Trials@uspto.gov
`571.272.7822
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`
`Paper 21
`
` Date: March 11, 2022
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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.
`
`
`
`DECISION
`Granting Institution of Post-Grant Review
`35 U.S.C. § 324
`
`
`
`
`
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`Paper 21
`
` Date: March 11, 2022
`
`
`
`
`
`
`
`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.
`
`
`
`DECISION
`Granting Institution of Post-Grant Review
`35 U.S.C. § 324
`
`
`
`
`
`
`
`
`
`
`
`
`
`PGR2021-00114
`Patent 11,096,346 B2
`
` INTRODUCTION
`RiceTec, Inc. (“Petitioner”) filed a Petition requesting a post-grant
`review of claims 1–17 of U.S. Patent No. 11,096,346 B2 (Ex. 1001, “the
`’346 patent”). Paper 2 (“Pet.”). BASF SE (“Patent Owner”) filed a
`Corrected Preliminary Response. Paper 16 (“Prelim. Resp.”). With our
`authorization, Petitioner filed a Reply to Patent Owner’s Preliminary
`Response (Paper 18, “Reply”), and Patent Owner filed a Sur-Reply (Paper
`20).
`
`We have authority under 35 U.S.C. § 324(a), which provides that a
`post-grant review may not be instituted “unless . . . the information
`presented in the petition . . ., if such information is not rebutted, would
`demonstrate that it is more likely than not that at least 1 of the claims
`challenged in the petition is unpatentable.” Upon considering the arguments
`and evidence presented by the parties, we determine Petitioner has
`demonstrated that it is more likely than not that at least one of the claims
`challenged in the Petition is unpatentable.
`Real Parties-in-Interest
`A.
`In the Petition, Petitioner identifies itself, RiceTec 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. 4. Patent
`Owner identifies itself as the real party-in-interest. Paper 6, 1.
`Related Proceedings
`B.
`Petitioner states that they are unaware of any related matters. Pet. 4.
`Patent Owner identifies PGR2021-00113, involving U.S. Patent No.
`11,096,345, as related to the ’346 patent. Paper 6, 1.
`
`2
`
`
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`PGR2021-00114
`Patent 11,096,346 B2
`
`The ’346 Patent
`C.
`The ’346 patent “generally relates to treatment of domestic rice crop
`plants for the control of weeds.” Ex. 1001, 1:27–28. According to the
`specification, domestic rice tolerant to imidazolinone herbicides have been
`developed, but imidazolinone herbicide-tolerant red rice and weeds have
`emerged. Id. at 1:49–56.
`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 active ingredients: aryloxyphenoxypropanoates
`(“FOPs”), cyclohexanediones (“DIMs”), and phenylpyrazolines (“DENs”).
`Id. at 1:65–2:3. ACCase-inhibitor-tolerance (“AIT”) mutations that are
`tolerant toward DIM and FOP herbicides have been found in monocot weed
`species and maize. Id. at 2:4–6. 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 specification explains, however, that “[i]n some cases, herbicide-
`tolerance-inducing mutations create a severe fitness penalty in the tolerant
`plant.” Id. at 2:15–17. The ’346 patent therefore states that “there remains a
`need in the 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
`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 2:24–34. The ’346 patent describes embodiments in which the
`domestic rice crop plant includes and expresses “an endogenous non-
`transfected mutant ACCase nucleic acid whose sequence encodes a multi-
`
`3
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`PGR2021-00114
`Patent 11,096,346 B2
`functional, plastidic ACCase containing a mutation that causes the ACCase
`to be tolerant to the herbicide.” Id. at 2:37–41. The mutation can be
`selected from I1781L, G2096S, and W2027C. Id. at 2:43–45.
`Illustrative Claim
`D.
`Petitioner challenges claims 1–17 of the ’346 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:
`(i)
`providing
`at
`least
`one ACCase-inhibiting
`aryloxyphenoxypropanoate herbicide selected from the group
`consisting of quizalofop, an ester of quizalofop, an enantiomer
`of quizalofop, and an agriculturally acceptable salt of quizalofop;
`(ii) providing a domestic rice crop plant grown from seed, the
`domestic rice crop plant comprising and expressing an
`endogenous non-transfected mutant ACCase nucleic acid whose
`sequence encodes a multi-functional, plastidic ACCase
`containing a mutation selected from the group consisting of
`I1781L (Am), G2096S (Am), and W2027C (Am) that causes the
`ACCase to be tolerant to the herbicide, the nucleic acid thereby
`providing
`to
`the
`plant
`tolerance
`to
`the
`aryloxyphenoxypropanoate herbicide;
`(iii) applying an effective amount (measured in grams of
`active ingredient per hectare (g AI/Ha)) of the at least one
`aryloxyphenoxypropanoate herbicide to the domestic rice crop
`plant, post-emergence; thereby creating a treated rice plant; and
`(iv) growing the treated rice plant,
`wherein the effective amount of the at least one ACCase
`inhibiting aryloxyphenoxypropanoate herbicide is 14 g AI/Ha1
`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
`
`
`1 “g AI/Ha” refers to grams of active ingredient per hectare.
`4
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`PGR2021-00114
`Patent 11,096,346 B2
`an ester of quizalofop, and
`the
`of
`amount
`wherein
`the
`effective
`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, 269:55–271:5.
`The Asserted Grounds of Unpatentability
`E.
`Petitioner challenges claims 1–17 of the ’346 patent based on the
`grounds set forth in the table below.
`Claims Challenged
`35 U.S.C. §
`1–17
`112
`1–17
`112
`1–17
`102(a)(1)
`5–10
`103
`11, 12
`103
`13, 14
`103
`
`Reference(s)/Basis
`Written Description
`Enablement
`Hinga2
`Hinga, Hinga20133
`Hinga, Anyszka4
`Hinga, Hinga2013, Assure
`II,5 Maneechote6
`Petitioner also relies on the Declaration of Dale Shaner, Ph.D.
`(Ex. 1002). Patent Owner relies on the Declaration of Dr. Nilda Roma-
`Burgos (Ex. 2003).
`Person of Ordinary Skill in the Art
`F.
`Petitioner asserts that a person of ordinary skill in the art “would have
`been a person with a Ph.D. in plant molecular biology, plant physiology,
`
`2 US 2015/0038331 A1, published Feb. 5, 2015 (Ex. 1003).
`3 US 2013/0023416 A1, published Jan. 24, 2013 (Ex. 1004).
`4 The response of snap bean and barnyardgrass (Echinochloa
`crus-galli) on quizalofop-P-tefuryl, 51 Vegetable Crops Research
`Bulletin 95–102 (January 1999) (Ex. 1006).
`5 Assure II label, E. I. du Pont de Nemours and Co. (1999) (Ex. 1005).
`6 Resistance to ACCase-inhibiting herbicides in
`sprangletop (Leptochloa chinensis), 53 Weed Science 290–95
`(May 2005) (Ex. 1007).
`
`5
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`PGR2021-00114
`Patent 11,096,346 B2
`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 “at least a PhD in agriculture, weed
`science, or related discipline with at least five years of research experience
`in the same field.” Prelim. Resp. 20.
`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 person of ordinary skill in the art 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 a doctoral program). On this record, 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 on this record that Dr. Shaner and Dr. Burgos 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. 2003 ¶¶ 5–17.
`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).
`
`6
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`PGR2021-00114
`Patent 11,096,346 B2
`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).
`Petitioner argues that “endogenous non-transfected mutant” should be
`construed to mean:
`(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
`(a)
`it contains herbicide-tolerance mutation(s) produced
`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.
`Pet. 28 (citing Ex. 1001, 7:7–21).
`Petitioner also states that “effective amount” should be construed to
`mean “at least 14 g AI/Ha quizalofop or its equivalent, or any amount that
`causes the specified phytotoxicity (at least 65%) to conventional rice.” Pet.
`28 (citing Ex. 1001, 2:46–49, 6:34–37; Ex. 1016, 392).
`Patent Owner states that it “agrees that the claim terms of the ’346
`Patent should be given their ordinary and customary meaning.” Prelim
`Resp. 20. We interpret Patent Owner’s statement to mean that it agrees with
`Petitioner’s proposed constructions of “endogenous non-transfected mutant”
`and “effective amount.”
`Because Petitioner’s construction of “endogenous non-transfected
`mutant” is consistent with the ’346 patent’s express construction of the term,
`
`7
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`PGR2021-00114
`Patent 11,096,346 B2
`and because Patent Owner agrees with Petitioner’s construction, we apply
`that construction in this proceeding.
`We disagree, however, with Petitioner’s construction of “effective
`amount” to the extent it is inconsistent with the claim language. The ’346
`patent specification states, “As used herein, an ‘effective amount’ refers to
`the amount of an herbicide required to achieve at least about 65%
`phytotoxicity of conventional rice (e.g., red rice) in field applications.”
`Ex. 1001, 6:34–37. But claim 1 also recites, in 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.
`
`Id. at 270:57–271:5.
`Thus, claim 1 requires a specific range for the effective amount of
`quizalofop (i.e., 14 g AI/Ha to 40 g AI/Ha) and a specific result for the
`effective amount beyond the specific phytotoxicity to conventional rice (i.e.,
`less than 10% injury to the treated rice plant). Similarly, claims 4, 6, and 9
`specifically require an effective amount of 14 g AI/Ha. Petitioner’s
`construction, however, suggests that “any amount that causes the specified
`phytotoxicity” would satisfy the claim. Pet. 28. We disagree. Rather, we
`construe the term “effective amount” to mean the recited amount of
`quizalofop or its equivalent that causes the specified phytotoxicity (at least
`
`8
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`PGR2021-00114
`Patent 11,096,346 B2
`65%) to conventional rice and causes less than 10% injury to the treated rice
`plant in field applications.
`We determine it is unnecessary to expressly construe any other claim
`terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem.
`Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be
`construed ‘to the extent necessary to resolve the controversy.’” (quoting
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`1999))).
`
` ELIGIBILITY FOR POST-GRANT REVIEW
`We must first determine whether the ’346 patent is eligible 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).
`The ’346 patent issued on August 24, 2021, which is the day the
`Petition was filed. Ex. 1001, code (45); Pet. 85. Thus, the petition was filed
`
`9
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`PGR2021-00114
`Patent 11,096,346 B2
`less than nine months after the date the patent was granted. Petitioner
`asserts that the ’346 patent is eligible for post-grant review because the
`challenged claims are only entitled to an effective filing date of its actual
`application of February 27, 2017. Ex. 1001, code (22); Pet. 3. Patent Owner
`disagrees and asserts that each of the challenged claims is entitled to the
`benefit of the filing dates of two prior related applications that pre-date
`March 16, 2013. Prelim. Resp. 25–79. As explained below, we agree with
`Petitioner that the challenged claims are eligible for post-grant review.
`Background
`A.
`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”). The ’714 Application also
`claims priority to two patent family lines, the Neuteboom and Mankin
`families. The patent family tree provided by the parties and annotated by
`Patent Owner is reproduced below:
`
`10
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`PGR2021-00114
`Patent 11,096,346 B2
`
`
`
`Prelim. Resp. 19; Pet. 31.
`The Neuteboom line is shown on the left, with the Neuteboom PCT
`application, filed on November 13, 2012, highlighted in the red box. The
`Mankin line is on the right, with the Mankin PCT application, filed on
`September 1, 2010, highlighted in the blue box. According to Patent Owner,
`the Neuteboom and Mankin PCT applications are “representative of the
`disclosures of all applications within each respective family, as the
`specifications within each family are identical.” Prelim. Resp. 2 n.1.
`
`11
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`Patent 11,096,346 B2
`
`Legal Background
`B.
`To be eligible for post-grant review, Petitioner must show the ’345
`patent is not entitled to claim priority to an application filed before March
`16, 2013. 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, 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 Pharm., 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
`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., 589 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 . . .
`
`12
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`Patent 11,096,346 B2
`contain a written description of a broadly claimed invention without
`describing all species that [the] claim encompasses.” Id.
`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.,
`598 F.3d at 1351 (citing Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d
`1570, 1575; 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 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.
`Gateway, Inc., 543 F.3d 710, 718 (Fed. Cir. 2008) (citations omitted). We
`therefore address whether the challenged claims have written description
`support in both the Mankin Line and the Neuteboom Line of the ’345 patent
`family. Because it is dispositive of the issue, we focus on whether the
`priority applications adequately describe the “effective amount” limitation of
`claim 1, which we consider as a whole (as Patent Owner does):
`(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-
`
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`PGR2021-00114
`Patent 11,096,346 B2
`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.
`Prelim. Resp. 71.
`C. Written Description Support in the Mankin Line
`The ’346 patent issued from the ’714 Application, which is a
`continuation of the ’832 Application, 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 U.S. Application No. 13/393,780 (“the ’780
`Application”), filed as Application No. PCT/US2010/047571 (“the Mankin
`PCT”) on September 1, 2010. Although Petitioner relies on the ’780
`Application and Patent Owner relies on the Mankin PCT to support their
`respective arguments, their disclosures are substantively the same and we
`therefore consider any arguments regarding one application to apply to the
`other. Compare Ex. 1013 (’780 Application) with Ex. 2034 (Mankin PCT).
`To avoid confusion in discussing the parties’ arguments, we refer to both the
`’780 Application and the Mankin PCT as “the Mankin Application.”
`Petitioner asserts the Mankin Application fails to describe the
`“effective amount” limitation for quizalofop. Pet. 40–43. Petitioner’s expert
`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, and to state quizalofop has isomers. 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-
`
`14
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`PGR2021-00114
`Patent 11,096,346 B2
`emergence rice plants containing the G2096S ACCase mutation with the
`specific dose of 14 [g AI/Ha] to 40 g AI/Ha of quizalofop herbicide causing
`less than 10% injury to the rice plant.” Id. at 41.
`Patent Owner argues the Mankin Application teaches applying an
`effective amount of FOP herbicides to domestic rice crops to produce a
`treated rice plant. Prelim. Resp. 72 (citing Ex. 2034 ¶¶ 13, 233). Patent
`Owner asserts the Mankin Application discloses an example of applying an
`effective amount of the DIM herbicide cycloxydim to rice crops. Id. at 72–
`73 (citing Ex. 2034 ¶ 291). Accordingly, Patent Owner claims that a person
`of ordinary skill in the art reading the Mankin Application “would have been
`able to arrive at the specific ranges of quizalofop or an ester of quizalofop,
`or an amount equivalent to such ranges claimed in the ’346 Patent based on
`its knowledge in the art.” Id. at 73. Moreover, Patent Owner argues the
`“effective amount” of an herbicide is a well-known concept to a person of
`ordinary skill in the art, and that person “would have understood that the
`effective ranges of herbicides include those known in the art and indicated
`on the labels.” Id. (citing Ex. 2003 ¶¶ 44–45, 51–54, 60–65). Patent Owner
`further argues “[t]here is no dispute—and neither RiceTec nor Dr. Shaner
`suggest anything to the contrary—that the numerical ranges claimed in the
`’346 patent are in fact ‘effective amounts’ as reflected in the labels for each
`of the claimed FOPs (or otherwise known to a [person of ordinary skill in
`the art]).” Id. at 73–74.
`Patent Owner also asserts that an ordinary artisan’s understanding of
`the effective amount ranges “would not have been critical to the invention of
`the ’346 Patent” and that “it is unimportant what specific ranges of
`herbicides are used, so long as the claimed herbicide effectively kills
`problematic weeds and causes less than 10% herbicide injury to the claimed
`
`15
`
`
`
`PGR2021-00114
`Patent 11,096,346 B2
`ACCase mutant rice plants.” Id. at 74. As such, Patent Owner argues a
`person of ordinary skill in the art “would have understood that the inventors
`of the ’346 Patent had possession of the claimed herbicide ranges without
`explicit disclosure in Mankin.” Id. at 74–75.
`We find Petitioner has shown sufficiently that the “effective amount”
`limitation of each of the challenged claims is not adequately supported by
`the Mankin Application. Although the Mankin Application does generally
`describe herbicidal compositions that “comprise an herbicidal effective
`amount” of at least one ACCase herbicide (Ex. 2034 ¶ 233), that generic
`disclosure is not sufficient written description support for the specific
`effective amount recited in the claims. Indeed, we agree with Petitioner that
`the Mankin Application does not disclose any effective amounts of
`quizalofop within the claimed range, let alone one that causes less than 10%
`injury. See Ex. 1002 ¶¶ 90, 91. 94; Ex. 1013 ¶¶ 128, 237 (Table 1), 248,
`Fig. 17.
`We are not persuaded by Patent Owner’s assertion that written
`description is satisfied because the Mankin Application’s disclosure of an
`herbicide tolerance study for a DIM herbicide would have led a person of
`ordinary skill in the art to the specific effective amount of quizalofop recited
`in the claims. Prelim. Resp. 72–73. Nor are we persuaded that there is
`adequate written description support because a person of ordinary skill in the
`art would have been able to ascertain the effective amounts for quizalofop
`based on the knowledge in the art. Id. at 73. That is not the test for written
`description. “It is not sufficient for purposes of the written description
`requirement of § 112 that the disclosure, when combined with the
`knowledge in the art, would lead one to speculate as to modifications that
`the inventor might have envisioned, but failed to disclose.” Lockwood v.
`
`16
`
`
`
`PGR2021-00114
`Patent 11,096,346 B2
`Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Rather, “[e]ach
`application in the chain must describe the claimed features.” Id.
`We also note that the dose ranges on the quizalofop labels provided in
`Appendix F of Dr. Burgos’s Declaration are not all within the claimed
`effective amount range of 14–40 g AI/Ha. In the chart below, we have
`reproduced the data from Appendix F for the various formulations of
`quizalofop:
`ACCase
`herbicide
`Quizalofop-
`p-ethyl
`
`
`
`Formulation Crop
`
`Targa 0.88
`EC
`
`Assure® II
`0.88 EC
`
`Preplant
`
`
`Broadleaf
`crops
`
`
`
`Provisia 0.88
`EC
`
`Provisia®
`rice
`
`Dose
`(g AI/Ha)
`19.3
`
`38.5
`38–123
`
`100–134
`
`Weed or Crop
`Situation
`3-inch grass
`
`4- to 5-inch grass
`2- to 12-inch seedling
`johnson grass or
`shattercane
`1-leaf rice to panicle
`initiation; 1-4 leaf
`weedy rice, 2-6 leaf
`other grasses
`
`As shown above, the effective dosage range of the Assure II label
`only slightly overlaps with the claimed effective amount range, and the
`effective dose on the Provisia label is much higher. Although Dr. Burgos
`explains that herbicide labels generally have a low range for small weed
`seedlings and a high range for the highest level of control (Ex. 2003 ¶ 63),
`she does not explain the differences between the specific claimed range and
`the various herbicide labels in Appendix F. Moreover, it is unclear whether
`a person of ordinary skill in the art reading an herbicide label would know
`whether that dosage range would result in less than 10% herbicide injury to
`the treated rice plant, as required by the claims. Thus, on this record, we are
`not persuaded that a person of ordinary skill in the art reading the doses on
`
`17
`
`
`
`PGR2021-00114
`Patent 11,096,346 B2
`the quizalofop labels disclosed in Appendix F would have understood the
`inventors were in possession of the “effective amount” limitation of
`quizalofop.
`Finally, we are not persuaded by Patent Owner’s argument that the
`specific claimed effective amount range was not “critical to the invention”
`and “it is unimportant what specific ranges of herbicides are used, so long as
`the claimed herbicide effectively kills problematic weeds and causes less
`than 10% herbicide injury to the claimed ACCase mutant rice plants.”
`Prelim. Resp. 74. We note that Patent Owner amended the original claims to
`add the “effective amount” limitation and then argued that the cited
`references “do[] not teach or suggest applying an effective amount of an
`aryloxyphenoxypropoanoate herbicide that causes less than 10% injury to a
`rice plant in field applications, as claimed.” See Ex. 1016 (Part 2), 420, 426.
`Moreover, Patent Owner admits that “it was the ‘herbicide causes less than
`10% injury to the rice plant in field applications’ limitation . . . that
`distinguished the claims from the prior art and led to allowance.” Sur-Reply
`6 (citing Ex. 1047 (Part 3), 914–21, 1007). As explained above, we consider
`the “less than 10% injury” together with the effective amount of quizalofop
`to constitute the “effective amount” limitation (as Patent Owner does in its
`Preliminary Response, see Prelim. Resp. 71). Thus, on this record, we are
`not persuaded that the “effective amount” limitation is “unimportant.”
`Moreover, Patent Owner cites In re Peters, 723 F.2d 891 (Fed. Cir.
`1983) for the proposition that “no explicit disclosure is required for
`uncritical known elements.” Prelim. Resp. 74–75. We disagree that Peters
`applies to the facts of this case. In Peters, the Board rejected the applicant’s
`broadening reissue claim for lack of support in the original disclosure. The
`applicant sought to broaden the claim by deleting a structural limitation
`
`18
`
`
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`PGR2021-00114
`Patent 11,096,346 B2
`directed to a specific shape disclosed in the specification. The Federal
`Circuit reversed the Board’s decision because it “erroneously confined
`Peters to the specific embodiment disclosed in the original patent.” Id. at
`893. Thus, in Peters, the Federal Circuit found the Board erred by limiting
`the applicant’s broad claims to a specific embodiment in the specification.
`Here, we find the Mankin Application lacks written description support for
`Patent Owner’s narrower limitation that recites a specific range of effective
`amounts of quizalofop. Thus, we find Peters is inapposite.
`We find Los Angeles Biomedical Research Institute at Harbor-UCLA
`Medical Center v. Eli Lilly & Co., 849 F.3d 1049 (Fed. Cir. 2017) to be
`instructive. The patent at issue claimed a method comprising administering
`a drug “at a dosage up to 1.5 mg/kg/day.” Id. at 1054. The Federal Circuit
`found the patent at issue was not entitled to the priority date of an earlier
`provisional application because the provisional application failed to describe
`the required dosage. The patentee argued the provisional’s disclosure of a
`rat study sufficiently described the recited dosage because a person of
`ordinary skill in the art “would be able to calculate the corresponding human
`dosage” according to a conversion method known in the art. Id. at 1057–58.
`The Federal Circuit rejected this argument, stating “proof of priority requires
`written description disclosure in the parent application, not simply
`information and inferences drawn from uncited references.” Id. at 1058.
`Similarly, here, Patent Owner suggests a person of ordinary skill in the art
`could determine the “effective amount” of quizalofop through uncited
`herbicide labels, which is insufficient to satisfy the written description
`requirement.
`Having considered the parties’ respective arguments and evidence
`presented, we find Petitioner has shown sufficiently that the Mankin
`
`19
`
`
`
`PGR2021-00114
`Patent 11,096,346 B2
`Application does
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