DETAILED ACTION
Status of the Application
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Claims 84, 85, 88, 90-105, 107 and 108 are pending.
3. Claims 100-101 remain withdrawn.
4. Claims 84, 85, 88, 90-99, 102-105, 107, and 108 are examined herein.
5. The rejection under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendments to the claims.
Election/Restrictions
6. Applicant’s election without traverse of claims 84-99 in the reply filed on November 11, 2021 is acknowledged. Claims 100 and 101 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 11, 2021.
Claim Interpretation
7. The following is noted with regard to claim interpretation. Claim 84 encompasses a rice plant comprising a wild-type AHAS or any herbicide-tolerant AHAS that is “non-transgenic and free of site-directed mutation.” The term “non-transgenic” is reasonably interpreted as “not comprising an exogenously introduced transgene.” However, to the extent that the requirement that the plant be “free of site directed mutation” is applied to a nucleotide substitution resultant in a point mutation in the encoded protein, the clause would not introduce any structural limitations to the plant beyond the presence of said substitution. Thus, a plant, comprising said point mutation and obtained using a method of direct mutagenesis would be structurally indistinguishable from a plant obtained using a mutagenesis and selection approach.
The recitation that follows the term “has been determined” and the phrase “the plant’s rice line is derived from a plant having a phenotype of tolerance” are interpreted as encompassing a “rice line plant” that possesses the recited tolerance to the two imidazolinones. The term “rice line plant,” which in the previous amendments replaced the term “rice crop,” is read to encompass any cultivated rice plant.
Claim 88 is read to encompass any level of tolerance to said recited application rates, which is reasonably interpreted as any phenotypical manifestation of herbicide damage so long as that damage is lower than that which is observed for wild-type control rice plants. Similarly, in claims 84 and 88 the term “phenotype of tolerance” is read as being inclusive of any level of tolerance, however small, determined in any way, so long as it is higher than that of a wild-type plant.
It is noted that the phenotype of tolerance recited in claims 84 and 88 is a property of the recited rice plant: the claims do not require the actual application of the two herbicides at the recited rates. It is also noted that claim 84 is inclusive of additional herbicides other than the ones recited, in the context of both, the phenotype and the “applying” step. Claims 97-99 are drawn to said method, wherein the amount of an AHAS inhibiting herbicide is sufficient to kill the weed of the recited species, including barnyardgrass or red rice.
The term “phytotoxic symptoms,” in claim 84, is not defined in the specification, and is interpreted as inclusive of any one of the known manifestations of imidazolinone toxicity that can be statistically evaluated, such as chlorosis.
Claim Rejections - 35 USC § 102
8. The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
9. Claims 84, 85, 88, 90, 91, 93, 97-99, 102-105, and 108 remain rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Croughan (U.S. Patent Application Publication 2003/0217381 A1, WIPO Publication 01/85970 A2, PCT filed 9 May 2001, issued as US Patent 6,943,280), taken with the evidence of Webster et al (Weed Science (2001) 49:652-657) and Ducar et al (Weed Technology (2004) 18:1018-1022). Applicant’s argument filed on February 10, 2026 was fully considered but it is not persuasive.
The claims are drawn to a method for treating rice, comprising providing a “rice line” plant that is non-transgenic and free of site-directed mutagenesis, and at least one AHAS inhibiting herbicide, wherein the rice plant comprising a phenotype of tolerance to two applications of 75 cc ai/ha imazapyr and 24.85 g ai/ha imazapic; applying an effective amount of said herbicide post-emergence; and growing the resultant rice plant, including wherein said herbicide is imazethapyr, imazapyr, or imazapic. The claims are drawn to said method, further comprising harvesting seed from the treated rice plant. The claims are drawn to said method, wherein the phenotype is observable as the plants being “not killed or inhibited in its growth.”
Croughan discloses obtaining herbicide tolerance rice plants comprising mutant AHAS, comprising the S627N substitution, by EMS or X-ray mutagenesis and subsequent selection (Examples 1-15; Example 28). Croughan discloses applying, post-emergence, imidazolinone herbicides to non-transgenic herbicide resistant rice plants, including wherein said herbicides are imazethapyr, imazapyr, and imazapic; and teaches obtaining seeds of resistant plants (paragraphs 0079-0082; 0088; Tables 1-4). Croughan discloses that resistant plants possessed resistance to a number of AHAS inhibitors, including imazethapyr, imazapyr, and imazapic (paragraph 0077). Croughan discloses applying herbicides in a solution (paragraphs 0076, 0093)
One would recognize that in view of the disclosure of Croughan, the step of growing said resistant rice plants must have been inherently practiced in order to obtain the seeds of said plants. In addition, given that Croughan disclose the post-emergence application to the rice plant, and the application to both, weeds and rice plants, said application steps must inherently entail at least some foliar application and at least some soil application of the herbicide (instant claims 102 and 103).
Croughan discloses applying imazapyr to rice plants, post-emergence, at the rate of 0.05-0.1 lb ai/A (equivalent to 60-110 g ai/ha), imazethapyr at the rate of 0.125 lb ai/A (equivalent to 140 g ai/ha), and imazapic at 0.075-0150 lb ai/A (equivalent to 80-168 g ai/ha); and discloses that the rice plants to which said doses were applied were tolerant to said herbicides (Tables 1-3). Croughan discloses applying, post-emergence, a combination of imazapic at 0.75 lb ai/A (equivalent to 840 g ai/ha) and imazapyr at 0.025 lb ai/A (equivalent to 30 g ai/ha), wherein the plants were tolerant to said combination (Table 3). Croughan discloses that imazapic and imazapyr were applied as two applications (Table 3). Croughan discloses using a non-ionic surfactant in the herbicide composition (paragraph 0076). One would recognize that the surfactant of Croughan will read on the “detergent” of the instant claim 108.
Webster et al provide evidence that imazapic at 70-140 g ai/ha or imazapyr at 32-64 g ai/ha were sufficient to control red rice and barnyardgrass (Echinochloa crus-galli) (Tables 3-4). Ducar et al teach that the rate of 36 or 72 g ai/ha of post-emergence imazapic was sufficient to control large crabgrass (Digitaria sanguinalis) (Table 1). It is noted that the instant claims do not recite a specific level of weed control. Thus, the rates of Croughan, which encompass the rates of Webster et al and Ducar et al, would be inherently sufficient to kill at least some of the red rice, barnyardgrass, or large crabgrass.
Barring any evidence to the contrary, the phenotype of tolerance to the recited application rates of imazapyr and imazapic would be inherent in the rice plants of Croughan, in view of the application doses of said two herbicides to which the plants of Croughan were tolerant, and given the claim interpretation above, including, the fact that claims do not specify a level of tolerance.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01.
Response to Arguments
Applicant argues that Croughan does not disclose all the limitations of the instant claims and that the herbicide application rates of Croughan are higher than the ones recited in the claims (page 6 of the Remarks).
This is not found to be persuasive. The active steps of the method of claim 84 do not recite application rates, and will encompass any affective amount of the “at least one AHAS-inhibiting herbicide composition.” The rates are recited only as a property of the plant used in said method. This is set forth in the claim interpretation section, above. The application dosages of Croughan were cited to address said property: the fact at the plants of Croughan were tolerant to two applications of the rates that were higher than the instantly recited ones indicates that the plants of Croughan inherently possess the property of tolerance to those rates. The application of any effective amount of an herbicide, including those in Croughan will read on the “applying” step of claim 84. The rejection is maintained.
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 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.
11. Claims 84, 85, 88, 90, 91, 93, 95-99, 102-105 and 107-108 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), taken with the evidence of Webster et al (Weed Science (2001) 49:652-657) and Ducar et al (Weed Technology (2004) 18:1018-1022), in view of Kolkman et al (2004, Theoretical and Applied Genetics 109:1147-1159), Okuzaki et al (Plant Cell Rep. (2004) 22:509-512), and Battista (May 2002, Better Crops International Vol. 16, Special Supplement, pages 41-42). Applicant’s argument filed on February 10, 2026 was fully considered but it is not persuasive.
The claims are drawn to a method for treating rice, comprising provide a “rice line” plant and at least one AHAS inhibiting herbicide, wherein the rice plant comprising a phenotype of tolerance to two applications of 75 cc ai/ha imazapyr and 24.85 g ai/ha imazapic; applying an effective amount of said herbicide post-emergence; and growing the resultant rice plant, including wherein said herbicide is imazethapyr, imazapyr, or imazapic. The claims are drawn to said method, further comprising harvesting seed from the treated rice plant. The claims are drawn to said method, wherein the phenotype is observable as the plants “being not killed or inhibited in its growth.”
The claims are drawn to the method of claim 84 wherein the rice plant comprises an endogenous AHALS polypeptide having an alanine to valine substitution at a position corresponding to position 179 of SEQ ID NO: 2; or wherein the plant comprises SEQ ID NO: 2. The instant specificaiton provides evidence that the rice AHAS polypeptide of SEQ ID NO: 2 was obtained by mutagenizing the AHASL gene of rice cultivar IRGA 417 (Example 1).
Croughan teaches a method of controlling weeds in the vicinity of a rice plant comprising an AHAS nucleic acid encoding an AHAS (AHASL1) protein with a S627N substitution, said process comprising applying a herbicide to the weeds and to the rice plant, wherein the herbicide normally inhibits the growth of a rice plant (claims 8, 15-16).
Croughan teaches applying, post-emergence, imidazolinone herbicides to resistant rice plants, including wherein said herbicides are imazethapyr, imazapyr, and imazapic; and teaches obtaining seeds of resistant plants (paragraphs 0079-0082; 0088; Tables 1-4). Croughan teaches that resistant plants possessed resistance to a number of AHAS inhibitors, including imazethapyr, imazapyr, and imazapic (paragraph 0077). Croughan teaches applying herbicides in a solution (paragraphs 0076, 0093). Croughan teaches applying pre-emergence spraying to “dry ground” (paragraph 0102).
One would recognize that in view of the disclosure of Croughan, the step of growing said resistant rice plants must have been inherently practiced in order to obtain the seeds of said plants. In addition, given that Croughan teaches the post-emergence application to the rice plant, and the application to both, weeds and rice plants, said application steps must inherently entail at least some foliar application and at least some soil application of the herbicide (instant claims 102 and 103).
Croughan teaches applying imazapyr to rice plants, post-emergence, at the rate of 0.05-0.1 lb ai/A (equivalent to 60-110 g ai/ha), imazethapyr at the rate of 0.125 lb ai/A (equivalent to 140 g ai/ha), and imazapic at 0.075-0150 lb ai/A (equivalent to 80-168 g ai/ha); and discloses that the rice plants to which said doses were applied were tolerant to said herbicides (Tables 1-3). Croughan teaches applying, post-emergence, a combination of imazapic at 0.75 lb ai/A (equivalent to 840 g ai/ha) and imazapyr at 0.025 lb ai/A (equivalent to 30 g ai/ha), wherein the plants were tolerant to said combination (Table 3). Croughan discloses that imazapic and imazapyr were applied as two applications (Table 3).
In addition, Croughan teaches, at SEQ ID NO: 17, the amino acid sequence of the wild-type AHAS protein from the wild-type Cypress rice, which sequence is encoded by the corresponding nucleic acid sequence of SEQ ID NO: 14 (paragraph 0144, pg. 19). The amino acid sequence of SEQ ID NO: 17 of Croughan has 99.5% sequence identity to the instant SEQ ID NO: 2. The sequence alignment between SEQ ID NO: 17 of Croughan and the instant SEQ ID NO: 2 is set forth below.
; Sequence 17, Application US/10258842
; Publication No. US20030217381A1
; 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
; ORGANISM: Oryza sativa
; OTHER INFORMATION: Inferred complete AHAS sequence, wild type var. Cypress
Query Match 99.5%; Score 3312; DB 4; 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
The amino acid sequence of Croughan differs from the instant SEQ ID NO: 2 at amino acid position 31, 179, 604, and 643. Position 179 is the only difference that lies within the art recognized conserved Domain D “AFQETP.” The other differences do not lie within the domains of a plant acetohydroxyacid synthase large subunit that are involved in herbicide tolerance. Given that the cultivar from which SEQ ID NO: 14 was isolated, Cypress, is identified as wild-type by Croughan, the differences at positions 31, 604, and 643 appear functionally silent, representing natural variance within the rice species.
Croughan teaches transforming a rice plant with a transformation vector comprising the mutant AHASL of their invention (claims 1, 6-15).
Webster et al provide evidence that imazapic at 70-140 g ai/ha or imazapyr at 32-64 g ai/ha were sufficient to control red rice and barnyardgrass (Echinochloa crus-galli) (Tables 3-4). Ducar et al teach that the rate of 36 or 72 g ai/ha of post-emergence imazapic was sufficient to control large crabgrass (Digitaria sanguinalis) (Table 1). It is noted that the instant claims do not recite a specific level of weed control. Thus, the rates of Croughan, which encompass the rates of Webster et al and Ducar et al, would be inherently sufficient to kill at least some of the red rice, barnyardgrass, or large crabgrass.
Croughan does not teach the instant SEQ ID NO: 2 or a substitution equivalent to Ala179Val.
Kolkman et al teach the Ala205Val mutation in sunflower AHASL conferring resistance to imazethapyr and chlorimuron (pg. 1153, right column, 1st paragraph). Kolkman et al teach that Ala205 is conserved in AHAS enzymes in numerous species (pg. 1157, left col.).
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 that the oligonucleotide-directed gene targeting is thought to be less complicated in rice than in tobacco or maize (pg. 512, right col).
Battista teaches that rice cultivar IRGA 417 was a publicly available commercial variety at the time of Applicants' invention (page 41, 3d paragraph).
It would have been prima facie obvious to one of ordinary skill in the art at the time of Applicant’s invention to modify the teachings of Croughan using the teachings of Kolkman et al, and introduce a valine at amino acid position 179 relative to SEQ ID NO: 2, into a rice acetohydroxyacid synthase large subunit to produce an herbicide-tolerant rice plant - either using the selection method of Croughan or the site-directed mutagenesis method of Okuzaki et al. It would have been obvious to use the resultant plant in a method of weed control by applying to said rice any appropriate herbicide to which said substitution confers tolerance, including the herbicides taught by Kolkman et al, including imazapic or imazapyr at their standard rates, as taught by Croughan, which rates encompass 24.85 g ai/ha imazapic. By applying said method to the plant and the rice AHASL of Croughan, one would have arrived at the method that would read on the method of claims 84 and 95.
Applying a herbicide composition wherein it comprises a detergent would have been obvious in view of the teachings of Croughan (claim 108). Applying the composition by dusting (just as by spraying) would have been obvious in view of the routine industry practice. In addition, the term “dusting” is not defined in the specification, and as one of ordinary skill in the art would recognize at least some of the sprayed herbicide solution would necessarily result in the application in the form of dust, after the evaporation of the liquid carrier.
In addition, it would have been prima facie obvious to apply said methods to any commercial rice variety, including IRGA 417 of Battista et al. Given the conserved nature of the AHASL domain in which position 179 is located, by applying the mutagenesis and selection method of Croughan or the targeted mutagenesis method of Okuzaki et al, and selecting for the presence of the Ala179Val substitution, one would have obtained a rice plant comprising a nucleic acid encoding the protein of the full-length SEQ ID NO: 2.
Moreover, it would have been also prima facie obvious to obtain a transformation vector comprising a nucleic acid encoding the resultant mutant AHAS comprising the Ala205Val substitution of Kolkman et al, and subsequently transform a rice plant with said vector, as taught by Croughan, and use said rice plant in a method for treating rice. The resultant method would read on that of the instant claim 84, in view of the above claim interpretation.
One would have been motivated to combine the above teachings given that Kolkman et al teach that the alanine to valine substitution at a position corresponding to position 179 confers resistance to imidazolinones and sulfonylureas, and given the desirability of AHAS-herbicide resistant crops. Because Okuzaki et al teach successfully using site-specific oligonucleotide-based mutagenesis to introduce point mutations into the rice AHAS gene, given that Croughan reduced the invention to practice, and given the highly conserved nature of the AHASL amino acid position corresponding to position 179 of SEQ ID NO: 2, one would have had a reasonable expectation of success.
Regarding the property of tolerance to the application rates of imazapyr and imazapic, it is noted that the rice plant obtained by introducing the Ala205Val substitution of Kolkman et la into the endogenous AHASL gene of the IRGA 417 cultivar of Battista et al will read on the structure of the rice plant recited in the instant claims 95 and 96. The instant specification admits that rice plants obtained by introducing said substitution into the endogenous AHALS gene of the IRGA 417 cultivar exhibit said property (Examples 1 and 2). Taken with that evidence, the prima facie obvious plants will inherently comprise the recited phenotype. The presence of said substitution is the only structural difference from the wild-type IRGA 417 plants, as taught by the specification.
12. Claims 92 and 94 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), taken with the evidence of Webster et al (Weed Science (2001) 49:652-657) and Ducar et al (Weed Technology (2004) 18:1018-1022), in view of Kolkman et al (2004, Theoretical and Applied Genetics 109:1147-1159), Okuzaki et al (Plant Cell Rep. (2004) 22:509-512), and Battista (May 2002, Better Crops International Vol. 16, Special Supplement, pages 41-42), as applied to claim 84, and further in view of Peng et al (Transgenic rice resistant to imidazolinone herbicides, in Khush et al, Ed. 2003. Advances in rice genetics. Supplement to Rice genetics IV. Proceedings of the Fourth International Rice Genetics Symposium, 22- 27 October 2000, Los Baños, Philippines; pg. 590-593). Applicant’s argument filed on February 10, 2026 was fully considered but it is not persuasive.
The claims are drawn to the method of claim 84, wherein the composition applied in said method comprises applying the equivalent of 75 cc ai/ha imazapyr or 24.85 g ai/imazapic, more than once.
Croughan does not expressly teach applying imazapyr or imazapic to imidazolinone tolerant plants, post-emergence, more than once.
Peng et al expressly teach applying imazapyr and imazapic to transgenic rice plants at 1x, 2x, 4x, and 6x application rates; and teach that 1x rate for imazapic is 32 g ai/ha and for imazapyr is 24 g ai/ha (Tables 1 and 3).
At the time the invention was made, it would have been prima facie obvious to modify the method of claim 84 and apply imazapyr or imazapic, as suggested by Croughan et al, using the protocol taught by Peng et al. Given the teachings of Peng et al, the specific application conditions, including the number of applications and the specific doses, would have been a matter of optimization within prior art conditions or optimization through routine experimentation, including applying a 2-4x dose as a single application or as several doses. It is noted that the application rates taught in Peng et al encompass the rates recited in the instant claims. Once would have been motivated to do so given the teachings of Peng et al.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Response to Arguments
Applicant reiterates the argument that Croughan does not teach all of the elements of the instant claims; and reiterates the previously submitted arguments directed to the teachings of Okuzaki and the recited phenotype of herbicide tolerance (pages 7-10).
Applicant’s argument is not found to be persuasive. To the extent that the instant Remarks reiterate the previously submitted arguments, those were addressed in detail in the previous Office Actions and remain unpersuasive for the reasons of record. For example, the Examiner maintains that Applicant’s argument that the “phenotype elements are structural elements” is supported by no factual evidence in the record. The teachings of Croughan, as applied in the context of the anticipation rejection, are addressed above.
Applicant’s arguments based on the Pfizer, Farnham, and Johnson Matthey decisions were also previously addressed and remain not persuasive for the reasons of record. The Examiner notes that the instant claim 84 recites no structural limitations for the rice plant used in the claimed method, and would encompass any rice plant exhibiting tolerance to the recited two applications of imazapyr and imazapic.
With regard to the teachings of Okuzaki, the argument remains not persuasive either. Frist, the argument ignores the fact that the method of Okuzaki et al it not the only method one could have used to predictably arrived at the claimed invention. For example, one could have used the standard mutagenesis and selection method of Croughan. Moreover, the method of Okuzaki does not require the introduction of a transgene into the genome of the target plant, and by using it, one would have predictably arrived at a plant whose structure would directly read on that of the plant used in the method of claim 84.
The Examiner maintains that the substitution recited in claim 95 was well-known in the prior art: Kolkman et al teach the Ala205Val substitution in sunflower AHASL conferring resistance to imazethapyr and chlorimuron (pg. 1153, right column, 1st paragraph). Kolkman et al teach that Ala205 is conserved in AHAS enzymes in numerous species (pg. 1157, left col.). This teaching would have been sufficient to motivate one of skill in the art to select said substitution. The fact that other herbicide tolerance-conferring AHAS mutations were known in the art at the time of invention would not have taught away from said substitution. Moreover, methods of predictably introducing said substitution into an AHASL of a rice plant were also known in the art at the time of invention. The rejection is maintained.
Conclusion
13. No claims are allowed.
14. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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