CTFR 18/536,941 CTFR 80990 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. Claims The amendments received on Jan. 22, 2026, have been entered. Claims 1-19 are pending and are examined in this Office Action. 07-30-03-h AIA Claim Interpretation Claim 3 is interpreted to encompass either an F1 of a selfed plant of the instant variety which is a member of the variety itself because the variety is an inbred, or an F1 hybrid which would contain one complete set of chromosomes of the instant variety along with chromosomes from the second parent plant. Claim 7 is interpreted to be directed to a BC2 seed containing one full set of chromosomes from the instant variety because the last breeding step is a backcross to a parent plant of the instant variety. Objections and Rejections That Are Withdrawn The objections to the specification are withdrawn in light of Applicant’s amendments to the specification. The objection to claim 2 is withdrawn in light of Applicant’s amendments. The portion of the written description rejection of claims 13-19 for encompassing plants with an unlimited number of locus conversions relative to the deposited seeds is withdrawn in light of Applicant’s amendments to claims 13-15. The rejection of claims 1-19 under 35 USC 112A for lack of enablement is withdrawn in light of Applicant’s statements that the deposit has been made under the Budapest Treaty and was accepted, and that all restrictions upon availability to the public will be irrevocably removed upon granting of a patent (Resp 8). The rejections of claims 1-19 under 35 USC 112B for indefiniteness are withdrawn in light of Applicant’s perfection of the biological deposit and amendments to claims 7, 12, and 15. The rejection of claim(s) 13-15 and 17-19 under 35 U.S.C. 102(a)(1) and (a)(2) is withdrawn in light of Applicant’s amendments to the claims limiting the locus conversions to a SINGLE locus conversion. The provisional double patenting rejections of claims 1-19 over copending Application No. 18/980,168 and Application No. 18/980,117 are withdrawn in light of Applicant’s amendments to the claims limiting the locus conversions to a SINGLE locus conversion. Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Inadequate Written Description Claims 1-19 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. Applicant’s arguments in the response received on Jan. 22, 2026, have been fully considered but were not found to be persuasive. The claims are broadly drawn to a plant, plant part, or seed of wheat variety PMWH80246940, and to products derived from said plants, plant parts, and seeds, and to methods of making and using the plants, plant parts, seeds, and products. Applicant has described wheat variety PMWH80246940, in part by depositing a representative sample of seed with the NCMA, and in part by including three trait tables (Spec 31-33). Presumably the plants grown to collect the data for these trait tables are from the same batch of seeds as the seeds deposited with the NCMA with no changes to the genetics between the deposited seeds and the seeds used for collecting the data. The MPEP requires: The 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 also referenced 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). In the BACKGROUND section, Applicant provides an excellent description of plant breeding for developing new wheat varieties (Spec 1). Specifically, in claim 1, applicant claims a new wheat variety, PMWH80246940. Aside from the deposit, this wheat variety is defined by both its traits as set forth in Tables 1 and 2 (Spec 31-33) and by its genetics, i.e., its breeding history). In the instant application however, the specification only provides a phenotypic description of traits with absolutely no description of the underlying genetics. The instant specification is silent regarding the breeding history of the claimed variety. In contrast, the specification is replete with discussion about how to change the genotype of the claimed variety (pp. 2-6) and how to use genetic markers (p 17), but other than what is inherent in the deposited seeds, Applicant provides no information regarding the genetics of the deposited seeds. See 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 ). None of the traits recited in Table 1 are unique to the claimed variety. For example, many other wheat plants are hard red, spring varieties and have white coleoptiles, yellow anthers, semi-erect juvenile growth habit, red seeds, green leaves, etc. (e.g. Spec 31-33). Their combination may provide a fingerprint that may be unique to this variety. However a wheat plant is not produced by selecting individual traits, it is produced by breeding. Thus, to protect an unintentional infringer, the breeding history is required. Further, availability of the breeding history will expedite a full and through examination of the pending claims To illustrate this point further, the breeding history features prominently in a recent decision by the Office’s Appeals Board. In the McGowen decision, after analyzing the breeding history (p. 7 (btm)-8), the Board found the claimed plants to be obvious (p. 10). Ex Parte McGowen (PTAB 2020) (decision in appl. ser. no. 14/996,093). The decision provided extensive discussion of the traits. (para 5-8 & 12 pp. 4-5) These differences were cited by the applicant when comparing the prior art and the new plant variety. But the trait tables insufficient to overcome the finding of obviousness. See, for example, McGowen , paras. 6 & 8 (pp. 4-5). The decision, however, turned on the breeding history. (pp. 8 & 17).Because the breeding history was available, the phenotypic differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible. Thus the breeding history is necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. This applies both to the examination process and also for the purposes of determining possible infringement after the patent issues. Providing the breeding history begins to provide an artisan with the necessary information to be able to anticipate potential infringement. It is routine in the art to rely on the breeding history for evaluating the underlying genetics in any given plant variety. Thus, a specification devoid of a breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement. In view of this variability, the breeding history is essential and is the least burdensome way to Applicant to provide genetic information needed by the Office and the public to adequately describe a newly developed plant. To overcome this rejection, applicant should amend the specification/drawing to provide the breeding history used to develop the instant variety. When identifying the breeding history, applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety. If, for example, applicant’s breeding history uses proprietary line names, applicant should include in the specification all other names of the proprietary lines / varieties. This is particularly important in the case of publicly disclosed or patented lines / varieties. 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 describe the trait or transgenic event that is being donated to the recurrent parent. If one 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 as well (i.e. grandparents). Applicant’s Arguments Applicant points to a Federal Circuit Court decision and several decisions from the PTAB as examples where a biological deposit was deemed sufficient for providing an adequate written description (Resp 7). This is not persuasive, however, because none of these applications were directed to a new plant variety/cultivar, therefore, the structures that needed to be adequately described were very different than the entire genome of a new plant variety. Applicant points to the Ex Parte C decision of the BPAI as an example of a biological deposit providing an adequate written description. This is not persuasive, however, because in Ex Parte C the biological deposit was provided in addition to the breeding history rather than as a substitution for a breeding history. Applicant points out that the Supreme Court recognized that the description requirement for plants includes a deposit of the biological material ( Id .). This is not persuasive, however, because an adequate written description is accomplished by a biological deposit along with a breeding history. The Examiner agrees that a deposit is included in the written description, but it is not a substitution for a breeding history. Double Patenting 08-30 AIA A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. 08-33 AIA 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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Provisional Double Patenting over Application No. 18/536,872 08-35 AIA Claim s 1-19 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-19 of copending Application No. 18/536,872 (reference application; now published as US Pre-Grant Publication US 2024/0196850) or, alternatively, claim 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-19 of copending Application No. 18/536,872 . Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending application, referred to hereafter as the ‘872 application, is directed to a wheat variety that is nearly identical compared with the instant variety (Spec 31-32; page 12 of the pre-grant publication for the ‘872 application). Small differences in quantitative traits cannot be relied upon because the data do not show standard deviation or error bars, and the two varieties would need to be grown side by side and shown to have a statistically significant difference to rely on a quantitative trait to differentiate. Furthermore, claims 13-19 allow for changes in the traits via locus conversions. The specific claim language is identical except for the name of the variety and the accession number. For this reason, the instant wheat variety and the variety claimed in the ‘872 patent are indistinguishable by both phenotype and by breeding history (genetics) . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Applicant argues that the varieties differ by 1.5 days for number of days to heading (heading date) and by 2 cm in height (Resp 11). This is not persuasive, however, because this type of quantitative trait cannot be relied upon to distinguish plant varieties unless they have been grown side-by-side or under the same controlled environment and shown to have a statistically significant difference. Applicant argues that there are phenotypical differences in glume/spike details and seed/kernel details ( Id. 10-11). This is not persuasive, because the description of these phenotypes appears to be identical with both plants having oblong spike shape, mid-dense spike density, inclined spike curvature, tan glume color, medium glume length, red and oval seeds, and 1,000 kernel weight of 30/31 (‘872 Spec 30-31 Table 1, instant Spec 31-32 Table 1). The kernel weight is another quantitative trait that cannot be relied upon to distinguish plant varieties unless they have been grown side-by-side or under the same controlled environment and shown to have a statistically significant difference. Furthermore, each of these applications has claims directed to plants of the respective variety having a locus conversion, so a change in a trait is encompassed by the claims. Summary No claim is allowed. Finality 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. Examiner’s Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. CATHY KINGDON Primary Examiner Art Unit 1663 /CATHY KINGDON/Primary Examiner, Art Unit 1662 Application/Control Number: 18/536,941 Page 2 Art Unit: 1663 Application/Control Number: 18/536,941 Page 3 Art Unit: 1663 Application/Control Number: 18/536,941 Page 4 Art Unit: 1663
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