Trials@uspto.gov
`571-272-7822
`
`Paper: 6
`Date: April 22, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COMMONWEALTHSCIENTIFIC AND INDUSTRIAL RESEARCH
`ORGANISATION,
`Petitioner,
`
`Vv.
`
`BASF PLANT SCIENCE GMBH,
`Patent Owner.
`
`PGR2021-00004
`Patent 10,533,183 B2
`
`Before ULRIKE W. JENKS, JO-ANNE M. KOKOSKI, and
`ROBERT A. POLLOCK,Administrative Patent Judges.
`
`KOKOSKI, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Post-Grant Review
`35 US.C. § 324(a)
`
`
`571-272-7822
`
`Paper: 6
`Date: April 22, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COMMONWEALTHSCIENTIFIC AND INDUSTRIAL RESEARCH
`ORGANISATION,
`Petitioner,
`
`Vv.
`
`BASF PLANT SCIENCE GMBH,
`Patent Owner.
`
`PGR2021-00004
`Patent 10,533,183 B2
`
`Before ULRIKE W. JENKS, JO-ANNE M. KOKOSKI, and
`ROBERT A. POLLOCK,Administrative Patent Judges.
`
`KOKOSKI, Administrative Patent Judge.
`
`DECISION
`Granting Institution of Post-Grant Review
`35 US.C. § 324(a)
`
`
`
`PGR2021-00004
`Patent 10,533,183 B2
`
`I.
`
`INTRODUCTION
`
`Commonwealth Scientific and Industrial Research Organisation
`
`(“Petitioner”) filed a Petition requesting post-grant review of claims 1—9
`(‘the challenged claims’) of U.S. Patent No. 10,533,183 B2 (Ex. 1001,
`“the 183 patent”). Paper 1 (“Pet.”). BASF Plant Science GmbH (“Patent
`
`Owner”) did notfile a Preliminary Response.
`Under 35 U.S.C. § 324(a), a post-grant review maybeinstituted only
`if “the information presented in the petition .
`.
`. demonstrate[s] that it is more
`likely than notthat at least 1 of the claims challengedin 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 considerationof the Petition and the evidenceof record,
`we determinethat 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 reasonsthat follow,
`weinstitute a post-grant review of claims 1—9 of the ’183 patent.
`
`A. Real Parties in Interest
`
`Eachparty identifies itself as the real party-in-interest. Pet. 4;
`
`Paper5, 1.
`
`B. Related Matters
`
`Theparties identify as a related matter pending U.S. Patent
`Application No. 16/371,696, which,like the application from which the ’183
`patent issued, is a continuation of U.S. Patent Application No. 15/256,914
`(“the 914 application,” issued as U.S. Patent No. 10,141,638 B2). Pet. 6;
`
`Paper5, 1.
`
`
`
`PGR2021-00004
`Patent 10,533,183 B2
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`C. The '183 Patent
`
`The ’183 patent, titled “Oils, Lipids and Fatty Acids Producedin
`
`Transgenic Brassica Plant,” issued on January 14, 2020 from U.S.
`Application No. 16/371,837 (“the ’837 application”), filed on April 1, 2019.
`Ex. 1001, codes (21), (22), (45), (54). The ’837 application is a continuation
`
`of the 914 application, which is a continuation of U.S. Application
`No. 12/280,090 (“the ’090 application”), which in turn was filed as
`Application No. PCT/EP2007/051675 on February 21, 2007. Jd.at
`
`code (63).
`The ’183 patent relates to a process for the production of
`eicosapentaenoic acid (“EPA”), docosapentaenoic acid (“DPA”), and/or
`docosahexaenoic acid (“DHA”)in transgenic plants, andto “oils, lipids,
`
`and/or fatty acids which have been produced bythe process.” Ex. 1001,
`code (54), 1:29-31, 2:3-5. The Specification explainsthatthere is “a great
`need for a simple, inexpensive process for the production of
`polyunsaturated, long-chainfatty acids, specifically in plant systems”for use
`in fortifying food and animalfeed. Jd. at 6:5—9. 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 A5-elongase sequencein transgenic plants.” Jd.at
`
`6:15-19.
`
`The process described in the ’183 patent includes providingto a plant
`nucleic acid sequencesthat code for each of a polypeptide having (1) A6-
`desaturase activity; (2) Aé-elongase activity; (3) A5-desaturase activity; and
`(4) A5-elongase activity. Id. at 6:27-42. “To produce DHA itis additionally
`necessary to provide at least one nucleic acid sequence which codes for a
`polypeptide having a A4-desaturaseactivity in the plant.” Jd. at 6:42—45.
`
`
`
`PGR2021-00004
`Patent 10,533,183 B2
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`The Specification teaches that the fatty acids EPA, DPA, and/or DHA
`produced bythe process are “present with a content of in each caseatleast
`5% by weight, preferably ofin each case at least 6, 7, 8 or 9% by weight,
`particularly preferably of in each caseat least 10, 11, or 12% by weight,
`most preferably of in each caseat least 13, 14, 15, 16, 17, 18, 19, or 20% by
`weight based onthetotal fatty acids in the transgenic plant.” Jd. 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 and
`animals, to produce other consumables,fibers and pharmaceuticals,” such as
`
`cereals, tubers, sugar plants, and oil and fat crops. Jd. 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—9 (“the challenged claims”) of the ’183
`patent. Claim 1 is the only independentclaim, and is reproduced below:
`
`lipids and/or fatty acids produced by a transgenic
`1. Oils,
`Brassica plant, wherein said oils,
`lipids and/or fatty acids
`comprise in the sn-2 position!'] 25% to 40% by weight of
`eicosapentaenoic (EPA) based on the total EPA.
`
`Ex. 1001, 61:33-36.
`
`E. Asserted Grounds
`
`Petitioner asserts that the challenged claims are unpatentable on the
`
`following twenty grounds. Pet. 26-29.
`
`! Petitioner’s expert explains that “sn position” refers to “stereospecifically
`numbered”positions on a glycerol molecule to which fatty acidsare
`attached. Ex. 1002 { 46.
`
`
`
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`PGR2021-00004
`Patent 10,533,183 B2
`
`Claim(s) Challenged
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`
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`
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`
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`
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`Petitioner relies on the Declaration of Narendra Yadav, Ph.D.
`
`(Ex. 1002) in support of its arguments.
`
`II.
`
`ANALYSIS
`
`A. Person of Ordinary Skill in the Art
`Petitioner asserts that a person ofordinary skill in the art (““POSITA”)
`
`as of the date of the invention “would have hadat least a Ph.D. in molecular
`
`biology, molecular genetics, biochemistry, or a related field and at least 3-5
`
`2G. Wuetal., Stepwise engineering to produce high yields ofvery long-
`chain polyunsaturatedfatty acids in plants, 23 NATURE BIOLOGY8, 1013-17
`(August 2005) (Ex. 1008).
`3 Published PCT Application No. WO 2005/083093 A2 (Ex. 1006).
`4 Published PCT Application No. WO 2007/096387 Al (Ex. 1003).
`
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`PGR2021-00004
`Patent 10,533,183 B2
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`years of experience in molecular genetics or biology, plant genetics, or
`recombinant DNAtechniques.” Pet. 32 (citing Ex. 1002 4 15). Petitioner
`
`further asserts 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.” Jd. at 32-33 (citing
`
`Ex. 1002
`15).
`Petitioner’s unopposed proposeddefinition is consistent with the cited
`prior art and the disclosure of the °183 patent, and we adoptit 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 “wherethepriorart 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
`
`Weconstrue each claim “in accordance with the ordinary and
`
`customary meaning of such claim as understood by oneofordinary skill in
`the art and the prosecutionhistory pertaining to the patent.” 37 C.F.R.
`§ 42.100(b) (2019). Underthis standard, claim terms are generally given
`their plain and ordinary meaning as would have been understood by a person
`of ordinaryskill in the art at the time of the invention andin the contextof
`the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313
`(Fed. Cir. 2005) (en banc). Only those terms in controversy needto 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)).
`
`
`
`PGR2021-00004
`Patent 10,533,183 B2
`
`Petitioner proposes constructions for the following claim terms:
`“comprise in the sn-2 position 25% to 40% by weight of eicosapentaenoic
`(EPA) based onthe total EPA” (claim 1); “comprise in the sn-2 position
`40% to 60% by weight of docosapentaenoic acid (DPA)basedontotal
`DPA”(claim 2); “comprise in the sn-2 position 15% to 35% by weightof
`docosahexanoic acid (DHA)based onthe total DHA”(claim 3); “by weight
`
`... based onthetotalfatty acids in the transgenic plant in the form of
`triacylglycerides” (claim 4); “based onthetotal fatty acids in the transgenic
`plant” (claims 5 and 7); “comprise at least about 25% by weight of EPA in
`the form of triacylglycerides based on thetotal fatty acids in the transgenic
`plant”(claim 6); and “polyunsaturated w3-fatty acids”(claim 8). Pet. 29—
`32. For purposesof this Decision, and based on the record before us, we
`determine that none of the claim terms require an explicit construction to
`
`determine whetherto institute post-grant review.
`
`C. Post-Grant Review Eligibility
`Asa threshold issue, we must determine whether the ’183 patentis
`
`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
`availableif the petition is filed within nine monthsof the issuance of the
`challenged patent. 35 U.S.C. § 321(c). Here, the Petition was filed on
`October 14, 2020, which is within nine monthsofthe ’183 patent’s
`
`January 14, 2020 issue date. Paper 3, 1; Ex. 1001, code (45).
`Second, as noted above, post-grant review is available only for patents
`
`that issue from applications that at one point containedat least one claim
`
`with an effective filing date of March 16, 2013 orlater. See AIA §§ 3(n)(1),
`
`6(f)(2)(A). The “effective filing date” for a claim is either the application’s
`
`
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`PGR2021-00004
`Patent 10,533,183 B2
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`actualfiling date orthe filing date of the earliest application that supports the
`
`claim. 35 U.S.C. § 100(i) (2018).
`
`Petitioner has the burden ofestablishing 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 ’183 patent is
`eligible for post-grant review, Petitioner bears the burden of proving that the
`challenged claims lack the benefit of the filing date ofthe earliest
`application that supports the claims. In particular, Petitioner must show that
`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 contendsthat the ’183 patentis eligible for post-grant
`
`review because none ofthe challenged claimsare entitled to an effective
`filing date earlier than the April 1, 2019 filing date of the ’837 application.
`Pet. 34-35. Petitioner’s contention is based on its argument that “the claims
`of the 7183 Patent lack written description and enablementin the priority
`applications,” and, thus, “are not disclosed in the manner provided by
`35 U.S.C. § 112(a) by any pre-AIA application.” Jd. at 2-3.
`
`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
`art that the inventor had possession”of the claimed inventionasofthe 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
`
`
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`PGR2021-00004
`Patent 10,533,183 B2
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`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 knowledgein the particular field, the extent and
`contentofthe 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-knownin theart”
`
`to satisfy written description).
`a)
`“wherein said oils, lipids and/orfatty acids comprise in the sn-
`2 position 25% to 40% eicosapentaenoic (EPA) based on the
`total EPA”’
`
`Claim 1 requires that the oils, lipids and/or fatty acids produced by a
`transgenic Brassica plant “comprisein the sn-2 position 25% to 40% by
`weight of eicosapentaenoic (EPA) based on the total EPA.” Ex. 1001,
`61:33-36. Claims 2-9 directly depend from claim 1, and also includethis
`limitation. Id. at 61:37-62:53. Petitioner contends that “the 183 Patent!>!is
`
`completely devoid of any mention ofoils, lipids and/orfatty acids
`
`> Petitioner cites to the ’183 patent when discussing the disclosures in
`the 090 application. Pet. 17 (“[A]ny statement made[in the Petition]
`regarding a lack of disclosure in the ’183 Patent applies equally to the
`priority applications.”) Petitioner asserts that “[n]Jone ofthe priority
`documents include disclosure thatis not also in the specification of the ’183
`Patent.” Jd. (citing Ex. 1002 J] 60-63). For convenience, our discussion
`also refers to the ’183 patent specification (“Specification”), rather than
`the ’090 application.
`
`
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`PGR2021-00004
`Patent 10,533,183 B2
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`comprising ‘in the sn-2 position 25% to 40% by weight of eicosapentaenoic
`(EPA) based on total EPA’”and “a POSITA could not reasonably conclude
`that the inventors had possession of the claimed subject matter.” Pet. 38
`(citing Ex. 1002 ¥ 89). In particular, Petitioner contends that the numerical
`range of 25 to 40% does not appearin the Specification, and “there is no
`example in the ’183 Patent where the positional distribution of EPA[i.e.,
`according to sn- position] is measured in Brassica lipid.” Id.
`
`In contrast, Petitioner points to Example 13, which “provides an
`
`analysis oflipids from the leaf material of an O. violaceous plant
`transformed with the binary vector pGPTV-D6DS5E6 (Tp)3PiE5D4.”
`
`Pet. 39; see Ex. 1001, 55:24-56:67, Table 3-5. Petitioner asserts that this
`“is the sole example in the entire 183 Patent which analyses the positional
`distribution of fatty acids, such as EPA, DPA, and DHA in variouslipid
`
`classes.” Pet. 39. Petitioner asserts that Tables 3-4 ofthe ’183 patent report
`the fatty acid composition andpositionaldistribution of EPA, DPA, and
`DHA in certain species of O. violaceous leaf lipid, and Table 5 reports the
`fatty acid composition andpositional distribution of EPA in certain other
`species of O. violaceousleaflipids. Jd. Petitioner further asserts that the
`Specification doesnot state “that the positional distribution offatty acids
`such as EPA reported in Tables 3—5 for O. violaceousleaflipids are
`representative ofthe positional distribution of fatty acids in Brassicalipids.”
`Id. Accordingto Petitioner, “a POSITA reading the specification had no
`
`basis for considering the positional distribution of EPA reported for O.
`violaceousleaflipids to be representative of the positional distribution of
`
`EPAin the lipids of any orall parts of a Brassica plant.” Id.
`
`Based onthe present record, wefind that Petitioner has demonstrated
`sufficiently that the invention described in claim 1 lacks written description
`
`10
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`PGR2021-00004
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`support in the 7189 patent (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 in the sn-2 position
`
`25% to 40% by weight of eicosapentaenoic (EPA) based on the total EPA”
`
`as required by claim 1. The Specification includes one example of a
`
`transgenic Brassica plant wherein the extracted seed oil contains 4.1-4.5%
`
`EPArelative to the total lipids in the seed, but does not provide any
`
`information regarding the positionaldistribution of the EPA. Ex. 1001,
`
`55:9-23, col. 61-62 (Table 6); Ex. 1002 J 58-59. Moreover, as Petitioner
`
`notes, there is no evidence onthis record that the positional distribution of
`
`EPAreported for O. violaceousleaflipids is representative of what was
`
`achievable in the Brassica plant at the time 090 application wasfiled. See
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`Pet. 39 (citing Ex. 1002 9 91).
`
`Accordingly, based on the current record, we find that the disclosures
`
`in the Specification are insufficient to show that the inventors were in
`
`possessionofoils, lipids, and/or fatty acids produced by a transgenic
`
`Brassica plant that comprise 25% to 40% by weight of EPA based onthe
`
`total EPA at the sn-2 position at the time the °090 application wasfiled. We
`
`therefore determine, based on the current record, that the disclosures in the
`
`Specification (and the ’090 application) are insufficient to provide sufficient
`
`written description support for independent claim 1, and claims 2-9that
`
`depend directly therefrom.
`
`b) Dependent Claims
`
`Petitioner also argues that certain limitations in dependent claims 2-8
`
`lack written description support in the Specification. Pet. 40-56. Having
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`already determined that Petitioner has sufficiently established that all of the
`
`challenged claims lack written description support in the Specification, we
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`1]
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`Patent 10,533,183 B2
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`do not reach the merits of Petitioner’s arguments that are directed to these
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`dependent claims.
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`c) Conclusion: Written Description
`
`After considering the Petition and 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. 57-73. Having determined that Petitioner
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`sufficiently demonstrates that the challenged claims lack written description
`
`support in the Specification, we need not reach the merits of Petitioner’s
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`enablement argumentfor the purposes of deciding whether the 7183 patent is
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`eligible for post-grant review.
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`3. Conclusion: PGR Eligibility
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`For the foregoing reasons, and on the current record, we are persuaded
`
`that Petitioner has satisfied its burden to prove that the Specification (and
`
`the 090 application) fails to provide written description support for the
`
`challenged claims. Therefore, we determine that the ’183 patent is not
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`entitled to the benefit of the filing date of the ’090 application (February 21,
`
`2007), and, thus, the °183 patent is eligible for post-grant review.
`
`D. Grounds 1-8: Lack of Written Description Support
`
`Petitioner contends that the challenged claims are unpatentable for
`
`lack of written description support for the same reasonsit contends the 7183
`
`patentis eligible for post-grant review. Pet. 73-74. Asset forth above, we
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`determinedthat the disclosures in the Specification are insufficient to
`
`provide written description support for the challenged claims. For the same
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`12
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`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 andinstitute post-grant review of claims 1—9 as
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`challenged under Grounds 1-8.
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`E. Grounds 7-16: Lack ofEnablement
`
`Petitioner contends that the challenged claims are unpatentable for
`
`failing to satisfy the enablement requirement. Pet. 57-75.
`
`Under 35 U.S.C. § 112(a), enablementis separate and distinct from
`
`the written description requirement. Ariad, 598 F.3d at 1344. “Thetest of
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`enablement is whether one reasonably skilled in the art could makeor use
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`the invention from the disclosures in the patent coupled with information
`
`knownin the art without undue experimentation.” U.S. v. Telectronics, Inc.,
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`857 F.2d 778, 785 (Fed. Cir. 1988). [A] patent specification complies with
`
`the statute even if a ‘reasonable’ amountof routine experimentation is
`
`required in order to practice a claimed invention.” Enzo Biochem,Inc.v.
`Calgene, Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999). “Whether undue
`experimentation is neededis not a single, simple factual determination, but
`
`rather is a conclusion reached by weighing manyfactual considerations.” Jn
`
`re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). These factors, referred to as
`
`the Wands factors, include:
`
`(1) the quantity of experimentation necessary, (2) the amount of
`direction or guidance presented, (3) the presence or absence of
`working examples, (4) the nature of the invention, (5) the state
`of the prior art, (6) the relative skill of those in theart, (7) the
`predictability or unpredictability of the art, and (8) the breadth
`of the claims.
`
`Td.
`
`13
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`1. Ground 9: “wherein said oils, lipids and/orfatty acids
`comprise in the sn-2 position 25% to 40% by weight of
`eicosapentaenoic (EPA) based on the total EPA”
`
`Claim 1 requires that the oils, lipids and/or fatty acids produced by a
`
`transgenic Brassica plant “comprise in the sn-2 position 25% to 40% by
`
`weight of eicosapentaenoic (EPA) based on the total EPA.” Ex. 1001,
`
`61:33-36. Claims 2-9 directly depend from claim 1 andalso includethis
`
`limitation. Jd. at 61:37-62:53. Petitioner argues that “[t]he °183 Patentis
`
`completely devoid of any mention of, muchless guidanceor direction for
`obtaining, oils[,] lipids and/or fatty acids comprising ‘in the sn-2 position
`
`25% to 40% by weight of eicosapentaenoic (EPA)based on the total EPA.”
`
`Pet. 59. In particular, Petitioner argues that “there is no example in the ’183
`Patent reporting the positional distribution of EPA in Brassicalipid,” and,
`due to the breadth of the claim, “a POSITA could not make anduse the
`
`claimed composition without undue experimentation.” /d. (citing Ex. 1002
`
`125),
`
`Based onthe evidenceof record, we find that Petitioner has
`adequately established, for purposes of this Decision, that the claim
`languagerelating to the amount of EPA in the sn-2 position ofoils, lipids,
`
`and/or fatty acids producedbya transgenic Brassica plant is not enabled.
`
`The Specification does not provide guidanceto oneskilled in the art how to
`produceoils, lipids, and/or fatty acids in a transgenic Brassica plantthat
`contain at least 25% to 40% by weight of EPA at the sn-2 position, based on
`
`the total weight of EPA. Asset forth above, the only example in the
`
`Specification of a transgenic Brassica plant producedseed oil that contained
`only 4.1-4.5% EPArelative to the total lipids in the seed. Ex. 1001, col. 61-
`
`62, Table 6. Because this example does not meet the recited positional
`
`
`
`PGR2021-00004
`Patent 10,533,183 B2
`
`distribution of EPA, we are not persuaded,on this record, that the
`
`Specification adequately teaches a skilled artisan how to producethe
`
`claimed amount of EPA (based on the total EPA) at the sn-2 position.
`
`Moreover, although the Specification does provide an example of a
`transgenic O. violaceous plant that identifies the positional distribution of
`
`EPA,the Specification does not teach how to achieve similar results in a
`
`transgenic Brassica plant.
`
`Because the only example of a transgenic Brassica plant in the
`
`Specification does not meet the claimed limitation, and the Specification
`does not provide adequate guidanceordirection to produce the claimed
`amount of EPA at the sn-2 position in oils, lipids, and/or fatty acids
`produced bya transgenic Brassicaplant, we find that Petitioner adequately
`demonstrates, for purposesof this Decision, that independent claim 1, and
`claims 2—9 that directly dependent therefrom, are not enabled. Accordingly,
`
`weinstitute a post-grant review of claims 1—9 under Ground9.
`
`2. Grounds 10-16
`
`In Grounds 10-16, Petitioner argues that certain limitations in
`
`dependent claims 2-8 are not enabled by the Specification. Pet. 60—75.
`Having already determinedthat Petitioner has sufficiently established that
`all of the challenged claims are not enabled by the Specification, we
`
`exercise our discretion andinstitute post-grant review of claims 2—8 under
`
`Grounds 10-16.
`
`F. Grounds 17-20
`
`Petitioner argues that (1) claims 1-3 and 5—9 are anticipated by Wu,
`
`(2) claims 1—9 are anticipated by, or would have been obviousover, the ’093
`
`publication, (3) claims 1-9 would have been obvious over the combined
`teachings of Wu and the ’093 publication, and (4) claims 1-9 are anticipated
`
`15
`
`
`
`PGR2021-00004
`Patent 10,533,183 B2
`
`by, or would have been obviousover, the ’387 publication. Pet. 76-90.
`Having determinedthat Petitioner has established it is more likely than not
`
`that at least one of the challenged claims is unpatentable under alternate
`
`groundsas discussed above (see above, § II.D), weinstitute a post-grant
`review based on Grounds 17-20 as well. See Guidance ofthe Impact ofSAS
`
`on AIA Trial Proceedings (April 26, 2018) (explaining that “the PTAB will
`
`institute as to all claims or none” and “if the PTAB institutesatrial, the
`
`PTABwill institute on all challenges raised in the petition”).
`
`Ill.
`
`CONCLUSION
`
`Based on the argumentsin the Petition, and the evidence of record, we
`determinethat Petitioner has sufficiently demonstrated that claims 1—9 of
`
`the °183 patent lack written description support in the 090 application, and
`that the °183 patentis eligible for post-grant review. Additionally, we
`determine that Petitioner has demonstrated, on the current record,thatit is
`
`morelikely than notthat at least one claim of the ’183 patent is
`unpatentable. Thus, we institute a post-grant review of all challenged claims
`
`on all the grounds presented.
`
`IV. ORDER
`
`In consideration of the foregoing,it is hereby:
`ORDEREDthat, pursuant to 35 U.S.C. § 324(a), a post-grant review
`
`of the ’183 patent is instituted with respect to the groundsset forth in the
`
`Petition; and
`
`FURTHER ORDEREDthat, pursuant to 35 U.S.C. § 324(d) and
`
`37 C.E.R. § 42.4, notice is hereby given oftheinstitution ofa trial
`
`commencingonthe entry date of this Decision.
`
`16
`
`
`
`PGR2021-00004
`Patent 10,533,183 B2
`
`For PETITIONER:
`
`Gary Gershik
`John White
`COOPER & DUNHAM LLP
`ggershik@cooperdunham.com
`jwhite@copperdunham.com
`
`For PATENT OWNER:
`
`Sandip Patel
`Mark Izraelewicz
`MARSHALL GERSTEIN & BORUN LLP
`spatel@marshallip.com
`mizraelewicz@marshallip.com
`
`
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