UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`
`
`AKER BIOMARINE AS
`Petitioner
`
`v.
`
`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`
`______________________
`
`CASE IPR2014-00003
`
`U.S. Patent No. 8,278,351
`
`______________________
`
`PATENT OWNER PRELIMINARY RESPONSE TO PETITION FOR
`
`INTER PARTES REVIEW OF U.S. PATENT NO. 8,278,351
`
`
`
`
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`
`
`

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`
`
`I.
`II.
`
`B.
`
`C.
`
`D.
`
`Patent Owner Preliminary Response
`Case No: IPR2013-00214
`
`TABLE OF CONTENTS
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`Page
`
`-i-
`
`Introduction ...................................................................................................... 1
`Petitioner has Failed to Establish a Reasonable Likelihood of Prevailing with
`Respect to at Least One Challenged Claim ..................................................... 3
`A.
`Petition Grounds 1 and 2: Claims 1-94 are not anticipated
`under 35 U.S.C. 102(b) over Beaudoin I and Beaudoin II .................... 4
`(i)
`Beaudoin I and II do not expressly or inherently disclose
`the claimed phospholipids ......................................................... 8
`Beaudoin does not disclose an extract “suitable for
`human consumption” ............................................................... 18
`Petition Ground 3: Claims 1-13, 19-36, 42-59, 65-83, and 89-94
`are not unpatentable under 35 U.S.C. 102(b) over Maruyama .......... 21
`(i)
`Maruyama does not expressly or inherently disclose the
`claimed phospholipid ............................................................... 21
`Maruyama does not enable one of ordinary skill to yield
`a krill extract “suitable for human consumption” ...................... 24
`Petition Ground 4: Claims 1-6, 9, 12-14, 19-29, 32, 35-37, 42-
`52, 55, 58-60. 65-76, 79, 82-84, and 89-94 are not
`unpatentable under 35 U.S.C. 102(b) over Fujita ............................... 26
`(i)
`Fujita does not teach or suggest the claimed
`phospholipid ............................................................................ 27
`Fujita does not disclose an extract “suitable for human
`consumption” ........................................................................... 30
`Petition Ground 5: Claims 1-6, 9, 19-29, 32, 42-52, 55, 65-76,
`79, and 89-94 are not unpatentable under 35 U.S.C. 102(b)
`over Fricke .......................................................................................... 32
`(i)
`Fricke does not expressly or inherently disclose the
`claimed phospholipid ............................................................... 32
`Fricke does not disclose an extract “suitable for human
`consumption” ........................................................................... 33
`
`(ii)
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`(ii)
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`(ii)
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`(ii)
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`

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`
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`
`
`III.
`
`E.
`
`F.
`
`G.
`
`H.
`
`I.
`
`Petition Ground 6: Claims 1, 19-21, 24, 42-44, 47, and 65-67
`are not unpatentable under 35 U.S.C. 102(b) over Rogozhin ............ 37
`(i)
`Rogozhin does not expressly or inherently disclose the
`claimed phospholipid ............................................................... 37
`Rogozhin does not disclose an extract “suitable for
`human consumption” ............................................................... 40
`Petition Ground 7: Claims 1-94 are not unpatentable under 35
`U.S.C. 103(a) over Beaudoin I in view of Bergelson .......................... 41
`Petition Ground 8: Claims 1-94 are not unpatentable under 35
`U.S.C. 103(a) over Beaudoin I in view of the Final Prospectus,
`2001 Press Release, and Bergelson .................................................. 48
`Petition Ground 9: Claims 1-94 are not unpatentable under 35
`U.S.C. 103(a) over Fujita in view of Watanabe and further in
`view of Itano and Yasawa ................................................................... 50
`Petition Ground 9: Claims 1-94 are not unpatentable under 35
`U.S.C. 103(a) over Fricke in view of Bergelson and further in
`view of Yasawa, Itano, and the WHO Bulletin .................................... 56
`Conclusion ..................................................................................................... 59
`
`Patent Owner Preliminary Response
`Case No: IPR2013-00214
`
`TABLE OF CONTENTS
`(continued)
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`Page
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`(ii)
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`-ii-
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`

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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
`
`
`I.
`
`
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.107, the Patent Owner, Neptune Technologies and
`
`Bioressources Inc. (the “Patent Owner” or “Neptune”), timely submits this Preliminary
`
`Response to the Petition for Inter Partes Review (the “Petition”) of U.S. Patent No.
`
`8,278,351 (“the ‘351 Patent”), filed by Aker Biomarine AS (the “Petitioner”) on October 1,
`
`2013 and seeking the cancellation of claims 1-94 of the ‘351 Patent (the “patented claims”).
`
`
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`In an effort to concoct rejections of the patented claims, Petitioner provides an
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`exhaustive list of close to eighty references and/or expert declarations which have either
`
`been previously considered by the United States Patent and Trademark Office (the “Office”)
`
`during the prosecution of the ‘351 Patent or are cumulative with information previously
`
`presented to, and considered by, the Office. Yet, as discussed herein, it is undisputed that
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`none of these references expressly disclose all elements of any patented claim. Instead,
`
`Petitioner resorts to a theory of inherency, which requires that the prior art “necessarily”
`
`includes the unstated limitation. See Transclean Corp. v. Bridgewood Servs., Inc., 290 F.3d
`
`1364, 1373 (Fed. Cir. 2002). Petitioner fails to meet this standard as its inherency argument
`
`is based on a series of flawed “recreation” experiments, which significantly deviate from the
`
`prior art, in the hopes of obtaining more favorable results. Petitioner’s arguments are further
`
`based on testing results which are largely hit or miss. In many samples, the claimed
`
`phospholipid and many other claim elements were not detected. In order to establish
`
`inherency, the evidence must make clear that the missing descriptive matter is necessarily
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`present in the item of prior art.1 Accordingly, the inconsistency of the testing results is fatal
`
`to Petitioner’s theory of inherency.2
`
`
`
`Petitioner adopts a similarly flawed and cursory theory of obviousness with respect
`
`to the patented claims. Specifically, Petitioner’s obviousness rejections employ the very
`
`reasoning the Federal Circuit has criticized as insufficient and “fraught with hindsight bias,”
`
`failing to “explain how specific references could be combined, which combination(s) of
`
`elements in specific references would yield a predictable result, or how any specific
`
`combination would operate or read on the asserted claims.” See ActiveVideo Networks, Inc.
`
`v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1328 (Fed. Cir. 2012). The obviousness
`
`arguments are based on various convoluted combinations of no less than ten references,
`
`none of which alone, or in combination, disclose all elements of the patented claims. A
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`significant number of these references do not even relate to krill, or teach away from the use
`
`of krill, and/or are antithetical to the notion of human use, as their extractions involve highly
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`toxic solvents intended merely for laboratory analysis.
`
`Accordingly, each of the proposed grounds of rejection in the Petition is based on
`
`
`1 Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331, 1346-47 (Fed. Cir. 2009).
`
`2 “‘Inherency, however, may not be established by probabilities or possibilities. The mere
`
`fact that a certain thing may result from a given set of circumstances is not sufficient.’”
`
`Bettcher Indus. v. Bunzl USA, Inc., 661 F.3d 629, 639 (Fed. Cir. 2011) (quoting In re
`
`Oelrich, 666 F.2d 578, 581 (CCPA 1981)).
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`either (i) a flawed inherency argument predicated on inaccurate and biased “recreation”
`
`experiments, or (ii) an obviousness argument concocted from a convoluted combination of
`
`references that does not teach or suggest all elements of any patented claim, and in some
`
`cases, even teaches away from the claimed inventions. As such, Petitioner has failed to
`
`establish a reasonable likelihood of prevailing with respect to at least one challenged claim
`
`as required under 35 U.S.C. § 314(a), and the Petition fails to meet the threshold
`
`requirement for instituting an inter partes review. Based on at least the foregoing, Patent
`
`Owner respectfully requests that the Petition be denied.
`
`II.
`
`
`
`PETITIONER HAS FAILED TO ESTABLISH A REASONABLE LIKELIHOOD OF
`PREVAILING WITH RESPECT TO AT LEAST ONE CHALLENGED CLAIM
`Each of the proposed grounds of rejection in the Petition fails to meet the legal
`
`standards under 35 U.S.C. §§ 102 and 103.
`
`
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`With respect to the anticipation rejections, Petitioner has not shown that “each and
`
`every limitation is found either expressly or inherently in a single prior art reference.”
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`Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998). Nor has
`
`Petitioner succeeded in showing that the way in which the elements are arranged or
`
`combined in the claim is disclosed, either expressly or inherently, in an anticipatory
`
`reference. Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332 (Fed. Cir.
`
`2010).
`
`
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`With respect to the obviousness rejections, the proposed grounds fail to meet the
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`legal standard for prima facie obviousness in several aspects, including, inter alia, (i)
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`improperly relying on inaccurate and biased recreation experiments, (ii) failing to provide a
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`proper motivation to combine the cited references, (iii) incorrectly interpreting the art, and
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`(iv) ignoring aspects of the cited references which teach away from the claimed invention.
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`As a result, Petitioner has failed to establish a reasonable likelihood of prevailing
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`with respect to at least one challenged claim as required under 35 U.S.C. § 314(a), and the
`
`Petition should be denied.
`
`A.
`
`Petition Grounds 1 and 2: Claims 1-94 are not anticipated under 35
`U.S.C. 102(b) over Beaudoin I and Beaudoin II
`Beaudoin I (AKBM Ex. 1001) and Beaudoin II (AKBM Ex. 1002) are directed to a
`
`
`
`method for extracting lipids from various marine sources, including fish, sea animals such
`
`as sharks, calanus, and krill. Beaudoin I and II contain very similar disclosures and teach
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`virtually the same process for obtaining lipid extracts.3 Accordingly, both references will be
`
`discussed collectively as “Beaudoin” unless indicated otherwise.
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`
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`The stated goal of Beaudoin’s process is to yield extracts rich in omega-3 fatty acids,
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`which Beaudoin suggests can offer certain health or nutritional benefits. Both Beaudoin I
`
`and II were considered extensively by the Examiner during prosecution of the ‘351 Patent.
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`
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`Importantly, Beaudoin does not distinguish between different sources of omega-3
`
`fatty acids. This is clear from Beaudoin’s application which states “[t]his invention relates to
`
`the extraction of lipid fractions from marine and aquatic animals such as krill, Calanus, fish
`
`
`3 Jaczynski Rebuttal Witness Statement (“Jaczynski Stmnt” NEPN Ex. 2001), at Q/A 377.
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`Patent Owner Preliminary Response
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`and sea mammals.”4 Beaudoin also does not suggest that the omega-3 fatty acids found in
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`krill oil are more valuable than, or even distinct from, the omega-3 fatty acids found in fish
`
`oil. Rather, Beaudoin equates all its disclosed sources of omega-3 fatty acids with one
`
`another, stating that:
`
`Considering the beneficial effects of omega-3 fatty acids, oils
`from krill, Calanus and
`fish could be used as dietary
`supplements to human diet. These fatty acids are essential for
`proper development of the brain and the eye. . . . .
`“Among the lipids found in krill, Calanus and fish, high
`concentrations of fatty acids 20:5 (eicosapentaenoic acid) and
`22:6 (docosahexaenoic acid) are present.5
`Accordingly, most of the extractions disclosed by Beaudoin were obtained from non-krill
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`sources such as fish, shark, and other marine organisms.6
`
`
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`Beaudoin’s lack of distinction between marine extraction sources of omega-3 fatty
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`acids is critical. Beaudoin teaches that omega-3 fatty acids are the most desirable
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`component of its marine extracts due to their medical benefits. Krill, unlike the other
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`organisms utilized by Beaudoin, offers omega-3 fatty acids bound to phospholipids, rather
`
`
`4 Beaudoin I (AKBM Ex. 1002), p. 1.
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`5 Beaudoin I (AKBM Ex. 1002), pp. 1-2.
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`6 See, e.g., Beaudoin I (AKBM Ex. 1002), pp. 9-10, Tables 3-12.
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`than to triglycerides.7 Beaudoin did not recognize this special quality of krill, and, instead,
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`equated it with the many other marine sources of omega-3s.
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`
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`Further still, Beaudoin did not distinguish between the different forms of fatty acid.
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`Omega-3 fatty acids can be found in several forms, including: (1) as free fatty acids; (2)
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`bound to triglycerides, as is the case with the oil of fish and the other marine extraction
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`sources utilized by Beaudoin; and (3) bound to phospholipids, as in the special case of krill
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`oil. Omega-3 fatty acids have their best bioavailability when, as in krill, they are bound to
`
`phospholipids.8 But, Beaudoin
`
`teaches
`
`that
`
`free omega-3s, omega-3s bound
`
`to
`
`triglycerides, or omega-3s bound to phospholipids are equally desirable. Beaudoin was
`
`simply interested in getting the maximum concentration of omega-3s, in whatever form.
`
`Failing to recognize the value of omega-3s bound to phospholipids, as well as other
`
`nutritional benefits of krill taught by the present patent, Beaudoin created a process that is
`
`inconsistent with obtaining the claimed krill extracts.
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`
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`Specifically, Beaudoin’s process relies on significant heating to remove solvents.9
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`Beaudoin applied heat, up to 125°C,10 to crude lipid extracts with high concentrations of
`
`
`7 Jaczynski Reexamination Decl. (AKBM Ex. 1053), pp. 7-14.
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`8 Jaczynski Reexamination Decl. (AKBM Ex. 1053), pp. 8-11.
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`9 Beaudoin I (AKBM Ex. 1002), p. 7, lines 18-19 and p. 10, lines 19-20.
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`10 Beaudoin I (AKBM Ex. 1002), p. 7, lines 18-19 and p. 10, lines 19-20.
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`water and solvent (e.g. up to 10%),11 and free fatty acids (e.g. up to about 25%).12
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`Beaudoin’s heating steps, applied to extracts with the high moisture, solvent, and free fatty
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`acid content disclosed in Beaudoin I, lead to a process called hydrolysis that severs the fatty
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`acids from the phospholipid carriers.
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`
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`Petitioner does not, and cannot, claim that either Beaudoin I or II expressly discloses
`
`all elements of any patented claim. For example, Beaudoin does not disclose omega-3 fatty
`
`acids bound to phospholipids. Rather, Petitioner argues that Beaudoin inherently anticipates
`
`the patented claims. This inherency theory, however, rests on a series of “recreations” that
`
`suffer from a catalog of infirmities.
`
`
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`As detailed below, Petitioner’s most recent attempted recreation, performed by Dr.
`
`Susan Budge and presumably undertaken to rectify the errors of its previous “recreations,”
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`significantly deviated from Beaudoin. These deviations would be expected to have the effect
`
`of altering the oil samples in ways that bias the testing favorably for Petitioner. Despite the
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`claims of inherency, the Petition discarded one-third of Dr. Budge’s samples, unwilling to
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`subject them to complete testing after seeing unfavorable preliminary results.13
`
`
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`Despite Petitioner’s strategic deviations from the Beaudoin process, perhaps
`
`designed to skew the results in Petitioner’s favor, the testing of the samples obtained from
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`11 Beaudoin I (AKBM Ex. 1002), p. 10, lines 17-18 and Table 13.
`
`12 Beaudoin I (AKBM Ex. 1002), Table 14.
`
`13 Jaczynski Stmnt (NEPN Ex. 2001), at Q/A 248-250.
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`all of these Beaudoin recreations revealed significant variation in composition, as shown by,
`
`for example, Avanti and Chemir’s testing of the Budge Beaudoin Recreation samples.14 This
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`high degree of variability is the antithesis of inherency. In view of these variant results, along
`
`with the inaccuracy and unreliability of the so-called “recreations,” Petitioner cannot prove
`
`that Beaudoin inherently anticipates any patented claims.
`
`(i) Beaudoin I and II do not expressly or inherently disclose the
`claimed phospholipids
`Petitioner does not allege that Beaudoin expressly discloses all elements of any
`
`
`
`patented claim. This is because there is no disclosure in Beaudoin I or Beaudoin II of any
`
`phospholipid with EPA and/or DHA attached, let alone with EPA and/or DHA concurrently
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`attached at both the sn-1 and sn-2 positions.
`
`
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`Instead, Petitioner argues that the Beaudoin krill extract would necessarily contain
`
`the claimed phospholipid. Patent Owner disagrees.
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`Beaudoin’s Heating Step Would Degrade Phospholipids
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`
`
`Beaudoin I teaches heating extracts to 125°C for 15 minutes to remove solvents.15
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`Beaudoin II, filed one year before Beaudoin I, teaches heating extracts to 60-70°C for 5
`
`minutes.16 These heating steps would result in heat-induced hydrolysis, especially in the
`
`
`14 Jaczynski Stmnt (NEPN Ex. 2001), at Q/A 1054.
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`15 Beaudoin I (AKBM Ex. 1002), p. 7, lines 18-19 and p. 10, lines 19-20.
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`16 Beaudoin II (AKBM Ex. 1003), p. 3, last paragraph.
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`presence of water and very high content of free fatty acids as disclosed in Tables 13 and
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`14, respectively, of Beaudoin I.17
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`
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`The heating step taught by Beaudoin is necessary because Beaudoin employs
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`acetone and ethanol to extract krill oil fractions. The resulting krill oil fractions contain high
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`amounts of moisture and solvent residue, including acetone and laboratory ethanol, which
`
`are not suitable for human consumption.18 Specifically, Beaudoin’s oil fractions contained
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`10% and 6.8% moisture and volatiles, even after rotary evaporation, since water-miscible
`
`acetone and ethanol were used as solvents.19 This high amount of remaining moisture
`
`would allow for a heat-induced hydrolytic reaction in lipids. Hydrolysis will result in rupturing
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`of the ester bonds attaching fatty acids to phospholipids, and consequently, release of free
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`fatty acids and/or rupturing intra-fatty acid chain bonds that may convert omega-3 fatty acids
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`to non-omega-3 fatty acids.
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`
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`In spite of the heating steps that are clearly inconsistent with obtaining an extract
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`containing the claimed phospholipid, Petitioner argues instead that Beaudoin’s disclosed
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`heating steps would not affect the results. Patent Owner disagrees. As would be recognized
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`by one of ordinary skill in the art, such heating treatments, particularly in the absence of any
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`17 See, e.g., Beaudoin I (AKBM Ex. 1002), p.s. 7-10.
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`18 See, e.g., MSDS Ethanol (NEPN Ex. 2003: “Ingestion Acute Exposure Effects: Poison.
`
`Cannot be made non-poisonous. May be fatal or cause blindness.” (emphasis added).
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`19 Beaudoin I (AKBM Ex. 1002), Table 13.
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`protective measures, would in fact cause substantial hydrolysis.
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`
`
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`Following thermodynamic principles and first order reaction kinetics, the higher the
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`temperature, the greater the extent of hydrolysis is expected. The principle that hydrolysis
`
`occurs upon heating is readily accepted in the field, especially in presence of water and high
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`content of free fatty acids as disclosed in Beaudoin I. For example, the Solomons and
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`Fryhle college Organic Chemistry textbook shows the following reaction:20
`
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`This schematic is highly applicable because based on the oil composition shown in
`
`Beaudoin I, the oil contains sufficient quantity of water for the hydrolysis to proceed. Even
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`the Petitioner’s expert, Dr. Oppenheim, admitted that “most phospholipids are inherently
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`unstable once they are in the presence of water or oxygen, they would necessarily degrade
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`over time and this is another problem that would have to be dealt with.”21 In addition, the
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`composition of Beaudoin oil shows free fatty acid content in excess of 20%. This certainly
`
`will facilitate hydrolysis of the ester bond via acid-induced hydrolysis. By looking at the
`
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`20 Solomons and Fryhle (NEPN Ex. 2004), at p. 1144.
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`21 Oppenheim Declaration (NEPN Ex. 2005), p. 6.
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`composition of Beaudoin oil, one skilled in the art quickly notices that this oil is highly
`
`susceptible to hydrolytic degradation.
`
`
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`Medina et al. further confirms this principle, showing a heat treatment during tuna
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`canning at 110°C for 55 minutes, which resulted in considerable hydrolysis and release of
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`DHA from the sn-2 position, as detected by C nuclear magnetic resonance (NMR)
`
`spectroscopy.22
`
`
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`Furthermore, heat applied to a krill oil extract also causes oxidation of the fatty acids.
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`Long chain polyunsaturated fatty acids like EPA and DHA are very sensitive to heat, and
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`heat can cause them to degrade into shorter chain and less unsaturated fatty acids.
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`
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`Petitioner has acknowledged the effect of heat in the context of krill extraction. For
`
`example, one of Petitioner’s patent applications describes that:
`
`krill is cooked . . . mixed with hot water . . . [and] hot steam. . .
`This operation . . . may also result in a degradation of
`unstable bioactive components in the krill oil, such as
`omega-3 fatty acids, phospholipids and astaxanthin. The
`presence of these compounds make krill oil an attractive source
`as a food supplement, a functional food product, and a
`pharmaceutical for the animal and human applications.23
`
`Although Petitioner’s application does not specifically intend to test for the hydrolysis during
`
`
`22 Medina, pp. 479 and 481.
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`23 Bruheim (NEPN Ex. 2007), ¶4 (emphasis added).
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`onboard cooking of krill to deactivate lipolytic and proteolytic enzymes, it explicitly
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`expresses a concern with heat-induced hydrolysis along with heat-induced oxidation of
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`omega-3 fatty acids and heat-induced degradation of astaxanthin.
`
`Petitioner’s Flawed Beaudoin Recreations Fail to Prove Inherency
`
`Despite the teachings of Beaudoin, which include a heating step that would degrade
`
`phospholipids, Petitioner nevertheless argues that the claimed phospholipid is inherent. In
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`an attempt to support this theory, Petitioner provides a series of recreations, including the
`
`latest by Dr. Susan Budge, which deviate significantly from Beaudoin. The following table
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`summarizes the deviations from, and unreliability of, these Beaudoin “recreations”:
`
`Performed/
`
`Tested by
`
`Date
`
`Purpose
`
`Illustrative Flaws/
`
`Bases for Unreliability
`
`Haugsgjerd/
`
`10/2011 Commissioned
`
` No testing to determine levels of water,
`
`Gundersen
`
`(“Haugsgjerd
`
`One”)
`
`by Petitioner for
`
`solvent, and free fatty acids in the samples
`
`reexamination
`
` Ineffective heating, inconsistent with
`
`of parent to
`
`present patent24
`
`Beaudoin, due to use of heat block versus
`
`
`24 Haugsgjerd ‘348 Reexamination Decl. (AKBM Ex. 1047).
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`Patent Owner Preliminary Response
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`
`water/oil bath
`
` Flushed samples with nitrogen and froze to
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`20°C prior to heating, a step not taught by
`
`Beaudoin25
`
` Never made available for deposition in
`
`litigation and did not submit a witness
`
`statement
`
`Haugsgjerd/
`
`4/2012 Commissioned
`
` No testing to determine levels of water,
`
`van Breemen
`
`(“Haugsgjerd
`
`Two”)
`
`by Petitioner for
`
`solvent, and free fatty acids in the samples
`
`reexamination
`
` Never made available for deposition in
`
`of parent to
`
`litigation and did not submit a witness
`
`present patent26
`
`statement
`
`Budge/
`
`9/2013 Commissioned
`
` Excessive water removal using steps not
`
`van Breemen
`
`Avanti/Chemir
`
`(“Budge
`
`Recreation”)
`
`by Petitioner for
`
`taught by Beaudoin
`
`Inter Partes
`
` No testing to determine levels of water,
`
`Review of the
`
`present patent
`
`solvent, and free fatty acids in the samples
`
` 1/3 of samples discarded without testing
`
`
`25 Haugsgjerd ‘348 Reexamination Decl. (AKBM Ex. 1047), para. 3 on pp. 000002-000003.
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`26 Haugsgjerd ‘348 Reexamination Supp. Decl. (AKBM Ex. 1048).
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`Prior art recreations that deviate from the reference, or that are not confirmed to be
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`reliable repeats, do not provide evidence of inherent anticipation. See Pfizer Inc. v. Teva
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`Pharm. U.S.A., Inc., 882 F. Supp. 2d 643, 680 (D. Del. 2012) (“[expert] did not accurately
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`reproduce the reaction … [c]onsequently, the court concludes that [expert]’s detection of 3-
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`[molecule] during his reaction is not reliable to establish inherent anticipation”). Given the
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`known deviations and unreliability of the Beaudoin recreations, they fail to prove that
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`Beaudoin inherently anticipates the claimed phospholipid.
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`Further, all of these Beaudoin recreations used different procedures. For example,
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`the Haugsgjerd One recreation used ineffective convection heating, placing the samples on
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`a heat block rather than in a water or oil bath as was done in other recreations such as
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`Haugsgjerd Two and the Budge recreation.27 The Budge recreation also added water-
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`removal methods, which were different and more extensive from the disclosed methods of
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`Beaudoin. For example, Dr. Budge added the use of separatory funnel, centrifugation, and
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`heating at reduced pressure to reduce the water content of the samples – steps which were
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`not taught by Beaudoin.28
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`It is simply nonsensical to claim, as Petitioner does, that all of these differing
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`procedures are consistent with Beaudoin’s disclosed process. Almost all of these
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`27 Jaczynski Stmnt (NEPN Ex. 2001), at Q/A 160-66; Haugsgjerd ‘348 Reexamination Decl.
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`(AKBM Ex. 1047); Gundersen Decl. (AKBM Ex. 1049).
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`28 See, e.g., Jaczynski Stmnt (NEPN Ex. 2001), at Q/A 199.
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`Patent Owner Preliminary Response
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`recreations, in particular, the Budge Recreation, added steps not disclosed by Beaudoin.
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`This disqualifies the samples obtained as evidence of any inherent qualities of Beaudoin’s
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`krill extracts. For example, in Eli Lily and Co. v. Barr Labs., Inc., 251 F.3d 955, 970 (Fed.
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`Cir. 2001), the Federal Circuit stated that “[a] reference includes an inherent characteristic if
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`that characteristic is the “natural result” flowing from the reference’s explicitly explicated
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`limitations” (emphasis added, internal citation omitted).
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`Furthermore, all of these deviations from Beaudoin significantly changed the
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`characteristics of the oil samples. For example, these deviations had the effect of (1)
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`removing more water and solvent from the extract prior to heating, and/or (2) subjecting the
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`samples to milder heating than taught by Beaudoin.29 Both of these effects would reduce
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`the hydrolysis that would occur upon heating of the samples, increasing the odds of
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`preserving the claimed phospholipid as well as other phospholipids in the extract.30 These
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`deviations skew the results of any analysis performed on Petitioner’s samples in favor of
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`Petitioner’s allegations.31
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`Petitioner provides no evidence that the work by Mr. Haugsgjerd or Dr. Gundersen
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`was accurate and reliable. The only record evidence of their experiments are cursory
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`declarations submitted to the Office, which do not provide sufficient detail to explain their
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`29 See, e.g., Jaczynski Stmnt (NEPN Ex. 2001), at Q/A 158, 165-66, 218.
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`30 Jaczynski Stmnt (NEPN Ex. 2001), at Q/A 158, 165-66, 218.
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`31 Jaczynski Stmnt (NEPN Ex. 2001), at Q/A 219-20, 227.
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`Patent Owner Preliminary Response
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`methods.32 Moreover, the Haugsgjerd One recreation actually rebuts Petitioner’s claim of
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`inherency, because Dr. Gundersen’s testing of these samples failed to detect the claimed
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`phospholipid in 25% of the samples tested.33
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`The most recent recreation, performed by Dr. Budge, is also unreliable because
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`Petitioner cherry-picked which samples would be tested for the presence of the claimed
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`phospholipid, discarding a full one-third of Dr. Budge’s samples. Petitioner’s own expert has
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`admitted that this significant group of samples was “anomalous” and that he did “not know
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`the cause’ of the results.34 Clearly, Petitioner was not confident that all of the Budge
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`samples would “necessarily” contain the claimed phospholipid.
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`In addition, none of recreations were tested to determine the concentration of water,
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`solvent, or free fatty acids.35 As detailed above, these are critical components that affect a
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`krill lipid extract’s susceptibility to hydrolysis and are explicitly taught in Beaudoin.36
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`The samples therefore cannot prove inherent anticipation because there is no
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`evidence that they were similar in various key aspects to Beaudoin’s extracts. See In re
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`32 Id., at Q/A 155, 175-78.
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`33 Gundersen Decl. (AKBM Ex. 1049).
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`34 Jaczynski Stmnt (NEPN Ex. 2001), at Q/A 248-250.
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`35 The Petitioner also failed to test numerous other characteristics of their recreated
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`samples that would have made it possible to the disclosure of Beaudoin.
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`36 Beaudoin I (AKBM Ex. 1002), pp. 22-23.
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`Patent Owner Preliminary Response
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`Armodafinil Patent Lit., 939 F. Supp. 2d 456, 478 (D. Del. 2013) (“defendants have failed to
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`prove anticipation . . . because they have not established that their Preparation I
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`experiments were accurate and produced the material intended by the ‘855 Patent’s
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`Preparation”). Petitioner’s team of experts could have easily tested the Budge Recreation,
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`or any of its other recreation, samples for water, solvent, and free fatty acid to attempt to
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`demonstrate their similarity to Beaudoin’s extracts. The failure to do so casts doubt on
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`Petitioner’s anticipation opinion based on this recreation. See Pfizer, 882 F. Supp. 2d at
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`679-80 (“[expert]’s failure to confirm whether he ran the reaction properly undermines the
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`reliability of his results and his anticipation opinion generated from those results.”).
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`Furthermore, even in some of Petitioner’s own recreations, such as Haugsgjerd One,
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`the claimed phospholipid was not detected. The Haugsgjerd One recreation produced
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`twelve “Beaudoin” oil samples, and the claimed phospholipid was not detected in three out
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`of the twelve.37 This in itself, is fatal to Petitioner’s inherency theory. See Glaxo Inc. v.
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`Novopharm Ltd., 52 F.3d 1043, 1047 (Fed. Cir. 1995) (even though defendant’s experts
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`reproduced a prior art method “thirteen times and each time they made [the claimed]
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`crystals,” the patentee’s chemists twice produced different crystals from the same method,
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`thus precluding inherency).
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`Having failed to prove that Beaudoin expressly or inherently discloses the claimed
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`phospholipid, Petitioner cannot prove anticipation of claims 1, 24, 47, 70, and 94, or of any
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`37 Gundersen Decl. (AKBM Ex. 1049), para. 5 on pp. 000002-000004.
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`claims that depend therefrom.
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`Patent Owner Preliminary Response
`Case No: IPR2014-00003
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`(ii) Beaudoin does not disclose an extract “suitable for human
`consumption”
`In addition to lacking the claimed phospholipid, Beaudoin does not disclose an
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`extract “suitable for human consumption” as required by all patented claims. For example,
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`Table 13 of Beaudoin I indicates that Beaudoin’s fractions contain high levels of moisture
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`and solvent, specifically, 10.0 and 6.8%.38
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`Indeed, Beaudoin