Trials@uspto.gov
`571-272-7822
`
`Paper 11
`Date: September 10, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH
`ORGANISATION,
`Petitioner,
`v.
`BASF PLANT SCIENCE GMBH,
`Patent Owner.
`
`PGR2020-00033
`Patent 10,301,638 B2
`
`
`
`
`
`
`
`
`
`Before ULRIKE W. JENKS, JO-ANNE M. KOKOSKI, and JEFFREY W.
`ABRAHAM, Administrative Patent Judges.
`KOKOSKI, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Post-Grant Review
`35 U.S.C. § 324(a)
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 11
`Date: September 10, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH
`ORGANISATION,
`Petitioner,
`v.
`BASF PLANT SCIENCE GMBH,
`Patent Owner.
`
`PGR2020-00033
`Patent 10,301,638 B2
`
`
`
`
`
`
`
`
`
`Before ULRIKE W. JENKS, JO-ANNE M. KOKOSKI, and JEFFREY W.
`ABRAHAM, Administrative Patent Judges.
`KOKOSKI, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Post-Grant Review
`35 U.S.C. § 324(a)
`
`
`
`
`
`
`
`
`
`PGR2020-00033
`Patent 10,301,638 B2
`
`INTRODUCTION
`I.
`Commonwealth Scientific and Industrial Research Organisation
`(“Petitioner”) filed a Petition requesting post-grant review of claims 1–23
`(“the challenged claims”) of U.S. Patent No. 10,301,638 B2 (“the ’638
`patent,” Ex. 1001). Paper 2 (“Pet.”). BASF Plant Science GmbH (“Patent
`Owner”) filed a Preliminary Response. Paper 9 (“Prelim. Resp.”).
`Under 35 U.S.C. § 324(a), a post-grant review may be instituted only
`if “the information presented in the petition . . . demonstrate[s] that it is more
`likely than not that at least 1 of the claims challenged in the petition is
`unpatentable.” Post-grant review is available for patents that issue from
`applications that at one point contained at least one claim with an effective
`filing date on or after March 16, 2013. See Leahy-Smith America Invents
`Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1),
`6(f)(2)(A). Upon consideration of the Petition, the Preliminary Response,
`and the evidence of record, we determine that the evidence and arguments
`presented in the Petition are sufficient to establish that it is more likely than
`not that at least one of the challenged claims is unpatentable. Accordingly,
`for the reasons that follow, we institute a post-grant review of claims 1–23
`of the ’638 patent.
`A. Real Parties-in-Interest
`Petitioner identifies Commonwealth Scientific and Industrial Research
`Organisation as the real party-in-interest. Pet. 4. Patent Owner identifies
`BASF Plant Sciences GmbH as the real party-in-interest. Paper 8, 1.
`B. Related Matters
`The parties identify as related matters several U.S. patent applications
`that claim the benefit of priority to the application that issued as the ’638
`patent. Pet. 5–6; Paper 8, 1.
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`PGR2020-00033
`Patent 10,301,638 B2
`C. The ’638 Patent
`The ’638 patent, titled “Oils, Lipids and Fatty Acids Produced in
`Transgenic Brassica Plant,” issued on May 28, 2019 from U.S. Application
`No. 15/256,914 (“the ’914 application”), filed on September 6, 2016.
`Ex. 1001, codes (21), (22), (45), (54). The ’914 application is a continuation
`of U.S. Application No. 12/280,090 (“the ’090 application”), which was
`filed as Application No. PCT/EP2007/051675 (“the ’675 PCT”) on Feb. 21,
`2007.
`The ’638 patent relates to a process for the production of
`eicosapentaenoic acid (“EPA”), docosapentaenoic acid (“DPA”), and/or
`docosahexaenoic acid (“DHA”) in transgenic plants, and to “oils, lipids,
`and/or fatty acids which have been produced by the process.” Ex. 1001,
`1:25–27, 2:1–3. The Specification explains that there is “a great need for a
`simple, inexpensive process for the production of polyunsaturated, long-
`chain fatty acids, specifically in plant systems” for use in fortifying food and
`animal feed. Id. at 6:4–8. To that end, the Specification teaches that the
`yield of long-chain polyunsaturated fatty acids (“LCPUFAs”), particularly
`EPA, DPA, and/or DHA “can be increased by expressing an optimized Δ5-
`elongase sequence in transgenic plants.” Id. at 6:15–19.
`The process described in the ’638 patent includes providing to a plant
`nucleic acid sequences that code for each of a polypeptide having (1) Δ6-
`desaturase activity; (2) Δ6-elongase activity; (3) Δ5-desaturase activity; and
`(4) Δ5-elongase activity. Id. at 6:27–42. “To produce DHA it is
`additionally necessary to provide at least one nucleic acid sequence which
`codes for a polypeptide having Δ4-desaturase activity in the plant.” Id. at
`6:42–45. The Specification teaches that the fatty acids EPA, DPA, and/or
`DHA produced by the process are “present with a content of in each case at
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`PGR2020-00033
`Patent 10,301,638 B2
`least 5% by weight, preferably of in each case at least 6, 7, 8 or 9% by
`weight, particularly preferably of in each case at least 10, 11, or 12% by
`weight, and most preferably of in each case at least 13, 14, 15, 16, 17, 18,
`19, or 20% by weight based on the total fatty acids in the transgenic plant.”
`Id. at 15:29–36.
`The Specification further teaches that useful plants that are suitable
`for the process include “plants which serve to produce foods for humans or
`animals, to produce other consumables, fibers and pharmaceuticals,” such as
`cereals, tubers, sugar plants, and oil and fat crops. Id. at 16:61–17:4.
`Several plant families are identified as being “advantageous,” including the
`Brassicaceae family. Id. at 17:4–16; see id. at 23:38–52.
`D. Challenged Claims
`Petitioner challenges claims 1–23 (“the challenged claims”) of
`the ’638 patent. Claims 1 and 9 are the only independent claims, and are
`reproduced below:
`1. Oils, lipids and/or fatty acids produced by a transgenic
`Brassica plant, wherein said oils, lipids, and/or fatty acids
`comprise 60 to 85% by weight of polyunsaturated fatty acids
`based on the total fatty acids in the transgenic plant, wherein
`said polyunsaturated fatty acids comprise at least 20% by
`weight of eicosapentaenoic acid (EPA), at least 2% by weight
`of docosapentaenoic acid (DPA), and at least 4% by weight of
`docosahexaenoic acid (DHA) based on the total fatty acids in
`the transgenic plant in the form of triacylglycerides.
`Ex. 1001, 61:36–45.
`9. Oils, lipids and/or fatty acids produced by a transgenic
`Brassica plant, wherein said oils, lipids and/or fatty acids
`comprise a total amount of at least 54% by weight of
`polyunsaturated ω3-fatty acids based on the total fatty acids in
`the transgenic plant.
`Id. at 62:63–67.
`
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`PGR2020-00033
`Patent 10,301,638 B2
`E. Asserted Grounds
`Petitioner asserts that claims 1–23 would have been unpatentable on
`the following grounds:
`Claim(s) Challenged 35 U.S.C. §
`1–23
`112(a)
`1–23
`112(a)
`
`9
`
`102(a)
`
`9, 10, 12, 13, 14, 16
`
`102(a)
`
`Reference(s)/Basis
`Lack of written description support1
`Lack of enablement2
`Published PCT Application
`No. WO 99/64614 (“the ’614
`publication,” Ex. 1012)
`Published PCT Application No. WO
`2015/196250 A1
`(“the ’250 publication,” Ex. 1014)
`Published PCT Application No. WO
`2005/083093 A2 (“the ’093
`publication,” Ex. 1006)
`Pet. 33–36. Petitioner relies on the Declaration of Narendra Yadav, Ph.D.,
`(Ex. 1002, “the Yadav Declaration”) to support its contentions.
`II. ANALYSIS
`A. Level of Ordinary Skill in the Art
`Petitioner contends that a person having ordinary skill in the art
`“would have had at least a Ph.D. in molecular biology, molecular genetics,
`biochemistry, or a related field and at least 3–5 years of experience in
`molecular genetics or biology, plant genetics, or recombinant DNA
`techniques,” but that “[a]n individual need not have every qualification
`enumerated above and more experience, such as research work on plant
`lipids, can compensate for less formal education.” Pet. 38 (citing Ex. 1002
`
`1–23
`
`102(a) or
`103
`
`
`1 Grounds 1–11 challenge subsets of claims 1–23 for lack of written
`description support based on different claim limitations.
`2 Grounds 12–22 challenge subsets of claims 1–23 for lack of enablement of
`different claim limitations.
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`5
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`PGR2020-00033
`Patent 10,301,638 B2
`¶ 15). Patent Owner responds that, “for the limited purposes of the Board’s
`consideration of the Petition,” it “does not contest” Petitioner’s proposed
`definition. Prelim. Resp. 7.
`Petitioner’s proposed definition is consistent with the cited prior art
`and the disclosure of the ’638 patent, and we adopt it for purposes of this
`Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001)
`(explaining that specific findings regarding ordinary skill level are not
`required “where the prior art itself reflects an appropriate level and a need
`for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State
`Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).
`B. Claim Construction
`We construe each claim “in accordance with the ordinary and
`customary meaning of such claim as understood by one of ordinary skill in
`the art and the prosecution history pertaining to the patent.” 37 C.F.R.
`§ 42.100(b) (2019). Under this standard, claim terms are generally given
`their plain and ordinary meaning as would have been understood by a person
`of ordinary skill in the art at the time of the invention and in the context of
`the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313
`(Fed. Cir. 2005) (en banc). Only those terms in controversy need to be
`construed, and only to the extent necessary to resolve the controversy. See
`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013,
`1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795, 803 (Fed. Cir. 1999)).
`Petitioner proposes constructions for the claim terms “polyunsaturated
`ω-3 fatty acids,” “by weight . . . based on the total fatty acids in the
`transgenic plant in the form of triacylglycerides,” “by weight . . . based on
`the total fatty acids in the transgenic plant,” and “by weight . . . present in
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`the sn-1, sn-2, or sn-3 position” of triacylglyceride. Pet. 37–38 (citing
`Ex. 1002 ¶¶ 73–76). Patent Owner argues that the claim terms in the form
`of “at least X%” should mean “greater than or equal to X%, and less than the
`inherent upper limit enabled by the specification.” Prelim. Resp. 12. For
`purposes of this Decision, and based on the record before us, we determine
`that none of the claim terms requires an explicit construction to resolve the
`controversy between the parties.
`C. Post-Grant Review Eligibility
`As a threshold issue, we must determine whether the ’638 patent is
`eligible for post-grant review. There are two requirements that must be met
`for post-grant review to be available. First, post-grant review is only
`available if the petition is filed within nine months of the issuance of the
`challenged patent. 35 U.S.C. § 321(c) (2018). Here, the Petition was filed
`on February 28, 2020, which is within nine months of the ’638 patent’s
`May 28, 2019 issue date. Exhibit 1001, code (45).
`Second, as noted above, post-grant review is available only for patents
`that issue from applications that at one point contained at least one claim
`with an effective filing date of March 16, 2013 or later. See AIA §§ 3(n)(1),
`6(f)(2)(A). The “effective filing date” for a claim is either the application’s
`actual filing date or the filing date of the earliest application that supports the
`claim. 35 U.S.C. § 100(i) (2018).
`Petitioner has the burden of establishing eligibility for post-grant
`review. See Mylan Pharms. Inc. v. Yeda Res. & Dev. Co., PGR2016-00010,
`Paper 9 at 10 (PTAB Aug. 15, 2016). To show that the ’638 patent is
`eligible for post-grant review, Petitioner bears the burden of proving that the
`challenged claims lack the benefit of the filing date of the earliest
`application that supports the claims. In particular, Petitioner must show that
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`Patent 10,301,638 B2
`at least one of the challenged claims “was not disclosed in compliance with
`the written description and enablement requirements of § 112(a) in the
`earlier application for which the benefit of an earlier filing date prior to
`March 16, 2013 was sought.” Inguran, LLC v. Premium Genetics (UK) Ltd.,
`PGR2015-00017, Paper 8 at 11 (PTAB Dec. 22, 2015).
`Petitioner contends that the ’638 patent is eligible for post-grant
`review because none of the challenged claims are entitled to an effective
`filing date earlier than September 6, 2016, which is the actual filing date of
`the application for the ’638 patent. Pet. 38–80. Petitioner’s contention is
`based on its argument that “the claims of the ’638 Patent lack written
`description and enablement in the priority applications,” and, thus, “are not
`disclosed in the manner provided by 35 U.S.C. § 112(a) by any pre-AIA
`application.” Id. at 2–3.
`Patent Owner responds that the ’638 patent is a direct continuation of,
`and shares an identical specification with, the ’090 application that was filed
`on February 21, 2007, and is entitled to this pre-AIA priority date. Prelim.
`Resp. 25. In particular, Patent Owner argues that “the prosecution history of
`the patent makes clear that the patent is a pre-AIA patent, ineligible for post-
`grant review, because the Patent Office repeatedly treated and referenced it
`as a pre-AIA application during examination.” Id. at 27 (citing Ex. 1009,
`507, 528, 889, 935, 945, 1000). Although we recognize that the pre-AIA
`status designations during prosecution may be considered, that alone is not
`conclusive. See Mylan, Paper 9 at 7 (noting that patent examiner
`substantively considered whether the subject matter in the claims at issue
`was disclosed by the ancestor application because the examiner initially
`rejected the claims for obviousness-type double patenting); Merck Sharp &
`Dohme Corp. v. Wyeth LLC, PGR2017-00016, Paper 9 at 14–15 (PTAB
`
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`Oct. 20, 2017) (noting that the challenged patent’s assignment of pre-AIA
`status during prosecution was “consistent with our decision that Petitioner
`fails to demonstrate adequately that the [challenged patent] is eligible for
`post-grant review”). Therefore, contrary to Patent Owner’s arguments, we
`do not treat the pre-AIA designation made during prosecution as dispositive
`of the issue of whether the ’638 patent is eligible for post-grant review.
`Patent Owner also argues that instituting a post-grant review “for a
`continuation patent that shares an identical disclosure to its pre-AIA parent
`. . . would invite post-grant reviews that Congress did not intend, because
`the” requirement that the challenged patent have an effective filing date that
`post-dates the AIA “would effectively be eliminated.” Prelim. Resp. 26.
`We disagree. It is well-established by prior Board decisions that a patent
`claiming the benefit of a priority application filed before March 16, 2013
`must have written description support in, and be enabled by, the earlier-filed
`application to avoid PGR-eligibility. See, e.g., Inguran, Paper 8 at 10–11;
`Arkema Inc. v. Honeywell Int’l Inc., PGR2016-00011, Paper 54 at 21–22
`(PTAB Aug. 31, 2017). That the ’638 patent claims priority to a pre-AIA
`filing date does not relieve us of our obligation to determine whether
`the ’638 patent is eligible for post-grant review by confirming that the
`claims have sufficient written description and are enabled in the priority
`application.
`We, therefore, turn to the merits of Petitioner’s arguments as to why
`the challenged claims are not entitled to the benefit of the earlier priority
`application.
`1. Written Description
`To satisfy the written description requirement under 35 U.S.C.
`§ 112(a), the specification must “reasonably convey[] to those skilled in the
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`Patent 10,301,638 B2
`art that the inventor had possession” of the claimed invention as of the filing
`date. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir.
`2010) (en banc). An adequate description does not require any particular
`form of disclosure or that the specification recite the claimed invention in
`haec verba, but must do more than render the claimed invention obvious.
`Id. at 1352. In evaluating the adequacy of the disclosure, a court may
`consider “the existing knowledge in the particular field, the extent and
`content of the prior art, the maturity of the science or technology, [and] the
`predictability of the aspect at issue.” Capon v. Eshhar, 418 F.3d 1349, 1359
`(Fed. Cir. 2005) (cited with approval in Ariad, 598 F.3d at 1352); see also
`Boston Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1366 (Fed. Cir.
`2011) (holding that because the assessment for written description is made
`from the perspective of a person of ordinary skill in the art, in some
`instances, a patentee can rely on information that is “well-known in the art”
`to satisfy written description).
`a) “wherein said oils, lipids and/or fatty acids comprise a total
`amount of at least 54% by weight of polyunsaturated ω3-fatty
`acids based on the total fatty acids in the transgenic plant”
`Claim 8 (which depends from claim 1) and independent claim 9
`require that the oils, lipids, and /or fatty acids produced by a transgenic
`Brassica plant “comprise a total amount of at least 54% by weight of
`polyunsaturated ω3-fatty acids based on the total fatty acids in the
`transgenic plant.” Ex. 1001, 62:59–67. Claims 10–16 directly depend from
`claim 9 and, therefore, also include this limitation. Id. at 63:1–31.
`Petitioner argues that “[t]he priority applications are completely devoid of
`disclosure that suggested possession” of “at least 54% by weight of
`polyunsaturated ω3-fatty acids.” Pet. 43. In particular, Petitioner argues
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`Patent 10,301,638 B2
`that the ’638 patent3 does not include any embodiments that have at least
`54% by weight of polyunsaturated ω3-fatty acids, and that, in the one
`example that is present, “the seed-oil of a transgenic Brassica juncea plant
`comprised between 17.2% and 19.6% polyunsaturated ω3-fatty acids, far
`below the ‘at least 54%’ recited in” claims 8 and 9. Id. at 43–45 (citing
`Ex. 1002 ¶¶ 85–86).
`In contrast, Petitioner points to examples in the ’638 patent of other
`transgenic plants, such as O. violaceous and A. thaliana, that do contain at
`least 54% by weight of polyunsaturated ω3-fatty acids, and argues that
`the ’638 patent does not assert that “the amount of the polyunsaturated ω3-
`fatty acids in O. violaceous or A. thaliana leaf is representative of the
`amount of polyunsaturated ω3-fatty acids in the total fatty acids of
`transgenic Brassica.” Pet. 44–47 (citing Ex. 1002 ¶¶ 87–90). Petitioner
`also argues that the “[d]ata in the ’638 patent shows that transgenic
`Brassica juncea, transformed with many of the same enzymes used to
`transform O. violaceous comprises far lower levels of polyunsaturated ω3-
`fatty acids.” Id. at 45 (citing Ex. 1002 ¶ 88).
`Based on the present record, we find that Petitioner has demonstrated
`sufficiently that the invention described in claims 8 and 9 lacks written
`description support in the Specification (and the ’090 application). In
`
`
`3 For convenience, our discussion refers only to the ’638 patent specification
`(“Specification”), rather than to the ’090 application. There is no dispute that
`the content of the specification of the ’090 application and the specification
`of the ’638 patent are the same. Pet. 19; Prelim. Resp. 19. Moreover,
`Petitioner cites to the ’638 patent when discussing the disclosures in the
`priority applications. See Pet. 19 (“[A]ny statement made [in the Petition]
`regarding a lack of disclosure in the ’638 Patent applies equally to the
`priority applications.”).
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`Patent 10,301,638 B2
`particular, we find that the Specification does not adequately describe a
`transgenic Brassica plant wherein the “oils, lipids and/or fatty acids
`comprise a total amount of at least 54% by weight of the polyunsaturated
`ω3-fatty acids based on the total fatty acids in the transgenic plant” as
`required by claims 8 and 9. The Specification includes one example of a
`transgenic Brassica plant that produced 17.2–19.6% polyunsaturated ω-3
`fatty acids, which does not meet the “at least 54% by weight of
`polyunsaturated ω-3 fatty acids” required by claims 8 and 9. Ex. 1001,
`col. 61–62, Table 6; Ex. 1002 ¶ 55.
`Although the Specification does disclose other transgenic plants that
`appear to meet the claimed limitation, there is no indication in the
`Specification that similar results would be achieved in a Brassica plant. On
`the contrary, the example transgenic Brassica plant that does not meet the
`claimed limitation indicates that the results seen in the O. violaceous plant
`are not representative of what was achievable in the Brassica plant at the
`time the ’090 application was filed. Accordingly, based on the current
`record, we find that the disclosures in the Specification (and the ’090
`application) are insufficient to show that the inventors were in possession of
`oils, lipids, and/or fatty acids produced by a transgenic Brassica plant that
`comprise at least 54% by weight of polyunsaturated ω-3 fatty acids at the
`time the ’090 application was filed.
`At this stage of the proceeding, Patent Owner does not substantively
`respond to Petitioner’s contentions regarding whether the challenged claims
`are sufficiently described in the Specification. See generally Prelim. Resp.
`Instead, Patent Owner argues that the Petition should be denied because
`Petitioner’s contentions here are contrary to positions Petitioner took in a
`prior litigation between the parties concerning Petitioner’s patents (“Prior
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`Litigation”). In particular, Patent Owner argues that Petitioner’s
`contentions here “depend on claim construction positions Petitioner
`expressly disavowed when construing Petitioner’s nearly indistinguishable
`claim terms sharing a similar priority date (2005) to [the ’638 patent].”
`Prelim. Resp. 19; see id. at 10–11. Patent Owner argues that, in the Prior
`Litigation, Petitioner took the position that an “at least X%” type limitation
`means “greater than or equal to X% and less than the inherent upper limit
`enabled by the specification,” but, in this proceeding, contends that “at least
`X%” extends to the full scope of X% to 100%. Id. at 10–12, 19. According
`to Patent Owner, “[t]he Board should not ignore Petitioner’s advocacy
`before a federal district court, much less tolerate such a blatant
`inconsistency to abuse the Board’s limited time and resources.” Id. at 19.
`Patent Owner also contends that, in the Prior Litigation, Petitioner
`argued that the successful production of a fatty acid with one transgenic
`plant species provided written description support for production in a
`different species, which contradicts Petitioner’s position here that claims
`directed to a transgenic Brassica plant are not sufficiently supported with
`data from the O. violaceous plant. Prelim. Resp. 12–13, 20–22. Patent
`Owner contends that “the Board should not countenance Petitioner’s change
`in that position to the Board to review and cancel [Patent Owner’s] claims.”
`Id. at 21. Patent Owner further contends that “Petitioner’s shifting positions
`on these key issues—saying one thing to the district court and another to the
`Board—are a sufficient reason to deny institution” under 35 U.S.C.
`§ 324(a). Id. at 16.
`We disagree. Petitioner’s arguments in the Prior Litigation were
`directed to claim terms in a patent that is not related to the ’638 patent.
`And, even if the claim terms and subject matter at issue in the Prior
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`Litigation are similar to those at issue here, Petitioner is not bound by the
`arguments it made with respect to a different patent on a different record.
`Moreover, we fail to see how, as Patent Owner argues, Petitioner is
`attempting to “game the system” or “harass patent owners” by challenging
`the ’638 patent, when Petitioner has not previously challenged the ’638
`patent before the Board or in district court. On this record, we decline to
`exercise our discretion under 35 U.S.C. § 324(a).
`b) at least 20% by weight of eicosapentaenoic acid (EPA), at
`least 2% by weight of docosapentaenoic acid (DPA), and at
`least 4% by weight of docosahexaenoic acid (DHA) based on
`the total fatty acids in the transgenic plant in the form of
`triacylglycerides”
`Claim 1 requires that the oil, lipids, and/or fatty acids produced by a
`transgenic Brassica plant includes polyunsaturated fatty acids that comprise
`“at least 20% by weight of eicosapentaenoic acid (EPA), at least 2% by
`weight of docosapentaenoic acid (DPA), and at least 4% by weight of
`docosahexaenoic acid (DHA) based on the total fatty acids in the transgenic
`plant in the form of triacylglyerides.” Ex. 1001, 61:36–45. Claims 2–8 and
`17–23 depend, directly or indirectly, from claim 1 and, therefore, also
`contain this requirement. Id. at 61:46–62:62, 63:32–64:41. Petitioner
`argues that the Specification’s only description of “an embodiment with ‘at
`least 20% EPA,’ ‘at least 2% DPA,’ or ‘at least 4% DHA’ recite[s] these
`amounts ‘by weight based on the total fatty acids in the transgenic plants,’
`not based on the total fatty acids in the transgenic plants in the form of
`triacylglycerides.” Pet. 48–49 (citing Ex. 1001, 15:29–36, 25:4–12;
`Ex. 1002 ¶ 93). Petitioner also argues that in the only example in the
`Specification of oils, lipids, and/or fatty acids produced by a transgenic
`Brassica plant “the seedoil of a transgenic Brassica juncea plant comprised
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`between 4.1–4.5% EPA, far below the ‘at least 20%’ recited in the claims.”
`Id. at 49.
`In contrast, Petitioner points to an example in the Specification of a
`transgenic O. violaceous leaf that reports the triacylglycerides contained
`24.96% EPA, 2.22% DPA, and 41.5% DHA, and argues that
`the Specification does not assert that “the amount of EPA, DPA, and DHA
`in the triacylglycerides of O. violaceous leaf is representative of the amount
`of EPA, DPA, and DHA in the triacylglycerides of transgenic Brassica.”
`Pet. 51–52 (citing Ex. 1002 ¶¶ 96–97). Petitioner also argues that the
`“[d]ata in the ’638 patent shows that transgenic Brassica juncea,
`transformed with many of the same enzymes used to transform O.
`violaceous, comprises far lower levels” of EPA and DHA based on the total
`fatty acids in its seed oil. Id. at 45 (citing Ex. 1002 ¶ 88).
`As set forth above, at this stage of the proceeding Patent Owner does
`not substantively respond to Petitioner’s contentions regarding whether the
`challenged claims are sufficiently described in the Specification (and
`the ’090 application). See generally Prelim. Resp.
`Based on the present record, we find that Petitioner has demonstrated
`sufficiently that the invention described in claim 1 lacks written description
`support in the Specification (and the ’090 application). In particular, we
`find that the Specification does not adequately describe a transgenic
`Brassica plant wherein the oils, lipids and/or fatty acids comprise
`polyunsaturated fatty acids that comprise at least 20% by weight EPA based
`on the total fatty acids in the transgenic plant in the form of
`triacylglycerides. The Specification includes one example of a transgenic
`Brassica plant that contains 4.1–4.5% EPA, which does not meet this claim
`limitation. Ex. 1001, col. 61–62, Table 6. Petitioner presents testimony
`
`15
`
`
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`PGR2020-00033
`Patent 10,301,638 B2
`from Dr. Yadav, which is unrebutted on the current record, that because
`most triacylglycerides “in an oilseed crop such as Brassica juncea is in the
`seedoil, based on this data, a [person having ordinary skill in the art] would
`not reasonably conclude that the inventors had possession” of oils, lipids,
`and/or fatty acids “produced by a transgenic Brassica plant which comprise
`‘at least 20% by weight of EPA […] based on the total fatty acids in the
`transgenic [Brassica] plant in the form of triacylglycerides.” Ex. 1002 ¶ 94
`(internal footnote omitted). Moreover, the Specification teaches that the
`content of “[t]he fatty acids EPA, DPA and/or DHA produced in the
`process of the invention” is measured “by weight based on the total fatty
`acids in the transgenic plant.” Ex. 1001, 15:29–36. Claim 1, however,
`requires that the amount of EPA, DPA, and DHA is “based on the total fatty
`acids in the transgenic plant in the form of triacylglycerides.” Id. at 61:40–
`43.
`
`Although the Specification does disclose an O. violaceous plant that
`appears to include “at least 20% by weight of EPA” based on total fatty
`acids in the form of triacylglycerides, there is no indication in the
`Specification that similar results could be achieved in a Brassica plant. On
`the contrary, the example transgenic Brassica plant that does not meet the
`“at least 20% by weight of EPA” indicates that the results seen in the O.
`violaceous plant are not representative of what was achievable in the
`Brassica plant at the time the ’090 application was filed.
`Accordingly, based on the current record, we find that the disclosures
`in the Specification are insufficient to show that the inventors were in
`possession of oils, lipids, and/or fatty acids produced by a transgenic
`Brassica plant, wherein the polyunsaturated fatty acids comprise at least
`20% by weight of EPA, at least 4% by weight of DHA, and at least 4% by
`
`16
`
`
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`PGR2020-00033
`Patent 10,301,638 B2
`weight of DPA based on the total fatty acids in the transgenic plant in the
`form of triacylglycerides. We therefore determine, based on the current
`record, that the disclosures in the Specification (and the ’090 application)
`are insufficient to provide written description support for claim 1, and
`claims 2–8 and 17–23 that depend directly or indirectly therefrom.
`c) Dependent Claims
`Petitioner also argues that certain limitations in dependent claims 2,
`3, 5–7, and 11–17 lack written description support in the Specification.
`Pet. 54–61. Having already determined that Petitioner has sufficiently
`established that all of the challenged claims lack written description support
`in the Specification, we do not reach the merits of Petitioner’s arguments
`that are directed to these dependent claims.
`d) Conclusion: Written Description
`After considering the Petition and the Preliminary Response, as well
`as the supporting evidence, we determine that Petitioner sufficiently
`demonstrates that it is more likely than not the challenged claims lack
`written description support in the Specification (and the ’090 application).
`2. Enablement
`Petitioner also argues that the Specification does not enable the
`challenged claims. Pet. 61–78. Having determined that Petitioner
`sufficiently demonstrates that the challenged claims lack written description
`support in the Specification, we need not reach the merits of Petitioner’s
`enablement argument for the purposes of deciding whether the ’638 patent is
`eligible for post-grant review.
`3. Conclusion: PGR Eligibility
`For the foregoing reasons, and on the current record, we are persuaded
`that Petitioner has satisfied its burden to prove that the Specification (and
`
`17
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`PGR2020-00033
`Patent 10,301,638 B2
`the ’090 application) fails to provide written description support for the
`challenged claims. We, therefore, determine that the ’638 patent is not
`entitled to the benefit of the filing date of the ’090 application (February 21,
`2007), and, thus, the ’638 patent is eligible for post-grant review.
`D. Grounds 1–11: Lack of Written Description Support
`Petitioner contends that the challenged claims are unpatentable for
`lack of written description support for the same reasons it contends the ’638
`patent is eligible for post-grant review. Pet. 78–79. There is no dispute that
`the content of the specification of the ’090 application and the Specification
`of the ’638 patent are the same (id. at 19; Prelim. Resp. 19), and Petitioner
`cites to the ’638 patent when discussing the disclosures in the ’090
`application. See Pet. 19 (“[A]ny statement made [in the Petition] regarding a
`lack of disclosure in the ’638 Patent applies equally to the priority
`applications.”). As set forth above, we determined that the disclosures in the
`Specification are insufficient to provide written description support for the
`challenged claims. For the same reasons, we also determine that Petitioner
`has demonstrated that it is more likely than not that the challenged claims
`are unpatentable. Thus, we exercise our discretion and institute post-grant
`review of claims 1–23 as challenged under Grounds 1–11.
`E. Ground 12–22: Lack of Enablement
`Petitioner
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