Fonterra Co-operative Group Limited v Meiji Dairies Corporation - [2014] APO 64

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Fonterra Co-operative Group Limited v Meiji Dairies Corporation [2014] APO 64

Patent Application: 2006288405

Title:Milk material with good flavor and physico-chemical properties and process of producing the same

Patent Applicant:  Meiji Dairies Corporation
Opponent:  Fonterra Co-operative Group Limited
Delegate:  Dr S.D. Barker
Decision Date:  16 September 2014
Hearing Date:  19 August 2014 in Canberra
Catchwords:  PATENTS – opposition to the grant of a patent – invention described has heat treatment after reduction in dissolved oxygen – other heating processes can take place prior to reduction in dissolved oxygen – claims construed as having the same requirement – claims are novel and inventive – claims 7 and 8 lack clarity – opportunity to amend

Representation: Patent applicant: Dr Andrew Blattman and Dr Daniel Sieveking of Spruson & Ferguson
Opponent:Denis Tuffery and Kate McHaffie of AJ Park

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2006288405

Title:Milk material with good flavor and physico-chemical properties and process of producing the same

Patent Applicant: Meiji Dairies Corporation
Date of Decision: 16 September 2014
DECISION
The opposition succeeds on the ground of lack of clarity in relation to claims 7 and 8.
I allow the applicant two (2) months from the date of this decision to propose amendments to overcome this deficiency.
I make no award of costs.
REASONS FOR DECISION

Patent application number 2006288405 was filed on 29 August 2006 (as an application under the provisions of the Patent Cooperation Treaty). The applicant is Meiji Dairies Corporation (Meiji). The application was examined and accepted by the Commissioner, and subsequently opposed by Fonterra Co-operative Group Limited (Fonterra). A hearing was held on 19 August 2014 in Canberra to decide the opposition.
The opposition
The statement of grounds and particulars identified several grounds of opposition. At the hearing, the opposition was conducted on the grounds of novelty, inventive step, manner of manufacture and section 40.
The parties relied upon evidence by several declarants. Evidence in support consists of declarations by Anura Rohan Wewala, Scott James Gardiner, Dennis Charles Hurren (Hurren 1). Evidence in answer consists of a declaration by Geoffrey W. Smithers (Smithers 1). Evidence in reply was not filed in time (Fonterra Co-operative Group Limited v Meiji Dairies Corporation [2014] APO 11). Further evidence was filed in the form of a declaration by Dennis Charles Hurren (Hurren 2). Responding evidence consists of a declaration by Geoffrey W. Smithers (Smithers 2). I will refer to the relevant parts of the evidence where appropriate.
The specification
The specification relates to milk products. The specification ends with 8 claims. Claims 1 and 6 are the only independent claims.
What is the invention as described
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214, 100 IPR 451 at [139]:
"It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date."
The background to the invention
The specification relates generally to the production of concentrated milk or milk powder (page 1):
"a process of producing concentrated milk or milk powder, concentrated milk or milk powder obtainable by the process; and foods and beverages with good flavor and physico-chemical properties which uses the same"
At page 2 the specification sets out what can be regarded as the problem that the present invention addresses:
"since milk powder is produced via processes such as concentration and drying, milk powder has been problematic so far in that the great freshness, smooth touch and aftertaste essential to raw milk are all poor in the case of milk powder. Although concentrated milk has no such unpleasant reconstituting odor as that of milk powder and has good flavor in comparison with milk powder, concentrated milk never has the good freshness, highly smooth touch and good aftertaste of fresh milk."
The cause of flavour problems is already recognised in the art. At page 3 the specification notes:
"The flavor of phospholipid is readily deteriorated via oxidation, which is one of the causes of the flavor deterioration of concentrated milk and milk powder."
Later on that same page the role of ions in flavour is noted:
"Various ingredients such as ion are concentrated and present in milk powder and concentrated milk. Generally, it is known that chloride ion not only influences flavor itself but also damages vitamin or reacts with organic matters in food. Additionally, metal ion is known as a cause of salty taste, bitterness and astringent taste."
The specification acknowledges that methods of removing ions from milk are known. Several methods are listed: ion exchange, electrodialysis and membrane separation. The specification acknowledges that methods of removing dissolved oxygen from butter milk are known, and this gives an improved flavour to the butter milk powder (page 6):
"A process of obtaining butter milk powder with good flavor by concentrating and drying butter milk sterilized under heating in a condition with reduced dissolved oxygen concentration is disclosed (Patent reference 3)."
The aim of the invention
The specification sets out to address the problem of flavour in concentrated milk and milk powder. At page 7 the issue is summed up:
"Concerning the problem of conventional concentrated milk and milk powder that, although they are simply handled, they are not at a level sufficiently satisfactory in terms of flavor, it is an object of the invention to provide concentrated milk and milk powder not only with flavor such as good taste, freshness, great smooth touch and good aftertaste essential to fresh milk as a raw material but also with further improvement of the flavor, as well as a process of producing the same."
The nature of the invention
At page 6 the specification sets out in general terms the basis of the invention. That is, oxidation of proteins and fatty acids can take place during the heating of the milk. Oxidation leads to the formation of sulphides and aldehydes, which have an off-flavour. The relevant passage reads:
"On the other hand, it is remarked that the change of milk flavor due to heating and sterilization is caused by the generation of sulfides and aldehydes on the basis of the heating oxidation of milk protein and fatty acids. In a case of concentrated milk and milk powder, steps of heating treatment such as concentration under heating and spray-drying in hot air are added. Therefore, it is expected that these products from oxidation under heating will increase. It is expected that, in the case of the concentrated milk and milk powder, there occurs further loss of the flavor such as good taste, freshness great smooth and good aftertaste essential to fresh milk, in comparison with the case of sterilized milk."
At page 8 the specification identifies the invention as follows:
"The present inventors made intensive studies so as to solve the above problems. Consequently, the inventors have found that concentrated milk and milk powder obtainable by removing a part of ions, followed by heating treatment in a condition of low dissolved oxygen have good flavor, in comparison with usual milk powder and concentrated milk, and that they give the good taste, freshness, good smooth touch and good aftertaste essential to fresh milk when they were used as raw materials for beverages and the like. Further, the inventors have found that, when such concentrated milk and milk powder are used as raw materials for milk products and bread, not only the improvement of flavor but also the improvement of physicochemical food properties such as fine texture and porosity can be exerted."
It is clear that the process that is described requires sterilisation to take place after the reduction in oxygen content. This arrangement reduces oxidation during sterilisation.
Meiji argued that the invention should be construed as eliminating any active heating prior to the sterilisation. The specification contains little support for such a construction. The specification is silent on whether active heating steps can take place prior to sterilisation. The examples demonstrate processes in which there is no explicit heating step prior to sterilisation (but see my consideration of the examples below).
Given what the specification says about reducing the dissolved oxygen content prior to heat treatment, it is an obvious inference that the dissolved oxygen causes oxidation during the heat treatment. From this it might be inferred that it would be undesirable to carry out any steps involving heating until after the oxygen content had been reduced, as this would minimise the chance of oxidation. However, the specification does not say this, and it does not specify any control of temperature in other processing steps (see the discussion of "heat treatment" below). I do not consider that the specification suggests avoiding heating steps prior to the heat treatment.
This is not an absurd view of the invention. The temperature conditions used for sterilisation are much higher than those used in other processing steps. It is quite reasonable that the presence of oxygen at the high temperatures of sterilisation is the cause of the bulk of off-flavours compared to any oxidation that may take place during other processing steps.
The examples
The specification contains examples in which milk is treated to remove ions, reduce oxygen content and heat treated. In Example 1 raw milk is filtered using a nanofiltration membrane at 10°C, and then the oxygen content is reduced by bubbling nitrogen gas through the milk. The milk is sterilised by heating to 100°C for 45 seconds. The product is evaporated under reduced pressure to give a concentrated milk, and then spray dried to give a milk powder.
In Example 2 raw milk is defatted using a continuous centrifuge separator. The defatted milk is then treated in different ways to demonstrate the effect on flavour. For instance, in a control product the defatted milk was sterilised then dried. In a first comparative example the defatted milk was filtered and then sterilised. In a first example of the invention the defatted milk was filtered and then sealed with nitrogen gas until the dissolved oxygen content reduced, and subsequently sterilised. In a second example of the invention the defatted milk was sealed with nitrogen gas until the dissolved oxygen content reduced and then filtered, and subsequently sterilised.
Does the product have better taste?
The specification contains results of taste testing (page 26):
"So as to assess the flavor and characteristic features of these reconstituted defatted milk samples, an organoleptic assessment was done. The organoleptic assessment was done by a panel of 10 experts having been trained to discriminate five types of taste (sweetness, sourness, salty taste, bitterness, umami) according to a two-point comparative method."
A number of tables are included in the specification, and these broadly support the assertion of improved flavour. The Wewala declaration contains criticism of this methodology. However, whatever the limitations of the methodology used, the specification contains a basis to assert that the products of the process have improved flavour.
Construction of claim 1
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228 at [118] – [120]:
"the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification"
Claim 1 is the key claim. It reads:
A process of producing concentrated milk or milk powder, comprising:
removing ions from milk, and
reducing the dissolved oxygen concentration, followed by subjecting the milk to a heat treatment.
The first thing to note is that claim 1 is a process. As such it is characterised by the steps of the process. The process involves the treatment of milk to produce concentrated milk or milk powder.
The starting material for the process is milk. Fonterra said that it is not clear what type of milk can be used. The answer surely is any type of milk. The dictionary definition of milk is a fluid secreted by female mammals for nourishment of their young. Further, I see no reason to read down the language to only raw milk and to exclude defatted milk. This accords with what the specification says at page 11. The product of the process is either concentrated milk or milk powder.
The process is defined as "comprising" three specified steps. It was submitted that "comprising" should be interpreted in an inclusive manner, so that the process can include additional steps. This is entirely logical. The process will not produce a concentrate or powder without further processing steps, so "comprising" must be understood to be inclusive.
The three specified steps of the process are:
(a)"removing ions from milk",
(b)"reducing the dissolved oxygen concentration", and
(c)"subjecting the milk to a heat treatment".
What is the order of steps?
The words of the claim tell us that steps (a) "and" (b) are "followed by" step (c). Clearly step (c) must happen after steps (a) and (b). However, there is no limitation on whether step (a) takes place before or after step (b). Further, I see no reason that steps (a) and (b) could not take place in a single stage.
What is heat treatment?
The declarants disagreed over the meaning of "heat treatment". Mr Hurren said in Hurren 2 at [6]:
"The term 'heat treatment' in my view is a process in which heat is applied to milk to effect some or total kill of bacteria present in the milk."
Dr Smithers thought that "heat treatment" means any process in which the temperature is deliberately increased. In Smithers 2 at [13] he says:
"In my view, heat can be applied to a material in either an active manner whereby a source of energy is actively applied to the material in order to raise the temperature, or a passive manner where the source of energy is indirect (such as the shearing effects associated with pumping milk) and results in elevation of the temperature of the material in unintentional way. I understand the term 'heat treatment' to relate to application of heat to a material in an active manner."
However, Mr Hurren thought that the term "heat treatment" is being used in claim 1 in this broader sense (Hurren 2 at [8]):
"It is clear to me that in the context of claim 1 of the opposed application the term 'heat treatment' is being used to include both processes that I have identified as 'heat treatment' and 'pre-heating'."
Mr Hurren does not provide an explanation why he would not use the plain meaning of "heat treatment" (as he understands that term) when construing claim 1. I am forced to give little weight to Mr Hurren's view that the plain meaning should not apply to the claim. Given that the term seems to mean different things to different people, there is a potential ambiguity. In order to resolve the ambiguity it is permissible to resort to the body of the specification to define or clarify the meaning of words used in the claims (Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461 at 479).
The specification does not contain a dictionary that defines the term "heat treatment". Instead there are a number of uses of the term throughout the specification. At page 6, while discussing the background art, the specification suggests that a broad interpretation should apply to the term "heating treatment":
"steps of heating treatment such as concentration under heating and spray-drying in hot air"
However, elsewhere the specification seems to equate sterilisation and heat treatment. Under the heading "Best Mode for Carrying out the Invention" at page 10 the specification says:
"The invention relates to a process of producing concentrated milk and milk powder, including a combination of removing ions from milk and reducing the dissolved oxygen concentration in milk, followed by conducting heat sterilization"
On page 13 the specification says:
"Milk after the ion removal and the reduction of the dissolved oxygen concentration is then subjected to a heat sterilization treatment, for the purpose of killing bacteria and inactivating enzymes such as protease."
Example 1 shows a process in which the treatment following removal of ions and reduction of oxygen is a sterilisation:
"Immediately, sterilization under heating at 100°C for 45 seconds was done with a UHT plate type experimental sterilizer"
In Example 2, the heat treatment is also "sterilization of the processed milk under heating at 125°C for 15 seconds".
While I am reluctant to come to a conclusion that is at variance from the views of the declarants, I am left with the predominant impression that the specification is using the term "heat treatment" to mean sterilisation. This is the way that I construe the term for the purposes of claim 1.
Can there be a heating stage prior to the heat treatment?
Meiji argued that if steps (a) and (b) are "followed by" a heat treatment, then there necessarily cannot be any heating prior to steps (a) or (b). I think that goes beyond the plain meaning of the words. All that the words require is that a sterilising heat treatment take place after steps (a) and (b). Any other steps, including steps involving heating, may take place prior to steps (a) or (b).
Construction of claims 7 and 8
The other claims that need to be considered for the purposes of this decision are claims 7 and 8. Claim 7 reads as follows:
Concentrated milk or milk powder with good flavor, which is obtainable by the process according to any one of claims 1 to 6.
Claim 7 is directed to a product "with good flavour". Mr Hurren is of the view that this is an ambiguous term (see Hurren 1 at [161]: "A milk powder that may be good flavour for one customer or use may not be a good flavour for another", and [164]: "There is no standard measure of 'good flavour' of milk powder"). Dr Smithers thought that it was an inherent property of all of the products of the process claims (Smithers 1 at [81]: "a person of skill would appreciate that flavour enhancement would be inherent to the claimed invention"). In the context of the specification, which asserts that the processes described produce products of improved flavour, I consider the claim is intended to refer to "good flavour" as an inherent property, not as a limitation.
The other significant aspect of the claim is that the product is "obtainable" by the process of any of claims 1 to 6. The plain meaning of "obtainable" is that the product is able to be produced by that process. Consequently it is a requirement of claim 7 that the product can be produced by the process, not that it is produced by the process.
Claim 8 reads as follows:
Concentrated milk or milk powder with excellent properties as a raw food material, which is obtainable by the process according to any one of claims 1 to 5.

This claim is directed to a product that has "excellent properties as a raw food material". Similarly to what I said in relation to "good flavour" in relation to claim 7, I consider that this is intended to be a statement of an inherent property. The product is also "obtainable" by the process of any one of claims 1 to 5. Similarly to what I said above, this means that the product can be produced by the process of any one of claims 1 to 5, not that it is produced by that process.
Novelty
It is a requirement of subsection 18(1) of the Patents Act (the Act) that the invention, so far as claimed in any claim, is novel. Subsection 7(1) states that an invention is taken to be novel unless it is not novel in the light of the prior art. A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim.
It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 at [20], 137 CLR 228 at 235:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement"
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must "contain clear and unmistakeable directions to do what the patentee claims to have invented" (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486).
Fonterra relied solely on the disclosure of the processes carried out at the Murray Goulburn Leongatha Branch in September 1997 (the Murray Goulburn process). Hurren 2 describes the Murray Goulburn process at [65] – [69]:
"The process initially was to separate incoming milk at <10°C by preheating to 50°C and then separating into defatted milk at 0.05% fat and cream at 40% fat. The resultant defatted milk was chilled to <10°C and stored in a 150,000 litre silo. After a period of time the 10°C defatted milk was supplied to an ultrafiltration plant where ash (ions) and lactose was removed and the proteins concentrated to 50% in the dry solids (retentate). This concentrate was then supplied to a vacuum evaporator where the product was pasteurised (heat treated) heated to 75°C and held for 30 seconds, before being concentrated to 45% total solids and then spray dried.
So this process comprised:
(i)Raw <10°C raw [sic] whole milk allowed to stand in silo for more than 1 hour (remove air).
(ii)Milk preheated to 50°C (removal of dissolved oxygen to a level of about 4 ppm)
(iii)Then defatted through a normal warm or hot bowl.
(iv)Defatted milk stored in silo at <10°C for up to 5 hours (remove air). I would not expect the level of dissolved oxygen to change significantly during this storage period.
(v)Ultrafiltration (remove ions).
(vi)Product heat-treated in evaporator (heat treatment after air (oxygen) removal and ions removal).
In approximately September 2003 an ultrafiltration plant was installed at Murray Goulburn Maffra Plant to produce MPC-42 (milk protein content 42% in the dry solids).
MPC-42 was produced several days a week before August 2005 and sold to customers in Australia. As at January 2014 it is still installed and operational at Maffra.
The process is identical to that detailed above for manufacture of MPC-50 except that proteins are only concentrated to 42%."
At [72] – [73] he goes on to say:
"I am aware that similar plants were installed by at least one other company (Fonterra now owns this plant) and various MPC products were produced and were sold in Australia before August 2005.
I believe this was using standard technology that any dairy technologist in Australia was familiar with and capable of installing and operating a plant prior to August 2005."
The risk associated with evidence drawn from recollection is at the heart of the long established principle that evidence of prior use should be corroborated. Meiji referred me to Windsurfing International Inc v Petit (1983) 3 IPR 449 at 489:
"It is essential that an allegation of prior public use should be strictly proved. Evidence which is uncorroborated is undoubtedly suspect and should be scrutinized with particular care. The Court must be satisfied that the proof is sufficient in the circumstances, having regard to the gravity of the allegation."
I note the evidence in Hurren 2 is not corroborated in any way, and is a rudimentary and selective description of the process. It is rudimentary because it is a summary of the process that omits technical information to enable me to form my own opinion of whether the process is the same as that which is claimed in the present application. It is selective as it only provides the information that matches the claimed invention and is silent on any additional information that would allow me to fully understand the process. Clearly the evidence has significant limitations. However, even if I accept the evidence at face value it does not establish a lack of novelty.
At the hearing I questioned whether this process could be properly said to involve reduction of the dissolved oxygen level followed by heat treatment. The reason for this is that it is well established that the level of dissolved oxygen is inversely related to temperature – at higher temperatures the dissolved oxygen level decreases, and at lower temperature the dissolved oxygen level increases. This is a fairly normal physical chemistry observation of the solubility of gases, and is shown in graphical representation in Figure 2 in Exhibit DCH-3 attached to Hurren 1. In the Murray Goulburn process there is a heating step (which necessarily reduces dissolved oxygen) followed by a cooling and holding for up to 5 hours. Mr Hurren says this step is to "remove air". My understanding is that this allows bubbles to escape, rather than reduce dissolved oxygen. In fact the dissolved oxygen content should increase as the temperature of the milk falls. Such a process could only fall within the scope of the claims of the present application if the word "comprising" in claim 1 permits an extra step of increasing the dissolved oxygen content after the oxygen content has been reduced and before the heat treatment. I consider this an absurd construction of the claim. Even if the information about the Murray Goulburn process can be considered it does not establish a lack of novelty.
Inventive step
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art. A document is prior art for this purpose if "a skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded [the document] as relevant" (subsection 7(3)).
The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12 at [45], 148 CLR 262 at 286 Aickin J stated:
"The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."
The High Court approved this approach in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59, 212 CLR 411.
Fonterra relied upon the common general knowledge alone to allege lack of inventive step. The evidence shows that each of the steps of the process (considered individually) is well known in the milk processing art. I will accept that they are part of the common general knowledge. The only question is whether it would have been a matter of routine to combine the steps in the claimed order. The evidence fails to address this point directly.
I was referred to Hurren 1 at [56] as providing indirect support for the proposition:
"There is no technical reason at all why the two systems could not be used together, for instance a vacuum flash vessel prior to a nano filtration plant or a nano filtration plant prior to an evaporator."
and
"By combining one of the ion exchange removal processes with one of the dissolved oxygen removal systems would not have any adverse effect on flavour."
However, this does not address the critical question of whether it would have been a matter of routine. In the absence of evidence, I am not satisfied that it would have been a matter of routine, and consequently it has not been established that the claimed invention lacks inventive step.
Clarity
It is a requirement of subsection 40(3) of the Act that the claims must be clear. This requirement is understood to be satisfied if there would be "no difficulty in a third party ascertaining whether or not what he proposes to do falls within the ambit of the claim" (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59). Lack of precision in language is acceptable, within limits:
"Lack of precise definition in claims is not fatal to their validity, so long as they provide a workable standard suitable to their intended use."
(Austal Ships Sales Pty Ltd v Stena Rederi Aktiebolag [2008] FCAFC 121, 77 IPR 229 at [81])
Claim 1 contains several terms that are of broad scope. I discussed these terms in my construction of the claim earlier, and none of them render the claim unclear.
Claim 7
Following from my construction of this claim, the aspect of claim 7 that needs to considered is the term "obtainable". As discussed above, the product defined by claim 7 must be the same as that produced by the process of any one of claims 1 to 6, but it may be produced by any process.
It was argued by Fonterra that this claim imposes a heavy burden on a person in order to determine whether or not they are infringing the claim. This is because it is irrelevant whether they are carrying out the process of any of claims 1 to 6. What they need to determine is whether they are making a product that could be produced by the process of any of claims 1 to 6. In other words, if a person had a milk product that was not produced by the process of any of claims 1 to 6, could they determine from an inspection of the product whether it could be produced by the process of any of claims 1 to 6? I think the answer is NO. The only way that a person could determine whether a product is "obtainable" by the process of claim 1 is to assemble the equipment necessary to perform the range of processes covered by claim 1, prepare ALL of the milk products that can be made by the process of claim 1, and then analyse those products. I have looked to the evidence of the declarants to see whether they consider this to be an acceptable standard in the art.
Mr Hurren seems to have construed the claim as limited to products that are produced by the process of any of claims 1 to 6 (Hurren 1 at [159]: "Claim 7 claims that concentrated milk or milk powder obtained by the process is good flavour [sic]"). Consequently, he does not consider this point. Dr Smithers seems to have had the same views (Smithers 1 at [22]: "the milk powder and/or concentrate generated by the process, as per claims 7 and 8"). Consequently, there is no evidence whether either declarant considers this an acceptable standard.
A lack of evidence on a key point is often the basis for finding that an opponent has failed to make out their case. I do not believe that this is such a case. To determine whether a product fell within the scope of claim 7 a person would be required to carry out at least thousands (and probably many millions) of tests according to the method of any one claims 1 to 6. This would involve years of work solely to determine the scope of the claim. I have no doubt that this is not a workable standard.
This is not to say that the term "obtainable" will always lead to ambiguity in a claim. It is the context in which the term "obtainable" appears in claim 7 that makes the claim unclear.
Claim 8
Claim 8 similarly suffers from a lack of clarity due to the use of the term "obtainable".
Full description
It is a requirement of subsection 40(2) of the Act that the specification must describe the invention fully. The High Court in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at [25], 207 CLR 1 at 17 explained this requirement as:
"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?"
It is ambiguous whether Example 2 relates to a process in which the defatting is carried out at low or high temperature. Either is possible. Both fall within the scope of claim 1. Example 1 does not suffer from any such difficulty. There is sufficient disclosure to enable a person to produce something within the claims. There is no lack of full description.
Manner of manufacture
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.
Fonterra allege that the invention defined by claim 1 is a mere collocation of known steps, in order to bring about known effects in milk and produce known substances. As discussed under the ground of inventive step, I accept that the steps of the process are each known and part of the common general knowledge. However, the specification shows that there is a flavour advantage if ion removal and oxygen reduction take place prior to heat treatment (for instance, the tests forming part of Example 2). This provides a basis to conclude that there is a working interrelationship between the steps, and they are not a mere collocation.
Conclusion
The opposition succeeds. Claims 7 and 8 lack clarity. As this is a matter than can be easily overcome by amendment I will allow a period of time for Meiji to propose amendments.
Costs
The parties submitted that costs should follow the event. In this case Fonterra has succeeded in the opposition, but that success is only in relation to the clarity of claims 7 and 8. The clarity of these claims is a matter that was not explicitly particularised in the statement of grounds and particulars (although the ground of lack of clarity is included). At the hearing Fonterra said that clarity was the major issue, but it was a minor part of the opposition that was foreshadowed by the statement of grounds and particulars.
The award of costs should reflect the fact that Fonterra's success was limited to a clarity matter that was not particularised. It is appropriate to make no award of costs.
Dr S.D. Barker
Delegate of the Commissioner of Patents