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 Application
2. Claims 31-37, 39, 40, 42, 45, 46, 48, 49, and 51-57 are pending and examined.
3. The objection to claim 57 has been withdrawn in view of Applicant’s amendments to the claim.
Continued Examination Under 37 CFR 1.114
4. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 17, 2025 has been entered.
Claim Rejections - 35 USC § 112 - New Matter
5. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 31-37, 39, 40, 42, 45, 46, 48, 49, 51, and 52-57 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s arguments submitted on December 17, 2025 have been fully considered but they are not persuasive.
As previously and instantly amended, claims 31, 34, and 40 recite as follows: “a phenotype of increased cycloxydim tolerance, relative to a wild-type plant, upon expressing the ACCase-W2027C substitution, wherein the ACCase-W2027C substitution is capable of increasing the tolerance of rice cells expressing an ACCase-I1781L substitution in the same ACCase as that containing said W2027C substitution, such that a callus of said cells exhibits 867% growth in one month, in the presence of cycloxydim.” This recitation is New Matter, because neither the instant specification nor the original claims provide adequate written support for it. The specificaiton appears entirely silent with regard to cycloxydim tolerance of any plants comprising the individual Trp2,027Cys substitution. Thus, the disclosure fails to provide express or implied written support for the above limitation. Given that claims 32, 33, 35-37, 39, 42, 45, 48, 49, and 51-57 depend from claims 31, 34, 40, or 46, they contain New Matter as well.
The Examiner maintains that the portions of the specification to which Applicant referred for support in the previous Remarks ([paragraphs] [0115], [0129], [0136], [0299] - [0311], Figure 16 - now Figure 5) fail to provide the required written support for the reasons set forth in the previous Office Actions. Applicant also cited paragraphs [0007], [0008], and [0027], and Example 7 for support. The three paragraphs recite large lists of ACCase positions that could be mutated. And Example 7 teaches tolerance of plants comprising the Ile1,781Leu substitution alone or in combination with the others. Neither the Example nor the cited paragraphs teach a rice plant comprising the Trp2,027Cys alone and possessing “increased cycloxydim tolerance, relative to a wild-type plant,” including wherein the Trp2,027Cys “is capable of increasing the tolerance of rice cells expressing an ACCase-I1781L substitution in the same ACCase.”
For example, while Table 6 teaches that the callus of the Ile1,781Leu/Trp2,027Ccys double mutants grew “867%” in one month, there is no indication anywhere in the specification that said growth rate is an “increase” over the growth of the callus of single-mutated cells.
Response to Arguments
Applicant argues that the amendments to the claims overcome the rejection (page 7 of the Remarks).
This is not found to be persuasive. The rejection has been modified in view of the amendments. However, the claims remain rejected for the reasons set forth above. The Examiner maintains that the specification describes no rice plant or cell, comprising the W2027C alone and being tolerant to any concentrations of cycloxydim, and Applicant has pointed to no portions of the disclosure indicating otherwise.
Claim Rejections - 35 USC § 112 - Indefiniteness
7. 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.
8. Claims 31-37, 39, 40, 42, 45, 46, 48, 49, 51, and 52-57 remain 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 pre-AIA the applicant regards as the invention.
This rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s arguments submitted on December 17, 2025 have been fully considered but they are not persuasive.
In claims 31, 34, and 40, as instantly amended, the recitation “a phenotype of increased cycloxydim tolerance, relative to a wild-type plant, upon expressing the ACCase-W2027C substitution, wherein the ACCase-W2027C substitution is capable of increasing the tolerance of rice cells expressing an ACCase-I1781L substitution in the same ACCase as that containing said W2027C substitution, such that a callus of said cells exhibits 867% growth in one month, in the presence of cycloxydim” renders the claims indefinite for the following reasons.
First, the limitation recites a property of a rice plant comprising a mutant ACCase with the tryptophan to cysteine substitution at the relative position 2,027. As set forth in the New Matter rejection above, the specification does not teach any rice plants comprising the Trp2,027Cys substitution alone and having tolerance to cycloxydim. The prior art teaches that plants comprising the Trp2,027Cys substitution are, in fact, sensitive to cycloxydim, including plants homozygous for the mutation, while plants comprising the Ile1,781Leu substitution are tolerant to said herbicide (see Delye et al-2, Plant Physiol. (2005) 137:794-806, Table 1; Delye et al-1, Pest Management Sci. (2008) 64:1179-1186, Table 2). Thus, given said absence of tolerance, it is unclear how one would evaluate the claimed phenotype, particularly, where it is expressed in relative terms, such as recited in the amended claims.
In addition, in the above recitation, the term “increased” is used to refer to the increase in the tolerance of a plant relative to a wild-type plant, yet in the subsequent clause, the term “increasing” appears to refer to the property of a substitution when present in combination with another substitution. This use of the term introduced further ambiguity into the claim language. Moreover, the wording of the clause also makes it unclear relative to what the “increasing” (as referring to the tolerance of a cell) is meant to be measured. For example, if the term is meant to the tolerance to a double mutant over that of a single mutant, this should be clearly reflected in the claim language.
Next, in the clause “wherein the ACCase-W2027C substitution is capable of increasing the tolerance of rice cells expressing an ACCase-I1781L substitution in the same ACCase as that containing said W2027C substitution, such that a callus of said cells exhibits 867% growth in one month, in the presence of cycloxydim,” it is unclear how “the tolerance of rice cells” would relate to the “phenotype of increase cycloxydim tolerance” of the rice plant; there is also no clear connection between said “cells” and said “plant.” It is also unclear how the fact that, as taught in the specification, the callus of rice cells comprising both substitution at issue grew at “867%” in a month could be interpreted as an indication of increased tolerance (of said callus or plant from which said callus is derived) relative to a single mutant comprising only the Trp2,027Cys substitution, particularly given that the specification has not taught any plants or cells comprising said substitution alone and tolerant to any application rate of cycloxydim.
For these reasons, the metes and bounds of the claims are unclear.
Since claims 32, 33, 35-37, 39, 42, 45, 46, 48, 49, and 51-57 depend from claims 31, 34, or 40, and do not recite additional limitations overcoming the indefiniteness of said three claims, they are indefinite as well.
Response to Arguments.
Applicant argues that the amendments to the claims obviate the rejection (page 7 of the Remarks). This argument is not persuasive. Applicant’s amendments to the claims are acknowledged and the rejection has been modified accordingly. However, the amendments are not sufficient to overcome the rejection and metes and bounds of the claims remain unclear for the reasons set forth above.
Claim Interpretation
9. The following is noted with regard to claim interpretation. The limitations “ non-transgenic mutagenized,” “obtained by an induced, random mutagenesis method exclusive of any directed mutagenesis technique” and “as a result of said mutagenesis,” in claims 31, 34, and 40, are interpreted as product-by-process limitations that do not affect the structure of the nucleic acid to which they refer. See MPEP 2113.
As set forth above, the recitation of the Trp2,027Cys substitution-comprising rice plant and cell’s tolerance to cycloxydim, as recited in the amended claims renders the claims indefinite and constitutes New Matter. For the purpose of the examination, it is noted that the recitation would encompass any concentration of cycloxydim and any method of estimating tolerance. In addition, the claim language is inclusive of a mutant rice plant comprising a Trp2,027Cys mutant allele as well an Ile1,781Leu mutant allele. Delye et al-1 teaches that plants homozygous for the Ile1,781Leu allele exhibited the level of tolerance that was approximately 3.5 times the level exhibited by the plants heterozygous for both Trp2,027Cys and Ile1,781Leu alleles (Table 3). It is noted that part (i) of claim 31 is inclusive of plants heterozygous for the Trp2,027Cys and Ile1,781Leu substitutions, while part (ii) is inclusive of plants homozygous for the Ile1,781Leu substitution.
In claim 57, the recitation “said plant exhibits tolerance to 600 g/ha cycloxydim” is recited as a property of the plant and does not limit the active step of contacting the plant with an herbicidal composition, wherein the step is recited in the of the method of claim 40, from which claim 57 depends. Claim 57 will thus encompass any application dosage of cycloxydim.
Claim Rejections - 35 USC § 103
10. 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.
11. Claims 31-36, 40, 42, 45, 51 and 52-57 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Delye et al-1 (Pest Management Sci. (2008) 64:1179-1186), in view of Delye et al-2 (Plant Physiol. (2005) 137:794-806), Hawkes et al (PCT Publication WO 98/54330, published December 3, 1998), Okuzaki et al (Plant Cell Rep. (2004) 22:509-512), Suzuki et al (Mol. Genet. Genomics (2008) 279:213-223), and Rutger et al (Crop Science (2005) 45:1170-1171). Applicant’s arguments submitted on December 17, 2025 have been fully considered but they are not persuasive.
Delye et al-1 teach that in a grass plastidic ACCase, five amino acid residues are involved in resistance to ACCase inhibitor herbicides, and that one of these residues is a cysteine at position 2,027, in the Alopecurus myosuroides numbering (Abstract). Delye et al-1 teach that a tryptophan to cysteine substitution at position 2,027 confers resistance to fenoxaprop, clodinafop, and haloxyfop in A. myosuroides plants, in seed-based bioassays and at herbicide field rate (Tables 2 and 3) Delye et al-1 teach that the fenoxaprop application rate was 69 g ai/ha (pg. 1181, left col.).
Delye et al-1 do not teach a rice plant or seed comprising a nucleic acid encoding a rice plastidic ACCase comprising the Trp2,027Cys substitution.
Delye et al-2 teach that Trp2,027 is “absolutely conserved in all homomeric ACCase sequences known so far” (pg. 802, left col). Delye et al-2 teach that the Trp2,027Cys substitution confers resistance to APPs, including fenoxaprop, clodinafop and diclofop, but not CHDs (pg. 798, left col.; Table II)
Hawkes et al teach a chimeric oligonucleotide-based method of producing herbicide resistant plants by modifying in a plant cell, in situ, an endogenous gene responsible for herbicide resistance, including the ACCase gene (claims 1, 6, 8). Hawkes et al teach applying said method to rice (claim 16). Hawkes et al teach using the resultant plants in a method of controlling weeds, which comprises applying to the field, where said plants are growing, a herbicide to which said plants have been rendered resistant (claims 18 and 19). Hawkes et al teach applying herbicide to resistant plants by spraying (Example 1 on page 12).
Okuzaki et al teach successfully using chimeric oligonucleotide-based site-specific mutagenesis to introduce herbicide resistance-conferring point mutations into rice genome (Abstract; pg. 512, left col.). Okuzaki et al teach that the “[chimeric oligonucleotide]-directed gene targeting is feasible in rice and creates opportunities for ... the manipulation of agricultural traits in rice” (pg. 512, left 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 (pg. 1, Abstract; pg. 214, left and top of right col.).
Rutger et al teach the characteristics of nine Indica rice germplasms (Oryza sativa), including the germplasm called “Indica-1,” along with their seeds (Table 1 on pg. 1171).
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 method of Suzuki et al or the method of Hawkes et al to modify a rice plant (or its seed or cells), including the Indica-1 variety of Rutger et al, and obtain a rice plant (or its seeds or cells) that comprises a mutation in the rice ACCase gene that encodes the Trp2,027Cys substitution, taught by and Delye et al-1, Delye et al-2. The plants and seeds thus obtained would read on the plants and seeds of the instant claims. Given that the methods of Hawkes et al and Suzuki et al do not involve the introduction of a transgene into the genome of a plant, the resultant rice nucleic acid and plants and seed comprising it would be considered non-transgenic. In addition, it would have been obvious to introduce the nucleic acid encoding the mutant ACCase into another rice plant or seed not comprising said mutant ACCase.
Given the teachings of Delye et al-1 and Delye et al-2, one would have reasonably expected that the resultant rice plant or seed would be resistant to ACCase inhibitors that include fenoxaprop, clodinafop and/or haloxyfop, including to their field application doses. Given that Delye et al-1 teach that the Trp2,027Cys substitution conferred resistance to 69 g ai/ha dose of fenoxaprop, one would have reasonably expected the recited tolerance to fenoxaprop.
In addition, in view of the teachings of the prior art, and the above claim interpretation, it would not have been unexpected that the level of tolerance to cycloxydim conferred by the Trp2,027Cys substitution would have been lower than that conferred by the Ile1,781Leu substitution, at least under some conditions, none of which are excluded from the claims. Moreover, the fact that Applicant “has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Using the resultant plant or seed in a method of weed control by applying an herbicidally effective dose of any of said herbicides to which the Trp2,027Cys substitution confers resistance would have been prima facie obvious in view of the teachings of Hawkes et al, as well as Delye et al-1 and Delye et al-2 (instant claims 40 and 57). A plant used in said method would necessarily comprise herbicide composition on its surface, including wherein the composition comprises an herbicide taught by Delye et al-1. Such plant would read on the plant of claims 51 and 52. It would have been obvious to use said method to control any common grass weed against said ACCase inhibitor herbicides are active. It would have been obvious to apply said herbicide to the rice plant and weeds by spraying it in an aqueous solution, in view of the teachings of Hawkes et al, and as a matter of routine industry practice.
One having ordinary skill in the art would have been motivated to combine the above teachings given the agronomic desirability of an herbicide resistant rice, the importance of position 2,027 for ACCase inhibitor resistance, as taught by Delye et al-1 and Delye et al-2, and in view of the fact that the Trp2,027Cys substitution confers resistance to least three commercial ACCase inhibitors. Given the teachings of Hawkes et al, Suzuki et al, and Okuzaki et al regarding the feasibility of their mutagenesis methods, including in rice, and given that residue Trp2,027 is “absolutely conserved” in grass ACCases, as taught by Delye et al-2, one would have had reasonable expectation of success.
12. Claims 37, 39, 46, 48, and 49 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Delye et al-1 (Pest Management Sci. (2008) 64:1179-1186), in view of Delye et al-2 (Plant Physiol. (2005) 137:794-806), Hawkes et al (PCT Publication WO 98/54330, published December 3, 1998), Okuzaki et al (Plant Cell Rep. (2004) 22:509-512), Suzuki et al (Mol. Genet. Genomics (2008) 279:213-223), and Rutger et al (Crop Science (2005) 45:1170-1171), as applied to claims 31-36 and 40-45, further in view of Shaner et al (US Patent 6,281,168, issued on August 28, 2001). Applicant’s argument filed on December 17, 2025 has been fully considered, but it is not found to be persuasive.
The claims are drawn to a rice seed of claim 34, wherein the seed further comprises a seed treatment, and to a method of using said seed for weed control, wherein the seed treatment comprises an herbicidal composition, including wherein said composition comprises fenoxaprop.
The teachings of Delye et al-1, Delye et al-2, Hawkes et al, Okuzaki et al, Suzuki et al, and Rutger et al have been set forth above. These references do not expressly teach a rice seed comprising a seed treatment, wherein seed treatment comprises a herbicidal composition that includes an ACCase inhibiting herbicide.
Shaner et al teach applying a mixture that comprises herbicidally effective amounts of an ACCase inhibitor to rice seeds (claims 1, 2, 6, and 13). In addition, applying herbicides to the seeds of herbicide-resistant plants is one of the art-standard approaches to pre-emergence herbicide application.
Applying ACCase inhibitors, including fenoxaprop, to the ACCase inhibitor-resistant seeds made obvious by the combination of the above references, would have been prima facie obvious in view of the teachings of Shaner et al and as a matter of routine industry practice. It would have been also obvious to use the treated seed in a method of weed control.
One would have been motivated to do so, because it would enable pre-emergence weed control of rice weeds. Given that the Trp2,027Cys substitution confers resistance to APPs, including to fenoxaprop, and including in seed-based assays (as taught by Delye et al-1 on pg. 1180; Table 1), one would have had reasonable expectation of success.
Response to Arguments
Applicant argues that the phenotype of tolerance structurally limits the claimed plant and cites the PTAB decision in appeal 2025-003055 for support (page 8 of the Remarks).
Applicant’s argument is not found to be persuasive. The decision, including the portion cited by Applicant, reflects the facts of a specific application that dealt with an unrelated enzyme. Applicant has provided no explanation as to how the facts of said unrelated application could be applied to the instant scenario. Nor has Applicant supplied any evidence that the cited decision is precedential legal authority.
Applicant’s previously submitted arguments were considered in detail in the previous Office Actions and remain unpersuasive for the reasons of record.
The Examiner maintains that the fact that a plant comprising the Trp2,027Cys substitution was known in the art to be sensitive to cycloxydim would not have taught away from the instant invention. This is because the substitution was known to confer tolerance to least three commercial ACCase inhibitors, including fenoxaprop. This would have been sufficient to motivate one of ordinary skill in the art to introduce that substitution into a rice plant. Applicant’s argument fails to address this reasoning.
It is noted that “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.” In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006). MPEP 2144. In the instant case, the expected beneficial result would have been a rice plant tolerant to several commercial ACCase inhibitors. At the same time, the feasibility of introducing herbicide resistance-conferring point mutations into rice genome was expressly confirmed in the prior art.
With regard to the teachings of Hawkes and Okuzaki, the argument is not persuasive because one of ordinary skill in the art would have predictably used said those teachings to arrive at a rice plant comprising the “non-transgenic mutagenized” rice ACCase nucleic acid, wherein the structure of said nucleic acid is indistinguishable from the nucleic acid encompassed by the instant claims. See MPEP 2113. The structure of a nucleic acid is determined by its nucleotide sequence and not its method of production. See MPEP 2113. Given that the cited art makes the structure of the claimed product prima facie obvious, contrary to Applicant’s position, said art, including Hawkes et al and Okuzaki et al, are directly relevant and applicable to the claimed subject matter. Applicant’s designation of the claimed invention as belonging to one “class of agriculture” or another is beside the point of the instant analysis and does not obviate the obviousness of the claimed structure.
The Examiner maintains that the instant invention amounts to introducing a known substitution at the ACCase position that is “absolutely conserved” in all grasses, and whose herbicide tolerance properties were well-characterized, into rice, a grass crop. One would have been motivated to do so view of the fact that the Trp2,027Cys substitution confers resistance to least three commercial ACCase inhibitors, and in view of the agronomic desirability of rice tolerant to said inhibitors. The rejection is maintained.
Conclusion
13. No claims are allowed.
14. 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.
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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRATISLAV STANKOVIC can be reached at (571)270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662