Fonterra Co-operative Group Limited v Nestec S.A - [2017] APO 18

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Fonterra Co-operative Group Limited v Nestec S.A. [2017] APO 18

Patent Application: 2012203568

Title:Oligosaccharide mixture

Patent Applicant: Nestec S.A.

Opponent: Fonterra Co-operative Group Limited

Delegate: Dr Leslie F. McCaffery, Deputy Commissioner of Patents

Decision Date: 18 April 2017

Hearing Date: 31 January 2017, in Sydney

Catchwords: PATENTS - section 59 – opposition to the grant of a patent – grounds of clarity, full description, fair basis, novelty, inventive step – section 40 – claim 8 found to lack clarity and fair basis – claim 1 clear and fairly based – the invention is fully described – novelty – citations do not disclose all the features of the claims – inventive step – lack of inventive step not established – amendment of the statement of grounds and particulars – relevant considerations of the prospect of undue prejudice, timing and reasonableness of the request, and the public interest weighs against the request – request for amendment of the statement of grounds and particulars refused – costs awarded – applicant provided 2 months from the date of the decision to propose suitable amendments to address the issues identified in claim 8.

Representation: Counsel for the applicant: Mr Patrick Flynn
Patent attorneys for the applicant: Mr Paul Harrison and Ms Katrina Crooks of Shelston IP
Counsel for the opponent: Mr Andrew Fox
Patent attorneys for the opponent: Mr Denis Tuffery and Ms Helen Bellchambers of AJ Park

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: 2012203568

Title:Oligosaccharide mixture

Patent Applicant: Nestec S.A.

Date of Decision: 18 April 2017

DECISION

The opposition is unsuccessful on the grounds argued at the hearing by Fonterra Co-operative Group Limited. Claim 8 found to lack clarity and fair basis. Nestec S.A given 2 months from the date of this decision to propose amendments to address these issues. Costs according to Schedule 8 awarded against Fonterra.

REASONS FOR DECISION

Background

Application 2012203568 (the present application) was filed on 19 June 2012 by the applicant, Nestec S.A (Nestec). It is a divisional application of 2006215603 (the parent application) which was filed on 21 February 2006 under the provisions of the Patent Cooperation Treaty. The parent application claimed priority from EP 05075420.9 which was filed on 21 February 2005. The parent application lapsed without gaining acceptance. No challenge was raised against the priority claim and I therefore accept this as being the priority date of the present application.

The present application was examined and eventually advertised as accepted by the Commissioner on 19 February 2015. An opposition under section 59 of the Patents Act 1990 (the Act) was subsequently filed by Fonterra Co-operative Group Limited (Fonterra) on 19 May 2015.

The statement of grounds and particulars sets out the following grounds of opposition: novelty, inventive step, patentable invention, manner of manufacture, full description, clarity and fair basis. At the hearing Fonterra pressed the grounds of novelty, inventive step, full description, clarity and fair basis. However Fonterra acknowledged that their submissions in relation to most of the grounds were pursuant to certain terms being found to lack clarity.

An amended statement of grounds and particulars was filed on 17 January 2017. Nestec objected to this amendment, and the Commissioner advised the parties that it would be considered at the hearing. This is further discussed below.

The hearing to decide the opposition was held on 31 January 2017 in Sydney at the offices of Shelston IP. Fonterra was represented by Mr Andrew Fox and Nestec was represented by Mr Patrick Flynn.

Onus

The request for examination for the present application was filed on 21 December 2012. Accordingly substantive amendments of the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent if satisfied on the balance of probabilities that a ground of opposition exists. Any subsequent reference to sections of the Act relate to the Act prior to amendment by the Raising the Bar Act.

The onus of proof in this opposition therefore lies with the opponent who must establish that it is clear that a valid patent cannot be granted.[1]
[1] F Hoffman-La Roche AG v New England Biolab Inc. (2000) 50 IPR 305 at [67]; Commissioner of Patents v Sherman (2008) 79 IPR 426 at [18].

Evidence

The parties relied on evidence from a number of declarants:

Evidence in Support consists of declarations from Professor Richard Hamilton Archer (Archer), Dr Ross Crittenden (Crittenden), Dr Lynley Ngaio Drummond (Drummond 1), Dr Christopher Paul McJarrow (McJarrow 1), and Dr Martin J Playne (Playne).

Evidence in Answer consists of declarations from Dr Patricia Lynne Conway (Conway) and Mr Kenneth John McNaught (McNaught).

Evidence in Reply consists of declarations from Mr Denis Eng Tuffery; Dr Drummond (Drummond 2); and Dr McJarrow (McJarrow 2).

I will refer to the relevant parts of the evidence as required.

Amendment of the Statement of Grounds and Particulars

10. The request of 17 January 2017 for amendment of the statement of grounds and particulars sought to introduce:

Additional particulars under the ground of novelty and specifically inclusion of documents D2 to D4. These documents had originally been particularised under the ground of inventive step only.
An additional prior use: “Use by Ildong Foodis on Infant formula supplied by Fonterra produced in New Zealand”. This prior use related to the content of infant formulas “True Mom Step 1” and “True Mom Step 2” (hereinafter A3).
Additional particulars under lack of sufficiency, and specifically that the specification does not provide adequate teaching as to (a) what the oligosaccharide profile of human milk was (with any precision), and (b) what the oligosaccharide profile of the mixture may be, or how an oligosaccharide profile closer to human milk is to be achieved.

11. Regulation 5.16 provides that an opponent may request to amend their statement of grounds and particulars to:

Correct an error or omission in the grounds of opposition;
Update the grounds of opposition to reflect an amendment to the patent request or complete specification to which the statement relates; or
Amend the facts and circumstances forming the basis for the grounds.

12. Subregulations 5.16(3)(a) and 5.16(3)(b) preclude amendment of the statement of grounds and particulars in certain circumstances but none of these apply to the present case so I will not discuss these any further. An amendment will otherwise be made provided it is appropriate to do so. Relevant considerations in this regard include:

The prospect of undue prejudice to a party;
The timing of the amendment request and the reasonableness of the explanation of the delay;
The public interest – noting that a correct determination of the opposition is one based on the issues properly raised in the opposition proceedings. [2]

[2] CSL Limited v Isconova AB et al. [2016] APO 82.

13. In the present case the stated purpose of the amendment was to align the statement of grounds and particulars with the opposition submissions.

14. Documents D1 to D4 were set out in the original statement of ground and particulars. Nestec would arguably have been aware relatively early of the nature of the case they had to answer in the opposition and therefore would not have been unduly prejudiced by the amendment. But on closer consideration I note that only D1 was particularised under novelty. D2 to D4 were particularised under inventive step only.

15. Furthermore, Dr Drummond discussed D2 and D3 in her first declaration, but it is unclear from her statements as to whether she considered these documents novelty destroying. In particular she concludes that it is not possible for the levels of oligosaccharides and b-galacto-oligosaccharides (GOS) to be compared in D2 and that D2 and D3 (in addition to some other documents) would have been referred to her by their information supply service.[3] These comments are not consistent with a novelty case. Dr Conway and Mr McNaught were each asked to review D1 to D4 and provide a comparison with the application in their evidence in answer, but while they addressed the ground of novelty this was not specifically in relation to any case forwarded by Fonterra.[4] They also addressed some of the specific comments made by Dr Drummond in relation to D1 to D3.[5]

[3] Drummond 1 at [134] to [142].

[4] Conway at [53] to [66], McNaught at [34] to [46].

[5] Conway at [94] to [96], McNaught at [84] to [86].

16. A3 was first raised by Dr Drummond in Evidence in Support as exhibit LND-12.[6] Dr McJarrow also discussed A3 in his first declaration, as well as another product Sialyl Oligolac.[7] However in my opinion these statements are in the nature of a discussion of the common general knowledge in relation to the use of GOS in infant formula, rather than specifically relating to the novelty of the present claims. Furthermore, the original statement of grounds and particulars provided two particulars under prior use: use by Maeil Dairies Co Limited and use by New Zealand Milk Products (referred to as A1 and A2 in the original statement). Prima facie, A3 was not given any greater significance than any other background art document provided the opposition proceedings and therefore Nestec would not have been alerted to this document requiring more detailed consideration.

[6] Drummond 1 at [149] to [156].

[7] McJarrow 1 at [19] to [24].

17. The third addition to the statement of grounds and particulars relates to the issue of the oligosaccharide profiles of both human milk and the oligosaccharide mixtures of the invention. At the hearing Nestec questioned whether the oligosaccharide profile of human milk was relevant to sufficiency and argued that the specification gave details as to how to obtain the claimed invention. They also noted that no evidence had been provided to establish that the claimed invention did not work. As discussed further in the decision below, I have found this line of argument to be unsuccessful.

18. In the ordinary run of events an incremental development of the case might be expected as evidence is adduced by the parties and the key points of contention are identified. However, it seems reasonable to me that such developments should occur as early as possible in the opposition process, and ideally the statement of grounds and particulars and evidence should be consistent so that the applicant is in no doubt of the case to be answered in the opposition. This will also ensure that the opposition proceeds more efficiently and delays are avoided as parties are able to concentrate on the key evidence and issues. Prima facie, in the present case Nestec would not have been fully aware of the case they needed to answer in the opposition until the submissions for the hearing and the amended statement of grounds and particulars were received.

19. A consideration that arises from the present circumstances is whether Nestec has suffered undue prejudice as a result of the amendment. I am mindful that not all amendments to particulars give rise to undue prejudice. For example undue prejudice is unlikely to arise where there is no substantial change to the case the applicant has to answer. However, the timing and nature of the present amendment have resulted in a situation where Nestec could only have become fully aware of the case they had to answer when they received Fonterra’s submissions for hearing. For example, while D2 to D4 were raised in the original statement and discussed by the declarants, the case shifted significantly from inventive step to novelty. This was not apparent from the original statement or indeed from any evidence adduced by Fonterra and weighs heavily towards refusal of the request.

20. The public interest and the need for a correct determination of the opposition is a further consideration. Nestec maintained their objection to the amendment on the basis that the material was not relevant and to this end the parties agreed to proceeding with the submissions at hand in order to make an assessment of the relevance. The gist of Fonterra’s argument was that certain terms used in the claims lacked clarity, and the novelty and inventive step arguments rested on such a determination. I have been able to construe these terms to have meaning and have found that the opposition in relation to the issues raised by Fonterra to be unsuccessful. Documents D2 to D4 and prior use A3 are not relevant to the grounds raised in the amended statement and therefore do not contribute to a proper determination of the hearing.

21. Finally the timing and reasonableness of the request is a relevant consideration. Fonterra provided no reason for the delay in making the amendment to the statement of grounds and particulars. In any case, the amended particulars are not consistent with the case that was provided in the original statement and that was pursued during the evidentiary stages of the opposition. I therefore consider that the request being made at such a late stage of the opposition process is unreasonable.

22. The weight of the consideration lies with a refusal of the request. I therefore refuse the request for amendment of the statement of grounds and particulars dated 17 January 2017.

The specification

23. Bacteria such as clostridia and bacteroides can cause pathogenic effects such as diarrhoea, infections, liver damage, carcinogenesis and intestinal putrefaction. Beneficial bacteria such as bifidobacteria and lactobacilli can inhibit the growth of harmful bacteria and provide beneficial effects including improved digestion, absorption of essential nutrients and synthesis of vitamins.

24. Immediately before birth the gastrointestinal tract of a baby is thought to be sterile. During birth it encounters bacteria from the mother’s digestive tract and skin and starts to become colonised. There are significant differences in the gut bacteria of breast- and formula-fed babies: formula-fed infants generally have more complex microbiota with bifidobacteria, bacteroides, clostridia and streptococci all usually present, while breast-fed infants generally have appreciable populations of bifidobacteria with some lactobacilli also present. After weaning the pattern of bacteria gradually begins to resemble that found in adults.

25. The specification states that one way of promoting the number and/or activity of beneficial bacteria is through the addition of prebiotics to foodstuffs. Prebiotics are non-digestible substances that selectively stimulate beneficial bacteria.

26. Human milk contains a larger amount of indigestible oligosaccharides than any other animal milk. Over 100 different oligosaccharides have been detected in human milk, many of which are not detected in animal milk or are present in only minor amounts. These include sialylated and fucosylated oligosaccharides. The resistance of these oligosaccharides to enzymatic hydrolysis suggests that they have functions other than providing calorific value. Some indigestible oligosaccharides such as fructooligosaccharides (FOS) and GOS are widely used in products such as infant formula for their prebiotic properties.

27. The specification states that the invention “relates to an oligosaccharide mixture derived from animal milk, food products comprising said oligosaccharide mixture and a process for producing said oligosaccharide mixture.”[8] An object of the invention is to provide an oligosaccharide mixture which is effective as a prebiotic and which has an oligosaccharide profile closer to that of human milk than is provided by mixtures of FOS and GOS.[9]

[8] Specification at page 1a, lines 5 to 7.

[9] Specification at page 4, lines 8 to 11.

28. According to a first aspect the invention is said to provide:

“an oligosaccharide mixture derived from animal milk, the mixture comprising a lactose:oligosaccharide ratio of less than 250 and containing a spectrum of oligosaccharides that is the same as a spectrum of oligosaccharides of milk from which it was derived wherein the mixture further comprises an oligosaccharide:b-galacto-oligosaccharide ratio ranging between 1:2 and 1:20.”[10]

[10] Specification at page 4, lines 15 to 20.

29. The specification indicates that the oligosaccharide mixture having a lactose:oligosaccharide ratio of less than 250 and having the same spectrum of oligosaccharides as the milk from which it was derived is a new protective and immunomodulating ingredient that is structurally closer to human breast milk oligosaccharides. For example they can contain a higher proportion of sialylated oligosaccharides as compared to available prebiotic FOS and GOS mixtures. The low lactose:oligosaccharide ratio is said to have the additional advantage that the oligosaccharide mixture can be added to infant formula and other food products without introducing unnaturally high amounts of lactose.[11]

[11] Specification at page 4a, lines 12 to 23.

30. The specification also states that the oligosaccharide optionally contains GOS, but I note that this component is an essential feature of the claimed invention. The GOS component is said to provide an oligosaccharide profile closer to that of human milk. The oligosaccharide:GOS ratio is preferably in the range between 1:2 and 1:20 and more preferably in the range between 1:2 and 1:6.[12]

[12] Specification at page 4a, line 27 to page 4b, line 4.

31. A second aspect of the invention is a food product comprising such mixtures.[13] A third aspect is said to provide a process for producing an oligosaccharide mixture which, in short, comprises deproteinisation, concentration, lactose removal, and demineralisation.[14] Treatment with a b-galactosidase produces GOS through the breakdown of lactose to galactose and glucose and the subsequent formation of GOS via addition of saccharide units.[15]

[13] Specification at page 5, line 1.

[14] Specification at page 5, lines 9 to 16.

[15] Specification at page 8, lines 11 to 26.

32. The product may be further treated in various ways before being added to food products.[16]

[16] Specification at pages 9 to 11.

33. The description ends with three examples. The first example describes concentration of a whey ultrafiltration permeate to reach a total solid content of 59%. Two lactose crystallisation steps are performed, followed by a demineralisation step. The resulting liquor comprises about 2 grams of oligosaccharides and 70 grams of lactose per 100g total solids.

34. The second example describes treatment of the product of the first example with a b-galactosidase. The concentrations of lactose, glucose, galactose, GOS and oligosaccharides are monitored. These are shown in the following table. The composition shown for Time 0 represents the product of Example 1, while the product shown at Time 3 hours corresponds to the product of Example 2. This is a representative example of the claimed invention.

% Dry matter	Lactose	Glucose	Galactose	OS	GOS
Time 0	70	3	5	2	0.7
Time 3 hours	29	12	11	2	10

35. Example 3 describes an infant formula comprising the oligosaccharide formula of the invention. In addition to other typical ingredients, the formulation contains 1g per litre of the concentrated oligosaccharide material from Example 1 and 5 grams of the GOS-enriched material from Example 2.

36. The specification ends with 20 claims. Claim 1 defines an oligosaccharide mixture and is discussed in greater detail below. Claim 6 defines food products comprising such mixtures. Claim 8 defines methods of preparing the mixtures and is also discussed in greater detail below.

Construction: legal principles

37. The submissions at the hearing focussed on the clarity of certain terms in the claims. Indeed this was the keystone of Fonterra’s case – they acknowledged that if the claims were found to be clear in meaning then other grounds of opposition were unlikely to be successful.

38. The principles of construction are well established. As Middleton J stated:

“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.”[17]

[17] Eli Lilly and Co Ltd v Apotex Pty Ltd [2013] FCA 214; 100 IPR 451 at 482 [139].

39. Middleton J went on to provide a useful summary of relevant principles:[18]

[18] Ibid at [143].

a patent is a public instrument which must, if it is to be statutorily valid, define a monopoly which is not reasonably capable of being misunderstood;
the Court, when reading the entire patent specification, must place itself in the position of a person who is skilled in the relevant art, given their general knowledge, and the common general knowledge and the state of the art that existed before the priority date of the patent;
the words used in a specification, including the claims, are to be construed from this standpoint in a “commonsense” and not abstract manner;
what is disclosed in the body of the specification will also assist the skilled person in the art to understand the claims, bearing in mind that a patent is a unilateral document and the patentee has chosen particular words to describe the invention;
the claims define the monopoly claimed by the patent;
terms which are unclear in the claims may be defined or clarified by reference to the body of the specification;
language which has no positive meaning in the claims may become clear when the specification is used as a “dictionary” for the jargon in the claims; and
that said, given the special function of the claims, it is impermissible to read into a claim an additional integer, or otherwise vary the scope of the claim by reference to the body of the specification.

40. Middleton J also cautioned that:

“It is clear from the above propositions (particularly the latter three points) that the use the Court can make of the body of a specification will vary from case to case. As Apotex submitted, there is a fine line between using the specification to construe the claim, and using the specification in such a way that adds an impermissible gloss to the claims.”[19]
[19] Ibid at [144].

41. These are the principles that I will apply in this determination.

The person skilled in the art

42. As indicated above, the specification is construed through the eyes of the person skilled in the relevant art. This is the hypothetical person to whom the specification is addressed.[20] This determination plays a central role in determining the validity of the patent:

“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…”[21]
[20] General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (1971) 1A IPR 121 at 134.
[21] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; 49 IPR 225 at [70] – [71].

43. The person skilled in the art is assumed to be a skilled but unimaginative and non-inventive worker in the field of the invention.[22] A classic formulation describes them as “those likely to have a practical interest in the subject matter of [the] invention”.[23] Notably:

“The identification of the relevant field will, in its turn, determine the characteristics of the notional worker skilled in the art who must provide the answer to the question of whether the invention was obvious. Such characteristics will include the qualifications of the notional worker, the setting in which he or she operates and the practices and techniques that he or she will regard as commonplace and known”.[24]

[22] Minnesota Mining and Manufacturing Co & 3M Australia Pty Ltd v Beiersdorf (Aust) Ltd (1980) 144 CLR 253 at 293.

[23] Catnic Components v Hill & Smith Ltd [1982] RPC 183.

[24] Aktiebolaget Hässle v Alphapharm Pty Limited [2002] HCA 59 at 153; (2002) 212 CLR 411 at 465 [152] to [153].

44. While there are differences in the manner in which the parties characterised the skilled person, I do not consider the differences significant. Nestec submitted that the person skilled in the art is a chemist, biochemist or food nutritionist with qualifications and experience in the field of prebiotics and in particular in the use of oligosaccharides as a prebiotic. Fonterra submitted that the person skilled in the art is a food technologist who had knowledge and experience in the use of oligosaccharides in making milk products.

45. It strikes me from the evidence provided by both parties that a person having a “practical interest” in working the present invention would be aware of the properties of the oligosaccharide mixtures (and especially milk oligosaccharides) and would be seeking to exploit those properties. Furthermore, given the nature of the invention I consider that the skilled person would have knowledge and experience of milk products such as infant formula. Thus I consider the skilled person to be a chemist, biochemist or food nutritionist working in the field of milk products with a knowledge of the properties and use of oligosaccharides in food products.

46. In the present case evidence was provided by a number of declarants:

Dr Richard Archer is a Professor and Head of the Institute of Technology and Engineering at Massey University in New Zealand. Prior to this he was a Development Manager at FonterraTech and Technical Manager with the Lactose Company of New Zealand. His development work at these companies included manufacture of lactose for applications such as infant formula and the bioconversion of lactose to give GOS products.
Dr Ross Crittenden is Senior Vice President – Research and Development and Business Units for Baby Foods, Dairy Powders, Technology Sales & Culture Production at Valio Ltd (Helsinki). He previously held the position of Senior Research Scientist at Food Science Australia (CSIRO) with research interests focussed on use of prebiotic oligosaccharides and probiotic bacteria in foodstuffs including milk products.
Dr Martin Playne is a former colleague of Dr Crittenden at CSIRO, and they co-authored several articles on the production of oligosaccharides and their use in food products (including infant formula). He retired in 1999.
Dr Paul McJarrow has been a Senior Research Scientist at the Fonterra Research and Development Centre since 2006. He was previously a Research Scientist with the New Zealand Dairy Research Institute. He has carried out research and product development using oligosaccharides and galacto-oligosaccharides in food products including infant formula.

Dr Lynley Drummond is the Director of the consultancy businesses ‘Drummond Food Science Advisory Limited’ and ‘PYX Limited’ which assist companies to develop and commercialise nutritional foods. She was previously a Product Development Manager at Fonterra, and Technical Manager at New Zealand Dairy Ingredients. One of her tasks at Fonterra was to manage development and commercialisation of new infant formula products.
Dr Patricia Conway is the Director of a consultancy business ProBiOz Pty Ltd. She has held visiting and adjunct professorial positions at the University of NSW, was Chief Scientist at VRI BioMedical (now Probiomics Ltd), and held various research positions in several Swedish research organisations and CSIRO. Dr Conway’s research interests are listed as gastrointestinal microbiology, probiotics and prebiotic with particular emphasis on bacterial colonization of the gastrointestinal tract and mechanisms of bacterial adhesion, pathogen inhibition and immune modulation on animals and humans.

Mr Kenneth McNaught is the Technical Director of a consultancy business Kasala & Associates Pty Ltd. He has previously held positions as Director, R&D Food Ingredients Applications Asia Africa Division at Corn Products International and Technical Manager Penford Australia Limited. His research achievements are listed as being in the field of starch chemistry and modified starch technology.

47. At the hearing, Fonterra submitted that neither Dr Conway nor Mr McNaught had direct experience with milk processing, infant formula, oligosaccharides in general or GOS in particular. On the face of it there does seem a reasonable basis for this assertion – while Dr Conway and Mr McNaught provided evidence as to the state of the art in milk oligosaccharides at the priority date, none of this appeared to be from direct experience. Indeed Dr Drummond and Dr McJarrow in their second declarations highlighted what they considered were errors in their declarations and opined that these may have resulted from a lack of practical experience.[25]

[25] See for example Drummond 2 at [15], [20], [23] and [32], McJarrow 2 at [3].

48. However I note that the skilled person may comprise a team of workers, each with their own area of expertise and knowledge. The experience of Dr Conway and Mr McNaught in gastrointestinal microbiology and prebiotics does appear relevant in this regard. I am therefore satisfied that I can have regard to their evidence. Nevertheless where there is conflicting evidence I will appropriately evaluate and weigh the evidence in order to resolve that conflict.

Construction and Section 40 issues

Construction of claim 1

49. Claim 1 is as follows:

An oligosaccharide mixture derived from animal milk, the mixture comprising a lactose:oligosaccharide ratio of less than 250 and containing a spectrum of oligosaccharides that is the same as a spectrum of oligosaccharides of milk from which it was derived, wherein the mixture further comprises an oligosaccharide:b-galacto-oligosaccharide ratio ranging between 1:2 and 1:20.

50. Fonterra argued that the claims lacked clarity and as a consequence the claims could not be considered to disclose a best method or define the alleged invention.

51. A claim will lack clarity if a third party cannot ascertain whether a proposed action would fall within the ambit of a claim.[26] Fonterra’s submissions in relation to this ground focussed on several features as set out below.

[26] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59.

Definition of oligosaccharides and the ratio of oligosaccharide:GOS

52. As an initial point, Fonterra noted that the specification uses both the terms galacto-oligosaccharides and b-galacto-oligosaccharides interchangeably. They submitted that the majority, if not all, commercial products at the priority date were b-galacto-oligosaccharides. I note as well that throughout the specification and evidence (and indeed this decision) the shorthand reference, GOS, is also used. I do not see this as a major issue, and consider that these two terms can be read in the context of the specification as referring to the same thing.

53. The term “oligosaccharides” is defined in the specification as those found naturally occurring in animal milks and having a degree of polymerisation (DP) ranging from 3 to 20 inclusive. This means, for example, that disaccharides such as lactose are not included in the definition of oligosaccharides.

54. Fonterra submitted that galacto-oligosaccharides are oligosaccharides that comprise two or more galacto groups and they therefore fall within the scope of the term oligosaccharides. A clear consequence of this construction is that if the term oligosaccharide includes GOS then as a matter of logic there can never be a product in which there is more GOS than oligosaccharide as required by the ratio of between 1:2 and 1:20.

55. Where there is more than one alternative meaning then a construction according to which the invention will work is generally to be preferred to one according to which it may not do so.[27] As submitted by Fonterra, the interpretation of the term oligosaccharide as including GOS results in an illogical result, so I consider it reasonable that the skilled person having the intention to make the invention work would not read it in this way.

[27] Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1997) 39 IPR 56.

56. The oligosaccharides present in the starting milk are supplemented with GOS by treatment of the reduced-lactose material with a b-galactosidase. The terms for the original oligosaccharides and GOS are used exclusively of one another throughout the specification and there is otherwise nothing to suggest that the terms should be read inclusively. I therefore construe the term oligosaccharide as being exclusive of GOS.

“comprising a lactose:oligosaccharide ratio of less than 250”

57. Fonterra argued that this was meaningless as a ratio requires two amounts to be provided and also needs to identify the units being compared (weight, mass, molar or energy).[28]

[28] McJarrow 2 at [56] and [65].

58. Nestec noted that there was no suggestion of any lack of clarity in this reference by Dr Drummond or Dr McJarrow in their first declaration and their statements in relation to the ratio were essentially directed at the arbitrary choice of the limit and the difficulties in obtaining an accurate analysis of oligosaccharide components.[29] Fonterra acknowledged this at the hearing but submitted that while the experts could work out what was meant if an opportunity was given to amend then Nestec should take it.

[29] Drummond 1 at [106] to [124], McJarrow 1 at [7].

59. Under the circumstances I am satisfied that the scope of the term is clear. Construing the term with reference to the specification I understand the ratio to be less than 250:1 based on a % weight measurement.

Spectrum of oligosaccharides

60. Claim 1 includes the feature of “containing a spectrum of oligosaccharides that is the same as a spectrum of oligosaccharides of milk from which it was derived”.

61. Fonterra noted that the term “spectrum” is not defined in the specification, and there is a base question of whether the term was used in a “qualitative” or “quantitative” manner. In this regard, qualitative means that the same oligosaccharides are present while quantitative means that the same relative amounts of the oligosaccharides are present.[30]

[30] McJarrow 2 at [57].

62. There was general agreement between the declarants that the term “spectrum” is not commonly used in the art. For example, Dr Archer[31] stated that:

“[S]pectrum is not a term I have heard used in this context before but it does not sound strange.”

[31] Archer at [15].

63. Dr Archer does not appear to have been provided with the specification but when asked what he would understand from the phrase “a spectrum of oligosaccharides that is the same as a spectrum of oligosaccharides of milk”, he discussed the distribution of molecular weights and the different substitutions and charges associated with milk oligosaccharides:

“[w]hen I first thought (sic) heard the term ‘spectrum of oligosaccharides’ I thought about the range of oligosaccharide molecular weights that are found in milk…

I also consider that the term ‘spectrum’ encompasses the charge of the oligosaccharides. Milk oligosaccharides have a range of substituents and charges, e.g. neutral, phosphorylated, sialylated. Charged oligosaccharides will very likely be affected if ion-exchange is used to demineralise the permeate or mother liquor, i.e. the charged oligosaccharides may be (inadvertently) taken out of the permeate or mother liquor.

There is a third possible shade of meaning: from forms of GOS generated by the cow to those generated enzymatically (probably from extracellular microbial enzymes) or as microbial metabolites. It is easily conceivable that all forms might be present in mother liquor and thus also represent a ‘spectrum’.

Therefore I consider that the term ‘spectrum of oligosaccharides’ used in the context described to me would mean that the oligosaccharides in the final product would have the same chemical type, charge and distribution as the original milk.” [32]

[32] Archer at [16] to [19].

64. I take this to mean that Dr Archer understood the term to have only a qualitative meaning. On the other hand, Dr Drummond considered the term “spectrum” meant that:

“the range of different OS would remain the same as that in the starting milk so that none of the individual OS would be selectively increased or decreased”.[33]

[33] Drummond 1 at [96].

65. At first blush I read this to mean that the “range” of oligosaccharides in the starting material and the final product remain the same. However the further definition “so that none of the individual OS would be selectively increased or decreased” suggests Dr Drummond reads the term to indicate an amount that is present, rather than a group of different oligosaccharides. This is reinforced in Dr Drummond’s second declaration wherein she states:

“[T]he relative amounts of oligosaccharides don’t change if you are just concentrating the milk (the process described in the specification). Therefore, in the absence of any further processing steps, I would expect the relative amounts of the oligosaccharides to stay the same”.[34]

[34] Drummond 2 at [10].

66. Dr Conway and Mr McNaught took a different approach and simply applied a plain English meaning to the term. This would certainly be consistent with the principle of construction that as a general rule the terms of the specification should be given their ordinary English meaning.[35] For example Mr McNaught stated that:

“In my view, while the term ‘spectrum’ may not have been used extensively in the dairy industry, it is a common English word generally applied when one is looking at a range of items. It is often used in ordinary language to refer to a range of materials each differing slightly from the previous one though still having some commonality. In this case, a ‘spectrum of oligosaccharides’ simply means ‘a range of oligosaccharides’”.[36]

[35] Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331 at [81].

[36] McNaught at [87].

67. However, Dr McJarrow questioned that such a conclusion could be made, noting that:

“The Concise Oxford Dictionary (9^th ed) states that spectrum means ‘the entire range of anything arranged by degree or quality’. This shows that there is an option for ‘spectrum’ to be given a qualitative and/or quantitative meaning.”[37]

[37] McJarrow 2 at [57].

68. I do not dispute that a group of things arranged by “degree” could include them being grouped by quantity. But it does seem to me that if this was the case then an express reference to a quantitative unit would be given. I am also mindful of the need to construe the terms in the claim in context:

“The body of the specification is often of particular importance where the subject matter of the patent is complex. Technical and new matter is difficult to describe, and the words used in the specification will have been specifically chosen, usually after much advice and deliberation by the patentee: Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2004] UKPC 6; (2004) 64 IPR 444 at 454-455 [33] - [34] per Lord Hoffmann. It would be wrong in principle to ignore the body of the specification when considering the claim.

On their own, claims may be isolated so as to be devoid of any meaning. In such a situation, the specification may provide particular meaning as to the ambit of the claims.”[38]

[38] Eli Lilly and Company Limited v Apotex Pty Ltd supra at [150].

69. On balance I am inclined to take a plain meaning to apply in this case: that is, the term spectrum refers to a range, or a group, of different oligosaccharides. This also appears to be consistent with the context in which the term is used throughout the specification. I consider that the term will include oligosaccharides of different molecular weights, charges and substituents as indicated by Dr Archer, but I do not consider that the relative amounts of the oligosaccharides are to be taken into account.

70. At the hearing I also queried that the claim defines “containing a spectrum of oligosaccharides that is the same as a spectrum of oligosaccharides of milk from which it was derived”. In particular, the claim uses the indefinite article (a spectrum… is the same as a spectrum) in reference to the oligosaccharides rather than the definite (the spectrum… is the same as the spectrum). This could potentially be read in two ways: either the mixture contains a single spectrum of oligosaccharides which is essentially the full spectrum of oligosaccharides present in the milk from which it is derived, or alternatively it could be read as the product contains only a subset of particular oligosaccharides present in the milk from which it is derived (for example only sialylated oligosaccharides).

71. None of the declarants found particular issue with this terminology. Indeed all declarants read the claim as requiring the range of oligosaccharides in the product to be the same as the milk from which it was derived, albeit with different views on whether or not the relative amounts of each was necessary. Moreover, there is nothing in the specification to suggest that an alternative interpretation should be taken. On balance I am satisfied that it should be read as being the full range of oligosaccharides (other than GOS as noted above) which is present in the milk from which it is derived rather than any subset of oligosaccharides.

72. In conclusion I have been able to construe claim 1 to give it meaning. Fonterra’s arguments in relation to clarity (and their consequential arguments as to whether the specification discloses a best method or defines the alleged invention) are therefore unsuccessful.

Construction of claim 8

73. Claim 8 is as follows:

“A process for producing an oligosaccharide mixture, the process comprising:

(a)concentrating a deproteinised milk material to 50 to 75% total solids;
(b)subjecting the concentrated milk material to a lactose removal step to produce a liquor having a lactose:oligosaccharide ratio of less than 250; and
(c)demineralising the milk material to produce the oligosaccharide mixture derived from animal milk and having the same spectrum of oligosaccharides from which it was derived,
wherein, the oligosaccharide mixture produced in step (c) comprises an oligosaccharide beta-galacto-oligosaccharide ratio ranging between 1:2 and 1:20.”

74. As an initial point of construction, prima facie (a), (b) and (c) are consecutive steps in the process. However the specification states that:

“The starting material should be a deproteinised product… The starting material can also be demineralised by any known means, for example reverse osmosis, nanofiltration or ion exchange. Alternatively, the demineralisation step can be carried out after the lactose removal step(s) again using any known means”.[39]

[39] Specification at page 7, lines 20 to 28.

75. I therefore interpret the claim as including within its scope processes wherein steps (a), (b) and (c) are consecutive, but also where step (c) may be carried out prior to step (a) or prior to step (b).

76. At the hearing I queried that there is no explicit definition in the claim of a step that produces the GOS. The claim instead defines the ultimate GOS-containing product, and in effect the claim includes any means of providing GOS to the mixture. In response, Nestec submitted that it is not essential that all steps in a process be defined, particularly if those undefined steps are known. This is a reasonable argument where the undefined step is not essential to the claimed invention or where the skilled addressee would read it as being implicit. In my opinion these are key considerations in the present case as they may potentially impact on the clarity and fair basis of the claim.

77. Referring to the evidence I note that the declarants differed as to how they construed this claim. Dr Conway read the last part of the claim to mean that the liquor produced in step (c) is treated with b-galactosidase.[40] Mr McNaught similarly considered that the claimed process included treatment with b-galactosidase, and stated that:

“a distinguishing feature of this process is that it provides for the in situ production of b-galacto-oligosaccharide. As discussed above, prior to February 2005, the widely accepted and common approach was to treat oligosaccharide products as specific additives. Oligosaccharides such as GOS were therefore generally artificially made and to the extent that GOS was added to food, such as infant formula, it was more likely the case that it was the only oligosaccharide (or one of the few) included.”[41]

[40] Conway at [52].

[41] McNaught at [35].

78. In contrast, Dr McJarrow stated that the GOS levels could be mediated through the addition of GOS or alternatively through the in situ production of GOS. He also noted that claim 14 specified the use of a b-galactosidase in the process. This is a salient point – if the claims are construed against redundancy then claim 8 must include methods of providing the desired GOS ratio other than treatment with b-galactosidase. Claim 14 would otherwise be redundant.[42] However, this is only one approach to construction, and a consideration must be made in view of the document as a whole.

[42] McJarrow 2 at [101].

79. To this end the specification generally describes two products. The claims were limited to the second product during examination. The first product is the oligosaccharide mixture comprising a lactose:oligosaccharide ratio of less than 250 and containing a spectrum of oligosaccharides that is the same as a spectrum of oligosaccharides of milk from which it was derived.[43] This product optionally comprises GOS with a oligosaccharide:GOS in the range from 0.01 to 99, and preferably between 1:2 and 1:20.[44] The GOS can be formed using a b-galactosidase prior to concentration of the milk (step (a) above) and/or after the lactose removal step.[45]

[43] Specification at page 4a, lines 12 to 23.

[44] Specification at page 4a, line 27 to page 4b, line 4.

[45] Specification at page 6, lines 6 to 12.

80. The specification then describes the conditions under which the lactose removal step is performed. This provides a liquor which is said to have a ratio of oligosaccharides:lactose which is 2-200 times higher than the milk from which it was derived. The specification goes on to say that:

“The liquor is preferably also treated with b-galactosidase to form b-galacto-oligosaccharides as described above. This results in a second proposed ingredient for food products which comprises milk oligosaccharides as defined above and GOS with a DP [degree of polymerisation] of from 3 to 10.”[46] [emphasis added].

[46] Specification at page 9, lines 16 to 20.

81. A preferred embodiment of this second product corresponds to the mixture presently defined in Claim 1.

82. I read this as meaning that GOS-containing materials may be obtained from the first product by various means (including treatment with b-galactosidase before or after the concentration of the deproteinised milk starting material), but the second product (and the one claimed in the present claims) specifically results from treatment of the lactose-reduced mother liquor with b-galactosidase.

83. Admittedly there is an argument that the GOS could be introduced, as noted by Dr McJarrow, by addition of GOS rather than by treatment with b-galactosidase. However there is no explicit disclosure of the addition of GOS to the first product in order to obtain the second product, and indeed all discussion of the optional inclusion of GOS in the first product involves the use of b-galactosidase.

84. In conclusion I consider that the preparation of the oligosaccharide mixture of the claimed invention requires sequential steps of concentration, lactose reduction and treatment with a b-galactosidase. I do not consider this is clearly defined by Claim 8. As noted above the claim is construed such that the steps (a), (b) and (c) are not necessarily sequential, and the claim does not explicitly define a b-galactosidase treatment step. To read these steps into the words in the claim would, in my opinion, inappropriately import a gloss from the specification.

85. A further consideration that arises from my analysis is whether Claim 8 is fairly based. A claim will lack fair basis if the claims are not consistent with what the specification as a whole describes as the invention. The general principle for fair basis is set out in Kimberly-Clark v Arico as:

“where the issue is one under a 40(3) of ‘fair basing’ of a claim, what the 1990 Act requires is a comparison between the matter described in the specification and the claim which defines the scope of the monopoly”.[47]

[47] Kimberly-Clark Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at 15; 207 CLR 1.

86. The assessment requires a consideration of whether there is a “real and reasonable disclosure” of the invention as defined by the claim,[48] or whether the claims “travel beyond the subject matter of the invention”.[49]

[48] Société Des Usines Chimiques Rhône-Poulenc v Commissioner of Patents (1958) 100 CLR 5.

[49] Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236.

87. As noted above I consider the method of preparing the mixtures according to the invention as described involves the sequential steps of concentration, lactose removal and treatment with a b-galactosidase. The invention claimed in Claim 8 is not limited to such a sequential series of steps and therefore travels beyond the subject matter of the invention.

88. I therefore conclude that Claim 8 lacks clarity and fair basis.

Sufficiency

89. Subsection 40(2) of the Act requires that the specification describe the invention fully, including the best method known to the applicant of performing the invention. The general test for full description is set out in Universal Oil Products:

“The specification is sufficient if the patentee makes the nature of his invention, and how to perform it, clear and intelligible to persons having reasonably competent knowledge of what was known before on the subject to which the patent relates, and having reasonably competent skill in the practical mode of doing what was then known.”[50]

[50] Universal Oil Products v Monsanto (1972) 46 ALJR 658.

90. These requirements are met if it is possible to ascertain the nature of the invention from a reading of the specification as a whole,[51] and provided the description enables the addressee to “produce something within each claim without new invention or additions or prolonged study of matters presenting initial difficulty”.[52]

[51] Welch Perrin and Co Pty Ltd v Worrel (1961-1962) 106 CLR 588.

[52] Kimberly-Clark v Arico (2001) 207 CLR 1 at [25].

91. One of the objects of the invention is to provide an oligosaccharide mixture which is effective as a prebiotic and has an oligosaccharide profile closer to that of milk than provided by mixtures of fructo- and galacto-oligosaccharides.[53] At the hearing Fonterra submitted that the application is deficient in that it contains no disclosure sufficient to understand what the oligosaccharide profile may be and how it may be achieved, nor does it identify the oligosaccharide profile of human milk which is desired.

[53] The specification at page 4, line 8.

92. As noted in Universal Oil Products, whether a specification fully describes the invention is a question of fact that is established by evidence. The gist of Fonterra’s submissions appears to lie in whether the invention is enabled. None of the declarants provided evidence on this point. Perhaps the closest evidence in relation to enablement was provided by Dr McJarrow in his second declaration:

“Dr McNaught, like Dr Conway, attempts to distinguish the GOS products produced in the prior art from those in the claim. However nowhere does he actually refer to any of the GOS or oligosaccharide molecules that supposedly are present in the alleged mixtures of the invention that were not in the prior art.
His comment at the end of paragraph 32 that the objective is to provide a product having a profile closer to that of human breast milk again is not in the claims and how that is achieved is not described.”[54]

[54] McJarrow 2 at [106] to [107].

93. Dr McJarrow did not adduce any evidence to the extent that the claimed invention was not enabled, but rather his comments are directed at the statement in the specification concerning the properties of the claimed product.

94. I do not consider this a relevant consideration in relation to full description. The general nature of the invention may be determined from the specification. The claims define that the spectrum of oligosaccharides in the product are the same as the spectrum in the milk from which it was derived. The specification provides general methods for preparing the mixture, as well as a specific example of an oligosaccharide mixture. Prima facie the requirements for full description have been met, and no evidence was adduced that establishes otherwise.

95. Even if there is a concern about whether or not the oligosaccharide profile of the claimed oligosaccharide mixture is closer to that of human milk, the evidence indicates that the inclusion of GOS in oligosaccharide mixtures was considered as providing a profile closer to human milk and the objects given in the specification are consistent with such lines of research in the art. For example Dr Drummond stated that:

“The recognition that naturally occurring OS in bovine milk are more closely related to HMO [human milk oligosaccharides] than FOS for example was well known – so in itself this is not an invention or a surprise – it is simply what you will get if you concentrate bovine milk.”[55]

[55] Drummond 1 at [112].

96. This suggests that an oligosaccharide mixture comprising a spectrum of oligosaccharides that is the same as the milk from which it is derived would be expected by those in the art to have a profile closer to human milk than GOS and/or FOS. Dr Drummond and Dr McJarrow also stated that the inclusion of GOS in infant formula was known to result in products that were closer in profile to human milk.[56] The evidence therefore does not appear to support the issues raised by Fonterra on this point.

[56] Drummond 1 at [79], McJarrow 2 at [10].

97. Accordingly I find that Fonterra’s submissions in relation to sufficiency are unsuccessful.

Novelty

98. 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.

99. 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:

“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”.[57]

[57]Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; 137 CLR 228 at 235.

This test is satisfied if the alleged anticipation discloses all the essential features of the invention claimed.[58] Furthermore, in order to meet this requirement, the prior art:

“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.”[59]

[58] Nicaro Holdings Pty Limited v Martin Engineering Company [1990] FCA 40; 16 IPR 545 at 549.

[59] The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited supra at 486.

In some cases a prior publication may not explicitly disclose all of the features of the invention, but could still deprive the claimed invention of novelty if the missing information or feature is inherent:

“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.”[60]

[60] The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited supra at 485 to 486.

Fonterra cited 4 documents in relation to novelty:

D1      WO 2001060171
D2      Chen et al., “Optimization of the enzymic process for manufacturing low-lactose milk containing oligosaccharides”, Process Biochemistry (2002) 38 801-808.
D3      AU 642256
D4 US 4944952

Fonterra acknowledged that their novelty arguments relied upon the present claims being found to lack clarity. Specifically, they argued that the oligosaccharide:GOS ratio lacked clarity since GOS is an oligosaccharide and therefore there cannot be a mixture in which there is more GOS than oligosaccharide. They considered this feature was meaningless and should be disregarded. I have found the claims clear in this regard, but for sake of completeness I will cover off on their submissions on novelty. In short:

D1 discloses methods of isolating sialyloligosaccharides from a dairy stream which also contains lactose. These components are generally difficult to separate, and the process involves hydrolysing the lactose into glucose and galactose and then separating the sialyloligosaccharides from the stream. The examples show hydrolysis using a b-galactosidase, followed by separation of the sialyloligosaccharides from glucose and galactose using nanofiltration.

D2 discloses the preparation of a low-lactose milk product. Two methods are disclosed – the first involves evaporation of milk followed by direct treatment with a b-galactosidase. The second involves ultrafiltration of skim milk and treatment of the permeate with b-galactosidase. The enzyme-treated permeate is added back into the retentate from the ultrafiltration step to provide a “complete milk containing oligosaccharides”.

D3 discloses the preparation of GOS-containing skim milk products. The skim milk is concentrated to a solids content of up to 50% by weight and then treated with a b-galactosidase. The mixture is then heated at 85˚C to terminate the enzymatic reaction. This gives a product that contains 10.5% by weight GOS and 33.8% by weight lactose.

D4 discloses treatment of skim milk with b-galactosidase from certain bacteria to produce a milk product in which at least 15% of the lactose is converted to GOS. Example 1 results in a product containing 0.94% GOS, 1.54% disaccharide (including 0.45% lactose) and 2.02% monosaccharide.

None of the documents cited above specifically discloses mixtures having an oligosaccharide:GOS ratio in the range defined by the present claims. There is also no explicit disclosure in any of the cited documents that the range of oligosaccharides in the final product is the same as in the starting milk from which it is derived. Fonterra argued that this feature was inherent in each of the disclosures based on evidence from Dr Drummond,[61] and Dr McJarrow,[62] as well as the common general knowledge as indicated by Dr Archer.[63]
[61] Drummond 1 at [140].
[62] McJarrow 2 at [78].
[63] Archer at [10], [11], [14] and [21].

In my opinion none of these statements provides sufficient detail as to why the feature would be inherent, including for example a consideration of the conditions used in obtaining the GOS-containing products and how these would retain the spectrum of oligosaccharides present in the starting material. I also note that the conditions used in the prior art documents appear to differ markedly from those used in the present application since a lactose reduction step is not carried out prior to the treatment with b-galactosidase. Prima facie this would impact on the lactose:oligosaccharide and oligosaccharide:b-galacto-oligosaccharide ratios.

Given the apparent differences in the conditions by which the present mixtures are made and the lack of definitive evidence on this point, I am unable to conclude that it would be an inevitable or inexorable outcome of the teachings of the citations to obtain the oligosaccharide mixtures presently claimed.

Therefore I am not satisfied that the citations disclose the invention as defined by the present claims and conclude that the claims are novel in view of documents D1 to D4.

Inventive step

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.[64]
[64] Subsections 7(2) and 7(3), Patents Act 1990.

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.”[65]

[65] Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12; 148 CLR 262 at 286.

In Alphapharm,[66] the High Court accepted the approach taken by Graham J in Olin Mathieson,[67] where he 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]?”

[66] Aktiebolaget Hassle v Alphapharm Pty Ltd supra at [53].

[67] Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at [187].

Where the invention involves a combination of integers, 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.”

Fonterra submitted that the invention was obvious in light of the common general knowledge when considered separately or with information within the operation of s 7(3) of the Act.

Common general knowledge

The inventive step determination requires a consideration of the common general knowledge:

"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."[68]

[68] Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9; 144 CLR 253 at 292.

There were very few significant areas in which the parties differed as to the common general knowledge in the art. Some of the key points of the common general knowledge are provided below.

Oligosaccharides are prebiotics which are found in human and animal milk.[69]
[69] Drummond 1 at [64].

Human milk contains a large number of oligosaccharides.[70] Human milk also contains high levels of lactose.[71]
[70] Drummond 1 at [74] to [75].
[71] Drummond 1 at [24].

GOS are present in both human and animal milks. GOS is present in human milk at a higher concentrations compared to other naturally occurring oligosaccharides.[72] GOS can be produced by treatment of lactose with b-galactosidase.[73] GOS was known to have prebiotic properties and was added to some infant formula for sale in Asia.[74]

Infant products contained defined levels of protein, fat, carbohydrates, ash (minerals), and vitamins. Certain other optional ingredients were allowed.[75] This included FOS and GOS.[76]
Whey permeate or milk permeate may be prepared by skimming and ultrafiltration of whole milk or whole whey. Proteins are concentrated in this way, and oligosaccharides generally report to the permeate since most oligosaccharides are smaller than the pore size.[77]
Lactose can be isolated from whey permeate or milk permeate by techniques such as crystallisation. The product remaining after the lactose has been removed is referred to as mother liquor.[78] Demineralisation and decolourisation may be carried out before or after lactose removal.[79]
Demineralisation may be carried out by nanofiltration, ion exchange or, less frequently, electrodialysis. Oligosaccharides are too big to be removed by nanofiltration and therefore remain in the mother liquor.[80]
[72] Drummond 1 at [64], McNaught at [19].
[73] Archer at [9].
[74] Crittendon at [16].
[75] Drummond 1 at [17].
[76] Drummond 1 at [68].
[77] Archer at [11].
[78] Archer at [12].
[79] Archer at [13].
[80] Archer at [14].

The problem to be solved

Neither party specifically identified a problem, nor a starting point for the inventive step consideration,[81] but each identified an inventive concept. Fonterra considered that the closest the application came to identifying the invention was the statement that the aim of the invention is:
“to provide an oligosaccharide mixture which is effective as a prebiotic, particularly in the human gut and which has an oligosaccharide profile closer to that of human milk than that provided by mixtures of fructo- and galacto-oligosaccharides”.
[81] AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 at [202] to [203].

Based on this statement they argued that the inventive concept lies in:

The identification of an oligosaccharide mixture which is effective as a prebiotic, particularly in the human gut; and
The mixture has an oligosaccharide profile closer to that of human milk than that provided by mixtures of fructo- and galacto-oligosaccharides.

In contrast Nestec framed the inventive concept in more specific terms. They submitted that the inventive concept resulted from a consideration of the complexity of oligosaccharides in human breast milk and the apparent prebiotic role these play. Nestec submitted that the invention lay in providing an oligosaccharide mixture that:

Captures and concentrates the spectrum of oligosaccharides from the milk from which it is derived;
Balances the oligosaccharide:GOS ratio within the range of 1:2 to 1:20 to maintain the functionality of the oligosaccharides without them being swamped by the GOS content; and
Still maintains a low lactose:oligosaccharide ratio of less than 250.

The evidence indicates that there was a great deal of interest in developing new ingredients for addition to infant formula. The role of indigestible oligosaccharides as prebiotics had been recognised and mixtures of FOS and GOS were widely used. [82] Researchers were attempting to match the composition of human breast milk,[83] and the potential advantages of supplementing cow’s milk formula with oligosaccharides were widely recognised.[84] These were present in only relatively small amounts in bovine milk, and technology needed to be developed to manufacture oligosaccharides such as GOS.[85]
[82] Drummond 1 at [30].
[83] Drummond 1 at [64].
[84] Crittenden at [6].
[85] Drummond 1 at [45].

It is clear from the evidence that researchers were attempting to better match the composition of human breast milk, and to develop new ingredients. I therefore consider that the problem may be formulated as the provision of oligosaccharide mixtures that better match the components in human breast milk.

Inventive step in view of the common general knowledge

Fonterra submitted that the processes and conditions described in the present application (including deproteinisation, demineralisation, concentration and lactose removal) are well known in the art. They also argued that it was known in the art to treat mother liquor to increase the amount of oligosaccharide, and in particular the GOS content.

However the claims define a specific oligosaccharide mixture, and while the individual features may be well known it is the specific combination of features that must be shown to be obvious. I am not satisfied that the evidence establishes that the person skilled in the art would be led as a matter of routine to concentrate the oligosaccharides present in the starting milk in order to obtain a product having a range of different oligosaccharides. To the contrary, the common general knowledge as provided in the evidence focusses on the use of GOS and not on the additional oligosaccharides already present in the milk from which the product is derived.

In particular Dr Drummond stated that two complementary approaches were taken to formulating infant formula.[86] The first of these attempted to match the composition of human milk such as total fat, total protein and ash and to this end Fonterra was using GOS in their formulations.[87] Indeed Dr Drummond stated that “when considering what ingredient to add to infant formula, GOS would have been the first ingredient that came to mind”.[88] Similarly Dr Archer stated that:

“The GOS present in the mother liquor would have been a closer approximation to the suite of GOS materials in human breast milk than the synthetic GOS made by transgalactosylation with commercial b-galactosidase, the latter not being at all phosphorylated or sialylated. However, over the 1990s and beyond I was considering various synthetic routes for making a functionalised GOS product much closer to human breast milk than either standard GOS or the mix likely to be present in bovine lactose mother liquor.”

[86] Drummond at [40].

[87] Drummond at [48].

[88] Drummond 1 at [161].

Furthermore, while the processes described in the specification are also well known, it appears that specific conditions would need to be employed in order to achieve the product of the present claims. The selection of these conditions would require the knowledge of the desired product. In this regard Dr Archer stated that:

“A person would need to pick their processing steps and parameters (e.g. time, temperature, pH) carefully if they wanted to have the spectrum of oligosaccharides from milk end up in the mother liquor. Even then, based on my experience with dairy processing, I couldn’t guarantee that all of the oligosaccharides would be intact at the end of the general lactose processing step.”

As a consequence I consider that the evidence teaches towards the development and use of specific additives such as GOS to approximate the oligosaccharide content of human milk rather than the concentration of the oligosaccharides in the milk from which the product was derived. I therefore find the claims inventive in view of the common general knowledge.

Inventive step in light of section 7(3) information

Fonterra submitted that the claims lack inventive step in view of each of D1 to D4 when considered in light of the common general knowledge. They also relied upon the prior use of the products “True Mom Step 1” and “True Mom Step 2”.[89]
[89] Exhibit LND-12 and Drummond 1 at [149] – [159].

Nestec argued that there was no evidence as to whether any of the documents cited would have been ascertained in a search directed at any particular problem, or the nature of any other literature or patent searches which they would have conducted if faced with the problem solved in the application. They noted that Dr Drummond’s evidence on her sources of information were too general to be of assistance, and for example included broad topics such as “what was in milk” and “infant formula”.[90] Fonterra acknowledged that D1, D3 and D4 are patent documents, but they noted that Dr Drummond identified patents as a source of information that she relied upon in her research,[91] and Dr McJarrow stated that his work had given him a wide background of publications and patents pertaining to milk oligosaccharides.[92]
[90] Drummond 1 at [34] to [35].
[91] Drummond 1 at [35].
[92] McJarrow 1 at [4].

Nestec’s arguments appear to have some merit. The evidence does not sufficiently establish that the documents would have been ascertained in light of the problem to be solved, and if ascertained, whether they would have been considered relevant under all the circumstances. However, even if it could be argued that these requirements are met, I am not satisfied that the cited documents and uses would render the claims obvious.

I have formulated the problem to be solved as being as the provision of oligosaccharide mixtures that better match the components in human breast milk. I have also found that the common general knowledge teaches towards the use of GOS to approximate the oligosaccharide content of human milk, rather than the concentration of the oligosaccharides in the milk from which the product was derived. None of the cited documents address the deficiencies in the common general knowledge. D1 is directed to a method of separating sialyloligosaccharides from lactose and is of little apparent relevance to the claimed invention. D2, D3 and D4 focus on the generation of GOS from milk products and at most confirm the approach of adding GOS to infant formula rather than utilising the oligosaccharides present in the milk from which the products are derived. A similar conclusion is reached in relation to the prior uses cited by Fonterra.

I therefore find the claims inventive in view of the cited documents and uses in view of the common general knowledge.

Conclusion

The amendment to the statement of grounds and particulars dated 17 January 2017 is refused.

Claim 8 lacks clarity and fair basis. I consider that this may be overcome by amendment, and allow Nestec 2 months from the date of this decision to propose appropriate amendments to overcome these issues.

The opposition argued by Fonterra is unsuccessful.

Costs

The parties submitted that costs should follow the event. While I have found that Claim 8 lacks clarity and fair basis, the opposition argued by Fonterra at the hearing has been unsuccessful. I therefore award costs according to Schedule 8 against Fonterra.

Dr Leslie F. McCaffery
Deputy Commissioner of Patents