and I would aim for a sugar concentration that is above this level. However, this sugar concentration is different depending on the colligative properties of the sugar and this concentration may need to be determined experimentally.”[70]
[70] White #1 at [38].
Dr White also states that HMF formation should be avoided.[71]
[71] White #1 at [39].
Dr Himstedt’s evidence is focused specifically on allulose syrups, having been aware that the opposed application related to allulose syrups and shown the field and background section of the specification. He first focused on achieving a suitable Brix of approximately 70-73%.[72] A Brix value is a measure of total soluble solids given in the number of grams of sucrose per 100 grams of solution and so is a measure of strength, and for sucrose would be the same as dry solid content, however, when other sugars are used a correlation chart is needed. Dr Himstedt said he would do this by starting with crystalline allulose and adding pure water.[73]
[72] Himstedt #1 at [3.10].
[73] Ibid.
Dr Himstedt states that crystallisation of the allulose out of the syrup would be an issue with impurities and increases at higher Brix. He said it would be important to make sure it is free of impurities which can seed crystallization.[74] Dr Himstedt also stated that browning is undesirable. Other colour changes may occur due to the Maillard reaction which leads to the formation of HMF in reducing sugars such as fructose.[75]
[74] Himstedt #1 at [3.14].
[75] Ibid.
On pH Dr Himstedt states:
“Firstly, the lower the pH, the better the microbial stability of the syrup, and the less chance for growth. However, as the pH is lowered, the probability of HMF formation is increased. Prior to 24 February 2015, it was well known that lower acidity increases the likelihood of HMF production, especially if using a heat step during the production of the syrup itself (hence, also promoting browning and HMF production). So, depending on the pH of the natural fresh allulose syrup, it may be necessary to adjust the pH to optimise the ultimate storage time. Maybe, the pH would need to be increased using the likes of a buffer like sodium citrate, ascorbate or potassium citrate et cetera. Or, maybe the pH needs to be lowered using an acid, such as an approved food acid. The key is to find the best range, say between 3.5 and 5.0. The lower the pH the better stability, but much more chance of browning and HMF production. So, you need to find that best balance.”[76]
[76] Himstedt #1 at [3.15].
Both the Applicant’s declarant and that of the Opponent stated that there are challenges in producing sugar syrups such as stability relating to crystallization as well as HMF formation and microbial growth.
It would appear that the issues of stability discussed in the opposed application would have been an issue for the PSA regardless of whether the starting point was allulose itself and other sugar syrups or an allulose syrup per se.
Manner of Manufacture
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.
The Opponent’s argument focused on the invention being no more than CGK or what can be predicted from the CGK.
In Commissioner of Patent v Microcell Ltd (Microcell) the High Court identified a lack of manner of manufacture on the face of the specification:
“We have in truth nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. A claim for nothing more than that cannot be subject matter for a patent.” [77]
[77] (1959) 102 CLR 232 at 251.
The Opponent also referred to Microcell for the proposition that an express admission that a claim is not inventive is not needed to make out the ground, but it must be clear enough on the face of the specification that no inventive step is disclosed.[78] This concept with the law of manner of manufacture was developed further in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd:
.“.. if it is apparent on the face of the relevant specification that the subject matter of the claim is, by reason of absence of the necessary quality of inventiveness, not a manner of manufacture for the purposes of the Statute Monopolies. That does not mean that the threshold requirement of “an alleged invention” corresponds with or renders otiose the more specific requirements of novelty and inventive step (when compared with the prior art base) contained in s 18(1)(b). It simply means that, if it is apparent upon the face of the specification, when properly construed, that the quality of inventiveness necessary for there to be a proper subject of letters patent under the Statute of Monopolies is absent, one need go no further.”[79]
[78] Ibid at 246.
[79] (1995) 183 CLR 655 at 663-665.
The Opponent further submitted:
“While the High Court in in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [No 2] (1995) 183 CLR 655 at 671 denied that the decision in Microcell involved a threshold test, and suggested that Microcell stood for a narrow proposition that a Commissioner of Patents, or his or her Delegate, may refuse an application for patent protection where a specification "on its face" shows the invention claimed is not a manner of manufacture, subsequent High Court decisions Myriad and Aristocrat have not read down Microcell so narrowly. For example, Myriad at [12] French CJ, Kiefel, Bell and Keane JJ confirmed, citing Mirabella, that an "anterior exclusion" may arise "based upon an admission, on the face of the specification, which makes clear that the invention claimed is not novel or does not involve an inventive step". See also Gordon J at [219].”[80]
[80] Opponent’s submission at 105.
The Opponent also cited both pluralities in Aristocrat[81] to support the approach from Mirabella that there is a threshold requirement for an alleged invention. The Opponent also stated that the claimed invention is characterised by “focusing on the features of the claimed invention that differentiate it from the CGK” citing Kiefel CJ, Gageler and Keane JJ in Aristocrat.[82]
[81] Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents [2022] HCA 29 at [65]-[72],[106] and [111].
[82] Ibid at [66].
The Opponent characterised the claimed invention as “an allulose syrup composition for conventional use in food and beverage products.” The Opponent submitted that the parameters in the claim are nothing new or inventive. The Opponent further argued that these are known parameters used by the PSA to create stable syrups of similar known monosaccharides. They also argue that because there is no step change in the results set out in tables 1, 2 and 3 of the specification there is no new technical effect but rather a gradual trend.
I disagree with the Opponent’s submissions. The evidence on CGK clearly shows that sugar syrups have issues with stability (see above), and it has not been established that allulose syrups were known. It is also clear from the evidence that each sugar will have different propensity to crystallise, different susceptibility to pH and microbial contamination and different rates at which HMF formation occurs. Since these parameters are not known, or common general knowledge, for allulose syrups, a lack of manner of manufacture has not been made out.
Furthermore, the specification does not make admissions to any known allulose syrup, let alone with the parameters claimed. I therefore do not consider there to be a lack of manner of manufacture based on the face of the specification.
Novelty
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, is novel. Subsection 7(1) states that an invention is considered novel unless it is not novel in the light of prior art information.
The well-established test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement."[83]
[83] [1977] HCA 19; 137 CLR 228 at 235.
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed.[84] In reviewing a citation one must look at the citation to determine what it tells the skilled reader to do. Determining what is taught or disclosed requires some consideration.
[84] Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40;(1990) 91 ALR 513 at 517.
In determining what is taught or disclosed Australian courts have often cited with approval the words of the UK Court of Appeal in the General Tire[85] case which provides guidance on assessing a disclosure for novelty. It is useful to look at that discussion in full from pages 485-486:
“If the prior inventor's publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim but would be at least as likely to be carried out in a way which would not do so, the patentee's claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee's claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented. A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee."[86] (citations omitted).
[85] The General Tire & Rubber Company v. The Firestone Tyre and Rubber Company Limited and others [1972] RPC 457.
[86] [1972] RPC 457 at 486.
General Tire explains the well-known requirement for clear and unmistakable directions in the prior publication. However, it also states that if carrying out the directions in the prior art leads inevitably to doing something within the scope of the claim in suit, then there will be a lack of novelty. This inevitable consequence of carrying out the directions in the prior art occurred in Novozymes v Danisco[87] with Jessop J providing the following guidance (with Yates J and Greenwood J concurring):
“In my view, the General Tire approach, if taken at all, may be taken only with respect to the whole of any claim asserted to have been anticipated. The “precise destination” at which the flag must have been planted is one which includes every integer of the claim. The approach cannot, in my view, be taken for some integers only, leaving others to be dealt with by reference to the understanding of the skilled addressee. In the present context, what this means is that, to the extent that the appellants’ case is based on General Tire, it is not sufficient that they be able to point to passages in the Novo patent from which it would appear to the skilled addressee that inactivation was contemplated or intended by the earlier inventors. It is necessary that they show that, if Example 20 were worked as directed, it would inevitably, as a matter of hard fact, have involved inactivation of the enzyme (to the standard set up under Claims 1 and 7 of the patent in suit as identified by the primary Judge) at the baking stage.” [88]
[87] Novozymes A/S v Danisco A/S [2013] FCAFC 6
[88] Novozymes A/S v Danisco A/S [2013] FCAFC 6 at [145].
In the current case the Opponent alleged a lack of novelty existed when compared to three documents:
D1 United States Food and Drug Administration GRAS Notice No. 498.
D2 WO 2011/119004 A2D25 relates to the certificate of analysis and sale of psicose filed in the first opposition.
Lack of Novelty when compared to D1.
D1 is concerned with the approval by the FDA for a powdered allulose product of 98.5 % purity. The Opponent submitted that although D1 is concerned with crystalline allulose it also makes a liquid product in the process. They submit that it is the liquid Product 2 made that destroys the novelty of claims 1-8 and 12-20 of the opposed application.
Shown below is the process by which allulose products are manufactured as described in D1.
The liquid form of Product 2 in D1 is said to come after Product 1 (which is another liquid form) but before Product 3 which is the crystalline product. This Product 2 is said to have a higher Brix than product 1. D1 provides an analysis of product 2 on page 5, this is reproduced below:
Product 2- Liquid Form
Specification Acceptable Value Appearance Clear yellow liquid Odor No Odor Brix 30.0 % minimum pH 3.0 – 7.0 Ash <0.5% Heavy Metal <5.0 ppm Lead <1.0 ppm Arsenic <1.0 ppm Total Plate Count <10,000 CFU/g Allulose Content >10.0 % DSB* *Allulose content may vary by process
The Opponent submitted that the pH of 3.0 to 7.0 in D3 anticipates the current claimed range because the commercial product was likely to have a pH of 5. Dr Himstedt stated:
Product 1 is an allulose syrup having an initial total dry solids content of at least 30% by weight (30% Brix), a pH of between 3.0 and 7.0, and an allulose content of at least 1.0% DSB. Product 2 is an allulose syrup having an initial total dry solids content of at least 30% by weight (30% Brix), a pH of between 3.0 and 7.0, and an allulose content of at least 10% DSB. Note that Product 3, being a crystallised or powdered form of Product 2, maintains a pH of 3.0 to 7.0, and the total dry solids and allulose content of Product 2 would have increased as Product 2 was being concentrated to produce Product 3. Product 3, if reconstituted in water, also could have all of the features of claims 1 to 4. Regardless of this, Products 1 and 2 have all of the features of claims 1 to 4.[89]
[89] Himstedt #2 at [5.3].
I note that Dr Himstedt’s statement merely states that this disclosure has all the features of claims 1 to 4, however, he does not elaborate on why he thinks a broader range of pH and a minimum Brix of 30% provides clear and unmistakable directions to the features of the current claims (that is, dry solids content of from 70% to 80% and a pH of from 3.5 to 5.0). Furthermore, the comment that if product 3 is reconstituted it could have all the features of claims 1 to 4 does not satisfy me that a lack of novelty exists.
Dr White on the other hand did not consider the disclosure of D1 to destroy to the novelty of the current claims:
While this document specifically mentions two liquid products, the description of these products is very broad. Product 1 has a minimum Brix of 30%, a pH of 3-7 and an allulose content of greater than 1.0% on a dissolved solids basis. Product 2 has a minimum Brix of 30%, a pH of 3-7 and an allulose content of greater than 10.0% on a dissolved solids basis. These are very broad ranges and the document does not describe the narrow ranges recited in the claims. This document also provides the skilled worker with no motivation to select the narrow ranges recited in the claims. It also does not indicate that the narrow ranges recited in the claims would be expected to produce an allulose syrup with improved properties, such as lower color formation, lower impurities formation and/or lower allulose degradation.[90]
[90] White #1 at [118].
The broad range of pH in D1 and the low minimum Brix value does not provide clear and unmistakable directions for the PSA to arrive at the current claimed ranges.
Lack of Novelty when compared to D2.
D2 discloses a method of producing allulose crystals. This is done by making a super saturated solution. Indeed, D2 uses a solution of allulose which is concentrated to achieve crystallisation. However, D2 is silent on pH, and this is acknowledged by the Opponent. The Opponent submitted that the pH of the syrup would likely be within the range of the claims quoting Dr Himstedt where he said:
“Although not explicitly stated, one or more of the allulose syrups of D2 is very likely to have a pH between 3.5 and 5.0”[91]
[91] Himstedt #2 at [5.35].
In all of the examples of D2 the allulose is purified to remove colored material, salts and ions. Example 2 of D2 purifies the allulose solution before further chromatography in example 3. Example 2 states:
“When an ionic component is present in a solution to be separated, an active group in a separation resin is substituted by the ionic component, reducing the separation capability of the resin and thus it is impossible to use the separation resin repetitively. Accordingly, the decolored D-psicose solution prepared above was passed through a column filled with a cation exchange resin substituted by a hydrogen group and an anion exchange resin substituted by a hydroxyl group, followed by passage through an ion exchange column filled with a mixture of a cation exchange resin and an anion exchange resin in a final step to remove the ionic components in the solution. Removal of the ionic components in the solution was confirmed by measurement of electric conductivity using conductometer. The electric conductivity of the purified solution was controlled to be about 10 microsiemens /cm or less.”[92]
[92] D2 page 8 at [69].
This step of purification would remove any buffers present that would keep the pH in the claimed ranges. This sample is then concentrated in example 3 to 60% (g/g) and passed through an ion exchange resin. Then in example 4 the purified solution from example 3 is concentrated to 80 %. Dr Himstedt had stated in his evidence in support that pH is adjusted for storage and said:
“depending on the pH of the natural fresh allulose syrup, it may be necessary to adjust the pH to optimise the ultimate storage time. Maybe, the pH would need to be increased using the likes of a buffer like sodium citrate, ascorbate or potassium citrate et cetera. Or, maybe the pH needs to be lowered using an acid, such as an approved food acid.”[93]
[93] Himstedt #1 at [3.15]
Given that Dr Himstedt says pH is adjusted for storage and this is done using buffers or acids, I find it difficult to accept that the pH of the purified solution in D2 would likely be 3.5 to 5. The purification steps in D2 would have likely removed any buffers or acids controlling pH. Dr Himstedt provides no evidence as to why this would not be the case and he does not say what the pH of a natural fresh allulose syrup is.
Dr White made the following observation on the pH in D2:
“…in the examples only temperature and concentration is used to control the crystallisation of D-psicose. The D-psicose solution used for crystallisation contains D-psicose and deionized water which is the solvent used during the purification steps. Accordingly I would expect the pH of the solution to be near neutral or slightly acidic (e.g. pH 6) due to dissolved carbon dioxide. There is no mention of pH in the examples.”
Dr White’s comments reflect the disclosure in D2. Given the disclosure of D2, I do not consider the pH of the claim is anticipated. Consequently, I do not consider that D2 discloses all the features of the current claims.
Lack of Novelty in relation to D25
100. The Opponent sought to rely on the evidence from the first opposition and the written submissions of the Opponents Archer and Samyang as part of their request under s 5.23. In that case I was not satisfied from the evidence that D25 was publicly available at the priority date. I therefore do not see any reason to consider it in this opposition.
Conclusion on Novelty
101. This ground of opposition is unsuccessful.
Inventive Step
102. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the CGK, considered alone or together with the prior art (subsection 7(3)).
103. The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd[94] Aickin J stated:
[94] [1981] HCA 12; 148 CLR 262 at 286.
"The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."
104. In Hassle,[95] the High Court endorsed the use of the reformulated "Cripps question":
[95] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411.
"Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and the facts directly be led as a matter of course to try”…the invention as claimed… “in the expectation that it might well produce a useful alternative to or" the desired result.[96]
[96] Hassle at [53].
105. This has been elaborated on in the Full Federal Court’s decision Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft:
“We do not think that the plurality in Alphapharm [Hassle] were saying that the reformulated Cripps question was the test to be applied in every case. Rather, it is a formulation of the test which will be of assistance in cases, particularly those of a similar nature to Alphapharm [Hassle]. The plurality did not reject as an alternative expression of the test the question whether experiments were of a routine character to be tried as a matter of course (The Wellcome Foundation Limited v VR Laboratories (Aust) Proprietary Limited (1981) 148 CLR 262, at 280‑281, 286, per Aickin J). We do not think there is a divide here in terms of whether an expectation of success is relevant between a test which refers to routine steps to be tried as a matter of course and the reformulated Cripps question. It is difficult to think of a case where an expectation that an experiment might well succeed is not implicit in the characterisation of steps as routine and to be tried as a matter of course.“[97]
[97] [2014] FCAFC 73 at [71].
106. In relation to having multiple options to try the Full Federal Court in Nichia[98] said that the words of Laddie J in Brugger v Medic-Aid Ltd [1996] RPC at 661 were orthodox:
[98] Nichia Corporation v Arrow Electronics Australia Pty Ltd [2019] FCAFC 2 at [93].
“… if a particular route is an obvious one to take or try, it is not rendered any less obvious from a technical point of view merely because there are a number, and perhaps a large number, of other obvious routes as well. If a number of obvious routes exist it is more or less inevitable that a skilled worker will try some before others. The order in which he chooses to try them may depend on factors such as the ease and speed with which they can be tried, the availability of testing equipment, the costs involved and the commercial interests of his employer. There is no rule of law or logic which says that only the option which is likely to be tried first or second is to be treated as obvious for the purpose of patent legislation.”
107. In Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2)[99] the High Court provided guidance on admissions of prior art and CGK in patent specifications stating:
[99] [2007] HCA 21; 235 CLR 173 at [105]-[109].
“Admissions may be made in a specification, particularly about prior art and CGK. This is consistent with conventional methods of drafting patent specifications intended and recognised as a way of clearly articulating the advance over prior art made by the invention. Such an approach also facilitates an understanding of the relevant inventive step, irrespective of whether the inventive step is identified with any precision in the specification, a task which may be difficult. While not every invention constitutes a solution to a problem, it is commonplace so to describe an invention where it is appropriate to do so. Admissions in a specification about any problem said to be overcome by an invention are made from the vantage point of knowing the solution. When used as evidence, they would always need to be weighed with evidence, if it exists, from persons skilled in the relevant art of their perception of any problem at the time before the priority date, before their exposure to any solution contained in the invention.
[…]
In Sonotone Corporation v Multitone Electric Coy Ltd ("Sonotone"), which concerned an invention that applied a known scientific principle to the construction of a hearing aid, the English Court of Appeal noted that express admissions in a specification about matters of CGK must carry great weight but that such admissions do not estop a patentee from leading evidence in order to resile from them. Blanco White's comment on Sonotone ‘that something nobody has ever suggested can in any sense form part of existing knowledge seems almost a contradiction in terms’ is particularly apposite to the notion that a solution to a problem is an ‘implicit “corollary” admission’ in a specification which states the problem. Admissions in a specification on CGK are, without doubt, relevant but they are to be assessed as to their probative force like all other evidence.”
108. In AstraZeneca AB v Apotex Pty Ltd[100] (AstraZeneca), the Full Court held that it is not permissible to incorporate information that is not available to the person skilled in formulating the problem in the art either as CGK or information available under subsection 7(3).
[100] [2014] FCAFC 99; 107 IPR 177.
109. The Opponent submitted that the claims lacked an inventive step in the light of the CGK considered alone and also that the claims lacked an inventive step when the CGK is considered together with any one of D1, D2 or D25.
The Problem
110. The Opponent submitted that the alleged invention aims to address one or more of the problems of allulose syrups that include degradation over time, color formation, the formation of impurities (such as HMF), crystallisation and/or inadequate microbial stability. They relied on passages within the opposed application to support this:
“It has been found that allulose syrups may be susceptible to degradation over time (i.e. gradual reduction in allulose content), to color formation, to the formation of impurities (such as hydroxymethylfurfural -HMF), to crystallization and/or to inadequate microbial stability. It is desirable to provide an allulose syrup that addresses one or more of the above problems.”[101]
[101] Page 2 line 26 to page 3 lines 2.
111. The Applicant did not accept that this was the problem as the words used here “It has been found” is not a statement of admission and is not saying that it is well known. I agree with the Applicant that “it has been found” is not a statement that it was CGK or well known. Nor does this passage provide any information on who found it, no reference is given and it is possible it could have been unpublished work by the inventors and simply a discovery made on the path to invention.
112. I have found that allulose itself was part of the CGK and that sugar syrups were also part of the CGK and often made depending on use. However, allulose syrups as such were not. Therefore, the problem is to make a formulation of allulose for use in manufacturing such as a syrup.
113. The current claims are to an allulose syrup with a specific pH range, a dry solids content and a purity of allulose specified. The question then becomes are these features matters of routine?
114. The Opponent relied on evidence of Dr Himstedt that he would consider the Brix; water activity; pH; purity; crystallisation point; storage directions for use; flowability/viscosity and browning potential over time.[102]
[102] Himstedt #1 at [3.8]
115. Dr Himstedt had been shown the background of the opposed application and said:
“Prior to 24 February 2015, hypothetically, I would make the allulose syrup by dissolving crystalline pure allulose with water. I would ensure pure clean filtered water is used, and would progressively add the allulose until it reached a target Brix of approximately 70-73 Degrees (as an initial target of total dissolved solids). Brix is simply a measure of the total soluble solids, which in this case means that the total allulose percentage would be approximately 70%-73% Degrees Brix. I may even make a lower Brix solution, say 60% to 66% Degrees Brix, if we were to use a hot fill (sterile fill process into bags). This would be sufficient for some downstream applications. But if I wanted to store the allulose syrup at ambient conditions, for a longer period, I would target as mentioned approximately 70% Degrees Brix or slightly higher. This is similar to what I would normally make with fructose solutions/and also similar to how invert sugar would have been purchased from third party suppliers and arrived into my factory prior to 24 February 2015. It is also similar to how sorbitol arrived into my factory prior to 24 February 2015.”[103]
[103] Himstedt #1 at [3.10].
116. Dr Himstedt goes on to say that high Brix values, of 75%, to inhibit microbial growth could be used, however, this would increase the potential for crystallization:
“It could be considered to make the solution of allulose at even greater Brix (percentage dissolved allulose), in order to reduce the Aw to an even lower amount, to make an even safer microbial barrier. For example, at 75% Degrees Brix allulose (pure allulose), the Aw might have dropped to 0.7 to further restrict growth of possible spoilage organisms. However, there is a balance which must be considered. At high concentration, for example, over 75% Degrees Brix, there is a significantly increased potential for detrimental problems to occur, such as crystallisation. The higher the concentration, the more likely the product could crystallise, rendering the product unusable for future use.”[104]
[104] Himstedt #1 at [3.12]
117. Dr Himstedt did also say that pH was an important factor to consider and stated that at lower pH HMF formation is more likely to occur and that buffers such as citrates or approved acids were used.[105]
[105] Himstedt #1 at [3.14]-[3.15].
118. Dr White’s evidence differed from that of Dr Himstedt in that he thought these factors would depend on the specific sugar. That is, they are not merely predicted parameters as submitted by the Opponent. On the concentration and crystallization issue he said:
“I would attempt to lower the concentration of the sugar in solution to avoid concentrations which approach the solubility limit of the sugar. The solubility limit of a sugar will depend on the physical and functional properties of the sugar, and is commonly known to vary from sugar to sugar. I would also consider the recommended storage temperature for the sugar, as the solubility of a sugar will typically decrease as temperature decreases. For example, fructose is more soluble than glucose and can therefore be transported at lower temperatures without crystallisation.”[106]
[106] White #1 at [37].
119. Dr White also said that pH could be manipulated to prevent microbial growth, however, it is clear that it would depend on the properties of the sugar and would not be predicted.
“Microbial species are able to survive and grow under specific conditions of temperature, pH and sugar concentration and osmotic pressure. When formulating a sugar syrup I would try to avoid conditions under which microbial species can survive and/or grow by manipulating these properties of the syrup. In general, the lower the pH, the lower the microbial growth. However, each microbial species will have a pH range in which they are able to survive and/or grow and I would consider the preferred pH range of microbial species commonly encountered in sugar syrups, food or beverages and try to avoid formulating the syrup with a pH in the optimal growth range. For sugar syrups, the osmotic pressure is dictated by the concentration of the sugar in solution and by the colligative properties of the sugar. Generally, microbial species will not grow and/or survive when the sugar concentration is above a certain value and I would aim for a sugar concentration that is above this level. However, this sugar concentration is different depending on the colligative properties of the sugar and this concentration may need to be determined experimentally. Finally, I would consider elevating the temperature of the sugar syrup for a period of time to try to reduce the number of microbial species present in the syrup. However, I would also be aware that increased temperatures can cause sugars to degrade and care would have to be taken to minimise exposure to conditions that caused unacceptable degradation.”[107]
[107] White #1 at [38].
120. Both declarants acknowledged the issue of HMF formation and colour. On reading the specification Dr White stated that:
“…the inventors found that color formation increased with increasing temperature and pH. While increasing pH decreased allulose content loss, it increased color formation. Indeed, it is a surprisingly narrow range where there is a balance of both color and composition stability. None of the documents I have reviewed in this opposition have shown such a narrow pH range for an allulose syrup. The inventors also found that HMF content increases over time, but the change was greatest for low pH and higher temperature.”[108]
[108] White #1 at [87].
121. Dr White went on to explain why he found this surprising, saying that:
“I am not aware of a similar phenomenon with other sugars, including fructose, glucose and HFCS. One has to appreciate that all sugars are different and they have different chemical reactivities.”[109]
[109] White #1 at [81].
122. In my view the pH range in the claims is narrow compared to any known syrups and would not be predicted. That is, I accept Dr White’s evidence that different sugars have different properties. The question becomes would it be routine for the PSA to carry out tests and arrive at the claimed parameters. After reviewing the specification Dr White concludes that:
“The Opposed Specification is focused on defining factors that affect the stability of allulose in solution including pH, concentration and dissolved solids. The inventors have made several time course comparisons between different variables. They identify in detail the measurement of important parameters and outcomes like pH, dry solids content, temperature and various impurities, such as HMF content. My overall impression is that the approach that the inventors took was more like a scientific paper than I would normally find in a patent specification or the prior art documents I have discussed in the previous section. Overall, the examples provide a significant body of work that surprisingly demonstrates that an allulose syrup that is defined narrowly in terms of pH and DS has improved stability when allulose content, HMF formation and color formation are all considered.[110] (my emphasis)
[110] White #1 at [91].
123. Dr White’s evidence that the approach in the opposed application that it is more like a scientific paper supports the view that it was not a matter of routine.
124. Dr Himstedt on reading the specification said:
“Ultimately, the hurdle faced by the Applicant was to produce the best set of combined parameters to produce optimal shelf life and stability for an allulose syrup.”[111]
[111] Himstedt #2 at [2.20].
125. He then went on to say that:
“The question in my mind is whether the series of tests together uncover and prove a truly unique situation or chemical and physical characteristics which allow for allulose to be made into a solution with the desired properties which otherwise would not be known. In my mind, the answer is “no.” The tests as described in the opposed application represent standard evaluation techniques which are performed time and time again when developing food systems with high dissolved solids such as sugar syrups, and nothing unexpected was discovered in the opposed application. Although the tests represent a comprehensive battery of stability trial parameters, it is my opinion that there is no unique combination of parameters uncovered. Although it is true that less is known about the allulose sugar due to its relatively new commercial uptake (compared with fructose, for example), this does not change anything. The principles employed by the Applicant to establish the processing and parameters for a stable allulose syrup are the same as those that were well-known and common practice as at the earliest priority date of the opposed application.”[112](my emphasis)
[112] Himstedt #2 at [2.21].
126. Dr Himstedt appears to acknowledge that less is known about allulose and that the parameters for the syrup would need to be worked out. He states that the techniques used were standard evaluations techniques employed “time to time again.” He does not say what would be done as a matter of routine for a new syrup. Would all the parameters in the specification be tested? There is no evidence on what would be routine or a matter of course for a PSA looking to develop a new type of sugar syrup. Would a narrow pH range be contemplated and tested a long a range as a matter of routine? It appears that pH was a variable that was might be assessed. But there is no evidence from a naïve expert on how this would be done.
127. This question as not been in evidence nor has any steps taken been set out. Without knowledge of what would be routine for the PSA to do insofar as pH and other experimentation I do not consider the narrow range claimed to be obvious. There are a number of parameters to consider, of which pH is one and CGK does not give any direction as to which of the many possible choices is likely to be successful.[113]
[113] See Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 at [76].
128. Given this I do not find that the Opponent has demonstrated on the balance of probabilities that a lack of inventive step exists based on the CGK alone.
Lack of inventive step when compared to D1 in the light of the CGK.
129. The Opponent submitted that the current claims lacked an inventive step when compared to D1 in light of the CGK. For claim 1, they relied on their submissions for novelty.
130. D1 is concerned with the approval by the FDA for a powdered allulose product of 98.5 % purity. It mentions syrups can be taken out of the process for making the solid products, namely product 2 which is discussed above for novelty. As discussed for novelty, this syrup is outside of the range of the current claims.
131. Given what I have found about whether allulose syrups were CGK and the lack of evidence on routine steps to arrive at the narrow range of the pH, I do not find that going from the powder disclosed in D1 to the syrup with the dry solids and pH of the current claims is obvious. Consequently, a lack of inventive step has not been made out.
Lack of inventive step when compared to D2 in the light of the CGK.
132. D2 is discussed above and like D1, the Opponent relied on their submissions for novelty for claim 1. As I have outlined above for novelty D2 discloses a method of producing purified crystals of allulose. This is done from a supersaturated solution. The Opponent’s submissions for novelty were that the supersaturated solution is novelty destroying for the current claims. However, I have found that this was subjected to purification and had no disclosure of the pH being controlled. There is no evidence that the PSA would routinely modify this supersaturated solution to arrive at the current claims. Therefore, a lack of inventive step when compared to D2 has not been made out.
133. Insofar as D25 as it was found that it was not publicly available in the first opposition, it cannot be used for a lack of inventive step here.
Conclusion on inventive step.
134. The evidence does not establish a lack of inventive step. This ground of opposition has been unsuccessful.
Conclusion
The Opposition has been unsuccessful on all grounds.
Costs
135. It is usual for costs to follow the event. I therefore award costs as outlined in Schedule 8 against the Opponent.
K. Wagg
Delegate of the Commissioner of Patents
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