DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
2. Claims 1-16, 18, 19 and 21-24 are pending.
3. Claim 19 remains withdrawn.
4. Claims 1-16, 18, and 21-24 are examined herein.
5. All rejections of claim 17 are moot in view of its cancelation by Applicant.
Continued Examination Under 37 CFR 1.114
6. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 23, 2025 has been entered.
Election/Restrictions
7. Applicant's election with traverse of Group I, claims 1-17 in the reply filed on November 18, 2022 is acknowledged. The traversal was not found persuasive. Given that the examination of the elected Group uncovered prior art readable on claim 18, that claim was rejoined and examined together with the elected claims. However, with regard to Groups I, III, and IV, the requirement was still deemed proper and is therefore made FINAL.
Claim 19 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 18, 2022.
Claim Interpretation
8. The following is noted with regard to claim interpretation.
Claim 1, as instantly amended, recites the step of “making a visual determination that the domestic rice plant is without injury.” This limitation does not require selecting a plant “without injury,” and is thus interpreted as encompassing evaluating the injury caused by the herbicide formulation in the “domestic rice plant” recited in step (b), wherein the plant may or may not be injured.
Claim 16 recites the limitation “free of any mutation from a directed mutagenesis technique.” The specification recites the term “directed mutagenesis” in the following single sentence on page 23: “Methods of inducing mutations may induce mutations at random positions in the genetic material or may induce mutations in specific locations in the genetic material (i.e., may be directed mutagenesis techniques).” In view of this, said limitation in claim 16 is reasonably interpreted as encompassing a rice plant comprising no nucleic acids obtained using directed mutagenesis. However, while the limitation is not phrased as a product-by-process, it is noted that the structure of a nucleic acid is determined by its sequence, not its method of making. Thus, barring evidence to the contrary, a plant comprising a mutant endogenous ACCase gene encoding the ACCase enzyme with a leucine substitution at the relative position 1,781, wherein said mutation was produced using a directed mutagenesis method would be structurally indistinguishable from a plant wherein said mutation was produced using, for example, a chemical mutagenesis and herbicide pressure selection-based method. See MPEP 2113.
Claim Rejections - 35 USC § 103
9. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
10. Claims 1-6, 10-16, 18, 21, 23, and 24 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Raymer et al (US Patent Publication 2010/0048405, published on February 25, 2010, filed on June 19, 2009), in view of Tal et al (Pest Manag. Sci. (2004) 60:1013-1018), Eleftherohorinos et al (Weed Technology (2002) 16:537-540), and Suzuki et al (Mol. Genet. Genomics (2008) 279:213-223). Applicant’s argument submitted on December 23, 2025 was fully considered but it is not persuasive.
Raymer et al teach plants comprising nucleic acid and amino acid sequences of plastidic ACCases that comprise an isoleucine substitution at the relative position 1,781, said substitution conferring resistance to ACCase inhibitors, including wherein said plants are non-transgenic (paragraphs 0008, 0015, 0078-0080, 0091; Table C on pg. 8; see also paragraph 0005; claims 1-8 and 11).
Raymer et al teach a method of controlling weeds in the vicinity of an herbicide resistant plant comprising said mutant ACCase, the method comprising contacting the herbicide resistant plant with an ACCase inhibitor herbicide, including wherein a herbicide is applying by dusting or spraying (paragraphs 0016-0018 on pg. 2; see also claims 16-31; paragraph 0099). Raymer et al teach quizalofop as one of the herbicides that can be used in the methods of their invention (paragraphs 0007, 0014, 0020, 0024, for example). Raymer et al teach a herbicidal composition comprising a surfactant (Example 9). Raymer et al teach selecting plants and cells tolerant to ACCase inhibitor herbicides (paragraph 0005; 0012; 0023; 0046; Fig. 2; claims 2; 16, 33-35; Example 28). Raymer et al teach visually estimating crop injury in treated plants (paragraphs 127, 132 and 137).
Raymer et al do not expressly teach using a rice plant in a method of weed control.
Tal et al teach that that the I1,781L substitution in the ACCase (corresponding to I1769L in the wheat numbering used in Tal et al) confers tolerance to quizalofop-P-ethyl in Lolium rigidum, a grass weed (Abstract; pg. 1014, left col.; Table 1). Tal et al teach that said substitution had been reported in herbicide resistant O. sativa (Fig. 1).
Eleftherohorinos et al teach that quizalofop-ethyl is highly effective at controlling red rice, a common weed of rice, in cultivated rice population, wherein the herbicide is applied either pre- or post-emergence (Abstract; pg. 538 both col.).
Suzuki et al teach using high-performance modified Targeting Induced Local Lesions in Genomes (“TILLING”) on rice mutant pools as an efficient method of identifying any gene mutation in rice (Suzuki et al, pg. 1, Abstract; pg. 214, left and top of right col.).
At the time the invention was made, it would have been prima facie obvious to one having ordinary skill in the art to use the mutagenesis methods of Suzuki et al to modify a domestic rice plant, such as a plant taught by Eleftherohorinos et al, by introducing the isoleucine to leucine substitution at the relative position 1,781 of the plastidic ACCase, as taught by Raymer et al and Tal et al. It would have been obvious to use the resultant plant in a method of weed control of Raymer et al, wherein an herbicide is applied, including by spraying, to the rice and the surrounding area, and follow said application by visually estimating the injury to the plants and the weeds. It would have been obvious to select a plant tolerant to said application, as suggested by Raymer et al.
It would have been further obvious to use, in said method, any commercial formulation of quizalofop, including quizalofop-P-ethyl taught by Tal et al and Eleftherohorinos et al. It would have been also obvious to use, in said formulation, an “auxiliary” such as a surfactant, as taught by Raymer et al, and which is also standard industry practice. Applying said method to the rice plant and to the weeds, including red rice taught by Eleftherohorinos et al, would have been prima facie obvious in view of the teachings of Raymer et al and Eleftherohorinos et al.
Given the teachings of Tal et al and the teachings of Suzuki et al, one would have had reasonably expectation of success in using the MNU-based TILLING to obtain a non-transgenic rice plant (comprising “no directed mutagenesis product”), wherein the plant is tolerant to quizalofop.
One would have been motivated to introduce the I1,781L substitution into the rice plant because it would allow effective control of known grass weeds of rice, particularly red rice which belongs to the same species as the cultivated rice. One would have been motivated to use, specifically, quizalofop in a method of weed control using the resultant mutant cultivated rice given the efficacy of quizalofop in controlling red rice, as taught by Eleftherohorinos et al and susceptible populations of Lolium rigidum, as taught by Tal et al.
11. Claims 7-9 and 22 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Raymer et al (US Patent Publication 20100048405, published on February 25, 2010, filed on June 19, 2009), in view of Tal et al (Pest Manag. Sci. (2004) 60:1013-1018), Eleftherohorinos (Weed Technology (2002) 16:537-540), and Suzuki et al (Mol. Genet. Genomics (2008) 279:213-223), as applied to claims 1 and 6, and further in view of Fowler et al (US Patent Application 20080248955, published on October 9, 2008). Applicant’s argument submitted on December 23, 2025 was fully considered but it is not persuasive.
The teachings of Raymer et al, Tal et al, Eleftherohorinos et al, and Suzuki et al are set forth above. The references do not teach an herbicidal composition comprising quizalofop and an adjuvant or a safener, including wherein the safener is isoxadifen (claims 8-9) or a “(quinoline-8-oxy)acetic acid” (claim 22).
Fowler et al teach emulsifiable herbicidal compositions comprising quizalofop, or quizalofop-P-ethyl, combined with an adjuvant, such as an oil adjuvant, and/or with a safener, including wherein the safener is isoxadifen or cloquintocet (paragraphs 0043, 0048-0050, 0052, 0054, 0055, 0079; claims 1-11). One of ordinary skill in the art would recognize that cloquintocet, whose synonym is 2-((5-chloro-8-quinolinyl)oxy)acetic acid,” is a quinoline derivative that comprises the quinoline-8-oxy-acetic acid moiety.
At the time the invention was made, it would have been prima facie obvious to one having ordinary skill in the art to further modify the method made obvious by the teachings of Raymer et la, Tal et al, Eleftherohorinos et al, and Suzuki et al, by applying quizalofop or its salt or ester in combination with an adjuvant and/or safener, including isoxadifen, or cloquintocet taught by Fowler et al. One would have been motivated to do so given the express teachings of Fowler et al, and the known advantages of adjuvants and safeners in herbicide formulations.
Response to Arguments
Applicant maintains previously submitted arguments (page 5 of the Remarks).
Applicant’s arguments were considered in details in the previous Office Actions and remain not persuasive for the reasons of record. For example, the argument directed to the number of known plants and mutations does not apply in the instant scenario. In contrast to the fact pattern discussed by PTAB in the case cited by Applicant, Ex Parte Coalition for Affordable Drugs, in the instant case, there would have been no need to screen numerous solutions, because the art would have directed one of ordinary skill in the art specifically to the I1781L substitution in rice, for the reasons set forth above.
Similarly, the argument submitted in the previous Remarks and directed to the teachings of Tal et al remains not persuasive. First, Applicant cited no authority or factual evidence supporting the statement regarding the leucine in the cytosolic ACCase of Poaceae. Second, Applicant’s position is contradicted by the plain language of the reference - Figure 1 of Tal et al expressly refers to the Oryza sativa ACCase as being from a resistant species (as indicated by an “R”). The fact that the accession number for the rice ACCase in Tal might contain a typographical error does not make the argument persuasive either, because the accession number itself is not the teachings for which the reference was cited (see the rejection above), and given the well-known conserved nature of the 1781 residue and the ACCase CT domain in which it is located. This is illustrated by the teachings of Tal itself (Fig. 1; Abstract; pg. 1013, right col.) and Raymer see Table C. Finally, there is no indication in Tal that the leucine highlighted in Fig. 1 of Tal as being present in the rice ACCase is the native residue for that position (and Applicant supplied no reasoning to support that allegation). Instead, the text on page 1015, right column and the legend for Figure 1 refer to the “isoleucine to leucine substitution” and “mutation,” and Figure 1 clearly shows the presence of the isoleucine only in the sensitive wheat ACCase, whereas all resistant ACCases, including the rice one, comprise the leucine.
The Examiner maintains that the I1781L substitution in a grass plastidic ACCase, as well as its herbicide tolerance properties, were well-known in the art at the time of invention. A rice plant comprising said substitution would have been made obvious by the combined teachings of the cited art. The active steps of the method of claim 1, including the use of quizalofop, would have been also obvious as set forth above. The additional limitations of claims 7-9 and 22 would have been made obvious by the teachings of Fowler et al. The rejection is maintained.
Conclusion
12. No claims are allowed.
13. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
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/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662