DETAILED ACTION
Status of the Application
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Claims 1, 2, 5-8, 12-16, 19-27, 30, 31, and 33 are pending.
3. Claims 1, 2, 5-8, 12-16, 19-27, 30, 31, and 33 are examined herein.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 3, 2025 has been entered.
Priority
5. 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. 112 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. 11/816,884, 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.
Independent claims 1 and 16 are directed to a method of using a rice plant, wherein the plant comprises an AHASL1 polynucleotide that encodes an AHASL1 protein with a leucine substitution at the relative position 171 (corresponding to the Pro197Leu substitution in the Arabidopsis numbering), wherein the plant, upon expressing said AHASL1 protein, possesses a phenotype of tolerance to an AHAS inhibiting herbicide.
The original claims and the specification of the parent application 11/816,884 refer to a rice plants comprising the Pro197Leu substitution, but only wherein said plant comprises both the Ala205Val and the Pro197Leu (see pages 15, 19, 43, and 49 of the specification; see original claims filed on August 22, 2007). The instant claims, however, read on a rice plant comprising the Pro197Leu substitution alone. To the extent that the claims read on an AHASL1 comprising the Pro197Leu substitution without any additional substitutions, the prior-filed application fails to provide adequate written support for that limitation. The prior-filed application also fails to describe any AHASL1 comprising the Pro197Leu substitution, wherein a rice plant comprising it possesses a phenotype of tolerance to AHAS inhibitors as a result of said substitution. Given that claims 2, 5-15, and 19-29 depend from claim 1 or 16, they are not adequately supported by the disclosure of the prior-filed application as well. As a result, the instant application is given the priority date of May 10, 2017, the filing date of the continuation application.
This application repeats a substantial portion of prior Application No. 11/816,884, filed on September 9, 2009, claiming priority to provisional application 60/657,968, filed on March 2, 2005, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq.
Response to Arguments.
Applicant maintains the previous position that the priority is met and refers to Table 2 and pages 18-19 of the parent application (pages 7-9 of the Remarks). Applicant argues that the PCT application teaches that one can produce AHASL1 polypeptides having one amino acid substitution (page 8-9 of the Remarks).
This argument remains not persuasive for the reasons of record. The Examiner maintains that Table 2 merely lists amino acid substitutions in the conserved domains of AHASL that are known to confer herbicide tolerance “and their equivalent position in rice.” The fact that the table lists said equivalent position in rice does not expressly or implicitly disclose a rice plant comprising said mutation and possessing the phenotype recited in the instant claims.
Applicant supplies no explanation for how one or ordinary skill in the art would have arrived at the conclusion of written support for the claimed plant (and the method of using it) based on said table or cited portions of the disclosure. It is also noted that Chang et al (Biochem. J (1998) 333:765-777) (listed in the Information Disclosure Statement), the reference that Table 2 cites for the teaching of the Pro197Leu substitution in rice, does not appear to teach that substitution in rice. Neither does Table 1 cited by Applicant in the instant remarks (page 8). Applicant has provided no evidence to the contrary. At the same time, the specification clearly contemplates a double-mutated AHASL, wherein the Pro171Leu substitution is present in addition to a substitution at the relative position 179 (see pages 18-19 of the specification).
Similarly, the original claim 43 clearly requires SEQ ID NO: 2 with at least one additional substitution, wherein one of such additional substitutions is Pro171Leu. This is not sufficient to provide written support for the claimed subject matter.
Claim Interpretation
6. The following is noted with regard to claim interpretation. Claims 1 and 16, as previously amended, recite the following clauses: “possessing, upon expressing said AHASL protein and by virtue of the presence of said substitution, a phenotype of tolerance to an effective weed-controlling amount of an AHAS inhibiting herbicide that would kill or severely inhibit the growth of a wild-type plant” and “wherein said plant, upon expressing said AHASL1 protein possesses a phenotype of tolerance to an effective weed-controlling amount of an AHAS inhibiting herbicide that would kill or inhibit to growth of a wild-type plant.” The clauses recite the phenotype of tolerance and do not introduce any further structural limitations to the plant beyond requiring the expression of the mutant AHASL1 protein.
The only claimed structural feature of the rice plants is the presence of the AHASL1 protein (and polynucleotide encoding it), wherein the protein comprises the Pro171Leu substitution relative to SEQ ID NO: 2. It is noted that SEQ ID NO: 2 is recited as a references sequence. Neither do said clauses limit the active steps of the claimed methods, because the herbicide application rates are recited as a property of the plant and not as an herbicide application step.
With regard to the recitations of the phenotype of tolerance, including “the plant not exhibiting any phytotoxic symptoms,” “plant not being killed or not being inhibited in its growth,” and “the plant exhibiting decreased phytotoxic symptoms,” these are given their broadest reasonable interpretation as encompassing any type of phytotoxic symptoms, however defined and under any conditions; or wherein the plant shows any level of growth inhibition reduction so long as it is lower than that of a control plant, under any environmental conditions.
Claims 1 and 16, as previously amended, also recite the following limitation, in reference to the nucleic acid encoding the mutant AHASL1 protein: “having been obtained by random chemical mutagenesis and being free of site-directed mutation.” The clause is interpreted as a product-by-process limitation that does not limit the structure of the recited polynucleotide. The structure of a polynucleotide is determined by its nucleotide sequence. A mutant nucleic acid comprising a specific nucleotide substitution wherein said substitution was made using a site-directed mutagenesis and a mutant nucleic acid comprising the same substitution that was obtained using a different method would have identical nucleotide sequences and thus would not be patentably distinguishable.
The Examiner maintains the “determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113.
Claim Rejections - 35 USC § 103
7. 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 of this title, 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.
8. Claims 1, 2, 5-8, 15, 16, 19-27, 30 and 31 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Croughan (U.S. Patent Application Publication 2003/0217381 A1, issued as US Patent 6,943,280) in view of Sibony et al (Weed Res. (2001) 41:509-522), and Okuzaki et al (Plant Cell Rep. (2004) 22:509-512). Applicant’s arguments submitted on September 3, 2025 were fully considered but they are not persuasive.
The claims are directed to a method for treating rice comprising applying at least one AHAS inhibiting herbicide to said rice, wherein the rice comprises a mutant AHASL1 protein comprising a leucine substitution at a position corresponding to position 171 of SEQ ID NO: 2. It is noted that the specification teaches that SEQ ID NO: 2 is an amino acid sequence of an imidazolinone-resistant AHASL1 protein from rice with the Ala179Val substitution relative to the wild-type (see pg. 11, lines 6-8). It is also noted that the instant claims do not require the full-length SEQ ID NO: 2, but only refer to is as a reference sequence for a substitution at position 171. One would recognize that the proline at position 171 of SEQ ID NO: 2 (and of the wild-type rice AHASL) corresponds to the proline at position 197 in Arabidopsis numbering (see, for example, Sibony et al).
Croughan teaches mutant nucleotide sequences encoding an imidazolinone and sulfonylurea resistant acetohydroxyacid synthase large subunit (AHASL), isolated from mutant rice plants (Abstract; paragraph 0044 on pg. 4). Croughan teaches using said nucleotide sequences to transform rice plants to render them tolerant to AHAS-inhibiting herbicides. Croughan teaches rice plants comprising said nucleotide sequences (Abstract; paragraph 0045 on pg. 5; see also Table 8 on page 18).
Croughan teaches, at SEQ ID NO: 17, a wild-type AHAS sequence from rice cultivar Cypress, which has 99.4% sequence identity to the instant SEQ ID NO: 2 (see paragraph 0144). The sequence alignment is set forth below.
US-10-258-842-17
; Sequence 17, Application US/10258842
; Patent No. 6943280
; GENERAL INFORMATION:
; APPLICANT: Board of Supervisors of Louisiana State University and Agricultural and
; APPLICANT: Mechanical College
; APPLICANT: Croughan, Timothy
; TITLE OF INVENTION: RESISTANCE TO ACETOHYDROXYACID SYNTHASE-INHIBITING HERBICIDES
; FILE REFERENCE: 98A9.2-PCT Croughan
; CURRENT APPLICATION NUMBER: US/10/258,842
; CURRENT FILING DATE: 2002-10-28
; PRIOR APPLICATION NUMBER: US 60/203,434
; PRIOR FILING DATE: 2000-05-10
; NUMBER OF SEQ ID NOS: 25
; SOFTWARE: PatentIn version 3.0; and WordPerfect version 8
; SEQ ID NO 17
; LENGTH: 644
; TYPE: PRT
; ORGANISM: Oryza sativa
; FEATURE:
; NAME/KEY: misc_feature
; OTHER INFORMATION: Inferred complete AHAS sequence, wild type var. Cypress
US-10-258-842-17
Query Match 99.5%; Score 3312; DB 3; Length 644;
Best Local Similarity 99.4%;
Matches 640; Conservative 2; Mismatches 2; Indels 0; Gaps 0;
Qy 1 MATTAAAAAATLSAAATAKTGRKNHQRHHVFPARGRVGAAAVRCSAVSPVTPPSPAPPAT 60
|||||||||||||||||||||||||||||| |||||||||||||||||||||||||||||
Db 1 MATTAAAAAATLSAAATAKTGRKNHQRHHVLPARGRVGAAAVRCSAVSPVTPPSPAPPAT 60
Qy 61 PLRPWGPAEPRKGADILVEALERCGVSDVFAYPGGASMEIHQALTRSPVITNHLFRHEQG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PLRPWGPAEPRKGADILVEALERCGVSDVFAYPGGASMEIHQALTRSPVITNHLFRHEQG 120
Qy 121 EAFAASGYARASGRVGVCVATSGPGATNLVSALADALLDSVPMVAITGQVPRRMIGTDVF 180
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||| |
Db 121 EAFAASGYARASGRVGVCVATSGPGATNLVSALADALLDSVPMVAITGQVPRRMIGTDAF 180
Qy 181 QETPIVEVTRSITKHNYLVLDVEDIPRVIQEAFFLASSGRPGPVLVDIPKDIQQQMAVPV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 QETPIVEVTRSITKHNYLVLDVEDIPRVIQEAFFLASSGRPGPVLVDIPKDIQQQMAVPV 240
Qy 241 WDTSMNLPGYIARLPKPPATELLEQVLRLVGESRRPILYVGGGCSASGDELRRFVELTGI 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 WDTSMNLPGYIARLPKPPATELLEQVLRLVGESRRPILYVGGGCSASGDELRRFVELTGI 300
Qy 301 PVTTTLMGLGNFPSDDPLSLRMLGMHGTVYANYAVDKADLLLAFGVRFDDRVTGKIEAFA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 PVTTTLMGLGNFPSDDPLSLRMLGMHGTVYANYAVDKADLLLAFGVRFDDRVTGKIEAFA 360
Qy 361 SRAKIVHIDIDPAEIGKNKQPHVSICADVKLALQGLNALLDQSTTKTSSDFSAWHNELDQ 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 SRAKIVHIDIDPAEIGKNKQPHVSICADVKLALQGLNALLDQSTTKTSSDFSAWHNELDQ 420
Qy 421 QKREFPLGYKTFGEEIPPQYAIQVLDELTKGEAIIATGVGQHQMWAAQYYTYKRPRQWLS 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 QKREFPLGYKTFGEEIPPQYAIQVLDELTKGEAIIATGVGQHQMWAAQYYTYKRPRQWLS 480
Qy 481 SAGLGAMGFGLPAAAGASVANPGVTVVDIDGDGSFLMNIQELALIRIENLPVKVMVLNNQ 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 SAGLGAMGFGLPAAAGASVANPGVTVVDIDGDGSFLMNIQELALIRIENLPVKVMVLNNQ 540
Qy 541 HLGMVVQWEDRFYKANRAHTYLGNPECESEIYPDFVTIAKGFNIPAVRVTKKSEVRAAIK 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 HLGMVVQWEDRFYKANRAHTYLGNPECESEIYPDFVTIAKGFNIPAVRVTKKSEVRAAIK 600
Qy 601 KMLDTPGPYLLDIIVPHQEHVLPMIPSGGAFKDMILDGDGRTVY 644
|||:||||||||||||||||||||||||||||||||||||||:|
Db 601 KMLETPGPYLLDIIVPHQEHVLPMIPSGGAFKDMILDGDGRTMY 644
As the sequence alignment shows, the protein of Croughan comprises a proline at position 171, and thus represents a wild-type AHASL with respect to said position. Croughan teaches a nucleic acid sequence that encodes SEQ ID NO: 17 (paragraph 0144).
Croughan teaches an art-standard method of making mutant rice plants and selecting such for herbicide tolerance (Example 28, beginning at paragraph 0075). Croughan teaches isolating nucleic acids encoding mutated, herbicide-resistant AHASL (comprising a substitution at position 627) from a plant derived by mutating said Cypress rice (Example 36 beginning at paragraph 0147 on pg. 20). Croughan teaches isolating AHAS enzyme from the herbicide resistant rice plants (paragraphs 0112-0113 and Table 5 on pg. 15). Croughan teaches using said isolated AHAS DNA sequences, under the control of an appropriate promoter, to transform crop plants (paragraphs 0171-0175). Croughan teaches that plants suitable for transformation are both monocots and dicots; such as rice, maize, wheat, rye, barley, sunflower, alfalfa, canola, soybean, peanut, tobacco, tomato and potato (paragraph 0185).
Croughan teaches methods of producing transformed plants and cells, comprising transforming plant cells with a transformation vector comprising said resistant AHASL nucleic acids, using selection media to select for AHAS-inhibitor resistant cells, and subsequently regenerating herbicide-resistant plants from those cells (paragraphs 0176-0180). Croughan teaches obtaining seeds from AHASL-inhibitor resistant rice plants (Examples 1-15, paragraphs 0061-0068).
Croughan teaches imidazolinone and sulfonylurea herbicides by trade names, generic names and chemical names, including for example, imazethapyr, imazapyr, imazamox, metsulfuron methyl, and nicosulfuron, among others (Abstract; paragraph 0225; see also paragraphs 0044; 0213-0214). Croughan teaches applying an imidazolinone herbicide as a pre-emergence application (paragraphs 0061-0063). Croughan teaches a process for controlling weeds in the vicinity of rice plants comprising resistant AHAS, comprising applying a herbicide to the weeds and to the plant, wherein the herbicide normally inhibits AHAS at the levels of the herbicides that would normally inhibit the growth of a plant of the same species (claim 14).
Croughan teaches that red rice, which belongs to the same species as cultivated rice, Oryza sativa, is a common weed of rice, teaches that while red rice can be controlled by a number of commercial herbicides, but the simultaneous herbicide sensitivity of cultivated rice makes using said herbicides impossible with wild-type cultivars; and teaches that AHAS inhibiting herbicides could be used to control red rice (paragraphs 0003-0007). Croughan teaches that besides controlling red rice, many AHAS-inhibiting herbicides effectively control other weeds commonly found in rice field (paragraph 0046). Croughan teaches spraying herbicide, onto plants (paragraph 0067, 0070, 0076). Croughan teaches soil and foliar applications of herbicides (paragraph 0108). Croughan teaches using “non-ionic surfactants” in herbicide spray solutions (paragraph 0076; Example 28).
Croughan does not expressly teach a rice AHAS comprising a leucine substitution at the position corresponding to position 171 of SEQ ID NO: 2.
Sibony et al teach that the Pro197Leu substitution in the AHAS of Amaranthus retroflexus confers resistance sulfonylureas and imidazolinones (Abstract; Table 4; pg. 517 under “Discussion”). Sibony et al teach that Pro197 is located in one of the enzyme’s five conserved domains, Domain A. Sibony et al teach that all of the potential nucleotide substitutions that lead to an amino acid change at Pro197 have been observed (including to serine, leucine, glutamine, alanine, threonine, arginine or histidine) and that all led to resistance to AHAS inhibitors (pg. 510, paragraphs 3-4).
Sibony et al teach sequencing the portions of the AHAS gene comprising the five conserved domains, and teach the sequence of the mutant allele and protein (Figure 4; pg. 520). Sibony et al teach applying various commercial formulations of sulfonylureas and imidazolinones to resistant plants. Sibony et al teach applying nicosulfuron, post-emergence, at a rate of 0.47-480 g ai/ha, and teach that the Pro197Leu substitution resulted in resistance ratio of 13 for said herbicide (Tables 1 and 2). Sibony et al teach that the highest resistance ratios of 118 and 127 were observed for chlorsulfuron. Sibony et al teach resistance ratios of 4 for imazapyr, and 63 for imazamethapyr (syn. imazapic) in Amaranthus plants (Table 2) and 24 and 116, respectively, in vitro (Table 4). Sibony et al teach that the tolerance AHAS enzyme showed high degree of resistance to imazethapyr in in vitro assays (Table 4). Sibony et al teach mixing sulfometuron-methyl in the sand before sowing (page 511).
Okuzaki et al teach successfully using site-specific oligonucleotide-based mutagenesis to introduce point mutations into the rice AHAS gene (Abstract and Introduction). Okuzaki et al teach specifically targeting Pro171 (in the rice numbering) and successfully introducing a mutation that resulted in the Pro171Ala substitution into said gene (pg. 510, right col). Okuzaki et al teach that the oligonucleotide-directed gene targeting is thought to be less complicated in rice than in tobacco or maize (pg. 512, 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 modify the teachings of Croughan and introduce, using the method of Okuzaki et al, a mutation into a rice AHASL, which would result in a substitution at a position corresponding to Pro171, as taught by Okuzaki et al and Sibony et al, including wherein the substitution is Pro171Leu taught by Sibony et al. It would have been obvious to apply said method to any rice crop plant, including the rice variety taught by Croughan. It would have been obvious to use the resultant rice plants in a method of weed control, such as the methods taught by Croughan, using any appropriate AHAS inhibiting herbicide to which the Pro197Leu substitution confers tolerance, including, for example, imazethapyr or chlorsulfuron, as taught by Sibony et al.
It would have been obvious to apply said method specifically to control red rice, a known rice weed, as suggested by Croughan. Applying an AHAS inhibiting herbicide in a liquid preparation via a spray, including foliar and soil application, would have been obvious in view of the suggestion of Croughan as well as standard industry practice.
With regard to applying a herbicide as a granular formulation, given that the term is not defined in the specification, it would read on a formulation in which an herbicide is mixed with any granular carrier, such as, for example, a mixture with sand as taught by Sibony et al.
Moreover, using a granular formulation of an appropriate imidazolinone or sulfonylurea would have been a matter of routine practice in the context of the soil application of an AHAS inhibiting herbicide. Similarly, applying in the form of a solution, including with an appropriate solvent, such as water, as taught by Sibony et al and Croughan et al or any appropriate commercial formulation, such as gel, powder or another form, would have been obvious as matter of routine industry practice. It is noted that Sibony et al teaches a number of commercial herbicide formulations (Table 1). Applying a herbicide in a solution comprising a surfactant, including a non-ionic surfactant would have been obvious in view of the teachings of Croughan.
With regard to the phenotype of tolerance to an imidazolinone herbicide, in view of the teachings of Sibony et al, one would reasonably expect the resultant plants to show said tolerance, including wherein the plant is not killed by the herbicide. Moreover, said property would have naturally flowed from the prima facie obvious structure of said plant. “The fact that appellant 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). In addition, said property does not limit the active steps of the instantly claimed method, as explained above.
Given that Okuzaki et al successfully introduced a substitution at Pro171 into the rice AHAS, and given the highly conserved nature of Pro171, one would have had reasonable expectation of success in arriving at the instantly claimed method.
9. Claims 12 and 14 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Croughan (U.S. Patent Application Publication 2003/0217381 A1, issued as US Patent 6,943,280 ) in view of Sibony et al (Weed Res. (2001) 41:509-522), and Okuzaki et al (Plant Cell Rep. (2004) 22:509-512), as applied to claims 1, 2, and 5-11, above, and further in view of Webster et al (Weed Science (2001) 49:652-657). Applicant’s arguments submitted on September 3, 2025 were fully considered but they are not persuasive.
The teachings of Croughan, Sibony et al, and Okuzaki et al have been set forth above. The references do not expressly teach application doses that are effective to kill, specifically, red rice or a weed of the genera recited in claim 12. It is noted that the instant claims do not recite any specific application doses or the level of weed control.
Webster et al teach that the post-emergence rates of 35 g ai/ha of nicosulfuron and 70 g ai/ha of imazethapyr were sufficient to control red rice and barnyardgrass (Echinochloa crus-galli) (Tables 3-5). Webster et al teach application doses that could control barnyardgrass and red rice for a number of other herbicides, including several that are taught by Sibony et al (Tables 3-5).
At the time the invention was made, it would have been prima facie obvious to modify the method made obvious by the teachings of Croughan, Sibony et al, and Okuzaki et al, and use a rice plant comprising the Pro171Leu substitution in a method of controlling red rice or barnyardgrass. It would have been obvious to use nicosulfuron, imazethapyr, or other herbicides to which Pro171Leu confers tolerance, at the application rates suggested by Webster et al. In addition, given the ranges of herbicide application rates taught by Sibony et al, and given the rates used to control red rice and barnyardgrass, as taught by Webster et al, it would have been obvious to arrive at specific appropriate application rates for the recited weed species, using routine optimization within the conditions taught by the prior art. MPEP 2144.05.
Given the teachings of Sibony et al and Webster et al, one would have had reasonable expectation of success at arriving at the application rates sufficient to kill at least some of the red rice or barnyardgrass plants within a population of cultivated rice comprising the Pro171Leu substitution.
10. Claim 13 remains rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Croughan (U.S. Patent Application Publication 2003/0217381 A1, issued as US Patent 6,943,280) in view of Sibony et al (Weed Res. (2001) 41:509-522), and Okuzaki et al (Plant Cell Rep. (2004) 22:509-512), as applied to claims 1, 2, and 5-11; and 30 above, and further in view of Ducar et al (Weed Technology (2004) 18:1018-1022). Applicant’s arguments submitted on September 3, 2025 were fully considered but they are not persuasive.
The teachings of Croughan, Sibony et al, and Okuzaki et al have been set forth above. The references do not expressly teach application doses that are affective to kill, specifically, a weed of the genera recited in claim 13. It is noted that the instant claims do not recite any specific application doses or the level of weed control
Ducar et al teach that post-emergence application of 35 g ai/ha of nicosulfuron or 36 g ai/ha of imazapic provided control of large crabgrass (Digitaria sanguinalis) (Table 1).
At the time the invention was made, it would have been prima facie obvious to modify the method made obvious by the teachings of Croughan, Sibony et al, and Okuzaki et al, and use a rice plant comprising the Pro171Leu substitution in a method of controlling large crabgrass. It would have been obvious to use nicosulfuron, for example at the application rates suggested by Ducar et al. Moreover, given that the Pro171Leu substitution confers resistance to sulfonylureas and imidazolinones, as taught by Sibony et al, and in view of the fact that large crabgrass is susceptible to both nicosulfuron and imazapic, it would have been obvious to use additional appropriate sulfonylureas or imidazolinones to control said weed in a population of rice comprising Pro171Leu, using routine optimization of conditions taught by the prior art. MPEP 2144.05.
Given the teachings of Sibony et al and Ducar et al, one would have had reasonable expectation of success at arriving at the application rates sufficient to kill at least some of the large crabgrass plants within a population of cultivated rice comprising the Pro171Leu substitution.
11. Claim 33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Croughan (U.S. Patent Application Publication 2003/0217381 A1, issued as US Patent 6,943,280 ) in view of Sibony et al (Weed Res. (2001) 41:509-522), and Okuzaki et al (Plant Cell Rep. (2004) 22:509-512), as applied to claims 1 and 30, above, and further in view of Agbaje et al (US Patent 6,165,939, issued on December 26, 2000).
The teachings of Croughan, Sibony et al, and Okuzaki et al have been set forth above. The references do not expressly teach using an emulsifier agent in an herbicidal composition.
Agbaje et al teach using emulsifiers in an herbicidal composition (Abstract; col. 4 lines 25-35; claim 1). At the time the invention was made, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of claims 1 and 30, using the teachings of Agbaje et al and use an emulsifier agent in the herbicidal composition used in said method. One would have been motivated to do so given the express teachings of Agbaje, and in order to enhance dispersion of the herbicidal composition.
Response to Arguments
Applicant maintains previously submitted arguments, including those directed to impermissible hindsight, motivation, reasonable expectation of success, the “different field of art” and the teachings of Okuzaki. Applicant reiterates the argument based on the Ex parte Christensen, In re Stepan, and Ex parte Malec decisions (pages 10-13 of the Remarks).
Applicant’s arguments were considered in detail in the previous Office Actions and remain not persuasive for the reasons of record. This includes the arguments directed to the phenotype of tolerance, impermissible hindsight, unexpected results, as well as the arguments based on the cited legal opinions and the Mankin Declaration.
The arguments based on the Pfizer and Johnson Matthey decisions remain not found to be persuasive as well. First, the reliance on the Johnson Matthey is misplaced. In that case, the Court addressed the indefiniteness of the functional limitations “effective for catalyzing” and “effective to catalyze,” and held that the terms were not indefinite under the Nautilus “reasonable certainty” standard. 875 F.3d 1362, 1366 (Fed. Cir. 2017). This is not the issue here, as there is no dispute regarding the metes and bounds of the recited phenotypes.
Second, Applicant’s argument based on the analogy to the Pfizer decision is not persuasive. Enantiomers are structurally distinct compounds, in spite of the fact that they share the same elemental composition, as reflected in their chemical formula. This is well-known in the art and was expressly addressed by the Federal Circuit in the opinion: “Stereochemistry is the study of the three-dimensional structure of molecules. Stereoisomers have the same molecular formula or atomic composition, but different spatial arrangements. Enantiomers are a pair of stereoisomers that are non-superimposable mirror images of each other and often have distinct physical properties.” 457 F.3d 1284, 1287.
In contrast, in the instant case, Applicant has pointed to no structural difference between the rice plant of the instant claims and a rice plant that would have been made prima facie obvious by the combined teachings of the cited prior art.
With regard to the Hoffer v. Microsoft opinion, cited by Applicant in the previous Remarks, and the “whereby” clause it addresses, the argument is not persuasive either. There is no dispute that in some cases, a “whereby” clause, including where it recites a property, may actually be material to patentability. This is determined on a case-by-case basis. See MPEP 2111.04. In the instant case, the recited property was not unexpected, as set forth in the rejection above.
The Examiner maintains that position Pro197 is located in one of the five domains of the AHALS that are highly conserved in all plant species in which the enzyme has been studied. Introducing a substitution at said position would not only have been an obvious way to achieve an agronomically desirable result, but doing so was actually reduced to practice by Okuzaki et al.
Okuzaki et al expressly teach introducing a substitution into a rice AHAS at Pro171, while the leucine substitution at said position is taught by Sibony et al. A plant thus obtained would read on the structure of the plant used in the claimed methods. The Examiner notes that the plant obtained using the method of Okuzaki et al would be considered “non-transgenic” and would read on the plant used in the claimed method. Applicant supplied no evidence that the method of Okuzaki et al would have resulted in a product that is structurally different than the product encompassed by the instant claims.
With regard to the herbicide tolerance properties conferred by the Pro197Leu substitution, Sibony et al teach that the Pro197Leu substitution confers tolerance to imazethapyr to whole plants and strong tolerance to the AHASL enzyme in in vitro assays (Tables 2 and 4). Thus, one would have reasonably expected that a rice plant comprising said substitution would “possess a phenotype of tolerance to an affective weed-controlling amount of an AHAS inhibiting herbicide.” It is noted that the instant claims encompass any degree of tolerance to any AHAS inhibiting herbicide.
Moreover, as explained in the previous Office Actions, all known herbicide-tolerance substitutions at the relative position Pro197 confer tolerance to sulfonylureas, but only one, Pro197Leu, “has been implicated in strong resistance to imidazolinones.” See McCourt et al (2006) PNAS 103:569-573, page 572, paragraph spanning the columns (citing Sibony et al). This teaching (which Applicant fails to address) further confirms that one would have been able to predictably use a rice plant comprising the Pro197Leu substitution in a method of weed control, in which either an imidazolinone or a sulfonylurea is applied; and that one would also have been able to reasonably expect the plant to be tolerant to imidazolinones, including imazethapyr. Therefore, the prior art makes obvious both, the active steps of the claimed method and the property of the plant used in said method. The rejection is maintained.
Double Patenting
12. 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.
13. Claims 1, 2, 5-8, 12-16, 19-27, 30, and 31 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7, 8, and 22-25 of copending Application No. 16/160,268 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the instant application are drawn to a method for treating rice comprising applying to said rice at least one AHAS inhibiting herbicide, including wherein the herbicide is sulfonylurea and/or imidazolinone, wherein said rice comprises a rice AHASL polypeptide comprising the P197L substitution.
The claims of the co-pending application are drawn to a method for treating rice comprising applying a sulfonylurea herbicide to rice, wherein the plant comprises an AHASL with the P197L substitution, including wherein the AHASL comprises the polynucleotide of a plant of IMINTA 15, and wherein said method further comprises applying an imidazolinone herbicide to said plant. It is noted that the claims do not require or recite a specific sequence for the limitation “polynucleotide of a plant of line IMINTA 15.” Given the substitution at issue, while recited relative to different reference sequences, is identical in the instant and co-pending application, and given the overlap in the active steps of the claimed methods, the claims of the co-pending application make obvious the method of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant argues that Applicant will consider filing a terminal disclaimer upon the indication that the claims are otherwise in condition for allowance (page 12 of the Remarks). This is not found to be persuasive, as the claims remain rejected on the grounds set forth above, and no terminal disclaimer has been filed. The rejection is maintained.
Conclusion
14. No claims are allowed.
15. 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.
16. 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