Rimfrost AS v Aker BioMarine Antarctic AS [2022]  
APO 47 (7 July 2022)  
Last Updated: 7 July 2022  
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  
1. 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granted after an opposition by Rimfrost AS was withdrawn.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from 2011213836 (the great grandparent), now withdrawn.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  
[1]  
28 March 2007.  
2. 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.  
3. 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.  
4. 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.  
5. 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  
[2]  
2020, 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.  
6. 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.  
7. 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  
8. 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  
9. 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.  
10. 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 Declarant Declaration  
Exhibits  
Reference  
Barrow A  
opposed  
date  
Colin  
Barrow  
06 November CB-1 to CB-27  
2019  
2017201340  
(current  
opposition)  
2011213836  
2013227998  
2014256345  
Colin  
Barrow  
14 August  
2014  
Curriculum vitae of Colin Barrow  
[3]  
Barrow  
#1  
19 January  
2015  
None included for the  
current opposition  
Barrow  
#2  
[4]  
[5]  
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]  
Colin  
Barrow  
01 September None included for the  
2017 current opposition  
Barrow #  
[8]  
5
11. 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  
[9]  
the opponent alleged were relevant to the current opposition. It has not been helpful  
that the opponent chose not to provide any written submissions.  
12. 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.  
13. 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  
14. The field of the invention is stated in the specification as relating to extracts from  
[10]  
Antarctic krill that comprise bioactive fatty acids.  
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.  
Principles of construction  
15. 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  
[11]  
date.”  
The person skilled in the art  
16. 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  
[12]  
whether a patent is obvious.”  
17. 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  
[13]  
not involve an inventive step.”  
18. 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  
[14]  
compounds from marine organisms.  
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  
[15]  
oil and carotenoid food ingredients.  
19. 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  
20. 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  
[16]  
Ocean.  
21. 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  
[17]  
krill lipids from krill by using a ketone solvent, such as acetone.  
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  
[18]  
another solvent, such as ethanol.  
The specification states that compositions produced  
by these methods contain at least 75 µg/g astaxanthin and preferably 90 µg/g  
[19]  
astaxanthin.  
22. 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  
[20]  
controlling blood glucose levels in patients.  
23. The specification cites another prior patent application, WO 03/011873 (Sampalis),  
[21]  
which discloses a krill oil composition comprising a phospholipid and a flavonoid.  
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),  
[22]  
to be as high as 35% (w/w).  
The specification also states that Sampalis discloses the  
[23]  
use of the phospholipids extracts in nutraceutical, pharmaceutical and cosmetics.  
24. The specification states that it had previously been shown that supercritical fluid  
extraction (SFE) using neat carbon dioxide (CO ) could be used to prevent extraction of  
2
phospholipids and extract the neutral lipid fraction, which was comprised of esterified  
[24]  
and free astaxanthin, from krill.  
25. The specification also states that extraction of phospholipids from salmon roe by a  
[25]  
method using SFE and a solvent modifier had previously been used.  
26. 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  
[26]  
phosphatidylcholine and partly decomposed triglycerides.  
Aim of the invention  
27. The specification states that methods for processing krill that do not require  
transporting frozen krill over long distances and products produced by those methods  
[27]  
are needed in the art.  
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  
[28]  
meal which was stored at room temperature for subsequent krill oil extraction.  
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.  
The invention as described in the specification  
28. The specification sets out different aspects and embodiments of the invention in the  
[29]  
section titled “Summary of the invention”. These include krill oil compositions,  
[30]  
methods of producing krill oil compositions,  
and methods of treating various  
[31]  
disorders using the krill oil compositions.  
29. The components of krill oil compositions described include phospholipids, triglycerides,  
astaxanthin esters, free astaxanthin, free fatty acids, omega-3 fatty acids, and  
[32]  
arachidonic acid.  
The specification defines some of these components, and it is useful  
to provide the definitions here.  
30. 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  
[33]  
nitrogen containing compound choline, ethanolamine, inositol or serine.  
In the  
structure shown below the fatty acids and the phosphate group are joined together by a  
glycerol backbone.  
Chart, diagram,  
box and whisker  
chartDescription  
automatically  
generated  
Ether phospholipid  
31. 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  
[34]  
alkylacylphosphatidylethanolamine (AAPE).  
32. A non-ether phospholipid is a phospholipid that does not have an ether bond at position  
[35]  
1 of the glycerol backbone.  
Examples of non-ether phospholipids include  
[36]  
phosphatidylcholine, phosphatidylserine, and phosphatidylethanolamine.  
33. 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,  
[37]  
10, 13, 16, 19-docosapentanoic acid (DPA).  
[38]  
34. Astaxanthin is defined by the chemical structure shown below:  
2022_4701.jpg  
Astaxanthin esters  
35. An astaxanthin ester is defined as having fatty acids esterified to the OH group in the  
[39]  
astaxanthin molecule shown above.  
36. The different embodiments of krill oil compositions described in the specification are  
characterised by different concentrations of components in the oil. One embodiment  
[40]  
comprises from about 3% to 10% ether phospholipids on a w/w basis (w/w),  
from  
about 35% to 50% non-ether phospholipids (w/w), from about 20% to 45% triglycerides  
[41]  
(w/w), and from about 400 to about 2500 mg/kg astaxanthin.  
The total amount of  
ether phospholipids and non-ether phospholipids in the composition is from about 38%  
[42]  
to 60 %.  
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  
[43]  
phospholipids.  
The specification also described a further krill oil embodiment  
[44]  
comprising at least 65% phospholipids (w/w).  
While Euphausia superba is the  
preferred species of krill for use in the invention, other krill species are described as  
[45]  
being suitable.  
37. 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%  
[46]  
phosphatidylcholine,  
or  
ii. the krill oil (i.e., composition as a whole) is described as having a  
[47]  
phosphatidylcholine content greater than 50%, 70% or 80% (w/w).  
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).  
38. 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  
[48]  
(w/w).  
Other compositions are described as low-astaxanthin krill oil and have less  
[49]  
than about 70, 60, 50, 40, 30, 20, 10, 5 or 1 mg/kg astaxanthin esters (w/w).  
The  
concentration of astaxanthin in krill oil can be altered by using different extraction  
methods which I will discuss.  
39. 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  
[50]  
less than about 0.5g/100g total cholesterol.  
40. The specification explains that acceptable excipients or carriers are included in the krill  
oil compositions which are formulated for oral consumption using conventional  
[51]  
techniques. The oral formulations include capsules and tablets.  
In some  
embodiments, the krill oil compositions are formulated as a dietary supplement in  
[52]  
combination with one or more ingredients such as herbs, vitamins, and minerals.  
Methods of producing krill oil compositions  
41. The specification describes methods of producing krill oil compositions by extracting oil  
[53]  
from krill material.  
In some embodiments, the krill material is a krill meal produced  
[54]  
by heat-treating fresh krill to denature the lipases and phospholipases in the krill.  
The denatured krill product may be stored at room temperature, or below, between the  
[55]  
denaturation step and the extraction step.  
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 (CO ) and a low concentration of co-solvent (e.g., from about 1-10% co-solvent)  
2
and a second extraction step with supercritical CO and a high concentration of co-  
2
[56]  
solvent (e.g., from about 10-30% co-solvent).  
The preferred embodiment of the co-  
[57]  
solvent is described as a C -C monohydric alcohol, preferably ethanol.  
In other  
1
3
[58]  
embodiments, supercritical CO is used without a co-solvent.  
Using neat  
2
supercritical CO , or supercritical CO in combination with 5% ethanol, extracts the  
2
2
neutral lipid fraction from krill oil. The neutral lipid fraction is described to consist  
[59]  
mostly of triglycerides and cholesterol.  
42. The specification also discloses the use of a low amount of polar solvent with  
supercritical CO in the first extraction step facilitates extracting the neutral lipid  
2
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  
[60]  
phospholipids and non-ether phospholipids.  
43. 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  
[61]  
of phospholipids, astaxanthin and other oil components.  
44. The specification also describes that an extraction step with neat supercritical CO can  
2
be used to remove astaxanthin from krill material, or krill oil, to produce a low-  
[62]  
astaxanthin krill oil.  
Extraction with neat supercritical CO also removes odour  
2
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  
[63]  
mg/kg trimethylamine.  
45. 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  
[64]  
properties as compared to previously available krill oils.”  
Methods of treatment using krill oil compositions  
46. 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  
[65]  
have been disclosed to have anti-inflammatory effects.  
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  
[66]  
dysregulation.  
47. 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  
[67]  
disorder.  
The krill oil compositions administered in this embodiment are described  
[68]  
as not limited to any particular formulation.  
48. 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  
[69]  
liver of a subject.  
Examples described in the specification  
49. 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  
[70]  
oil referred to as asta oil.  
Professor Barrow stated that asta oil is neutral oil that is  
[71]  
pressed out of the krill meal.  
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.  
50. 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  
[72]  
ethanol.  
51. Example 3 relates to a two-step SFE method of the krill meal of example 1. During step 1,  
neat supercritical CO was used to extract the neutral lipids to produce what is referred  
2
to as neutral krill oil. In step 2, supercritical CO and 20% ethanol was used to extract  
2
[73]  
the polar lipids to produce what is referred to as polar krill oil.  
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  
[74]  
(NKO).  
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.  
52. Example 4 relates to another two-step SFE method of the krill meal using neat  
supercritical CO in the first step and a mixture of neat supercritical CO and 20%  
2
2
ethanol in the second step. The neutral lipids from step 1 were mixed with the polar  
[75]  
lipids from step 2 in a 50/50 ratio to produce a blended krill oil.  
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  
[76]  
esters.  
Example 5 describes the composition of another blended krill oil composition  
[77]  
obtained by mixing the polar lipids of example 4 with the asta oil of example 1.  
53. Example 6 describes processing fresh krill to obtain a denatured and dried krill meal.  
o
Fresh krill from a harvesting trawl is denatured by heating to 90 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 CO was used in a first step, and supercritical CO plus 20%  
2
2
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  
[78]  
have 9.05% phosphatidylcholine and 4.60 % decomposed phosphatidylcholine.  
54. 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 CO and 5% ethanol to  
2
remove the neutral lipids and astaxanthin from the krill meal. The second step uses  
supercritical CO and 23% ethanol. The composition of a krill oil produced is shown in  
2
[79]  
Table 21, reproduced here.  
TableDescription automatically generated  
TableDescription automatically generated  
31  
55. Example 8 and Figure 1 describe analyses of the krill oil of Example 7 using P 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  
[80]  
alkylacylphosphatidylethanolamine at <1% of TPL.  
56. Example 9 and Figures 2-9 describe the effect of different omega-3 fatty acid sources on  
[81]  
metabolic parameters in the Zucker rat model of obesity and insulin resistance.  
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,  
[82]  
including glucose tolerance, insulin resistance and hyperinsulinaemia.  
The omega-3  
fatty acid sources compared in example 9 are fish oil (FO), commercially available NKO  
TM  
and krill oil prepared according to example 7 (Superba ). The specification states:  
“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  
[83]  
was greatest with the krill oil prepared as in example 7 (Figure 10).”  
57. 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.  
58. 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  
[84]  
the same amount of omega-3 fatty acids.  
The krill oil administered to mice was  
described to be prepared according to a method like that described for example 5 but the  
[85]  
oil contained 500 mg/kg astaxanthin and 0.36% omega-3 fatty acids.  
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  
[86]  
lipid, serum adiponectin reduction and hepatic steatosis.  
Common general knowledge (CGK)  
59. 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  
[87]  
which discloses the feature of the “ether phospholipids” of the claimed invention.  
reasons provided later in my decision, I consider the priority date of the claims of the  
opposed application is 28 January 2008.  
For  
60. 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  
[88]  
CGK as of 28 March 2007.  
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.  
61. 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  
[89]  
of knowledge.”  
62. 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]  
63. 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,  
[91]  
when it becomes part of their common stock of knowledge relating to the art.”  
64. 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,  
[92]  
including Australia.  
However, Professor Barrow also states that the information on  
methods known for extracting oil from biological and marine-based materials was his  
[93]  
“knowledge generally”.  
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.  
Professor Barrow gave evidence regarding the CGK on krill, lipids, and solvent extraction. I  
will discuss these matters now.  
Krill oil  
65. Professor Barrow stated that krill is characterised by its high content of phospholipid  
(approximately 60%, mainly phosphatidylcholine and phosphatidylethanolamine), and  
[94]  
about 30-40% neutral fats (mono-, di- and triglycerides).  
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  
[95]  
(Grantham article).  
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  
[96]  
oil production.  
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.  
66. 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  
[97]  
total lipids.  
Another journal article authored by Bottino, N.R., et al., disclosed krill oil  
[98]  
to comprise 58% (w/w) phospholipids and 36% (w/w) triglycerides of total lipids.  
also note that the specification of the opposed application states the phospholipid  
I
content in the krill lipid extract could be as high as 60% (w/w) citing prior publication  
[99]  
WO 03/011873 (Sampalis).  
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  
[100]  
that there are seasonal variations in the fat content of krill.  
Therefore, I am not  
satisfied the evidence shows that the proportion of phospholipids or triglycerides in krill  
oil is part of the CGK.  
67. 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  
[101]  
with fish meal/oil processing. ”  
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  
[102]  
Neptune Krill Oil product from March 2007...”  
68. 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  
[103]  
in the literature to alleviate several disorders.  
Astaxanthin is also stated in the  
[104]  
specification to have been previously shown to be a powerful antioxidant.  
69. 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  
[105]  
phospholipids had a better bioavailability, and therefore better health benefits...”  
70. 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  
71. Professor Barrow stated that krill meal has been produced since the 1960s by cooking,  
[106]  
pressing, and drying.  
This statement is consistent with the disclosure in the  
Grantham article that cooking, pressing, and drying was the most common method of  
[107]  
producing krill meal at the time of journal publication, 1977.  
72. Professor Barrow also stated that cooking krill on-board a fishing vessel inactivates  
enzymes (lipases and phospholipases) and eliminates the possibility of degradation of  
[108]  
the oil by enzyme activity.  
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  
[109]  
an indicator of more general degradation of krill oil.  
Professor Barrow considered it  
was reasonable to infer that a low free fatty acid concentration in krill oil indicates that  
[110]  
there was little enzymatic degradation in the krill meal production method.  
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  
[111]  
decomposed glycerides, and free fatty acids.  
73. 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  
74. 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  
[112]  
generally”.  
75. 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  
[113]  
under high pressure to squeeze out the liquid from the meal.  
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  
[114]  
through heating and pressing.  
76. Professor Barrow referred to the Grantham article when providing evidence about krill  
[115]  
oil extraction methods  
. 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  
[116]  
oil while the pressed cake is dried to produce krill meal.  
described to be very poor after cooking and pressing.  
Fat separation was  
[117]  
The fat content of the press  
cake was shown to be comparatively higher than the oil separated from the liquid  
[118]  
phase.  
77. 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  
[119]  
worthwhile extracting and recovering them.”  
78. 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  
[120]  
extraction was the extraction method typically used to extract oil from krill.”  
79. 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,  
[121]  
extracts polar lipids, particularly the phospholipids.  
80. Professor Barrow further stated:  
“One specialised method of solvent extraction of a biomass is supercritical CO extraction  
2
(‘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 CO functions as a solvent. CO is compressed above its critical pressure and  
2
2
heated above its critical temperature to become a supercritical fluid which is used to extract oil  
and lipids. Supercritical CO can also be used as part of a sequential extraction. The  
2
triglycerides are mostly obtained in a first extraction with pure CO , and then in a subsequent  
2
extraction, the phospholipids can be mostly obtained by adding a polar co-solvent to the CO .  
2
A co-solvent, such as ethanol, can be used to improve selectivity and solubility, thereby  
[122]  
enabling the extraction of polar phospholipids.”  
81. 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  
[123]  
biomass.  
82. Professor Barrow stated he would mix hexane with the biomass in a first extraction step  
[124]  
to extract the non-polar lipids which comprise mainly triglycerides.  
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  
[125]  
be removed from the oil-solvent fraction by evaporation to obtain the triglycerides.  
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  
[126]  
extracted phospholipid-rich oil as in the starting material.  
83. Professor Barrow stated that if he had access to supercritical CO extraction (SCE)  
2
methods, he would follow the method outlined above and use supercritical CO in a first  
2
stage extraction to extract the triglycerides, and then use supercritical CO and ethanol  
2
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  
[127]  
phospholipids, such as 20%.  
84. 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.  
85. 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.  
86. These documents are a journal article by Yamaguchi et al., published in 1986  
[128]  
[129]  
(Yamaguchi),  
a journal article by Tanaka et al., published 2004 (Tanaka),  
and a patent document WO 2007/123424 A1 (Catchpole), published on 01 November  
[130]  
2007.  
87. Yamaguchi disclosed that SCE of Antarctic krill using neat supercritical CO yielded oils  
2
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  
[131]  
krill oils.  
The article noted that application of SCE to animal sources, particularly  
[132]  
seafood, was limited.  
I interpret that while the method of extracting of oils from  
marine-based materials using supercritical CO was known at the time of journal article  
2
publication in 1986, use of SCE as a method of solvent extraction was limited.  
88. Tanaka disclosed a study using a mixture of supercritical CO and ethanol (SC-CO ) to  
2
2
extract phospholipids from salmon fish roe. Phospholipids were not found to be  
extracted with 0 and 5% ethanol in SC-CO . Extractions with 10, 15 or 20% ethanol in  
2
SC-CO were effective in extracting phospholipids. Increasing the concentration of  
2
ethanol in the increased the amount of extracted phospholipids. When the extraction  
was performed with SC-CO and 20% ethanol mixture, more than 80% of the  
2
[133]  
phospholipids were recovered.  
The journal article suggests to me that the use of a  
mixture of SC-CO was still being developed at the time of journal article publication in  
2
2004.  
89. Catchpole disclosed the use of supercritical CO and ethanol to extract phospholipids  
2
from egg, soy, marine animals, and other food sources. Example 18 disclosed extraction  
of oil from freeze-dried krill powder using pure supercritical CO in a first extraction  
2
step followed by a second extraction step using supercritical CO and 11% ethanol. The  
2
extract from the first step contained no phospholipids and was substantially all neutral  
[134]  
lipids. The second extraction step produced a phospholipid-rich extract.  
The  
disclosure in Catchpole suggests that use of supercritical CO with or without ethanol to  
2
extract lipids from krill was still being developed at the time of publication of the patent  
application on 01 November 2007.  
90. 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  
91. Professor Barrow stated that it was well known prior to March 2007 that different  
[135]  
fractions of oil could be blended to form an oil with the desired characteristics.  
Professor Barrow noted that the commercially available Neptune Krill Oil is a blended  
[136]  
oil.  
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.  
92. 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  
93. 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  
[137]  
reference to the body of the specification”  
Claim 1  
94. 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.  
95. 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.  
96. 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.  
[138]  
97. The opponent alleged that appended claims 3, 8, 9, 10, 17, 18 to 23 are not clear.  
I
will now address these issues.  
Clarity  
98. 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  
[139]  
would fall within the ambit of the claim.  
99. The opponent alleged that claim 3 is not clear because there is no antecedent for “ether  
[140]  
lipids”.  
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.  
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  
[141]  
phospholipids”.  
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  
[142]  
phospholipids on a w/w basis.  
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.  
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  
[143]  
to comprise 7.38% ether phospholipids and 40.52% non-ether phospholipids,  
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.  
103. The opponent alleged that claim 17 is unclear because “the skilled person would be left  
[144]  
wondering what constitutes a ‘dietary supplement’”.  
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  
[145]  
being offered commercially as omega-3 supplements.  
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,  
[146]  
vitamins, and minerals.  
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  
[147]  
components make it suitable or not suitable.  
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  
[148]  
particular krill oil composition.  
106. The opponent alleged that the scope of “fatty heart” and “fatty liver” of claim 21 and  
[149]  
claim 22, respectively, is unclear.  
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  
[150]  
pathology disclosed in the specification.  
Therefore, I consider the scope of the terms  
“fatty heart” and “fatty liver” would be clear to the person skilled in the art.  
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  
[151]  
in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) (Merck),  
Industries Inc. v Nalco Company (Cytec).  
and in Cytec  
[152]  
Rofe J recently considered the two new  
requirements in Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd (Jusand)  
[153]  
and adopted Burley J’s approach in Cytec.  
109. Burley J referred to the requirement in paragraph 40(2)(a) as the disclosure  
[154]  
obligation.  
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  
110. Burley J also referred to the requirement in subsection 40(3) as the claim support  
[155]  
obligation.  
Subsection 40(3) states:  
The claim or claims must be clear and succinct and supported by matter disclosed in the  
specification.  
111. The secondary materials accompanying the introduction of the two new requirements to  
[156]  
section 40 were discussed in Merck  
. 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:  
[157]  
Merck at [544].”  
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  
[158]  
information necessary to make and use the invention.”  
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  
[159]  
corresponding provisions of UK legislation and the European Patent Convention.”  
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  
[160]  
support a broad claim following the amendments.”  
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-  
[161]  
makers to assist in interpreting the new provision.”  
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  
[162]  
UK (HL)) at [86] (per Neuberger LJ).”  
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  
[163]  
the claims...”  
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  
[164]  
“classical insufficiency”.  
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  
[165]  
would be necessary and normal to produce a practical result.”  
118. Burley J discussed the way the disclosure requirement has been applied in the UK under  
[166]  
the name “classical sufficiency”.  
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?”  
119. Burley J also quoted the convenient summary, by learned editors of Terrell on the Law  
th  
of Patents (Terrell) (19 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;  
(vii) the specification must be sufficient to allow the invention to be so performed without  
[167]  
undue burden.”  
120. In Cytec, Burley J referred to CSR Building Products Limited v United States Gypsum  
Company (CSR), [2015] APO 72, where a Deputy Commissioner, Dr Barker,  
determined at [95] that the steps involved in assessing whether the disclosure  
requirement is satisfied are:  
“(1) Construe the claims to determine the scope of the invention as claimed;  
(2) Construe the description to determine what it discloses to the person skilled in the art; and  
(3) Decide whether the specification provides an enabling disclosure of all the things that fall  
[168]  
within the scope of the claims.”  
121. His Honour also referred to the further questions developed in Evolva SA [2017] APO 57  
(Evolva) where another Deputy Commissioner, Dr McCaffery, added the following to  
the third question stated in CSR:  
“(1) Is it plausible that the invention can be worked across the full scope of the claim?  
(2) Can the invention be performed across the full scope of the claim without undue  
[169]  
burden?”  
122. Burley J observed that the steps proposed in Terrell and outlined above do not differ  
materially from those set out in the decisions of the Deputy Commissioners of Patents.  
His Honour also observed that the emphasis in Evolva, that the answer to the question  
involves consideration of whether the invention can be performed across the full scope  
of the claims without undue experimentation, represents a significant shift from the  
previous law, as set out in Kimberly-Clark Australia Pty Ltd v Arico Trading  
[170]  
International Pty Ltd, [2001] HCA 8; 207 CLR 1 at 25.  
His Honour stated that the  
language of paragraph 40(2)(a) indicates that this is the correct approach in  
[171]  
Australia.  
123. In Jusand Rofe J adopted the approach for the disclosure obligation set out by Burley J  
[172]  
in Cytec at [143]-[144], as quoted above.  
I will adopt the approach taken in CSR and  
Evolva which have been given judicial approval when considering the disclosure  
obligation in the present opposition.  
The opponent’s allegations  
124. The opponent alleged that there is no enabling disclosure for the invention as claimed in  
any of the claims because none of the examples in the specification disclose the  
[173]  
invention as claimed.  
125. More specifically, the opponent alleged that the “only examples which describe krill oil  
as per the purported invention (disclosing ether and non-ether phospholipids, and  
[174]  
astaxanthin) are Example 7 (Table 21) and Example 8 (Tables 22 and 23).”  
The  
opponent then alleged that, since the total polar lipids (TPL) of the krill oil of example 7  
(reported in Table 21) is different from the TPL of the krill oil of example 8 (reported in  
Table 22), the krill oil samples of example 7 and 8 are different and “cannot necessarily  
[175]  
be combined”.  
above.  
Table 22 is reproduced in Annex B. Table 21 has been reproduced  
126. The opponent also alleged that:  
◦ the “astaxanthin” concentration reported in Table 21 appears outside the  
[176]  
“astaxanthin ester” concentration claimed in claim 1;  
◦ Examples 7 and 8 are silent on the concentration of free fatty acids as claimed in  
claim 1;  
◦ Table 22 describes a phosphatidylcholine concentration that is not within the  
range of claim 1; and  
◦ Examples 7 and 8 provide no information on the concentration of components  
(such as cholesterol, arachidonic acid and trimethylamine) or features claimed in  
[177]  
claims 11-17.  
127. I understand the opponent to be alleging that:  
◦ only Examples 7 and 8 describe krill oil with ether and non-ether phospholipids,  
and astaxanthin;  
◦ the concentrations of the various krill oil components reported in Tables 21 and 22  
cannot be read collectively to represent values of a single krill oil sample since the  
TPL reported in the tables are different;  
◦ Examples 7 and 8 do not disclose the concentration of non-ether phospholipid,  
astaxanthin ester or free fatty acid claimed in claim 1; and  
◦ Examples 7 and 8 do not disclose the specific features claimed in some dependent  
claims  
128. The opponent further alleged that there is no statistically significant data for Examples 9  
to 12, and Figures 2 to 19 to show administration of the claimed krill oil can be used for  
[178]  
the methods of treatment defined in claims 18-23.  
What is the invention as claimed?  
129. As previously discussed, claim 1 defines a krill oil composition having the recited  
components present at the concentration ranges recited in the claim. Claims 2-23 define  
further features regarding the components of krill oil or define the uses for the krill oil  
composition.  
What does the specification disclose?  
130. I have previously discussed that the specification discloses krill oil compositions  
comprising different concentrations of ether phospholipid, non-ether phospholipids,  
triglycerides, omega-3 fatty acids, astaxanthin esters and free fatty acids. The different  
embodiments disclosed in the specification encompass the concentration range of the  
components defined in claim 1.  
131. The methods of producing krill oil compositions disclosed in the specification have also  
been previously discussed. These methods include a two-step SFE using neat  
supercritical CO , or supercritical CO in combination with a polar solvent such as  
2
2
ethanol. The neutral lipids and polar lipids from a krill material is disclosed to be  
sequentially extracted by SFE using varying the amounts of ethanol in combination with  
supercritical CO The concentration of astaxanthin in krill oil is disclosed to be altered  
2.  
by extraction with neat supercritical CO or supercritical CO in combination with  
2
2
ethanol. The neutral lipid fraction (comprising triglycerides and astaxanthin) is  
disclosed to be blended with the polar lipid fraction (comprising ether phospholipids  
and non-ether phospholipids) to provide krill oil compositions comprising the desired  
concentrations of phospholipids, astaxanthin esters and other oil components.  
Extraction with neat supercritical CO is also disclosed to remove odour causing  
2
compounds such as trimethylamine to provide a krill oil composition that is  
substantially odourless.  
132. The opponent appears to be alleging that the specification does not enable the skilled  
addressee to perform the invention because Examples 7 and 8 do not disclose some of  
the components of krill oil defined in claim 1, and where the components are disclosed,  
the concentration range is outside the range defined in the claim.  
133. I accept that Examples 7 and 8 do not disclose all the components of krill oil in the  
concentrations defined in claim 1. However, for the reasons which follow – reasons  
relating to the nature of the invention and how the invention has been disclosed in the  
specification – I do not consider it is necessary in this case for a single example to  
disclose all the components of krill oil in the concentrations defined in claim 1 for the  
disclosure obligation of s 40(2)(a) to be satisfied.  
134. In the present case, when I assess the specification as a whole (that being a  
consideration of the description and the claims), I find examples where the components  
of the krill oil are present in concentrations as defined in claim 1. For example, Table 22,  
Example 8 discloses the krill oil to comprise alkylacylphosphatidylcholine (AAPC), lyso-  
alkylacylphosphatidylcholine (LAAPC) and alkylacylphosphatidylethanolamine (AAPE)  
to a combined concentration of 15.4% TPL, and non-ether phospholipids to comprise  
84.6% TPL. This is the equivalent of 7.38% ether phospholipids (w/w) and 40.52% non-  
[179]  
ether phospholipids (w/w) in the krill oil.  
Therefore, I consider the concentrations of  
ether phospholipids and non-ether phospholipids in the krill oil composition of Example  
7 (and shown in Table 22, Example 8) are within the ranges claimed in claim 1 of the  
opposed application.  
135. Table 21, Example 7 discloses a krill oil composition to comprise 25.9% w/w  
triglycerides, and 2091 mg/kg astaxanthin. I accept the opponent’s observation that the  
TPL, 50.55% (w/w), reported in Table 21 is different to Table 22. However, I note that  
the methods of assessing the TPL for Examples 7 and 8 are different and mostly likely  
explain the differences in TPL reported. I have previously discussed that the  
concentration of astaxanthin and its esters in a krill oil composition depend on the  
extraction method. While the concentration of astaxanthin shown for the krill oil in  
Table 21 is outside the range claimed in claim 1 of the opposed application, other  
examples in the specification disclose methods that produced astaxanthin esters within  
the concentration range defined in claim 1.  
136. Example 3 discloses neutral krill oil comprising 98 mg/kg astaxanthin esters and polar  
krill oil comprising 580 mg/kg astaxanthin esters. The blended krill oil of Example 4  
comprises 0.5% (w/w) free fatty acids and 151 mg/kg astaxanthin esters. The methods  
used in Examples 3, 4, 7 and 8 all involve the two-step SFE using supercritical CO and  
2
ethanol. I note that the concentration of ethanol, the pressure conditions and  
temperatures used in the examples are different.  
137. I consider the specification has disclosed that the SFE method can be modified by  
varying factors such as ethanol concentration, pressure, and temperature to adjust the  
levels of extraction of the different components of krill oil. This disclosure teaches the  
skilled person that the concentrations of phospholipids, triglycerides, fatty acids,  
astaxanthin esters, and other components of krill oil can be tailored using the SFE  
method. Additionally, blending of lipid fractions has also been disclosed as a way to  
tailor the final content of the krill oil composition.  
Is it plausible to obtain the krill oil composition defined in claim 1 by following the teachings  
of the specification?  
138. The Deputy Commissioner in Evolva discussed Warner-Lambert Company LLC v  
Generics (UK) Limited (trading as Mylan) and another where Floyd LJ stated that the  
[180]  
threshold of plausibility is a low one designed to prohibit speculative claiming.  
The  
Deputy Commissioner then stated that the threshold of plausibility may be based on the  
slimmest evidence:  
“As noted above the threshold for plausibility is a low one, and may be based on the slimmest  
of evidence. Indeed in HGS v Eli Lilly, Lord Neuberger stated that in some cases a ‘plausible’  
[181]  
or ‘reasonably credible’ claimed use, or an ‘educated guess’, can suffice.”  
139. The question of plausibility was considered in the context of the nature of the invention  
and in light of the CGK of the skilled person in the decisions mentioned above.  
140. I have previously found that the specification discloses methods of extracting different  
components of krill, modifying the conditions of extraction methods to vary the amounts  
of krill components extracted, and blending different lipid fractions to produce an oil of  
the desired characteristic. Therefore, I consider that it is plausible to obtain the krill oil  
composition defined in claim 1 by following the disclosure in the specification.  
Can the invention be performed across the full scope of the claim without undue burden?  
141. The opponent has provided no evidence that the skilled person is required to carry out  
any prolonged research, enquiry or experiment to arrive at the invention claimed in the  
claims. In fact, Professor Barrow stated that the concentration of the non-ether  
phospholipids, ether phospholipids as recited in claim 1 is simply a function of the levels  
of phospholipids in krill and is the natural result of extracting a phospholipid-rich  
fraction from krill meal, or simply obtained by blending phospholipids and triglyceride  
[182]  
oil in appropriate concentrations.  
Professor Barrow also stated that krill naturally  
[183]  
has a low concentration of free fatty acids.  
142. In view of Professor Barrow’s comments and the absence of evidence to the contrary, I  
consider the steps the skilled person would need to take in following the teaching of the  
specification, such as how to vary the ethanol concentration, pressure, and temperature  
of the SFE method to adjust the levels of extraction of the different components of krill  
oil, are part of ordinary methods of trial and error which a skilled person would perform,  
without exercising inventive skill, to perform the invention across the full scope of the  
claim 1.  
143. Naturally occurring krill also includes components, such as omega-3 fatty acids and  
arachidonic acid, defined in the appended claims 2-17. I consider the skilled person can  
follow teachings of the specification and use ordinary methods of trial and error, which  
involve no inventive step, to perform the invention across the full scope of the appended  
claims which define a composition, a capsule containing the composition or a dietary  
supplement containing the composition.  
144. Regarding the use of krill oil to treat the various conditions claimed in claims 18-23, I  
understand the opponent to allege that the results of Examples 9-12 and Figures 2-19 do  
not show there is a statistically significant difference in effect between krill oil of the  
TM  
opposed application (Superba ) and commercially available Neptune Krill oil (NKO) or  
[184]  
fish oil (FO).  
145. In the present case, I do not consider the examples of the specification need to  
TM  
demonstrate a statistically significant difference in effect between Superba  
and NKO  
or FO. I consider the relevant question here is whether it is plausible that the krill oil  
compositions are suitable for treating the claimed conditions.  
146. Figures 2-10 relate to results from Example 9 where the Zucker rat model was used to  
supplement rats with krill oil prepared according to the method in example 7. Professor  
Barrow stated it was impossible to tell whether the effects of the different forms of  
TM  
omega-3 fatty acids from Superba , NKO and FO, shown in some figures, are real  
[185]  
because there are no error bars in the figures.  
Professor Barrow did state that the  
effect of dietary omega-3 fatty acids on lipid accumulation in liver, shown in Figure 7,  
TM  
appeared to show a trend whereby Superba  
provided a lower lipid accumulation in  
the liver. However, Professor Barrow’s view was that the performance of all three oils  
could be within the same experimental error. He further stated that the effects of dietary  
TM  
omega-3 fatty acids from Superba  
and NKO on lipid accumulation in the muscle  
(Figure 8) and heart (Figure 9) were within the same experimental error or  
[186]  
equivalent.  
Therefore, Professor Barrow was of the view that there is no statistically  
TM  
[187]  
significant difference between the performance of Superba , NKO and FO.  
TM  
147. In view of Professor Barrow’s comments, I understand that Superba  
is at least as  
effective as NKO and FO. Professor Barrow also stated that any krill oil composition,  
including known oils in the art, would be suitable for treating the conditions of the  
[188]  
claimed invention.  
Therefore, I am satisfied that it is plausible that the krill oil  
compositions are suitable for treating the claimed conditions.  
148. Performing the invention of claims 18-23 requires the skilled person to know how to  
make and administer the claimed krill oil compositions. I have previously found that the  
specification enables a skilled person to perform the invention across the full scope of  
the claims which define a composition. I have also previously found that, as of March  
2007, krill oil compositions are administered as a health supplement due to the content  
of phospholipids, omega-3 fatty acids, triglycerides and astaxanthin. Therefore, I  
consider the skilled person can follow teachings of the specification and use ordinary  
methods of trial and error, which involve no inventive step, to perform the invention  
across the full scope of the claims 18-23.  
149. Consequently, I conclude that the opponent has not established that there is lack of a  
clear enough and complete enough disclosure for the invention in the opposed  
specification.  
The claim support obligation: “Biogen insufficiency”  
150. In Merck Burley J noted that “classical insufficiency” is to be distinguished from “Biogen  
insufficiency” which is also considered to form part of the disclosure obligation under  
[189]  
UK law.  
His Honour explained that Biogen insufficiency draws on the law of  
support, identified in s 14(5)(c) of the UK Act, and was developed in UK authorities due  
to a “logical gap” arising from drafting of legislation. While s 14(5)(c) imposes a claim  
support obligation as a statutory requirement for grant of a patent, there is no  
corresponding provision whereby a granted patent that fails to satisfy the claim support  
obligation may be revoked. The gap was plugged when the House of Lords resolved that  
the claim support obligation fell under the umbrella of the requirement that the patent  
specification contain an enabling disclosure in Biogen Inc v Medeva Plc [1996] UKHL  
[190]  
18; [1997] RPC 1 at 47 (Biogen).  
151. Burley J noted that an “enabling disclosure” is a requirement for both the disclosure  
obligation (or classical insufficiency) and the claim support obligation (or Biogen  
[191]  
insufficiency).  
His Honour also noted there is no gap in the Patents Act akin to the  
one in the UK Act discussed above, and the grounds under paragraph 40(2)(a) and s  
[192]  
40(3) are to be considered separately.  
152. Burley J referred to the summary provided in Terrell which distinguished between  
classical insufficiency and Biogen insufficiency:  
“The self-standing objection that a claim is broader than the technical contribution of the  
patent, even when it can be performed, is sometimes referred to as ‘Biogen insufficiency’. It is  
to be contrasted with ‘classical insufficiency’ which is concerned with whether or not  
embodiments within the claim can be performed. Thus peculiarly under English law it is said  
that at [sic] patent can be insufficient even if it is possible to make everything within the scope  
[193]  
of the claim, if the scope of the claims exceed the technical contribution.”  
153. The claim support obligation can be summarised as a requirement for the scope, or  
[194]  
breadth, of the claims to correspond to the technical contribution to the art.  
154. The technical contribution to the art is a subtle concept that is not to be confused with  
the inventive concept that is often discussed in relation to inventive step. The distinction  
was explained by Walker LJ in Generics:  
“The expressions are certainly connected, but I do not think it is helpful (either in considering  
Lord Hoffmann's opinion, or generally) to treat them as having precisely the same meaning.  
‘Inventive concept’ is concerned with the identification of the core (or kernel, or essence) of  
the invention – the idea or principle, of more or less general application (see Kirin-Amgen  
[2004] UKHL 46; [2005] RPC 9 paras 112-113) which entitles the inventor’s achievement to be  
called inventive. The invention’s technical contribution to the art is concerned with the  
evaluation of its inventive concept – how far forward has it carried the state of the art? The  
inventive concept and the technical contribution may command equal respect but that will not  
[195]  
always be the case.”  
155. An important question will often be whether the technical contribution to the art is a  
general principle or the specific examples in the specification. Lord Hoffmann gave some  
examples in Biogen:  
“Thus if the patentee has hit upon a new product which has a beneficial effect but cannot  
demonstrate that there is a common principle by which that effect will be shared by other  
products of the same class, he will be entitled to a patent for that product but not for the class,  
even though some may subsequently turn out to have the same beneficial effect. On the other  
hand, if he has disclosed a beneficial property which is common to the class, he will be entitled  
to a patent for all products of that class (assuming them to be new) even though he has not  
[196]  
himself made more than one or two of them.”  
[citations omitted]  
156. In Merck Burley J referred to the CSR decision where Dr Barker adopted the summary  
provided by Aldous J in Schering Biotech Corp’s Application, [1993] RPC 249 at  
252-253, to answer the question of the claim support obligation:  
“... to decide whether the claims are supported by the description it is necessary to ascertain  
what is the invention which is specified in the claims and then compare that with the  
invention which has been described in the specification. Thereafter the court’s task is to decide  
whether the invention in the claims is supported by the description. I do not believe that the  
mere mention in the specification of features appearing in the claim will necessarily be a  
sufficient support. The word ‘support’ means more than that and requires the description to  
[197]  
be the base which can fairly entitle the patentee to a monopoly of the width claimed.”  
157. Burley J stated:  
“That approach encapsulates broadly the claim support obligation under s 40(3). To it may be  
added the requirement that the technical contribution to the art must be ascertained. Where it  
is a product, it is that which must be supported in the sense that the technical contribution to  
[198]  
the art disclosed by the specification must justify the breath of the monopoly claimed.”  
158. The considerations for the approach as stated in CSR, which remain relevant in view of  
the subsequent Federal Court decisions, are:  
“i) construe the claims to determine the scope of the invention as claimed,  
ii) construe the description to determine the technical contribution to the art, and  
[199]  
iii) decide whether the claims are supported by the technical contribution to the art.”  
The opponent’s allegations  
159. The opponent alleged that the scope of the claims of the opposed application is not  
[200]  
justified by the extent of the disclosure and the technical contribution to the art.  
The opponent alleged that there is no enabling disclosure in the body of the specification  
to support the scope of claim 1. The opponent’s reasons for lack of support are similar to  
those provided for lack of a clear enough and complete enough disclosure. The opponent  
argued that only Examples 7 and 8 are relevant to the claims and these examples do not  
describe all the features of claims 1-15 and do not describe how to obtain the full width of  
[201]  
the claimed ranges of the components of the krill oil.  
The opponent also alleged that  
since there is no statistically significant data for Examples 9 to 12 and Figures 2 to 19 to  
show that administration of the claimed krill oil can be used for the treatment methods  
defined in the claims, the experimental evidence does not show a technical contribution  
to the art. Consequently, the opponent alleged that the scope of the claims is not  
[202]  
supported by matter disclosed in the specification.  
What is the technical contribution to the art?  
160. The opponent appears to be alleging the opposed application provides no technical  
contribution to the art. Presumably, this was why the opponent provided no evidence  
regarding what it considered to be the technical contribution to the art.  
161. Professor Barrow stated he was unclear what the invention of the opposed application  
[203]  
was.  
He was of the view that there was nothing special about the claimed krill oil  
compositions because the content of phospholipids and triglycerides were simply a  
[204]  
function of the krill naturally having these components.  
Professor Barrow also  
stated that he did not see any new steps for processing krill over and above what he  
[205]  
considered known.  
As previously discussed, Professor Barrow stated that any krill  
oil composition, including known oils in the art, would be suitable for treating the  
[206]  
conditions of the claimed invention.  
162. As previously discussed, the specification discloses use of the SFE method to extract  
different amounts of krill oil components by varying conditions of the extraction,  
blending the fractions obtained from the SFE method to tailor the final content of an oil,  
and producing a krill oil with particular concentrations of krill components to provide  
health benefits. Therefore, I consider a technical contribution of the specification  
includes producing krill oil compositions having particular concentrations of ether  
phospholipids, non-ether phospholipids, triglycerides, astaxanthin esters, free fatty  
acids, and other krill oil components to provide health benefits.  
Are the claims supported?  
163. I previously found the specification to provide an enabling disclosure of how to produce  
krill oil compositions having components with the concentration ranges defined in claim  
1 and the appended claims. I also found the specification to provide an enabling  
disclosure for administering krill oil compositions as a health supplement to treat the  
conditions claimed in the appended claims. I consider the scope of all the claims  
corresponds with the technical contribution of the art.  
164. Consequently, I conclude that the opponent has not established that the claims are not  
supported by subject matter disclosed in the opposed specification.  
Best method of performance  
165. Paragraph 40(2)(aa) of the Act reads:  
A complete specification must:  
....  
(aa) disclose the best method known to the applicant of performing the invention  
166. The relevant principles for the best method of performance requirement are set out in in  
the decision of the Full Federal Court in Les Laboratoires Servier v Apotex Pty Ltd  
[207]  
(Servier).  
167. The Court in Servier confirmed that the best method of performance requirement is  
[208]  
separate and additional to the requirement of paragraph 40(2)(a).  
The basis of the  
obligations of disclosure is to provide members of the public with the knowledge on how  
practically to obtain the benefit of the invention when the patent is expired. The Court in  
Servier stated:  
“... a patentee was held to be bound to give the best information in his (or her) power as to  
how to carry out the invention. This was an element of the required good faith on the part of  
the patentee and the requirement to give to the public the consideration of knowledge of the  
[209]  
best method that corresponds with the obtaining of the benefit of monopoly.”  
168. In order to appreciate what is required of an inventor by way of disclosure in the  
[210]  
specification, it is necessary to understand the invention itself.  
This understanding  
requires taking into account the nature of the invention being described and claimed,  
[211]  
and involves a question of fact, that being knowledge of the patent applicant.  
169. The Court in Servier noted the approach of Bennett J in Expo-Net Danmark A/S v  
[212]  
Buono-Net Australia Pty Ltd (No 2) (Expo-Net).  
In Expo-Net Bennett J stated:  
“... it must be established that there was a better method known to the applicant as at the date  
of filing of the patent than the one described in the specification. This is clearly a subjective  
[213]  
question.”  
and  
“... it is necessary first to understand what the invention is. Indeed, this is perhaps the first  
[214]  
question that needs to be answered.”  
170. In other words, it is necessary to determine what method is disclosed in the  
specification, and then to ask whether there is any evidence that the applicant was aware  
of a better method of performing the invention.  
The opponent’s allegations  
171. The opponent alleged that the opposed application does not disclose the best method  
known to the applicant for performing the invention because there is no example of a  
krill oil which has properties that fall within the scope of the claims.  
The disclosure of the invention in the specification  
172. I have previously discussed what the opposed specification describes, and claims, as the  
invention. I have also discussed that the specification as a whole discloses examples with  
methods to produce krill oil compositions having components present in concentrations  
as defined in claim 1. In this case, due to the nature of the invention and how the  
invention has been disclosed in the specification, I found it is not necessary for all the  
components of krill oil in the concentrations defined in claim 1 be disclosed in a single  
example.  
173. I consider that the various examples disclosed in the specification provide the  
information which the applicant knew at the date of filing the patent application  
regarding how to carry out the invention.  
Was the applicant aware of a better method?  
174. The opponent has not provided any evidence that the applicant was aware of a better  
method of performing the invention.  
175. Consequently, I conclude that the opponent has not established that the opposed  
specification has not disclosed the best method known to the applicant for performing  
the invention.  
Utility  
176. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in  
any claim, must be useful. The issue of utility was considered by the Full Court of the  
[215]  
Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd (Lundbeck).  
Emmett J  
stated:  
“A claim is bad if it covers means that will not produce the desired result, even if a skilled  
person would know which means to avoid. That is to say, everything that is within the scope of  
[216]  
a claim must be useful, otherwise the claim will fail for inutility...”  
177. In Apotex Pty Ltd v AstraZeneca AB (No 4) Jagot J pointed out that lack of utility  
requires evidence, not just speculation:  
“Ultimately, an asserted lack of utility must be established by appropriate evidence, not by  
mere speculation that the invention will not work or meet the promise set out in the  
[217]  
specification.”  
178. In Artcraft Urban Group Pty Ltd v Streetworx Pty Ltd., Greenwood J (Rares J  
concurring) stated an assessment of the utility requirement involves an analysis of what  
the specification itself says is the promise of the invention, and whether by following the  
teaching of the specification the claimed invention does attain the result promised:  
“Put another way, the two questions are: first, what is the promise of the invention derived  
from the whole of the specification?; second, by following the teaching of the specification,  
does the invention, as claimed in the patent, attain the result promised for it by the  
[218]  
patentee?...”  
The opponent’s allegations  
179. The opponent alleged that the invention claimed in each of claims 1-23 of the opposed  
application is not useful. The opponent alleged that the promises of the invention set out  
[219]  
in the specification have not been fulfilled.  
evidence to support its allegations.  
However, the opponent has not filed any  
The promise of the invention  
180. I have previously found that an aim of the invention, from a reading of the whole  
specification, is to provide an alternative krill oil composition which is rich in  
phospholipids and used to provide health benefits. Therefore, a skilled person following  
the teaching of the specification needs only to produce an alternative krill oil  
composition which is rich in phospholipids and not necessarily a better krill oil  
composition to fulfil the utility requirement.  
181. I have previously found that by following the teaching of the specification, the skilled  
person can prepare krill oil compositions which are rich in phospholipids and administer  
the compositions to treat the claimed disorders.  
182. Consequently, I conclude that the opponent has not established a lack of utility for any of  
the claims of the opposed application.  
Priority date  
183. The opponent asserts that the claims of the opposed application are entitled to a priority  
date of 28 January 2008, this being the filing date of US 61/024,072 – one of four  
provisional applications from which the opposed application ultimately claims priority.  
The opponent cites the decision of a delegate of the Commissioner in Rimfrost AS v Aker  
BioMarine Antarctic AS (Rimfrost 2019), [2019] APO 28, to support this  
[220]  
assertion.  
I note that patent application 2013227998, the subject of Rimfrost 2019,  
is the grandparent of the presently opposed application.  
184. In Rimfrost 2019, the delegate found priority documents US 60/920, 483, US  
60/975,058 and US 60/983,446 disclose phospholipids generally and mention  
phosphatidylcholine, phosphatidylserine, phosphatidylethanolamine and  
phosphatidylinositol as phospholipid components of krill oil compositions. However,  
only priority document US 61/024,072 disclosed alkylacylphosphatidylcholine, lyso-  
alkylacylphosphatidylcholine, alkylacylphosphatidylethanolamine as the main classes of  
ether phospholipids. Consequently, the delegate found that three of the four priority  
documents did not provide a real and reasonably clear disclosure for the claimed  
invention discussed in Rimfrost 2019, and the priority date for the claims was 28  
[221]  
January 2008, the filing date of US 61/024,072.  
The claims of the grandparent  
considered in Rimfrost 2019 related to an encapsulated Euphausia superba krill oil and  
the components of the claimed krill oil included phosphatidylcholine, ether  
phospholipids, and other components of krill oil. The disclosure of the ether  
phospholipids and non-ether phospholipids in the priority documents and the ancestor  
applications is relevant to the determination of the priority date of claims of the present  
opposed application.  
185. As discussed previously, the amendments of the Act brought about by the Raising the  
Bar Act apply to the opposed application. Since the applications for the parent  
2014256345 and grandparent 2013227998 were filed after 15 April 2013, the  
amendments brought about by the Raising the Bar Act also apply to the parent and the  
[222]  
grandparent.  
However, the applications, and requests for examination, for the great  
grandparent 2011213836 and the original ancestor 2008231570 were filed before 15  
[223]  
April 2013.  
Therefore, the great grandparent and original ancestor are governed by  
provisions prior to commencement of the Raising the Bar Act. The means that the  
priority date of a claim in the opposed application, parent and grandparent is  
determined by provisions brought about by the Raising the Bar Act while the priority  
date of a claim in the great grandparent and original ancestor is determined by the  
provisions before the Raising the Bar Act.  
186. Subsection 43(2A), reproduced below, is relevant for determining the priority dates of  
claims under the provisions bought about by the Raising the Bar Act.  
(2A) This subsection applies to a claim if:  
(a) prescribed circumstances apply in relation to the invention defined in the claim; and  
(b) a prescribed document discloses, or a prescribed set of prescribed documents considered  
together disclose, the invention in the claim in a manner that is clear enough and complete  
enough for the invention to be performed by a person skilled in the relevant art.  
187. Where subsection 43(2A) of the Act applies, the priority date is determined under the  
[224]  
Patents Regulations 1991.  
Regulation 3.13D applies to a claim where the  
specification containing the claim that defines the invention was filed for a divisional  
application under s 79B of the Act and the specification mentioned in subsection 79B(1)  
[225]  
of the Act (the earlier specification) clearly discloses the invention in the claim.  
Subject to regulation 3.12, the priority date is the date that the claim would have had if  
[226]  
the claim was in the earlier specification.  
Sub regulation 3.12(4) states that a  
document clearly discloses an invention if the document discloses the invention in a  
manner that is clear enough, and complete enough, for the invention to be performed by  
a person skilled in the relevant art.  
188. This means that where there is a clear enough and complete enough disclosure of a  
claimed invention of the opposed application in the parent, the priority date of the claim  
is the date the claim would have had if the claim were in the parent.  
189. I have reviewed the specifications of the parent and opposed application. The  
description, drawings and abstract of both applications appear to be identical. Professor  
[227]  
Barrow also made these observations.  
From my previous findings, I am satisfied  
that there is a clear enough and complete enough disclosure for the claimed inventions  
in the opposed application. It follows that I am satisfied that there is a clear enough and  
complete enough disclosure for the claimed inventions in the parent. Consequently, the  
claims of the opposed application are entitled to claim priority from the parent.  
190. As discussed previously, the opposed application is one in a series of divisional  
applications which ultimately claims priority from patent application 2008231570, the  
original ancestor. The original ancestor is a national phase entry application of  
PCT/GB2008/001080 and claims priority from four provisional applications, the  
[228]  
earliest filing date of these applications is 28 March 2007.  
191. Under the provisions before commencement of the Raising the Bar Act, the priority date  
of a claim of a specification filed for a divisional application under s 79B of the Act  
[229]  
requires the claim to be fairly based on matter disclosed in the prior specification.  
Where a claim is fairly based on matter disclosed in one or more priority documents, the  
priority date is the date of filing the priority document in which the matter was first  
[230]  
disclosed.  
192. The test to determine whether a claim is “fairly based on matter disclosed” in the prior  
specification, the requirement in reg 3.12 (1)(c), is referred to as the external fair basis  
test. Whether a claim is “fairly based on matter disclosed” in the prior specification  
depends on whether there is a “real and reasonably clear disclosure” of that matter in the  
[231]  
prior specification.  
193. The High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd  
(Lockwood) approved the approach of Gummow J in Rehm Pty Ltd v Websters  
Security Systems (International) Pty Ltd (Rehm) who stated:  
“...the question is whether there is a real and reasonably clear disclosure in the body of the  
specification of what is then claimed, so that the alleged invention as claimed is broadly, that  
[232]  
is to say in a general sense, described in the body of the specification.”  
194. The Court in Multigate Medical Devices Pty Ltd v B Braun Melsungen AG (Multigate)  
observed that there is a subtlety between “fairly based on matter disclosed” in the prior  
specification arising from requirement in reg 3.12 (1)(c) and “fairly based on matter  
described in the specification” arising from the requirement in s 40(3) as the provisions  
[233]  
stood prior to the Raising the Bar Act.  
The Court stated that external fair basis can  
arise if some part of the overall disclosure made in the prior specification disclosed the  
[234]  
relevant matter.  
The Court also stated that the use of “disclosed” rather than  
“described” connotes greater flexibility in the test for external fair basis in terms of  
[235]  
ascertaining from the prior specification the requisite disclosure.  
195. In Court in Multigate further stated:  
“In the context of external fair basis, the test of real and reasonably clear disclosure requires  
attention not on whether a subsequent claim had previously been made, but whether in the  
earlier specification there had been a real and reasonably clear disclosure of the invention that  
is claimed. Further, a real and reasonably clear disclosure in the prior specification need not  
be made only in the verbal description, but can appear from the accompanying drawings  
(CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 at 280; 122 ALR 417 at 436; 28 IPR 481 at  
500 (CCOM) per Spender, Gummow and Heerey JJ; Leonardis at FCR 137; IPR 36 per  
Burchett, Hill and Tamberlin JJ referring also to the fact that expert assistance may be  
necessary to interpret the drawings). Further, the relevant passage(s) from the prior  
specification need not be disclosed as part of the invention claimed therein. Further, the task  
of determining whether there has been a real and reasonably clear disclosure is not to be  
undertaken with an over-meticulous verbal analysis: Olin Corporation v Super Cartridge Co  
Pty Ltd (1977) 180 CLR 236 at 240; 14 ALR 149 at 152; 1A IPR 197 at 200 per Barwick CJ;  
approved in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001)  
207 CLR 1; 177 ALR 460; 50 IPR 513; [2001] HCA 8 at [15] per Gleeson CJ, McHugh,  
Gummow, Hayne and Callinan JJ and in Lockwood No 1 at [57], [68] and [69]. Further, the  
[236]  
relevant disclosure is not limited to the description of preferred embodiments.”  
196. I have reviewed the specification of the original ancestor and find a disclosure of the use  
and modification of the SFE method to adjust the levels of extraction of the different  
components of krill oil to thereby tailor the concentrations of ether phospholipids, non-  
ether phospholipids, triglycerides, fatty acids, astaxanthin esters and other components  
of krill oil in the final oil composition. The Examples and drawings of the original  
ancestor as well as the abstract are identical to the opposed application. It appears that  
all the content of the description (body of the specification including Examples and  
drawings) of the original ancestor are included as part of the description of the opposed  
application, parent, grandparent, and great grandparent. I also note that the description  
of the opposed application, parent, grandparent, and great grandparent appear identical.  
197. I have reviewed the four provisional applications and find that only US 61/024,072  
provides an explicit disclosure of the ether phospholipids as a component of the krill oil  
compositions. The other three provisional applications do disclose the use of the SFE  
method to extract different components of krill oil, including the non-ether  
phospholipids, triglycerides, astaxanthin esters free fatty acids and other krill oil  
components. However, ether phospholipids are not explicitly disclosed as a component  
of the krill oil compositions in US 60/920, 483, US 60/975,058 and US 60/983,446.  
The concentration ranges of the ether phospholipids in the krill oil compositions,  
including the ranges claimed in the opposed application, are certainly only explicitly  
disclosed in US 61/024,072 and I have no basis to consider they are implicitly disclosed  
in earlier priority documents. Consequently, I consider that only US 61/024,072  
provides a real and reasonably clear disclosure of the proportion of ether phospholipids  
in the krill oil compositions. It follows that the priority date of the claims in the original  
ancestor which include, or would have included, the concentration ranges of the ether  
phospholipids in the krill oil compositions as part of the claim are entitled to a priority  
date of 28 January 2008, the date of filing of US 61/024,072. Therefore, the claims in  
subsequent ancestor applications which include, or would have included, the  
concentration ranges of the ether phospholipids in the krill oil compositions as part of  
the claim ultimately draw priority from US 61/024,072.  
198. Consequently, I conclude that the claims of the opposed application are entitled to a  
priority date of 28 January 2008, the date of filing of US 61/024,072.  
Novelty  
199. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in  
any claim, is novel. Subsection 7(1) states that an invention is taken to be novel unless it  
is not novel in the light of the prior art. A citation is part of the prior art base for the  
purposes of novelty if it was published before the priority date of the claim. Additionally,  
information in a published patent specification for a complete application is part of the  
prior art base for the purposes of novelty where (a) the information is, or were to be, the  
subject of a claim of the specification, the claim has, or would have, a priority date earlier  
than the claim under consideration, and (b) the specification was published on or after  
the priority date of a claim under consideration, and (c) the information was contained  
[237]  
in the specification on its filing date.  
200. It is well established that the general test for lack of novelty is the reverse infringement  
test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty  
Ltd. v Vicarr Industries Ltd.:  
“The basic test for anticipation or want of novelty is the same as that for infringement and  
generally one can properly ask oneself whether the alleged anticipation would, if the patent  
[238]  
were valid, constitute an infringement”  
201. This test is satisfied if the alleged anticipation discloses all the essential features of the  
[239]  
invention as claimed.  
202. Australian courts have often identified the principles of the UK Court of Appeal in The  
General Tire & Rubber Company v The Firestone Tyre and Rubber Company  
[240]  
Limited  
(the General Tire case) as the criteria for determining anticipation by a  
prior publication. Most relevantly, to anticipate the patentee’s claim the prior  
publication must contain clear and unmistakable directions to do what the patentee  
claims to have invented.  
203. The disclosure necessary to support the ground of lack of novelty has also variously been  
described as “planting the flag” (ICI Chemicals & Polymers Ltd. v The Lubrizol  
[241]  
Corporation Inc  
), “the accuracy of a sniper, not the firing of a 12 gauge shotgun”  
[242]  
(Apotex Pty Ltd. v Sanofi-Aventis  
) or “what a prior art document teaches” as  
distinct from “what might be ‘included’ or ‘encompassed in’ a prior art document”  
[243]  
(Sanofi-Aventis Australia Pty Ltd. v Apotex Pty Ltd. (No 3)  
). These various  
descriptions of the disclosure necessary to support lack of novelty emphasise that there  
is a degree of specificity that is required.  
204. The opponent relies on the following two prior art citations to allege lack of novelty:  
• WO 2007/123424 (D1, also referred to as Catchpole), published on 01 November 2007;  
and  
[244]  
• WO 2008/060163 (D2, also referred to as Breivik), published 22 May 2008.  
205. Catchpole was published before 28 January 2008, the priority date of the claims of the  
opposed application. Therefore, Catchpole is part of the prior art base. Breivik is a patent  
application that was published after 28 January 2008 but claims a priority date of 16  
November 2006. Since the priority document for Breivik does not appear to have been  
filed, I am unable to assess whether Breivik is entitled to a priority date of 16 November  
2006. Normally it would follow that the opponent has not made out a case for lack of  
novelty. However, given the circumstances of the present case, I will assume the priority  
claim for Breivik is valid and consider the information in Breivik to be part of the prior  
art base under the definition of prior art base, part b(ii) in Schedule 1 of the Act. As will  
become evident, nothing material turns on this assumption.  
206. Catchpole discloses a method for separating the lipids which are contained in various  
food sources. The method uses supercritical, or near-critical, CO with or without a co-  
2
solvent (an alcohol entrainer). Example 18 discloses fractionating krill lipids from a  
freeze-dried krill powder using a two-step supercritical CO extraction method. In the  
2
first step, the krill powder was extracted with supercritical CO at 300 bar, 313K. The  
2
extract (extract 1) contained no phospholipids and was substantially all neutral lipids.  
The residual powder was subsequently extracted with supercritical CO and ethanol  
2
using a mass ratio of ethanol to CO of 11 %. The CO -ethanol extract phase was passed  
2
2
through two sequential separators in which the pressure was 95 and 60 bar, respectively.  
The bulk of the phospholipid-rich extract (extract 2) was obtained in the first separator,  
and the bulk of the co-solvent in the second separator. The composition of extract 2 and  
residual powder are disclosed in Table 16 of Catchpole, reproduced below. The  
alkylacylphosphatidylcholine (AAPC) is highly enriched in extract 2 while  
alkylacylphosphatidylethanolamine (AAPE) is not extracted to any great degree. Extract  
2 is also disclosed to contain phosphatidylcholine (PC) and phosphatidylethanolamine  
(PE).  
TableDescription automatically generated  
207. In a declaration, Professor Barrow calculated the proportion of ether phospholipids and  
non-ether phospholipids of a krill lipid fraction from the disclosure of Example 18 of  
[245]  
Catchpole.  
I understand Professor Barrow to have calculated the extract 2 shown in  
Table 16 of Catchpole 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  
[246]  
phospholipids in extract 2 is 45.1% (w/w).  
I agree that 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).  
208. Regarding the triglyceride concentration of extract 2, Professor Barrow stated:  
“Extract 2 of Catchpole has 53.7% w/w ‘other compounds’. The majority of the other  
compounds will be triglycerides, with minor components of mono- and di-glycerides, free fatty  
acids and sterols/waxes.  
I would expect that at least half of the ‘other compounds’ would be triglycerides (so at least  
26% w/w of the total oil). Not all of the 53.7% w/w ‘other compounds’ would be triglycerides.  
It is highly likely that the triglycerides would be under the upper claimed limit of 50%. Even if  
the full 53.7% of ‘other compounds’ in Catchpole were to be triglycerides, there would be an  
[247]  
insignificant therapeutic effect in lowering triglycerides by 3. 7%.”  
209. The reasons why Professor Barrow expected extract 2, a polar-rich lipid fraction, to  
[248]  
comprise the concentration of triglycerides he specified is unclear to me.  
I am not  
satisfied the evidence has established that the extraction method of Example 18 of  
Catchpole would inevitably result in any of the extracts comprising 20-50% triglycerides  
(w/w). I consider Example 18 of Catchpole does not provide a clear and unmistakeable  
disclosure of the concentration of triglycerides in any krill lipid fractions.  
210. Professor Barrow stated that the typical concentration of total astaxanthin in a krill meal  
is about 150 to 200 ppm and approximately 95% is esterified. Professor Barrow cites  
[249]  
several documents in the literature to support this statement.  
Professor Barrow  
further stated that he expected around 95% of the astaxanthin and its esters would be  
extracted using the two-stage extraction process of Example 18 of Catchpole. He  
calculated this to be a total of about 800 to 1070 mg astaxanthin in extract 1 and extract  
[250]  
2.  
Professor Barrow did not provide a value for the concentration of astaxanthin  
esters for any of the extracts of Example 18 of Catchpole. I infer this is because it is  
possible to calculate the total astaxanthin esters which can be extracted from krill  
powder but the concentration of astaxanthin esters in a lipid fraction would depend on  
the types and proportions of solvents used in each extraction step. Example 18 of  
Catchpole does not provide a clear and unmistakable disclosure of the concentration of  
astaxanthin esters in any krill oil fraction.  
211. I consider Example 18 of Catchpole does not provide a clear and unmistakable disclosure  
of the concentrations of triglycerides, astaxanthin esters, or free fatty acids of any krill  
lipid fraction. I have viewed the remaining portions of Catchpole and have found no  
other disclosure of krill oil compositions. Consequently, I conclude that the opponent  
has not established that claim 1 or any other claim of the opposed application lacks  
novelty in light of Catchpole.  
212. Breivik discloses a process for extracting a substantially total lipid fraction from fresh  
krill and a process for subsequently separating the phospholipids from the total lipid  
[251]  
fraction.  
The process for extracting a substantially total lipid fraction from fresh krill  
comprises (a) reducing the water content of krill raw material and (b) isolating the lipid  
fraction. In a preferred embodiment, there is an intervening step (a-1) where the water  
reduced krill material from step (a) is extracted with supercritical CO containing  
2
ethanol, the extraction performed under a supercritical pressure, and a lipid fraction is  
[252]  
isolated from the ethanol.  
The amount of ethanol used for step (a-1) is 5-20% by  
[253]  
weight, more preferably 10-15% by weight.  
The extract containing the total lipids of  
krill is disclosed to be extracted under supercritical pressure into different lipid classes.  
The extraction of the total lipid krill fraction is performed with supercritical pure CO or  
2
supercritical CO containing less than 5% ethanol. One of the objectives of Breivik is to  
2
[254]  
produce a phospholipid having high concentrations of omega-3 fatty acids.  
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%  
[255]  
w/w.”  
and  
Example 7 in Breivik describes 58% w/w basis, phospholipids. The remainder is mainly  
[256]  
triglycerides (approximately 42% w/w).  
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  
[257]  
phospholipids).”  
o
215. Example 7 of Breivik discloses fresh E. superba (12 kg) heated to 80 C 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  
o
extracted at 280 bar and 50 C with CO (156kg) containing ethanol (15 kg) to produce  
2
“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 CO extraction method using neat supercritical CO followed by  
2
2
supercritical CO and ethanol. Professor Barrow does not explain why he assumed an  
2
extraction of fresh krill with ethanol first followed by supercritical CO and ethanol  
2
would produce the same proportions of ether phospholipids and non-ether  
phospholipids as the two-step supercritical CO extraction of Example 18 of Catchpole.  
2
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  
[258]  
extraction.  
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 CO and  
2
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.  
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  
[259]  
available through doing an act anywhere.  
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,  
[260]  
whether they be the steps of the inventor or not.”  
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  
[261]  
course.”  
Obviousness in light of CGK alone  
225. The opponent alleged that the claims of the opposed application are obvious to the  
[262]  
person skilled in the art in light of CGK before the priority date of the claims.  
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  
[263]  
characteristics.  
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  
[264]  
astaxanthin to be present in any krill oil.”  
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  
[265]  
[266]  
inventive step.  
three citations are:  
Professor Barrow gave particular focus to three citations.  
The  
• 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  
[267]  
• WO 03/011873 (D4, also referred to as Sampalis), published 13 February 2003.  
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.  
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.  
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  
[268]  
stated as incorporated by reference.  
The extraction method generally comprises  
successive acetone and alcohol treatments, starting with freshly harvested marine or  
aquatic animal.  
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  
[269]  
comprising greater than 100 ppm astaxanthin.  
Sampalis discloses that the  
astaxanthin is mainly esterified but non-esterified forms may be present.  
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  
[270]  
Table 5 would be >4.0% (i.e. 10% x >40%).”  
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  
[271]  
concentration of NKO™ would be >4.2%.”  
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 CO extraction of Example 18 of Catchpole.  
2
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  
[272]  
extraction.  
The concentration of ether phospholipids in the extract of Table 5 of  
Sampalis is not clear to me.  
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  
TM  
compositions, NKO , for being Generally Recognised As Safe (GRAS) under the US  
[273]  
Federal Food, Drug and Cosmetic Act.  
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.  
TM  
243. NKO  
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  
TM  
tables in the document. Table 1 discloses that the specification for NKO  
is to comprise  
≥40.0g/100g (40% w/w) total phospholipids and >150.0mg/100g (>1500mg/kg)  
TM  
esterified astaxanthin. Table 2 discloses analyses of three batches of NKO  
and  
TM  
demonstrated all three batches met the specification profile. For example, NKO  
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  
TM  
in NKO  
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  
TM  
Administration to assess the applicant’s krill oil compositions, Superba  
Krill Oil, for  
being Generally Recognised As Safe (GRAS) under the US Federal Food, Drug and  
[274]  
Cosmetic Act.  
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.  
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  
TM  
available through the commercial making available of NKO  
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  
TM [275]  
publicly available through the commercial making available of NKO .  
TM  
250. Professor Barrow stated that NKO  
was commercially available prior to March 2007  
[276]  
and its properties are documented in NKO GRAS notification Notice 000242.  
TM  
251. I have previously found the disclosure of the profile of NKO  
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  
TM  
of NKO .  
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  
[277]  
of Monopolies is absent, one need go no further”.  
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  
[278]  
of inventiveness is not met.”  
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  
[279]  
claim for nothing more than that cannot be subject matter of a patent, ...”  
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  
[280]  
naturally occurring in krill oil, and which are found in well-known krill oil extracts.  
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  
[281]  
something falling within claims 1-15.  
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  
A picture containing tableDescription automatically generated  
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 (www.neptunebiotech.com) located on the Web Archive (Wayback  
Machine - https://web.archive.org/) 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)  
[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.  
[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.  
[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.  
[9]  
The amended SGP dated 26 March 2020.  
[10]  
[11]  
[12]  
The specification at page 1, lines 4-5.  
[2013] FCA 214 at [139]; [2013] FCA 214; 100 IPR 451.  
Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70];  
[2000] FCA 980; 177 ALR 231.  
[13]  
AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]; [2015] HCA 30; 89 ALJR 798.  
[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].  
[16]  
The specification at page 1, lines 8-9.  
[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.  
[20]  
The specification at page 1, lines 23-27.  
[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.  
[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.  
[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.  
[26]  
The specification at page 2, lines 5-12.  
[27]  
The specification at page 2, lines 13-15.  
[28]  
The specification at page 42, Example 6.  
[29]  
The specification at pages 2a-3.  
[30]  
The specification at pages 5-7.  
[31]  
The specification at pages 8-9.  
[32]  
The specification at pages 3-4.  
[33]  
The specification at page 10, line 29 to page 11, line 5.  
[34]  
The specification at page 11, lines 9-12.  
[35]  
[36]  
[37]  
[38]  
[39]  
[40]  
The specification at page 11, lines 12-13.  
The specification at page 3, lines 13-14.  
The specification at page 11, lines 14-18.  
The specification at page 11, line 20.  
The specification at page 12, lines 1-2.  
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.  
[46]  
The specification at page 4, line 15.  
[47]  
The specification at page 6, lines 8-10.  
[48]  
The specification at page 16, lines 15-17.  
[49]  
The specification at page 16, line 32 to page 17, line 2.  
[50]  
The specification at page 16, lines 11-12; page 4, lines 19-20.  
[51]  
The specification at page 18, lines 5-22.  
[52]  
The specification at page 18, lines 23-34.  
[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.  
[60]  
The specification at page 14, lines 19-22.  
[61]  
The specification at pages 15, line 22 to page 16, line 3.  
[62]  
The specification at page 16, line 34, to page 17, line 8.  
[63]  
The specification at page 17, lines 9-16.  
[64]  
[65]  
[66]  
[67]  
[68]  
[69]  
[70]  
[71]  
[72]  
[73]  
[74]  
[75]  
[76]  
[77]  
[78]  
[79]  
[80]  
[81]  
[82]  
[83]  
[84]  
[85]  
[86]  
[87]  
[88]  
The specification at page 14, lines 23-26.  
The specification at page 21, lines 5-9.  
The specification at page 21, lines, 5-11, 17-21; page 22, lines 5-6, 17-23.  
The specification at page 8, lines 3-6.  
The specification at page 8, lines 9-11.  
The specification at page 9, lines 15-29.  
The specification at pages 23-26.  
Barrow A at [148].  
The specification at pages 27-29.  
The specification at page 29.  
The specification at pages 29-37; Tables 9-16.  
The specification at page 37.  
The specification at pages 39-40.  
The specification at pages 40-42.  
The specification at page 42, lines 3-14.  
The specification at page 42, lines 16-25.  
The specification at pages 43-44, Figure 1.  
The specification at page 45, Figures 2-9.  
The specification at page 22, lines 31-33.  
The specification at page 45, lines 21-29.  
The specification at page 46, line 33 to page 47; Figures 12-19.  
The specification at page 47, lines 3-4.  
The specification at page 47, lines 12-15.  
The amended SGP dated 26 March 2020, page 1.  
Barrow A at [11]-[73], CB-3 (Barrow #3) at [36]-[93], CB-1 (Barrow #1), CB-2 (Barrow  
#2), CB-5 (Barrow #5).  
[89]  
Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9 at [115];  
[1980] HCA 9; 144 CLR 253 at page 292.  
[90]  
ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc [1999] FCA 345; 45 IPR 577 at [112].  
[91]  
Ranbaxy Laboratories Limited v AstraZeneca AB [2013] FCA 368; 101 IPR 11 at [217].  
[92]  
CB-3 (Barrow#3) at [36]-[93].  
[93]  
[94]  
[95]  
[96]  
[97]  
CB-3 (Barrow#3) at [78].  
Barrow A at [34].  
CB-7, Grantham article, Table 6 at page 12.  
Barrow A at [33].  
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.  
[101]  
Barrow A at [34].  
[102]  
Barrow A at [69].  
[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.  
[105]  
CB-3 (Barrow# 3) at [54].  
[106]  
Barrow A at [37].  
[107]  
CB-7, Grantham article at page 27.  
[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.  
[112]  
Barrow A at [52]-[65], CB-3 (Barrow#3) at [78]-[93].  
[113]  
CB-3 (Barrow#3) at [80].  
[114]  
Ibid.  
[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.  
[119]  
Barrow A at [45].  
[120]  
CB-3 (Barrow#3) at [81].  
[121]  
[122]  
[123]  
[124]  
[125]  
[126]  
[127]  
[128]  
CB-3 (Barrow#3) at [82].  
CB-3 (Barrow#3) at [83].  
Barrow A at [58], CB-3 (Barrow#3) at [88]-[91].  
CB-3 (Barrow#3) at [88].  
CB-3 (Barrow#3) at [89].  
CB-3 (Barrow#3) at [90].  
CB-3 (Barrow#3) at [91].  
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.  
[131]  
Yamaguchi, abstract.  
[132]  
Yamaguchi, page 904, left-hand column.  
[133]  
Tanaka, abstract.  
[134]  
WO 2007/123424 A1, CB-21, page 24.  
[135]  
CB-3 (Barrow#3) at [82], [93].  
[136]  
Barrow A at [183], item 5.0  
[137]  
[2009] FCAFC 70 at [118] – [120]; [2009] FCAFC 70; 81 IPR 228.  
[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.  
[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.  
[143]  
CB-5 (Barrow #5) at [64].  
[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.  
[147]  
The amended SGP dated 26 March 2020 at section 6.1.5, pages 19-20.  
[148]  
The specification at page 8, lines 9-10.  
[149]  
The amended SGP dated 26 March 2020 at section 6.1.6.  
[150]  
[151]  
[152]  
[153]  
[154]  
[155]  
[156]  
[157]  
[158]  
[159]  
[160]  
[161]  
[162]  
[163]  
[164]  
[165]  
[166]  
[167]  
[168]  
[169]  
[170]  
[171]  
[172]  
[173]  
[174]  
[175]  
[176]  
The specification at page 8.  
[2020] FCA 1477; 155 IPR 1 at [502]- [547].  
[2021] FCA 970; 162 IPR 202.  
[2022] FCA 540 at [352]- [379], [450]-[520].  
Merck at [505].  
Merck at [503].  
Merck at [511]-[514].  
Jusand at [357]-[360].  
Explanatory Memorandum, item 8.  
Ibid.  
Jusand at [363].  
Explanatory Memorandum, item 9.  
Merck at [521]-[522].  
Merck at [528].  
Merck at [523].  
Merck at [524].  
Merck at [525]-[526], Cytec at [142].  
Merck at [526].  
Cytec at [143].  
Cytec at [144].  
Cytec at [145].  
Cytec at [146].  
Jusand at [450].  
The amended SGP dated 26 March 2020 at section 5.1.4, page 18.  
The amended SGP dated 26 March 2020 at section 5.1.2, page 17.  
Ibid.  
In Professor Barrow’s declaration, Barrow A at [160], he has referred to the krill oil  
characterised in Table 21 as having 2091 ppm astaxanthin esters even though Table 21 itself  
reports 2091 mg/kg astaxanthin. Earlier in his declaration, Barrow A at [115], Professor  
Barrow stated that he knew that most of the astaxanthin in krill is in the form of esters and he  
understood a reference to astaxanthin in the opposed specification to include both free  
astaxanthin and its esters. He also stated that it was common in the literature to utilise the  
term astaxanthin when referring to a mixture of astaxanthin and its esters. I understand  
Professor Barrow to be stating that most of the astaxanthin in the krill oil of Table 21  
comprises astaxanthin esters.  
[177]  
[178]  
[179]  
The amended SGP dated 26 March 2020 at section 5.1.2, pages 17-18.  
The amended SGP dated 26 March 2020 at section 5.1.3, page 17.  
Ether phospholipids comprise 15.4% of TPL and TPL form 47.9% of the krill oil of  
Example 7, shown in Table 22 of Example 8 (see Annex B of this decision). This equates to  
[(15.4 x 47.9)/100], i.e., 7.38% ether phospholipids (w/w) in the krill oil of Example 7. Non-  
ether phospholipids comprise 84.6 % of TPL. This equates to [(84.6 x47.9)/100], i.e., 40.52%  
non-ether phospholipids (w/w) of the krill oil of Example 7. The calculated concentration of  
ether phospholipids and non-ether phospholipids calculated here is consistent with the figures  
calculated by Professor Barrow (CB-5 at [64]) and by the opponent (the amended SGP dated  
26 March 2020 at section 5.1.2, page 17).  
[180]  
[2016] EWCA Civ 1006 at [46] – [47].  
[181]  
Evolva at [59] which references Human Genome Sciences, Inc v Eli Lilly & Co [2011]  
UKSC 51; [2012] RPC 6 at [107].  
[182]  
Barrow A at [113].  
[183]  
Barrow A at [116].  
[184]  
The amended SGP dated 26 March 2020 at section 5.1.3, page 18.  
[185]  
CB-3, (Barrow#3) at [175].  
[186]  
Ibid.  
[187]  
CB-3, (Barrow#3) at [176].  
[188]  
Barrow A at [124]-[127]; [182], item 20.0; [183], item 20.0.  
[189]  
Merck at [527].  
[190]  
Ibid.  
[191]  
Merck at [527], [534].  
[192]  
Merck at [544].  
[193]  
Merck at [529].  
[194]  
Merck at [530]-[531] citing Walker LJ in Generics UK(HL) at 19 who referenced Fuel  
Oils/EXXON (T409/91) [1994] OJ EPO 653 (Exxon) at 659.  
[195]  
Generics UK(HL) at [30].  
[196]  
Biogen at [49].  
[197]  
Merck at [546].  
[198]  
Merck at [547].  
[199]  
CSR at [115].  
[200]  
The amended SGP dated 26 March 2020 at section 6.2.1, page 20.  
[201]  
The amended SGP dated 26 March 2020 at section 6.2.2, page 20.  
[202]  
The amended SGP dated 26 March 2020 at section 6.2.3, pages 20-21.  
[203]  
[204]  
[205]  
[206]  
[207]  
[208]  
[209]  
[210]  
[211]  
[212]  
[213]  
[214]  
[215]  
[216]  
[217]  
[218]  
[219]  
[220]  
[221]  
[222]  
Barrow A at [110].  
Barrow A at [113].  
Barrow A at [119].  
Barrow A at [124]-[127]; [182], item 20.0; [183], item 20.0.  
[2016] FCAFC 27; 117 IPR 415.  
Servier at [109].  
Servier at [75].  
Servier at [103].  
Servier at [59].  
[2011] FCA 710.  
Expo-Net at [15].  
Expo-Net at [16].  
[2009] FCAFC 70; 81 IPR 228.  
Lundbeck at [81].  
[2013] FCA 162; 100 IPR 285 at [352].  
[2016] FCAFC 29; 117 IPR 210 at [121].  
The amended SGP dated 26 March 2020 at section 4, page 16.  
The amended SGP dated 26 March 2020, background section, page 1; section 7, page 21.  
Rimfrost 2019 at [116].  
The filing date for the parent, patent application 2014256345, was the 29 October 2014.  
The filing date for the grandparent, patent application 2013227998, was the 11 Sept 2013.  
[223]  
The filing date and request for examination date for the great grandparent, patent  
application 2011213836, was, the 23 August 2011 and 13 October 2011, respectively. The  
request for national phase entry date and request for examination date for the original  
ancestor, patent application 2008231570, was 27 October 2009.  
[224]  
The Act, s 43(2)(a).  
[225]  
The Patents Regulations 1991, sub regulation 3.13D(1).  
[226]  
The Patents Regulations 1991, sub regulation 3.13D(3).  
[227]  
Barrow A at [101].  
[228]  
The four provisional applications from which 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.  
[229]  
Regulation 3.12 (1)(c), prior to commencement of the Raising the Bar Act.  
[230]  
[231]  
Regulation 3.12 (1)(b), prior to commencement of the Raising the Bar Act.  
Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132, 119 IPR 194;  
Inverness Medical Switzerland GmbH v MDS Diagnostics Pty Ltd [2010] FCA 108, 85 IPR  
525; Multigate Medical Devices Pty Ltd v B Braun Melsungen AG (Multigate) [2016] FCAFC  
21; 117 IPR 1.  
[232]  
Lockwood, 217 CLR 274, [2004] HCA 58 at [69] citing Gummow J in Rehm (1988) 81  
ALR 79, 11 IPR 289 at 304 and using Fullager J’s expression of “a real and reasonably clear  
disclosure” in Société des Usines Chimiques Rhône-Poulenc v Commissioner of Patents [1958]  
HCA 27; (1958) 100 CLR 5 at 11.  
[233]  
[2016] FCAFC 21; 117 IPR 1 at [188]- [189].  
[234]  
Multigate at [189] citing Yates J in Vehicle Monitoring Systems Pty Ltd v Sarb  
Management Group Pty Ltd (t/as Database Consultants Australia) (No. 2), [2013] FCA 395,  
101 IPR 496, who applied Leonardis v Sartas No 1 Pty Ltd[1996] FCA 449; , (1996) 67 FCR  
126, 35 IPR 23.  
[235]  
Ibid.  
[236]  
Multigate at [190].  
[237]  
The Act, Schedule 1, definition of prior art base.  
[238]  
[1977] HCA 19 at [20]; [1977] HCA 19; 137 CLR 228 at 235.  
[239]  
Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40; [1990] 91 ALR 513 at  
517; [1990] FCA 40; 16 IPR 545.  
[240]  
[1972] RPC 457 at 485 – 486.  
[241]  
[2000] FCA 1349 at [51]; [2000] FCA 1349; 106 FCR 214, citing the General Tire case at  
[485]-[486].  
[242]  
[2008] FCA 1194; 78 IPR 485 at [91].  
[243]  
[2011] FCA 846; 92 IPR 320 at [180].  
[244]  
The amended SGP dated 26 March 2020 at section 2, page 5. Professor Barrow has  
provided comments in his declaration on whether the claims of the opposed application are  
new compared to the disclosure in Catchpole and Breivik- Barrow A at [182] – [183], [185].  
Catchpole is referenced as exhibit CB-21 in the EIS. Breivik is referenced as exhibit CB-22 in  
the EIS.  
[245]  
CB-3 (Barrow # 3) at [100]-[104].  
[246]  
CB-3 (Barrow # 3) at [103].  
[247]  
Barrow A at [182], item 1.3.  
[248]  
I note that Professor Barrow stated that triglycerides are neutral fats, Barrow A at [34].  
Professor Barrow also stated that in extraction methods polar solvents extract the polar lipids,  
in particular the phospholipids, while non-polar solvents extract mainly the non-polar or  
neutral triglycerides, CB-3 (Barrow #3) at [82].  
[249]  
CB-3 (Barrow #3) at [71] – [73].  
[250]  
CB-3 (Barrow # 3) at [102].  
[251]  
Breivik, CB-22, abstract, description pages 4-5 and claims.  
[252]  
[253]  
[254]  
[255]  
[256]  
[257]  
[258]  
[259]  
[260]  
[261]  
Breivik, CB-22, description page 4.  
Breivik, CB-22, description page 5.  
Ibid.  
Barrow A at [184], item 1.1.  
Barrow A at [184], item 1.3.  
CB-3 (Barrow #3) at [128].  
CB-3 (Barrow #3) at [84].  
The Act, Schedule 1, definition of prior art base.  
[1981] HCA 12 at [45]; [1981] HCA 12; 148 CLR 262 at 286.  
Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73 (Generic  
Health); [2014] FCAFC 73; 314 ALR 91 at [71].  
[262]  
The amended SGP dated 26 March 2020 at section 3.1, page 5.  
[263]  
CB-3 (Barrow #3) at [81] – [93].  
[264]  
CB-3 (Barrow #3) at [92].  
[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.  
[268]  
WO 00/23546 (Beaudoin) referenced as CB-19 in the EIS.  
[269]  
Barrow A at [183], item 1.4.  
[270]  
CB-3 (Barrow#3) at [119].  
[271]  
CB-3 (Barrow#3) at [117], [122].  
[272]  
CB-3 (Barrow #3) at [84].  
[273]  
NKO GRAS Notice 000242 is referenced as exhibit CB-25 in the EIS and D3 in the  
amended SGP dated 26 March 2020.  
[274]  
GRAS notice No.371 is references as D7 in the originally filed SGP dated 07 August 2019.  
[275]  
The amended SGP dated 26 March 2020 at section 3.6, page 16.  
[276]  
CB-5 (Barrow #5) at [73], CB-3 (Barrow#3) at [123]-[124], [185].  
[277]  
[1995] HCA 15; 183 CLR 655 at [9].  
[278]  
[2000] FCA 316; 46 IPR 553 at [30].  
[279]  
[1959] HCA 71; (1959) 102 CLR 232 at 251.  
[280]  
The amended SGP dated 26 March 2020 page 3.  
[281]  
Ibid.  


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