BAYER CROPSCIENCE NV et al.

Patent Trials and Appeals Board

Mar 16, 2022

2022000295 (P.T.A.B. Mar. 16, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/892,702 11/20/2015 Frank Michiels 039621.00421 1836 4372 7590 03/16/2022 ARENTFOX SCHIFF LLP 1717 K STREET, NW WASHINGTON, DC 20006-5344 EXAMINER KOVALENKO, MYKOLA V ART UNIT PAPER NUMBER 1662 NOTIFICATION DATE DELIVERY MODE 03/16/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): patentdocket@arentfox.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte FRANK MICHIEL, KIRK JOHNSON, and NANYEN CHOU Appeal 2022-000295 Application 14/892,702 Technology Center 1600 BEFORE DONALD E. ADAMS, JOHN E. SCHNEIDER, and RYAN H. FLAX, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL Appeal 2022-000295 Application 14/892,702 2 STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 2, 4, 18, 29-31, and 34-36.2 We have jurisdiction under 35 U.S.C. § 6(b).3 We AFFIRM. CLAIMED SUBJECT MATTER The claims are directed to “improved and versatile production schemes for hybrid seeds and plants having increased vigor or other qualities following from the crossing of genetically different male and female plant lines, wherein the hybrid seeds and plants further comprise a trait of interest such as a herbicide tolerance gene.” Spec. ¶ 1. Claim 2, reproduced below, is illustrative of the claimed subject matter: 2. A method for producing herbicide-tolerant hybrid seed using (a) a male-sterile plant line (A-line); (b) a male-sterile plant line comprising a herbicide tolerance gene in heterozygous or hemizygous state (AHT- line); (c) an isogenic maintainer plant line (B-line); (d) an isogenic maintainer plant line comprising a herbicide tolerance gene m homozygous state (BHT-line); (e) and a male fertile line comprising said herbicide tolerance gene in homozygous state (R-line); said method comprising the steps of 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as BASF SE. Appeal Br. 1. 2 Claims 5-17, 19-28, 32, and 33 are pending in the application but have been withdrawn from consideration. 3 Oral Arguments in this appeal were heard on March 4, 2022. A transcript of the argument will be made of record. Appeal 2022-000295 Application 14/892,702 3 i) producing pre-basic seed of the A-line by crossing plants grown from pre-basic seed of the A-line with plants of the B-line and collecting seeds produced on plants of the A- line; ii) producing basic seed of the AHT-line by crossing plants grown from said pre-basic seed of the A-line with plants of the BHT-line and collecting the seeds produced on plants of the Aline; and iii) producing hybrid seed by crossing plants grown from basic seed of the AHT-line and plants of the R-line and collecting the seeds produced on plants of the AHT-line, wherein the method does not introduce herbicide tolerance at any pre-basic seed production stages. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Huang4 CN 1988048612 May 11, 1998 Wang5 CN 1247699 Nov. 22, 2000 Toldi et al., Production of phosphinothricin-tolerant rice (Oryza sativa L.) through the application of phosphinothricin as a growth regulator, 19 Plant Cell Reports 1226 (2000) Arncken et al., Hybrid Varieties of Organic Cereals? Prospects and acceptance of hybrid breeding for organic production, Coop Naturaplan Fund Organic Seed Project, Module 1.4, Final Report (June 2005) U.S. Dept. Agri, Glycophospate-Tolerant H7-1 Sugar Beet: Request for Nonregulated Status, Final Environmental Impact Statement (May 2012) McRobert et al., International Maize and Wheat Improvement Center, Maize Hybrid Seed Production Manual (2014) REJECTIONS The Examiner has rejected the claims as follows: 4 Citations are to the English translation of record. 5 Citations are to the English translation of record. Appeal 2022-000295 Application 14/892,702 4 Claims 2, 4, 18, 29, 31, 34, and 36 have been rejected under 35 U.S.C. § 103 as unpatentable over Wang in view of Arncken and Huang. Claims 30 and 35 have been rejected under 35 U.S.C. § 103 as unpatentable over Wang in view of Arncken, Huang, and Toldi. OPINION Obviousness Based on Wang Combined with Arncken and Huang Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 2, 4, 18, 29, 31, 34, and 36 would have been obvious over Wang combined with Arncken and Huang. The Examiner finds Wang teaches a three-line hybridization technique comprising crossing a male sterile line with a maintainer line wherein the maintainer line comprises a herbicide resistance transgene. Final Act. 3. The Examiner finds Wang teaches that the resulting hybrid A line is the crossed with a restorer or R-line. Id. The Examiner finds Wang does not teach crossing the A-line and the B-line at the pre-basic seed stage or crossing the herbicide-resistant B-line with the A-line at the basic seed stage. The Examiner finds Arncken teaches a pre-basic seed production seed stage where the A-line is pollinated a maintainer to produce a pre-basic seed. Id. at 4. The pre-basic seed is then used to propagate basic seed where the B- line is crossed with the A-line and the resultant seed is then crossed with a restorer line to produce a three-line hybrid seed. Id. The Examiner finds Huang teaches a three-line hybridization technique where the herbicide resistance is introduced into the restorer line. The Examiner concludes: Appeal 2022-000295 Application 14/892,702 5 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, followed by a cross to a male fertile line, such as an R-line. 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 PPT. It would have been obvious to apply said method to any crop species, for which CMS sterile A- line, as well as B-, and R-lines are available, including rice, as taught by Wang et al and Huang et al. 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, 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 also 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. 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. Id. at 4-5. Appellant contends the references do not teach all of the elements of the claims. Appeal Br. 3. Specifically, Appellant contends that the references Appeal 2022-000295 Application 14/892,702 6 do not teach “a male-sterile plant line comprising a herbicide tolerance gene in heterozygous or hemizygous state (AHT-line).” Id. Appellant contends that one skilled in the art would not have been motivated to combine the teachings of the references. Id. at 4-5. Appellant contends the references relate to different and incompatible seed production techniques. Id. at 5. Appellant contends “Wang involves introducing a herbicide resistance transgene into the maintainer line, whereas Huang hybridizes a herbicide resistant male restorer line with a sterile line not comprising herbicide tolerance.” Id. With respect to Arncken, Appellant contends “Arncken is concerned with the feasibility of hybrid cereals for organic farming and would not motivate one of ordinary skill in the art to use its teachings with another reference, such as Wang and Huang, to modify a seed production method using herbicide tolerance.” Id. Finally, Appellant argues there is sufficient evidence of unexpected results to overcome the Examiner’s prima facie case of obviousness. Id. at 6. Appellant contends that the increase in seed production achieved by the claimed method was unexpected and surprising. Id. Appellant contends that, contrary to the Examiner’s position, the data compares the claimed method with that of the closest prior art and that the results are commensurate with the scope of the claims. Id. at 6-8. Analysis We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and Answer regarding this rejection. We find the Examiner has established a prima facie showing that the subject matter of the claims would have been obvious over Wang combined with Arncken and Huang to a person of Appeal 2022-000295 Application 14/892,702 7 ordinary skill in the art at the time the invention was made. Appellant has not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellant in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). We have identified claim 2 as representative; therefore, claims 4, 18, 29, 31, 34, and 36 fall with claim 24. We address Appellant’s arguments below. Appellant contends that the combined references do not teach or suggest the use of “a male-sterile plant line comprising a herbicide tolerance gene in heterozygous or hemizygous state (AHT-line).” Appeal Br. 3. We are not persuaded by this argument. As the Examiner points out, “Wang et al teach introducing herbicide tolerance into the maintainer line (B-line) and crossing it with the male sterile line (A-line), thus obtaining an herbicide tolerant progeny (corresponding to the AHT-line), which progeny could later be separated from non-herbicide tolerant plants by applying the relevant herbicide.” Ans. 12. Appellant contends that one skilled in the art would not been motivated to combined the teaching of the references. Appeal Br. 4-6. Appellant contends Wang and Huang teach different and incompatible seed production methods. Id. at 5. Appellant argues Arncken relates to developing seed for organic farming and one skilled in the art would not look to Arncken for guidance regarding herbicide resistance. Id. We have considered Appellant’s arguments and are not persuaded that the rejection is in error. We agree with the Examiner that one skilled in he art would have been motivated to cross a herbicide resistant AHT-line with a Appeal 2022-000295 Application 14/892,702 8 herbicide resistant restorer line to ensure that all hybrid plants are herbicide resistant eliminating the need for herbicide selection. See Ans. 13. Appellant contends there is evidence of unexpected results sufficient to demonstrate non-obviousness. Appeal Br. 6. In support of this contention, Appellant points to the declaration6 of one of the inventors Dr. Michiels (“Michiels Decl.”), and the dissertation of Chou7 (“Chou”). The Chou reports a comparison of results of a method within the scope of the claims (breeding rice plants) with the prior art. Michels Decl. ¶¶ 18-19. The appellant’s method reportedly resulted in a two-fold increase in seed production, which was asserted to be surprising and unexpected. Id., Chou, Table 4. The Examiner responds that the results reported are not indicative of non-obviousness for several reasons. Final Act. 12-14. The Examiner contends that the results are not unexpected and that the experiments reported do not compare the results with the closest prior art. Id. The Examiner also finds the results are not commensurate with the scope of the claims. Ans. 15. We have considered the arguments presented by the Examiner and Appellant and conclude that while the record contains evidence of unexpected results, the results appear to be limited to rice. See Chou Abst., 104. Thus, we agree with the Examiner that the results are not commensurate with the scope of the claims as the present claims are not 6 Declaration Under 37 C.F.R. § 1.132, filed July 21, 2020. 7 Nan-Yen Chou, Novel Hybrid Rice Seed Production Method Incorporating Herbicide Tolerance (May 2017) (unpublished Ph.D. dissertation, Texas A&M University) (Exhibit B to Michiels Decl.) Appeal 2022-000295 Application 14/892,702 9 limited to rice, but broadly claim the production of herbicide-tolerant hybrid seeds of any plant. See Appeal Br. 10 (Claims Appx.). Appellant contends that there is evidence in the record that the unexpected results achieved with rice would also be achieved using other crops. Reply Br. 8. Appellant points to the statement in Chou that the method taught therein is not limited to rice. Id. citing Chou, 138. We are not persuaded that the evidence supports the conclusion that the unexpected results of increased seed production would be found in other crops. The cited portion of Chou refers to the method of incorporating herbicide resistance and does not discuss increased seed production or how this phenotype might relate to any plant, as claimed. Chou, 138. Similarly, Dr. Michiels’ Declaration does not support Appellant’s contention that the claimed method would result in increased seed production in crops other than rice. Conclusion We conclude that a preponderance of the evidence supports the Examiner’s finding that the subject matter of claims 2, 4, 18, 29, 31, 34, and 36 would have been obvious over Wang combined with Arncken and Huang. Obviousness Based on Wang, Arncken, Huang, and Toldi Appellant’s sole argument with respect to this rejection is that Toldi does not remedy the deficiencies of Wang combined with Arncken and Huang. Appeal Br. 8. AS discussed above, we do not find the combination of Wang, Arncken, and Huang to be deficient. Therefore, we affirm this rejection. CONCLUSION The Examiner’s rejections are affirmed. Appeal 2022-000295 Application 14/892,702 10 More specifically, The rejection of claims 2, 4, 18, 29, 31, 34, and 36 under 35 U.S.C. § 103 as unpatentable over Wang in view of Arncken and Huang is affirmed. The rejection of claims 30 and 35 under 35 U.S.C. § 103 as unpatentable over Wang in view of Arncken, Huang, and Toldi is affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 2, 4, 18, 29, 31, 34, 36 103 Wang, Arncken, Huang 2, 4, 18, 29, 31, 34, 36 30, 35 103 Wang, Arncken, Huang, Toldi 30, 35 Overall Outcome 2, 4, 18, 29- 31, 34-36 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED