DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/9/2026 has been entered.
Claims 1-2, 5-10 and 13-24 are pending. Claims 1 and 17 are amended.
Response to Amendment
The rejection of claims 1-2, 5-6, 9, and 13-21, and 23 under 35 U.S.C. 102 (a)(1) over Hinga (US9370149B2, published on Jan. 24, 2013, priority filing date Sep. 30, 2011), is withdrawn in view of amendment to the claims removing G2096S mutation.
The rejection of claims 1-2, 5, 7, 9, and 17-24, under 35 U.S.C. 103 is withdrawn in view of amendment to the claims.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 13/393,780, filed January 7, 2013; which is a 35 U.S.C. 371 National Stage entry of PCT/US10/47571, filed on September 1, 2010; which claims priority of U.S. Provisional Application Serial Nos. 61/365,298, filed July 16, 2010, and 61/238,906, filed September 1, 2009; or US. Application Serial No. 14/357,691, filed on May 12, 2014; which is a 35 U.S.C. 371 National Stage entry of PCT/US 12/64831, filed on November 13, 2012, which claims priority of US. Provisional Application Serial No. 61/559,618, filed on November 14, 2011, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The ‘691 Application discloses mutations in the rice ACCase, such as the I1781L mutation, singularly or in combination with other ACCase mutations. The ‘691 application does not describe any non-transgenic rice plant harboring the I1781L (Am), G2096S (Am), and W2027C (Am)-ACCase and the method of applying 14 grams of active ingredient per hectare (g AI/ha of quizalofop, 56 g AI/Ha offluazifop, or 11 g AI/Ha of clodinafop, or 226 g AI/Ha of diclofop, to a field of such rice plants post-emergence.
The ’780 Application discloses mutant rice plant calli harboring a mutation selected selected from the group consisting of 1,785(Am), 1,786(Am), 1,811(Am), 1,824(Am), 1,864(Am), 2,039(Am), 2,049(Am), 2,059(Am), 2,074(Am), 2,075(Am), 2,078(Am), 2,079(Am), 2,080(Am), 2,081(Am), 2,088(Am), 2,095(Am), and 2,098(Am), wherein the calli showed tolerance to certain amounts of Cycloxidim or Sethoxydim (“DIMs”). However, although the ’780 Application does generally describe herbicidal compositions that “comprise an herbicidal effective amount” of at least one ACCase herbicide, that generic disclosure is not sufficient written description support for the effective amounts of quizalofop or an ester thereof, fluazifop or an ester thereof, clodinafop, or clodinafop-propargyl, required in practicing the instantly claimed method of field application to rice plant, post-emergence. Indeed, the ’780 Application does not disclose any effective amounts for filed application to mutant rice plants, let alone the less than 10% herbicidal injury (at least regarding claim 10).
Moreover, while the ’780 Appl. recites the G2096S mutation among a list of several dozen other generic potential mutations of combinations of mutations, this list does not convey to one of skill in the art that the inventors actually possessed rice plants from seed that contains the G2096S mutation such that the rice plant is tolerant to quizalofop at the claimed levels and field conditions.
Lastly, the instantly amended claims recite the mutations to be “product of direct mutagenesis” which also lacks priority support from the ‘780 application, which teaches random mutagenesis and selection.
Therefore, it is found that the claims lacks written description support in any parent application filed before 2013, especially regarding G2096S mutation. Hence, the effective filing date of the claims is deemed to remain being December 30, 2016, (filing date for US. Application Serial No. 15/395,832) for the purpose of applying prior art.
Response to Applicant’s Remarks:
Applicant argued that Paragraph 108 of US2013/0111618-the publication of the '780 application-positively recites that one type of mutagenesis is "directed mutagenesis." The MPEP makes clear that "[i]f alternative elements are positively recited in the specification, they may be explicitly excluded in the claims." See MPEP § 2173.05(i); see also See Novartis Pharma. Corp. v. Accord Healthcare, Inc., 38 F. 4th 1013, 1016-107 (Fed. Cir. 2022) ("For negative claim limitations... there is adequate written description when, for example, ... the specification 'distinguishes among' the element and alternatives to it. ... The common denominator of these examples is disclosure of the element.") (internal citations omitted). Accordingly, Applicant respectfully submits that the above recitation is supported by the '780 application.
This argument has been fully considered but not deemed persuasive. As Applicant insisted, MPEP makes clear that "[i]f alternative elements are positively recited in the specification, they may be explicitly excluded in the claims." See MPEP § 2173.05(i). However, para. 108 of the ‘780 Application (cited as the ‘618 PGPUB) only mentions “Methods of inducing mutations may induce mutations in random positions in the genetic material or may induce mutations in specific locations in the genetic material (i.e., may be directed mutagenesis techniques).” This does not positively recite all of the alternative elements. Therefore, the argument is not deemed persuasive.
Applicant argued that
First, effective amounts for the recited herbicides are described in the '780 application. See, e.g., US2013/0111618 at 128; 237; 248; 251.
This argument has been fully considered but not deemed persuasive. In ‘618, para.128 does not discuss any effective amount at all. Para. 237 discusses suitable examples of herbicides, e.g., a list provided in Table 1 therein. Para. 248 discusses that those skilled in the art will recognize that some of the above mentioned herbicides and/or safeners are capable of forming geometrical isomers; Para. 251 simply reads that the “herbicidal compositions comprise an herbicidal effective amount of at least one of the acetyl-Coenzyme A carboxylase-inhibiting herbicides and potentially other herbicides and/or safeners and auxiliaries which are customary for the formulation of crop protection agents.” There is no teaching –in the cited parts--of the effective amount for post-emergence treatment of the mutant rice plants as claimed.
Second, the examples of the '780 application show transgenic calli from rice with I1781L and W2027C having resistance to both cycloxydim and tepraloxydim, in addition to haloxyfop, and thus herbicide resistance is shown both for DIMs and FOPs. See US2013/0111618 at 306, Table 6.
This argument has been fully considered but not deemed persuasive. It is not always reliably predictable to determine the field rate of tolerance based on performance of tolerant calli. For example, Parker et al taught that while a maize tissue culture showed >40x tolerance to sethoxydim, the regenerated maize plants only showed up to 2x tolerance. (Parker, William B., et al. "Dominant mutations causing alterations in acetyl-coenzyme A carboxylase confer tolerance to cyclohexanedione and aryloxyphenoxypropionate herbicides in maize." Proceedings of the National Academy of Sciences 87.18 (1990): 7175-7179). Moreover, the alleged examples from the ‘780 application, as Applicant admitted, are from “transgenic calli”—while the instant claims are drawn to “domestic” rice “free of transfection products”. Thus, the resistance data of transgenic calli does not necessarily provide the priority basis for the effective amount for post-emergence treatment of the mutant rice plants as claimed.
Third, the Asher declaration (submitted July 18, 2025) refers to, inter alia, clodinafop, quizalofop and fluazifop and specifically addresses effective amounts of the herbicides recited in the claims. The Asher declaration confirms that the claim language is supported in the application as originally filed (and the '780 application).
This argument has been fully considered but not deemed persuasive. For starters, Asher Declaration listed, under quizalofop for rice, as “none”. Therefore, at least for quizalofop, --or fluazifop, -- Applicant’s testimony states that there is no support for the effective amount for post-emergence treatment of the mutant rice plants as claimed from the ordinary skills in the art.
Therefore, at least for these reasons, the position regarding priority is maintained.
Previously, applicant argued that “the purported "claimed levels" are not recited”.
This argument has been fully considered but not deemed persuasive. Applicant claimed an effective amount applied in a specific manner on a specifically modified rice plant. A claimed level is inherent to the claim.
Applicant further argued that the G2096S mutation, the various herbicides recited in the claims, and effective amounts are described in the '780 application; and that, the examples of the '780 application show transgenic calli from rice with I1781L and W2027C having resistance to both cycloxydim and tepraloxydim, in addition to haloxyfop. and thus herbicide resistance is shown both for DIMs and FOPs. Applicant cited as evidence in ‘780 (US2013/0111618) at para 306, Table 6.
This argument has been fully considered but not deemed persuasive. It should be noted that ‘780 at para 306, Table 6 describes transgenic calli, and the instant claims are drawn to “domestic rice crop plant comprises and expresses an endogenous mutant ACCase nucleic acid whose sequence is free of transfection products and products of directed mutagenesis”—i.e., non-transgenic mutant plant. It should also be noted that regarding the transgenic calli, ‘780 has not described the expression control—e.g., promoter—used to express the mutant ACCase gene. It has not been described how the transgenic calli, with the mutant ACCase gene under undescribed expression control, would express the mutant ACCase in the transgenic plant in what level, and how, the transgenic rice plants in field, would tolerate to what levels of the herbicides. ‘780 application has not described those. It is even further from description how the transgenic plant would compare with mutation in the endogenous gene, in the context of the claimed method of post-emergence application in a field, compared with in media selection of transgenic calli.
Applicant also invoked the the Declaration Under 37 C.F.R. 1.132 from Brady Scott Asher, Ph.D. ("Asher Dec." July 18, 2015), which has been addressed in the previous Office Action.
NEW MATTER
Claims 6, 8, and 10, remain rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Neither the instant specification nor the originally filed claims appear to provide support for the concept “the effective amount is the manufacturer's recommended rate” for treating the domestic rice crop plant comprising the mutant ACCase tolerant to the herbicide. As discussed above, the priority filing ‘780 does not provide such support. Moreover, the instant Specification, while listing the herbicides and the manufacturers (e.g., in Table 1), does not provide any direct information regarding the recommended rates for treating rice plants as specified in the claims with the effect as defined in the instant Specification. However, the manufacturers do not provide such recommended rates for treating rice plants as specified in the claims, either, as no searches yielded meaningful information for recommended rates for treating the rice plants as specified in the claims with the effect as defined in the instant Specification.
Thus, such a concept “the effective amount is the manufacturer's recommended rate” for treating the domestic rice crop plant comprising the mutant ACCase tolerant to the herbicide constitutes NEW MATTER. In response to this rejection, Applicant is required to point to support for the concept or to cancel the new matter.
Response to Applicant’s Remarks:
See above under Priority.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 8, and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 6, 8 and 10 are rejected as being indefinite for the recitation of “manufacturer’s recommend rate” because it is not clear which manufacturer, which product, which rate for which application.
Claims 1-2, 5-10 and 17-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims are rejected as being indefinite for the recitation of “effective amount”. It is not clear what these amounts are, and the standard by which the effectiveness is determined. For example, it is not clear if the amount is meant to be effective as long as a weed (target) species is controlled of whether the non-target crops have to be free of damage or to an unspecified degree of damage. Moreover, it is not clear if the effective amount is the amount the phenotypically distinguishes the wild type rice from the rice plants harboring the claimed mutations. The Specification under different occasions gives differing amounts. It is not clear what the recited “effective amount” in the claims are alluring to.
Double Patenting-Nonstatutory
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 5-6, and 13-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 of US Patent No. US10694694B2 (reference Patent). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are drawn to a method for treating rice, comprising: providing a domestic rice crop plant and at least one AOPP herbicide is quizalofop or an ester of quizalofop; (ii) applying an effective amount of the at least one AOPP herbicide to the domestic rice crop plant, post-emergence; thereby creating a treated rice plant; and (iii) growing the treated rice plant, wherein the effective amount of the at least one AOPP herbicide is at least 14 g AI/Ha to of quizalofop or an ester of quizalofop; harvesting seed from the treated rice plant;
wherein the domestic rice crop plant comprises and expresses an endogenous non-transfected mutant ACCase tolerant to the herbicide, the mutation selected from the group consisting of I1781L (Am), and W2027C (Am).
The patented claims are drawn to a method for treating rice, comprising: providing a domestic rice crop plant and at least one AOPP herbicide selected from the group consisting of quizalofop, an ester of quizalofop, an enantiomer of quizalofop, and an agriculturally acceptable salt of quizalofop; (ii) applying an effective amount (measured in grams of active ingredient per hectare (g AI/Ha)) of the at least one AOPP herbicide to the domestic rice crop plant, post-emergence; thereby creating a treated rice plant; and (iii) growing the treated rice plant, wherein the effective amount of the at least one AOPP herbicide is 70 g AI/Ha to 140 g AI/Ha of quizalofop-P-ethyl, or an amount equivalent to 70 g AI/Ha to 140 g AI/Ha of quizalofop-P-ethyl; harvesting seed from the treated rice plant;
wherein the domestic rice crop plant comprises and expresses an endogenous non-transfected mutant ACCase tolerant to the herbicide, the mutation selected from the group consisting of I1781L (Am), and W2027C (Am).
The difference is that the instant claims encompass a range of quizalofop or its equivalent ester or salt of at least 14 g AI/Ha, while the copending claims encompass the range of 70 to 140 g AI/Ha. The copending claims are considered a subspecies of the instantly claimed genus.
Although the Patented claims do not explicitly recite dusting or a protective colloid component in the formulation, such are either obvious (e.g., “The herbicide compositions can be applied by any means known in the art, including, for example, spraying, atomizing, dusting, spreading, watering, seed treatment, or co-planting in admixture with the seed.” ‘694 Patent at Col. 51) or customary (Col. 55).
Therefore, although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-2, 5-6, and 13-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US Patent No. US11096346B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patented claims are drawn to a method for treating rice, comprising: providing a domestic rice crop plant and at least one AOPP herbicide selected from the group consisting of quizalofop, an ester of quizalofop, an enantiomer of quizalofop, and a suitable salt of quizalofop; (ii) applying an effective amount (measured in grams of active ingredient per hectare (g AI/Ha)) of the at least one AOPP herbicide to the domestic rice crop plant, post-emergence; thereby creating a treated rice plant; and (iii) growing the treated rice plant; wherein the effective amount of the at least one AOPP herbicide is at least 14 g AI/Ha to of quizalofop or an ester of quizalofop harvesting seed from the treated rice plant;
wherein the domestic rice crop plant comprises and expresses an endogenous non-transfected mutant ACCase tolerant to the herbicide, the mutation selected from the group consisting of I1781L (Am), G2096S (Am), and W2027C (Am).
The difference is that the instant claims encompass a range of quizalofop or its equivalent ester or salt of at least 14 g AI/Ha, while the patented claims encompass the range of 70 to 140 g AI/Ha. The patented claims are considered a subspecies of the instantly claimed genus.
Therefore, although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-2, 5, 7, 9, 11, and 24, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40, 42, 45, 46, 48-49 and 54 of copending Application No. 15/428,248 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are summarized supra.
The copending claims are drawn to a method for controlling weeds in the vicinity of a rice plant, said method comprising: a) providing a rice plant comprising a mutagenized rice ACCase W2027C(Am) mutant with increased tolerance to an ACCase inhibiting herbicide and b) contacting said rice plant (i.e. post emergence) with an ACCase-inhibiting herbicide; wherein said herbicide is an AOPP herbicide, such as clodinafop, diclofop, fluazifop, fluazifop-P, haloxyfop, haloxyfop-P, isoxapyrifop, quizalofop, quizalofop-P, quizalofop-P-tefuryl, wherein the weeds are controlled (i.e. effective amount).
Although the copending method is a method of “weed control” in comparison with the instantly claimed method of “treating rice”, these two methods sahre patentably indistinguishable steps of treating post emergence rice plant comprising the W2027C mutant ACCase with the same herbicides. Growing and harvesting are also inherent components of the agricultural activity involving rice.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 5-10, 13-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US Patent No. US12048281B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patented claims are drawn to method for treating rice, comprising applying an effective amount of aryloxyphenoxypropanoate herbicide to a domestic rice crop plant comprising an endogenous non-transfected mutant ACCase containing an I1781(Am)L substitution conferring tolerance to quizalofop or an ester thereof, wherein said plant exhibits less than 10% herbicide injury to a field application of at least 14 to 140 g AI/ha of quizalofop or an ester thereof, and harvesting seed from the treated rice plant.
Conclusion
No claims are allowed.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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