Rimfrost AS v Aker BioMarine Antarctic AS
[2018] APO 34
•30 May 2018
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Rimfrost AS v Aker BioMarine Antarctic AS [2018] APO 34
Patent Application: 2014256341
Title:A new method for making krill meal
Patent Applicant: Aker BioMarine Antarctic AS
Opponent: Rimfrost AS
Delegate: Dr A. Lim
Decision Date: 30 May 2018
Hearing Date: 27 February 2018, in Canberra
Catchwords: PATENTS – section 59 – opposition to the grant of a patent – allowability of amendments to the statement of grounds and particulars under regulation 5.16 considered – it has not been established that any of the claims fail to comply with the grounds of clarity, claims defining the invention, sufficiency, support, utility, novelty and manner of manufacture – all the claims lack an inventive step in light of prior art citations – opposition succeeds – costs awarded against the applicant – opportunity to amend
Representation: Patent attorney for the applicant: Dr Thomas Mark Boyce from Pizzeys Patent and Trade Mark Attorneys
Counsel for the opponent: Ms Katrina Crooks from Shelston IP Pty Ltd.
Patent attorney for the opponent: Dr Michael Zammit from Shelston IP Pty Ltd.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2014256341
Title:A new method for making krill meal
Patent Applicant: Aker BioMarine Antarctic AS
Date of Decision: 30 May 2018
DECISION
The opposition is successful on the ground of inventive step.
Each of claims 1-6 lacks an inventive step in light of the prior art.
It has not been established that claims 1-6 fail to comply with the grounds of clarity, claims defining the invention, sufficiency, support, utility, novelty and manner of manufacture.
I allow Aker BioMarine Antarctic AS two months from the date of this decision to propose amendments.
Costs according to Schedule 8 are awarded against Aker BioMarine Antarctic AS.
REASONS FOR DECISION
Patent application number 2014256341 (the opposed application) was filed on 29 October 2014 as a divisional application from 2013202260 (the parent application). The parent application is a divisional application from 2012244229 (the grandparent application). The grandparent application is a divisional application from 2008291978 (the great grandparent application). The opposed application claims priority from US 60/968,765 (the priority document) filed on 29 August 2007. The applicant at the time of filing the opposed application was Aker BioMarine AS which subsequently assigned its rights to Aker BioMarine Antarctic AS (Aker).
The opposed application was examined and advertised accepted by the Commissioner on 14 April 2016. The application was subsequently opposed under section 59 of the Patents Act 1990 (the Act) by Rimfrost AS (Rimfrost) and Enzymotec Ltd (Enzymotec). Enzymotec subsequently withdrew its opposition on 14 October 2016, and this withdrawal was advertised on 27 October 2016. The present matters concern the opposition by Rimfrost. Rimfrost served a notice of opposition on 14 July 2016 and filed a statement of grounds and particulars (SGP) on 14 October 2016.
Aker requested leave to make voluntary amendments to the claims of the opposed application on 13 April 2017. These amendments were allowed 10 August 2017, and details of allowance were advertised on 24 August 2017. Consequently the amendments form part of the specification.
A hearing was held on 27 February 2018 in Canberra to decide the opposition. Aker was represented by Dr Thomas Mark Boyce who did not attend the hearing and relied solely on written submissions. Rimfrost was represented by Ms Katrina Crooks and Dr Michael Zammit, both from Shelston IP Pty Ltd.
1 Amendments to the SGP
An application to amend Rimfrost’s SGP was filed on 10 February 2017. Particulars in relation to the ground of novelty regarding four new documents that were uncovered during the preparation of evidence in support (EIS) and filed with the EIS were added to the SGP. Additional common general knowledge identified by the expert witness, Professor Colin Barrow, was also added to the SGP. The amendments were allowed 08 March 2017.
A second request to amend Rimfrost’s SGP was filed on 17 July 2017. Particulars forming the basis of paragraph 40(2)(b), failure of the specification to end with a claim or claims defining the invention, were added to the SGP. The amendments were allowed on 04 August 2017.
A third request to amend Rimfrost’s SGP was filed on 01 March 2018 to correct errors in the citation used in the previously filed SGP to reference two documents filed in evidence. Rimfrost provided written confirmation with their request that the two documents intended to be referred to in the SGP and considered by their expert witness are those filed in evidence. Aker was given an opportunity to make further submissions in relation to the two documents in light of the errors identified in the evidence of the opponent and in the SGP should it wish to do so. Aker filed a letter in response confirming that they had also relied on the two documents filed in evidence.[1] Aker also stated in their letter that they did not object to the amendments to the SGP proposed by Aker.
[1] Letter from Aker dated 09 March 2018.
I am satisfied the amendments to the SGP filed on 01 March 2018 should be allowed.
2 The opposition
The grounds of opposition pressed at the hearing were:
·lack of clarity,
·failure of the specification to end with a claim or claims defining the invention,
·lack of a clear enough and complete enough disclosure in the specification,
·lack of support,
·lack of utility,
·lack of novelty,
·lack of inventive step, and
·claimed invention is not for a manner of manufacture
The evidence is summarised in the table below.
Evidence Declarant Exhibits Date Reference In Support Colin Barrow CB-1 to CB-12 13 January 2017 Barrow #1 In Answer Finn Myhren FM-1 to FM-2 10 April 2017 Myhren In Reply Colin Barrow None 15 June 2017 Barrow # 2
The request for examination of the opposed application was filed on 31 October 2014. As a consequence, the amendments of the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 apply to the present application. This includes subsection 60(3A) of the Act which states:
(3A) If the Commissioner is satisfied, on the balance of probabilities, that a ground of opposition to the grant of the standard patent exists, the Commissioner may refuse the application.
The standard of proof that applies to the present opposition is the balance of probabilities, and Rimfrost carries the onus of proof.
3 The specification
The specification relates to processing krill to provide oil and meal products. The specification has six claims. Claim 1 is an independent claim. Each claim is reproduced in this decision and will be discussed in due course.
3.1 Principles of construction
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd:
“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.”[2]
[2] [2013] FCA 214 at [139]; 100 IPR 451.
3.2 The field of the invention
The specification states the following in regard to the technical field:
“The invention relates to processing crustaceans such as krill to provide oil and meal products, and in particular to the production of oils containing astaxanthin and phospholipids comprising omega-3 fatty acid moieties and meal rich in astaxanthin.”[3]
[3] The present specification at page 1A, lines 4 – 6.
3.3 The person skilled in the art
It is well established that many of the issues in an opposition are answered by reference to the person skilled in the art:
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”[4]
[4] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70]; 177 ALR 231.
However, the person skilled in the art is an artificial construct that is used as a tool of analysis, and there is a danger in trying to identify them as an actual person or persons:
“The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.”[5]
[5] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]; 89 ALJR 798.
An understanding of the person skilled in the art is based on evidence from persons with knowledge of the art as to the things that they know and do, and what they understand to be commonly known and done. Professor Barrow has many years’ industry and academic experience in identifying and isolating bioactive compounds from marine organisms.[6] From 2001 to 2009, Professor Barrow headed the research and development division of Ocean Nutrition Canada Ltd (ONC) with the aim of developing nutraceutical and functional food ingredients from marine organisms.[7] Professor Barrow states that ONC become the world’s largest supplier of fish oil for human nutrition during his time in ONC.[8] Mr Myhren has many years’ academic and industry experience in organic chemistry.[9] From 1984-2001, Mr Myhren was the director of research organic chemistry at Norsk Hydro Research Centre (Norsk Hydro) in Norway and was involved in various projects including the development of tailored surfactant systems used in off-shore oil fields, use of deuterium technology in fibre optics, solvents for NMR spectroscopy and pharmaceutical products. [10] Mr Myhren stated that he was a project resource, and not a project leader, for a project at Norsk Hydro to isolate and purify the omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA), from marine sources.[11] From 2001-2013 Mr Myhren lead the chemical and pharmaceutical development of cancer drugs at Clavis Pharma (Oslo).[12] Mr Myhren stated that his work at Clavis Pharma gave him good insights in production, isolation and use of phospholipids, their chemistry, behaviour and functionality in formulations.[13] In 2013, Mr Myhren became an employee of Aker Biomarine AS.[14]
[6] Barrow #1 at [1] – [19]; Annexure CB-1.
[7] Barrow #1 at [6] – [8].
[8] Barrow #1 at [6].
[9] Myhren [1] – [10]; Annexure FM1.
[10] Myhren [4] – [6].
[11] Myhren at [6].
[12] Myhren at [9]; Annexure FM1.
[13] Myhren at [9].
[14] Myhen at [10]; Aker Biomarine AS subsequently assigned its rights to Aker BioMarine Antarctic AS, the applicant of the opposed application.
Rimfrost submit that since Mr Myhren is an employee of Aker, his evidence lacks the independence required of an expert witness.[15] Rimfrost also submit that Mr Myhren cannot be considered as a person skilled in the art as at the priority date he had no experience in processing crustaceans such as krill to provide oil and meal products, and had no experience in the production of oils as at 29 August 2007.[16] Consequently, Rimfrost submit I should treat Mr Myhren’s evidence with considerable caution.[17] I consider Mr Myhren’s employment with Aker only after the priority date does not necessarily disqualify him as a skilled person. This is because he can at least acquire knowledge, known at the priority date, from his colleagues at Aker regarding processes used to produce krill oil and krill meal products. Mr Myhren’s knowledge and experience as a chemist can be helpful to an understanding of the production, isolation and use of phospholipids.
[15] Rimfrost’s written submissions dated 13 February 2018 at [23].
[16] Rimfrost’s written submissions dated 13 February 2018 at [19].
[17] Rimfrost’s written submissions dated 13 February 2018 at [23].
I consider that all of the declarants mentioned above are in a position to provide evidence as to what the person skilled in the art knew and would have done. The weighing and evaluating of the evidence to decide the characteristics of the person skilled in the art is part of the normal work of a delegate of the Commissioner.
3.4 The aim of the invention
Krill, a crustacean which lives in all the major oceans world-wide, is the food source for many animals such as fish, birds, sharks and whales. [18] Euphausia superba (also known as Antarctic krill) is a species that can be found in the Southern Ocean around Antartica.[19]
[18] The present specification at page 1A, lines 9 - 13.
[19] ibid.
Antarctic krill feeds on phytoplankton during the short Antarctic summer, but its food supply during the winter is limited resulting in a depletion of body protein for energy.[20] The specification describes that in order to accommodate variations in food supply krill has an efficient enzymatic digestive system for the rapid breakdown of proteins.[21] This enzymatic system becomes, post mortem, an autoproteolysis process which is highly efficient, making it a challenge to catch and store krill in a way that preserves the nutritional quality of the krill.[22]
[20] The present specification at page 1A, lines 15 – 17.
[21] The present specification at page 1A, lines 20 – 21.
[22] ibid.
In order to prevent degradation of krill the enzymatic activity is either reduced by storing the krill at low temperatures or the krill is made into a krill meal.[23] Krill is cooked during the krill meal process to denature all the active enzymes.[24]
[23] ibid.
[24] ibid.
The specification states:
“During the krill meal process the krill is cooked so that all the active enzymes are denatured in order to eliminate all enzymatic activity. Krill is rich in phospholipids which act as emulsifiers. Thus it is more difficult to separate water, fat and proteins using mechanical separation methods than it is in a regular fish meal production line. In addition, krill becomes solid, gains weight and loose liquid more easily when mixed with hot water. Eventually this may lead to a gradual build up of coagulated krill proteins in the cooker and a non-continuous operation due to severe clogging problems.” [25]
[25] The present specification at page 1A, lines 26 – 32.
I understand the above-quoted portion of the specification to mean that during the process to make krill meal, krill is heated in hot water to denature active enzymes. I also understand that since krill is rich in phospholipids, the phospholipids emulsify the fats making it difficult to separate the fats (oil)[26] from the protein solids using mechanical separation methods that are commonly used for making fish meal.
[26] The present specification on page 42 describes extracted oil to comprise phospholipids, triglycerides, cholesterol and fatty acids which include omega-3 fatty acids. I therefore interpret the fats which are dispersed in the in the hot water when heating krill to include phospholipids, triglycerides, and fatty acids.
The specification describes that in order to alleviate the clogging problems in the cooker, hot steam must be added directly to the cooker.[27] Addition of hot steam is described as energy demanding and may result in degradation of bioactive compounds such as omega-3 fatty acids, phospholipids and astaxanthin.[28]
[27] The present specification at page 1A.
[28] The present specification at pages 1A – 2.
The specification states:
“Hence, there is a need for a method of processing krill into a krill meal at more gentle conditions which prevents the degradation of these valuable bioactive compounds.”[29]
[29] The present specification at page 2, lines 7 – 9.
Therefore, I conclude that the aim of the invention is to provide an alternative method of processing krill using more gentle conditions in order to preserve the quality of oils (such as omega-3 fatty acids and phospholipids) and other bioactive compounds (such as astaxanthin) of krill. I understand that preserving the quality of krill oil and bioactive compounds improves the quality of the krill meal produced as well as the quality of the extracted oil.
3.5 The invention as described in the specification
Under the heading “Summary of the invention”, the specification sets out various different aspects of the invention. These include processes for preparing phospholipid compositions from krill,[30] processes for forming a meal,[31] processes for extracting oil from the liquid phase that results from heating the krill in water,[32] processes for extracting oil from the solid phase that is separated from the liquid phase after heating krill in water,[33] and a process for extracting oil from a membrane filtered portion of the liquid phase—termed retentate in the specification—that results from heating the krill in water.[34]
[30] The present specification at page 2.
[31] The present specification at page 3.
[32] The present specification at page 4, line 14, to page 5, line 10.
[33] The present specification at page 5, lines 22 – 32.
[34] The present specification at page 5, lines 13 – 22.
The specification states that previous processes for treating krill have utilised a single high temperature treatment to provide a proteinaceous product which has relatively low lipid content.[35] The specification distinguishes the process of the opposed application to be a process in which krill is first heated to moderate temperatures to provide an aqueous phase which is subsequently heated to a higher temperature.[36] The process is described to provide a novel protein-lipid composition which has a higher lipid content than previously described compositions produced from krill.[37]
[35] The present specification at page 13, lines 20 – 25.
[36] The present specification at page 13, lines 25 – 27.
[37] The present specification at page 13, lines 27 – 29.
Two-heating step process
The abstract of the opposed application describes a new two-step cooking process for krill meal production and states:
“A new method for krill meal production has been developed using a two step cooking process. In the first step the proteins and phospholipids are removed from the krill and precipitated as a coagulum. In the second stage the krill without phospholipids are cooked. Following this, residual fat and astaxanthin are removed from the krill using mechanical separation methods. A novel krill meal product with superior nutritional and technical properties is prepared.”
The specification states:
“In some embodiments, the biomass (preferably krill, freshly harvested or frozen) is heated to a temperature in the range of 25 to 80°C, preferably 40 to 75°C, and most preferably 60 to 75°C in order to dissolve/disperse lipids and proteins from the krill into the water phase, which is called krill milk.”[38] (emphasis added)
[38] The present specification at page 14, lines 3 – 7.
and
“In some embodiments, the processes then utilize a second heating step. The proteins and phospholipids are precipitated out of the water phase produced from the first heating step by heating the krill milk (after removal of the krill solids) to a temperature of greater than about 80°C, preferably 80 to 120°C, most preferably 95 to 100°C. ….. The precipitate formed (hereafter called a coagulum) can be isolated and characterized. In some embodiments, the processes further comprise the steps of pressing and drying the coagulum to form a coagulum meal.”[39]
[39] The present specification at page 14, lines 9 –13, and lines 19 – 22.
First heating step: Heating krill in water to a temperature about 80°C or below
I understand from the above-quoted portions of the specification that a portion of the phospholipids are removed from the krill in a step where krill is heated in water to a temperature about 80°C or below. The temperature range of this heating step (termed first heating step in the specification) is stated to be about 25 to 80°C, preferably 50 to 75°C, and most preferably 60 to 75°C.[40] This first heating step results in dissolution or dispersion of lipids and proteins from krill into the water phase. The water phase containing the lipids and proteins dispelled from krill is termed “krill milk” in the specification.
[40] The present specification at page 4, lines 15 – 18.
Second heating step: Heating krill solids or krill milk to a temperature of greater than about 80°C
After the first heating step, the krill milk is separated from the krill solids by a separation step, for example, sieving through a metal sieve or filtration.[41] At this point, there can be a second heating step—heating to a temperature greater than about 80°C—resulting in one of the following three possible paths:
[41] The present specification at page 15, lines 26 –33; Example 2, page 22 – 23, Figure 1; Example 4, page 30.
1.the krill solids are heated to a temperature of greater than about 80°C (path 1 method);
2.the krill milk is heated to a temperature of greater than about 80°C (path 2 method); and
3.the krill milk is filtered through a membrane (path 3 method).
The temperature range of the second heating step is stated in the specification to be preferably about 80 to 120°C, most preferably about 90 to 100°C.[42]
[42] The present specification at page 4, line 35 to page 5, line 1.
I will now discuss example 2 and example 4 of the opposed specification as these examples describe the above-mentioned different paths which result in production of a krill meal and extraction of krill oil.
Example 2
The specification describes example 2 as a “process of making krill meal with a two-stage cooking process” and includes Figure 1 to provide an overview of the process.[43] Figure 1 has been reproduced in Annex A of this decision.
[43] The present specification at pages 22 – 23.
Professor Barrow has made a diagrammatic representation of example 2 in his first declaration at paragraph 159. I have also reproduced Professor Barrow’s diagrammatic representation of example 2 in Annex B of this decision.
Heating krill in water to a temperature of 75°C—the first cooking step
Example 2 describes a first cooking step where frozen krill and preheated water (95-100°C) were mixed in a cooker (Cooker 1, Figure 1) at a temperature of 75°C for 6 minutes. The heated krill (termed “preheated krill” in Example 2 and Figure 1) and hot water (termed “liquid” in Figure 1) were then separated by filtration.
Heating the preheated krill to a temperature of 90°C—the second cooking step of a method which processes the krill solids that result from the first heating step (Path 1 method)
The preheated krill was further cooked (in cooker 2) by mixing with hot water (95°C) and maintaining the temperature at 90°C for 2 minutes. The cooked krill was then separated from the hot water, transferred to a food processor and cut. The cut hot krill was added back to the hot water and centrifuged to provide a solid fraction (termed “Solid (Ds)” in Figure 1, or decanter solids in the specification) and a liquid fraction (termed “Liquid (Dl)” in Figure 1, or “decanter liquid” in the specification). Processing preheated krill (krill solids), produced from the first heating step, to form decanter solids and a decanter liquid in example 2 is an exemplification of what I have previously categorised as a path 1 method. In Professor Barrow’s diagrammatic representation of example 2, this method is depicted as the left-hand path, after the first fork. Table 3 of the specification describes the distribution of fat and astaxanthin in the decanter solids and decanter liquid of example 2.
Heating the liquid that results from the first cooking step to a temperature of 95-100°C—the second cooking step of a method which processes the liquid (krill milk) from the first cooking step (Path 2 method)
The “liquid” from the first cooking step (cooker 1) was described in example 2 to be heated to 95-100°C to coagulate “the extracted protein”.[44] I understand the “liquid” from cooker 1 to be krill milk because this is the water phase that is separated from the preheated krill (krill solids) after the first heating step where krill was heated in water to a temperature of 75°C. I also understand “the extracted protein” to be the proteins that were dispelled into the water phase as a result of the first cooking step where krill was heated in water to a temperature of 75°C. Therefore, I understand the coagulum of example 2 to be the precipitate (comprising proteins and phospholipids) formed when the krill milk from cooker 1 is heated to 95-100°C. The coagulum of example 2 is described to be separated from the coagulated liquid (termed “Cl” in Figure 1, or “coagulated cooker liquid” in Table 2 and Table 3) by sieving.
[44] The present specification at page 23, lines 6 –7.
I consider the process of heating the krill milk to a higher temperature of 95-100°C to form the coagulum to be an exemplification of what I previously categorised as a path 2 method. In Professor Barrow’s diagrammatic representation of example 2, this method is depicted as the right-hand path, after the first fork. Tables 3 and 4 of the specification describe the distribution of fat and astaxanthin in the coagulum and coagulated cooker liquid of example 2.
Example 4
Example 4 describes the three different method paths I categorised above—path 1, path 2 and path 3 methods. Professor Barrow has made a diagrammatic representation, termed Figure 3, of the methods of example 4 in his first declaration at paragraph 164. I will refer to Figure 3 contained in Professor Barrow’s declaration as Figure 3, Barrow #1 and have reproduced this figure in Annex C of this decision.
Heating step 1: A step common to path 1-3 methods
Krill was added to water at 95°C and mixed to obtain a mixture at a temperature of 75°C.[45] This heating step, common to the path 1-3 methods, is termed “heating step no. 1” in the specification.[46] The heated krill was separated from the water by sieving.[47]
[45] The present specification at page 30, lines 15 – 19.
[46] ibid.
[47] ibid.
The specification states that the fat content in cooked krill is reduced because of the fat in the krill milk which is separated from the cooked krill.[48] I understand this statement to mean that as a result of heating krill to a temperature of 75°C, some lipids are dispelled into the water and therefore separated as krill milk such that the cooked krill (which is separated from krill milk) has a reduced fat content.
[48] The present specification at page 31, lines 9 – 11.
Heating step 2 (path 1 method; Figure 3, Barrow #1, “second heating step route”)
The sieved preheated krill, produced after heating step 1, was added to hot water and heated to 85°C. [49] This heating step is termed “heating step 2” in the specification.[50] The krill was sieved again, fed into a press to produce a press liquid[51] and a press cake.[52] Oil was separated from the press liquid by centrifugation.[53] The oil produced from the pressed liquid has quite a high content of astaxanthin.[54]
[49] The present specification at page 30, lines 19 – 20.
[50] ibid.
[51] The present specification at page 30, lines 20 – 22.
[52] The present specification at page 33, lines 24 – 25, page 34, Tables 16 and 17.
[53] The present specification at page 34, lines 8 – 9; Table 18.
[54] ibid.
I consider the process described in example 4 which includes the following steps:
·heating krill in water to a temperature of 75°C;
·separating the krill solids and krill milk by sieving;
·heating the krill solids to a higher temperature of 85°C;
·separating the twice-cooked krill solids from the liquid by sieving;
·pressing the twice-cooked krill solids to obtain a liquid and a solid fractions; and
·centrifuging the liquid fraction to extract an oil
to be another exemplification of the path 1 method. In Figure 3, Barrow #1, this method is termed “second heating step route” and depicted as the left-hand path.
Tables 43-46 provide information regarding the content of different lipids, protein and astaxanthin of the press cake meal. I consider the press cake meal that was analysed in Tables 43-46 to be the press cake meal produced by the path 1 method. My interpretation is consistent with Figure 3, Barrow #1 which refers to Tables 43-46 in the second heating step route.
Tables 39 - 42 provide information regarding the content of lipids, protein and astaxanthin of the press cake meal produced by what the specification terms a “traditional process”.[55] Professor Barrow states that it is unclear what the “traditional process” comprises.[56] I consider that it is a reasonable interpretation that the “traditional process” being referred to is a conventional process of processing krill with a single high temperature treatment which the specification described to have been previously used.[57]
[55] The present specification at page 47, line 3.
[56] Barrow #1 at [181].
[57] The present specification at page 13, lines 20 – 25.
Comparing the information in Tables 44 and 45 to that in Tables 40 and 41, the values for the content of fat, triacylglycerol and free fatty acids are reported lower for the press cake meal produced by the path 1 method of the opposed application compared to the respective values of krill meal produced by the traditional method. Comparing the information in Table 46 to that in Table 42, the protein content of the press cake meal produced by the path 1 method is reported higher compared to krill meal produced by the traditional method. This is consistent with the description in the specification that the krill meal product produced from the solid phase left after the first heating step has a low fat and a high protein content.[58]
[58] The specification at page 17, lines 27 – 30.
Coagulation and microfiltration (Path 2 method; Figure 3, Barrow #1, “Coagulation / microfiltration route”)
The krill milk that was separated from the preheated krill after heating step 1 was coagulated at about 95°C and the solids formed as a result of the coagulation (termed “coagulum”) separated from the liquid by microfiltration.[59] The coagulum was pressed in a press to form a coagulum press cake. [60] The coagulum press cake was dried to form a coagulum meal.[61]
[59] The present specification at page 30, line 21; page 31, lines 14 – 15.
[60] The present specification at page 31, lines 15 – 16; Tables 13, 19, and 21.
[61] The present specification at page 31, lines 15 – 16; page 35, lines 5 – 6; Table 21.
The coagulum meal produced was extracted by supercritical fluid extraction (SFE) in a two-step process described in Example 5. The first extraction step used carbon dioxide to extract a fraction described in the specification as a neutral fraction.[62] The components of the neutral fraction are described in Table 29. The second extraction used carbon dioxide and ethanol to extract a fraction described in the specification as a polar fraction.[63] The components of the polar fraction are described in Table 30. The content of lipids, fatty acids and astaxanthin of the oil extracted by SFE is described in Tables 32, 33 and 34 of Example 8.
[62] The present specification at page 39.
[63] The present specification at pages 39 – 40.
I consider the process described in example 4 which includes the following steps:
·heating krill in water to a temperature of 75°C;
·separating the krill solids and krill milk by sieving;
·heating krill milk at a higher temperature of about 95°C to form a coagulum;
·separating the coagulum from the liquid by microfiltration;
·pressing the coagulum to form a coagulum press cake;
·drying the coagulum press cake; and
·extracting an oil from the dried coagulum press cake by SFE
to be another exemplification of a path 2 method. In Figure 3, Barrow #1, this method is termed “Coagulation/microfiltration route” and is depicted as the middle path.
Membrane Filtration (Path 3 method; Figure 3, Barrow #1, “Membrane Filtration” route)
The krill milk that was separated from the preheated krill after heating step 1 was filtered through a sieve (having openings of 100 µm) and subsequently filtered through a membrane filter (having openings of 100 nm) to collect the lipids from the krill milk.[64] Microfiltration produces a fraction called a retentate (solid phase) and a liquid permeate.[65] The permeate and retentate of example 4 was concentrated by evaporation.[66] The composition of the permeate and retentate were analysed and compared to vacuum dried coagulum. Tables 14, 15, 20 and 37 describe the compositions of the various fractions. Table 20 shows that there is very little difference in composition between the retentate from microfiltration compared to coagulum. Table 37 shows the phospholipid content of retentate including 1.7% alkylacylphosphatidylcholine (AAPC) and 0.28% lyso- alkylacylphosphatidylcholine (LAAPC).
[64] The present specification at page 32, lines 10 – 14.
[65] The present specification at page 14, lines 24 – 25; page 16, lines 12 – 13.
[66] The present specification at page 33, lines 3 – 9.
The specification describes that in some embodiments a retentate oil is extracted from the retentate concentrate.[67]
[67] The present specification at page 5, lines 21 – 22.
I consider the process described in example 4 which includes the following steps:
·heating krill in water to a temperature of 75°C;
·separating the krill solids and krill milk by sieving;
·separating the krill milk by microfiltration into the fractions termed retentate and permeate;
·concentrating the retentate by evaporation; and
·extracting an oil from the retentate concentrate
to be another exemplification of a path 3 method. In Figure 3, Barrow #1, this method is termed “membrane filtration route” and depicted as the right-hand path.
Summary
The embodiments of the paths 1-3 processes described above have a first common step of heating krill to a temperature of 75°C. The temperature range of the first heating step is stated in the specification to be about 25 to 80°C, preferably 50 to 75°C, and most preferably 60 to 75°C. The first heating step functions to denature the active digestive enzymes of krill and disperses lipids and proteins from krill into the hot water to form krill milk.
The specification states:
“By removing the coagulum, the krill meal process is less susceptible to clogging problems and the use of hot steam in the cooker can be avoided. The data disclosed show the coagulum contains a high percentage of phospholipids, hence the separation of the fat in the new krill meal process can be obtained using mechanical methods as in standard fish meal processes. In fact, the separation of fat from the meal is important. Ideally, the krill meal should have a low fat value in order to have satisfactory technical, properties. Mechanically separating the fat from the meal will result in a neutral oil rich in astaxanthin.”[68]
[68] The present specification at page 16, lines 21 – 27.
I understand the portion of the specification quoted above to mean that because the proteins and phospholipids are removed from the krill after the first heating step, further heating of the preheated krill is less susceptible to clogging problems and the use of hot steam in the cooker can be avoided. I also understand that because a large proportion of the phospholipids are removed in the first heating step, mechanical methods used in standard fish meal processes can be used to extract oil from the twice-cooked krill solids produced by the path 1 method since the emulsifying effect of the phospholipids no longer limits the separation of fat. My understanding is consistent with the process described in the abstract which I previously discussed.
The first step of heating krill in water produces:
·a liquid phospholipid-protein fraction (krill milk) by dispersing phospholipids and proteins into the hot water; and
·a solid phospholipid-protein fraction (krill solids) that can be separated from the krill milk, and from which krill oil can be extracted by mechanical methods (such as pressing or centrifugation) because the emulsifying effect of the phospholipid has been reduced.
I consider the embodiments of the paths 1-3 processes each have a second step that can be broadly described as producing a solid composition from either the krill milk or krill solids. In the path 1 process, the solid composition produced is the sieved twice-cooked krill solid fraction or press cake meal. In the path 2 process, the solid composition produced is coagulum meal formed by precipitating phospholipids and proteins in the krill milk. In the path 3 process, the solid composition produced is retentate concentrate or retentate meal formed by filtering krill milk and concentrating the solid phase by evaporation.
I consider the embodiments of the paths 1-3 processes each have a third step that can be broadly described as extracting krill oil from the solid composition produced.
In summary, I consider the processes of extracting oil from krill described in the opposed specification and exemplified by the paths 1-3 processes to have the following three broad steps:
·heating krill to a first temperature, which includes a temperature range of about 25 to 80°C, to produce two phospholipid-protein fractions (krill milk and krill solids);
·producing a solid composition from the krill milk or krill solids; and
·extracting krill oil from the solid composition produced.
3.6 Technical background that forms part of the common general knowledge
Before construing the claims it is helpful to review what was already known in the art before the priority date, 29 August 2007, about krill, krill oil, krill meal, methods for processing krill and methods for extracting krill oil.
Common general knowledge (CGK) is the background knowledge and experience available to all those working in the relevant art:
“The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”[69]
[69] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9 at [115]; 144 CLR 253 at page 292.
Professor Barrow states in evidence that he considers all information in an article authored by Grantham G. J., entitled ‘The utilisation of krill’, and published by the Food and Agriculture Organisation of the United Nations in 1977 (Grantham article), to be part of the common general knowledge as at August 2007.[70] Professor Barrow also notes that Mr Myhren does not contest his statements regarding what he considered commonly known in the field as at August 2007.[71] I have read Mr Myhren’s evidence and agree that he does not contest Professor Barrow’s characterisation of the CGK. As part of weighing and evaluating evidence, I will also take into account statements in the published documents filed in evidence when considering Professor Barrow’s uncontested statements. I will now consider Professor Barrow’s evidence which relates to krill oil, krill meal, methods for processing krill and methods for extracting oil from biological and marine-base material.
[70] Barrow #1 at [72].
[71] Barrow #2 at [28].
Krill oil
Professor Barrow states that krill is characterised by a high content of phospholipids (approximately 60%, which consist of mainly phosphatidylcholine and phosphatidylethanolamine), and has about 30-40% neutral fats (which consist of mono-, di and triglycerides).[72] I understand Professor Barrow’s characterisation of the fat content in krill is based on the values reported in the Grantham article.[73] The Grantham article presents reported literature values for the composition of crude lipids from krill, and states that although the fat content of krill varies markedly, its composition seem to remain fairly constant. [74] I understand the statement to be a statement of fact that even where there is variation in the fat content of krill, the proportion of the various lipids which constitute the fat composition remains constant.
[72] Barrow#1 at [73].
[73] Grantham article, Table 6, page 12.
[74] Grantham article, Table 6, page 12; section 2.5, page 11.
Professor Barrow states that the term “lipid” is generally used to denote the group of naturally occurring molecules that includes fats, fatty acids and their derivatives (including tri-, di-, monoglycerides, and phospholipids), as well as waxes, sterols and fat-soluble vitamins.[75]
[75] Barrow #1 at [38].
Professor Barrow also states that any reference to “oil” in his declaration should be taken to be synonymous with the terms fats, lipids, fatty acids and their derivatives (including tri-, di-, monoglycerides, free fatty acids and phospholipids).[76] I understand Professor Barrow’s statement to mean that a person skilled in the art would use the terms “oil”, “fats”, “lipids”, “fatty acids”, “triglycerides”, “diglycerides”, “monoglycerides”, and “phospholipids” interchangeably.
[76] Barrow #1 at [39].
Professor Barrow states that phospholipids are a class of lipids that are a major component of all cell membranes.[77] Phospholipids can be categorised into various species which include non-ether phospholipids (for example, phosphatidylcholine, phosphatidylserine, phosphatidylinositol and phosphatidylethanolamine), ether phospholipids (for example, alkylacylphosphatidylcholine or AAPC, lyso-alkylacylphosphatidylcholine or LAAPC, and alkylacylphosphatidylethanolamine or AAPE), and lyso-phospholipid (for example, lyso- phosphatidylcholine or LPC, lyso-phosphatidylinositol or LPI, and lyso- phosphatidylserine or LPS).[78]
[77] Barrow #1 at [43].
[78] Barrow #1 at [46] – [49].
Professor Barrow states:
“Krill oil commands a significantly higher price in the marketplace than fish oil (and did as at August 2007), mainly due to: a) the presence of phospholipids, b) a high level of omega-3 fatty acids in phospholipid form rather than triglyceride form, and c) the presence of astaxanthin. Whilst krill meal is a valuable product, it is the krill oil which is the most valuable component, and therefore krill are usually treated with more gentle processing steps in order to minimise any damage to the krill oil. Processing is also optimised at oil extraction, rather than meal production, as was at least traditionally the case with fish meal/oil processing.”[79]
[79] Barrow #1 at [73].
I understand from the above quote that both krill meal and krill oil were commonly known to be valuable products at the priority date of the opposed application.
Professor Barrow also states that to avoid mechanical damage and the onset of enzymatic degradation, krill is usually piped on board in sea water, and then either stored on board in a frozen state (around 0°C, or preferably lower), substantially dried to slow down the autolysis process, or processed into oil/meal on board.[80]
[80] Barrow #1 at [74].
Shell and gut removal are stated by Professor Barrow to be common processing steps which are accomplished by centrifugal action or by gentle pressing, but pressing is less preferred because it tends to remove some of the soluble proteins and some of the triglycerides.[81]
[81] ibid.
Krill meal
Professor Barrow states that krill meal has been produced since the 1960s by cooking, pressing and drying.[82] Professor Barrow refers to the Grantham article and the process for krill meal and krill oil production outlined in a flow sheet on page 29 of that article.[83] A copy of this flow sheet and the table has been reproduced in Annex D of this decision.
[82] Barrow#1 at [75] – [78].
[83] Grantham article, pages 27 – 30.
The Grantham article states:
“The most common present-day method of cooking, pressing and drying has been found to be readily applicable to krill; ..”[84]
[84] Grantham article, page 27.
I consider Professor Barrow’s characterisation of the processes used for krill meal production, and the statement from the Grantham article quoted above, tell me that cooking, pressing and drying krill were processes for krill meal production that were commonly known to the person skilled in the art, at the priority date. Since the flow chart on page 29 of the Grantham article shows pressing or centrifuging as methods for extracting oil from the cooked krill, I consider these methods were commonly used to extracting oil from krill.
The Grantham article also states that fat separation is very poor after cooking and pressing, and suggests that this is probably due to the high phospholipid content of krill fat forming a stable emulsion.[85] The optimal heating temperature for cooking krill was stated to be 90 - 95°C.[86] The Grantham article also states that as a consequence, little or no oil is recoverable from the application of traditional fish meal processing.[87] I understand the Grantham article to characterise oil separation as poor in the context of cooking at the optimal temperature of 90 - 95°C.
[85] Grantham article, page 28, paragraph (iii).
[86] Grantham article, page 27.
[87] ibid.
Professor Barrow notes that the Grantham article states that the yields and quality of krill meal are adversely affected by prolonged heating or excessive temperature, and reduction of boiling temperature to around 85°C substantially reduces these losses while still inactivating enzymes that degrade krill.[88] Tyrosinase, described in the Grantham article to be the most heat stable, is stated to be inactivated at 78°C.[89] Professor Barrow also states:
[88] Barrow #1 at [76]; Grantham article, page 30, section 3.4.6.
[89] ibid.
“By 2007, further investigations had been made into lower cooking temperatures. It was recognised that cooking temperature was also an important factor determining the yield of krill meal. For example, even as early as FAO Fisheries Technical Paper 268: Possibilities of processing and marketing of products made from Antarctic krill (1985) (Budzinski) (a copy of which is annexed marked ‘CB-4’), it is noted at page 20 that the optimum temperature is believed to be at around 80-85°C.
On page 30, Grantham also notes that cooking has traditionally been achieved on board ship by immersion in tanks of boiling seawater. Budzinski, at page 20, also notes the possibility of use of a flow heat exchanger such as the Contherm
apparatus, which I have discussed above.” [90][90] Barrow #1 at [76] – [77]; the article referenced on paragraph 76 was authored by Budzinski, E., Bykowski, P., and Dutkiewicz, D, and produced as part of the program of the Food and Agriculture Organization of the United Nations concerning the state and prospects of world fisheries.
I have viewed the FAO Fisheries Technical Paper 268 by Budzinski et al. (Budzinski article) and the mentioned optimum cooking temperature of 80-85°C for krill meal production is described in the context of model-based and commercial trials. I note that the information in the Budzinski article is not advanced by Professor Barrow as being part of the CGK. I consider the description in the Budzinski article and the “further investigations” by 2007 that Professor Barrow refers to in the above-quoted statements do not establish that a cooking temperature of 80-85°C for krill meal production was commonly known in the art at the priority date, 29 August 2007.
I note that page 30 of the Grantham article which Professor Barrow refers to in the above-quoted statements indicates that cooking has traditionally been achieved by immersion in boiling sea-water. A reference is made to a Japanese patent (Kyokuyo 1976) which describes continuous boiling at 90°C. Another reference of cooking made on page 30 of the Grantham article is to a method by the West Germans where cooking in saturated steam at atmospheric pressure provided a krill meal of similar quality and higher yield. The descriptions of cooking temperatures in the Grantham article are consistent with a finding that 90 - 95°C was commonly known in the art to be the cooking temperature for krill meal production at priority date, 29 August 2007.
Methods for processing krill
Krill Meal Production
The flow sheet on page 29 of the Grantham article (see Annex D) shows that the cooked krill (item “2”) is pressed or centrifuged to produce a liquid phase (item “4”) and a residue or press cake (item “3”). The liquid phase is centrifuged to produce oil (item “5”) and stickwater (item “6”). The stickwater is evaporated to produce a concentrate (item “8”) which is added to the wet milled residue or press cake to form a wet meal (item “9”). The wet meal is dried in a dryer and milled to form krill meal (item “11”).
I understand the commonly used method to extract krill oil involved pressing or centrifuging cooked krill to produce a liquid phase which was subsequently centrifuged to obtain krill oil.
Professor Barrow states:
“The liquid phase contains some oil, which I expect to be mostly triglycerides, since pressing of krill does not generally liberate much of the phospholipid content, even after cooking. The residue or press cake (3), wet meal (9) and krill meal (11) (which is formed after drying of the wet meal) contain mostly protein with the majority of the oil which is initially present in the krill, which will comprise around 60:40 phospholipids:triglycerides and astaxanthin. The oil and astaxanthin are clearly present in appreciable quantities, and so it is worthwhile extracting and recovering them.”[91]
[91] Barrow #1 at [78].
The proportion of water, fat and total fat free dry substances of the various fractions of the process represented on the flow sheet on page 29 of the Grantham article are shown in a table below the flow sheet. The table shows that the fat content of the residue or press cake (item 3) is comparatively higher than the liquid phase (item 4) or oil (item 5).
I understand Professor Barrow’s characterisation of the proportion of phospholipids, triglycerides and astaxanthin in the oil, in the paragraph quoted above, to be based on the fact that proportion of these components in krill oil remains constant. This characterisation is consistent with the fact, as previously discussed, that even where there is variation in the fat content of krill, the proportion of the various lipids which constitute the fat composition remains constant. Professor Barrow’s characterisation that pressing krill after cooking does not liberate much of the phospholipid content is consistent with the characterisation in the Grantham article that fat separation is poor after cooking at 90-95°C and subsequent pressing.
The Russian paste process
The Grantham article states a Russian method of processing krill to produce krill paste is best documented.[92] A flow sheet of the Russian method is provided on page 25 of the Grantham article. A copy of this flow sheet is reproduced in Annex E of this decision.
[92] Grantham article, pages 24 – 26.
The text on page 24 of the Grantham article describes the basic Russian paste process involves heat coagulation of minced krill at 90-97°C to produce flakes. The flakes are separated from the remaining uncoagulated broth and then ground to form a paste which is then frozen and packed. The flow sheet appears to indicate heating a liquid fraction (“juice”), produced by pressing krill that has previously been subjected to autolysis, also coagulates krill proteins to produce flakes. An article authored by Yanase, M and filed in evidence describes modifying the Russian paste process by autolysing krill at 45°C for 1-4 h, pressing the autolysed krill to obtain a liquid which is heated to 95°C to coagulate the krill proteins[93] The references at the bottom of the flow sheet cite Yanase 1974b, and page 26 of Grantham describes a process of Yanase 1974b similar to that disclosed in the Yanase article filed in evidence. Therefore, I consider it is reasonable to interpret the flow sheet on page 25 of the Grantham article to mean that heating a liquid fraction, produced from pre-heated or autolysed krill, to 90-97°C coagulates krill proteins.
[93]Yanase, M., “Modification of Russian Method for Separating Heat Coagulated Protein from Antartic Krill”, 1974, Bulletin of Tokai Regional Fisheries Research Laboratory, No.78, pages 79 – 84. ). A copy of the paper was filed as part of Professor Barrow’s evidence in support and entitled annexure CB-7.
Professor Barrow states in evidence that heating is a typical method used to coagulate proteins in fish meal production at the priority date of the opposed application.[94] Professor Barrow also states that the method for krill meal production is effectively the same as for fish meal production with little modification.[95] The typical method for fish and oil production as at 29 August 2007 was as follows:
[94] Barrow #1 at [53] – [55].
[95] Barrow #1 at [71], [75].
“heating, which coagulates the protein, ruptures the fat deposits and liberates oil and physiochemically bound water;
pressing or centrifugation, which removes a large fraction of the liquids from the mass;
separation of the liquid into oil and water (stickwater);
evaporation of the stickwater into a concentrate (fish solubles);
drying of the solid material (presscake) plus added solubles, which removes sufficient water from the wet material to form a stable meal, and
grinding the dried material to the desired particle size to form fish meal.”[96]
[96] Barrow #1 at [55] – [56] which references FAO Fisheries Technical Paper 142, “The production of fish meal and oil”, published by the Food and Agriculture Organization of the United Nations in 1986 (Technical paper 142). A copy of the paper was filed as part of Professor Barrow’s evidence in support and entitled annexure CB-2.
Professor Barrow states the most common practice of cooking raw fish material was to heat to 95° to 100°C for a short time, such as 15 to 20 minutes.[97] Professor Barrow states that over time it became recognised that lower temperature could be used, and refers to FAO Fisheries Technical Paper 142 (Technical paper 142) to further state there is little to be gained by using temperature above 75°C.[98] Professor Barrow subsequently states that the teaching in Technical paper 142 is consistent with his understanding that exposing fish to temperatures between 50 to 75°C is sufficient to break down cells, coagulate proteins and inactivate enzymes. I have viewed the Technical Paper 142 and the portion Professor Barrow refers to describes the use of temperatures between 50 to 75°C to heat fish to as “new experiments” and “new knowledge”.[99] Therefore, I consider heating fish to a temperature between 50 to 75°C was not commonly known for heating fish to produce fish meal and oil. I conclude heating fish to 95° to 100°C was commonly known for fish and oil production as at 29 August 2007.
[97] Barrow #1 at [61] which references FAO Fisheries Technical Paper 142, citation details outlined in footnote 94.
[98] ibid.
[99] FAO Fisheries Technical Paper 142 at pages 19 – 20.
In light of the typical method for fish meal production characterised by Professor Barrow, and Professor Barrow’s statement that krill meal production is effectively the same as fish meal production, I consider that heating of krill was used to coagulate krill proteins. From the processes described above for producing krill paste and krill meal, I consider it is a reasonable interpretation that a skilled person would understand heating krill solids and krill liquid to a temperature range of about 90 - 100°C was known, at the priority date, to be a typical method used to coagulate krill proteins.
I note that Technical paper 142 describes a pre-straining step that occurs before the pressing or centrifugation step in the typical method for fish meal production.[100] This step separates a large amount of liquid from the solids by simple draining and is stated to facilitate pressing to extract oil and reduce moisture in the press cake.[101] The patent US4,133,077, filed in evidence states that draining is a conventional method used to separate excess water from heated krill which was further processed to obtain krill protein[102] Therefore, I consider straining was commonly known, at the priority date, to be used to remove excess water after heating fish or krill in a typical method of meal production.
[100] FAO Fisheries Technical Paper 142 at page 23, section 3.1.2.
[101] FAO Fisheries Technical Paper 142 at page 23, sections 3.1.2 and 3.1.3.
[102] US 4,133,077 was filed in evidence as annexure CB-11.
Methods for extracting oil from biological and marine-base material including krill
At the start of his evidence on CGK (section D) Professor Barrow makes overarching statements that he has provided information based on what was known to him as at August 2007, and believes that this information would have been well known to others in the field of utilisation of marine biomass, including the krill oil industry, in Australia and throughout the world.[103] However, at the start of his evidence in relation to methods known for extracting oil from biological and marine-based materials (section D.4) Professor Barrow states that the information is his knowledge generally.[104] In his second declaration, Professor Barrow again refers to knowledge of solvent extraction methods used to extract oil from biological materials as his knowledge.[105] As part of evaluating whether section D.4 of Professor Barrow’s evidence is his knowledge rather than the knowledge of the bulk of persons working in the art I will take into account what the published documents filed in evidence state about solvent extraction methods used in the field of marine biomass. I note that Mr Myhren does not contest evidence Professor Barrow’s evidence in regard to what was commonly known about solvent extraction methods used to extract oil from biological materials.
[103] Barrow #1 at [37].
[104] Barrow #1 at [96] – [102].
[105] Barrow #2 at [28].
Professor Barrow states that pressing is the most basic oil extraction method applied to fish in order to obtain fish meal. In this method, fish meal is heated to liberate oil from fat deposits and then pressed with a screw press under pressure to squeeze out as much of the liquid as possible from the meal.[106] Professor Barrow stated:
[106] Barrow #1 at [97].
“It was well known that pressing does not extract all of the oil from the fish. In particular, pressing cannot extract any significant amount of phospholipids because the polar components are bound up, for example in cell walls, and cannot be easily released through heating and pressing. Also the aim in fish meal production is normally to have some oil remaining in the fish meal as a certain amount of oil is nutritionally advantageous.”[107]
[107] ibid.
As previously discussed, the Grantham article characterises fat separation as very poor after cooking krill at 90-95°C and pressing. I conclude it was commonly known, at the priority date, that pressing does not extract any significant amount of oil containing phospholipids from krill or fish that was heated to about 90°C or above this temperature.
Professor Barrow also states:
“Solvent extraction is an alternative method of oil extraction. It is more efficient at extracting oil from biomass than pressing, but it is also more expensive. Solvent extraction has been well known and used as an extraction method since at least the 1970s. The biomass is treated with one or more solvents, such as acetone, hexane or ethanol……..
A combination of solvents, particularly polar and non-polar, was also used prior to August 2007 to extract different types of fats, i.e. a selective lipid/oil extraction. The solvents can be used sequentially to remove non-polar and then polar oils….
One specialised method of solvent extraction of a biomass is supercritical CO2 extraction (SCE). SCE has been known since at least the 1990s. SCE is a species of solvent extraction in which supercritical CO2 functions as a solvent. CO2 is compressed above its critical pressure and heated above its critical temperature to become a supercritical fluid which is used to extract oil and lipids. Supercritical CO2 can also be used as part of a sequential extraction. The triglycerides are mostly obtained in a first extraction with pure CO2, and then in a subsequent extraction, the phospholipids can be mostly obtained by adding a polar solvent to the CO2 (e.g. ethanol). A co-solvent, such as ethanol, can be used to improve selectivity and solubility, thereby enabling the extraction of more polar phospholipids.
Once the oil-solvent mixture is separated from the residue, there are a number of options to separate the solvent from the extracted oil, the most common being solvent evaporation, typically under reduced pressure.
In summary, it was commonly known before August 2007 to use different solvents to remove different types of oils from a biomass (polar and non-polar). As mentioned above, this was the method I used at ONC to conduct research into the triglyceride and phospholipid proportions in krill oil.”[108]
I understand Professor Barrow’s statements quoted above to tell me that solvent extraction is (1) a known method for extracting oil from biomass that is an alternative to pressing, (2) more expensive, and (3) used by him in the context of research. I also understand that supercritical CO2 extraction (SCE) is a specialised method which involves the use of different solvents to extract the polar and non-polar components of krill oil, and not a commonly used method.
I will now outline how the published documents filed in evidence characterise solvent extraction methods used to extract oil from krill and fish.
The Grantham article states fat and astaxanthin to be by-products of the process of krill meal production that are of potential interest. Solvent extraction is stated to be one means of recovering fat and astaxanthin from dried krill protein concentrates and whole boiled krill or shell waste. Solvent mixes included acetone and petroleum ether, iso-propanol and n-hexane, and chloroform[109]. I consider statements characterising fat and astaxanthin as by-products of potential interest and solvent extraction as one method of recovering the by-products do not characterise solvent extraction as commonly used to extract fat and astaxanthin from krill products.
The Technical Paper 142 states solvent extraction of fish meal is used for “certain special purposes” where further reducing or practically eliminating fat from fish meal of oily fish is done because of extremely low tolerance to fat of marine origin.[110] The Technical Paper 142 also states solvent extraction of fish meal introduces an extra cost that has proved difficult to retrieve from actual markets.[111]
[108] Barrow #1 at [98] – [102].
[109] Grantham article, section 3.4.8, page 31.
[110] FAO Fisheries Technical Paper 142, section 3.3.5, page 44.
[111] ibid.
100. The Budzinski article states that krill oil could be a valuable raw material for the oil, cosmetic and pharmaceutical industries but since solvent extraction costs are high and special installations are needed, “it is unrealistic to expect production of krill oil in practice.”[112]
[112] Budzinski, E., Bykowski, P. and Dutkiewicz, D., FAO Fisheries Technical Paper 268, “Possibilities of processing and marketing of products made from Antarctic krill”, 1985, published by the Food and Agriculture Organization of the United Nations, section 4.7, page 24. A copy of the paper was filed as part of Professor Barrow’s evidence in support and entitled annexure CB-4.
101. I understand the Technical Paper 142 and the Budzinski article to tell me that whilst solvent extraction can be done, this method is not practical on an industrial scale for krill oil and fish meal production because of the high costs involved. The characterisation of solvent extraction in the articles tells me that solvent extraction was not commonly used to extract oil from krill or fish on an industrial scale. I note these articles were published 8 to 9 years after the Grantham article.
102. I will now discuss two later published documents which were filed as part of Professor Barrow’s evidence-in-support in order to establish what was known about the use of solvent extraction to extract oils containing phospholipids around the priority date of the opposed application. These documents are an article by Tanaka et al (Tanaka), published 2004,[113] and a patent document WO 2007/123424 A1, published on 01 November 2007[114] (Catchpole).
[113] Tanaka, Y. , Sakaki, I. and Ohkubo, T., “Extraction of Phospholipids from Salmon Roe with Supercritical Carbon Dioxide and an Entrainer”, Journal of Oleo Science, 2004, Vol. 53, No.9, pages 417 – 424. A copy of the paper was filed in evidence as annexure CB-9.
[114] WO 2007/123424 was filed in evidence as annexure CB-5.
103. Tanaka states that supercritical carbon dioxide (SC-CO2) is a suitable substance to extract non-polar substances (such as triacylglycerols) but extraction of polar substances (such as phospholipids) with SC-CO2 is not effective. The article reports a study using a mixture of SC-CO2 and ethanol to extract phospholipids from salmon fish roe. I conclude that the use of SC-CO2 was being developed at the publication date of Tanaka in 2004.
104. Catchpole described the use of supercritical fluid extraction processes using carbon dioxide and another solvent for extracting phospholipids from sources, such as egg, soy, and marine animals and plants. Example 18 described extraction of freeze-dried krill material using supercritical CO2 and ethanol. The background section of the patent states that existing methods for isolation of phospholipids rely on chromatographic techniques which are slow and costly processes to operate, and also states these techniques can require the use of solvents that are unsuitable or undesirable in products for nutritional, pharmaceutical or human use.
105. I consider the description in Catchpole to tell me use of solvents, such as ethanol, in combination with SC-CO2 to extract phospholipids from food sources was still being developed before the publication of Catchpole on 01 November 2007 and therefore not commonly used at the priority date of the opposed application. Additionally, I consider the statements characterising existing solvent extraction methods to be time-consuming and costly, as well as solvents being unsuitable or undesirable in products for nutritional, pharmaceutical or human use, to be strong reasons against solvent extraction being commonly used to extract krill oil on an industrial scale.
106. The specification states:
“Removal of lipids from krill has previously required solvent extraction using liquids such as ethanol or other polar solvents. Solvent extraction is time-consuming and may also result in loss of material and is therefore not wanted.”[115]
[115] The present specification at page 14, lines 30 – 32.
The statements in the specification are consistent with how the published documents in evidence describe the state of the art in relation to solvent extraction of marine biomass as at August 2007.
107. Having considered Professor Barrow’s evidence, the published documents in evidence and the opposed specification itself, I find it is reasonable to conclude that solvent extraction was used as an alternative method since little oil is extracted from krill and fish using pressing methods. However, since solvent extraction was known to be costly, time-consuming and undesirable for nutritional, pharmaceutical or human use, this method was considered by the skilled person to be impractical for krill oil and fish meal production on an industrial scale.
108. Professor Barrow states that in 2006 he became aware through salespersons for ONC, the company that was at the time a large supplier of fish oil for human nutrition, that another company called Neptune Technologies and Bioresources had started to produce commercial quantities of krill oil and were selling it.[116] Professor Barrow also states that he was aware at that time that krill oil could be produced to have relatively high phospholipid content, and the high phospholipid content of krill oils was an obvious way that the krill oil manufacturers could differentiate their products.[117] Another perceived advantage of krill oil was that the oil contains astaxanthin which is, firstly, a carotenoid which promotes eye health, secondly, a powerful antioxidant and, thirdly, an antioxidant which could protect krill oil from oxidation and degradation.[118] The krill oil market rapidly increased and competed with omega-3 fish oil products.[119]
[116] Barrow #1 at [81].
[117] ibid.
[118] ibid.
[119] Barrow #1 at [82].
109. Professor Barrow also states:
“As at August 2007, krill meal was commonly used as a starting material for the extraction of valuable oils, in particular the phospholipids, in order to obtain oil which is rich in omega-3s. These products were sold as nutraceuticals. Solvent extraction was the most common method of extracting krill oil. Such extraction techniques are discussed as far back as Grantham where fat and pigment (astaxanthin) are noted as krill products of interest. At page 31, Grantham notes that the fat and pigment phases will inevitably arise in conjunction and will prove difficult to separate. Solvent extraction is described as a means of removing the fat and pigment, with solvent mixes including acetone and petroleum ether, isopropanol and n-hexane, and chloroform.”[120]
[120] Barrow #1 at [83].
110. I understand, from the statements referenced above, that Professor Barrow’s reason for stating that krill meal was commonly used as a starting material for extracting oil was the commercial value of krill oil—this being found in the relatively high phospholipid content of krill oil in addition to the rich content in omega-3 fatty acids which differentiated krill oil from fish oil.
111. However, I consider Professor Barrow’s characterisation of solvent extraction being the most common method of extracting krill oil to be inconsistent with that of the Grantham article and documents, published up to November 2007, that are in evidence. Whilst I can accept that solvent extraction was known, as at 29 August 2007, to be a method of extracting oil from krill meal, it does not automatically follow that solvent extraction was used as a matter of routine. As discussed above, time and cost efficiency, as well as producing pharmaceutical grade krill oil for human use, are considerations that weigh against the use of solvent extraction.
112. I conclude the evidence does not establish that solvent extraction was used as a matter of routine to extract oil containing phospholipids from krill as at 29 August 2007.
113. As part of his evidence, Professor Barrow outlines the steps he would have undertaken if he had to extract oil from krill. Professor Barrow states:
“Once the krill was landed on board the fishing vessel, I would process it fairly quickly as krill has powerful enzymes which would start breaking down the proteins and oils (triglycerides and phospholipids). If the krill could not be processed immediately it could be snap frozen. Otherwise, I would substantially dewater the krill to remove most of the salt, remove the shell via a mechanical device, and then heat the krill to deactivate the enzymes. A suitable temperature would be around 65°C to 75°C in order not to waste energy heating the krill to temperatures higher than necessary, and in order to keep the temperature low enough so that the oil is not thermally degraded. Any remaining water can then [sic] removed by drying. The krill can then be stored, preferably under low temperatures, and can be shipped to shore for further processing. The krill can be ground up before any one of these processing steps. Once the krill meal is landed the oil can be extracted by suitable methods, such as supercritical CO2 to obtain triglycerides, and in a second step including a co-solvent such as ethanol to obtain the phospholipids. Extracting krill oil in this way was a matter of routine as at August 2007.”[121]
[121] Barrow #1 at [103] – [104].
114. I note the steps outlined above are steps Professor Barrow, an expert with high technical skills, would have taken and not necessarily what the bulk of the persons working in the art as at August 2007 would have done. Whilst I can accept that the choice of a lower temperature to heat krill would save energy and prevent thermal degradation of krill oil, it is unclear to me how the skilled person would arrive at a temperature range of 65°C to 75°C in light of different temperatures suggested as being optimum in the published documents in evidence. I have previously concluded that heating krill in water at 90-95°C was commonly known in the art as at the priority date of the opposed application. I have also previously found solvent extraction to be one means of extracting krill oil from krill, and SCE is a specialised method. Therefore, I consider the way Professor Barrow characterises extracting oil from krill is inconsistent with the evidence and is not a matter of routine as at 29 August 2007.
Summary
115. I have found the evidence indicates the following matters were part of the CGK as at 29 August 2007:
·Shell and gut removal were common processing steps accomplished by centrifuging or pressing;
·Cooking, pressing and drying krill were commonly used processes for krill meal production;
·Heating krill in water at a temperature of 90 - 95°C was commonly known to be the method used for cooking krill;
·Heating krill was known to inactivate degrading enzymes and coagulate krill proteins;
·Heating the krill solid fraction and the krill liquid fraction to a temperature of 90-100°C was used to coagulate krill proteins;
·Straining was commonly known to be used to remove excess water after heating krill;
·Pressing or centrifuging were methods commonly used to extract oil from cooked krill;
·Oil separation is very poor after cooking krill at 90 - 95°C and pressing; and
·Both krill meal and krill oil were commonly known to be valuable products.
3.7 The invention as claimed
116. The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd.:
“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”[122]
[122] [2009] FCAFC 70 at [118] – [120]; 81 IPR 228.
Claim 1
117. Claim 1 is the only independent claim of the present application. It reads:
“A process for extracting oil from krill comprising:
treating krill by mixing said krill with water at from about 50 to 75 C;
drying the treated krill to provide a krill meal; and
extracting an oil containing phospholipids and astaxanthin from said krill meal,
wherein said phospholipids comprise from about 1% to about 10%
alkylacylphosphatidylcholine.”
What does claim 1 define?
118. Reading the words of the claim in the context in which they appear, claim 1 is directed to a process for extracting oil from krill comprising a series of steps which when performed result in an oil having the defined features.
119. I will now consider the meaning of several terms in claim 1.
“comprising”
120. Rimfrost submitted that it is unclear whether the term “comprising” is to be interpreted such that the process would include steps other than those explicitly recited in claim 1.[123] I note that the case law has interpreted the term “comprising” both in an exhaustive sense and a non-exhaustive sense. In Asahi Kasei Kogyo Kabushiki Kaisha v WR Grace and Co, it was held that “comprise” was being used exhaustively in the context of the use of the term.[124] In General Clutch Corporation v Sbriggs Pty Ltd, after a review of authorities and several dictionaries, Lindgren J concluded that the normal linguistic meaning is that comprising means made up of, composed of, or constituted by the integers listed.[125] In Fresenius Medical Care Australia Pty Ltd v Gambro Pty Limited, the court found “comprise” to be used in a non-exhaustive sense, noting that the meaning of the term is context driven.[126] In Actavis Pty Ltd v Orion Corporation, the court stated that the indication of the specification must be borne in mind when considering the meaning of the term “comprise”.[127]
[123] Rimfrost’s written submissions dated 13 February 2018 at [58] – [63].
[124] [1991] FCA 530; 22 IPR 491 at 515.
[125] [1997] FCA 499; 38 IPR 359 at 374.
[126] [2005] FCAFC 220; 67 IPR 230 at [57], [64].
[127] [2016] FCAFC 121 at [177] – [182].
121. Accordingly, I will give the term “comprising” an interpretation appropriate to the context of its use. This has been the practice of the Australian Patent Office.[128]
[128] The Patent Manual of Practice & Procedure, section 2.11.2.3.4.
122. The question is whether the person skilled in the art would interpret claim 1 to include steps other than those explicitly recited in the claim taking into consideration what is indicated by the specification.
123. Professor Barrow stated:
“The claim 1 process is also significantly differentiated from the processes described in the examples in that it does not stipulate separation of the solid krill material from the krill milk after the heating step. In all the examples, the treated krill is sieved or filtered to strain away most of the water, which itself is processed to recover dissolved phospholipids, triglycerides and water soluble proteins. Claim 1, on the other hand, defines that the water-treated krill, which will be a slurry, is dried to a substantially dry mass without separation of any of the liquid. This process will mean that all the components of the treated krill remain, including the material which has leeched into the water during the heating process….
There is no example in the specification where water is added at temperature and then removed by drying without separation of the solid and liquid. Nor is such a process discussed anywhere else in the specification. The examples which describe meal production processes are Examples 2 and 4. In both of these examples, the krill solids and krill milk are separated by filtration or sieving after the initial heating step. In Example 2 there is also further no drying of either the krill solids or krill milk. In Example 4, following the coagulation-microfiltration route, the liquid krill milk is coagulated at 95°C and the solids are separated by microfiltration. The solids are pressed to produce a press cake which is then subject to SFE. The press cake is not a krill meal as I understand the term.”[129]
and
“Given the disparity between claim 1 as written and the examples, I have given to [sic] consideration to whether claim 1 is wide enough to include other steps such as separation of the krill solids and liquid. If this is the case, I see no way to determine what those steps would be. …”[130]
[129] Barrow #1 at [197] – [198].
[130] Barrow #1 at [201].
124. I consider that it is reasonable to interpret claim 1 in the context of what a skilled person would understand to be commonly known and done, at the priority date, for processing krill to produce krill meal and krill oil. As I have previously found that shell and gut removal by centrifugation or gentle pressing are steps commonly known for processes to produce krill meal, I consider it is a reasonable interpretation that the skilled person would understand claim 1 can include this step.
125. Consequently, I conclude that the term “comprising” interpreted in the context of the CGK could include other steps not explicitly recited in claim 1.
126. In regard to whether there is a step to separate the heat treated krill from the liquid, as previously discussed, straining was commonly known by the skilled person to remove excess water after heating krill. Therefore, I consider that the skilled person would understand claim 1 to include a separation step, such as straining. This interpretation is consistent with all the examples in the specification which use filtering or sieving to separate liquid from krill heated in water. Furthermore, it would seem counter-intuitive to treat krill with water and further process the treated krill without separating the treated krill from the liquid phase. However, it is not necessary for me to construe claim 1 to include a separation step by giving the term “comprising” a non-exhaustive interpretation. This will become clear with what follows in my decision when I interpret the scope of “drying the treated krill to provide a krill meal” to include a separation step.
[203] I note that whilst the amendments to the SGP filed 10 February 2017 and 17 July 2017, as well as Professor Barrow’s evidence, refer to an article by Yanase, M. with a different title, the opponent has confirmed that Professor Barrow considered the document filed in evidence—Yanase, M., “Modification of Russian Method for Separating Heat Coagulated Protein from Antartic Krill”, 1974, Bulletin of Tokai Regional Fisheries Research Laboratory, No.78, pages 79 – 84. A request to amend the SGP filed 01 March 2018 sought to correct the error to the citation details.
240. Apart from D13, it is clear that all the citations have a publication date before 29 August 2007. I consider D11, D14, D7, D2 and D12 are part of the prior art base.
241. A copy of D13 was provided along with Professor Barrow’s evidence as annexure CB-8. D13 shows an application date of January 24, 1995 but the document does not show a date of publication. The pages of the copy provided in evidence have various receipt dates stamped by the Department of Industrial Property in Chile, the latest date is 20 April 1999. Both parties appear to have proceeded on the basis that D13 is part of the prior art base. I consider it is more likely than not that D13 was publicly available before 29 August 2007, this being more than 12 years after its application date. I will treat D13 as part of the prior art base.
Grantham article (D11)
242. Rimfrost relies on a disclosure of variations of the Russian paste process (see Annex E) combined with a disclosure on page 31 of the Grantham article regarding solvent extraction for a submission that the claims of the opposed application lack an inventive step in light of D11 considered together with CGK.[204]
[204] Rimfrost’s written submissions dated 13 February 2018 at [189]; Barrow #1 at section G.1.1 which is not a numbered paragraph on pages 55 and 56 of Professor Barrow’s first declaration.
243. One variation of the Russian paste process discloses autolysis of krill in water at 45°C (Annex E, right hand side of the figure) and subsequently forming a paste after heat coagulating either the krill mince or the liquid pressed out of the autolysed krill. In another variation, krill is subjected to microwave treatment at 36-40°C before pressing and further heat coagulation. In a further variation, a paste is formed from a krill meal that is produced by heating krill with 2-3% sodium chloride in water to a temperature of 70-100°C (Annex E, left hand side of Figure). Whilst autolysis is disclosed to be used to improve the yield of the paste, there is no mention that autolysis or microwave treatment of krill are variations made to improve the quality of the paste.
244. I consider a skilled person reading D11 in 2007 would understand the variations of the Russian paste process to teach a method of improving the yield (quantity) of krill paste and not the quality of krill paste or krill oil. Therefore, I consider that a skilled person faced with a problem of improving the quality of extracted krill oil using methods of processing krill with gentler conditions would not be motivated to extract oil from the krill paste of D11. Consequently, I conclude it would not be a matter of routine for the skilled person to extract oil from the krill paste produced by variations of the Russian paste process.
245. There is also no evidence that a skilled person would as a matter of routine select, from the broader temperature range of 70-100°C, the lower temperature range as claimed in claim 1 for a method of producing krill paste. Consequently, I conclude the evidence does not establish that claim 1, or any other claim of the opposed application, lacks an inventive step in light of D11 considered together with CGK.
US 4,133,077 (D14)
246. D14 discloses a method for obtaining edible meat from Antarctic krill by separating the meat from the non-edible fragments. Example 1, discloses that fresh krill is thermally treated by heating in water at a temperature of 70°C and subjected to a mechanical process that destroys the krill body. A mixture of meat and krill body fragments is placed in a water bath where the meat settles to the bottom while the non-edible fragments, which remained in the upper layers of the bath, are removed. Excess water is separated from the meat by conventional methods, such as straining.
247. Referring to D14, Professor Barrow states:
“The crumbled up meat (or krill meal) which is obtained via this process could be used for oil extraction. If I was intending to extract oil, I would dry the (strained/filtered) filter cake as this would improve the efficiency of the solvent extraction method and avoid the water acting as solvent which might not be desirable.”[205]
[205] Barrow #1 at [133].
248. Professor Barrow states that he could expect to extract oil, rich in phospholipids and containing some astaxanthin, from the filter cake using standard solvent extraction methods.[206]
[206] Barrow #1 at [134].
249. Mr Myhren states that D14 does not relate to extraction of oil or phospholipid and does not teach modifying what was known for further extraction of oil or phospholipid from the krill meat.[207]
[207] Myhren at [44] – [52].
250. Proferssor Barrow further states:
“In my view, suggesting that only earlier documents which specifically refer to oil extraction would be relevant to developing a process of preparing a krill meal for oil extraction simply does not reflect the approach that the person skilled in art would have taken at the time. The fact that many of the older documents I referred to in my first declaration did not focus primarily on krill oil extraction is, in my view, a product of their age. By 2007, oil extraction had become the primary use of krill biomass. Having produced a krill meal or other proteinacious krill product by any previously known methods, the obvious use of such material would have been to extract krill oil from it. By suggesting that known methods of producing krill meal become inventive merely because they were not specifically linked in earlier documents with oil extraction, Mr Myhren effectively suggests that the Applicant can now take a monopoly over those krill meal production methods even though oil extraction was basic common knowledge at the relevant time, and even where no particular properties of the resulting oil have been identified which would differentiate it from oil produced by any other method.”[208]
[208] Barrow #2 at [38].
251. The relevant question, here, for assessing obviousness, is whether it would have been a matter of routine to extract oil from the krill meat taught by D14. In answering this question, I need to take into account what the skilled person understood the document to teach, and what was commonly known by the skilled person, at the priority date, in regard to krill oil and krill meal.
252. I have previously concluded that, at the priority date, it was commonly known that krill meal and krill oil were both valuable products. I consider it is reasonable to conclude that a skilled person, reading D14 in 2007, would understand D14 to teach a method of producing better quality krill meat (and therefore krill meal). Since the krill meat contains oil, I consider it is reasonable to infer that the skilled person would consider better quality meat contains better quality oil. My conclusion is consistent with Professor Barrow’s statement that preserving the quality of oil in krill meal is an important consideration for the skilled person when making the meal.[209]
[209] Barrow #2 at [40].
253. Whilst D14 does not suggest extraction of oil by pressing, or any other means, from the krill meat prepared using the lower temperatures, I consider a skilled person following the teaching of D14 in 2007 and faced with a problem of improving the quality of extracted krill oil using methods of processing krill with gentler conditions would as a matter of routine extract oil from the krill meat of D14 that was prepared using a lower heating temperature.
254. I have previously found the evidence does not establish the use of solvent extraction for extracting oil from krill meal was commonly known as at August 2007. Therefore, I conclude it would not have been a matter of routine for the skilled person to use solvent extraction to extract oil from the krill meat of D14.
255. I previously concluded it was commonly known that pressing or centrifuging were methods commonly used to extract oil from krill. However, heating krill to 90 -95°C and pressing did not extract any significant amount of oil from the krill. Since I previously concluded that the problem addressed by the opposed application does not include improving the quantity of the krill oil extracted, I consider the skilled person would as a matter of routine extract improved quality oil from the krill meat of D14 despite the quantity of oil obtained. Therefore, I conclude it would be a matter of routine for the skilled person to use pressing or centrifuging to extract oil from the krill meat of D14 to obtain improved quality krill oil.
256. I have previously concluded that krill phospholipids inherently contain about 1-10% AAPC and astaxanthin is inevitably extracted in conjunction with krill oil. Therefore, I conclude that it would be a matter of routine for the skilled person to extract krill oil with the characteristics defined in claim 1 when pressing or centrifuging to extract oil from the krill meat of D14.
257. I conclude claim 1 lacks an inventive step in light of D14 considered together with CGK.
258. I will now consider the claims appended to claim 1.
259. Claims 2, 3 and 4: The question here is whether it would have been a matter of routine for a skilled person to add the compounds, vitamins or chemical combinations of ions recited in the claims to a krill oil extract. Professor Barrow’s answer to this question is ‘yes’.[210] I am satisfied this is a reasonable conclusion.
[210] Barrow #1 at page 61, [181]. I note that the number of the paragraphs in Professor Barrow’s first declaration is non-sequential after page 56.
260. Claims 5 and 6: The question here is whether it would have been a matter of routine for a skilled person to encapsulate a krill oil extract. Professor Barrow’s answer to this question is ‘yes’.[211] I am satisfied this is a reasonable conclusion.
[211] ibid.
261. I conclude claims 1-6 lack an inventive step in light of D14 considered together with the CGK.
US 4,038,722 (D7)
262. D7 discloses a method of processing krill to provide a meat portion that is used as a food product. The process includes heating krill in water to a temperature of about 78-80°C, centrifuging the heated krill to remove juices produced in a gap formed between the shell and thermally shrunken meat, freezing the partially dry krill material and abrading the brittle shell, eyes, gills, feelers and legs in the frozen krill material by pellet shooting and crushing to thereby isolate the meat portion.
263. Professor Barrow states that given the lower temperatures used in D7, he would expect krill oil to be relatively undamaged, and could be extracted from the resulting krill meal product by standard solvent extraction methods as a matter of routine.[212]
[212] Barrow # 1 at [128].
264. Mr Myhren stated that he could find no statements in D7 that describe the temperatures are chosen to assist releasing oil, and that the only mention of oil was in relation to the danger of oxidation of oil and deterioration of the protein product.[213] I consider a skilled person reading D7 in 2007 would understand D7 to teach a method for producing a better quality krill meat. As previously discussed, I consider it is reasonable to infer that the skilled person would consider better quality meat contains better quality oil since the krill meat contains oil. This is consistent with the evidence which establishes that preserving the quality of oil in krill meal is an important consideration for the skilled person when making the meal.[214]
[213] Myhren at [42].
[214] Barrow #2 at [40].
265. The relevant question, here, for assessing obviousness is whether it would have been a matter of routine to extract oil from the krill meat of D7.
266. Whilst D7 does not suggest extraction of oil by pressing, or any other means, from the krill meat prepared using the lower temperatures, I consider a skilled person following the teaching of D7 in 2007 and faced with a problem of improving the quality of extracted krill oil using methods of processing krill with gentler conditions would as a matter of routine extract oil from the krill meat of D7 that was prepared using a lower heating temperature.
267. For the same reasons as discussed previously in relation to D14, I conclude it would not have been a matter of routine for the skilled person to use solvent extraction to extract oil from the krill meat of D7 but it would have been a matter of routine for the skilled person to use pressing or centrifuging to extract oil from the krill meat of D7 to obtain improved quality krill oil.
268. I conclude claim 1 lacks an inventive step in light of D7 considered together with CGK.
269. For the same reasons as discussed previously in relation to D14, I conclude it would have been a matter of routine for the skilled person to add the compounds, vitamins or chemical combinations of ions recited in the claims to a krill oil extract, and encapsulate a krill oil extract.
270. I conclude claims 1-6 lack an inventive step in light of D7 considered together with the CGK.
Chilean Patent No. 40348 (D13)
271. D13 discloses a process of producing krill oil by cooking krill at different temperatures, followed by pressing the pre-cooked krill, collecting and accumulating the press liquor, removal of the suspended solids and centrifuging to separate the oil. The cooking process described includes cooking in water. Example 3 of D13 discloses krill cooked at 75°C and 95°C. The cooked krill was then pressed to produce a press cake and press liquor. The press liquor was heated to 95°C and processed further to obtain oil. Use of a lower cooking temperature was disclosed to produce press liquors with higher fatty acid content and higher soluble protein content, and resulted in increased yield in oil production. An increase in the content of phospholipids and polyunsaturated fatty acids was disclosed to parallel increase in yield. D13 suggested the possibility of controlling the chemical composition and fractional distribution of oil by controlling the cooking temperature of the krill.
272. Professor Barrow states it would have been routine to extract oil from the press cake by solvent extraction.[215]
[215] Barrow #2 at [50].
273. Mr Myhren states that since it was the press liquor that was subjected to further processing to extract oil and not the press cake, D13 is to be understood as teaching away from extracting oil from the press cake or meal.[216]
[216] Myhren at [41].
274. A relevant question, here, for assessing obviousness is whether it would have been a matter of routine to extract oil from the press cake of D13.
275. I have previously found the evidence does not establish solvent extraction was used as a matter of routine for extracting oil from krill meal as at August 2007. Consequently, I conclude it would not have been a matter of routine for the skilled person to use solvent extraction to extract oil from the press cake of D13.
276. Another relevant question, here, for assessing obviousness, is whether it would have been a matter of routine to add a step of drying the pre-cooked krill before extracting the oil by pressing the pre-cooked krill and centrifuging to press liquor. I note this question was not considered by either of the parties. I have previously found straining was commonly known to be used to remove excess water after heating krill. The removal of excess water was known to facilitate pressing to extract oil. Therefore, I conclude it would have been a matter of routine for the skilled person to add a step of straining the pre-cooked krill to the process of D13 before extracting oil by pressing the precooked krill and centrifuging of the press liquor.
277. I have previously concluded that krill phospholipids inherently contain about 1-10% AAPC and astaxanthin is inevitably extracted in conjunction with krill oil. Therefore, I conclude that it would be a matter of routine for the skilled person to extract krill oil with the characteristics defined in claim 1 upon pressing the precooked krill of D13 and subsequently centrifuging of the press liquor.
278. I conclude claim 1 lacks an inventive step in light of D13 considered together with CGK.
279. For the same reasons as discussed previously in relation to D14, I conclude it would have been a matter of routine for the skilled person to add the compounds, vitamins or chemical combinations of ions recited in the claims to a krill oil extract, and encapsulate a krill oil extract.
280. I conclude claims 1-6 lack an inventive step in light of D13 considered together with the CGK.
Kolakowski, E. and Gajowiecki, L. (D2)
281. D2 discloses a method of obtaining a protein food product with high quality and high yield by optimising autoproteolysis of Antarctic krill. In the step of autoproteolysis, fresh krill was mixed with water and heated to 12-55°C. In a separation step, centrifuging or decanting was used to separate the shell-less hydrolysate from the chitin waste. The hydrolysate was heated to 92 ± 3°C for 3-5 minutes to coagulate krill proteins and strained to remove effluent. The krill meat was homogenised, packed and frozen.
282. Mr Myhren states that D2 is solely concerned with production of protein and that there is no connection between the objectives of D2 and the extraction of phospholipids.[217]
[217] Myhren at [39].
283. Professor Barrow states that the fact the documents do not describe extraction of oil from the krill meal obtained does not suggest that the documents would be considered irrelevant by the skilled person in regard to the question of how to produce a krill meal from which to extract oil.[218] I consider a skilled person reading D2 in 2007 would understand D2 to teach a method for producing a better quality krill meat. As previously discussed, I consider it is reasonable to infer that the skilled person would consider better quality meat contains better quality oil since the krill meat contains oil. This is consistent with the evidence which establishes that preserving the quality of oil in krill meal is an important consideration for the skilled person when making the meal.[219]
[218] Barrow #2 at [44].
[219] Barrow #2 at [40].
284. I understand Rimfrost to submit that it would have been routine to extract oil by solvent extraction from krill meat produced by the method of D2 after a step of drying the krill meat.[220] It is unclear to me whether the submission is that a skilled person would use the shell-less hydrolysate or the heated krill hydrolysate (produced upon heating the shell-less hydrolysate to 92 ± 3°C) as the starting material to extract oil. Since I have previously found the evidence does not establish solvent extraction was used as a matter of routine for extracting oil from krill meal as at August 2007, it is immaterial which krill meat is used as starting material. I conclude it would not have been a matter of routine for the skilled person to use solvent extraction to extract oil from the krill meat produced by the method of D2.
[220] Rimfrost’s written submissions dated 13 February 2018 at [209].
285. A relevant question is whether it would have been a matter of routine to extract oil from the shell-less hydrolysate or the heated krill hydrolysate produced by the method of D2 by pressing or centrifuging. I note this question was not raised by either of the parties. There is no evidence that pressing or centrifuging shell-less hydrolysate was a matter of routine at the priority date. I have previously found pressing or centrifuging cooked krill was a matter of routine at the priority date. I consider the skilled person faced with a problem of improving the quality of extracted krill oil using methods of processing krill with gentler conditions would as a matter of routine use pressing or centrifuging to extract oil from the heated krill hydrolysate of D2 to obtain improved quality krill oil.
286. I conclude claim 1 lacks an inventive step in light of D2 considered together with CGK.
287. For the same reasons as discussed previously in relation to D14, I conclude it would have been a matter of routine for the skilled person to add the compounds, vitamins or chemical combinations of ions recited in the claims to a krill oil extract, and encapsulate a krill oil extract.
288. I conclude claims 1-6 lack an inventive step in light of D2 considered together with the CGK.
Yanase, M. (D12)
289. D12 discloses a modification of the Russian method for separating a heat coagulated protein fraction from Antarctic krill—this being a modification of the Russian paste process discussed previously. The protein fraction has a paste form and is rich in proteins and fats. The aim of D12 is stated to be to increase the yield of the protein fraction. This was stated to be achieved by using autolysis. Frozen krill Antarctic krill is mixed with water heated to 45°C for 1-4 hours so that the krill undergoes autolysis. The autolysed krill is pressed to separate a residue from the liquid. The liquid is then heated at 95°C for 15 mins to coagulate the proteins and centrifuged to separate the protein fraction from the remaining extract. Table 1 and Figure 1 of D12 disclose the yields of components of various fractions (residue, protein and extract) obtained from the method after 1, 2, 3 and 4 hours of autolysis. There is no mention of any considerations regarding the quality of the fractions produced by the method of D12.
290. I consider a skilled person reading D12 in 2007 would understand D12 to teach a method for improving the yield (quantity) of krill protein and not the quality of krill protein or krill oil. Therefore, I consider the skilled person faced with a problem of improving the quality of extracted krill oil using methods of processing krill with gentler conditions would not be motivated to extract oil from the krill fractions of D12. Consequently, I conclude it would not be a matter of routine for the skilled person to extract oil from the krill fractions of D12.
291. I note that even if the skilled person did consider extracting oil from the residue (this being the solid fraction obtained after pressing autolysed krill) or coagulated protein (this being obtained after heating the liquid fraction pressed out of the autolysed krill, and to be distinguished from heating krill itself to coagulate proteins), there is no evidence that pressing or centrifuging the residue or coagulated protein (obtained by heating the liquid fraction pressed out of autolysed krill) was a matter of routine at the priority date it. Additionally, I have previously found the evidence does not establish solvent extraction was used as a matter of routine for extracting oil from krill meal as at August 2007
292. I conclude it has not been established that any of claims 1-6 lacks an inventive step in light of D12 considered together with CGK.
Conclusion on inventive step
293. I conclude that claims 1-6 of the opposed application lacks an inventive step in light of D2, D7, D13 and D14 considered together with CGK.
10 Manner of Manufacture
294. 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. It is well established that this involves asking whether the necessary quality of inventiveness is apparent on the face of the specification. In NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd the High Court said:
“if it is apparent upon the face of the specification, when properly construed, 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”.[221]
and in Bristol-Myers Squibb Co v FH Faulding & Co Ltd the Federal Court said:
“if, on the basis of what was known, as revealed on the face of the specification, the invention was obvious or did not involve an inventive step – that is, would be obvious to the hypothetical non-inventive and unimaginative skilled worker in the field – then the threshold requirement of inventiveness is not met.”[222]
[221] [1995] HCA 15; 183 CLR 655 at [9].
[222] [2000] FCA 316; 46 IPR 553 at [30].
295. Another formulation of the requirement is found in Commissioner of Patents v Microcell Ltd:
“We have in truth nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. A claim for nothing more than that cannot be subject matter of a patent, …”[223]
[223] [1959] HCA 71; (1959) 102 CLR 232 at 251.
296. Rimfrost submitted:
“The allegedly novel processing step cannot provide a manner of manufacture when there is no evidence on the face of the specification that it results in a new product. In other words, the claim involves the use of known material (krill) in the manufacture of a known product (krill oil, including encapsulated krill oil, having no new characteristics) in a process for which it is known to be suitable.”[224]
[224] Rimfrost’s written submissions dated 13 February 2018 at [137].
297. I have previously found that heating krill in water to a temperature between 50 to 75°C was not commonly known in the art at the priority date. The evidence does not establish that there is a lack of invention on the face of the specification. It has not been shown that the invention as claimed is not a manner of manufacture
11 Conclusion
298. Each of claims 1-6 lacks an inventive step in light of each of D2, D7, D13 and D14 considered together with CGK.
299. It has not been established that claims 1-6 fail to comply with the grounds of clarity, claims define the invention, sufficiency, support, utility, novelty and manner of manufacture.
300. It may be possible to overcome the deficiencies by amendment. Therefore, I allow Aker a period of two months from the date of this decision in which to proposed amendments.
12 Costs
301. The opposition is successful. It is normal that costs should follow the event. I see no reason to depart from that result. Costs according to Schedule 8 are awarded against Aker.
Dr A. Lim
Delegate of the Commissioner of PatentsAnnex A:
Figure 1 of the opposed specification
Annex B:
Figure at paragraph [159] of Professor Barrow’s declaration dated 13 January 2017.
Annex C:
Figure at paragraph [164] of Professor Barrow’s declaration dated 13 January 2017 (herein referred to as Figure 3, Barrow #1).
Annex D:
The process for krill meal production as outlined in a flow sheet on page 29 of an article authored by Grantham G. J., entitled ‘The utilisation of krill’, and published by the Food and Agriculture Organisation of the United Nations in 1977 (Grantham article).
Annex E:
The Russian paste process.
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