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 SUR-REPLY
`
`

`

`PGR2021-00113
`U.S. Patent No. 11,096,345
`Patent Owner Response
`
`TABLE OF CONTENTS
`
`Page
`
`Introduction ............................................................................................................... 1
`A.
`BASF’s Claim Charts Support Written Description of the Challenged
`Claims in the Mankin PCT as an “Integrated Whole,” and the Holding
`in Novozymes Is Otherwise Inapplicable ....................................................... 3
`B. Mutation G2096S Is Identified as a “Most Preferred Embodiment” in
`Mankin, Which Would “Reasonably Lead” a POSITA to This
`Particular Species ............................................................................................ 6
`C. Generating and Finding the G2096S Mutation in Rice ACCase
`Through Random Mutagenesis Was Described in and Enabled by
`Mankin .......................................................................................................... 11
`The Prosecution History of BASF’s Related Patent Applications Is
`Not Dispositive of the Issues in the PGR ..................................................... 15
`E. Mankin Describes “Effective Amounts” of Quizalofop Herbicides as
`Claimed in the ’346 Patent ........................................................................... 16
`The Data for the I1781L and D2078G Mutations in Mankin Would
`Lead a POSITA to Expect Cross-Tolerance ................................................. 18
`G. Dr. Somers’ Opinions Support the “Less than 10%” Limitation of the
`Claims, and RiceTec’s Failure to Provide its Own Expert Evidence on
`the Subject in its Reply is a Failure to Meet its Burdens of Production
`and Proof ....................................................................................................... 21
`BASF Satisfied its Burden of Production Regarding Enablement in
`the Patent Owner’s Response by Addressing the Limited Enablement
`Arguments in the Petition with Respect to Priority to Mankin .................... 24
`RiceTec Has Not Met its Burden of Proof on Non-Enablement of the
`’346 Patent .................................................................................................... 25
`
`D.
`
`F.
`
`H.
`
`I.
`
`i
`
`

`

`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner’s Sur-Reply
`TABLE OF AUTHORITIES
`
`Page
`
`CASES
`Amgen v. Sanofi,
`872 F.3d 1367 ..................................................................................................... 23
`Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
`598 F. 3d 1336 (Fed. Cir. 2010) ........................................................................... 3
`Dynamic Drinkware, LLC v. National Graphics, Inc.,
`800 F. 3d 1375 (Fed. Cir. 2015) ........................................................................... 1
`Elcommerce. com, Inc. v. SAP AG,
`745 F. 3d 490 (Fed. Cir. 2014) ............................................................................. 2
`Flash-Control, LLC v. Intel Corp.,
`2021 U.S. App. LEXIS 20790 .............................................................................. 4
`Fujikawa v. Wattanasin,
`93 F.3d 1559 (Fed. Cir. 1996) .............................................................. 8, 9, 10, 15
`In re Wands,
`858 F.2d 731 (Fed. Cir. 1988) ................................................................ 13, 25, 26
`Invitrogen Corp. v. Clontech Labs.,
`429 F.3d 1052 (Fed. Cir. 2005) ............................................................................ 2
`Novartis Pharma. Corp. v. Accord Healthcare, Inc.,
`38 F. 4th 1013 (Fed. Cir. 2022) ............................................................................ 6
`Novozymes A/S v. Dupont Nutrition Biosciences APS,
`723 F.3d 1336 (Fed. Cir. 2013) ...................................................................passim
`Nuvo Pharms v. Dr. Reddy’s Labs,
`923 F.3d 1368 (Fed. Cir. 2019) ............................................................................ 6
`
`ii
`
`

`

`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner’s Sur-Reply
`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
`
`iii
`
`

`

`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner’s Sur-Reply
`No.
`Document
`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
`
`Referred To As
`
`Hardke and Chlapecka 2020
`
`Carvalho-Moore et al. 2021
`
`Roma-Burgos et al. 2021a
`
`Roma-Burgos et al. 2021b
`
`Norsworthy et al. 2013
`
`2014 Burgos NR, JK Norsworthy, RC Scott, and
`KL Smith (2008). Red rice status after five
`
`Burgos et al. 2008
`
`iv
`
`

`

`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner’s Sur-Reply
`No.
`Document
`years of ClearfieldTM rice technology in
`Arkansas. Weed Technol. 22:200-208.
`
`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
`
`2020 Eleftherohorinos IG and KV Dhima
`(2002). Red rice (Oryza sativa) control in
`rice (O. sativa) with preemergence and
`
`v
`
`Referred To As
`
`Jang et al. 2013
`
`Christoffers et al. 2002
`
`Cui et al. 2015
`
`Maneechote et al. 2005
`
`Mohamed et al. 2012
`
`Eleftherohorinos and Dhima
`2002
`
`

`

`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner’s Sur-Reply
`No.
`Document
`postemergence herbicides. Weed Technol.
`16:537-540
`
`2021 Uchiyama M, N Washio, T Ikai, H
`Igarashi, K Suzuki (1986). Stereospecific
`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.
`
`Referred To As
`
`Uchiyama et al. 1986
`
`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
`
`vi
`
`

`

`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner’s Sur-Reply
`No.
`Document
`2030 https://rapdb.dna.affrc.go.jp/ ;
`https://www.gramene.org/
`
`2031 Barber LT, TR Butts, JW Boyd, K
`Cunningham, G Selden, JK Norsworthy,
`NR Burgos, M Bertucci (2021).
`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
`
`Referred To As
`N/A
`
`Barber et al. 2021
`
`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.
`
`vii
`
`

`

`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner’s Sur-Reply
`No.
`Document
`2038 Discover® NG, Syngenta Crop Protection
`Label
`
`Referred To As
`Discover® NG, Syngenta
`
`2039 Fusilade® II, Syngenta Crop Protection
`Label
`
`Fusilade® II, Syngenta
`
`2040 Errata Sheet for Transcript of July 27, 2022
`Deposition of David Alan Somers
`
`N/A
`
`viii
`
`

`

`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner’s Sur-Reply
`
`Introduction
`BASF’s burden in its Response was to produce evidence that the Hinga and
`
`Hinga2013 published patent applications that RiceTec relies on in its Petition
`
`(purportedly setting out a prima facie case of invalidity) are not prior art because
`
`the Challenged Claims are entitled to the earlier filing date of Mankin. Dynamic
`
`Drinkware, LLC v. National Graphics, Inc., 800 F. 3d 1375, 1379-80 (Fed. Cir.
`
`2015). BASF did so, relying on expert testimony of Dr. Somers and the in haec
`
`verba disclosures in the Mankin specification, both considered in connection with
`
`the associated Federal Circuit case law controlling the written description and
`
`enablement issues implicated by Dr. Somers’ opinion and BASF’s arguments. The
`
`burden then shifted to RiceTec to rebut BASF’s evidence and arguments with
`
`competent evidence of its own, that would ultimately be necessary to satisfy its
`
`burden of proof of invalidity. Id. at 1380.
`
`RiceTec has failed to do so. Where RiceTec’s arguments would require the
`
`perspective of a POSITA, it offers only attorney arguments and attorney
`
`interpretation of Mankin, none of which is competent evidence on written
`
`1
`
`

`

`PGR2021-00114
`U.S. Patent No. 11,096,346
`Patent Owner’s Sur-Reply
`description and enablement.1 RiceTec could have produced additional expert
`
`evidence in the form of a reply declaration, but it chose not to,2 and the bald and
`
`unsupported statements of its attorneys are directly controverted by Dr. Somers’
`
`expert testimony. And, where RiceTec attempts to impeach Dr. Somers’ opinions
`
`during cross-examination at his deposition, it can only do so—and, eventually
`
`fails—by misapprehending the technology and prior art references or by seriously
`
`misrepresenting the record evidence (concerning the “Mankin Declarations”) to the
`
`1 Invitrogen Corp. v. Clontech Labs., 429 F.3d 1052, 1068 (Fed. Cir. 2005)
`
`(“extensive . . . and unsubstantiated attorney argument regarding the meaning of
`
`technical evidence is no substitute for competent substantiated expert testimony”;
`
`Elcommerce. com, Inc. v. SAP AG, 745 F. 3d 490, 506 (Fed. Cir. 2014) (“Without
`
`evidence, [a court cannot] decide whether, for a specific function, the description
`
`in the specification is adequate from the viewpoint of a [POSITA] . . . . The burden
`
`was on [defendant] to prove its case, and in the absence of evidence provided by
`
`technical experts . . . there is a failure of proof. Attorney argument is not
`
`evidence.”).
`
`2 RiceTec cites to Dr. Shaner’s original expert opinions in support of its
`
`Petition only twice in its Reply.
`
`2
`
`

`

`PGR2021-00114
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`Patent Owner’s Sur-Reply
`Board and to Dr. Somers. Finally, there’s RiceTec’s Hail Mary pass near the end of
`
`the Reply, attempting to shoehorn in twelve pages of new non-enablement
`
`evidence and arguments regarding priority that should have been specifically
`
`identified on this subject in its Petition. At every turn, RiceTec has failed to meet
`
`its burden of production and, accordingly, its burden of proof.
`
`A. BASF’s Claim Charts Support Written Description of the Challenged
`Claims in the Mankin PCT as an “Integrated Whole,” and the Holding in
`Novozymes Is Otherwise Inapplicable3
`The “hallmark of written description is disclosure” (Ariad Pharmaceuticals,
`
`Inc. v. Eli Lilly and Co., 598 F. 3d 1336, 1351 (Fed. Cir. 2010)), and BASF
`
`provided that disclosure for the Challenged Claims by referencing (in a series of
`
`claim charts) the in haec verba support in the Mankin PCT specification. Response
`
`at 17-33. Faced with these express disclosures, and with no credible basis to
`
`dispute the direct word-for-word correspondence between the claims and the
`
`specification, RiceTec now argues that it was “legally erroneous” for BASF to do
`
`so because it failed to consider the claims as an “integrated whole” as required by
`
`Novozymes A/S v. Dupont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir.
`
`3 Each of BASF’s Sections A-I correspond to Sections A-I in RiceTec’s
`
`Reply.
`
`3
`
`

`

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`2013). Reply at 3. But RiceTec treats the “integrated whole” rubric as a soundbite
`
`with no accompanying analysis; and failing to treat the claims as an “integrated
`
`whole” has a very specific meaning in Federal Circuit jurisprudence—one that
`
`RiceTec fails to adduce evidence in support of. Under the case law construing the
`
`“integrated whole” principle, a patentee cannot show written description “by
`
`picking and choosing claim elements from different embodiments that are never
`
`linked together in the specification . . . . The written description requirement is not
`
`met when . . . the specification provides at best disparate disclosures that an
`
`artisan might have been able to combine in order to make the claimed invention.”
`
`Flash-Control, LLC v. Intel Corp., 2021 U.S. App. LEXIS 20790, at 12 (citing
`
`Ariad Pharms.). Here, RiceTec has provided no evidence—neither from an expert
`
`or by way of attorney argument—that a POSITA would have understood the in
`
`haec verba support in BASF’s claim charts to be taken from “disparate
`
`disclosures” or from “different embodiments” in Mankin. The in haec verba
`
`disclosures supporting written description in BASF’s claim charts remain
`
`unrebutted, and RiceTec has failed to meet its burden of production on this issue.
`
`Moreover, Novozymes was decided on very specific circumstances not
`
`present here. The patent claim in Novozymes called for a “BSG alpha-amylase”
`
`enzyme having an amino acid mutation at position “S239” that increased
`
`4
`
`

`

`PGR2021-00114
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`Patent Owner’s Sur-Reply
`thermostability of the enzyme. 723 F.3d at 1341. The specification listed BSG
`
`alpha-amylase as one of seven different alpha-amylase enzymes, and it included
`
`S239 among a group of thirty-three positions that could be mutated to produce a
`
`thermostable alpha-amylase mutant. Id. at 1348. Notably, most of the specification
`
`focused on a different alpha-amylase, BLA alpha-amylase, which had only 65.4%
`
`sequence similarity to BSG alpha-amylase, and the only described substitution at
`
`position 239 did not confer thermostability. Id. at 1348-49. On these facts, the
`
`court held that despite the express disclosures in the specification of the claim
`
`limitations, the patent failed the written description analysis because the
`
`specification did not disclose “even a single species that falls within the claims
`
`or… any ‘blaze marks’ that would lead an ordinarily skilled investigator toward
`
`such a species among a slew of competing possibilities.” Id. at 1349. “[T]o actually
`
`possess the variant enzymes claimed… would have required Novozymes to
`
`confirm its predictions by actually making and testing individual variants or at
`
`least identifying subclasses of variants that could be expected to possess the
`
`claimed properties.” Id. at 1350 (emphasis added). As discussed below in Sections
`
`B, C and F, Mankin provides such “blaze marks” to select the G2096S mutation
`
`and contains experimental data for the I1781L, D2027C and D2078G mutants that
`
`5
`
`

`

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`would lead a POSITA to expect that the G2096S mutation would have the claimed
`
`properties of quizalofop herbicide resistance.4
`
`B. Mutation G2096S Is Identified as a “Most Preferred Embodiment” in
`Mankin, Which Would “Reasonably Lead” a POSITA to This Particular
`Species
`RiceTec persists in its Reply in arguing that the G2096S mutation is
`
`4 Although written description cannot be satisfied by an obviousness
`
`standard (Reply at 4-5), Federal Circuit precedent, including Novozymes as quoted
`
`above, is clear that what a POSITA would “expect” from the specification’s
`
`disclosures informs the POSITA’s understanding of what the inventors possessed
`
`for purposes of written description. Nuvo Pharms v. Dr. Reddy's Labs, 923 F.3d
`
`1368, 1384 (Fed. Cir. 2019) (finding no written description where “the evidence
`
`demonstrates that a [POSITA] reading the specification . . . would not have
`
`expected” the disclosed embodiment to function as claimed”). This reflects the
`
`general rule that there is “no specific form of disclosure required” to satisfy written
`
`description: “limitations [can] be supported in the specification through express,
`
`implicit, or inherent disclosure . . . . What is critical is how a person of skill in the
`
`art would read the disclosure—not the exact words used.” Novartis Pharma. Corp.
`
`v. Accord Healthcare, Inc., 38 F. 4th 1013, 1023 (Fed. Cir. 2022).
`
`6
`
`

`

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`“buried” in a “laundry list” of “hundreds of other mutations” among which it is
`
`“nowhere distinguished.” Reply at 5-7, 13; see also Petition at 34-36. BASF in its
`
`Response (at 42-45) pointed to the disclosures in Mankin identifying the 2096
`
`location as a “most preferred embodiment” among only four other locations
`
`(Mankin at ¶151) and also specifically calling out G2096S as a “more preferred
`
`embodiment” as well as a “most preferred embodiment” among only ten other
`
`mutations (Id., ¶152 (emphasis added)). Moreover, G2096S is the sole subject of
`
`claim number 17 (among only eleven other mutations in separate claims).
`
`These disclosures, among others, led BASF’s expert Dr. Somers to conclude
`
`that Mankin would “reasonably lead” a POSITA to the G2096S mutation and
`
`would support the claim limitation “G2096S” in the claims. Somers Decl.,
`
`EX2036, ¶¶61-66. During prosecution of RiceTec’s U.S. Patent Application No.
`
`13/554,675,14 (issued as Hinga2013), the Examiner came to the same conclusion,
`
`observing that Mankin “teaches G2096S mutation in a short list of limited number
`
`of tolerance-endowing mutations . . . wherein only 5 positions and total of 11
`
`substitutions are taught as most preferred embodiment” and finding that
`
`[t]herefore the list is not extremely long, and is within the
`scope of one of skill in the art to apply the teachings to reproduce any
`of the most preferred mutations including G2096S . . . . MANKIN has
`provided sufficient teaching to point out to a person of skill in the
`
`7
`
`

`

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`art how to easily implement the G2096S ACCase in rice for
`resistance to ACCase inhibitor herbicides . . . .
`
`EX2005, at 151-152 (emphasis added).
`
`The analysis and conclusions of Dr. Somers are consistent with the same
`
`Federal Circuit case law that RiceTec relies on to purportedly support its
`
`arguments. Fujikawa v. Wattanasin (cited in the Petition at page 35) sets out the
`
`applicable written description standard for so-called “laundry list” disclosures: the
`
`specification must “reasonably lead” a POSITA to the particular species that is the
`
`subject of the claim. 93 F.3d 1559, 1571 (Fed. Cir. 1996). In Fujikawa, written
`
`description was not satisfied because the species of compounds in the claim “were
`
`not Wattanasin’s preferred, and . . . his application contained no blazemarks as to
`
`what compounds, other than those disclosed as preferred, might be of special
`
`interest.” Id. (emphasis added). Importantly, the Federal Circuit held that the
`
`species of compounds that were identified as preferred embodiments in
`
`Wattanasin’s disclosure would have satisfied written description: “Wattanasin’s
`
`preferred embodiments do blaze a trail through the forest.” Id. (emphasis added).
`
`Here, the G2096S mutation is not only a preferred embodiment, but a most
`
`preferred one, and the holding of Fujikawa controls the outcome: Mankin satisfies
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`the written description requirement for G2096S—the designation of it as “most
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`preferred” is the blazemark that alerts the POSITA to its special interest.
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`RiceTec’s Reply ignores the above facts and law arrayed against it, never
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`even attempting to distinguish the holding in Fujikawa. Undeterred by the futility
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`of its argument, it resorts instead to distorting the record in an attempt to
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`rehabilitate its arguments. Rather than addressing the disclosure of G2096S as a
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`“most preferred embodiment” it references other, less pertinent parts of Mankin
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`identifying G2096S only as a general “embodiment” of the invention. Reply at 6.
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`And with respect to G2096S being the subject of its own claims in Mankin among
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`only eleven such other mutations, RiceTec twists the record, pointing to “22
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`[other] listed positions” also specifically claimed.” Id. at 7. But these “hundreds of
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`potential mutations” are all the subject of a single claim (claim 24), whereas
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`G2096 is the subject of its own, standalone claim.
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`Finally, RiceTec points to Dr. Somers’ alleged “critical admission” at his
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`deposition that “the PCT does not distinguish the claimed G2096S mutation from
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`these lists.” Id. at 6. Whatever was meant by the vague term “distinguish” (and the
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`question at his deposition drew a form objection on this basis, EX1052, at 109:16-
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`205), the test in Fujikawa is not whether a species is “distinguished,” but rather,
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`whether the disclosure has blazemarks that would “reasonably lead” a POSITA to
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`the species—and Dr. Somers’ opinion that the preferred embodiment disclosures of
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`G2096S in Mankin would “reasonably lead” a POSITA to this specific mutation
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`(Somers Decl., EX2036, ¶66) was left unchallenged at his deposition. Moreover,
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`Dr. Somers’ testimony that the “the multitudes of embodiments within the PCT…
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`were just ‘lists’” (Reply at 7) is also of no moment, as merely being in a list is not
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`dispositive of written description under Fujikawa— the correct test is whether the
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`disclosure contains blazemarks to certain species within the list, and the unrebutted
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`evidence here of G2096S identified as a “most preferred embodiment” satisfies
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`that test.
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`5 In any event, Dr. Somers elsewhere provided testimony distinguishing the
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`claimed mutations (including G2096S) among the list of other mutations in
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`Mankin: “Q. And would that person of skill in the art have that expectation [of
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`inducing the mutation and imparting FOP tolerance] with respect to each of the 22
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`locations here listed in paragraph seven? A. I can't really answer that based on all
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`22, but certainly the main three that are in question: 2027, 2096, 1781.” EX1052 at
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`78:5-10.
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`C. Generating and Finding the G2096S Mutation in Rice ACCase Through
`Random Mutagenesis Was Described in and Enabled by Mankin
`RiceTec does not dispute that Mankin discloses methodologies to induce
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`random mutations to rice ACCase and to screen the resulting ACCase mutants for
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`the ability to survive exposure to ACCase inhibitor herbicides. The only issues in
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`dispute are: (1) does the random nature of the mutagenesis matter for purposes of
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`written description and enablement? and, (2) does Mankin enable a POSITA to
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`screen for ACCase mutants with quizalofop herbicides (as opposed to DIMs)?
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`The answer to the first question is “no.” RiceTec’s position appears to stem
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`from a fundamental misunderstanding of the difference between, on the one hand,
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`the difficulty in predicting whether any single randomly mutagenized rice plant
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`cell would have the G2096S mutation (or another mutation); and, on the other
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`hand, the high likelihood, based on the Mankin PCT teachings and experimental
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`data, that across a large population of randomly mutagenized rice plant cells, a
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`POSITA would expect the G2096S mutation to appear in some frequency and be
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`able to identify the G2096S mutation by applying selection pressure using routine
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`herbicide screening. As Dr. Somers testified:
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`Q. … [U]sing random mutagenesis, based upon the teachings . .
`. in example one of the PCT application, would one have been able to
`predict the induced mutation specifically at the 2096 position?
`A. Yes. Because it was -- that mutation was known in nature.
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`Q. But how would one be able to predict whether it would
`occur at the 2096 position, opposed to another location such as 2078,
`1781, 2078, 2027?
`A. … [Y]ou’re generating mutations throughout the molecule.
`You're selecting for those that can withstand the presence of the
`herbicide . . . . [I]t’s the combination of the mutation frequency and
`the selection pressure.
`Q. But the mutation frequency, that wouldn't be able to predict
`where the mutation within ACCase would be; right?
`A. You would screen millions of events to identify the mutation
`of interest.
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`Somers Depo., EX1052, at 262:12-263:13; see also Id. at 73:7-14 (“[T]he
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`mutations are randomly generated. The key is selecting for the mutation . . . .
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`Mankin describes working out the selection systems across DIMS and FOPS,
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`and… that was absolutely key to the invention. So, it's not just the mutation. It's
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`how it was selected and then how it was characterized.”); Id. at 80:15-81:6 (same).
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`RiceTec overstates its case by pointing to the fact that Mankin does not
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`disclose a G2096S mutation that was actually induced and identified by screening.
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`Reply at 8-9. Actual reduction to practice is not a requirement for satisfying
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`written description (or enablement); moreover, this did not impact Dr. Somers’
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`opinions: he testified that Mankin “certainly showed that selection of mutations
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`was possible in ACCase” and “showed how all the elements required by a POSITA
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`to be able to do it.” Somers Depo., EX1052, at 263:14-264:5. Similarly, Dr.
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`Somers’ testimony (cited in the Reply at page 8) that he “ha[d] no idea” how long
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`the “routine methods” he described to screen for the claimed mutants would take to
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`find a G2096S mutation is irrelevant. The law of enablement considers effort
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`(routine versus undue), not simply the amount of time routine effort might take.
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`See In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) (“The test is not merely
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`quantitative, since a considerable amount of experimentation is permissible, if it is
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`merely routine . . . .”). Finally, as discussed in additional detail in Section F, even
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`without an actual reduction to practice of the G2096S variant, it was the other rice
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`ACCase mutations experimentally identified in Mankin as imparting FOP and/or
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`DIM herbicide resistance—I1781L, D2078G6 and W0227C7—that cemented Dr.
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`6 The D2078G resistant mutant’s stunted characteristics (Reply at 9) did not
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`matter to Dr. Somers: “the selection of that plant is very important because it
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`indicates the system they had developed for their tissue culture selection was
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`capable of isolating alleles other than . . . 1781 . . . . [I]t's a very important
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`finding.” Somers Depo., EX1052, at 85:17-22.
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`7 The W2027C resistant mutant in Example 7 was transgenic, not randomly
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`produced (Reply at 9-10), but was still informative to Dr. Somers’ opinions: “I
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`Somers’ opinions that with the data from Mankin in hand, a POSITA “would be
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`able to guarantee” G2096S could be randomly induced and have FOP tolerance,
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`and could be screened for and identified “as a matter of routine experimentation.”
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`Somers Depo., EX1052, at 77:17-78:3, 291:7-18; see also Somers Decl., EX2036,
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`¶78.
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`The answer to the second question above is “yes,” FOP, such as quizalofop
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`herbicides, selection is taught and enabled by Mankin. RiceTec argues in its Reply
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`(at page 10) that the teachings in Mankin are limited to DIM selection. RiceTec is
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`wrong. The only competent evidence of record on FOP selection was provided by
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`Dr. Somers in Paragraphs 42-44 and 75-78 of his Declaration (EX2036), and
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`supplemented at his deposition as discussed immediately above, which carefully
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`think they were very important in terms of the overall demonstration that they had
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`developed a selection system for FOPs because . . . they describe that Haloxyfop
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`selection of both the single and double mutants of those mutations yielded
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`transgenic events . . . .” “So, my understanding of that is that they're showing that
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`they had enabled Haloxyfop or Fop selection of a single cell and tissue culture,
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`which I think is probably very critical to eventually isolating the [G20]96-S.”
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`Somers Depo., EX1052, at 95:13-96:3, 98:3-7.
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`sets out the FOP selection experiments in Mankin and how they would be used by
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`a POSITA to screen for the G2096S mutant. RiceTec’s has no response to this
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`evidence, and doesn’t even address the teachings relied on by Dr. Somers; instead,
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`in a single footnote at page 10, it offers only attorney argument that there is no
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`such teaching. This does not meet RiceTec’s burden of production on the issue,
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`and the unrebutted evidence, from the perspective of a POSITA, is that Mankin
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`does enable a FOP selection methodology to screen for the G2096S mutant.
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`D. The Prosecution History of BASF’s Related Patent Applications Is Not
`Dispositive of the Issues in the PGR
`RiceTec