Trials@uspto.gov
`Tel: 571-272-7822
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`
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`Paper 22
`Entered: March 24, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AKER BIOMARINE AS
`Petitioner
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`_______________
`
`Case IPR2014-00003
`Patent 8,278,351 B2
`_______________
`
`
`Before LORA M. GREEN, JACQUELINE WRIGHT BONILLA, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`Case IPR2014-00003
`Patent 8,278,351 B2
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`I. INTRODUCTION
`Aker Biomarine AS (“Aker”) filed a Petition to institute an inter partes review
`of claims 1-94 (Paper 6; “Pet.”) of U. S. Pat. No. 8,278,351 B2 (Ex. 1001; “the ’351
`patent”). Neptune Technologies and Bioressources, Inc. (“Neptune”) filed a patent
`owner Preliminary Response. Paper 16 (“Prelim. Resp.”). On January 30, 2014,
`the Parties filed a Joint Motion to Limit Petition under 37 C.F.R. § 42.71, which
`requested limiting the Petition to claims 1-6, 9, 12, 13, 19-29, 32, 35, 36, and 42-46
`of the ’351 patent. Paper 18. The Joint Motion to Limit Petition was granted.
`Paper 21. Accordingly, this proceeding is limited to the aforementioned claims.
`We have jurisdiction under 35 U.S.C. § 6. The standard for instituting an
`inter partes review is set forth in 35 U.S.C. § 314(a), which states:
`THRESHOLD.—The Director may not authorize an inter
`partes review to be instituted unless the Director
`determines that the information presented in the petition
`filed under section 311 and any response filed under
`section 313 shows that there is a reasonable likelihood
`that the petitioner would prevail with respect to at least 1
`of the claims challenged in the petition.
`Upon consideration of the above-mentioned Petition and Preliminary
`Response, we conclude that Aker has established that there is a reasonable
`likelihood that it will prevail with respect to at least one of the challenged claims.
`We grant the Petition and institute an inter partes review as to claims 1-6, 9, 12,
`13, 19-29, 32, 35, 36, and 42-46.
`
`A. The ’351 Patent (Ex. 1001)
`
`The ’351 patent relates to phospholipids and compositions containing the
`phospholipids. The ’351 patent discloses a phospholipid including two fatty acids
`chains of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA)
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`simultanneously. TThe generaal formula ffor the phoospholipid
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`is:
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`TThe phosphholipids aree derived ffrom naturaal marine oor aquatic ssources. IdId. at
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`B. Illusstrative Claaims
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`CClaims 1 annd 24 are thhe only inddependent
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`ms, nged claimclaims of tthe challen
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`a phoospholipid of the genneral formuula (I),
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` 3
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`and are reproduceed below:
`1
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`. A krill exxtract compprising:
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`whereinn X represeents a moieety normally found inn a phosphholipid. Id.. at col. 2,
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`l. 46
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`to col. 33, l. 2.
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`col. 1, ll. 19-22. KKrill is desscribed as tthe preferreed source oof the disc
`losed
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`Antarctic OOcean (Eupuphasia
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`phosphoolipids, whhich includdes krill fouund in the
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`superbaa) and in thhe Pacific OOcean (Eupphasia paccifica). Id.. at col. 15
`The
`, ll. 8-21.
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`contain 400%
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`’351 paatent descriibes the preeparation oof krill extrracts that ppreferably
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`weight pper weightt (w/w) phoospholipidd. Id. at coll. 15, ll. 422-45. Polyyunsaturateed
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`fatty aciids, in partticular omeega-3 fattyy acids, preeferably maake up at leeast 15% ww/w
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`of the tootal lipids iin the extraact. Id. at
`col. 16, ll.
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` 47-51. D
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`ocosahexaaenoic acidd
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`(DHA) or eicosappentaenoic acid (EPAA) may accoount for at t least 32%% w/w of thhe
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`total lippid content of the extrract. Id. att col. 16, lll. 51-54
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`wherrein R1 andd R2, eachh together wwith the reespective ccarboxyl
`esents a
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`groups to wwhich eacch is attachhed, each
`independ
`ently repr
`or an e
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`docosahexaaenoic acid (DHA)
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`eicosapentaanoic acidd (EPA)
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`H2CH2NHH3, —CH2CCH2N(CH3
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`eesidue, andd X is —C
`)3, or
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`gdr
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` and wherein the extractt is suitablee for humaan consummption.
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`24. AA capsule,
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`a krill extraact comprissing:
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`tablet, solution, syruup, or susppension commprising
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`a phosphholipid of thhe general formula (II),
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`wherrein R1 andd R2, eachh together wwith the reespective ccarboxyl
`esents a
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`groups to wwhich eacch is attachhed, each
`independ
`ently repr
`or an e
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`docosahexaaenoic acid (DHA)
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`eicosapentaanoic acidd (EPA)
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`H2CH2NHH3, —CH2CCH2N(CH3
`
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`eesidue, andd X is —C
`)3, or
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`gdr
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`and wwherein thee extract iss suitable ffor human
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`CClaims 2-6,, 9, 12, 13, and 19-233 depend frrom claim
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`1, either ddirectly or
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`indirecttly. Claimss 25-29, 322, 35, 36, aand 42-46 ddepend froom claim 224, either
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`directlyy or indirecctly.
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`consumptiion.
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`C. The PPrior Art aand Supporting Evideence
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`Aker relies on the folllowing prioor art:
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`Beaudoin ett al., WO 000/23546, ppublished
`
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`““Beaudoinn I”).
`
`A B(
`
` B(
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`
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`Beaudoin ett al., CA 2,251,265, ppublished
`
`
`
`
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`““Beaudoinn II”).
`
`
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`April 27, 22000 (Ex.
`
`1002)
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`
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`April 21, 22000 (Ex.
`
`1003)
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`Maruyama et al., JP HH2-215351
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`
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`
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`““Maruyamma”).
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`
`
`, publishedd August 228, 1990 (EEx. 1004)
`
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` M(
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`Marine
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`
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`Fujita, Reseearch & Deevelopmennt for Proceessing and d Usage of
`
`
`
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`
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`Products—CCompreheensive Repoort, Chapteer 6, Fisherries Agenccy Researcch
`
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`Departmentt, Library oof the Min
`
`istry of Aggriculture,
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`Forestry, aand Fisheriies
`
`
`
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`MMarch 19885) (Ex. 10005) (“Fujitta”).
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`
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`Fricke et al., Lipid, Stterol and FFatty Acid CCompositiion of Antaarctic Krilll,
`
`
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`9(11) LIPID
`
`
`DS 821-8277 (1984) (EEx. 1006)
`(“Fricke”)
`.
`
` FPD(
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` F1 R(
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`Rogozhin eet al., CA 1,098,900, issued Aprril 7, 1981
`
`
`
`
`
`
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`““Rogozhinn”).
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`
`
`(Ex. 10088)
`
` L
`
`eparation,
`Lipid Biochhemical Pr
`LD Berge
`
`
`
`lson (ed.),
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`
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`Elsevier/NNorth-Hollland
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`Case IPR2014-00003
`Patent 8,278,351 B2
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`Biomedical Press (1980) (Ex. 1017) (“Bergelson”).
`
`Final Prospectus dated May 11, 2001, Neptune Technologies &
`Bioressources Inc. (Ex. 1011) (“Final Prospectus”).
`
`“Neptune Technologies & Bioressources Soon to Obtain a Major
`Patent in Over 30 Countries” (Ex. 1012) (“2001 Press Release”).
`
`Watanabe et al., Effective Components in Cuttlefish Meal and Raw Krill for
`Improvement of Quality of Red Seabream Pagrus major Eggs, 57(4) NIPPON
`SUISAN GAKKAISHI 681-694 (1991) (Ex. 1039) (“Watanabe”).
`
`Itano, Refrigerated Food Co., Ltd., Bio & High Technology Announcement
`and Natural Astaxanthin & Krill Lecithin, pp. 1-16 (on or before December
`28, 1994) (Ex. 1009) (“Itano”).
`
`Yasawa et al., JP H8-231391, published September 10, 1996 (Ex. 1015)
`(“Yasawa”).
`
`Bulletin of the World Health Organization, “WHO News and activities,”
`73(4):547-551 (1995) (Ex. 1018) (“the WHO Bulletin”).
`
`Aker further relies on declarations from the following witnesses: Drs. Van
`Breemen (“Van Breemen” Ex. 1040); Brenna (“Brenna” Ex. 1042); Storrø
`(“Storrø” Ex. 1046); Budge (“Budge” Ex. 1041); Welch (“Welch” Ex. 1043);
`Moore (“Moore” Ex. 1044); Lee (“Lee” Ex. 1045); Haugsgjerd (“Haugsgjerd” Ex.
`1047, Ex. 1048, and Ex. 1080); and Gundersen (“Gundersen” Ex. 1049 and Ex.
`1050).
`
`D. The Asserted Grounds
`
`Aker challenges claims 1-6, 9, 12-13, 19-29, 32, 35-36, and 42-46 of the
`’351 patent on the following grounds under 35 U.S.C. § 102(b) and § 103(a). Pet.
`15-59 and Paper 18.
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`Case IPR2014-00003
`Patent 8,278,351 B2
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`
`Reference[s]
`
`Beaudoin I
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`Beaudoin II
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`Maruyama
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`Fujita
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`Fricke
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`Rogozhin
`
`Beaudoin I and Bergelson
`Beaudoin I, the Final
`Prospectus, 2001 Press
`Release, and Bergelson
`Fujita, Watanabe, Itano, and
`Yasawa
`Fricke, Bergelson, Yasawa,
`Itano, the WHO Bulletin
`
`
`
`Basis
`
`§ 102(b)
`
`§ 102(b)
`
`§ 102(b)
`
`§ 102(b)
`
`§ 102(b)
`
`§ 102(b)
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`§ 103(a)
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`§ 103(a)
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`§ 103(a)
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`§ 103(a)
`
`Claims challenged
`1-6, 9, 12, 13, 19-29, 32,
`35, 36, and 42-46
`1-6, 9, 12, 13, 19-29, 32,
`35, 36, and 42-46
`1-6, 9, 12, 13, 19-29, 32,
`35, 36, and 42-46
`1-6, 9, 12, 13, 19-29, 32,
`35, 36, and 42-46
`1-6, 9, 19-29, 32, and 42-46
`
`1, 19-21, 24, and 42-44
`1-6, 9, 12, 13, 19-29, 32,
`35, 36, and 42-46
`1-6, 9, 12, 13, 19-29, 32,
`35, 36, and 42-46
`1-6, 9, 12, 13, 19-29, 32,
`35, 36, and 42-46
`1-6, 9, 12, 13, 19-29, 32,
`35, 36, and 42-46
`
`A. Claim Interpretation
`
`II. DISCUSSION
`
`Consistent with the statute and legislative history of the America Invents Act
`(AIA), the Board interprets claims using the “broadest reasonable construction
`in light of the specification of the patent in which [they] appear[].” 37 C.F.R.
`§ 42.100(b); see also Office Patent Trial Practice Guide, 77 Fed. Reg. 48756,
`48766 (Aug. 14, 2012).
`Under the broadest reasonable construction standard, claim terms are given
`their ordinary and customary meaning, as would be understood by one of ordinary
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`skill in the art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d
`1249, 1257 (Fed. Cir. 2007). “Absent claim language carrying a narrow meaning,
`the PTO should only limit the claim based on the specification . . . when [it]
`expressly disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320, 1325
`(Fed. Cir. 2004). “Although an inventor is indeed free to define the specific terms
`used to describe his or her invention, this must be done with reasonable clarity,
`deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Aker contends that the claim terms take on the ordinary and customary
`meaning that the terms would have to one of ordinary skill in the art. Pet. 8.
`Neptune does not appear to dispute this contention. See generally Prelim. Resp.
`We generally agree that, for purposes of this decision, claim terms are given
`their plain and ordinary meaning in the context of the specification. We note,
`however, that the specification of the ’351 patent, at col. 21, line 61-63, expressly
`defines the term “about,” where it discloses that “in the claims, where the term
`‘about’ is used with a numerical value, the numerical value may vary by at least ±
`50%.” Ex. 1001, 21:61-63. In other words, unless a claim otherwise recites that
`“about” has a specific value (see, e.g., claim 2, reciting “about 40% w/w, wherein
`about represents ± 10%”), the term “about” means that the numerical value just
`after the term “about” may vary by ± 50% (see, e.g., claim 5 reciting “about 5%
`w/w”).
`
`B. Asserted Grounds of Unpatentability
`
`1. Anticipation of Claims 1, 3-6, 9, 12, 13, 19-24, 26-29, 32, 35, 36, and
`42-46 by Beaudoin I (Ex. 1002)
`
`a. Summary of Beaudoin I
`
`Beaudoin I relates to the extraction of lipid fractions from marine and
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`aquatic animals such as krill. Ex. 1002, 1, ll. 5-6. Lipids are extracted from
`freshly collected marine and aquatic material with a ketone, such as acetone. Id. at
`4, ll. 29-30. Beaudoin I discloses that krill lipid fractions have various uses,
`including medical and nutritional applications. Id. at 1, ll. 11-26.
`Beaudoin I provides a description of the general extraction method used to
`prepare extracts from marine and aquatic animal material. Ex. 1002, 5, l. 21 to 6, l.
`20. Beaudoin I discloses that the starting material is subjected to acetone
`extraction, under inert atmosphere, and at a temperature of about 5° C or less, for
`at about two hours, and preferably overnight. Id.
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`TTable 19 off Beaudoinn I is reprodduced beloow.
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`Id. at 288. Table 19 providess the suggeested proceedure and ooptimal connditions foor
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`lipid extraction off aquatic annimal tissuues.
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`BBeaudoin I discloses tthe preparaation of kriill oil usingg various ssolvents. IId. at
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`8, ll. 4-119; see also, Id. at 233, ll. 39-55
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` (Table 122). The chaaracteristiccs of certainn
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`lipid fraactions of tthe krill oill were anallyzed. Thee krill oil ffractions wwere heatedd to
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`about 1225° C for aabout 15 mminutes to rremove traaces of solvvents. Id. aat 10, ll. 6--20.
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`TThe inventoor of Beauddion I, Dr. Adrien Beeaudoin, inngested lip
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`id fractionns of
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`krill, and disclosed that no side effect profile was observed. Id. at 12, ll. 13-14.
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`b. Analysis
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`(1) Claims 1 and 24
`
`Aker argues that Beaudoin I discloses lipid extracts from krill. Pet. 18.
`Beaudoin I does not identify the lipid composition of the krill extracts.
`Nonetheless, Aker contends that the krill extracts of Beaudoin I would inherently
`contain the phospholipids in claim 1 because the E. pacifica krill used to produce
`the Beaudoin I extract is a naturally occurring source of krill identified in the ’351
`patent. Id. at 11-12. In addition, Aker argues that the claimed and Beaudoin I
`products are produced by identical or substantially identical processes. Id. at 12,
`citing Storrø, Ex. 1046, ¶ 7, Brenna, Ex. 1042, ¶ 63 (presenting a line-by-line
`comparison of the ‘351 patent and Beaudoin I extraction processes). Aker
`contends that if the claimed and prior art products are identical or substantially
`identical in structure or composition, or are produced by identical or substantially
`identical processes, a prima facie case of either anticipation or obviousness has
`been established. Id. (citing In re Best, 562 F.2d 1252, 1255 (CCPA 1977)).
`Aker further relies on extensive declaration evidence related to the
`reproduction and testing of the Beaudoin I extracts to establish that the Beaudoin I
`krill extracts contained the claimed phospholipids. Pet. 11, citing van Breemen
`(Ex. 1040), Budge (Ex. 1041), Haugsgjerd (Ex. 1080), and Gundersen (Ex. 1050).
`The van Breemen Declaration, in particular, provides mass spectrometry evidence
`that the E. pacifica acetone extracts contained PC-EPA/EPA, PC-DHA/DHA, and
`PC-EPA-DHA. Ex. 1040, ¶¶ 73-85, 93-98.
`With regard to suitability for human consumption, Aker contends that Dr.
`Beaudoin demonstrated that the Beaudoin I krill extracts are suitable for human
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`consumption by consuming the disclosed extracts himself. Pet. 19.
`Neptune contends that Beaudoin I does not distinguish between different
`sources of omega-3 fatty acids, and does not recognize the special quality of krill
`omega-3 fatty acids that render them particular useful in, for example, medical
`uses. Prelim. Resp. 4-6. This argument is unpersuasive, as it fails to consider that
`the recognition of useful properties is not a patentable feature for known
`compositions. See e.g., Titanium Metals Corp. of Am. v. Banner, 778 F.2d 775,
`782 (Fed. Cir. 1985) (“Congress has not seen fit to permit the patenting of an old
`[composition], known to others . . ., by one who has discovered its . . . useful
`properties.”). Claims 1 and 24 are directed to a compositions and not any
`particular method of use. Beaudoin I expressly discloses a krill extract containing
`omega-3 fatty acids. Ex. 1002, 24-25. In addition, evidence cited by Aker tends to
`show that Beaudoin I inherently disclosed the claimed phospholipid, as discussed
`above.
`Neptune further contends that Beaudoin I discloses heating extracts to 125°C
`for 15 minutes in order to remove solvents, and that this heating step would cause
`substantial hydrolysis, oxidation, and/or degradation of unstable bioactive
`components. Prelim. Resp. 8-12, citing Ex. 1002, 7, ll. 18-19 and 10, ll. 19-20.
`This argument is unpersuasive, as it fails to consider that Beaudoin I expressly
`discloses a general extraction method (Ex. 1002, 5, ll. 22-28), as well as an optimal
`extraction method (id. at 11, ll. 6-7 and 28 (Table 19)), which do not contain
`heating steps. While Beaudoin I performed a heating step in conjunction with
`compositional analysis of the extracts, that method differed from methods used to
`prepare the krill extracts in the first instance, before any preparation of the sample
`for analysis.
`Neptune argues that the samples produced by Dr. Budge and Dr. Haugsgjerd
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`are flawed recreations of the Beaudoin I extracts. Specifically, Neptune contends
`that Dr. Budge and Dr. Haugsgjerd failed to adequately heat the samples according
`to the methods disclosed by Beaudoin I. Prelim. Resp. 12-17. This argument also
`is unpersuasive, as it do not consider that Beaudoin I expressly discloses a general
`extraction method and an optimal extraction method that do not require a heating
`step. The adequacy of the heating step in the preparation of test samples is,
`therefore, not relevant to the analysis of whether or not the Beaudoin I extracts
`prepared by either the disclosed general extraction method or optimal extraction
`method inherently comprise the claimed phospholipids.
`Finally, Neptune contends that Beaudoin I does not disclose an extract
`“suitable for human consumption” because, inter alia, Beaudoin I acknowledges
`solvent removal as an unresolved challenge in the art, and because U.S. FDA
`certification recognizing a krill product as Generally Recognized as Safe (GRAS)
`would require very low levels of residual solvent and water. Id. at 18-20. This
`argument is unpersuasive because the specification of the ’351 patent, as well as
`the ordinary meaning of claim terms, do not support narrowly interpreting the
`recited phrase “suitable for human consumption” to require FDA certification.
`Further, Beaudoin I expressly discloses that the krill extracts were purified by
`standard techniques, such as filtration and evaporation (Ex 1002, 6, ll. 4-13 and 28
`(Table 19), and consumed by a human (id. at 12, ll. 13-14).
`We conclude that the evidence presented by Aker tends to demonstrate that
`the E. pacifica krill extract disclosed in Beaudoin I comprised at least one
`phospholipid defined by the general formula of claim 1 under the principles of
`inherency as explained by Aker. Pet. 12. Thus, after considering both the Petition
`and the Preliminary Response, we conclude that there is a reasonable likelihood
`that Aker will prevail in demonstrating unpatentability of claims 1 and 24 as
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`anticipated by Beaudoin I.
`
`(2) Claims 3 and 26
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`Dependent claims 3 and 26 require the claimed extract or solution to have a
`total phospholipid concentration in an amount of about 45% w/w, wherein about
`represents ±20%. Aker contends that Beaudoin I discloses a krill oil containing
`54.1 ±6.1% phospholipids, which falls within the ranges recited in the claims. Ex.
`1002, 23 (Table 14). In view of the evidence presented by Aker, we conclude that
`there is a reasonable likelihood that Aker will prevail in demonstrating
`unpatentability of claims 3 and 26 as anticipated by Beaudoin I.
`
`(3) Claims 4, 5, 27, and 28
`
`Dependent claims 4 and 27 require the claimed extract or solution to have an
`additional lipid, such as a free fatty acid. Dependent claims 5 and 28 require a
`concentration of free fatty acids of about 5% w/w of the lipids in the extract. Aker
`contends that the Beaudoin I extracts contained free fatty acids at a concentration
`of 23.7 ±1.1%. Pet. 20, citing Ex. 1002, 23 (Table 14). Aker further contends that
`23.7 ±1.1% is within the range of “about 5%” as defined in the ‘351 patent. Id.;
`see also Ex. 1001, col. 21, ll. 62-64. As noted above, unless the claim requires
`otherwise, the term “about” term refers to ± 50%. Claims 4 and 27 do not define
`the term “about,” and, therefore, “about 5%” encompasses 23.7 ±1.1%.
`In view of the evidence presented by Aker, we conclude that there is a
`reasonable likelihood that Aker will prevail in demonstrating unpatentability of
`claims 4, 5, 27, and 28 as anticipated by Beaudoin I.
`
`(4) Claims 6, 9, 29, and 32
`
`Dependent claims 6 and 29 require the claimed extract or solution to have
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`polyunsaturated fatty acids (PUFAs) at a concentration of at least 15% w/w.
`Dependent claims 9 and 32 require the PUFAs to be omega-3 fatty acids. Aker
`contends that the Beaudoin I extracts contain 54.4% PUFAs. Pet. 21, citing Ex.
`1002, 23-24 (Table 15). In view of the meaning of the term “about,” as discussed
`above, as well as evidence presented by Aker, we conclude that there is a
`reasonable likelihood that Aker will prevail in demonstrating unpatentability of
`claims 6, 9, 29, and 32 for anticipation by Beaudoin I.
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`(5) Claims 12, 13, 35 and 36
`
`Dependent claims 12 and 35 require the claimed extract or solution to
`comprise a metal. Dependent claims 13 and 36 require the metal to be zinc,
`selenium, or a mixture thereof. Aker relies on testimony from Drs. Budge and Lee
`to demonstrate that E. pacifica extracts inherently contain metal such as zinc. Pet.
`21. Dr. Budge prepared acetone extractions of E. pacifica and sent the samples to
`Dr. Lee of Chemir Analytical Services. Ex. 1041, ¶¶ 7-10. Dr. Lee confirmed the
`presence of zinc in the unheated sample of E. pacifica extract. Ex. 1045, Exhibit A
`(Sample “S6,” corresponding to sample “SB2 8/19/2013 BEA-P0” prepared by Dr.
`Budge (Ex. 1041)).
`In view of evidence presented by Aker, we conclude that there is a
`reasonable likelihood that Aker will prevail in demonstrating unpatentability of
`claims 12, 13, 35, and 36 as anticipated by Beaudoin I.
`
`(6) Claims 19, 20, 21, 42, 43, and 44
`
`Dependent claims 19, 20, 21, 42, 43, and 44 require the claimed extract to
`have PC-EPA/DHA (claims 19 and 42), PC-EPA/EPA (claims 20 and 43), and PC-
`DHA/DHA (claims 21 and 44). Aker relies on testimony from Drs. Haugsgjerd
`and van Breemen to demonstrate that E. pacifica extracts inherently contain the
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`recited EPA and DHA species. Pet. 22. Dr. Haugsgjerd prepared acetone
`extractions of E. pacifica and sent the samples to Dr. van Breemen, of the
`University of Illinois, for analytical analysis. Ex. 1048, ¶¶ 2-3. Aker contends that
`Dr. van Breemen detected the presence of all of the species (PC-EPA/EPA, PC-
`DHA/DHA, and PC-EPA-DHA) in the tested E. pacifica extracts. Pet. 22; Ex.
`1040, ¶¶ 57, 73, and 93.
`In view of evidence presented by Aker, we conclude that there is a
`reasonable likelihood that Aker will prevail in demonstrating unpatentability of
`claims 19, 20, 21, 42, 43, and 44 as anticipated by Beaudoin I.
`
`(7) Claims 22, 23, 45, and 46
`
`Dependent claims 22, 23, 45, and 46 require the claimed extract to have an
`antioxidant such as astaxanthin. Aker indicates that Beaudoin I expressly discloses
`that the extracts described in that reference contain astaxanthin. Pet. 22; citing Ex.
`1002, 27 (Table 18).
`In view of the evidence presented by Aker, we conclude that there is a
`reasonable likelihood that Aker will prevail in demonstrating unpatentability of
`claims 22, 23, 45, and 46 as anticipated by Beaudoin I.
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`2. Anticipation of Claim 2 and 25
`
`Dependent claims 2 and 25 require the claimed extract or solution to
`comprise a total phospholipid concentration in an amount of about 40% w/w,
`wherein “about represents ±10%.” For the following reasons, we are not
`persuaded that there is a reasonable likelihood that Aker would prevail at trial with
`respect to claims 2 and 25 of the ’351 patent, based on anticipation by any one of
`Beaudoin I, Beaudoin II, Maruyama, Fujita, or Fricke.
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`a. Beaudoin I (Ex. 1002)
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`Aker contends that Beaudoin I’s disclosure of krill oil containing 54.1
`±6.1% phospholipids (Ex. 1002, Table 14, p. 23) falls within the claimed ranges.
`Pet. 20. We are not persuaded. Aker fails to explain adequately how the range
`disclosed by Beaudoin I fell within a range defined as about 40% w/w, wherein
`about represents ±10%, i.e., from 30% to 50%. While it is possible that 54.1
`±6.1% included 48% to 50%, which would have fallen within the recited range,
`Aker does not persuade us adequately, with argument or evidence, that the amount
`disclosed in Table 14 of Beaudoin I necessarily included such an amount.
`MEHL/Biophile Int'l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)
`(“Inherency . . . may not be established by probabilities or possibilities. The mere
`fact that a certain thing may result from a given set of circumstances is not
`sufficient.”).
`Aker further contends that Neptune’s expert, Dr. Yeboah, has explained that
`the Beaudoin I extracts tested by Dr. White contain about 40% phospholipids. Pet.
`20 (citing Ex. 1054, ¶ 36). Dr. Yeboah, however, makes no such statement in the
`cited paragraph. Rather, in the passage relied on by Aker, Dr. Yeboah relies on
`general teachings in the scientific literature that discuss the phospholipid content of
`oil extracted from E. superba, which is not the same species of krill examined in
`Beaudoin I. Ex. 1054, n. 7. Accordingly, we do not consider the statement of Dr.
`Yeboah to be material to the phospholipid concentration of the krill oil
`compositions disclosed by Beaudoin I.
`In view of the above, we arenot persuaded that there is a reasonable
`likelihood that Aker would prevail at trial with respect to claims 2 and 25 of the
`‘351 patent based on anticipation by Beaudoin I.
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`b. Beaudoin II (Ex. 1003)
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`Aker contends that Beaudoin II anticipates claims 2 and 25, and relies on
`Beaudoin I as evidence that the krill oil inherently contains 54.1 ±6.1%
`phospholipids. Pet. 25. For the same reasons discussed above, we are not
`persuaded by this contention because Aker fails to explain adequately how the
`range disclosed by Beaudoin I necessarily falls within a range defined as about
`40% w/w, wherein about represents ±10%.
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`c. Maruyama (Ex. 1004)
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`Aker contends that some of the extracts disclosed in Maruyama would have
`contained about 40% w/w phospholipids within the meaning of claims 2 and 25.
`Pet. 31, citing Ex. 1004, 327 (Table 1). Table 1 of Maruyama, however, discloses
`the lipid composition of dried krill, not the lipid composition of a krill extract or
`solution. Aker does not explain adequately, for example, why one with ordinary
`skill in the art would have understood a krill extract to have the same % w/w
`phospholipids as dried krill raw material discussed in Table 1 of Maruyama. We
`are, therefore, not persuaded by Aker that Maruyama necessarily discloses a krill
`extract according to claims 2 and 25.
`We are also not persuaded by the corresponding declaration testimony of Dr.
`Brenna. Pet. 31, citing Ex. 1042, ¶ 253. In the declaration, Dr. Brenna states:
`Maruyama discloses a krill extract that inherently has a total
`phospholipid concentration in an amount of about 40%, as recited in
`claim 2 of the ’351 patent. See Ex. 1004 at p. 327, Table 1.
`
`Ex. 1042, ¶ 253. Dr. Brenna’s testimony is conclusory, as it does not explain why
`one with ordinary skill in the art would have understood Table 1 of Maruyama,
`relating to dried krill raw material, to disclose an extract having a total
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`phospholipid concentration in an amount of about 40% w/w, wherein about
`represents ±10%.
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`d. Fujita (Ex. 1005)
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`Aker contends that Fujita discloses hexane, hexane-ethanol, and hexane
`once-through extracts containing from 41% to 71% polar lipids. Pet. 37, citing Ex.
`1005, 284-286 (Tables 4-6). Aker, however, does not explain adequately why one
`with ordinary skill in the art would have understood that an extract having 41% to
`71% polar lipids would necessarily equate to having a total phospholipid
`concentration in an amount of about 40% w/w, wherein about represents ±10%.
`We are, therefore, not persuaded by Aker that Fujita necessarily discloses a krill
`extract according to claims 2 and 25.
`We are also not persuaded by the corresponding declaration testimony of Dr.
`Brenna. Pet. 37, citing Ex. 1042, ¶ 309. In the declaration, Dr. Brenna states:
`The Fujita Reference discloses a krill extract that has a total
`phospholipid concentration in an amount of about 40% w/w, wherein
`about represents ±10%, as recited in claim 2 of the ‘351 patent. See,
`Ex. 1005 at pp. 284-286, Tables 4-6.
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`Ex. 1042, ¶ 309. Dr. Brenna’s testimony does not explain why one with ordinary
`skill in the art would have understood Tables 4-6 of Fujita to disclose an extract
`having a total phospholipid concentration in an amount of about 40% w/w, wherein
`about represents ±10%, and is thus conclusory.
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`e. Fricke (Ex. 1006)
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`We are not persuaded by Aker that Fricke necessarily discloses a relevant
`extract that “is suitable for human consumption,” as recited in independent claims
`1 and 24, upon which claims 2 and 25 depend, respectively. Aker contends that
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`Fricke discloses removing the solvent from the extracts, thereby rendering the
`extracts suitable for human consumption. Pet. 41, citing Ex. 1006, 821. Aker
`relies on declaration testimony of Dr. Brenna as support for this position. Id.,
`citing Ex. 1042. In the declaration, Dr. Brenna states:
`The Fricke Article discloses a krill extract that is suitable for human
`consumption. See, e.g.: “Krill samples of 5 kg were quick-frozen and
`stored at -35 C until analyzed. Subsamples prepared from the core of
`the 5 kg samples were homogenized in a mortar under liquid nitrogen,
`and lipid extraction was performed according to Folch et al. (15).
`Lipids were dissolved in dichloromethane: methanol 1:1 (v/v) and
`stored under a nitrogen atmosphere at -23 C.” See Fricke at p. 821. It
`follows from the passage above that those performing the analyses
`described in the Fricke Article necessarily evaporated the solvents
`used for extraction before conducting such analyses – leaving behind
`an extract suitable for human consumption.
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`Ex. 1042, ¶ 281.
`Dr. Brenna’s testimony, however, is conclusory because it does not explain
`why one of ordinary skill in the art would have understood the solvents to have
`necessarily evaporated. Rather, based on the information presented by Aker, it
`appears that Fricke discloses extracts dissolved in dichloromethane and methanol.
`The evidence on this record favors a conclusion that the presence of chloroform
`and methanol rendered Fricke’s extracts potentially toxic and unsuitable for human
`consumption. Prelim. Resp. 33-34, citing Ex. 2013; Ex. 2014; Ex. 1002, 3; Ex.
`1017, 3.
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`. Obvioussness of Cllaims 1-6, 99, 12-13, 119-29, 32, 335, 36, andd 42-46 Ovver
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`the Commbination oof Fricke (EEx. 1006),
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`(Ex.10155), Itano (EEx. 1009), and the WWHO Bulle
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`a. Suummary off Fricke
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`reparation
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`FFricke disclloses the p
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`superbaa). Ex. 10006, 821. TTable 1 of FFricke is reeproduced
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`of lipid exxtractions ffrom Antarrctic krill ((E.
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`Id. at 8222 (Table 11). Table 11 disclosess the total llipid contennt and the
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`Id.
`rch 1981.
`and Ma
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`compossition data of two krilll samples obtain fromm krill cauught in Deccember 19777
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`TTable 6 of FFricke is reeproduced below.
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`Id. at 8226 (Table 66). Table 66 disclosess the fatty aacid positioonal analy
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`phosphaatidylcholiine (PC) annd phosphaatidylethannolamine (PPE) detecteed in the
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`Decembber 1977 EE. superba sample. Idd.
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`b. Annalysis
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`(1) Claimms 1, 19, 200, 21, 24, 442, 43, andd 44
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`solutions ffrom E.
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`AAker contennds that Frricke disclooses lipid eextracts or
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`superbaa, an Antarrctic krill. Pet. 39-41, citing Exx. 1006, 8221-822 andd Table 1.
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`Aker fuurther conteends that FFricke speccifically teaaches that kkrill phosppholipids hhave
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`positions oof PC. Id.
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