throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`AKER BIOMARINE AS and ENZYMOTEC LTD. and ENZYMOTEC USA, INC.
`Petitioners
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`
`______________________
`
`CASE IPR2014-000031
`U.S. Patent No. 8,278,351 B2
`______________________
`
`PATENT OWNER’S RESPONSE TO IPR2014-00556 PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 8,278,351
`
`
`
`
`
`
`1 Case IPR2014-00556 has been joined with this proceeding.
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`
`
`
`
`

`
`Table of Contents
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`
`Page
`INTRODUCTION ........................................................................................................ 1
`LEGAL STANDARDS ................................................................................................. 2
`ARGUMENT: BEAUDOIN DOES NOT INHERENTLY ANTICIPATE CLAIMS
`2, 3, 25, OR 26 ........................................................................................................... 3
`A.
`The Highly Variant Recreation Data Refute Inherency ................................... 5
`B.
`The Board Cannot Find Inherency By Ignoring Unfavorable Test
`Results ............................................................................................................ 7
`1.
`The Recreation Evidence Must Be Considered in Its Totality ............. 8
`2.
`Considering Individual Species of Recreation Extracts in
`Isolation Does Not Prove Inherency .................................................. 12
`CONCLUSION ......................................................................................................... 15
`
`-i-
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`
`
`I.
`II.
`III.
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`IV.
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`
`
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`

`
`
`
`TABLE OF AUTHORITIES
`
`Cases 
`Allergan, Inc. v. Apotex, Inc.,
`754 F.3d 952 (Fed. Cir. 2014) ............................................................................................ 5
`ArcelorMittal France v. AK Steel Corp.,
`700 F.3d 1314 (Fed. Cir. 2012) .......................................................................................... 2
`Bettcher Indus. v. Bunzl USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011) ............................................................................................ 3
`Glaxo Group Ltd. v. Apotex, Inc.,
`376 F.3d 1339 (Fed. Cir. 2004) .......................................................................................... 5
`Glaxo Inc. v. Novopharm Ltd.,
`52 F.3d 1043 (Fed. Cir. 1995) ...................................................................................... 7, 13
`In re Arkley,
`59 C.C.P.A. 804, 455 F.2d 586 (1972) ............................................................................... 9
`In re Armodafinil Patent Lit. Inc.,
`939 F. Supp. 2d 456 (D. Del. 2013) ........................................................................... 10, 13
`Sanofi-Syntheslabo v. Apotex, Inc.,
`550 F.3d 1075 (Fed. Cir. 2009) .......................................................................................... 9
`Therasense, Inc. v. Becton, Dickinson & Co.,
`593 F. 3d 1325 (Fed. Cir. 2010) ......................................................................................... 7
`Trintec Indus., Inc. v. Top-U.S.A. Corp.,
`295 F.3d 1292 (Fed. Cir. 2002) .......................................................................................... 2
`Statutes 
`35 U.S.C. § 102(b) ................................................................................................................ 15
`Regulations 
`37 C.F.R. § 42.120 ................................................................................................................. 1
`
`
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`-ii-
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`

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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
`
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.120, Patent Owner Neptune Technologies and
`
`I.
`
`Bioressources Inc. (“Patent Owner” or “Neptune”) Responds to the Petition for Inter Partes
`
`Review (“Petition”) of U.S. Patent No. 8,278,351 (“the ‘351 Patent”) filed by Enzymotec Ltd.
`
`and Enzymotec USA, Inc. (“Enzymotec”).
`
`On July 9, 2014, the Patent and Trial and Appeal Board (“Board”) instituted inter
`
`partes review of the ‘351 Patent in IPR2014-00556 based on Enzymotec’s Petition, and also
`
`granted Enzymotec’s motion to join IPR2014-00556 with IPR2014-00003.2 The Petitioner in
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`IPR2014-00003 is Aker BioMarine AS (“Aker”) (Aker and Enzymotec are referred to
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`collectively as “Petitioners”). In IPR2014-00556, the Board instituted trial on the identical
`
`alleged grounds of unpatentability previously instituted in IPR2014-00003, and in addition,
`
`on the alleged anticipation of claims 2, 3, 25, and 26 by Beaudoin I (“Beaudoin”).3
`
`
`
`Neptune submitted its Patent Owner Response on July 1, 2014 to all grounds then
`
`currently instituted in IPR2014-00003. Pursuant to the Board’s joinder decision in IPR2014-
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`00556, this Response addresses only Enzymotec’s challenge of claims 2, 3, 25, and 25 as
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`inherently anticipated by Beaudoin.4
`
`2 IPR2014-00556, Paper 18 (hereinafter, “IPR2014-00556 Institution Decision”), Paper 19
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`(hereinafter, “Joinder Decision”).
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`3 IPR2014-00556 Institution Decision, p. 22.
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`4 Joinder Decision, p. 6.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`Enzymotec’s evidence falls far short of the high bar for inherent anticipation. In most
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`cases, the alleged Beaudoin “recreation” extracts came nowhere close to meeting the
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`limitations of the claims. The data therefore refute the notion that the claimed limitations are
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`“necessarily present” in the prior art extracts. Enzymotec also cannot selectively discard the
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`unfavorable test results based on the species of krill used for extraction. It is undisputed
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`that neither the claims nor the prior art are limited to, or distinguish between, particular
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`species of krill. In addition, even if one attempts to isolate the recreation test results by
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`species, the evidence still fails to prove inherency.
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`Patent Owner therefore respectfully submits that the Board should uphold the
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`patentability of claims 2, 3, 25, and 26 as novel over Beaudoin.5
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`II.
`
`LEGAL STANDARDS
`Anticipation requires that a single prior art reference disclose each and every
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`limitation, either expressly or inherently. ArcelorMittal France v. AK Steel Corp., 700 F.3d
`
`1314, 1322 (Fed. Cir. 2012) (internal quotation omitted). Anticipation by inherent disclosure
`
`requires proof that the missing descriptive material is “necessarily present, not merely
`
`probably or possibly present, in the prior art.” Trintec Indus., Inc. v. Top-U.S.A. Corp., 295
`
`F.3d 1292, 1295 (Fed. Cir. 2002) (internal quotations omitted). The fact that a certain thing
`
`5 The Background and Claim Construction sections of Neptune’s July 1, 2014 Patent Owner
`
`Response are hereby incorporated by reference. See IPR2014-00003, Paper 66
`
`(hereinafter, “July 1, 2014 Patent Owner Resp.”), pp. 2-7, 9-14.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`may result from a given set of circumstances is not sufficient to prove inherent anticipation.
`
`Bettcher Indus. v. Bunzl USA, Inc., 661 F.3d 629, 639 (Fed. Cir. 2011).
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`III.
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`
`
`ARGUMENT: BEAUDOIN DOES NOT INHERENTLY ANTICIPATE CLAIMS 2, 3,
`25, OR 26
`Claims 2-3 and 25-26 depend from claims 1 and 24, respectively, and further require
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`as follows:
`
`Claims 2 and 25
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`Claims 3 and 26
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`“the extract has a total phospholipid concentration in an amount of about
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`40% w/w, wherein about represents ± 10%”
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`“the extract has a total phospholipid concentration in an amount of about
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`45% w/w, wherein about represents ± 20%”
`
`The Board instituted trial on claims 2, 3, 25, and 26 as allegedly inherently
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`anticipated by Beaudoin based on a purported “recreation” performed by Dr. Suzanne
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`Budge.6 Dr. Budge extracted nine lipid samples allegedly according to the process for
`
`obtaining Beaudoin fraction I (“the Budge samples”).7 At Petitioners’ direction, three of the
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`6 IPR2014-00556 Institution Decision, p. 12. The Board did not institute trial on claims 2, 3,
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`25, or 26 based on express anticipation by Beaudoin. See id. at 11-12. Nevertheless,
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`Beaudoin does not expressly anticipate any of these claims for reasons explained by Dr.
`
`Jaczynski and previously noted by the Board. See NEPN Ex. 2061, Jaczynski Supp. Decl.,
`
`¶¶ 6-9; IPR2014-00003, Paper 45 (May 16, 2014).
`
`7 See AKBM Ex. 1041, Budge Decl.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`Budge samples were extracted from E. pacifica krill and six were extracted from Antarctic
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`krill, or E. superba. Another of Petitioners’ declarants, Dr. Moore, tested all of the Budge
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`samples for phospholipid concentration.8
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`Dr. Moore’s results soundly refute inherency, as they reveal highly variant
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`phospholipid concentrations among the samples. Most samples did not contain the claimed
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`phospholipid concentrations. Enzymotec’s inherency argument as to claims 2, 3, 25 and 26
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`is so weak that Petitioner Aker did not make it, even though Aker submitted and otherwise
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`relied on the same Budge and Moore declarations submitted by Enzymotec.9
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`Furthermore, the recreation data cannot be rehabilitated by selectively considering
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`the E. pacifica samples in isolation from the E. superba samples (or vice-versa). All parties
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`and experts agree that neither the claims at issue nor the Beaudoin method alleged to
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`anticipate are limited to, or distinguish between, different species of krill. The claims
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`therefore cannot be invalid for inherent anticipation based on data specific to one species,
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`because other data prove that the claimed limitations are not necessarily present in
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`Beaudoin krill extracts. But as detailed below, even if one considers the E. superba and E.
`
`pacifica results separately, the record evidence fails to establish inherency.
`
`
`8 See AKBM Ex. 1044, Moore Decl.
`
`9 See IPR2014-00003, Paper 6, AKBM Petition (hereinafter, “AKBM Pet.”), p. 20.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`The Board should therefore conclude that Beaudoin does not anticipate claims 2, 3,
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`
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`25, or 26.10
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`The Highly Variant Recreation Data Refute Inherency
`A.
`To inherently anticipate, Beaudoin’s process must produce, each and every time,
`
`extracts that necessarily contain the claimed concentrations of phospholipids. Glaxo
`
`Group Ltd. v. Apotex, Inc., 376 F.3d 1339, 1348 (Fed. Cir. 2004); see also Allergan, Inc. v.
`
`Apotex, Inc., 754 F.3d 952, 960-61 (Fed. Cir. 2014) (affirming no inherent anticipation where
`
`facts showed “it was at least possible to [practice the prior art] in a way” that did not
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`anticipate). Petitioners and their experts maintain that Dr. Budge later faithfully repeated
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`Beaudoin, and Dr. Budge followed the same extraction process to produce all samples.
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`Thus, to prove inherent anticipation, Petitioners had to show that all of the Budge samples
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`necessarily contained the claimed concentrations of phospholipids.
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`Petitioners’ data come nowhere close to meeting this standard. The Budge samples
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`contained phospholipids ranging from 0.1% to 44% of the weight of the extract, as shown in
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`10 The Board should find that Beaudoin fails to expressly or inherently anticipate claims 2, 3,
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`25, and 26 for the additional reason that Beaudoin does not expressly or inherently
`
`anticipate the independent claims from which they depend. See July 1, 2014 Patent Owner
`
`Resp., pp. 16-36. In particular, the Board should conclude that none of Petitioners’ alleged
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`recreations, including the Budge recreation, faithfully repeated the Beaudoin method, and
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`accordingly reject the recreation testing data as evidence of anticipation. See id. at 25-31.
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`the demonstrative below.11
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`
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`Far from “necessarily” meeting the claims, most samples came nowhere close to the
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`claimed ranges.
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`
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`Under the proper construction, nearly all of the Budge samples—seven or eight out
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`of nine—do not anticipate the claims. As detailed in Neptune’s initial Patent Owner
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`Response and the supporting declaration of Dr. Jacek Jaczynski, a person of ordinary skill
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`would construe “about 40%” as used in claims 2 and 25 to require an extract containing 36-
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`44% phospholipids.12 Even Petitioners’ expert Dr. Brenna rendered his inherency opinions
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`11 This demonstrative illustrates the total phospholipids in each of Petitioners’ recreation
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`samples, including recreations of the Fujita and Rogozhin references, which are no longer
`
`at issue. See AKBM Ex. 1044, Moore Decl., Table 11, p. 16.
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`12 See July 1, 2014 Patent Owner Resp., p. 13.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`with the understanding that “about 40%” as used in claims 2 and 25 means 36-44%.13 Only
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`one of the Budge samples (E. superba SU2) had a phospholipid concentration of 36-44%.
`
`Applying the same reasoning to interpret claims 3 and 26 as Dr. Jaczynski and Dr.
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`Brenna used to interpret claims 2 and 25, “about 45%” as used in claims 3 and 26 means
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`36-54%.14 Only two of the nine Budge samples (E. pacifica P2 and E. Superba SU2) had a
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`phospholipid concentration of 36-54%.
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`While the Board’s claim construction ruling will determine exactly how many of the
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`Budge samples do not meet the claims, at least three of the nine, or a full one-third, clearly
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`do not. S0, S1, and S2 all had less than 0.5% phospholipids. This is itself sufficient to
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`refute inherency. See Therasense, Inc. v. Becton, Dickinson & Co., 593 F. 3d 1325, 1332
`
`(Fed. Cir. 2010) ("Inherency, however, may not be established by probabilities or
`
`possibilities.”) (internal quotation omitted); Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043,
`
`1047 (Fed. Cir. 1995) (no inherency where reproductions of the prior art method met the
`
`claims 13 out of 15 times).
`
`The Board Cannot Find Inherency By Ignoring Unfavorable Test Results
`B.
`Undeterred by the totality of data that refute inherency, Enzymotec attempts to
`
`simply cherry-pick the minority of favorable results and ignore the rest. Specifically,
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`13 NEPN Ex. 2037, Brenna Tr. 136:6-14. Petitioners also agreed with this construction in the
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`2013 litigation between the parties at the International Trade Commission.
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`14 See July 1, 2014 Patent Owner Resp., pp. 13-14.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`Enzymotec and Dr. Brenna argue that Beaudoin inherently anticipates because some
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`Budge samples extracted from a certain species met the claims, even though samples
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`extracted from other species, using the same process, did not. Enzymotec’s approach fails
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`on multiple levels.
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`First, both the claims at issue and Beaudoin’s method are directed to “krill,” not a
`
`species of krill. It is undisputed that one may practice Beaudoin’s method using E. pacifica
`
`or E. superba. Indeed, with the exception of Enzymotec’s arguments for claims 2, 3, 25,
`
`and 26, all of Petitioners’ inherency arguments expressly rely on recreation E. superba
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`extracts. One therefore cannot find inherent anticipation by selectively relying on Beaudoin
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`recreation extracts of E. pacifica or E. superba while ignoring the recreation extracts
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`obtained from the other species.
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`Second, even if one considers the E. superba extracts separately from the E.
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`pacifica extracts, the record evidence fails to establish inherency.
`
`The Board therefore has no basis on which to invalidate claims 2, 3, 25, or 26 as
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`inherently anticipated by Beaudoin.
`
`The Recreation Evidence Must Be Considered in Its Totality
`1.
`As the Board has noted, all three of the Budge E. pacifica extracts had phospholipid
`
`
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`concentrations of 30-50%.15 But there is no legal or factual basis for considering these E.
`
`pacifica results in isolation from the other Budge samples extracted from E. superba.
`
`15 IPR2014-00556 Institution Decision, p. 12.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`The claims at issue recite “krill extracts” without requiring or distinguishing between
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`
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`particular species of krill. The only ‘351 Patent claim directed to a particular species is claim
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`94, which requires an Antarctic krill extract, i.e., E. superba. Therefore, if anything, the ‘351
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`Patent teaches a preference for E. superba.
`
`
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`The Beaudoin method alleged to inherently anticipate is also not limited to a
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`particular species of krill. Beaudoin, as the Board explained, provides a “general
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`extraction method used to prepare extracts from marine and aquatic animal material.”16
`
`While Beaudoin discloses E. pacifica extracts, Beaudoin also discloses extracts from other
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`krill species such as M. norvegica.17 The mere disclosure of E. pacifica extracts does not
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`disqualify recreation evidence from other krill species because Beaudoin gives no reason to
`
`choose E. pacifica over other species.18 See Sanofi-Syntheslabo v. Apotex, Inc., 550 F.3d
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`1075, 1083 (Fed. Cir. 2009) (for a reference to inherently anticipate, it must “clearly and
`
`unequivocally disclose the claimed [invention] … without any need for picking, choosing,
`
`and combining various disclosures not directly related to each other by the teachings of the
`
`cited reference.”) (quoting In re Arkley, 59 C.C.P.A. 804, 455 F.2d 586, 587 (1972)).
`
`16 Id. at 9 (emphasis added); see also AKBM Ex. 1002, Beaudoin, p. 1 (“This invention
`
`relates to the extraction of lipid fractions from marine and aquatic animals such as krill,
`
`Calanus, fish and sea mammals.”).
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`17 AKBM Ex. 1002, Beaudoin, Tables 3, 4.
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`18 NEPN Ex. 2061, Jaczynski Supp. Decl., ¶ 15.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`All parties and their experts agree that the Beaudoin method alleged to anticipate
`
`
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`may be practiced with E. pacifica or E. superba. See In re Armodafinil Patent Lit. Inc., 939
`
`F. Supp. 2d 456, 479 (D. Del. 2013) (“defendants have not demonstrated that all reasonable
`
`ways to practice Preparation I would necessarily result in Form I armodafinil consistent with
`
`the limitations of the asserted claims”). Dr. Budge testified that she faithfully repeated
`
`Beaudoin by extracting lipids from both E. pacifica and E. superba, even though, as Dr.
`
`Budge agreed, Beaudoin does not disclose E. superba extracts.19 Dr. Budge further
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`testified that she did not expect her E. pacifica extracts to differ from her E. superba
`
`extracts.20 Dr. Brenna similarly opined that “Beaudoin I discloses that the extracts are made
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`by extracting lipids from ‘krill,’ which includes Antarctic krill.”21
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`
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`Dr. Jaczynski agrees that Beaudoin does not suggest that any particular species of
`
`krill is a superior extraction source.22 Dr. Jaczynski, like Dr. Budge, would also not expect
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`that the species of krill would itself cause meaningful variation in the phospholipid content of
`
`the extracts. Rather, as Dr. Jaczynski explains, the composition of a krill lipid extract
`
`depends largely on extraction technique, particularly the choice of solvents, and may also
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`19 NEPN Ex. 2039, Budge Tr. 115:18-116:4; 52:4-22 (“Beaudoin mentions krill. Superba is
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`a type of krill.”); accord AKBM Ex. 1042, Brenna Decl., ¶ 81.
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`20 NEPN Ex. 2039, Budge Tr. 53:2-6; accord NEPN Ex. 2037, Brenna Tr. 273:20-274:4.
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`21 AKBM Ex. 1042, Brenna Decl., ¶ 209.
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`22 NEPN Ex. 2061, Jaczynski Supp. Decl. ¶ 15.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`be affected by other factors such as the season, diet, and maturity of the krill at the time of
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`catch.23 In other words, one of skill would not expect that E. pacifica extracts would be
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`more likely to satisfy claims 2, 3, 25, or 26 than E. superba extracts, all other factors being
`
`equal. Aker and Enzymotec’s expert in prior litigation between the parties at the
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`International Trade Commission, Dr. David Pond, rendered a similar opinion, testifying that
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`“the most studied species of krill are E. superba and E. pacifica, and it is generally
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`understood that these two types of krill have similar lipid compositions.”24
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`
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`Petitioners themselves rely on E. superba recreation extracts for all of their
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`inherency arguments, except those Enzymotec makes with respect to claims 2, 3, 25, and
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`26. Petitioners designed all three of their Beaudoin recreations to utilize both E. pacifica
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`and E. superba starting material.25 Based on all of these recreation extracts, Petitioners
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`argue inherent anticipation of independent claims 1 and 24 and dependent claims 12, 13,
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`19-21, 35, 36, and 42-44, without distinguishing between E. superba and E. pacifica.26 In
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`fact, Aker contended that Beaudoin E. pacifica extracts are “indistinguishable” from
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`Antarctic krill extracts (i.e., E. superba) in support of its arguments regarding claim 94:
`
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`23 Id. ¶ 16.
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`24 See id.; NEPN Ex. 2062, Pond Witness Statement Excerpts, ¶ 118.
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`25 NEPN Ex. 2039, Budge Tr. 50:11-51:20; AKBM Ex. 1047 & 1048, Haugsgjerd Decls., ¶ 2.
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`26 AKBM Pet., pp. 18-19, 21-22; IPR2014-00556, Paper 1, Enzymotec Pet., pp. 17-20.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`
`Beaudoin I discloses lipid extracts from krill. Claim 94 [directed to an
`Antarctic krill extract] contains no composition limitations that distinguish
`Antarctic krill extracts from other krill extracts. Thus, as [sic] the claimed krill
`extracts of Beaudoin I are indistinguishable from Antarctic krill extracts
`and meet that limitation.27
`
`Only after seeing the unfavorable phospholipid test results did Enzymotec concoct an
`
`inherent anticipation argument based on a species-specific subset of the data.
`
`
`
`Enzymotec cannot run away from the test results it commissioned and relied on for
`
`all its other inherency arguments. The parties and the experts agree that the species of krill
`
`is merely a circumstance or, as Dr. Brenna put it, a “condition” of a Beaudoin extraction—it
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`has nothing to do with Beaudoin’s teachings. Accordingly, there is no basis to exclude the
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`Budge E. superba samples from the inherency analysis for claims 2, 3, 25, and 26.
`
`2.
`
`Considering Individual Species of Recreation Extracts in Isolation
`Does Not Prove Inherency
`Even under the specious approach that Enzymotec urges, considering either the E.
`
`pacifica or E. superba extracts in isolation still does not prove inherency.
`
`First, the evidence does not prove that the claimed phospholipid concentrations are
`
`necessarily present in Beaudoin E. pacifica extracts. Dr. Brenna actually testified to the
`
`contrary. Dr. Brenna opined that only one E. superba sample, SU2, anticipates claims 2
`
`
`27 AKBM Pet., p. 18 (emphasis added). Claim 94 is not at issue in this proceeding.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`and 25 and that the remaining Budge samples do not.28 Dr. Brenna also conceded during
`
`his deposition that he merely “know[s] of one set of conditions” that produced an extract that
`
`satisfies claims 2 and 25, and “can’t answer” whether use of Beaudoin’s method under
`
`different conditions would satisfy the claims.29 Dr. Brenna’s opinions therefore refute
`
`inherency. See Armodafinil Patent Lit Inc., 939 F. Supp. 2d at 465 (“if the teachings of the
`
`prior art can be practiced in a way that yields a product lacking the allegedly inherency
`
`property, the prior art in question does not inherently anticipate”) (citing Glaxo Inc., 52 F.3d
`
`at 1047-48).
`
`Dr. Brenna did agree, in response to leading questions on redirect examination, that
`
`if claim 2 is construed to require 30-50% phospholipids, then all of the Budge E. pacifica
`
`samples would satisfy the claim.30 But the fact that these three samples happened to fall
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`with the range of 30-50% is a far cry from establishing that every Beaudoin E. pacifica
`
`extract will necessarily have 30-50% phospholipids. Further, Dr. Brenna’s testimony
`
`undercuts any assumption that Beaudoin E. pacifica extracts inherently contain 30-50%
`
`phospholipids. When asked whether E. pacifica extracts resulting from a repeat Budge
`
`experiment would be more likely than the E. superba extracts to satisfy claim 2, Dr. Brenna
`
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`28 AKBM Ex. 1047, Brenna Decl., ¶ 180; NEPN Ex. 2037, Brenna Tr. 140:19-141:20.
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`29 NEPN Ex. 2037, Brenna Tr. 145:5-12; see also id. at 145:13-18, 274:12-22.
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`30 Id. at 265:7-11.
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`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
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`answered, “I don’t know what she would get. I know what she got.”31 Other than the
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`fact that Dr. Budge happened to get a certain set of results the first time, Dr. Brenna had no
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`basis for expecting similar results if she repeated her experiment.32
`
`Dr. Brenna’s admitted uncertainty about the outcome of a repeat Budge experiment
`
`reveals that even he does not deem the claimed limitations necessarily present in
`
`Beaudoin’s extracts. Dr. Jaczynski concurs there is no reasonable basis to expect that in a
`
`repeat Budge experiment, the E. pacifica extracts would be more likely than the E. superba
`
`extracts to satisfy claims 2, 3, 25, or 26.33
`
`At the same time, Petitioners cannot establish inherency based only on the E.
`
`superba samples. Three of the six E. superba samples, S0, S1, and S2, had less than
`
`0.5% phospholipids and therefore cannot anticipate any of claims 2, 3, 25, or 26. While Dr.
`
`Brenna did not consider these samples, characterizing them as “anomalous,” his opinion is
`
`not credible because he reached it based on the unfavorable testing results.34 Dr. Brenna
`
`also performed no statistical or other analysis one of skill in the art would perform to justify
`
`
`31 Id. at 274:12-19.
`
`32 Id. at 275:14-276:1. Dr. Brenna also could not say whether E. pacifica and E. superba,
`
`on average, contain different amounts of phospholipids. Id. at 273:20-274:11.
`
`33 NEPN Ex. 2061, Jaczynski Supp. Decl. ¶¶ 16-17.
`
`34 NEPN Ex. 2037, Brenna Tr. 147:3-148:2.
`
`-14-
`
`

`
`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
`
`disregarding three of the nine data points, or a full one-third of the data, as outliers.35
`
`Further, Dr. Brenna lacks sufficient experience to judge krill lipid extracts as “anomalous”—
`
`he has never performed extractions, done lab work, or published any papers on krill.36
`
`Thus, even if the Board considers the E. superba or E. pacifica samples in isolation
`
`while ignoring the full set of test results, there is no basis on which to conclude that
`
`Beaudoin inherently anticipates any of claims 2, 3, 25, or 26.
`
`IV.
`
`CONCLUSION
`For these reasons, this Board should find that Petitioners have failed to prove that
`
`Beaudoin inherently anticipates claims 2, 3, 25, or 26 under 35 U.S.C. § 102(b).
`
`Respectfully submitted,
`COOLEY LLP
`
`/J. Dean Farmer /
`J. Dean Farmer, Ph.D.
`Reg. No. 57,917
`
`
`
`
`
`
`By:
`
`
`
`
`
`Dated: August 11, 2014
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue, N.W.
`Suite 700
`Washington, DC 20004-2400
`
`Tel: (617) 937-2371
`Fax: (202) 842-7899
`
`
`
`
`
`
`
`35 AKBM Ex. 1047, Brenna Decl., ¶ 84 n4; NEPN Ex. 2037, Brenna Tr. 148:17-19; NEPN
`
`Ex. 2061, Jaczynski Supp. Decl. ¶ 18.
`
`36 NEPN Ex. 2037, Brenna Tr. 15:9-17.
`
`-15-
`
`

`
`Patent Owner’s Response
`Case No: IPR2014-00003/-000556
`
`
`CERTIFICATION OF SERVICE UNDER 37 C.F.R. §§ 42.6(e), 42.205(b)
`I, J. Dean Farmer, Ph.D., hereby certify that the foregoing PATENT OWNER’S
`
`RESPONSE TO IPR2014-00556 PETITION FOR INTER PARTES REVIEW OF U.S.
`PATENT NO. 8,278,351; UPDATED EXHIBIT LIST; and EXHIBITS 2061 and 2062 were
`served electronically (as consented to by Petitioners), on August 11, 2014, the same day as
`the filing of the above-identified documents in the United States Patent and Trademark
`Office (USPTO), upon:
`
`Amanda Hollis
`amanda.hollis@kirkland.com
`Hand delivery address:
`KIRKLAND & ELLIS
`300 North LaSalle
`Chicago, IL 60654
`Telephone: 312-862-2011
`Facsimile: 312-862-2200
`Reg. No. 55,629
`
`
`Elizabeth J. Holland
`eholland@kenyon.com
`Daniel P. Margolis
`dmargolis@kenyon.com
`Hand delivery address:
`Kenyon & Kenyon LLP
`One Broadway
`New York, NY 10004-1007
`Telephone: (212) 908-6307
`Facsimile: (212) 425-5288
`Reg. No. 47,657
`
`Cynthia Lambert Hardman
`chardman@kenyon.com
`Hand delivery address:
`Kenyon & Kenyon LLP
`One Broadway
`New York, NY 10004-1007
`Telephone: (212) 908-6370
`Facsimile: (212) 425-5288
`Reg. No. 53,179
`
`J. Mitchell Jones
`jmjones@casimirjones.com
`docketing@casimirjones.com
`Hand delivery address:
`CASIMIR JONES SC
`2275 Deming Way, St. 310
`Middleton, WI 53562
`Telephone: (608) 662-1277
`Facsimile: (608) 662-1276
`Reg. No. 44,174
`
`Dated: August 11, 2014
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue, N.W
`Suite 700
`Washington, DC 20004-2400
`Tel: (617) 937-2371
`Fax: (202) 842-7899
`
`
`
`Respectfully submitted,
`
`COOLEY LLP
`
`/J. Dean Farmer/
`J. Dean Farmer, Ph.D.
`Reg. No. 57,917
`
`
`
`By:
`
`
`
`-16-

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