Fonterra Co-Operative Group Limited v S.A. Corman

[2015] APO 74

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Fonterra Co-Operative Group Limited v S.A. Corman [2015] APO 74

Patent Application:                2007276203

Title:Milk ingredient enriched in polar lipids and uses thereof

Patent Applicant:                   S.A. Corman

Opponent:  Fonterra Co-Operative Group Limited

Delegate:  R Subbarayan

Decision Date:  9 November 2015

Hearing Date:  20 August 2015, in Canberra

Catchwords:  PATENTS – section 59 – opposition to grant of patent – dairy ingredient enriched in phospholipids – whether the claimed invention is novel – whether the claimed invention is inventive – whether the claimed invention is fully described – whether the claimed invention is a manner of manufacture – none of the grounds made out – costs awarded

Representation:  Patent applicant:  Katrina Howard SC instructed by Shahnaz Irani of Spruson & Ferguson

Opponent:AJ Park

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                2007276203

Title:Milk ingredient enriched in polar lipids and uses thereof

Patent Applicant:                   S.A. Corman

Date of Decision:                   9 November 2015

DECISION

None of the grounds of the opposition has been made out. The claimed invention is novel, inventive, fully described and a manner of manufacture.

The application is to proceed to grant subject to any appeal being filed within the relevant period.

I award costs according to schedule 8 against Fonterra Co-Operative Group Limited.

REASONS FOR DECISION

BACKGROUND

1. Patent application 2007276203 in the name of S.A.Corman (the applicant) was filed on 13 July 2007 as a PCT application (PCT/EP2007/057247) and claims an earlier priority date of 17 July 2006. It is titled “Milk ingredient enriched in polar lipids and uses thereof”. It was examined and advertised as accepted on 13 December 2012. The grant of the patent has been opposed under section 59 of the Patents Act by Fonterra Co-Operative Group Limited (the opponent). The claims of the opposed application were amended after the filing of evidence in support and the claims that are the subject of this decision are those that were filed on 12 February 2014. The matter was heard on 20 August 2015 in Canberra. While the applicant appeared in person, the opponent appeared by way of written submissions.

   GROUNDS OF OPPOSITION

2. The Statement of Grounds and Particulars lists the grounds of opposition as Novelty, Inventive Step, Manner of Manufacture, Sufficiency, Clarity, Fair Basis and Utility. However at the hearing, the opponent did not press the grounds of Clarity, Fair Basis and Utility.

   EVIDENCE

3. The opponent's evidence in support comprises:

   • Statutory declaration of Christine Lennon Buchan executed 13 September 2013 (Buchan). Mrs Buchan is a legal assistant employed by AJ Park. She gives evidence about the publication of prior art documents.
   • Statutory declaration of David Scott Munro declared 8 October 2013 (Munro). Mr Munro is principal scientist at David Munro Consultants. He has extensive practical experience with dairy technology and dairy processing. He gives evidence about the opposed specification and the phospholipids levels in the cited prior art.
   • Statutory declaration of Philip Joseph Silvester declared 8 October 2013 (Silvester). Mr Silvester is a production assistant employed by the opponent at the Edgecumbe plant. He gives evidence about the publication of product information.
   • Statutory declarations of Geoffrey Welsford Smithers declared 28 August 2013 (Smithers #1) and 11 October 2013 (Smithers #2). Dr Smithers is an independent food industry consultant. In Smithers #1 he gives evidence about the dairy industry in Australia as it existed in 2006. In Smithers #2, he gives further evidence after reviewing the opposed application and the prior art.

4. The applicant's evidence in answer comprises:

   • Statutory declaration of Dennis Charles Hurren declared 7 January 2014 (Hurren). Dr Hurren is a consultant with extensive experience in dairy manufacture including over 18 years with Murray Goulburn Co-op as Engineering Manager and R&D Manager. He gives evidence about the common general knowledge in the art and compares the claimed invention with the cited prior art.
   • Statutory declaration of Hilton Clement Deeth declared 8 January 2014 (Deeth). Professor Deeth is Emeritus Professor of Food and Science at the School of Agriculture and Food Sciences, University of Queensland. He gives evidence about the common general knowledge in the art and compares the claimed invention with the cited prior art.

5. The opponent's evidence in reply comprises:

   • Statutory declaration of Geoffrey Welsford Smithers declared 30 September 2014 (Smithers #3).

   SPECIFICATION

6. The present invention relates to a milk ingredient that is enriched in polar lipids, especially in phospholipids and sphingolipids and a method for obtaining such a milk ingredient. Polar lipids are naturally occurring molecules that bear a polar head or group at one of their ends and are a major component of cell membranes including those of milk fat globules. They are fundamental in milk for the emulsification of fat in water and together with proteins are the main constituents of the milk fat globule membrane. Phospholipids belong to the class of polar lipids and are defined as lipids containing phosphoric acid groups. Sphingolipids also include a polar group but no glycerol group. According to the specification, phospholipids constitute 0.22% of pasteurised cream milk. Phospholipids and sphingolipids are stated to provide various health benefits including lowering of cholesterol, prevention against cancer and in particular colon cancer, a prebiotic effect and prevention against digestive disorders.

7. The specification briefly discusses various prior art including the following that describe methods of producing a milk ingredient that is enriched in phospholipids and sphingolipids.

8. WO 02/34062 describes a method in which lactic buttermilk is ultrafiltered on a membrane having a cutoff value of 5000 to 20000 Da to obtain an enriched product in which the percentage of phospholipids is less than 3% by weight relative to the dry matter of the ingredient.

9. WO 03/071875 describes a method in which cheese factory lactoserum is proteolysed and then subjected to ultrafiltration and diafiltration to obtain an enriched product in which the concentration of phospholipids is less than 20%. The opposed specification states that the product disclosed in this document will have deteriorated organoleptic properties due to the presence of peptide compounds used in the proteolysis. 

10. Sachdeva et al. describes a method in which sweet cream buttermilk powder is subjected to coagulation and then ultrafiltration to obtain an enriched product in which the concentration of phospholipids is less than 20%.

11. JP 03/047192 describes a method in which phospholipids derived from milk are subjected to fractionation and purification to obtain extracts having purities greater than 80% or even 90%, but the method includes extraction with solvents such as ether and acetone.

12. JP 2005027621 describes a method in which skimmed milk is subjected to microfiltration using membranes with a pore size between 1 and 2 µm to obtain an enriched product having more than 30% by weight of phospholipids and optionally more than 35% by weight. However as skimmed milk only contains 0.1% of fat, the yield of phospholipids is very low, i.e. 200 gm of phospholipids-rich extract from 20 tons of skimmed milk. 

13. The specification then states that one of the aims of the invention is to obtain a milk ingredient enriched in polar lipids, in particular in phospholipids and sphingolipids, which retains the organoleptic properties of the dairy product from which it is derived and a method for obtaining this enriched milk ingredient which is of simple and inexpensive conception and which has an improved yield in producing polar lipids.

14. This is then followed by a number of consistory clauses, two of which basically mirror independent claims 1 and 10.

15. The specification then describes under the heading “Detailed description of the invention” two examples of a method of obtaining a milk ingredient that is enriched in phospholipids. In both examples, the starting dairy material for obtaining the phospholipid enriched ingredient is pasteurised cream milk. The steps involved in the methods are schematically represented in figures 1a, 1b, 2, 3a, 3b, 4a and 4b that are reproduced below:

16. As can be seen from these figures, the methods primarily involve the steps of concentration by centrifugation and membrane filtration using ultrafiltration and diafiltration and are also devoid of any extraction steps using an organic solvent.

17. The characteristics of the composition of the different products obtained by the described methods are then given in Tables 1-5. According to these Tables, products C5, C11, C13 and B12 have a phospholipid concentration of more than 20% by weight of the dry matter of the ingredient and products C5 and C11 further have a phospholipid concentration of more than 36% by weight of the dry matter of the ingredient.

18. The specification then identifies a few uses of this phospholipid enriched dairy ingredient. These include food compositions for humans and animals, cosmetics, pharmaceutical compositions to provide some of the beneficial effects mentioned earlier and as an emulsifying agent for improving the creaminess of food products and the whippability of milk.

19. The specification ends with 18 claims of which independent claims 1 and 10 read as follows:

    1. A dairy ingredient enriched with polar lipids and especially with phospholipids and sphingolipids wherein the weight percentage of phospholipids is higher than 36% calculated on the percentage of dry matter of the ingredient, said dairy ingredient further comprising one of the elements selected from the group consisting of proteins, carbohydrates, minerals, water-soluble vitamins, enzymes and ashes; and wherein said dairy ingredient is prepared by a method which does not comprise a solvent extraction step using an organic solvent.

    10. A method to obtain a dairy ingredient enriched with polar lipids, especially with phospholipids and sphingolipids, in which the weight percentage of phospholipids is higher than 20% calculated on the percentage of dry matter of the ingredient, and in which a pasteurised milk cream is subjected to a physical treatment that comprises at least two steps, selected from the group made of one concentration by centrifugation, one ultrafiltration step and one ultrafiltration/diafiltration step; and wherein the method does not comprise a solvent extraction step using an organic solvent.

    ONUS OF PROOF

20. The examination request for this patent application was filed prior to 15 April 2013. As a consequence, substantive amendments of the Patents Act 1990 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 application if satisfied on the balance of probabilities that a ground of opposition exists.

21. Consequently the former standard for opposition proceedings applies and the opponent must establish that it is clear or practically certain that the patent is invalid (F Hoffman La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29] , [67]; [2000] FCA 283; 50 IPR 305 at 311, 319; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18] , [22]; [2008] FCAFC 182; 79 IPR 426; Genetics Institute Inc v Kirin-Amgen Inc [1999] FCA 742; [1999] 92 FCR 106 at [17] ).

    CLAIM CONSTRUCTION

22. While the opponent did not raise any construction or clarity issue with the terms “microfiltration”, “ultrafiltration”, and “diafiltration”, I think it is important to construe these terms.

23. While both microfiltration and ultrafiltration are filtration techniques using a filtration membrane, the main difference between these two techniques primarily lies in the pore size of the membrane used. In microfiltration the pore sizes are larger and are typically between 0.1 to 10µm. In ultrafiltration, the pore sizes are smaller and are typically between 0.001 to 0.1µm. While these pore sizes are typical, it would appear from some of the literature in the art that that there can be some variation in these ranges and that there is also a bit of overlap between microfiltration and ultrafiltration around the 0.1µm pore size. Despite this, I am satisfied that the distinction between these terms is well understood in the art.

24. In relation to the term “diafiltration”, I understand this term to refer to a process of microfiltration or ultrafiltration in which the retentate is diluted with water and then again microfiltered or ultrafiltered to further reduce the concentration of soluble permeate components and thereby further increase the concentration of retained components.

    NOVELTY

25. A claimed invention is deprived of novelty if it has been given to the public before the priority date, either by prior use of a product or process, or by publication of information that equates to the claimed invention (Danisco A/S v Novozymes A/S (No 2) [2011] FCA 282; 91 IPR 209 at [248]). It is well settled that the general test for anticipation or want of novelty is the reverse infringement test (Meyers Taylor Pty Ltd v Vicarr Industries Ltd ([1977] HCA 19; 137 CLR 228 at [19]), and this test is satisfied if the alleged anticipation discloses all of the essential features of the invention as claimed (Nicaro Holdings Pty Ltd v Martin Engineering Co ([1990] FCA 40; 16 IPR 545 at [19]).

26. To meet this requirement, the prior art must contain “clear and unmistakable directions” to produce the invention as claimed (Pfizer Overseas Pharmaceuticals v Eli Lilley and Company [2005] FCAFC 224; 68 IPR 1 at [314]). However, if the prior publication contains a direction which is capable of being carried out in a manner which would infringe the claimed invention, but would at least as likely be carried out in such a way that would not do so, the invention as claimed will not be anticipated (General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457 at 485-486; 1A IPR 121 at 138, Novozymes A/S v Danisco A/S [2013] FCAFC 6; 99 IPR 417 at [177]).

27. In AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 , the full Federal Court held:

    "Sufficiency of disclosure is a cardinal anterior requirement in the analysis of whether a prior art document anticipates a claimed invention. It is only after the stage of assessing the sufficiency of disclosure which involves a determination about whether a prior document has "planted the flag" as opposed to having provided merely "a signpost, however clear, upon the road" or, perhaps, something less that the notion of reverse infringement comes into play as the final and resolving step of the required analysis. It is not the first step of the required analysis; nor is it the only step".

28. In relation to the specificity required in order for a prior art document to anticipate the claimed invention, the full court in AstraZeneca (supra) also quoted with approval the following quote from Gyles J in Apotex Pty Ltd and Another v Sanofi-Aventis and Another [2008] FCA 1194; (2008) 78 IPR 485:

    "anticipation is deadly but requires the accuracy of a sniper, not the firing of a 12 gauge shotgun".

    D3: JP 2005027621

29. The opponent contends that the invention of claim 1 is anticipated by document D3 which as noted earlier is admitted prior art in the specification.

30. D3 is in Japanese and the opponent solely relies on an English abstract of this document as published by the European Patent Office on its Espacenet website. They have not filed a verified English translation of the full Japanese document. The applicant submitted that the opponent has not established that this English abstract was available on the Espacenet website at the priority date of 17 July 2006 and that in the circumstances I should therefore not have regard to this document.

31. While I accept that the opponent has not discharged its onus in clearly establishing the availability of this abstract at the priority date of the opposed application, it is my understanding that the English language abstracts on Espacenet are generally published on the same day as the stated date of publication of the full patent document. The publication date of the full patent document is 3 February 2005. Given my conclusions on the disclosure of D3 below, I will treat the English abstract of D3 as if it had been published on Espacenet before the priority date and that this document is therefore part of the prior art base for Novelty.

32. The English abstract of D3 states that it provides “a method for inexpensively producing a raw material containing highly phospholipid derived from milk, usable as a natural emulsifier through using the fraction of a concentrated liquid side obtained by subjecting skim milk to minute filtration (MF) film treatment” and that “This method for producing the raw material containing highly phospholipid derived from milk and having ≥30 wt.% of phospholipid and ≥35 wt.% of neutral lipid in the total solid comprises washing in water a cream layer collected from the fraction of the concentrated liquid side obtained by subjecting skim milk to the MF film treatment, and  destroying emulsification of the cream layer so as to collect water phase”.

33. The opponent argued that as the abstract states that the phospholipid content can be more than 30%, this can extend to 36% and therefore comes within the scope of claim 1. They also submitted that the opposed application itself acknowledges that the phospholipid content can be more than 35% and there is no mention of any steps involving solvent extraction.

34. In relation to this last mentioned submission, the applicant argued that the reference to “more than 35% by weight of phospholipids” in their specification is an error and that this is a reference to neutral lipids.

35. I agree. It is clear from the English abstract that the reference to “≥35 wt.%” is a reference to neutral lipids. There is no evidence from the opponent that would suggest that neutral lipids are also necessarily phospholipids. While the abstract does state that the method can produce a raw material having ≥ 30% phospholipids, there is no clear teaching that it can be greater than 36% or that the method does not involve any steps involving solvent extraction with organic solvents. While the abstract does not mention the use of organic solvents, without a translation of the full document, I cannot be satisfied that the method of D3 does indeed not involve any extraction steps using an organic solvent. It was open to the opponent to have filed as evidence a verified translation of the full Japanese document, but for reasons best known to them they have chosen not to.

36. The opponent has not established that the English abstract of D3 provides clear and unmistakable directions to produce a dairy ingredient that has a phospholipid content greater than 36% and wherein the production process does not involve a solvent extraction step using organic solvents. Claim 1 is therefore novel over D3.

37. The opponent did not press that independent claim 10 lacks novelty over D3. In any event, I note that it uses skim milk and not pasteurised cream milk as the starting material and does not disclose two of the three steps specified in this claim. Claim 10 is also therefore novel over D3.

    INVENTIVE STEP

38. Under the provisions of subsections 7(2) and 7 (3) of the Patents Act 1990, an invention is taken to involve an inventive step when compared with the prior art base unless it would have been obvious to a person skilled in the art. The invention must be obvious in the light of the common general knowledge as it existed in the patent area before the priority date, either on its own or together with information in a document, or combination of documents, that the person skilled in the art could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant and, where necessary, combined. Obvious means ‘very plain’ (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21 at [ 51] - [52]; (2007) 72 IPR 447 at 461 [51] - [52]).

1. The test for obviousness was provided by Justice Aicken in Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12 at [45]; 148 CLR 262 at 286 as follows:

   "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."

2. More recently, in Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59 at [53]; 212 CLR 411 at [53] the High Court also approved the approach taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at 187 in which Graham J had 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 of integers] in the expectation that it might well produce a [useful or desired result]?"

3. Where the invention lies in a combination of features, the question is whether the combination, not each individual feature, is obvious when compared to the prior art base:

   "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 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." (Alphapharm (supra) at [41])

4. An important consideration is also the impermissible use of hindsight. The High Court in Alphapharm (supra) also warned against the misuse of hindsight noting that the danger of such misuse will be "particularly acute where what is claimed is a new and inventive combination for the interaction of integers, some or all of which are known". In that regard, the court referred with approval to Lord Diplock's comments in Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [1972] RPC 346 (at 362):

   "Once an invention has been made it is generally possible to postulate a combination of steps by which the inventor might have arrived at the invention that he claims in his specification if he started from something that was already known. But it is only because the invention has been made and has proved successful that it is possible to postulate from what starting point and by what particular combination of steps the inventor could have arrived at his invention. It may be that taken in isolation none of the steps which it is now possible to postulate, if taken in isolation, appears to call for any inventive ingenuity. It is improbable that this reconstruction a posteriori represents the mental process by which the inventor in fact arrived at his invention, but, even if it were, inventive ingenuity lay in perceiving that the final result which it was the object of the inventor to achieve was attainable from the particular starting point and in his selection of the particular combination of steps which would lead to that result."

5. The High Court in Alphapharm (supra) also noted that “It is important also to remember that in Australia, a "scintilla of inventiveness" will suffice: "no smallness or simplicity will prevent a patent being good"”.

   No inventive step in view of the common general knowledge (CGK)

6. The opponent submitted that the claimed invention lacked an inventive step in light of the CGK in the art for the following reasons:

   • Phospholipid enriched ingredients were known and being produced before the priority date.
   • The person skilled in the art would have been well aware of the physical treatment steps of centrifugation, ultrafiltration and diafiltration and the use of these treatment steps successively to isolate dairy fractions to thereby produce a phospholipid enriched product.
   • The utility of these physical treatment steps was well known including the use of centrifugation as a first step and the use of membrane filtration to selectively separating out components.
   • The use of these physical techniques to remove non-phospholipid components including protein and lactose was a known way to increase phospholipid content.
   • The lack of a solvent extraction step using organic solvents cannot confer inventiveness.

7. The applicant argued that it has not been proven that phospholipid enriched compositions or the preparation of such compositions without solvent extraction was common general knowledge in the art.

8. Based on the evidence, I am satisfied that phospholipid enriched compositions were CGK at the priority date. While the applicant relied on Mr Hurren’s statement in his declaration that he was not aware of any work being carried out on phospholipids in 2006, that is not to say that phospholipid enriched dairy ingredients were not well known. In paragraph 41 of his declaration, Mr Hurren clearly acknowledges that phospholipid enriched buttermilk powder is used in the manufacture of ice cream. However the evidence does not establish what were the levels of phospholipids in these enriched compositions. While reference was made to the NZMP Phospholipid Concentrate 700 and the NZMP Phospholipid Concentrate 500 products made by the opponent, which have phospholipid levels of 60% and 34% respectively, the evidence in my view does not clearly establish that these products were CGK in the art. Even if it does, it is clear from their product brochures that both these products were obtained by methods that involve solvent extraction using the organic solvent ethanol.  

9. Again based on the evidence I am satisfied that each of the physical treatment steps of centrifugation, ultrafiltration and diafiltration and the use of these treatment steps to isolate dairy fractions was well known in the art.

10. The question is therefore armed with the CGK, would the skilled addressee as a matter of course have come up with a method that combines these well known physical treatment steps but without solvent extraction using organic solvents, to produce from a dairy starting material a phospholipid enriched product in which the levels of phospholipids is significantly higher?

11. While I accept that centrifugation and membrane filtration were well known techniques to remove non-phospholipid components from dairy products, the evidence of Mr Smithers does not establish that the use of these techniques alone without involving solvent extraction using organic solvents would produce a phospholipid enriched product that has the high levels of phospholipids as claimed. It is clear from reading the specification that it is the specific combination of some of these physical treatment techniques and the processing parameters that yields these high levels of phospholipids without the use of organic solvents. While Mr Smithers states that “combination of the unit processes revealed in the opposed patent and in the order revealed in the opposed patent, in order to isolate milk ingredients enriched in polar lipids (including phospholipids) and to avoid the use of typical organic solvents used for the purpose, would be obvious to a skilled person in 2006” (Smithers #3, at [73]), I note that this statement is made with the benefit of hindsight, after having read the opposed specification. The authorities that I have noted earlier have clearly cautioned against relying on such hindsight to establish obviousness.

12. The evidence does not satisfy me that it is clear or practically certain that the claimed invention lacks an inventive step in light of the CGK in the art.

    Ascertain, Understood and Regarded as Relevant

13. The opponent also submitted that the claimed invention is obvious in light of the CGK together with any one of the documents D3: JP 2005027621, D6: Sachdeva, D11: WO 02/34062 or D7: WO 03/071875.

14. Although the applicant submitted that the person skilled in the art would not have searched patent documents, I note that this is not supported by any of the experts. Mr Smithers states that the “skilled person would regularly use scientific literature and patent search engines (eg, PubMed, Scopus, Derwent) where they would find a large database of abstracts, citations,  peer-reviewed scientific literature, and patents relevant to dairy science, technology and research” (Smithers #3 at [25]). Even Mr Hurren acknowledges that while he was at Murray Goulburn “we were regularly sent patent abstracts in the milk/dairy area by a patent attorney firm charged with informing us of patenting developments in this area. I generally briefly reviewed them to determine their relevance”. I am therefore satisfied that the person skilled in the art would have searched patent documents when trying to come up with an improved method to produce a milk ingredient with high levels of phospholipids.

15. Each of the documents relied on by the opponent is clearly directed to methods to produce a dairy ingredient enriched in phospholipids. I am therefore satisfied that these documents would have been ascertained, understood and regarded as relevant.

    D3: JP 2005027621

16. The opponent did not provide any additional submissions in relation to lack of inventive step over what they provided for lack of novelty. While there is evidence to suggest that dairy ingredients with a phospholipid concentration greater than 36% were known, these were obtained by methods involving solvent extractions steps. While D3 mentions that the phospholipid concentration can be ≥30%, the evidence does not satisfy me that it would have been obvious to produce a dairy ingredient having a phospholipid concentration greater than 36% without using solvent extraction based on the limited disclosure of the English abstract.

17. The claimed invention is inventive over D3 and the CGK.

    D6: Sachdeva

18. D6 relates to recovery of phospholipids from buttermilk using membrane processing to selectively remove casein, whey proteins, lactose and minerals. It discloses two methods for obtaining the phospholipid enriched product.

19. In both methods, reconstituted buttermilk is first subjected to a process for the precipitation and removal of casein. This involves the addition of calcium chloride to the buttermilk followed by either rennet or citric acid to induce precipitation and coagulation of the casein. The citric acid method is very similar to the deproteinization step of the opposed application in that involves the addition of 0.1% calcium chloride, heating to 70°C and acidification with citric acid to adjust the pH of the serum to 5.2. However unlike the present invention, the precipitated casein is removed by a cheese cloth rather than by centrifugation.

20. In the first method, the buttermilk whey obtained after removal of the casein is subjected to microfiltration and diafiltration using a 0.2µm membrane to isolate and concentrate the phospholipid rich fraction from the whey with simultaneous removal of soluble proteins, salts, lactose and water. The concentration of phospholipids in the final product is stated to be 16.95%.

21. In the second method, the buttermilk whey obtained after removal of the casein is subjected to an ultrafiltration step and then to a microfiltration step with diafiltration using a 0.1µm membrane. The concentration of phospholipids in the final product is stated to be 15.18%.

22. Mr Smithers for the opponent states “I consider D6 is very close to the opposed patent. The only real difference seems to be that it uses microfiltration rather than ultrafiltration (as noted by Mr Hurren), but there is a grey line between ultrafiltration and microfiltration and I don't see this as being an inventive difference in any event. D6 describes using membrane technology, diafiltration, and removal of lactose to get a concentrated phospholipid ingredient, as does the opposed application” (Smithers #3 at [47]). He further states that while D6 uses buttermilk as the starting material, this buttermilk would have been derived from milk cream using centrifugation and therefore the use of cream as a starting material and the use of centrifugation as one of the steps is inherently disclosed.

23. The applicant argued that D6 differs from the claimed invention in that it uses buttermilk as the feed material, it does not have two of the steps of centrifugation, ultrafiltration and diafiltration and that the phospholipid concentration is only 16.95%.  

24. While I agree that the process steps employed in D6 appear to be very similar to those employed in the method of the second embodiment of the opposed application that is schematically shown in figure 2, in that both include a deproteinization step using calcium chloride and citric acid which is then followed by a membrane filtration step, in my view there are differences between the methods of D6 and those of the opposed application as noted by the applicant.

25. In relation to the starting material, while the buttermilk powder in D6 would have been initially derived from milk cream, there is no evidence to suggest that the milk cream from which it would have been obtained was heated to a temperature between about 60°C and 75°C for the duration of the centrifugation similar to the methods of the claimed invention. Furthermore the present application clearly notes at paragraph [0044] that the particularly high phospholipids concentration of the present invention is not obtained when soft buttermilk powder is used as a raw material.

26. While the deproteinization step of D6 is almost identical to that of the present application, the same cannot be said of the membrane filtration step. The first method of D6 uses microfiltration with a 0.2µm membrane but does not use ultrafiltration or ultrafiltration/diafiltration. While the second method uses ultrafiltration, this is an initial filtration step in order to reduce the bulk of the feed which is then followed by a microfiltration step with microfiltration/diafiltration. There is no suggestion in D6 to use just ultrafiltration with diafiltration as disclosed in the opposed application. A further distinction is that after the precipitation, the precipitated proteins are separated by a cheese cloth in D6 whereas in the opposed application they are separated by a centrifugal decantation step.

27. While I accept that heating, centrifugation, ultrafiltration and ultrafiltration/diafiltration are individually well known techniques in this art, that does not necessarily make the invention obvious. Where, as here, the invention involves a combination of features, it is the inventiveness of the combination as a whole that must be examined and the “inventiveness of particular integers is irrelevant to the inventiveness of a combination of them” (LockwoodSecurity Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58; 217 CLR 274; 212 ALR 1 at [78]).

28. While Mr Smithers states that the claimed invention is not inventive, I note that this statement has been made with the benefit of hindsight after having read the opposed specification. The authorities that I have noted earlier have clearly stated that statements as to the obviousness of a claimed invention that are made with the benefit of hindsight should be treated with caution.

29. Based on the evidence, I am not satisfied that it is clear or practically certain that the person skilled in the art would have as a matter of course modified the process of D6 to make milk cream as the starting material, included a centrifugation step after the precipitation of the casein and also replaced the microfiltration with ultrafiltration and diafiltration in the expectation that it would lead to significantly higher levels of phospholipids in the dairy ingredient.

30. The claimed invention is inventive over D6 and the CGK.

    D11: WO 02/34062

31. D11 relates to a method for obtaining products enriched in phospholipids and sphingolipids from milk cream using steps including centrifugation and ultrafiltration with membranes. The phospholipid concentration achieved is stated to be 2.84% on a dry matter basis, but notes that the final concentration can still be increased by diafiltration.

32. The opponent submitted that dairy ingredients with phospholipid concentration greater than 20% and 36% were commercially available before the priority date and therefore increasing the phospholipid concentration to the levels claimed is not inventive.

33. I fail to see the basis for this contention. The invention is all about achieving higher levels of phospholipids and the higher levels defined in the claimed invention are obtained by methods that involve certain steps including centrifugation, ultrafiltration and diafiltration. While the general method of D11 also includes the steps of centrifugation, ultrafiltration and diafiltration, the actual steps of the method and some of the parameters employed in these steps are not the same. For example, in the deproteinization step of D11, buttermilk obtained from the preparation of butter is acidulated with HCl to a pH of 3.3, then centrifuged, then filtered, then pH adjusted to 6.75 by adding NaOH and then ultrafiltered and if desired diafiltered. In the present application, the deproteinization step involves adding calcium chloride to the cream serum obtained from cream milk, followed by heating to a temperature of 70°C and adjusting the serum pH to about 5.2 by addition of citric acid, and maintaining the serum at this temperature for 40 minutes. The precipitated proteins are extracted by an additional centrifugal decantation step and the supernatant of deproteinized serum is then submitted to ultrafiltration and diafiltration.

34. Although neither of the independent claims 1 and 10 define the steps that I have mentioned above, it is the use of this method and those of some of the other embodiments that provides for the phospholipid levels of greater than 36% and 20% respectively.

35. In my view, clearly the methods of D11 are not the same as those of the present invention. While Mr Smithers states that the disclosure of D11 “appears remarkably similar to the method described in the opposed application” (Smithers #2 at [22]), he does not state that the person skilled in the art would have as a matter of course modified the process of D11 to include the steps of the present application in the expectation that it would lead to significantly higher levels of phospholipids in the dairy ingredient. Furthermore as noted earlier, the prior art products with phospholipids concentration more than 36% were obtained using steps that included extraction using organic solvents and I therefore fail to see why increasing the phospholipids concentration without the use of organic solvents should be obvious.

36. The claimed invention does not lack an inventive step over D11 and the CGK.

    D7: WO 03/071875

37. D7 relates to a method for obtaining products enriched in polar lipids including phospholipids and sphingolipids from a dairy material such as full cream milk. It specifically states that it provides a new approach to obtaining and concentrating polar lipids, especially in the absence of organic solvents. While it describes a number of methods of obtaining the polar lipid enriched product, all of them primarily involve an initial hydrolysis step in which two or more enzymes, one with protease activity and the other with peptidase activity, are added to dairy material. Upon achieving a desired degree of hydrolysis, the mixture is heated for a duration that is sufficient  to inactivate the enzymes and form a first hydrolyzed intermediate. This is then cooled and then subjected to one or more membrane filtration steps such as microfiltration, diafiltration and ultrafiltration. The maximum concentration of polar lipids obtained is 12.15%.

38. The opponent conceded that there is no disclosure of a phospholipid content of higher than 20%, but again argued that the higher phospholipid level alone cannot render the claims inventive and relied on Mr Smithers statement in relation to D7 that “Although the phospholipid content is not as high as that claimed in the opposed patent, I don't consider there is anything inventive alone simply in a higher phospholipid content, particularly when the applicant provides no basis for how they achieve this level. Further, you cannot differentiate D7 on the basis it uses an enzyme hydrolysis process to separate the proteins, when the opposed patent allows for the use of rennet instead of citric acid” (Smithers #3 at 49).

1. Similar to D11, while the methods of D7 include deproteinization and ultrafiltration and diafiltration, these methods are not the same as those of the present application. I also do not agree with Mr Smithers’ statement that the application provides no basis for how the claimed high levels of phospholipids are achieved. As discussed earlier, the specification does provide details of the methods that were used to achieve these high levels and there is no evidence from the opponent that establishes that following these methods would not lead to these claimed high levels. While I accept that D7 does mention that rennet can be used instead of citric acid, it also then states that coagulation by adding a suitable rennet for obtaining coagulation is not effective for forming intermediate products. The examples of the present application all involve the use of citric acid rather than rennet.

2. The evidence does not establish that the person skilled in the art would have as a matter of course modified the process of D7 in such a manner that would lead to the increased levels of phospholipids as claimed.  

3. The claimed invention does not lack an inventive step over D7 and the CGK.

   SUFFICIENCY

4. The legal test for sufficiency is set out in the High Court decision in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd ( 2001) HCA 8; 207 CLR 1; 177 ALR 460; 75 ALJR 518 at [25]:

   "The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?"

5. This test clearly recognises that there can be an element of trial and error involved which would not necessarily lead to a problem with sufficiency. As McTiernan J pointed out in AMP v Utilux, (1971) 45 ALJR 123 at page 128:

   "Specifications very frequently contain mistakes; they also have omissions. But if a man skilled in the art can easily rectify the mistakes and readily supply the omissions, the patent will not be held to be invalid. The test to be applied for the purpose of ascertaining whether a man skilled in the art can readily correct the mistakes or readily supply the omissions has been stated to be this: Can he rectify the mistakes and supply the omissions without the exercise of any inventive faculty? If he can, then the description of the specification is sufficient. If he cannot, the patent will be void for insufficiency."

6. The opponent submitted that the claimed invention is not fully described for the following reasons:

   • The claimed dairy ingredient is produced using a combination of two or more processing steps selected from concentration by centrifugation, an ultrafiltration step and a ultrafiltration/diafiltration step.
   • The details of the processing steps are critical to the use of the invention, and in particular to achieve the high phospholipid content claimed.
   • The high level of phospholipid in the opposed application cannot be attributed to the methods used to produce the dairy ingredient, as the methods are the same as prior art. Accordingly the applicant’s process must involve something different and that something different has not been described in the specification.
   • Dr Smithers is of the view that the specification does not disclose the operational parameters to be used with centrifugation and ultrafiltration and that there is no such thing as “standard” or “typical” parameters with centrifugation and ultrafiltration.
   • The skilled addressee would not know how to select these parameters or at least he or she would not be able to perform the invention without considerable difficulty.

7. The opponent’s submissions in relation to this ground appear to be premised on their contention that the methods used in the opposed application for achieving the high levels of phospholipids are the same as some of the prior art and that therefore it must be the operating parameters used for the centrifugation and ultrafiltration that results in these high levels. However it is clear from my discussion under Novelty and Inventive Step that the methods of the prior art, even though they employ centrifugation and membrane filtration, are not the same as those of the opposed application. There is also nothing in the opposed specification that would suggest that it is the operating parameters of the ultrafiltration and the centrifugation that are the critical elements for obtaining the high levels of phospholipids. So I do not accept the argument that the applicant’s process must involve something different and that something different has not been described in the specification.

8. While it is plainly evident that the specification does not provide the operational parameters to be used for the centrifugation and ultrafiltration, the question is whether the skilled addressee would be able to perform the invention without prolonged investigation of such parameters. Clearly there is difference of opinion between Mr Smithers and Mr Hurren in this regard and both parties argued that the evidence of their respective expert is to be preferred.

9. Mr Smithers describes himself as a research scientist, scientific entrepreneur and food industry consultant. While he states that he has extensive experience in dairy processing, particularly around isolation, separation and purification technologies, it would appear from his Curriculum Vitae that his experience is primarily as a researcher rather than as a dairy processing technologist/engineer with direct involvement in the selection and installation of dairy processing equipment.

10. Mr Hurren on the other hand, in my view clearly appears to have substantial experience in the selection and installation of centrifuges and membrane filtration plants during his long tenure as a Processing Engineer and Manager with Murray Goulburn Co-op. He is clearly of the view that the skilled addressee would be able to perform the invention without significant experimentation. For example he has stated:

    “The type of centrifuge and its operating conditions are well established in butter oil/AMF manufacture.” [197]

    “The ultrafiltration techniques, the type, construction and pore size of the membranes and their operating conditions are well established in the Dairy Industry particularly in protein fractionation and it would be very easy to utilize these same conditions to carry out the method of opposed application.” [198]

    “…..membrane plants are well established in the Dairy Industry for the separation of lactose and minerals from protein where the fat and protein is retained and the lactose and minerals pass through the membrane. In the opposed application, the membrane plant is required to retain protein and minerals, with lactose and minerals passing through, so I would be confident of the operating conditions of the plant plus the type of membrane required together with pore size. The proteins being separated are standard dairy proteins so I would be confident that a UF Plant operating at standard pressures with a 10,000 kDa polysulphone membrane would be suitable.” [201]

11. While Mr Smithers argues that “no engineer would ever contemplate putting together a schematic (eg, Piping and Instrumentation Diagram or P&ID) for a plant layout and operation without any information about the processing parameters, or the sizing and nature of equipment to be used” (Smithers #3 at [55]), there is no requirement that schematic drawings in a patent specification should provide the level of detail one would expect from a P&ID. Mr Hurren who has clearly been involved in setting up process plants for the dairy industry is of the view that the claimed invention can be performed using standard or typical parameters and without undue experimentation. He has also identified what he considers would be suitable parameters for the ultrafiltration module. While Mr Smithers counters this by stating that he doesn’t agree that this would necessarily lead to the high phospholipid levels claimed he has not backed it up with any test results.

12. Based on their respective experience and skills, I am of the view that the evidence of Mr Hurren is to be preferred in this regard. I am therefore satisfied that the disclosure of the specification will enable the skilled addressee to perform the claimed invention without prolonged study of matters presenting initial difficulty.

13. The opponent further submitted that the opposed application does not disclose the best method of performing the invention on the basis that the high level of phospholipid in the opposed application cannot be attributed to the methods used to produce the dairy ingredient as they are the same as the prior art and that the applicant must have therefore established particular parameters for these methods which have not been disclosed. I have already found that the methods of the opposed application are not the same as those of the prior art and there is nothing in the specification to suggest that any undisclosed parameters are primarily responsible for the high levels of phospholipids claimed. I am satisfied that the specification provides a best method of performing the invention.

14. This ground of the opposition has not been made out.

    MANNER OF MANUFACTURE

15. The opponent also submitted that the claimed invention is not a manner of manufacture on the basis that there is no was no substantial exercise of invention in what is claimed in independent claims 1 and 10. They relied on the decision in Dura-post (Aust) Pty Ltd v Delnorth Pty Ltd [2009] FCAFC 81, where the Full Court said at[31]:

    “We accept, moreover, that Microcell stands for "a narrow proposition that a Commissioner of Patents, or his or her delegate, may refuse an application for patent protection where a specification ‘on its face’ shows the invention claimed is not a manner of new manufacture": see Lockwood 235 ALR at 229 [106] per Gummow, Hayne, Callinan, Heydon and Crennan JJ; Mirabella 183 CLR at 663- 664 per Brennan, Deane and Toohey JJ; and Merck 154 FCR at 51-53 per Heerey, Kiefel and Dowsett JJ. As their Honours there said in Mirabella, 'if it is apparent on the face of the specification that the quality of inventiveness necessary for there to be a proper subject of letters patent under the Statute of Monopolies is absent, one need go no further".”

16. In relation to claim 1, their reasoning is as follows:

    • Dairy ingredients highly enriched in phospholipids and sphingolipids were known at the priority date.
    • Dairy ingredients enriched in phospholipids and sphingolipids have been prepared by methods not involving a solvent extraction step.
    • The claim does not contain any other feature that constitutes an inventive contribution over what was published and known at the priority date.

17. In relation to claim 10, their reasoning is as follows:

    • Dairy ingredients highly enriched in phospholipids and sphingolipids were known at the priority date.
    • Processing steps such as centrifugation, ultrafiltration, diafiltration and preparing/breaking emulsions were all well-known techniques in the dairy context.
    • Combining processing steps such as centrifugation and ultrafiltration to isolate dairy fractions was known.
    • Dairy ingredients enriched in phospholipids and sphingolipids have been prepared by methods not involving a solvent extraction step.
    • Claim 10 is merely a collocation of known steps/techniques, with each working independently of the others. Combining these steps to remove different components from the original feedstock is routine.
    • A collocation of known integers used in accordance with their ordinary use does not amount to a manner of manufacture.

18. The applicant submitted that where the claimed invention is shown to be inventive, it is not appropriate to consider whether there is manner of manufacture by reference only to the face of the specification and in support they relied on the decision of the Full Federal Court in

    Bristol-Myers Squibb Co. v F H Faulding & Co Ltd (1999) 46 IPR 553 at [20]-[30], where the court said:

    “Although Philips suggests that there may be such cases (it does not decide the question, because obviousness was not pressed), it is not easy to envisage circumstances in which a claimed invention may lack the threshold requirement of inventiveness, but yet involve (for the purposes of s 18(1)(b)(ii)) an inventive step. This is not a case, like Philips, where there was no attack on the patents on the ground of obviousness. It was, instead, a case where expert evidence, including evidence as to common general knowledge, was available (and was given). Where the Court has evidence on the basis of which it can make a finding about common general knowledge, and the other information referred to in s 7(2) and (3), and about what would or would not have been obvious to persons skilled in the relevant art, it must be only rarely that it will be appropriate to find (by resort to a “threshold test”) lack of inventiveness on the face of the specification. In our opinion this is not a case where such a finding is justified.”

19. The present case is similar to Bristol-Myers (supra) in that there is evidence from both parties on the basis of which I have already found that the claimed invention is inventive. I am not satisfied that the present invention is one of those rare instances where an invention that has been found to be inventive can then found to be lacking in manner of manufacture on the basis that the claimed invention lacks an invention on the face of the specification. It is possible therefore on this basis alone to reject this ground of the opposition.

20. Nonetheless, I will consider the opponent’s submissions in relation to each of the independent claims. In relation to claim 1, the only disclosure of a dairy ingredient having a phospholipid content greater than 36% is the reference in paragraph [0017] to JP 2005027621 (D3) where the specification states that “it is possible to obtain a product having more than 30% by weight of phospholipids, optionally more than 35% by weight of phospholipids”. However there is no indication that the ingredient with this concentration of phospholipids is produced by a method which does not comprise a solvent extraction step using an organic solvent, as clearly required by claim 1. I am not therefore satisfied that it is clear from the face of the specification that the invention of claim 1 lacks the threshold requirement of inventiveness.

21. In relation to claim 10, while the techniques of centrifugation, ultrafiltration and ultrafiltration/diafiltration individually may be well known, none of the prior art discussed in the specification would immediately suggest that by using these well known techniques it is possible to obtain a phospholipid concentration of greater than 20% without also involving any solvent extraction steps using an organic solvent. I am not therefore satisfied that it is clear from the face of the specification that the invention of claim 10 lacks the threshold requirement of inventiveness.

22. This ground of the opposition has not been made out.

    CONCLUSION

23. None of the grounds of the opposition has been made out. The claimed invention is novel, inventive, fully described and a manner of manufacture.

100. The application is to proceed to grant subject to any appeal being filed within the relevant period.

COSTS

101. It is normally the case that costs follow the event. I see no reason to vary that usual approach on this occasion. As the opposition has been entirely unsuccessful I award costs according to Schedule 8 against the opponent.

R Subbarayan
Delegate of the Commissioner of Patents