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 .
This is a Final Office Action in response to Amendment filed on March 11, 2026.
Claims 1-2, 5-10 and 13-24 remain pending. NO claim amendment is entered.
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:
In the most recent Remarks, 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.
Therefore, at least for these reasons, the decision regarding the priority date is maintained.
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:
In the most recent Remarks (7/18/2025), Applicant reiterated, that “the recitation of "the effective amount is the manufacturer's recommended rate" and which is supported by the instant application and can be derived from the '780 application by the skilled person.”
This argument has been fully considered previously and not deemed persuasive. To reiterate: The manufacturer’s recommended rates are for treating sensitive weeds and “wild type” rice, not the rice plant having the herbicide tolerant ACCase mutation(s). Applicant has argued that one skilled in the art would not be able to predict the proper rates that the mutant rice plant would tolerate. Therefore, such rates are not enabled in the previous filings.
Therefore, the ‘780 application has not provided enabling teachings of the “effective amount” of quizalofop or an ester thereof, fluazifop or an ester thereof, clodinafop, andclodinafop-propargyl in the claimed methods of applying to rice crop field, post-emergence.
Therefore, at least for these reasons, the rejection is maintained.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-6, 9, and 13-21 remain, and claim 23 is newly, rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Hinga (US9370149B2, published on Jan. 24, 2013, priority filing date Sep. 30, 2011), with evidence from Anyszka (Vegetable crops research bulletin 51 (1999)) and/or Lancaster (International Journal of Agronomy 2018 (2018)).
This rejection is toward the embodiments drawn to the G2096S (Am) ACCase mutant rice plant and method.
Claim 1 is drawn to a method for treating rice, comprising applying an effective amount of AOPP herbicide to a domestic rice crop plant comprising an endogenous non-transfected mutant ACCase having the G2096S (Am) mutation, and wherein the AOPP herbicide is quizalofop or an ester thereof, clodinafop, clodinafop-propargyl, post-emergence; thereby creating a treated rice plant; and growing the resulting treated rice plant.
Claim 2 is drawn to the method of claim 1, further comprising harvesting seed from the treated rice plant.
Claims 5-6 are drawn to the method of Claim 1, wherein the AOPP herbicide is quizalofop or an ester thereof, the effective amount is the manufacturer's recommended rate.
Claims 9-10 are drawn to the method of Claim 1, wherein the AOPP herbicide is clodinafop or clodinafop-propargyl, the effective amount is the manufacturer's recommended rate.
Claims 13-16 are drawn to the method of Claim 1, wherein the effective amount is effective for killing a weed of the genus Echinochloa, e.g., E. crus-galli, or a weed of the genus Leptochloa, e.g., L. chinensis, L. fascicularis, L. panacea, or L. panicoides.
Claim 21 is drawn to the method of claim 1, wherein the AOPP herbicide is in a ready-to-spray aqueous solution, a powder, or a suspension composition.
Claims 17-20 are drawn to a method for treating rice, comprising applying an effective amount of AOPP herbicide to a domestic rice crop plant comprising an endogenous non-transfected mutant ACCase having the G2096S (Am) mutation, and wherein the AOPP herbicide is quizalofop or an ester thereof, clodinafop, clodinafop-propargyl, diclofop, or diclofop-methyl, post-emergence; thereby creating a treated rice plant; and growing the resulting treated rice plant, wherein said effective amount is 0.5x of an amount that causes both at least 90% phytotoxicity in wild type Echinochloa crusgalli and more than 10% phytotoxicity in wild-type Oryza sativa; further comprising harvesting seed from the treated rice plant.
Regarding claim 23, Hinga used the herbicide quizalofop (Assure II®) which inherently has a protective colloid component (e.g., petroleum distillates).
Regarding claims 1, 5-6, 9 and 13-21, Hinga disclosed a method of treating rice (domestic rice) post-emergence (“at 2-3 leaf stage”) with AOPP herbicides quizalofop-p-ethyl (221 g/ha), clodinafop-propargyl (112 or 168 g/Ha) or diclofop-methyl (2285g/Ha) (Example 1, Fig. 6, 7, and 9). Hinga disclosed that the herbicide was sprayed in a solution (Example 1). Hinga disclosed the rice plant has a G2096S mutation in the endogenous ACCase (Example 1 and 2) which confers “greater tolerance in rice to two common FOP type of ACCase inhibiting herbicides” (Example 2, and Figs 6, 7, and 9). Hinga disclosed for example, 77g/Ha of quizalofop causes almost 100% phytotoxicity in wild-type Oryza sativa. (Fig. 7). Hinga disclosed seeds of treated rice plants were harvested (Example 4, Col. 10, lines 11-23).
Regarding the effectiveness of such dosages used in Hinga against weeds of the genus Echinochloa, e.g., E. crus-galli, or Leptochloa, it is noted that since as stated in the instant Application, the effective dosage—i.e., manufacturer’s recommended rate-- for these weeds starts at as low as 14 g/Ha of quizalofop, e.g.. Therefore, Hinga’s dosages, e.g., 221 g/Ha quizalofop, are inherently effective against the same weeds and the manufacturer's recommended rate. This notion is further supported by evidence from Anyszka, (Vegetable crops research bulletin 51 (1999)) that E. crus-galli, (barnyardgrass), is effectively controlled by 40 g/ha quizalofop-P-tefuryl or 50 g/Ha quizalofop-P-ethyl, in comparasion to Hinga’s disclosure of quizalofop-p-ethyl at 221 g/ha. Similarly, Lancaster (International Journal of Agronomy 2018 (2018)) showed that at 80 g/Ha, quizalofop almost completely controlled L. panicoides (compared with Hinga’s dosage of 77g/Ha).
Therefore, claims 1-2, 5-6, and 9-21 are anticipated by Hinga with regard to G2096S mutation.
Response to Applicant’s Remarks:
Applicant argued that support for the present claims can be found in the '780 priority application and therefore claim 1 validly claims priority from the '780 priority application, and Hinga is disqualified as prior art. This argument has been fully considered but not deemed persuasive, for the reasons stated above in the Priority section. Therefore, the rejection over Hinga is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 5, 7, 9, 13-14, 17-21, and 23 remain, and claim 24 is newly, rejected under 35 U.S.C. 103 as being unpatentable over Raymer (US20100048405A1, published on Feb. 25, 2010, filed on Jun. 19, 2009), in view of Endo (The Plant Journal 52.1 (2007): 157-166), and Wright et al (PGPUB US 20090093366 A1, published April 9, 2009), with evidence from Won (Weed & Turfgrass Science 3.2 (2014): 110-113).
The teachings of prior art:
Raymer teaches methods of making and using ACCase inhibitor herbicide-resistant plant (claim 1) wherein the herbicide resistance is conferred by a mutation at least one amino acid position of ACCase gene selected from the group of: 1756, 1781, 1999, 2027, 2041, 2078, 2099 and 2096 (claim 8); wherein the herbicide resistance is conferred by an isoleucine to leucine mutation at amino acid position 1781 (I1781L; Claim 9); wherein the plant is resistant to clodinafop, clofop, , diclofop, fluazafop-butyl, fluazifop, haloxyfop, quizalofop, and so on (Claim 10); Raymer also teaches that the mutation is Trp 2027 to Cys (W2027C; [0079]; and Table C, for example).
Raymer teaches treating herbicide-resistant plants and herbicide-susceptible control plants with varying rates of herbicide, ranging from 0 to 20 times the known lethal dose for the species of interest ([0082]).
Raymer teaches successful making and identifying the non-transgenic mutant plants through in vitro callus generation and selection for mutations (Example 2, and Table 3). It is worth noting that Raymer succeeded in identifying 3 calli harboring the I1781L mutation from a total of 65 calli (Example 2, and Table 3).
Raymer teaches treating the whole plant (i.e. postemergence) of “Line A” plant (having the I1781L mutation) by spraying herbicide fluazifop-p-butyl, at the rates 0, 25, 50, 100, 200, 400, 800, 1600 and 3200 g ai/ha; and Line A showed significantly less injury than (control plants) at all rates above 50 g ai/ha (Example 10, Fig. 14). Raymer teaches treating herbicide resistant plants and herbicide-susceptible control plants with varying rates of herbicide, ranging from 0 to 20 times the known lethal dose for the species of interest. ([0082]). AS evidenced from Won, regular Barnyardgrass (Echinochloa crus-galli) is sensitive to 175 to 300 g/ha fluazifop-p-butyl. Therefore, the herbicide amount used in Raymer is an effective amount against Echinochloa crus-galli weed.
Raymer does not teach the ACCase herbicide resistant mutant plant being a domestic rice plant.
Endo teaches developing herbicide tolerant “non-GMO” rice plants that is without any insertion of foreign DNA (i.e., “free of transfection products”) which is successful in obtaining “clean GT plants with high efficiency” (Abstract, and p. 163).
Wright et al teaches the motivation to produce a rice plant tolerant to a higher dose of AOPP herbicide that is damaging to wild type rice: Wright et al teaches making a rice transgenic plant resistant to 140 g ae/ha quizalofop (Example 24, p. 65, and Table 35).
Conclusion:
It would have been obvious and within the scope of one of ordinary skill in the art at the time of filing of the instant application, to have used the screening method of Raymer for identifying and herbicide-treating mutant plant having a mutation allele such as I1781L-ACCase to make a rice mutant plant having endogenous non-transfected ACCase comprising the I1781L or W2027C mutations, or using the methods of Endo to create the desired mutant alleles without any residue of foreign DNA, and arrived at the instantly claimed invention.
The person of ordinary skill in the art would have been motivated to do so, given the teachings of Raymer for taking the prior knowledge of mutant alleles in ACCase—such as comprising the I1781L or W2027C mutations—that has been well-documented in multiple species for conferring tolerance to various ACCase-inhibiting herbicides including the FOPs, to apply to a plant species of choice and screen for the plant having one of these alleles, thereby arriving at the herbicide-tolerant plant and the method of treating with the herbicide. The motivation is further enhanced by Endo for herbicide tolerant “non-GMO” rice plants, Wright for making a rice plant tolerant to higher doses of quizalofop, and so on.
The person of ordinary skill in the art would have had reasonable expectation of success in firstly obtaining a non-transgenic rice plant comprising the mutant endogenous ACCase having the I1781L or W2027C mutation, given the teachings and success of Raymer in a simple screening scheme. Alternatively, Endo has successfully demonstrated a gene-targeting method for making a mutant plant free of transfection products. Once such a rice plant is made, the person of ordinary skill in the art would have had reasonable expectation of success in practicing the instantly claimed method of treating rice and harvesting seeds.
Therefore, the invention as whole is prima facie obvious over the combined teachings of prior art.
Response to Applicant’s Remarks:
Regarding the 103 rejection above, Applicant traversed by referring to arguments proffered in the Remarks of 8/5/2024, pp 10-12. It should be noted that these arguments have been answered in the subsequent Office Action of 9/3/2024, which is not repeated here.
However, it is worthwhile to point out that a key element of Applicant’s argument of 8/2/2024 was that “Raymer does not provide any enabling disclosure and is not relevant to the inventive step of the pending claims” (Remarks of 8/4/2024, p. 11, para. 3) because the Examples were “written in present tense.” This has not been found persuasive.
MPEP 2121.I states that PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING “When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability.”. It should be noted other than the mere allegation, Applicant has not provided any evidence to meet their burden of proof in rebutting the presumption, or why the prior art was not operable.
On the contrary, Raymer has actually tested the field performance of plants carrying the I1781I mutant ACCase with various rates of SegmentTM (sethoxydim), at 50, 100, 200, 400, 800, 1600, and 3200 g ai ha rates showing Line A (I1781L mutant plant) as “more than adequate to provide effective control of susceptible weedy grasses without concerns over herbicide injury.” With only 4.2% injury at 3000 g/ha rate 42 days after treatment while the control plant suffered 100% injury at 800 g/ha (Table 4). It should be noted that SegmentTM suggested field rate is 313 to 525 g/ha. Therefore, a PHOSITA would have been reasonably taught that I1781L mutant would be capable of conferring a level of herbicide tolerance at least several times higher than the recommended field rate.
In contrast, the instant Specification disclosed treatment using Sethoxydim at a rate of 600 g AI/Ha. This does not indicate any unexpectedness in view of the prior art. In other words, the instant disclosure further supports the notion that the PHOSITA would have succeeded, using the I1781L mutant.
In the Remarks of January 3, 2025, Applicant argued that “Endo explains that its directed mutagenesis technique is superior to "those produced by conventional mutation breeding protocols or transgenic technology." Id. at Abstract. As such, one of ordinary skill in the art would have no reason to consider Endo in the context of the instant claims nor would there be any reason to combine Endo with the other references” because Endo “describes a directed mutation insertion method, using T-DNA, and resulting in homologous recombination to incorporate into an endogenous gene an introduced mutation”. Accordingly, “for at least this reason, Applicant respectfully requests withdrawal of the rejection.”
This argument has been fully considered but not deemed persuasive.
The claims are amended to recite the mutant rice plants comprises and expresses an endogenous mutant ACCase nucleic acid whose sequence is “free of transfection products” and is “product[s] of directed mutagenesis”. As Applicant admitted, Endo does teach a superior directed mutagenesis method. And Endo has explicitly taught the mutant plant comprise the desired m point mutation(s) “exclusively” and “without any insertion of foreign DNA such as border sequences of T-DNA”. It is interpreted that the phrase “free of transfection products” recited in the instant claims reads on Endo “without any insertion of foreign DNA”. Therefore, as Applicant admitted, Endo provides at least one of the directed mutagenesis method required by the claims.
However, that being said, it should be noted that the instantly claimed method is practiced on the mutant rice plant. The claims attempt to define the mutant rice plant as a product by the method of making. However, it should be noted that determination of patentability is based on the product itself. See for example, MPEP 2113. In the instant case, the claimed rice plant comprising the mutation in the native ACCase gene and “free of transfection products” is indistinguishable from the mutant rice plant isolated by screening spontaneous mutants arisen from callus culture (as admitted in the instant Specification). It should be noted that just as the instantly claimed rice mutant plants are isolated by screening herbicide tolerance calli, so are the mutant plants of Raymer. As the instant Specification admits, any directed mutagenesis method known to skilled artisan at the time of the invention could be adopted to reproduce such mutations, as demonstrated in Endo.
Applicant also argued that Raymer fails to disclose or suggest rice plants, let alone rice plants comprising a mutation selected from I1781(Am)L, G2096(Am)S, or W2027(Am)C, and that Wright is unrelated to the target-site tolerance provided by the ACCase amino acid substitutions as instantly claimed. The argument is a repeat of response filed on 8/5/24. This argument has been fully considered but not deemed persuasive.
Firstly, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because “[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA].” In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012). See MPEP 2145 IV.
In the instant case, as discussed amply in the rejection above, Raymer provides motivation and teachings for making and using plants with the claimed mutant ACCase (I1781L, W2097C) to confer tolerance to clodinafop, clofop, , diclofop, fluazafop-butyl, fluazifop, haloxyfop, quizalofop, and so on; Endo teaches developing herbicide tolerant “non-GMO” rice plants that is without any insertion of foreign DNA; and Wright provide the motivation to apply the methods of Raymer and Endo to rice plants. Therefore, the combined teachings provided a case of prima facie obviousness.
Therefore, the rejection is maintained.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hinga (US9370149B2, published on Jan. 24, 2013, priority filing date Sep. 30, 2011), with evidence from Anyszka (Vegetable crops research bulletin 51 (1999)) and/or Lancaster (International Journal of Agronomy 2018 (2018)), as applied to claim 17 as discussed above, and further in view of More (WO2015055448A1, published 2015).
Claim 17 and the teachings of Hinga is discussed supra.
Claim 22 is drawn to the method of claim 17, such that the application is by dusting.
Hinga does not teach dusting application or formulation.
More teaches a quizalofop formulation of dusting powders (p. 50, line 37, e.g.).
Therefore, it would have been prima facie obvious for a person having ordinary skill in the art to use any quizalofop formulation in place of the quizalofop formulation used in Hinga, such as dusting, thereby arriving at the claimed invention. Such a choice would have been an routine choice by the artisan as to choose whichever formulation suitable for the situation, with the advantages offered by different formulations and application methods.
Therefore, the claimed invention is prima facie obvious over the combined teachings of the prior art.
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), G2096S (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, 7, and 9, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-48, 50-54 of copending Application No. 15/094,325 (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 comprising: a) providing a non-genetically modified, rice plant in a field, said rice plant (A) comprising a non-genetically engineered, randomly mutagenized rice acetyl- Coenzyme A carboxylase (ACCase) nucleic acid encoding a rice plastidic ACCase, the ACCase comprising, as a result of that mutagenesis, a substitution of the glycine at amino acid position 2,107 relative to SEQ ID NO:2 with a serine (G2096S) (Am); and (B) comprising: (i) a phenotype of tolerance to cycloxydim that is about 28% that of a rice plant expressing in the rice plastidic ACCase an isoleucine-to-leucine substitution at the amino acid position corresponding to position 1,781 (Am) (I1781L) (Am) instead of said G2096S (Am) when measured, in living cells that are cultured in the presence of 100 pM cycloxydim, at day three of said culturing; and (ii) a phenotype of increased tolerance to quizalofop and tepraloxydim when compared to that of a corresponding wild-type plant; and b) applying an herbicidal composition comprising an ACCase-inhibiting herbicide to said rice plant wherein said plant exhibits increased tolerance to said ACCase- inhibiting herbicide when compared to that of a corresponding wild-type rice plant.
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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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