Spicer Spicer Pty Ltd. v The Coca-Cola Company & PureCircle Sdn Bhd
[2021] APO 31
•11 August 2021
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Spicer Spicer Pty Ltd. v The Coca-Cola Company & PureCircle Sdn Bhd [2021] APO 31
Patent Application: 2018200689
Title:Methods for purifying steviol glycosides and uses of the same
Patent Applicants: The Coca-Cola Company, PureCircle Sdn Bhd
Opponent:Spicer Spicer Pty Ltd.
Delegate:Felix White
Decision Date: 11 August 2021
Hearing Date: 11 May 2021, by videoconference
Catchwords: PATENTS –sweetener composition comprising steviol glycoside component – opposition under s59 – inventive step – clarity – utility – nature of the problem to be solved – all grounds unsuccessful.
Representation:
Counsel for the applicants: Clive Elliott QC
Patent attorneys for the applicants: Dr John Landells and Dr Marianne Repacholi of FB Rice
Counsel for the opponent: Andrew Fox
Patent attorney for the opponent: John Spicer of Spicer Spicer
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2018200689
Title:Methods for purifying steviol glycosides and uses of the same
Patent Applicant: The Coca-Cola Company, PureCircle Sdn Bhd
Date of Decision: 11 August 2021
DECISION
The Opposition is dismissed. Costs according to Schedule 8 are awarded against Spicer Spicer Pty Ltd.
REASONS FOR DECISION
Background
Patent application 2018200689 (the application) was filed by The Coca-Cola Company and PureCircle Sdn Bhd (the Applicants) on 30 January 2018 as a divisional application from patent application 2016204928, itself a divisional application of patent application 2012359078. The application claims the effective filing date of 19 December 2012, and claims an earliest priority date of 19 December 2011. The priority entitlement of the application is not in dispute.
The application was examined and advertised accepted on 4 July 2019. This decision is based on the specification as accepted (the specification).[1] Spicer Spicer Pty Ltd. (the Opponent) filed a notice of opposition under section 59 of the Patents Act 1990 (the Act) on 4 October 2019.
[1] All page and figure references are to the specification unless indicated otherwise.
The statement of grounds and particulars (SG&P) was filed on 6 January 2020. The SG&P was accompanied by copies of eighteen citations (D1-D18). After the usual rounds of evidence, an oral hearing was held on 11 May 2021 by videoconference. The SG&P contained numerous grounds of opposition, but only three grounds were pressed at the oral hearing: lack of clarity, lack of utility, and lack of inventive step over either D1[2] or D2[3] in view of common general knowledge.
[2] M. Ohta, et al, “Characterization of Novel Steviol Glycosides from Leaves of Stevia rebaudiana Morita”, J. Appl. Glycosci., 2010, 57, 199-209. Exhibit MGL-6
[3] US2011/0183056 A1 (Morita) Exhibit MGL-7
Evidence
The parties relied upon evidence as set out in the table below.
| Evidence | Declarant | Date of Declaration | Reference | Exhibits |
| In support | Dr. Michael Lindley | 2 April 2020 | Lindley #1 | MGL-1 to MGL-11 |
| Dr. Michael Lindley | 30 April 2020 | Lindley #2 | MGL-12 to MGL-16 | |
| John Spicer | 2 April 2020 | Spicer #1 | JLS-1 to JLS-5 | |
| John Spicer | 1 May 2020 | Spicer #2 | JLS-6 to JLS-7 | |
| In answer | Dr John White | 4 August 2020 | White | JW-1 to JW-11 |
| In reply | Dr. Michael Lindley | 8 October 2020 | Lindley #3 | MGL17 to MGL-20 |
Onus
This Application was filed post the “Raising the Bar” amendments to the Act. The standard of proof that applies in the present case is the balance of probabilities. Under subsection 60(3A) of the Act, if I am satisfied, on the balance of probabilities, that a ground of opposition to the grant of a patent exists, I may refuse the application.
Field of the invention
According to the specification, the present invention relates to a process for purifying steviol glycosides such as Rebaudioside X (Reb X)[4], to sweetener compositions comprising steviol glycosides including Reb X, and methods of providing a sugar-like flavour and temporal profile to sweetener compositions using Reb X.[5]
[4] The compound named Reb X in the application (see Figure 19 of the specification) is structurally identical to the compound described as Reb M in D1 and known as such elsewhere in the art (such as the press release in Exhibit JW-11). For clarity I will refer to this compound as Reb X consistently in this decision, even if the prior art uses different nomenclature.
[5] p. 1 l. 10-16
I note that the “grandparent” application 2012359078 was granted with claims to processes for purifying Reb X, whereas the accepted claims of the present application are directed to sweetener compositions comprising Reb X. Therefore, it is fair to say that the field of the present application is artificial sweetener compositions.
The person skilled in the art
It is well established that many of the issues in an opposition are answered by reference to the person skilled in the art:
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”[6]
[6]Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at 70.
The hypothetical skilled person works in the field with which the invention is connected and is a non-inventive person or team likely to have a practical interest in the subject matter of the invention.[7]
[7]Op cit at 70-72.
Given that the field of the invention is artificial sweeteners, I consider that the nominal skilled worker or team would have comprised a food technologist or beverage formulator.
Common general knowledge
Common general knowledge is the background knowledge and experience available to all those working in the relevant art:
"The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”[8]
[8] Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9 at 292
Guidance on this consideration was provided in British Acoustic Films Ld v Nettlefold Productions (1936) RPC 221 at 250:
“In my judgement it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or a series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less merely because it is widely circulated. Such a piece of knowledge only becomes common general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.”
To summarise, if it can be demonstrated by evidence that something is generally accepted by the hypothetical skilled worker, then this can be treated as common general knowledge. Scientific papers can be used to support such evidence but they do not generally themselves constitute common general knowledge.
The parties have provided evidence from experts in the field of artificial sweeteners: Dr. Lindley and Dr. White. It can be seen from their respective CVs[9] that both of them have decades of experience working in the field of artificial sweeteners. Both of these experts have given their evidence in light of the Federal Court Expert Evidence Practice Note[10] and were briefed in stages, with progressive knowledge of the prior art citations and the opposed specification.
[9] Exhibits MGL-2 and JW-2
[10] Exhibits MGL-1 and JW-1
The Opponent submitted that Dr Lindley’s evidence is to be preferred over that of Dr. White[11] as Dr. Lindley’s experience relates to non-nutritive sweeteners (including sucralose, thaumatin and isomaltulose)[12] whereas Dr. White’s experience relates to nutritive (caloric) sweeteners, in particular fructose.
[11] Opponent’s submission (OS) at 30
[12] OS at 21
Given that I have found that the field of the invention is artificial sweetener compositions, I consider that both Dr. Lindley and Dr. White’s evidence is of value in establishing what would have been common general knowledge to the hypothetical skilled worker. However, it must be borne in mind that although expert evidence can shine some light on what the notional skilled team would have known at the priority date, care must be taken not to conflate the testimony of a declarant with the notional skilled team:
“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]
[13] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at 23.
The Opponent’s evidence also contains a declaration[14] from Dr. John Fry, a food technologist with similar experience to Drs. Lindley and White, which was presented before the European Patent Office as part of European Opposition proceedings against the corresponding European Patent EP 2 793 618 B1. I am also able to take the Fry Declaration into account as being indicative of what the notional skilled person would know and do, but I am cognisant that Dr. Fry was not briefed according to the Federal Court rules, and that all of Dr. Fry’s declaration was made with full knowledge of the patent specification, D1 and D2.[15]
[14] Exhibit JLS-1 (“The Fry Declaration”)
[15] Fry declaration, p. 1 paragraph 4
Where there is conflicting evidence, I will decide which evidence should be given greater weight bearing in mind the parties’ submissions, including the submissions above regarding knowledge and experience of the experts.
Having considered the evidence[16] I understand that the following points are of the most importance for assessing the grounds raised in this Opposition.
[16] Taken from a synthesis of the Opponent’s position at OS 131 (a)-(ff) and the Applicants’ position at AS 52-74
High potency sweeteners (HPSs) were in widespread use in the food industry, particularly beverages, to replace some or all of the sugar content.[17] Although HPSs have a higher perceived sweetness than sucrose (sometimes measured in terms of multiples of sucrose), they have a non-linear relationship of sweetness with concentration and their sweetness could “plateau” at different levels.[18] HPSs also did not have the same “sweetness profiles” as sucrose, including temporal differences (time to sweetness onset and lingering sweetness) and “off-tastes” such as bitterness or licorice.[19]
[17] Lindley #1 at 3.13 and 3.22
[18] Lindley #1 at 3.19 and White at 28
[19] Lindley #1 at 3.17 and Lindley #3 at 2.11
The skilled worker would have known that the flavour profile of HPSs was due to their interactions with taste receptors. However, I am not satisfied that the nature of such interactions was common general knowledge in the sense of being accepted without question. Dr. Lindley’s evidence[20] is that in his opinion it would have been known to anyone working in the sweetener area as of the priority date that the balance between lipophilicity and hydrophilicity was an important parameter for sweetness and potency of HPSs. Dr. Lindley provided three scientific papers[21] published between 1966 and 1996 providing theories on structure-activity relationships in sweet taste. Dr. White’s evidence is that he was not aware of such a relationship, and pointed to sucralose as a counterexample, where “incorporating three chlorines into the structure of sucrose increased lipophilicity and increased potency, the incorporation of a further chlorine which further increased lipophilicity was actually detrimental to potency and introduced a bitter taste component”.[22] Dr. Lindley responded to this by stating that position of substituents was also important.[23]
[20] Lindley #1 at 3.32 and Lindley #2 at 2.4
[21] Exhibits MGL-17 to MGL-19
[22] White at 127
[23] Lindley #3 at 2.5
Taken together, this evidence does not satisfy me that the structure-activity properties of HPSs were generally known and accepted without question by the skilled worker at the priority date. If anything, it demonstrates that the skilled worker would have known that structural changes would have an uncertain effect on flavour profile. Tellingly, food technology textbooks submitted in evidence[24] disclosed the potency of various artificial sweeteners but did not contain any theory as to structure-activity relationship.
[24] MGL-3 from 1987 and JW-10 from 2012 – just after the priority date but indicative of common general knowledge at the time.
The specification
Before construing the specification, I note the comments of Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd[25]:
“It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”
[25][2013] FCA 214 at 139
The application is titled “Methods for purifying steviol glycosides and uses of the same”. As can be seen from the title, the specification provides information on purifying, formulating and the taste properties of steviol glycosides. However, the claims at issue are only in relation to sweetened beverage compositions. Therefore, for the purposes of this decision, I will focus on those parts of the description relating to beverage compositions.
The background of the invention sets out that natural sugars, in particular sucrose, are preferred by consumers but there is also a demand for non-caloric or low caloric sweeteners. However, non-caloric sweeteners are said to “continue to frustrate consumers” due to flavour qualities that differ from sugar, in particular delayed sweetness onset, lingering sweet aftertaste, bitter taste, metallic taste, astringent taste, cooling taste and/or licorice-like taste.[26] The application goes on to give an overview of steviol glycosides, which are naturally derived sweeteners 150-450 times sweeter than sugar but which share the above-described undesirable taste properties. Stevioside and Reb A are disclosed to be available in commercial quantities. The specification states there is a need to develop natural reduced or non-caloric sweeteners that provide a temporal and flavour profile similar to that of sucrose.[27]
[26] p. 1 l. 18-29
[27] p. 2 l. 28-29
The “summary of the invention” at pp. 3 and 3a mirrors the language of the claims which will be addressed in detail later. To summarise, the invention is directed to soft drinks (and syrups for making them) having a non-trivial amount of Reb X as the major steviol glycoside sweetener. However, it is worth noting that p 8 lines 4-6 refers to a method for imparting a more sugar-like temporal profile, flavour profile, or both, to a sweetenable composition using Reb X, which is consistent with meeting the above-described need.
The “detailed description of the invention” from pp. 9-120 contains a large amount of information, at a fairly high level of generality, relating to the purification of Reb X (not relevant to the present consideration), and to the makeup of sweetener compositions comprising Reb X. These appear to be directed to describing the ways Reb X could be used in many possible commercial formulations. This seems consistent with the evidence of the experts as to the conventional makeup of soft drinks. Very little will turn on this “boilerplate” text.
The specification concludes with ten examples. Examples 1 and 3 relate to the purification and structural characterisation of Reb X and Example 5 is a solubility test. The remaining examples relate to the taste characterisation of beverage compositions comprising Reb X.
Example 2 discloses the results of taste comparisons by twenty panellists of stevioside, Reb A, Reb D, Reb X (all 500 ppm) and sucrose (10,000 ppm) in acidified water (pH 3.0). Unlike Stevioside and Reb A, the sensory profile of Reb X was considered by all panellists to be similar to that of sucrose in terms of bitterness, astringency, licorice taste, aftertaste, cleanliness of taste and satisfactory experience. Reb D rated between Reb A and Reb X, only being rated unsatisfactory by 9 of the 20 panellists.
Example 4 details a taste comparison of 500 ppm solutions of Reb X, Reb A and Reb D in pH 3.22 citrate buffer at 4°C and room temperature by a single experienced panelist. Reb X was reported to have a much better taste quality than Reb A or Reb D, with no bitter or licorice off-notes and a temporal profile and quality similar to sucrose, although it was not reported to display a pure sugar-like tasting quality.
Example 6 details an isosweetness determination for Reb X, i.e. determining the % sucrose equivalence of different concentrations of Reb X in citrate buffer at 4°C and room temperature. This was carried out by a single experienced taster using dilute Reb X solutions and sucrose controls and repeated twice. There was no significant difference in isosweetness between the two temperatures. Relevantly for the present claims, 12.5 ppm Reb X is disclosed to be equivalent to 0.5% – 0.75% sucrose, 50 ppm Reb X to 3% - 3.75% sucrose, 400 ppm Reb X to 14%-14.5% sucrose, and 600 ppm Reb X to 16.5%-17% sucrose, although it was said to be difficult to determine isosweetness above 400 ppm Reb X due to different mouthfeel.
Example 7 details use of Reb X to produce a zero calorie black tea drink, an enhanced water drink (with 200-250 ppm Reb X) and a zero calorie orange-flavoured sparkling beverage (with 400-750 ppm Reb X). In all examples the drinks containing Reb X were said to be superior to a similar formulation using Reb A as the sweetener, having a cleaner finish, less linger, more rounded taste quality (at the low sweetener levels) and no negative aftertaste at the high sweetener level.
Example 8 is an isosweetness determination to match Reb X concentration to sucrose concentrations between 2.5% - 10% carried out by a panel of trained testers at room temperature. This had broadly similar results to example 6 except that 422 ppm Reb X was found to be equivalent to 10% sucrose.
Example 9 reports a sensory comparison of Reb X and Reb A carried out by 34 semi-trained panel members using filtered water, and 23 semi-trained panel members using acidified water. The panellists rated different attributes. The results in Fig 11 and 12 show that Reb X is superior to Reb A in terms of bitterness, astringency, and lingering bitterness.
Example 10 reports a similar study to Example 9 but done to compare pure Reb X with mixtures of Reb X with other sweeteners including Reb A, mogroside V and erythritol.
The claimed invention
The opposed application ends with 17 claims, all of which refer to claim 1. Claim 1 is directed to a beverage comprising a defined sweetener composition. Claims 2-10 place further limitations as to the nature of the sweetener composition. Claims 11-16 place further limitations as to the type of the beverage (in particular, to a cola). Claims 17 and 18 are directed to a method of making the beverage of claim 1 using the sweetener composition defined in claim 1, and to a syrup comprising the same sweetener composition. The full claim set is attached in an appendix. Claim 1 is reproduced in full below:
A beverage comprising a sweetener composition, wherein Reb X is the sole sweetener in the sweetener composition; or the sweetener composition comprises a steviol glycoside mixture, the steviol glycoside mixture comprising Reb X in an amount of at least about 70% by weight on a dry basis of the steviol glycoside mixture;
wherein Reb X is present in an amount effective to provide sweetness in the beverage in the range equivalent to from about 0.50 to about 14 degrees Brix of sugar; and
wherein the concentration of Reb X in the beverage is in the range from about 50 ppm to about 600 ppm.
Claim construction
The correct approach to the construction of the claims was summarised by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd[28]:
“the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear. Words used in a specification, including the claims, are to be given the meaning which the person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification. 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. However, terms in the claim which are unclear may be defined or clarified by reference to the body of the specification. The construction of a specification, including the claims, is ultimately a question of law for the decision maker.”
[28] [2009] FCAFC 70 at 118–120
Claim 1 defines the beverage in the two ways: the nature of the sweetener composition and the amount of the composition in the beverage. The former is the subject of the Opponent’s inventive step attack while the latter is the subject of the alleged lack of clarity and utility.
Regarding the nature of the sweetener composition, the claim sets out two options: one is that the sole sweetener is Reb X, the other is that the sweetener composition comprises (includes) steviol glycosides and Reb X is the major steviol glycoside component, defined as 70% or more w/w of the steviol glycosides. This definition is compatible with embodiments where the sweetener composition also comprises other non-steviol sweeteners such as sucrose (cf. claims 9 and 11).
The nature limitation can be summarised to say that Reb X is either the sole or the majority[29] steviol glycoside in the beverage.
[29] Strictly speaking 70% or more of all steviol glycosides present.
Regarding the amount of sweetener in the composition, the claim sets out two distinct criteria: one is that Reb X provides sweetness in the range equivalent to about 0.5 to 14 degrees Brix[30] (the Brix limitation), and the other is that the concentration of Reb X is in the range from 50-600 ppm (the ppm limitation).
[30] One degree Brix is 1% sucrose w/w
The ppm limitation is straightforward but the Brix limitation requires some consideration when Reb X is not the only sweetener present. The specification does not provide any definition about what is meant by “provide sweetness”. Excluding consistory statements that echo the claims, the only mention of this concept is at p. 32 lines 22 and 32, both of which are in the context of pure Reb X sweeteners. The concept of additional sweeteners is only introduced later at p. 33 line 18 and “providing sweetness” is not mentioned thereafter.
Since it is generally known that HPSs such as steviol glycosides have non-linear sweetness profiles, it does not seem possible to attribute with any certainly how much sweetness in a mixed sweetener composition is due to Reb X. This is the nub of the Opponent’s submission as to why the claims lack clarity.[31]
[31] OS at 100
However an alternative reading of the Brix limitation (put forward by the Applicants[32]) is simply that the beverage itself has a Brix value within the claimed range. This is how both Drs Lindley and White read the claim[33] and both of them commented that the Brix range is consistent with sweetness values for commercially available soft drink beverages. Bearing in mind that the claim is read through the eyes of the skilled addressee and with a measure of common sense, I find that this reading is to be preferred.
[32] AS at 167
[33] Lindley #1 at 5.33.6, White at 94-95
It is clear that both the Brix and ppm limitations must be satisfied for a beverage to fall within the scope of the claim. That is, claim 1 excludes beverages with less than 0.5 or more than 14 degrees Brix, or less than about 50 or more than about 600 ppm Reb X. I note that the syrups mentioned in claims 16-17 are necessarily more concentrated than this and the Brix and ppm limitations do not apply to them; rather these claims are only defined by the major steviol glycoside limitation.
The claims could be summarised in a very succinct fashion as being directed to soft drinks (and syrups for making them) having a non-trivial amount of Reb X as the majority steviol glycoside sweetener.
Clarity
It is a requirement of subsection 40(3) of the Act that the claims be clear. This requirement is satisfied if a person could ascertain “whether or not what he proposes to do falls within the ambit of the claim”[34]. Sufficient clarity will be provided if the claim provides a “workable standard suitable to the intended use.”[35]
[34] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59 at 60
[35] Minnensota Mining & Manufacturing Cov Beiersdorf (Australia) Ltd [1980] HCA 9 at 274
I have found above that when reading the claims in context and through the eyes of the skilled worker there is no lack of clarity as to the metes and bounds of the claims. This ground of opposition therefore fails.
Utility
The Opponent set out legal principles for utility which are uncontroversial: the invention must do what it is intended to do (satisfy the promise of the invention) [36] and the utility requirement must be satisfied over the full the scope of the claim.[37]
[36] Rehm v Websters Security (1988) 81 ALR 79 at 96
[37] Cf H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 at 81, 217
The Opponent’s submission as to lack of utility is that the claims make several competing promises as to the amount of Reb X that is useful (the ppm feature) and the amount of sweetness that is useful (the Brix feature). The Opponent points to examples in the specification that show that the lowest end of the Brix feature is not sweet enough to be attained by Reb X concentrations that satisfy the ppm feature, and that the highest end of the ppm feature is too sweet and therefore incompatible with the Brix feature.[38]
[38] OS 89-92
While I do not disagree with the Opponent’s reading of the examples, I disagree with the proposition that there are promises made by the claims that are not satisfied. My claim construction is that both features must be satisfied for a formulation to fall within the scope claim; any formulation that only satisfies one of the Brix and ppm features is excluded from the scope and the question of whether it satisfies the promise of the invention is moot. This ground of opposition therefore fails.
Inventive Step
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[39] Aickin J stated:
“The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they are the steps of the inventor or not.”
[39] (1981) 148 CLR 262 at 286
More recently, the High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd[40] referred to this approach with approval and further held:
[40] (2002) 212 CLR 411 at 53
“That way of approaching the matter has an affinity with the reformulation of the ‘Cripps question’ by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157. This court had been referred to Olin in the argument in Wellcome Foundation. Graham J had posed the question:
'Would the notional research group at the relevant date in all the circumstances directly be led as a matter of course to try [the claimed invention] in the expectation that it might well produce [the desired result]?'
That approach should be accepted.”
This “reformulated Cripps question” is not the only way to approach inventive step but it is a useful approach that has been endorsed by the High Court.
The expectation of success was considered in Nichia Corporation v Arrow Electronics Australia Pty Ltd[41] (Nichia). The Full Court in Nichia noted that the relevant test is merely an expectation that the steps may work, and stressed that “directly led” and “in the expectation” in the Cripps question are not separate tests but are a single qualified question, citing with approval the observation in Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft[42] that 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”.
[41] [2019] FCAFC 2
[42] [2014] FCAFC 73 at 71
The Full Court in Nichia also pointed to the importance of correctly construing the problem to be solved (also described as the outcome to be sought or the useful result). It agreed that considering the issue of obviousness by reference to “the outcome that is sought” is an orthodox approach.[43]
[43] Nichia at 81
In the case at issue in Nichia, the Full Court criticised the primary judgment for applying “too high a standard” of expecting a white LED which is durable, with good colour tone and high luminance,[44] whereas the primary judge had found that the claims and specification read as a whole disclosed that the invention in Nichia need meet only one of those objects.[45] The Full Court then emphasised that “the concept of a useful result, for the purposes of the Cripps question, cannot exceed that which the claims and the specification as a whole in the context of the prior art identifies as useful.”[46]
[44] Nicha at 120
[45] Nichia at 118
[46] Nichia at 119
However the Full Court did not accept the proposition that the qualitative aspects of the useful result needed to be integers in the claims[47] and cited with approval Middleton J in Eli Lilly and Co Ltd v Apotex Pty Ltd: “It is impermissible to divorce olanzapine from its context and subject it to an obviousness test that completely disregards its utility as an antipsychotic drug”.[48]
[47] Nichia at 68
[48] Nichia at 76, citing [2013] FCA 214 at 533
From the above guidance, the nature of the problem to be solved (referred to as “useful result” or “outcome to be sought” in Nichia) is critical to the determination of inventive step according to the reformulated Cripps question, as it is the nature of the problem to be solved which provides the context for determining the skilled worker’s expectation of success.
It also follows that the problem to be solved must be something that is accomplished over the whole scope of the claim.
Nature of the prior art
Although it is usual for the hearing officer to provide their construction of the disclosure of the prior art, it will be apparent from the following discussion that even taking the Opponent’s characterisation of these citations at face value, they do not deprive the present claims of an inventive step. I can briefly summarise D1 and D2 as follows: they are a scientific publication and patent application respectively from the same research group; they contain analyses of the minor steviol glycoside components of Stevia rebaduiana extracts; and they identify and structurally characterise Reb X. D1 also discloses the result of a taste test of Reb X, which identifies it as equivalent to Reb A.
The question is then: in view of this prior art, would the uninventive skilled worker have been directly led as a matter of course to try Reb X as the majority steviol glycoside sweetener in a soft drink in the expectation that it might well produce the desired result?
The answer to this question turns on what the desired result, or problem to be solved, is.
The problem to be solved
The Applicants set out under “The Problem” that in their submission the problem is providing an improved non/low caloric sweetener having a temporal and flavour profile similar to sucrose,[49] or alternatively stated, providing a sweetener composition with full sweetness and an improved flavour profile.[50]
[49] AS at 36 and 106
[50] AS at 104
The Opponent appears to dispute this: at OS 36 they state that “the Opposed Application purports to solve the following problems” (emphasis added) with reference to p. 2 lines 28-32 of the specification which refers to natural reduced or non-caloric sweeteners that provide a temporal and flavour profile similar to that of sucrose. Their preferred formulation of the problem to be solved or useful result was not set out explicitly in their written submissions but appears to be that it is providing a commercially useful sweetener in a sweetener composition for use in food and beverages.[51] This is consistent with the Opponent’s analysis of the citations, as per the evidence of Dr Lindley, that both D1 and D2 identify Reb X as a beneficial sweetener for use in foods and beverages.[52]
[51] OS at 157
[52] OS at 147 and 156
I concur with the Opponent’s factual analysis of D1 and D2.[53] These documents identify Reb X as a steviol glycoside component of Stevia rebaduiana extracts, with similar properties to Reb A.[54] I agree it would have been as identified as an obvious and logical candidate for further investigation and evaluation for potential commercial application. It follows that if the Opponent’s problem is preferred, the Cripps question would be satisfied.
[53] OS at 137-156
[54] p. 207 r.h. column 2nd paragraph of D1 is the most relevant passage, which states: “The relationship between a structure and the intensity of its sweetness has been investigated, and it was disclosed that glycosylation at both C13 (R2) and C19 (R1) of steviol are essential for sweetness … It was shown that SG17 [Reb X] and SG19, which contained a large sugar chain at the C19 position, had a sweetness equivalent to rebaudioside A, and gave a slightly latent sweet sensation to some volunteers in our laboratory (data not shown). The relationship between the structure and sweetness remains to be clarified in further detail.”
On the other hand, I have found above that it was not generally accepted in the common general knowledge that the flavour profile of a sweetener could be predicted from its structure. Even D1 conceded that “[t]he relationship between the structure and sweetness remains to be clarified in further detail.”[55] Therefore if the Applicants’ problem is preferred, it follows that the Cripps question would not be satisfied as there is nothing in the evidence suggesting that the skilled worker would have had a reasonable expectation of obtaining a sweetener with a temporal and flavour profile similar to sucrose.
[55] ibid
For the following reasons the Applicants’ formulation is to be preferred.
The specification does seek to address the problem of providing natural reduced or non-caloric sweeteners that provide a temporal and flavour profile similar to that of sucrose. The specification then demonstrates by way of numerous examples that formulations having Reb X as the sole or majority sweetener do have a temporal and flavour profile similar to that of sucrose. Furthermore the specification demonstrates that this effect is obtained in a range of different beverages (Example 7) and in mixed formulations (Example 10).
I am therefore satisfied that providing a temporal and flavour profile similar to that of sucrose is the “useful result for the purposes of the Cripps question” in the Nichia sense because it appears to be found across the full scope of the claims.
I disagree with the Opponent’s submission at OS 143 that due to the additional glucose moeities in Reb X “evaluation of Reb X would, before the Priority Date, have been an obvious course of action with a reasonable expectation that Reb X would deliver superior taste quality” in light of my finding that structure-activity relationships were not part of the common knowledge and the disclosure in D1 that Reb X and Reb A have the same sweetness. Even Dr. Fry concedes that studying minor steviol glycosides was only done “in the hope of locating SGs of improved taste”.[56]
[56] Fry declaration p. 2 second last paragraph
The ground of lack of inventive step therefore fails.
Costs
Costs typically follow the event, and there is no reason to deviate from that approach in this case. I therefore award costs according to Schedule 8 against Spicer Spicer Pty Ltd.
Felix White
Delegate of the Commissioner of Patents
Appendix – Accepted claims
1. A beverage comprising a sweetener composition, wherein Reb X is the sole sweetener in the sweetener composition; or the sweetener composition comprises a steviol glycoside mixture, the steviol glycoside mixture comprising Reb X in an amount of at least about 70% by weight on a dry basis of the steviol glycoside mixture;
wherein Reb X is present in an amount effective to provide sweetness in the beverage in the range equivalent to from about 0.50 to about 14 degrees Brix of sugar; and wherein the concentration of Reb X in the beverage is in the range from about 50 ppm to about 600 ppm.
2. The beverage of claim 1, wherein Reb X is the sole sweetener in the sweetener composition; or the sweetener composition comprises a steviol glycoside mixture, the steviol glycoside mixture containing Reb X in an amount greater than about 90% by weight on a dry basis of the steviol glycoside mixture.
3. The beverage of claim 2, wherein Reb X is the sole sweetener in the sweetener composition; or the sweetener composition comprises a steviol glycoside mixture, the steviol glycoside mixture containing Reb X in an amount greater than about 95% by weight on a dry basis of the steviol glycoside mixture.
4. The beverage of any one of the preceding claims, wherein the beverage comprises Reb X in an amount effective to provide sweetness in the beverage in the range equivalent to from about 5 to about 11 degrees Brix of sugar.
5. The beverage of any one of the preceding claims, wherein the concentration of Reb X in the beverage is in the range of from about 100ppm to about 400ppm.
6. The beverage of any one of the preceding claims, wherein the steviol glycoside mixture comprises Reb A.
7. The beverage of claim 6, wherein the relative weight percent of Reb X and Reb A is 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, or about 75% Reb X / 25% Reb A.
8. The beverage of claim 7, wherein the beverage comprises about 300ppm Reb X and about 100ppm Reb A.
9. The beverage of any one of the preceding claims, wherein the beverage comprises sucrose.
10. The beverage of claim 9, wherein the beverage comprises sucrose in an amount in the range of from about 5,000ppm to about 80,000ppm.
11. The beverage of any one of the preceding claims, wherein the beverage is selected from a mid-calorie, low-calorie and zero-calorie beverage.
12. The beverage of any one of the preceding claims, wherein the beverage is carbonated.
13. The beverage of any one of the preceding claims, wherein the beverage comprises caffeine.
14. The beverage of any one of the preceding claims, wherein the beverage is a cola.
15. The beverage of any one of the preceding claims, which is a cola comprising:
- caffeine;
- carbonation;
and -a sweetener composition;
wherein Reb X is the sole sweetener in the sweetener composition; or the sweetener composition comprises a steviol glycoside mixture, the steviol glycoside mixture comprising Reb X in an amount of at least about 70% by weight on a dry basisof the steviol glycoside mixture, and comprising Reb A, wherein the relative weight percent of Reb X and Reb A is 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, or about 75% Reb X / 25% Reb A;
wherein Reb X is present in an amount effective to provide sweetness in the beverage in the range equivalent to from about 5 to about 11 degrees Brix of sugar; and
wherein the concentration of Reb X in the beverage is in the range of from about 100 ppm to about 400ppm.
16. The beverage of claim 15, wherein the beverage comprises about 300ppm Reb X and about 100ppm Reb A.
17. A method of preparing the beverage of any one of claims I to 16, comprising:
preparing a syrup by adding an initial volume of water and beverage ingredients including a sweetener composition as defined in any one of claims 1 to 16; and
adding a further volume of water.
18. A syrup comprising a volume of water and beverage ingredients including a sweetener composition as defined in any one of claims 1 to 16, for use in the method of claim 17.
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