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 1, 5, 11-13, 17-22, 28-30, and 36-38 are pending.
3. Claims 1, 5, 11-13, 17-22, 28-30, and 36-38 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 24, 2026 has been entered.
Claim Interpretation
5. As set forth below, the claims have been found indefinite. The following is noted with regard to claim interpretation. The recitation in the preamble of claim 1, “greater than three cell clones per hundred grams of plant cells and greater than that resulting from use of sethoxydim as a plant cell selection agent,” is read as a desired result of the claimed method. See MPEP 2111.04.
Step (d) of claim 1 recites “identifying a number of cells surviving step (b) that is both (i) greater than three cell clones per hundred grams of plant cells or tissue culture cultured in step (b), and (ii) greater than the number of cell clones that would result from using, in step (b), sethoxydim as the ACCase inhibitor; each cell clone independently containing a mutant plastidic ACCase comprising at least one ACCase-inhibitor-tolerance mutation that was not present in the plant cells or tissue of step (a).” The limitation “identifying” is reasonably interpreted as such that can be achieved via a mental step, without any further transformation to the cells that survived the active steps of culturing them in the presence of 0 to 2.5 uM of cycloxydim, in step (b), which cells have also been screened for mutations, in step (c).
Moreover, the step of “identifying a number of cell clones surviving step (b) that is … greater than three cell clones per hundred grams of plant cells or tissue cultured in step (b)” (emphasis supplied) does not require that the presence of any specific number of “cell clones.” The claim does not require any actual physical manipulation or transformation of the “cell clones” identified in step (d) (such, as for example, would be required by selecting a certain number of clones) – besides using “at least one surviving clone” in step (e).
The mutagenesis rate, recited in step (d), would have been a naturally flowing consequence of the active method steps. This is particularly true given the conditional nature of the recitation “would result from using … sethoxydim.” See MPEP 2111.04.
Response to Arguments
Applicant disagrees with the Examiner’s claim interpretation, and argues that the “preamble clause is a substantive claim limitation because it gives meaning and purpose to the manipulative steps of the method. For example, a skilled person performing the stated steps, but with addition of harmful steps or with antibiotic conditions or ingredients that inhibit the biological processes underlying the method defined by the present claims - thereby artificially lessening the mutation throughput rate to one below the minimum rate stated in the preamble - would thus produce a method outside the scope of the claimed method” (page 6 of the Remarks).
This is not found to be persuasive. It is unclear how Applicant’s hypothetical scenario in the argument above relates to the substance of the claim interpretation issue. The claimed method is limited by its active steps that require culturing rice plants in the presence of incremental concentrations of cycloxydim and screening the surviving cells for the presence of ACCase mutations. The “identifying” step, besides rendering the claim indefinite, does not require an actual selection or manipulation of any specific cells; nor does step (d) or any other portions of the claim require that any number of cells actually survive step (b), beyond the “at least one” clone used in step (e). For these reasons, the rate of mutagenesis obtained using the active steps of the claimed method is properly interpreted as an intended result.
Claim Rejections - 35 USC § 112 - Indefiniteness
6. 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.
7. Claims 1, 5, 11-14, 17-22, 28-30, and 36-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, the following recitation renders the claim indefinite: “(d) identifying a number of cell clones surviving step (b) that is both (i) greater than three cell clones per hundred grains of plant cells or tissue cultured in step (b), and (ii) greater than the number of cell clones that would result from using, in step (b),sethoxydim as the ACCase inhibitor.” It is unclear how to practice step (d), for the following reasons.
First, it is unclear whether step (d) needs to be practiced after step (c), as the former step refers only to step (b). As a result, it is unclear whether the screening step (c) is meant to be practiced before or in the alternative to step (d). Second, it is unclear how subpart (ii) of step (d) is meant to be practiced: the claim does not recite any active steps that mention sethoxydim, and it is thus unclear how one would be able to determine what “number of cell clones” would result from using sethoxydim in step (b). Third, it is unclear whether the number of “surviving clones” as recited in subpart (d)(ii) is actually required to practice the method. For example, it is unclear whether “identifying” a single cell “per hundred grams” of cell culture would be within the scope of the instant method or not; particularly given that only a single surviving cell is needed for the regeneration of a plant in step (e).
Given that claims 5, 11-14, 17-22, 28-30, and 36-38 depend from clam 1 and fail to recite additional limitations overcoming its indefiniteness, these dependent claims are indefinite as well.
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 1, 5, 11-13, 17-22, 28-30, and 38 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Somers et al (US Patent 5,290,696), in view of Ferrero et al (Crop Protection (1999) 18:245-251), Bekavac et al (Abstract in Poljopriverda/Agriculture J. (2008) Supplement, Vol. 14, No. 1), Terakawa et al (Japan J. Breed. (1992) 42:267-275), Delye et al (Pest Mgmt. Sci. (2008) 64:1179-1186) and Delye et al (Planta (2002) 214:421-427). This rejection has been modified in view of Applicant’s amendments to the claims. Applicant's arguments filed on March 24, 2026 have been fully considered but they are not persuasive.
The claims are directed to a method for screening herbicide-tolerant mutants of a rice plastidic ACCase, comprising culturing the cells or tissues of said plant in the presence of cycloxydim, wherein the cells and tissues are tolerant to cycloxydim due to the presence of a mutation (unspecified in the claims) in the ACCase, wherein said mutation is not present before the culturing in the cycloxydim; including wherein said culturing comprises the step of culturing in the presence of a mutagen. The claims are drawn to a seed, cell, or part of a rice plant produced by the method of claim 1, to a progeny or descendant of said plant; to a method of treating said plant with an agriculturally acceptable composition; and to a method of breeding said plant.
Somers et al teach a method of imparting herbicide tolerance to maize plants comprising forming a maize callus tissue culture of plant cells; subjecting said maize callus tissue culture to a cyclohexanedione herbicide; selecting for plant cells from said maize callus tissue culture which comprise a gene encoding for an acetyl coenzyme A carboxylase (ACCase) which is tolerant of inhibition by a cyclohexanedione herbicide at levels which normally inhibit the activity of ACCase; and generating maize plants from said selected maize callus tissue culture of plant cells, wherein said cells comprise said gene encoding an acetyl coenzyme A carboxylase (ACCase) which is tolerant of inhibition by a cyclohexanedione herbicide at levels which normally inhibit the activity of ACCase (claim 1).
Somers et al teach said method wherein the callus tissue culture of said cells is exposed to increasing concentrations of said herbicide prior to selecting for said plant cells comprising said gene encoding for an acetyl coenzyme A carboxylase (ACCase) which is tolerant of inhibition by a cyclohexanone herbicide at levels which normally inhibit the activity of ACCase (claim 5, Example II, beginning in col. 14). Somers et al teach growing calli in agar-based media and exposing the calli to 0.5, 1.0, 2.0, 5.0 and 10.0 uM of sethoxydim (col. 14, lines 21-59). Somers et al teach selecting one of the two sethoxydim resistant lines exhibiting growth at the highest concentration of the herbicide, 10 uM, transferring portions of the callus of said line onto filter paper overlaying agar, and exposing those calli to tissue culture medium containing increasing amounts of sethoxydim, up to 100 uM (col. 14, line 61 - col. 15, line 12). Somers et al teach conducting ACCase activity assays of the ACCase from the resistant line and determining that the enzyme from the resistant line was significantly more tolerant to sethoxydim that the enzyme from a non-resistant control line (col. 15, lines 16-28). Somers et al teach the use of mutagens to introduce mutations into ACCase genes (col. 10, lines 28-47).
Somers et al teach regenerating sethoxydim resistant maize plant from said resistant cell line and obtaining seeds and progeny of the regenerated plants (Example III in col. 15-16). Somers et al teach using the resistant plant in a breeding program to obtain herbicide tolerant progeny seed (col. 16, lines 1-16 and 50-68). Somers et al teach that the resistance to sethoxydim is controlled by a single dominant nuclear gene (col. 16, lines 44-46).
Somers et al teach as follows: “The present invention contemplates the introduction of herbicide tolerance into certain monocotyledons, preferably maize. Other monocotyledons into which herbicide tolerance may be introduced by the present invention include other cereal crops such as rice, wheat, barley, sorghum, oats, rye, millet, turf and forage grasses, and the like” (col. 9, lines 44-62).
Somers et al do not expressly teach using cycloxydim in their methods.
Ferrero et al teach that cycloxydim is effective in controlling red rice in rice field, in pre-emergent applications (Abstract). Ferrero et al teach that close similarities between cultivated rice and red rice limit the use of herbicides to control red rice in rice fields, and that preventive measures are difficult to apply in part because the seeds of red rice cannot be easily distinguished from those of cultivated varieties (pg. 246, left col., first and second paragraphs). Ferrero et al teach that “It is to be expected that, in the near future, the problem of red rice will be faced by the introduction of herbicide tolerant varieties … which could allow the selective post-emergence control of the weed” (pg. 246, left col., fourth paragraph). Ferrero et al expressly identify cycloxydim as a cyclohexanedione herbicide, which is also known in the art (pg. 250, left col.).
Bekavac et al teach that cycloxydim-tolerant maize has been developed, wherein the plants were regenerated from tissue culture selected for callus growth in the presence of cycloxydim (Abstract, single page).
Terakawa et al teach a method of making a rice plant resistant to a sulfonylurea herbicide, comprising obtaining calli from a commercial rice variety, growing said calli in a selection media comprising said herbicide, selecting surviving calli, and subsequently regenerating mature herbicide resistant plants (pg. 268, under “Callus materials;” pg. 269, under “Callus selection” on pg. 270).
Delye et al (2008) teach that the I1781L substitution in the ACCase of black grass (Alopecurus myosuroides) confers resistance to cycloxydim at field rates (Abstract; Table 2; Table 3; pg. 1184, right col.).
Delye et al (2002) teach that a chloroplastic ACCase allele with one point mutation, I1781L, is a dominant gene for resistance to sethoxydim. Delye et al teach that the region where the mutation is found, CT domain, is highly conserved in eukaryotes ranging from maize to humans, and teaches amino acid sequences of said region (pg. 425, left col., Fig. 3 on pg. 426).
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 method of Somers et al and apply cycloxydim, taught by Ferrero et al and Bekavac et al, to in vitro tissue culture of a Poaceae crop plant, including rice, select resistant cells or tissues, and regenerate cycloxydim resistant plant from said tissues or cells. The specific concentrations of cycloxydim, as recited in claims 1 and 28-30, would have been prima facie obvious given the range of concentrations taught by Somers et al, as a matter of routine optimization within prior art conditions. MPEP 2144.05. It would have been obvious to culture said cells or tissues in the presence of a chemical or physical mutagen, in addition to the presence of cycloxydim, as taught by Sommers et al .
It would have been obvious to apply cycloxydim in a step-wise fashion, as taught by Somers et al for sethoxydim. It would have also been obvious to apply said method to any crop that is a Poaceae BEP clade member, including, for example, the commercially important rice variety taught by Terakawa et al.
The step of regenerating a rice plant from tissue culture following the cycloxydim selection would have been obvious given the teachings of Terakawa et al. Breeding the resultant rice plant would have been obvious as a matter of standard industry practice and in view of the teachings of Somers et al. Treating the resultant rice plant with an agriculturally acceptable composition, such as cycloxydim-containing field compositions taught by Ferraro, would have been obvious as well.
One would have been motivated to modify the teachings of Somers et al, and use cycloxydim in a selection method in view of the teachings of Ferraro et al regarding the effectiveness of cycloxydim in controlling red rice, and given Ferraro et al’s teachings of the desirability of cultivated rice plants resistant to said herbicide. One would have been further motivated to use cycloxydim given the teachings of Delye et al (2008) with regard to the I1781L substitution conferring resistance to cycloxydim. One would have been motivated to use rice given the express suggestion of Somers et al.
One would have had reasonable expectation of success in applying the modified method of Somers to rice cells, and in obtaining regenerated cycloxydim-resistant rice plants, in view of the teachings of Terakawa et al. One would have had reasonable expectation of success in applying the cycloxydim selection method to a grass crop given the teachings of Bekavac et al and the teachings of Delye et al (2008). Given the teachings of Delye et al (2008), one would have had reasonable expectation of success in arriving at rice cells and plants (comprising an ACCase with the I1781L substitution) that are resistant to field rates of cycloxydim.
Moreover, one would have had reasonable expectation of success in using the sethoxydim selection method of Somers et al to obtain cycloxydim-tolerant plants and cells, because both sethoxydim and cycloxydim belong to the class of cyclohexanedione herbicides, and because the same substitution in the conserved CT domain of grass ACCase, I1,781L confers resistance to sethoxydim, as taught by Delye et al (2002) and to cycloxydim, as taught by Delye et al (2008).
The limitations of “greater than three cell clones per hundred grams of plant cells or tissue” (claim 1) and “improved rate” (claim 5) would have naturally flowed from the steps of the method of claim 1, which steps would have been prima facie obvious. Moreover, the process of selecting surviving calli, as taught by Somers et al, would read on the step of “determining” the mutation rate or “observing” the surviving calli.
Identifying specific mutations (claim 13), including only one mutation, or multiple mutations in the resistant ACCase in said monocot plant would have been obvious given the teachings of Delye (2008) and Delye et al (2002), and one having ordinary skill in the art would have had reasonable expectation of success in doing so using the ACCase sequence information of Delye et al (2002).
With regard to the limitations “wherein said method comprises culturing of cells on a membrane” (claim 11), and “wherein said culturing of cells is in semi-solid media” (claim 12), a tissue-culture in vitro selection method comprising those modifications, would have been obvious as a matter of routine design choice, and given that Somers et al expressly teach the method of sethoxydim-based selection of maize calli, where the calli are grown on filter paper and in agar-based media.
10. Claims 36 and 37 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Somers et al (US Patent 5,290,696), Ferrero et al (Crop Protection (1999) 18:245-251), Bekavac et al (Abstract in Poljopriverda/Agriculture J. (2008) Supplement, Vol. 14, No. 1), Terakawa et al (Japan J. Breed. (1992) 42:267-275), Delye et al (Pest Mgmt. Sci. (2008) 64:1179-1186) and Delye et al (Planta (2002) 214:421-427), as applied to claims 1 and 16, and further in view of Collavo (PhD Thesis, University of Padova, January 2008) and Valverde (Weed Technology (2007) 21:310-323). Applicant's arguments filed on March 24, 2026 have been fully considered but they are not persuasive.
The clams are drawn to the method of claim 1, further comprising identifying a cell or a regenerated plant that possesses tolerance to tepraloxydim and increased tolerance to cycloxydim. It is noted that the claims do not limit said tolerance by herbicide concentration or application rate, and thus would encompass any degree of tolerance to any dose of the two herbicides. It is also noted that the limitation “tolerance to tepraloxydim” does not require that said tolerance be increased in comparison with the cells or plants of step (a) of claim 1.
The teachings of Somers et al, Ferrero et al, Bekavac et al, Terakawa et al, Delye et al (2008), and Delye et al (2002) have been set forth above. The references do not expressly teach identifying cells or plants tolerant to cycloxydim and tepraloxydim.
Collavo teaches that in Alopecurus myosuroides, the presence of leucine at position 1781 of the plastidic ACCase conferred resistance to tepraloxydim, a cyclohexanedione herbicide (Table II on page 22; paragraph spanning pages 41 and 42).
Valverde teaches that tepraloxydim can be successfully used, in an herbicide mixture, to control herbicide tolerant grass weeds (pg. 318, right col.).
At the time the invention was made, it would have been prima facie obvious to one of ordinary skill in the art to further modify the method of claim 1 and select the cells or regenerated plants that survived the cycloxydim selection pressure, including, wherein the resultant plants or cells comprise the I1781L substitution in the ACCase. It would have been obvious to do so given the teachings of Somers et al, Ferrero et al, as well Delye et al (2008).
Given the teachings of Collavo et al, one would have reasonably expected that a plant or cell comprising the ACCase with the I1781L substitution would also possess at least some tolerance to at least some application rates of tepraloxydim. In addition, it would have been obvious, in view of the teachings of Collavo et al and Valverde et al to identify the cells and plants that are tolerant to tepraloxydim in addition to cycloxydim.
One would have been motivated to identify cells and plants, including rice cells and plants, comprising the I1781L substitution in view of the teachings of Delye et al (2002) and Delye et al (2008). One would have been motivated to identify plants and cells tolerant to cycloxydim and tepraloxydim in view of the teachings of Delye et al (2008), Ferrero et al, and Valverde.
Given the teachings of Delye et al (2008), one would have had reasonable expectation of success in arriving at cells and plants (comprising an ACCase with the I1781L substitution) that are resistant to cycloxydim. And given the teachings of Collavo, one would have reasonably expected that said cells and plants would be tolerant to tepraloxydim as well.
11. Claims 17-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over in view of Delye et al (Pest Management Sci. (2008) 64:1179-1186), in view of Hawkes et al (PCT Publication WO 98/54330, published December 3, 1998), and Okuzaki et al (Plant Cell Rep. (2004) 22:509-512).
The claims are drawn to a progeny or descendant of a plant produced by the method of claim 1, wherein said plant is rice and said progeny or descendant comprises said endogenous, plastidic ACCase having said mutations, and thereby comprises tolerance to cycloxydim. The claims are drawn to a plant part, seed, or cell of said plant.
These claims are drawn to a product-by-process. Neither claim 17 nor claim 1, which recites the method of making the plant, recite any specific ACCase substitutions. Consequently, claim 17 will encompass any rice plant comprising any substitution in its endogenous plastidic ACCase that provides tolerance to any concentration of cycloxydim. The claim does not require tolerance to the cycloxydim doses used for the selection step in claim 1, only that the progeny or the descendant plant comprise tolerance to cycloxydim. See MPEP 2113. “[E]ven though product-by-process claims are limited by and defined by the process, 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)
Delye et al (2008) teach that the I1781L substitution in the ACCase of black grass (Alopecurus myosuroides) confers resistance to cycloxydim at field rates (Abstract; Table 2; Table 3; pg. 1184, right col.).
Delye et al (2008) do not teach a rice plant tolerant to cycloxydim.
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 the genome of an Oryza sativa japonica rice plant (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.).
At the time of filing, it would have been prima facie obvious to one having ordinary skill in the art to use the mutagenesis method of Hawkes and Okuzaki, to modify a wild-type cultivated (domestic) rice plant, including O. sativa japonica taught by Okuzaki, and obtain a rice plant or its seed that comprises a mutation in a plastidic ACCase gene that encodes an ACCase with the I1781L substitution as taught by Delye et al (2008).
One having ordinary skill in the art would have been motivated to combine said teachings in view of the agronomic desirability of herbicide resistant rice and the fact that the I1781L substitution confers resistance to multiple ACCase inhibitors, including cycloxydim.
Given the teachings of Delye et al (2008) regarding the properties of the I1781L substitution in the ACCase of black grass (Alopecurus myosuroides), and given the conserved nature of the position in grass ACCases, one would have reasonably expected that the resultant rice would possess at least some level of tolerance to cycloxydim, as well as other ACCase inhibitor herbicides.
Response to Arguments
The Examiner notes that Applicant’s arguments in the instant Remarks are directed only to the obviousness rejections set forth in the Final Office Action mailed on December 10, 2025 and do not apply to the newly added rejection of claims 17-20.
Applicant argues as follows: “Nothing in the rejection articulates why a person of ordinary skill in the art, in attempting to use a stepped-herbicide-concentration selection program — such as that of Somers — would have known to select as the initial plant cell culturing steps: (1) a first step of culturing 1n the presence specifically of cycloxydim at the specific concentration of between 0 and 2.5 uM, exclusive; and (2) a second step of culturing in the presence specifically of cycloxydim at the specific concentration of at least 2.5 uM, for the specific purpose of achieving an ACCase-mutation-production rate that was, in general, greater than any such rate then known and had, in specific, the surprisingly greater rate defined by the present claims. In order for the presently claimed method to be found obvious, a skilled person would have had to find motivation in the cited references to select the steps of that method, and would have had to find therein a basis upon which to reasonably expect that, by selecting those steps, the improvement provided by the presently claimed method would thereby be obtained” (page 7 of the Remarks).
Applicant cites the teachings of the individual references and concludes that “the cited references fail to raise a prima facie case of obviousness” (page 7). Applicant argues that one would not have been motivated to use cycloxydim as a selection agent. Applicant reiterates the argument directed to the teachings of Bekavac (pages 7-8 of the Remarks).
Applicant’s argument is not found to be persuasive. To the extent that the instant Remarks reiterated the previously submitted arguments, those arguments were considered in detail in the previous Office Actions and remain not persuasive for the reasons of record. This includes the arguments based on the Declaration of Dr. Mankin, the teachings of Bekavac, and those directed to unexpected results and motivation.
The Examiner maintains that the recited methods steps, including the selection agent concentration and the use of cycloxydim would have been prima facie obvious in view of the cited prior art. Specifically, Somers expressly teaches using the step-wise increase in the concentrations of an ACCase inhibitor (which concentrations encompass the values recited in the instant claims) in a method of selecting an herbicide tolerant plant.
Regarding the previous amendments to claim 1 to recite rice in the preamble, that is not sufficient to overcome the rejection: it would have been obvious to apply the selection method at issue to rice, specifically. This is suggested by Somers et al, and would have been also obvious in view of the combined teachings of the cited prior art.
The isoleucine at position 1781 of a plastidic ACCase was known to be conserved in all grasses; the I1781L substitution was also known. Delye et al (2002) teach that a chloroplastic ACCase allele with one point mutation, I1781L, is a dominant gene for resistance to sethoxydim. Delye et al teach that the region where the mutation is found, CT domain, is highly conserved in eukaryotes ranging from maize to humans, and teaches amino acid sequences of said region (pg. 425, left col., Fig. 3 on pg. 426). Applicant’s argument fails to address this teaching.
The Examiner maintains that Somers et al, expressly claim using their method with any cyclohexanedione herbicide, including wherein the herbicide is applied in a stepwise fashion. Below are claims 1 and 5 of Somers et al in their entirety: “[Claim 1]. A method of imparting herbicide tolerance to maize plants comprising forming a maize callus tissue culture of plant cells; subjecting said maize callus tissue culture to a cyclohexanedione herbicide, an aryloxyphenoxypropanoic acid herbicide, or mixtures thereof; selecting for plant cells from said maize callus tissue culture which comprise a gene encoding for an acetyl coenzyme A carboxylase (ACCase) which is tolerant of inhibition by a cyclohexanedione herbicide, an aryloxyphenoxypropanoic acid herbicide, or mixtures thereof, at levels which normally inhibit the activity of ACCase; and generating maize plants from said selected maize callus tissue culture of plant cells, wherein said cells comprise said gene encoding an acetyl coenzyme A carboxylase (ACCase) which is tolerant of inhibition by a cyclohexanedione herbicide, an aryloxyphenoxypropanoic acid herbicide, or mixtures thereof, at levels which normally inhibit the activity of ACCase. … [Claim 5]. The method of claim 1 wherein the callus tissue culture of said cells is exposed to increasing concentrations of said herbicide prior to selecting for said plant cells comprising said gene encoding for an acetyl coenzyme A carboxylase (ACCase) which is tolerant of inhibition by a cyclohexanone herbicide, an aryloxyphenoxypropanoic acid herbicide, or mixtures thereof, at levels which normally inhibit the activity of ACCase” (emphasis supplied).
Moreover, Somers et al teach using the ranges of concentrations that overlap with the concentrations recited in the instant claims, and also teach starting at 1/20th of the lethal does and doubling it until the lethal concentration is reached (Example II of Somers). These teachings of Somers et al would have made obvious the concentrations recited in the instant claim 1. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In addition, “[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 MPEP 2144.05. The Examiner notes that determining the lethal concentration of cycloxydim would have also been a matter of routine experimentation.
Nothing in the prior art or in the record of the instant application indicates that one of ordinary skill in the art would not have been able to use cycloxydim, a cyclohexanedione, in the method of Somers et al (including wherein cycloxydim is used instead of sethoxydim) with reasonable expectation of success, particularly given the teachings of Delye et al (2008). Applicant has pointed to no such evidence.
It is not disputed that Somers et al do not expressly teach using cycloxydim, specifically, as one of the CHD herbicides. However, the Examiner maintains that the motivation to use cycloxydim as a selection agent is supplied by the prior art. Not only is it a common cyclohexanedione, as taught by Delye et al (2008), but it is among the best ACCase inhibitors to control red rice, an important weed of the cultivated rice, as taught by Ferrero et al. The latter teaching, in particular, would have provided motivation to obtain cycloxydim-tolerant rice. Applicant’s argument fails to reconcile these teachings of Ferrero et al with the argument directed to the lack of motivation to select cycloxydim as an agent for the method of Somers et al.
Contrary to Applicant’s argument in the previous Remarks, the teachings of Ferrero et al were not cited to show reasonable expectation of success in obtaining the instantly claimed method. That showing is supplied by the other cited art, as discussed above. And with regard to the reasonable expectation of success of actually being able to regenerate rice plants from callus, it is taught by Terakawa et al, for example.
With regard to the mutagenesis rates, the Examiner maintains that the active step of culturing plant tissues or cells in the presence of 0 to 2.5 uM of an inhibitor, in this case, cycloxydim, would have been prima facie obvious. The mutagenesis rate would have been a naturally flowing consequence of said step. See MPEP 2111.04. Moreover, the step of “identifying” the number of surviving clones would have been prima facie obvious as part of a standard herbicide-pressure selection method, such as the method of Somers et al.
The Examiner maintains that the Bekavac reference was cited because its plain language indicates the feasibility of obtaining cycloxydim tolerant maize via cell culture selection, which is relevant to the claimed invention, and provides evidence of reasonable expectation of success. In challenging the veracity of the teachings of Bekavac et al, Applicant relies on the opinion in Dr. Mankin’s Declaration and on the interpretation of several publications, none of which supply any factual evidence contradicting what the Bekavac reference clearly states.
More importantly, even assuming, for the sake of the argument, that Bekavac et al actually meant to refer to a method of sethoxydim- (and not cycloxydim-) based selection, it would not obviate the rejection or make the argument persuasive given the express teachings of Somers et al discussed above, and the fact that a well-characterized and commercially used ACCase substitution, I1781L, was known in the prior art to confer tolerance to cycloxydim, at field rate, as did a less common substitution D2078G, in both homozygous and heterozygous populations (Delye et al (2008); Abstract; Tables 2 and 3, for example). Applicant fails to reconcile these teachings with the argument in the instant or previous Remarks.
Applying herbicide selection to a callus to identify herbicide tolerance mutations in ACCase (and other common herbicide tolerance enzymes, such as ALS) was known and practiced in the art at the time of invention. The rejection is maintained.
Relevant Prior art
12. The following prior art, while not relied upon in the above rejections, is deemed relevant to Applicant’s disclosure. 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 (Mol. Genet. Genomics (2008) 279:213-223; pg. 1, Abstract; pg. 214, left and top of right col.).
Double Patenting
13. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
14. Claims 17-20 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 52 of copending Application No. 13/393,744. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of a co-pending application are drawn to a monocot plant that expresses a recombinant or mutagenized ACCase that differs from the wild-type ACCase at two or more amino acid positions, and wherein said ACCase confers herbicide tolerance to said plant. The instant claims are product-by-process claims that read on any rice plant, plant part, cell, or seed, comprising a mutant, herbicide resistant plastidic ACCase. The claim of the co-pending application thus encompasses a species of the instantly claimed genus and make obvious the instantly claimed invention. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant argues that “Applicants reserve the right to file a terminal disclaimer upon the indication of allowable subject matter” (page 12 of the Remarks). This is not found to be persuasive. No terminal disclaimer has been filed. The rejection is maintained.
Conclusion
15. No claims are allowed.
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
