Trials@uspto.gov
`571.272.7822
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` Paper 35
`
` Date: March 8, 2023
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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.
`
`PGR2021-00113
`Patent 11,096,345 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)
`
`
`
`
`
`
`
`
`
`
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`I.
`
`INTRODUCTION
`
`RiceTec, Inc. (“Petitioner”) filed a Petition requesting post-grant
`
`review of claims 1–15 of U.S. Patent No. 11,096,345 B2 (Ex. 1001,
`
`“the ’345 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 challenged claims of the ’345 patent. Paper 21 (“Institution Decision”
`
`or “Dec. Inst.”).
`
`After institution, Patent Owner filed a Response (Paper 24, “PO
`
`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
`
`was held in this proceeding and PGR2021-00114 on December 13, 2022,
`
`and a copy of the transcript was entered into the record. Paper 34 (“Tr.”).
`
`We have jurisdiction under 35 U.S.C. § 6, and we issue this Final
`
`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 1–15 of the ’345 patent are
`
`unpatentable.
`
`A.
`
`Real Parties-in-Interest
`
`In the Petition and supplemental mandatory notices, Petitioner
`
`identifies itself, Liechtenstein Group Holding AG, Liechtenstein Group AG,
`
`Agritec Ventures Corporation, and Makhteshim Agan of North America,
`
`Inc. d/b/a ADAMA as the real parties-in-interest to this proceeding. Pet. 5;
`
`Paper 3, 1; Paper 11, 1. Patent Owner identifies itself as the real party-in-
`
`interest. Paper 6, 1.
`
`2
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`B.
`
`Related Proceedings
`
`Petitioner states that it is unaware of any related matters. Pet. 5.
`
`Patent Owner identifies PGR2021-00114 (“-114 PGR”), involving U.S.
`
`Patent No. 11,096,346, as related to this proceeding. Paper 6, 1.
`
`C.
`
`The ’345 Patent
`
`The ’345 patent “generally relates to treatment of domestic rice crop
`
`plants for the control of weeds.” Ex. 1001, 1:24–25. The ’345 patent
`
`explains that Acetyl-Coenzyme A carboxylase (“ACCase”) enzymes are
`
`involved in the fatty acid synthesis pathway in plant chloroplasts. Id. at
`
`1:54–56. ACCase enzymes are inhibited by three classes of herbicidal
`
`active ingredients: aryloxyphenoxypropanoates (“FOPs”),
`
`cyclohexanediones (“DIMs”), and phenylpyrazolines (“DENs”). Id. at 1:62–
`
`67. ACCase-inhibitor-tolerance (“AIT”) mutations that are tolerant toward
`
`DIM and FOP herbicides have been found in monocot weed species and
`
`maize. Id. at 2:1–3. According to the ’345 patent, it would be advantageous
`
`to provide rice that is tolerant to DIMs and FOPs. Id. at 2:8–10. The
`
`Specification explains, however, that “[i]n some cases, herbicide-tolerance-
`
`inducing mutations create a severe fitness penalty in the tolerant plant.” Id.
`
`at 2:12–14. The ’345 patent therefore states that “there remains a need in the
`
`art for an AIT rice that also exhibits no fitness penalty.” Id. at 2:14–16.
`
`The ’345 patent describes a method for treating rice that includes the
`
`steps of providing a domestic rice crop plant and at least one ACCase-
`
`inhibiting FOP herbicide, and applying an effective amount of the herbicide
`
`to the domestic rice crop plant, post-emergence, to create a treated rice plant.
`
`Id. at 2:21–31. The ’345 patent also describes embodiments in which the
`
`domestic rice crop plant includes and expresses “an endogenous non-
`
`transfected ACCase nucleic acid whose sequence encodes a multi-
`
`3
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`functional, plastidic ACCase containing a mutation that causes the ACCase
`
`to be tolerant to the herbicide.” Id. at 2:34–38. The mutation can be
`
`selected from I1781L,1 G2096S,2 and W2027C.3 Id. at 2:40–42.
`
`The ’345 patent describes in Example 8 the results of one study
`
`testing the tolerance of AIT rice sown into a field to various herbicides in
`
`varying amounts. Id. at 69:8–70:13. The results for the AIT rice are shown
`
`in Figure 20B, reproduced below:
`
`
`
`
`
`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 ¶ 37; 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 ¶ 37; 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 ¶ 37; Ex. 2036
`¶ 37.
`
`4
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`Figure 20B depicts the amount of injury to various herbicides applied
`
`at varying rates, including quizalofop-p-ethyl at rates of 35, 70, and
`
`140 g AI/Ha4 and clodinafop-propargyl at rates of 35, 70, and 140 g AI/Ha.
`
`Ex. 1001, Fig. 20B.
`
`D.
`
`Illustrative Claim
`
`Petitioner challenges claims 1–15 of the ’345 patent, of which claim 1
`
`is the only independent claim. Claim 1 is illustrative and is reproduced
`
`below:
`
`1. A method for treating rice, comprising:
`
`(A) providing
`
`(1) a domestic rice crop plant grown from seed, the
`domestic rice crop plant
`
`(a) comprising and expressing an endogenous
`nontransfected 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); and
`
`(b) possessing a phenotype of tolerance to quizalo-
`fop or an ester thereof, fluazifop or an ester thereof,
`clodinafop, clodinafop-propargyl, or diclofop or diclo-
`fop methyl, wherein said plant exhibits less than 10%
`herbicide injury to a field application of
`
`at least 70 g AI/[H]a to 140 g AI/Ha of clodinafop-
`propargyl,
`
`at least 11 g AI/Ha to 34 g AI/Ha of clodinafop,
`
`at least 56 g AI/Ha to 140 g AI/Ha of fluazifop or
`an ester thereof,
`
`
`
`4 “g AI/Ha” refers to grams of active ingredient per hectare.
`
`5
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`at least 14 g AI/Ha to 140 g AI/Ha of quizalofop or
`an ester thereof,
`
`or at least 226 g AI/Ha to 540 g AI/Ha of diclofop
`or diclofop-methyl;5 and
`
`(2) at least one ACCase-inhibiting aryloxyphenoxy-
`propanoate herbicide comprising quizalofop or an ester
`thereof, fluazifop or an ester thereof, clodinafop, clodinafop-
`propargyl, diclofop, or diclofop-methyl;
`
`(B) 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
`
`(C) growing the treated rice plant;
`
`wherein the effective amount of the at least one ACCase-
`inhibiting aryloxyphenoxy-propanoate herbicide is
`
`at least 70 g AI/Ha to 140 g AI/Ha of clodinafop-propargyl,
`
`at least 11 g AI/Ha to 34 g AI/Ha of clodinafop,
`
`at least 56 g AI/Ha to 140 g AI/Ha of fluazifop or an ester
`thereof,
`
`at least 14 g AI/Ha to 140 g AI/Ha of quizalofop or an ester
`thereof,
`
`or at least 226 g AI/Ha to 540 g AI/Ha of diclofop or diclofop-
`methyl.
`
`Ex. 1001, 271:2–41.
`
`Dependent claim 2 further recites harvesting seed from the treated rice
`
`plant; dependent claims 3–10 further recite a specific FOP herbicide;
`
`dependent claims 11–14 further recite specific weeds that are killed by the
`
`
`
`5 We have altered the formatting of the original claims to improve the
`readability of the various dosage ranges for each herbicide.
`
`6
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`herbicide; and dependent claim 15 further recites providing the FOP
`
`herbicide in the absence of safeners. Id. at 272:1–40.
`
`E.
`
`The Asserted Grounds of Unpatentability
`
`Petitioner challenges claims 1–15 of the ’345 patent based on the
`
`grounds set forth in the table below.
`
`Claim(s) Challenged
`1–15
`1–15
`1–3, 7, 11–15
`
`35 U.S.C. §
`112
`112
`102(a)(1)
`
`11, 12
`
`13, 14
`
`103
`
`103
`
`Reference(s)/Basis
`Written Description
`Enablement
`Hinga6 or Hinga20137
`Hinga or Hinga2013,
`Anyszka8
`Hinga, Hinga2013, Assure
`II,9 Maneechote10
`
`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
`
`type of problems encountered in the art, the prior art solutions to those
`
`
`
`6 US 2015/0038331 A1, published Feb. 5, 2015 (“Hinga,” Ex. 1003).
`
`7 US 2013/0023416 A1, published Jan. 24, 2013 (“Hinga2013,” Ex. 1004).
`
`8 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).
`
`9 Assure II label, E. I. du Pont de Nemours and Co. (1999) (“Assure II,”
`Ex. 1005).
`
`10 C. Maneechote et al., Resistance to ACCase-inhibiting Herbicides in
`Sprangletop (Leptochloa chinensis), 53 WEED SCIENCE 290–95 (2005)
`(“Maneechote,” Ex. 1007).
`
`7
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
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`problems, the rapidity with which innovations are made, the sophistication
`
`of the technology, and the educational level of active workers in the field.
`
`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.
`
`As explained in our Institution Decision (Dec. Inst. 6–7), we do not
`
`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
`
`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
`
`8
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`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
`
`Ex. 1002 ¶¶ 5–15; 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.”).
`
`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.,
`
`200 F.3d 795, 803 (Fed. Cir. 1999)).
`
`In our Institution Decision, we construed the term “endogenous non-
`
`transfected mutant” consistently with the ’345 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
`
`9
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`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`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, 7:1–16).
`
`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.” In PGR2021-00114, we construed
`
`the term to mean “the recited amount of quizalofop or its equivalent that
`
`causes the specified phytotoxicity (at least 65%) to conventional rice and
`
`causes less than 10% injury to the treated rice plant in field applications.”11
`
`See -114 PGR, Paper 21 (Dec. Inst.) 8–9.
`
`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
`
`
`
`11 Because neither party raised the claim construction issue in their pre-
`institution papers, we did not expressly construe the term “effective amount”
`in our Institution Decision in this proceeding. We made clear, however, that
`we considered the 10% injury limitation to be part of the “effective amount”
`limitation, as we considered those limitations together and “refer[red] to
`[them] collectively as the ‘effective amount’ limitation.” Dec. Inst. 12–13.
`Patent Owner understood that we construed the term consistently in this
`proceeding. PO Resp. 11 (stating Patent Owner “presumes the Board
`intended to construe the term ‘effective amount’ in the ’345 Patent to have
`the same meaning as in the ’346 Patent”).
`
`10
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`65% phytotoxicity of conventional [i.e., wild, non-mutant] rice (e.g., red
`
`rice) in field applications.” PO Resp. 11 (quoting Ex. 1001, 6:28–31).
`
`Because the inventors served as their own lexicographers, Patent Owner
`
`asserts the Specification’s express definition controls. Id. (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 ’345 Patent claims.” Id. at 11–12.
`
`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
`
`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 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.
`
`11
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`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`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-
`
`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. 8–22. The ’345 patent issued
`
`on August 24, 2021, which is the day the Petition was filed. Ex. 1001, code
`
`(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 ’345 patent claims.
`
`Petitioner asserts—and we agreed—that the ’345 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 December 30, 2016. 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. 12–
`
`12
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`64. 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 ’345 patent issued from U.S. Application No. 15/395,832 (“the
`
`’832 Application”), filed on December 30, 2016. Ex. 1001, codes (21), (22).
`
`The ’832 Application claims priority to two patent family lines, the
`
`Neuteboom and Mankin families. The annotated patent family tree provided
`
`by the parties is reproduced below:
`
`Dec. Inst. 10.
`
`
`
`13
`
`

`

`PGR2021-00113
`Patent 11,096,345 B2
`
`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
`
`highlighted in the blue box. Although Patent Owner relied on both lines
`
`before our Institution Decision, Patent Owner now relies solely on the
`
`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 ’345
`
`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
`
`14
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`

`

`PGR2021-00113
`Patent 11,096,345 B2
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`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
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`specification.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
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`(Fed. Cir. 2010) (en banc). The written description requirement is satisfied
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`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
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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
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`support for the claimed subject matter at issue. Fujikawa v. Wattanasin,
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`93 F.3d 1559, 1570 (Fed. Cir. 1996). Moreover, “the written description
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`requirement does not demand either examples or an actual reduction to
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`practice.” Ariad Pharms., 598 F.3d at 1352. “[A]n applicant is not required
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`to describe in the specification every conceivable and possible future
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`embodiment of his invention.” Cordis Corp. v. Medtronic AVE, Inc., 339
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`F.3d 1352, 1365 (Fed. Cir. 2003). Furthermore, “[a] specification may . . .
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`contain a written description of a broadly claimed invention without
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`describing all species that [the] claim encompasses.” Id. (second alteration
`
`in original).
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`Finally, the written description inquiry is a question of fact, is context
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`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
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`1570, 1575 (Fed. Cir. 1985); Capon v. Eshhar, 418 F.3d 1349, 1357–1358
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`Patent 11,096,345 B2
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`(Fed. Cir. 2005)). “[T]he level of detail required to satisfy the written
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`description requirement varies depending on the nature and scope of the
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`claims and on the complexity and predictability of the relevant technology.”
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`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
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`particular field”; 2) “the extent and content of the prior art”; 3) “the maturity
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`of the science or technology”; and 4) “the predictability of the aspect at
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`issue.” Id. (citing Capon, 418 F.3d at 1359).
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`“Patent claims are awarded priority on a claim-by-claim basis based
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`on the disclosure in the priority applications.” Lucent Techs., Inc., v.
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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
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`the Mankin Line of the ’345 patent family to determine if the ’345 patent
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`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).
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`C. Written Description Support in Mankin
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`The ’345 patent issued from the ’832 Application, filed on December
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`30, 2016, which is a continuation-in-part of U.S. Application No.
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`15/156,671 (“the ’671 Application”), filed on May 17, 2016, which is a
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`continuation of the ’780 Application, filed as the Mankin PCT on September
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`1, 2010. Ex. 1001, codes (21), (63).
`
`Claim 1 of the ’345 patent recites, in relevant part:
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`wherein said plant exhibits less than 10% herbicide
`injury to a field application of at least 70 g AI/[H]a to
`140 g AI/Ha of clodinafop-propargyl, at least 11 g
`AI/Ha to 34 g AI/Ha of clodinafop, at least 56 g AI/Ha
`to 140 g AI/Ha of fluazifop or an ester thereof, at least
`14 g AI/Ha to 140 g AI/Ha of quizalofop or an ester
`thereof, or at least 226 g AI/Ha to 540 g AI/Ha of
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`diclofop or diclofop-methyl; and;
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`* * *
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`(B) 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;
`
`* * *
`
`wherein the effective amount of the at least one ACCase-
`inhibiting aryloxyphenoxy-propanoate herbicide is at least 70
`g AI/Ha to 140 g AI/Ha of clodinafop-propargyl, at least 11 g
`AI/Ha to 34 g AI/Ha of clodinafop, at least 56 g AI/Ha to 140
`g AI/Ha of fluazifop or an ester thereof, at least 14 g AI/Ha to
`140 g AI/Ha of quizalofop or an ester thereof, or at least 226 g
`AI/Ha to 540 g AI/Ha of diclofop or diclofop-methyl.
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`Ex. 1001, 271:15–23, 28–32, 34–41 (emphases added).12 Thus, the
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`’345 patent claims recite two limitations that are relevant to our
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`analysis:
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`(1) applying specific ranges of effective amounts of the claimed
`herbicides (i.e., “the range limitation”); and
`
`(2) the effective amounts of herbicide cause “less than 10%
`herbicide injury” to the mutant plants (i.e., “the ‘less than 10%
`injury’ limitation”).
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`Because it is dispositive of the issue, we focus on whether the Mankin
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`Application describes these two limitations of the ’345 patent claims.
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`
`
`12 In our Institution Decision, we referred to the above limitations
`collectively as the “‘effective amount’ limitation.” Dec. Inst. 12–13. In
`light of our separate construction of the term “effective amount” above, we
`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.
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`1.
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`Overview of the Mankin Application (Ex. 203413)
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`The Mankin Application describes herbicide-tolerant plants and
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`methods for controlling the growth of weeds by applying an herbicide
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`to which the herbicide-tolerant plants are tolerant. Ex. 2034, Abstract.
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`Mankin describes rice plants that express a mutant ACCase. Id. ¶ 7.
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`Mankin provides 22 ACCase amino acid positions where the
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`herbicide-tolerant plant differs from a wild-type plant, including
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`1,781 (Am), 2,027 (Am), and 2,096 (Am). Id. Specifically, the
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`Mankin Application states, among other mutations, that the amino
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`acid at 1,781 (Am) is leucine, threonine, valine, or alanine; at 2,027
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`(Am) is cysteine; and at 2,096 (Am) is alanine or serine. Id. ¶ 9.
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`Mankin further states “[i]n a most preferred embodiment, [ACCase]
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`enzymes of the invention will have only one of the following
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`substitutions: a leucine at position 1,781 (Am), . . . a cysteine or
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`arginine at position 2,027 (Am), . . . and a serine at position 2,096
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`(Am).” Id. ¶ 152.
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`The Mankin Application also describes methods for controlling
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`growth of weeds in vicinity to rice plants, comprising applying
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`herbicides to the weeds and rice plants at levels of herbicide that
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`would normally inhibit the growth of a rice plant. Id. ¶ 12. But
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`because the rice plants comprise mutant ACCase activity, the rice
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`plants are tolerant to the applied amount of herbicide. Id.
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`Mankin states that any herbicide that inhibits ACCase activity
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`can be used with the plants of the invention. Id. ¶ 218. Table 1 of the
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`
`
`13 Petitioner cites Exhibit 1013, which is the ’780 Application and is
`substantively the same as Exhibit 2034.
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`Mankin Application provides a list of examples of DIM and FOP
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`herbicides that can be used with the herbicide-tolerant plants of the
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`invention. Id. ¶ 219. Table 1 is reproduced below and annotated by
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`highlighting some of the FOP herbicides claimed in the ’345 patent:
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`Ex. 2034 ¶ 219. Table 1 of Mankin identifies a list of FOP and DIM
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`herbicides and their trade names that can be used with the described
`
`herbicide-tolerant plants. We have highlighted clodinafop-propargyl,
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`diclofop-methyl, fluazifop-P-butyl, and quizalofop-P-ethyl in Table 1,
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`as those FOP herbicides are recited in the ’345 patent claims.
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`Mankin states the herbicidal compositions of the invention
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`“comprise an herbicidal effective amount of at least one of the
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`[ACCase]-inhibiting herbicides and potentially other herbicides and/or
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`safeners and auxiliaries which are customary for the formulation of
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`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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`growth of the weed. Mankin further states that “[c]oncentrations of
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`herbicide sufficient to kill or inhibit the growth of weeds are known in
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`the art.” Id. ¶ 250.
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`Example 5 of Mankin describes a “[d]emonstration of
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`herbicide-tolerance.” Id. ¶ 289. Selected mutants were transferred to
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`small pots and, three weeks later, were sprayed with cycloxydim. Id.
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`¶¶ 290–291. After the plants had adapted to greenhouse conditions, a
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`subset was sprayed with 800 g AI/Ha cycloxydim. Id. ¶ 291. Sprayed
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`plants were rated for herbicide injury at one and two weeks after
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`treatment. Id. Mankin states that “[n]o injury was observed on plants
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`containing the I1,781(Am)L heterozygous mutation, while control
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`plants . . . were heavily damaged.” Id. Figure 17, reproduced and
`
`annotated below, provides a graph showing results for mutant rice
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`versus various ACCase inhibitors:
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`
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`Figure 17 of Mankin shows the results of herbicide-tolerance studies
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`of I1781L mutant rice, wild type rice, and red weedy rice against
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`various FOP and DIM herbicides in various amounts. We have
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`annotated in red boxes those herbicides claimed in the ’345 patent
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`(albeit claimed in different effective amounts): 56 g AI/Ha
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`clodinafop-propargyl, 840 g AI/Ha diclofop-methyl, and 175 g AI/Ha
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`fluazifop-P-butyl.14
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`2.
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`Petitioner’s Contentions
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`Petitioner asserts that the challenged claims of the ’345 patent are
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`only entitled to an effective filing date of its application, i.e., December