Trials@uspto.gov
`571-272-7822
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`Paper: 6
`Date: April 22, 2021
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`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.
`
`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 U.S.C. § 324(a)
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper: 6
`Date: April 22, 2021
`
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`
`
`
`
`
`
`
`
`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.
`
`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 U.S.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 not file a Preliminary Response.
`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 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 1–9 of the ’183 patent.
`A. Real Parties in Interest
`Each party identifies itself as the real party-in-interest. Pet. 4;
`Paper 5, 1.
`B. Related Matters
`The parties 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;
`Paper 5, 1.
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`2
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`PGR2021-00004
`Patent 10,533,183 B2
`C. The ’183 Patent
`The ’183 patent, titled “Oils, Lipids and Fatty Acids Produced in
`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. Id. 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, and to “oils, lipids,
`and/or fatty acids which have been produced by the process.” Ex. 1001,
`code (54), 1:29–31, 2:3–5. 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 6:5–9. 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 Δ5-elongase sequence in transgenic plants.” Id. at
`6:15–19.
`The process described in the ’183 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 a Δ4-desaturase activity in the plant.” Id. at 6:42–45.
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`3
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`PGR2021-00004
`Patent 10,533,183 B2
`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 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,
`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 and
`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 1–9 (“the challenged claims”) of the ’183
`patent. Claim 1 is the only independent claim, and is reproduced below:
`
`1. Oils, lipids and/or fatty acids produced by a transgenic
`Brassica plant, wherein said oils, lipids and/or fatty acids
`comprise in the sn-2 position[1] 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.
`
`
`1 Petitioner’s expert explains that “sn position” refers to “stereospecifically
`numbered” positions on a glycerol molecule to which fatty acids are
`attached. Ex. 1002 ¶ 46.
`
`4
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`PGR2021-00004
`Patent 10,533,183 B2
`Claim(s) Challenged
` 1–9
` 2
` 3
` 4
` 5
` 6
` 7
` 8
` 1–9
` 2
` 3
` 4
` 5
` 6
` 7
` 8
` 1–3, 5–9
` 1–9
` 1–9
` 1–9
`
`35 U.S.C. §
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`112(a)
`102(a)
`102(a)/103
`103
`103
`
`Reference(s)/Basis
`Written description
`Written description
`Written description
`Written description
`Written description
`Written description
`Written description
`Written description
`Enablement
`Enablement
`Enablement
`Enablement
`Enablement
`Enablement
`Enablement
`Enablement
`Wu2
`’093 publication3
`Wu, ’093 publication
`’387 publication4
`
`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 of ordinary skill in the art (“POSITA”)
`as of the date of the invention “would have had at least a Ph.D. in molecular
`biology, molecular genetics, biochemistry, or a related field and at least 3–5
`
`
`2 G. Wu et al., Stepwise engineering to produce high yields of very long-
`chain polyunsaturated fatty acids in plants, 23 NATURE BIOLOGY 8, 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 A1 (Ex. 1003).
`
`5
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`Patent 10,533,183 B2
`years of experience in molecular genetics or biology, plant genetics, or
`recombinant DNA techniques.” Pet. 32 (citing Ex. 1002 ¶ 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.” Id. at 32–33 (citing
`Ex. 1002 ¶ 15).
`Petitioner’s unopposed proposed definition is consistent with the cited
`prior art and the disclosure of the ’183 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)).
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`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 on the total EPA” (claim 1); “comprise in the sn-2 position
`40% to 60% by weight of docosapentaenoic acid (DPA) based on total
`DPA” (claim 2); “comprise in the sn-2 position 15% to 35% by weight of
`docosahexanoic acid (DHA) based on the total DHA” (claim 3); “by weight
`. . . based on the total fatty acids in the transgenic plant in the form of
`triacylglycerides” (claim 4); “based on the total 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 the total fatty acids in the transgenic
`plant” (claim 6); and “polyunsaturated ω3-fatty acids” (claim 8). Pet. 29–
`32. For purposes of this Decision, and based on the record before us, we
`determine that none of the claim terms require an explicit construction to
`determine whether to institute post-grant review.
`C. Post-Grant Review Eligibility
`As a threshold issue, we must determine whether the ’183 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). Here, the Petition was filed on
`October 14, 2020, which is within nine months of the ’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 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
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`Patent 10,533,183 B2
`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 ’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 of the 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 contends that the ’183 patent is eligible for post-grant
`review because none of the challenged claims are 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 ’183 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.
`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 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
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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 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 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 “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, and also include this
`limitation. Id. at 61:37–62:53. Petitioner contends that “the ’183 Patent[5] is
`completely devoid of any mention of oils, lipids and/or fatty acids
`
`
`5 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]one of the priority
`documents include disclosure that is not also in the specification of the ’183
`Patent.” Id. (citing Ex. 1002 ¶¶ 60–63). For convenience, our discussion
`also refers to the ’183 patent specification (“Specification”), rather than
`the ’090 application.
`
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`Patent 10,533,183 B2
`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 appear in 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 of lipids from the leaf material of an O. violaceous plant
`transformed with the binary vector pGPTV-D6D5E6 (Tp)ω3PiE5D4.”
`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 various lipid
`classes.” Pet. 39. Petitioner asserts that Tables 3–4 of the ’183 patent report
`the fatty acid composition and positional distribution of EPA, DPA, and
`DHA in certain species of O. violaceous leaf lipid, and Table 5 reports the
`fatty acid composition and positional distribution of EPA in certain other
`species of O. violaceous leaf lipids. Id. Petitioner further asserts that the
`Specification does not state “that the positional distribution of fatty acids
`such as EPA reported in Tables 3–5 for O. violaceous leaf lipids are
`representative of the positional distribution of fatty acids in Brassica lipids.”
`Id. According to Petitioner, “a POSITA reading the specification had no
`basis for considering the positional distribution of EPA reported for O.
`violaceous leaf lipids to be representative of the positional distribution of
`EPA in the lipids of any or all parts of a Brassica plant.” Id.
`Based on the present record, we find that Petitioner has demonstrated
`sufficiently that the invention described in claim 1 lacks written description
`
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`Patent 10,533,183 B2
`support in the ’189 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%
`EPA relative to the total lipids in the seed, but does not provide any
`information regarding the positional distribution of the EPA. Ex. 1001,
`55:9–23, col. 61–62 (Table 6); Ex. 1002 ¶¶ 58–59. Moreover, as Petitioner
`notes, there is no evidence on this record that the positional distribution of
`EPA reported for O. violaceous leaf lipids is representative of what was
`achievable in the Brassica plant at the time ’090 application was filed. See
`Pet. 39 (citing Ex. 1002 ¶ 91).
`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 that comprise 25% to 40% by weight of EPA based on the
`total EPA at the sn-2 position at the time the ’090 application was filed. 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 2–9 that
`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
`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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`Patent 10,533,183 B2
`do not reach the merits of Petitioner’s arguments that are directed to these
`dependent claims.
`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
`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 ’183 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
`the ’090 application) fails to provide written description support for the
`challenged claims. Therefore, we determine that the ’183 patent is not
`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 reasons it contends the ’183
`patent is eligible for post-grant review. Pet. 73–74. 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
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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 and institute post-grant review of claims 1–9 as
`challenged under Grounds 1–8.
`E. Grounds 7–16: Lack of Enablement
`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), enablement is separate and distinct from
`the written description requirement. Ariad, 598 F.3d at 1344. “The test of
`enablement is whether one reasonably skilled in the art could make or use
`the invention from the disclosures in the patent coupled with information
`known in the art without undue experimentation.” U.S. v. Telectronics, Inc.,
`857 F.2d 778, 785 (Fed. Cir. 1988). “[A] patent specification complies with
`the statute even if a ‘reasonable’ amount of 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 needed is not a single, simple factual determination, but
`rather is a conclusion reached by weighing many factual considerations.” In
`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 the art, (7) the
`predictability or unpredictability of the art, and (8) the breadth
`of the claims.
`
`Id.
`
`13
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`1. Ground 9: “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”
`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 and also include this
`limitation. Id. at 61:37–62:53. Petitioner argues that “[t]he ’183 Patent is
`completely devoid of any mention of, much less guidance or 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 Brassica lipid,” and,
`due to the breadth of the claim, “a POSITA could not make and use the
`claimed composition without undue experimentation.” Id. (citing Ex. 1002 ¶
`125).
`
`Based on the evidence of record, we find that Petitioner has
`adequately established, for purposes of this Decision, that the claim
`language relating to the amount of EPA in the sn-2 position of oils, lipids,
`and/or fatty acids produced by a transgenic Brassica plant is not enabled.
`The Specification does not provide guidance to one skilled in the art how to
`produce oils, lipids, and/or fatty acids in a transgenic Brassica plant that
`contain at least 25% to 40% by weight of EPA at the sn-2 position, based on
`the total weight of EPA. As set forth above, the only example in the
`Specification of a transgenic Brassica plant produced seed oil that contained
`only 4.1–4.5% EPA relative to the total lipids in the seed. Ex. 1001, col. 61–
`62, Table 6. Because this example does not meet the recited positional
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`distribution of EPA, we are not persuaded, on this record, that the
`Specification adequately teaches a skilled artisan how to produce the
`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 guidance or direction to produce the claimed
`amount of EPA at the sn-2 position in oils, lipids, and/or fatty acids
`produced by a transgenic Brassica plant, we find that Petitioner adequately
`demonstrates, for purposes of this Decision, that independent claim 1, and
`claims 2–9 that directly dependent therefrom, are not enabled. Accordingly,
`we institute a post-grant review of claims 1–9 under Ground 9.
`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 determined that Petitioner has sufficiently established that
`all of the challenged claims are not enabled by the Specification, we
`exercise our discretion and institute 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 obvious over, 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 obvious over, the ’387 publication. Pet. 76–90.
`Having determined that Petitioner has established it is more likely than not
`that at least one of the challenged claims is unpatentable under alternate
`grounds as discussed above (see above, § II.D), we institute a post-grant
`review based on Grounds 17–20 as well. See Guidance of the Impact of SAS
`on AIA Trial Proceedings (April 26, 2018) (explaining that “the PTAB will
`institute as to all claims or none” and “if the PTAB institutes a trial, the
`PTAB will institute on all challenges raised in the petition”).
`III. CONCLUSION
`Based on the arguments in the Petition, and the evidence of record, we
`determine that Petitioner has sufficiently demonstrated that claims 1–9 of
`the ’183 patent lack written description support in the ’090 application, and
`that the ’183 patent is eligible for post-grant review. Additionally, we
`determine that Petitioner has demonstrated, on the current record, that it is
`more likely than not that 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:
`ORDERED that, pursuant to 35 U.S.C. § 324(a), a post-grant review
`of the ’183 patent is instituted with respect to the grounds set forth in the
`Petition; and
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 324(d) and
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial
`commencing on the 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
`
`
`
`17
`
`
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