Rimfrost As v Aker BioMarine Antarctic As - [2022] APO 47

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Rimfrost AS v Aker BioMarine Antarctic AS [2022] APO 47

Patent Application: 2017201340

Title:Bioeffective krill oil compositions

Patent Applicant:                   Aker BioMarine Antarctic AS
Opponent:  Rimfrost AS
Delegate:  Dr A. Lim
Decision Date:  7 July 2022
Hearing Date:  The parties chose not to appear at an oral hearing. No written submissions were filed.

Catchwords: PATENTS – section 59 – opposition to the grant of a patent – priority date considered – it has not been established that any of the claims fail to comply with the grounds of clarity, sufficiency, support, disclosure of best method, utility, novelty, inventive step and manner of manufacture – opposition unsuccessful – costs awarded against the opponent

Representation: Patent attorney for the applicant: Pizzeys Patent and Trade Mark Attorneys
Patent attorney for the opponent: Spruson & Ferguson

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2017201340

Title:Bioeffective krill oil compositions

Patent Applicant: Aker BioMarine Antarctic AS
Date of Decision: 7 July 2022
DECISION
The opposition is unsuccessful.
The opponent has not established that claims 1-23 fail to comply with the grounds of clarity, sufficiency, support, disclosure of best method, utility, novelty, inventive step and manner of manufacture.
Subject to appeal, I direct the application to proceed to grant.
Costs according to Schedule 8 are awarded against Rimfrost AS.
REASONS FOR DECISION
Background

Patent application 2017201340 (the opposed application) was filed by Aker BioMarine Antarctic AS (the applicant) on 28 February 2017. The patent request claims divisional status from patent application 2014256345 (the parent) which was granted after an opposition by Rimfrost AS was withdrawn. The parent is itself a divisional application from 2013227998 (the grandparent), now refused after a successful opposition by Rimfrost AS – Rimfrost AS v Aker BioMarine Antartic AS [2019] APO 28 (the ’998 decision). The grandparent is itself a divisional application from 2011213836 (the great grandparent), now withdrawn. The great grandparent is itself a divisional of granted patent 2008231570 (the original ancestor). The opposed application claims an earliest priority date of 28 March 2007. I note that the original ancestor was re-examined and amended post-grant. The original ancestor claims priority from four US provisional applications and the earliest filing date of these applications is 28 March 2007.[1]
[1] The four US provisional applications from which the original ancestor, patent application 2008231570, claims priority are US 60/920,483 having a filing date of 28 March 2007, US 60/975,058 having a filing date of 25 September 2007, US 60/983,446 having a filing date of 29 October 2007 and US 61/024,072 having a filing date of 28 January 2008.
The opposed application was examined and advertised accepted by the Commissioner on 07 February 2019. The application was subsequently opposed under section 59 of the Patents Act 1990 (the Act) by Rimfrost AS (the opponent). The opponent filed a notice of opposition on 07 May 2019 and a statement of grounds and particulars (SGP) on 07 August 2019.
The applicant wrote to the Commissioner on 06 November 2019 to request withdrawal of the opposed application. On 07 November 2019, a delegate of the Commissioner responded to the applicant stating that unless the applicant made an undertaking not to pursue the same, or substantially the same, invention of the opposed application in any further applications, the Commissioner would not consent to withdrawal of the opposed application. The delegate noted at the time that several applications related to the opposed application were still active including 2019202956 (an application which claims divisional child status from the opposed application) and 2008231570, the original ancestor. No response to this letter was received.
Evidence in support (EIS) was filed by the opponent on 07 November 2019. The applicant did not file any evidence in answer. On 27 February 2020, a delegate of the Commissioner wrote to the parties to check if there were matters that needed to be raised or addressed before setting a hearing date.
On the 26 March 2020, the opponent responded that it did not intend to withdraw the opposition and requested amendments to the SGP. On the 03 April 2020, the applicant responded, that it had been prevented from withdrawing the opposed application because it did not wish to provide the undertaking required by the Commissioner. The applicant also noted that in the circumstances and economic environment in April 2020,[2] the applicant was seeking to minimise costs in the matter and believed that no hearing was necessary and would not be making any appearances or written submissions. The applicant, however, expressed that it reserved the right to make submissions regarding any proposed award of costs for opposition proceedings.
[2] I infer the circumstances and economic environment the applicant was referencing to be the public health emergency caused by the coronavirus (COVID-19) pandemic.
The applicant was given an opportunity to provide comments on the amendments to the SGP but did not do so. The amendments were allowed on 21 April 2020.
On the 07 May 2020, the opponent informed the Commissioner that it had decided not to make any appearance at a hearing or provide any written submissions. On 12 May 2020, a delegate of the Commissioner wrote to the parties informing them that given that the opponent did not wish to withdraw the opposition, and both parties did not wish to be heard or even file any written submissions, the opposition would be decided based on the matters documented in the amended SGP and EIS on file.
The opposition
The grounds of opposition stated in the amended SGP are:
·claimed invention is not for a manner of manufacture,
·lack of novelty,
·lack of inventive step,
·lack of utility
·lack of a clear enough and complete enough disclosure in the specification,
·lack of support
·no disclosure of the best method
·lack of clarity
The opponent also alleges that the priority date of the opposed application is a later date than claimed in the patent request. This is because, while the opposed application claims priority from four US provisional applications and the earliest filing date of these applications is 28 March 2007, only one application, US 61/024,072, discloses the feature of “ether phospholipids” of the claimed invention. The filing date of US 61/024,072 is 28 January 2008. I will discuss the issue of priority date later in my decision.
The evidence on file consists only of the EIS. While there is a declaration from Colin Barrow dated 06 November 2019 and accompanying Exhibits CB-1 to CB-27, this declaration in its content has brought in 5 other declarations from 3 other opposition proceedings which the opponent and the applicant had been involved in. A summary of the evidence relevant for this opposition is summarised in the table below:

Patent Application opposed Declarant Declaration date Exhibits Reference

2017201340
(current opposition) Colin Barrow 06 November 2019 CB-1 to CB-27 Barrow A

2011213836 Colin Barrow 14 August 2014 Curriculum vitae of Colin Barrow Barrow #1[3]

19 January 2015 None included for the current opposition[4] Barrow #2[5]

2013227998 Colin Barrow 19 July 2017 None included for the current opposition Barrow #3[6]

05 March 2018 None included for the current opposition Barrow #4[7]

2014256345 Colin Barrow 01 September 2017 None included for the current opposition Barrow # 5[8]
[3]Barrow #1 to Barrow #5 are the references used by Colin Barrow in his declaration for the current opposition, see Barrow A at [7]. Barrow #1 is provided as annexure CB-1 in the current opposition.
[4]Barrow A at [8]. In his declaration dated the 06 November 2019 Colin Barrow stated that the annexures of his declarations for previous oppositions, except his curriculum vitae accompanying Barrow #1, are not included for the current opposition.
[5] Barrow # 2 is provided as annexure CB-2 in the current opposition.
[6] Barrow # 3 is provided as annexure CB-3 in the current opposition.
[7] Barrow # 4 is provided as annexure CB-4 in the current opposition.
[8] Barrow # 5 is provided as annexure CB-5 in the current opposition.

I note that the SGP was amended to include an additional 16 documents which were not mentioned in the originally filed SGP. Therefore, there are a total of 23 documents which the opponent alleged were relevant to the current opposition.[9] It has not been helpful that the opponent chose not to provide any written submissions.
[9] The amended SGP dated 26 March 2020.
The opposed application was filed on 28 February 2017. 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 the opponent carries the onus of proof.
The specification
The field of the invention is stated in the specification as relating to extracts from Antarctic krill that comprise bioactive fatty acids.[10] The specification as accepted has 23 claims. Claim 1 is the only independent claim. The claim set is reproduced in Annex A of this decision.
[10] The specification at page 1, lines 4-5.
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.”[11]
[11] [2013] FCA 214 at [139]; 100 IPR 451.
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.”[12]
[12] 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.”[13]
[13] 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 extracting nutritional and therapeutic compounds from marine organisms.[14] From 2001 to 2009, Professor Barrow led the research and development division of Ocean Nutrition Canada Ltd (ONC) with the aim of developing nutraceutical and functional food ingredients from marine organisms. Professor Barrow’s research at ONC included developing an omega-3 microencapsulation and stabilisation technology for commercialisation of functional food products and establishing a microbial fermentation program to produce omega-3 oil and carotenoid food ingredients.[15]
[14] Barrow A at [3]; Curriculum vitae of Professor Colin Barrow is provided as part Exhibit CB-1 in the current opposition.
[15] CB-1 (Barrow#1) at [6]-[7].
I consider Professor Barrow can provide evidence as to what the person skilled in the art knew and would have done. Since the applicant has not filed any evidence or written submissions, I will also have regard to statements in (1) the specification of the opposed application which have referenced prior publications, and (2) published documents filed in evidence when evaluating Professor Barrow’s evidence. 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.
The background to the invention
Antarctic krill (Euphausia superba) is described to be found in large quantities, ranging from 300-500 million metric tons of biomass, off the coast of Antarctica in the Southern Ocean.[16]
[16] The specification at page 1, lines 8-9.
The specification states that methods for extracting krill oil from krill using solvents are known. Prior patent application WO 00/23546 (Beaudion) is cited to teach extracting krill lipids from krill by using a ketone solvent, such as acetone.[17] The method of Beaudoin is stated to involve recovering the lipid soluble fraction by evaporation of the solvent and then extracting the remaining soluble lipids from the solid krill by using another solvent, such as ethanol.[18] The specification states that compositions produced by these methods contain at least 75 µg/g astaxanthin and preferably 90 µg/g astaxanthin.[19]
[17] WO 00/23546 (Beaudoin) is referenced as exhibit CB-19 in the EIS. US Patent No. 6,800,299, stated by the opponent to be the equivalent of WO 00/23546 (Beaudoin) has been raised as a prior art citation in the current opposition. US Patent No. 6,800,299 is referenced as D5 in the schedule of documents of the originally filed SGP.
[18] The specification at page 1, lines 12-19.
[19] The specification at page 1, lines 19-20.
The specification then states that krill oil compositions have been described to be effective in treating various disorders including decreasing cholesterol, inhibiting platelet adhesion, inhibiting artery plaque formation, preventing hypertension, and controlling blood glucose levels in patients.[20]
[20] The specification at page 1, lines 23-27.
The specification cites another prior patent application, WO 03/011873 (Sampalis), which discloses a krill oil composition comprising a phospholipid and a flavonoid.[21] The specification states Sampalis discloses the phospholipid content in the krill lipid extract could be as high as 60% (w/w) and the content of certain omega-3 fatty acids, namely eicosapentaenoic acid and docosahexaenoic acid (EPA and DHA, respectively), to be as high as 35% (w/w).[22] The specification also states that Sampalis discloses the use of the phospholipids extracts in nutraceutical, pharmaceutical and cosmetics.[23]
[21] WO 03/011873 (Sampalis) has been raised as a prior art citation in the current opposition. WO 03/011873 is reference as D4 in the schedule of documents of the originally filed SGP and exhibit CB-18 in the EIS.
[22] The specification at page 1, lines 27-30.
[23] The specification at page 1, lines 31-32.
The specification states that it had previously been shown that supercritical fluid extraction (SFE) using neat carbon dioxide (CO₂) could be used to prevent extraction of phospholipids and extract the neutral lipid fraction, which was comprised of esterified and free astaxanthin, from krill.[24]
[24] The specification at page 1, line 32 to page 2, line 1, citing Yamaguchi et al., J. Agric. Food Chem (1986), 34(5), pages 904-7. Yamaguchi et al. has been raised as a prior art citation in the current opposition and is referenced as D12 in the amended SGP and exhibit CB-10 in the EIS.
The specification also states that extraction of phospholipids from salmon roe by a method using SFE and a solvent modifier had previously been used.[25]
[25] The specification at page 2, lines 1-4, citing Tanaka et al., J. Oleo Sci (2004), 53(9), 417-424. Tanaka et al. has been raised as a prior art citation in the current opposition and is referenced as D14 in the amended SGP and exhibit CB-12 in the EIS.
The specification states that these previous methods relied on processing frozen krill transported from the Southern Ocean to the processing site. The transportation is stated to be expensive and can result in degradation of the krill starting material. Citing data in prior literature which shows rapid decomposition of the oil in krill, the specification suggests that this decomposition explains why some krill oil offered as omega-3 supplements in the marketplace contains very high amounts of partly decomposed phosphatidylcholine and partly decomposed triglycerides.[26]
[26] The specification at page 2, lines 5-12.
Aim of the invention
The specification states that methods for processing krill that do not require transporting frozen krill over long distances and products produced by those methods are needed in the art.[27] I note that the claimed inventions do not explicitly address the issue of transporting frozen krill. Read as a whole, the specification relates to various methods used to produce krill oil compositions with different proportions of krill components. One method involves cooking and drying fresh krill to produce a dried krill meal which was stored at room temperature for subsequent krill oil extraction.[28] I infer that an aim of the invention is to provide an alternative krill oil composition which is rich in phospholipids and used to provide health benefits.
[27] The specification at page 2, lines 13-15.
[28] The specification at page 42, Example 6.
The invention as described in the specification
The specification sets out different aspects and embodiments of the invention in the section titled “Summary of the invention”. These include krill oil compositions,[29] methods of producing krill oil compositions,[30] and methods of treating various disorders using the krill oil compositions.[31]
[29] The specification at pages 2a-3.
[30] The specification at pages 5-7.
[31] The specification at pages 8-9.
The components of krill oil compositions described include phospholipids, triglycerides, astaxanthin esters, free astaxanthin, free fatty acids, omega-3 fatty acids, and arachidonic acid.[32] The specification defines some of these components, and it is useful to provide the definitions here.
[32] The specification at pages 3-4.
Phospholipid
A phospholipid is defined as an organic compound with the general structure shown below. R1 is a fatty acid residue, R2 is a fatty acid residue or −OH, and R3 is a −H or nitrogen containing compound choline, ethanolamine, inositol or serine.[33] In the structure shown below the fatty acids and the phosphate group are joined together by a glycerol backbone.
[33] The specification at page 10, line 29 to page 11, line 5.
Ether phospholipid
An ether phospholipid is defined as a phospholipid having an ether bond at position 1 of the glycerol backbone. Examples of ether phospholipids include alkylacylphosphatidylcholine (AAPC), lyso-alkylacylphosphatidylcholine (LAAPC), and alkylacylphosphatidylethanolamine (AAPE).[34]
[34] The specification at page 11, lines 9-12.
Non-ether phospholipid
A non-ether phospholipid is a phospholipid that does not have an ether bond at position 1 of the glycerol backbone.[35] Examples of non-ether phospholipids include phosphatidylcholine, phosphatidylserine, and phosphatidylethanolamine.[36]
[35] The specification at page 11, lines 12-13.
[36] The specification at page 3, lines 13-14.
Omega-3 fatty acids

An omega-3 fatty acid is a polyunsaturated fatty acid that has a final double bond in the hydrocarbon chain between the third and fourth carbon atoms from the methyl end of the molecule. Non-limiting examples of omega-3 fatty acids include 5,8,11,14,17-eicosapentaenoic acid (EPA) and 4,7,10,13, 16, 19-docosahexaenoic acid (DHA) and 7, 10, 13, 16, 19-docosapentanoic acid (DPA).[37]
[37] The specification at page 11, lines 14-18.
Astaxanthin
Astaxanthin is defined by the chemical structure shown below:[38]
[38] The specification at page 11, line 20.

Astaxanthin esters
An astaxanthin ester is defined as having fatty acids esterified to the OH group in the astaxanthin molecule shown above.[39]
[39] The specification at page 12, lines 1-2.
Krill oil compositions
The different embodiments of krill oil compositions described in the specification are characterised by different concentrations of components in the oil. One embodiment comprises from about 3% to 10% ether phospholipids on a w/w basis (w/w),[40] from about 35% to 50% non-ether phospholipids (w/w), from about 20% to 45% triglycerides (w/w), and from about 400 to about 2500 mg/kg astaxanthin.[41] The total amount of ether phospholipids and non-ether phospholipids in the composition is from about 38% to 60 %.[42] Another embodiment described is an Euphausia superba krill oil composition comprising from about 30% to 60% phospholipids (w/w), from 20% to 50 % triglycerides (w/w), from about 400 to about 2500mg/kg astaxanthin (w/w), and from about 20% to 35% omega-3 fatty acids as a percentage of total fatty acids in the composition where from about 70% to 95% of the omega-3 fatty acids are attached to the phospholipids.[43] The specification also described a further krill oil embodiment comprising at least 65% phospholipids (w/w).[44] While Euphausia superba is the preferred species of krill for use in the invention, other krill species are described as being suitable.[45]
[40] The term w/w is stated in the specification to mean weight/weight. The term is used to refer to the amount of a given substance in a composition on a weight basis. For example, a composition comprising 50% w/w phospholipids means the mass of the phospholipids is 50% of the total mass of the composition, that is, 50 grams of phospholipids in 100 grams of the composition, such as oil; see page 12, lines 3-6.
[41] The specification at page 3, lines 4-9.
[42] The specification at page 3, lines 23-28.
[43] The specification at page 7, lines 4-8.
[44] The specification at page 4, lines 9-11.
[45] The specification at page 4, lines 1-5.
In some embodiments:
i. the phospholipids of the krill oil, which is necessarily only part of the oil composition, are described as comprising greater than 50% phosphatidylcholine,[46] or
[46] The specification at page 4, line 15.
ii.the krill oil (i.e., composition as a whole) is described as having a phosphatidylcholine content greater than 50%, 70% or 80% (w/w).[47]
[47] The specification at page 6, lines 8-10.
Therefore, I understand that various krill oil compositions are described in the specification, with some having a phosphatidylcholine content less than 50% (w/w) while others have a phosphatidylcholine content greater than 50% (w/w).
The specification describes krill oil compositions with both high and low concentration of astaxanthin esters. Some krill oil compositions comprise greater than about 100, 200, 300, 400, 500 mg/kg astaxanthin esters and up to about 700 mg/kg astaxanthin esters (w/w).[48] Other compositions are described as low-astaxanthin krill oil and have less than about 70, 60, 50, 40, 30, 20, 10, 5 or 1 mg/kg astaxanthin esters (w/w).[49] The concentration of astaxanthin in krill oil can be altered by using different extraction methods which I will discuss.
[48] The specification at page 16, lines 15-17.
[49] The specification at page 16, line 32 to page 17, line 2.
The krill oil compositions are described to comprise less than about 5%, 4%, 3%, or preferably 2% free fatty acids (w/w), less than about 0.45% arachidonic acid (w/w) and less than about 0.5g/100g total cholesterol.[50]
[50] The specification at page 16, lines 11-12; page 4, lines 19-20.
The specification explains that acceptable excipients or carriers are included in the krill oil compositions which are formulated for oral consumption using conventional techniques. The oral formulations include capsules and tablets.[51] In some embodiments, the krill oil compositions are formulated as a dietary supplement in combination with one or more ingredients such as herbs, vitamins, and minerals.[52]
[51] The specification at page 18, lines 5-22.
[52] The specification at page 18, lines 23-34.
Methods of producing krill oil compositions
The specification describes methods of producing krill oil compositions by extracting oil from krill material.[53] In some embodiments, the krill material is a krill meal produced by heat-treating fresh krill to denature the lipases and phospholipases in the krill.[54] The denatured krill product may be stored at room temperature, or below, between the denaturation step and the extraction step.[55] In some embodiments, the extraction step comprises extraction by supercritical fluid extraction (SFE). In one embodiment, the SFE is a two-step process comprising a first extraction step with supercritical carbon dioxide (CO₂) and a low concentration of co-solvent (e.g., from about 1-10% co-solvent) and a second extraction step with supercritical CO₂ and a high concentration of co-solvent (e.g., from about 10-30% co-solvent). [56] The preferred embodiment of the co-solvent is described as a C₁-C₃ monohydric alcohol, preferably ethanol.[57] In other embodiments, supercritical CO₂ is used without a co-solvent.[58] Using neat supercritical CO₂, or supercritical CO₂ in combination with 5% ethanol, extracts the neutral lipid fraction from krill oil. The neutral lipid fraction is described to consist mostly of triglycerides and cholesterol.[59]
[53] The specification at pages 5-7.
[54] The specification at page 5, lines 26-33.
[55] The specification at page 5, lines 31-33.
[56] The specification at page 5, lines 18-23.
[57] The specification at page 5, lines 23-24.
[58] The specification at page 5, line 34 to page 6, line 3.
[59] The specification at page 12, lines 14-17.
The specification also discloses the use of a low amount of polar solvent with supercritical CO₂ in the first extraction step facilitates extracting the neutral lipid components and astaxanthin in a single step. Use of a high amount of polar solvent in the second extraction step facilitates the extraction of the polar lipids; that is, the ether phospholipids and non-ether phospholipids.[60]
[60] The specification at page 14, lines 19-22.
In some embodiments, the neutral fraction (comprising triglycerides and astaxanthin) is blended with the polar fraction (comprising ether phospholipids and non-ether phospholipids) to provide krill oil compositions comprising the desired concentrations of phospholipids, astaxanthin and other oil components.[61]
[61] The specification at pages 15, line 22 to page 16, line 3.
The specification also describes that an extraction step with neat supercritical CO₂ can be used to remove astaxanthin from krill material, or krill oil, to produce a low-astaxanthin krill oil.[62] Extraction with neat supercritical CO₂ also removes odour causing compounds such as trimethylamine to provide a krill oil composition that is substantially odourless. Some krill oil compositions have less than about 10, 5 or 1 mg/kg trimethylamine. [63]
[62] The specification at page 16, line 34, to page 17, line 8.
[63] The specification at page 17, lines 9-16.
The specification states:
“The present invention is distinguished from previously described krill oil products, such as those described in U.S. Pat. No. 6,800,299 or WO 03/011873 and Neptune brand krill oil, by having substantially higher levels of non-ether phospholipids, ether phospholipids, and astaxanthin. The krill oils of the present invention also have unexpected and superior properties as compared to previously available krill oils.”[64]
[64] The specification at page 14, lines 23-26.
Methods of treatment using krill oil compositions
The specification states that omega-3 fatty acids have previously been known to have anti-inflammatory properties. Phospholipids from a marine source are also stated to have been disclosed to have anti-inflammatory effects.[65] A diet rich in omega-3 fatty acids is stated to have previously been shown to have health benefits, such as improving sensitivity to insulin, reducing inflammation in adipose tissue, and alleviating metabolic dysregulation.[66]
[65] The specification at page 21, lines 5-9.
[66] The specification at page 21, lines, 5-11, 17-21; page 22, lines 5-6, 17-23.
The specification describes administering krill oil compositions to treat several disorders including diet-induced hyperinsulinemia, insulin insensitivity, muscle mass hypertrophy, serum adiponectin reduction and hepatic steatosis. Subjects having the disorders are administered an effective amount of krill oil composition to alleviate the disorder. [67] The krill oil compositions administered in this embodiment are described as not limited to any particular formulation.[68]
[67] The specification at page 8, lines 3-6.
[68] The specification at page 8, lines 9-11.
In some embodiments, an effective amount of a krill oil composition is administered to induce diuresis, decrease protein catabolism, or decrease lipid content in the heart or liver of a subject.[69]
[69] The specification at page 9, lines 15-29.
Examples described in the specification
The specification describes several examples of the invention, and it is useful to discuss these examples here. Example 1 describes the compositions of a krill meal and a neutral oil referred to as asta oil.[70] Professor Barrow stated that asta oil is neutral oil that is pressed out of the krill meal.[71] Table 4 of the specification shows that asta oil has 575 mg/kg phospholipids and 1245 mg/kg astaxanthin. The method by which the krill meal is produced is not disclosed in example 1.
[70] The specification at pages 23-26.
[71] Barrow A at [148].
Example 2 relates to ethanol extraction of the krill meal of example 1 using a method previously disclosed in a Japanese patent application. Tables 6-8 of the specification describe the composition of the krill meal and krill oil extracted from the meal using ethanol.[72]
[72] The specification at pages 27-29.
Example 3 relates to a two-step SFE method of the krill meal of example 1. During step 1, neat supercritical CO₂ was used to extract the neutral lipids to produce what is referred to as neutral krill oil. In step 2, supercritical CO₂ and 20% ethanol was used to extract the polar lipids to produce what is referred to as polar krill oil. [73] The compositions of neutral krill oil, polar krill oil from the SFE method are compared to a commercial krill oil from Neptune Biotech (Laval, Quebec, Canada), referred to as Neptune krill oil (NKO).[74] Table 16 of the specification shows that the concentration of astaxanthin esters is 98 mg/kg in neutral krill oil, 580 mg/kg in polar krill oil and 472 mg/kg in NKO. The concentration of free astaxanthin is <1 mg/kg in neutral and polar krill oil and 11mg/kg in NKO.
[73] The specification at page 29.
[74] The specification at pages 29-37; Tables 9-16.
Example 4 relates to another two-step SFE method of the krill meal using neat supercritical CO₂ in the first step and a mixture of neat supercritical CO₂ and 20% ethanol in the second step. The neutral lipids from step 1 were mixed with the polar lipids from step 2 in a 50/50 ratio to produce a blended krill oil.[75] The composition of the blended oil is described in Tables 19A, 19B and 19C of the specification. The blended krill oil is described to comprise 0.5% (w/w) free fatty acids and 151 mg/kg astaxanthin esters.[76] Example 5 describes the composition of another blended krill oil composition obtained by mixing the polar lipids of example 4 with the asta oil of example 1.[77]
[75] The specification at page 37.
[76] The specification at pages 39-40.
[77] The specification at pages 40-42.
Example 6 describes processing fresh krill to obtain a denatured and dried krill meal. Fresh krill from a harvesting trawl is denatured by heating to 90^o C, then pressed to remove water, and subsequently vacuum dried. The denatured meal was stored at room temperature. After 19 months, the denatured meal was extracted using a two-step SFE method where supercritical CO₂ was used in a first step, and supercritical CO₂ plus 20% ethanol was used in a second step. The fractions from the two steps were combined to produce an oil which was found to comprise 42.22% phosphatidylcholine and 1.68% decomposed phosphatidylcholine. The phosphatidylcholine content of the krill oil of example 6 is contrasted with that in a commercial krill oil sample which was shown to have 9.05% phosphatidylcholine and 4.60 % decomposed phosphatidylcholine.[78]
[78] The specification at page 42, lines 3-14.
Example 7 describes a krill oil produced using a two-step SFE method starting with a food grade powder of krill meal. The method used to obtain the krill meal is not disclosed. The first step of the SFE method uses supercritical CO₂and 5% ethanol to remove the neutral lipids and astaxanthin from the krill meal. The second step uses supercritical CO₂and 23% ethanol. The composition of a krill oil produced is shown in Table 21, reproduced here.[79]
[79] The specification at page 42, lines 16-25.
Example 8 and Figure 1 describe analyses of the krill oil of Example 7 using ³¹P NMR to identify and quantify various phospholipids in the oil. The phospholipid profile of the krill oil of example 7 was compared to commercially available NKO. The main polar ether lipids reported are AAPC (alkylacylphosphatidylcholine) at 7-9% of total polar lipids (TPL), LAAPC (lyso-alkylacylphosphatidylcholine) at 1% of TPL, and AAPE alkylacylphosphatidylethanolamine at <1% of TPL.[80]
[80] The specification at pages 43-44, Figure 1.
Example 9 and Figures 2-9 describe the effect of different omega-3 fatty acid sources on metabolic parameters in the Zucker rat model of obesity and insulin resistance.[81] The specification states that it is well known in the art that the obese Zucker rat is a useful rat model to study metabolic Syndrome X and non-insulin dependent diabetes mellitus, including glucose tolerance, insulin resistance and hyperinsulinaemia.[82] The omega-3 fatty acid sources compared in example 9 are fish oil (FO), commercially available NKO and krill oil prepared according to example 7 (Superba^TM). The specification states:
[81] The specification at page 45, Figures 2-9.
[82] The specification at page 22, lines 31-33.
“This example shows that supplementation of the Zucker rat with krill oil prepared as in example 7 results in an improvement of metabolic parameters characteristic of the obesity induced type two diabetic condition. The effect induced by the novel krill oil is often more pronounced than the effect of FO an [sic] in several cases greater than the effect induced by NKO. Specifically, the effects of the two types of krill oil differentiated with respect to the reduction of blood LDL cholesterol levels as well as lipid accumulation in the liver and muscle (Figures 2-9). Furthermore, the efficacy of transfer of DHA from the diet to the brain tissue was greatest with the krill oil prepared as in example 7 (Figure 10).”[83]
[83] The specification at page 45, lines 21-29.
I note there is no example 10. Example 11 describes the effect of supplementing human diets with krill oil, fish oil (this being a positive control) or no omega-3 fatty acids (this being a negative control) on blood urea nitrogen (BUN). BUN measures the amount of nitrogen in the blood that comes from urea and the measurement is used as an indication of renal function.
Example 12 and Figures 12-19 describe the effect of dietary krill oil on the metabolic parameters in high-fat fed mice and compares that effect with dietary fish oil containing the same amount of omega-3 fatty acids.[84] The krill oil administered to mice was described to be prepared according to a method like that described for example 5 but the oil contained 500 mg/kg astaxanthin and 0.36% omega-3 fatty acids.[85] The specification states that supplementation of high-fat fed mice with krill oil resulted in amelioration of diet-induced hyperinsulinemia, insulin resistance, increase in muscle lipid, serum adiponectin reduction and hepatic steatosis.[86]
[84] The specification at page 46, line 33 to page 47; Figures 12-19.
[85] The specification at page 47, lines 3-4.
[86] The specification at page 47, lines 12-15.
Common general knowledge (CGK)
Before construing the claims, it is helpful to review what was already known in the art before the priority date about krill, krill oil, methods for processing krill and methods for extracting krill oil. The opposed application claims an earliest priority date of 28 March 2007. The opponent has alleged that the priority date of the claims of the opposed application is 28 January 2008, this being the filing date of the only priority document which discloses the feature of the “ether phospholipids” of the claimed invention.[87] For reasons provided later in my decision, I consider the priority date of the claims of the opposed application is 28 January 2008.
[87] The amended SGP dated 26 March 2020, page 1.
Since the opponent’s expert witness, Professor Barrow, has made statements in evidence regarding what was already known in the art as of 28 March 2007, I will consider the CGK as of 28 March 2007.[88] I note that the opponent did not provide any evidence that there was a change to the CGK in the relevant intervening period. I consider it is reasonable to infer that the CGK did not relevantly change between 28 March 2007 and 28 January 2008.
[88] Barrow A at [11]-[73], CB-3 (Barrow #3) at [36]-[93], CB-1 (Barrow #1), CB-2 (Barrow #2), CB-5 (Barrow #5).
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.”[89]
[89] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9 at [115]; 144 CLR 253 at page 292.
The CGK is not limited to knowledge which the person skilled in the art might have memorised but also includes information which the skilled person knows exists and would have referred to as a matter of course. Emmett J stated:
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·     standard texts and handbooks;
·     standard English dictionaries;
·     technical dictionaries relevant to the field;
·     magazines and other publications specific to the field.”[90]
[90] ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc [1999] FCA 345; 45 IPR 577 at [112].
However, it is not enough that information is recorded in a document, even if that document is widely circulated − it is only part of the CGK when it is generally known and accepted. Middleton J stated:
“… information does not constitute common general knowledge merely because it might be found, for example, in a journal, even if widely read by persons in the art … Reference in this regard is made to the words of Luxmoore J in British Acoustic Films (1936) 53 RPC 221 at 250, cited by Lehane J in Aktiebolaget Hässle v Alphapharm Pty Ltd (1999) 44 IPR 593; [1999] FCA 628 at 605 [39]:
In my judgment it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less because it is widely circulated. Such a piece of knowledge only becomes general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.”[91]
[91] Ranbaxy Laboratories Limited v AstraZeneca AB [2013] FCA 368; 101 IPR 11 at [217].

At the start of his evidence on CGK, Professor Barrow makes overarching statements that he has provided information based on what was known to him as of March 2007 and believes this information would have been well known to others in the field of utilisation of marine biomass and the nutraceutical oils industry throughout the world, including Australia.[92] However, Professor Barrow also states that the information on methods known for extracting oil from biological and marine-based materials was his “knowledge generally”.[93] As part of evaluating the evidence, I will assess whether it is sufficient to establish that the information Professor Barrow discusses is known to the bulk of persons working in the art.
[92] CB-3 (Barrow#3) at [36]-[93].
[93] CB-3 (Barrow#3) at [78].
Professor Barrow gave evidence regarding the CGK on krill, lipids, and solvent extraction. I will discuss these matters now.
Krill oil
Professor Barrow stated that krill is characterised by its high content of phospholipid (approximately 60%, mainly phosphatidylcholine and phosphatidylethanolamine), and about 30-40% neutral fats (mono-, di- and triglycerides).[94] I understand Professor Barrow’s characterisation of the fat content in krill was based on the values disclosed in a journal 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).[95] Professor Barrow considered all the information in the Grantham article was generally known and common to workers in the field as of March 2007 because the article is a seminal review article referenced in many studies on krill oil production.[96] I do not have to decide whether all the information in the Grantham article was part of the CGK as of March 2007. I consider it reasonable and sufficient for the purposes of my decision to determine whether the proportions of phospholipids and triglycerides in krill oil were part of the CGK.
[94] Barrow A at [34].
[95] CB-7, Grantham article, Table 6 at page 12.
[96] Barrow A at [33].
I note Professor Barrow stated a journal article authored by Fricke, H., et al. disclosed krill oil to comprise 44 to 46 % (w/w) phospholipids and 33-40 % (w/w) triglycerides of total lipids.[97] Another journal article authored by Bottino, N.R., et al., disclosed krill oil to comprise 58% (w/w) phospholipids and 36% (w/w) triglycerides of total lipids.[98] I also note that the specification of the opposed application states the phospholipid content in the krill lipid extract could be as high as 60% (w/w) citing prior publication WO 03/011873 (Sampalis).[99] Therefore, the cited literature suggests that krill oil has about 44-60 % (w/w) phospholipids and about 33-40% (w/w) triglycerides of total lipids. However, information regarding the proportions of phospholipids, triglycerides or other krill oil components found in the literature, even if widely read by persons skilled in the art, does not constitute CGK. Furthermore, the Grantham article stated that there are seasonal variations in the fat content of krill.[100] Therefore, I am not satisfied the evidence shows that the proportion of phospholipids or triglycerides in krill oil is part of the CGK.
[97] CB-3 (Barrow #3) at [63]. Journal article authored by Fricke, H., et al., entitled ‘Lipid, sterol and fatty acid composition of Antarctic krill (E. superba Dana)’, was published in Lipids, Vol.19, No.11, 1984, pp 821-827. This journal article is referenced as D7 in the amended SGP in the current opposition.
[98] CB-3 (Barrow #3) at [64]. Journal article authored by Bottino, N.R., et al., entitled ‘Lipid composition of two species of Antartic krill: Euphausia Superba and E. Crystallorophias’, was published in Comp. Biochem. Physiol, 1975, Vol 50B, pp 479-484.
[99] The specification at page 1, lines 27-30.
[100] CB-7, Grantham article, page 3.
Professor Barrow stated that:
“Krill oil commands a significantly higher price in the marketplace than fish oil (and did as at March 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 than fish in order to minimise any damage to the krill oil and to preserve it as much as possible. Processing is also optimised for oil extraction, rather than meal production, as was at least traditionally the case with fish meal/oil processing. ”[101]
[101] Barrow A at [34].
and
“… as at March 2007 krill oil producers marketed krill oil not only for the benefits associated by that time generally with omega-3, but also as having additional benefits over and above fish oil, mainly better bioavailability and the presence of astaxanthin, which was known to be a powerful antioxidant, [sic] For example, this can be seen in the marketing materials for the Neptune Krill Oil product from March 2007…”[102]
[102] Barrow A at [69].
The quotes above suggest to me that krill oil was a valuable product in March 2007 because the phospholipids, omega-3 fatty acids, triglycerides, and astaxanthin in the oil were known to provide health benefits. The specification of the opposed application also states that krill oil was commercially available as an omega-3 supplement and disclosed in the literature to alleviate several disorders.[103] Astaxanthin is also stated in the specification to have been previously shown to be a powerful antioxidant.[104]
[103] The specification at page 2, lines 7-10, pages 21-23.
[104] The specification at page 22, line 33 to page 23, line 2.
Professor Barrow also stated:
“From around 2003/2004, phospholipids became more and more important in the marketplace as producers sought to distinguish their products from the omega-3 products already available. There was a suggestion in some literature and discussed at conferences that phospholipids had a better bioavailability, and therefore better health benefits…”[105]
[105] CB-3 (Barrow# 3) at [54].
I am satisfied that as of 28 March 2007 it was part of the CGK that the content of krill oil includes phospholipids, omega-3 fatty acids, triglycerides and astaxanthin and these components provide health benefits. However, while it was commonly known that the components themselves provide health benefits, I consider that the proportions of these components in krill oil were not commonly known.
Methods of processing krill
Professor Barrow stated that krill meal has been produced since the 1960s by cooking, pressing, and drying.[106] This statement is consistent with the disclosure in the Grantham article that cooking, pressing, and drying was the most common method of producing krill meal at the time of journal publication, 1977.[107]
[106] Barrow A at [37].
[107] CB-7, Grantham article at page 27.
Professor Barrow also stated that cooking krill on-board a fishing vessel inactivates enzymes (lipases and phospholipases) and eliminates the possibility of degradation of the oil by enzyme activity.[108] He stated it was known around 1980 that cooking krill resulted in a lower free fatty acid content, and free fatty acids had long been regarded as an indicator of more general degradation of krill oil. [109] Professor Barrow considered it was reasonable to infer that a low free fatty acid concentration in krill oil indicates that there was little enzymatic degradation in the krill meal production method.[110] The specification of the opposed application also makes an inference that the degradation of oil in krill starting material may explain why commercially offered omega-3 supplements contain very high amounts of partly decomposed phosphatidylcholine, partly decomposed glycerides, and free fatty acids.[111]
[108] Barrow A at [39].
[109] Barrow A at [40], [42].
[110] Barrow A at [42].
[111] The specification at page 2, lines 8-12.
I am satisfied that as of 28 March 2007 cooking, pressing, and drying krill were commonly used processes for krill meal production, heating krill was known to inactivate degrading enzymes and a low free fatty acid content is an indicator of increased quality of krill oil.
Methods of extracting krill oil
Professor Barrow stated that his evidence on methods known for extracting oil from biological and marine-based materials as of March 2007 was based on his “knowledge generally”.[112]
[112] Barrow A at [52]-[65], CB-3 (Barrow#3) at [78]-[93].
Pressing was stated to be the most basic oil extraction method that was applied to fish. In this method, fish meal is heated to liberate oil from fat deposits and then pressed under high pressure to squeeze out the liquid from the meal.[113] It was stated that it was well known that pressing does not extract all the oil from fish. It was also stated that 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.[114]
[113] CB-3 (Barrow#3) at [80].
[114] Ibid.
Professor Barrow referred to the Grantham article when providing evidence about krill oil extraction methods[115]. The Grantham article disclosed pressing of cooked krill to produce a liquid phase and a pressed cake. The liquid phase is centrifuged to produce an oil while the pressed cake is dried to produce krill meal. [116] Fat separation was described to be very poor after cooking and pressing.[117] The fat content of the press cake was shown to be comparatively higher than the oil separated from the liquid phase.[118]
[115] Barrow A at [45].
[116] CB-7, Grantham article at page 29.
[117] CB-7, Grantham article at page 28, first paragraph.
[118] CB-7, Grantham article at page 29.
Referring to the krill oil extraction method disclosed in the Grantham article, Professor Barrow stated:
“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 … press cake ... and krill 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.”[119]
[119] Barrow A at [45].
Professor Barrow stated:
“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. … As at March 2007, solvent extraction was the extraction method typically used to extract oil from krill.”[120]
[120] CB-3 (Barrow#3) at [81].
Professor Barrow also stated that prior to March 2007 polar and non-polar solvents were used to selectively extract different types of lipids or oils. The solvents are used to sequentially remove non-polar and polar oils. Non-polar solvents, such as hexane, mainly removes non-polar triglycerides. Polar solvents, such as acetone or ethanol, extracts polar lipids, particularly the phospholipids.[121]
[121] CB-3 (Barrow#3) at [82].
Professor Barrow further stated:
“One specialised method of solvent extraction of a biomass is supercritical CO₂ extraction (‘SCE’). SCE has been known since at least the 1990s and was also commonly used for extraction of krill oil as at March 2007. 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 co-solvent to the CO₂. A co-solvent, such as ethanol, can be used to improve selectivity and solubility, thereby enabling the extraction of polar phospholipids.”[122]
[122] CB-3 (Barrow#3) at [83].
Professor Barrow also explained a method for extracting and recovering oil from a dry biomass he would have used as of March 2007. This method would involve using different solvents to extract different types of oils selectively and sequentially in the biomass.[123]
[123] Barrow A at [58], CB-3 (Barrow#3) at [88]-[91].
Professor Barrow stated he would mix hexane with the biomass in a first extraction step to extract the non-polar lipids which comprise mainly triglycerides.[124] The oil-solvent mixture comprising the non-polar lipids would be separated from the resulting solids by filtration or centrifugation. A solid cake produced by the separation step would contain phospholipids, proteinaceous materials, and other insoluble materials. The hexane could be removed from the oil-solvent fraction by evaporation to obtain the triglycerides.[125] In a second extraction step, the solid cake would be mixed with a polar solvent, such as ethanol since phospholipids are highly soluble in polar solvents. The phospholipids would be extracted into the solvent to produce a phospholipid-ethanol solution which could then be separated from the remaining solids by filtration or centrifugation. The ethanol in the phospholipid-ethanol solution could be removed by evaporation to produce a phospholipid-rich oil. Professor Barrow stated that he would expect the relative abundance of each type of phospholipid would be approximately the same in the extracted phospholipid-rich oil as in the starting material.[126]
[124] CB-3 (Barrow#3) at [88].
[125] CB-3 (Barrow#3) at [89].
[126] CB-3 (Barrow#3) at [90].
Professor Barrow stated that if he had access to supercritical CO₂extraction (SCE) methods, he would follow the method outlined above and use supercritical CO₂in a first stage extraction to extract the triglycerides, and then use supercritical CO₂and ethanol in a second stage extraction to extract the phospholipids. Professor Barrow also stated that he would use a concentration of ethanol that would maximise the ability to extract phospholipids, such as 20%.[127]
[127] CB-3 (Barrow#3) at [91].
I understand Professor Barrow’s statements discussed above to mean that as of March 2007 solvents were commonly used to extract oil from biological and marine-based materials. However, solvent extraction was known as an alternative to pressing but was more expensive.
I also understand that SCE is a specialised method of solvent extraction. I infer from Professor Barrow’s statements that SCE was a method not readily accessible to him as a person skilled in the art. In my view the apparently limited accessibility of SCE raises doubt as to whether this method was commonly used by persons working in the art. I will consider some of the prior publications referenced by Professor Barrow in his evidence, which characterise solvent extraction methods used to extract oil from krill and fish, to assess whether SCE was commonly used to extract krill oil as of March 2007.
These documents are a journal article by Yamaguchi et al., published in 1986 (Yamaguchi),[128] a journal article by Tanaka et al., published 2004 (Tanaka),[129] and a patent document WO 2007/123424 A1 (Catchpole), published on 01 November 2007.[130]
[128] Yamaguchi et al., J. Agric. Food Chem (1986), 34(5), pages 904-7. Yamaguchi et al. has been raised as a prior art citation in the current opposition and is referenced as exhibit CB-10 in the EIS.
[129] Tanaka et al., J. Oleo Sci (2004), 53(9), 417-424. Tanaka et al. has been raised as a prior art citation in the current opposition and is referenced as exhibit CB-12 in the EIS.
[130] WO 2007/123424 A1 is a prior art citation in the current opposition and is referenced as exhibit CB-21 in the EIS.
Yamaguchi disclosed that SCE of Antarctic krill using neat supercritical CO₂yielded oils which comprised solely non-polar lipids, largely triglycerides, without phospholipids. The article stated that SCE was effective at obtaining non-polar lipids from krill in only one-step extraction and excluded phospholipids which interfere with the utilisation of krill oils.[131] The article noted that application of SCE to animal sources, particularly seafood, was limited.[132] I interpret that while the method of extracting of oils from marine-based materials using supercritical CO₂was known at the time of journal article publication in 1986, use of SCE as a method of solvent extraction was limited.
[131] Yamaguchi, abstract.
[132] Yamaguchi, page 904, left-hand column.
Tanaka disclosed a study using a mixture of supercritical CO₂ and ethanol (SC-CO₂) to extract phospholipids from salmon fish roe. Phospholipids were not found to be extracted with 0 and 5% ethanol in SC-CO₂. Extractions with 10, 15 or 20% ethanol in SC-CO₂ were effective in extracting phospholipids. Increasing the concentration of ethanol in the increased the amount of extracted phospholipids. When the extraction was performed with SC-CO₂ and 20% ethanol mixture, more than 80% of the phospholipids were recovered.[133] The journal article suggests to me that the use of a mixture of SC-CO₂was still being developed at the time of journal article publication in 2004.
[133] Tanaka, abstract.
Catchpole disclosed the use of supercritical CO₂ and ethanol to extract phospholipids from egg, soy, marine animals, and other food sources. Example 18 disclosed extraction of oil from freeze-dried krill powder using pure supercritical CO₂ in a first extraction step followed by a second extraction step using supercritical CO₂ and 11% ethanol. The extract from the first step contained no phospholipids and was substantially all neutral lipids. The second extraction step produced a phospholipid-rich extract.[134] The disclosure in Catchpole suggests that use of supercritical CO₂ with or without ethanol to extract lipids from krill was still being developed at the time of publication of the patent application on 01 November 2007.
[134] WO 2007/123424 A1, CB-21, page 24.
None of the cited documents I have discussed suggest that SCE was a commonly used technique or well known to persons skilled in the art as of March 2007. It appears that this method was not readily available to the bulk of persons working in the art. Having considered Professor Barrow’s evidence and reviewed of some of the published documents he referred to in evidence, I am not satisfied that the use of a SCE method to extract lipids from krill was part of the CGK as of 28 March 2007. I have no evidence to suggest that this was not still the situation as of 28 January 2008, the priority date to which the opposed application is entitled. I also consider the two-step SCE method (with a high ethanol concentration in the second extraction step) Professor Barrow outlined above to sequentially extract lipids from a dry biomass to be a method an expert with high technical skills and access to SCE would have taken as of March 2007, and not a method commonly used by the person skilled in the art.
Blending different types of oils
Professor Barrow stated that it was well known prior to March 2007 that different fractions of oil could be blended to form an oil with the desired characteristics.[135] Professor Barrow noted that the commercially available Neptune Krill Oil is a blended oil.[136] I am satisfied that blending different types of oils to form an oil with the desired characteristics was part of the CGK as of 28 January 2008.
[135] CB-3 (Barrow#3) at [82], [93].
[136] Barrow A at [183], item 5.0
Summary for CGK
I have found the evidence indicates the following were part of the CGK as of 28 March 2007, and by inference 28 January 2008 (as discussed previously):
·The phospholipids, omega-3 fatty acids, triglycerides, and astaxanthin of krill oil provided health benefits.
·Cooking, pressing, and drying krill were commonly used processes for producing krill meal.
·Heating krill was known to inactivate degrading enzymes.
·Low free fatty acid content is an indicator of increased quality of krill oil.
·Solvents were used to extract oil from biological and marine-based materials.
·Blending different types of oils to form an oil with the desired characteristics.
The invention as claimed

The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd. (Lundbeck):
“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”[137]
[137] [2009] FCAFC 70 at [118] – [120]; 81 IPR 228.
Claim 1
Claim 1 is the only independent claim of the opposed application. It reads:
A krill oil composition comprising:
from 3% to 10% ether phospholipids on a w/w basis;
from 35% to 50% non-ether phospholipids on w/w basis, so that the total amount of ether phospholipids and non-ether phospholipids in the composition is from 38% to 60% on a w/w basis;
from 20% to 50% triglycerides on a w/w basis,
from 100 to 700 mg/kg astaxanthin esters; and
less than 3% w/w free fatty acids.
Claim 1 is directed to a krill oil composition having the recited components present at the concentration ranges defined in the claim. I consider the meaning of the terms in the claim to be sufficiently clear in the context of the specification. I have also previously discussed what these terms mean.
The appended claims 2-23 define further features regarding the components of krill oil or define the uses for the krill oil composition. A complete claim set is reproduced in Annex A. I have previously discussed the different features of the appended claims.
The opponent alleged that appended claims 3, 8, 9, 10, 17, 18 to 23 are not clear.[138] I will now address these issues.
Clarity
It is a requirement of subsection 40(3) of the Act that the claims must be clear. A claim will lack clarity if a third party could not ascertain whether or not a proposed action would fall within the ambit of the claim.[139]
The opponent alleged that claim 3 is not clear because there is no antecedent for “ether lipids”.[140] While I accept that both claim 1 and claim 2 do not define “ether lipids”, I consider that it would be obvious to the person skilled in the art that there is a typographic error in claim 3 and the term “ether phospholipids” was intended instead of “ether lipids”. This error would have been evident to the skilled person given that claim 3 defines the ether lipids as comprising alkylacylphosphatidylcholine, one of the ether phospholipids recited in claim 2. While it is not ideal for claims to contain typographic errors, I consider that a third party would easily ascertain the scope of claim 3. The applicant may, if it wishes, amend claim 3.
[138] The amended SGP dated 26 March 2020, pages 19-20.
[139] Monsanto Co v Commissioner of Patents (1974) 48ALJR 59.
[140] The amended SGP dated 26 March 2020, section 6.1.1, page 19.

100. The opponent alleged that claims 8-10 are not clear because there is no antecedent for the term “said phospholipids”, only “ether phospholipids” and “non-ether phospholipids”.[141] The opponent also alleged that claims 8-10 are inconsistent with claim 1 and therefore unclear. It appears the opponent has interpreted each of claims 8-10 to define a krill oil composition comprising greater than 50% phosphatidylcholine (w/w) of the whole krill oil composition and consequently inconsistent with claim 1 which defines the oil composition to comprise from 35% to 50% non-ether phospholipids on a w/w basis.[142] Claim 8 defines a composition according to any of claims 1-7 characterised in that “said phospholipids comprise greater than 50% phosphatidylcholine (w/w).” Claims 9 and 10 specify that “said phospholipids” comprise greater than 70% and 80% phosphatidylcholine (w/w), respectively.
[141] The amended SGP dated 26 March 2020, section 6.1.2, page 19.
[142] The amended SGP dated 26 March 2020, section 6.1.3, page 19.
101. Claim 1 defines “ether phospholipids”, “non-ether phospholipids” and “the total amount of ether phospholipids and non-ether phospholipids”. I consider a plain meaning of “said phospholipids” in claims 8-10 refers to all the phospholipids in the krill oil composition, i.e., total of the ether phospholipids and non-ether phospholipids. By taking “said phospholipids” to mean all the phospholipids of the krill oil composition, it follows that the percentage of phosphatidylcholine defined in claims 8-10 is a proportion of the phospholipid fraction (comprising both ether phospholipids and non-ether phospholipids) and not a proportion of the whole krill oil composition.

102. Adopting this interpretation, the concentration of phosphatidylcholine defined in claims 8-10 would have an interpretation which is consistent with the range defined for the non-ether phospholipids in claim 1. This interpretation is also consistent with the phospholipid profile of the krill oil composition of Example 7, and shown in Table 22, of the specification. Table 22, reproduced in Annex B to this decision, shows phosphatidylcholine (PC) comprises 75.3% of the total polar lipids (TPL). The TPL (i.e., the phospholipid fraction of krill oil comprising the ether phospholipids and non-ether phospholipids) forms 47.9% of the whole krill oil composition. In his evidence, Professor Barrow calculated the krill oil of Example 7, and shown in Table 22, of the specification to comprise 7.38% ether phospholipids and 40.52% non-ether phospholipids,[143] concentrations which fall within the scope of claim 1 of the presently opposed application. Consequently, I consider the scope of claims 8-10 is clear to the person skilled in the art.
[143] CB-5 (Barrow #5) at [64].
103. The opponent alleged that claim 17 is unclear because “the skilled person would be left wondering what constitutes a ‘dietary supplement’”.[144] I disagree. I consider a plain meaning of the term to be an additional nutrient used to complement a diet, such as omega-3 supplements. I consider this interpretation would be clear to the person skilled in the art. To the extent that there could be an ambiguity, this can be resolved by reference to the specification which, as I have previously discussed, describes krill oil being offered commercially as omega-3 supplements.[145] I have also discussed that the specification describes krill oil compositions of the present invention formulated as a dietary supplement in combination with one or more ingredients such as herbs, vitamins, and minerals.[146]
[144] The amended SGP dated 26 March 2020, section 6.1.4, page 19.
[145] The specification at page 2, lines 7-9.
[146] The specification at page 18, lines 23-34.

104. The opponent alleged that scope of claims 18-23 is unclear. The opponent argues that since a claim to a composition for a particular use is interpreted as a claim to the composition per se under Australian law, it is unclear how the scope of each of claim 18-23 differs from claims 1-15. The opponent alternatively argues that claim 18 may be interpreted as selecting just those krill oil compositions defined in claims 1-15 that are suitable for the treatment of the defined conditions and disclaiming those that are not. Therefore, it is unclear to the opponent which of the combinations of krill oil components make it suitable or not suitable.[147]
[147] The amended SGP dated 26 March 2020 at section 6.1.5, pages 19-20.

105. Under Australian law, the compositions defined in each of claims 18-23 are interpreted as being suitable for, but not limited to, the uses recited in the claims. I interpret the use recited in claims 18-23 to indicate the intended use of the compositions claimed in any one of claims 1-15. The words of claims 18-23 do not limit the use of the compositions of claims 1-15 to the recited uses. I consider this interpretation would be clear to the person skilled in the art. I also consider there is nothing in the claims which would suggest the alternative interpretation which the opponent argued. I have previously discussed the specification states that the treatment of described conditions is not limited to any particular krill oil composition.[148]
[148] The specification at page 8, lines 9-10.

106. The opponent alleged that the scope of “fatty heart” and “fatty liver” of claim 21 and claim 22, respectively, is unclear.[149] I consider that the skilled person would understand “fatty heart” as a technical term for accumulation of excess fat surrounding the heart while “fatty liver” means excess fat accumulation in the liver. I also consider the skilled person would understand fatty liver as a characteristic of hepatic steatosis, a pathology disclosed in the specification.[150] Therefore, I consider the scope of the terms “fatty heart” and “fatty liver” would be clear to the person skilled in the art.
[149] The amended SGP dated 26 March 2020 at section 6.1.6.
[150] The specification at page 8.
107. I conclude the opponent has not established any of the claims of the opposed application lacks clarity.
Disclosure and support
108. The Raising the Bar Act introduced two new requirements to section 40: a requirement for disclosure and a requirement for support. Burley J considered the two requirements in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) (Merck),[151] and in Cytec Industries Inc. v Nalco Company (Cytec).[152] Rofe J recently considered the two new requirements in Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd (Jusand) and adopted Burley J’s approach in Cytec.[153]
[151] [2020] FCA 1477; 155 IPR 1 at [502]-[547].
[152] [2021] FCA 970; 162 IPR 202.
[153] [2022] FCA 540 at [352]-[379], [450]-[520].
109. Burley J referred to the requirement in paragraph 40(2)(a) as the disclosure obligation.[154] Paragraph 40(2)(a) states the complete specification must:
(a) disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art
[154] Merck at [505].

110. Burley J also referred to the requirement in subsection 40(3) as the claim support obligation.[155] Subsection 40(3) states:
The claim or claims must be clear and succinct and supported by matter disclosed in the specification.
[155] Merck at [503].

111. The secondary materials accompanying the introduction of the two new requirements to section 40 were discussed in Merck[156]. The themes evident from the secondary materials were summarised by Rofe J who stated:
“Three themes are evident in the secondary materials. The themes are linked by their emphasis on the disclosure of the invention.
First, it is plain that the intention of the changes was to raise the standard of granted patents by bringing the requirements into conformity with the requirements of Australia’s major trading partners.
Second, the secondary materials place a heavy emphasis on disclosure as being the cornerstone of the patent system. The Parliament intended to increase the standard of disclosure so that the public would receive sufficient disclosure of the invention in return for the 20 year monopoly granted to the patentee.
Third, the intention of Parliament in amending ss 40(2)(a) and 40(3) of the Act was to align the law in relation to these requirements with that of the United Kingdom and Europe. It is also apparent from the language adopted in the sections and also the secondary materials that there can be little doubt that Parliament considered that it is appropriate for the Court to have regard to the law in the European Union and the United Kingdom in considering their scope: Merck at [544].”[157]
[156] Merck at [511]-[514].
[157] Jusand at [357]-[360].

112. The Explanatory Memorandum to the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (the Explanatory Memorandum) explained that amendments to paragraph 40 (2)(a) were intended to:
“… align the disclosure requirement with that applying in other jurisdictions with the effect that sufficient information must be provided to enable the whole width of the claimed invention to be performed by the skilled person without undue burden, or the need for further invention. This more clearly reflects a fundamental principle of the patent system: in exchange for the exclusive rights given to the patentee, the patentee must share with the public the information necessary to make and use the invention.”[158]

and
“… modify the wording of paragraph 40(2)(a) of the Act so as to require enablement across the full width of the claims, while adopting language that is consistent with that used in other jurisdictions. The wording in the amendment is similar to s 14(3) of the UK patents legislation, which has been interpreted as imposing this requirement. The wording is also similar to art 83 of the European Patent Convention, which has been interpreted with similar effect. The intention is that paragraph 40(2)(a) be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation and the European Patent Convention.”[159]
[158] Explanatory Memorandum, item 8.
[159] Ibid.

113. Rofe J referred to the Explanatory Memorandum regarding the disclosure obligation and stated:
“Disclosure of one thing within the claim would suffice for sufficiency prior to the Raising the Bar Act amendments. The Explanatory Memorandum noted that such narrow disclosure was not consistent with the fundamental nature of the patent bargain, and would be inadequate to support a broad claim following the amendments.”[160]
[160] Jusand at [363].

114. The claim support obligation was introduced as a replacement for the former requirement of fair basis. The purpose of this change is explained in the Explanatory Memorandum:
“Overseas law generally requires there to be a relationship between the claims and the description, and between the claims and any document from which priority is being claimed. This is expressed by the requirement that a claim be ‘supported by’ or ‘fully supported by’ the description. Broadly speaking, the terms ‘support’ and ‘full support’ pick up two concepts:
· there must be a basis in the description for each claim; and
· the scope of the claims must not be broader than is justified by the extent of the description, drawings and contribution to the art.
…

This item is intended to align the Australian requirement with overseas jurisdictions’ requirements (such as the UK). Overseas case law and administrative decisions in respect of the ‘support’ requirement will be available to Australian courts and administrative decision-makers to assist in interpreting the new provision.”[161]
[161] Explanatory Memorandum, item 9.

115. The corresponding provisions in the United Kingdom (UK) legislation (i.e. section 14(3) of the Patents Act 1977 (UK) in relation to the disclosure obligation and section 14(5)(c) in relation to the claim support obligation) have been considered many times by UK courts. In Merck, Burley J stated:
“It will be seen immediately that the s 40(2)(a) Patents Act disclosure obligation is expressed in terms that are virtually the same as in s 14(3) of the UK Act. The language of the claim support obligation in s 40(3) (“...claims must be...supported by matter disclosed in the specification”) is very similar to that in s 14(5)(c) of the UK Act.
It may be noted that in the United Kingdom, the highest courts have emphasised the influential effect of the European Patent Office Technical Board on the development of the law in that Country: Generics (UK) Ltd v H Lundbeck A/S [2009] UKHL 12; RPC 13 (Generics UK (HL)) at [86] (per Neuberger LJ).”[162]

and
“The main difference between the two is that the disclosure obligation under s 14(3) relates to the specification as a whole whereas the claim support obligation under s 14(5)(c) relates to the claims which define the invention: Generics UK (HL) at [19]. As Walker LJ said in Generics (UK) at [20]:
Ss 14(3) and (5)(c) operate together, as EPC Arts 83 and 84 operate together, to spell out the need for an “enabling disclosure”, which is central to the law of patents…The disclosure must be such as to enable the invention to be performed (that is, to be carried out if it is a process, or to be made if it is a product) to the full extent of the claims. The question whether there is sufficient enabling disclosure often interacts with a question of construction as to the extent of the claims...”[163]
[162] Merck at [521]-[522].
[163] Merck at [528].

116. Although the obligations are similar, they are distinct and must be considered separately according to their own criteria.
The disclosure obligation: “classical insufficiency”
117. In Merck, Burley J discussed that under the UK Act, the disclosure obligation is interpreted to require the teaching of the specification to enable the skilled addressee to perform the invention, and failure to meet this requirement is often referred to as “classical insufficiency”.[164] His Honour quoted Aldous J at first instance in Mentor Corp v Hollister Inc [1991] 3 WLUK 167; FSR 557 at 562, a passage endorsed by the Court of Appeal in Mentor Corp v Hollister Inc (No 2) [1992] 7 WLUK 465; [1993] RPC 7 at 14:
“The section requires the skilled man to be able to perform the invention, but does not lay down the limits as to the time and energy that the skilled man must spend seeking to perform the invention before it is insufficient. Clearly there must be a limit. The subsection, by using the words “clearly enough and completely enough”, contemplates that patent specifications need not set out every detail necessary for performance, but can leave the skilled man to use his skill to perform the invention. In so doing he must seek success. He should not be required to carry out any prolonged research, enquiry or experiment. He may need to carry out the ordinary methods of trial and error, which involve no inventive step and generally are necessary in applying the particular discovery to produce a practical result. In each case, it is a question of fact, depending on the nature of the invention, as to whether the steps needed to perform the invention are ordinary steps of trial and error which a skilled man would realise would be necessary and normal to produce a practical result.”[165]
[164] Merck at [523].
[165] Merck at [524].

118. Burley J discussed the way the disclosure requirement has been applied in the UK under the name “classical sufficiency”.[166] His Honour quoted Jacob LJ in Novartis AG v Johnson & Johnson Medical Limited [2010] EWCA Civ 1039 at 74 who stated:
“The heart of the test is: ‘Can the skilled person readily perform the invention over the whole area claimed without undue burden and without needing inventive skill?”
[166] Merck at [525]-[526], Cytec at [142].

119. Burley J also quoted the convenient summary, by learned editors of Terrell on the Law of Patents (Terrell) (19^th ed, Sweet & Maxwell, London 2020), of the passage provided by Kitchin J (as his lordship the was) in Eli Lilly & Co v Human Genome Sciences, Inc [2008] 7 WLUK 978; RPC 29 at [239]:
“The specification must disclose the invention clearly and completely enough for it to be performed by a person skilled in the art. The key elements of this requirement which bear on the present case are these:
(i) the first step is to identify the invention and that is to be done by reading and construing the claims;
(ii) in the case of a product claim that means making or otherwise obtaining the product;
(iii) in the case of a process claim, it means working the process;
(iv) sufficiency of the disclosure must be assessed on the basis of the specification as a whole including the description and the claims;
(v) the disclosure is aimed at the skilled person who may use his common general knowledge to supplement the information contained in the specification;
(vi) the specification must be sufficient to allow the invention to be performed over the whole scope of the claim;

[251] Breivik, CB-22, abstract, description pages 4-5 and claims.
[252] Breivik, CB-22, description page 4.
[253] Breivik, CB-22, description page 5.
[254] Ibid.
213. The opponent appears to allege Example 7 of Breivik discloses a krill oil of the claims of the opposed application. Professor Barrow stated:
“Example 7 on page 9 describes krill extract having basis; 58% w/w phospholipids. The ether phospholipid concentration is therefore around 5.8% w/w, and non-ether around 52.2% w/w.”[255]

and
Example 7 in Breivik describes 58% w/w basis, phospholipids. The remainder is mainly triglycerides (approximately 42% w/w).[256]
[255] Barrow A at [184], item 1.1.
[256] Barrow A at [184], item 1.3.

214. Breivik only describes phospholipids generally and does not disclose ether phospholipids or non-ether phospholipids. Breivik also does not disclose the concentration of triglycerides, astaxanthin esters or free fatty acids in any of the krill lipid fractions. I understand Professor Barrow to have calculated the concentration of the different phospholipids based on an assumption that phosphatidylcholine forms around 88% (w/w) of total phospholipids in the ethanol extract of fresh krill in Example 7 of Breivik because Professor Barrow stated:
“Example 7 on page 9 describes a krill extract having 58% phospholipids. Based on data from Catchpole (phosphatidylcholine around 88% of total phospholipids), the phosphatidylcholine concentration in Breivik would be around 51% w/w of the extract, and the ether-phospholipids present at around 5.8% of the extract (based again on Catchpole, around 10% of total phospholipids).”[257]
[257] CB-3 (Barrow #3) at [128].

215. Example 7 of Breivik discloses fresh E. superba (12 kg) heated to 80^oC and then extracted with ethanol (26 kg) to produce “an ethanol extract of 0.82kg (7%)”. Analysis of the lipids by High Performance Liquid Chromatography (HPLC) showed a content of 58% phospholipids. Analysis by Gas Chromatography (GC) showed a content of 24.0 % EPA and 11.4% DHA giving a sum EPA + DHA of 35.4%. The remaining krill was extracted at 280 bar and 50^oC with CO₂ (156kg) containing ethanol (15 kg) to produce “an extract of 0.24 kg (2%)”. Analysis showed the extract had a content of 19% phospholipids, 8.9% EPA and 4.8% DHA.
216. I note the method disclosed in Example 7 of Breivik is different to the method disclosed in Example 18 of Catchpole, discussed previously. Example 7 of Breivik does not disclose a two-step supercritical CO₂ extraction method using neat supercritical CO₂ followed by supercritical CO₂ and ethanol. Professor Barrow does not explain why he assumed an extraction of fresh krill with ethanol first followed by supercritical CO₂ and ethanol would produce the same proportions of ether phospholipids and non-ether phospholipids as the two-step supercritical CO₂ extraction of Example 18 of Catchpole. There is no evidence on file to support this assumption. In fact, when Professor Barrow explained the use of co-solvents in the SCE method, he stated that krill phospholipids have a range of polarities and will extract to different degrees according to the overall solvent polarity which depends on the concentration of ethanol used in the extraction.[258]
[258] CB-3 (Barrow #3) at [84].

217. There is also no evidence on file to show that an extraction of fresh krill with ethanol followed by an extraction of the remaining krill material with supercritical CO₂ and ethanol, as disclosed in Example 7 of Breivik, will produce a krill oil composition as claimed in the opposed application. Additionally, there is no evidence on file to show that any of the other methods disclosed in Breivik for extracting krill lipid fractions would inevitably lead to a krill oil composition as claimed in the opposed application.

218. I conclude that the opponent has not established that claim 1 or any other claim of the opposed application lacks novelty in light of Breivik.
Conclusion on novelty
219. I conclude that the opponent has not established that any of the claims of the opposed application lacks novelty in light of the cited prior art documents.
Inventive step
220. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art:
For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed (whether in or out of the patent area) before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).

221. Subsection 7(3) prescribes the information that may be considered as:
The information for the purposes of subsection (2) is:
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.

222. The prior art base for the purposes of inventive step is made up of (1) information in a document that is publicly available anywhere, and (2) information that is made publicly available through doing an act anywhere.[259]
[259] The Act, Schedule 1, definition of prior art base.
223. Once the CGK and relevant information have been identified, the test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd Aickin J stated:
“The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.”[260]
[260] [1981] HCA 12 at [45]; 148 CLR 262 at 286.

224. An expectation of success is not an additional requirement over and above matters of routine:
“It is difficult to think of a case where an expectation that an experiment might well succeed is not implicit in the characterisation of steps as routine and to be tried as a matter of course.”[261]
[261] Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73 (Generic Health); 314 ALR 91 at [71].

Obviousness in light of CGK alone
225. The opponent alleged that the claims of the opposed application are obvious to the person skilled in the art in light of CGK before the priority date of the claims.[262] The opponent’s allegations appear to be based on Professor Barrow’s views that (1) solvent extraction methods, including SFE, were well known before March 2007, and (2) it was well known that different fractions of oil could be blended to form an oil with the desired characteristics.[263]
[262] The amended SGP dated 26 March 2020 at section 3.1, page 5.
[263] CB-3 (Barrow #3) at [81] – [93].
226. The opponent’s proposition appears to be that, given the fact that krill oil has about 40-60 % (w/w) phospholipids and about 30-40% (w/w) triglycerides of total lipids, it would be a matter of routine to use well known solvent extraction and blending methods to produce a krill oil composition within the scope of the claims of the opposed application. When asked what an ‘ideal’ or target commercial krill oil would comprise as of March 2007, Professor Barrow stated he would aim to produce krill oil with at least the same or similar relative concentrations of phospholipids and triglycerides as present in the krill starting material. Professor Barrow stated that he would, specifically, blend a krill oil having about 40-60% phospholipids and the remainder triglycerides. He also stated:
“It would be a matter of routine to mix the phospholipid and triglyceride extracts I have discussed above in order to produce this target oil. The target oil would also contain astaxanthin and astaxanthin esters. Astaxanthin would inevitably be present in the oil as it is soluble in the extraction solvent(s) and would co-extract along with the phospholipid and triglyceride extracts. Ideally I would want as much astaxanthin as possible present. By virtue of the extraction techniques I have discussed above, I would expect at least 100 ppm astaxanthin to be present in any krill oil.”[264]
[264] CB-3 (Barrow #3) at [92].

227. While Professor Barrow believes that the proportions of phospholipids and triglycerides in krill oil were well known in March 2007, this information appears to only come from the cited prior art. I do not accept the proportions of phospholipids and triglycerides in krill oil were well known for reasons which I previously discussed. There is also no evidence on file to indicate that the proportions of ether phospholipids and non-ether phospholipids were part of the CGK as of the priority date of the claims of the opposed application. Therefore, the evidence has not established it was a matter of routine for the person skilled in the art to use extraction and blending methods with a view of achieving a krill oil composition with the particular combination of concentrations of components as claimed in the opposed application.
228. Consequently, I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light of CGK before the priority date of the claims.
Obviousness in light of citations considered together with CGK
229. The opponent relies on 23 citations, which I have listed in Annex C, to allege lack of inventive step.[265] Professor Barrow gave particular focus to three citations.[266] The three citations are:
·WO 2007/123424 (D1, also referred to as Catchpole), published on 01 November 2007;
·WO 2008/060163 (D2, also referred to as Breivik), published 22 May 2008; and
·WO 03/011873 (D4, also referred to as Sampalis), published 13 February 2003.[267]
[265] The amended SGP dated 26 March 2020 at section 3.4-3.5, pages 13-16.
[266] Barrow A at [182] – [185].
[267] Catchpole is referenced as exhibit CB-21 in the EIS. Breivik is referenced as exhibit CB-22 in the EIS. Sampalis is referenced as exhibit CB-18 in the EIS.

230. The publication dates of Catchpole and Sampalis are before the priority date, 28 January 2008, of the claims of the opposed application. However, the publication date of Breivik is after 28 January 2008. Consequently, Catchpole and Sampalis are part of the prior art base for the purposes of inventive step but Breivik is not. It follows that I do not need to consider Breivik in my assessment of inventive step.
Catchpole
231. I have previously discussed the disclosure of Catchpole. I considered Example 18 of Catchpole discloses extract 2 to comprise 4.8% ether phospholipids (w/w) and 40.3% non-ether phospholipids (w/w), so that the total amount of ether phospholipids and non-ether phospholipids in extract 2 is 45.1% (w/w). The concentrations of triglycerides, astaxanthin esters and free fatty acids for extract 2 of Catchpole are not clearly disclosed for the reasons I previously discussed.
232. There is no evidence on file indicating it would be a matter of routine for a person skilled in the art to modify the method disclosed in Example 18 of Catchpole to produce a krill oil composition comprising 20 to 50 % triglycerides (w/w). There is also no evidence on file indicating it would be a matter of routine for a skilled person to produce a krill oil having 100 to 700 mg/kg astaxanthin esters.
233. I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light of Catchpole considered together with the CGK before the priority date of the claims.
Sampalis
234. Sampalis is a patent application filed by Neptune Technologies & Bioresources Inc. from Laval, Quebec in Canada. Sampalis discloses a method of producing a phospholipid extract from marine or aquatic biomass, including krill. The extraction method is disclosed to be similar to the method of WO 00/23546 (also referred to as Beaudoin), published on 27 April 2000, and the disclosure of the extraction method of Beaudoin is stated as incorporated by reference.[268] The extraction method generally comprises successive acetone and alcohol treatments, starting with freshly harvested marine or aquatic animal.
[268] WO 00/23546 (Beaudoin) referenced as CB-19 in the EIS.
235. The phospholipid extract of Sampalis is disclosed to comprise at least 40% (w/w) phospholipids, preferably about 45-60% (w/w) phospholipids. Table 5 of Sampalis discloses the lipid composition of an extract to include ≥2.50 g/100g phosphatidylethanolamine, ≥0.20 g/100 g phosphatidylinositol, ≥0.20 g/100 g phosphatidylserine, ≥35.00 g/100 g phosphatidylcholine, ≥3.00 g/100g triglycerides and ≥5.00 g/100g free fatty acids. This is the equivalent of ≥ 2.5% (w/w) phosphatidylethanolamine, ≥0.2% (w/w) phosphatidylinositol, ≥0.2% (w/w) phosphatidylserine, ≥35% (w/w) phosphatidylcholine ≥3% (w/w) triglycerides and ≥5% (w/w) free fatty acids. The extract is also disclosed to have ≥10mg/100ml astaxanthin. Professor Barrow stated that he considered Table 5 of Sampalis to show an extract comprising greater than 100 ppm astaxanthin.[269] Sampalis discloses that the astaxanthin is mainly esterified but non-esterified forms may be present.
[269] Barrow A at [183], item 1.4.
236. I understand Table 5 of Sampalis to disclose an extract comprising greater than 35% (w/w) non-ether phospholipids, greater than 3% (w/w) triglycerides and greater than 5% (w/w) free fatty acids and greater than 100mg/kg astaxanthin (comprising mainly astaxanthin esters). I have viewed Sampalis and Beaudoin and have found no disclosure of ether phospholipids in both documents.
237. Professor Barrow stated:
“…Table 5 on page 30 of Sampalis … provides minimum concentrations for various species of phospholipid in the extracted oil. Total phospholipid is >40 wt% (g/100 g of sample). The phosphatidylcholine concentration is stated to be ≥35 wt% (g/100g of sample). From Catchpole I understand that ether phospholipid concentration in krill oil is around 10% of total phospholipids. Based on this property, the ether phospholipid content of the extract of Table 5 would be >4.0% (i.e. 10% x >40%).”[270]
[270] CB-3 (Barrow#3) at [119].

238. Professor Barrow also observed that the krill oil disclosed Sampalis is referred in the document as Neptune Krill oil and stated:
“…the method of Sampalis is the same as Beaudoin and the resulting oil is the commercial product sold as NKO™. From this document, I understand that the ether phospholipid concentration of NKO™ would be >4.2%.”[271]
[271] CB-3 (Barrow#3) at [117], [122].

239. The methods disclosed in Catchpole and Sampalis that were used to extract lipids from the krill material are different. Professor Barrow does not explain why he assumed an extraction of fresh krill using successive acetone and alcohol treatments of Sampalis would produce the same proportions of ether phospholipids as extraction of freeze-dried krill powder using the two-step supercritical CO₂ extraction of Example 18 of Catchpole. There is no evidence on file to support this assumption. In fact, when Professor Barrow explained the use of co-solvents in the SCE method, he stated that krill phospholipids have a range of polarities and will extract to different degrees according to the overall solvent polarity which depends on the concentration of ethanol used in the extraction.[272] The concentration of ether phospholipids in the extract of Table 5 of Sampalis is not clear to me.
[272] CB-3 (Barrow #3) at [84].
240. There is no evidence on file indicating it would be a matter of routine for a person skilled in the art to modify the method disclosed in Sampalis so as to arrive at krill oil as claimed in claim 1 of the opposed application.
241. I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light of Sampalis considered together with the CGK before the priority date of the claims.
Other prior art documents relied on by the opponent for allegations of lack of inventive step
242. NKO GRAS Notice 000242 dated 18 January 2008 (NKO GRAS Notification, D3) is an application by Neptune Technologies & Bioresources Inc. (Laval, Quebec, Canada) (Neptune) to the US Food and Drug Administration to assess Neptune’s krill oil compositions, NKO^TM, for being Generally Recognised As Safe (GRAS) under the US Federal Food, Drug and Cosmetic Act.[273] The application is dated 18 January 2008. The opponent stated this document is available from the website of the US Food and Drug Administration. It is unclear to me whether this document was made publicly available by 28 January 2008, the priority date of the claims of the opposed application. Therefore, it is unclear to me whether this document is part of the prior art base for the purposes of inventive step. As will become evident, the disclosure in NKO GRAS Notice 000242 does not assist in a finding of lack of inventive step for the claims of the opposed application. Therefore, I do not have to decide whether in NKO GRAS Notice 000242 is part of the prior art base.
[273] NKO GRAS Notice 000242 is referenced as exhibit CB-25 in the EIS and D3 in the amended SGP dated 26 March 2020.
243. NKO^TM is disclosed to be extracted from Euphasia superba using a method of successive acetone extractions. The profiles of the extracted oil are disclosed in various tables in the document. Table 1 discloses that the specification for NKO^TM is to comprise ≥40.0g/100g (40% w/w) total phospholipids and >150.0mg/100g (>1500mg/kg) esterified astaxanthin. Table 2 discloses analyses of three batches of NKO^TM and demonstrated all three batches met the specification profile. For example, NKO^TM batch 060116 comprised 47.3 g/100 g (47.3%w/w) total phospholipids and 162.6 mg/100g (1626 mg/kg) esterified astaxanthin. The concentration of astaxanthin esters disclosed in NKO^TM is therefore greater than that of the claimed invention.

244. There is no evidence on file indicating it would be a matter of routine for a person skilled in the art to modify the method disclosed in NKO GRAS Notice 000242 so as to arrive at krill oil as claimed in claim 1 of the opposed application.

245. Even if NKO GRAS Notice 000242 was part of the prior art base, I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light of NKO GRAS Notice 000242 considered together with the CGK before the priority date of the claims.

246. GRAS notice No.371 dated 14 December 2010 (Superba GRAS notice, D7) is an application by Aker Biomarine Antarctic AS (the applicant), to the US Food and Drug Administration to assess the applicant’s krill oil compositions, Superba^TM Krill Oil, for being Generally Recognised As Safe (GRAS) under the US Federal Food, Drug and Cosmetic Act.[274] Since the date of this document was created is after 28 January 2008, GRAS notice No.371 is not part of the prior art base for the purposes of inventive step.
[274] GRAS notice No.371 is references as D7 in the originally filed SGP dated 07 August 2019.

247. I have viewed the remaining documents, D5, D6 and D8-D23 (details of citation are listed in Annex C), which have been cited by the opponent as being relevant prior art documents for the purposes of inventive step. I have found the disclosure in each document do not assist in a finding of lack of inventive step for the claims of the opposed application. None of D5, D6 and D8-D23 disclose a krill oil having the concentration of ether phospholipids or astaxanthin esters as claimed in the opposed application. There is no evidence on file indicating it would be a matter of routine for a person skilled in the art to consider the disclosure in any one of D5, D6 and D8-D23 together with CGK so as to arrive at krill oil as claimed in any of the claims of the opposed application. There is also no evidence on file indicating that the skilled person could, before the priority date of the claims, be reasonably expected to have combined any of the cited prior art documents.

248. I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light of CGK before the priority date of the claims, whether that knowledge is considered separately or together with the information in the cited documents.
Obviousness in light of CGK considered together with information made publicly available through the commercial making available of NKO^TM
249. The opponent alleged the claims of the opposed application would be obvious to a person skilled in the art in light of CGK considered together with information made publicly available through the commercial making available of NKO^TM.[275]
[275] The amended SGP dated 26 March 2020 at section 3.6, page 16.
250. Professor Barrow stated that NKO^TM was commercially available prior to March 2007 and its properties are documented in NKO GRAS notification Notice 000242.[276]
[276] CB-5 (Barrow #5) at [73], CB-3 (Barrow#3) at [123]-[124], [185].

251. I have previously found the disclosure of the profile of NKO^TM in the NKO GRAS Notice 000242 does not assist in a finding of lack of inventive step for the claims of the opposed application. The opponent has not provided any further evidence regarding what information was made publicly available in the process of commercial making available of NKO^TM.

252. The opponent has not established that any of the claims of the opposed application lacks an inventive step in light of CGK before the priority date of the claims considered together with information that was made publicly available through doing an act.
Conclusion on inventive step
253. I conclude that the opponent has not established a lack of inventive step for any of the claims of the opposed application.
Manner of manufacture
254. 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”.[277]

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.”[278]
[277] [1995] HCA 15; 183 CLR 655 at [9].
[278] [2000] FCA 316; 46 IPR 553 at [30].

255. 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, …”[279]
[279] [1959] HCA 71; (1959) 102 CLR 232 at 251.

256. The opponent alleged that the invention claimed in all the claims of the opposed application are not for a manner of manufacture. The opponent alleged that claims 1-15 of the opposed application constitutes a mere combination of components which are naturally occurring in krill oil, and which are found in well-known krill oil extracts.[280] The opponent also alleged that the krill oil composition of claim 1 is produced by known processing steps, or could be produced by blending different krill oil extracts to produce something falling within claims 1-15.[281]
[280] The amended SGP dated 26 March 2020 page 3.
[281] Ibid.
257. I have previously found that the proportions of ether phospholipids, non-ether phospholipids, triglycerides, astaxanthin, and other components in krill oil were not commonly known in the art at the priority date of the claims of the opposed application. The evidence does not establish that there is a lack of invention on the face of the specification. The opponent has not established that the invention in any of the claims is not a manner of manufacture.
Conclusions
258. I have found a typographical error in claim 3 which does not result in a lack of clarity of the scope of any of the claims. The applicant may correct this by amendments if it wishes.
259. The opponent has not established that claims 1-23 of the opposed application fail to comply with the grounds of clarity, sufficiency, support, disclosure of best method, utility, novelty, inventive step and manner of manufacture. Therefore, the opposition is unsuccessful.

260. Subject to appeal, I direct the application proceed to grant.
Costs
261. 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 Rimfrost AS.
Dr A. Lim
Delegate of the Commissioner of Patents
Annex A: The claims of the opposed specification
1. A krill oil composition comprising:
from 3% to 10% ether phospholipids on a w/w basis;
from 35% to 50% non-ether phospholipids on w/w basis, so that the total amount of ether phospholipids and non-ether phospholipids in the composition is from 38% to 60% on a w/w basis;
from 20% to 50% triglycerides on a w/w basis,
from 100 to 700 mg/kg astaxanthin esters; and
less than 3% w/w free fatty acids.

2. The composition claim 1, wherein said ether phospholipids are selected from the group consisting of alkylacylphosphatidylcholine, lyso-alkylacylphosphatidylcholine, alkylacylphosphatidylethanolamine, and combinations thereof.
3. The composition of any one of claims 1 to 2, wherein said ether lipids are greater than 90% alkylacylphosphatidylcholine.
4. The composition of any one of claims 1 to 3, wherein said non-ether phospholipids are selected from the group consisting of phosphatidylcholine, phosphatidylserine, phosphatidylethanolamine and combinations thereof.
5. The composition of any one of claims 1 to 4, wherein said composition comprises a blend of lipid fractions obtained from Euphausia superba.
6. The composition of any one of claims 1 to 5, wherein said composition comprises from about 25% to 40% omega-3 fatty acids as a percentage of total fatty acids and wherein from about 80% to 90% of said omega-3 fatty acids are attached to said phospholipids.
7. The composition of any one of claims 1 to 6, wherein said composition comprises less than 2% free fatty acids.
8. The composition of any one of claims 1 to 7, further characterized in that said phospholipids comprise greater than 50% phosphatidylcholine (w/w).
9. The composition of any one of claims 1 to 8, further characterized in that said phospholipids comprise greater than 70% phosphatidylcholine (w/w).
10. The composition of any one of claims 1 to 9, further characterized in that said phospholipids comprise greater than 80% phosphatidylcholine (w/w).
11. The composition of any one of claims 1 to 10, further characterized in comprising less than about 0.5g/100g total cholesterol.
12. The composition of any one of claims 1 to 11, further characterized in comprising less than about 0.45% arachidonic acid (w/w).
13. The composition of any one of claims 1 to 12, further characterized in being free from acetone.
14. The compositions of any one of claims 1 to 13, wherein said composition is odorless.
15. The composition of any one of claims 1 to 14, wherein said composition comprises less than about 10 mg/kg (w/w) trimethylamine.
16. A capsule containing the composition of any one of claims 1 to 15.
17. A dietary supplement comprising the composition of any one of claims 1 to 15.
18. A composition as claimed in any one of claims 1 to 15 for the prevention or treatment of diet-induced hyperinsulinemia, insulin insensitivity, muscle mass hypertrophy, serum adiponectin reduction or hepatic steatosis.
19. A composition as claimed in any one of claims 1 to 15 for inducing diuresis.
20. A composition as claimed in any one of claims 1 to 15 for decreasing protein catabolism.
21. A composition as claimed in any one of claims 1 to 15 for prevention or treatment of fatty heart.
22. A composition as claimed in any one of claims 1 to 15 for prevention or treatment of fatty liver.
23. A composition as claimed in any one of claims 1 to 15 for prevention or treatment of insulin resistance, inflammation, blood lipid profile and oxidative stress.
Annex B: Table 22 of Example 8 of the opposed specification shows the phospholipid profiles of a krill powder, Neptune Krill Oil (NKO) and krill oil of Example 7 of the opposed specification
Annex C: List of citations the opponent relies on to allege lack of inventive step
D1: WO 2007/123424 (Catchpole), published on 01 November 2007
D2: WO 2008/060163 (Breivik), published 22 May 2008
D3: NKO GRAS Notice 000242 dated 18 January 2008
D4: WO 03/011873 (Sampalis), published13 February 2003
D5: WO 00/23546 (Beaudoin), published 27 April 2000; US Patent No. 6,800,299, the equivalent of WO 00/23546 (Beaudoin) published 05 October 2004
D6: Fricke, H., et al., “Lipid, sterol and fatty acid composition of Antarctic krill (Euphausia superba Dana)”, Lipids, Vol. 19, No. 11, 821-827, (1984)
D7: GRAS notice No.371 dated 14 December 2010 (Superba GRAS notice)
D8: FAO Fisheries Technical Paper 142 titled “The production of fish meal and oil”, (1986)
D9: Grantham G. J., “The utilisation of krill”, Food and Agriculture Organisation of the United Nations, (1977)
D10: Budzinski, E., et al., FAO Fisheries Technical Paper 268 titled “Possibilities of processing and marketing of products made from Antarctic krill”, (1985)
D11: Krill: Biology, Ecology and Fisheries, edited by Everson, I., (2000), Chapter 10, Products derived from krill
D12: Yamaguchi, K., et al., “Supercritical Carbon Dioxide Extraction of Oils from Antarctic Krill”, J. Agric. Food Chem. 1986, 34, 904-907
D13: “Supercritical Fluid Processing of Food and Biomaterials” by Rizvi, Syed S. H., ISBN: 9780834213562. Publication Date: October 1998, Publisher: Aspen Publishers Inc., U.S., Chapter 17, Supercritical CO2 extraction of oil from a seaweed, Palmaria palmata
D14: Tanaka, Y., et al., “Extraction of phospholipids from Salmon Roe with supercritical carbon dioxide and an entrainer”, J. of Oleo Sci., 53(9), 417-424, (2004)
D15: Chandrasekar, B, et al., “Tissue-specific regulation of transforming growth factor beta by omega-3 lipid-rich krill oil in autoimmune murine lupus”, Nutrition Research, Vol. 16, No. 3, 489-503, (1996)
D16: Deutsch, L. “Evaluation of the Effect of Neptune Krill Oil on Chronic Inflammation and Arthritic Symptoms”, Journal of the American College of Nutrition, 26:1, 39-48, (2007)
D17: Kidd, P. “Omega-3 DHA and EPA for Cognition, Behaviour, and Mood: Clinical Findings and Structural-Functional Synergies with Cell Membrane Phospholipids”, Alternative Medicine Review, 12(3), (2007)
D18: Neptune website ( located on the Web Archive (Wayback Machine - which were captured on 21 June 2003, and 24 November 2005 (Neptune website)
D19: Bunea, R., et al., “Evaluation of the Effects of Neptune Krill Oil on the Clinical Course of Hyperlipidemia”, Alternative Medicine Review, 9(4), 420-428, (2004)
D20: AU 2002322233, Australian national phase entry of WO 03/011873 (Sampalis)
D21: Calder, P. C. “n-3 Polyunsaturated fatty acids, inflammation, and inflammatory diseases”, Am. J. Clin. Nutr. Volume 83, (2006)
D22: Todoric, J., et al., “Adipose tissue inflammation induced by high-fat diet in obese diabetic mice is prevented by n-3 polyunsaturated fatty acids”, Diabetologia Volume 49, (2006)
D23: Itoh, M. et al., “Increased Adiponectin Secretion by Highly Purified Eicosapentaenoic Acid in Rodent Models of Obesity and Human Obese Subjects”, Arterioscler. Thromb. Vasc. Biol., (2007)

Patent Application opposed	Declarant	Declaration date	Exhibits	Reference
2017201340 (current opposition)	Colin Barrow	06 November 2019	CB-1 to CB-27	Barrow A
2011213836	Colin Barrow	14 August 2014	Curriculum vitae of Colin Barrow	Barrow #1[3]
2011213836	Colin Barrow	19 January 2015	None included for the current opposition[4]	Barrow #2[5]
2013227998	Colin Barrow	19 July 2017	None included for the current opposition	Barrow #3[6]
2013227998	Colin Barrow	05 March 2018	None included for the current opposition	Barrow #4[7]
2014256345	Colin Barrow	01 September 2017	None included for the current opposition	Barrow # 5[8]