Südzucker Aktiengesellschaft Mannheim/Ochsenfurt v Evonik Degussa GmbH
[2017] APO 3
•12 January 2017
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Südzucker Aktiengesellschaft Mannheim/Ochsenfurt v Evonik Degussa GmbH [2017] APO 3
Patent Application: 2010335313
Title:Sweetener and method for the production thereof
Patent Applicant: Evonik Degussa GmbH
Opponent: Südzucker Aktiengesellschaft Mannheim/Ochsenfurt
Delegate: Dr M-A. Fam
Decision Date: 12 January 2017
Hearing Date: 28 November 2016, in Canberra
Catchwords: PATENTS – section 59 – opposition to the grant of a patent – grounds of novelty, inventive step, utility, clarity and fair basis considered – novelty – citations do not disclose all the features of the claims – inventive step – lack of inventive step not established – claims are clear and fairly based – lack of utility not established – opposition unsuccessful
Representation: Counsel for the applicant: Ms Katrina Howard
Patent attorney for the applicant: Mr Richard Grant of Spruson & Ferguson
Counsel for the opponent: Mr Ben Fitzpatrick
Patent attorney for the opponent: Mr David Tadgell of Phillips Ormonde Fitzpatrick
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2010335313
Title:Sweetener and method for the production thereof
Patent Applicant: Evonik Degussa GmbH
Date of Decision: 12 January 2017
DECISION
The opposition is unsuccessful on all grounds. Subject to appeal, I direct that the application proceed to grant.
Costs according to Schedule 8 awarded against Evonik Degussa GmbH up to and including the date that the section 104 amendments were allowed on 21 July 2016 and against Südzucker Aktiengesellschaft Mannheim/Ochsenfurt from the date of allowance onwards.
REASONS FOR DECISION
1. Background
The present application was filed by Evonik Degussa GmbH (Evonik) on 15 December 2010 and claims priority from DE 10 2009 055 256.1 which was filed on 23 December 2009. Following examination, the application was advertised accepted on 6 March 2014. A notice of opposition was filed by Südzucker Aktiengesellschaft Mannheim/Ochsenfurt (Südzucker) on 4 June 2014.
Evonik subsequently filed amendments under section 104 on 23 February 2015. These were advertised allowed on 2 July 2015. Further amendments under section 104 were filed on 1 March 2016, which were advertised allowed on 4 August 2016. A hearing was held in Canberra on 28 November 2016.
The request for examination in relation to the application was filed on 25 January 2013. Consequently, substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar) do not 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 prior to amendment by the Raising the Bar Act. A similar qualification applies to references to the Patents Regulations 1991.
2. Grounds of opposition
The statement of grounds and particulars was filed on 3 September 2014. The grounds pressed at the hearing were novelty, inventive step, utility, fair basis and clarity.
3. Standard of proof
The onus of proof in this opposition proceeding rests with the opponent, who must demonstrate that it is clear that a valid patent cannot be granted (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283; 50 IPR 305 at [67]; Commissioner of Patents v Sherman [2008] FCAFC 182; 79 IPR 426 at [18]).
4. Evidence
The evidence is summarised in the table below.
Evidence Declarant Exhibits Date Reference Ralph Cartarius
RC-1 to RC-44 1 December 2014 Cartarius In Support Spencer J. Williams
SJW-1 to SJW-29 3 December 2014 Williams-1 Rodney Ian Lindsay Cruise 3 December 2014 Cruise Antony John Fairbanks
AJF-1 to AJF-4 18 June 2015 Fairbanks In Answer Richard James Payne RJP-1 to RJP-2 25 June 2015
Payne Marc Becker
MB-1 2 March 2015 Becker Thomas Haas TH-1 to TH-2 2 March 2015 Haas Alireza Haji Begli
AHB-1 19 August 2015 Haji Begli-1 In Reply
Alireza Haji Begli 20 August 2015 Haji Begli-2 Spencer J. Williams SJW-30 to SJW-39 25 August 2015 Williams-2 5. The subject matter of the specification
5.1 Background of the invention
The specification relates to sweeteners and methods for their production.
Isomalt (Palatinit®) is a sugar substitute prepared from sucrose, usually via a two-step procedure. Sucrose is initially isomerised to isomaltulose, which then undergoes catalytic hydrogenation to form isomalt. The isomalt produced is an isomeric mixture of a-D-glucopyranosyl-1, 6-D-sorbitol (1, 6-GPS) and a-D-glucopyranosyl-1, 1-D-mannitol (1, 1-GPM).
The specification indicates that the isomerisation of sucrose is generally carried out using enzymes (page 1, line 23 – page 2, line 7). However, in all known methods of isomerisation the sucrose is never completely converted to isomaltulose. Residual sucrose must be removed prior to the hydrogenation process, as this substance has a strong glycaemic action (page 3, lines 31 ‑ 34). Removal of the sucrose may involve crystallisation of the isomaltulose, or alternately the residual sucrose is cleaved to fructose and glucose and these monosaccharides subsequently separated (page 2, lines 15 – 23). Such removal processes inevitably result in the loss of isomaltulose (page 4, lines 1 – 3).
The hydrogenation of isomaltulose is performed in the presence of a catalyst that contains, for example, nickel (page 2, line 25 – page 3, line 6). Nickel and/or ruthenium catalysts can be used to vary the ratio of 1, 6-GPS to 1, 1‑GPM produced (page 3, lines 7 – 14).
The specification states that isomalt may contain components other than 1, 6-GPS and 1, 1-GPM, depending upon the purification process used following the isomerisation of sucrose. Thus, trehalulose, glucose and fructose that are formed as by-products during the isomerisation process may be carried through to the hydrogenation reaction. This results in the production of substances including a-D-glucopyranosyl-1, 1-D-sorbitol (1, 1-GPS), mannitol and sorbitol, which may be present in the final isomalt sweetener (page 3, lines 16 – 29).
5.2 The aim of the invention
The specification states at page 4, lines 5 – 10 that:
“The task of the present invention consists of providing a sucrose-based sweetener, in the production of which the step of separation of the residual sucrose from the isomerization stage is not required, and which has excellent properties for further processing, for example it can be formulated as sweets.”
5.3 Nature of the invention
The specification indicates that the invention relates to a sweetener derived from sucrose and a catalytic process for the production thereof. The sweetener, when compared with conventional isomalt and relative to the amount of 1, 1-GPM, is enriched in 1, 6 –GPS (page 5, lines 14 – 20).
The sweetener may be produced by reaction of a carbohydrate mixture containing isomaltulose and sucrose, and optionally trehalulose, fructose and glucose, with hydrogen in the presence of a catalyst based on ruthenium (Ru) or an oxide thereof (page 7, lines 28 – 36). The isomaltulose, and optionally trehalulose, are hydrogenated to 1, 6-GPS and 1, 1-GPM and optionally 1, 1-GPS. The sucrose is cleaved to form fructose and glucose, which are subsequently hydrogenated to produce sorbitol and mannitol (page 7, line 37 – page 8, line 3). These latter two substances are also sugar substitutes (page 8, lines 4 – 6). Thus, the reaction corresponds to a catalytic hydrogenation accompanied by cleavage of sucrose to fructose and glucose (page 8, lines 7 – 10).
5.4 The claims of the specification
The specification contains 30 claims and these are reproduced in Annex A. Claims 1 – 4 are directed to a sweetener, claims 5 – 27 are method claims, claim 28 is an omnibus claim and claims 29 and 30 are product by process claims.
6. The person skilled in the art
The person skilled in the art was considered in Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; 49 IPR 225 at [70] – [71]:
“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. …
In Catnic Lord Diplock said (at 242) that skilled addressees are ‘those likely to have a practical interest in the subject matter of [the] invention’. A variety of people may have that interest. There are those who might wish to make or construct the invention, those who may wish to compound the invention and those who may wish to use the invention. The skilled addressee seems to me to be a relative expression which does not identify any specific person.”
Associate Professor Williams has research experience in the field of carbohydrate chemistry and knowledge of products including isomalt and isomaltulose. Professor Fairbanks has research experience in synthetic carbohydrate chemistry and the application of carbohydrates to biology and medicine. Professor Payne has conducted research in the field of carbohydrate chemistry. Dr Becker and Dr Haas are inventors of the present application. Dr Haji Begli has experience in the chemical-catalytic processes for the derivatisation of carbohydrates and in particular the hydrogenation of sugars. Dr Cartarius has employment experience with companies that produce speciality ingredients including isomaltulose and isomalt.
I consider that all of the declarants would have a practical interest in the invention and I will give regard to their evidence. Where there is conflicting evidence, I will use the normal practice of evaluating and weighing that evidence in order to resolve any conflict.
7. Claims construction
The principles of construction have been considered by the courts. These were summarised by the Full Court of the Federal Court in Kinabalu Investments Pty Ltd v Barron Rawson Pty Ltd [2008] FCAFC 178 at [44] – [45]:
“When determining the nature and extent of the monopoly claimed, the specification must be read as a whole. But as a whole it is made up of several parts which have different functions. The claims mark out the legal limits of the monopoly granted. The specification describes how to carry out the process claimed and the best method known to the patentee of doing that. Although the claims are construed in the context of the specification as a whole, it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim, by adding to those words glosses drawn from other parts of the specification. If a claim is clear and unambiguous, it is not to be varied, qualified or made obscure by statements found in other parts of the document. It is legitimate, however, to refer to the rest of the specification to explain the background of the claims, to ascertain the meaning of technical terms and resolve ambiguities in the construction of the claims. See Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331 at [73] – [75] (Hely J).
Other more specific principles of construction collected in Flexible Steel at [81] are:
·a specification should be given a purposive construction rather than a purely literal one;
·the hypothetical addressee of the specification is the non-inventive person skilled in the art before the priority date;
·the words used in a specification are to be given the meaning the hypothetical addressee would attach to them, both in the light of the addressee’s own general knowledge and in the light of what is disclosed in the body of the specification;
·as a general rule, the terms of the specification should be according their ordinary English meaning;
·evidence can be given by experts on the meaning those skilled in the art would give to technical or scientific terms and phrases, and on unusual or special meanings given by such persons to words which might otherwise bear their ordinary meaning;
·however, the construction of the specification is for the court, not for the expert. In so far as a view expressed by an expert depends upon a reading of the patent, it cannot carry the day unless the court reads the patent in the same way.”
As stated by Middleton J in Eli Lilly & Co Ltd v Apotex Pty Ltd [2013] FCA 214; 100 IPR 451 at [139]:
“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.”
7.1 Construction of claim 1
Claim 1 is as follows:
A sweetener containing
20 wt.% to 75 wt.% of a-D-glucopyranosyl-1, 6-D-sorbitol,
20 wt.% to 75 wt.% of a-D-glucopyranosyl-1, 1-D-mannitol,
0.02 wt.% to 15 wt.% of a-D-glucopyranosyl-1, 1-D-sorbitol,
0.02 wt.% to 15 wt.% of sorbitol and
0.2 wt.% to 15 wt.% of mannitol,
in each case relative to the total amount of a-D-glucopyranosyl-1, 1-D-mannitol, a-D-glucopyranosyl-1, 6-D-sorbitol, a-D-glucopyranosyl-1, 1-D-sorbitol, sorbitol and mannitol,
with the provisos
that the weight ratio of a-D-glucopyranosyl-1, 6-D-sorbitol to a-D-glucopyranosyl-1, 1-D-mannitol is greater than 1:1; and
that the sweetener contains sucrose; and
that said sucrose is present in an amount less than 0.3 wt.% relative to the total weight of dry matter of the sweetener.
(a)Containing
The plain meaning of the word “contain” is “comprise; include” (Macquarie Dictionary).
The courts have given some consideration to the terms “contain” and “comprise”. In NV Philips Gloeilampenfabrieken v Mirabella International Pty Limited (1993) 44 FCR 239 at 257, Lockhart J stated:
“The word ‘contains’ is susceptible of more than one meaning. So far as relevant in this case it may mean ‘contains’ in the sense of ‘comprises or consists of’ or in the sense of ‘has within it’, though, depending on the context, there is overlap between these concepts. The dictionaries attribute either meaning to the word”.
In Asahi Kasei Kogyo Kabushiki Kaisha v W R Grace & Co (1991) 22 IPR 491 at 514 – 515, Heerey J held that in the context of that case “comprise” meant “consists of” and that the word was used in an exhaustive sense rather than an inclusive sense, i.e. the claim did not cover an infinite number of substances.
In General Clutch Corporation v Sbriggs Pty Ltd [1997] FCA 499; (1997) 38 IPR 359 at 376, Lindgren J concluded:
“In my opinion, the words ‘spring clutch comprising’ signify that what is claimed is a device which possesses the four functional elements to which I referred earlier, and which consists of, is made up of, is composed of, or is constituted by, the integers described in Claim 1, and no more.” (emphasis in original)
In Fresenius Medical Care Australia Pty Limited v Gambro Pty Limited [2005] FCAFC 220; (2006) 67 IPR 230 at [56] – [64], the Full Court considered whether “comprise” means “consists only of” or “includes”. The Full Court held that in this context “comprise” had an inclusive meaning, and was not intended to mean and does not mean “consists only of”.
In view of the above, I consider it appropriate to construe the term “containing” in context. The specification indicates that the sweetener optionally contains water (page 5, lines 32 – 35) and that any water present may be removed in order to convert the sweetener from a liquid form to a dry form (page 13, lines 4 – 9).
It is therefore apparent that components other than those specifically listed in claim 1 may be present in the sweetener, i.e. “containing” has an inclusive meaning. Claim 1 is therefore considered to define a sweetener that is made up of the listed components, however additional ingredients may also be present.
(b)“The sweetener contains sucrose; and that said sucrose is present in an amount less than 0.3 wt.% relative to the total weight of dry matter of the sweetener”
The specification at page 7, lines 22 – 26 states:
“Preferably the sweetener according to the invention contains less than 2.5 wt.%, in particular less than 0.3 wt.%, and most preferably no detectable amounts of sucrose, relative to the total weight of dry matter of the sweetener.”
At page 6, line 17 – page 7, line 8, a preferred composition is stated to be one that consists of 1, 6‑GPS, 1, 1-GPM, 1, 1-GPS, sorbitol and mannitol, with no mention of sucrose.
In regard to the hydrogenation of a carbohydrate mixture containing isomaltulose and sucrose, it is stated at page 13, lines 1 – 2 that:
“Preferably the method is carried out until sucrose can no longer be detected in the sweetener obtained.”
Examples 1 to 4 indicate that some sucrose remains following the hydrogenation of a mixture of isomaltulose and sucrose, in amounts ranging from 0.06 wt.% to 2.28 wt.%.[1]
[1] Payne [118] – [121]. Note that the amount of sucrose remaining in Example 3 should be 1.2 wt.% rather than 0.12 wt.%.
Südzucker submitted that the requirement for the presence of sucrose in the sweetener is at odds with the purpose of the invention, i.e. to more efficiently remove residual sucrose. It was further submitted that a purposive approach to understanding the invention would necessarily encompass compositions having no detectable sucrose. Evonik stated that provided sucrose is present, it does not matter whether it is detectable, provided that it is below the limit of 0.3 wt.%.
Adopting the plain meaning of the words, the claim defines a sweetener wherein sucrose is present in an amount that is greater than zero and less than 0.3 wt.% in relation to the total weight of dry matter. I consider that the presence of sucrose in such amounts still satisfies the objective of providing a low sucrose sweetener. As stated by Professor Payne[2]:
“A product having a small residual amount of sucrose would still satisfy the ultimate aim of the application: to produce a sweetener having a much lower sucrose level than pure sucrose by a simpler, and hence more cost effective, process.”
[2] Payne [122].
Turning to whether the amount of sucrose must be detectable, the claim states “that said sucrose is present.” The plain meaning of the word “present” is “being, existing” (Macquarie Dictionary). For the sucrose to exist in the defined amount, this necessarily requires confirmation of its presence by some means. For practical purposes this would involve measurement or detection. However, it would be possible to infer the presence of sucrose, for example, if a sweetener was prepared by mixing the components in the stated ratios, the presence of the sucrose would be confirmed by knowledge that the substance had been added in a particular amount.
To my mind an amount of sucrose that is not detectable is not an amount that is “present”, unless there is a sound, logical basis to infer its presence. Following a common sense approach, if there is no detectable sucrose, then the presence of the substance has not been established as required by the claim.
Claim 1 is construed to define a sweetener containing sucrose in an amount that is greater than zero and less than 0.3 wt.%. Where there is no detectable sucrose, then that sucrose is not “present” and does not fall within the scope of the claim.
Südzucker made submissions with respect to the clarity of the proviso in claim 1 and these are discussed in part 8 below.
(c)Parameteritis
Südzucker further submitted that the addition of the proviso relating to the sucrose content has not been chosen to achieve any particular technical effect, i.e. it is a case of “parameteritis”.
A parametric claim is one that defines a product in terms of its parameters. “Parameteritis” or “parametritis” was considered by Laddie J in Raychem Corp.’s Patents (Raychem) [1998] RPC 31 at [37]:
“This is the practice of seeking to repatent the prior art by limiting claims by reference to a series of parameters which were not mentioned in the prior art. Sometimes it includes reference to parameters measured on test equipment which did not exist at the time of the prior art. The attraction of this to a patentee is that it may be impossible to prove now that the prior art inevitably exhibited the parameters and therefore it is impossible for an opponent to prove anticipation. Even if that is what has happened here, it does not alter the task of the court. It must decide whether the opponent has proved anticipation or some other statutory ground of invalidity. Parametritis may make the court’s task more difficult, but at the end of the day the test of invalidity must be the same, whatever the form of the claims.”
In this case the parameter S/D volume ratio was considered essentially arbitrary and of little technical significance (Raychem at [46]).
As stated in Euroceltique S.A. v Sandoz Pty Ltd [2009] APO 21 at [112], the critical question is whether the parameter chosen achieves a technical effect, or whether it is an arbitrary convenience.
The evidence indicates that when preparing a sweetener, a low sucrose content is desirable as its presence affects caloric content, glycaemic index and cariogenicity.[3] The amount of sucrose present in a sweetener can be measured using standard techniques known to the person skilled in the art, including HPLC, GC-MS and enzymatic tests.[4]
[3] Specification at page 3, lines 31 – 34; Williams-1 [24]; Fairbanks [46].
[4] Cartarius [53]; Haji Begli-1 [13]; WO 2008/077640 (D18), page 11, lines 1 – 2.
I conclude that the amount of sucrose defined in claim 1 is of technical significance and is not an arbitrary choice. This is not a case of parameteritis.
7.2 Construction of claim 4
Claim 4 is as follows:
A sweetener according to any one of claims 1 to 3, said sweetener consisting of:
20 wt.% to 75 wt.% of a-D-glucopyranosyl-1, 6-D-sorbitol,
20 wt.% to 75 wt.% of a-D-glucopyranosyl-1, 1-D-mannitol,
0.02 wt.% to 15 wt.% of a-D-glucopyranosyl-1, 1-D-sorbitol,
0.02 wt.% to 15 wt.% of sorbitol and
0.2 wt.% to 15 wt.% of mannitol,
less than 0.3 wt.% sucrose.
(a)Consisting of
The plain meaning of the term “consist of” is “to be made up or composed of” (Macquarie Dictionary). The courts have given some consideration to this term, albeit in the context of construing the words “comprising” or “comprise” as discussed above. It therefore appears that the natural meaning of “consists of” is “consists only of”, i.e. the term is used in an exhaustive sense. This construction is consistent with the specification, which indicates that the sweetener contains, and preferably consists of, certain components (page 6, line 17 – page 7, line 8).
Claim 4 is construed to define a sweetener that is made up of only the listed components.
(b)Sucrose
Claim 4 is appended to any one of claims 1 to 3. Consequently, the provisos that apply to claim 1 are imported into claim 4. For the reasons discussed above, claim 4 is construed to define a sweetener wherein sucrose is present in an amount that is greater than zero and less than 0.3 wt.%. Where there is no detectable sucrose, then that sucrose is not “present” and does not fall within the scope of the claim.
7.3 Construction of claim 5
Claim 5 is as follows:
A method of production of a sweetener by hydrogenation of a carbohydrate mixture containing isomaltulose and sucrose, characterized in that the hydrogenation is carried out in the presence of at least one catalyst, which is based on ruthenium (Ru) and/or at least one oxide of ruthenium, wherein said hydrogenation is accompanied by cleavage of the sucrose.
The specification indicates that the process of the invention permits simultaneous hydrogenation of isomaltulose to isomalt and sucrose to sorbitol and mannitol (page 5, lines 9 – 12). Further details are provided at page 8, lines 1 – 10, which states that the sucrose is cleaved to fructose and glucose and these substances then hydrogenated to mannitol and sorbitol.
Thus, the hydrogenation of sucrose is understood to be a two-step process involving hydrolysis, which is generally acid catalysed, to convert sucrose to fructose and glucose, followed by hydrogenation of these substances to mannitol and sorbitol.[5] Therefore the process is more appropriately considered a hydrolysis/hydrogenation reaction.
[5] Williams-1 [31]; Fairbanks [48], [88]; Payne [96], [169]; Haas [20].
The specification states that the method is preferably carried out until sucrose can no longer be detected in the sweetener obtained (page 13, lines 1 – 2). In Examples 1 to 4, some unreacted isomaltulose and sucrose remains. I therefore consider that in carrying out the method, both the isomaltulose and sucrose are hydrogenated, however the conversion of these substances may be incomplete.
The claim does not specify the composition of the sweetener produced by the method. However, the sweetener components must necessarily include those that are formed from isomaltulose and sucrose under the reaction conditions and, as indicated above, unreacted isomaltulose and sucrose may also be present. Where conversion of the sucrose is complete, the claim necessarily includes within its scope methods for producing a sweetener that does not contain this substance.
Claim 5 is construed to define a method for producing a sweetener wherein both the isomaltulose and sucrose are subject to hydrogenation, however the conversion of these substances is not necessarily complete. The hydrogenation of sucrose is a hydrolysis/hydrogenation reaction involving hydrolysis (cleavage) of the substance to form fructose and glucose, which are subsequently hydrogenated to mannitol and sorbitol.
The claim also includes within its scope methods for producing a sweetener that does not contain sucrose.
7.4 Construction of claim 7
Claim 7 is as follows:
A method of production of a sweetener by hydrogenation of a carbohydrate mixture containing isomaltulose and sucrose, characterized in that the hydrogenation is carried out in the presence of at least one catalyst, which is based on ruthenium (Ru) and/or at least one oxide of ruthenium, said ruthenium and/or at least one oxide of ruthenium being immobilized on a support, said support being an acid support or being a neutral support which has acquired acid functionality.
The specification states that the term “acid support” in the context of the invention means certain supports that are familiar to the person skilled in the art (page 5, line 37 – page 6, line 13). Thus, the specification has set up a dictionary[6] such that “acid support” has a particular meaning. Neutral supports are discussed at page 10, lines 11 – 16. The processes by which such supports may acquire acid functionality are described in the definition for “acid support”.
[6] The nature of the dictionary principle was discussed by Viscount Haldane in British Thomson-Houston Company Ld. v Corona Lamp Works Ld. (1922) 39 RPC 49 at 67.
The plain meaning of the words indicates that the claim defines a process for producing a sweetener wherein both the isomaltulose and sucrose are subject to hydrogenation. Although the claim does not specifically mention that the hydrogenation is accompanied by cleavage of the sucrose, the evidence indicates that sucrose will hydrolyse under acidic conditions,[7] and these conditions are provided by the support.
[7] Williams-1 [31]; Fairbanks [88]; Payne [169]; Haas [20].
Following the same reasoning as discussed above for claim 5, I consider that in carrying out the method of claim 7 both the isomaltulose and sucrose are hydrogenated, however the conversion of these substances may be incomplete.
Similarly, the components of the sweetener produced by the method must necessarily include those that are formed from isomaltulose and sucrose under the reaction conditions, and unreacted isomaltulose and sucrose may also be present. Where conversion of the sucrose is complete, the claim includes within its scope methods for producing a sweetener that does not contain sucrose.
Claim 7 is construed to define a method for producing a sweetener wherein both the isomaltulose and sucrose are subject to hydrogenation, however the conversion of these substances is not necessarily complete. Under the acidic conditions, the hydrogenation of the sucrose is a hydrolysis/hydrogenation reaction involving hydrolysis (cleavage) of the substance to form fructose and glucose, which are subsequently hydrogenated to mannitol and sorbitol.
The claim includes within its scope methods for producing a sweetener that does not contain sucrose.
I further note that claim 8 defines:
A method according to claim 7 wherein said hydrogenation is accompanied by cleavage of the sucrose.
I consider that this feature is implicit in claim 7 for the reasons discussed above and that claim 8 merely makes this explicit.
7.5 Construction of claim 18
Claim 18 is as follows:
A method according to any one of claims 5 to 17, wherein the sweetener contains less than 0.3 wt.% sucrose relative to the total weight of dry matter of the sweetener.
As discussed previously, independent claims 5 and 7 include within their scope methods for producing a sweetener that does not contain sucrose. Therefore claim 18 merely defines the upper limit for this substance.
Claim 18 is construed to define a method for producing a sweetener, wherein the sweetener contains less than 0.3 wt.% sucrose relative to the total weight of dry matter of the sweetener. This includes sweeteners that do not contain sucrose.
7.6 Construction of claim 28
Claim 28 is an omnibus claim as follows:
A method of producing a sweetener substantially as hereinbefore described with reference to any one of the Examples but excluding the comparative examples.
Examples 1 to 4 describe the ruthenium catalysed hydrogenation of a mixture of isomaltulose and sucrose. In each of these examples the sucrose is hydrogenated to mannitol and sorbitol, i.e. the sucrose undergoes hydrolysis/hydrogenation involving hydrolysis (cleavage) of the substance to form fructose and glucose, which are subsequently hydrogenated to mannitol and sorbitol.
Example 5 describes the nickel catalysed hydrogenation of a mixture of isomaltulose and sucrose “not according to the invention.” I consider Example 5 to be a comparative example.
Claim 28 is construed to define a method for producing a sweetener wherein a mixture of isomaltulose and sucrose is subject to hydrogenation in the presence of a ruthenium catalyst, under the reaction conditions described in Examples 1 to 4.
8. Clarity
Subsection 40(3) requires that the claims must be clear. A claim will lack clarity if a third party could not ascertain whether a proposed action would fall within the ambit of the claim (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59).
Südzucker submitted that the proviso relating to the sucrose content in the final sweetener composition renders claim 1, and its dependent claims, and method claim 18, unclear. In particular, it is unclear whether the claims encompass compositions with only de minimis sucrose, possibly at the very levels of detectability. Südzucker stated that as there is no lower limit on the amount of sucrose required in the final composition, the scope of the claims is ultimately dependent on the sensitivity of the method used to detect residual sucrose.
Evonik submitted that provided sucrose is present in the composition, it does not matter whether it is detectable, provided it is below the stated limit of 0.3 wt.%.
I have construed claim 1 and claim 18 as discussed above and found their meaning to be clear.
I also note that although none of the declarants saw the final version of claims 1 and 18 as reproduced above (filed on 1 March 2016), Professor Fairbanks, Professor Payne, Associate Professor Williams and Dr Haji Begli were all given a copy of the amended claims filed on 23 February 2015. Whilst not conclusive, none of the declarants indicated that these claims were unclear.
It has not been established that the claims lack clarity.
9. Novelty
Under subsection 7(1), an invention is taken to be novel unless it is not novel in the light of the prior art base. Information in a document forms part of the prior art base for the purposes of novelty if it was published before the priority date of a claim.
It is well established that the general test for anticipation is the reverse infringement test. The classic formulation of this test is that given by Aicken J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; 137 CLR 228 at 235:
“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”.
This test is satisfied if the alleged anticipation discloses all the essential features of the invention claimed (Nicaro Holdings Pty Limited v Martin Engineering Company [1990] FCA 40; 16 IPR 545 at 549). In order to meet this requirement, the prior art “must contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486).
Südzucker submitted that claims 1 – 4 are not novel in view of WO 2008/077640 (D18), US 5936081 (D3), GRAS petition 6G0321: ISOMALT (D2) and US 5578339 (D1). It was further submitted that certain method claims lack novelty in light of US 2006/0009661 (D8).
9.1 WO 2008/077640 (D18)
D18 was published on 3 July 2008 and therefore forms part of the prior art base. D18 describes a process for the hydrogenation of sugar mixtures to produce compositions enriched in 1, 6-GPS and 1, 1-GPM. Examples 4 and 11 of this document are the most relevant and these are discussed in further detail below.
(a)Example 4
Example 4 describes the hydrogenation of an isomaltulose/trehalulose solution (page 14) and the composition of the resultant product is shown in Table 6. The first point to note is that there is no indication that sucrose is present. In addition, the amounts of 1, 6 -GPS and 1, 1-GPS, and the weight ratio of 1, 6-GPS to 1, 1-GPM, cannot be calculated as only the total amount of GPS is stated. The footnote to Table 2 (page 11) indicates that GPS consists primarily of 1, 6-GPS and minor amounts of 1, 1-GPS.
Example 4 was reworked by Dr Haji Begli.[8] The starting materials used by Dr Haji Begli (Trial 1 and Trial 2) and in D18 are shown below.
[8] Haji Begli-1 [7] – [13].
Ingredient[9] Trial 1 Trial 2 D18 Isomaltulose 86.2 85.8 85.8 Dextrose (Glucose) 1.61 1.61 1.5 Fructose 2.53 2.51 2.6 Isomaltose 0.88 0.89 0.5 Trehalulose 8.87 8.78 8.0 Sucrose 0.14 0.14 0.1 Others 1.55 1.63 1.5 Total 101.78 101.36 100 [9] All ingredients stated as % dry matter.
Whilst the starting materials for Trial 1, Trial 2 and D18 are similar, they are not identical. The main differences relate to the amounts of isomaltose and trehalulose. During the hydrogenation process these are converted to 1, 6-GPS, and 1, 1-GPM and 1, 1-GPS, respectively.[10] However, I consider that these differences do not have a significant impact on the results obtained by Dr Haji Begli, with respect to the amounts of 1, 6-GPS, 1, 1-GPM and 1, 1-GPS contained in the final product.
[10] Williams-1 [23].
I also note that the sum of the ingredients for Trial 1 and Trial 2 is greater than 100%, however no explanation is provided as to the reason for this. The sum of the components is of greater importance when considering the products of the reaction and this is discussed in further detail below.
In D18 the nickel catalyst Degussa, BK 111 W was used, whereas the nickel catalyst Evonik Industries MC 811 was employed in the trials. Dr Haji Begli states that according to the manufacturer, the MC 811 catalyst is the same as the one used in D18, which is no longer available under the name of Degussa, BK 111W.[11] Evonik submitted that although Dr Haji Begli was told the products are identical, products are known to vary over time and it is not possible to be certain that the catalyst has remained the same.
[11] Haji Begli-1 [9].
D18 was published in 2008 and Dr Haji Begli’s reworking of Example 4 was performed in 2015. Although the catalyst could have changed during this time, there is no evidence to this effect and furthermore the manufacturer has indicated that this is not the case. I therefore consider it reasonable to infer that the two catalysts are the same.
The compositions obtained following the hydrogenation process are detailed below.
Component[12] Trial 1
(4% catalyst)D18
(4% catalyst)Trial 2
(7% catalyst)D18
(7% catalyst)1, 1-GPS 2.88 3.11 1, 6-GPS 48.4 52.9 GPS 52.4 54.4 1, 1-GPM 43.4 41.3 38.7 39.4 Sorbitol 2.69 3.1 2.77 3.1 Mannitol 1.2 1.2 1.05 1.2 Isomaltulose 0.04 <0.05 0.03 <0.05 Sucrose 0.15 0.13 Others 2.66 1.9 1.87 1.9 Total 101.42 ~99.95 100.56 ~100.05 [12] Stated as % dry matter.
Thus, sample analysis indicates that Trial 1 and Trial 2 produced compositions containing sucrose and wherein the weight ratio of 1, 6-GPS to 1, 1-GPM is greater than 1:1.[13]
[13] Haji Begli-1 [19].
Evonik submitted that the sum of sucrose plus others is 2.81% compared with 1.9% for D18. It was submitted that this could indicate that there is a significant difference between the trials and what was done in the prior art, and demonstrates that one cannot be certain that the experiment has been accurately reproduced. Südzucker submitted that this is only the case for Trial 1 and that in Trial 2 the sum of sucrose plus others is 2.0%.
In relation to the sucrose content, Dr Haji Begli states:
“Table 6 of Example 4 does not refer to the sucrose content of the final composition. However, following my re-working of Example 4, I have demonstrated that the sugar content remains the same. Table 5 shows that the isomaltulose/trehalulose solution of the starting material had 0.1% sucrose. I believe my re-worked example shows that the final composition would also have approximately 0.1% sucrose which I believe would be part of the 1.9% ‘other’ listed in Table 6.”[14]
[14] Haji Begli-1 [20].
On this point it is useful to refer to D18. Example 11 involves the hydrogenation of an isomaltulose/trehalulose solution and the resultant product is detailed in Table 14 (page 22). I note that this example distinguishes between sucrose and “others” and lists these as separate components. Therefore it is not unreasonable to expect that if sucrose was present in Example 4, it would be listed as such and not classified as “others”, consistent with Example 11. Whilst this is not conclusive, it raises some uncertainty as to whether D18 provides clear and unmistakeable directions to produce a sweetener as defined by the claims.
I also note that the sum of the components for Trial 1 and Trial 2 exceeds 100%, by 1.42% and 0.56% respectively. Whilst these differences are not large, it is not clear which components have been inaccurately measured. This becomes important when considering the amounts of mannitol and sucrose present in the composition defined by claim 1. The minimum amount of mannitol defined by the claim is 0.2 wt.%. The product of Trial 1 contains 1.2 wt.% mannitol, however there is 1.42 wt.% excess material unaccounted for. Therefore it is possible that the amount of mannitol present in the product is less than that stated, such that it no longer falls within the scope of claim 1. This also raises uncertainty as to whether the amount of sucrose in the products of Trial 1 and Trial 2 has been accurately determined. It seems likely that the products contain some sucrose, since its presence was detected. However, as previously mentioned, the sum of the starting materials for Trial 1 and Trial 2 exceeds 100%, by 1.78% and 1.36% respectively. It is not clear which ingredients were inaccurately measured and in particular whether this applies to sucrose.
Evonik further stated that Dr Haji Begli analysed samples of the reaction mixture, which is not a sweetener as required by claim 1. In particular, there is no indication that the catalyst was removed. Evonik submitted that it is quite possible that all of the sucrose could remain bound to the catalyst at the end of the reaction, such that there is no sucrose present in the final composition when the catalyst is removed.
I have already discussed uncertainties regarding the sucrose content in the products of Trial 1 and Trial 2. In relation to whether Dr Haji Begli produced a sweetener, the evidence indicates that the results of Trial 1 and Trial 2 are based on the analysis of samples taken from the reaction mixture.[15]
[15] Haji Begli-1 [12] – [13].
The present specification indicates that a sweetener is a mixture of compounds that tastes sweet (page 5, lines 32 – 35). Clearly a reaction mixture does not meet this requirement.
Turning to Example 4 of D18, the composition shown in Table 6 is similarly that of a sample taken from the reaction mixture. D18 provides instructions for processing the mixture following the hydrogenation in order to produce a composition that would be suitable for use as a sweetener (page 9, lines 7 – 31). However, it is not clear whether the final product after such processing would have an identical composition to that shown in Table 6.
I therefore conclude that the evidence does not unequivocally demonstrate that Example 4 provides clear and unmistakeable directions to produce a sweetener as defined by present claim 1. By reworking Example 4, Dr Haji Begli has established that this example results in the formation of a mixture wherein the weight ratio of 1, 6-GPS to 1, 1-GPM is greater than 1:1 as required by the claim. However, inconsistencies in the composition of both the starting material and the final product lead to uncertainty as to the amounts of mannitol and sucrose present in the final product, and whether these fall within the range defined by claim 1. Finally, D18 itself states that the product arising from Example 4 does not contain sucrose.
I will now consider Example 11.
(b)Example 11
Example 11 similarly describes the hydrogenation of an isomaltulose/trehalulose solution (pages 21 – 22) and the composition of the resulting product is shown in Table 14. Sucrose is stated to be present in the amount of 0.1%. However, the amounts of 1, 6-GPS and 1, 1-GPS, and the weight ratio of 1, 6-GPS to 1, 1-GPM, cannot be calculated as only the total amount of GPS is stated.
The starting material for the reaction is stated to be an isomaltulose/trehalulose solution with the composition shown in Table 6, with reference to Example 5. However, Table 6 lists the product of Example 4 (discussed above), whilst Example 5 relates to the hydrogenation of fructose. I note that Example 4 is the only other preparative example that describes the hydrogenation of isomaltulose/trehalulose and the starting material for this reaction is shown in Table 5. Therefore it is possible that the starting material for Example 11 also has this composition.
Professor Fairbanks[16] and Professor Payne[17] also identify the ambiguity in the starting material. However, neither declarant provides any comment as to what the nature of the material might be. Consequently, I consider that the exact composition of the starting material for Example 11 is uncertain.
[16] Fairbanks [187].
[17] Payne [193].
Furthermore, Example 11 has not been reworked and therefore it is not clear how much 1, 6-GPS and 1, 1-GPS are present, and whether the weight ratio of 1, 6-GPS to 1, 1-GPM is greater than 1:1.
As discussed above, Dr Haji Begli determined the amounts of 1, 6-GPS and 1, 1-GPS during his reworking of Example 4 and calculated that the weight ratio of 1, 6 –GPS to 1, 1-GPM is greater than 1:1. However, it is not clear whether his results can be extrapolated to Example 11 as the reaction conditions although similar, are not identical. In the reworked Example 4 the reactor was flushed three times with each of nitrogen and hydrogen, whereas in Example 11 this was performed twice. In reworked Example 4 the isomaltulose/trehalulose mixture was heated from 30°C to 130°C with a heating rate of 3°C per minute, whereas in Example 11 the mixture was heated from about 20°C to 130°C at various heating rates. One heating rate in Example 11 was 3°C per minute, however the starting temperature was 20°C rather than 30°C. As previously indicated, the exact composition of the starting material for Example 11 is uncertain. Finally, there is no evidence to indicate that the results Dr Haji Begli obtained for reworked Example 4 would equally apply to Example 11.
The cumulative effect of the differences in reaction conditions, together with the lack of evidence on whether the experimental data can be extrapolated, leads me to conclude that the amounts of 1, 6-GPS and 1, 1-GPS, and the weight ratio of 1, 6-GPS to 1, 1-GPM, cannot be reliably determined. Consequently, Example 11 does not provide clear and unmistakeable directions to prepare a sweetener as defined by claim 1.
(c)Conclusion on D18
It has not been demonstrated that the claims lack novelty in light of D18.
9.2 US 5936081 (D3)
D3 was published on 10 August 1999 and therefore forms part of the prior art base. This document describes a process for the hydrogenation of sugar mixtures to produce compositions containing sugar alcohols.
Example 3 relates to the hydrogenation of a sugar mixture which contains 0.06% saccharose (sucrose) (Table 4). The composition of the resultant product is shown in Table 5.[18] However, there is no indication that any sucrose is present, as required by claim 1.
[18] Mannite and sorbite correspond to mannitol and sorbitol respectively; see Williams-1 [61].
Professor Fairbanks indicates that the presence of sucrose in the product cannot be definitively concluded, and that it is entirely possible that all the sucrose in the starting material could remain bound to the hydrogenation catalyst at the end of the reaction.[19]
[19] Fairbanks [114], [116] – [120].
Associate Professor Williams states that it is likely that some sucrose remains in the product, but no more than 0.06%.[20] He further comments that “If no sucrose can be detected then this would not be reported”.[21]
[20] Williams-2 [20].
[21] ibid.
As I have previously found, where there is no detectable sucrose that sucrose is not “present” and does not fall within the scope of claim 1. I therefore conclude that the product of Example 3 does not contain any detectable sucrose and consequently is not encompassed by claim 1.
I further note that only the total amount of 1, 6-GPS and 1, 1-GPS is provided in Table 5. Therefore it is not possible to calculate the exact amount of each component that is present, and consequently the weight ratio of 1, 6-GPS to 1, 1-GPM cannot be determined.
Associate Professor Williams, Professor Fairbanks and Professor Payne all comment on how much 1, 6-GPS, 1, 1-GPS and 1, 1-GPM may be present, based on the fact that the starting material in Example 3 contains 7.64% trehalose and this is hydrogenated to form 1, 1-GPS and 1, 1-GPM.[22] I note that a variety of different possible scenarios are described, some of which fall within the scope of the claims and others which do not, depending upon the assumptions made.
[22] Williams-1 [61] – [62]; Fairbanks [122] – [125]; Payne [132] – [137]; Williams-2 [15] – [20].
Whilst I acknowledge that some scenarios may be more likely than others, this does not amount to clear and unmistakeable directions to produce a sweetener containing 1, 6-GPS, 1, 1-GPM and 1, 1-GPS in the quantities defined by claim 1.
It has not been demonstrated that the claims lack novelty in view of D3.
9.3 GRAS petition (D2)
The evidence indicates that D2 was publicly available on or shortly after 2 February 2007[23] and therefore this document forms part of the prior art base. D2 relates to the manufacture of isomalt.
[23] Cruise [2] – [5].
Table 1 on page 10 lists the components of two isomalt compositions. Neither contains sucrose and the table heading indicates that the isomaltulose, from which the isomalt is derived, is sucrose free. In addition, one isomalt composition contains 0.1 wt.% mannitol, whereas claim 1 requires a minimum of 0.2 wt.%. The second isomalt composition has a weight ratio of 1, 6-GPS to 1, 1‑GPM that is less than 1:1, whereas claim 1 requires a ratio that is greater than 1:1.
The isomalt compositions described in Table 2 on page 14 do not contain sucrose and 1, 1-GPS is not listed as a component. Furthermore, the amount of mannitol present is less than 0.2 wt.% and/or the weight ratio of 1, 6-GPS to 1, 1-GPM is less than 1:1. Similarly, the compositions listed on pages 64 and 72 do not contain sucrose and the amount of mannitol present is less than 0.2 wt.% or the weight ratio of 1, 6-GPS to 1, 1-GPM is less than 1:1.
Finally, the isomalt specifications on pages 3 and 13 do not list sucrose as a component. Furthermore, it is not apparent whether any 1, 1-GPS is present.
It has not been demonstrated that the claims lack novelty in light of D2.
9.4 US 5578339 (D1)
D1 was published on 26 November 1996 and therefore forms part of the prior art base. The document describes the preparation of various sweeteners, the composition of which is given in column 3, lines 20 – 30.
Südzucker submitted that the weight ranges in column 3 for 1, 6-GPS, 1, 1-GPM, 1, 1-GPS, mannitol, sorbitol and sucrose overlap with those defined by the present claim 1. It was further submitted that the weight ratio of 1, 6-GPS to 1, 1-GPM disclosed in D1 (column 3, lines 32 – 33) includes a ratio of greater than 1:1, as required in claim 1.
However, I note that the weight ranges for each of 1, 6-GPS, 1, 1-GPS and sucrose encompass values that do not fall within the scope of claim 1. Similarly, the weight ratio of 1, 6-GPS to 1, 1‑GPM may be less than 1:1.
Turning to the preparative examples, none of these produce a sweetener wherein the weight ratio of 1, 6-GPS to 1, 1-GPM is greater than 1:1. Furthermore, none of the sweeteners contain sucrose. D1 does not provide clear and unmistakeable directions to produce a sweetener as defined by claim 1.
It has not been established that the claims lack novelty in view of D1.
9.5 US 2006/0009661 (D8)
D8 was published on 12 January 2006 and therefore forms part of the prior art base. The document describes methods for preparing sugar alcohols via catalytic hydrogenation of suitable saccharides.
D8 indicates that the hydrogenation process involves the use of a ruthenium catalyst ([0009]) on a silicon dioxide[24] based support material ([0020]). Suitable saccharides are listed in paragraphs [0012] – [0013] and D8 further states that these may be used individually or as mixtures ([0016]). Although sucrose and isomaltulose are mentioned, they are only two saccharides out of a range of possibilities.
[24] Silicon dioxide is an acidic material; see Haas [20].
The preparative examples describe the hydrogenation of corn starch (glucose) ([0062]) and xylose ([0065]). Thus, there is no disclosure of the hydrogenation of either isomaltulose or sucrose, or a mixture of the two. Consequently, D8 does not provide clear and unmistakeable directions for a method of producing a sweetener as defined by the claims.
It has not been demonstrated that the claims lack novelty in light of D8.
9.6 Conclusion on novelty
It has not been established that the claims lack novelty in view of the prior art.
10. Inventive step
Under subsections 7(2) and 7(3), an invention is taken to involve an inventive step unless it would have been obvious to the person skilled in the art in the light of the common general knowledge, either considered alone or together with the prior art. The prior art is information that the skilled person could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant.
The test for whether an invention is obvious is whether it would have been a matter of routine to proceed to the claimed invention.
“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.” (Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12; 148 CLR 262 at 286)
In Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 at [53] (Alphapharm), the High Court accepted the approach taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at [187] where Graham J posed the reformulated Cripp’s 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 combination] in the expectation that it might well produce a [useful or better result]?” (emphasis in original)
Where the invention involves a combination of integers (as for the present compositions), obviousness is to be determined by reference to the combination as a whole and not each integer individually. As stated in Alphapharm at [41]:
“The claim is for a combination, the interaction between the integers of which is the essential requirement for the presence of an inventive step. It is the selection of the integers out of ‘perhaps many possibilities’ which must be shown by Alphapharm to be obvious, bearing in mind that the selection of the integers in which the invention lies can be expected to be a process necessarily involving rejection of other possible integers.”
In AstraZeneca AB v Apotex Pty Ltd (AstraZeneca) [2014] FCAFC 99; 107 IPR 177, the court held that in formulating the problem it is not permissible to incorporate information that is not available to the person skilled in the art either as common general knowledge or information available under subsection 7(3).
10.1 Determining the problem
Südzucker submitted that the problem addressed by the specification is the development of a method for the production of isomalt wherein the step of separation of the residual sucrose from the isomerisation stage is not required.
Evonik stated that the specification addresses the problem of producing a sucrose-based sweetener that is effective and has excellent properties for further processing, but has very low sucrose content. Evonik acknowledged that it was known in the sweetener industry that the isomerisation of sucrose produces isomaltulose, however some residual sucrose remains in the product. Whilst those in the industry knew that the residual sucrose needed to be removed prior to the hydrogenation of isomaltulose, they did not recognise that it was a problem capable of solution other than by using the conventional methods that had been employed for decades. Evonik submitted that the problem as stated by Südzucker has not been proven to have been common general knowledge in Australia before the priority date or otherwise able to be considered under subsection 7(3).
In determining the problem it is necessary to have regard to the specification, and the common general knowledge and subsection 7(3) information as per AstraZeneca. Consistent with my previous discussion of the specification (see parts 5.1 and 5.2), I consider that the specification addresses two problems; firstly, to provide a low sucrose sweetener, and secondly, to provide a method for the production of a sucrose-based sweetener wherein the step of separation of the residual sucrose from the isomerisation stage is not required. Both problems incorporate information that is part of the common general knowledge, which is discussed below.
10.2 Common general knowledge
The common general knowledge was considered by Emmett J in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc [1999] FCA 345; 45 IPR 577 at [112]:
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·standard texts and handbooks;
·standard English dictionaries;
·technical dictionaries relevant to the field;
·magazines and other publications specific to the field.”
The evidence indicates that the following matters are all part of the common general knowledge.
·The presence of sucrose in sweeteners, such as isomalt, is undesirable because of its caloric content, glycaemic index and cariogenicity.[25]
·Isomalt is produced via a two stage process. This involves isomerisation of sucrose to isomaltulose and subsequent catalytic hydrogenation of the isomaltulose to isomalt.[26]
·The isomaltulose obtained from the isomerisation process is not pure. Other components that may be produced include trehalulose, fructose and glucose, and unreacted sucrose may also remain.[27] The isomaltulose may be purified using techniques such as recrystallisation or chromatography.[28] Alternatively, chemical or enzymatic processes can be used to transform starting materials or side products and leave the isomaltulose intact.[29]
·The hydrogenation of isomaltulose commonly uses a nickel catalyst, such as Raney nickel.[30] The ratio of 1, 6-GPS to 1, 1-GPM in the isomalt produced is close to 1:1, however this will vary depending on the specific method used for the hydrogenation.[31]
·Sucrose is inert under Raney nickel hydrogenation conditions[32] and the separation of the sucrose before hydrogenation of the isomaltulose is standard practice.[33]
·The “hydrogenation” of sucrose is more appropriately considered a hydrolysis/hydrogenation reaction in which sucrose is initially hydrolysed to form fructose and glucose, and these substances then hydrogenated to form mannitol and sorbitol.[34]
[25] Williams-1 [24].
[26] Williams-1 [16].
[27] Williams-1 [18]; Haas [11].
[28] Williams-1 [19].
[29] ibid.
[30] Williams-1 [20] – [21].
[31] Williams-1 [20].
[32] Williams-1 [23], [35].
[33] Haas [9].
[34] Williams-1 [31].
10.3 Lack of inventive step – composition claims 1 – 4
Südzucker submitted that claims 1 – 4 are not inventive in the light of any one of WO 2008/077640 (D18), US 5936081 (D3), the GRAS petition (D2) and US 5578339 (D1). It was further submitted that Dr Cartarius’ declaration provides evidence that isomalt is sold throughout the world and that at least some batches of isomalt contain sucrose. Reference was made to Batch Numbers L443 (D26; Exhibit RC-42) and L437 (Exhibit RC-43) (Isomalt Batches).
The first question to consider is whether D18, D3, D2, D1 and the Isomalt Batches would have been ascertained, understood and regarded as relevant.
Associate Professor Williams states that he is aware of patents relating to the hydrogenation of isomaltulose and that he would refer to patent specifications if he was considering ways to solve any perceived problems in the known manufacturing processes for isomalt.[35] Professor Fairbanks[36]and Professor Payne[37] indicate that they would have regard to the patent literature. Therefore I consider that D18, D3 and D1 would have been ascertained.
[35] Exhibit SJW-4 [7], [12].
[36] Fairbanks [26] – [27].
[37] Payne [19] – [20].
The evidence indicates that D2 forms part of the file history for EP 1284102 available from the European Patent Register.[38] However, I do not consider that file histories on the European Patent Register fall into the category of information that the skilled addressee would refer to as a matter of course. In this regard I note that Associate Professor Williams[39] and Professor Payne[40] state that they were not aware of the existence of this document. I therefore conclude that D2 would not have been ascertained and will not consider this document further.
[38] Cruise [2] – [5].
[39] Williams-1 [59].
[40] Payne [131].
The Isomalt Batches are considered to relate to the use of isomalt as a commercial product. The evidence indicates that isomalt is a well known sweetener that was produced and sold before December 2009.[41] Therefore the Isomalt Batches would have been ascertained.
[41] See, for example, Cartarius [10] – [12]; Exhibit SJW-4 [2]; Exhibit SJW-5, pages 502 – 504.
In determining the relevance of a document, it was stated in Beecham Group Limited’s (Amoxycillin) Application [1980] RPC 261 at 282 that:
“The test in my judgment is whether it can be expected that the skilled man will be likely to recognise the document in question as being particularly pertinent to, though it may not specifically solve the problem before him.”
D18, D3 and D1 relate to sweeteners as discussed above and therefore would be regarded as relevant. Although the exact information disclosed by the use of isomalt, namely the Isomalt Batches, is less clear, these are nevertheless relevant.
I will consider D18, D3, D1 and the Isomalt Batches in turn.
10.3.1 WO 2008/077640 (D18)
As discussed previously in part 9.1, Examples 4 and 11 of this document are the most relevant.
Example 4 produces a composition that does not contain sucrose (Table 6). The presence of sucrose in a sweetener is undesirable due to its glycaemic index, caloric content and cariogenicity.[42] Therefore it seems unlikely that the person skilled in the art, in seeking to address the problem of providing a low sucrose sweetener, would be motivated to add sucrose to the composition of Example 4.
[42] Williams-1 [24].
A further consideration is whether the skilled addressee, in seeking to solve the problem, would have repeated Example 4. However, it is not necessary for me to determine this matter for the reasons outlined below.
Dr Haji Begli reworked Example 4 and the evidence indicates that he performed this experimental procedure as a matter of routine. However, the question to consider is whether it would have been a matter of routine to prepare a sweetener that falls within the scope of the claims by repeating Example 4. As I have previously found, there are inconsistencies in the composition of both the starting material and the final product in the reworked Example 4. This leads to uncertainty in the amounts of mannitol and sucrose present in the final product. Consequently it has not been demonstrated that the skilled addressee, in repeating Example 4, would as a matter of routine produce a sweetener that falls within the scope of the claims.
Example 11 produces a composition that contains sucrose. However, as discussed previously, the amounts of 1, 6-GPS and 1, 1-GPS, and the weight ratio of 1, 6-GPS to 1, 1-GPM, are not stated.
Example 11 was not reworked by Dr Haji Begli. As discussed earlier, the exact nature of the starting material used in this example is uncertain. Consequently from the outset repeating this example would not be a matter of routine.
The alternate view is that the starting material for Example 11 is the same as that used in Example 4, with the composition shown in Table 5. However, even if I adopt this approach, there are nevertheless still variations in the reaction conditions between Examples 4 and 11 as I discussed previously. Furthermore, there is doubt as to whether the results that Dr Haji Begli obtained in reworked Example 4 can be extrapolated to Example 11. Consequently it has not been demonstrated that the skilled addressee, in repeating Example 11, would as a matter of routine produce a sweetener that falls within the scope of the claims.
It has not been demonstrated that there is a lack of inventive step in view of D18.
10.3.2 US 5936081 (D3)
This document was considered in part 9.2, where I concluded that the product of Example 3 (shown in Table 5) does not contain any detectable sucrose and therefore does not fall within the scope of claim 1.
As the presence of sucrose in a sweetener is undesirable due to its glycaemic index, caloric content and cariogenicity, the person skilled in the art, in seeking to address the problem of providing a low sucrose sweetener, would not as a matter of routine add sucrose to the composition of Example 3.
It has not been established that there is a lack of inventive step in view of D3.
10.3.3 US 5578339 (D1)
As indicated previously in part 9.4, there is no sucrose present in any of the preparative examples described in this document. As I have already stated, the presence of sucrose in a sweetener is undesirable due to its glycaemic index, caloric content and cariogenicity. Consequently the person skilled in the art, in seeking to address the problem of providing a low sucrose sweetener, would not as a matter of routine add sucrose to the compositions of D1.
It has not been demonstrated that there is a lack of inventive step in light of D1.
10.3.4 Isomalt Batches
The Isomalt Batches relate to the use of isomalt as a sweetener. Dr Cartarius states that isomalt was produced and commercially available prior to December 2009.[43] Batches L443 (Exhibit RC‑42) and L437 (Exhibit RC-43) establish the composition of isomalt sold at this time.
[43] Cartarius [10] – [12].
The analytical results indicate that both batches contain mannitol in the amount of 0.04 wt.%. This is less than the minimum amount of 0.2 wt.% required in claim 1. There is no evidence to indicate whether the skilled person, in seeking to address the problem of providing a low sucrose sweetener, would as a matter of routine increase the mannitol content.
It has not been established that there is a lack of inventive step in light of the Isomalt Batches.
10.3.5 Conclusion on inventive step – composition claims 1 – 4
It has not been demonstrated that claims 1 – 4 lack an inventive step in view of the prior art.
10.4 Lack of inventive step – method claims
Südzucker submitted that certain method claims are not inventive in the light of the common general knowledge alone, or any one of US 5679781 (D4), US 2006/0009661 (D8), WO 2006/093364 (D9) and US 2868847 (D12) when considered together with the common general knowledge.
The first question to consider is whether these documents would have been ascertained, understood and regarded as relevant. As discussed previously, Associate Professor Williams, Professor Fairbanks and Professor Payne indicate that they consult the patent literature. Therefore I consider that D4, D8, D9 and D12 would have been ascertained. All four documents relate to the hydrogenation of sugars to produce sugar alcohols and consequently would be regarded as relevant.
I will firstly consider lack of inventive step in view of the common general knowledge alone.
10.4.1 Lack of inventive step in the light of the common general knowledge
As discussed previously, independent claims 5 and 7 are construed to define methods for producing a sweetener wherein both isomaltulose and sucrose are subject to hydrogenation in the presence of a catalyst which is based on ruthenium and/or an oxide thereof. The hydrogenation of the sucrose is a hydrolysis/hydrogenation reaction involving hydrolysis (cleavage) of the substance to form fructose and glucose, which are subsequently hydrogenated to mannitol and sorbitol. Independent claim 28 is an omnibus claim which, as discussed earlier, is construed to define a method for producing a sweetener as described in Examples 1 to 4.
Südzucker submitted that if faced with the problem of developing a method for the production of isomalt where the step of separation of the residual sucrose from the isomerisation stage is not required, the skilled person would have, as a matter of routine, used a ruthenium based catalyst on a naturally acidic support, or on a support that has been treated to become acidic, to both hydrogenate isomaltulose to produce the isomalt, and hydrolyse and hydrogenate the residual sucrose.
Professor Payne states:
“In order to minimise the sucrose in the sweetener product I would initially have considered trying to find an enzyme which would completely convert the sucrose.”[44]
[44] Payne [44].
Prior to receiving a copy of the present specification, Professor Payne comments that catalysts that he would have considered using for the catalytic hydrogenation of a sugar include palladium on carbon, rhodium on carbon, platinum on carbon and palladium hydroxide on alumina.[45]
[45] Payne [34].
Professor Fairbanks when asked to comment, prior to having been shown a copy of the present specification, on how he would approach the task of reducing a sugar states:
“At 23 December 2009, I would most likely have sought to reduce a sugar using NaBH4(aq) rather than using hydrogen gas and a metal catalyst. This is because the use of hydrogen gas is more dangerous (due to the risk of fire) and involves using an expensive catalyst such as palladium.
Known catalysts for use in catalytic hydrogenation of sugars at 23 December 2009 included palladium and platinum and oxides thereof. When seeking to identify a suitable catalyst for a particular transformation I would have carried out a literature search. If a particular catalyst did not work for the transformation I would try a different catalyst. I am not aware of a systematic way to determine the best catalyst for a particular transformation and so the determination of a suitable catalyst would have generally been by trial and error using commonly used available catalysts.”[46]
[46] Fairbanks [41] – [42].
Thus, neither Professor Fairbanks nor Professor Payne indicates that they would consider using a ruthenium catalyst for the hydrogenation process. Professor Payne additionally states that if he was faced with the problem of developing a method for the production of isomalt wherein the step of separation of the residual sucrose from the isomerisation stage is not required, he would firstly consider using a different enzyme.
Associate Professor Williams indicates that in the industrial production of isomalt, isomaltulose was typically hydrogenated using a Raney nickel catalyst.[47] He further states:
“Hydrogenation of isomaltulose can be performed by a range of different reagent/catalyst combinations, including heterogeneous catalysts based on nickel, cobalt, ruthenium and others.”[48]
…
Before The Priority Date I was aware of a range of methods different to the industrially applied Raney nickel hydrogenation approach that could be used to hydrogenate isomaltulose. The Lichtenthaler Opinion [Exhibit SJW-7], provided to me in 2005, and a document I was familiar with in 2005, provides a summary of several known procedures in either the scientific literature or the patent literature, including: … ruthenium on carbon or ruthenium/nickel on carbon as catalysts can provide ratios of 1, 6-GPS to 1, 1-GPM between the extremes of 44:56 to 57.1:42.9 …”[49]
[47] Williams-1 [20] – [21]; Exhibit SJW-4 [3], [7].
[48] Williams-1 [26].
[49] Williams-1 [29].
Exhibit SJW-7 is an expert opinion with respect to the appellation “Hydrogenated Isomaltulose.” Page 3 of this document discusses the use of ruthenium catalysts, with reference to a German patent, the English equivalent of which is D4.[50] However, I do not consider that an expert opinion or D4 form part of the common general knowledge and there is no evidence to suggest that this is the case.
[50] Payne [101] – [102].
Later Associate Professor Williams outlines the approach he would take in reducing a sugar.[51] He indicates that he would have considered using a ruthenium based catalyst and that such a catalyst would well have been within the trial and error methodology as suggested by Professor Fairbanks.[52] However, I note that these comments were made after Associate Professor Williams was provided with a copy of the present specification and appear to be made with the benefit of hindsight.
[51] Williams-2 [52] – [64].
[52] ibid., [63] – [64].
The evidence does not establish that it would have been a matter of routine to produce a sweetener by hydrogenation of a mixture of isomaltulose and sucrose using a catalyst based on ruthenium and/or an oxide thereof, based on the common general knowledge.
It has not been demonstrated that the claimed invention lacks an inventive step in the light of the common general knowledge alone.
10.4.2 Lack of inventive step in light of the prior art
Südzucker submitted that certain method claims are not inventive in the light of any one of D4, D8, D9 and D12 when considered together with the common general knowledge.
10.4.2.1 US 5679781 (D4)
D4 was published on 21 October 1997 and therefore forms part of the prior art base. The document describes the hydrogenation of isomaltulose in the presence of a catalyst selected from ruthenium, nickel and mixtures thereof (abstract). Supports for the catalyst include alumina, carbon and silica (column 3, lines 11 – 13). The pH in the “system” is between 3 to 8, and generally between 4 to 6 (column 3, lines 14 – 18).
Examples 1 to 6 describe the hydrogenation of isomaltulose using a ruthenium on carbon catalyst to form a product that consists only of 1, 6-GPS and 1, 1-GPM. There is no indication that there is any sucrose present in the starting material.
Südzucker submitted that the skilled person would understand that sucrose must be present in the isomaltulose. As D4 indicates that saccharose (sucrose) is the starting material for the production of isomaltulose, the person skilled in the art would understand that this has been performed using standard enzymatic methods, which will leave sucrose as a residue together with the isomaltulose. Alternately, the skilled addressee in applying the teachings of D4 would prepare the isomaltulose using the standard enzymatic method. Either way, the residual sucrose would be hydrogenated in the process disclosed in D4.
Associate Professor Williams states:
“The Examples of US ’781 [D4] do not list the starting composition of isomaltulose, and do not comment on whether it includes sucrose. I believe that sucrose must be present in the isomaltulose used as at column 1, lines 10 and 11, it is clear that saccharose (sucrose) is the starting material for production of isomaltulose, and it can be assumed that this has been performed using standard enzymatic methods which will leave sucrose as a residue together with isomaltulose.”[53]
[53] Williams-1 [79].
Professor Fairbanks comments that:
“it is speculation on the part of Williams that the isomaltulose used for these experiments contained any sucrose. Indeed, as it was thought by those skilled in the art at that date that ‘sucrose could not be hydrogenated’ (see for example D1), then one could safely assume that sucrose was routinely removed unless otherwise explicitly specified. Furthermore this supposition relies on the second assumption that the isomaltulose had been produced by the enzymatic method, and had not been subsequently purified.
Supporting evidence that the substrate was pure isomaltulose is the fact that only two products are reported from these reactions, 1, 6-GPS and 1, 1-GPM. If other materials, such as sucrose, had been present in the starting material then other products, e.g. sorbitol and mannitol would also have been produced. Furthermore the lack of any 1, 1-GPS in the product reported here also means that no trehalulose was present in the starting material, again refuting the speculation made by Williams that the starting material was a mixture produced by an enzymatic method without subsequent purification.
I conclude that the substrate for all of these reactions was the pure disaccharide isomaltulose.”[54]
[54] Fairbanks [151] – [153].
Professor Payne states that his understanding is that D4 relates to the hydrogenation of pure isomaltulose and that as there is no mention of the presence of sucrose, it is reasonable to assume that the isomaltulose is not contaminated by sucrose.[55] He further comments that the product isomaltitol (isomalt) is described as consisting of GPM and GPS:
“There is no mention here of isomaltitol containing other components. There is no reported sucrose, no reported 1, 1-GPS and no reported sorbitol or mannitol. Moreover, the examples refer to isomaltulose and percentages of GPM (i.e. 1, 1-GPM in accordance with column 1, lines 56-58) and GPS (i.e. 1, 6-GPS in accordance with column 1, lines 56-58) adding up to 100%.”[56]
[55] Payne [157].
[56] Payne [158].
As I have previously stated, D4 itself does not indicate that there is any sucrose present in the starting isomaltulose. Furthermore, it is common general knowledge that the separation of sucrose before hydrogenation of isomaltulose is standard practice.[57] For these reasons I give greater weight to the evidence of Professor Fairbanks and Professor Payne over that of Associate Professor Williams. Consequently, I am not satisfied that the starting isomaltulose in D4 contains sucrose.
[57] Haas [9].
Therefore the question to consider is whether the skilled addressee, when faced with the problem of developing a method for the production of a sucrose-based sweetener wherein the step of separation of the residual sucrose from the isomerisation stage is not required would, as a matter of routine, apply the teachings of D4 to a mixture of isomaltulose and another sugar, namely sucrose.
None of the evidence before me demonstrates that the person skilled in the art would, as a matter of routine, apply the hydrogenation method disclosed in D4 to a carbohydrate mixture containing isomaltulose and sucrose.
It has not been established that the claims lack an inventive step in view of D4.
10.4.2.2 US 2006/0009661 (D8)
The disclosure of D8 is discussed above in part 9.5 with respect to novelty. To reiterate, the document describes the catalytic hydrogenation of saccharides in the presence of a ruthenium catalyst.
Südzucker submitted that in view of D8, the skilled person would try to hydrogenate isomaltulose containing some sucrose with a ruthenium based catalyst and would have a very high expectation of success in reducing both the isomaltulose and sucrose.
D8 discusses specific saccharides that are suitable for use in the hydrogenation process. Sucrose is one of 27 listed monosaccharides or disaccharides ([0012]). Paragraphs [0013] and [0014] state:
“Suitable mono- and oligosaccharides for the inventive hydrogenation process which may be mentioned are, in particular, the monosaccharides mannose …, galactose … and xylose …, preferably the D form of the monosaccharides, and also the disaccharides maltose …, isomaltulose … and lactose …
A preferred starting material for the preparation of the sugar alcohol sorbitol is glucose and also glucose-rich syrup such as corn starch hydrolyzates, wheat starch hydrolyzates and potato starch hydrolyzates. The preparation of D-sorbitol by hydrogenation of the D form of the above mentioned monosaccharides is of particular interest.”
This interest in the preparation of sorbitol is reflected in the preparative example described at paragraph [0062] and in dependent claims 2 and 3 (there is only one other dependent claim). I also note that the only other preparative example relates to the hydrogenation of xylose ([0065]).
Although D8 indicates that the monosaccharides and oligosaccharides can be used as such or as mixtures, the starting materials are preferably used in pure form ([0016]). There is also a reference to a saccharide mixture in the context of invert sugar (a mixture of glucose and fructose[58]). Thus, paragraph [0038] states:
“In the inventive process, the saccharide is preferably hydrogenated by hydrogenating an aqueous solution of the respective saccharide, or in the case of invert sugar as starting material, of the saccharide mixture.” (emphasis added)
[58] Fairbanks [157].
I further note that claim 1 defines “A continuous process for preparing sugar alcohols by comprising catalytically hydrogenating an aqueous solution of a saccharide” (emphasis added).
I consider that the emphasis in D8, particularly with regard to the preparative examples and the claims, is on the hydrogenation of a single saccharide (preferably glucose). However, the document suggests that it is possible to hydrogenate mixtures of sugars. Therefore, the question to consider is whether the skilled addressee, faced with the problem of developing a method for the production of a sucrose-based sweetener wherein the step of separation of the residual sucrose from the isomerisation stage is not required would, as a matter of routine, apply the teachings of D8 to a mixture of sucrose and isomaltulose.
Associate Professor Williams states:
“Paragraph [0012] describes suitable saccharides including tetroses, pentoses, hexoses and heptoses and their disaccharides and oligosaccharides. Monosaccharides that can be used in the invention process include glucose. Invert sugar which is obtainable by hydrolysis out of sucrose is also suitable, as is the disaccharide sucrose. Paragraph [0013] discloses that preferred disaccharides include isomaltulose (palatinose) for the preparation of isomaltitol. Paragraph [0016] discloses mixtures thereof which would include a mixture of sucrose and isomaltulose.
In other words, the process described in paragraphs [0009] through to [0013] and [0016] discloses a process for the production of a sweetener by reaction of a carbohydrate mixture that could include isomaltulose and sucrose, the process being carried out in the presence of a ruthenium catalyst.”[59]
[59] Williams-1 [84] – [85].
He later reiterates that D8:
“discloses a method for production of a mixture of sugar alcohols by reaction of disaccharides including sucrose (paragraph 0012), and disaccharides including isomaltulose (paragraph 0013), and mixtures thereof (paragraph 0016), which I consider to be a ‘carbohydrate mixture’.”[60]
[60] Williams-2 [30].
Professor Payne states:
“I disagree with the statement at Williams’ paragraph 84 where he states that [0016] of US2006/0009661 [D8] discloses mixtures which would include a mixture of sucrose and isomaltulose. Sucrose is mentioned at [0012]. Isomaltulose is mentioned at [0013]. [0016] is as follows:
‘[0016] The mono-or oligosaccharides can be used as such or as mixtures, the starting materials preferably being used in pure form.’
This is not the same as disclosing a mixture of sucrose and isomaltulose. Nowhere in US2006/0009661 are such mixtures described.
I note a disparity between Williams’ paragraphs 84 and 85. At paragraph 84, he states that paragraph [0016] discloses
‘mixtures … which would include a mixture of sucrose and isomaltulose’ (emphasis added)
whereas his paragraph 85 he refers to
‘mixtures that could include isomaltulose and sucrose’ (emphasis added).
Use of the word ‘could’ introduces doubt. There does not appear to be a clear disclosure in this document of a sucrose/isomaltulose mixture being used as a starting carbohydrate mixture for hydrogenation.”[61]
[61] Payne [163] – [164].
Professor Fairbanks comments that D8:
“does not contain any specific examples of the reduction of disaccharides by hydrogenation and is non-specific as to whether disaccharides are cleaved into their monosaccharide components along with reduction, or whether reduced disaccharides, which still contain an acetal linkage, are the reaction products.
Although [0012] claims that the process is in principle applicable to a variety of saccharides, no examples of sucrose reduction are given, and indeed sucrose is the only non-reducing sugar listed. I have a doubt as the [sic] whether the process was actually capable of effecting reduction of sucrose, or whether ‘sucrose’ was added to the claims without experimental evidence by patent applicants, who did not understand the fundamental difference in reactivity between reducing and non-reducing sugars. Moreover, if sucrose was reducible by this method then ‘invert sugar’ (a mixture of glucose and fructose obtained by the hydrolysis of sucrose) would not need to be used as a substrate, and yet is specifically named in [0048].”[62]
[62] Fairbanks [156] – [157].
I consider that Associate Professor Williams’ comments on D8 are more akin to him regarding this document as a novelty disclosure, however, as I have previously found, this is not the case.
Professor Payne comments that D8 does not appear to clearly disclose the use of a sucrose and isomaltulose mixture as a starting mixture for the hydrogenation reaction. However, he does not indicate whether the use of such a mixture in the reaction would be a matter of routine.
Professor Fairbanks expresses doubt that the process of D8 would result in the hydrogenation of sucrose.
I am not satisfied that the evidence establishes that the skilled addressee, faced with the problem of developing a method for the production of a sucrose-based sweetener wherein the step of separation of the residual sucrose from the isomerisation stage is not required would, as a matter of routine, hydrogenate a mixture of isomaltulose and sucrose.
It has not been demonstrated that the claims lack an inventive step in view of D8.
10.4.2.3 WO 2006/093364 (D9)
D9 was published on 8 September 2006 and therefore forms part of the prior art base. The document discloses a method for producing sugar alcohols by hydrogenation of sugars in the presence of a catalyst in which ruthenium is supported on zirconia ([1]). The sugars to be hydrogenated are selected from a group that includes isomaltulose and sucrose ([56]). D9 states that mixtures of sugars may also be hydrogenated ([56]). The preparative examples describe the hydrogenation of xylose, glucose and a mixture of xylose, arabinose, galactose and glucose. However, the hydrogenation of sucrose and/or isomaltulose is not exemplified.
Südzucker submitted that D9 motivates and teaches the skilled person to use a ruthenium catalyst to hydrogenate isomaltulose containing residual sucrose so as to avoid additional separation processes.
Associate Professor Williams states that D9 “is yet another document that discloses the process of at least Claim 4 of The Opposed Application.”[63] I note that Associate Professor Williams’ comments are made with respect to claim 4 as accepted and as filed on 23 February 2015. The text of this claim is reproduced below:
A method of production of a sweetener by reaction of a carbohydrate mixture containing isomaltulose and sucrose, characterized in that the reaction is carried out in the presence of at least one catalyst, which is based on ruthenium (Ru) and/or at least one oxide of ruthenium.
[63] Williams-1 [88]; see also Williams-2 [34].
Professor Fairbanks states:
“Only reducing sugars (such as xylose, glucose etc) are used as substrates in the examples. It is pure unsubstantiated speculation that this particular approach could be extended to disaccharides, and particularly non-reducing disaccharides, such as sucrose”.[64]
[64] Fairbanks [160].
D9 states that the ruthenium catalyst is prepared according to a procedure wherein the reduced catalyst is washed with distilled water, aqueous ammonia or an inorganic basic aqueous solution ([42], [44]). Aqueous ammonia is preferred ([44]) and this is the solution that is used in all of the examples.
Professor Payne comments:
“This document does not contain any examples using a mixture of sucrose and isomaltulose. All of the examples are monosaccharides.
This document only looks at monosaccharides, all of which have a reducing end which can be hydrogenated. There are no examples of hydrolysis-hydrogenation and I would not expect to [sic] sucrose to be hydrolysed and hydrogenated by the catalyst described in WO 2006/093364 [D9]. As discussed earlier, it seems to me that sucrose can only be hydrogenated if it is first hydrolysed, and this hydrolysis generally requires acid. In WO 2006/093364 the catalyst is washed with ammonia, which would neutralise it and inhibit hydrolysis of sucrose.”[65]
[65] Payne [168] – [169].
Dr Haji Begli, in relation to comparative experiments that he performed, states:
“Comparative experiments using different ruthenium-based catalysts for hydrogenating isomaltulose and residual sucrose containing solutions have been carried out. These comparative experiments demonstrate that sucrose can only be cleaved and hydrogenated by ruthenium catalysts which are characterized by resulting in an acidic pH value in hydrogenated solutions. No cleavage and no hydrogenation of the sucrose contained in the educt solution is observed when a ruthenium-based catalyst resulting in a neutral or weak basic pH value in the hydrogenated solution is used.”[66]
[66] Haji Begli-2 [23].
This raises doubts as to whether sucrose would be hydrolysed and hydrogenated under the reaction conditions disclosed in D9. Consequently it has not been demonstrated that the skilled addressee, faced with the problem of developing a method for the production of a sucrose-based sweetener wherein the step of separation of the residual sucrose from the isomerisation stage is not required would, as a matter of routine, hydrogenate a mixture of isomaltulose and sucrose.
It has not been established that the claims lack an inventive step in view of D9.
10.4.2.4 US 2868847 (D12)
D12 was published on 13 January 1959 and therefore forms part of the prior art base. The document discloses the catalytic hydrogenation of sugars using a ruthenium catalyst (column 1, lines 14 – 16 and lines 47 – 63). Example III describes the hydrolysis and hydrogenation of sucrose to produce the appropriate hexitols, i.e. mannitol and sorbitol. There is no exemplification of, or reference to, the hydrogenation of isomaltulose.
Südzucker submitted that the catalytic hydrogenation of isomaltulose was part of the common general knowledge at the priority date and that the skilled addressee would understand the need to remove residual sucrose in the production of isomalt. They would also understand that the hydrogenation of isomaltulose was typically performed using metal catalysts. Therefore the skilled person would have a strong and immediate motivation to use the process in D12 to produce isomalt and remove or reduce the residual sucrose.
Associate Professor Williams states:
“While this example [Example III] does not include hydrogenation of isomaltulose, it provides evidence that the hydrolysis/hydrogenation reaction of sucrose over a ruthenium catalyst to afford sorbitol and mannitol was known at the date of the patent application”.[67]
[67] Williams-1 [91].
Professor Payne agrees that there is no mention of isomaltulose. He notes that:
“There is an inconsistency in this document in that column 3, lines 51-52 refer to hydrogenation of sucrose whereas column 3, lines 55-56 refer to hydrolysis and hydrogenation. It is not entirely clear to me whether the hydrolysis is conducted as a separate preliminary step or is simply part of the hydrogenation step.”[68]
[68] Payne [176].
Professor Fairbanks states:
“Isomaltulose was not used as a substrate. US 2,868,847 [D12] indicates (column 3, lines 54-58) that both sucrose and lactose were hydrolysed and hydrogenated to give the corresponding hexitols, but states that ‘in the case of maltose, maltitol was more easily formed’. This observation indicates a difference in reactivity observed between two what could otherwise be considered as ‘very similar’ reducing disaccharide substrates – lactose and maltose – indicating that it is very difficult even for one skilled in the art to predict reactivity patterns and the transformations that may be achievable a priori.”[69]
[69] Fairbanks [166].
The question to consider is whether the skilled addressee, faced with the problem of developing a method for the production of a sucrose-based sweetener wherein the step of separation of the residual sucrose from the isomerisation stage is not required would, as a matter of routine, apply the teachings of D12 to a mixture of sucrose and isomaltulose.
As previously indicated, D12 does not exemplify the hydrogenation of isomaltulose and this sugar is not mentioned anywhere in the document. Furthermore, there is no disclosure of the hydrogenation of mixtures of sugars. In this regard I note that D12 refers to “the sugar to be hydrogenated” (column 2, lines 41 – 43; emphasis added) and all of the examples describe the hydrogenation of a single sugar. Similarly, independent claims 1, 9 and 10 refer to “A process for the production of a polyhydric alcohol which comprises treating a solution of a compound” (emphasis added).
Associate Professor Williams states that D12 provides evidence of the hydrolysis/hydrogenation of sucrose and acknowledges that there is no disclosure of the hydrogenation of isomaltulose. However, he does not indicate whether it would be a matter of routine to apply the hydrogenation method disclosed in D12 to a carbohydrate mixture containing sucrose and isomaltulose.
The evidence does not establish that the claims lack an inventive step in view of D12.
10.4.3 Conclusion on inventive step – method claims
It has not been demonstrated that claims 5 – 30 lack an inventive step in view of the prior art.
10.5 Conclusion on inventive step
It has not been demonstrated that the claims lack an inventive step.
11. Utility
Paragraph 18(1)(c) requires that the claimed invention be useful. The requirements for utility were considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228 at [81]:
“A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid. That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility”.
As discussed in Ronneby Road Pty Ltd v ESCO Corporation [2016] FCA 588 at [65] – [66], everything that is within the scope of a claim must attain the result promised for the invention by the patentee.
Südzucker submitted that the specification promises to avoid a disadvantage of known methods of production of sucrose-based dietetic sweeteners by providing a sucrose-based sweetener wherein in the production of the sweetener, the step of separation of the residual sucrose from the isomerisation stage is not required. These steps are not characterised in the composition claims and therefore claims 1 to 4 do not fulfil the promise of the invention.
As previously discussed in part 5.2, the specification states that the aim or task of the invention is to provide a sucrose-based sweetener which has excellent properties for further processing (page 4, lines 5 – 10). Claims 1 to 4 are directed to a low sucrose sweetener and are considered to fulfil this promise of the invention.
Südzucker further submitted that the method claims encompass methods wherein there is no significant reduction in the amount of sucrose, as the claims do not specify any starting amount of sucrose in the educt solution relative to the quantities remaining after the working of the process. Furthermore, claim 7 does not require any hydrogenation of sucrose, rather only the hydrogenation of isomaltulose.
I have construed claims 5 and 7 to define methods wherein both isomaltulose and sucrose are subject to hydrogenation. Whilst the conversion of sucrose may not necessarily be complete, the amount of this substance will nevertheless be reduced, as demonstrated in Examples 1 to 4.
Südzucker additionally stated that claims 5 and 6 are not limited to a catalyst/support having acid functionality and therefore these claims encompass the hydrogenation and cleavage of sucrose in neutral/basic conditions. It was submitted that no cleavage or hydrogenation of sucrose is observed when a ruthenium based catalyst resulting in a neutral or weak basic pH value in the hydrogenated solution is used.[70]
[70] Haji Begli-2 [23].
As discussed previously, claim 5 is construed to define a method wherein sucrose undergoes hydrolysis/hydrogenation and therefore the reaction conditions used in the method must be such as to achieve this. If the reaction conditions used do not result in the cleavage and hydrogenation of sucrose, then that method does not fall within the scope of the claim.
Südzucker further submitted that the hydrogenation of isomaltulose and sucrose using a ruthenium catalyst requires a support in order to work and accordingly the claims which are not limited by reference to a support lack utility.
The specification indicates that the ruthenium catalyst is preferably immobilised on a support (page 8, lines 14 – 18). I further note that Südzucker has not provided any evidence to establish that the claimed methods will not work in the absence of a support.
It has not been demonstrated that there is a lack of utility.
12. Fair basis
Subsection 40(3) requires that the claims must be fairly based on the matter described in the specification. The test for fair basis was stated by the High Court in Lockwood Security v Doric Products [2004] HCA 58 at [69]; 217 CLR 274 as:
“Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.”
Südzucker submitted that the method claims do not specify any starting amount of sucrose in the educt solution relative to the quantities remaining after the working of the process, i.e. the claims encompass methods where there is no significant reduction in the amount of sucrose resulting from the method. It was further submitted that claim 7 encompasses methods that do not involve the hydrogenation of sucrose at all and as such travels beyond the disclosure of the invention, which is asserted to be the simultaneous hydrogenation of sucrose and isomaltulose.
As discussed previously, claims 5 and 7 are construed to define methods wherein both isomaltulose and sucrose are subject to hydrogenation. Whilst the conversion of sucrose may not necessarily be complete, the amount of this substance will nevertheless be reduced. This is demonstrated in Examples 1 to 4, wherein the conversion with respect to sucrose ranges from 24% to 98%. Thus, the specification provides a real and reasonably clear disclosure of a method wherein both isomaltulose and sucrose are hydrogenated and the amount of sucrose is reduced.
Südzucker further stated that claims 5 and 6 are not limited to a catalyst/support having acid functionality. The claims therefore encompass cleavage and hydrogenation of sucrose in neutral/basic conditions. Reference was made to Dr Haji Begli’s statements that no cleavage or hydrogenation of sucrose is observed when a ruthenium based catalyst resulting in a neutral or weak basic pH value in the hydrogenated solution is used.[71]
[71] Haji Begli-2 [23].
As I have indicated previously, claim 5 is construed to define a method wherein sucrose undergoes hydrolysis/hydrogenation. If the reaction conditions used do not result in the cleavage and hydrogenation of sucrose, then that method does not fall within the scope of the claim.
The specification states that the reaction preferably takes place in an aqueous solution, the pH of which is preferably in the neutral or acid range, corresponding to a pH below 8 (page 8, lines 20 ‑ 27). I note that this pH range encompasses solutions that are basic. The specification further states that neutral supports are suitable (page 10, lines 11 – 13 and page 11, lines 21 – 26). I therefore consider that the specification provides a real and reasonably clear disclosure of neutral/basic reaction conditions.
In regard to Dr Haji Begli’s statements in his second declaration about experiments that he performed, I consider these to be more relevant to the issue of utility (and I have previously found there is no lack of utility).
Südzucker also noted that as the method claims do not provide any lower limit on the amount of sucrose in the starting material, it appears that the method claims cover claimed compositions where most of the sucrose has already been removed in a separate step. Furthermore, as claim 7 covers processes where there is no hydrogenation of sucrose at all, it encompasses methods involving the separate removal of most of the sucrose followed by hydrogenation of the isomaltulose with the residual sucrose remaining.
As I have discussed above, claim 7 defines a method wherein both isomaltulose and sucrose are subject to hydrogenation and the amount of sucrose is reduced. The specification provides a real and reasonably clear disclosure of such a process, particularly Examples 1 to 4.
Südzucker additionally submitted that the claims which encompass methods not requiring any support travel beyond the invention disclosed. Further, there is no exemplification of methods without a support that has acquired acid functionality.
The specification indicates that the use of a support is preferable (page 8, lines 14 – 18). As I have discussed above, the specification also provides disclosure of neutral supports and reaction conditions that are neutral or basic.
It has not been demonstrated that there is a lack of fair basis.
13. Conclusion
The opposition is unsuccessful on all grounds.
14. Costs
Both parties submitted that costs should follow the event. The opposition has been unsuccessful on all grounds. However, Evonik amended the claims twice under section 104 following the filing of the notice of opposition. In this sense Südzucker can be considered to be partially successful.
The first amendments were filed on 23 February 2015 and included amendments to claim 1. The second amendments were filed on 1 March 2016 and allowed on 21 July 2016. These included amendments to claim 1 and independent claims 5 and 7, all of which were considered in detail in this decision. I also note that Evonik, at the time of filing the second amendments, stated that “the proposed amendments, if accepted, would have a significant bearing on the opposition.”
As a consequence, I award costs according to Schedule 8 against Evonik up to and including the date that the amendments were allowed on 21 July 2016 and against Südzucker from the date of allowance onwards.
Dr M-A. Fam
Delegate of the Commissioner of PatentsAnnex A – Claims of the specification
- A sweetener containing
20 wt.% to 75 wt.% of a-D-glucopyranosyl-1, 6-D-sorbitol,
20 wt.% to 75 wt.% of a-D-glucopyranosyl-1, 1-D-mannitol,
0.02 wt.% to 15 wt.% of a-D-glucopyranosyl-1, 1-D-sorbitol,
0.02 wt.% to 15 wt.% of sorbitol and
0.2 wt.% to 15 wt.% of mannitol,
in each case relative to the total amount of a-D-glucopyranosyl-1, 1-D-mannitol, a-D-glucopyranosyl-1, 6-D-sorbitol, a-D-glucopyranosyl-1, 1-D-sorbitol, sorbitol and mannitol,
with the provisos
that the weight ratio of a-D-glucopyranosyl-1, 6-D-sorbitol to a-D-glucopyranosyl-1, 1-D-mannitol is greater than 1:1; and
that the sweetener contains sucrose; and
that said sucrose is present in an amount less than 0.3 wt.% relative to the total weight of dry matter of the sweetener.- A sweetener according to claim 1 with the proviso that the weight ratio of a-D-glucopyranosyl-1, 6-D-sorbitol to a-D-glucopyranosyl-1, 1-D-mannitol is greater than 53:47.
- A sweetener according to claim 1 or claim 2 characterized in that the sum of the wt. % of a-D-glucopyranosyl-1, 6-D-sorbitol and a-D-glucopyranosyl-1, 1-D-mannitol is greater than 86 wt. % relative to the total dry weight of dry matter of the sweetener.
- A sweetener according to any one of claims 1 to 3, said sweetener consisting of:
20 wt.% to 75 wt.% of a-D-glucopyranosyl-1, 6-D-sorbitol,
20 wt.% to 75 wt.% of a-D-glucopyranosyl-1, 1-D-mannitol,
0.02 wt.% to 15 wt.% of a-D-glucopyranosyl-1, 1-D-sorbitol,
0.02 wt.% to 15 wt.% of sorbitol and
0.2 wt.% to 15 wt.% of mannitol,
less than 0.3 wt.% sucrose.- A method of production of a sweetener by hydrogenation of a carbohydrate mixture containing isomaltulose and sucrose, characterized in that the hydrogenation is carried out in the presence of at least one catalyst, which is based on ruthenium (Ru) and/or at least one oxide of ruthenium, wherein said hydrogenation is accompanied by cleavage of the sucrose.
- A method according to claim 5, characterized in that the catalyst, the ruthenium (Ru) and/or the oxide of ruthenium is immobilized on a support.
- A method of production of a sweetener by hydrogenation of a carbohydrate mixture containing isomaltulose and sucrose, characterized in that the hydrogenation is carried out in the presence of at least one catalyst, which is based on ruthenium (Ru) and/or at least one oxide of ruthenium, said ruthenium and/or at least one oxide of ruthenium being immobilized on a support, said support being an acid support or being a neutral support which has acquired acid functionality.
- A method according to claim 7 wherein said hydrogenation is accompanied by cleavage of the sucrose.
- A method according to any one of claims 6 to 8, characterized in that the total pore volume of the support according to DIN 66133 is in a range from 0.01 to 3 ml/g.
- A method according to any one of claims 6 to 9, characterized in that the support has a surface area in a range from 0.001 to 1500 m2/g in the BET test according to DIN 66131.
- A method according to any one of claims 6 to 10, characterized in that the support is a neutral support which has acquired acid functionality.
- A method according to claim 11 wherein the neutral support is TiO2 or activated charcoal.
- A method according to any one of claims 6 to 12 wherein the support is activated charcoal.
- A method according to any one of claims 6 to 10, characterized in that the support is selected from the group comprising acid oxides and mixed oxides, natural and synthetic silicates.
- A method according to any one of claims 6 to 11 or 14, characterized in that the support consists at least partially of an oxide compound of at least one of the elements selected from the group comprising Si, Ti, Te, Zr, Al, P or a combination of at least two of these elements.
- A method according to claim 15 wherein the support comprises Al2O3.
- A method according to any one of claims 6 to 10, characterized in that the support is a super-acid support selected from zeolites of the H-Y type or from acid ion exchangers.
- A method according to any one of claims 5 to 17, wherein the sweetener contains less than 0.3 wt.% sucrose relative to the total weight of dry matter of the sweetener.
- A method according to any one of claims 5 to 18, characterized in that the carbohydrate mixture contains 0.01 wt.% to 15 wt.% of sucrose relative to the dry weight of the total carbohydrate mixture.
- A method according to any one of claims 5 to 19, characterized in that the carbohydrate mixture contains 0.02 wt.% to 30 wt.% of trehalulose relative to the dry weight of the total carbohydrate mixture.
- A method according to any one of claims 5 to 20, characterized in that the carbohydrate mixture contains 20 wt.% to 70 wt.% of water relative to the total carbohydrate mixture.
- A method according to any one of claims 5 to 21, characterized in that the method is carried out in a temperature range from 80°C to 150°C.
- A method according to claim 22, characterized in that the method is carried out at a temperature below 120°C.
- A method according to any one of claims 5 to 22, characterized in that the method is carried out up to a conversion of 50% to 95% relative to the hydrogenation of the isomaltulose in a temperature range between 80 to 120°C and the further, essentially 100% conversion relative to the hydrogenation of the isomaltulose in a temperature range between 100°C to 150°C.
- A method according to claim 24, characterized in that the two different temperature ranges are spatially separate from one another, and in both temperature ranges a catalyst is used in which ruthenium (Ru) and/or an oxide of ruthenium is immobilized on an oxide‑containing support, the oxide being selected in particular from Al2O3 and TiO2.
- A method according to claim 24, characterized in that the two different temperature ranges are spatially separate from one another, and in the temperature range from 80°C to 150°C, a catalyst is used in which ruthenium (Ru) and/or an oxide of ruthenium is immobilized on an oxide-containing support, the oxide being selected in particular from Al2O3 and TiO2, and in the temperature range from 100°C to 150°C, a catalyst is used in which ruthenium (Ru) and/or the oxide of ruthenium is immobilized on a carbon-containing support.
- A method according to at least one of claims 5 to 26, characterized in that the pressure used during the process is at least 15 bar.
- A method of producing a sweetener substantially as hereinbefore described with reference to any one of the Examples but excluding the comparative examples.
- A sweetener produced by the method of any one of claims 5 to 28.
- The sweetener of claim 29 which contains
20 wt.% to 75 wt.% of a-D-glucopyranosyl-1, 6-D-sorbitol,
20 wt.% to 75 wt.% of a-D-glucopyranosyl-1, 1-D-mannitol,
0.02 wt.% to 15 wt.% of a-D-glucopyranosyl-1, 1-D-sorbitol,
0.02 wt.% to 15 wt.% of sorbitol and
0.2 wt.% to 15 wt.% of mannitol,
in each case relative to the total amount of a-D-glucopyranosyl-1, 1-D-mannitol, a-D-glucopyranosyl-1, 6-D-sorbitol, a-D-glucopyranosyl-1, 1-D-sorbitol, sorbitol and mannitol,
with the provisos
that the weight ratio of a-D-glucopyranosyl-1, 6-D-sorbitol to a-D-glucopyranosyl-1, 1-D-mannitol is greater than 1:1; and
that the sweetener contains sucrose; and
that said sucrose is present in an amount less than 0.3 wt.% relative to the total weight of dry matter of the sweetener.
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