UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`RICETEC, INC.
`Petitioner
`
`v.
`
`BASF SE,
`Patent Owner
`_______________
`
`Case: PGR2021-00114
`
`U.S. Patent 11,096,346
`
`Title: Method for Treating Post-Emergent Rice
`
`PATENT OWNER’S RESPONSE
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`RICETEC, INC.
`Petitioner
`
`v.
`
`BASF SE,
`Patent Owner
`_______________
`
`Case: PGR2021-00114
`
`U.S. Patent 11,096,346
`
`Title: Method for Treating Post-Emergent Rice
`
`PATENT OWNER’S RESPONSE
`
`
`
`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
`
`TABLE OF CONTENTS
`
`I.
`II.
`III.
`
`IV.
`V.
`VI.
`
`Page
`INTRODUCTION .......................................................................................... 1
`SUMMARY OF ARGUMENTS .................................................................. 4
`THE ’346 PATENT ........................................................................................ 7
`A.
`Overview .............................................................................................. 7
`PERSON OF ORDINARY SKILL IN THE ART ....................................... 10
`CLAIM CONSTRUCTION ......................................................................... 10
`THE CORRECT PRIORITY DATE FOR THE ’346 PATENT ................. 11
`A. Mankin PCT Overview ...................................................................... 12
`VII. THE CHALLENGED CLAIMS HAVE WRITTEN DESCRIPTION
`AND ENABLEMENT SUPPORT IN THE MANKIN
`APPLICATION ............................................................................................ 17
`A.
`Claim Chart ........................................................................................ 17
`B.
`RiceTec’s Specific Arguments Regarding Written Description
`and Enablement Are Refuted on the Full Record .............................. 33
`1.
`The Claimed Numerical Ranges of an “Effective
`Amount” of a FOP Herbicide Are Sufficiently Described
`by and Could be Derived by a POSITA from the Mankin
`PCT’s Disclosure of an “Effective Amount” of FOP
`Herbicides ................................................................................ 33
`The G2096S Mutation Is Not “Buried” in the Mankin
`PCT Among a “Laundry List” of Several Dozen Other
`Mutations ................................................................................. 42
`
`2.
`
`i
`
`
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`PGR2021-00114
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`TABLE OF CONTENTS
`(continued)
`
`Page
`
`3.
`
`4.
`
`The Inventors Showed Possession of a Rice Plant with
`the G2096S or W2027C Mutations Without Actually
`Reducing the Mutations to Practice or Depositing with
`ATCC Rice Seeds Having the Mutations ................................ 46
`The I1781L and D2078G Mutants Experimentally
`Determined to Have FOP-Resistance in the Mankin
`Application Would Lead a POSITA to Reasonably
`Expect that the Claimed G2096S and W2027C Mutations
`Would Have the Same Characteristics ..................................... 47
`A POSITA Could Routinely Make and Select a Rice
`Plant Having the FOP-Resistant G2906S and W2027C
`Mutations Imparted Through Random Mutagenesis
`Following the Instructions in the Mankin PCT ....................... 53
`The “Herbicide Causes Less Than 10% Injury to the Rice
`Plant in Field Applications” Limitation Is Described in
`the Mankin PCT ....................................................................... 59
`VIII. RICETEC HAS NOT DEMONSTRATED THAT THE ‘346
`PATENT CLAIMS FAIL TO SATISFY THE ENABLEMENT AND
`WRITTEN DESCRIPTION REQUIREMENTS ......................................... 63
`IX. CONCLUSION ............................................................................................. 65
`
`5.
`
`6.
`
`ii
`
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`TABLE OF AUTHORITIES
`
`Page
`
`Cases
`Alcon Rsch. Ltd. v. Barr Lab’ys, Inc.,
`745 F.3d 1180 (Fed. Cir. 2014) .......................................................................... 46
`All Dental Prodx, LLC v. Advantage Dental Prod., Inc.,
`309 F.3d 774 (Fed. Cir. 2002) ............................................................................ 41
`Allergan, Inc. v. Sandoz Inc.,
`796 F.3d 1293 (Fed. Cir. 2015) .......................................................................... 46
`Application of Ruschig, 379 F.2d 990 (1967) .......................................................... 45
`Bos. Sci. Corp. v. Johnson & Johnson,
`647 F.3d 1353 (Fed. Cir. 2011) .......................................................................... 35
`In re Edwards,
`568 F.2d 1349 (C.C.P.A. 1978) .......................................................................... 43
`Enzo Biochem Inc. v. Gen-Probe Inc.,
`285 F.3d 1013 (Fed. Cir. 22) .............................................................................. 47
`Falko-Gunter Falkner v. Inglis,
`448 F.3d 1357 (Fed. Cir. 2006) .......................................................................... 35
`Fujikawa v. Wattanasin,
`93 F.3d 1559 (Fed. Cir. 1996) ...................................................................... 43, 45
`In re Global IP Holdings LLC,
`927 F.3d 1373-78 ................................................................................................ 42
`Grunenthal GmbH v. Antecip Bioventures II LLC,
`PGR2017-00008, Paper 43 (PTAB June 22, 2018) ............................................ 42
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 56
`
`iii
`
`
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`PGR2021-00114
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`TABLE OF AUTHORITIES
`(continued)
`
`Page
`
`In re Lundak,
`773 F.2d 1216 (Fed.Cir.1985) ............................................................................ 47
`Martek Biosciences Corp. v. Nutrinova, Inc.,
`579 F.3d 1363 (Fed. Cir. 2009) .......................................................................... 11
`Phigenix, Inc. v. Genentech Inc.,
`238 F. Supp. 3d 1177 (N.D. Cal. 2017) .............................................................. 45
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 11
`Source Search Techs., LLC v. LendingTree, LLC,
`588 F.3d 1063 (Fed. Cir. 2009) .......................................................................... 56
`In re Strahilevitz,
`668 F.2d 1229, 212 U.S.P.Q. 561 (C.C.P.A. 1982) ............................................ 46
`The General Hospital Corp. v. Sienna Biopharmaceuticals, Inc.,
`888 F.3d 1368 (Fed. Cir. 2018) .................................................................... 41, 42
`Statutes
`35 U.S.C. §102 ..................................................................................................... 4, 44
`35 U.S.C. §103 ........................................................................................................... 4
`35 U.S.C. §112 ......................................................................................................... 64
`
`iv
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`PATENT OWNER’S EXHIBIT LIST
`
`Document
`No.
`2001 Declaration of Lisa M. Ferri
`
`Referred To As
`N/A
`
`2002 Mayer Brown Professional Profile of Lisa
`M. Ferri
`
`N/A
`
`2003 Declaration of Dr. Nilda Roma-Burgos
`
`Burgos Decl.
`
`2004 Prosecution of RiceTec’s U.S. Patent
`Application No. 15/019,701
`
`2005 Prosecution of RiceTec’s U.S. Patent
`Application No. 13/554,675
`
`N/A
`
`N/A
`
`2006 Roma-Burgos N±, K Al-Khatib K, EP
`Webster, BM McKnight, J Bond, M
`Bagavathiannan (2017). Rice Weeds and
`Management in North America. In: Rao,
`A.N. and Matsumoto, H. (Eds.). Weed
`management in rice in the Asian-Pacific
`region. pp. 308 – 345. Asian-Pacific Weed
`Sci Soc (APWSS); Weed Sci Soc of Japan
`and Indian Soc of Weed Sci. ISBN -13:
`978-81-931978-4-4
`
`2007 Hardke J, and CE Wilson, Jr. (2013).
`Introduction. pp. 1-8. In: Hardke, J. (Ed.).
`Arkansas Rice Production Handbook.
`University of Arkansas Division of
`Agriculture, Cooperative and Extension
`Service MP192, Little Rock, Arkansas,
`USA.
`
`Roma-Burgos et al. 2017
`
`Hardke and Wilson 2013
`
`2008 Hardke J, Barber T, Bateman N, Butts T,
`Hamilton M, Henry C, Lorenz G, Mazzanti
`
`Hardke et al. 2021
`
`v
`
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`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
`
`R, Norsworthy J, Roberts T, Wamishe Y
`(2021) Rice Information: 2021 Rice
`Management Guide. 28 pp.
`
`2009 Hardke JT, Chlapecka JL (2020) Arkansas
`Furrow-irrigated Rice Handbook. Little
`Rock: University of Arkansas Division of
`Agriculture, Arkansas Cooperative
`Extension Service. 38 p
`
`2010 Carvalho-Moore P, Rangani G, Heiser J,
`Findley D, Bowe SJ, Roma-Burgos N±
`(2021) PPO2 mutations in Amaranthus
`palmeri: Implications on cross-resistance.
`Agriculture 11:760.
`doi.org/10.3390/agriculture11080760
`
`2011 Roma-Burgos N±, Butts TR, Werle IS,
`Bottoms S, Mauromoustakos A (2021a).
`Weedy rice update in Arkansas, USA, and
`adjacent locales Weed Sci 69(5): 514 - 525
`doi: 10.1017/wsc.2021.45
`
`2012 Roma-Burgos N±, San Sudo MP, Olsen
`KM, Werle I, Song B-K (2021b). Weedy
`Rice (Oryza spp.): What’s in a name?
`Weed Sci Sp. Issue 69(5): 505-513. DOI:
`10.1017/wsc.2021.22
`
`2013 Norsworthy JK, Bond J, Scott RC (2013)
`Weed management practices and needs in
`Arkansas and Mississippi rice. Weed
`Technol 27:623–630
`
`2014 Burgos NR, JK Norsworthy, RC Scott, and
`KL Smith (2008). Red rice status after five
`years of ClearfieldTM rice technology in
`Arkansas. Weed Technol. 22:200-208.
`
`vi
`
`Hardke and Chlapecka 2020
`
`Carvalho-Moore et al. 2021
`
`Roma-Burgos et al. 2021a
`
`Roma-Burgos et al. 2021b
`
`Norsworthy et al. 2013
`
`Burgos et al. 2008
`
`
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`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
`
`2015
`
`Jang SR, J Marjanovic, P Gornicki (2013).
`Resistance to herbicides caused by single
`amino acid mutations in acetyl-CoA
`carboxylase in resistant populations of
`grassy weeds. New Phytol. 197:1110-1116.
`Doi: 1111/nph.12117
`
`2016 Christoffers MJ, ML Berg, CG
`Messersmith (2002). An isoleucine to
`leucine mutation in acetyl COA
`carboxylase confers herbicide resistance in
`wild oat. Genome 45(6):1046 p
`
`2017 Cui H, W Cangyue, Y Han, L Chen, X Li
`(2015). Cross-resistance of Japanese foxtail
`(Alopecurus japonicus) to ACCase
`inhibitors in China. Weed Technol. 29:444-
`450 DOI:10.1614/WT-D-14-00134.1
`
`2018 Maneechote C, S Samanwong, and X-Q
`Zhang (2005). Resistance to ACCase-
`inhibiting herbicides in sprangletop
`(Leptochloa chinensis). Weed Sci. 53:290-
`295.
`
`2019 Mohamed IA, R Li, Z You, Z Li (2012).
`Japanese foxtail (Alopecurus japonicus)
`resistance to fenoxaprop and pinoxaden in
`China. Weed Sci. 60:167-171.
`DOI:10.1614/WS-D-11-00111.1
`
`Jang et al. 2013
`
`Christoffers et al. 2002
`
`Cui et al. 2015
`
`Maneechote et al. 2005
`
`Mohamed et al. 2012
`
`2020 Eleftherohorinos IG and KV Dhima
`(2002). Red rice (Oryza sativa) control in
`rice (O. sativa) with preemergence and
`postemergence herbicides. Weed Technol.
`16:537-540
`
`2021 Uchiyama M, N Washio, T Ikai, H
`Igarashi, K Suzuki (1986). Stereospecific Uchiyama et al. 1986
`
`Eleftherohorinos and Dhima
`2002
`
`vii
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`U.S. Patent No. 11,096,346
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`
`responses to R-(+)- and S-(-)-quizalofop-
`ethyl in tissues of several plants. J Pestic
`Sci 11:459-467
`
`2022 Huan Z, Z Xu, D Lv, J Wang (2013).
`Determination of ACCase sensitivity and
`gene expression in quizalofop-P-ethyl-
`resistant and -susceptible barnyardgrass
`(Echinochloa crus-galli) biotypes. Weed
`Sci. 61:537-542 DOI: 10.1614/WS-D-13-
`00010.1
`
`2023 Bushong J, T Peeper, M Boyles, A Stone
`(2011). Italian ryegrass (Lolium perenne),
`feral rye (Secale cereale), and volunteer
`wheat (Triticum aestivum) control in winter
`canola.
`
`Huan et al. 2013
`
`Bushong et al. 2011
`
`2024 Targa®, Gowan Co Label
`
`Targa®, Gowan Co
`
`2025 Assure® II, AMVAC Chem. Corp. Label
`
`Assure® II, AMVAC Chem.
`Corp.
`
`2026 Hoelon®, Bayer Crop Science Label
`
`Hoelon®, Bayer Crop Science
`
`2027 Poast Plus®, BASF Chem. Co. Label
`
`Poast Plus®, BASF Chem. Co.
`
`2028 Arrow®, ADAMA Essentials Label
`
`Arrow®, ADAMA Essentials
`
`2029 Burgos NR (2015). Whole-plant and seed
`bioassays for resistance confirmation.
`Weed Sci. 2015 Special Issue:152-165.
`DOI: 10.1614/WS-D-14-00019.1
`
`Burgos 2015
`
`2030 https://rapdb.dna.affrc.go.jp/ ;
`https://www.gramene.org/
`
`N/A
`
`2031 Barber LT, TR Butts, JW Boyd, K
`Cunningham, G Selden, JK Norsworthy,
`NR Burgos, M Bertucci (2021).
`
`Barber et al. 2021
`
`viii
`
`
`
`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
`
`Recommended chemicals for weed and
`brush control. MP44. Cooperative
`Extension Service, University of Arkansas
`System, U.S. Department of Agriculture
`and County Governments Cooperating. 104
`pp.
`
`2032 Rouse CE, NR Burgos±, JK Norsworthy,
`TM Tseng, CE Starkey, RC Scott (2018).
`Echinochloa resistance to herbicides
`continues to increase in Arkansas rice
`fields. Weed Technol.
`https://doi.org/10.1017/wet.2017.82
`
`2033 Talbert RE and NR Burgos (2007).
`History and management of herbicide-
`resistant barnyardgrass (Echinochloa crus-
`galli) in Arkansas rice. Weed Technol.
`21:324-331.
`
`2034 WO2011/028832
`
`2035 WO2013/074524
`
`Rouse et al. 2018
`
`Talbert and Burgos 2007
`
`Mankin PCT or Mankin
`
`Neuteboom PCT or
`Neuteboom
`
`2036 Declaration of Dr. David Alan Somers
`
`Somers Decl.
`
`2037 May 4, 2022 Dr. Dale Shaner Deposition
`Transcript
`
`Shaner Depo. Tr.
`
`2038 Discover® NG, Syngenta Crop Protection
`Label
`
`Discover® NG, Syngenta
`
`2039 Fusilade® II, Syngenta Crop Protection
`Label
`
`Fusilade® II, Syngenta
`
`ix
`
`
`
`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
`
`I.
`
`INTRODUCTION
`Patent Owner BASF SE submits this Response to RiceTec’s Petition for Post
`
`Grant Review of U.S. Patent No. 11,096,346 (“’346 Patent”). RiceTec argues in its
`
`Petition that (1) the ’346 Patent is statutorily eligible for Post Grant Review, (2) the
`
`’346 Patent claims do not satisfy the written description and enablement
`
`requirements (Grounds 1 and 2), and (3) the ’346 Patent claims are anticipated or
`
`rendered obvious by the Hinga and Hinga 2013 (collectively “Hinga”) prior art
`
`references (Grounds 3-5). In its Institution Decision, the Board found that the ’346
`
`Patent was eligible for post-grant review and instituted on all grounds. Paper 21 at
`
`9-22, 27-33. However, concerning Grounds 1-2, the Board found that Petitioner
`
`failed to establish that it is more likely than not that any of the claims of the ’346
`
`Patent failed to meet the written description and enablement requirements (id. at 22-
`
`27)—and found so sua sponte, on the record presented only by RiceTec, insofar as
`
`BASF in its Preliminary Response chose not to rebut Petitioner’s arguments and did
`
`not address the issues of enablement and written description of the ’346 Patent.
`
`BASF now asks the Board to find that all of the claims of the ’346 Patent are
`
`entitled to an effective filing date as early as September 1, 2009, and no later than
`
`1
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`March 1, 2012,1 based on a series of priority claims to earlier-filed applications. In
`
`particular, the ’346 Patent predecessor application number 13/393,780 (“the ’780
`
`Application,” EX1013) contains a disclosure which satisfies the written description
`
`and enablement requirements for all of the ’346 Patent claims.2 Although the Board
`
`found in the Institution Decision on the preliminary record before it that the ’346
`
`Patent claims lacked written description support in the Mankin Application—and in
`
`1 Although U.S. Application No. 13/393,780 entered the United States from the
`
`Mankin PCT on March 1, 2012, only after a number of preliminaries were addressed
`
`did the Patent Office assign an Official filing date of January 7, 2013.
`
`2 The disclosure of the ’780 Application (filed March 1, 2012) is substantively the
`
`same as the disclosure of Application No. PCT/US2010/047571 (“the Mankin PCT,”
`
`EX2034, filed September 1, 2010), which in turn is identical to Provisional
`
`Application No. 61/238,906 (“’906 Provisional Application,” EX1015, filed
`
`September 1, 2009). Petition, Paper No. 2, at 31; Institution Decision, Paper No. 21,
`
`at 14. In this Response, BASF cites primarily to the Mankin PCT but also provides
`
`parallel citations to the ’780 Application in the claim charts appearing at pages 18-
`
`34. Collectively, the ’780 Application, Mankin PCT, and ’906 Provisional
`
`Application are referred to herein as “the Mankin Application.”
`
`2
`
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`particular the “effective amount” limitation for the claimed “FOP” herbicides and
`
`their associated numerical ranges (Institution Decision, Paper No. 21, at 13-20)—
`
`the full record, including the deposition testimony from Petitioner’s expert Dale
`
`Shaner (EX2037), now refutes Petitioner’s arguments and the initial conclusions
`
`regarding priority.3 Dr. Shaner testified that the numerical range of an effective
`
`amount of a FOP herbicide could be determined by a POSITA at the time of filing
`
`of the Mankin Application by reference to the publicly available labels for the
`
`herbicide: a POSITA would start with half of the lower end of the label range and
`
`increase that four-fold, with the “rule of thumb” being that the rice crop must be able
`
`to tolerate twice the maximum label amount. When this framework is applied to the
`
`FOP herbicide labels available when the Mankin Application was filed, the resulting
`
`calculated ranges align with the numerical ranges in the ’346 Patent claims.
`
`An effective filing date for the ’346 Patent of September 1, 2009 (or as late as
`
`March 1, 2012), would antedate the Hinga and Hinga 2013 references (published
`
`3 In its Preliminary Response, BASF also relied on the priority filing date of a
`
`separate family of applications (referred to as the Neuteboom line) related to the
`
`’346 patent. Paper No. 16, at 2, n. 1. In this Response, BASF relies only on the
`
`Mankin Application for priority.
`
`3
`
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`February 5, 2015, and January 24, 2013, respectively) and remove them as prior art
`
`under Sections 102(a)(1) and 103. This would require a finding by the Board that all
`
`of the claims of the ’346 Patent are not unpatentable based on Grounds 3-5.
`
`Moreover, because the Mankin Application describes and enables the claims of the
`
`’346 Patent, this necessarily means that the ’346 Patent claims themselves are also
`
`not unpatentable for lack of written description and enablement insofar as the ’346
`
`Patent is a continuation-in-part of the Mankin Application and has at least the same
`
`amount of disclosure in its specification as the Mankin Application.
`
`II.
`
`SUMMARY OF ARGUMENTS
`The claims of the ’346 Patent are directed to a method of treating rice crops
`
`with certain “FOP” herbicides at established ranges of effective amounts (in grams
`
`of herbicide active ingredient per hectare, “g AI/Ha”) that are known to kill weeds
`
`of rice crops by inhibiting the enzyme Acetyl‐CoA carboxylase (“ACCase”).
`
`Importantly, the herbicide does not substantially injure the rice crop plant because it
`
`has one of three mutations (imparted by random mutagenesis) in the rice ACCase
`
`enzyme, which confers FOP herbicide tolerance to the rice crop. Rice plants having
`
`one of the claimed ACCase mutations will exhibit less than 10% injury when
`
`exposed to the FOP herbicide applied within the claimed ranges of effective
`
`amounts. (Relatedly, the mutant ACCase rice plants can also have resistance to
`
`4
`
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`another class of herbicides, called “DIMs.”)
`
`The crux of RiceTec’s argument that the ’346 Patent is not entitled to an
`
`effective filing date that would antedate the Hinga references is this: the Mankin
`
`Application does not describe or enable a randomly mutagenized rice crop plant
`
`actually having the claimed randomly imparted genetic mutation to the rice ACCase
`
`gene designated “G2906S”,4 where the mutation imparts resistance (< 10% injury)
`
`to the rice plant against the FOP herbicide “quizalofop” used at a range of known
`
`effective amounts for weed control. The full extent of RiceTec’s arguments is found
`
`at pages 34 to 41 of its Petition, based on the disclosures of the ’780 Application as
`
`representative of the earlier-filed applications (i.e., the Mankin PCT and the ‘906
`
`Provisional Application).
`
`Across these eight pages, RiceTec’s contentions can be summarized as
`
`follows:
`
`1) The claimed numerical ranges of effective amounts of the
`quizalofop herbicides are not expressly disclosed in the Mankin
`Application (Petition, Paper No. 2, at 40-41; see also Institution
`
`4 Other ACCase mutations are also claimed (“I17181L” and “W2027C”) but
`
`Petitioner does not set forth any arguments as to a lack of priority with respect to
`
`these mutants.
`
`5
`
`
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`Decision, Paper No. 21, at 14-15);
`2) The ’346 Patent inventors could not have possessed a rice plant
`with the G2096S mutation without having actually reduced the
`mutation to practice and demonstrated that it imparts the claimed
`quizalofop resistance or without depositing with ATCC a rice
`seed having the mutation (id. at 34-38);
`3) The G2096S mutation is “buried” in the ’780 Application among
`a “laundry list” of several dozen other mutations (id., at 34-36);
`4) The I1781L mutant FOP-resistance data in the Mankin
`Application would not lead a POSITA to reasonably predict that
`the G2096S mutation would have the same characteristics (id. at
`41, n. 5); and
`5) A POSITA could not make and then select a rice plant having the
`FOP-resistant G2906S mutation imparted through random
`mutagenesis
`following
`the
`instructions
`in
`the Mankin
`Application because the only experimental selection in the
`Mankin Application (for the I1781L mutant) was with a DIM
`herbicide (id. at 39-40).
`(Notably, RiceTec presents no arguments regarding lack of priority with respect to
`
`the specific weed species covered by dependent claims 11-14.)
`
`Of these five arguments, RiceTec frames the first four as being based on a
`
`lack of written description; only the fifth argument expressly references enablement.
`
`The Board’s Institution Decision relied exclusively on RiceTec’s first argument in
`
`finding that the ’346 Patent claims were not entitled to the Mankin Application filing
`
`date, while also focusing on the “less than 10% injury” limitation. Institution
`
`Decision, Paper No. 21 at 14-20. As discussed below in Sections VII.B.1-6, each
`
`6
`
`
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`one of these arguments is refuted on the full record developed by BASF in discovery
`
`of Petitioner and in the accompanying declaration of BASF’s expert David Somers
`
`(EX2036).
`
`III. THE ’346 PATENT
`A.
`Overview
`The ’346 Patent is generally directed to a method for treating domestic rice
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`crops by applying certain Acetyl‐CoA carboxylase (“ACCase”)-inhibiting
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`aryloxyphenoxypropanoate herbicides (“FOPs”) to a rice plant that has certain
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`ACCase mutation(s) in the rice genome, which confer herbicide tolerance to the rice
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`crop. A number of commercially available herbicides were developed to target
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`ACCase because ACCase catalyzes the first step of fatty acid biosynthesis, and the
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`inhibition of ACCase leads to serious developmental arrest or death in plants. FOPs
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`and cyclohexanediones (“DIMs”) are examples of herbicides that work by inhibiting
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`ACCase, which in turn downregulates fatty acid synthesis and blocks the production
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`of phospholipids used in building new membranes required for cell growth.
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`The claims of the ’346 Patent cover herbicide-tolerant rice plants grown from
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`seeds that have I1781L, G2096S, or W2027C mutations of the ACCase gene within
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`the rice genome. The single independent claim is reproduced below, with limitations
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`highlighted in gray that the Board considered in the Institution Decision (Paper No.
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`7
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`
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`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
`
`21, at 13-14) to be dispositive to the priority determination.5
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`1. A method for treating rice, comprising:
`(i) providing at least one ACCase-inhibiting
`aryloxyphenoxypropanoate herbicide selected from the group
`consisting of quizalofop, an ester of quizalofop, an enantiomer of
`quizalofop, and an agriculturally acceptable salt of quizalofop;
`(ii) providing a domestic rice crop plant grown from seed, the
`domestic rice crop plant comprising and expressing an endogenous
`non-transfected mutant ACCase nucleic acid whose sequence
`encodes a multi-functional, plastidic ACCase containing a mutation
`selected from the group consisting of I1781L (Am), G2096S (Am),
`and W2027C (Am) that causes the ACCase to be tolerant to the
`herbicide, the nucleic acid thereby providing to the plant tolerance to
`the aryloxyphenoxypropanoate herbicide;
`(iii) applying an effective amount (measured in grams of active
`ingredient per hectare (g AI/Ha)) of the at least one
`aryloxyphenoxypropanoate herbicide to the domestic rice crop plant,
`post-emergence; thereby creating a treated rice plant; and
`(iv) growing the treated rice plant, wherein the effective amount of
`the at least one ACCase-inhibiting aryloxyphenoxypropanoate
`herbicide is 14 g AI/Ha to 40 g AI/Ha of quizalofop or an ester of
`quizalofop, or an amount equivalent to 14 g AI/Ha to 40 g AI/Ha of
`quizalofop or an ester of quizalofop, and wherein the effective
`amount of the aryloxyphenoxypropanoate herbicide causes less than
`10% injury to the rice plant in field applications, wherein the injury
`to the rice plant is evaluated 2-3 weeks after herbicide treatment.
`
`5 The Board referred to the highlighted language collectively as the “effective
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`amount” limitation. Institution Decision, Paper No. 21, at 13.
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`8
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`
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`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
`
`“I1781L” indicates an isoleucine (I) to leucine (L) mutation at position 1781 of the
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`amino acid sequence of ACCase based on the numbering of the ACCase in
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`Alopercurus myosuroides (blackgrass) (GenBank CAC84161.1) and is denoted with
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`an (Am). “G2096S” indicates a glycine to serine mutation at position 2096 of the
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`ACCase enzyme (Am), and “W2027C” indicates a tryptophan (W) to cysteine (C)
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`mutation at position 2027 of the ACCase enzyme (Am).6 These herbicide-tolerant
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`mutations are “endogenous non-transfected,” meaning that they are “produced
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`randomly by a technique involving no step of introducing exogenous nucleic acid(s)
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`or nucleic acid analog(s), into a plant cell or into other plant material.” ’346 Patent
`
`(Ex. 1001), at 7:14-17. Example 1 of the ’346 Patent teaches production of these
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`herbicide-tolerant mutants via in vitro tissue culture mutagenesis assays utilizing the
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`spontaneous nature of somaclonal variations. Example 2 teaches selection of the
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`herbicide-tolerant rice calli by application of DIMs and FOPs to the mutant tissues.
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`Example 3 teaches regeneration of the herbicide-tolerant plants having the ACCase
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`6 In comparison to the standard blackgrass numbering of positions 1781(Am),
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`2096(Am), and 2027(Am), the rice ACCase contains these same residues at the
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`corresponding rice (Oryza sativa “(Os)”) positions 1792(Os), 2107(Os), and
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`2038(Os).
`
`9
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`
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`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
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`gene sequence mutation. Example 4 describes the sequence analysis process for the
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`ACCase mutation. Examples 5 and 8 discuss the herbicide-tolerance data for the
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`selected ACCase-inhibitor-tolerant mutants.
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`IV. PERSON OF ORDINARY SKILL IN THE ART
`For purposes of this proceeding only, a person of ordinary skill in the art
`
`(“POSITA”) relevant to the ’346 Patent would have at least a PhD in agriculture,
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`weed science, or related discipline with at least five years of research experience in
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`the same field.
`
`V.
`
`CLAIM CONSTRUCTION
`In its Institution Decision, the Board formally construed the term “effective
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`amount” to mean “the recited amount of quizalofop or its equivalent that causes the
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`specified phytotoxicity (at least 65%) to conventional rice and causes less than 10%
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`injury to the treated rice plant in field applications.” PGR2021-00114, Paper No. 21,
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`at 8-9 (emphasis added). BASF respectfully disagrees with the Board’s
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`construction. The inventors of the ’346 Patent clearly and expressly defined
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`“effective amount” to mean “the amount of herbicide required to achieve at least
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`about 65% phytotoxicity of conventional [i.e., wild, non-mutant] rice (e.g., red rice)
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`in field applications.” ’346 Patent, Ex1001, at 6:34-37. In acting as their own
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`lexicographers, the inventors’ definition is controlling on the issue of claim
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`10
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`
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`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
`
`construction. Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380
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`(Fed. Cir. 2009) (“When a patentee explicitly defines a claim term in the patent
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`specification, the patentee’s definition controls.”) (citing Phillips v. AWH Corp., 415
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`F.3d 1303, 1321 (Fed. Cir. 2005) (en banc)). While the “less than 10% injury”
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`language is indeed a limitation of the ’346 Patent claims, it is not part of the
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`inventors’ definition of “effective amount,” nor is it implicated in the question of
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`whether “effective amount” per se is described in the Mankin PCT (as discussed
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`below in Section VII.B.1). The “less than 10% injury” language serves only to
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`further clarify the required effect on the mutant ACCase rice plant of applying a
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`fixed “effective amount” of herbicide falling within the claimed numerical ranges
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`that otherwise results in at least 65% injury on the non-mutated red (“weedy”) rice
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`plants. (Of course, there must also be a written description of the “less than 10%
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`injury” limitation in the Mankin PCT, which BASF addresses below in Section
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`VII.B.6).
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`VI. THE CORRECT PRIORITY DATE FOR THE ’346 PATENT
`RiceTec argues that the challenged claims should have an effective filing date
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`of December 30, 2016 (the U.S. filing date of the parent application that eventually
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`issued as the U.S. Patent No. 11,096,345) and that the challenged claims are not
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`entitled to the filing dates of any related applications. As explained below, because
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`11
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`
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`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
`
`the ’346 Patent is entitled to the filing date of the Mankin Application (exemplified
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`below in the Mankin PCT), the ’346 Patent antedates the alleged Hinga prior art
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`references.
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`A. Mankin PCT Overview
`WO 2011/028832 (“Mankin PCT,” EX2034) was filed September 1, 2010 and
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`generally discloses herbicide-tolerant plants and methods for controlling weed
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`growth with herbicides to which the plants are herbicide-tolerant. The Mankin PCT
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`relates specifically to the growth of rice crops and an ACCase mutation in rice crops
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`making them herbicide-tolerant. “Examples of amino acid positions at which an
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`acetyl-Coenzyme A carboxylase of an herbicide-tolerant plant of the invention
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`differs from the acetyl-Coenzyme A carboxylase of the corresponding wild-type
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`plant include, but are not limited to, one or more of the following positions:
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`1,781(Am) . . . 2,027(Am) . . . 2096(Am) . . . .” EX2034, Mankin PCT, at [0007]. In
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`addition to these three positions (corresponding to the three positions in the patent
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`claims), the Mankin PCT also lists a number of other positions (for a total of twenty-
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`two positions) amenable to mutation to confer herbicide resistance, including
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`1,999(Am), 2,041(Am), 2,078(Am) and 2,088(Am). Id. Specific mutations at all
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`twenty-two of these positions that would confer herbicide resistance are also
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`identified, including the three mutations covered by the ’346 Patent claims: I1781L,
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`12
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`
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`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner Response
`
`W2027C and G2096S. Id. In addition, a number of other specific mutations are
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`mentioned, including W1999C, I2041N, I2041V, D2078G, C2088R and G2096A.
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`Id.7
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`Mankin specifically relates to ACCase mutations in rice crops that are tolerant
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`to FOP herbicides. “For example, plants of the invention tolerant to acetyl-
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`Coenzyme A carboxylase inhibitors, such as ‘dims’ (e.g., cycloxydim, sethoxydim,
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`clethodim, or tepraloxydim), ‘fops’ (e.g., clodinafop, diclofop, fluazifop, haloxyfop,
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`or quizalofop) . . . .” Id. at [0115]. Mankin further explains that “[t]he herbicidal
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`compositions comprise an herbicidal effective amount of at least one of the acetyl-
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`Coenzyme A carboxylase-inhibiting herbicides and potentially other herbicides
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`and/or safeners
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