DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
2. Claims 1-8 are pending and examined.
3. The objection to claim 2 is withdrawn in view of Applicant’s amendments to the claim.
4. The rejection of claim 3 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
6. Claims 1-8 remain rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN1247699A, published March 22, 2000; English translation), in view of Arncken et al (Hybrid Varieties for Organic Cereals, June 2005, Coop Naturaplan Fund Organic Seed Project) and Huang et al (WO1998048612 published May 11, 1998; English translation). Applicant’s arguments filed on June 11, 2026 have been fully considered but they are not persuasive.
The claims are directed to a method for producing a herbicide-tolerant hybrid seed, comprising producing pre-basic seed by crossing the A-line and the B-line, crossing the resultant seed with the plants of the BHT-line, which is the B-line comprising an herbicide-tolerance gene; and subsequently producing the hybrid seed by crossing the resultant AHT line with a male fertile line or an R-line. The claims are directed to said method, wherein the herbicide tolerance gene provides tolerance against glutamine synthetase inhibitors.
Wang teaches a three-line rice hybridization method, comprising the crossing of the male sterile line with the maintainer line, wherein an herbicide resistance transgene, including the bar gene, had been introduced into the maintainer line (pages 1 and 2 of the translation). Wang et al teach that the herbicide resistance transgene could be introduced into the maintainer line using transformation or breeding (page 2). Wang et al teach that the result of said cross is a male sterile line that comprises herbicide resistance gene. Wang et al teach that the application of the herbicide will remove non-sterile seedlings; and teach that one of the advantages of said method is being able to produce high purity seeds for the production of the hybrid seed (pages 2 and 4 of the translation). Wang et al teach the male-sterile, the maintainer, and the restorer rice lines, including wherein the maintainer comprises the bar gene (pages 5 and 6 of the translation; Fig. 3 and 4).
Wang et al do not expressly teach crossing the A-line and the B-line at the pre-basic seed stage, or crossing the herbicide-resistance-comprising B-line with the A-line at the basic seed stage.
Arncken et al teach the art-standard CMS three-line hybrid production system and its application in rye. Arncken et al teach that at the pre-basic seed production stage, the male sterile A-line is pollinated by the pollen of the maintainer line, which is a “fertile maintainer form of maternal line.” (pg. 12, paragraphs 1 and 2; Fig. 3). The pre-basic seed is propagated to the basic seed, at which stage the B-line pollinates the A-line, and the resultant seed is then crossed with the fertile restorer line to produce the three-line hybrid seed. Arncken et al teach that in vegetative crops (wherein the seed is not the product) restorers are not used, but crops where the seed is the product, the hybrid variety’s paternal line must be a restorer (pg. 12, paragraphs 1 and 2; Fig. 3).
Arncken et al teach that established CMS systems are available for a large number of crops and that using CMS, hybrid seed can be produced economically and on a large scale (pg. 12, paragraphs 1 and 3).
Huang et al teach a three-line hybridization system, wherein the herbicide resistant gene is introduced into the restorer line, such that the restorer is herbicide resistant. Huang et al teach hybridizing said restorer with the sterile line to produce herbicide resistant rice seed (page 5 of the translation). Huang et al teach using the bar or pat genes, and that their product, phosphinothricin acetyltransferase, provides resistance against glutamine synthetase inhibitors, including phosphinothricin (synonymous with glufosinate) (pages 4 and 6 of the translation). Huang et al teach that the bar or pat genes could be introduced into the maintainer rice line either via transformation or conventional breeding (page 3 of the translation). Huang et al teach male sterile lines and restorer lines (pages 6-7 of the translation). Huang et al teach a number of advantages of their method (page 8 of the translation).
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 Wang using the teachings of Arncken et al and cross the B-line comprising the bar gene with the A-line at the basic seed stage to obtain the herbicide resistant A-line (AHT-line), followed by a cross to a male fertile line, such as an R-line (instant claim 1). It would have been obvious to introduce the bar gene into the B-line in the homozygous state (using, for example, an introgression method, as suggested by Wang), because doing so would ensure that all male-sterile plants comprise the bar gene and are resistant to glufosinate (instant claims 1-3 and 5).
One would have been motivated to combine said teachings because it would ensure the supply of the herbicide resistant A-line for the cross with the R-line, resulting in the F1 hybrid having the herbicide resistance transgene.
In addition, it would have been obvious to use non-transgenic A- and B-line at the pre-basic stage, as recited in claim 1, because it would maintain a population of the CMS A-line that could be used to introduce other genes or traits of interest, including genes conferring resistance to herbicides, such as EPSPS, also taught by Wang (see page 3).
It would have been obvious to further modify the resultant method using the teachings of Huang et al and introduce the herbicide resistance gene not only into the B-line, but the R-line as well, as suggested by Huang et al (instant claims 4 and 6). Doing so would enable one to remove non-resistant F1 plants by applying the herbicide, thus ensuring the purity of the hybrid seed, as well as its herbicide resistance.
Given that both, Wang and Huang et al reduced their invention to practice and the availability of A-, B-, and R-lines in a variety of species, one would have had reasonable expectation of success.
7. Claims 7 and 8 remain rejected under 35 U.S.C. 103 as being unpatentable over Wang (CN1247699A, published March 22, 2000; English translation), in view of Arncken et al (Hybrid Varieties for Organic Cereals, June 2005, Coop Naturaplan Fund Organic Seed Project) and Huang et al (WO1998048612; English translation), as applied to claims 1-6 above, and further in view of Toldi et al (Plant Cell Reports (2000) 19:1226-1231). Applicant’s arguments filed on June 11, 2026 have been fully considered but they are not persuasive.
The claims are drawn to the method of claims 1 or 4, wherein the herbicide tolerance is provided by a variant allele endogenous to said plant. The teachings of Wang, Arncken et al, and Huang et al have been set forth above. The references do not expressly teach a plant wherein the herbicide tolerance is provided by a variant allele of a gene endogenous to said plant.
Toldi et al teach using a selection method to produce rice tolerant to PPT (Abstract). Toldi et al teach obtaining fertile rice plants that showed tolerance to PPT under greenhouse conditions (Discussion on pages 1230-1231). Toldi et al teach that their data on glutamine synthetase activity indicated that in their PPT-tolerant plants either the enzyme was produced in greater amounts or the enzyme with higher activity was produced (pg. 1231, left col.). It is noted that regardless of the mechanism, the PPT resistance in the plants of Toldi et al must necessarily have been provided by a gene endogenous to rice. Since the instant claim recites no structure for the “variant allele,” an allele naturally present in the rice plants of Toldi et al will read on the “variant allele” that is endogenous to said plant.
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 made obvious by the teachings of Wang, Arncken et al, and Huang et al, and introgress the resistance to PPT into a rice line, including a maintainer, using conventional breeding techniques, as expressly suggested by Huang et al. One would have been motivated to combine said teachings because it would enable one to practice the three-line hybridization method without having to transform the plants with the bacterial pat or bar gene. Given that Toldi et al have successfully demonstrated producing a mature rice plant resistant to PPT, and given the routine nature of the introgression methods, one would have had reasonable expectation of success.
Response to Arguments
Applicant argues as follows: “Wang does not expressly disclose the claimed staging of that introduction, that is, maintaining non-herbicide-tolerant A-line pre-basic seed production and introducing herbicide tolerance into the A-line only at the basic seed production stage by crossing plants grown from pre-basic A-line seed with the BHT-line. Wang does not distinguish between pre-basic versus basic A-line production stages or teach delaying the use of the herbicide-resistant maintainer until the basic seed stage while using the ordinary B- line for pre-basic A-line increase” (page 4 of the Remarks).
Applicant argues that “Arcken is materially different because it appears to teach the standard CMS production framework, not Applicant's modified framework for late- stage introduction of herbicide tolerance into the A-line through a BHT-line. Arncken does not teach or suggest modifying that standard system so that herbicide tolerance is deliberately excluded from pre-basic A-line production and introduced into the A-line only at the basic seed stage using an isogenic BHT-line homozygous for the herbicide tolerance gene” (page 5 of the Remarks).
Applicant argues that “Huang does not teach producing non-herbicide-tolerant pre-basic A-line seed, delaying introduction of herbicide tolerance into the A-line until basic seed production, or producing basic AHT-line seed by crossing plants grown from pre-basic A-line seed with a homozygous BHT- line. Further, Huang does not teach using such a maintainer line only at the basic seed production stage after pre-basic A-line production has been carried out without herbicide tolerance.” (page 5 of the Remarks).
Applicant argues that “there is nothing in the cited references, individually or in combination, that would motivate a person of ordinary skill in the art to modify the primary hybrid seed production system to arrive at the claimed subject matter with a reasonable expectation of success” (page 6 of the Remarks). Applicant argues that “the proposed combination [of references] also relies on impermissible hindsight” because “the cited references do not direct the skilled artisan to maintain a non-herbicide-tolerant pre-basic A-line, introduce the herbicide tolerance gene through a homozygous BHT-line at the basic seed stage and then produce hybrid seed using an AHT-line and a homozygous R-line” (page 6 of the Remarks). Applicant argues that the cited teachings “do not show that a person of ordinary skill in the art would have reasonably expected success in Applicant's specific staged production scheme, in which herbicide tolerance is deliberately excluded from pre-basic A-line production, introduced into the A-line only at the basic seed stage through a homozygous BHT-line, and then combined with an R-line homozygous for the same herbicide tolerance gene during hybrid seed production. The cited references do not evaluate this staged substitution, do not address whether the BHT-line would maintain the A-line appropriately when used only at the basic seed stage, and do not teach that the resulting AHT-line basic seed would provide the production flexibility and hybrid seed purity achieved by Applicant's method” (page 7 of the Remarks).
With regard to claims 7 and 8, Applicant argues that “the addition of Toldi does not cure the deficiencies” of the other cited references, and that Toldi does not teach “that the resistance is provided by a variant allele endogenous to rice” (pages 7-8 of the Remarks).
Applicant’s argument is not found to be persuasive. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, there is no dispute that, for example, Wang et al do not teach all of the limitations of the claimed invention. However, the claimed method would have been obvious in view of the combined teachings of the prior art.
The argument directed to motivation is not found to be persuasive either. The rejection above expressly addresses the issue of motivation, including, as follows: “One would have been motivated to combine said teachings because it would ensure the supply of the herbicide resistant A-line for the cross with the R-line, resulting in the F1 hybrid having the herbicide resistance transgene. In addition, it would have been obvious to use non-transgenic A- and B-line at the pre-basic stage, as recited in claim 1, because it would maintain a population of the CMS A-line that could be used to introduce other genes or traits of interest, including genes conferring resistance to herbicides, such as EPSPS, also taught by Wang (see page 3).” Applicant’s argument does not address this reasoning.
In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, no knowledge was gleaned only from Applicant’s disclosure. The individual limitations that the steps of the claimed method comprise are taught by the cited prior art and their combination would have been prima facie obvious for the reasons set forth in the rejection. On the other hand, Applicant’s impermissible hindsight argument, above, amounts to a conclusory statement and does not supply any premises in support.
Applicant’s argument directed to reasonable expectation of success is not persuasive either. In the instant case, the CMS-based three-line hybrid production methods were well-known in the art, including the methods where the maintainer or the restorer line comprise a herbicide tolerance transgene, such as pat/bar. Modifying the known methods, by, for example, crossing the A-line and the B-line at the pre-basic seed stage, or crossing the herbicide-resistance-comprising B-line with the A-line at the basic seed stage, would have been obvious and readily achievable by one of ordinary skill in the art, thus arriving at the active steps of the claimed method.
A prima facie finding of obviousness does not require that the cited art actually reduce to practice a claimed invention. For example, contrary to Applicant’s position, there is no need for any of the cited prior art to “evaluate this staged substitution” or “address whether the BHT-line would maintain the A-line appropriately when used only at the basic seed stage.”
Applicant is reminded that “Obviousness does not require absolute predictability of success. Indeed, for many inventions that seem quite obvious, there is no absolute predictability of success until the invention is reduced to practice. ... For obviousness under § 103, all that is required is a reasonable expectation of success” (In re O'Farrell, 853 F1894, 903-904 (Fed. Cir. 1988).
With regard to Toldi et al, Applicant’s argument is not persuasive, because it is contradicted by the plain language of the reference. Toldi et al teach that the rice plants tolerant to PPT were obtained “by means of in vitro selection” and, as stated by the authors, “this is the first report on the production of rice plants tolerant to this herbicide without genetic transformation” (Toldi et al, Abstract). Thus, the herbicide tolerance of the plants of Toldi et al would have been necessarily provided by “a variant allele endogenous to said plant.” The rejection is maintained.
Conclusion
8. No claims are allowed.
9. 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.
10. 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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