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` Paper 45
`Entered: May 16, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`AKER BIOMARINE AS
`Petitioner
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`v.
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`NEPTUNE TECHNOLOGIES AND BIORESSOURCES INC.
`Patent Owner
`_______________
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`Case IPR2014-00003
`Patent 8,278,351 B2
`_______________
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`
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`Before LORA M. GREEN, JACQUELINE WRIGHT BONILLA, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
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`BONILLA, Administrative Patent Judge.
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`DECISION
`Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
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`Case IPR2014-00003
`Patent 8,278,351 B2
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`I.
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`INTRODUCTION
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`Aker Biomarine AS (“Aker”) filed a Petition to institute an inter partes review
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`of claims 1-94 of U.S. Patent No. 8,278,351 B2 (Ex. 1001; “the ’351 patent”).
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`Paper 6 (“Pet.”). Neptune Technologies and Bioressources, Inc. (“Neptune”) filed a
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`Patent Owner Preliminary Response. Paper 16. Thereafter, the Parties filed a Joint
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`Motion to Limit Petition, requesting that the Board limit the Petition to claims 1-6,
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`9, 12-13, 19-29, 32, 35-36, and 42-46 of the ’351 patent. Paper 18. We granted
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`the Joint Motion, thereby limiting this proceeding to the aforementioned claims.
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`Paper 21.
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`On March 23, 2014, we instituted a trial based on Petitioner’s challenges to:
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`(1) claims 1, 3-6, 9, 12, 13, 19-24, 26-29, 32, 35, 36, and 42-46, but not claims 2
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`and 25, as anticipated by WO 00/23546 (Ex. 1002, “Beaudoin I”), and (2) all
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`challenged claims as obvious over the combination of Fricke (Ex. 1006), Bergelson
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`(Ex. 1017), Yasawa (Ex. 1015), Itano (Ex. 1009), and the WHO Bulletin
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`(Ex. 1018). Paper 22 (“Decision”). We denied all remaining grounds of
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`unpatentability as redundant to the above grounds, except that we denied all
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`anticipation grounds asserted in the Petition regarding claims 2 and 25. Id. at 27-
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`28, 16-20. In its Request for Rehearing, Aker asks that the Board reconsider its
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`denial to institute a review of claims 2 and 25 as anticipated by Beaudoin I.
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`Paper 26 (“Rehearing Req.”) 1-3.
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`II. ANALYSIS
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`When rehearing a decision on petition, the Board reviews the decision for an
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`abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may be
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`determined if a decision is based on an erroneous interpretation of law, if a factual
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`finding is not supported by substantial evidence, or if the decision represents an
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`Patent 8,278,351 B2
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`unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United
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`States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d
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`1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315-16 (Fed. Cir.
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`2000). The party requesting rehearing has the burden of showing the decision
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`should be modified, and “[t]he request must specifically identify all matters the
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`party believes the Board misapprehended or overlooked, and the place where each
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`matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R.
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`§ 42.71(d).
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`Claims 2 and 25
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`Dependent claims 2 and 25 each recite the krill extract of claim 1 or 24,
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`respectively, having “a total phospholipid concentration in an amount of about
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`40% w/w, wherein about represents ±10%.” Ex. 1001, 28:65-67, 31:36-38. We
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`denied Aker’s ground that Beaudoin I anticipates claims 2 and 25. Decision 17.
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`In its Request for Rehearing, Aker contends two points. Rehearing Req. 2.
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`First, Aker asserts that the Board incorrectly applied the standard of inherent
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`anticipation, and overlooked that “Beaudoin I explicitly discloses a phospholipid
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`concentration within the claimed range.” Id. at 2, 5-6. We note that we addressed
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`both express and inherent anticipation in our Decision when stating that “Aker fails
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`to explain adequately how the range disclosed by Beaudoin I fell within a range
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`defined as about 40% w/w, wherein about represents ±10%, i.e., from 30% to
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`50%.” Decision 17. That said, we grant the Request for Rehearing to explain
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`more fully why we denied Aker’s ground of anticipation of claims 2 and 25 by
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`Beaudoin I, whether it be express or inherent anticipation.
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`As Aker correctly notes in its Petition, “Beaudoin I discloses 54.1+/-6.1%
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`phospholipids and polar material w/w in Fraction I extracts.” Pet. 20 (citing
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`Ex. 1002, 23, Table 14) (emphasis added). Thus, Beaudoin I’s description of
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`concentration percentages of “[p]hospholipids or other polar material” in Table 14
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`does not disclose explicitly a total phospholipid concentration as recited in
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`challenged claims 2 and 25. Ex. 1002, Table 14. Rather, Table 14 in Beaudoin I
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`describes percentages, in krill oil Fractions I and II, of material having
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`phospholipids (at some undisclosed concentration) plus “other polar material” (at
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`some undisclosed concentration). Thus, Aker does not explain sufficiently in its
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`Petition, or in its Request for Rehearing, how one can ascertain the total
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`phospholipid concentration of Fraction I by looking at Table 14 or elsewhere in
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`Beaudoin I.
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`It is possible that Fraction I contains the recited total phospholipid
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`concentration (see Decision 17), but Table I does not describe expressly that it
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`does. Table 14 of Beaudoin I indicates that the total phospholipid concentration in
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`Fraction I depends on the amount of “other polar material,” as well as the final
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`concentration of “[p]hospholipids or other polar material,” existing in that fraction.
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`Ex. 1002, Table 14. Aker fails to establish adequately, with argument or evidence,
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`that “Beaudoin I expressly discloses phospholipid concentrations within the ranges
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`claimed by claims 2 and 25.” Rehearing Req. 6-7. Thus, Aker does not establish a
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`reasonable likelihood that it would prevail on the ground that Beaudoin I expressly
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`anticipates challenged claims 2 and 25.1
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`1 In its Request for Rehearing, Aker also contends that Beaudoin I alone renders
`claims 2 and 25 prima facie obvious. See, e.g., Rehearing Req. 9-10, 14. A
`rehearing request “must specifically identify all matters the party believes the
`Board misapprehended or overlooked, and the place where each matter was
`previously addressed in a motion . . . .” 37 C.F.R. § 42.71(d). Aker fails to show
`where it asserted this obviousness ground in its Petition. See, e.g., Pet. i-ii, Table
`of Contents. Consistently, the “error” asserted by Aker in its Request for
`Rehearing relates to the ground of anticipation by Beaudoin I.
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`In its second point, Aker further contends that the “Board adopted Aker’s
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`argument that because ‘the processes described in the ’351 patent and . . . the prior
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`art [Beaudoin I] are virtually indistinguishable,’ as a result so, too, ‘would be the
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`resulting extracts.’” Rehearing Req. 2-3, 11 (citing Pet. 12;2 Decision 13). Thus,
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`according to Aker, it established a prima facie case of anticipation, and under In re
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`Best and “its progeny,” the burden shifted to Neptune to produce evidence as to
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`why the resulting compositions would be different, which Aker contends Neptune
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`failed to do. Id. at 3, 10-13 (citing In re Best, 562 F.2d 1252, 1255 (CCPA 1977);
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`In re Spada, 911 F.3d 705, 708 (Fed. Cir. 1990)).
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`Contrary to Aker’s assertion, we did not “adopt” Aker’s contention that the
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`processes of the ’351 patent and Beaudoin I are virtually indistinguishable.
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`Rehearing Req. 2-3, 11. Aker cites our Decision at page 13, which discusses the
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`asserted ground of anticipation of claims 1 and 24 by Beaudoin I. While we
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`discuss some of Aker’s contentions, the Decision concludes that “evidence
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`presented by Aker tends to demonstrate that the E. pacifica krill extract disclosed
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`in Beaudoin I comprised at least one phospholipid” recited in claim 1 “under the
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`principles of inherency as explained by Aker,” citing page 12 of Aker’s Petition.
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`Decision 13 (citing Pet. 12). On page 12 of its Petition, Aker asserts that Neptune
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`“identif[ies] phospholipid molecules that naturally occur in krill and all prior krill
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`extracts,” i.e., an inherency position. Pet. 12.
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`In support of its inherency position regarding claims 1 and 24, Aker cited
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`declaration evidence, including the van Breeman Declaration (Ex. 1040). Pet. 14.
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`Specifically, as noted in our Decision, the “van Breemen Declaration, in particular,
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`2 The Request for Rehearing cites Paper 4 at 12. See Rehearing Req. 2-3. Paper 4
`is a Certificate of Service. We assume that Aker intends to refer to its Petition
`(Paper 6) at 12.
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`provides mass spectrometry evidence that the E. pacifica acetone extracts
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`contained PC-EPA/EPA, PC-DHA/DHA, and PC-EPA-DHA.” Decision 11 (citing
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`Ex. 1040, ¶¶ 73-85, 93-98). That declaration evidence, not Aker’s contention that
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`the processes of Beaudoin I and the ’351 patent are virtually indistinguishable,
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`persuaded us that Aker established a reasonable likelihood that it would prevail on
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`the ground that Beaudoin I anticipates claims 1 and 24.
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`Moreover, in relation to claims 2 and 25, Aker argued in its Petition that
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`“Beaudoin I discloses 54.1+/-6.1% phospholipids and polar material w/w in
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`Fraction I extracts (Ex. 1002, Table 14, p. 23[])[,] which falls within or touches the
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`claimed ranges.” Pet. 20. Thus, Aker did not assert the “virtually
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`indistinguishable” process argument in relation to claims 2 and 25 in its Petition,
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`nor did it explain how In re Best applies in the context of the additional limitations
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`added by these two dependent claims. Rather, Aker only made that argument in
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`relation to independent claims 1 and 24. Id.; see also id. at 12-19.
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`Even if we assume that Aker’s contentions regarding claims 1 and 24 apply
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`equally to claims 2 and 25, however, Aker still fails to establish a reasonable
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`likelihood of prevailing. In its Request for Rehearing, Aker contends that it
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`explained previously that the extraction processes in Beaudoin I and the
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`’351 patent are “virtually indistinguishable.” Rehearing Req. 10-11 (citing
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`Pet. 12). In its Petition, Aker relies on declarations by Drs. Storrø and Brenna,
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`“which present a line-by-line comparison of the ’351 and the Beaudoin I and II
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`methods,” and points to certain processes described in Beaudoin I and the
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`’351 patent. Pet. 12, 17 (citing Ex. 1046, ¶ 7; Ex. 1042, ¶ 63; Ex. 1002, 5:21-6:20;
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`Ex. 1001, 18:53-19:9).
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`Notably, the “line-by-line” comparisons presented in the declarations by
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`Drs. Storrø and Brenna, as well as cited disclosures in Beaudoin I and the
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`’351 patent themselves, describe that multiple steps in the referenced processes
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`include different options. See, e.g., Ex. 1046, ¶ 7 (using terms such as
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`“preferable,” “preferred,” “preferably,” and “optionally”); Ex. 1042, ¶ 63 (using
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`terms such as “best,” “preferred,” “preferably,” and “optionally”). Aker does not
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`establish sufficiently what specific processes (i.e., which exact options) Beaudoin I
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`used when making extracts, such as the fractions described in Table 14.
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`Moreover, evidence cited by Aker in relation to its “virtually
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`indistinguishable” contention, including the “line-by-line comparison,” all indicate
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`that the relevant processes in Beaudoin I and the ’351 patent include two separate
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`extraction steps, e.g., “a 2 hour extraction with 6:1 volume ratio of acetone,” and
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`extraction “with alcohol, such as ethanol, isopropanol, t-butanol or alternatively
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`with ethyl acetate, preferably two volumes (original volume of material).”
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`Ex. 1002, 5:30-6:17; Ex. 1001, 18:32-45 (stating that the “most preferred
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`extraction solvent system is 100% acetone in the first extraction followed with a
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`95%/5% ethyl acetate/ethanol mixture” extraction). Table 14 of Beaudoin I,
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`however, describes “[p]hospholipids or other polar material” in Fractions I and II.
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`Ex. 1002, 23, Table 14. Beaudoin I describes that Fraction I (subjected to the first
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`extraction step only) contains 54.1 ±6.1 percent of “[p]hospholipids or other polar
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`material,” while Fraction II (subjected to both extraction steps) contains only
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`8.5 ±1.6 % of the same material. Id. at Table 14, notes a) and b).
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`Thus, Beaudoin I describes that its processes involving two extraction steps,
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`which Aker contends are “virtually indistinguishable” to processes described in the
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`’351 patent, produce an extract (Fraction II) that does not have the total
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`phospholipid concentration recited in claims 2 and 25. Instead, Beaudoin I’s
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`Fraction II has a lower total phospholipid concentration (i.e., a portion of 8.5
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`±1.6 % of “[p]hospholipids or other polar material,” as compared to 30-50%
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`phospholipids), indicating that processes of Beaudoin I and the ’351 patent are not,
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`in fact, “virtually indistinguishable.” Aker has not established sufficiently,
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`therefore, that Beaudoin I, when preparing extracts, such as those analyzed in
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`Table 14, used a process that was “virtually indistinguishable” from that used by
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`the ’351 patentee when preparing the extracts recited in claims 2 and 25 (see, e.g.,
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`Ex. 1001, 17:49-18:6, Table 5).
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`Thus, on the record before us, Aker does not establish that the Board abused
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`its discretion when concluding that Aker failed to establish a reasonable likelihood
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`that it would prevail on the ground that Beaudoin I anticipates challenged claims 2
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`and 25, expressly or inherently.
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`Claims 3 and 26
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`Having granted Aker’s Request for Rehearing with regard to claims 2 and
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`25, we also address a matter misapprehended in our Decision regarding dependent
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`claims 3 and 26. Claims 3 and 26 are similar to claims 2 and 25, except that each
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`of claims 3 and 26 recite the krill extract of claim 1 or 24, respectively, having “a
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`total phospholipid concentration in an amount of about 45% w/w, wherein about
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`represents ±20%,” i.e., a total phospholipid concentration in the range of 25-65%
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`w/w. Ex. 1001, 29:1-3, 31:39-41. We previously concluded that “there is a
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`reasonable likelihood that Aker will prevail in demonstrating unpatentability of
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`claims 3 and 26 as anticipated by Beaudoin I.” Decision 14.
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`Upon reconsideration of our Decision regarding these claims, we conclude
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`that Aker has not established a reasonable likelihood that it would prevail on the
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`ground that Beaudoin I anticipates challenged claims 3 and 26, expressly or
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`inherently, for all of the same reasons discussed above, and in our previous
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`Decision (Decision 17), in relation to claims 2 and 25. For example, Beaudoin I’s
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`Fraction II has a lower total phospholipid concentration (i.e., a portion of
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`8.5 ±1.6 % of “[p]hospholipids or other polar material,” as compared to 25-65%
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`phospholipids as required by claims 3 and 26), indicating that processes of
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`Beaudoin I and the ’351 patent are not, in fact, “virtually indistinguishable.”
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`Similarly, we conclude that Aker has not established a reasonable likelihood that it
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`would prevail on the ground that Beaudoin II (Ex. 1003), Maruyama (Ex. 1004),
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`Fujita (Ex. 1005), or Fricke (Ex. 1006) anticipates challenged claims 3 and 26, for
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`the same reasons discussed above and previously (Decision 18-20), in relation to
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`claims 2 and 25.
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`Thus, we modify our previous Decision to deny Aker’s grounds that
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`Beaudoin I, Beaudoin II, Maruyama, Fujita, or Fricke anticipates claims 3 and 26.
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`III. CONCLUSION
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`We grant Aker’s Request for Rehearing to explain in more detail our
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`reasoning for denying institution of a trial based on the ground of anticipation of
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`claims 2 and 25 by Beaudoin I. For the reasons discussed above, Aker has not
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`carried its burden of demonstrating an abuse of discretion in our Decision in
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`relation to anticipation of claims 2 and 25. 37 C.F.R. § 42.71(c). We modify our
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`previous Decision, however, to deny Aker’s ground that Beaudoin I anticipates
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`claims 3 and 26, and to clarify that we deny Aker’s grounds that Beaudoin II,
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`Maruyama, Fujita, and Fricke each anticipate claims 3 and 26, for the same reasons
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`discussed above in relation to claims 2 and 25.
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`For the reasons given, it is
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`IV. ORDER
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`ORDERED that our previous Order in our Decision instituting inter partes
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`review (Paper 22, 28-29) is modified to the extent that we deny the Petition with
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`respect to the grounds that claims 3 and 26 of the ’351 patent, under 35 U.S.C.
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`§ 102, are anticipated by each of Beaudoin I, Beaudoin II, Maruyama, Fujita, and
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`Fricke.
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`PETITIONER:
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`J. Mitchell Jones
`Casimir Jones SC
`jmjones@casimirjones.com
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`Amanda Hollis
`Kirkland & Ellis
`amanda.hollis@kirkland.com
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`PATENT OWNER:
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`Stephen L. Altieri
`Cooley LLP
`saltieri@cooley.com
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`J. Dean Farmer
`Cooley LLP
`dfarmer@cooley.com
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