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`PAPER 19
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`RIMFROST AS
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`Petitioner
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`v.
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`AKER BIOMARINE ANTARCTIC AS
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`Patent Owner
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`Case No.: IPR2018-01179
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`U.S. Patent 9,375,453
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`Issue Date: June 28, 2016
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`Title: Bioeffective Krill Oil Compositions
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`MOTION TO AMEND THE CLAIMS
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`Inter Partes Review Case No.: IPR2018-01179
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`TABLE OF CONTENTS
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`U.S. Patent No. 9,375,453
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`INTRODUCTION ........................................................................................... 1
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`SUBSTITUTE CLAIMS 62-74 ARE NOT PATENTABLE.......................... 2
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`I.
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`II.
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`III.
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`A.
`B.
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`C.
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`There Is No Written Description Support For Claims 75-84 ................ 5
`“Grinding, Cooking and Drying” Treatment Steps Are
`Expressly Taught And Disclosed In The Prior Art ............................... 6
`The Prior Art Teaches Polar Krill Oil Having
`“From 5% to 8%” Ether Phospholipids ................................................ 8
`D. Krill Oil Having 100 mg/kg to 700 mg/kg Astaxanthin Esters
`Is Expressly Disclosed in the Prior Art ...............................................13
`A POSITA Would Have Combined The Conventional Krill
`Processing Techniques Of The Cited References To Obtain
`The Recited Polar Krill Oil .................................................................14
`SUBSTITUTE CLAIMS 75-84 WOULD HAVE BEEN OBVIOUS ..........18
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`E.
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`B.
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`A. Yoshitomi, Catchpole, Bottino II, Sampalis I, Randolph,
`Sampalis II and NKO Render Claims 75-77 and 79-82 Obvious .......18
`Yoshitomi, Catchpole, Bottino II, Sampalis I, Sampalis II,
`Randolph and NKO Render Substitute Claim 78 Obvious .................22
`Yoshitomi, Catchpole, Bottino II, Sampalis I, Fricke, Randolph
`Sampalis II and NKO Render Claim 83 Obvious ...............................23
`D. Yoshitomi, Catchpole, Bottino II, Sampalis I, Sampalis II,
`Randolph and NKO Renders Substitute Claim 84 Obvious ...............24
`IV. CONCLUSION ..............................................................................................25
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`C.
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`i
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`Inter Partes Review Case No.: IPR2018-01179
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`U.S. Patent No. 9,375,453
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`I.
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`INTRODUCTION
`Patent Owner requests that the Board substitute claims 75-84 in place of
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`original claims 33 and 37-45 of U.S. Patent No. 9,375,453 (“the ‘453 patent”) if
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`these original claims are found unpatentable. However, substitute claims 75-84, as
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`challenged claims 33 and 37-45, simply recite conventional methods of producing
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`polar krill oil having ranges of phospholipids, triglycerides and astaxanthin esters,
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`all of which Patent Owner’s expert, Dr. Hoem, acknowledged are naturally present
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`in krill. Exhibit 1080, pp. 0007-0010. Simply amending claims 33 an 37-45 by
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`adding known “grinding, cooking and drying” treatment steps, and upper limits to
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`the ranges of ether phospholipids (i.e., from 5% to 8%) and astaxanthin esters (i.e.,
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`100 mg/kg to 700 mg/kg) does not render substitute claims 33 and 37-45
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`patentable.1
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`As an initial matter, U.S.S.N. 14/020,162, to which the ‘453 patent claims
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`priority, lacks written description support for the proposed “grinding, cooking and
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`drying” limitation in each substitute claim. See 37 C.F.R. 42.121 (b)(1).
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`1 Patent Owner’s amended ether phospholipid range (5-8%) combined with the
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`recited range of non-ether phospholipids (27-50%) fails to support the claimed
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`total phospholipid content (30-60%), thus rendering the proposed claims indefinite.
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`Inter Partes Review Case No.: IPR2018-01179
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`U.S. Patent No. 9,375,453
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`The substitute claims are also unpatentable. In particular, treating krill by
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`“grinding, cooking and drying,” and then extracting polar krill oil having the
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`ranges of ether phospholipids, triglycerides and astaxanthin esters recited in the
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`substitute claims is taught in the prior art. For example, Yoshitomi (Exhibit 1033),
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`describing “grinding, cooking and drying” krill to obtain a denatured krill product
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`with all the components present in krill, in combination with prior art that was the
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`focal point of three previous “krill IPRs” (i.e., IPR2018-00295; IPR2017-00746;
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`and IPR2017-00745), demonstrates that substitute claims 75-84 are not patentable
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`by a preponderance of evidence. Patent Owner’s motion should be denied.2
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`II.
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`SUBSTITUTE CLAIMS 62-74 ARE NOT PATENTABLE
`Patent Owner’s Motion to Amend (“MTA”) is contingent upon a finding that
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`claims 33 and 37-45 are unpatentable based on the teachings of Breivik II (Exhibit
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`1037), Catchpole (Exhibit 1009), Bottino II (Exhibit 1038) Sampalis I (Exhibit
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`1012) Sampalis II (Exhibit 1013), Fricke (Exhibit 1010) and Randolph (Exhibit
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`2 The failure to acknowledge, much less address, Yoshitomi after it was expressly
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`discussed in Dr. Tallon’s Declaration, (Exhibit 1006, ¶¶ 357-366), calls into
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`question Patent Owner’s duty of candor. See 37 C.F.R. § 42.11; Masterimage 3D,
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`Inc. v. Reald Inc., IPR2015-00040 (Paper 42), p. 2 (July 15, 2015); Idle Free Sys.,
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`Inc. v. Bergstrom, Inc., IPR2012-00027 (Paper 26), p. 7 (June 11, 2013).
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`2
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`Inter Partes Review Case No.: IPR2018-01179
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`U.S. Patent No. 9,375,453
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`1011). See Petition (Paper 2), pp. 32-89. The Board is well versed in the teachings
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`of these references; each formed the bases for finding all claims of U.S. Patent
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`Nos. 9,320,765 (“the ‘765 patent”), 9,028,877 (“the ‘877 patent”) and 9,078,905
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`(“the ‘905 patent”) unpatentable: IPR2018-00295, Final Written Decision (Paper
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`35) (“-295 FWD”, Exhibit 1129); IPR2017-00746, Final Written Decision (Paper
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`23) (“-746 FWD”, Exhibit 1104); IPR2017-00745, Final Written Decision (Paper
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`24) (“-745 FWD”, Exhibit 1103).3
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`Since “the Board determines whether substitute claims are unpatentable by a
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`preponderance of the evidence based on the entirety of the record, including any
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`opposition made by petitioner,” Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-
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`01129, Paper 15, p. 4 (Feb. 25, 2019), Petitioner only addresses the “grinding,
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`cooking and drying” limitation, and the amended ether phospholipids and
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`astaxanthin ester upper limits Patent Owner seeks to add. All remaining claim
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`limitations are addressed in the Petition. Petition (Paper 2), pp. 32-89; see, e.g.
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`Tallon Decl. (Exhibit 1006), ¶¶ 409-458, Appendix A.
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`In an attempt to support the patentability of the substitute claims, Patent
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`3 The ‘453, ‘765, ‘877 and ‘905 patents are in the same family, share the same
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`specification and priority date, and recite, inter alia, krill oil having materially
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`identical ranges of ether phospholipids, triglycerides and astaxanthin esters.
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`3
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`Inter Partes Review Case No.: IPR2018-01179
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`U.S. Patent No. 9,375,453
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`Owner makes three meritless arguments, two of which were previously litigated,
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`fully considered and expressly rejected by the Board in IPR2018-00295.
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`First, Patent Owner’s only new argument, that the references relied on do
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`not teach the “grinding, cooking and drying” treatment step, is unavailing. MTA,
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`pp. 13-15. As evidenced by at least two references already discussed by
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`Petitioner’s expert, Dr. Tallon (i.e., Yoshitomi (Exhibit 1033) and Grantham
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`(Exhibit 1032)), treating fresh krill by “grinding, cooking and drying” to obtain a
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`denatured krill product has been known for years and encompasses conventional
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`processing techniques. See, e.g., Tallon Decl. (Exhibit 1006), ¶¶ 357-366; 331-
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`339; see infra, pp. 6-8. Simply specifying that the claimed treating step includes
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`“grinding, cooking and drying” is not new, and therefore, not patentable.
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`Second, Patent Owner urges that all neutral lipids, including triglycerides
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`were removed during the initial extraction described in Catchpole Example 18 and,
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`as a result, Extract 2 contained no triglycerides. MTA, pp. 16-19. The Board is
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`quite familiar with Patent Owner’s “no triglycerides” argument; it was fully
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`considered and soundly rejected in finding all claims of the ‘765 patent
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`unpatentable. -295 FWD, pp. 34-39. Using the “no triglycerides” argument as a
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`springboard, Patent Owner again incorrectly presupposes that triglycerides must be
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`added to Extract 2 to increase the triglycerides content from 0% to 20-50%, thus
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`diluting the ether phospholipids from 4.8% to 2.88-3.84%. MTA, pp. 18-19.
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`4
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`U.S. Patent No. 9,375,453
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`Rejecting Patent Owner’s “no triglycerides” and “dilution” arguments, the Board
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`found that Petitioner established that neutral lipids and triglycerides were not
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`totally removed during the initial extraction step of Example 18, and that Extract 2
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`contained 20-50% triglycerides. See -295 FWD, pp. 37-39. Patent Owner should
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`be precluded from re-arguing that Extract 2 contained no triglycerides, or that
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`triglycerides must be added to reach the recited triglycerides content.
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`Third, Patent Owner argues that the prior art fails to teach krill oil having
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`100-700 mg/kg astaxanthin esters. MTA, pp. 19-21. The Board is also well versed
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`with this argument. In IPR2018-00295, the Board rejected this same argument
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`when Patent Owner tried to add the identical limitation to claims of the ‘765
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`patent, and found that Randolph (Exhibit 1011) describes krill oil compositions
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`with at least 158 mg/kg of astaxanthin esters. -295 FWD, pp. 67-68.
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`A. There Is No Written Description Support For Claims 75-84
`Patent Owner, inter alia, must set forth “[t]he support in the original
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`disclosure of the patent for each claim that is added or amended.” 37 C.F.R. §
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`42.121(b)(1); Lectrosonics, IPR2018-01129, Paper 15, p. 7. To satisfy this
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`requirement, Patent Owner directs the Board to only three excerpts of U.S.S.N.
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`14/020,162 (“the ‘162 application”) purportedly providing written description
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`support for the proposed “grinding, cooking and drying” limitation. MTA, p. 5.
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`Of these excerpts, only one actually uses the term “grinding.” Exhibit 2012 p. 6,
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`5
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`U.S. Patent No. 9,375,453
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`lines 12-14 (“In some embodiments, the denaturation step comprises heating said
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`fresh krill after grinding.”). This is the only use of the term “grinding” in the ‘162
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`application, and is buried in a paragraph with eight other so-called “embodiments”
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`-- the term “embodiment” being used more than 175 times in the application.
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`While the written description requirement “does not demand any particular
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`form of disclosure, or that the specification recite the claimed invention in haec
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`verba, a description that merely renders the invention obvious does not satisfy the
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`requirement.” Ariad Pharm., Inv. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed.
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`Cir. 2010) (citations omitted). Here, the single isolated use of the term “grinding”
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`in the ‘162 application does not demonstrate that applicants were sufficiently
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`aware of the proposed “grinding, cooking and drying” step as inventive to satisfy
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`35 U.S.C. § 112 (b). There is insufficient written description support for the full
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`scope of the proposed claims, and Patent Owner’s MTA should be denied.
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`B.
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`“Grinding, Cooking and Drying” Treatment Steps
`Are Expressly Taught And Disclosed In The Prior Art
`“Grinding, cooking and drying” to obtain a denatured krill product is
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`conventional, well known and disclosed in the prior art. See, e.g., Yoshitomi
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`(Exhibit 1033), ¶¶ 0021, 0025, 0032-033, 0037, 0049; Grantham (Exhibit 1032),
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`pp. 0032-34; see Tallon Decl. (Exhibit 1006), ¶¶ 357-366; 331-338; Tallon
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`Reply/Opp. (Exhibit 1086), ¶¶ 23-24, 252-259. For example, Yoshitomi discloses
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`a process to produce a “dried powdery and granular krill product which contains all
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`components” of freshly captured Euphasia superba krill. Exhibit 1033, ¶¶ 0002,
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`0009, 0055; see Grantham (Exhibit 1032), p. 0033. As part of that process krill is
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`“first chopped into pieces . . . and then are put into a heating and drying machine.”
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`Exhibit 1033, ¶ 0037. Further, Example 1 discloses that fresh krill is:
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`coarsely crushed by a chopper and are then supplied to a
`drier. The materials are boiled in the drier under heating
`with vapor, followed by further drying. Id. at ¶ 0049.
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`As previously recognized, the need to denature krill and reduce and prevent
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`decomposition of the beneficial lipids and phospholipids was well known. See
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`-746 FWD, pp. 28-29, 46-47; see also Breivik II (Exhibit 1037), p. 0010, lines 11-
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`12. Yoshitomi teaches that boiling (i.e., heating) krill will “perfectly disable” the
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`proteolytic enzymes which would also denature the lipases and phospholipases.
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`See, e.g., Exhibit 1033, Abstract ¶¶ 0009, 0022, 0041, 0049, 0051; Tallon
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`Reply/Opp. (Exhibit 1086), ¶ 259. Yoshitomi also teaches grinding increases
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`thermal efficiency of the heating and drying steps used to denature krill because,
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`inter alia, chopped or ground krill “did not adhere to the heating surface,” thereby
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`improving quality of the resulting denatured krill product. Exhibit 1033, ¶¶ 0032,
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`0037. A POSITA would have also appreciated that grinding krill would improve
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`the efficiency of a subsequent extraction step and the quality of the resulting
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`extract. See Exhibit 1009 (Catchpole), p. 7, lines 20-21; p. 11, lines 30-32.
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`7
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`U.S. Patent No. 9,375,453
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`Patent Owner urges that Breivik and Yamaguchi teach away from “grinding,
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`cooking and drying” krill. MTA, pp. 13-14. Patent Owner is again wrong. Tallon
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`Reply/Opp. (Exhibit 1086), ¶¶ 260-272. Breivik teaches that cooking denatures
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`krill lipases, thus permitting grinding without hydrolysis concerns. See Exhibit
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`1037, p. 0004, lines 2-6; Tallon Decl. (Exhibit 1006), ¶ 189. Also, Yamaguchi
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`does not teach away from grinding, cooking and drying, but instead states that
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`“SC-CO2 extraction is suitable method to obtain undenatured oils from meals of
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`marine origin.” Exhibit 2002, p. 2.
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`C. The Prior Art Teaches Polar Krill Oil Having
`“From 5% to 8%” Ether Phospholipids
`Patent Owner’s assertion that Catchpole does not “teach or suggest krill oils
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`that contain 5% to 8% ether phospholipids” is clearly incorrect. MTA, pp. 15-16.
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`The Board previously concluded, “although Catchpole might not contain a specific
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`example of a krill oil composition having in excess of 5% ether phospholipids,
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`Catchpole teaches that it is desirable to prepare such a composition. As Dr. Tallon
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`has testified, one skilled in the art would have been able to create such a
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`composition using conventional extraction techniques.” -295 FWD, p. 51.
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`Catchpole Example 18 describes a process to obtain a krill extract having at
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`least 4.8% ether phospholipids. Exhibit 1009, p. 0024, lines 1-19; Tallon Decl.
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`(Exhibit 1006), ¶¶ 222-225. Catchpole also teaches that varying extraction
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`8
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`U.S. Patent No. 9,375,453
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`conditions, such as temperature, pressure, solvents, and solvent concentration,
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`influences the amount of material extracted and the purity of the resulting extract.
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`Exhibit 1009, p. 0011, lines 11-18; p. 0012, lines 1-3, 13-17. Tallon Reply/Opp.
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`(Exhibit 1086), ¶¶ 289-300. For example, Examples 7 and 8 shows that increasing
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`the solvent concentration, increases the phospholipids extracted. Exhibit 1009, p.
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`0018, line 1- p. 0019, line 4. Claim 95 of Catchpole discloses and claims extracts
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`having greater than 5% acylalkyphospholipids, an ether phospholipid. Id. at p. 35,
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`lines 11-12; p. 9, lines 18-20, Tallon Reply/Opp. (Exhibit 1086) ¶¶ 90-101. In fact,
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`the Board found that “Catchpole specifically teaches a preference for compositions
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`containing greater than 5% by weight acylalkyphospholipids.” -295 FWD, p. 49.
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`Relying on the same argument previously proffered, Patent Owner again
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`urges that there were no triglycerides in Extract 2 because they were purportedly
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`removed during the initial extraction of Example 18. MTA, pp. 16-19; see
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`IPR2018-00295, Patent Owner’s Reply (Paper 22) (“-295 PO Reply”, Exhibit
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`1132), pp. 5-7; IPR2018-00295, Patent Owner’s Sur-Reply (Paper 27) (“-295 PO
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`Sur-Reply”, Exhibit 1133), pp. 5-6. To support its erroneous proposition, Patent
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`Owner fancifully relies on Fricke to approximate the neutral lipids/triglycerides
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`present in the krill feed material. MTA, p. 17-18. Using its rejected “no
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`triglycerides” argument as a predicate, Patent Owner again theorizes that because
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`all neutral lipids and triglycerides were supposedly removed during the initial
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`9
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`extraction, triglycerides must be added to Extract 2 to increase the level of
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`triglycerides from 0% to 20-50%, thereby diluting the reported ether phospholipid
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`content from 4.8% to 2.88-3.84%. MTA, pp. 18-19.
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`Patent Owner’s “no triglycerides” and “dilution” arguments have already
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`been fully considered and expressly rejected by the Board. -295 FWD, pp. 35-39.
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`Patent Owner’s hypothetical calculation of neutral lipids, including
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`triglycerides, in the krill feed material is unnecessary. A POSITA would have
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`understood that Extract 2 contained 32-37% triglycerides. Tallon Reply/Opp.
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`(Exhibit 1086), ¶¶ 11-14, 32-36, 76; see -295 FWD, p. 37 (“the evidence of record
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`supports the conclusion that Extract 2 of Catchpole contained a significant amount
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`of triglycerides”).4 This is also consistent with the data in Example 18 reporting
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`that the krill feed contained 765 grams of neutral lipids, including triglycerides
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`(i.e., weight total lipids - weight phospholipids = weight neutral lipids) which
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`corresponds to approximately 33% triglycerides. See, e.g., Tallon Reply/Opp.
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`(Exhibit 1086), ¶¶ 45, n.7, 51. This is in sharp contrast to Patent Owner’s
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`hypothetical approximation of 647 grams. MTA, p. 17-18. Thus, triglycerides did
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`4 Even accepting Patent Owner’s argument that the feed contained some lyso-
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`phospholipids, a POSITA would have expected that the triglyceride content of
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`Extract 2 to still be greater than 20%. Tallon Reply/Opp. (Exhibit 1086), ¶¶ 52-62.
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`10
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`not need to be added to Extract 2. Tallon Reply/Opp. (Exhibit 1086), ¶¶ 11-14,
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`281-284. Additionally, Catchpole expressly discloses that in addition to lipids and
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`phospholipids, Extract 2 also contained “53.7% other compounds” which would
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`include a “significant amount of triglycerides.” -295 FWD, p. 37 (“Dr. Tallon has
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`credibly testified that, based on his calculations, the other materials would include
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`a significant amount of triglycerides.”); see Tallon Decl. (Exhibit 1006), ¶¶ 224,
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`414.
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`Patent Owner disingenuously asserts that two sentences from Catchpole
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`shows that all neutral lipids would have been necessarily removed in the initial
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`extraction described in Example 18:5 “The feed material can be processed using
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`pure CO2 before the co-solvent is introduced to remove much or all neutral
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`lipids.” (Exhibit 1009, p. 0011, lines 23-24); (“The extraction was optionally
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`carried out using CO2 only until all of the compounds soluble in CO2 only, such as
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`neutral lipids, were extracted.” (Id., p. 0013, lines 20-22). MTA, pp. 16-18; see
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`5 Both statements are similar to those in Tanaka II that note the first extraction
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`removed “as much of the TGs [triglycerides] as possible,” and that additional
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`triglycerides were removed after the polar solvent concentration was increased.
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`Exhibit 1015, pp. 0006-0007; Tallon Reply/Opp. (Exhibit 1086), ¶¶ 77, 82-84.
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`11
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`-295 PO Reply, pp. 6-7. These statements simply confirm that Catchpole’s
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`extraction techniques can be readily adjusted depending on various constituents
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`desired by a POSITA. Tallon Reply/Opp. (Exhibit 1086), ¶¶ 289-300.
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`Patent Owner also grabs onto an excerpt from Example 18 stating the initial
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`extraction was performed “until no further extract was obtained,” and then boldly
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`proclaims this excerpt “indicate[s] to a POSITA that the process was intended to
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`remove all neutral lipids (including triglycerides).” MTA, pp. 17-18; see -295 PO
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`Reply, pp. 6-7. Contrary to Patent Owner’s assertion, this excerpt simply reflects
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`the known fact that some triglycerides in the krill feed would be associated with
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`other constituents found in the feed. Thus, these triglycerides would not be soluble
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`in 100% CO2, and therefore could not be extracted using the process conditions of
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`the initial extraction described in Example 18 (e.g., pure CO2 at 300 bar and 40ºC).
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`Instead, a POSITA would have recognized that even after an initial CO2 extraction,
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`a second CO2-ethanol extraction would remove additional triglycerides and
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`phospholipids from the first extracted feed. Tallon Reply/Opp. (Exhibit 1086), ¶¶
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`72-84; see, e.g., Tanaka II (Exhibit 1015).
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`The statements Patent Owner culls from Catchpole actually confirm what
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`was known in the art; supercritical extraction processes can be readily adjusted
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`based on the amount of neutral lipids desired in the resulting extract. See, e.g.,
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`Tanaka II (Exhibit 1015); Tallon Reply/Opp. (Exhibit 1086), ¶¶ 289-300.
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`12
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`Inter Partes Review Case No.: IPR2018-01179
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`D. Krill Oil Having 100 mg/kg to 700 mg/kg Astaxanthin
`Esters Is Expressly Disclosed in the Prior Art
`Replacing “greater than about 100 mg/kg” with “from” 100, 200, 300 and
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`400 mg/kg to 700 mg/kg astaxanthin esters, Patent Owner offers the same
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`unpersuasive argument made in IPR2018-00295. Compare MTA, pp. 19-22 with
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`IPR2018-00295, Motion to Amend (Paper 16) (“-295 MTA”, Exhibit 1131), pp.
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`17-20. Rejecting this argument, the Board concluded that Randolph describes
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`compositions having about 300 mg to about 3000 mg krill oil having at least 158
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`mg/kg of astaxanthin esters. -295 FWD, pp. 67-68; Tallon Reply/Opp. (Exhibit
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`1086), ¶¶ 300-311; Tallon Decl. (Exhibit 1006), ¶ 278.
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`Sampalis II also describes krill oil having at least 20 mg/100 ml (i.e., 200
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`mg/kg astaxanthin and 190 mg/kg astaxanthin esters), a fact confirmed by Patent
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`Owner’s expert. Exhibit 1013, 30:1-7; Exhibit 1128, 207:13-209:9.
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`Neptune’s NKO product was available in different commercial formulations.
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`Tallon Reply/Opp. (Exhibit 1086), ¶ 320. Table 16 of the ‘453 patent reports that a
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`particular NKO product necessarily contained 472 mg/kg astaxanthin esters.
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`Exhibit 1001, 27:50-59; see Tallon Reply/Opp. (Exhibit 1086), ¶¶ 302-304. In
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`fact, Patent Owner admitted that this specific NKO product, with 472 mg/kg
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`astaxanthin esters, was the “closest prior art.” Exhibit 1002, p. 36; Exhibit 1004,
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`p. 34; Exhibit 1005, p. 36. Patent Owner’s admission regarding this specific NKO
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`formulation can be relied upon to find the substitute claims obvious:
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`We see no reason why [patentee’s] representations in
`their [specification] should not be accepted at face value
`as admissions that . . . may be considered ‘prior art’ for
`any purpose, including use as evidence of obviousness
`under § 103. . . .
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`In re Nomiya, 509 F.2d 566, 570-71 (CCPA 1975); see, e.g., Pharmastem
`
`Therapeutics v. Viacell, 491 F.3d 1342, 1362 (Fed. Cir. 2007)
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`Patent Owner urges that the prior art taught away from astaxanthin ester
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`levels of 100-700 mg/kg because higher levels of astaxanthin provide enhanced
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`antioxidant properties. MTA, pp. 21-22. This argument is unavailing as there
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`were many reasons to increase or decease the astaxanthin level. Tallon Reply/Opp.
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`(Exhibit 1086), ¶¶ 317-319. Further, disclosure of a preferred or optimal amount is
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`not “teaching away.” See Galderma Labs. v. Tolmor, Inc., 737 F.3d 731, 739 (Fed.
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`Cir. 2013) (“teaching that a composition may be optimal” does not teach away).
`
`E. A POSITA Would Have Combined The Conventional
`Krill Processing Techniques Of The Cited References
`To Obtain The Recited Polar Krill Oil
`Patent Owner proffers two meritless arguments attempting to demonstrate
`
`that a POSITA would not have combined the cited references. MTA, pp. 22-24.
`
`First, Patent Owner avers that a POSITA would not have combined
`
`“selective” extraction techniques such as Catchpole and Breivik II with a “non-
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`U.S. Patent No. 9,375,453
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`selective” extraction technique such as Bottino II to arrive at a process to obtain
`
`krill oil having the ranges recited in the substitute claims. MTA, p. 22.
`
`Patent Owner’s narrative that conventional extraction techniques can be
`
`categorized as either “selective” or “non-selective” is contrived. Contrary to the
`
`distinction Patent Owner wishes to draw, all extraction techniques are selective.
`
`Tallon Reply/Opp. (Exhibit 1086), ¶¶ 20, 105-110. Even Patent Owner’s expert
`
`conceded he was unaware of any references drawing the distinction Patent Owner
`
`proposes, and acknowledged that it is what the process does that actually matters.
`
`Exhibit 1128, 19:21-20:24, 25:5-19. The substitute claims simply recite
`
`conventional treatment and extraction techniques that result in an almost limitless
`
`number of krill oils having broad ranges of components naturally present in krill
`
`(e.g., 5-8% ether phospholipids, 27-50% non-ether phospholipids, 20-50%
`
`triglycerides and 100-700 mg/kg of astaxanthin esters). The use and modification
`
`of these known techniques based on the teachings in the prior art would be within
`
`the purview of a POSITA. Tallon Reply/Opp. (Exhibit 1086), ¶¶ 108-115, 288-
`
`300. To support this argument Patent Owner curiously relies upon its “no
`
`triglycerides” and “dilution” arguments to mistakenly assert that “a POSITA would
`
`not combine the references to arrive at the claimed method of producing krill oil.”
`
`MTA, p. 22. However, the Board concluded previously that Patent Owner’s “no
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`triglycerides” and “dilution” arguments lack merit. -295 FWD, pp. 35-39; see
`
`supra, pp. 9-12.
`
`Second, Patent Owner urges that PAF concerns would have “discouraged” a
`
`POSITA from using krill oil with the levels of ether phospholipids recited in the
`
`substitute claims. MTA, pp. 23-24; see -295 MTA, pp. 14-17. On three prior
`
`occasions, Patent Owner made the same “PAF teaching away” argument, and on
`
`each occasion, the argument was rejected by the Board. See, e.g., -295 FWD, pp.
`
`38-47; -746 FWD, pp. 53-61; -745 FWD, pp. 29-38. Patent Owner should be
`
`estopped from revisiting its “PAF teaching away” argument. Ohio Willow Wood
`
`Co. v. Alps South, LLC, 735 F.3d 1333, 1342-43 (Fed. Cir. 2013).
`
`The two PAF references expressly cited by Patent Owner, Tanaka I and
`
`Blank are not new to the Board. MTA, p. 23; see, e.g., -295 FWD, pp. 25-26, 44.
`
`Tanaka I states the identified foodstuffs, including krill, are only “potential
`
`sources of compounds with high PAF-like activity,” and “[t]he occurrence of
`
`PAF-like lipids in some stored foods is still speculative and requires further
`
`investigation.” Exhibit 1014, pp. 0001, 0005 (emphasis added); Tallon
`
`Reply/Opp. (Exhibit 1086), ¶¶ 138-140, 148-152. Tanaka’s speculation and call
`
`for “further investigation” does not teach away from krill oil having 5-8% ether
`
`phospholipids. Hoffmann La Roche, Inc. v. Apotex Inc., 748 F.3d 1326, 1330-31
`
`(Fed. Cir. 2014) (“speculation did not amount to an affirmative teaching away”).
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`Blank relates to dietary diacylphospholipids, not krill ether phospholipids.
`
`See, e.g., -295 FWD, pp. 25. In fact Blank was unable to draw any conclusion
`
`regarding the formation of PAF. Exhibit 2009, pp. 5-6 (“the production of, and
`
`subsequent biological responses induced by PAF, in humans are presently
`
`unknown”); see Tallon Reply/Opp. (Exhibit 1086), ¶¶ 160-163.
`
`Each of the remaining “PAF teaching away” references cited by Dr. Hoem,
`
`Exhibit 2001, ¶ 93, are also not new to the Board and fare no better. For example,
`
`Prescott teaches that ether phospholipids having longer acyl groups, such as those
`
`present in krill and krill oil, would not exhibit PAF activity. Exhibit 2008, p. 13;
`
`see-295 FWD, pp. 43-45, 47; -746 FWD, pp. 57-58; -745 FWD. pp. 34-36, 38.
`
`Zierenberg (Exhibit 2008) relates to diacylphosphatidylacholine which is not an
`
`ether phospholipid. Tallon Reply/Opp. (Exhibit 1086), ¶ 159; see -295 FWD, pp.
`
`44-45. Hartvigsen (Exhibit 2010) describes only the peroxidation of diacylglycerol
`
`ethers (“DAGE”) which is also not an ether phospholipid. Tallon Reply/Opp.
`
`(Exhibit 1086) ¶¶ 167-168; see -295 FWD, pp. 24-25. Lastly, Marathe focuses on
`
`short-chained C4 analogs and homologs, and “actually teaches that the ether
`
`phospholipids in krill oil would not act like PAF molecules.” -295 FWD, pp. 45;
`
`Exhibit 1094, pp. 0001, 0007; see Tallon Reply/Opp. (Exhibit 1086), ¶¶ 130-132.
`
`“Commercial realities” conclusively demonstrate that Patent Owner’s PAF
`
`concerns were baseless. See, e.g., -295 FWD, p. 46-47; -746 FWD, pp. 60-61;
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`-745 FWD, pp. 26-37. For example, Neptune’s commercial NKO krill oil product
`
`contained levels of ether phospholipids that Dr. Hoem testified were “high” or
`
`“substantial,” and that would have purportedly raised PAF concerns. Exhibit 1090,
`
`58:10-20; 54:16-55:10. Yet Patent Owner’s GRAS Notice relied on the use and
`
`administration of NKO to represent that its own “high phospholipid krill oil” was
`
`safe, and stated that Sampalis I (Exhibit 1012) “suggest[s] that krill oil softgels
`
`were well tolerated,” and that Bunea (Exhibit 1020) reported “no adverse affects.”
`
`Exhibit 1089, pp. 0019-0020; see Tallon Reply/Opp., ¶¶ 170-173, 207-211.
`
`III. SUBSTITUTE CLAIMS 75-84 WOULD HAVE BEEN OBVIOUS
`Yoshitomi, Randolph, Sampalis II and NKO in combination with the
`
`Grounds and analysis that renders claims 33, 37-38 and 40-43 unpatentable also
`
`applies to substitute claims 75-77 and 79-82; that renders claim 39 unpatentable
`
`applies to claim 78; that renders claim 44 based also applies to claim 83; and that
`
`renders claim 45 unpatentable also applies to claim 84. Tallon Reply/Opp.
`
`(Exhibit 1086), ¶¶ 237- 348; see Petition, pp. 32-89.
`
`A. Yoshitomi, Catchpole, Bottino II, Sampalis I, Randolph, Sampalis
`II and NKO Render Claims 75-77 and 79-82 Obvious
`Yoshitomi describes a process to grind, cook and dry fresh krill to obtain a
`
`denatured krill product having al the components found in krill. See supra, pp. 6-
`
`8; Exhibit 1033, ¶¶ 0037, 0049; see Tallon Decl. (Exhibit 1006), ¶¶ 357-366;
`
`Tallon Reply/Opp. (Exhibit 1086), ¶¶ 22-24, 252-259. Yoshitomi also teaches that
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`krill should be chopped or ground “to improve thermal efficiency” of the
`
`subsequent cooking and drying steps. Exhibit 1033, ¶¶ 0032, 0037.
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`Catchpole states that it is an object of the invention to provide a method of
`
`producing a product that contains desirable levels of particular phospholipids.
`
`Exhibit 1009, p. 0003, lines 27-29. “Catchpole specifically teaches a preference
`
`for compositions containing greater than 5% by weight acylalkyphospholipids.”
`
`-295 FWD, p. 49; see Tallon Reply/Opp. (Exhibit 1086), ¶¶ 97-101. Catchpole
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`Example 18 describes a method to extract a polar krill oil having least 4.8% ether
`
`phospholipids, 45.1% total phospholipids and 40.3% non-ether phospholipids.
`
`Exhibit 1009, p. 0024; Tallon Decl. (Exhibit 1006), ¶¶ 222-225. Catchpole also
`
`discloses that varying extraction conditions influences the amount of material
`
`extracted and the purity of the resulting extract. Exhibit 1009, p. 0011, lines 11-18,
`
`p. 0012, lines 1-3; see Ta
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