`by:
`Gary J. Gershik
`Cooper & Dunham LLP
`30 Rockefeller Plaza
`New York, NY 10112
`(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. 10,301,638
`Issued: May 28, 2019
`____________
`PETITION FOR POST-GRANT REVIEW
`PURSUANT TO 35 U.S.C. §§ 321-328 AND C.F.R. § 42.200 et seq.
`
`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`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 ................................................................................... 4
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2) .......................................... 5
`1. Continuation applications .................................................................. 5
`2. 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 ................................................................................... 7
`A. Payment of Fees Under 37 C.F.R. § 42.15 ................................................ 7
`B. Timing Under 37 C.F.R. § 42.202 ............................................................. 7
`C. Grounds for Standing Under 37 C.F.R. § 42.204(a) ................................. 8
`IV. Technology Background .................................................................................... 8
`A. Fatty acid nomenclature ............................................................................ 8
`B. Fatty acid biosynthesis ............................................................................ 11
`1. The aerobic biosynthetic pathway ................................................... 12
`2. Transformation of plants with binary vectors ................................. 13
`C. Triacylglycerides and the fatty acid composition of plants .................... 14
`V. Summary of the ‘638 Patent ............................................................................ 15
`A. The disclosure of the ‘638 Patent and its priority applications ............... 15
`1. The disclosure of the ‘638 Patent .................................................... 15
`2. The disclosure of the priority applications ...................................... 19
`B. The disclosure of the ‘638 Patent compared to the disclosure of Cirpus et
`al., PCT International Application Publication No. WO 2005/083093
`A2, published September 9, 2005 ........................................................... 20
`1. Binary vectors used for transformation of plant cells ..................... 22
`
`ii
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`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`2. The ‘638 Patent recites in claims 18-23 the same codon-optimized
`Δ5 elongase that was disclosed in the earlier ‘093 publication ...... 24
`3. Lipids produced by transformed plants ........................................... 24
`C. Examination of the ‘638 Patent ............................................................... 25
`1. No statement of support was provided for the claims filed with the
`application ....................................................................................... 25
`2. There is no record of the Examiner analyzing the Written
`Description or Enablement of the claims during prosecution ......... 26
`3. There is no record of the Examiner analyzing Enablement provided
`by the disclosure of the ‘638 Patent when accepting PO’s
`arguments that the disclosure of WO 2005/083093 did not enable
`certain claimed features ................................................................... 26
`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) ................................................. 32
`A. Claim Construction (37 C.F.R. § 42.204(b)(3)) ...................................... 36
`B. Person of Ordinary Skill in the Art ......................................................... 38
`VII. The ‘638 Patent is PGR Eligible ...................................................................... 38
`A. The ‘638 Patent should have been examined under the AIA .................. 40
`B. The Priority Applications Lack Written Description Support ................ 41
`1. Legal Standard for Written Description .......................................... 41
`2. Ground 1: 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 claims 8-16
` ......................................................................................................... 42
`3. Ground 2: No Written Description for “at least 20% by weight of
`EPA, at least 2% by weight of docosapentaenoic acid (DPA), and at
`least 4% by weight of docosahexaenoic acid (DHA) based on the
`total fatty acids in the transgenic [Brassica] plant in the form of
`triacylglycerides,” recited in 1-8, and 17-23 ................................... 48
`4. Ground 3: No Written Description for “at least 20% by weight of
`EPA based on the total fatty acids in the transgenic [Brassica] plant
`in the form of triacylglycerides” recited in claim 11 ...................... 54
`
`iii
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`CSIRO Exhibit 1017
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`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`5. Ground 4: No Written Description for “at least 2% by weight of
`DPA based on the total fatty acids in the transgenic [Brassica] plant
`in the form of triacylglycerides” recited in claim 12 ...................... 54
`6. Ground 5: No Written Description for “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 13 ............. 54
`7. Ground 6: No Written Description for the amounts of EPA, DPA
`“and” DHA at “the sn-1, sn-2 or sn-3” position recited in claim 2 55
`8. Ground 7: No Written Description for the amounts of EPA, DPA
`“and” DHA at “the sn-2 position” recited in claim 3 ...................... 57
`9. Ground 8: No Written Description for “at least 30% long chain
`polyunsaturated fatty acids (LCPUFAs) based on the total fatty
`acids in the transgenic [Brassica] plant” recited in claims 5 and 14
` ......................................................................................................... 57
`10. Ground 9: No Written Description for “about 25% by weight of
`EPA in the form of triacylglycerides based on the total fatty acids
`in the transgenic [Brassica] plant” recited in claims 6 and 15 ....... 60
`11. Ground 10: No Written Description for “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 claims 7
`and 16 .............................................................................................. 61
`12. Ground 11: No Written Description for the amounts of EPA, DPA,
`and DHA recited in claim 17 “based on the total fatty acids in the
`transgenic [Brassica] plant.” ........................................................... 61
`C. Lack of Enablement in the Priority Applications .................................... 61
`1. Legal Standard for Enablement ....................................................... 61
`2. Ground 12: 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 claims 8-16, are not
`enabled ............................................................................................ 64
`3. Ground 13: 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 docosapentaenoic acid (DPA), and at least 4% by
`
`iv
`
`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`weight of docosahexaenoic acid (DHA) based on the total fatty
`acids in the transgenic [Brassica] plant in the form of
`triacylglycerides,” recited in claims 1-8 and 17-23 are not enabled
` ......................................................................................................... 67
`4. Ground 14: Oils, lipids and/or fatty acids produced by a transgenic
`Brassica plant comprising “at least 20% by weight of EPA based
`on the total fatty acids in the transgenic [Brassica] plant in the form
`of triacylglycerides,” recited in claim 11 is not enabled ................. 72
`5. Ground 15: Oils, lipids and/or fatty acids produced by a transgenic
`Brassica plant comprising “at least 2% by weight of DPA based on
`the total fatty acids in the transgenic [Brassica] plant in the form of
`triacylglycerides,” recited in claim 12 is not enabled ..................... 72
`6. Ground 16: Oils, lipids and/or fatty acids produced by a transgenic
`Brassica plant comprising “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 13 is not enabled ..................... 72
`7. Ground 17: The amounts of EPA, DPA and DHA at the sn-1, sn-2
`or sn-3 positions recited in claim 2 are not enabled ........................ 73
`8. Ground 18: The amounts of EPA, DPA and DHA at the sn-2
`position recited in claim 3 are not enabled ..................................... 74
`9. Ground 19: Oils, lipids and/or fatty acids produced by a transgenic
`Brassica plant comprising “at least 30% long chain polyunsaturated
`fatty acids (LCPUFAs) based on the total fatty acids in the
`transgenic [Brassica] plant,” recited in claims 5 and 14, are not
`enabled ............................................................................................ 75
`10. Ground 20: Oils, lipids and/or fatty acids produced by a transgenic
`Brassica plant comprising “about 25% by weight of EPA based on
`the total fatty acids in the transgenic [Brassica] plant,” recited in
`claims 6 and 15, are not enabled ..................................................... 77
`11. Ground 21: Oils, lipids and/or fatty acids produced by a transgenic
`Brassica plant comprising “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 claims 7 and 16, are not
`enabled ............................................................................................ 77
`
`v
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`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`12. Ground 22: Oils, lipids and/or fatty acids produced by a transgenic
`Brassica plant comprising the amounts of EPA, DPA, and DHA
`recited in claim 17 “based on the total fatty acids in the transgenic
`[Brassica] plant” are not enabled .................................................... 78
`VIII. Claims 1-23 of the ‘638 Patent Are Unpatentable ........................................... 78
`A. Grounds 1-11: Claims 1-23 lack written description in the ‘638 Patent
`for the same reasons that the claims lack entitlement to the priority
`applications .............................................................................................. 78
`B. Grounds 12-22: Claims 1-23 lack enablement in the ‘638 Patent for the
`same reasons that the claims lack entitlement to the priority applications
` ................................................................................................................. 79
`C. Ground 23: Claim 9 is Anticipated by WO1999/64614 (Calgene) (“the
`‘614 publication”) published December 16, 1999 .................................. 80
`1. Disclosure of WO1999/64614......................................................... 80
`2. Claim 9 is anticipated by the ‘614 publication ............................... 81
`D. Ground 24: Claims 9, 10, 12, 13, 14, and 16 are Anticipated by
`WO 2015/196250 (Petrie et al.), published December 30, 2015 (“the
`‘250 publication”) .................................................................................... 81
`1. Disclosure of WO2015/196250 ...................................................... 81
`2. Claims 9, 10, 12, 13, 14, and 16 are anticipated by the ‘250
`publication ....................................................................................... 82
`E. Ground 25: Claims 1-23 Are Anticipated by, or obvious over,
`WO 2005/083093 – the ‘093 publication (BASF Plant Science GmbH)84
`1. Disclosure of the ‘093 publication .................................................. 85
`2. Claims 1-23 are anticipated by the ‘093 publication ...................... 85
`IX. Conclusion ....................................................................................................... 92
`
`
`
`
`
`vi
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`CSIRO Exhibit 1017
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`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`TABLE OF AUTHORITIES
`
`Cases
`AK Steel Corp. v. Sollac,
`344 F.3d 1234 (Fed. Cir. 2003)................................................... 63, 65, 70, 74, 76
`Amgen, Inc. v. Chugai Pharm. Co.,
`927 F.2d 1200 (Fed. Cir. 1991)............................................................................ 62
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) ........................................................... 41
`Enzo Biochem, Inc. v. Calgene, Inc.,
`188 F.3d 1362 (Fed. Cir. 1999)............................................................................ 62
`Enzo Biochem, Inc. v. Gen-Probe, Inc.,
`323 F.3d 956, 63 USPQ2d 1609 (Fed. Cir. 2002) ............................................... 42
`Genentech, Inc. v. Novo Nordisk, A/S,
`108 F.3d 1361 (Fed. Cir. 1997)............................................................................ 62
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988).............................................................................. 62
`MagSil Corp. v. Hitachi Global Storage Techs., Inc.,
`687 F.3d 1377 (Fed. Cir. 2012)......................................................... 63, 65, 66, 70
`Nat’l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc.,
`166 F.3d 1190 (Fed. Cir. 1999)............................................................................ 62
`Nat’l Recovery v. Magnetic Separation 166 F.3d at 1198 ....................................... 80
`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) ......................... 36
`Sitrick v. Dreamworks, LLC,
`516 F.3d 993 (Fed. Cir. 2008).............................................................................. 63
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998)............................................................................ 41
`Statutes
`35 U.S.C. § 100(i) .................................................................................................... 40
`35 U.S.C. § 119(e)(1) .......................................................................................... 3, 40
`35 U.S.C. §112(a) ...................................................................................................... 3
`35 U.S.C. §120 .................................................................................................... 3, 40
`AIA, § 3(n)(1) .......................................................................................................... 41
`AIA, § 6(f)(2)(A) ..................................................................................................... 39
`Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) ...... 39
`
`vii
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`CSIRO Exhibit 1017
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`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`Rules
`37 C.F.R. § 42.10(b) .................................................................................................. 7
`37 C.F.R. § 42.202(a) ................................................................................................. 7
`37 C.F.R. § 42.8 (b)(1) ............................................................................................... 4
`37 C.F.R. § 42.8(b)(2) ................................................................................................ 5
`37 C.F.R. § 42.8(b)(3) ................................................................................................ 7
`37 C.F.R. § 42.8(b)(4) ................................................................................................ 7
`
`
`
`viii
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`CSIRO Exhibit 1017
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`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`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. 10,301,638, “Oils, Lipids and Fatty
`Acids Produced in Transgenic Brassica Plant,” issued May 28, 2019
`
`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
`
`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.
`
`Comparison of claims filed on September 6, 2016 with U.S.
`Application No. 15/256,914 and the claims of the ‘638 Patent
`
`File History of U.S. Application No. 15/256,914, 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 ‘063 patent
`
`Knutzon, PCT International Application Publication No. WO
`1999/64614, published December 16, 1999
`
`Cirpus et al., U.S. Patent No. 9,458,436 B2, issued October 4, 2016
`
`ix
`
`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`Description
`
`Petrie et al., PCT International Application Publication No. WO
`2015/089587, published December 30, 2015
`
`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.
`
`Exhibit No.
`
`1014
`
`1015
`
`1016
`
`1017
`
`
`
`x
`
`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`INTRODUCTION
`Commonwealth Scientific and Industrial Research Organisation (“CSIRO”)
`
`I.
`
`respectfully requests institution of a post-grant review (“PGR”) of claims 1-23 of
`
`U.S. Patent No. 10,301,638 (“the ‘638 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 (Ex. 1002), demonstrates that
`
`claims 1-23 the ‘638 Patent are not patentable.
`
`The ‘638 Patent issued from U.S. Application No. 15/256,914 (the ‘914
`
`application), filed on September 6, 2016 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 (Ex. 1004), and European Patent Application No. 06120309.7,
`
`filed September 7, 2006 (Ex. 1005).1
`
`The claims of the ‘638 Patent are exceptionally broad. Claim 1 of the ‘638
`
`Patent broadly claims oils, lipid and/or fatty acids produced by a transgenic Brassica
`
`
`1 Collectively, all the applications to which the ‘638 Patent claims priority (i.e. U.S.
`
`Application No. 12/280,090, PCT/EP2007/051675, DE 10 2006 008 030.0, and
`
`06120309.7) are referred to herein as “the priority applications.”
`
`1
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`CSIRO Exhibit 1017
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`
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`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`plant wherein said oils, lipids and/or fatty acids comprise 60 to 85% by weight of
`
`polyunsaturated fatty acids based on the total fatty acids in the transgenic plant,
`
`wherein said polyunsaturated fatty acids comprise at least 20% by weight of
`
`eicosapentaenoic acid (EPA), at least 2% by weight of docosapentaenoic acid
`
`(DPA), and at least 4% by weight of docosahexaenoic acid (DHA) based on the total
`
`fatty acids in the transgenic plant in the form of triacylglycerides. Ex. 1001, claim 1.
`
`Claim 9, a second independent claim of the ‘638 Patent, is even broader,
`
`reciting oils, lipids and/or fatty acids produced by a transgenic Brassica plant
`
`comprising a total amount of at least 54% by weight of polyunsaturated ω3-fatty
`
`acids based on the total fatty acids in the transgenic plant. Ex. 1001, claim 9.
`
`As detailed herein, the specification of the ‘638 Patent provides neither
`
`written description nor enablement for the breadth of patent protection it seeks to
`
`cover by its claims 1-23. For example, the feature of “at least 54% by weight of
`
`polyunsaturated ω3-fatty acids” simply does not appear anywhere in the text of the
`
`specification and appeared for the first time in the claims filed on September 6, 2016
`
`with the ‘914 application.
`
`As further detailed herein, the claims of the ‘638 Patent lack written
`
`description and enablement in the priority applications. The specification of the ‘638
`
`Patent does not differ from that of its parent application, U.S. Application
`
`No. 12/280,090, the national stage entry of and sharing the same disclosure with
`
`2
`
`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`PCT/EP2007/051675. 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 ‘638 Patent are not disclosed in the
`
`manner provided by 35 U.S.C. §112(a) by any pre-AIA application, they are eligible
`
`for post-grant review. Because the claims of the ‘638 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 the meet the written description and enablement
`
`requirements of AIA 35 U.S.C. §112(a).
`
`Further, the claims of the ‘638 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 1-23 of the ’638 Patent.
`
`3
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`CSIRO Exhibit 1017
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`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`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.
`
`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:
`
`4
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`CSIRO Exhibit 1017
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`Petition for Post-Grant Review
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`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.
`
`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
`There are at least three continuation applications of U.S. Application
`
`No. 15/256,914, from which the ‘638 Patent issued:
`
`1. U.S. Application No. 16/371,837, filed on April 1, 2019, as a
`
`continuation of U.S. Application No. 15/256,914 and issued as U.S.
`
`Patent No. 10,533,183 on January 14, 2020;
`
`2. U.S. Application No. 16/371,451, filed on April 1, 2019, as a
`
`continuation of U.S. Application No. 15/256,914 and issued as U.S.
`
`Patent No. 10,533,182 on January 14, 2020; and
`
`5
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`CSIRO Exhibit 1017
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`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
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`3. U.S. Application No. 16/371,696, filed on April 1, 2019, as a
`
`continuation of U.S. Application No. 15/256,914 and is currently
`
`pending.
`
`2.
`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:
`
`1. BASF PLANT SCIENCE, LP v. NUSEED AMERICAS, in the United
`
`States District Court for the District of Delaware, Civil Action No. :17-
`
`cv-00421-VAC-CJB;
`
`2. BASF Plant Science, LP et al. v. Commonwealth Scientific and
`
`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
`
`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.
`
`6
`
`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`
`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
`
`attorney designating the above-identified counsel.
`
`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
`
`follows:
`
`Gary J. Gershik
`Cooper & Dunham LLP
`30 Rockefeller Plaza, 20th Floor
`New York, New York 10112
`Tel: 212-278-0552
`Fax: 212-391-0525
`Email: ggershik@cooperdunham.com
`Email: dhaber@cooperdunham.com
`
`John P. White
`Cooper & Dunham LLP
`30 Rockefeller Plaza, 20th Floor
`New York, New York 10112
`Tel: 212-278-0421
`Fax: 212-391-0525
`Email: jwhite@cooperdunham.com
`Email: pdocketing@cooperdunham.com
`
`
`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.
`
`B.
`Timing Under 37 C.F.R. § 42.202
`The ‘683 Patent issued on May 28, 2019. Pursuant to 37 C.F.R. § 42.202(a),
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`a petition for post-grant review of a patent must be filed no later than the date that is
`
`7
`
`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`nine months after the issued date of the patent. Accordingly, the deadline to file a
`
`petition for post-grant review of the ‘638 Patent is February 28, 2020, and this
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`Petition is being timely filed.
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`C. Grounds for Standing Under 37 C.F.R. § 42.204(a)
`Petitioner hereby certifies that the ʼ638 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 ʼ638
`
`Patent.
`
`IV. TECHNOLOGY BACKGROUND
`Generally, fatty acids are biomolecules (important component of lipids or oils)
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`consisting of a chain of carbon atoms with a carboxyl group (COOH) on one end
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`and a methyl group (CH3) on the other end. The carbons in the middle of the chain
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`are each bonded to one or more hydrogen atoms. Fatty acids may be “saturated fatty
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`acids” (no double bonds between carbons in the chain); “unsaturated fatty acids” (at
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`least one double bond between carbons in the chain); or “polyunsaturated fatty
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`acids” (“PUFAs”) (at least two such double bonds). Ex. 1002, ¶25.
`
`A.
`Fatty acid nomenclature
`Fatty acids can be represented using the nomenclature “C:D” where “C” is the
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`number of carbon atoms in the fatty acid and “D” is the number of double bonds in
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`the fatty acid. Thus, fatty acids with a “D” of 2 or greater are “polyunsaturated fatty
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`acids.” This notation, however, is not a complete representation because different
`
`8
`
`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`fatty acids can have the same C:D numbers. Accordingly, this notation is usually
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`paired with either a Δx or ω−x term as discussed below. Ex. 1002, ¶26.
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`As an example, the chemical structure of one fatty acid, stearidonic acid, is
`
`provided below:
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`Ex. 1002, ¶27.
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`
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`The carbon next to the carboxyl group (COOH) on the left is labeled as carbon “α”
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`(alpha) and the last carbon, at the methyl group (CH3) is labelled as ω (omega).
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`Ex. 1002, ¶28.
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`The position of the carbon atoms in the backbone of a fatty acid can be
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`indicated by numbering them, either from the carboxyl end or from the methyl end
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`of the carbon chain. Counted from the carboxyl end, it is represented by the Δx, or
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`equivalently, by the C-x notation, with x=1, 2, 3, etc. (numbers under the carbon
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`chain in the diagram, where “C-1” or “Δ1” is the carbon in the carboxyl group). If
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`the position is counted from the methyl end, then it is represented by the ω-x
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`notation, or equivalently, by the n-x notation (numbers above the carbon chain in the
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`diagram, where ω-1 or n-1 refers to the methyl carbon). Ex. 1002, ¶29.
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`Accordingly, when Δ notation is used, the 18-carbon fatty acid shown in the
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`diagram is named “18:4 Δ6,9,12,15.” When “ω-x” notation is used, only the position
`
`9
`
`CSIRO Exhibit 1017
`
`
`
`Petition for Post-Grant Review
`of U.S. Patent No. 10,301,638
`
`of the double bond which is closest to the methyl end is indicated, even if multiple
`
`double bonds exist and the 18-carbon fatty acid shown in the diagram is named
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`“18:4ω-3” or “18:4n-3.” Accordingly, any PUFA that has its first double bond on
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`the third carbon from the methyl end of the carbon chain is designated as omega-3
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`(ω-3), whereas a PUFA with its first double bond on the sixth carbon from end of
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`the carbon chain is designated as omega-6 (ω-6). Ex. 1002, ¶30.
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`A summary of ω-3 and ω-6 polyunsaturated fatty acids is provided below:
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`Omega-6 (ω6) Fatty Acids
`Name
`
`Linoleic acid (LA)
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`γ-Linolenic acid (GLA)
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`Δ notation
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`18:2Δ9,12
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`18:3Δ6,9,12
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`Dihomo-γ-linoleni