Filed on behalf of Commonwealth Scientific and Industrial Research Organisation
`by:
`Gary J. Gershik
`Cooper & Dunham LLP
`845 Third Avenue
`New York, NY 10022
`(212)278-0400
`ggershik@cooperdunham.com
`
`
`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.
`____________
`U.S. Patent No. 10,533,183
`Issued: January 14, 2020
`____________
`PETITION FOR POST-GRANT REVIEW
`PURSUANT TO 35 U.S.C. §§ 321-328 AND C.F.R. § 42.200 et seq.
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`TABLE OF CONTENTS
`Introduction ........................................................................................................ 1
`I.
`II. Mandatory Notices Under 37 C.F.R. § 42.8(A)(1) ............................................ 4
`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ................................ 4
`1. Related parties ................................................................................... 5
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2) .......................................... 6
`1. Continuation applications .................................................................. 6
`2.
`Post-grant review trials ..................................................................... 6
`3. Disputes between the parties ............................................................. 6
`C. Lead and Back Up Counsel Under 37 C.F.R. § 42.8(b)(3) ....................... 7
`D. Service Information Under 37 C.F.R. § 42.8(b)(4) ................................... 7
`III. Additional Requirements ................................................................................... 8
`A. Payment of fees under 37 C.F.R. § 42.15 ................................................. 8
`B. Timing under 37 C.F.R. § 42.202.............................................................. 8
`C. Grounds for standing under 37 C.F.R. § 42.204(a) ................................... 8
`IV. Technology Background .................................................................................... 9
`A. Fatty acid nomenclature ............................................................................ 9
`B. Fatty acid biosynthesis ............................................................................ 10
`C. Triacylglycerides and the fatty acid composition of plants .................... 10
`1.
`Positional distribution of fatty acids in different lipid species ....... 11
`V. Summary of the ‘183 Patent ............................................................................ 13
`A. The disclosure of the ‘183 Patent and its priority applications ............... 13
`1. The disclosure of the ‘183 Patent .................................................... 13
`2. The disclosure of the priority applications ...................................... 17
`B. The disclosure of the ‘183 Patent compared to the disclosure of WO
`2005/083093 A2 ...................................................................................... 17
`1. Binary vectors used for transformation of plant cells ..................... 20
`2. The codon-optimized Δ5 elongase used in examples 4-13 of the
`‘183 Patent was disclosed in the earlier ‘093 publication ............... 22
`
`ii
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`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`3. Lipids produced by transformed plants ........................................... 22
`C. Examination of the ‘837 application ....................................................... 23
`1.
`PO did not provide a specific statement of support for the claims
`at any point during prosecution ....................................................... 23
`2. There is no record of the Examiner analyzing the Written
`Description or Enablement of the claims during prosecution ......... 24
`3. The Examiner’s statement of reasons for allowance reflect the
`Examiner’s confusion regarding the scope of the claims ............... 25
`VI. Statement of the Precise Relief Requested and the Reasons Therefor Under
`37 C.F.R. § 42.22(A) and 37 C.F.R. § 42.204(b) ............................................ 26
`A. Claim construction (37 C.F.R. § 42.204(b)(3)) ....................................... 29
`B. Person of ordinary skill in the art ............................................................ 32
`VII. The ‘183 Patent is PGR Eligible ...................................................................... 33
`A. The ‘638 Patent contains claims that are not entitled to a pre-AIA
`filing date ................................................................................................. 35
`B. The claims lack written description support ........................................... 36
`1. Legal standard for written description ............................................ 36
`2. Ground 1: No written description for “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”
`recited in claim 1 ............................................................................. 38
`3. Ground 2: No written description for “wherein said oils, lipids
`and/or fatty acids comprise in the sn-2 position 40% to 60% by
`weight of docosapentaenoic acid (DPA) based on the total DPA”
`recited in claim 2 ............................................................................. 40
`4. Ground 3: No written description for “wherein said oils, lipids
`and/or fatty acids comprise in the sn-2 position 15% to 35% by
`weight of docosahexanoic acid (DHA) based on the total DHA”
`recited in claim 3 ............................................................................. 42
`5. Ground 4: No written description for “at least 20% by weight of
`EPA”, “at least 2% by weight of DPA”, or “at least 4% by weight
`of DHA”, “based on the total fatty acids in the transgenic
`
`iii
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`[Brassica] plant in the form of triacylglycerides” alone or in
`combination, recited in claim 4 ....................................................... 43
`6. Ground 5: No written description for “at least 20% long chain
`polyunsaturated fatty acids (LCPUFAs) based on the total fatty
`acids in the transgenic [Brassica] plant” recited in claim 5 ........... 48
`7. Ground 6: No written description for “at least about 25% by
`weight of EPA in the form of triacylglycerides based on the total
`fatty acids in the transgenic [Brassica] plant” recited in claim 6 ... 51
`8. Ground 7: No written description for “at least about 30% by
`weight of EPA and DHA in the form of triacylglycerides based
`on the total fatty acids in the transgenic [Brassica] plant” recited
`in claim 7 ......................................................................................... 51
`9. Ground 8: No written description for oils, lipids and/or fatty
`acids produced by a transgenic Brassica plant comprising “at
`least 54% by weight of polyunsaturated ω3-fatty acids” recited
`in claim 8 ......................................................................................... 52
`C. The claims are not enabled ...................................................................... 57
`1. Legal standard for enablement ........................................................ 57
`2. Ground 9: 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 25% to 40% by weight of
`eicosapentaenoic (EPA) based on the total EPA” recited in claim
`1 are not enabled ............................................................................. 59
`3. Ground 10: 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 40% to 60% by weight of
`docosapentaenoic acid (DPA) based on the total DPA” recited in
`claim 2 are not enabled ................................................................... 60
`4. Ground 11: 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 15% to 35% by weight of
`docosahexanoic acid (DHA) based on the total DHA” recited in
`claim 3 are not enabled ................................................................... 61
`
`iv
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`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`5. Ground 12: Oils, lipids and/or fatty acids produced by a
`transgenic Brassica plant comprising “at least 20% by weight of
`EPA”, “at least 2% by weight of DPA”, or “at least 4% by weight
`of DHA”, “based on the total fatty acids in the transgenic
`[Brassica] plant in the form of triacylglycerides” recited in claim
`4 are not enabled ............................................................................. 62
`6. Ground 13: Oils, lipids and/or fatty acids produced by a
`transgenic Brassica plant comprising “at least 20% long chain
`polyunsaturated fatty acids (LCPUFAs) based on the total fatty
`acids in the transgenic [Brassica] plant,” recited in claim 5 are
`not enabled ...................................................................................... 67
`7. Ground 14: Oils, lipids and/or fatty acids produced by a
`transgenic Brassica plant comprising “at least about 25% by
`weight of EPA in the form of triacylglycerides based on the total
`fatty acids in the transgenic [Brassica] plant,” recited in claim 6,
`are not enabled ................................................................................ 68
`8. Ground 15: Oils, lipids and/or fatty acids produced by a
`transgenic Brassica plant comprising “at least about 30% by
`weight of EPA and DHA in the form of triacylglycerides based
`on the total fatty acids in the transgenic [Brassica] plant,” recited
`in claim 7 are not enabled ............................................................... 69
`9. Ground 16: Oils, lipids and/or fatty acids produced by a
`transgenic Brassica plant comprising “at least 54% by weight of
`polyunsaturated ω3-fatty acids,” recited in claim 8, are not
`enabled ............................................................................................ 70
`VIII. Claims 1-9 of the ‘183 Patent are unpatentable ............................................... 73
`A. Grounds 1-8: Claims 1-9 lack written description in the ‘183 Patent
`for the same reasons that the claims lack entitlement to the priority
`applications .............................................................................................. 73
`B. Grounds 9-16: Claims 1-9 lack enablement in the ‘183 Patent for the
`same reasons that the claims lack entitlement to the priority
`applications .............................................................................................. 74
`C. Ground 17: Claims 1-3 and 5-9 are anticipated by Wu et al. (2005)
`Nat. Biotech. 1013-1017 ......................................................................... 76
`
`v
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`1. Disclosure of Wu et al. (2005) ........................................................ 76
`2. Claims 1-3 and 5-9 are anticipated by Wu et al. ............................. 78
`D. Ground 18: Claims 1-9 are anticipated by, or obvious over,
`WO 2005/083093 – the ‘093 publication (BASF Plant Science
`GmbH) ..................................................................................................... 81
`1. Disclosure of the ‘093 publication .................................................. 81
`2. Claims 1-9 are anticipated by, or obvious over, the ‘093
`publication ....................................................................................... 82
`E. Ground 19: Claims 1-9 are obvious over Wu et al. in view of the ‘093
`publication ............................................................................................... 85
`1. The disclosures of the ‘093 publication and Wu et al. .................... 86
`2. Claims 1-9 are obvious over Wu et al. in view of the ‘093
`publication ....................................................................................... 86
`F. Ground 20: Claims 1-9 are anticipated by, or obvious over, WO
`2007/096387 A1 – the ‘387 publication (BASF Plant Science GmbH)
` ................................................................................................................. 89
`1. The disclosure of the ‘387 publication ............................................ 90
`2. Claims 1-9 are anticipated by, or obvious over the ‘387
`publication ....................................................................................... 90
`IX. Conclusion ....................................................................................................... 90
`
`
`
`
`
`vi
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`TABLE OF AUTHORITIES
`
`Cases
`AK Steel Corp. v. Sollac,
`344 F.3d 1234 (Fed. Cir. 2003)......................................................... 58, 64, 68, 72
`Amgen, Inc. v. Chugai Pharm. Co.,
`927 F.2d 1200 (Fed. Cir. 1991)............................................................................ 57
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ........................................................... 36
`Enzo Biochem, Inc. v. Calgene, Inc.,
`188 F.3d 1362 (Fed. Cir. 1999)............................................................................ 57
`Enzo Biochem, Inc. v. Gen-Probe, Inc.,
`323 F.3d 956, 63 USPQ2d 1609 (Fed. Cir. 2002) ............................................... 37
`Genentech, Inc. v. Novo Nordisk, A/S,
`108 F.3d 1361 (Fed. Cir. 1997)............................................................................ 57
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988).............................................................................. 57
`MagSil Corp. v. Hitachi Global Storage Techs., Inc.,
`687 F.3d 1377 (Fed. Cir. 2012)............................................................... 58, 64, 65
`Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc.,
`166 F.3d 1190 (Fed. Cir. 1999)..................................................................... 58, 75
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .................................................... 29, 30
`Sitrick v. Dreamworks, LLC,
`516 F.3d 993 (Fed. Cir. 2008).............................................................................. 58
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998)............................................................................ 36
`Statutes
`35 U.S.C. § 119(e)(1) .......................................................................................... 3, 34
`35 U.S.C. §112(a) ...................................................................................................... 3
`35 U.S.C. §120 .................................................................................................... 3, 34
`Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) ...... 33
`Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011),
`§ 3(n)(1) ........................................................................................................ 34, 35
`
`vii
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011),
`§ 3(n)(1)(B) .......................................................................................................... 36
`Rules
`37 C.F.R. § 42.10(b) .................................................................................................. 7
`37 C.F.R. § 42.202(a) ................................................................................................. 8
`37 C.F.R. § 42.8 (b)(1) ............................................................................................... 4
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 6
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 7
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 7
`
`
`
`viii
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`EXHIBIT LIST
`Description
`
`Exhibit No.
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`Cirpus et al., U.S. Patent No. 10,533,183, “Oils, Lipids and Fatty
`Acids Produced in Transgenic Brassica Plant,” issued January 14,
`2020
`
`Declaration of Dr. Narendra Yadav in Support of Petition
`
`Cirpus et al., PCT International Application Publication No. WO
`2007/096387 A1, published August 30, 2007
`
`Cirpus et al., German Patent Application No. DE 10 2006 008
`030.0, filed February 21, 2006
`
`Cirpus et al., European Patent Application No. 06120309.7, filed
`September 7, 2006
`
`Cirpus et al., PCT International Application Publication No. WO
`2005/083093 A2, published September 9, 2005
`
`Cirpus et al., U.S. Patent No. 10,301,638, “Oils, Lipids and Fatty
`Acids Produced in Transgenic Brassica Plant,” issued May 28, 2019
`
`Wu, Guohai, et al. “Stepwise engineering to produce high yields of
`very long-chain polyunsaturated fatty acids in plants.” Nature
`biotechnology 23.8 (2005): 1013-1017.
`
`File History of U.S. Application No. 15/256,914, excluding copies
`of references submitted with Information Disclosure Statements
`
`File History of U.S. Application No. 16/371,837, excluding copies
`of references submitted with Information Disclosure Statements
`
`English translation of Cirpus et al., German Patent Application
`No. DE 10 2006 008 030.0, filed February 21, 2006
`
`Alignment of SEQ ID NO:197 from the ‘093 publication with SEQ
`ID NO:64 from the ‘638 Patent
`
`Cirpus et al., U.S. Patent No. 9,458,436 B2, issued October 4, 2016
`
`ix
`
`

`

`Exhibit No.
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`Description
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`
`
`Ohlrogge, J., & Browse, J. (1995). Lipid biosynthesis. The Plant
`Cell, 7(7), 957.
`
`Begna, S. H., & Angadi, S. V. (2016). Effects of planting date on
`winter canola growth and yield in the southwestern US. American
`Journal of Plant Sciences, 7(1), 201-217.
`
`Li, Q, et al. (2015). Wrinkled1 accelerates flowering and regulates
`lipid homeostasis between oil accumulation and membrane lipid
`anabolism in Brassica napus. Frontiers in plant science, 6, 1015.
`
`Petition for Post-Grant Review Pursuant to 35 U.S.C. §§ 321-328
`and C.F.R. § 42.200 et seq. filed February 28, 2020 against U.S.
`Patent No. 10,301,638, before the Patent Trial and Appeal Board
`
`September 10, 2020 Decision Granting Institution of Post-Grant
`Review under 35 U.S.C. § 324(a) of U.S. Patent No. 10,301,638
`
`U.S. Patent Application Publication No. US 2010/0227924 A1,
`published September 9, 2010, from U.S. Serial No. 12/280,090
`
`x
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`INTRODUCTION
`Commonwealth Scientific and Industrial Research Organisation (“CSIRO”)
`
`I.
`
`respectfully requests institution of a post-grant review (“PGR”) of claims 1-9 of U.S.
`
`Patent No. 10,533,183 (“the ‘183 Patent,” Ex. 1001) pursuant to 35 U.S.C. §§ 321-
`
`329 and 37 C.F.R. § 42.200 et seq. This Petition, supported by the accompanying
`
`Declaration of Dr. Narendra Yadav (“Yadav Declaration,” Ex. 1002), demonstrates
`
`that claims 1-9 the ‘183 Patent are not patentable.
`
`The ‘183 Patent issued from U.S. Application No. 16/371,837 (“the ‘837
`
`application”), filed on April 1, 2019 as a continuation of U.S. Application
`
`No. 15/256,914, which was filed on September 6, 2016 and issued as U.S. Patent
`
`No. 10,301,638 on May 28, 2019 (“the ‘638 Patent”, Ex. 1007). U.S. Application
`
`No. 15/256,914 was filed as a continuation of U.S. Application No. 12/280,090,
`
`which was filed as a §371 national stage entry of PCT International Application
`
`No. PCT/EP2007/051675, filed February 21, 2007 (Ex. 1003), which claims priority
`
`to German Patent Application No. DE 10 2006 008 030.0, filed February 21, 2006
`
`1
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`(Ex. 1004), and European Patent Application No. 06120309.7, filed September 7,
`
`2006 (Ex. 1005).1
`
`The claims of the ‘183 Patent are completely unsupported, reciting claim
`
`features that appear nowhere in the specification of the patent or any of the priority
`
`applications. For example, claim 1 of the ‘183 Patent claims “[o]ils, lipid and/or fatty
`
`acids produced by a transgenic Brassica plant wherein said oils, lipids and/or fatty
`
`acids comprise in the sn-2 position 25% to 40% by weight eicosapentaenoic [acid]
`
`(EPA) based on the total EPA” (Ex. 1001, claim 1), but the specification is entirely
`
`devoid of description of oils, lipids and/or fatty acids produced by a transgenic
`
`Brassica plant comprising “25% to 40% by weight EPA” “in the sn-2 position.”
`
`Indeed, the specification does not contain a single disclosure of the threshold range
`
`“25% to 40% by weight EPA,” much less a disclosure of this range of EPA “in the
`
`sn-2 position.”
`
`As detailed herein, the specification of the ‘183 Patent provides neither
`
`written description nor enablement for the patent protection it seeks to cover by its
`
`claims 1-9.
`
`
`1 Collectively, all the applications to which the ‘183 Patent claims priority (i.e., U.S.
`
`Application Nos. 15/256,914 and 12/280,090, PCT/EP2007/051675, DE 10 2006
`
`008 030.0, and 06120309.7) are referred to herein as the “priority applications.”
`
`2
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`As further detailed herein, the claims of the ‘183 Patent lack written
`
`description and enablement in the priority applications. The specification of the ‘183
`
`Patent does not differ from that of its parent application, U.S. Application
`
`No. 15/256,914, or its grandparent application, U.S. Application No. 12/280,090.2
`
`Further, the two applications to which PCT/EP2007/051675 claims priority, i.e.,
`
`German Patent Application No. DE 10 2006 008 030.0 and European Patent
`
`Application No. 06120309.7, do not contain any disclosure that is not in the
`
`specification of PCT/EP2007/051675.
`
`Entitlement to the benefit of an earlier application’s filing date under 35
`
`U.S.C. §§ 119 and 120 is premised on disclosure of the claimed invention “in the
`
`manner provided by [35 U.S.C.] section 112(a)” in the earlier application. 35 U.S.C.
`
`§§ 119(e)(1), 120. Because the claims of the ‘183 Patent are not disclosed in the
`
`manner provided by 35 U.S.C. §112(a) by any pre-AIA application, they are eligible
`
`for PGR. Because the claims of the ‘183 Patent are not disclosed in the manner
`
`provided by 35 U.S.C. §112(a) by any pre-AIA or AIA application, they should be
`
`cancelled as failing to meet the written description and enablement requirements of
`
`AIA 35 U.S.C. §112(a).
`
`
`2 The national stage entry of and sharing
`
`the same disclosure with
`
`PCT/EP2007/051675.
`
`3
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`Further, the ‘183 Patent issued from an application that was a continuation of
`
`U.S. Application No. 15/256,914, which issued on May 28, 2019 as the ‘638 Patent.
`
`The Board ruled in a September 10, 2020 Decision Granting Institution of Post-
`
`Grant Review 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.” Ex. 1018, p.17-18. Consequently, the ‘183 Patent is also eligible
`
`for PGR.
`
`Finally, the claims of the ‘183 Patent are anticipated or rendered obvious by
`
`one or more prior art references as detailed herein.
`
`Accordingly, Petitioner requests institution of a PGR and cancellation of
`
`claims 1-9 of the ’183 Patent.
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(A)(1)
`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`Pursuant to 37 C.F.R. § 42.8 (b)(1), the real party-in-interest for this Petition
`
`is Commonwealth Scientific and Industrial Research Organisation (“CSIRO”), a
`
`Government Agency organized under the laws of Australia, having a place of
`
`business at CSIRO Black Mountain Science and Innovation Park, Clunies Ross
`
`Street, Acton ACT 2601, Australia.
`
`4
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`1.
`Related parties
`For the sake of transparency, Petitioner advises the Board that the following
`
`parties are commercial partners of CSIRO, and co-owners with CSIRO of their own
`
`patents in the field of polyunsaturated ω3-fatty acids:
`
`1. Grains Research and Development Corporation (“GRDC”), an
`
`Australian statutory corporation with its principal place of business
`
`located at Level 4, East Building, 4 National Circuit, Barton ACT 2600,
`
`Australia.
`
`2. Nuseed Pty Ltd., an Australian proprietary limited company with its
`
`principal place of business at 103–105 Pipe Road, Laverton, North
`
`Victoria, 3026, Australia.
`
`Further:
`
`3. Nufarm Limited, located at 103-105 Pipe Road Laverton North Victoria
`
`3026, Australia, is the parent company of Nuseed Pty. Ltd.
`
`4. Nufarm Limited is also the parent company of Nuseed Americas Inc.,
`
`which is located at 1000 Burr Ridge Pkwy, Burr Ridge, IL 60527.
`
`None of these related parties are controlling or otherwise have an opportunity
`
`to direct or control this Petition or Petitioner’s participation in any resulting PGR.
`
`5
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`Pursuant to 37 C.F.R. § 42.8(b)(2), Petitioner identifies the following judicial
`
`or administrative matters that could be affected by a decision in this proceeding:
`
`1.
`Continuation applications
`U.S. Application No. 16/371,837, from which the ‘183 patent issued, was
`
`filed as a continuation of U.S. Application No. 15/256,914, from which the
`
`following two continuation applications were filed:
`
`1. U.S. Application No. 16/371,451, filed on April 1, 2019, and issued as
`
`U.S. Patent No. 10,533,182 on January 14, 2020; and
`
`2. U.S. Application No. 16/371,696, filed on April 1, 2019, currently
`
`pending.
`
`2.
`A PGR
`
`Post-grant review trials
`trial has been
`instituted
`
`in connection with U.S. Patent
`
`No. 10,301,638, which issued from a parent application of the ‘183 patent. The PGR
`
`Trial has been assigned AIA Trial Number PGR2020-00033.
`
`3.
`Disputes between the parties
`The Petitioner and related parties have been involved in judicial proceedings
`
`relating to Petitioner’s patents in the field of ω-3 polyunsaturated fatty acid
`
`synthesis. These judicial matters will not be affected by a decision in this
`
`proceeding:
`
`6
`
`

`

`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`1. BASF PLANT SCIENCE, LP v. NUSEED AMERICAS, in the United
`
`States District Court for the District of Delaware, Civil Action No. :17-
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`cv-00421-VAC-CJB;
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`2. BASF Plant Science, LP et al. v. Commonwealth Scientific and
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`Industrial Research Organisation et al., in the United States District
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`Court for the Eastern District of Virginia Norfolk Division, Civil
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`Action No. 2:17-cv-00503-HCM-LRL; and
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`3. BASF Plant Science, LP v. Commonwealth Scientific and Industrial
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`Research Organisation / Commonwealth Scientific and Industrial
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`Research Organisation, et al., v. BASF Plant Science, LP, et al., in the
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`United States Court of Appeals for the Federal Circuit, Appeal
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`Nos. 2020-1415, 2020-1416.
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`C. Lead and Back Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`Pursuant to 37 C.F.R. § 42.8(b)(3), lead counsel and back-up counsel for this
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`Petition are Gary J. Gershik (Reg. No. 39,992) and John P. White (Reg. No. 28,678),
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`respectively. Pursuant to 37 C.F.R. § 42.10(b), Petitioner has filed a power of
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`attorney designating the above-identified counsel.
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`D.
`Service Information Under 37 C.F.R. § 42.8(b)(4)
`Pursuant to 37 C.F.R. § 42.8(b)(4) service information for the Petition is as
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`follows:
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`Gary J. Gershik
`Cooper & Dunham LLP
`845 Third Avenue, 6th Floor
`New York, NY 10022
`Tel: 212-278-0552
`Fax: 212-391-0525
`Email: ggershik@cooperdunham.com
`Email: dhaber@cooperdunham.com
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
`
`
`John P. White
`Cooper & Dunham LLP
`845 Third Avenue, 6th Floor
`New York, NY 10022
`Tel: 212-278-0421
`Fax: 212-391-0525
`Email: jwhite@cooperdunham.com
`Email: pdocketing@cooperdunham.com
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`
`III. ADDITIONAL REQUIREMENTS
`A.
`Payment of fees under 37 C.F.R. § 42.15
`Petitioner submits herewith the required fees in accordance with 37 C.F.R.
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`§§ 42.203(a) and 42.15(a). If any additional fees are due during this proceeding, the
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`Office is authorized to charge such fees to Deposit Account No. 03-3125.
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`B.
`Timing under 37 C.F.R. § 42.202
`The ‘183 Patent issued on January 14, 2020. Pursuant to 37 C.F.R.
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`§ 42.202(a), a petition for PGR of a patent must be filed no later than the date that is
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`nine months after the issued date of the patent. Accordingly, the deadline to file a
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`petition for PGR of the ‘183 Patent is October 14, 2020, and this Petition is being
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`timely filed.
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`C. Grounds for standing under 37 C.F.R. § 42.204(a)
`Petitioner hereby certifies that the ʼ183 Patent is available for PGR and that
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`Petitioner is not barred or estopped from requesting PGR of any claim of the ʼ183
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`Patent.
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`IV. TECHNOLOGY BACKGROUND
`The ‘183 Patent relates generally to the production, in transgenic plants, of
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`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
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`oils and lipids with certain fatty acid components. A brief discussion of the structure
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`of fatty acids is provided in paragraph 25 of the Yadav Declaration (Ex. 1002).
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`A.
`Fatty acid nomenclature
`A summary of ω-3 polyunsaturated fatty acids is provided below3:
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`Omega-3 (ω3) Fatty Acids
`Name
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`Hexadecatrienoic acid (HTA)
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`α-Linolenic acid (ALA)
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`Stearidonic acid (SDA)
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`Eicosatetraenoic acid (ETA)
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`Δ notation
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`16:3Δ7,10,13
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`18:3Δ9,12,15
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`18:4Δ6,9,12,15
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`20:4Δ8,11,14,17
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`ω notation
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`16:3ω-3
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`18:3ω-3
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`18:4ω-3
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`20:4ω-3
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`Eicosapentaenoic acid (EPA)
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`20:5Δ5,8,11,14,17
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`20:5ω-3
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`Docosapentaenoic acid (DPA)
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`22:5Δ7,10,13,16,19
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`22:5ω-3
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`Docosahexaenoic acid (DHA)
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`22:6Δ4,7,10,13,16,19 22:6ω-3
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`Tetracosapentaenoic acid
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`24:5Δ9,12,15,18,21
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`24:5ω-3
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`Tetracosahexaenoic acid
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`24:6Δ6,9,12,15,18,21 24:6ω-3
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`Ex. 1002, ¶31.
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`3 The nomenclature and notation of fatty acids is discussed in detail in paragraphs
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`26-31 of the Yadav Declaration (Ex. 1002).
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`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
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`B.
`Fatty acid biosynthesis
`Although there are multiple pathways for the biosynthesis of PUFAs and LC-
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`PUFAs4, the ‘183 Patent focuses on the biosynthesis of PUFAs and LC-PUFAs in
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`transgenic plants that have been transformed with binary vectors comprising
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`enzymes with activity in the aerobic biosynthetic pathway, an overview of which is
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`provided in paragraphs 33-37 of the Yadav Declaration (Ex. 1002).
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`C. Triacylglycerides and the fatty acid composition of plants
`Claims of the ‘183 Patent recite amounts of fatty acids, relative to either “the
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`total fatty acids in the plant,” or relative to “the total fatty acids in the plant in the
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`form of triacylglycerides.” Ex. 1002, ¶38.
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`The total fatty acids in a plant are present as fatty acids esters, such as
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`triacylglycerides (TAG), diacylglycerides (DAG), monoacylglycerides (MAG),
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`phospholipids (i.e., phosphatidylglycol (PG), phosphatidylethanolamine (PE),
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`phosphatidylcholine
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`(PC)), galactolipids
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`(i.e., monogalactosyldiacylglycerol
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`4 Long-chain polyunsaturated fatty acids (“LC-PUFAs”) typically refers to
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`polyunsaturated fatty acids with 18-20 or more carbons, although for the purposes
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`of this Petition, it is not necessary for there to be a precise definition of LC-PUFA
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`because the claims reciting LC-PUFA specify “C20 and/or C22 fatty acid molecules
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`having at least four double bonds” Ex. 1002, ¶32, footnote 1.
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`Petition for Post-Grant Review
`of U.S. Patent No. 10,533,183
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`(MGDG), and digalactosyldiacylglycerol (DGDG)), or free fatty acids. The ‘183
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`Patent states that “as a rule” fatty acid esters and free fatty acids are generally present
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`in plants “with an approximate distribution of 80 to 90% by weight of
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`tri[acyl]glycerides, 2 to 5% by weight of di[acyl]gly