Trials@uspto.gov
`571-272-7822
`
`Paper 35
`Date: March 6, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`RIMFROST AS.,
`Petitioner,
`v.
`AKER BIOMARINE ANTARCTIC AS.,
`Patent Owner.
`
`IPR2018-01730
`Patent 9,072,752 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`SCHNEIDER, 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)
`
`
`
`
`
`
`571-272-7822
`
`Paper 35
`Date: March 6, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`RIMFROST AS.,
`Petitioner,
`v.
`AKER BIOMARINE ANTARCTIC AS.,
`Patent Owner.
`
`IPR2018-01730
`Patent 9,072,752 B2
`
`
`
`
`
`
`
`
`
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`SCHNEIDER, 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)
`
`
`
`
`
`
`
`IPR2018-01730
`Patent 9,072,752 B2
`
`
`INTRODUCTION
`I.
`This is a Final Written Decision in an inter partes review challenging
`the patentability of claims 1–20 (“the challenged claims) of U.S. Patent
`9,072,752 B2 (“the ’752 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”).
`A. Procedural History
`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 March 12, 2019, pursuant to 35 U.S.C. § 314(a), we instituted trial
`to determine whether any of the challenged claims are unpatentable on the
`grounds raised in the Petition. Paper 7 (“Inst. Dec.”).
`Patent Owner filed a Patent Owner Response to the Petition. Paper 13
`(“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
`Response. Paper 18. (“Pet. Reply”). Patent Owner filed a Sur-Reply to
`Petitioner’s Reply. Paper 25 (“PO Sur-Reply”).
`Patent Owner filed a Contingent Motion to Amend. Paper 12
`(“MTA”). Patent Owner supported the motion with the Reply Declaration
`of Nils Hoem, Ph.D. Ex. 2025. Petitioner filed an Opposition to the motion.
`
`2
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`
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`IPR2018-01730
`Patent 9,072,752 B2
`Paper 19 (“MTA Opp.”). Petitioner supported 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 24 (“MTA Reply”). Petitioner filed a Sur-Reply
`to Patent Owner’s Reply to Opposition to Motion to Amend. Paper 31
`(“MTA Sur-Reply”).
`On December 9, 2019, the parties presented arguments at an oral
`hearing. Paper 30. The hearing transcript has been entered in the record.
`Paper 34 (“Tr.”).
`
`B. Real Parties in Interest
`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.
`C. Related Matters
`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
`’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 U.S. Patent No. 9,375,453 (“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
`
`3
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`IPR2018-01730
`Patent 9,072,752 B2
`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); (c) the ’765 patent (IPR2018-00295,
`Paper 35, claims 1–48 shown to be unpatentable); (d) the ’453 patent
`(IPR2018-01178, paper 34, claims 1–32 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).
`D. The ’752 Patent
`The ’752 patent, titled “Bioeffective Krill Oil Compositions” issued
`on July 7, 2015, from U.S. Patent Application No. 14/620,784 filed on
`February 12, 2015. Ex. 1001, at [54], [45], [21], [22]. The ’752 patent is a
`continuation of U.S. Patent Application No. 12/057,775, filed on March 28,
`2008. The ’752 patent claims priority to U.S. Provisional Application No.
`60/920,483 filed on March 28, 2007; U S. Provisional Application No.
`60/975,058 filed on September 25, 2007; U.S Provisional Application No.
`60/983,446, filed on October 29, 2007; and U.S. Provisional Application No.
`61/024,072, filed on January 28, 2008. Id. [60].
`The ’752 patent teaches krill oil compositions characterized by having
`“high amounts of phospholipids, astaxanthin esters and/or omega-3
`
`4
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`IPR2018-01730
`Patent 9,072,752 B2
`contents.” Ex. 1001, Abstract. According to the specification, the
`compositions disclosed in the ’752 patent are effective “in a number of areas
`such as anti-inflammation, antioxidant effects, improving insulin resistances
`and improving blood lipid profile.” Id.
`The ’752 patent acknowledges 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 at the time of the
`invention. Id. at col. 1, ll. 52–57. In addition, the ’752 patent recognizes
`that a myriad of health benefits have been attributed to krill oil in the prior
`art. For example, the ’752 patent states 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.” Id. at col. 1, ll.
`46–52.
`
`E. Illustrative Claims
`Claims 1 and 14 are illustrative of the challenged claims. Claim 1
`reads as follows:
`1. A polar krill oil comprising greater than about 40%
`phosphatidylcholine w/w of said krill oil and greater than
`about 5% ether phospholipids w/w of said krill oil.
`Ex. 1001, col. 34, ll. 65–67.
`
`5
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`IPR2018-01730
`Patent 9,072,752 B2
`Claim 14 reads as follows:
`14. A Euphausia superba krill oil comprising greater than
`about 45% phosphatidylcholine w/w of said krill oil, greater
`than about 5% ether phospholipids w/w of said krill oil, less
`than about 25% triglycerides w/w of said krill oil, at least 36%
`omega-3 fatty acids w/w of said krill oil, and astaxanthin.
`
`
`Id. at col. 36, ll. 1–11.
`
`F. Evidence
`Petitioner relies on the following references:
`Catchpole and Tallon, WO 2007/123424 A1, published Nov. 1, 2007
`(“Catchpole”) (Ex. 1009).1
`F. Sampalis, WO 03/011873 A2, published Feb. 13, 2003
`(“Sampalis”) (Ex. 1013).
`Grynbaum et al., Unambiguous detection of astaxanthin and
`astaxanthin fatty acid esters in krill (Euphausia superba Dana), 28 J. Sep.
`Sci. 1685 (2005) (“Grynbaum”) (Ex. 1039).
`Randolph et al., US 2005/0058728 A1, published Mar. 17, 2005
`(“Randolph”) (Ex. 1011).
`Enzymotec, GRAS Notice No. GRN 000226 for “Krill-based Lecithin
`in Food” and “Krill-derived lecithin”
`https://www.fda.gov/downloads/Food/Ingredients
`PackagingLabeling/GRAS/NoticeInventory/ucm263930.pdf, dated May 26,
`2007, and filed by the FDA May 29, 2007 (“Enzymotec”) (Ex. 1048).
`
`
`1 Catchpole claims priority to NZ 546681, filed April 20, 2006. Ex. 1009
`(30).
`
`6
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`IPR2018-01730
`Patent 9,072,752 B2
`
`G. Asserted Grounds
`Petitioner asserts that claims 1–20 are unpatentable on the following
`grounds:
`
`Claim(s) Challenged
`1, 5, 6, 11
`4, 7, 12, 13
`8–10
`1–3, 5, 6, 11
`14–16, 20
`
`35 U.S.C. §
`102(e)
`103(a)
`103(a)
`103(a)
`103(a)
`
`Reference(s)/Basis
`Catchpole
`Catchpole, Sampalis
`Catchpole, Grynbaum,
`Randolph
`Catchpole, Enzymotech
`Catchpole, Enzymotech,
`Sampalis
`Catchpole, Enzymotech,
`Sampalis, Grynbaum, Randolph
`
`17–19
`
`
`
`103(a)
`
`II. ANALYSIS
`A. Legal Standards
`To prevail in its challenges to the patentability of all claims of the
`’752 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
`
`7
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`IPR2018-01730
`Patent 9,072,752 B2
`Int’l, Ltd., 829 F.3d 1364, 1375–78 (Fed. Cir. 2016) (discussing the burden
`of proof in inter partes review).
`“Anticipation requires that all of the claim elements and their
`limitations are shown in a single prior art reference.” In re Skvorecz, 580
`F.3d 1262, 1266 (Fed. Cir. 2009). “[U]nless a [prior art] reference discloses
`within the four corners of the document not only all of the limitations
`claimed but also all of the limitations arranged or combined in the same way
`as recited in the claim, it cannot be said to prove prior invention of the thing
`claimed and, thus, cannot anticipate under 35 U.S.C. § 102.” Net MoneyIN,
`Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).
`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
`
`8
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`IPR2018-01730
`Patent 9,072,752 B2
`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 at1367. 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.
`B. Level of Ordinary Skill in the Art
`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,
`
`9
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`IPR2018-01730
`Patent 9,072,752 B2
`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. 6–7 (citing Ex. 1006 ¶¶ 33–34).
`At institution, we preliminarily adopted Petitioner’s definition of an
`ordinarily skilled artisan, and determined that the prior art itself was
`sufficient to demonstrate the level of ordinary skill in the art at the time of
`the invention. Inst. Dec. 8. We note that Patent Owner states that it “accepts
`[Petitioner’s] definition of a POSITA.” PO Resp. 15. 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.
`
`C. Claim Construction
`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);2 Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
`
`
`2 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
`
`10
`
`
`
`IPR2018-01730
`Patent 9,072,752 B2
`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
`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).
`1. “greater than about 5% w/w ether phospholipids”
`Claim 1 requires the polar krill oil to comprise “greater than about 5%
`w/w ether phospholipids.” Ex. 1001, 34, ll. 67–68. The parties offer
`different claim constructions for that phrase. Pet. 22–27; PO Resp. 12–14.
`Petitioner asserts that the broadest reasonable interpretation of the phrase
`“greater than about 5%” w/w is “greater than 4.5% ether phospholipids.”
`Pet. 26–27 (citing Ex. 1006 ¶¶ 166–68). According to Petitioner, the whole
`number values referenced in the Specification for the ether phospholipid
`content of krill oil “are also 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 26.
`
`
`and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (amending 37
`C.F.R. § 42.100(b) effective November 13, 2018).
`
`11
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`IPR2018-01730
`Patent 9,072,752 B2
`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. 13 (citing Ex. 1006 ¶ 72). Patent
`Owner asserts that, based on Dr. Tallon’s 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 13–14. 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 5.
`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
`
`12
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`IPR2018-01730
`Patent 9,072,752 B2
`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, not the nearest tenth. Id.
`at col. 32, ll. 11–15. This is consistent with the approach
`advanced by Petitioner.
`
` IPR2018-00295, Paper 35, 12.3
`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, 32:18–44 (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.
`2. “Greater than about 40% phosphatidylcholine”
`Applying the same analysis, we construe the term “greater than about
`40% phosphatidylcholine” to mean greater than 39.5% phosphatidylcholine.
`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.
`
`
`3 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.
`
`13
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`IPR2018-01730
`Patent 9,072,752 B2
`D. Ground 1 - Anticipation by Catchpole
`Petitioner contends that claims 1, 5, 6, and 11 are unpatentable under
`35 U.S.C. §102(e) as anticipated by Catchpole. Pet. 28–34.
`1. Catchpole4
`Catchpole discloses “a process for separating lipid materials
`containing phospholipids” (Ex. 1009, 1, ll. 5–6) in order to produce a
`product containing “desirable levels of particular phospholipids” (id. at 3, ll.
`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, l. 29–2, l. 2. Catchpole further
`discloses that products having high levels of particular phospholipids “may
`be employed in a number of applications, including infant formulas, brain
`health, sports nutrition and dermatological compositions.” Id. at 25, ll. 9–13.
`Catchpole describes products that preferably contain greater than 5%
`acylalkyphospholipids5, more preferably greater than 10%
`acylalkyphospholipids, and most preferably greater than 25%
`acylalkyphospholipids. Id. at 9, ll. 18–21.
`
`
`4 Petitioner contends that Catchpole qualifies as prior art to the ’752 patent
`pursuant to pre-AIA § 102(a) and §102(e). Pet. 8–9, n.2; Ex. 1006 ¶ 40.
`Patent Owner has not contended otherwise. See PO Resp. 15–17. For
`purposes of this decision we conclude that Catchpole is prior art under pre-
`AIA §§ 102(a) and (e).
`5 Alkylacylphospholipids and acylalkyphospholipids are also known as ether
`phospholipids. Exhibit 1006 ¶¶ 210, 212, 214.
`
`14
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`IPR2018-01730
`Patent 9,072,752 B2
`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, ll.
`1–16. Table 16, reproduced below, reports the phospholipid concentrations
`present in the krill oil extract obtained by Catchpole.
`
`
`
`As shown in Table 16 above, which reports the phospholipid concentrations
`present in the krill oil extract obtained by Catchpole, the composition of
`Extract 2 includes 39.8% phosphatidylcholine (“PC”). Id. at Table 16. The
`ether phospholipids alkylacylphosphatidylcholine (“AAPC”) and
`alkylacylphosphatidylethanolamine (“AAPE”) were also present in Extract
`2, representing 4.6% and 0.2%, respectively, of the extracted composition
`for a total of 4.8% ether phospholipids. Id.; Ex 1006 ¶¶ 145, 146.
`2. Analysis of Claims 1 and 11
`As shown above, claim 1 recites a krill oil composition comprising
`greater than about 40% phosphatidylcholine w/w of said krill oil and greater
`than about 5% ether phospholipids w/w of said krill oil. Petitioner contends
`that the krill oil composition disclosed in Table 16 of Catchpole meets these
`limitations in that Extract 2 contained 39.8% phosphatidylcholine and 4.8%
`ether phospholipids. Pet. 33–34 (citing Ex. 1009, 24, ll. 17–19). Petitioner
`contends that, as used in claim 1, the terms “about 40%” and “about 5%”
`embrace the values of 39.8% and 4.8% respectively. Id. Petitioner relies on
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`IPR2018-01730
`Patent 9,072,752 B2
`the testimony of Dr. Tallon to support this contention. Ex. 1006 ¶¶ 166–
`168.
`
`Claim 11 depends from claim 1 and adds the limitation that the krill
`oil composition is for oral administration to a human. Ex. 1001, col. 35, ll.
`25–26. Petitioner contends that the compositions of Catchpole meet this
`limitation as Catchpole discloses that compositions can be employed in baby
`food and sports nutrition. Pet. 35 (citing Ex. 1009, 25, ll. 9–13). Petitioner
`relies on the testimony of Dr. Tallon to support this contention. Ex. 1006
`¶¶ 217–218.
`Patent Owner contends that Catchpole does not anticipate claims 1
`and 11 as Catchpole does not disclose a krill oil composition having greater
`than about 5% ether phospholipids. PO Resp. 15–17. Patent Owner’s
`argument is premised on its construction of the term “greater than about 5%”
`as meaning 4.95% or greater. Id.
`As discussed above, we have declined to adopt Patent Owner’s
`construction of the term “greater than about 5%” and have construed the
`term to mean greater than 4.5%. Catchpole discloses a krill oil composition
`having 4.8% by weight ether phospholipids, which is within the range of
`“greater than about 5%.” Ex. 1009, 16, Table 16; Ex. 1002 ¶ 226.
`We also agree with Petitioner that Catchpole discloses a krill oil
`composition that contains greater than about 40% phosphatidylcholine.
`Table 16 of Catchpole, reproduced above, reports a phosphatidylcholine
`(PC) level of 39.8 %. Ex. 1009, 24. This is within the range of “greater than
`about 40%.”
`With respect to claim 11, Catchpole teaches that the compositions
`described therein can be used in infant formulas and sports nutrition.
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`IPR2018-01730
`Patent 9,072,752 B2
`Ex. 1009, 25. Thus, we agree that the compositions in Catchpole are for
`human oral consumption.
`Based on the foregoing we conclude that Petitioner has established by
`a preponderance of the evidence that claims 1 and 11 are anticipated by
`Catchpole.
`
`3. Analysis of Claims 5 and 6
`Claims 5 and 6 depend from claim 1 and recite the limitation that the
`ether phospholipid is present in amounts greater than about 6% and greater
`than about 7% respectively. Ex. 1001, col. 35, ll. 10–15. Petitioner
`contends that Catchpole anticipates these claims in that Catchpole discloses
`that the compositions can be prepared from marine animals such as Krill and
`preferably contain greater than 10% acylalkyphospholipids. Pet. 34–35
`(citing Ex. 1009, 9 and 35). Petitioner also contends that Catchpole claims
`compositions prepared from marine animals that contain greater than 5% or
`greater than 10% acylalkyphospholipids. Id. (citing Ex. 1009, 31 and 35,
`claims 40, 95 and 96). Petitioner also supports this contention with the
`testimony of Dr. Tallon. Ex. 1006 ¶¶ 213–261, 424.
`Patent Owner contends that Catchpole does not anticipate claims 5
`and 6 as Catchpole does not disclose a krill oil composition containing
`greater than about 6 or greater than about 7% ether phospholipids. PO Resp.
`17–18. Patent Owner contends that while Catchpole teaches that the
`compositions described therein may have an ether phospholipid content
`greater than 5% or greater than 10%, there is nothing in Catchpole that links
`that teaching to the krill oil compositions disclosed in Catchpole. Id.
`We have considered the arguments of the parties and the evidence of
`record and conclude that claims 5 and 6 are not anticipated by Catchpole.
`While we agree with Petitioner that Catchpole teaches compositions that can
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`IPR2018-01730
`Patent 9,072,752 B2
`contain greater than 10% acylalkyphospholipids, we do not agree that
`Catchpole discloses a krill oil composition having that amount of
`acylalkyphospholipids. Catchpole teaches a method of separating lipid
`materials from a feed material. Ex. 1009, 4. The feed material used in
`Catchpole may be derived from “terrestrial animals, marine animals,
`terrestrial plants, marine plants, or micro-organisms such as microalgae,
`yeast and bacteria. Preferably the feed material is derived from sheep, goat,
`pig, mouse, water buffalo, camel, yak, horse, donkey, llama, bovine or
`human.” Id. at 7. Catchpole does not specifically disclose a Krill extract
`that contains greater than 10% acylalkyphospholipids. The only specific
`disclosure of the acylalkyphospholipid content of krill oil is in Table 16
`discussed above, which discloses an acylalkyphospholipid content of 4.8%,
`less than the 6% and 7% recited in claims 5 and 6.
`Based on the foregoing we conclude that claims 5 and 6 are not
`anticipated by Catchpole.
`E. Ground 2 - Obviousness Based on Catchpole Combined with Sampalis
`Petitioner contends that the subject matter of claims 4, 7, 12, and 13
`would have been obvious to one of ordinary skill in the art at the time the
`invention was made over Catchpole combined with Sampalis.
`1. Sampalis
`Sampalis discloses the preparation of phospholipid compositions from
`natural marine or aquatic sources. Ex. 1013. Sampalis teaches that the
`preferred source for the phospholipid compositions is krill such as
`Euphausia superba. Id. at 25. Sampalis teaches that the phospholipid
`compositions have a phospholipid content of “at least 40% w/w, preferably
`at least 45% w/w. More preferably, the amount of phospholipid is from
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`IPR2018-01730
`Patent 9,072,752 B2
`about 45-60% w/w.” Id. at 26.6
`Sampalis teaches that the phospholipid composition may also contain
`fatty acids with omega-3 and omega-6 fatty acids preferred. Id. Sampalis
`teaches “Polyunsaturated fatty acids, in particular omega-3 fatty acids,
`preferably make up at least 15% w/w, more preferably at least 40% w/w, and
`even more preferably at least 45% w/w, of the total lipids in the extract.” Id.
`at 28.
`Sampalis teaches that the phospholipid compositions may also contain
`antioxidants such as astaxanthin. Id. at 30. Sampalis teaches that the
`phospholipid composition can be in the form of foods, beverages, energy
`bars, sports drinks, supplements and the like. Id. at 35. Sampalis teaches
`that the compositions can be in the form of a capsule. Id.
`
`2. Analysis of Claims 4, 7, 12, and 13
`Claim 4 further defines claim 1 wherein the krill oil composition
`includes at least about 36% omega-3 fatty acids by weight of the krill oil
`composition. Ex. 1001, col. 35, ll. 7–9. Petitioner relies on Sampalis as
`teaching this claim requirement, asserting that Sampalis teaches a krill oil
`composition comprising between 15% w/w and 45% w/w omega-3 fatty
`acids. Pet. 36 (Citing Ex. 1013, 30). Petitioner also asserts that a person of
`ordinary skill in the art would have had a reason to combine the omega-3-
`fatty acid levels taught in Sampalis with the krill oil disclosed in Catchpole
`because of the known significant health benefits of omega-3-fatty acids. Pet.
`39 (citing Ex. 1006 ¶¶ 93, 94, 97, and 99).
`
`
`6 Citations are to the page number of the references.
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`IPR2018-01730
`Patent 9,072,752 B2
`Claim 7 further d
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