`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`RIMFROST AS
`Petitioner,
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`v.
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`AKER BIOMARINE ANTARCTIC AS
`Patent Owner.
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`Case IPR2018-00295
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`U.S Patent No. 9,320,765
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`Patent Owner’s Motion to Amend the Claims
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`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`RIMFROST EXHIBIT 1105 Page 0001
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`

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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1 
`
`STATEMENT OF RELIEF REQUESTED .................................................... 2 
`
`
`
`I. 
`
`II. 
`
`III.  THE SUBSTITUTE CLAIMS MEET ALL THE REQUIREMENTS
`OF 37 C.F.R. § 42.121 ..................................................................................... 2 
`
`IV.  THE PROPOSED SUBSTITUE CLAIMS ARE SUPPORTED BY
`U.S. PATENT APPLICATION SERIAL NO. 14/020,155 ............................ 3 
`
`A.
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`Independent Claim 49 ........................................................................... 5
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`B. Dependent Claims 50-56 ..................................................................... 10
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`V. 
`
`LEVEL OF ORDINARY SKILL IN THE ART ........................................... 11 
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`VI.  CLAIM CONSTRUCTION ............................................................................ 9 
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`VII.  THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE
`OVER THE CITED PRIOR ART ................................................................. 10 
`
`A. 
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`B. 
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`The Proposed Substitute Claims Are Patentable Over The Prior
`Art At Issue In This Proceeding ....................................................................12 
`
`1. 
`
`None of Petitioner’s references, alone or in combination,
`teaches or suggests encapsulated krill oil compositions
`comprising “from 5% to 8% ether phospholipids w/w of
`said krill oil.” ..........................................................................................12 
`
`2. 
`
`None of Petitioner’s references, alone or in combination,
`teaches or suggests encapsulated krill oil compositions
`comprising “astaxanthin esters in amount of from 100
`mg/kg to 700 mg/kg of said krill oil.” ..............................................17 
`The Proposed Substitute Claims Are Patentable Over The Prior
`Art At Issue During Prosecution ......................................................... 21 
`
`VIII.  CONCLUSION ................................................................................... 25
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`RIMFROST EXHIBIT 1105 Page 0002
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`I.
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`INTRODUCTION
`Patent Owner Aker BioMarine Antarctic AS (“Patent Owner” or “Aker”)
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`respectfully moves under 35 U.S.C § 316(d) and C.F.R. § 42.121 to amend U.S.
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`Patent No. 9,320,765 (“the ‘765 patent”), contingent on the outcome of this trial. In
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`the event the Board finds the original claims unpatentable, Patent Owner
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`respectfully requests that the Board grant this motion to amend and issue the
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`corresponding substitute claims presented in the attached appendix. Patent Owner
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`relies on the Declaration of Dr. Nils Hoem (Ex. 2013) and the additional exhibits
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`in the Exhibit Listing that is filed concurrently herewith.
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`As the motion and the accompanying declaration of Dr. Hoem demonstrate,
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`this motion and the substitute claims meet all the requirements of 37 C.F.R §
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`42.121. Namely, each contingent amendment is responsive to a ground of
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`unpatentability involved in this proceeding, none of the amendments seeks to
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`enlarge the scope of the claims or introduce new subject matter, each amendment
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`proposes no more than one substitute claim for each conditionally canceled claim,
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`and the motion clearly shows the changes sought and the support in the original
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`disclosure of the patent for each claim that is added or amended.
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`The Federal Circuit has recently held that “the PTO has not adopted a rule
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`placing the burden of persuasion with respect to the patentability of amended
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`claims on the patent owner that is entitled to deference; and [] in the absence of
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`RIMFROST EXHIBIT 1105 Page 0003
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`anything that might be entitled deference, the PTO may not place that burden on
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`the patentee.” Aqua Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017).
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`Although Patent Owner respectfully believes that it should not bear the burden of
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`either persuasion or production regarding the patentability of the proposed
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`substitute claims as a condition of allowance, the instant motion and supporting
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`declaration of Dr. Hoem demonstrate that the proposed substitute claims are
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`patentable over the references at issue in this proceeding.
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`II.
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`STATEMENT OF RELIEF REQUESTED
`To the extent the Board finds any original claim unpatentable in this
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`proceeding, Patent Owner respectfully requests that the Board grant this motion to
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`amend with respect to each corresponding substitute claim presented herein. The
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`Board should not consider this motion for any original claim it finds patentable.
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`III. THE SUBSTITUTE CLAIMS MEET ALL THE REQUIREMENTS
`OF 37 C.F.R. § 42.121
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`As shown in the attached claims appendix (Appendix A), proposed
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`substitute independent claim 49 retains all features of the corresponding original
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`claim 25 of the ‘765 patent and does not broaden the scope of the claims in any
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`way. Rather, the contingent amendments add upper limits to the ranges of two
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`different components of the claimed encapsulated krill oil, each of which narrows
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`the scope of the claims. Specifically, the substitute claims add the following
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`limitations to the original claims: (1) a range of ether phospholipids of from 5% to
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`RIMFROST EXHIBIT 1105 Page 0004
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`8%, deleting the term “about”; and (2) an upper limit of 700 mg/kg to the range of
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`astaxanthin esters (“from 100 mg/kg to 700 mg/kg”). For the same reasons, the
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`proposed substitute dependent claims 50-56 likewise do not broaden the scope of
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`any original claim of the ’765 patent. See 37 C.F.R. § 42.121(a)(2)(ii).
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`Proposed substitute dependent claims 50-56 correspond
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`to original
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`dependent claims 26-32 of the ‘765 patent and are amended only to reflect their
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`new dependency from the amended substitute independent claims and to be
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`consistent with substitute independent claim 49. Because the dependent claims
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`have not been substantively amended, the proposed substitute dependent claims are
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`also responsive to the § 103 grounds of unpatentability. See Idle Free Sys., Inc. v.
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`Bergstrom, Inc., IPR2012-00027, Paper 26, Decision at 9 (PTAB June 11, 2013).
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`And as demonstrated in the next section, the proposed substitute claims are
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`supported by U.S. Patent Appln. Serial No. 14/020,155 (Ex. 2012; “the ‘155
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`application”), which is the originally filed application from which the ‘765 patent
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`was granted; therefore, they do not introduce new subject matter. See 37 C.F.R. §
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`42.121(a)(2)(ii).
`
`IV. THE PROPOSED SUBSTITUE CLAIMS ARE SUPPORTED BY U.S.
`PATENT APPLICATION SERIAL NO. 14/020,155
`The ‘765 patent was filed as U.S. Patent Appln. Serial No. 14/020,155 (Ex.
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`2012; “the ‘155 application”) and is a continuation of Application No. 12/057,775,
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`filed on March 28, 2008, now U.S. Patent No. 9,034,388. The ‘765 patent claims
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`priority to U.S. Provisional Application No. 60/920,483, filed on March 28, 2007,
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`U.S. Provisional Application No. 60/975,058, filed on September 25, 2007, U.S.
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`Provisional Application No. 60/983,446, filed on October 29, 2007, and U.S.
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`Provisional Application No. 61/024,072, filed on January 28, 2008. The
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`specification for the ‘155 application is identical to the specification of the initial
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`filed non-provisional application (Appl. No. 12/057,775).
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`For purposes of this Motion to Amend, Patent Owner identifies the
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`following portions of the ‘155 application (Ex. 2012) that provide §112 support for
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`the proposed substitute claims.
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`A. Independent Claim 49
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`The ‘155 application supports the preamble of proposed substitute claim 49,
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`“Encapsulated krill oil.” Hoem Decl. (Ex. 2013), ¶25; Tallon Decl. (Ex. 2013) at
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`¶¶ 69-70. Specifically, Example 5 of the ‘155 application discloses that “[t]he asta
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`oil obtained in example 1 was blended with the polar lipids obtained in example 4
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`in a ratio of 46:54 (v/v). Next the ethanol was removed by evaporation and a dark
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`red and transparent product was obtained. The product was analyzed and the
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`results can be found in Tables 20A-C. Furthermore, the product was encapsulated
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`into soft gels successfully.” Ex. 2012 at 41; Tallon Decl. (Ex. 1006) at ¶¶ 69-70.
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`The ‘155 application supports “a capsule containing a safe and effective
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`
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`amount of Euphausia superba krill oil,” as recited in proposed substitute claim 49.
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`Hoem Decl. (Ex. 2013), ¶26; Tallon Decl. (Ex. 1006) at ¶¶ 99-102. Additionally,
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`the ‘155 application discloses, “In another embodiment of the invention, the krill
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`oil compositions are found to be effective and safe for the treatment of metabolic
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`syndrome in humans.” Ex. 2012 at 23; Tallon Decl. (Ex. 1006) at ¶¶ 99-102.
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`The ‘155 application also supports a “krill oil comprising from 5% to 8%
`
`ether phospholipids w/w of said krill oil,” as recited in proposed substitute claim
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`49. Hoem Decl. (Ex. 2013), ¶27; Tallon Decl. (Ex. 1006) at ¶¶ 92-93. Specifically,
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`the ‘155 application discloses, “In some preferred embodiments, the krill oil
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`compositions of the present invention comprise from about 1%, 2%, 3% or 4% to
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`about 8%, 10%, 12% or 15% w/w ether phospholipids or greater than about 4%,
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`5%, 6%, 7%, 8%, 9% or 10% ether phospholipids.” Ex. 2012 at 15; Tallon Decl.
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`(Ex. 1006) at ¶¶ 92-93. Additionally, Example 7 and accompanying Table 22 of
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`the ‘155 application disclose compositions that contain 15.4% ether phospholipids
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`(13.0% (AAPC) + 0.9% (LAAPC) + 1.5% (AAPE)) as a percentage by weight of
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`phospholipids. Hoem Decl. (Ex. 2013), ¶28; Ex. 2012 at 43-45. Because
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`phospholipids make up 47.9% of the krill oil compositions in Example 7, ether
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`phospholipids comprise approximately 7.4% by weight of this krill oil (i.e., 15.4%
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`x .479 = 7.38%). Ex. 2012 at 43-45; Tallon Decl. (Ex. 1006) at ¶¶ 44-49. Indeed,
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`Petitioner confirms that the inventive subject matter of the ‘155 application
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`“includes krill oil extracts with an ether phospholipid content of 7.4% by weight of
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`krill oil. (Exhibit 1001).” Petition, IPR2018-00295 Paper 2 at 8.
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`Furthermore, the testimony of Petitioner’s own expert, Dr. Tallon, admits
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`that
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`the specification provides written, enabling disclosure for krill oil
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`compositions containing up to 8% ether phospholipids as supported by the working
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`examples. See, e.g., Tallon Decl. (Ex. 1006) at ¶ 49. Accordingly, Patent Owner
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`respectfully asserts that “krill oil comprising from 5% to 8% ether phospholipids
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`w/w of said krill oil,” as recited in proposed substitute claim 49, is fully supported
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`by the ‘155 application. Hoem Decl. (Ex. 2013), ¶29.
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`The ‘155 application also supports “from about 27% to 50% non-ether
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`phospholipids w/w of said krill oil so that the amount of total phospholipids in the
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`composition is from about 30% to 60% w/w of said krill oil,” as recited in
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`proposed substitute claim 49. Hoem Decl. (Ex. 2013), ¶30; Tallon Decl. (Ex. 1006)
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`at ¶¶ 145, 146, 281, 282. The ‘155 application discloses, “In some embodiments,
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`the present invention provides methods of making a Euphausia superba krill oil
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`composition comprising…combining said polar extract and said neutral extract to
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`provide Euphausia superba krill oil comprising from about 30% to 60% w/w
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`phospholipids…In some embodiments, the methods further comprise the step of
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`encapsulating the Euphausia superba krill oil.” Ex. 2012 at 7-8. Regarding “from
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`about 27% to 50% non-ether phospholipids,” the ‘155 application discloses, “In
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`some embodiments, the krill oil compositions comprise…from about 30%, 33%,
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`40%, 42%, 45%, 48%, 50%, 52%, 54%, 55% 56%, 58% to about 60% non-ether
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`phospholipids.” Ex. 2012 at 15; Tallon Decl. (Ex. 1006) at ¶¶ 145, 146, 281, 282.
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`The ‘155 application also supports “from about 20% to 50% triglycerides
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`w/w of said krill oil,” as recited in proposed substitute claim 49. Hoem Decl. (Ex.
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`2013), ¶31; Tallon Decl. (Ex. 1006) at ¶¶ 53, 283. More specifically, the ‘155
`
`application discloses “In some embodiments, the present invention provides
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`methods
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`of making
`
`a Euphausia
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`superba krill
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`oil
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`composition
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`comprising…contacting Euphausia superba with a neutral solvent to provide a
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`neutral extract comprising triglycerides and astaxanthin; combining said polar
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`extract and said neutral extract
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`to provide Euphausia superba krill oil
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`comprising…from about 20% to 50% triglycerides…In some embodiments, the
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`methods further comprise the step of encapsulating the Euphausia superba krill
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`oil.” Ex. 2012 at 7-8; see also, Ex. 2012, Tables 13 and 21.
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`The specification of the ‘155 application also supports encapsulated krill oil
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`compositions containing “astaxanthin esters in amount of from 100 mg/kg to 700
`
`mg/kg of said krill oil,” as recited in proposed substitute claim 49. Hoem Decl.
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`(Ex. 2013), ¶32; Tallon Decl. (Ex. 1006) at ¶¶ 290, 300, 311, 312. More
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`specifically, the ‘155 application discloses “In some embodiments, the krill oil
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`compositions comprise greater than about 100, 200, 300, 400, or 500 mg/kg
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`astaxanthin esters and up to about 700 mg/kg astaxanthin esters.” Ex. 2012 at 16-
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`17; see also, Ex. 2012, Tables 17C, 19C, and 20C.
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`Additionally, Petitioner acknowledges support for “astaxanthin esters in
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`amount of from 100 mg/kg to 700 mg/kg of said krill oil” in the specification of
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`the ‘765 patent in a related case, PGR2018-00033, challenging U.S. Patent No.
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`9,644,170 (also a continuation of U.S. Patent No. 9,034,388). In that case,
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`Petitioner acknowledges, “The independent and dependent claims encompass
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`astaxanthin esters amounts far greater than 0.25% (i.e., 2,500 mg/kg), the highest
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`amount arguably supported by the ‘170 patent. (Tallon Decl. (Exhibit 1006), ¶¶
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`103-10).” Ex. 2014, PGR2018-00033 Petition at 40. Accordingly, Patent Owner
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`respectfully asserts that “astaxanthin esters in amount of from 100 mg/kg to 700
`
`mg/kg of said krill oil,” as recited in proposed substitute claim 49, is fully
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`supported by the ‘155 application. Hoem Decl. (Ex. 2013), ¶33.
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`B. Dependent Claims 50-56
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`Proposed substitute dependent claims 50-56 correspond
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`to original
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`dependent claims 26-32 of the ‘765 patent and are amended only to reflect their
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`new dependency from the amended substitute independent claims and to be
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`consistent with substitute independent claim 49. The specification of the ‘155
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`application supports all features of the proposed substitute dependent claims.
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`Hoem Decl. (Ex. 2013), ¶34. Proposed dependent claims 50, 51 and 52 further
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`limit the astaxanthin ester ranges to 200, 300 and 400 to 700 mg/kg astaxanthin
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`esters, respectively. These claims limitations are supported as described above.
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`See, Ex. 2012 at 16-17; see also, Ex. 2012, Tables 17C, 19C, and 20C. Proposed
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`claims 53 and 54 relate to omega-3 fatty acid content (20-35%) and attachment to
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`phospholipids. See, Ex. 2012 at 15. Proposed claim 55 designates the capsule as a
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`soft gel capsule. See, Ex. 2012 at 18. Proposed claim 56 provides that the
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`encapsulated krill oil may further comprise a plant phytonutrient. See, Ex. 2012 at
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`20.
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`V.
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`LEVEL OF ORDINARY SKILL IN THE ART
`For the purposes of this proceeding, Patent Owner accepts Petitioner’s
`
`definition of a person of ordinary skill in the art (“POSITA”). See, Tallon Decl.
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`(Ex. 1006) at ¶ 28.
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`VI. CLAIM CONSTRUCTION
`The claims at issue should be given their broadest reasonable interpretation
`
`in light of the specification. 37 C.F.R. § 42.100(b); see also In re Translogic Tech.,
`
`Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). In accordance with these standards,
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`Patent Owner submits that, in relation to this Contingent Motion to Amend, the
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`newly added claims terms define a range for ether phospholipids of from 5% to 8%
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`of the encapsulated krill oil composition and further define a range of astaxanthin
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`esters of from 100 to 700 mg/kg of the encapsulated krill oil compositions. As
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`such, the claims do not encompass encapsulated krill oil compositions containing,
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`for example, 4.8% ether phospholipids as referenced in Catchpole, or 1,000 (or
`
`more) mg/kg astaxanthin esters as referenced in Breivik II.
`
`VII. THE PROPOSED SUBSTITUTE CLAIMS ARE PATENTABLE
`OVER THE CITED PRIOR ART
`Patent Owner confirms that no combination of the cited prior art teaches or
`
`suggests the subject matter of the proposed substitute claims. This Contingent
`
`Motion to Amend and the supporting declaration of Dr. Hoem discuss the known
`
`art closest to the features highlighted above based on a review of the prior art in the
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`prosecution history of the ’765 patent, the prosecution history of the applications to
`
`which it claims priority, and the asserted prior art in this proceeding. See
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`MasterImage 3D, Inc. v. RealD Inc., IPR2015-00040, Paper 42 at 2 (PTAB July
`
`15, 2015); Nike, Inc. v. Adidas AG, 812 F. 3d 1326, 1350-51 (Fed. Cir. Feb. 11,
`
`2016). Patent Owner is not aware of any other prior art material to the claimed
`
`elements or the system as a whole. Consistent with its duty under 37 C.F.R. §
`
`42.11, Patent Owner discloses and distinguishes below not just the closest primary
`
`reference(s), but also the closest secondary references that might be deemed
`
`material to the claimed features. See VMWare, Inc. v. Clouding Corp., IPR2014-
`
`01292, Paper 23 at 2 (PTAB April 7, 2015).
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`The Petition alleges that all claims of the ‘765 patent are obvious over the
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`
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`cited prior art, and therefore, invalid. A patent is invalid as obvious only “if the
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`differences between the claimed invention and the prior art are such that the
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`claimed invention as a whole would have been obvious before the effective filing
`
`date of the claimed invention to a person of ordinary skill in the art to which the
`
`claimed invention pertains.” 35 U.S.C. § 103(a). To invalidate a claim for
`
`obviousness, the prior art must teach or suggest each and every claimed feature.
`
`CFMT, Inc. v. YieldUp Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003).
`
`Significantly, “a patent composed of several elements is not proved obvious
`
`merely by demonstrating that each of the elements was, independently, known in
`
`the prior art.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1741 (2007). To prove
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`obviousness based on more than one reference, one must show that (1) a person of
`
`ordinary skill in the art would have been motivated to combine the references, and
`
`(2) there would have been a reasonable expectation of successfully achieving the
`
`claimed invention from such combination. See Leo Pharma. Prods., Ltd. v. Rea,
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`726 F.3d 1346, 1355-57 (Fed. Cir. 2013); see also In re Kubin, 561 F.3d 1351,
`
`1359 (Fed. Cir. 2009) (“courts should not succumb to hindsight claims of
`
`obviousness”). Moreover, secondary considerations “can be the most probative
`
`evidence of nonobviousness” and are useful to “avert the trap of hindsight.’” Leo
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`Pharma., 726 F.3d at 1358 (internal citation omitted). These secondary
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`considerations may include commercial success, copying, and prior art that teaches
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`away from the claimed inventions. See, e.g., Kinetic Concepts, Inc. v. Smith &
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`Nephew, Inc., 688 F.3d 1342, 1370 (Fed. Cir. 2012).
`
`A.
`
`The Proposed Substitute Claims Are Patentable Over The Prior
`Art At Issue In This Proceeding
`The proposed substitute claims retain all features of the corresponding
`
`original claim 25 of the ‘765 patent and do not broaden the scope of the claims.
`
`Rather, the contingent amendments add upper limits to the ranges of two different
`
`components of the claimed encapsulated krill oil and remove the term “about.”
`
`Specifically, the substitute claims add the following limitations to the original
`
`claims: (1) an upper limit of 8% (w/w) to the range of ether phospholipids (“from
`
`5% to 8%”); and (2) an upper limit of 700 mg/kg to the range of astaxanthin esters
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`(e.g., “from 100 mg/kg to 700 mg/kg”). As demonstrated below, none of
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`Petitioner’s prior art references teaches these limitations as recited in the proposed
`
`substitute claims.
`
`1.
`
`None of Petitioner’s references, alone or in combination, teaches
`or suggests encapsulated krill oil compositions comprising “from
`5% to 8% ether phospholipids w/w of said krill oil.”
`The Petition in this proceeding relies on a combination of three main prior
`
`art references to support the allegation that original independent claims 1 and 25
`
`are obvious, and therefore, invalid. Petitioner asserts that Catchpole (Ex. 1009)
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`provides the ether phospholipid, non-ether phospholipid and total phospholipid
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`IPR2018-00295
`U.S. Patent No. 9,320,765
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`ranges, that Fricke 1984 (Ex. 1010) provides the triglyceride range, and that
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`Breivik II (Ex. 1037) provides the astaxanthin range. The fourth reference in the
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`combination, Sampalis I, is cited by Petitioner for the “safe and effective amount”
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`and soft gel capsule limitations.
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`More specifically, regarding original claims 1 and 25 of the ‘765 patent,
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`Petitioner alleges that Catchpole discloses krill oil extract having 4.8% ether
`
`phospholipids (see, e.g., Ex. 1009, Table 16, Extract 2). Petition, IPR2018-00295
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`Paper 2 at 31-32, 38-39; Tallon Decl. (Ex. 1006) at ¶¶ 145, 146, 282. Regarding
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`original claim 18 of the ‘765 patent, Petitioner alleges that “greater than about 5%
`
`w/w ether phospholipids” should be construed to include a range greater than
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`4.5%, which includes the 4.8% ether phospholipids disclosed in Catchpole.
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`Petition, IPR2018-00295 Paper 2 at 24-27, 37-38; Tallon Decl. (Ex. 1006) at ¶¶
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`295-298. Therefore, Petitioner alleges “it would have been obvious to a POSITA
`
`for the krill oil to include greater than about 5% w/w ether phospholipid in the krill
`
`oil.” (Tallon Decl., ¶¶ 295-298).” Petition, IPR2018-00295 Paper 2 at 38.
`
`Proposed substitute claim 49, which is based on original claim 25, is
`
`directed to encapsulated krill oil compositions comprising “a safe and effective
`
`amount of Euphausia superba krill oil, said krill oil comprising from 5% to 8%
`
`ether phospholipids w/w of said krill oil.” As discussed above, and based on
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`Petitioner’s own claim construction, absence of the term “about” excludes from the
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`claimed range of ether phospholipids any numeric values below 5%, such as the
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`4.8% disclosed in Catchpole. Although Sampalis I is cited by Petitioner for the
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`“safe and effective amount” and soft gel capsule limitations, Sampalis I fails to
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`disclose encapsulated krill oil compositions “comprising from 5% to 8% ether
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`phospholipids w/w of said krill oil.” Indeed, no combination of Fricke, Breivik II,
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`and Sampalis I remedy the deficiencies of Catchpole regarding the claimed ether
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`phospholipid content. Hoem Decl. (Ex. 2013), ¶49. Accordingly, Patent Owner
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`respectfully submits that the failure of Petitioner’s cited prior art to disclose “krill
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`oil comprising from 5% to 8% ether phospholipids w/w of said krill oil” precludes
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`establishment of a prima facie case of obviousness.
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`Petitioner may argue that a POSITA would consider “from 5% to 8% ether
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`phospholipids” recited in proposed substitute claim 49 to be an obvious extension
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`of the 4.8% value disclosed in Catchpole. Patent Owner respectfully submits that a
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`POSITA would be discouraged from increasing ether phospholipid content from
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`the 4.8% disclosed in Catchpole to the “from 5% to 8% ether phospholipids”
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`recited in proposed substitute claim 49. Hoem Decl. (Ex. 2013), ¶¶50-55.
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`For example, Petitioner points to Sampalis I and its alleged disclosure of
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`encapsulated krill oil supplements
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`to
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`treat
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`inflammation associated with
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`premenstrual syndrome (PMS), in combination with the krill oil compositions
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`disclosed in Catchpole, Fricke, and Breivik II, as evidence of the obviousness of
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`original claims 1 and 25. Petition, IPR2018-00295 Paper 2 at 42-43; Tallon Decl.
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`(Ex. 1006) at ¶¶ 50-54, 200-203. However, a POSITA considering the prior art as a
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`whole would have been discouraged from using krill oil with the levels of ether
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`phospholipids recited in the substitute claims for the treatment of inflammatory
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`condition such as PMS, and therefore, would not have combined Sampalis I with
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`the other prior art references to provide the claimed encapsulated krill oil
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`compositions. Hoem Decl. (Ex. 2013), ¶51,55.
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`More specifically, the prior art taught that peroxidated ether phospholipids,
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`especially those derivable from krill oil, are potent Platelet Activating Factor
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`(PAF) analogs that could cause inflammation when included in the diet. Hoem
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`Decl. (Ex. 2013), ¶51. PAF is the trivial name for the phospholipid signaling
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`molecule, 1-O-alkyl-2-acetyl-sn-glycero-3-phosphocholine. Hoem Decl. (Ex.
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`2013), ¶52. The “1-O-alkyl” portion of the molecule is an ether-linked fatty acid,
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`meaning
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`that PAF
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`is an ether phospholipid, and
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`in particular an
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`alkylacylphosphatidylcholine (AAPC). PAF is involved in triggering acute
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`inflammatory and thrombotic cascades and is known to cause platelet aggregation.
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`See, e.g., Prescott et al., (2000) Annu. Rev. Biochem. 69:419-45 (Ex. 2003) and
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`Zimmerman et al., (2002) Crit. Care Med. 30(5):S294-S301 (Ex. 2004). These
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`known activities of PAF are antagonistic to the known uses of omega-3 fatty acids
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`to reduce, for example, inflammation and platelet aggregation. See, e.g., Calder
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`(2006) Am. J. Clin. Nutr. 83(suppl.):1505S-19S (Ex. 2005).
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`Ingestion of ether lipids, and in particular, ether phospholipids, was
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`recognized as a potential source of inflammatory PAF activity as early as 1990.
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`Hoem Decl. (Ex. 2013), ¶53; Blank et al. (Ex. 2009) at 1001. This continued to be
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`a concern in the art up until the priority date of the present invention. Id. For
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`example, Hartvigsen et al. (Ex. 2010) addresses the feasibility that peroxidation
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`and lipolysis of 1-O-alkyl-2,3-diacyl-sn-glycerols (DAGE) found in shark liver oil
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`and human milk fat constitutes a potential source of dietary precursors of platelet
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`activating factor (PAF) mimics. While this study addresses ether-linked glycerol
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`molecules, the same concerns would apply to ether phospholipids. Hoem Decl.
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`(Ex. 2013), ¶53. As described in Hartvigsen et al., the “major source of PAF-like
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`lipids (or mimics/analogues) is the unregulated oxidative modification of cellular
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`and plasma phospholipids…The immediate precursors of these mimics are the 1,2-
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`diacyl- and 1-O-alkyl-2-acyl-sn-GroPCho with saturated acyl and alkyl chains in
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`the sn-1-position.” Ex. 2010 at 0009. Furthermore, the prior art identified krill oil
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`as being of particular concern as a source of ether phospholipids that can be
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`peroxidated to PAF-like molecules after ingestion. Hoem Decl. (Ex. 2013), ¶54. As
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`disclosed in the abstract of Tanaka I (Ex. 1014), foodstuffs, and particularly krill,
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`“that are rich in 1-O-alkyl-2-docosahexaenoyl-sn-glycero-3-phosphocholine are
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`potential sources of compounds with high PAF-like activity formed by deleterious
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`lipid peroxidation.”
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`A POSITA would have known that oral administration of supplements
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`containing ether phospholipids presented health risks, including increasing
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`inflammation. Hoem Decl. (Ex. 2013), ¶55. Thus, a POSITA would not be
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`motivated to administer a krill oil composition having the levels of ether
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`phospholipids disclosed in Catchpole to reduce inflammation as taught by
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`Sampalis I, let alone a krill oil composition having levels higher than those
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`disclosed in Catchpole, as recited in proposed substitute claim 49.
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`2.
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`None of Petitioner’s references, alone or in combination, teaches
`or suggests encapsulated krill oil compositions comprising
`“astaxanthin esters in amount of from 100 mg/kg to 700 mg/kg
`of said krill oil.”
`Proposed substitute claim 49 is also directed to encapsulated krill oil
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`
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`compositions comprising “astaxanthin esters in amount of from 100 mg/kg to 700
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`mg/kg of said krill oil.” Regarding original claims 1 and 25 of the ‘765 patent,
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`Petitioner alleges that Breivik II (Ex. 1037) discloses a krill oil product that
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`includes ≥ 1.0 mg/g esterified astaxanthin, which is equivalent to ≥ 1000 mg/kg.
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`Petition, IPR2018-00295 Paper 2 at 34-35; Tallon Decl. (Ex. 1006) at ¶130.
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`Petitioner alleges that the amount of astaxanthin esters disclosed in Breivik II
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`satisfies the element of greater than about 100 mg/kg recited in original claims 1
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`and 25. Petition, IPR2018-00295 Paper 2 at 35.
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`Proposed substitute claim 49 recites krill oil compositions comprising
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`“astaxanthin esters in amount of from 100 mg/kg to 700 mg/kg of said krill oil.”
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`Breivik II’s disclosure of ≥ 1000 mg/kg is well outside the range of 100 mg/kg to
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`700 mg/kg for astaxanthin esters recited in proposed substitute claim 49, and no
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`combination of Catchpole, Fricke, and Sampalis I remedy the deficiencies of
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`Breivik II regarding the claimed astaxanthin ester content. Hoem Decl. (Ex. 2013),
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`¶56. Accordingly, Patent Owner respectfully submits that the failure of Petitioner’s
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`cited prior art to disclose “astaxanthin esters in amount of from 100 mg/kg to 700
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`mg/kg of said krill oil” precludes establishment of a prima facie case of
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`obviousness.
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`Furthermore, Patent Owner respectfully submits that the cited prior art
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`teaches away from “astaxanthin esters in amount of from 100 mg/kg to 700 mg/kg
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`of said krill oil,” as recited in proposed substitute claim 49. Hoem Decl. (Ex.
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`2013), ¶57. For example, Randolph (Ex. 1011) discloses, “A composition can
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`contain any amount of an astaxanthin ingredient. For example, at least about 1
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`percent (e.g., at least about 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, or
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`90 percent) of a dietary supplement can be astaxanthin. Typically, a composition
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`contains between about 0.5 mg and about 50 mg of an astaxanthin ingredient.” Ex.
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`1011 at ¶ 44. The lowest amount of an astaxanthin ingredient disclosed in
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`Randolph is 1%, which is equivalent to 10,000 mg/kg. This is over 13 times greater
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`than the highest amount of astaxanthin esters recited in proposed substitute claim
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`49. Thus, Patent Owner contends that Randolph’s disclosure of at least 10,000
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`mg/kg of an astaxanthin ingredient teaches away from krill oil compositions that
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`include the 100 mg/kg to 700 mg/kg astaxanthin esters recited in proposed
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`substitute claim 49.
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`Additionally, Dr. Tallon acknowledges that Breivik I (Ex. 1035), Breivik II
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`(Ex. 1037), and Breivik III (Ex. 1036) disclose a process that leads to less
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`deterioration of krill lipid antioxidants (i.e., astaxanthin esters). Tallon Decl. (Ex.
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`1006) at ¶ 131. Specifically, Dr. Tallon states, “A lipid prod