Trials@uspto.gov
`571.272.7822
`
`
`
`
` Paper 35
`
` Date: March 8, 2023
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`
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`RICETEC, INC.,
`Petitioner,
`
`v.
`
`BASF SE,
`Patent Owner.
`
`PGR2021-00114
`Patent 11,096,346 B2
`
`
`
`
`Before ULRIKE W. JENKS, TINA E. HULSE, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 328(a)
`
`
`
`
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
` Paper 35
`
` Date: March 8, 2023
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`RICETEC, INC.,
`Petitioner,
`
`v.
`
`BASF SE,
`Patent Owner.
`
`PGR2021-00114
`Patent 11,096,346 B2
`
`
`
`
`Before ULRIKE W. JENKS, TINA E. HULSE, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 328(a)
`
`
`
`
`
`
`
`
`
`
`
`
`
`PGR2021-00114
`Patent 11,096,346 B2
`
`I.
`
`INTRODUCTION
`
`RiceTec, Inc. (“Petitioner”) filed a Petition requesting post-grant
`
`review of claims 1–17 of U.S. Patent No. 11,096,36 B2 (Ex. 1001, “the ’346
`
`patent”), which is owned by BASF SE (“Patent Owner”). Paper 2 (“Pet.”).
`
`After considering the Petition, Preliminary Response (Paper 16, “Prelim.
`
`Resp.”), Petitioner’s pre-institution Reply (Paper 18), and Patent Owner’s
`
`pre-institution Sur-reply (Paper 20), we instituted post-grant review of the
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`challenged claims of the ’345 patent. Paper 21 (“Institution Decision” or
`
`“Dec. Inst.”).
`
`After institution, Patent Owner filed a Response (Paper 24, “PO
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`Resp.”), Petitioner filed a Reply (Paper 27, “Pet. Reply”), and Patent Owner
`
`filed a Sur-reply (Paper 29, “PO Sur-reply”). A consolidated oral argument
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`was held in this proceeding and PGR2021-00113 on December 13, 2022,
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`and a copy of the transcript was entered into the record. Paper 34 (“Tr.”).
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`We have jurisdiction under 35 U.S.C. § 6, and we issue this Final
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`Written Decision under 35 U.S.C. § 328(a) and 37 C.F.R. § 42.73. For the
`
`reasons discussed below, we conclude that Petitioner has proven by a
`
`preponderance of the evidence that claims 1–17 of the ’346 patent are
`
`unpatentable.
`
`A.
`
`Real Parties-in-Interest
`
`In the Petition and supplemental mandatory notices, Petitioner
`
`identifies itself, Agritec Ventures Corporation, Makhteshim Agan of North
`
`America, Inc. d/b/a ADAMA, Liechtenstein Group Holding AG, and
`
`Liechtenstein Group AG as the real parties-in-interest to this proceeding.
`
`Pet. 4; Paper 3, 1; Paper 11, 1. Patent Owner identifies itself as the real
`
`party-in-interest. Paper 6, 1.
`
`2
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`
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`PGR2021-00114
`Patent 11,096,346 B2
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`B.
`
`Related Proceedings
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`Petitioner states that it is unaware of any related matters. Pet. 4.
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`Patent Owner identifies PGR2021-00113, involving U.S. Patent No.
`
`11,096,345, as related to this proceeding. Paper 6, 1.
`
`C.
`
`The ’346 Patent
`
`The ’346 patent “generally relates to treatment of domestic rice crop
`
`plants for the control of weeds.” Ex. 1001, 1:27–28. The ’346 patent
`
`explains that Acetyl-Coenzyme A carboxylase (“ACCase”) enzymes are
`
`involved in the fatty acid synthesis pathway in plant chloroplasts. Id. at
`
`1:57–59. ACCase enzymes are inhibited by three classes of herbicidal
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`active ingredients: aryloxyphenoxypropanoates (“FOPs”),
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`cyclohexanediones (“DIMs”), and phenylpyrazolines (“DENs”). Id. at 1:65–
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`2:3. ACCase-inhibitor-tolerance (“AIT”) mutations that are tolerant toward
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`DIM and FOP herbicides have been found in monocot weed species and
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`maize. Id. at 2:4–6. According to the ’346 patent, it would be advantageous
`
`to provide rice that is tolerant to DIMs and FOPs. Id. at 2:12–14. The
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`Specification explains, however, that “[i]n some cases, herbicide-tolerance-
`
`inducing mutations create a severe fitness penalty in the tolerant plant.” Id.
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`at 2:15–17. The ’346 patent therefore states that “there remains a need in the
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`art for an AIT rice that also exhibits no fitness penalty.” Id. at 2:17–19.
`
`The ’346 patent describes a method for treating rice that includes the
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`steps of providing a domestic rice crop plant and at least one ACCase-
`
`inhibiting FOP herbicide, and applying an effective amount of the herbicide
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`to the domestic rice crop plant, post-emergence, to create a treated rice plant.
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`Id. at 2:22–34. The ’346 patent also describes embodiments in which the
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`domestic rice crop plant includes and expresses “an endogenous non-
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`transfected ACCase nucleic acid whose sequence encodes a multi-
`
`3
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`
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`PGR2021-00114
`Patent 11,096,346 B2
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`functional, plastidic ACCase containing a mutation that causes the ACCase
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`to be tolerant to the herbicide.” Id. at 2:37–41. The mutation can be
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`selected from I1781L,1 G2096S,2 and W2027C.3 Id. at 2:43–45.
`
`The ’346 patent describes in Example 8 the results of one study
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`testing the tolerance of AIT rice sown into a field to various herbicides in
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`varying amounts. Id. at 68:55–70:3. The results for the AIT rice are shown
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`in Figure 20B, reproduced below:
`
`
`
`
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`1 I1781L refers to a mutation from isoleucine (I) to leucine (L) at position
`1781 of the amino acid sequence of ACCase using a numbering system
`based on Alopercurus myosuroides, which is referenced as “(Am).”
`See Ex. 1002 ¶ 36; Ex. 2036 ¶ 37.
`
`2 G2096S refers to a mutation from glycine (G) to serine (S) at position 2096
`of the ACCase enzyme (Am). See Ex. 1002 ¶ 36; Ex. 2036 ¶ 37.
`
`3 W2027C refers to a mutation from tryptophan (W) to cysteine (C) at
`position 2027 of the ACCase enzyme (Am). See Ex. 1002 ¶ 36; Ex. 2036
`¶ 37.
`
`4
`
`
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`PGR2021-00114
`Patent 11,096,346 B2
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`Figure 20B depicts the amount of injury to various herbicides applied
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`at varying rates, including quizalofop-p-ethyl at rates of 35, 70, and
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`140 g AI/Ha.4 Ex. 1001, Fig. 20B.
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`D.
`
`Illustrative Claim
`
`Petitioner challenges claims 1–17 of the ’346 patent, of which claim 1
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`is the only independent claim. Claim 1 is illustrative and is reproduced
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`below:
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`1. A method for treating rice, comprising:
`
`one ACCase-inhibiting
`least
`at
`providing
`(i)
`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 aryloxyphenoxy-
`propanoate 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
`
`
`
`4 “g AI/Ha” refers to grams of active ingredient per hectare.
`
`5
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`
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`PGR2021-00114
`Patent 11,096,346 B2
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`of quizalofop, and
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`wherein the effective amount of the aryloxyphenoxy-
`propanoate 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.
`
`Ex. 1001, 269:55–271:5.
`
`Dependent claim 2 further recites harvesting seed from the treated rice
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`plant and dependent claim 17 further recites the seed harvested by the
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`method of claim 2; dependent claims 3–10 further recite a specific forms and
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`effective amounts of quizalofop; dependent claims 11–14 further recite
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`specific weeds that are killed by the herbicide; and dependent claims 15 and
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`16 further recite a domestic rice crop treated by the method of claim 1. Id. at
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`271:6–272:24.
`
`E.
`
`The Asserted Grounds of Unpatentability
`
`Petitioner challenges claims 1–17 of the ’346 patent based on the
`
`grounds set forth in the table below.
`
`Claim(s) Challenged
`1–17
`1–17
`1–17
`5–10
`11, 12
`
`35 U.S.C. §
`112
`112
`102(a)(1)
`103
`103
`
`Reference(s)/Basis
`Written Description
`Enablement
`Hinga5
`Hinga, Hinga20136
`Hinga, Anyszka7
`
`
`
`5 US 2015/0038331 A1, published Feb. 5, 2015 (“Hinga,” Ex. 1003).
`
`6 US 2013/0023416 A1, published Jan. 24, 2013 (“Hinga2013,” Ex. 1004).
`
`7 Z. Anyszka et al., The Response of Snap Bean and Barnyardgrass
`(Echinochloa crus-galli) on Quizalofop-P-tefuryl, 51 VEGETABLE CROPS
`RESEARCH BULLETIN 95–102 (1999) (“Anyszka,” Ex. 1006).
`
`6
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`
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`PGR2021-00114
`Patent 11,096,346 B2
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`Claim(s) Challenged
`
`35 U.S.C. §
`
`13, 14
`
`103
`
`Reference(s)/Basis
`Hinga, Hinga2013, Assure
`II,8 Maneechote9
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`Petitioner also relies on the Declaration of Dale Shaner, Ph.D.
`
`(Ex. 1002). Before institution, Patent Owner relied on the Declaration of
`
`Dr. Nilda Roma-Burgos (Ex. 2003). After institution, however, Patent
`
`Owner relies on the Declaration of David Alan Somers (Ex. 2036).
`
`F.
`
`Person of Ordinary Skill in the Art
`
`In determining the level of ordinary skill in the art, we consider the
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`type of problems encountered in the art, the prior art solutions to those
`
`problems, the rapidity with which innovations are made, the sophistication
`
`of the technology, and the educational level of active workers in the field.
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`Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962
`
`(Fed. Cir. 1986).
`
`Petitioner asserts that a person of ordinary skill in the art (“POSITA”
`
`or “POSA”) would have had “a Ph.D. in plant molecular biology, plant
`
`physiology, agronomy, or the equivalent, with at least 1-2 years of
`
`postdoctoral experience in herbicide mechanisms of action and weed
`
`management.” Pet. 27 (citing Ex. 1002 ¶ 66). Patent Owner contends that a
`
`person of ordinary skill in the art would have had “at least a PhD in
`
`agriculture, weed science, or related discipline with at least five years of
`
`research experience in the same field.” PO Resp. 10.
`
`
`
`8 Assure II label, E. I. du Pont de Nemours and Co. (1999) (“Assure II,”
`Ex. 1005).
`
`9 C. Maneechote et al., Resistance to ACCase-inhibiting Herbicides in
`Sprangletop (Leptochloa chinensis), 53 WEED SCIENCE 290–95 (2005)
`(“Maneechote,” Ex. 1007).
`
`7
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`
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`PGR2021-00114
`Patent 11,096,346 B2
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`As explained in our Institution Decision (Dec. Inst. 5–6), we do not
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`discern a substantive difference between the parties’ respective definitions
`
`for the level of ordinary skill in the art. Although Petitioner states a
`
`POSITA must have one to two years of postdoctoral research experience and
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`Patent Owner’s definition requires at least five years of “research
`
`experience,” Patent Owner’s definition does not indicate a specific time for
`
`that research (i.e., it could include research during or after a doctoral
`
`program). Neither party addresses or contests the other party’s definition in
`
`their post-institution papers. See generally PO Resp.; Pet. Reply; PO Sur-
`
`reply. Accordingly, we find the parties’ respective definitions to be
`
`equivalent and consistent with the level of ordinary skill in the art as
`
`reflected by the prior art in this proceeding. See Okajima v. Bourdeau, 261
`
`F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding
`
`ordinary skill level are not required “where the prior art itself reflects an
`
`appropriate level and a need for testimony is not shown” (quoting Litton
`
`Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir.
`
`1985))).
`
`Moreover, we find that Dr. Shaner and Dr. Somers are both qualified
`
`to opine from the perspective of a skilled artisan as both are persons of at
`
`least ordinary skill in the art, based on either party’s definition. See
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`Ex. 1002 ¶¶ 4–15; Ex. 2036 ¶¶ 5–11, App’x A; see also Kyocera Senco
`
`Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir.
`
`2022) (“To offer expert testimony from the perspective of a skilled artisan in
`
`a patent case—like for claim construction, validity, or infringement—a
`
`witness must at least have ordinary skill in the art.”).
`
`8
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`
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`PGR2021-00114
`Patent 11,096,346 B2
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`G. Claim Construction
`
`The Board applies the same claim construction standard that would be
`
`used to construe the claim in a civil action under 35 U.S.C. § 282(b).
`
`37 C.F.R. § 42.200(b) (2021). Under that standard, claim terms “are
`
`generally given their ordinary and customary meaning” as understood by a
`
`person of ordinary skill in the art at the time of the invention. Phillips v.
`
`AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Moreover,
`
`“claim terms need only be construed ‘to the extent necessary to resolve the
`
`controversy.’” See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355,
`
`1361 (Fed. Cir. 2011) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
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`200 F.3d 795, 803 (Fed. Cir. 1999)).
`
`In our Institution Decision, we construed the term “endogenous non-
`
`transfected mutant” consistently with the ’346 patent specification’s express
`
`definition of the term:
`
`(1) that the nucleic acid is endogenous to the respective cell,
`seed, plant, or plant part and
`
`(2) that its nucleotide sequence is “nontransfected” in that
`
`it contains herbicide-tolerance mutation(s) produced
`(a)
`randomly by a technique involving no step of introducing
`exogenous nucleic acid(s) or nucleic acid analog(s), into a plant
`cell or into other plant material, and
`
`(b) it contains no mutation(s) produced by a technique involving
`a step of introducing exogenous nucleic acid(s) or nucleic acid
`analog(s), into a plant cell or into other plant material.
`
`Dec. Inst. 7–8 (citing Ex. 1001, 7:7–21).
`
`We also construed the term “effective amount” to mean “the recited
`
`amount of quizalofop or its equivalent that causes the specified phytotoxicity
`
`9
`
`
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`PGR2021-00114
`Patent 11,096,346 B2
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`(at least 65%) to conventional rice and causes less than 10% injury to the
`
`treated rice plant in field applications.” Id. at 8–9.
`
`Since our Institution Decision, the only construction disputed by the
`
`parties is for the term “effective amount.” Specifically, the parties dispute
`
`whether the construction includes “caus[ing] less than 10% injury to the
`
`treated rice plant in field applications.”
`
`After institution, Petitioner adopted our construction of “effective
`
`amount.” Pet. Reply 14. Patent Owner, however, argues that we erred in
`
`our construction because the Specification explicitly defines “effective
`
`amount” to mean “the amount of herbicide required to achieve at least about
`
`65% phytotoxicity of conventional [i.e., wild, non-mutant] rice (e.g., red
`
`rice) in field applications.” PO Resp. 10 (quoting Ex. 1001, 6:34–37).
`
`Because the inventors served as their own lexicographers, Patent Owner
`
`asserts the Specification’s express definition controls. Id. at 10–11 (citing
`
`Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380 (Fed. Cir.
`
`2009) (“When a patentee explicitly defines a claim term in the patent
`
`specification, the patentee’s definition controls.”)). Nevertheless, Patent
`
`Owner acknowledges that the “less than 10% injury” language “is indeed a
`
`limitation of the ’346 Patent claims.” Id. at 11.
`
`Having considered the arguments and evidence presented at trial, we
`
`agree with Patent Owner that the inventors acted as their own lexicographer
`
`to define “effective amount” and that that definition governs its meaning.
`
`Phillips, 415 F.3d 1316 (“[O]ur cases recognize that the specification may
`
`reveal a special definition given to a claim term by the patentee that differs
`
`from the meaning it would otherwise possess. In such cases, the inventor’s
`
`lexicography governs.”). We, therefore, construe the term “effective
`
`amount” to mean “the amount of an herbicide required to achieve at least
`
`10
`
`
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`PGR2021-00114
`Patent 11,096,346 B2
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`about 65% phytotoxicity of conventional rice (e.g., red rice) in field
`
`applications.” As explained further below, however, whether incorporated
`
`into the construction of “effective amount” or not, the claim language itself
`
`further requires that the “effective amount” encompass a specific range of
`
`amounts of herbicide (i.e., 14 g AI/Ha to 40 g AI/Ha of quizalofop) and
`
`cause “less than 10% injury” to the mutant rice. See Ex. 1001, claim 1.
`
`We determine it is unnecessary to expressly construe any other claim
`
`terms for purposes of this Decision. See Wellman, 642 F.3d at 1361.
`
`II.
`
`ELIGIBILITY FOR POST-GRANT REVIEW
`
`Section 6(d) of the Leahy-Smith America Invents Act, Pub. L. No.
`
`112-29, 125 Stat. 284 (Sept. 16, 2011) (“AIA”) sets forth the post-grant
`
`review provisions, which apply only to patents subject to the first-inventor-
`
`to-file provisions of the AIA. AIA § 6(f)(2)(A) (stating the provisions of
`
`Section 6(d) “shall apply only to patents described in section 3(n)(1)”).
`
`Post-grant reviews are only available for patents that issue from applications
`
`“that contain[] or contained at any time . . . a claim to a claimed invention
`
`that has an effective filing date . . . on or after” March 16, 2013. AIA
`
`§ 3(n)(1). Moreover, “[a] petition for a post-grant review may only be filed
`
`not later than the date that is 9 months after the date of the grant of the patent
`
`or of the issuance of a reissue patent (as the case may be).” 35 U.S.C.
`
`§ 321(c). Petitioner has the burden of demonstrating eligibility for post-
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`grant review. See Mylan Pharms. Inc. v. Yeda Res. & Dev. Co., PGR2016-
`
`00010, Paper 9 at 10 (PTAB Aug. 15, 2016).
`
`In our Institution Decision, we determined that the challenged claims
`
`are eligible for post-grant review. Dec. Inst. 9–22. The ’346 patent issued
`
`on August 24, 2021, which is the day the Petition was filed. Ex. 1001, code
`
`11
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`PGR2021-00114
`Patent 11,096,346 B2
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`(45); Pet. 85. Thus, there is no dispute that the Petition was filed less than
`
`nine months after the date the patent was granted. See 35 U.S.C. § 321(c).
`
`Rather, the parties dispute the effective filing date of the ’346 patent claims.
`
`Petitioner asserts—and we agreed—that the ’365 patent is eligible for post-
`
`grant review because the challenged claims are only entitled to claim priority
`
`to the filing date of its actual application of February 27, 2017. Ex. 1001,
`
`code (22); Pet. 29. Patent Owner contends that we erred in our decision,
`
`asserting that the challenged claims are entitled to the benefit of the filing
`
`date of an ancestor application that pre-dates March 16, 2013. PO Resp. 11–
`
`63. As explained further below, we are not persuaded by Patent Owner’s
`
`arguments and determine that Petitioner has shown by a preponderance of
`
`the evidence that the challenged claims are eligible for post-grant review.
`
`A.
`
`Background
`
`The ’346 patent issued from U.S. Application No. 15/443,714 (“the
`
`’714 Application”), filed on February 27, 2017. Ex. 1001, codes (21), (22).
`
`The ’714 Application is a continuation of U.S. Application No. 15/395,832
`
`(“the ’832 Application”), filed on December 30, 2016, which issued as U.S.
`
`Patent No. 11,096,345 B2 (“the ’345 patent”), which is the subject of
`
`PGR2021-00113. The ’714 Application also claims priority to two patent
`
`family lines, the Neuteboom and Mankin families. The annotated patent
`
`family tree provided by the parties is reproduced below:
`
`12
`
`
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`PGR2021-00114
`Patent 11,096,346 B2
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`
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`Dec. Inst. 11.
`
`The “Neuteboom line” is shown on the left, and includes U.S.
`
`Application No. 14/357,691 (“the ’691 Application”), which is the national
`
`phase entry of the Neuteboom PCT application, which was filed on
`
`November 13, 2012, and is highlighted in the red box. The “Mankin line” is
`
`on the right, and includes U.S. Application No. 13/393,780 (“the ’780
`
`Application,” Ex. 1013), which is the national phase entry of the Mankin
`
`PCT application (Ex. 2034), which was filed on September 1, 2010, and is
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`highlighted in the blue box. Although Patent Owner relied on both lines
`
`before our Institution Decision, Patent Owner now relies solely on the
`
`13
`
`
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`PGR2021-00114
`Patent 11,096,346 B2
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`Mankin line for purposes of priority. PO Resp. 3 n.3 (“In this Response,
`
`[Patent Owner] relies only on the Mankin Application for priority.”).
`
`According to Patent Owner, the disclosure of the ’780 Application is
`
`substantively the same as the Mankin PCT application, which is identical to
`
`Provisional Application No. 61/238,906 (“the ’906 Provisional”). PO Resp.
`
`2 n.2. We, therefore, refer to the ’780 Application, the Mankin PCT, and the
`
`’906 Provisional interchangeably as “Mankin” or “the Mankin Application.”
`
`B.
`
`Legal Background
`
`To be eligible for post-grant review, Petitioner must show the ’346
`
`patent contains, or contained at any time, a claim that has an effective date
`
`that is on or after March 16, 2013. AIA § 3(n)(1). To claim the benefit of
`
`an earlier date under 35 U.S.C. §§ 119, 120, 121, or 365, the claimed
`
`invention must be disclosed “in the manner provided by [§] 112(a) (other
`
`than the requirement to disclose the best mode)” in the earlier application.
`
`See 35 U.S.C. §§ 119(e), 120. In other words, to claim the benefit of an
`
`ancestor application, the claimed invention must have adequate written
`
`description support and be enabled in an ancestor application filed before
`
`March 16, 2013.
`
`The test for written description support is “whether the disclosure of
`
`the application relied upon reasonably conveys to those skilled in the art that
`
`the inventor had possession of the claimed subject matter as of the filing
`
`date” based on an “objective inquiry into the four corners of the
`
`specification.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
`
`(Fed. Cir. 2010) (en banc). The written description requirement is satisfied
`
`when the specification “set[s] forth enough detail to allow a person of
`
`ordinary skill in the art to understand what is claimed and to recognize that
`
`14
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`PGR2021-00114
`Patent 11,096,346 B2
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`the inventor invented what is claimed.” Univ. of Rochester v. G.D. Searle &
`
`Co., 358 F.3d 916, 928 (Fed. Cir. 2004).
`
`The specification does not have to provide exact or verbatim textual
`
`support for the claimed subject matter at issue. Fujikawa v. Wattanasin,
`
`93 F.3d 1559, 1570 (Fed. Cir. 1996). Moreover, “the written description
`
`requirement does not demand either examples or an actual reduction to
`
`practice.” Ariad Pharms., 598 F.3d at 1352. “[A]n applicant is not required
`
`to describe in the specification every conceivable and possible future
`
`embodiment of his invention.” Cordis Corp. v. Medtronic AVE, Inc., 339
`
`F.3d 1352, 1365 (Fed. Cir. 2003). Furthermore, “[a] specification may . . .
`
`contain a written description of a broadly claimed invention without
`
`describing all species that [the] claim encompasses.” Id. (second alteration
`
`in original).
`
`Finally, the written description inquiry is a question of fact, is context
`
`specific, and must be determined on a case-by-case basis. Ariad Pharms.,
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`598 F.3d at 1351 (citing Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d
`
`1570, 1575 (Fed. Cir. 1985); Capon v. Eshhar, 418 F.3d 1349, 1357–1358
`
`(Fed. Cir. 2005)). “[T]he level of detail required to satisfy the written
`
`description requirement varies depending on the nature and scope of the
`
`claims and on the complexity and predictability of the relevant technology.”
`
`Id. (citing Capon, 418 F.3d at 1357–1358). Factors used to evaluate the
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`sufficiency of a disclosure include: 1) “the existing knowledge in the
`
`particular field”; 2) “the extent and content of the prior art”; 3) “the maturity
`
`of the science or technology”; and 4) “the predictability of the aspect at
`
`issue.” Id. (citing Capon, 418 F.3d at 1359).
`
`“Patent claims are awarded priority on a claim-by-claim basis based
`
`on the disclosure in the priority applications.” Lucent Techs., Inc., v.
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`15
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`PGR2021-00114
`Patent 11,096,346 B2
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`Gateway, Inc., 543 F.3d 710, 718 (Fed. Cir. 2008). We therefore must
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`address whether the challenged claims have written description support in
`
`the Mankin Line of the ’346 patent family to determine if the ’346 patent
`
`contains, or contained at any time, a claim having an effective filing date
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`that is on or after March 16, 2013. See AIA § 3(n)(1).
`
`C. Written Description Support in Mankin
`
`The ’346 patent issued from the ’714 Application, filed on February
`
`27, 2017, which is a continuation of the ’832 Application, filed on December
`
`30, 2016, which is a continuation-in-part of U.S. Application No.
`
`15/156,671 (“the ’671 Application”), filed on May 17, 2016, which is a
`
`continuation of the ’780 Application, filed as the Mankin PCT on September
`
`1, 2010. Ex. 1001, codes (21), (63).
`
`Claim 1 of the ’346 patent recites, in relevant part:
`
`(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 aryloxyphenoxy-
`propanoate 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.
`
`Ex. 1001, 270:57–271:5 (emphases added).10 Thus, the ’346 patent
`
`
`
`10 In our Institution Decision, we referred to the above limitations
`collectively as the “‘effective amount’ limitation.” Dec. Inst. 13–14. In
`light of our separate construction of the term “effective amount” above, we
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`16
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`Patent 11,096,346 B2
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`claims recite two limitations that are relevant to our analysis:
`
`(1) applying a specific range of effective amounts of quizalofop
`(i.e., “the range limitation”); and
`
`(2) the effective amount of quizalofop causes less than 10%
`injury to the mutant plants (i.e., “the ‘less than 10% injury’
`limitation”).
`
`Because it is dispositive of the issue, we focus on whether the Mankin
`
`Application describes these two limitations of the ’346 patent claims.
`
`1.
`
`Overview of the Mankin Application (Ex. 203411)
`
`The Mankin Application describes herbicide-tolerant plants and
`
`methods for controlling the growth of weeds by applying an herbicide
`
`to which the herbicide-tolerant plants are tolerant. Ex. 2034, Abstract.
`
`Mankin describes rice plants that express a mutant ACCase. Id. ¶ 7.
`
`Mankin provides 22 ACCase amino acid positions where the
`
`herbicide-tolerant plant differs from a wild-type plant, including
`
`1,781 (Am), 2,027 (Am), and 2,096 (Am). Id. Specifically, the
`
`Mankin Application states, among other mutations, that the amino
`
`acid at 1,781 (Am) is leucine, threonine, valine, or alanine; at 2,027
`
`(Am) is cysteine; and at 2,096 (Am) is alanine or serine. Id. ¶ 9.
`
`Mankin further states “[i]n a most preferred embodiment, [ACCase]
`
`enzymes of the invention will have only one of the following
`
`substitutions: a leucine at position 1,781 (Am), . . . a cysteine or
`
`
`
`recognize that referring to the above limitations collectively as the
`“‘effective amount’ limitation” may be confusing. Accordingly, we consider
`the limitations separately in our analysis below.
`
`11 Petitioner cites Exhibit 1013, which is the ’780 Application and is
`substantively the same as Exhibit 2034.
`
`17
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`PGR2021-00114
`Patent 11,096,346 B2
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`arginine at position 2,027 (Am), . . . and a serine at position 2,096
`
`(Am).” Id. ¶ 152.
`
`The Mankin Application also describes methods for controlling
`
`growth of weeds in vicinity to rice plants, comprising applying
`
`herbicides to the weeds and rice plants at levels of herbicide that
`
`would normally inhibit the growth of a rice plant. Id. ¶ 12. But
`
`because the rice plants comprise mutant ACCase activity, the rice
`
`plants are tolerant to the applied amount of herbicide. Id.
`
`Mankin states that any herbicide that inhibits ACCase activity
`
`can be used with the plants of the invention. Id. ¶ 218. Table 1 of the
`
`Mankin Application provides a list of examples of DIM and FOP
`
`herbicides that can be used with the herbicide-tolerant plants of the
`
`invention. Id. ¶ 219. Table 1 is reproduced below and annotated by
`
`highlighting the quizalofop-p-ethyl herbicide claimed in the ’346
`
`patent:
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`18
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`Patent 11,096,346 B2
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`
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`Ex. 2034 ¶ 219. Table 1 of Mankin identifies a list of FOP and DIM
`
`herbicides and their trade names that can be used with the described
`
`herbicide-tolerant plants. We have highlighted quizalofop-P-ethyl in
`
`Table 1, as that FOP herbicide is recited in the ’346 patent claims.
`
`Mankin states the herbicidal compositions of the invention
`
`“comprise an herbicidal effective amount of at least one of the
`
`[ACCase]-inhibiting herbicides and potentially other herbicides and/or
`
`safeners and auxiliaries which are customary for the formulation of
`
`crop protection agents.” Id. ¶ 233. Mankin states the herbicide may
`
`be applied to a plot at a concentration sufficient to kill or inhibit the
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`PGR2021-00114
`Patent 11,096,346 B2
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`growth of the weed. Mankin further states that “[c]oncentrations of
`
`herbicide sufficient to kill or inhibit the growth of weeds are known in
`
`the art.” Id. ¶ 250.
`
`Example 5 of Mankin describes a “[d]emonstration of
`
`herbicide-tolerance.” Id. ¶ 289. Selected mutants were transferred to
`
`small pots and, three weeks later, were sprayed with cycloxydim. Id.
`
`¶¶ 290–291. After the plants had adapted to greenhouse conditions, a
`
`subset was sprayed with 800 g AI/Ha cycloxydim. Id. ¶ 291. Sprayed
`
`plants were rated for herbicide injury at one and two weeks after
`
`treatment. Id. Mankin states that “[n]o injury was observed on plants
`
`containing the I1,781(Am)L heterozygous mutation, while control
`
`plants . . . were heavily damaged.” Id. Figure 17, reproduced below,
`
`provides a graph showing results for mutant rice versus various
`
`ACCase inhibitors:
`
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`PGR2021-00114
`Patent 11,096,346 B2
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`Figure 17 of Mankin shows the results of herbicide-tolerance studies
`
`of I1781L mutant rice, wild type rice, and red weedy rice against
`
`various FOP and DIM herbicides in various amounts, including 56 g
`
`AI/Ha clodinafop-propargyl, 840 g AI/Ha diclofop-methyl, and 175 g
`
`AI/Ha fluazifop-P-butyl.12
`
`2.
`
`Petitioner’s Contentions
`
`Petitioner asserts that the challenged claims of the ’346 patent are
`
`only entitled to an effective filing date of its application, i.e., February 27,
`
`2017, and are thus subject to post-grant review. Pet. 28–29. Specifically,
`
`Petitioner asserts that the ’346 patent is not entitled to claim priority to the
`
`Mankin line of applications.13 Id. at 34–41.
`
`Petitioner asserts that the Mankin Application fails to describe the
`
`range limitation and the “less than 10% injury” limitation for any of the
`
`recited herbicides. Pet. 40–43. Petitioner notes the Mankin Application
`
`only mentions quizalofop three times: to state quizalofop is a “fops”
`
`herbicide, to identify quizalofop as a commercially available ACCase
`
`inhibitor herbicide, and to state that quizalofop has isomers. Id. at 40; Ex.
`
`1002 ¶ 91 (citing Ex. 1013 ¶¶ 128, 237 (Table 1), 248). According to
`
`Petitioner, this “scant disclosure” of quizalofop in the Mankin Application
`
`“does not demonstrate that the inventors possessed or envisioned treating
`
`post-emergence rice plants containing the G2096S ACCase mutation with
`
`
`
`12 The parties’ experts agree that “iclofop-methyl” and “luazifop-P-butyl” in
`Figure 17 are typographical errors and likely refer to diclofop-methyl and
`fluazifop-P-butyl, respectively. Ex. 1002 ¶¶ 92–93, 95; Ex. 2036 ¶ 68.
`
`13 Petitioner also asserts that the challenged claims are not entitled to claim
`priority to the Neuteboom line. Pet. 42–45. Because Patent Owner no
`lo
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