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 1-20 are pending.
3. Claims 19-20 are withdrawn.
4. Claims 1-18 are examined herein.
Election/Restrictions
5. Applicant's election with traverse of the I1781L substitution as a species, with traverse, in the reply filed on May 7, 2026 is acknowledged. The traversal is on the grounds that there is no serious burden to examine all of the species and that they were all examined in the parent application (page 2 of the Remarks).
This is not found to be persuasive. When the Restriction Requirement was issued in the parent application on September 19, 2022, the claims recited the three substitutions in separate dependent claims, and each of the dependent claims was grouped in a separate group. Applicant elected the group that encompassed the I1781L substitution, and also introduced all three substitutions into the independent claim. However, only the elected species, I1781L, and only the claims that read on that species, were examined in the Non-Final Office Action issued on December 30, 2022. This is consistent with the instant requirement. In addition, the three individual substitutions represent distinct structures with different herbicide tolerance profile. Thus, examining them together would amount to substantial examination burden.
Since claims 19 and 20 are drawn only to a non-elected species, they are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 7, 2026.
Drawings
6. The Drawings are objected to because Figure 5 of the drawings filed on December 29, 2023 and Figures 5-15 of the drawings filed on March 18, 2024 duplicate sequences that are shown in the sequence listings, which is improper. See 37 CFR 1.83; MPEP 608.02(d).
Improper Markush Grouping
7. Claim 17 is rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 17 is improper because the alternatives defined by the grouping do not share both a single structural similarity and a common use for the following reasons. The three recited individual amino acid substitutions represent structurally distinct mutants of ACCase with different and distinct herbicide resistance profile. Thus, the members of the instant Markush grouping do not share both a single structural similarity and a common use.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112(b)
8. 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.
9. Claims 1-18 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.
In claim 1, the phrase “the manufacturer-recommended rate that would normally inhibit the growth of a wild-type rice plant” renders the claim indefinite. First, there is no antecedent basis for the phrase “the manufacturer-recommended” within the claim. Second, the term “normally” is a subjective term that requires a personal judgment as to what is “normal” in the context of the claim language. At the same time, the specification provides no definition of the term nor any guidance for how to ascertain the rates. See MPEP 2173.05(b). Third, in the phrase “the manufacturer-recommended rate,” the term “recommended,” is a term whose metes and bounds cannot be readily ascertained by one of ordinary skill in the art without specific guidance as to said rate, which guidance is missing from the specification, particularly given that manufacturer recommendations can and do change over time.
The phrase “a rice crop of rice plants that are non-wild-type rice plants” renders the claim indefinite because it is unclear what “non-wild-type rice plants” are. The specificaiton does not define the term and the claim does not provide any structures or other characteristics for said “non-wild-type” plants such that one would be able to meaningfully compare them to the “wild-type” plants as recited in the claim language.
In claim 15, the term “significant injury” is a term of degree that renders the claim indefinite. The specification provides no guidance as to what injury would be considered significant, and given the relative nature and context-dependent variability of the term, without said guidance, its scope would not be readily apparent to one of ordinary skill in the art. See MPEP 2173.05(b).
In claim 17, the terms “I1781(Am)L,” G2096(Am)S,” and “W2027(Am)C” render the claim indefinite. The terms appear to refer to amino acid substitutions at the ACCase amino acid positions referenced in Alopecurus myosuroides numbering. However, the fact that said terms refer to a rice ACCase, without specifying a reference amino acid sequence, renders the claim indefinite.
Given that claims 2-14, 16 and 18 depend from claim 1, and fail to recite limitations overcoming its indefiniteness, those claims indefinite as well.
Claim Interpretation
10. The following is noted with regard to claim interpretation. The term “non-wild-type plants” in claim 1 is interpreted as being inclusive of plants having increased tolerance to quizalofop compared to the “wild-type plant.”
In claim 13, the step of “making a visual determination of injury to plants of the treated crop” does not actually require selecting for plants without said injury and would thus encompass a scenario wherein the step of “visual determination” identifies injured plants.
Claim Rejections - 35 USC § 103
11. 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.
12. Claims 1-6 and 10-18 are 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).
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 (paragraphs 0016-0018 on pg. 2; see also claims 16-31). 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 spraying herbicide onto weeds and herbicide resistant plants (paragraph 0099).
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 to the rice and the surrounding area, and follow said application by visual estimate of injury to the plants and the weeds.
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 bene obvious to apply the herbicide by spraying it in a liquid formulation as taught by Raymer et al. Given that Raymer et al teach applying herbicides in liquid commercial formulations, the formulation will necessarily comprise a carrier or an auxiliary (water or solvent would read on both terms).
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.
13. Claims 7-9 are 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).
The teachings of Raymer et la, 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.
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 (paragraphs 0043, 0048, 0052, 0054, 0055, 0079; claims 1-7).
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, 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.
Double Patenting
13. 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 and 18 of copending Application 17/662,558 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the co-pending application are drawn to a process of applying quizalofop to a domestic rice plant comprising an ACCase I1781L substitution; including wherein the method comprises applying said herbicide to weeds comprising red rice; and applying it in a formulation comprising a carrier, an auxiliary or a safener. The claims of the co-pending application thus represent a species of the instant method and make obvious the invention of the instant claims. It is noted that while the co-pending application is a parent of the instant one, the instant species election is not consonant with Applicant’s response to the restriction requirement in the parent application, because the instantly elected substitution, I1781L would have been included with the elected group in the parent application. For this reason, this rejection is proper. See MPEP 804.01.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
14. No claims are allowed.
15. 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
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