Fonterra Co-Operative Group Limited v N.V. Nutricia - [2018] APO 38

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Fonterra Co-Operative Group Limited v N.V. Nutricia [2018] APO 38

Patent Application: 2011353251

Title:Non-medical increase or maintenance of body weight of a mammal

Patent Applicant:  N.V. Nutricia
Opponent:  Fonterra Co-Operative Group Limited
Delegate:  Dr S. J. Smith
Decision Date:  19 June 2018
Hearing Date:  Written submissions filed 23 February 2018, final date for submissions expired 2 March 2018

Catchwords: PATENTS – opposition to the grant of a patent under section 59 – grounds of clarity, support, disclosure, novelty, inventive step and utility – regulation 5.23 considered – all grounds unsuccessful – costs awarded against opponent

Representation: Patent attorney for the applicant: FB Rice
Patent attorney for the opponent: AJ Park

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2011353251

Title:Non-medical increase or maintenance of body weight of a mammal

Patent Applicant: N.V. Nutricia
Date of Decision: 19 June 2018
DECISION
The opposition is unsuccessful. Subject to appeal, I direct the application proceed to grant.
I award costs according to Schedule 8 against Fonterra Co-Operative Group Limited.
REASONS FOR DECISION
Background

Patent application 2011353251 was filed by N.V. Nutricia (the Applicant) on 11 August 2011 under the provisions of the Patent Cooperation Treaty. The application claims priority from PCT/NL2010/050892 which was filed on 28 December 2010.
Acceptance of the application was advertised on 5 May 2016. Fonterra Co-Operative Group Limited (the Opponent) filed a notice of opposition under section 59 of the Patents Act 1990 (the Act) on 5 August 2016.
The statement of grounds and particulars (SGP) was filed on 7 November 2016 and identifies the following grounds of opposition: novelty, inventive step, utility, sufficiency, support and clarity.
The Applicant proposed post-acceptance amendments to the specification on 5 May 2017 which were allowed unopposed on 29 September 2017 and this decision therefore relates to the specification as amended.
The evidence filed during the evidentiary periods is summarised in the table below:

Evidence Declarant Exhibits Declaration Date Reference

In Support

Angela Rowan

-

7 February 2017

Rowan

Christine Lennon Buchan

CLB-1 to CLB-9

7 February 2017

Buchan

In Answer

Ladislaus Maria Broersen

EIA-1 to EIA-2

1 May 2017

Broersen

The request for examination of the opposed application was filed on 23 January 2015. Consequently, the amendments of the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act) apply to the present application. This includes section 60(3A) of the Act, which provides that the Commissioner may refuse an application if satisfied on the balance of probabilities that a ground of opposition exists. It is the opponent who carries the onus of proof.
The Opponent elected not to make any submissions in the hearing. The Applicant accordingly directed its submissions to the grounds of opposition identified in the SGP and I will decide the opposition as particularised. This approach is somewhat complicated by the fact that the claims have been amended quite significantly and the Opponent’s evidence and particulars are not directed to the claims in their present form.
I note that when an opponent has lost interest in prosecuting an opposition, as appears to be the case, the usual and appropriate course of action is for the opponent to withdraw their opposition. In that circumstance the Commissioner’s usual practice is to consider whether the application should be re-examined on the basis of the material filed in the opposition prior to grant.
The specification
The specification relates to non-medical use of a composition comprising a combination of components for increasing or maintaining the body weight of a mammal. The specification ends with 10 claims. Claim 1 is the only independent claim.
Before construing the specification, I note the comments of Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd[1]:
“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.”
[1] [2013] FCA 214; 100 IPR 451 at [139].
The person skilled in the art
It is well established that many of the issues in an opposition are answered by reference to the person skilled in the art:
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”[2]
The hypothetical skilled person works in the field with which the invention is connected, and is a non-inventive person or team likely to have a practical interest in the subject matter of the invention.[3] As indicated above, the present specification is directed to non-medical use of a composition comprising a combination of components for increasing or maintaining the body weight of a mammal, and therefore the person skilled in the art will have experience or a practical interest in this field, or nutritional compositions more generally.
[2] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70].
[3] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70]-[72].
The key declarants in this matter are Angela Rowan and Ladislaus Maria Broersen. Ms Rowan is General Manager, Nutrition, at Fonterra Co-Operative Group Limited and leads a team of nutritionists and nutrition scientists who design and support development of nutritional products.[4] Dr Broersen is a Principal Scientist at Nutricia Research and is responsible for scientific research collaborations focusing on “development and testing of nutritional concepts and products promoting health through nutrition”.[5] Both declarants have confirmed that the evidence they have provided is within their area of expertise[6] and I am satisfied that both declarants have backgrounds that enable them to understand the specification and provide evidence in relation to what a person skilled in the art knew or would have done at the relevant date. Where there is conflicting evidence I will decide which evidence should be given greater weight.
[4] Rowan at 1.1-1.2.
[5] Broersen at [1]-[2].
[6] Broersen at [8]; Rowan at 2.4.
The invention as described
Background of the invention
The specification states that once maturation of the human body has stopped muscle mass typically gradually and steadily decreases over time, resulting in a decrease of lean body mass.[7] Muscle strength is dependent on muscle mass and so muscle strength decreases as part of the aging process.[8] That is, undesirable loss in body weight, lean body weight, muscle mass and muscle strength occurs as part of the normal aging process.[9] Food intake, lifestyle and metabolism change with increasing age, which can lead to “physiological anorexia of aging” and the specification states that “[i]nvoluntary weight loss during aging above 65 years is strongly associated with impaired mood and low stamina”.[10]
[7] Page 1, lines 16-18.
[8] Page 1, lines 23-29.
[9] Page 2, lines 10-11.
[10] Page 2, line 31 – page 3, line 13.
The specification also describes abnormal weight loss and resulting health problems, including frailty and pre-frailty.[11]
[11] Page 2, lines 14-30.
The specification notes that supplementation of protein and energy to elderly persons at risk of malnutrition produces a small but consistent weight gain.[12] However, this approach demands consumption of food on top of daily meals and proper organ function and the elderly may experience difficulty consuming large quantities of food, suffer impairments in organ function, experience low appetite or have practical difficulties cooking.[13]
The aim of the invention
[12] Page 4, lines 9-10.
[13] Page 4, lines 13-19.
Against this background, the specification states:
“Accordingly, there is a need for an alternative way of nutritional management of elderly which are in need of an increased body weight, body mass index, lean body weight, muscle mass or muscle strength, to perform appropriately…”[14]
Nature of the invention
[14] Page 4, lines 21-23.
The specification states that the invention relates to the non-medical use of a composition comprising at least two, preferably three and more preferably four components selected from the group of nucleoside equivalents; n-3 polyunsaturated fatty acids selected from DHA (docosahexaenoic acid), DPA (docosapentaenoic acid) and EPA (eicosapentaenoic acid); vitamins B selected from vitamin B6, vitamin B9 and vitamin B12; a phospholipid; an antioxidant selected from vitamin C, vitamin E and selenium; and cholines, provided that at least one nucleoside or one vitamin B is present, for increasing or maintaining the body weight of a mammal. The specification indicates that such a composition can be administered in a diet without essentially increasing the daily caloric intake of the mammal.[15]
[15] Page 6, lines 19-29.
The specification further identifies that the composition may be used to improve or maintain the ability to perform an activity of daily living of a mammal.[16] In particular, the specification identifies the use of the claimed composition in the elderly, and defines, in the context of the specification, an elderly person to be a person aged 50 or more.[17] This use may contribute to improving quality of life, for example by slowing down normal aging effects or allowing an elderly person to live independently to a later age.[18] Other benefits associated with the composition of the invention are also described, including improvement in stamina, an increase in feeling energetic, decrease in fatigue, increased eagerness to demonstrate initiative and become more active and improved gait.[19]
The Examples
[16] Page 7, lines 6-15.
[17] Page 16, lines 5-23.
[18] Page 7, lines 1-3.
[19] Page 8, lines 16-24.
The specification ends with twelve examples. Of particular relevance to the claims in their present form are Examples 3-6 and 8-10. Examples 3 and 9 describe increased body weight in mice fed a diet enriched with DHA, UMP (uridine monophosphate), vitamins B6, B12 and folic acid, and phospholipids relative to mice fed an isocaloric control diet. Examples 4 and 10 describe increased body weight in mice fed a nutritional composition comprising, or a diet enriched with, UMP, DHA, choline, phospholipids, B vitamins and antioxidants compared to an isocaloric control diet. Examples 5, 6 and 8 describe formulations including the components of the present claims.
Other examples demonstrate weight gain in mice fed a composition comprising (i) UMP and DHA or (ii) B vitamins, a phospholipid and antioxidants relative to mice fed an isocaloric control diet, and other formulations are also exemplified.
The invention as claimed
The principles to be applied in construing claims are well established,[20] and a “generous measure of common sense should be used” in construing claims.[21]

[20] H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228 at 254, [118]-[120].

[21] Product Management Group Pty Ltd v Blue Gentian LLC [2015] FCAFC 179 at [36].

The entire claim set is reproduced at Annex A. Claim 1 reads:
Use of a composition comprising at least four components selected from the group of:
(i) a uridine source;
(ii) n-3 polyunsaturated fatty acids selected from the group of DHA, DPA and EPA;
(iii) vitamins B selected from the group of vitamin B6, vitamin B9 and vitamin B12;
(iv) phospholipids;
(v) antioxidants selected from the group of vitamin C, vitamin E and selenium; and
(vi) cholines,
with the proviso that at least: (i) one uridine source, (ii) DHA, (iii) one vitamin B and (iv) one phospholipid is present,
for increasing or maintaining the body weight of a human, wherein the composition is administered to the human in a diet without essentially increasing the daily caloric intake of the human, said human being an elderly person of the age of 50 or more.
It is apparent that the proviso further limits the initial requirement in the claim that the “at least four components” be selected from groups (i) to (vi), such that the composition the subject of the claims must contain a uridine source, DHA, a B vitamin and a phospholipid.
Use of … for increasing or maintaining the body weight of a human
Claims of the “use of … for” style are typically construed as process claims and I understand the claim to be directed to a process whereby the defined composition is administered to a human. The question then arises as to whether the process must be carried out with an objective of increasing or maintaining the body weight of the human, or whether it is sufficient that increase or maintenance of body weight results from the process when it is carried out, irrespective of the objective. I note that a Deputy Commissioner recently considered the requirement of an intention in claims directed to methods of locally anaesthetising a patient, and concluded that an intention to achieve an anaesthetic effect was not a feature of the claim.[22]
[22] Sanofi-Aventis Healthcare Pty Limited v Reckitt Benckiser Healthcare (UK) Limited [2018] APO 11 at [65].
While I can see merit in both approaches, in the context of this application, where the composition is a nutritional composition administered in a non-medical context, I think that it is reasonable to adopt the latter construction, that is, the use must result in increase or maintenance of body weight irrespective of any intention of achieving that result. I understand the claim to encompass a process wherein the defined composition is administered to the defined population (that is, elderly persons) in the defined manner (that is, without essentially increasing the daily caloric intake) and results in the increase or maintenance of the body weight.
The specification indicates that:
“A non-medical use for increasing or maintaining body weight in accordance with the invention, is generally a healthy increase or maintenance of the body weight, i.e. an increase not causing health problems, such as cardiovascular problems.”[23]
[23] Page 21, lines 26-28.
I understand the reference to maintenance to mean that body weight is maintained at what it was immediately prior to commencing administration of the composition.
Composition
The specification provides a definition of composition:
“A composition according the invention is a nutritional composition. … such composition has both a nutritional and a medical effect or benefit, i.e. the composition comprises macronutrients which provide a substantial source of energy, other than the active components… It preferably comprises food grade components, which make it suitable for safe oral intake or enteral administration. The components can also be dissolved in a matrix which makes it suitable for parenteral administration. A pharmaceutical composition on the other hand, it is understood that such composition has only a medical effect or benefit, i.e. the composition comprises essentially no ingredients which provide a substantial source of energy, other than the active components.
The composition according to the invention can have any form or physical condition. …
The composition according to the invention may also be a kit-of-parts comprising the components according to the invention, packed for simultaneous or sequential administration to a person in need thereof.”[24]
[24] Page 24, line 12 – page 25, line 2.
Elsewhere in the specification it is clear that a pharmaceutical composition is also envisaged, for example, “[i]n one embodiment, the components (i) to (v) are included in a pharmaceutical composition according to the invention”[25] and:
“Further, one or more additional ingredients may be present that are commonly used in the prior art, dependent on the form – nutritional or pharmaceutical composition – in which the combination is provided.
If the dosage form is a pharmaceutical composition, the pharmaceutical composition may comprise one or more excipients known in the prior art to provide a pharmaceutical composition in a dosage form of choice. … Examples of solid formulations are tablets, capsules (e.g. hard or soft shell gelatine capsules), pills, sachets, powders, granules and the like which contain the active ingredients together with a conventional carrier.”[26]
[25] Page 34, lines 18-19.
[26] Page 39, lines 2-11.
Consistent with these passages, the examples include both drink and tablet formulations of the components defined in the claims.
Ms Rowan indicated that for a composition not to essentially increase the daily caloric intake of a person it must either be a composition with no or negligible caloric value (e.g. a tablet or capsule) or a meal replacement composition intended to replace an isocaloric part of the diet, but it is not clear which of these, or if both, fall within the scope of the claimed invention.[27] Having regard to the specification as whole and the evidence of both declarants,[28] I am satisfied that the composition defined in the claim may take any form, i.e. it may be a pharmaceutical or a nutritional composition as described in the specification.
[27] Rowan at 4.9-4.11.
[28] Broersen at [37]; Rowan at 4.3.
It is clear however, that the claims are not directed to a composition per se, but to the use of a composition for increasing or maintaining the body weight of a human of the age of 50 or more, wherein the composition is administered to the human without essentially increasing daily caloric intake. The scope of the claims is therefore limited in effect to a method in which the composition defined in the claims is administered to a human aged 50 or more in a diet in which the daily caloric intake of the human is not essentially increased (i.e. relative to the daily caloric intake prior to commencing use of the composition), but the body weight of the human is increased or maintained.
Uridine source
The specification does not provide an explicit definition of “uridine source”. However, “nucleoside equivalents”, which include compounds comprising a nucleobase, such as nucleotides, oligonucleotides, nucleobases and derivatives thereof that may be converted into the nucleoside or a nucleotide in vivo, such as esters, are described.[29] The declarants have not indicated any difficulty in understanding the scope of this term and in the context of the specification I understand uridine source as meaning the same as uridine equivalent – that is, a compound which provides uridine in vivo.
Without essentially increasing daily caloric intake
[29] Page 26, lines 10-14.
Ms Rowan stated that it is not clear whether when essentially is used in relation to increase of daily caloric intake it means that the caloric intake of the person cannot increase at all, or if there is a permissible degree of increase allowed.[30] In her opinion any composition resulting in more than a negligible increase in daily caloric intake would not be encompassed by the scope of the claims, as any weight gain would likely be attributable to the caloric intake rather than combination of actives in the composition.[31]
[30] Rowan at 4.6.
[31] Rowan at 4.7.
In contrast, Dr Broersen did not experience difficulty understanding this phrase, stating:
“The term ‘essentially free’ is normally used to indicate that something is not present or does not significantly affect a property.
I would understand that a conventional way to increase body weight would be to significantly increase the daily caloric intake. So ‘essentially increasing the daily caloric intake’ would then be an increase in daily caloric intake that is effective in significantly increasing body weight. Consequently ‘without essentially increasing daily caloric intake’ would be to not increase the daily caloric intake at all or to increase the daily caloric intake in an amount that is insufficient to cause a significant increase of body weight on its own.”[32]
[32] Broersen at [25]-[26].

I consider Dr Broersen’s understanding of “essentially” to be consistent with the description, which refers to the effect of the composition being achieved by incorporating the active components into a small food product that acts as a vehicle,[33] the Examples, which describe administration of an isocaloric control diet, and indeed with Ms Rowan’s statement that more than a negligible increase (i.e. that would result in weight gain on its own) cannot be encompassed by the claims. Further, the meaning ascribed to “without essentially increasing daily caloric intake” by Dr Broersen is consistent with what I understand to be the usual meaning of essentially and with the specification as a whole, and I understand the phrase in this way.
[33] Page 34, lines 15-18.
Ms Rowan also stated:
“If the applicant considers that its invention encompasses use of a composition with a more than negligible caloric value that can be administered to a person without increasing the daily caloric intake, but where the person’s diet is not kept exactly isocaloric, then the specification doesn’t tell the skilled worker how to produce such a composition.
Further, if the applicant considers that its invention encompasses use of a composition that results in some increase in the daily caloric intake of the person taking the composition, that would seem to be entirely inconsistent with what the applicant claims to have invented. Further, a composition that increases the daily caloric intake of the person taking it will, in my opinion, inevitably result in some weight gain, or at least maintain body weight, and therefore is clearly not an invention.”[34]
[34] Rowan at 4.12-4.13.
In contrast, Dr Broersen stated:
“It is possible to simply administer a nutritional composition providing a substantial source of energy without essentially increasing daily caloric intake by eating less from other nutritional compositions that are used to provide the daily caloric intake.
Before and at the priority date, for most nutritional compositions the caloric values are known. This information generally forms part of the packaging for a large raft of food items and beverages.
Thus, by simply monitoring daily food intake, calculating the caloric value of that food and not administering more calories than before administration with the nutritional composition started, one can administer a nutritional composition without increasing total daily caloric intake.”[35]
[35] Broersen at [33]-[35].
Dr Broersen’s approach seems to me inherently reasonable. I agree with the Applicant’s submissions in relation to this point[36] and I consider that a person skilled in the art would understand that it is possible to administer the composition without essentially increasing the daily caloric intake (i.e. relative to what it was prior to commencing administration of the composition) by reducing caloric intake from other sources.
Elderly person of age 50 or more
[36] Applicant’s submissions at [261].
As noted previously, the specification defines an elderly person to be a person aged 50 or more.[37] Accordingly use of both descriptors in the claim – elderly and age 50 or more – seems redundant. For the purpose of this decision I have adopted this meaning of elderly.
Appended claims
[37] Page 16, lines 5-23.
Claim 2 defines the use according to claim 1 wherein the increase or maintenance of body weight comprises increasing or maintaining lean body weight and/or muscle mass. Claim 3 defines the use of claim 1 or 2 wherein the use comprises increasing or maintaining body mass index.
Claim 4 defines the use according to any one of claims 1-3 wherein the composition comprises at least one of antioxidants and cholines.
Claims 5, 6 and 7 define the use according to any one of the preceding claims wherein the human is non-frail and/or does not have dementia; the human is above 65 years of age; and the human has had a specified level of weight loss in the preceding one or two years preceding starting the use, respectively.
Claims 8 and 9 define the use according to any one the preceding claims but define that the uridine source is UMP and that the phospholipid is selected from phosphatidylserine, phosphatidylinositol, phosphatidylcholine and phosphatidylethanolamine, respectively.
Claim 10 defines the use according to any one of claims 1-9, but specifies that the components are administered as part of a nutritional composition. While construction of claims to avoid redundancy is not an inviolable rule,[38] this limitation reinforces my view explained above that the composition of claim 1 may be a pharmaceutical composition or a nutritional composition.
[38] David Kahn Inc. v Conway Steward & Co. Ltd. [1974] RPC 279 at 308.
Clarity
It is a requirement of subsection 40(3) of the Act that the claims be clear. This requirement is satisfied if a person could ascertain “whether or not what he proposes to do falls within the ambit of the claim”.[39] However, the terms used in claims need not be precise and absolute, as set out in Flexible Steel Lacing Company v Beltreco Ltd[40] (with references omitted):

“Lack of precise definition in claims is not fatal to their validity, so long as they provide a workable standard suitable to the intended use. The consideration is whether, on any reasonable view, the claim has meaning. In determining this, the expressions in question must be understood in a practical, commonsense manner. Absurd constructions should be avoided and mere technicalities should not defeat the grant of protection.”

[39] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59 at 60.
[40] [2000] FCA 890; (2001) 49 IPR 331 at [81] (cited with approval in Austal Ships Sales Pty Ltd v Stena Rederi Aktiebolag [2008] FCAFC 121; (2008) 77 IPR 229).

The SGP particularises the ground of clarity as follows:
“It is not clear what the claim feature ‘without essentially increasing daily caloric intake’ means. In particular:
6.2.1 It is not clear whether the claims are limited to bare supplementation of the diet with a composition of the invention, or also include substitution of the composition for an isocaloric meal/composition.
6.2.2 It is not clear what ‘essentially’ means.
6.2.3It is not clear how a nutritional composition as that is disclosed in the specification cannot increase daily caloric intake.”
I have considered the evidence of the declarants when construing the claims and concluded that the composition may take any suitable form and the phrase “without essentially increasing daily caloric intake”, and how the claimed composition can achieve that result, can be given a clear meaning. It follows that the Opponent has not established that the claims lack clarity.
Novelty
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, is novel. Subsection 7(1) provides that an invention is taken to be novel unless it is not novel in light of the prior art base. Prior art information made publicly available in a document or through the doing of an act forms part of the prior art base for the purpose of novelty if it was published before the priority date of a claim.
It is well established that the general test for lack of novelty is the reverse infringement test, as set out by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd[41]:
“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”.
[41] [1977] HCA 19 at [20]; 137 CLR 228 at 235.
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed.[42]The level of disclosure required is set out in General Tire & Rubber Co v Firestone Tyre and Rubber Co Ltd[43] (with references omitted):
“If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent, the patentee’s claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor’s publication will inevitably result in something being made or done which, if the patentee’s patent were valid, would constitute an infringement of the patentee’s claim, this circumstance demonstrates that the patentee’s claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee’s claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented. A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.”
[42] See Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517.
[43] General Tire & Rubber Co v Firestone Tyre and Rubber Co Ltd [1972] RPC 457 at 485-486.
That is, a prior art disclosure will only anticipate a claim if by carrying out the directions of the prior art a person skilled in the art would, rather than could, arrive at the claimed invention.[44]
[44] See Novozymes A/S v Danisco A/S [2013] FCAFC 6 at [177].
In the SGP the following nine documents and five acts of alleged prior use are identified as novelty destroying:
D1: US 2003/0124237
D2: US 2010/0104545
D3: US 2007/0254062
D4: WO 2009/002146
D5: Mintel GNPD database record for Abbott product ‘Prosure’
D6: Mintel GNPD database record for product Carnation ‘Instant Breakfast Essentials’
D7: Mintel GNPD database record for product Abbott ‘Ensure Muscle Health’
D8: Mintel GNPD database record for product Nestle ‘Boost Nutritional Energy Drink’
D9: Mintel GNPD database record for product Nestle ‘Boost High Protein Complete Nutritional Powder’
A1: Sale of product disclosed in D5
A2: Sale of product disclosed in D6
A3: Sale of product disclosed in D7
A4: Sale of product disclosed in D8
A5: Sale of product disclosed in D9
D1-D4
While documents D1-D4 were filed with the SGP, they have not been filed as evidence in the opposition.[45] Accordingly, although both parties have filed declaratory evidence referring to these documents and the Applicant has addressed the documents in its submissions, unless I decide to consult the documents under regulation 5.23 they will not form part of this opposition.
Regulation 5.23
[45] I note that Office correspondence of 8 November 2016 and 24 February 2017 to the parties advised that any documents not filed as evidence do not form part of the evidence in support.
The operation of regulation 5.23 was considered in Merial Limited v Bayer Intellectual Property GmbH[46]:
“I conclude that a decision under regulation 5.23 must have regard to the nature of the information and whether the information is likely, if not certain, to change the outcome of the opposition in a significant way.”
Subsequent decisions have elaborated on other relevant factors to consider in relation to regulation 5.23,[47] but for the present purposes the above test is sufficient. I will consider each of the documents to the extent necessary to form a view as to their relevance.
[46] [2015] APO 16 at [24].
[47] Reflex Instruments Asia Pacific Pty Ltd v Minnovare Limited [2017] APO 8; Intervet International B.V. v E.I. du Pont de Nemours and Company [2017] APO 11.
I have reviewed the documents in light of the declarants’ comments and the Applicant’s submissions and I generally agree with the Applicant’s submissions in relation to the documents.[48] Each of D1 and D3 are directed to infant formula. Prima facie these documents are not relevant to the novelty of the present claims, which are directed to administration of compositions to humans aged 50 or more. D2 is directed to nutritional compositions, in particular for infants. It is not apparent to me, and the evidence does not suggest, that there is a specific disclosure directed to the administration of the composition to an older population or that the composition of D2 is to be administered in a diet without essentially increasing daily caloric intake. Therefore I cannot see that D2 is relevant to the novelty of the present claims.
[48] Applicant’s submissions at [29]-[54].
D4 discloses a composition comprising the required combination of components, that is, a uridine source (UMP), DHA, phospholipids and vitamin B[49] for supporting activities in daily living.[50] The compositions of D4 are disclosed as being of benefit to patients suffering from Alzheimer’s disease or dementia and the elderly.[51] D4 indicates that many subjects experience a loss in appetite or become malnourished, and accordingly it is advantageous to include other nutrients in the composition.[52] The compositions of D4 preferably contain between 0.2 and 3 kcal/ml, are formulated to have a relatively low impact on appetite and should not interfere with normal eating habits.[53] D4 indicates that the composition preferably contains protein, and muscle strength (which the present specification indicates is dependent on muscle mass) is preferably improved upon administration of the composition.[54]
[49] Table 2; Example 2.
[50] See Abstract.
[51] Page 10, lines 29-31.
[52] Page 11, lines 7-9.
[53] Page 3, lines 24-25; page 11, lines 9-12.
[54] Page 11, lines 23-26.
D4 does not specifically disclose weight gain or maintenance upon administration of the disclosed composition or exemplify use according to the present claims. However, it does disclose administration of a composition comprising the presently defined integers to an elderly population. D4 states that the composition should not interfere with normal eating habits. I understand this to mean that the composition of D4 is additional to existing/normal food intake, and, as indicated above, the composition preferably contains both the specified components and additional nutrients. The parties have not directed me to, and I cannot see, any clear and unmistakable directions in D4 to the administration of this composition in a diet without essentially increasing daily caloric intake. Given this, I am not satisfied that a person skilled in the art following the teaching of D4 would, as opposed to could, administer the disclosed composition such that daily caloric intake was not essentially increased. Accordingly, I cannot conclude that the present claims would lack novelty in light of D4.
It follows that I am not satisfied that any of D1-D4 are likely to change the outcome of the opposition in a significant way in relation to novelty.
The documents are also cited in relation to inventive step. I will discuss the test for inventive step below, but it suffices to say in relation to D1-D3 that there is no evidence that supports a conclusion that a person skilled in the art would, as a matter of routine, administer the compositions of these documents to a human aged 50 or over, wherein the composition is administered in a diet without essentially increasing daily caloric intake and results in weight maintenance or weight gain.[55]
[55] Ms Rowan’s evidence in relation to D2-D4, at 6.12, 6.18, 6.23, is merely that “[i]f substituted for an isocaloric composition, the composition disclosed in [D2-D4] would inevitably increase or maintain the body weight of a human without essentially increasing daily caloric intake.”
D4, as stated above, discloses administration of a composition comprising the presently defined integers to an elderly population, and there is reference in D4 to compositions in a form which would be expected to have minimal impact on daily caloric intake (i.e. pills and capsules are referred to as suitable forms[56] but are not exemplified) and, according to the teaching of the present specification, would be expected to result in increase or maintenance of body weight. However, in the absence of a clear reference in the document to use of the disclosed composition in relation to maintaining or increasing weight I am not satisfied that a person skilled in the art would be motivated, as a matter of routine, to solve the problem (as discussed below) using the disclosure of D4. Dr Broersen’s evidence is consistent with this conclusion.[57]
[56] Page 10, line 23.
[57] Broersen at [102]-[103].
Accordingly, it is not apparent to me that any of D1-D4 would be likely to change the outcome of the opposition in a significant way, and I will not have regard to any of these documents under regulation 5.23. I note, however, that it remains open to the Opponent to request re-examination on the basis of any of these documents.
D5-D9 and A1-A5
The product description of D5 indicates that the product is specially designed for people at risk of or experiencing cancer induced weight loss, and has been shown to promote weight gain and build muscle. D6 is a breakfast drink, the product description of which indicates that it helps to build and maintain muscles and includes B vitamins that are essential for converting food to energy. The product description of D7 indicates that it helps rebuild muscle and strength lost naturally over time. The product description of D8 indicates that it is a high protein drink for muscle strength and energy and can “make a meal on the go”. The product description of D9 indicates that it helps build and maintain muscle and can be used as a meal replacement.
The SGP and Ms Rowan’s evidence identify the relevant components disclosed in the documents, but neither suggests that any of D5-D9 include a uridine source.[58] The Applicant has submitted that such a component is not clearly identified in these documents.[59] I have reviewed the ingredient listings for each of the documents and it is not evident to me that a uridine source is identified. Similarly, the Applicant pointed to the lack of any clear disclosure of DHA in any of D6-D9.[60] There is no suggestion in the SGP or Ms Rowan’s evidence that DHA is present in the products disclosed in these documents and it is not apparent to me that they include DHA. Furthermore, none of D5-D9 provide any clear teaching that they should be administered to elderly persons of 50 or more to maintain or increase body weight without essentially increasing daily caloric intake. While Ms Rowan stated that because D6, D8 and D9 can be used as meal replacements they would be administered in a diet without essentially increasing daily caloric intake,[61] Dr Broersen did not agree that was necessarily the case[62] and there is no clear and unmistakable direction apparent to me that caloric intake from other sources should be adjusted to account for the consumption of these products or that meal replacement use should be essentially isocaloric.
[58] Rowan at 7.5, 7.10, 7.15 (relating to D6, D8 and D9).
[59] Applicant’s submissions at [59], [68], [77], [86], [95].
[60] Applicant’s submissions at [68], [77], [86], [95].
[61] Rowan at 7.6, 7.11, 7.16.
[62] Broersen at [61]-[64].
It follows that I am not satisfied that D5-D9 disclose each of the features of claim 1 and the claims are therefore not anticipated by these documents. For the same reasons, the Opponent’s case that the claims lack novelty in light of the sale of the products disclosed in D5-D9 (that is, A1-A5) cannot succeed.

The Opponent has not established that the claims lack novelty.
Inventive step
Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim when considered alone or together with the information mentioned in subsection 7(3).
Subsection 7(3) defines the relevant information as:
The information for the purposes of subsection (2) is:
(a)any single piece of prior art information; or
(b)a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.
Having identified the common general knowledge and any relevant information as defined in subsection 7(3), the test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention, as set out by Aickin J:
“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.”[63]
[63] Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12; (1981) 148 CLR 262 at 286.
The High Court in Aktiebolaget Hässle v Alphapharm Pty Ltd[64] approved this approach as well as that taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd,[65] of asking whether the person skilled in the art would be directly led as a matter of course to try what was claimed in the expectation that it might well produce a useful or desired result.
[64] [2002] HCA 59; 212 CLR 411 at 432-433, [50]-[53].
[65] [1970] RPC 157 at 187.
Where a claim is directed to a combination of known integers obviousness is not established merely by identifying each of those features in the prior art or the common general knowledge – the question is whether the combination of those features is obvious.[66]
The problem
[66] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9; 1A IPR 231 at 256; Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 at 429, [41].
Neither party made submissions identifying the problem addressed by the specification, and the Applicant referred to comments of the High Court providing a caution regarding the use of the problem/solution approach to inventive step:
“…the ‘problem and solution’ approach may be particularly unfair to an inventor of a combination, or to an inventor of a simple solution, especially as a small amount of ingenuity can sustain a patent in Australia.”[67]
[67] Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21; (2007) 235 ALR 202 at [65].
Taking those comments into consideration, but also noting the Court’s comment that the problem/solution approach may be an aid to the avoidance of ex post facto analysis,[68] I have formed the view that this approach is useful in this case. Having considered the specification, I think that a reasonable formulation of the problem addressed by the present claims is the provision of a composition (and administration method) for the increase or maintenance of body weight in an elderly human.

Common general knowledge
[68] Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21; (2007) 235 ALR 202 at [65].
Common general knowledge is the background knowledge and experience available to all those working in the relevant art:
“The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”[69]
[69] Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9; (1980) 144 CLR 253 at 292.
Ms Rowan stated that all of the active components in the composition defined in the claims were known and used in nutritional compositions at the priority date.[70] This is consistent with the background prior art identified in the present specification.[71] Ms Rowan also identified the following information as known at the priority date:[72]
[70] Rowan at 5.2.
[71] Pages 5-6.
[72] Rowan at 5.2.1-5.5.
·   nucleotide supplementation may support weight gain in humans, in particular infants
·   DHA and/or EPA supplementation has a positive effect on body weight and/or muscle mass
·   vitamin C protects and maintains muscle structure as a cofactor for carnitine biosynthesis
·   antioxidants provide health benefits by protecting the body from oxidative stress and damage
·   some selenoproteins are important for muscle formation and repair
·   B vitamins that are associated with energy release efficiency are likely to assist with body weight maintenance and/or increase
·   choline is essential for structural integrity and signal functions of cell membranes and for normal muscle function; choline supplementation with phosphatidylcholine is associated with increased lean body mass
·   supplementation with nutrients above regular diet may improve body weight/muscle mass
·   supplements are beneficial if they supply a nutrient that is deficient in the diet
·   nutrient intake is an important determinant of lean body weight and fat mass.
The Applicant submitted that it is insufficient for Ms Rowan to allude to pieces of information and claim that it is common general knowledge.[73] Ms Rowan in her declaration has asserted that the information identified above was known and cited articles in which some of that information can be found, but none of these documents were filed as evidence. Dr Broersen did not specifically disagree with anything Ms Rowan asserted to be known, beyond suggesting that scientific papers are generally not part of the common general knowledge.[74] It is not entirely clear from Ms Rowan’s declaration whether this is information Ms Rowan considered common general knowledge with the references provided merely in support (but not presented as common general knowledge themselves), or information identified having regard to the claimed invention which forms part of the prior art but not the common general knowledge. However, as will become clear, nothing turns on this point, and so for the purpose of this decision I will proceed on the basis that this information is common general knowledge.
Inventive step in light of the common general knowledge
[73] Applicant’s submissions at [135]; Northern Rivers Pty Ltd v Janssen Oncology, Inc. [2015] APO 53 at [117].
[74] Broersen at [104]-[106].
The SGP asserts a lack of inventive step in light of the common general knowledge, and provides the following particulars:
“2.4.1 The claimed active ingredients have known nutritional benefits, including benefits directly or indirectly related to weight gain, increased muscle mass etc.
2.4.2 The applicant does not assert and has not demonstrated any synergy between the claimed active ingredients.
2.4.3 The applicant does not assert any inventiveness in selecting particular quantities or proportions of the claimed active ingredients.
2.4.4 The inventive concept must lie simply in the combination of the claimed active ingredients. Further, while the applicant claims six active ingredients, apart from the requirement that one active ingredient (iv) and one (i) or one (iii) active ingredient be present, any combination of ingredients will apparently achieve the effect of the invention.
2.4.5 When developing a composition for increasing or maintaining body weight, it would be obvious to combine active ingredients known to have nutritional benefits, including benefits directly or indirectly related to weight gain, increased muscle mass etc.”
Ms Rowan’s evidence effectively echoes these particulars:
“… the active components have known nutritional benefits, including benefits directly or indirectly related to weight gain, increased muscle mass etc. When developing a composition for increasing or maintaining body weight, it would be obvious to combine these active ingredients. The applicant does not describe any interaction between the components leading to a super-additive effect, or describe a particular level of each component that is necessary to produce the claimed effect.
Where the person taking the composition is suffering from illness- or age-related nutrient deficiencies, supplementing these nutrient levels would be expected to lead to maintenance or increase in body weight.”[75]
[75] Rowan at 5.10-5.11.
It appears to me that the Opponent’s approach is precisely that which the Courts have warned against – where a claim is for a combination:
“It is the selection of the integers out of ‘perhaps many possibilities’ which must be shown … 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.”[76]
[76] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; (2002) 212 CLR 411 at [41].
There is no reasoning in the evidence to support why any specific combination of integers would be selected out of the range of possible integers when seeking to formulate a composition for the maintenance or increase of body weight in an elderly human. In any event, the present claims define a use of a composition wherein the composition is administered to persons aged 50 or more without essentially increasing daily caloric intake and including four specific components, including a uridine source. To the extent that the evidence relates to the question of whether it would be routine to adopt a uridine source, it only goes so far as to say that “nucleotide supplementation may support weight gain in humans, and in particular infants”.[77] In my view this is not sufficient to render the use of a uridine source in a composition comprising the defined combination of integers and administered without essentially increasing daily caloric intake when seeking to support weight maintenance or gain in an older population obvious. For at least this reason I am not satisfied that the evidence establishes that a skilled person would, as a matter of routine and in light of the common general knowledge alone, arrive at the presently claimed invention.
[77] Rowan at 5.2.1.
The Opponent has not established that the claims lack inventive step in light of the common general knowledge alone.
Inventive step in light of the prior art documents
The SGP identifies each of D1-D9 and A1-A5 as relevant to inventive step. As I have discussed above, D1-D4 do not form part of this opposition. The particulars in relation to D5 are as follows (the SGP includes corresponding particulars in relation to D6-D9 and A1-A5):
“(i) The applicant does not assert or claim any inventiveness in particular quantities of the claimed active ingredients identified in the claims as (i) to (iv).
(ii) The applicant does not assert or claim that the increase/maintenance of body weight without essentially increasing daily caloric intake is a result of anything other than a mere combination of the claimed active ingredients.
(iii) Accordingly the invention must lie simply in the combination of the claimed active ingredients.
(iv) D5 discloses use of a combination of active ingredients that falls within the scope of the claim.
(v) Any differences between D5 and what is claimed in the opposed application are not inventive.”
In considering novelty I have discussed the differences between the present claims and D5-D9. As noted previously, Ms Rowan indicated in relation to D6 (and A2), D8 (and A4) and D9 (and A5) that the products are intended to be meal replacements and would therefore be administered to a human in a diet without essentially increasing daily caloric intake,[78] but Dr Broersen disputed that such administration would be inevitable, and also noted the lack of specific directions to administer the compositions to an elderly person.[79]
[78] Rowan at 7.6, 7.11, 7.16.
[79] Broersen at [60]-[64].
There is no evidence to support a proposition that a person skilled in the art would, as a matter of routine when seeking to formulate a composition for the maintenance or increase of body weight in an elderly human, modify the products of D5-D9 to include the requisite components of the claimed composition, including a uridine source and DHA, and use the resulting composition without essentially increasing daily caloric intake. In the absence of any such evidence the Opponent’s case in relation to these documents, or correspondingly A1-A5, cannot succeed.
The Opponent has not established that the claims lack inventive step.
Support
Subsection 40(3) as amended by the Raising the Bar Act requires that the claims must be supported by matter disclosed in the specification. The requirement of support can be summarised as requiring that the scope of the claims “should correspond to the technical contribution to the art”.[80]
[80] Fuel Oils/EXXON (T409/91) [1994] OJ EPO 653 at 659.
The requirement of support has been more fully explained as follows:
“in other words it is the definition of the invention in the claims that needs support. In the Board’s judgement, this requirement reflects the general legal principle that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified. This means that the definitions in the claims should essentially correspond to the scope of the invention as disclosed in the description. In other words, as was stated in Decision T 26/81, the claims should not extend to subject-matter which, after reading the description, would still not be at the disposal of the person skilled in the art. Consequently, a technical feature which is described and highlighted in the description as being an essential feature of the invention, must also be a part of the independent claim or claims defining this invention”.[81] (emphasis in the original, citations omitted)
[81] Fuel Oils/EXXON (T409/91) [1994] OJ EPO 653 at 659-660.
To determine whether the requirements of support are satisfied the following steps were set out in CSR Building Products Limited v United States Gypsum Company[82]:
“i. construe the claims to determine the scope of the invention as claimed,
ii. construe the description to determine the technical contribution to the art, and
[82] [2015] APO 72 at [115].
iii. decide whether the claims are supported by the technical contribution to the art.”
The SGP states that the experimental data in the patent specification do not support the claimed invention. Specifically, the SGP identifies as a first point:
“The experimental model (number of mice, formulation of control and enriched diet, standard deviation in results etc) used for examples 1, 2, 3, 4, 5, 9, 10, 11, and 12 is insufficiently disclosed to determine the significance of the experimental results or to reasonably predict these results would be seen in humans.”
and as a second point:
“Without disclosure of the mechanism of action by which the claimed active ingredients produce weight gain in mice without an increase in caloric intake, it cannot be reasonably predicted these results would be seen in humans.”
In support of this ground Ms Rowan stated:
“I doubt that simply administering to an otherwise healthy person with no nutritional deficiencies a combination of nutritional components while not at the same time increasing the caloric intake of that person will result in weight gain. The person’s weight might be maintained, because the nutritional components are in fact having no effect on the person, but that is not an invention.
If a person were suffering from some kind of nutritional deficiency, perhaps as a result of illness or age, then improving their health through nutritional supplementation would be very likely to lead to a degree of weight gain, even without an increase in caloric intake.”[83]
“The promised effects are based on experiments with mice. The examples in the opposed patent refer to compositions for administration to humans, but there is no data from experiments with humans.
Results from experiments using mice cannot be directly extrapolated to humans. This is particularly true where there is no data about the model. You cannot predict based on a mouse model alone that you will see the same result in a human.”[84]
[83] Rowan at [8.1]-[8.2].
[84] Rowan at [8.4]-[8.5].
Dr Broersen in contrast considered that in vivo experiments with mice are sufficient to demonstrate the benefits of the defined compositions.[85]
[85] Broersen at [119].
Following the steps for considering support set out above, I understand the scope of the claims to encompass administration of a composition comprising at least a uridine source, DHA, a B vitamin and a phospholipid to a person aged 50 or more and without essentially increasing daily caloric intake, wherein the administration results in maintenance of weight or weight gain.
I have previously discussed what the specification discloses. To summarise, the specification indicates that weight loss and lean body mass loss are normal, if undesirable, effects of aging and accordingly presents the need for a composition to enable weight maintenance or gain in an elderly population without the need for increased food consumption. The specification then describes a composition comprising combinations of the components defined in the claims as meeting this need. There are examples that demonstrate that various combinations of the components claimed results in weight gain in mice when compared with an isocaloric diet not including those components.
It appears that the question raised by the Opponent is effectively whether the technical contribution to the art is a composition that promotes weight gain in mice, or a composition that promotes weight gain in mammals generally, and in particular humans. The specification refers generally to mammals, and it is clear from the specification as a whole that the invention described relates to compositions primarily for use in elderly humans. The specification clearly asserts that the examples relating to mice are relevant to that invention. The Opponent has provided no evidence or logical basis for concluding that the examples provided in the specification cannot provide a plausible basis for predicting that corresponding results would be observed in humans. I note that the mice used in the examples were 3 months old at the start of the experiments. The limitation of the claims to an elderly population was introduced during the opposition and the Opponent did not file any evidence specifically directed to the adequacy of the mouse model in relation to an elderly population. In the absence of any evidence to the contrary I accept that the mouse model is an adequate model for an elderly human, and I agree with the Applicant that it is, in general, not necessary to provide data in humans for subject matter related to the treatment of humans to be enabled.[86] Further, while I accept that limited experimental detail regarding the examples has been provided, I can see no basis to conclude that that renders the results meaningless. I consider that the examples support a view of the technical contribution to the art as a composition comprising certain combinations of the components defined in the claims that can result in weight gain in mammals without increasing caloric intake. From the context of the specification, I consider that the technical contribution to the art can be generalised to the use of such a composition to increase weight or maintain weight in a population of mammals, particularly humans, at risk of weight loss, without the requirement for increasing caloric intake.
[86] This is consistent with the comments of Neuberger J in relation to Swiss-type claims that “in general, relatively rudimentary tests will do” (to provide support): Prendergast’s Applications [2000] RPC 446 at 450. I note that the Applicant provided with its submissions documents supporting the use of mouse models for treatments ultimately aimed at humans (Applicant’s submissions at [249]-[251]), but I have not found it necessary to have regard to these documents under regulation 5.23.

The claims define weight maintenance or gain without increasing caloric intake in a population at risk of weight loss, i.e. elderly people, using a composition comprising a specific combination of components shown in the specification to result in weight gain in mice. It follows that I am satisfied that the scope of the claims is supported by the technical contribution to the art and the Opponent has not established that the claims lack support.
Clear enough and complete enough disclosure
Paragraph 40(2)(a) as amended by the Raising the Bar Act requires that the claimed invention be described in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art.
It is clear that this provision requires the person skilled in the art must be able to perform the invention across the scope of the claim without undue burden or inventive skill.[87] A Deputy Commissioner recently considered paragraph 40(2)(a) in Evolva SA[88], and having reviewed recent cases adopted the following approach to assessing a clear enough and complete enough disclosure:
“What is the scope of the invention as claimed?
What does the specification disclose to the skilled person?
Does the specification provide an enabling disclosure of all the things that fall within the scope of the claims, and in particular:
(a) Is it plausible that the invention can be worked across the full scope of the claim?
(b) Can the invention be performed across the full scope of the claim without undue burden?”
[87] Novartis AG v Johnson & Johnson Medical Limited [2010] EWCA Civ 1039 at [74].
[88] [2017] APO 57 at [45].
The SGP sets out the following particulars in relation to this ground:
“(i) The applicant does not assert or claim any inventiveness in particular quantities of the claimed active ingredients identified in the claims as (i) to (iv).
(ii) The applicant does not assert or claim that the increase/maintenance of body weight without essentially increasing daily caloric intake is a result of anything other than a mere combination of the claimed active ingredients.
(iii) If there are other features needed to achieve the promise of the invention, then these have not been disclosed and the skilled person does not have sufficient information to perform the invention without more than reasonable experimentation.”
Based on the particulars, I understand the Opponent’s case to be that if there are features that have not been disclosed that are necessary to achieve the claimed result then the disclosure is insufficient. However, the Opponent has not suggested what those features might be or provided any evidence or logical basis to conclude that this is the case.
Following the approach to sufficiency set out above, I understand the scope of the claims to encompass administration of a composition comprising at least a uridine source, DHA, a B vitamin and a phospholipid to a person aged 50 or more and without essentially increasing daily caloric intake, wherein the administration results in maintenance of weight or weight gain. I have discussed above what the specification discloses. I will add here that the specification provides preferred dosages of the defined active components, and I note that example formulations are disclosed, as are examples of administering a composition according to the claims to mice resulting in weight gain.[89]
[89] Examples 3, 4, 9, 10.
In considering whether it is plausible that the invention can be worked across the full scope of the claims the extent of the Opponent’s evidence appears to be Ms Rowan’s statement to the effect that she doubts that administering a combination of nutritional components to a person with no nutritional deficiencies and without increasing caloric intake would result in weight gain.[90] However, it is apparent from the examples in the specification that administration of the claimed combination to mice results in weight gain compared to an isocaloric diet without the combination, and there is no evidence to support Ms Rowan’s doubts. There is also no evidence as to what would be considered reasonable experimentation in the art, or what level of experimentation would be required to carry out the invention across its full scope. To the extent that there is evidence in this regard Dr Broersen has indicated that “[c]ompositions akin to those disclosed and utilised in the application, can be formulated by a person skilled in the technical area” and “sufficient information is provided in the description in order to me [sic] to produce a viable composition that can be used in line with the claimed process.”[91]
[90] Rowan at 8.1.
[91] Broersen at [38].
It follows that the Opponent has not established that on the balance of probabilities the specification does not provide a clear and complete enough disclosure of the claimed invention.
Utility
Subsection 18(1) of the Act requires that the claimed invention be useful. The principles of utility were recently summarised by the Full Court of the Federal Court in Artcraft Urban Group Pty Ltd v Streetworx Pty Ltd[92] (with references omitted):
“The ‘basic principle’ of inutility is that if an invention ‘does what it is intended by the patentee to do, and the end attained is itself useful, the invention is a useful invention’. What the invention is ‘intended’ to do is a matter to be gathered from ‘title and the whole of the specification’.
Put another way, the two questions are: first, what is the promise of the invention derived from the whole of the specification?; second, by following the teaching of the specification, does the invention, as claimed in the patent, attain the result promised for it by the patentee? Further, ‘everything’ that is within the scope of a claim must be useful, that is, attain the result promised for the invention by the patentee.”
[92] [2016] FCAFC 29 at [120]-[121].
Furthermore, section 7A of the Act provides that for an invention to be considered useful the specification must disclose a specific, substantial and credible use for the invention. This requirement was introduced in the Raising the Bar Act and is elaborated on in the Explanatory Memorandum[93] (with references omitted):
[93] Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth), pages 44-45.
“The intent is that specific, substantial and credible be given the same meaning as is currently given by the US courts and the United States Patent and Trade Mark Office (USPTO).
Currently, the US courts interpret the terms as follows:
·‘specific’ means a use specific to the subject matter claimed and can ‘provide a well-defined and particular benefit to the public.’
·‘substantial’ means the claimed invention does not require further research to identify or reasonably confirm a ‘real world use’. ‘An application must show that an invention is useful to the public as disclosed in its current form, not that it prove useful at some future date after further research’.
·an asserted use will be ‘credible’ ‘unless there is evidence that the invention is inoperative (i.e. does not operate to produce the results claimed by the patent application) or there is reason to doubt the objective truth of the statements in the specification.’
The relevant principles are set out in more detail by the USPTO.
The amendment will strengthen the test for usefulness and prevent the speculative claiming of inventions that would require further experimental effort before they could be put into practice.”
The SGP sets out the following particulars in relation to this ground:
“(i) The applicant does not assert or claim any inventiveness in particular quantities of the claimed active ingredients identified in the claims as (i) to (iv).
(ii) The applicant does not assert or claim that the increase/maintenance of body weight without essentially increasing daily caloric intake is a result of anything other than a mere combination of the claimed active ingredients.
(iii) If there are other features needed to achieve the promise of the invention, then the claims lack utility over part of their scope.”
I therefore understand the basis of this ground of opposition to be that if the combination of components defined in the claim is insufficient in itself to achieve the result of weight maintenance or increase without essentially increasing daily caloric intake, then the claims lack utility insofar as they encompass compositions that will not achieve that result.
Ms Rowan’s evidence in relation to this ground is the same as set out above in relation to support.
The Applicant submitted that the present application “sets out a need for providing compositions that can help subjects maintain or increase their weight to help with an acceptable standard of living.”[94] I am satisfied that a reasonable construction of the promise of the invention is the provision of compositions that result in maintenance or increase in weight in humans aged 50 or more.
[94] Applicant’s submissions at [224].
The Examples demonstrate the efficacy of the combination of components in increasing weight in mice relative to an isocaloric diet not including those components. The Opponent has provided no evidence or logical basis to support the assertion that the claims may lack utility across their scope. Insofar as the Opponent’s concerns regarding mouse models could be considered to support an assertion that the disclosed use is not substantial or credible, I would repeat my comments made on that subject in relation to the support ground.
It follows that the Opponent has not established on the balance of probabilities that the claims lack utility, either on the basis that the claims do not achieve the promise of the invention, or that the specification does not disclose a specific, substantial and credible use.
Conclusion
The opposition fails on all grounds.
Costs
It is usual in matters before the Commissioner that costs follow the event and the Applicant has submitted that it should be awarded costs at scale. Where there have been amendments during the opposition the Commissioner may award costs against the applicant up to the date of allowance of the amendments and against the opponent after that date, if the amendment can reasonably be seen to have been made as a result of the opposition. However, in the absence of any submissions from the Opponent in that regard I am not satisfied that such a course of action is appropriate in this case. I will award costs according to Schedule 8 against the Opponent.
Dr S. J. Smith
Delegate of the Commissioner of Patents

Annex A: The claims
1. Use of a composition comprising at least four components selected from the group of: (i) a uridine source; (ii) n-3 polyunsaturated fatty acids selected from the group of DHA, DPA and EPA; (iii) vitamins B selected from the group of vitamin B6, vitamin B9 and vitamin B12; (iv) phospholipids; (v) antioxidants selected from the group of vitamin C, vitamin E and selenium; and (vi) cholines, with the proviso that at least: (i) one uridine source, (ii) DHA, (iii) one vitamin B and (iv) one phospholipid is present, for increasing or maintaining the body weight of a human, wherein the composition is administered to the human in a diet without essentially increasing the daily caloric intake of the human, said human being an elderly person of the age of 50 or more.
2. The use according to claim 1, wherein the increase or maintenance in body weight comprises one or more of: (i) increasing or maintaining lean body weight and (ii) increasing or maintaining muscle mass.
3. The use according to claim 1 or 2, wherein the use comprises increasing or maintaining the body mass index.
4. The use according to any one of claims 1-3, wherein the composition comprises at least one of (v) antioxidants and (vi) cholines.
5. The use according to any one of claims 1-4, wherein the human is non-frail and/or does not have dementia.
6. The use according to any one of claims 1-5, wherein the human is above 65 years of age.
7. The use according to any one of claims 1-6, wherein the human, who when starting with the use, has had a weight loss of 2-4.5 kg in the year preceding the start or 4-6 kg in the two years preceding the start.
8. The use according to any one of claims 1-7, wherein the uridine source is UMP.
9. The use according to any one of claims 1-8, wherein the phospholipid is selected from the group consisting of phosphatidylserine, phosphatidylinositol, phosphatidylcholine and phosphatidylethanolamine.
10. The use according to any one of claims 1-9, wherein the components are administered to the human as part of a nutritional composition.

Evidence	Declarant	Exhibits	Declaration Date	Reference
In Support	Angela Rowan	-	7 February 2017	Rowan
In Support	Christine Lennon Buchan	CLB-1 to CLB-9	7 February 2017	Buchan
In Answer	Ladislaus Maria Broersen	EIA-1 to EIA-2	1 May 2017	Broersen