throbber

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`Paper No. _______
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`LCY Biotechnology Holding, Inc.,
`
`Petitioner
`v.
`Radici Chimica S.p.A.,
`Patent Owner
`
`Patent No. 11,781,148
`Issue Date: October 10, 2023
`Title: Biological methods for preparing terpenes
`
`Case No. PGR2024-00044
`____________________________________________________________
`PETITION FOR POST-GRANT REVIEW
`OF CLAIMS 1-3 OF U.S. PATENT NO. 11,781,148
`UNDER 35 U.S.C. §§ 321-329 AND 37 C.F.R. § 42.200 et seq.
`
`
`
`

`

`
`
`
`
`TABLE OF CONTENTS
`
`Page(s)
`
`
`INTRODUCTION ........................................................................................... 1
`I.
`II. MANDATORY NOTICES ............................................................................. 2
`A.
`Real Parties-in-Interest (37 C.F.R. § 42.8(b)(1)) .................................. 2
`B.
`Related Matters (37 C.F.R. § 42.8(b)(2)) .............................................. 2
`C.
`Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)) ........................... 2
`D.
`Service Information (37 C.F.R. § 42.8(b)(4)) ....................................... 3
`E.
`Payment of Fees (37 C.F.R. § 42.15) .................................................... 3
`III. REQUIREMENTS FOR PGR UNDER 37 C.F.R. § 42.200 et seq. ............... 4
`A. Grounds for Standing (37 C.F.R. § 42.204(a)) ..................................... 4
`B.
`Eligibility for Post-Grant Review (37 C.F.R. § 42.202) ...................... 4
`C.
`Identification of Challenge and Statement of Precise Relief Requested
`for Each of the Challenged Claims (37 C.F.R. § 42.204(b)) ................ 4
`IV. THE ’148 PATENT ......................................................................................... 5
`A.
`The Alleged Invention ........................................................................... 5
`1.
`Genetically Modified Microorganisms ....................................... 6
`2.
`Heterologous Nucleic Acids and Terpene Biosynthesis
`Polypeptides .......................................................................................... 7
`3.
`Fatty Acid and Alkane Induction ................................................ 8
`4.
`Group Consisting of Candida ssp. and Blastobotrys ssp. ........... 9
`5.
`Terpene Biosynthesis Pathways .................................................. 9
`6.
`Nucleic Acids as Promoters ...................................................... 12
`Prosecution History of the ’148 Patent ............................................... 12
`B.
`V. OVERVIEW OF THE PRIOR ART ............................................................. 17
`
`ii
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`

`

`
`
`PCT Publication No. WO2008042338 (“Bailey”) .............................. 17
`A.
`B. U.S. Publication No. 20040265980 (“Zhang”) ................................... 22
`VI. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 25
`VII. CONSTRUCTION OF THE CLAIMS ......................................................... 27
`VIII. LEGAL STANDARDS ................................................................................. 28
`A.
`35 U.SC. § 103(a) ................................................................................ 28
`B.
`35 U.SC. § 112(a) ................................................................................ 30
`IX. CLAIM-BY-CLAIM EXPLANATION OF GROUNDS FOR
`UNPATENTABILITY .................................................................................. 32
`A. Ground 1: Claims 1-3 are Obvious Over Bailey in View of Zhang ... 32
`1.
`Claim 1 ...................................................................................... 32
`2.
`Claim 2 ...................................................................................... 50
`3.
`Claim 3 ...................................................................................... 53
`B. Ground 2: Claims 1-3 are Unpatentable Under 35 U.S.C. § 112(a) as
`Lacking Enablement in View of the Specification. ............................ 55
`1.
`Breadth of the Claims ............................................................... 56
`2.
`Predictability of the Art ............................................................ 68
`3.
`Quantity of Experimentation; Amount of Direction Provided;
`Working Examples .............................................................................. 77
`4.
`The ’148 Patent’s attempts to claim over 24 million
`permutations, requires undue experimentation, and therefore the
`claims are not enabled ......................................................................... 90
`X. NO BASIS FOR DISCRETIONARY DENIAL ........................................... 91
`A.
`The Asserted Grounds are Neither Excessive nor Redundant ............ 91
`B.
`The Petition Applies a Different Prior Art Combination than that
`Considered by the Office During Prosecution of the ’148 Patent, and
`so the PTAB Should not Exercise its Discretion Under 35 U.S.C. §
`325(d) .................................................................................................. 91
`
`iii
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`

`

`
`
`The Fintiv Factors do not Weigh Against Institution ......................... 95
`C.
`XI. CONCLUSION .............................................................................................. 96
`
`
`
`
`
`
`iv
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`

`

`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Adaptics Ltd. v. Perfect Company,
`IPR2018-01596, Paper 20 (PTAB Mar. 6, 2019) ......................................... 91, 92
`Advanced Bionics, LLC v. Med-El Elektromedizinische Geräte GmbH,
`IPR2019-01469, Paper 6 (PTAB Feb. 13, 2020) .................................... 93, 94, 95
`Alza Corp v. Andrx Pharms., LLC,
`603 F.3d 935 (Fed. Cir. 2010) .......................................................... 56, 79, 85, 91
`Amgen Inc. v. Sanofi,
`598 U.S. 594 (2023) ............................... 30, 31, 56, 57, 67, 69, 70, 78, 80, 84, 90
`Apple v. Fintiv,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) ............................................. 96
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed Cir. 2010) ........................................................................... 32
`Bayer CropScience LP & Monsanto Co. v. Corteva Agriscience LLC,
`IPR2023-01038, Paper 12 (PTAB Dec. 19, 2023) ............................................. 29
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ............................................... 93
`Best Med. Int’l, Inc. v. Elekta Inc.,
`46 F.4th 1346 (Fed. Cir. 2022) ........................................................................... 25
`Bristol Meyers Squibb Co. v. Teva Pharm. USA, Inc.,
`752 F.3d 967 (Fed. Cir. 2014) ............................................................................ 30
`CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359 (Fed. Cir. 2002) .......................................................................... 27
`Chiron Corp. v. Genentech, Inc.,
`363 F.3d 1247 (Fed. Cir. 2004) .......................................................................... 30
`Corning Glass Works v. Sumitomo Elec. U.S.A., Inc.,
`868 F.2d 1251 (Fed. Cir. 1989) .......................................................................... 33
`
`v
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`

`

`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co.,
`464 F.3d 1356 (Fed. Cir. 2006) .......................................................................... 25
`Env’t Designs, Ltd. v. Union Oil Co.,
`713 F.2d 693 (Fed. Cir. 1983) ............................................................................ 25
`Favored Tech Corp. v. P2i Ltd.,
`IPR2020-01198, Paper 9 (PTAB Jan. 27, 2021) .......................................... 91, 92
`In re Fisher,
`427 F.2d 833 (C.C.P.A. 1970) ............................................................................ 70
`Forte Biosciences Inc. v. University of Massachusetts,
`PGR2023-00014, Paper 10 (PTAB Dec. 22, 2022) ...................................... 94, 95
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966) .......................................................................................... 28, 29
`Idenix Pharms. LLC v. Gilead Scis. Inc.,
`941 F.3d 1149 (Fed. Cir. 2019) .................................................................... 56, 83
`Incept LLC v. Palette Life Scis., Inc.,
`77 F.4th 1366 (Fed. Cir. 2023) ........................................................................... 42
`KSR Int’l v. Teleflex Inc.,
`550 U.S. 398 (2007) ...................................................................................... 28, 29
`Metalcraft of Mayville, Inc. v. The Toro Co.,
`848 F.3d 1358 (Fed. Cir. 2017) .......................................................................... 29
`Neuroderm Ltd. v. Abbvie Inc.,
`PGR2022-00040, Paper 9 (PTAB Nov. 14, 2022) ............................................. 32
`Palette Life Scis., Inc., v. Incept LLC,
`IPR2020-00004, Paper 62 (PTAB Apr. 13, 2021) .......................... 42, 45, 52, 55
`
`
`
`
`vi
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`

`

`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .......................................................................... 27
`Samsung Electronics Co., Ltd. v. Immersion Corp.,
`IPR2018-01469, Paper 10 (PTAB March 7, 2019) ............................................ 95
`Snap Inc. v. SRK Technology LLC,
`IPR2020-00820, Paper 15 (PTAB Oct. 21, 2020) ........................................ 93, 94
`St. Jude Medical, LLC v. Snyders Heart Valve LLC,
`IPR2018-00105, Paper 15 (PTAB May 3, 2018) ............................................... 30
`Streck, Inc. v. Research & Diagnostic Sys.,
`665 F.3d 1269 (Fed. Cir. 2012) .......................................................................... 55
`Thorner v. Sony Computer Entm’t Am., LLC,
`669 F.3d 1362 (Fed. Cir. 2012) .......................................................................... 27
`Uship Intellectual Props., LLC v. United States,
`714 F.3d 1311 (Fed. Cir. 2013) .......................................................................... 27
`Vivid Techs. v. Am. Sci. & Eng’g,
`200 F.3d 795 (Fed. Cir. 1999) ............................................................................ 27
`Walt Disney Parks & Resorts U.S., Inc. v. Agile Journeys LLC,
`IPR2024-00029, Paper 7 (PTAB Apr. 15, 2024) ............................................... 29
`In re Wands,
`858 F.2d 717 (Fed. Cir. 1988) .......................................................... 31, 56, 68, 78
`Wellman, Inc. v. Eastman Chem. Co.,
`642 F.3d 1355 (Fed. Cir. 2011) .......................................................................... 27
`Western Union Co. v. MoneyGram Payment Sys., Inc.,
`626 F.3d 1361 (Fed. Cir. 2010) .......................................................................... 29
`ZUP, LLC, v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 29
`
`vii
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`

`

`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Statutes
`35 U.S.C. § 102(a)(1) and § 102(a)(2) ..................................................................... 15
`35 U.S.C. § 103 ...................................................................................... 13, 15, 28, 95
`35 U.S.C. § 103(a) ............................................................................................... 4, 28
`35 U.S.C. § 112(a) ......................................................................................... 5, 30, 55
`35 U.S.C. § 321(c) ..................................................................................................... 4
`35 U.S.C. § 322 .......................................................................................................... 5
`35 U.S.C. § 322(a)(1) ................................................................................................. 4
`35 U.S.C. § 325(d) ....................................................................................... 92, 94, 95
`Other Authorities
`37 C.F.R. §1.132 ................................................................................................ 14, 76
` (37 C.F.R. § 42.8(b)(1)) ............................................................................................ 2
` (37 C.F.R. § 42.8(b)(2)) ............................................................................................ 2
` (37 C.F.R. § 42.8(b)(3)) ............................................................................................ 2
` (37 C.F.R. § 42.8(b)(4)) ............................................................................................ 3
` (37 C.F.R. § 42.15) ................................................................................................... 3
`37 C.F.R. § 42.15(b) .................................................................................................. 3
`37 C.F.R. § 42.200 ..................................................................................................... 4
` (37 C.F.R. § 42.202) ................................................................................................. 4
` (37 C.F.R. § 42.204(a)) ............................................................................................. 4
`
`
`
`
`viii
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`
`No. Description
`
`APPENDIX OF EXHIBITS
`
`Referred To
`Herein As
`
`’148 Patent
`
`Corresponding
`Hall-Ellis
`Exhibit No.
`N/A
`
`’148 PH
`Bailey
`
`N/A
`N/A
`
`Zhang
`
`N/A
`
`N/A
`N/A
`
`Alper
`Hall-Ellis
`Decl.
`Weaver 2012 N/A
`
`Alberts 2008
`
`N/A
`
`Maimone 2007 N/A
`
`Zwenger 2008 N/A
`
`Blazeck 2013 N/A
`
`1001 U.S. Patent No. 11,781,148 (the “’148
`Patent”)
`1002 ’148 Patent Prosecution History
`1003 PCT Publication No. WO2008042338
`(“Bailey”) was filed by Microbia, Inc.
`on September 28, 2007, and published
`on April 10, 2008.
`1004 US20040265980 (“Zhang”) was filed
`by Cognis Corp. on July 29, 2003, and
`published on December 30, 2004.
`1005 Declaration of Dr. Hal S. Alper
`1006 Declaration of Dr. Sylvia Hall-Ellis
`
`1007 ROBERT F. WEAVER, Chapter 2: The
`Molecular Nature of Genes,
`MOLECULAR BIOLOGY (McGraw Hill
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`Future Potentials, 3 BIOTECHNOL.
`MOL. BIOL. REV. 1, 1-7 (2008).
`1011 John Blazeck & Hal S. Alper,
`Promoter engineering: Recent
`Advances In Controlling Transcription
`At The Most Fundamental Level, 8
`BIOTECHNOL. J., 46-58 (2013).
`
`ix
`
`

`

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`
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`Hall-Ellis
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`N/A
`
`Weinhandl
`2014
`
`N/A
`
`Kanai 2000
`
`N/A
`
`Kanai Fig. 3
`
`N/A
`
`Masuda 1995 N/A
`
`Masuda Fig. 2 N/A
`
`Lee 2015
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`van der Walt
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`NCYC 825
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`1025 Cletus P. Kurtzman & Christie J.
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`
`Kurtzman
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`
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`Hall-Ellis
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`N/A
`
`Kurtzman
`2015
`
`N/A
`
`de Hoog 2015 N/A
`
`Daniel 2014
`
`N/A
`
`Lachance 2011 N/A
`
`Smith 2011
`
`N/A
`
`

`

`Referred To
`Herein As
`
`Bailey 1991
`
`Corresponding
`Hall-Ellis
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`N/A
`
`Barns 1991
`
`N/A
`
`Barns 1991
`
`N/A
`
`Beopoulos
`2008
`
`N/A
`
`Dujon 2010
`
`N/A
`
`Dujon 2010
`
`N/A
`
`Gabaldon 2016 N/A
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`Referred To
`Herein As
`
`Kidd 2023
`
`Corresponding
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`N/A
`
`Kreger-van Rij
`1984
`
`N/A
`
`Kurtzman
`2003
`
`N/A
`
`Millerioux
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`
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`
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`1039 Sarah E. Kidd et al., Fungal
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`No. Description
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`1045 Kalaivani Paramasivan & Sarma
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`1048 Yuuki Yamada et al., Diversity and
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`1049 Ningyan Zhang & Zhiqiang An,
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`1050 LinkedIn Resume of Kimberly Ann
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`1051 LinkedIn Resume of Pierre-Yves De
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`xv
`
`Referred To
`Herein As
`
`Paramasivan
`2017
`
`Corresponding
`Hall-Ellis
`Exhibit No.
`N/A
`
`Suh 2006
`
`N/A
`
`Takashima
`2022
`
`N/A
`
`Yamada 2012 N/A
`
`Zhang 2010
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`

`

`
`
`No. Description
`
`Referred To
`Herein As
`
`N/A
`
`N/A
`
`N/A
`
`N/A
`
`1053 LinkedIn Resume of Michael
`Walbridge
`1054 LinkedIn Resume of Thomas
`Beardslee
`1055 Curriculum Vitae of Sylvia Hall-Ellis N/A
`1056 ROBERT F. WEAVER, Chapter 2: The
`N/A
`Molecular Nature of Genes,
`MOLECULAR BIOLOGY (McGraw Hill
`5th Ed. 2012).
`
`1057 BRUCE ALBERTS ET AL., MOLECULAR
`BIOLOGY OF THE CELL, Garland
`Science (5th Ed. 2008).
`1058 Thomas J. Maimone & Phil S. Baran,
`Modern Synthetic Efforts Toward
`Biologically Active Terpenes, 3 N.
`CHEM. BIO. 7, 396-407 (2007).
`
`1059 Sam Zwenger & Chhandak Basu,
`Plant Terpenoids: Applications and
`Future Potentials, 3 BIOTECHNOL.
`MOL. BIOL. REV. 1, 1-7 (2008).
`
`1060 John Blazeck & Hal S. Alper,
`Promoter engineering: Recent
`Advances In Controlling Transcription
`At The Most Fundamental Level, 8
`BIOTECHNOL. J., 46-58 (2013).
`
`1061 Vikki M. Weake & Jerry L. Workman,
`Inducible Gene Expression: Diverse
`Regulatory Mechanisms, 11 NATURE
`REV. GENET., 426-437 (2010).
`
`N/A
`
`N/A
`
`N/A
`
`Corresponding
`Hall-Ellis
`Exhibit No.
`N/A
`
`N/A
`
`N/A
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`xvi
`
`

`

`Referred To
`Herein As
`
`N/A
`
`Corresponding
`Hall-Ellis
`Exhibit No.
`1013
`
`N/A
`
`1014
`
`N/A
`
`1015
`
`N/A
`
`1016
`
`N/A
`
`N/A
`
`1017
`
`1018
`
`
`
`No. Description
`
`1062 Katrin Weinhandl et al., Carbon
`Source Dependent Promoters in
`Yeasts, 13 MICROBIAL CELL
`FACTORIES 5, 1-17 (2014).
`
`1063 Tamotsu Kanai et al., An n-Alkane-
`Responsive Promoter Element Found
`in the Gene Encoding the Peroxisomal
`Protein of Candida tropicalis Does
`Not Contain a C6 Zinc Cluster DNA-
`Binding Motif, 182 J. BACTERIOL. 9,
`2492-2497 (2000).
`
`1064 Tamotsu Kanai et al., An n-Alkane-
`Responsive Promoter Element Found
`in the Gene Encoding the Peroxisomal
`Protein of Candida tropicalis Does
`Not Contain a C6 Zinc Cluster DNA-
`Binding Motif, 182 J. BACTERIOL. 9,
`Figure 3 at 2496 (2000).
`
`1065 Yutaka Masuda et al., Cloning and
`Characterization of the POX2 Gene in
`Candida maltosa, 167 GENE 1-2, 157-
`161 (1995).
`
`1066 Yutaka Masuda et al., Cloning and
`Characterization of the POX2 Gene in
`Candida maltosa, 167 GENE 1-2,
`Figure 2 at 159 (1995).
`1067 Michael E. Lee et al., A Highly
`Characterized Yeast Toolkit for
`Modular, Multipart Assembly, 4 ACS.
`SYNTH. BIOL. 9, 975-986 (2015).
`
`
`xvii
`
`

`

`
`
`No. Description
`
`1068 J.P. van der Walt & J.A. von Arx, The
`Yeast Genus Yarrowia gen. nov., 46
`ANTONIE VAN LEEUWENHOEK, 517-521
`(1980).
`
`1069 J.P. van der Walt et al., Arxula gen.
`nov. (Candidaceae), a new
`anamorphic, arthroconidial yeast
`genus, 57 ANTONIE VAN
`LEEUWENHOEK, 59-61 (1990).
`
`1070 David L. Craft et al., Identification and
`Characterization of the CYP52 Family
`of Candida tropicalis ATCC 20336,
`Important for the Conversion of Fatty
`Acids and Alkanes to α,ω-Dicarboxylic
`Acids, 69 APPL. ENVIRON. MICROBIOL.
`10, 5983-5991 (2003)..
`
`1071 Catalogue entry for NCYC 825
`Yarrowia lipolytica (available at
`https://www.ncyc.co.uk/catalogue/yarr
`owia-lipolytica-825).
`1072 Gotthard Kunze et al., The complete
`genome of Blastobotrys (Arxula)
`adeninivorans LS3 - a yeast of
`biotechnological interest, 7
`BIOTECHNOLOGY FOR BIOFUELS 66, 1-
`15 (2014).
`
`
`Referred To
`Herein As
`
`N/A
`
`Corresponding
`Hall-Ellis
`Exhibit No.
`1019
`
`N/A
`
`1020
`
`N/A
`
`1021
`
`N/A
`
`N/A
`
`1022
`
`1023
`
`xviii
`
`

`

`Referred To
`Herein As
`
`N/A
`
`Corresponding
`Hall-Ellis
`Exhibit No.
`1024
`
`N/A
`
`1025
`
`Sloots 1991
`
`N/A
`
`Sloots Fig. 1
`
`N/A
`
`
`
`
`
`No. Description
`
`1073 W. J. Middelhoven et al.,
`Trichosporon adeninovorans sp. nov.,
`a yeast species utilizing adenine,
`xanthine, uric acid, putrescine and
`primary n-alkylamines as the sole
`source of carbon, nitrogen and energy,
`50 ANTONIE VAN LEEUWENHOEK, 369-
`378 (1984).
`
`1074 Kurtzman, Cletus P., and Christie J.
`Robnett. “Multigene Phylogenetic
`Analysis of the Trichomonascus,
`Wickerhamiella and Zygoascus Yeast
`Clades, and the Proposal of
`Sugiyamaella gen. nov. and 14 New
`Species Combinations.” FEMS Yeast
`Research, vol. 7, issue 1 (January
`2007): 141-151.
`
`1075 James A. Sloots et al., Glucose-
`responsive and oleic acid-responsive
`elements in the gene encoding the
`peroxisomal trifunctional enzyme of
`Candida tropicalis, 105 GENE 1, 129-
`134 (1991).
`1076 James A. Sloots et al., Glucose-
`responsive and oleic acid-responsive
`elements in the gene encoding the
`peroxisomal trifunctional enzyme of
`Candida tropicalis, 105 GENE 1, 130,
`Figure 1 (1991).
`
`xix
`
`

`

`
`
`I.
`
`INTRODUCTION
`The ’148 Patent consists of a nearly 300 page specification broadly directed
`
`to genetically modified microorganisms for the production of terpenes—a class of
`
`natural products that a person having ordinary skill in the art (“POSITA”) would
`
`understand to include over 55,000 distinct products—but notably providing only 16
`
`working examples that speak to the Challenged Claims and with these being in only
`
`two species of microorganisms and demonstrating the production of only 3 terpene
`
`products. The Challenged Claims are directed to any genetically modified
`
`organisms within the genera Candida or Blastobotrys that are modified to include
`
`non-native nucleic acids for the biosynthesis of terpenes regulated by a fatty-acid or
`
`alkane inducible promoter and which results in the production of a terpene.
`
`By the time of the ’148 Patent there was an abundance of research and
`
`technology surrounding the genetic modification of microorganisms, particularly
`
`yeasts, for
`
`the purpose of biomanufacturing
`
`terpene products, especially
`
`commercially desirable carotenoid products such as ß-carotene. As outlined below,
`
`in examining the ’148 Patent, the United States Patent and Trademark Office
`
`(“USPTO”) failed to consider a key prior art reference, that expressly teaches each
`
`and every element of the pending claims save one. Further, the overlooked prior art
`
`implicitly teaches even the last Claim Element in that it directly cites to a reference
`
`that is explicitly directed to the Claim Element in question. Thus, as outlined below,
`
`1
`
`

`

`
`
`when properly assessed in view of the entire field of eligible prior art, the Challenged
`
`Claims are unpatentable as being obvious over the prior art.
`
`Moreover, despite having to rely on inventor testimony to allegedly overcome
`
`the prior art, the ’148 Patent Claims are incredibly broad – encompassing over 24
`
`million possible embodiments while providing only a small number of working
`
`examples in a very narrow range of the total claim breadth. The specification of the
`
`’148 Patent fails to enable one skilled in the art to exercise the full scope of the
`
`claims without undue experimentation.
`
`In short, the ’148 Patent should be invalidated as it claims that which was
`
`known and fails to enable that which was not. Accordingly, Petitioner respectfully
`
`submits that a PGR should be instituted, and that the Challenged Claims should be
`
`canceled as unpatentable.
`
`II. MANDATORY NOTICES
`A. Real Parties-in-Interest (37 C.F.R. § 42.8(b)(1))
`LCY Biotechnology Holding, Inc. is the real party-in-interest.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`There are no judicial or administrative matters in the United States that would
`
`affect or be affected by a decision in this proceeding.
`
`C. Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3))
`For purposes of this Petition, the following attorneys are lead and back-up
`
`counsel for Petitioner:
`
`2
`
`

`

`
`
`Dorian Ojemen
`Registration No. 72,956
`BAKER & McKENZIE LLP
`800 Capitol Street, Suite 2100
`Houston, Texas 77002
`Tel: (713) 427-5000
`dorian.ojemen@bakermckenzie.com
`
`
`
`
`
`LEAD COUNSEL
`Mackenzie Martin
`Registration No. 77,950
`BAKER & McKENZIE LLP
`1900 North Pearl Street, Suite 1500
`Dallas, Texas 75201
`Tel: (214) 978-3048
`mackenzie.martin@bakermckenzie.com
`
`BACK-UP COUNSEL
`Jessica Greenwald
`Registration No. 75,936
`BAKER & McKENZIE LLP
`1900 North Pearl Street, Suite 1500
`Dallas, Texas 75201
`Tel: (214) 978-3063
`jessica.greenwald@bakermckenzie.com
`
`John G. Flaim
`Registration No. 37,323
`BAKER & McKENZIE LLP
`1900 North Pearl Street, Suite 1500
`Dallas, Texas 75201
`Tel: (214) 978-3097
`john.flaim@bakermckenzie.com
`
`
`D. Service Information (37 C.F.R. § 42.8(b)(4))
`For purposes of this Petition, Petitioner consents to electronic service by email
`
`at: DAL-LCYPGR@bakermckenzie.com.
`
`E. Payment of Fees (37 C.F.R. § 42.15)
`Petitioner authorizes the United States Patent and Trademark Office (USPTO)
`
`to charge the fees set forth in 37 C.F.R. § 42.15(b) for this Petition, and any
`
`3
`
`

`

`
`
`additional fees that might be due, to Deposit Account No. 13-0480 (Attorney Docket
`
`No. 10161517-51190324). This Petition meets the fee requirements of 35 U.S.C.
`
`§ 322(a)(1).
`
`III. REQUIREMENTS FOR PGR UNDER 37 C.F.R. § 42.200 et seq.
`A. Grounds for Standing (37 C.F.R. § 42.204(a))
`Petitioner certifies that the ’148 Patent is available for PGR. Petitioner is not
`
`the patent owner and is not barred or estopped from requesting a PGR that challenges
`
`the claims of the ’148 Patent on the grounds identified herein.
`
`B. Eligibility for Post-Grant Review (37 C.F.R. § 42.202)
`The ’148 Patent issued on October 10, 2023. Petitioner has filed this Petition
`
`within nine months after the date of the grant of the ’148 Patent, so the patent is
`
`eligible to be challenged in a PGR. See 35 U.S.C. § 321(c).
`
`C. Identification of Challenge and Statement of Precise Relief
`Requested for Each of the Challenged Claims (37 C.F.R. §
`42.204(b))
`Petitioner respectfully requests that PGR of the Challenged Claims (i.e.,
`
`Claims 1-3 of the ’148 Patent) be instituted and that each of the Challenged Claims
`
`be held unpatentable and cancelled based on the following grounds:
`
`No.
`1
`
`Claims Ground Reference(s)
`1-3
`103
`Unpatentable under 35 U.S.C. § 103(a) as
`obvious over Bailey in view of Zhang and th

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