Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`
` Paper: 34
` Date: January 13, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`RIMFROST AS,
`Petitioner,
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS,
`Patent Owner.
`____________
`
`IPR2018-01178
`Patent 9,375,453 B2
`____________
`
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`JUDGMENT
`
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`Denying Patent Owner’s Motion to Amend
`35 U.S.C. § 318(a)
`
`
`RIMFROST EXHIBIT 1157 Page 0001
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`

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`IPR2018-01178
`Patent 9,375,453 B2
`
`
` INTRODUCTION
`This is a Final Written Decision in an inter partes review challenging
`the patentability of claims 1–32 (“the challenged claims”) of U.S. Patent No.
`9,375,453 B2 (“the ’453 patent,” Ex. 1001). We have jurisdiction under
`35 U.S.C. § 6, and enter this Decision pursuant to 35 U.S.C. § 318(a) and
`37 C.F.R. § 42.73. For the reasons set forth below, we determine that
`Rimfrost AS (“Petitioner”) has shown, by a preponderance of the evidence,
`that the challenged claims are unpatentable. See 35 U.S.C. § 316(e) (2012).
`Additionally, we deny the contingent Motion to Amend filed by Aker
`Biomarine Antarctic AS (“Patent Owner”).
`Procedural History
`A.
`Petitioner filed a Petition for an inter partes review of the challenged
`claims under 35 U.S.C. § 311. Paper 2 (“Pet.”). Petitioner supported the
`Petition with the Declaration of Stephen J. Tallon, Ph.D. (Ex. 1006). Patent
`Owner declined to file a Preliminary Response to the Petition.
`On January 14, 2019, pursuant to 35 U.S.C. § 314(a), we instituted
`trial to determine whether any challenged claim of the ’453 patent is
`unpatentable based on the grounds raised in the Petition:
`
`
`
`
`
`
`2
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`IPR2018-01178
`Patent 9,375,453 B2
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`
`Claim(s) Challenged 35 U.S.C. § References
`1–3, 5–10, 12, 14–17,
`103(a)
`Breivik II1, Catchpole2, Bottino II3,
`19–20, 23–26, 28, 30–
`Sampalis I4
`32
`4
`
`103(a)
`
`Breivik II, Catchpole, Bottino II,
`Sampalis I, Sampalis II5
`Breivik II, Catchpole, Bottino II,
`Sampalis I, Fricke6
`Breivik II, Catchpole, Bottino II,
`Sampalis I, Randolph7
`
`11, 18, 21, 27
`
`13, 22, 29
`
`103(a)
`
`103(a)
`
`Paper 7 (“Institution Decision” or “Inst. Dec.”).
`Patent Owner filed a Patent Owner Response to the Petition. Paper 12
`(“PO Resp.”). Patent Owner supported the Response with the Declaration of
`Nils Hoem, Ph.D. Ex. 2001. Petitioner filed a Reply to the Patent Owner
`
`
`
` 1
`
` Breivik, WO 2008/060163 A1, published May 22, 2008 (“Breivik II”)
`(Ex. 1037).
`2 Catchpole, WO 2007/123424 A1, published Nov. 1, 2007 (“Catchpole)
`(Ex. 1009).
`3 Bottino, Lipid Composition of Two Species of Antarctic Krill: Euphausia
`superba and E. crystallorophias, 50B COMP. BIOCHEM. PHYSIOL. 479–484
`(1975) (“Bottino II”) (Ex. 1038).
`4 Sampalis et al., Evaluation of the Effects of Neptune Krill Oil™ on the
`Management of Premenstrual Syndrome and Dysmenorrhea, 8(2) ALT.
`MED. REV. 171–179 (2003) (“Sampalis I”) (Ex. 1012).
`5 Sampalis, WO 03/011873 A2, published Feb. 13, 2003 (“Sampalis II”)
`(Ex. 1013).
`6 Fricke et al., Lipid, Sterol and Fatty Acid Composition of Antarctic Krill
`(Euphausia superba Dana), 19(11) LIPIDS 821–827 (1984) (“Fricke”)
`(Ex. 1010).
`7 Randolph, US 2005/0058728 A1, published Mar. 17, 2005 (“Randolph”)
`(Ex. 1011).
`
`
`
`3
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`IPR2018-01178
`Patent 9,375,453 B2
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`Response. Paper 18 (“Pet. Reply”). Patent Owner filed a Sur-Reply to
`Petitioner’s Reply. Paper 22 (“PO Sur-Reply”).
`Patent Owner filed a Contingent Motion to Amend. Paper 11
`(“MTA”). Patent Owner supports the motion with the Reply Declaration of
`Nils Hoem, Ph.D. Ex. 2025. Petitioner filed an Opposition to the motion.
`Paper 19 (“MTA Opp.”). Petitioner supports the Opposition to the motion
`with the Reply and Opposition Declaration of Stephen J. Tallon, Ph.D.
`Ex. 1086. Patent Owner filed a Reply to Petitioner’s Opposition to the
`Motion to Amend. Paper 21 (“MTA Reply”). Petitioner filed a Sur-Reply
`to Patent Owner’s Reply to Opposition to Motion to Amend. Paper 30
`(“MTA Sur-Reply”).
`On October 16, 2019, the parties presented arguments at an oral
`hearing. Paper 31. The hearing transcript has been entered in the record.
`Paper 33 (“Tr.”).
`
`Real Parties in Interest
`B.
`Petitioner identifies its real parties in interest as Olympic Holding AS,
`Emerald Fisheries AS, Rimfrost USA, LLC, Rimfrost New Zealand Limited,
`Bioriginal Food and Science Corp., and Petitioner, Rimfrost AS. Pet. 1.
`Additionally, Petitioner asserts that, based upon a majority ownership
`interest in those entities, and in an abundance of caution, it also names Stig
`Remøy, SRR Invest AS, Rimfrost Holding AS, and Omega Protein
`Corporation as real parties in interest. Id. at 2. Patent Owner identifies its
`real party in interest as Aker BioMarine Antarctic AS. Paper 4, 1.
`Related Matters
`C.
`Petitioner and Patent Owner provide notice that two related patents,
`U.S. Patent Nos. 9,028,877 B2 (“the ’877 patent”) and 9,078,905 B2 (“the
`
`
`
`
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`IPR2018-01178
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`’905 patent”), have been asserted in Aker Biomarine Antarctic AS v. Olympic
`Holding AS, Case No. 1:16-CV-00035-LPS-CJB (D. Del.) (stayed). Pet. 2;
`Paper 4, 1. The parties note that the ’453 patent was asserted, along with
`related patents, including U.S. Patent No. 9,320,765 B2 (“the ’765 patent”),
`in In the Matter of Certain Krill Oil Products and Krill Meal for Production
`of Krill Oil Products, Investigation No. 337-TA-1019 (USITC). Pet. 2;
`Paper 4, 1. According to the parties, that matter has been “effectively
`terminated.” Pet. 2; Paper 4, 1.
`The Board has issued Final Written Decisions addressing challenges
`to claims of: (a) the ’877 patent (IPR2017-00746, Paper 23, claims 1–19
`shown to be unpatentable; IPR2017-00748, Paper 23, claims 1–19 not
`shown to be unpatentable); (b) the ’905 patent (IPR2017-00745, Paper 24,
`claims 1–20 shown to be unpatentable; IPR2017-00747, Paper 24, claims 1–
`20 not shown to be unpatentable); and (c) the ’765 patent (IPR2018-00295,
`Paper 35, claims 1–48 shown to be unpatentable). The Federal Circuit has
`affirmed the Board’s determination that the challenged claims of the ’877
`patent and ’905 patent would have been obvious based upon the grounds set
`forth in IPR2017-00746 and IPR2017-00745, respectively. Aker Biomarine
`Antarctic AS v. Rimfrost AS, 786 F. App’x 251 (Fed. Cir. Oct. 3, 2019).
`Petitioner has challenged, and we have instituted inter partes review
`of, claims 33–61 of the ’453 patent in IPR2018-01179.
`The ’453 Patent
`D.
`The ’453 patent describes extracts from Antarctic krill that include
`bioactive fatty acids. Ex. 1001, 1:19–20. The Specification states that the
`patent “discloses novel krill oil compositions characterized by containing
`
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`IPR2018-01178
`Patent 9,375,453 B2
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`high levels of astaxanthin, phospholipids, includ[ing] enriched quantities of
`ether phospholipids, and omega-3 fatty acids.” Id. at 9:28–31.
`The ’453 patent explains that “[k]rill oil compositions have been
`described as being effective for decreasing cholesterol, inhibiting platelet
`adhesion, inhibiting artery plaque formation, preventing hypertension,
`controlling arthritis symptoms, preventing skin cancer, enhancing
`transdermal transport, reducing the symptoms of premenstrual symptoms or
`controlling blood glucose levels in a patient.” Ex. 1001, 1:46–52. In
`addition, the ’453 patent recognizes that krill oil compositions, including
`compositions having up to 60% w/w phospholipid content and as much as
`35% w/w EPA/DHA content, were known in the art prior to the time of
`invention. Id. at 1:52–57. The ’453 patent also indicates that supercritical
`fluid extraction with solvent modifier was known to be a useful method for
`extracting marine phospholipids from salmon roe. Id. at 1:65–67.
`According to the ’453 patent, the solvent extraction methods used in
`the prior art to isolate krill oil from the krill “rely on the processing of frozen
`krill that are transported from the Southern Ocean to the processing site,”
`which transportation is expensive and may result in the degradation of the
`krill starting material. Id. at 2:3‒6. Such methods have included steps of
`placing the material into a ketone solvent, such as acetone, to extract the
`lipid soluble fraction, and recovering the soluble lipid fraction from the solid
`contents using a solvent such as ethanol. Id. at 1:32‒40. To overcome the
`above limitations, the ’453 patent discloses “methods for processing freshly
`caught krill at the site of capture and preferably on board a ship.” Id. at
`10:18‒20.
`
`
`
`
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`IPR2018-01178
`Patent 9,375,453 B2
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`
`The ’453 patent describes producing krill oil by first subjecting the
`krill to a protein denaturation step to avoid the formation of enzymatically
`decomposed oil constituents. Id. at 9:44‒50. The Specification explains that
`the invention is “not limited to any particular method of protein
`denaturation. In some embodiments, the denaturation is accomplished by
`application of chemicals, heat, or combinations thereof.” Id. at 10:26‒31.
`The Specification describes an embodiment wherein the krill oil is
`subsequently extracted using, e.g., a polar solvent and use of supercritical
`carbon dioxide. Id. at 9:51‒54.
`In Example 7 of the ’453 patent, “[k]rill lipids were extracted from
`krill meal (a food grade powder) using supercritical fluid extraction with
`co-solvent.” Id. at 31:45‒46.
`Initially, 300 bar pressure, 333°K and 5% ethanol
`(ethanol:CO2, w/w) were utilized for 60 minutes in order to
`remove neutral lipids and astaxanthin from the krill meal. Next,
`the ethanol content was increased to 23% and the extraction was
`maintained for 3 hours and 40 minutes. The extract was then
`evaporated using a falling film evaporator and the resulting krill
`oil was finally filtered.
`Id. at 31:47‒53.
`Example 8 of the ’453 patent prepared krill oil using the same method
`described in Example 7, from the same krill meal used in that example.
`Ex. 1001, 32:16‒17. The krill oil was then analyzed using 31P NMR
`analysis to identify and quantify the phospholipids in the oil. Id. at 32:17‒
`19. Table 228 shows the phospholipid profiles for the raw material, the final
`
`
`
` 8
`
` A reference in Example 8 of the ’453 patent to “table 25” (Ex. 1001, 32:45)
`appears to be a typographical error, as the Specification does not include a
`
`7
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`IPR2018-01178
`Patent 9,375,453 B2
`
`product, and a commercially available krill oil, Neptune Krill Oil (“NKO”).
`Id. at 32:44‒47. Table 22 is reproduced below:
`
`
`
`Id. at 32:53‒33:15.
`The ’453 patent teaches that the “main polar ether lipids of the krill
`meal are alkylacylphosphatidylcholine (AAPC) at 7–9% of total polar lipids,
`lyso-alkylacylphosphatidylcholine (LAAPC) at 1% of total polar lipids
`(TPL) and alkylacylphosphatidyl-ethanolamine (AAPE) at <1% of TPL.”
`Id. at 32:47–52.
`
`Illustrative Claim
`E.
`Of the challenged claims, claim 1, reproduced below, is the only
`independent claim and is illustrative of the claimed subject matter.
`
`
`
`Table 25. We understand that reference to “table 25” to instead mean
`“Table 22,” which sets forth the relevant phospholipid profiles.
`
`8
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`IPR2018-01178
`Patent 9,375,453 B2
`
`
`1. A method of production of polar krill oil from Euphausia
`superba comprising:
`a) treating the Euphasia superba to denature lipases and
`phospholipases to provide a denatured krill product;
`b) contacting the denatured krill product with a polar solvent to
`extract a polar krill oil comprising phospholipids, said polar krill
`oil comprises greater than about 3% ether phospholipids w/w of
`said polar krill oil; from about 27% to 50% non-ether
`phospholipids w/w of said polar krill oil so that the amount of
`total phospholipids is from about 30% to 60% w/w of said polar
`krill oil; from about 20% to 50% triglycerides w/w of said polar
`krill oil, and astaxanthin esters in amount greater than about 100
`mg/kg of said polar krill oil; and
`c) formulating said polar krill oil with a carrier for oral
`consumption.
`Ex. 1001, 35:43–58.
`
`
` PATENTABILITY ANALYSIS
`Principles of Law
`A.
`To prevail in its challenges to the patentability of all claims of the
`’453 patent, Petitioner must demonstrate by a preponderance of the evidence
`that the claims are unpatentable. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d)
`(2017). “In an [inter partes review], the petitioner has the burden from the
`onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic Inc. v. Avid. Tech., Inc., 815 F.3d 1356, 1363
`(Fed. Cir. 2016); see also 35 U.S.C. § 312(a)(3) (requiring inter partes
`review petitions to identify “with particularity . . . the evidence that supports
`the grounds for the challenge to each claim”). That burden of persuasion
`never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics,
`Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015); see also In re Magnum Oil Tools
`
`
`
`
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`Int’l, Ltd., 829 F.3d 1364, 1375–78 (Fed. Cir. 2016) (discussing the burden
`of proof in inter partes review).
`A claim is unpatentable for obviousness if, to one of ordinary skill in
`the pertinent art, “the differences between the subject matter sought to be
`patented and the prior art are such that the subject matter as a whole would
`have been obvious at the time the invention was made.” 35 U.S.C. § 103(a)
`(2006); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007).
`The question of obviousness is resolved on the basis of underlying factual
`determinations including the scope and content of the prior art, any
`differences between the claimed subject matter and the prior art, the level of
`ordinary skill in the art, and objective evidence of nonobviousness. Graham
`v. John Deere Co., 383 U.S. 1, 17–18 (1966). A petitioner cannot satisfy its
`burden of proving obviousness by employing “mere conclusory statements.”
`Magnum Oil, 829 F.3d at 1380. Moreover, a decision on the ground of
`obviousness must include “articulated reasoning with some rational
`underpinning to support the legal conclusion of obviousness.” KSR, 550
`U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
`“An obviousness determination requires finding both ‘that a skilled
`artisan would have been motivated to combine the teachings of the prior art
`references to achieve the claimed invention, and that the skilled artisan
`would have had a reasonable expectation of success in doing so.’” CRFD
`Research, Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (quoting
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367–
`1368 (Fed. Cir. 2016)). “The reasonable expectation of success requirement
`refers to the likelihood of success in combining references to meet the
`limitations of the claimed invention.” Intelligent Bio-Sys., Inc., 821 F.3d at
`
`
`
`
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`IPR2018-01178
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`1367. A reasonable expectation of success “does not require absolute
`predictability of success . . . all that is required is a reasonable expectation
`of success.” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (quoting In
`re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988)).).
`We analyze Petitioner’s asserted grounds of unpatentability in
`accordance with the above-stated principles.
`
`
`Level of Ordinary Skill in the Art
`B.
`We consider the asserted grounds of unpatentability in view of the
`understanding of a person of ordinary skill in the art, and thus we begin by
`addressing the level of ordinary skill in the art. The level of skill in the art is
`a factual determination that provides a primary guarantee of objectivity in an
`obviousness analysis. Al-Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324
`(Fed. Cir. 1999) (citing Graham v. John Deere Co., 383 U.S. 1, 17–18
`(1966); Ryko Mfg. Co. v. Nu-Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)).
`According to Petitioner, a person of ordinary skill in the art at the time
`of the invention would have
`held an advanced degree in marine sciences, biochemistry,
`organic (especially lipid) chemistry, chemical or process
`engineering, or associated sciences with complementary
`understanding, either through education or experience, of
`organic chemistry and in particular lipid chemistry, chemical or
`process engineering, marine biology, nutrition, or associated
`sciences; and knowledge of or experience in the field of
`extraction. In addition, a POSITA would have had at least five
`years applied experience.
`Pet. 6 (citing Ex. 1006 ¶¶ 30–31).
`At institution, we preliminarily adopted Petitioner’s definition of an
`ordinarily skilled artisan, and determined that the prior art itself was
`
`
`
`
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`IPR2018-01178
`Patent 9,375,453 B2
`
`sufficient to demonstrate the level of ordinary skill in the art at the time of
`the invention. Inst. Dec. 9. We note that Patent Owner states that it “accepts
`[Petitioner’s] definition of a POSITA.” PO Resp. 16. Accordingly, for this
`Decision, we adopt Petitioner’s definition, while maintaining that the prior
`art demonstrates the appropriate level of ordinary skill in the art. See
`Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art,
`itself, can reflect appropriate level of ordinary skill in art).
`Moreover, we have reviewed the credentials of Drs. Tallon and Hoem,
`and consider each of them to be qualified to provide their opinion on the
`level of skill and the knowledge of a person of ordinary skill in the art at the
`time of the invention.
`
`Claim Construction
`C.
`Having defined the ordinarily skilled artisan, we now turn to claim
`construction. For petitions filed before November 13, 2018—as here—the
`Board interprets claims in an unexpired patent using the “broadest
`reasonable construction in light of the specification of the patent.” 37 C.F.R.
`§ 42.100(b) (2017);9 Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
`2144–46 (2016). Under that standard, we presume that a claim term carries
`its “ordinary and customary meaning,” which “is the meaning that the term
`would have to a person of ordinary skill in the art in question” at the time of
`
`
`
` 9
`
` The amendment to this rule does not apply here because the Petition was
`filed before November 13, 2018. See Changes to the Claim Construction
`Standard for Interpreting Claims in Trial Proceedings Before the Patent Trial
`and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (amending
`37 C.F.R. § 42.100(b) effective November 13, 2018).
`
`
`
`
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`IPR2018-01178
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`the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007) (citation omitted). We need not explicitly interpret every claim term
`for which the parties propose a construction. See 35 U.S.C. § 314(a); Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)
`(“[O]nly those terms need be construed that are in controversy, and only to
`the extent necessary to resolve the controversy.”); see also Nidec Motor
`Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed.
`Cir. 2017) (applying Vivid Techs. in the context of an inter partes review).
`“greater than about 5% w/w ether phospholipids”
`Dependent claim 23 requires the polar krill oil to comprise “greater
`than about 5% w/w ether phospholipids.” Ex. 1001, 36:54–55. The parties
`offer different claim constructions for that phrase. Pet. 27–31; PO Resp. 14–
`15. Petitioner asserts that the broadest reasonable interpretation of the
`phrase “greater than about 5% w/w” is “greater than 4.5% ether
`phospholipids.” Pet. 31 (citing Ex. 1006 ¶ 158). According to Petitioner,
`the whole number values referenced in the Specification for the ether
`phospholipid content of krill oil “are accurate only to within the rounding
`values,” such that a person of ordinary skill in the art would have understood
`that “because the claimed ether phospholipid values are modified by the
`word ‘about,’ those values encompass a range extending 0.5% below the
`claimed numerical limitation, e.g., 4.5% which is rounded up to 5%.” Id. at
`30–31.
`Patent Owner notes that Petitioner’s declarant, Dr. Tallon,
`acknowledges in his declaration that the values for total phospholipids and
`ether phospholipids provided in Examples 7 and 8 of the Specification “are
`accurate to a tenth of a percent.” PO Resp. 14–15 (citing Ex. 1006 ¶ 75).
`
`
`
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`Patent Owner asserts that based on that testimony, and “applying the
`rounding rationale proposed by Petitioner, the actual rounding should be
`from the tenth of a percent. Thus, 4.95% would round up to 5.0% and be
`included in the term ‘about 5%.’” Id. at 15. Accordingly, Patent Owner
`contends that the broadest reasonable interpretation of the phrase “greater
`than about 5% w/w” is “greater than 4.95% ether phospholipids w/w of said
`krill oil.” Id. (citing Ex. 2001 ¶ 37).
`As noted by Petitioner, the Board construed the phrase “greater than
`about 5% w/w” as meaning “greater than 4.5% w/w” in a Final Written
`Decision addressing similar claims of a related patent. Pet. Reply 12.
`Specifically, in IPR2018-00295, the Board’s analysis of the claim phrase
`“greater than about 5% w/w” of krill oil in the Final Written Decision reads
`as follows:
`
`Such broadening usages as ‘about’ must be given
`reasonable scope; they must be viewed by the decision maker as
`they would be understood by persons experienced in the field of
`the invention. Although it is rarely feasible to attach a precise
`limit to ‘about,’ the usage can usually be understood in light of
`the technology embodied in the invention.” Modine Mfg. Co. v.
`U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1554 (Fed. Cir. 1996).
`After considering the parties’ arguments and reviewing the
`Specification of the ’765 patent, we conclude that Petitioner’s
`proposed construction is consistent with the intrinsic evidence.
`Although the ’765 patent does not explicitly address the issue of
`“about,” the meaning of the term can be discerned from a careful
`reading of the Specification. Example 8 of the ’765 patent reports
`the analysis of phospholipid fractions of a product of the
`invention and a commercially available Krill product. Ex. 1001,
`col. 31, l, 46–col. 32, l. 42. Table 22, reproduced above, reports
`the calculated values for the various phospholipids in values to a
`tenth of a percent. Id. at col. 32, ll. 18–38. In the discussion of
`the table, the values are rounded to the nearest whole number,
`
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`IPR2018-01178
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`
`not the nearest tenth. Id. at col. 32, ll. 11–15. This is consistent
`with the approach advanced by Petitioner.
`IPR2018-00295, Paper 35, 12.10 Similarly here, we find that although the
`Specification does not explicitly define the term “about,” its meaning may
`be discerned from the manner by which the Specification refers to reported
`values for phospholipid profiles of krill oil. Ex. 1001, 32:55–67 (Table 22).
`In the discussion of the lipids reported in Table 22, the values are rounded to
`the nearest whole number, not the nearest tenth. Id. at 32:47–52. This is
`more consistent with the approach advanced by Petitioner than by Patent
`Owner. Thus, as determined in that Final Written Decision, and for the
`reasons set forth therein, “the term ‘greater than about 5% w/w’ shall be
`construed to mean ‘greater than 4.5% w/w.’” IPR2018-00295, Paper 35, 13.
`Similarly, we construe the recitation in claim 1 requiring “greater than about
`3% ether phospholipids” as meaning “greater than 2.5% ether
`phospholipids,” and we construe the recitation in claim 14 of “greater than
`4% ether phospholipids” as meaning “greater than 3.5% phospholipids.”
`Although Petitioner and Patent Owner propose additional claim
`constructions, we determine that explicit construction of those additional
`claim terms is not necessary for purposes of this Decision.
`D. Overview of Asserted References
`Before turning to Petitioner’s asserted grounds of unpatentability, we
`provide a brief summary of the asserted references.
`
`
`
`10 Patent Owner has requested a rehearing in response to the Final Written
`Decision entered in IPR2018-00295. Id. at Paper 36. However, the
`rehearing request is limited to issues involving the denied motion to amend
`claims, and does not challenge the Board’s construction of any claim term.
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`
`Breivik II
`1.
`Breivik II “relates to a process for preparing a substantially total lipid
`fraction from fresh krill, and a process for separating phospholipids from the
`other lipids.” Ex. 1037, 1:8–10.11 According to Breivik II, approximately
`50% of the lipids in E. superba are phospholipids, and oil extracted from E.
`superba contains lower amounts of environmental pollutants than traditional
`fish oils. Id. at 1:32–33, 2:3–4. Breivik II explains that krill lipases remain
`active after the krill is dead, and, thus, krill oil may contain an undesired
`amount of free fatty acids, making it desirable to use a process that will
`provide for a low degree of hydrolysis of the krill lipids. Id. at 2:6–13.
`Breivik II teaches that its extraction process provides a substantially
`total lipid fraction from fresh krill, without using organic solvents like
`acetone. Id. at 3:29–31. That lipid fraction contains triglycerides,
`astaxanthin and phospholipids. Id. at 3:19–20. According to Breivik II, the
`process includes an optional heat pre-treatment of the krill to inactivate
`enzymatic decomposition of the lipids, ensuring a product with a low level
`of free fatty acids. Id. at 4:3–6.
`Breivik II describes an extraction process in which fresh krill is
`washed with ethanol, and the ethanol washed krill is then extracted with
`supercritical CO2 containing 10% ethanol. Id. at 7:31–8:3 (Example 2).
`Breivik II also discloses a process in which the raw material is pre-treated
`with heat at 80ºC for 5 minutes before the first wash with ethanol. Id. at
`9:5–11 (Example 6). According to Breivik II, “heat-treatment gives an
`
`
`
`11 Unless otherwise noted, the cited page numbers refer to those supplied by
`the original reference, and not the page numbers added by Petitioner.
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`increased yield of lipids compared to the same treatment with no heating.”
`Id. at 9:33–34 (emphasis omitted).
`Breivik II explains that “[a] lipid fraction or lipid product, derived
`from the process according to the invention may have some additional
`advantages related to quality compared to known krill oil products
`(produced by conventional processes), such as for instance a krill oil from
`Neptune Biotechnologies & Bioresources extracted from a Japanese krill
`source” having ≥ 40.0% total phospholipids and ≥ 1.0 mg/g esterified
`astaxanthin. Id. at 11:23–36. Breivik II states that a lipid fraction or product
`according to the invention would be expected, among other things, to
`“contain substantially less hydrolysed and/or oxidised lipids than lipid
`produced by conventional processes” and have “less deterioration of the krill
`lipid antioxidants from conventional processing.” Id. at 12:1–9 (emphasis
`omitted).
`
`Catchpole
`2.
`Catchpole discloses “a process for separating lipid materials
`containing phospholipids,” Ex. 1009, 1:5–6, in order to produce a product
`containing “desirable levels of particular phospholipids,” id. at 3:27–28.
`Catchpole states that phospholipids “have been implicated in conferring a
`number of health benefits including brain health, skin health, eczema
`treatment, anti-infection, wound healing, gut microbiota modifications, anti-
`cancer activity, alleviation of arthritis, improvement of cardiovascular
`health, and treatment of metabolic syndromes. They can also be used in
`sports nutrition.” Id. at 1:29–2:2. Catchpole further discloses that products
`having high levels of particular phospholipids “may be employed in a
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`number of applications, including infant formulas, brain health, sports
`nutrition and dermatological compositions.” Id. at 25:9–13.
`Catchpole describes, in Example 18, the fractionation of krill lipids
`from krill powder using a process that employs supercritical CO2 in a first
`extraction, and a CO2 and absolute ethanol mixture in a second. Id. at 24:1–
`16. Table 16, reproduced below, reports the phospholipid concentrations
`present in the krill oil extract obtained by Catchpole. Id. at Table 16.
`
`
`
`As shown in Table 16, the composition of Extract 2 includes 39.8%
`phosphatidylcholine (“PC”). Id. The ether phospholipids
`alkylacylphosphatidylcholine (“AAPC”) and alkylacylphosphatidyl-
`ethanolamine (“AAPE”) were also present in Extract 2, representing 4.6%
`and 0.2%, respectively, of the extracted composition. Id. In addition,
`summing each of the reported phospholipid amounts reported for Extract 2
`yields a total phospholipid concentration of 45.1%. See id.
`Bottino II
`3.
`Bottino II characterizes the lipids of two Antarctic euphausiids,
`Euphausia superba and Euphasia crystallorophias. Ex, 1038, Abstr.
`Bottino II explains, “when one refers to Antarctic krill, one generally means
`Euphausia superba, which is the most abundant and far better known
`species of krill in the Antarctic Oceans.” Id. at 479.
`Bottino II explains that the euphausiids were collected and, once on
`board the ship, the samples were rapidly sorted by hand and extracted with a
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`“chloroform:[methanol] (2:1, v/v) mixture.” Id. Fatty acid compositions
`were determined by gas-liquid chromatography. Id. at 480.
`Table 1 of Bottino II is reproduced below.
`
`
`Ex. 1038, Table 1. Table 1 discloses the fatty acid content of E. superba and
`E. crystallorophias obtained from different locations (i.e., stations) as a
`weight percent of total fatty acids. Id. at 480.
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`Table 2 of Bottino II is reproduced below.
`
`
`
`Ex. 1038, Table 2. Table 2 reports the identity and amount of each lipid
`present in the E. superba and E. crystallorophias samples analyzed as a
`weight percent of total lipids. Id. at 480–481.
`Sampalis I
`4.
`Sampalis I describes a clinical trial “[t]o evaluate the effectiveness of
`Neptune Krill OilTM (NKOTM) for the management of premenstrual
`syndrome and dysmenorrhea.” Ex. 1012, 171. Sampalis I explains that
`NKO is “extracted from Antarctic krill also known as Euphausia superba.
`Euphausia superba, a zooplankton crustacean, is rich in phospholipids and
`triglycerides carrying long-chain omega-3 polyunsaturated fatty acids,
`mainly EPA and DHA, and in various potent antioxidants including vitamins
`A and E, astaxanthin, and a novel flavonoid.” Id. at 174.
`Sampalis I discloses that each patient in the clinical trial was “asked to
`take two 1-gram soft gels of either NKO or omega-3 18:12 fish oil (fish oil
`containing 18% EPA and 12% DHA) once daily with meals during the first
`
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`month of the trial.” Id. Sampalis I reports that “[t]he final results of the
`present study suggest within a high level of confidence that Neptune Krill
`Oil can significantly reduce the physical and emotional symptoms related to
`p