Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 104
`Entered: March 23, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AKER BIOMARINE AS and ENZYMOTEC LTD. and
`ENZYMOTEC USA, INC.,
`Petitioner,
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.,
`Patent Owner.
`_______________
`
`Case IPR2014-000031
`Patent 8,278,351 B2
`____________
`
`
`Before LORA M. GREEN, JACQUELINE WRIGHT BONILLA, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`
`SNEDDEN, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`1 Case IPR2014-00556 has been joined with this proceeding.
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`Paper 104
`Entered: March 23, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AKER BIOMARINE AS and ENZYMOTEC LTD. and
`ENZYMOTEC USA, INC.,
`Petitioner,
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.,
`Patent Owner.
`_______________
`
`Case IPR2014-000031
`Patent 8,278,351 B2
`____________
`
`
`Before LORA M. GREEN, JACQUELINE WRIGHT BONILLA, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`
`SNEDDEN, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`1 Case IPR2014-00556 has been joined with this proceeding.
`
`
`
`
`
`IPR2014-00003
`US 8,278,351 B2
`
`
`I. INTRODUCTION
`
`The parties in the case are Aker Biomarine AS (“Aker”) and
`
`Enzymotec Ltd. and Enzymotec USA, Inc. (“Enzymotec”) (collectively,
`
`“Petitioner”), and Neptune Technologies and Bioressources, Inc. (“Patent
`
`Owner”). Aker filed a first Petition to institute an inter partes review of
`
`claims 1–27 (Paper 8; “Pet. I”) of Patent No. 8,278,351 B2 (Ex. 1001; “the
`
`’351 patent”). We instituted trial as to the challenged claims on the
`
`following grounds of unpatentability asserted by Aker:
`
`Reference(s)
`
`Beaudoin2
`
`Fricke,3 Bergelson,4
`Yasawa,5 Itano,6 and WHO
`Bulletin7
`
`Basis
`
`§ 102(b)
`
`Claims challenged
`1, 36, 9, 12, 13, 1924,
`2629, 32, 35, 36, and 4246
`
`§ 103
`
`16, 9, 12, 13, 1929, 32, 35,
`36, and 4246
`
`Decision to Institute, 18 (Paper 22 (“Dec. I”)).
`
`
`2 Beaudoin et al., WO 00/23546, published April 27, 2000. Ex. 1002.
`3 Fricke et al., Lipid, Sterol and Fatty Acid Composition of Antarctic Krill,
`19(11) LIPIDS 821-827 (1984). Ex. 1006.
`4 Lipid Biochemical Preparation, LD Bergelson (ed.), Elsevier/North-
`Holland Biomedical Press (1980). Ex. 1017.
`5 Yasawa et al., JP H8-231391, published September 10, 1996. The certified
`translation, Japanese language document, and translation certificate for
`Yasawa are provided as Exs. 1015, 1076 and 1077, respectively. We
`reference Ex. 1015 in this Decision.
`6 Itano Refrigerated Food Co., Ltd., Bio & High Technology Announcement
`and Natural Astaxanthin & Krill Lecithin, 116. Ex. 1009.
`7 WHO News and Activities, Bulletin of the World Health Organization,
`73(4), pp. 547-51 (1995). Ex. 1018.
`
`2
`
`
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`IPR2014-00003
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`
`After institution, Neptune Technologies and Bioressources, Inc.
`
`(“Patent Owner”), filed its Patent Owner’s Response. Paper 66 (“Resp. I”).
`
`Within a month of our Decision to Institute in the first case,
`
`Enzymotec filed a second Petition and Motion for Joinder. IPR2014-00556,
`
`Paper 1 (“Pet. II”), Paper 4. We then instituted inter partes review of the
`
`’351 patent in IPR2014-00556 based on the second Petition, and granted
`
`Enzymotec’s Motion to join IPR2014-00556 with IPR2014-00003. Paper 72
`
`(“Dec. II”). In IPR2014-00556, we instituted trial on the identical alleged
`
`grounds of unpatentability previously instituted in IPR2014-00003, and in
`
`addition, on the alleged anticipation of claims 2 and 25 over Beaudoin.8 Id.
`
`Patent Owner filed its second Patent Owner’s Response to address the added
`
`ground involving claims 2 and 25. Paper 77 (“Resp. II”).
`
`Petitioner filed a Reply, which was responsive to both of the Patent
`
`Owner Responses. Paper 84 (“Reply”). Patent Owner did not file a motion
`
`to amend claims.
`
`Petitioner relies upon the declarations of Drs. Van Breemen (“Van
`
`Breemen” Ex. 1040), Brenna (“Brenna” Ex. 1042) Storrø (“Storrø” Ex.
`
`1044), 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).
`
`
`8 In this paper, we refer to solely: Paper 66, Patent Owner’s Response
`(“Resp. I”); Paper 84, the Reply filed by Aker; and Paper 22, our Decision to
`Institute in IPR2014-00003. To the extent that there are differences in
`arguments and issues raised in the joined case, IPR2014-00556, we refer to
`the second Petition filed by Enzymotec (IPR2014-00556, Paper 1, “Pet. II”)
`and Paper 72, our Decision to Institute in IPR2014-00556.
`
`3
`
`
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`IPR2014-00003
`US 8,278,351 B2
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`
`Patent Owner relies upon the declaration of Dr. Jacek Jaczynski
`
`(“Jaczynski Declaration”) (Ex. 2059) in support of its Response.
`
`Patent Owner filed a Motion to Exclude certain of Petitioner’s
`
`evidence. Paper 89. Petitioner filed an Opposition (Paper 95), and Patent
`
`Owner filed a Reply. Paper 97.
`
`Oral argument was conducted on October 31, 2014. A transcript is
`
`entered as Paper 103 (“Tr.”).
`
`This Final Written Decision addresses challenges to the patentability
`
`of claims 16, 9, 12, 13, 1929, 32, 35, 36, and 4246. Petitioner has
`
`established by a preponderance of the evidence that claims 14, 6, 9, 12, 13,
`
`1927, 29, 32, 35, 36, and 4246 of the ’351 patent are unpatentable.
`
`Petitioner has failed to demonstrate by a preponderance of the evidence that
`
`claims 5 and 28 of the ’351 patent are unpatentable.
`
`A. Related Matters
`
`The parties represent that the ’351 patent is the subject of patent
`
`infringement lawsuits in the U.S. District Court for the District of Delaware:
`
`Neptune Technologies and Bioressources Inc., v. Aker Biomarine ASA, et
`
`al., No. 12-cv-1252 (filed October 2, 2012) and Neptune Technologies and
`
`Bioressources Inc., v. Enzymotec Limited, et al., No. 12-cv-1253 (filed
`
`October 2, 2012). Pet. I, 2; Paper 10.
`
`The parties represent that the ’351 patent is the subject of an
`
`International Trade Commission investigation, entitled Certain Omega-3
`
`Extracts from Marine or Aquatic Biomass and Products Containing the
`
`Same, Investigation No. 337-TA-877. Id.
`
`4
`
`
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`IPR2014-00003
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`
`The parties represent that the ’351 patent is the subject of an Ex Parte
`
`Reexamination, Control No. 90/012,698. Id.
`
`Petitioner Aker represents that the ’351 patent is a continuation of
`
`U.S. Pat. 8,030,348 (the “’348 patent”; Ex. 1069), which is currently subject
`
`to an Inter Partes Reexamination, Control No. 95/001,774. Pet. I, 2. The
`
`’348 patent is also the subject a patent infringement lawsuit filed by Neptune
`
`Bioressources & Technologies against Aker Biomarine in the United States
`
`District Court of Delaware (1:11-cv-00894-GMS). Id. The ’351 patent (Ex.
`
`1001)
`
`B. The ’351 patent (Ex. 1001)
`
`Phospholipids are made up of two chains of fatty acids attached to a
`
`chemical backbone made up of phosphoric acid, glycerol and nitrogenous
`
`bases (e.g., choline). Ex. 1001, 4:41–56. Phospholipids having choline as
`
`the nitrogenous base are referred to as phosphatidylcholines. Id.
`
`The ’351 patent relates to certain phospholipids and compositions
`
`containing phospholipids. The ’351 patent discloses a phospholipid
`
`including two fatty acids chains of eicosapentanoic acid (“EPA”) and
`
`docosahexanoic acid (“DHA”) simultaneously. The general formula for the
`
`phospholipid is:
`
`wherein X represents a moiety normally found in a phospholipid such as
`
`,
`
`5
`
`
`
`IPR2014-00003
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`phosphatidylcholine (PC), phosphatidylethanolamine (PE) and
`
`phosphatidylinositol (PI). Id. at 2:46–3:2, 21:1–25.
`
`The phospholipids are derived from natural marine or aquatic sources.
`
`Id. at 1:1922. Krill is described as the preferred source of the disclosed
`
`phospholipids, which includes krill found in the Antarctic Ocean (Euphasia
`
`superba) and in the Pacific Ocean (Euphasia pacifica). Id. at 15:821. The
`
`’351 patent describes the preparation of krill extracts that preferably contain
`
`40% weight per weight (w/w) phospholipid. Id. at 15:4245.
`
`Polyunsaturated fatty acids, in particular omega-3 fatty acids, preferably
`
`make up at least 15% w/w of the total lipids in the extract. Id. at 16:4751.
`
`DHA or EPA may account for at least 32% w/w of the total lipid content of
`
`the extract. Id. at 16:5154.
`
`C. Challenged Claims
`
`Claims 1 and 24 are the only independent claims among the
`
`challenged claims, and are reproduced below:
`
`1. A krill extract comprising:
`a phospholipid of the general formula (I),
`
`
`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
`
`6
`
`
`
`IPR2014-00003
`US 8,278,351 B2
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`
`
`is suitable for human
`
`the extract
`
` and wherein
`consumption.
`
`24. A capsule, tablet, solution, syrup, or suspension
`comprising a krill extract comprising:
`a phospholipid of the general formula (I),
`
`
`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
`
`the extract
`
`
`is suitable
`
`for human
`
`and wherein
`consumption.
`
`
`7
`
`
`
`IPR2014-00003
`US 8,278,351 B2
`
`
`Claims 26, 9, 12, 13, and 1923 depend from claim 1, either directly
`
`or indirectly. Claims 2529, 32, 35, 36, and 4246 depend from claim 24,
`
`either directly or indirectly.
`
`II. DISCUSSION
`
`A. Claim Interpretation
`
`In an inter partes review, claim terms in an unexpired patent are
`
`interpreted according to their broadest reasonable construction in light of the
`
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14,
`
`2012); In re Cuozzo Speed Techs., LLC, No. 2014-1301, 2015 WL 448667,
`
`at *5–*8 (Fed. Cir. Feb. 4, 2015). Claim terms are given their ordinary and
`
`customary meaning, as would be understood by one of ordinary skill in the
`
`art in the context of the entire disclosure. In re Translogic Tech., Inc., 504
`
`F.3d 1249, 1257 (Fed. Cir. 2007). Any special definition for a claim term
`
`must be set forth in the specification with reasonable clarity, deliberateness,
`
`and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`We expressly interpret below only those claim terms that require
`
`analysis to resolve arguments related to the patentability of the challenged
`
`claims.
`
`1. Construction of the phrase “suitable for human
`consumption”
`
`Petitioner suggests that “suitable for consumption” broadly covers
`
`“any form of consumption by a human (e.g., oral or topical administration).”
`
`Pet. I, 9.
`
`8
`
`
`
`IPR2014-00003
`US 8,278,351 B2
`
`
`Patent Owner contends that any interpretation of “suitable for human
`
`consumption” must cover extracts intended for oral ingestion. Resp. I, 910.
`
`To support this argument, Patent Owner cites to those passages of the ’351
`
`patent that disclose compositions intended for oral consumption such as
`
`foods, beverages, energy bars, sports drinks, and supplements. Id. (citing
`
`Ex. 1001, 20:34-36, 20:42-57, and Examples 2 and 3).
`
`Patent Owner’s analysis does not address the disclosure of “topical
`
`cosmetic products” in the ’351 patent. See e.g., Ex. 1001, 20:3841 (“[T]the
`
`phospholipid extract of the invention is also useful in cosmetic preparations,
`
`e.g., moisturizing creams, sun-block products and other topical cosmetic
`
`products as known in the art.”). In light of that disclosure in the ’351 patent,
`
`we agree with Petitioner that “suitable for consumption” broadly covers any
`
`form of human consumption (e.g., oral or topical administration).
`
`2. Construction of the phrase “capsule, tablet, solution, syrup,
`or suspension”
`
`Under a broadest reasonable interpretation, words of the claim must
`
`be given their plain meaning unless the plain meaning is inconsistent with
`
`the specification. In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989).
`
`Limitations from the specification are not to be read into the claims. In re
`
`Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993); see also Superguide
`
`Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875 (Fed. Cir. 2004)
`
`(“Though understanding the claim language may be aided by explanations
`
`contained in the written description, it is important not to import into a claim
`
`limitations that are not part of the claim. For example, a particular
`
`embodiment appearing in the written description may not be read into a
`
`claim when the claim language is broader than the embodiment.”); cf. Merck
`
`9
`
`
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`IPR2014-00003
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`
`& Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005)
`
`(reversing the district court’s construction of the term “about” because the
`
`interpretation was inconsistent with the specification).
`
`Patent Owner contends that that recitation of “solution, syrup, or
`
`suspension” in claim 24 refers to liquid preparations for oral administration.
`
`Resp. I, 14 (citing Ex. 2059 ¶ 40; Ex. 2037, 245:20246:2; Ex. 1001,
`
`20:1022 (“Liquid preparations for oral administration may take the form of,
`
`for example, solutions, syrups or suspensions . . . .”). Although we agree
`
`that that recitation of “solution, syrup, or suspension” encompasses liquid
`
`preparations for oral administration, we decline to interpret the phrase to be
`
`limited to liquid preparations for oral administration. Claim 24 recites, for
`
`example, solutions comprising a krill extract that are suitable for human
`
`consumption. The claim is absent any language that limits “consumption” to
`
`oral consumption and we must take care to not import limitations from the
`
`specification into the claim. Superguide Corp., 358 F.3d at 875.
`
`3. Construction of the term “about”
`
`The term “about” is defined in the ’351 patent as follows:
`
`As used herein and in the claims, where the term “about” is
`used with a numerical value, the numerical value may vary by
`at least ±50%. Preferably, the variation will be ±40% or ±30%
`and more preferably ±20% or ±10%. Even more preferred
`variations are in the range ±5%, ±4%, ±3% or ±2%. Most
`preferably, the variation is in the range of ±1%.
`
`Ex. 1001, 21:6163.
`
`Patent Owner contends that “±50%” would not be understood by a
`
`person of ordinary skill in the art to mean plus or minus an absolute value of
`
`50%, because it would be nonsensical as it would include negative values for
`
`10
`
`
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`IPR2014-00003
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`lower numerical numbers such as 5% (i.e., indicating a range of -45% to
`
`55%). Resp. I, 1112 (citing Ex. 2059 ¶ 37). Rather, a person of ordinary
`
`skill in the art would have interpreted “±50%” to be determined from the
`
`numerical value used with the variation. Id. Thus, for example, about 5% ±
`
`50% means plus or minus 50% of 5%, and therefore indicates a range of
`
`2.5% (5% minus 2.5%) to 7.5% (5% plus 2.5%). Id.
`
`Petitioner contends that the broadest reasonable interpretation of
`
`“about,” in view of the express definition set forth in the specification, is to
`
`read “±50%” as an absolute value. Reply 34. Petitioner contends that
`
`negative values would not render such an interpretation nonsensical as the
`
`term “about” is used in the context of amounts of compositional elements,
`
`which are not negative. Id. Thus, for example, claims 5 and 28 require free
`
`fatty acids and therefore would not encompass a negative amount.
`
`Upon consideration of the claims, Specification, other evidence, and
`
`the arguments summarized above, we conclude that a person of ordinary
`
`skill in the art would have interpreted “±50%” in the Specification, and thus
`
`the broadest reasonable interpretation of “about” in claims (lacking any
`
`other definition in the claims) in view of the Specification, to mean ±50% as
`
`determined from the numerical value used with the variation. Ex. 2059 ¶ 37.
`
`Thus, for example, “about 5% w/w” in claim 5 refers to a range of 2.5% to
`
`7.5% w/w.
`
`Patent Owner’s proposed claim construction does not address the
`
`presence of the phrase “at least” in the express definition of the term
`
`“about,” which provides that “the numerical value may vary by at least
`
`±50%.” Ex. 1001, 21:6163. In this regard, we read the phrase “at least
`
`50%” in the context of the entire definition of the term “about,” set forth in
`
`11
`
`
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`IPR2014-00003
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`the above paragraph, to mean ±50%, but may be less if indicated otherwise
`
`(e.g., ±40% or ±30%) %) in the claim. Thus, if “about” is defined in a claim
`
`with a particular percentage, that percentage is determined from the
`
`numerical value used with the variation. For example, “about 45% w/w,
`
`wherein about represents ±20%” in claim 3 refers to the range of 36% to
`
`54% w/w. As another example, claim 7 recites that the “extract further
`
`comprises polyunsaturated fatty acids which comprise at least 40% w/w of
`
`the lipids in the extract;” the “at least 40%” represents 40% or more.
`
`B. The Prior Art
`
`a. Summary of Beaudoin (Ex. 1002)
`
`Beaudoin relates to the extraction of lipid fractions from marine and
`
`aquatic animals such as krill. Ex. 1002, 1:56. Lipids are extracted from
`
`freshly collected marine and aquatic material with a ketone, such as acetone.
`
`Id. at 4:2930. Beaudoin discloses that krill lipid fractions have various
`
`uses, including medical and nutritional applications. Id. at 1:1126.
`
`Beaudoin provides a description of the general extraction method used
`
`to prepare extracts from marine and aquatic animal material. Id. at 5:21–
`
`6:20. Beaudoin discloses that the starting material is subjected to acetone
`
`extraction, under inert atmosphere, and at a temperature of about 5°C or less
`
`for about two hours, and preferably overnight. Id. Table 19 of Beaudoin is
`
`reproduced below.
`
`12
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`
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`
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`Id. at 28:1–36. Table 19 is disclosed as providing the suggested procedure
`
`and optimal conditions for lipid extraction of aquatic animal tissues. Id.
`
`Beaudoin discloses the preparation of krill oil using various solvents.
`
`Id. at 8:419; see also id. at 21:3955 (Table 12). The characteristics of
`
`certain lipid fractions of the krill oil were analyzed and the results are
`
`provided in Table 13 of Beaudoin. Id. at 22. In the paragraph summarizing
`
`Table 13, Beaudoin discloses that the krill oil fractions were heated to about
`
`125°C for about 15 minutes to remove traces of solvents. Id. at 10:620.
`
`13
`
`
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`IPR2014-00003
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`As stated in the reference, the inventor of Beaudoin, Dr. Adrien
`
`Beaudoin, ingested lipid fractions of krill, and no side effect profile was
`
`observed. Id. at 12:1314.
`
`b. Summary of Fricke (Ex. 1006)
`
`Fricke discloses the preparation of lipid extractions from Antarctic
`
`krill (E. superba). Ex. 1006, 821. Table 1 of Fricke is reproduced below.
`
`
`
`14
`
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`Id. at 822 (Table 1). Table 1 discloses the total lipid content and the lipid
`
`composition data of two krill samples obtained from krill caught in
`
`December 1977 and March 1981. Id.
`
`Table 6 of Fricke is reproduced below.
`
`Id. at 826 (Table 6). Table 6 discloses the fatty acid positional analysis in
`
`PC and PE detected in the December 1977 E. superba sample. Id.
`
`
`
`c. Summary of Itano (Ex. 1009)
`
`Itano describes the nutritional value of krill extracts. Ex. 1009, 715.
`
`Specifically, Itano discloses as follows:
`
`Phospholipid, a structural component of organic membranes,
`contributes to enzyme- activation and is said to be effective in
`lowering the concentration of cholesterol in human blood.
`
`Krill lecithin (phospholipid found in krill) is more effective in
`decomposing
`peroxides
`than
`ordinary
`soybean
`or
`vitellinephospholipid, and is equally effective in lowering
`cholesterol levels. A further characteristic of krill lecithin that
`
`15
`
`
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`IPR2014-00003
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`
`has been the focus of considerable attention in recent years is
`the high content of the highly unsaturated fatty acids, EPA
`(20:5) and DHA (22:6), both of which are considered to be
`effective in preventing and treating adult diseases such as
`myocardial infarction and thrombosis.
`
`Itano’s krill lecithin has the potential to make maximum use of
`these Characteristics through application to promising health
`foods and “functional foods.”
`
`Id. at 15.
`
`d. Summary of Yasawa (Ex.1015)
`
`Yasawa discloses the administration of DHA for improving dementia
`
`symptoms. Ex. 1015, Abstract. Yasawa discloses the use of krill oil as a
`
`carrier for DHA. Specifically, Yasawa discloses as follows:
`
`The DHA used in the present invention is an isolated acid, and
`refers
`to salt, ester, glyceride, phospholipids, choline
`compounds, ascorbic acid compounds, amino acid compounds.
`As for the oil that includes the DHA, an inclusion ratio of 10%
`or more DHA (as an isolated acid) within general fatty acids.
`As an example of such an oil, the fish oil extracted from blue
`backed fish such as Japanese pilchard, mackerel, horse
`mackerel, salmon, and Pacific saury, the fish oil from large
`ocean fish eye oil, such as that of the tuna or the shipjack tuna,
`oil coming from microorganisms, krill oil, and oil from
`industrial products extracted from the livers of Pacific cod and
`dolphins.
`
`Id. ¶ 8.
`
`e. Summary of Bergelson (Ex. 1017)
`
`Bergelson discloses techniques for the preparing lipid extracts from
`
`natural sources using various solvents, such as chloroform and methanol.
`
`Ex. 1017, 24. Bergelson discloses to remove solvent from lipid extracts by
`
`16
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`rotary evaporation using mild conditions (e.g., 35° C) or under nitrogen to
`
`avoid auto-oxidation. Id. at 1011.
`
`f. Summary of WHO Bulletin (Ex. 1018)
`
`The WHO Bulletin describes the nutritional value of Antarctic krill
`
`(Euphausia superba). Ex. 1018, 551. The WHO Bulletin identifies krill as
`
`a source of EPA, DHA, zinc, and selenium. Id.
`
`C. Analysis
`
`1. Anticipation of Claims 1, 46, 9, 12, 13, 1924, 2729, 32,
`35, 36, and 4246 by Beaudoin (Ex. 1002)
`
`a. Claims 1 and 24
`
`Claims 1 and 24 are directed to a krill extract and solution,
`
`respectively, containing a phospholipid of the general formula (I) that is
`
`suitable for human consumption. Petitioner contends that Beaudoin
`
`discloses lipid extracts from krill that necessarily contain the phospholipids
`
`recited in claims 1 and 24. Pet. I, 1519. Although Beaudoin does not
`
`identify the lipid composition of the E. pacifica krill extracts, Petitioner
`
`provides extensive declaration evidence, related to the reproduction and
`
`testing of krill extracts made according to the disclosure of Beaudoin, to
`
`show that the E. pacifica krill extracts disclosed in Beaudoin necessarily
`
`contained the claimed phospholipids. Van Breemen (Ex. 1040) ¶¶ 7385,
`
`9398; Budge (Ex. 1041) ¶¶ 710; Haugsgjerd (Ex. 1048) ¶¶ 25; Lee (Ex.
`
`1045), Table 7. Krill extract samples were prepared by Dr. Budge and Dr.
`
`Haugsgjerd and certain tests on the krill extract samples were performed by
`
`Drs. Lee and van Breeman. Id. The Van Breemen Declaration, in
`
`particular, provides mass spectrometry evidence that E. pacifica krill acetone
`
`17
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`extracts contain PC-EPA/EPA, PC-DHA/DHA, and PC-EPA/DHA. Ex.
`
`1040 ¶¶ 7385, 9398.
`
`With regard to the suitability-for-human-consumption element of
`
`claims 1 and 24, Beaudoin discloses that extract fractions were consumed
`
`with no side effect. Ex. 1002, 12:1314.
`
`With regard to the recitation of a krill solution in claim 24, Beaudoin
`
`krill oil extracts are solutions encompassed by claim 24, as the
`
`phospholipids and other components are dissolved in the extracts. Ex. 1042
`
`¶ 202.
`
`Patent Owner argues that Beaudoin fails to disclose expressly all
`
`elements of any patented claims. This argument is premised on the
`
`understanding that Beaudoin requires a heating step to obtain krill extracts.
`
`Resp. I, 1724. In this regard, Patent Owner contends that “the testimony of
`
`Dr. Jaczynski, Dr. Budge, and Dr. Brenna makes clear that the heating step
`
`is a required, or at least ‘optional’, part of Beaudoin’s process.” Id. at 22.
`
`Patent Owner further contends that:
`
`Dr. Budge clarified that while Table 19 does not recite the
`heating step, Beaudoin’s heating procedure is a “postextraction
`step,” not a part of the extraction procedure itself. Dr.
`Jaczynski concurred with Dr. Budge’s analysis, testifying that
`one of skill would view the heating step as a post-extraction
`step required to refine the oil, and therefore not expect to find it
`in the “optimal” extraction steps summarized in Table 19.
`
`Resp. I, 18 (citing Ex. 2039, 154:20155:11, 90:2091:3; Ex. 2059 ¶¶ 55–
`
`56). Patent Owner contends also that “the heating step is not an alternate
`
`embodiment that differs from the ‘optimal’ extraction method of Table 19; it
`
`is a required post-extraction step of Beaudoin’s method.” Id. (citing Ex.
`
`2059 ¶ 62; Ex. 2038, 200:29; Ex. 2028, 1).
`
`18
`
`
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`
`Patent Owner contends that this heating step distinguishes Beaudoin
`
`from the ’351 patent because the “heating step would result in both heat-
`
`induced and acid-induced hydrolysis due to the high level of water and free
`
`fatty acids in Beaudoin’s extracts, as disclosed in Tables 13 and 14.” Id. at
`
`2223 (citing Ex. 2059 ¶ 61). Patent Owner further contends that the
`
`heating step would oxidize and degrade EPA and DHA present in the extract
`
`into a variety of undesirable intermediate by-products. Id. at 23 (citing Ex.
`
`2059 ¶ 61).
`
`Patent Owner contends that because Dr. Budge and Dr. Haugsgjerd do
`
`not perform the heating step properly according to the extraction process
`
`disclosed in Beaudoin, their attempts to recreate samples of the krill extract
`
`obtained by Beaudoin fail. Resp. I, 2629.
`
`Patent Owner further contends that the claimed phospholipid was not
`
`detected in all heated and unheated recreation samples. Id.
`
`We first address the question of whether the extraction process
`
`disclosed in Beaudoin requires a heating step. We find it does not. The only
`
`mention of a heating step in Beaudoin is made in conjunction with
`
`compositional analysis of the extracts. Ex. 1002, 10:620. That method
`
`differed from methods used to prepare the krill extracts in the first instance,
`
`before any preparation of the sample for analysis (to be analyzed). For
`
`example, Beaudoin expressly discloses that the krill extracts were purified
`
`by standard techniques, such as filtration and evaporation. Ex 1002, 6:413,
`
`Furthermore, Table 19 of Beaudoin, entitled “Optimal Conditions for Lipid
`
`Extraction of Aquatic Animal Tissue,” summarizes the steps involved in a
`
`lipid extraction process, and does not provide for a heating step. Id. at 28.
`
`Rather, Table 19 suggests the use of an organic solvent resistant filter for the
`
`19
`
`
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`filtration step of the process. Id. Accordingly, we are not persuaded by
`
`Patent Owner’s arguments or the testimony of Dr. Jaczynski that Beaudoin
`
`requires a heating step.
`
`As we are not persuaded that the Beaudoin extraction process requires
`
`a heating step, we conclude that the adequacy of the heating steps in the
`
`preparation of test samples is not relevant to the analysis of whether or not
`
`the Beaudoin extracts prepared by either the disclosed general extraction
`
`method or the optimal extraction method inherently comprise the claimed
`
`phospholipids. The preponderance of evidence on the record suggests that
`
`the E. pacifica krill extracts disclosed in Beaudoin necessarily contained the
`
`claimed phospholipids. Ex. 1040 ¶¶ 7385, 9398
`
`Moreover, even if we were to agree that Beaudoin requires a post-
`
`extraction heating step to “refine the oil,” such a conclusion would not
`
`render the claims patentable over Beaudoin. Resp. I, 18. An intermediate
`
`product can anticipate a claimed product even if the intermediate product is
`
`merely a stage in the final production. In re Mullin, 481 F.2d 1333,
`
`133536 (CCPA 1973) (citing In re Herbert, 461 F.2d 1390, 1394 (CCPA
`
`1972)). In that regard, Patent Owner does not contend that the unheated
`
`extraction product produced by the Beaudoin extraction process is
`
`distinguishable from a product encompassed by the claims. Resp. I, 1731.
`
`Finally, Patent Owner contends that Beaudoin does not disclose an
`
`extract “suitable for human consumption” as required by claims 1 and 24.
`
`Id. at 3136. We are not persuaded. Beaudoin expressly discloses that the
`
`krill extracts were purified by standard techniques, such as filtration and
`
`evaporation (Ex 1002, 6:4-13, 28 (Table 19), and consumed by a human (id.
`
`at 12:13-14). We are not persuaded that the evidence relied on by Patent
`
`20
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`Owner supports a finding that the amounts of solvent remaining after
`
`removal efforts renders the extracts unsuitable for human consumption in
`
`any form. As discussed above, we decline to interpret the phrase “suitable
`
`for human consumption” to require oral ingestion.
`
`In view of the above, we conclude that Petitioner has established by a
`
`preponderance of the evidence that Beaudoin anticipates claims 1 and 24 of
`
`the ’351 patent.
`
`a. Claims 2, 3, 25, and 26
`
`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%.” We interpret claims 2 and 25 to
`
`recite a total phospholipid concentration range of 36% to 44% w/w.
`
`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%. We interpret claims 3 and 26 to recite a
`
`total phospholipid concentration range of 36% to 54% w/w.
`
`Petitioner contends that Beaudoin discloses 54.1±6.1% phospholipids
`
`and polar material w/w in Fraction I extracts, which falls within or touches
`
`the claimed ranges. Pet. II, 1819 (citing Ex. 1002, 23 (Table 14)).
`
`Beaudoin’s description of concentration percentages of “[p]hospholipids or
`
`other polar material” in Table 14, however, does not disclose explicitly a
`
`total phospholipid concentration, as recited in the challenged claims. Rather,
`
`Table 14 in Beaudoin describes percentages, in krill oil Fractions I and II, of
`
`material having phospholipids (at some undisclosed concentration) plus
`
`“other polar material” (at some undisclosed concentration). Thus, Petitioner
`
`does not explain sufficiently in its Petition how one can ascertain the total
`
`21
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`phospholipid concentration of Fraction I by looking at Table 14 or elsewhere
`
`in Beaudoin.
`
`Petitioner further directs our attention to the testimony of Patent
`
`Owner’s declarant, Dr. Yeboah. Id. at 19. Petitioner contends that Dr.
`
`Yeboah has explained that the Beaudoin extracts tested by Dr. White contain
`
`about 40% phospholipids. Id. (citing Ex. 1054 ¶ 36). Dr. Yeboah, however,
`
`makes no such statement in the cited paragraph. Rather, in the passage
`
`relied on by Petitioner, Dr. Yeboah refers to 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. 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.
`
`Petitioner also relies on declarations from Drs. Budge, Moore, and
`
`Brenna to demonstrate that the E. pacifica krill extracts disclosed in
`
`Beaudoin necessarily contained the phospholipids concentrations recited in
`
`claims 2, 3, 25 and 26. Pet. II, 1819 (citing Budge (Ex. 1041) ¶ 10; Moore
`
`(Ex 1044) at Exhibit A, Table 11; Brenna (Ex. 1042) ¶¶ 18081). Dr. Budge
`
`testifies that he prepared acetone extracts of E. pacifica krill following the
`
`method of Beaudoin in all relevant steps, and sent the samples to Dr. Moore.
`
`Ex. 1041, 4–7 (citing Ex. 1002, 5–6, Table 19). Dr. Moore conducted
`
`compositional analysis on the samples. Ex. 1044. The results obtained by
`
`Dr. Moore indicated that the unheated E. pacifica krill extracts prepared by
`
`Dr. Budge (SB1-8/19/2013-BEA-P0, SB5-8/19/2013-BEA-P1, and SB9-
`
`8/19/2013-BEA-P2) contained phospholipids
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