Steven Borovec v Suntory Holdings Limited
[2022] APO 33
•13 May 2022
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Steven Borovec v Suntory Holdings Limited [2022] APO 33
Patent Application: 2015325329
Title:Carbonated beverage, syrup used for preparing carbonated beverage, method for manufacturing carbonated beverage, and method for suppressing foaming in carbonated beverage
Patent Applicant: Suntory Holdings Limited
Opponent: Mr Steven Borovec
Delegate: K. Wagg
Decision Date: 13 May 2022
Hearing Date: 17 February 2021
Catchwords: PATENTS – Opposition to grant — section 59 — lack of clarity established — suppression of foaming — All other grounds of opposition fail — inevitable consequence considered — costs awarded against the Applicant.
Representation: Counsel for the Applicant: Neil R Murray SC; Ben Mee
Patent attorney for the Applicant: Davies Collison Cave
Counsel for the Opponent: Clive Elliot QC
Patent attorneys for the Opponent: F.B. Rice
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2015325329
Title:Carbonated beverage, syrup used for preparing carbonated beverage, method for manufacturing carbonated beverage, and method for suppressing foaming in carbonated beverage
Patent Applicant: Suntory Holdings Limited
Date of Decision: 13 May 2022
DECISION
The opposition has been successful on the ground of clarity. Subject to appeal, the Applicant has 60 days to file suitable amendments.
Costs are awarded against the Applicant under Schedule 8.
REASONS FOR DECISION
Background
Patent application number 2015325329 (the Application or the Specification) was filed on 30 September 2015 by Suntory Holdings Limited (the applicant).Consequently, 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 present application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. 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 application claims a priority date of 30 September 2014.
The application was examined and advertised as accepted by the Commissioner on 10 August 2017. Mr Steven Borovec (the opponent) filed a notice of opposition to grant on 10 November 2017 under section 59 of the Act. This decision concerns the opposition to grant under section 59 (this opposition).
The Grounds of Opposition
The Amended Statement of Grounds and Particulars identified all of the available grounds. At hearing the following grounds were pressed:
·Lack of Novelty
·Lack of Inventive Step
·That the application does not comply with s 40(2) and s 40(3), including a lack of clarity, a lack of a clear enough and complete enough disclosure and a lack of support.
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 comprises the following declarations:
Declarant Date Reference Exhibits Dr John C. Fry 28 April 2018 Fry #1 JF-1 to JF-15 Dr Grant Edwin DuBois 6 May 2018 DuBois #1 GD-1 to GD-15 Steven Borovec 9 February 2010 Borovec SB D1-D7 and SB P1-P5 I note that the Borovec declaration is not expert evidence but serves to add documents into the evidence.
The evidence in answer comprises the following declarations:
Declarant Date Reference Exhibits Dr Philip Roy Ashurst 8 August 2018 Ashurst #1 PRA-1 to PRA-8 Ms. Cydney A. Whitmoyer 8 August 2018 Whitmoyer CAW-1 to CAW-7
. The evidence in reply comprises the following declarations:
Declarant Date Reference Exhibits Dr John C. Fry 5 October 2018 Fry #2 JF-16 to JF-28 Dr Grant Edwin DuBois 4 October 2018 DuBois #2 GD-16 to GD-21
The material allowed under regulation 5.23 from the opponent comprises the following declarations:
Declarant Date Reference Exhibits Dr John C. Fry 8 May 2019 Fry #3 JF-29 Dr Grant Edwin DuBois 9 May 2019 DuBois #3 Dr John C. Fry 11 February 2020 Fry #4 JF-30 to JF-32 Dr Grant Edwin DuBois 24 February 2020 DuBois #4 GD-22
The applicant’s reply to the regulation 5.23 material comprised the following declaration
Declarant Date Reference Dr Philip Roy Ashurst 8 March 2019 Ashurst #2 Dr Philip Roy Ashurst 11 June 2019 Ashurst #3 The Specification
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.”[3]
[3] 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. A good starting point for this is the invention's field followed by whatever background the specification sets out.
The Field of the Invention
The Opposed Application begins by outlining the field of the invention as:
“This embodiment relates to a carbonated beverage, a syrup used for the preparation of a carbonated beverage, a method for producing a carbonated beverage, and a method for suppressing the foaming of a carbonated beverage.”[4]
[4] Page 1, [0002] (from here on in any reference to pages and paragraphs-numbered in square brackets-refer to the application unless otherwise specified).
The above field is clearly about carbonated beverages and matches the title of the specification. I note that a syrup and the method for suppressing the foaming of a carbonated beverage is clearly outlined as one of the four points the “embodiment” relates to.
Background
The Background Art section begins by discussing carbonated beverages and states that carbonated beverages are various and have properties such as visually pleasing a drinker by foaming when opening a container or when pouring the carbonated beverage into a glass. They also give a refreshing feeling in the throat.[5] The foaming is said to mainly be due to the carbon dioxide gas and the specification states:
“…but foaming may be a problem.”[6]
[5] Page 1 [0003].
[6] Ibid.
The specification does not go into detail about what the problems associated with foaming are but discusses prior art that addresses the current ways of suppressing foaming.[7] These prior art methods include the use of antifoaming agents such as silicon oil.[8] The next prior art discussed is about the use of a stevia extract which has improved carbon dioxide retention, but it is pointed out that they are not directed to the suppression of foaming.[9]
[7] Page 1 [0004] to page 2 [0005]..
[8] Page 1 [0004].
[9] Ibid.
The next section in the specification is the summary of invention and it begins by discussing natural sweeteners.[10] It states that the inventors have conducted a study on the use of natural sweeteners and says that natural sweeteners foam and bubble over the container in some cases, or foam over when poured into a glass.[11]
[10] Page 2 [0006].
[11] Page 2 [0006] – page 3.
The natural sweeteners extracted from stevia, stevioside and rebaudioside (Reb) are then introduced.[12] Stevia refers to Stevia rebaudiana bertoni which is a perennial plant native to Paraguay in South America.[13] Stevia leaves are dried and extracted to give a component about 300 times sweeter than sugar with individual compounds Reb, Reb A, Reb B, Reb C, Reb D and Reb E having been described.[14] More recently the glycoside Reb M has been described.[15]
[12] Ibid.
[13] Page 5-5a [0012]
[14] Ibid.
[15] Ibid.
Aim of the invention and problem
The present invention is said to be made in view of the “above-described problem” and the specification states:
“it is an aspect of the present invention to provide a carbonated beverage in which foaming is suppressed.[16]
[16] Page 3 [0007].
A syrup for and method of preparing a carbonated beverage and method of suppressing the foaming of a carbonated beverage are also stated as an aspect of the invention.
Given the background study on natural sweeteners mentioned at [0006], it appears that the aim is to provide a carbonated beverage with a natural sweetener wherein foaming is suppressed.
The Person Skilled in the Art (PSA)
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 with the following words:
“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.” [17]
[17] 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 expressed in AstraZeneca[18]:
“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.”[19]
[18] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30.
[19] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23].
Lord Diplock 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’)”[20]
[20] Catinc 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.”[21]
[21] 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 carbonated beverages and it is clear from the background that sweetener additives, including those from stevia are a key focus.
The expert witnesses in this case are:
·Dr John C. Fry—a consultant on food additives and ingredients, food innovation and development and specialty ingredients. Dr Fry also has experience in the development of Truvia stevia leaf extracts, a natural zero-calorie sweetener. [22]
·Dr Grant Edwin DuBois —a consultant for Sweetness Technologies, working with a client who manufacturs ultra-high purity Reb A. Dr Dubois also worked for the NutraSweet company and Coca cola.[23]
·Ms Cydney A. Whitmoyer—a beverage development consultant who has worked for Cadbury Schweppes and McCormick Flavors and worked on food ingredients for non-alcoholic beverages.[24]
·Dr Philip Roy Ashurst —a consultant with many years’ experience in beverage development including carbonated soft drinks and work as a flavourist. Ashurst has also authored chapters in textbooks on natural food extracts in soft drinks.[25]
[22] Fry #1 [1]-[3].
[23] Dubois #1 at [1]-[4].
[24] Whitmoyer #1 at [1]-[14].
[25] Ashurst #1 at [1]-[26].
It is clear that each of the experts have knowledge of sweeteners for carbonated beverages and their evidence will assist me in providing insights into aspects of the person skilled in the art.
The Opponent made submissions at the hearing about Dr Ashurst’s and Ms Whitmoyer’s evidence being tainted with hindsight. The Opponent was concerned they were told the problem before addressing the issue of foaming. The Applicant was given the opportunity to respond to this in further written submissions. The weighing and evaluation of evidence are part of the normal work of a delegate of the Commissioner, and I will therefore weigh and evaluate the evidence from all of the declarants in my capacity as a delegate. If I find that evidence is tainted with hindsight, its weight will also be affected.
The Invention Described in the Specification
The specification states that the inventors have found that Reb A is involved in foaming during opening of carbonated beverages and that foaming can be suppressed by decreasing the content of Reb A as a stevia extract in a carbonated beverage.[26]
[26] Page 5b [0013].
The specification states that Reb D and Reb M are less likely to foam than Reb A and that:
“..by replacing Reb A as a stevia extract with Reb D and/or Reb M in a carbonated beverage, sweetness derived from a stevia extract can be sufficiently given while the problem of the foaming of the carbonated beverage is addressed.” [27]
[27] Page 6 [0014]..
The specification also lists quantities in ppm of Reb A and Reb D or Reb M to be used in carbonated beverages, including mass ratios of Reb D and/or Reb M to Reb A. I note that Reb D and Reb M can be used singly or in combination.[28] When both Reb D and Reb M are used the total of both of them can be 486 ppm or less.
[28] Page 6 [0014].
It is said that when the carbonated beverage only contains Reb M then it is preferentially 450 ppm or less; 404 ppm or less and more preferably 271 ppm or less.[29]
[29]Ibid.
It is said that the total amount of Reb A, Reb D and Reb M in the carbonated beverage can be equivalent to Brix 0.5 to 13.5, preferably 0.5 to 12, more preferably 0.5 to 11.5 and further preferably 0.5 to 7.5 in terms of glucose.[30] Brix is a comparative measure of sweetness which in this case is compared to sucrose.[31] Dr Fry explains that a sample of 10 % by weight sucrose dissolved in water has a value of 10 Brix as does Dr Ashurst.[32] Reb A itself is said to be 300 times the sweetness of sucrose, Reb D is 285 times the sweetness of sucrose and Reb M is 285 times the sweetness of sucrose.[33]
[30]Page 7 [0015].
[31] Page 9 lines 18-20.
[32] Fry #1 at [30]; Ashurst #1 at [51].
[33] Page 7 [0016].
The specification measures the suppression of foaming by making up solutions with different degrees of sweetness according to Brix.[34] These are done for solutions of Reb A, Reb D and Reb M dissolved in 15.8 mL of water and made up to 100 mL with carbonated water, sealed and refrigerated at 4 ̊C for 1 hour. The container is then opened and an inverted 500 mL graduated cylinder placed over the top before the container and the inverted cylinder is flipped such that the test solution pours into the graduated cylinder. The scale on the graduated cylinder is used to read how far up the bubbles rise this is referred to in the specification as the bubble liquid level.[35] The results of this experiment are shown in Figure 1.
[34] Page 8 [0017].
[35] Ibid.
For Reb M when the amount blended was 11.5 or less in terms of sucrose, the bubble liquid level was decreased compared with that for Reb A.[36] From this the foaming suppression effect of Reb M was said to be effective in the alternative to Reb A at Brix 0.5 to 11.5 or 1.0 to 11.5 in terms of sucrose.[37] The bubble liquid level is also measured in Figure 2 for Reb A, Reb D and Reb M in a beverage with caffeine and cinnamaldehyde.[38]
[36] Page 8-9 [0017] Figure 1.
[37] Page 9[0018].
[38] See Figure 2.
The method for producing the carbonated beverage is provided in broad terms,[39] with paragraphs [0023]-[0029] providing the test solutions. At [0040] it is said that Reb D and/or Reb M may be in particular ratios to Reb A in the syrup being used and it can be preferably 0.45, 1.1; and further preferably 6.0. It is said at ratios less that 0.45 that the influence of the Reb A is strong and the foaming of the carbonated beverage sometimes cannot be suppressed.
[39].Beginning page 20 [0037].
The carbon dioxide that can be supplied is such that the gas pressure in the carbonated beverage is 1.7 kgf/cm2 or more; 1.89 kgf/cm2 or more or 2.15 kgf/cm2 or more. An upper limit and 5.0 kgf/cm2 or less and 4.0 kgf/cm2 or less is also stated.[40]
[40] Page 25 [0047].
The specification ends with 21 claims, with claims 1, 3 and 5 being the only independent claims. Claims 1 is directed to the carbonated beverage, claim 3 is directed towards a syrup for preparing a carbonated beverage and claim 5 is to a method of suppressing foaming in a carbonated beverage.
The Claims and Clarity
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” [41]
[41] [2009] FCAFC 70, 81 IPR 228 at [118] – [120].
This approach of reading the specification as whole through the PSA's eyes with the CGK in mind provides context and the intention behind what is meant[42] and is commonly referred to as a purposive construction.[43]
[42] Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183 (HC).
[43] Technip France S.A.’s Patent [2004] RPC 46.
It is a requirement of subsection 40(3) of the Act that the claims must be clear. This requirement is understood to be satisfied if a person could ascertain "whether or not what he proposes to do falls within the ambit of the claim".[44] Therefore if a construction of the claims where the monopoly is defined cannot be determined, then the claims must fail for want of clarity. However, 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.[45]
[44] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59.
[45] Minnesota Mining and Manufacturing Co. v Beiersdorf (Australia) Ltd. (1980) 144 CLR 253 at (46).
The claims were amended during the opposition, claim 1 currently stands is repeated below:
A carbonated beverage filled into a container, in which foaming is suppressed, wherein the beverage satisfies the following requirements:
a content of Reb A is 250 ppm or less,
a content of Reb M is 486 ppm or less,
Reb M/Reb A is 2.5 or more in a mass ratio,
a total content of Reb A and Reb M is 0.5 to 11.5 in Brix in terms of sucrose,
a content of caffeine is 1 to 200 ppm, and
a gas pressure of carbon dioxide is 2.15 kgf/cm2 or more when measured at 20̊C.The claim is directed to a carbonated beverage filled into a container, in which foaming is suppressed, followed by requirements on the beverage. The “beverage requirements” are the limits on the gas pressure of carbon dioxide at 20̊C and the limit on the content of Reb A and Reb M, the mass ratio of Reb M to Reb A and the total sweetness with Brix measured in terms of sucrose. The words “foaming is suppressed” were a focus of the Opponent’s arguments so I will discuss that separately to the beverage requirements.
“foaming is suppressed”
The Opponent submitted that there is difficulty with just stating “foaming is suppressed”. They submitted that third parties do not know whether a major or minor reduction in foaming is required in order to fall within the scope of the claims and there is no suitable standard provided in the specification to resolve these concerns. The applicant responded to this and submitted that this is a claim limited by result. The result being that there must be a suppression of foaming and when construed in the context of the specification it means that the foaming of the carbonated beverage containing the Reb M/Reb A sweetener as must be less than the foaming observed in a corresponding beverage containing only Reb A. With those submissions in mind it is useful to observe how the experts construed this feature.
Ms Whitmoyer stated that:
“In the context of the Opposed Application as a whole, I understand the term “suppressed” means the reduction of foaming, not the elimination of foaming. This is consistent with the Background of the Opposed Application, which describes carbonated beverages as being visually pleasing to the consumer due to foaming upon opening a container or when poured into a glass”[46]
That definition, in my view, leads to something quite subjective or an “I know it when I see it”[47] argument. Furthermore, there is still an implicit comparison that would need to be undertaken to ascertain whether or not a reduction has occurred.[48]
[46] Whitmoyer #1 at [129].
[47] Jacobellis v. Ohio, 378 U.S. 184 at 197
[48] NOTHING IN HERE
Dr Ashurst understood[49] that some foaming is desirable as identified in paragraph [0003] of the specification, where it is said to be visually pleasing and refreshing. However, when he was asked, he referred to the specification where the Reb M beverage properties had suppressed foaming compared to the Reb A beverage.[50] The Opponent is correct in their submissions that there is no precise definition of “foaming is suppressed” and instead there are only comparisons of Reb M (or Reb D) to Reb A.
[49] Ibid.
[50] Ashurst #1 at [232] refers to [0017]; [0018]; [0026] and [0031].
When Dr Fry read the specification he also noted that foaming is only measured in relative terms.[51] However, when he was shown the claims he did not comment on this feature.[52] When he was asked to compare the claims to the prior art Dr Fry made the following comments:
“I note that claim 1 of the Opposed Specification refers to reduction of foaming. I do not know whether that makes any difference, but it seems to me that since a skilled addressee would anyway have made a beverage having all the components of claim 1, the formulation would inevitably have had reduced foaming properties also (if it were properly demonstrated that the formulation actually achieves reduced foaming relative to a comparative Reb A-containing composition..)…”[53] my emphasis
[51] Fry #1 at [89].
[52] Fry #1 at [106] et seq.
[53] Fry #1 at [124]
In the above passage Dr Fry questions the need for the phrase “foaming is suppressed” given that the beverage requirements are what he supposes to cause the suppression. He also states that it is to be considered comparative to the Reb-A-containing composition. It is now worth noting that claims 8, 12 and 16 provide the comparison with a beverage made up with Reb A which defines suppression of foaming. This construction therefore leads to a redundancy.
Where the plain and unambiguous meaning of terms in a claim is clear, it cannot be varied by reference to the body of the specification.[54] If, however, the terms are unclear they may be defined or clarified by reference to the body of the specification.[55] In the current case the phrase “foaming is suppressed” is not defined other than in a subjective way (visually pleasing)[56] and in an alternative if the PSA reads in from the specification that is is suppressed relative to the same beverage made up with Reb A a redundancy of claim 1.
[54] Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at [15]
[55] Ibid.
[56] Whitmoyer #1 at [129].
It appears that the experts read different meanings into claim 1, some add the comparison to the Reb A beverage, because the phrase in the claim is unclear in itself, however, doing this leads to a redundancy in the claims and the alternative is something quite subjective “visually pleasing”. Consequently, the two alternative constructions of claim 1 do not satisfy me on balance that the claim is clear. Claim 1 lacks clarity because of the phase “foaming is suppressed”.
Claims 3 also uses the phrase “foaming is suppressed” and claim 5 is directed to “a method of supressing foaming. These claims suffer from the same issue as claim 1. It follows that these claims are also unclear.
The dependent claims 2, 4 , 6-7, 9-11, 13-15, 17-21 do not provide any clarification for the suppression of foaming and consequently, these claims lack clarity.
As mentioned above, claim 8, 12 and 16 provides the clarification of comparing the beverage claimed with the same beverage with Reb A, that is, where Reb A is substituted for the Reb M such that the Brix value is the same. The Opponent submitted that claim 8,12 and 16, although has the comparator, still has an absolute requirement for foaming to be suppressed and is still unclear. Given that the majority of the experts understood the comparison to be made using the examples, a workable standard exists for these claims. Consequently, claims 8, 12 and 16 are clear.
The beverage requirements
The Opponent submitted that “a content of Reb A is 250ppm ” with the content of “Reb M being 486 ppm”--the extremes in the claim, are impossible. That is they cannot be present at this level and also satisfy the mass ratio of 2.5 or more Reb M/Reb A. They state that the maximum amount of Reb A allowed in the claim is impossible to be achieved. Dr Fry noted this in his evidence.[57] I do not consider this to be a lack of clarity. What the Opponent appears to be suggesting would be something outside of the scope of the claim because it does not satisfy one of the features of the claim. Accordingly, this does not give rise to a lack of clarity.
[57] Fry #1 at [108].
The Opponent submitted that “Brix in terms of sucrose” is not specified in the claims and no standard test or method is given. Brix in terms of sucrose appears to be a relative test where sweetness is measured against a sucrose solution as the standard. Dr Fry did comment on the Brix numbers given in the specification[58] and said that a panel of tasters should be used.[59] However, he explained Brix in terms of sucrose in his background[60] and did not comment on the temperature required, as submitted by the Opponent. In fact all of the experts discussed Brix in terms of sucrose as a standard measure of sweetness and it is also used in the prior art cited. Dr Fry’s critisms instead appeared to relate to the specification assuming that the sweetness relationship of the Rebaudicides was linear.[61] Even with that criticism of how sweet Reb A and Reb M are, Dr Fry conceded that there may be a point on the curve where Reb A has 300x the sweetness of sucrose[62] and the issues he discussed appeared to be a problem where at high concentrations sweetness plateaus.[63] There was no evidence that the concentrations used in the claims suffered from this plateauing.
[58] Fry #1 at [92].
[59] Fry #1 at [96].
[60] Fry #1 at [30].
[61] Fry #1 at [92]-[93].
[62] Fry #1 at [94].
[63] Fry #1 at [95].
The Opponent also commented on the specification stating at paragraph [0016] Reb M being 403.65 and not 486 ppm as claimed, however, I fail to see how 486 ppm in the claims is unclear.
I am not satisfied that any of the evidence on the beverage requirements in the claims leads to a lack of clarity.
Conclusion on Clarity
Claims 1-7, 9-11, 13-15, 17-21 lack clarity. It has not been established that claims 8, 12 and 16 lack clarity.
Section 40(2)(a)
The amendments brought about by Raising the Bar introduced the following piece of legislation under s 40 (2):
“A complete specification must:
(a) disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art;”
In Merck Sharp & Dohme Corporation v Wyeth LLC (No 3[64]) (MSD), Burley J considered the law regarding the ground o support[65] and also considered s 40(2)(a). His honour consulted the explanatory memorandum, which discussed how the change brought about by Raising the Bar was intended to align the Australian disclosure requirements with those overseas.[66] His honour then considered s 40(2)(a) in comparison to the EPC and UK Act. He noted that s 40(2)(a) is expressed in terms that are virtually the same as in s 14(3) of the UK Act[67] but notes that the highest courts of the UK have emphasised the influential effect of the EPO Technical Board. I note that his approach is consistent with the approach used by this office in CSR Building Products Limited v United States Gypsum Company[68] (CSR) which involves the following three steps:
(1) Construe the claims to determine the scope of the invention as claimed,
(2) construe the description to determine what it discloses to the person skilled in the art, and
(3) decide whether the specification provides an enabling disclosure of all the things that fall within the scope of the claims.[69][64] [2020] FCA 1477.
[65] Ibid at [502]
[66] Ibid at [513]
[67] Ibid at [521]
[68] [2015] APO 72.
[69] Ibid at [89].
When deciding the third question the delegate in Evolva[70] included the following two questions:
(4)Is it plausible that the invention can be worked across the full scope of the invention?
(5)Can the invention be performed across the full scope of the claims without undue experimentation?[70] Evolva SA [2017] APO 57.
In Cytec Industries Inc. v Nalco Company[71] Burley J cited the above office decisions and appeared to state that this was the correct approach.
[71] [2021] FCA 970 at [145]-[146].
The Opponent submitted that the measuring of how “foaming is suppressed” was not described in a clear enough and complete enough manner. This included the method of measuring the bubble level by opening the container with a graduated cylinder on top and flipping it over such that the beverage pours out and measuring where the bubbles go to on the cylinder. I have discussed this issue under lack of clarity and it should be clear that the specification does measure foaming against the same product made up with Reb A and no Reb M.
The Opponent further criticised the experimental results in the specification, stating that there is high variability and poor reproducibility from looking at the Figures. Dr Fry used similar language in his evidence, stating that:
“By way of example, for one set the 200ppm caffeine experiment foamed to a level of greater than 1.5 times the level of the 1ppm caffeine experiment, whereas for other set the 200ppm caffeine experiment only foamed to just less than 1.3 times the level of the 1 ppm caffeine.”
The Opponent also submitted that the error bars in Figure 1 which compare the bubble levels of Reb A, Reb D and Reb M beverages were too large and in doing so suggested implausibility. I do accept that there are large error bars in Figure 1 particularly at the higher levels of Brix is reflective of some variability in the data. I do not understand this as indicative of an actual failure to achieve the result of reduced foaming, or prevent the skilled person working the invention. Consequently, I do not find that the suppression of foaming is implausible based on the error bars in this figure.
I am satisfied that the person skilled in art is provided with a methodology to work and assess the invention across the scope of the claims.
I am not satisfied this ground of opposition has been made out.
Section 40(3)
The amendments brought about by Raising the Bar introduced the following piece of legislation under s 40 (3):
“The claim or claims must be…supported by matter disclosed in the specification.”
Burley J did discuss the law of support in MSD. His honour accepted the rationale outlined in the CSR decision.[72]
[72] [2020] FCA 1477 at [546].
In CSR the delegate provided a three-step approach:
(1) construe the claims to determine the scope of the invention as claimed,
(2) construe the description to determine the technical contribution to the art, and(3) decide whether the claims are supported by the technical contribution to the art.[73][73] [2015] APO 72 at [110].
The technical contribution may be a general principle:
“if [the patentee] has disclosed a beneficial property which is common to the class, [the patentee] will be entitled to a patent for all products of that class (assuming them to be new) even though [the patentee] has not himself made more than one or two of them.”[74]
[74] Biogen [1997] RPC 1 at 49 per Lord Hoffman.
I have construed the claims and description above. The Opponent alleged a lack of support for the terms “foaming is suppressed” which included, in their view, where there is essentially no foaming. I do not accept that no foaming is within the scope of the claims; none of the experts considered that to be the case. The term is, however, unclear as discussed above.
The Oponent also made similar submissions based on the variability of the experiments to those above for s 40 (2) (a), however, in relation to support the Opponent went on to state that no beverage which provides the features of [0006] has been provided. At [0006] a beverage comprising natural stevia is said to foam and bubble over. It appears that the Opponent is arguing that at [0006] the technical contribution can be said to be a beverage which is artificially sweetened with stevia, but does not bubble over. The experimental results do show a difference between foaming levels of the Reb A vs Reb M drinks. At [0006] only a beverage with the natural sweetener of stevia is discussed, rather than a beverage made with Reb A. It is clear from the specification as a whole and the examples that a Reb A sweetened beverage foamed more than the Reb M beverage. There is no evidence that satisfies me that this contribution has not been achieved or cannot be achieved across the full scope.
This ground of opposition has not been made out.
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 compared to prior art information. The Act then states that prior art information can be information made publicly available in a single document.[75]
The prior art base under Subsection 7(1) includes information contained in a published specification filed in respect of a complete application where: the information is, or were to be, the subject of a claim of the specification, the claim has, or would have, a priority date earlier than that of the claim under consideration; and the specification was published after the priority date of the claim under consideration; and the information was contained in the specification on its filing date and when it was published. This is referred to in parlance as a “whole of contents” citation.
[75] ss 7(1)(a).
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".[76]
[76] [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.[77] In reviewing a citation one must look at the citation to determine what it tells the skilled reader to do.
[77] Nicaro Holdings Pty Ltd v Martin Engineering Co[1990] FCA 40;(1990) 91 ALR 513at 517.
Australian courts have often cited with approval the words of the UK Court of Appeal in the General Tire[78] 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 unmistakeable 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."[79] (citations omitted).
[78] The General Tire & Rubber Company v. The Firestone Tyre and Rubber Company Limited and others [1972] RPC 457.
[79] [1972] RPC 457 at 486.
The requirement for clear and unmistakable directions in the prior publicationfrom General Tire is well known. 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 was discussed in Novozymes v Danisco[80] 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.” [81]
[80] Novozymes A/S v Danisco A/S [2013] FCAFC
[81] Novozymes A/S v Danisco A/S [2013] FCAFC at [145].
With that in mind I will now consider the disclosures of the priort art.
The Opponent cited two documents for lack of novelty. The first one is listed below:
D1: WO 2013/096420 A1 (THE COCA-COLA COMPANY) 27 June 2013[82]
[82] Exhibit JF-7
D1 was published in 2013, which is before the priority date of the Opposed application.
D1 relates to the purification of steviol glycosides which includes what is referred to as Reb X.[83] The purification of Reb X is to address the need for sweeteners that taste like sucrose. Dr Fry compared the structure of Reb X in D1 (see abstract page and Figure 19) with the structure of Reb M (what is referred to in the Opposed claims).[84] To do this he referred to D5[85] which has the structure of Reb M in table 5 and Figure 2. There is no dispute that Reb X and Reb M are the same compound.
[83] See D1 abstract.
[84] Fry #1 at [39].
[85] PRAKASH ET AL. Foods (2014) 3: 162-175-exhibit JF-9.
D1 sets out the field of its invention on page 1 with:
“The present invention relates generally to a process for purifying one or more steviol glycosides, such as Rebaudioside X (Reb X), from a solution of steviol glycosides. The present invention also relates to sweetener compositions and sweetened compositions containing one or more steviol glycosides, including Reb X, and methods of preparing the same. The present invention also relates to methods of providing a sugar-like flavor and temporal profile to sweetener and sweetened compositions utilizing Reb X.”
D1 goes on to to discuss the purification of Reb X as the summary of the invention.[86] Then D1 broadly discusses sweetener compositions; of relevance D1 states:
“Sweetener compositions comprising Reb X are also provided herein. In one embodiment, Reb X is present in an effective amount to provide a sweetness equivalence from about 0.5 to about 14 Brix of sucrose when present in a sweetened composition. In another embodiment, Reb X is present in an effective amount to provide a sucrose equivalence of greater than about 10% when present in a sweetened composition.”[87]
[86] See D1 pages 3-5.
[87] D1 page 5 lines 29-35.
D1 does envisage the use of Reb X in a mixture here and states:
“Reb X can be used in any form. In one embodiment, Reb X is the sole sweetener in a sweetener composition. In another embodiment Reb X is provided as part of a composition or mixture. In one embodiment, Reb X is provided in a Stevia extract, wherein the Reb X component constitutes from about 5% to about 99% of the Stevia extract by weight on a dry basis. In a further embodiment, Reb X is provided in a mixture of steviol glycosides, wherein Reb X constitutes from about 5% to about 99% of the steviol glycosides mixture by weight on a dry basis.”[88]
[88] D1 Page 6 lines 1-7.
The above disclosure appears to be envisaging crude stevia extracts with Reb X, however, D1 also states:
“Particularly desirable sweetener compositions comprise Reb X and a compound from the group consisting of Reb A, Reb B, Reb D, NSF-02, mogroside V, erythritol or combinations thereof.”[89]
[89] D1 Page 6 lines 11-13.
D1 discusses mixtures with other ingredients such as antioxidants and saponins which have other functions in a processed food product.[90] D1 then provides some broad lists of possible foodstuffs and beverages the purified Reb X can be used in.[91]
[90] D1 page 6 lines 14- page 7 lines 10.
[91]
Beverages are then discussed with the following disclosure:
“In particular embodiments, beverages containing Reb X or the sweetener compositions of the present invention are also provided herein. The beverages contain a liquid matrix, such as, for example, deionized water, distilled water, reverse osmosis water, carbon-treated water, purified water, demineralised water, phosphoric acid, phosphate buffer, citric acid, citrate buffer and carbon-treated water.”[92]
[92] D1 page 7 lines 11-15.
The focus then shifts back to the purification of Reb X and that protocol before a broad discussion of sweetener compositions on page 30. D1 states that:
“In one embodiment, Reb X is the sole sweetener in the sweetener composition, i.e. Reb X is the only compound present in the sweetener composition that provides sweetness. In another embodiment, Reb X is one of two or more sweetener compounds present in the sweetener composition.”[93]
[93] D1 page 32 lines 11-14.
The amount of Reb X to be used is provided broadly with the following disclosure:
The amount of Reb X in the sweetener composition may vary. In one embodiment, Reb X is present in a sweetener composition in any amount to impart the desired sweetness when the sweetener composition is present in a sweetened composition. For example, Reb Xis present in the sweetener composition in an amount effective to provide a Reb X concentration from about 1 ppm to about 10,000 ppm when present in a sweetened composition, such as, for example, from about 1 ppm to about 4,000 ppm, from about 1 ppm to about 3,000 ppm, from about 1 ppm to about 2,000 ppm, from about 1 ppm to about 1,000 ppm. In another embodiment, Reb X is present in the sweetener composition in an amount effective to provide a Reb X concentration from about 10 ppm to about 1,000 ppm when present in a sweetened composition, such as, for example, from about 10 ppm to about 800 ppm, from about 50 ppm to about 800 ppm, from about 50 ppm to about 600 ppm or from about 200 ppm to about 250 ppm. In a particular embodiment, Reb Xis present in the sweetener composition in an amount effective to provide a Reb X concentration from about 300 ppm to about 600 ppm.[94]
[94] D1 page 33 lines 3-17.
D1 then discusses possible additional carbohydrate sweeteners being added to the sweetener composition containing Reb X with a large list from page 33-34. After broadly discussing dairy products, D1 then discusses beverage and beverage products on page 98. This broad discussion does state on page 101 that:
The carbonation of a sparkling beverage product has 0 to about 2% (w/w) of carbon dioxide or its equivalent, for example, from about 0.1 to about 1.0% (w/w).[95]
[95] D1 page 101 lines 25-26.
Among other combinations there is a discussion of a mixture of Reb X with Reb A bridging page 105-106 which states:
In another embodiment, a beverage comprises a sweetener composition comprising Reb X and Reb A as the sweetener component of the sweetener composition. The relative weight percent of Reb X and Reb A can each vary from about 1 % to about 99%, such as for example, about 95% Reb X/5% Reb A, about 90% Reb X/10% Reb A, about 85% Reb X/15% Reb A, about 80% Reb X/20% Reb A, about 75% Reb X/25% Reb A, about 70% Reb X/30% Reb A, about 65% Reb X/35% Reb A, about 60% Reb X/40% Reb A, about 55% Reb X/45% Reb A, about 50% Reb X/50% Reb A, about 45% Reb X/55% Reb A, about 40% Reb X/60% Reb A, about 35% Reb X/65% Reb A, about 30% Reb X/70% Reb A, about 25% Reb X/75% Reb A, about 20% Reb X/80% Reb A, about 15% Reb X/85% Reb A, about 10% Reb X/90% Reb A or about 5% Reb X 0% Reb A. In a particular embodiment, Reb A comprises from about 5% to about 40% of the sweetener component, such as, for example, from about 10% to about 30% or about 15% to about 25%. In another particular embodiment, Reb X is present in the beverage in a concentration from about 50 ppm to about 600 ppm, such as, for example, from about 100 to about 400 ppm, and Reb A comprises from about 5% to about 40% by weight of the sweetener component. In another embodiment, Reb X is present in a concentration from about 50 ppm to about 600 ppm and Reb A is present in a concentration from about 10 to about 500 ppm. In a more particular embodiment, Reb X is present in a concentration of about 300 ppm and Reb A is present in a concentration from of about 100 ppm. The pH of the beverage is preferably between about 2.5 to about 4.2.
There was little evidence on the above disclosure and given the broad nature of the document it is not a matter of hard fact that a person skilled in the art would in implementing the teaching of D1, arrive at the subject matter of the present claims.
It is clear that D1 has a number of very broad passages but the focus of D1 is to the purification of Reb X as it is said to have better taste qualities. The first example in D1 is to the purification of Reb X. Example 1 states that the yield of Reb X was 1.2 g with 97.3 % purity.[96] This purified form of Reb X is what was used in the latter examples which demonstrate its taste performance.
[96] D1 page 123 line 9.
In example 7 an orange flavoured sparkly beverage is made. I will repeat that example below:
Orange-flavored sparking beverage: Reb X levels were evaluated in a zero calorie orange-flavored sparking beverage base to determine the effect of increasing sweetness. Samples of the orange-flavored sparkling beverage with Reb X in amounts between 400 and 750 ppm (in 50 ppm increments) were prepared.
All samples tasted significantly better than comparable Reb A-containing formulations resulting in cleaner profiles with increased sweetness intensity and no negative aftertaste characteristic. Samples having 500 ppm and 550 ppm Reb X were found to be the closest in sweetness level to a 11.5 Brix high fructose corn syrup sweetened orange flavored sparkling beverage formulation.I note that purified Reb X is used and the samples which were closest to the sweetness level being sought were outside of the range in the claim. Furthermore, the carbonation levels are not provided and the beverage does not contain caffeine. The Reb X containing beverages are compared to a beverage containing Reb A only for a taste comparison. I do not consider this to be clear and unmistakable directions to make a beverage with all of the features of the current claims. Furthermore, Dr Fry’s reading of D1 appeared to be that he would use the Reb X product generally and although this included using it in carbonated beverages, that was only a general statement. [97]
[97] Fry #1 at [53].
The Opponent also argued that there was an inevitable consequence from following D1 that the PSA would arrive at the current claims.
Would the PSA arrive at the current claims as an inevitable consequence of following the directions in D1?
The Opponent relied on the evidence in reply and material filed under reg 5.23 to argue that the Reb X used in D1 inherently comprises some minor components of Reb A, thus arguing it is an inevitable consequence of D1 to arrive at an infringement of the claims. I note that the Reb X used in D1 is 97.3 % pure and samples having 500-550 ppm Reb X were said to be the best tasting. Indeed if the total amount of the impurity in the Reb X used was Reb A there would be 486 ppm Reb X and 14 ppm Reb A.
There is evidence that a commercially available Rex X/M product sold by PureCircle does contain Reb A as an impurity.[98] But this is a separate product, and there is no evidence to establish that it is the same as that produced using the purification method of D1 to give a 97.3 % pure product used in example 7. Absent such evidence, mosaicking the PureCircle product with D1 would not be following the teachings of D1 and instead merely using a commercially available product to make a different beverage.
[98] See for example Fry #2 at 25.
100. The Opponent filed declarations from Dr Dubois and Dr Fry in March 2020 relating to the purity of the Reb X/M used in D1. The Opponent requested it be considered as material under reg 5.23 and a delegate of the Commissioner acceded to the request. Relying on that evidence, the Opponent argued that the highly pure product of D1 did indeed contain Reb A as an impurity.
101. In Dr Dubois’ fourth declaration, the declaration brought in by way of reg 5.23, he stated that the HPLC of the highly pure Reb X in D1 showed that there was in fact Reb A in that sample. He produced the following figure:
102. In the above figure, Dr Dubois has expanded and blown up the HPLC trace of D1 and contends that the peak shown in the circle is Reb A.[99] I note that in D1 both Fig 3A and Fig 3B do not show retention times and have different scales. I also note that the major impurity in Fig 3A, which is said to be 80% Reb X has Reb D as the major impurity and this is shown. Reb A is not shown.
[99] Dubois #3 at [7].
103. Dr Ashurst responded to this evidence and stated:
“I maintain that the HPLC traces of Reb M do not show any relevant Reb A peaks after Reb M. I am concerned that Dr Dubois’ comments are based on imprecise interpretations of Figures 3A and 3B, as the versions of those figures” [shown above] “appear to be stretched and distorted compared to the versions of the figures reproduced in Document D1 itself. The only conclusion that may be safely drawn from these figures is the conclusion drawn by the document itself, namely that the Reb M samples contained Reb M and Reb D.”[100]
[100] Ashurst #4 at [6].
104. I agree with those comments of Dr Ashurst. Fig 3A shows 80 % pure Reb X and Fig 3B shows the 97 % Reb X, the only impurity of note is Reb D. Expanding and blowing up a figure from a patent to look for a minor peak has not satisfied me that Reb A is present. Furthermore, there is no retention time given and I am not convinced there can be any certainty that any blown up and expanded blip can be, on balance, a peak attributed to Reb A.
105. I note that Dr Fry stated when replying to Dr Ashurst:
“I have never contended that the high purity material described in D1 necessarily contained large quantities of Reb A. Rather, what I was trying to say at paragraphs 76, 135 and 136 of my Second Declaration was that, if I had been trying to implement the teaching of D1 or D5 (the Foods article) by using Reb M as a sweetener in a carbonated beverage, based on the information regarding Reb M purity in the regulatory documentation for the PureCircle product, I considered it likely that available sources of Reb M that I might have been able to obtain (rather than small scale quantities of highly pure material prepared for e.g. analytical studies or journal/patent publication work) would have contained some Reb A as
a minor component.[101][101] Fry #3 at [9].
106. As I noted above, I do not accept the argument that using a commercially available Reb M product in a beverage is the same as following the clear an unmistakable directions of D1 which is directed towards a highly purified product of Reb M. Furthermore, the above paragraph shows that even Dr Fry did not believe that the purified Reb X product of D1 contained Reb A in large quantities and did not confirm that there was any Reb A present.
107. Furthermore, D1 does not disclose the mass ratio of the current claims and the only example of a carbonated beverage with clear and unmistakable directions is the orange flavoured beverage with does not contain caffeine.
108. Therefore, based on the above evidence I am not satisfied that on following the directions of D1 a PSA would inevitably arrive at the current claims. Thus it has not been established that D1 is prejudicial to the novelty of the Opposed claims.
109. The next document cited for novelty is D2:
D2: WO 2014/186250 A1 (PEPSICO, INC.) 20 November 2014[102]
[102] Exhibit JF-10
110. Firstly, I note that D2 is published after the claimed priority date of the Opposed application.[103] The priority date of D2 and the claimed priority date of the Opposed application was not in dispute in this opposition.
[103] The priority date of the Opposed application is 30 September 2014.
111. D2 it titled “Rebaudioside Sweetener Compositions and Food Products Sweetened with the Same”.
112. Under the heading “Summary” on page 2 of D2 Rebaudioside M is introduced. It is useful to repeat that here:
“The present invention relates to new sweetener compositions, to new beverage products and other new food products as further disclosed and described below, which comprise a sweetening amount of rebaudioside M, that is, have rebaudioside M present in a concentration sufficient to perceptibly sweeten the food product. Rebaudioside M is a potent sweetener that can be produced by extraction from Stevia rebaudiana plant leaves, optionally followed by purification to obtain either pure rebaudioside M or to increase the concentration of rebaudioside M relative to other components of the extract, such as Reb A. It also can be produced enzymatically or synthetically. Some aspects of the present invention relate to beverage products sweetened with rebaudioside M, including beverage syrups (i.e., concentrates to be diluted with carbonated or uncarbonated (i.e., still) water to form ready-to-drink beverages, organic and/or natural beverages (i.e., beverage products made essentially of only organic and/or only natural ingredients), and other beverage products. Rebaudioside M has been found to have a sweetness intensity significantly higher than Reb A, and has also been found to provide beverages and other food products with a more desirable sweet taste profile than the same foods sweetened with other potent sweeteners, such as the other steviol glycosides, e.g., sweetened only with Reb A, or sweetened with artificial potent sweeteners, e.g., in cola beverage products, including more up front sweetness and substantially less bitter aftertaste.”[104]
[104] D2 pages 2-3
113. From there on, the focus of D2 is that using Reb M imparts a better “flavour” or sweetness than using Reb A. There did not appear to be dispute that D2 did involve the use of Reb M in typical carbonated beverages with the following disclosure stating:
“In certain exemplary embodiments, ready-to-drink beverage products ( e.g., cola beverage products) are provided comprising water and Rebaudioside M as disclosed here, where rebaudioside M is present in the beverage in an amount (i.e., a concentration) of from 100 ppm to 1200 ppm rebaudioside M in the beverage, e.g., from 360 ppm to 600 ppm.”[105]
[105] D2 page 21 at [40].
114. The carbon dioxide volumes are given as:
“In certain embodiments, for example, the beverage has a CO2 level up to about 4.0 volumes carbon dioxide. Typical embodiments may have, for example, from about 0.5 to 5.0 volumes of carbon dioxide.”[106]
[106] D2 page 39 at [76].
115. D2 also states that Reb M can be used in combination with other Rebaudiosides, including Reb D and Reb A:
“In certain embodiments of the sweetener compositions, beverage products and other food products disclosed here, rebaudioside M sweetener is used together with a combination of rebaudiosides ( optionally referred to as soluble rebaudioside D or soluble Reb D) comprising about 70 wt.% rebaudioside D and 30 wt.% rebaudioside A, perhaps with traces of other steviol glycosides or other compounds. Soluble Reb D is commercially available from Pure Circle Limited. It has been found that rebaudioside M in combination with soluble Reb D achieves cost-effective sweetening with a desirable taste profile in diet cola and other beverages and other foods. Surprisingly, substantial sweetening is obtained from the rebaudioside A component of the combination without incurring the unwanted lingering or bitter aftertaste typically associated with the use of rebaudioside A sweetener.”[107]
[107] D2 page 16 at [33].
116. In the examples Reb M is first compared to Reb D and aspartame—an artificial sweetener with a peptide structure, in example 1. Then in example 2 “ready-to-drink” cola beverages are prepared with the amount of caffeine given in grams. The carbonation levels are not given. Three variants of the cola beverage in example 2 are prepared, variant 1 is made with Reb A, variant 2 is made with Reb D and variant 3 is made with Reb M.
117. In example 2 part B three ready-to-drink cola beverages are made up with 400 ppm of either Reb A, Reb D or Reb M.[108] The amount of caffeine and carbonation is not given in part B. The source of the Reb M is not given in D2, however, Reb M is characterised, including with an LC- MS which only showed one peak.
[108] D2 page 34 at [90].
118. In example 2 part B the drink made with 400 ppm Reb A was found to have “significant detectable bitter aftertaste and judged as the least favored”[109].
[109] D2 page 45 at [90].
119. Example 3 then uses combination of Reb M and other low calorie sweeteners such as erythritol (a sugar alcohol). In Example 5 diet colas are made with Reb M, Reb D amd Reb A, however, these use grams of the rebaudiosides and are at higher concentrations than the Opposed claims.
120. Dr Fry commented on example 2 specifically when he was shown D2 and stated:
“If producing a carbonated beverage, variant 3 of example 2 of W02014/186250A1 would be a good place to start since the formulation contains a simple sweetener system, and Reb M was taught as being the best of the three rebaudiosides tested. It would be necessary to source a suitable specific flavouring component, but there are ingredient companies that can readily supply cola flavourings. The example does not expressly state what the carbonation level was, but I would also carbonate to 4 volumes, that is a typical carbonation level used with commercial cola products. W02014/186250A1 also singles out carbonating at up to 4.0 volumes alongside the broader 0.5 to 5.0 volume range elsewhere in the document.”[110]
[110] Fry #1 at [74]
121. Dr Fry also stated:
As mentioned above, the document also teaches using Reb M in combination with other sweeteners, e.g. example 4 describes cola formulations containing D-psicose and erythritol in combination with Reb M as having good sweetness taste profile and mouthfeel. I would also have made formulations containing blends of Reb M with other sweeteners such as those, and to see whether any improvements were significant. The simpler example 2 formulation would however be a good baseline, and given the reported properties, that example formulation may have provided suitable sweetness characteristics.[111]
[111] Fry # 1 at [75].
122. The above comments by Dr Fry state that he would use example 2 as a baseline and go from there. That is, he would undertake some experimentation or tweaking.
Would the PSA arrive at the current claims as an inevitable consequence of following the directions in D2?
123. The Opponent also argued that the commercially available Reb M products at the priority date would contain Reb A, and so if following the preparations in example 2 of D2 using the commercially available Reb M, then there would be an inevitable infringement of the Opposed claims. The evidence on this was filed in reply and in the Reg 5.23 material. Dr Fry stated in reply:
“Relevant to the above, I understand from Dr Ashurst’s comments regarding WO2013/186250 (D1) at paragraph 285 of the Ashurst Declaration, and his comments regarding the Foods article (D5) at paragraph 289, that he would have been directly led to try to produce a carbonated beverage containing Reb M alone, but may not have used a blend containing rebaudioside M and Reb A. Dr Whitmoyer expressed a similar view at paragraphs 175 and 180 of the Whitmoyer Declaration. However my understanding is that, whilst it may have been possible to obtain very small-scale quantities of high-purity Reb M as an analytical standard, the nature of the processes by which rebaudioside M was obtained from the mixture of steviol glycosides present in stevia leaf, and the increasing cost associated with achieving higher levels of purity, meant that it was not commercially viable to produce larger scale quantities of high purity Reb M at that time. An extract described as “Reb M” would have contained amounts of other steviol glycosides, very likely including Reb A, since the latter is a major component of crude stevia leaf extract. In support of this I refer to the GRAS notification GRN no. 473 dated 24 April 2013 filed with the US FDA by PureCircle to support the determination that their rebaudioside X (Reb M) product was Generally Recognised As Safe (GRAS) for use in foods and as a table top sweetener. Now shown to me and marked Exhibit JF-18 is a copy of this documentation. Table 3 on page 20 of the GRAS assessment shows the steviol glycoside distribution for 4 non-consecutive lots of rebaudioside X, and shows that all of the representative batches of rebaudioside X contained a number of other steviol glycosides, including between 0.49% and 7.57% rebaudioside A. The Table is reproduced below:”
[112]
[112] Exhibit JF-16 Table 3
Moreover, PureCircle’s own specification for rebaudioside X (Reb M) only calls for the rebaudioside X content to be greater than 50% (see Table 2 on page 19 of Exhibit JF-18). Thus, at the Priority Date a skilled person would likely not have had the option of using significant quantities of Reb M material that was completely free of Reb A and other steviol glycosides.”[113]
[113] Fry #2 at [25].
124. Dr Ashurst had admitted that he was not aware of commercially available Reb M products at the priority date but did not believe there were any that could be legally included in carbonated beverages for sale in Europe, Australia and New Zealand.[114] However, Dr Ashurst reponded to Dr Fry’s evidence on the PureCircle products and said:
[114] Ashurst #2 at [8].
“At paragraph 25 of Fry #2, Dr Fry also annexes documents relating to a GRAS notification designated GRN No. 473 (GRN 473 Documents). I was not aware of GRN No. 473 at the Priority Date and based on my interactions with colleagues, do not consider that it or the information contained in the GRN 473 Documents was commonly known in the Field at the time.”[115]
[115] Ashurst #2 at [15].
125. Dr Ashurst then goes on to state:
Dr Fry refers to Table 3 of GRN 473 as indicating that Reb M products available at the Priority Date contained Reb A. I understand that Table 3 describes a series of batches tested by the GRN applicant for authorisation purposes (rather than commercially available forms of Reb M). In this respect, page 13 of the GRN 473 Documents explains that PureCircle analysed 4 "additional batches" of a Reb M containing product "to demonstrate variability in the steviol glycoside composition following different numbers of crystallisation steps." The batches of Reb M the subject of the GRN 473 application designed for commercial use appear to be described in Table 2 of the GRN 473 Notice (page 12). These samples are described as having about 96% Reb M (apparently less than the 98% pure sample referred to in D5) and there is no suggestion that any of these samples contained any Reb A.
126. The GRAS notice being discussed shows that PureCircle applied to the FDA in April 2013 to market a stevia leaf extract as a general purpose sweetener.[116] It is said to be a Rebaudioside X extract from stevia. I note that Reb X is still the same as Reb M here. The extracts are said to be obtained by hot water extraction process from dry leaves.[117] It is said to be stable for use in acidic beverages and it makes the following statement
[116] See GRAS Assessment introduction.
[117] GRAS assessment part D and Figure 2.
“PureCircle intends to market rebaudioside X as a sweetening agent for use as a general purpose sweetener as either a high-purity material or as a component of a steviol glycoside material containing more than 50% rebaudioside X. All rebaudioside X products will therefore consist of not less than 95% steviol glycosides with rebaudioside X representing more than 50% of the finished product and the remainder comprising the following 9 related steviol glycoside in any combination and ratio: stevioside, rebaudioside A, rebaudioside B, rebaudioside C, rebaudioside D, rebaudioside F, dulcoside A, steviolbioside, and rebaudioside. Steviol glycosides (steviol conjugated with glucose, xylose, and/or rhamnose) are natural constituents of the S. rebaudiana plant. Rebaudioside X can be detected in commercially available stevia extract concentrations between 0.1 and 0.4%. Based on its intended uses as a general purpose sweetening agent, rebaudioside X will be added to a variety of food products, excluding infant formulas and meat and poultry products, consistent with the current uses of other related highintensity sweeteners that are already in the market (e.g., aspartame).” [118]
[118] GRAS assessment part D page 24.
127. Although this shows that PureCircle had an extract of Reb X that it intended to market near the priority date, it does not establish that the person skilled in the art would have inevitably used PureCircle’s product in D2. D2 does not mention the use of the Reb X product discussed in the GRAS assessment and instead characterises a pure form of Reb M. It is not established that this product would have been used, as a matter of hard fact or that all purification methods available to obtain Reb X at the priority date would have contained Reb A. D2 therefore does not dislcose any Reb A nor any ratio of Reb M to Reb A and is therefore outside of the scope of the current claims.
128. The evidence does not establish that the person skilled in the art would inevitably arrive at the current claims when following the directions of D2.
Inventive Step
129. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art (subsection 7(3)).
130. 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[119] Aickin J stated:
[119] [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."
131. In Alphapharm,[120] the High Court endorsed the use of the reformulated "Cripps question":
[120] 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 solution to the problem."[121]
[121] Alphapharm at [53].
132. 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 were saying that the reformulated Cripps question was the test to be applied in every case. Rather, it is a formulation of the test which will be of assistance in cases, particularly those of a similar nature to Alphapharm. The plurality did not reject as an alternative expression of the test the question whether experiments were of a routine character to be tried as a matter of course (The Wellcome Foundation Limited v VR Laboratories (Aust) Proprietary Limited (1981) 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.“[122]
[122] [2014] FCAFC 73 at [71].
133. In AstraZeneca AB v Apotex Pty Ltd[123] (AstraZeneca), the 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 common general knowledge or information available under subsection 7(3).
[123] [2014] FCAFC 99; 107 IPR 177.
134. The opponent submitted that the claims lacked an inventive step when compared to D1 or D5.[124] D1 has been discussed above for novelty and it focused on purification of Reb X. D5 is the corresponding non-patent document publication of D1 and has a similar disclosure but in a journal publication format. D5 is
[124] D2 was published after the priority date of the Opposed application.
D5 PRAKASH ET AL. Foods 3: 162-175 (Exhibit JF-9)
135. D5 was published on 27 February 2014, before the claimed priority date of the Opposed application.
136. At the hearing the Opponent did not allege that the claims lacked an inventive step based on the common general knowledge alone. However, I will note the following evidence:
“The most popular group of natural sweeteners were and are the stevia-type sweeteners.Sweeteners in this group have been used in Japan for about 40 years, but have become widely used in Western markets only more recently. The stevia sweeteners originate from the rebaudiana plant, a member of the sunflower family, which is a native of Paraguay but more recently has been cultivated mainly in parts of Asia. The leaves are the source of a family of steviol glycosides having sweet-tasting properties. Two of the major constituents are stevioside and rebaudioside A (Reb A), but there are also a large number of other steviol glycosides. My recollection is that Reb A was the first stevia-type sweetener to be commercialised in the US. It received a Generally Recognized As Safe (GRAS) classification from the FDA in 2008. Reb A has considerably better taste/sweetness properties than stevioside, but was also known to have some defects, particularly relating to having a bitter, liquorice aftertaste. Amongst other projects, I have been involved in work to develop stevia-based sweetener products since about 2006-2007.[125]
[125] Fry #1 at [27].
137. It has been noted in the Opponent’s submissions and in the evidence that the Coca-Cola Life product contained Reb A. I note Dr Fry’s comments:
“A notable example of a Reb A-containing commercial beverage was the Coca-Cola life® product, introduced in 2013-2014. This was a product in which Reb A was used to replace some, but not all, of the caloric sweetener present in the full-calorie Coca-Cola Classic® product, and was marketed as having an all-natural sweetener system with reduced caloric intake. Carbonated soft drinks are and were typically formulated to have a level of sweetness equivalent to the sweetness levels achieved with about 10-11% sucrose, with Coca-Cola Classic® having a sweetness level equivalent to about 10.4% sucrose. However, with Reb A it was well known that it is not practical to use that sweetener to achieve such levels of sweetness in a beverage by itself. Sweetness levels of 10-11% sucrose equivalence are close to the theoretical maximum sweetness achievable with Reb A. Moreover, the bitter/liquorice side-taste of Reb A becomes much more apparent at higher use levels. It was however common to use blends of sweeteners, since doing that can result in better masking of aftertaste and/or side taste associated with one or more of the sweeteners. Coca Cola life® contained a mixture of Reb A together with a carbohydrate sweetener, with the original formulation providing about a one third reduction in calorie levels compared with Coca-Cola Classic®. Now shown to me and marked Exhibit JF-5 is a copy of an article from the Independent newspaper from 2014 which discusses the launch of the Coca-Cola life® product in the UK.”[126]
[126] Fry #1 at [28].
138. It could be said that Reb A was known to the Opponent by way of the Coca-Cola Life product that used Reb A. I note that the Applicant for D1 is also the Coca-Cola company along with PureCircle. PureCircle were also involved in the GRAS assessment for the Reb X product that was discussed above for novelty. The Opponent made the comments in their submissions that the Opposed application would prevent Coca-Cola from using the PureCircle product in a carbonated beverage. This is irrelevant to the question of inventive step.
139. Both D1 and D5 discuss Reb X/M as imparting a more sugar-like temporal profile to sweetened compositions.[127] Both documents focus on the purification of Reb X[128] neither document discusses foaming.
[127]D1 page 8 lines 4-8; D5 page 172 Conclusions.
[128] See D1 filed of invention on page 1 and example 1 and D5 page 164 Experimental.
140. I have discussed the term “foaming is suppressed” under clarity and construction, but it is also clear from the Opposed specification that suppression of foaming is the problem sought to be solved.[129] Dr Fry commented on this stating:
[129] Page 1 [0003]-[0004].
“From the above passages the reader is invited to draw the inference that Reb A causes excessive foaming. However, the Opposed Application does not provide details of the actual levels of foaming achieved with Reb A. For example, the experiments only report relative foaming levels.”[130]
[130] Fry #1 at [89].
141. At the hearing the Opponent argued that foaming was not a real problem and instead people were shifting to use Reb X/M for taste. Indeed from D1 and D5 one is told that Reb X/M is sweet tasting and does not have the same aftertaste of Reb A. The Opponent also critised the evidence of the Applicant because they were asked about the problem of foaming before being shown the prior art. In fact Dr Ashurst commented on it in his background when he was naïve to the specification and before he was asked the hypothetical problem:
“Carbonation levels could also be associated with different but related problems of excessive "foaming" or "fobbing". In this declaration, I have used the term "excessive" foaming to simply refer to an undesirably high level of foaming.”[131]
[131] Fry #1 at [86]-[89].
142. Dr Ashurst also commented that:
“Excessive foaming could present itself at the production stage (making it difficult for the beverage to be filled or produced) and/or after production when the finished beverage was opened or poured out (manifesting as unwanted or prolonged levels of foam or "head"). Such issues are generally detected in the pilot stage of development (or even later). Foaming could be caused by matters such as an inappropriate manufacturing process, over-carbonation during production or the presence of certain ingredients such as surfactants (e.g., saponins) in the composition. At the Priority Date, saponins were commonly used in beverages as emulsifying agents. In the context of carbonated beverages, saponins could be used to introduce a cloudy effect due to the dispersion of oil in an aqueous medium (i.e., oil-in-water emulsion. However, because saponins are natural surfactants, they can cause excessive foaming and stabilisation of the foam.”[132]
[132] Ashurst #1 at [86].
143. Dr Ashurst also discussed “Fobbing”—where there is gushing of the beverage from the container during filling or upon opening the container.[133] Dr Ashurst said that at the priority date excess foaming and fobbing was solved using physical (removing nucleation points and different filling techniques) and using chemical antifoaming agents such as silicon oil.[134] I do not accept that foaming is not a real problem for carbonated beverages.
[133] Ashurst #1 at [87].
[134] Ashurst #1 at [88].
144. Both D1 and D5 are silent on the issue of foaming, however, the Opponent also argued that the person skilled in the art would, as a matter of routine, still arrive at the current claims based on D1 or D5 simply because Reb M tasted better. In a sense, that is an argument, that, on following routine steps from D1 or D5 even if solving a problem of taste, one would arrive at the current claims.
145. Dr Dubois said regarding the relevance of D1:
The mention of suppression of foaming in claim 1 does not change my view. As discussed above, I would not draw conclusions about whether there is any significant reduction of foaming between beverages sweetened with rebaudioside M versus those sweetened with rebaudioside X, based on the experiments and data in the opposed specification. In any event, since WO2013/096420A1 already teaches the same beverage formulation, I do not see how referring to foaming properties makes a practical difference. Foaming is a subsidiary property compared to the sweetening properties of the rebaudioside sweeteners. For example, if rebaudioside X or rebaudioside A were not sweeteners, they would not be included in the beverage regardless of their foaming properties. As I see it, the main point is that I, and I believe others also involved in making beverages at the relevant time, would already have been using a rebaudioside M-containing sweetener component, due to its superior taste properties. For these reasons I regard the beverage of claim 1 as entirely self-evident and obvious to make based on what WO2013/096420A1 describes.
146. However, Dr Dubois continued to state:
I do not think that the additional component required by claim 2, i.e. including 6-12g/100g sucrose, changes anything. Given the sucrose concentrations specified, this appears to be directed towards a Coca-Cola Life® type product in which instead of using rebaudioside A as the stevia sweetener, a rebaudioside M-containing sweetener is used instead. As I discussed above when discussing what was commonly known, the Coca-Cola Life® product used rebaudioside A to replace about 1/3 of the sugar present in a full-calorie product, and claim 2 includes products having similar levels of sucrose. Given that WO2013/096420A1 teaches that rebaudioside X is a better tasting sweetener than rebaudioside A, it would have been self-evident to use rebaudioside X in a Coca-Cola Life® - type formulation in place of the rebaudioside A. WO2013/096420A1 also refers to using the rebaudioside X sweetener system in a range of beverages, including mid-calorie beverages (see page 101), and discusses using the rebaudioside X sweetener in conjunction with carbohydrate sweeteners such as sucrose (see pages 99,102 and 103). There is nothing inventive associated with claim 2 in my opinion. I am of the same view with regard to claims 4 and 6, which also require concentrations of 6-12g/100g sucrose.
147. In my view, the evidence does not suggest that it would be routine to arrive at the combination of Reb M and Reb A based on the highly purified form of Reb M disclosed in D1. Instead, the Opponent appears to be more concerned about whether a purified Reb X product can be used in a Coca-Cola Life® type beverage. I do not consider that evidence from Dr Dubois to be indicative of routine steps that a person skilled in the art would do on following a document which focuses on purification of Reb X such as D1 or D5. D1 and D5 only teach an orange flavoured sparkling beverage using the purified form of Reb X. There is no evidence on the routine steps to include some Reb A, within the parameters of the claimed amount and ratio, and to add caffeine.
148. Therefore, the ground of a lack of inventive step has not been established for the Opposed claims.
Conclusion
149. The opposition has been successful on the ground of clarity. All other grounds fail. The Applicant is provided 60 days to file suitable amenments.
Costs
150. The opposition has been successful on the ground of clarity. Costs are awarded against the Applicant under Schedule 8.
K. Wagg
Delegate of the Commissioner of Patents
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