`Tel: 571-272-7822
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`Paper 18
`Entered: July 9, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ENZYMOTEC LTD. and ENZYMOTEC USA, INC.
`Petitioner
`
`v.
`
`NEPTUNE TECHNOLOGIES & BIORESSOURCES, INC.
`Patent Owner
`____________
`
`Case IPR2014-00556
`Patent 8,278,351
`_______________
`
`
`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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`IPR2014-00556
`Patent 8,278,351
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`I. INTRODUCTION
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`Petitioners Enzymotec Ltd. and Enzymotec USA, Inc. (collectively,
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`“Enzymotec”) filed a Petition (Paper 1; “Pet.”) requesting an inter partes review of
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`claims 16, 9, 12, 13, 1929, 32, 35, 36, and 4246 of U.S. Patent No. 8,278,351
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`(“the ’351 patent”). Neptune Technologies and Bioressources, Inc. (“Neptune”)
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`filed a Patent Owner Preliminary Response. Paper 11 (“Prelim. Resp.”).
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`We have jurisdiction under 35 U.S.C. § 314. The standard for instituting an
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`inter partes review is set forth in 35 U.S.C. § 314(a), which states:
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`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.
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`Upon consideration of the above-mentioned Petition and Preliminary
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`Response, we conclude that Enzymotec has established that there is a reasonable
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`likelihood that it would prevail with respect to at least one of the challenged
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`claims. We grant the Petition and institute an inter partes review as to claims 16,
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`9, 12, 13, 1929, 32, 35, 36, and 4246.
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`A. Related Matters
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`The ’351 patent is also the subject of an inter partes review in IPR2014-
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`00003. Aker Biomarine AS (“Aker”) is the Petitioner in IPR2014-00003.
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`Enzymotec filed a Motion for Joinder (Paper 4) requesting joinder of the current
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`proceeding with IPR2014-00003. We have granted Enzymotec’s Motion for
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`Joinder in an Order decided concurrently with this Decision.
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`IPR2014-00556
`Patent 8,278,351
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`B. The ’351 Patent (Ex. 1001)
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`Phospholipids are made up of two chains of fatty acids attached to a
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`chemical backbone made up of phosphoric acid, glycerol and nitrogenous bases
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`(e.g., choline). Ex. 1001, col. 4, ll. 41–56. Phospholipids having choline as the
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`nitrogenous base are referred to as phosphatidylcholines. Id.
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`The ’351 patent relates to certain phospholipids and compositions containing
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`phospholipids. The ’351 patent discloses a phospholipid including two fatty acids
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`chains of eicosapentanoic acid (“EPA”) and docosahexanoic acid (“DHA”)
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`simultaneously. The general formula for the phospholipid is:
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`,
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`wherein X represents a moiety normally found in a phospholipid such as
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`phosphatidylcholine (PC), phosphatidylethanolamine (PE) and
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`phosphatidylinositol (PI). Id. at col. 2, l. 46 to col. 3, l. 2 and col. 21, ll. 1–25.
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`The phospholipids are derived from natural marine or aquatic sources. Id. at
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`col. 1, ll. 1922. Krill is described as the preferred source of the disclosed
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`phospholipids, which includes krill found in the Antarctic Ocean (Euphasia
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`superba) and in the Pacific Ocean (Euphasia pacifica). Id. at col. 15, ll. 821.
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`The ’351 patent describes the preparation of krill extracts that preferably contain
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`40% weight per weight (w/w) phospholipid. Id. at col. 15, ll. 4245.
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`Polyunsaturated fatty acids, in particular omega-3 fatty acids, preferably make up
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`at least 15% w/w of the total lipids in the extract. Id. at col. 16, ll. 4751. DHA or
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`EPA may account for at least 32% w/w of the total lipid content of the extract. Id.
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`at col. 16, ll. 5154
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`C. Illustrative Claims
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`Claims 1 and 24 are the only independent claims among the challenged
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`claims and are reproduced below:
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`1. A krill extract comprising:
`a phospholipid of the general formula (I),
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`
`wherein R1 and R2, each together with the respective carboxyl
`groups to which each is attached, each independently represents a
`docosahexaenoic acid (DHA) or an eicosapentanoic acid (EPA)
`residue, and X is —CH2CH2NH3, —CH2CH2N(CH3)3, or
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` and wherein the extract is suitable for human consumption.
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`24. A capsule, tablet, solution, syrup, or suspension comprising
`a krill extract comprising:
`a phospholipid of the general formula (I),
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`wherein R1 and R2, each together with the respective carboxyl
`groups to which each is attached, each independently represents a
`docosahexaenoic acid (DHA) or an eicosapentanoic acid (EPA)
`residue, and X is —CH2CH2NH3, —CH2CH2N(CH3)3, or
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`and wherein the extract is suitable for human consumption.
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`Claims 26, 9, 12, 13, and 1923 depend from claim 1, either directly or
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`indirectly. Claims 2529, 32, 35, 36, and 4246 depend from claim 24, either
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`directly or indirectly.
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`D. The Prior Art and Supporting Evidence
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`Enzymotec relies on the following prior art:
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`Beaudoin et al., WO 00/23546 A1, published April 27, 2000 (Ex. 1002)
`(“Beaudoin I”).
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`Fricke et al., Lipid, Sterol and Fatty Acid Composition of Antarctic Krill
`(Euphausia superba Dana), 19(11) LIPIDS 821827 (1984) (Ex. 1006)
`(“Fricke”).
`
`Itano Refrigerated Food Co., Ltd., Bio & High Technology Announcement
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`and Natural Astaxanthin & Krill Lecithin, pp. 116 (on or before December
`28, 1994) (Ex. 1009) (“Itano”).
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`Ichira Yasawa et al., JP H8-231391, published September 10, 1996 (Ex.
`1015) (“Yasawa”).
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`Lipid Biochemical Preparations, L. D. Bergelson (ed.), Elsevier/North-
`Holland Biomedical Press (1980) (Ex. 1017) (“Bergelson”).
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`Bulletin of the World Health Organization, “WHO News and activities,”
`73(4):547551 (1995) (Ex. 1018) (“the WHO Bulletin”).
`
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`Enzymotec further relies on declarations from the following witnesses: Drs.
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`Richard B. Van Breemen (“Van Breemen” Ex. 1040); J. Thomas Brenna
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`(“Brenna” Ex. 1042); Ivar Storrø (“Storrø” Ex. 1046); Suzanne Budge (“Budge”
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`Ex. 1041); Theodore F. Welch (“Welch” Ex. 1043); Jeff D. Moore (“Moore” Ex.
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`1044); Albert C. Lee (“Lee” Ex. 1045); Bjørn Ole Haugsgjerd (“Haugsgjerd” Ex.
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`1047, Ex. 1048, and Ex. 1080); and Thomas Gundersen (“Gundersen” Ex. 1049
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`and Ex. 1050).
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`E. The Asserted Grounds
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`Enzymotec challenges claims 16, 9, 12, 13, 1929, 32, 35, 36, and 4246
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`of the ’351 patent on the following grounds under 35 U.S.C. § 102(b) and § 103(a).
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`Pet. 1527.
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`Reference[s]
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`Beaudoin I
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`Fricke, Bergelson, Yasawa,
`Itano, the WHO Bulletin
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`Basis
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`Claims challenged
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`§ 102(b)
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`§ 103(a)
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`16, 9, 12, 13, 1929, 32,
`35, 36, and 4246
`16, 9, 12, 13, 1929, 32,
`35, 36, and 4246
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`A. Claim Interpretation
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`II. DISCUSSION
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`Consistent with the statute and legislative history of the America Invents Act
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`(“AIA”), the Board interprets claims using the “broadest reasonable construction
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`in light of the specification of the patent in which [they] appear[].” 37 C.F.R.
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`§ 42.100(b); see also Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756,
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`48,766 (Aug. 14, 2012).
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`Under the broadest reasonable construction standard, claim terms are given
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`their ordinary and customary meaning, as would be understood by one of ordinary
`
`skill in the art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d
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`1249, 1257 (Fed. Cir. 2007). “Absent claim language carrying a narrow meaning,
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`the PTO should only limit the claim based on the specification . . . when [it]
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`expressly disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320, 1325
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`(Fed. Cir. 2004). “Although an inventor is indeed free to define the specific terms
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`used to describe his or her invention, this must be done with reasonable clarity,
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`deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
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`With one exception, Enzymotec contends that the claim terms take on the
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`ordinary and customary meaning that the terms would have to one of ordinary skill
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`in the art. Pet. 9. Enzymotec sets forth what it considers the broadest reasonable
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`interpretation of the following claim terms: 1) “krill extract;” 2) “suitable for
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`human consumption;” and 3) “solution.” Id. at 910. Neptune has not disputed
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`Enzymotec’s proposed constructions of these claim terms. See generally Prelim.
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`Resp. We have considered Enzymotec’s proposed constructions, taking into
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`account the plain meaning of the terms and their usage in the specification, and
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`have concluded that determination of the issues presented in Enzymotec’s Petition
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`does not require explicit construction of these terms at this time.
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`Regarding the one exception, Enzymotec contends that the specification of
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`the ’351 patent gives special meaning to the term “about.” Id. We agree.
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`Specifically, the specification of the ’351 patent, at column 21, lines 6163,
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`expressly defines the term “about” by stating that “in the claims, where the term
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`‘about’ is used with a numerical value, the numerical value may vary by at least
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`± 50%.” Ex. 1001, 21:6163. Thus, unless a claim otherwise recites that “about”
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`has a specific value (see, e.g., claim 2, reciting “about 40% w/w, wherein about
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`represents ± 10%”), we interpret the term “about” to mean that the numerical value
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`just after the term “about” may vary by at least ± 50% (see, e.g., claim 5 reciting
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`“about 5% w/w”). For example, “about 5%” means “0% to 55%” and about
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`“about 95%” means “45% to 100%.”
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`B. Asserted Grounds of Unpatentability
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`1. Anticipation of Claims 16, 9, 12, 13, 1929, 32, 35, 36, and 4246 by
`Beaudoin I (Ex. 1002)
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`a. Summary of Beaudoin I
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`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. 56. Lipids are extracted from
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`freshly collected marine and aquatic material with a ketone, such as acetone. Id. at
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`4, ll. 2930. Beaudoin I discloses that krill lipid fractions have various uses,
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`including medical and nutritional applications. Id. at 1, ll. 1126.
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`Beaudoin I provides a description of the general extraction method used to
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`prepare extracts from marine and aquatic animal material. Ex. 1002, 5, l. 21 to 6, l.
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`20. Beaudoin I discloses that the starting material is subjected to acetone
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`extraction, under inert atmosphere, and at a temperature of about 5° C or less for
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`about two hours, and preferably overnight. Id. Table 19 of Beaudoin I is
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`reproduced below.
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`Id. at 28. Table 19 provides the suggested procedure and optimal conditions for
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`lipid extraction of aquatic animal tissues.
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`Beaudoin I discloses the preparation of krill oil using various solvents. Id. at
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`8, ll. 419; see also id. at 21, ll. 3955 (Table 12). The characteristics of certain
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`lipid fractions of the krill oil were analyzed. The krill oil fractions were heated to
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`about 125° C for about 15 minutes to remove traces of solvents. Id. at 10, ll. 620.
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`The inventor of Beaudoin I, Dr. Adrien Beaudoin, ingested lipid fractions of
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`krill, and disclosed that no side effect profile was observed. Id. at 12, ll. 1314.
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`b. Analysis
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`(1) Claims 1 and 24
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`Claims 1 and 24 are directed to a krill extract and solution, respectively,
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`containing a phospholipid of the general formula (I) that is suitable for human
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`consumption. Enzymotec argues that Beaudoin I discloses lipid extracts from krill
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`that necessarily contain the phospholipids in claim 1. Pet. 1718. While Beaudoin
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`I does not identify the lipid composition of the E. pacifica krill extracts,
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`Enzymotec relies on extensive declaration evidence, related to the reproduction
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`and testing of krill extracts made according to the disclosure of Beaudoin I, to
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`show that the E. pacifica krill extracts disclosed in Beaudoin I necessarily
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`contained the claimed phospholipids. Id. (citing van Breemen (Ex. 1040), ¶¶
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`7385 and 9398; Budge (Ex. 1041), ¶¶ 710; Haugsgjerd (Ex. 1048), ¶¶ 25).
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`The van Breemen Declaration, in particular, provides mass spectrometry evidence
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`that E. pacifica krill acetone extracts contained PC-EPA/EPA, PC-DHA/DHA, and
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`PC-EPA/DHA. Ex. 1040, ¶¶ 7385 and 9398.
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`With regard to the suitability-for-human-consumption element of claims 1
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`and 24, Enzymotec contends that Beaudoin I discloses that the extract fractions
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`were consumed with no side effect. Id. (citing Ex. 1002, 12, ll. 1314).
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`With regard to the recitation of a krill solution in claim 24, Enzymotec
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`argues that the Beaudoin I krill oil extracts are solutions encompassed by claim 24
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`as the phospholipids and other components are dissolved in the extracts. Id. (citing
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`Ex. 1042, ¶ 202).
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`We conclude that the analysis and information presented by Enzymotec
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`tends to demonstrate that the E. pacifica krill extract disclosed in Beaudoin I
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`comprised at least one phospholipid defined by the general formula of claims 1 and
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`24 and was suitable for human consumption, as required by claims 1 and 24.
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`Accordingly, we determine that there is a reasonable likelihood that Enzymotec
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`would prevail in demonstrating unpatentability of claims 1 and 24 as anticipated by
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`Beaudoin I.
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`(2) Claims 2, 3, 25, and 26
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`Dependent claims 2 and 25 require the claimed extract or solution to
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`comprise a total phospholipid concentration in an amount of about 40% w/w,
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`wherein “about represents ±10%.” Dependent claims 3 and 26 require the claimed
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`extract or solution to have a total phospholipid concentration in an amount of about
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`45% w/w, wherein about represents ±20%.
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`Enzymotec contends that Beaudoin I discloses 54.1±6.1% phospholipids and
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`polar material w/w in Fraction I extracts, which falls within or touches the claimed
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`ranges. Pet. 1819 (citing Ex. 1002, 23 (Table 14)). Beaudoin I’s description of
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`concentration percentages of “[p]hospholipids or other polar material” in Table 14,
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`however, does not disclose explicitly a total phospholipid concentration, as recited
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`in the challenged claims. Rather, Table 14 in Beaudoin I describes percentages, in
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`krill oil Fractions I and II, of material having phospholipids (at some undisclosed
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`concentration) plus “other polar material” (at some undisclosed concentration).
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`Thus, Enzymotec does not explain sufficiently in its Petition how one can ascertain
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`the total phospholipid concentration of Fraction I by looking at Table 14 or
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`elsewhere in Beaudoin I.
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`Enzymotec further directs our attention to the testimony of Neptune’s
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`declarant, Dr. Yeboah. Id. at 19. Enzymotec contends that Dr. Yeboah has
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`explained that the Beaudoin I extracts tested by Dr. White contain about 40%
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`phospholipids. Id. (citing Ex. 1054, ¶ 36). Dr. Yeboah, however, makes no such
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`statement in the cited paragraph. Rather, in the passage relied on by Enzymotec,
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`Dr. Yeboah refers to general teachings in the scientific literature that discuss the
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`phospholipid content of oil extracted from E. superba, which is not the same
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`species of krill examined in Beaudoin I. Ex. 1054, n. 7. Accordingly, we do not
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`consider the statement of Dr. Yeboah to be material to the phospholipid
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`concentration of the krill oil compositions disclosed by Beaudoin I.
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`Enzymotec also relies on declarations from Drs. Budge, Moore, and Brenna
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`to demonstrate that the E. pacifica krill extracts disclosed in Beaudoin I necessarily
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`contained the phospholipids concentrations recited in claims 2, 3, 15 and 26. Pet.
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`1819 (citing Budge (Ex. 1041), ¶ 10; Moore (Ex 1044) at Exhibit A, Table 11;
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`Brenna (Ex. 1042), ¶¶ 18081). Dr. Budge testifies that he prepared acetone
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`extracts of E. pacifica krill following the method of Beaudoin I in all relevant
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`steps, and sent the samples to Dr. Moore. Ex. 1041, 4-7 (citing Ex. 1002, 5-6 and
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`Table 19). Dr. Moore conducted compositional analysis on the samples. Ex. 1044.
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`The information presented by Enzymotec indicates that each of the E. pacifica krill
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`extracts prepared by Dr. Budge (SB1-8/19/2013-BEA-P0, SB5-8/19/2013-BEA-
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`P1, and SB9-8/19/2013-BEA-P2) and tested by Dr. Moore contained phospholipids
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`concentrations (31.02 ± 0.07 %, 31.51 ± 0.12 %, and 44.40 ± 0.48 %, respectively)
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`within the ranges recited in claims 2, 3, 25 and 26. Based on this information,
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`there is a reasonable likelihood that Enzymotec would prevail in showing that the
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`E. pacifica krill extracts disclosed in Beaudoin I inherently contain the claimed
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`total phospholipid concentrations.
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`In view of the above, we are persuaded that there is a reasonable likelihood
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`that Enzymotec would prevail in demonstrating the unpatentability of claims 2, 3,
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`25 and 26 of the ’351 patent based on anticipation by Beaudoin I.
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`(3) Claims 4, 5, 27, and 28
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`Claims 4 and 5 depend directly from claim 1. Claims 27 and 28 depend
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`directly from claim 24. Dependent claims 4 and 27 require the claimed extract or
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`solution to have an additional lipid, such as a free fatty acid. Dependent claims 5
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`and 28 require a concentration of free fatty acids of about 5% w/w of the lipids in
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`the extract. Enzymotec contends that the Beaudoin I extracts contained free fatty
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`acids at a concentration of 23.7 ±1.1% and 20.3±0.3%. Pet. 19(citing Ex. 1002, 23
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`(Table 14)). Enzymotec contends further that 23.7 ±1.1% is within the range of
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`“about 5%,” as defined in the ’351 patent. Id.; see also Ex. 1001, col. 21, ll. 62-64.
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`As noted above, unless the claim requires otherwise, the term “about” refers to at
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`least ± 50%. Claims 4 and 27 do not define the term “about,” and, therefore,
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`“about 5%” encompasses 23.7±1.1%, the concentration of free fatty acids in the
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`extracts disclosed in Beaudoin I.
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`In view of the evidence presented by Enzymotec, we conclude that there is a
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`reasonable likelihood that Enzymotec would prevail in demonstrating
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`unpatentability of claims 4, 5, 27, and 28 as anticipated by Beaudoin I.
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`(4) Claims 6, 9, 29, and 32
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`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.
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`Dependent claims 9 and 32 require the PUFAs to be omega-3 fatty acids.
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`Enzymotec contends that the Beaudoin I extracts contain 54.4% PUFAs.
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`Pet. 20 (citing Ex. 1002, 2324 (Table 15)).
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`In view of the information and argument presented by Enzymotec, we
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`conclude that there is a reasonable likelihood that Enzymotec will prevail in
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`demonstrating unpatentability of claims 6, 9, 29, and 32 for anticipation by
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`Beaudoin I.
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`(5) Claims 12, 13, 35 and 36
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`Dependent claims 12 and 35 require the claimed extract or solution to
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`comprise a metal. Dependent claims 13 and 36 require the metal to be zinc,
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`selenium, or a mixture thereof. Enzymotec relies on testimony from Drs. Brenna,
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`Budge, and Lee to demonstrate that E. pacifica extracts inherently contain metal
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`such as zinc. Pet. 20 (citing Ex. 1042, ¶¶ 191192; Ex. 1045, Exhibit A (Table 7)).
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`Dr. Lee confirmed the presence of zinc in the unheated sample of an E. pacifica
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`acetone extract prepared by Dr. Budge. Ex. 1045, Exhibit A (Sample “S6,”
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`corresponding to sample “SB2 8/19/2013 BEA-P0” prepared by Dr. Budge (Ex.
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`1041)).
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`In view of evidence presented by Enzymotec, we conclude that there is a
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`reasonable likelihood that Enzymotec would prevail in demonstrating
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`unpatentability of claims 12, 13, 35, and 36 as anticipated by Beaudoin I.
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`(6) Claims 19, 20, 21, 42, 43, and 44
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`Dependent claims 19, 20, 21, 42, 43, and 44 require the claimed extract to
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`have PC-EPA/DHA (claims 19 and 42), PC-EPA/EPA (claims 20 and 43), and PC-
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`DHA/DHA (claims 21 and 44). Enzymotec relies on testimony from Drs. Brenna,
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`Haugsgjerd, and van Breemen to demonstrate that E. pacifica extracts inherently
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`contain the recited EPA and DHA species. Pet. 20. Dr. Haugsgjerd prepared
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`acetone extractions of E. pacifica and sent the samples to Dr. van Breemen, of the
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`University of Illinois, for analysis. Ex. 1048, ¶¶ 23. Enzymotec contends that
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`Dr. van Breemen detected the presence of all of the species (PC-EPA/EPA, PC-
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`DHA/DHA, and PC-EPA-DHA) in the tested E. pacifica extracts. Pet. 20; Ex.
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`1040, ¶¶ 57, 73, 93.
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`In view of evidence presented by Enzymotec, we conclude that there is a
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`reasonable likelihood that Enzymotec would prevail in demonstrating
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`unpatentability of claims 19, 20, 21, 42, 43, and 44 as anticipated by Beaudoin I.
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`(7) Claims 22, 23, 45, and 46
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`Dependent claims 22, 23, 45, and 46 require the claimed extract to have an
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`antioxidant such as astaxanthin. Enzymotec indicates that Beaudoin I expressly
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`discloses that the extracts described in that reference contain astaxanthin. Pet. 20
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`(citing Ex. 1002, 27 (Table 18)).
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`In view of the evidence presented by Enzymotec, we conclude that there is a
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`reasonable likelihood that Enzymotec would prevail in demonstrating
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`unpatentability of claims 22, 23, 45, and 46 as anticipated by Beaudoin I.
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`2. Obviousness of Claims 16, 9, 12, 13, 1929, 32, 35, 36, and 4246
`Over the Combination of Fricke (Ex. 1006), Bergelson (Ex. 1017),
`Yasawa (Ex.1015), Itano (Ex. 1009), and the WHO Bulletin (Ex. 1018)
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`a. Summary of Fricke
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`Fricke discloses the preparation of lipid extractions from Antarctic krill (E.
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`superba). Ex. 1006, 821. Table 1 of Fricke is reproduced below.
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`Id. at 822 (Table 1). Table 1 discloses the total lipid content and the lipid
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`composition data of two krill samples obtained from krill caught in December
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`1977 and March 1981. Id.
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`Table 6 of Fricke is reproduced below.
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`Id. at 826 (Table 6). Table 6 discloses the fatty acid positional analysis in
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`phosphatidylcholine (PC) and phosphatidylethanolamine (PE) detected in the
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`December 1977 E. superba sample. Id.
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`b. Analysis
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`(1) Claims 1, 19, 20, 21, 24, 42, 43, and 44
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`Claims 1 and 24 are directed to a krill extract and solution, respectively,
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`containing a phospholipid of the general formula (I) that is suitable for human
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`consumption. Dependent claims 1921 and 4244 require the claimed extract to
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`have PC-EPA/DHA (claims 19 and 42), PC-EPA/EPA (claims 20 and 43) and PC-
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`DHA/DHA (claims 21 and 44).
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`Enzymotec contends that Fricke discloses lipid extracts or solutions from E.
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`superba, an Antarctic krill. Pet. 2225 (citing Ex. 1006, 821822, Table 1).
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`Enzymotec contends further that Fricke specifically teaches that krill phospholipids
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`have EPA (20:5 n-3 in Table 6 of Fricke) and DHA (22:6 n-3 in Table 6 of Fricke)
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`at both sn-1 and sn-2 positions of PC. Id. at 23 (citing Ex. 1006, 826 (Table 6)).
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`According to Enzymotec, Fricke prepared lipid extracts according to the Folch
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`method. Id. at 22 (citing Ex. 1006, 82122). Enzymotec contends that Le
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`Grandois (Ex. 1013) demonstrates that krill oil extracted by the Folch method
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`contains PC-EPA/EPA, PC-DHA/DHA, and PC-EPA/DHA. Id. at 23 (citing Ex.
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`1013, 6018 (Table 2)). The conclusions of Le Grandois are further supported by
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`the declaration of Dr. van Breemen, which supports a determination that PC-
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`EPA/EPA, PC-DHA/DHA, and PC-EPA/DHA are found in E. superba extracts.
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`Ex. 1040, ¶ 93.
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`With regard to suitability for human consumption, Enzymotec relies on
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`Yasawa (Ex. 1015), Itano (Ex. 1009), and the WHO Bulletin (Ex. 1018) for
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`teaching the desirability of krill phospholipid compositions for human
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`consumption. Pet. 2527. Itano, for example, describes krill extract as a
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`seasoning for food. Ex. 1009, 7. Enzymotec further contends that Bergelson (Ex.
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`1017) teaches removal of chloroform/methanol solvents from lipids by rotary
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`evaporation. Pet. 25. Thus, Enzymotec points to information tending to show that
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`a process for preparing krill extracts suitable for human consumption was known
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`in the art. Id. Enzymotec also contends that a person of ordinary skill in the art
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`would have had reason to combine the different teachings of these references
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`because together they taught methods for extraction and concentration of krill
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`phospholipids for human consumption. Pet. 2627.
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`We conclude that the information and arguments presented by Enzymotec
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`are sufficient to show that there is a reasonable likelihood that Enzymotec would
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`prevail in its challenge of claims 1, 19, 20, 21, 24, 42, 43, and 44 as obvious over
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`the combination of Fricke, Bergelson, Yasawa, Itano, and the WHO Bulletin.
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`(2) Claims 2, 3, 25, and 26
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`Dependent claims 2 and 25 require the claimed extract or solution to have a
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`total phospholipid concentration in an amount of about 40% w/w, wherein about
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`represents ±10%. Dependent claims 3 and 26 require the claimed extract or
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`solution to have a total phospholipid concentration in an amount of about 45%
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`w/w, wherein “about” represents ± 20%.
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`Enzymotec contends that Fricke discloses krill extracts containing 39.6% to
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`42.5% phospholipids, which falls within the range recited in claims 2, 3, 25, and
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`26. Pet. 24 (citing Ex. 1006, 822 (Table 1)).
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`In view of the meaning of the term “about,” as discussed above, as well as
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`the evidence presented by Enzymotec, we conclude that there is a reasonable
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`likelihood that Enzymotec would prevail in its challenge of claims 2, 3, 25, and 26
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`as obvious over the combination of Fricke, Bergelson, Yasawa, Itano, and the
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`WHO Bulletin.
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`(3) Claims 4, 5, 27, and 28
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`Dependent claims 4 and 27 require the claimed extract or solution to have an
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`additional lipid, such as a free fatty acid. Dependent claims 5 and 28 require a
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`concentration of free fatty acids of about 5% w/w of the lipids in the extract.
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`Enzymotec contends that Fricke discloses krill extracts containing from
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`8.5% to 16.1% free fatty acids, which is encompassed by about 5% as defined in
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`the ’351 patent. Pet. 24 (citing Ex. 1006, 822 (Table 1)).
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`In view of the meaning of the term “about,” as discussed above, as well as
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`the evidence presented by Enzymotec, we conclude that there is a reasonable
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`likelihood that Enzymotec will prevail in its challenge of claims 4, 5, 27, and 28 as
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`obvious over the combination of Fricke, Bergelson, Yasawa, Itano, and the WHO
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`Bulletin.
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`(4) Claims 6, 9, 29 and 32
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`Dependent claims 6 and 29 require the claimed extract or solution to
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`comprise polyunsaturated fatty acids (PUFAs) at a concentration of at least 15%
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`w/w. Dependent claims 9 and 32 require the PUFAs to be omega-3 fatty acids.
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`Enzymotec contends that Fricke discloses krill extracts containing 21.42%
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`omega-3 fatty acids. Pet. 24 (citing Ex. 1006, 823 (sum of n-3s in Table 2)).
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`In view of the information and argument presented by Enzymotec, we
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`conclude that there is a reasonable likelihood that Enzymotec will prevail in its
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`challenge of claims 6, 9, 29 and 32 as obvious over the combination of Fricke,
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`Bergelson, Yasawa, Itano, and the WHO Bulletin.
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`(5) Claims 12, 13, 35 and 36
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`Dependent claims 12 and 35 require the claimed extract or solution to have a
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`metal. Dependent claims 13 and 36 require the metal to be zinc, selenium , or a
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`mixture thereof.
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`Enzymotec contends that it is well known that krill contain zinc and
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`selenium and that krill extracts disclosed in the prior art would inherently contain
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`zinc and selenium. Pet. 26 (citing Ex. 1018, 551, col. 2). Enzymotec further relies
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`on the WHO Bulletin for teaching the usefulness of Antarctic krill for a variety of
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`purposes, including as a source of zinc and selenium, thereby suggesting a
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`preparation of krill extracts that retain zinc and selenium. Id. at 2627 (citing Ex.
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`1042, ¶ 399). Enzymotec contends that a person of ordinary skill in the art would
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`have had a reasonable expectation of success in formulating krill extracts suitable
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`for human consumption and retaining useful components inherently present in
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`krill. Id. This conclusion is supported by the declaration of Dr. Lee, which
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`presents evidence that zinc and selenium may be successfully extracted from E.
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`superba. Ex. 1045, Exhibit A (Samples “S9,” “S10,” “S18,” “S19,” “S20,” and
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`corresponding samples prepared by Dr. Budge (Ex. 1041)).
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`In view of the evidence presented by Enzymotec, we conclude that there is a
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`reasonable likelihood that Enzymotec will prevail in its challenge of claims 12, 13,
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`35, and 36 as obvious over the combination of Fricke, Bergelson, Yasawa, Itano,
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`and the WHO Bulletin.
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`(6) Claims 22, 23, 45, and 46
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`Dependent claims 22, 23, 45, and 46 require the claimed extract or solution
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`to have an antioxidant such as astaxanthin. Enzymotec contends that Fricke
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`discloses krill extracts containing carotenoids, which are antioxidants. Pet. 2526
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`(citing Ex. 1006, 821 (Table 1, note b)).
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`In view of the evidence presented by Enzymotec, we conclude that there is a
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`reasonable likelihood that Enzymotec will prevail in its challenge of claims 22, 23,
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`45, and 46 as obvious over the combination of Fricke, Bergelson, Yasawa, Itano,
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`and the WHO Bulletin.
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`III. CONCLUSION
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`We institute an inter partes review of claims 16, 9, 12, 13, 1929, 32, 35,
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`36, and 4246 based on the following grounds:
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`(1) Anticipation of claims 16, 9, 12, 13, 1929, 32, 35, 36, and 4246 by
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`Beaudoin I; and
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`(2) Obviousness of claims 16, 9, 12, 13, 1929, 32, 35, 36, and 4246 over
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`the combination of Fricke, Bergelson, Yasawa, Itano, and the WHO Bulletin.
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`For the reasons given, it is
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`IV. ORDER
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`ORDERED that the Petition is granted as to claims 16, 9, 12, 13,
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`1929, 32, 35, 36, and 4246 of the ’351 patent with respect to the following
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`alleged grounds:
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`1. Claims 16, 9, 12, 13, 1929, 32, 35, 36, and 4246 of the ’351
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`patent under 35 U.S.C. § 102 as anticipated by Beaudoin I; and
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`2. Claims 16, 9, 12, 13, 1929, 32, 35, 36, and 4246 of the ’351
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`patent under 35 U.S.C. § 103 as obvious over the combination
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`Fricke, Bergelson, Yasawa, Itano, and the WHO Bulletin.
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`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
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`partes review of the ʼ351 patent is hereby instituted commencing on the entry date
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`of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is
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`hereby given of the institution of a trial.
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`FURTHER ORDERED that the trial is limited to the grounds listed in
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`the Order. No other grounds are authorized.
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`PETITIONER:
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`Elizabeth J. Holland
`Kenyon & Kenyon LLP
`One Broadway
`New York, NY 10004-1007
`eholland@kenyon.com
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`Cynthia Lambert Hardman
`Kenyon &Kenyon LLP
`One Broadway
`New York, NY 10004-1007
`chardman@kenyon.com
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`PATENT OWNER:
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`Stephen L. Altieri
`Cooley LLP
`ATTN: Patent Group
`1299 Pennsylvania Ave., NW
`Suite 700
`Washington, DC 20004
`saltieri@cooley.com
`
`
`J. Dean Farmer
`Cooley LLP
`ATTN: Patent Group
`1299 Pennsylvania Ave., NW
`Suite 700
`Washington, DC 20004
`dfarmer@cooley.com
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