CTFR 18/423,741 CTFR 88966 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first-inventor-to-file provisions of the AIA. Status Claims 1-29 as filed on 2 April 2024 are examined and rejected in an Office action posted on 1 October 2025. Claims 1-29 as amended in Applicant’s response filed 2 February 2026 are examined herein. The claimed invention appears to be a novel wheat line Examiner’s Notes Citations to Applicant’s specification are abbreviated herein “Spec.” Withdrawal of Objections and Rejections The objection to claim 11 is withdrawn in view of Applicant’s amendments to the claim. The rejection of claims 1-29 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite regarding the non-perfected deposit is withdrawn in view of the perfection of the deposit. The rejection of claims 1-29 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite regarding the use of the word “essentially” is withdrawn in view of Applicant’s amendments to the claims. The rejection of claims 1-29 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite regarding the expansive use of the term “variety” is withdrawn in view of Applicant’s amendments to the claims. The rejection of claims 1-29 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement regarding the expansive use of the term “variety” (p. 6, btm.) is withdrawn in view of Applicant’s amendments to the claims. The rejection of claims 5-7, 22, 23, 25, 26 28 and 29 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement (Office action, p. 7 – page 8 (upper) The rejection of claims 1-29 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement is withdrawn in view of Applicant’s perfection of the deposit. The rejection of claims 1-29 under 35 U.S.C. 102/103 is withdrawn in view of Applicant’s amendments to the claims. The double patenting rejection of claims 1-29 (mainly p. 14) is withdrawn in view of Applicant’s amendments to the claims. Written Description / Specification Claims 1-29 are rejected because the instant specification fails to satisfy the written description requirement of 35 U.S. l 12(a) because it does not provide a description sufficient to conduct an to conduct an examination, including search of the prior art, in particular in regard to the breeding history. 35 USC 112 (a) states that “The specification shall contain a written description of the invention.” In evaluating the written description requirement relative to the specification,, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim , 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).” The instant invention is a new wheat plant. Below is a consideration of what might constitute an adequate written description for a new variety. In evaluating this question of fact, consideration is given to the corresponding art in the public domain. Reviewing the art leads to a reasonable conclusion that generally the minimum requirements for an adequate description of a new plant line is a trait table of phenotypes and genetic information. The breeding history usually provides the genetic information. In reviewing the instant specification there is a phenotypic description in Table 1 (pp. 35-39. However, there is no accompanying breeding history in the specification for the claimed wheat plant. Because the specification lacks any breeding history, but the breeding history is part of the minimum description of a wheat line to illustrate the underlying genetics, Applicant fails to fulfil the requirement of 35 USC 112(a) to provide a written description of the claimed invention in the specification. A reasonable basis for challenging the adequacy of written description is informed by a review of the following: The MPEP requires: he written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art."). MPEP § 2163 (I). This is emphasized in the Enzo v. Gen-Probe decision. Furthermore, the Guidelines state that "'[o]nce the patent issues, the description must be sufficient to aid in the resolution of questions of infringement.'" Guidelines at 1107-08 n. 6 (quoting Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864, 34880 (Aug. 22, 1989) (codified at 37 C.F.R. pt. 800)). Enzo Biochem, Inc. v. Gen-Probe Inc. , 285 F.3d 1013, 1022, 62 U.S.P.Q.2d 1289, 1295 (Fed. Cir. 2002). The parental germplasm is important to understanding the claimed line. Applicant claims a novel wheat line. This analysis is a fact-based analysis. This variety is, in part, distinguishable by its phenotypes, e.g. Table 1 (p. 35-38). Its breeding history is not provided. The instant disclosure is incomplete as to the breeding history. The requirement of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. The following discussion regarding plant patents and PVP applications is offered as persuasive evidence. Regarding Plant Patents, MPEP § 1605 states that the description should include a complete detailed description of the plant and the characteristics thereof that distinguish the same over related known varieties . . . The specification should also include the origin or parentage. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to "determine if development is sufficient to consider the variety new. USDA (2023) Applying for a Plant Variety Certificate of Protection https://www.ams.usda.gov/services/pvpo/application-help/apply (accessed 1 May 2023). Additionally, the International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV (2017) Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, n 14 & n. 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected. Moreover, a specification devoid of a breeding history hampers the public's ability to resolve potential infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the complete breeding history, the public will not have an approach to resolve questions of infringement. Furhter, it has been long established that intracultivar heterogeneity exists in crop species. The assumption that elite cultivars are composed of relatively homogenous genetic pools may be false. Haun et al. (2011) Plant Physiol. 155:645-55; see p. 645, l col. Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (Iddd., p. 645, R col., para. 2, to 646, L col., para. 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. Großkinsky et al. (2015) J. Exp. Bot. 66:5429-40 (see p. 5430 L col., para. 2, and R col., para. 2). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant. Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention. To overcome this rejection, Applicant should amend the specification to identify any and all other potential names for all parental lines utilized in the development of the instant cultivar. For example, if Applicant's breeding history uses proprietary line names, Applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If either of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line(s) as well (i.e., grandparents). Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants, which should include any other plants created using similar breeding history (such as siblings of the instant cultivar). This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order). See also Vas-Gath Inc. v. Mahurkar , which teaches that "the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his [or her] infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification.” Vas-Gath Inc. v. Mahurkar , 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991). See also, the other three what varieties discussed below at the end of this Office action which share a number of phenotypes with the instant claimed variety. Thus, under a fact-based analysis, a description of the ancestral germplasm is necessary to understand the invention. Applicant’s Argument and Reply Applicant argues against the rejection. Response, pp. 3-10. Applicant, in an underlined assertion at the top of page 4, seems to dispute that examination is required. This is perplexing. Ariad Then Applicant turns to the Ariad decision. Response, p. 4. Applicant quotes the word "possession" and cites to page 1352 [1351?]. In response: Indeed, the word "possession" does appear four times on page 1351 (but not on p. 1352). The last three occurrences are in the following passage. The term "possession," however, has never been very enlightening. It implies that as long as one can produce records documenting a written description of a claimed invention, one can show possession. But the hallmark of written description is disclosure. Thus, "possession as shown in the disclosure" is a more complete formulation. Yet whatever the specific articulation, the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art." Ariad Pharmaceuticals, Inc. V. Eli Lilly & Co ., 598 F.3d 1336, 1351 (Fed. Cir. 2010) ( en banc ), In particular, "possession as shown in the disclosure" and "the four corners of the specification." Clearly the Ariad decision supports the rejection. Actually, the requirement for the specification in written description is quoted in Applicant’s response. The verb 'facilitate' does not appear in the decision and thus the underlined and italicaize portion of page 4 of the response is merely Applicant's interpretation and is not controlling. Applicant again seems to dispute the requirement for examination of a patent application. Applicant's emphasized point regarding "biological arts" on page 4 of the response (citing to 1350?) calls attention to the passage bridging pages 1352-53 of the Ariad decision. But this is in reference to a functional limitation. Thus not relevant to the current rejection. There is no functional limitation in question. Inari Bridging pages 4-5 Applicant cites to PGR2004-00020 (P.T.A.B. Sept. 24, 2024) but fails to provide an, with all due respect, understandable pinpoint citation. The quoted phrase occurs on pages 12, 21 and 26 of the decision. Be that as it may be , in the application before Board contained the breeding history. See, page 11 (btm.) of the decision. So it is tangential to the argument. Enzo Applicant then turns to the Enzo decision and asserts that a deposit accepted under the Budapest Treaty satisfies the written description requirement. Response, p. 5. The Office respectfully disagrees with Applicant’s interpretation. The Enzo decision states that written description requirement might, at least in the case before the court, be satisfied by a deposit. Enzo Biochem Inc. v. Gen-Probe Inc. , 323 F.3d 956, 63 USPQ2d 1609, 1613 (Fed. Cir. 2002) ( remanded ). However, the Federal Circuit remanded the case to the district court to resolve "genuine issues of material fact ... regarding satisfaction of the written description requirement" even in view of the deposit. Iddd., 323 F.3d at 960, 63 USPQ2d at 1610. Furthermore, the MPEP emphasizes that the Final Rule governing the deposit of biological materials requires that "[o]nce the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." MPEP § 2163(1) (quoting 54 Fed. Reg. 34,864, 34,880 (22 August 1989). Returning to the Enzo decision, the case concerned US Patent 4,900,659 ("the '659 Patent") where the inventors deposited 6 strains of Neisseria meningitides , 6 strains of Neisseria gonorrhoeae , and 3 phagemid clones comprising DNA insert regions consisting of genomic DNA from Neisseria gonorrhoeae flanked by restriction enzyme sites from the phages (see the '659 Patent, cols. 20-21 and claims 1 & 4). The deposits were clones from single colonies (see col. 21 ). The genome of Neisseria meningitides is 2,272,351 bases. Tettelin et al. (2000) Sci 287:1809-15. The genome of wheat is vastly larger and is extremely complex. Uauy (2017) Curr Opin Plant Biol 36:142-48, 1 st para. and 1 st Fig. Even in the Enzo decision, it was an open question as to whether the deposit of a significantly simpler genetic system satisfied the written description requirement. E.g., Enzo, 323 F.3d at 966, 63 USPQ2d 1615-16. The Federal Circuit did not conclude that a deposit satisfies the written description requirement. Additionally, in the ‘659 Patent, the essence of the invention was to identify similar genomes by hybridization (claim 1). Here, the required information in the specification is to distinguish other wheat plants. On pages 6-7 Applicant attacks the section of the rejection concerning Plant Patents and UPOV. In reply, they were offered as persuasive evidence and not controlling. Applicant apparently is not persuaded. However, as discussed elsewhere, the Ariad decision, which is the senior precedence, emphasizes the importance of the specification. Rule 105 Request Jumping ahead to page 9, Applicant asserts that the “proper remedy for obtaining information to facilitate examination is a Rule 105 request.” A Applicant, however, cites to no section of the MPEP or case law in support for the position. Certainly the Office is allowed to make requests for information under 37 C.F.R. § 1.105, but nothing requires the Office to do so. The undersigned does not set policy for the Office. However, Applicant’s arguments on this point is taken as ad admission of the materiality of the breeding history. Ex Parte C Applicant quotes extensively from the Ex Parte C decision. Response, pp. 8-9. In response, first, the Board considered the breeding history in its decision. Second, as can be seen at the top of the block quote on page 9, the issue was whether additional information was required. The parents were known, and thus at least a minimal breeding history was in the specification. In contrast, in the instant specification, NO breeding history at all is provided. Therefore Applicant’s argument fails to persuade. Conclusion No claim is allowed. As seen above, however, the only remaining issue it the lack of a breeding history in the specification. 07-39 AIA 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL T BOGGS whose telephone number is (571)272-2805. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /RUSSELL T BOGGS/Examiner, Art Unit 1663 Application/Control Number: 18/423,741 Page 2 Art Unit: 1663 Application/Control Number: 18/423,741 Page 3 Art Unit: 1663 Application/Control Number: 18/423,741 Page 4 Art Unit: 1663 Application/Control Number: 18/423,741 Page 5 Art Unit: 1663 Application/Control Number: 18/423,741 Page 6 Art Unit: 1663 Application/Control Number: 18/423,741 Page 7 Art Unit: 1663 Application/Control Number: 18/423,741 Page 8 Art Unit: 1663 Application/Control Number: 18/423,741 Page 9 Art Unit: 1663 Application/Control Number: 18/423,741 Page 10 Art Unit: 1663 Application/Control Number: 18/423,741 Page 11 Art Unit: 1663 Application/Control Number: 18/423,741 Page 12 Art Unit: 1663 Application/Control Number: 18/423,741 Page 13 Art Unit: 1663 Application/Control Number: 18/423,741 Page 14 Art Unit: 1663
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