UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________
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`RICETEC, INC.
`Petitioner
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`v.
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`BASF SE,
`Patent Owner
`_______________
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`Case: PGR2021-00113
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`U.S. Patent 11,096,345
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`Title: Method for Treating Post-Emergent Rice
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`PATENT OWNER’S SUR-REPLY
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`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________
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`RICETEC, INC.
`Petitioner
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`v.
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`BASF SE,
`Patent Owner
`_______________
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`Case: PGR2021-00113
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`U.S. Patent 11,096,345
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`Title: Method for Treating Post-Emergent Rice
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`PATENT OWNER’S SUR-REPLY
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`Patent Owner’s Sur-Reply
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` PGR2021-00113
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`Petitioner RiceTec’s Reply to Patent Owner BASF’s Preliminary Response
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`repeats the same faulty Section 112 legal analysis that pervades its PGR Petition.
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`RiceTec demands a working example of the G2096S mutant in the priority PCT
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`documents—the kind of disclosure that the Federal Circuit has repeatedly rejected
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`as being necessary to demonstrate compliance with the enablement and written
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`description requirements. Moreover, RiceTec seriously misstates the prosecution
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`history of the Challenged Claims, whereas an accurate presentation of the record
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`shows that the Examiner found that the “effective amounts” of the claimed FOP
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`herbicides actually align or overlap with the prior art disclosures of corresponding
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`numerical ranges of FOP concentrations—demonstrating that they were not new and
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`critical ranges that were crucial to the patentability of the Challenged Claims. The
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`Board allowed RiceTec to address the allegedly “unforeseeable” arguments in
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`BASF’s POPR, but RiceTec offers no additional evidence or arguments in its Reply
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`that it is more likely than not that the Challenged Claims are eligible for Post-Grant
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`Review. The Board should deny institution.
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`I.
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`BASF Applied the Correct Legal Standards in Demonstrating
`that the Claims have Section 112 Support in the Priority PCTs
`RiceTec wrongly frames BASF’s “central argument” for priority as being
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`improperly grounded in an obviousness standard. Reply, 1-2. Its basis for this
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`assertion comes from a single phrase (in several iterations) in BASF’s Response: a
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`POSITA would have a “reasonable expectation of success” in extrapolating the
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`Patent Owner’s Sur-Reply
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`results of the I1781L working example to a G2096 mutant. See, e.g., POPR, 67. But
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`a “reasonable expectation of success” is an important consideration under Federal
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`Circuit precedent for enablement and that is precisely the context that BASF relies
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`on here. In In re Wright, the court held that enablement can be satisfied if the results
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`of a working example “could be extrapolated with a reasonable expectation of
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`success” to embodiments for which there are no disclosed working examples. 999
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`F.2d 1557, 1564 (Fed. Cir. 1993). That BASF intended the formulation “reasonable
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`expectation of success” as being operative for enablement (and not implicating an
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`obviousness standard) is further demonstrated by the enablement case law that
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`BASF relies on for the proposition that a G2096S working example is not required
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`to satisfy Section 112. POPR, 68 (citing Allergan, Alcon and Strahilevitz).1
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`RiceTec treats the red herring of obviousness as an occasion to recapitulate
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`erroneous arguments regarding Section 112 and to shoehorn in new ones. The Reply
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`asserts that the priority PCTs fail to satisfy Section 112 because they do not disclose
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`a G2096S mutation “that actually causes the claimed effective tolerance levels.”
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`1 RiceTec also asserts that a POSITA would not have a reasonable expectation of
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`success because the claims require that the mutation be “produced randomly” and
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`that BASF ignores this limitation. Reply, 2. BASF did address this issue in detail.
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`POPR, 27-33, 55-64.
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`2
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`Patent Owner’s Sur-Reply
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`Reply, 3 (emphasis added); see also Pet., 34-35 (the BASF inventors had not
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`“actually possessed rice plants from seed that contains the G2096S mutation such
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`that the rice plant is tolerant to quizalofop at the claimed levels and field conditions.”
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`(emphasis added)). As already addressed in the POPR (at 67-68), this is not the law
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`under the enablement standard, nor is it the law for written description. In fact, the
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`Federal Circuit decision in Nuvo Pharm. v. Dr. Reddy's Labs. that RiceTec relies on
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`held that adequate written description “does not require experimental data…[and]
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`the invention does not actually have to be reduced to practice.” 923 F.3d 1368, 1380
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`(Fed. Cir. 2019); see also Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1309 (Fed.
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`Cir. 2015) (“no rigid requirement that the disclosure contain ‘either examples or an
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`actual reduction to practice’” to satisfy written description).
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`Moreover, RiceTec’s assertion that the Federal Circuit has “‘expressly
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`rejected’ an ipsis verbis approach of finding written description” (Reply, 3-4) is
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`simply wrong—the cases RiceTec relies on are quoted out of context or are
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`distinguishable from the present facts.2 In particular, in Enzo Biochem, Inc. v. Gen-
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`Probe Inc., the claimed composition of matter was defined only by its function
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`without regard to any structure. 323 F.3d 956, 968. In rejecting ipsis verbis support
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`2 RiceTec does not dispute that there is ipsis verbis support in the PCT—as laid out
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`in Section VIII in the POPR—for every limitation of every Challenged Claim.
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`3
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`Patent Owner’s Sur-Reply
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`for the claims, the court held that the “appearance of mere indistinct words” in the
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`specification corresponding to the functional claim language does not “necessarily
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`satisfy the description requirement.” Id. Here, to the contrary, the claims recite a
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`specific structure, the G2096S mutation—and not some abstracted function of an
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`undisclosed structure—which is not only expressly disclosed in Mankin, but also as
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`a most preferred embodiment. Thus, far from “the appearance of mere indistinct
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`words” as RiceTec claims, Mankin provides sufficient disclosures from which a
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`POSITA would have understood the inventors’ possession of the G2096S mutant.
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`RiceTec’s errors infect much of its analysis and dictate that institution be
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`denied. These errors are not rectified by RiceTec’s reliance (Reply, 4) on Novozymes
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`A/S v. DuPont Nutrition Biosciences. The patent specification in Novozymes
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`contained no working examples at all that supported the claimed function and
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`nothing more than a generic structure that purportedly corresponded to the claimed
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`function; the only disclosed embodiment with experimental data had the opposite
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`function than that required by the claims. 723 F.3d at 1348-49. Under these facts,
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`the Federal Circuit held that the patentee sought “to derive written description
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`support from an amalgam of disclosures plucked selectively from the priority
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`application.” Id. at 1349. There is no such hindsight reconstruction required in the
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`priority PCTs that BASF relies on: it is undisputed that there is at least one
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`embodiment (the I1781L mutant) with experimental data supporting the claimed
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`4
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`Patent Owner’s Sur-Reply
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` PGR2021-00113
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`function and that the disclosed G2096S mutant is a specific structure (and not a
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`generic one) that was predicted to have the same function as the I1781L mutation.
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`In other words, these disclosures in the priority PCTs provide written description
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`support for the claimed invention as an “integrated whole.”
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`Given the facts of the case and applying the correct legal analysis here, it is
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`not surprising that RiceTec does not address in its Reply, even briefly (as permitted
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`by the Board on the conference call), BASF’s reliance on the Examiner’s assessment
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`of Mankin during prosecution of the RiceTec patent application. There, the
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`Examiner determined that Mankin describes and enables the G2096S mutant, even
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`in the absence of a working example: “Regarding the description (or enablement),
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`Mankin has provided sufficient description of the structure and function relationship
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`of G2096S in terms of herbicide tolerance, and enabling guidance of making (such
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`as through random and directed mutagenesis, or genetic modification) and using the
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`claimed rice plant.” POPR at 15 (quoting EX2004 at 130).
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`II. BASF Accurately Described the File History
`Regarding the Claimed Numerical Ranges
`Accusing BASF of false statements, RiceTec argues that the Challenged
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`Claims were allowed because the effective amount ranges of herbicides were added
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`to overcome the prior art. Reply, 5-6. This is the false statement. The numerical
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`ranges were not the Examiner’s basis for allowing the Challenged Claims. Reply,
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`5-6. In fact, the Examiner specifically noted the prior art disclosed ranges
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`Patent Owner’s Sur-Reply
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`encompassed within the claimed effective amounts. For example, the Maneechote
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`prior art disclosed 25-50 g/HA of quizalofop, and the claims recite quizalofop in the
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`range of 14-140 g/HA — this range encompasses the prior art. Therefore, it is
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`incorrect that the ranges were added to distinguish the prior art. Notably, on August
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`24, 2020, the Examiner recognized this exact point: “Maneechote teaches applying
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`quizalofop herbicides to rice field in an effective amount to control (sprangletop)
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`weeds, and that the amount of 30 g AI/ha quizalofop-P is effective in killing
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`sprangletop grass . . . . Thus 30 g AI/ha quizalofop-P is an effective amount.”
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`EX1046-Part 3, 919-920 (emphasis added).
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`The Examiner’s observation aligns with a POSITA’s understanding and
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`BASF’s arguments that the effective amount ranges of herbicides include those well-
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`known in the art and indicated on the labels and were not new and critical ranges
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`that were crucial to the patentability of the Challenged Claims. POPR, 73-75. As
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`further acknowledged by the Examiner, “none of the prior art teach or suggest the
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`rice ACCase mutant would provide the claimed levels of tolerance … with less than
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`10% injury to the treated rice plant in field application post-emergence.” EX1047-
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`Part 3, 920 (emphasis added). Thus, it was the “herbicide causes less than 10%
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`injury to the rice plant in field applications” limitation – not the effective amount
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`ranges of herbicides– that distinguished the claims from the prior art and led to
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`allowance. EX1047-Part 3, 914-921, 1007.
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`6
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` PGR2021-00113
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`Respectfully submitted,
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`/Richard J. McCormick/
`Richard J. McCormick (Reg. No. 55,902)
`Lisa M. Ferri (pro hac vice)
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`Ying-Zi Yang (Reg. No. 52,381)
`Mayer Brown LLP
`1221 Avenue of the Americas
`New York, NY 10020
`Tel: (212) 506-2500
`rmccormick@mayerbrown.com
`lferri@mayerbrown.com
`yyang@mayerbrown.com
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`Amanda Streff Bonner (Reg. No. 65,224)
`71 South Wacker Dr.
`Chicago, IL 60606-4637
`Tel: (312) 782-0600
`asbonner@mayerbrown.com
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`Attorneys for Patent Owner BASF SE
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`Patent Owner’s Sur-Reply
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`Dated: January 18, 2022
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`7
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`Patent Owner’s Sur-Reply
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` PGR2021-00113
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`CERTIFICATE OF SERVICE
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`I hereby certify that a true and correct copy of the foregoing PATENT
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`OWNER’S SUR-REPLY was served on January 18, 2022, via email pursuant to
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`consent from Petitioner to electronic service by email, to counsel for Patent Owner
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`at the following email addresses:
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`gnorton@foxrothschild.com
`rmiller@foxrothschild.com
`HSuh@foxrothschild.com
`tcooper@foxrothschild.com
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`Gerard Norton
`Ryan Miller
`Howard Suh
`Tanya Cooper
`FOX ROTHSCHILD LLP
`Princeton Pike Corporate Center
`997 Lenox Drive
`Lawrenceville NJ 08648-2311
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`Dated: January 18, 2022
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`/Richard J. McCormick/
`Richard J. McCormick (Reg. No. 55,902)
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`8
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