DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Aug. 13, 2026, has been entered. Claims 1-19 are pending and are examined in this Office Action.
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 (or further generation, such as BC3, BC4, etc) 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.
Claim Rejections - 35 USC § 112
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 Aug. 13, 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.
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.
Applicant has described wheat variety PMWH80246940, in part by depositing a representative sample of seed with the NCMA, and in part by including two 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 office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “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” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023).
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, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30).
Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety. (See Ex Parte C (USPQ 2d 1492 (1992) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020). In both of these cases, there were many differences cited by the Applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these 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.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 645, left column). 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 (Haun 645, right column and 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015, p. 5430, left column, 1st full paragraph, and right column, 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in the instant disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
MPEP 2163 (I) states “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) states “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
Moreover, a specification devoid of a complete 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. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve questions of infringement. 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.
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 must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. 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 cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar 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 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 should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is 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). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. 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).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”.
Applicant’s Arguments
Applicant argues that the Examiner has improperly conflated the PVP and UPOV requirements to justify a breeding history requirement (Resp 7). This is not persuasive because 35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, 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 clearly 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).”
So, the examiner will evaluate what is an adequate written description for a new wheat variety. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history).
The PVP and UPOV requirements are one way to assess what is an art accepted description of a new plant variety, and this provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in the instant disclosure a description of the invention defined by the claims. (See MPEP 2163.04). The references cited, above, are relied upon for establishing the art accepted criteria for a description of a new variety and are not relied upon for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The reference to art accepted criteria is part of the finding of fact that a breeding history is necessary to the adequate description of a plant.
Applicant argues the Examiner conflates 35 USC 112’s focus on disclosing the invention itself with concerns about enforcement (Resp 7). The Examiner disagrees. The Examiner did not conflate these two things, however, the Examiner does believe there should be some consideration as to whether or not a practitioner would know if they are infringing. See Vas-Cath 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-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991 ).
Applicant argues that the deposit system is a more reliable infringement tool as it allows direct side-by-side testing of the patented variety versus the accused plant using molecular or phenotypic assays (Resp 7). This is not persuasive, however, because in order to perform the side-by-side testing, a practitioner would need to infringe on claims 1, 3, and 12.
Applicant argues that they have submitted a breeding history as a Trade Secret along with a petition to expunge the information (Resp 7). This does not solve the problem of the instant specification lacking an adequate written description. Applicant asserts that the Examiner had directed them to submit breeding history information including notations about the most similar plants, such as siblings (Id.). With regard to Applicant’s duty to disclose, the Examiner was referring to the breeding history which needs to be included in the specification in addition to citations to be included on an information disclosure statement (published reference and/or issued patents or co-pending patent applications). The Examiner never requested Applicant to submit non-public information other than co-pending US Patent applications.
With regard to the written description specifically for claims 13-19, this rejection was withdrawn in the final Office Action mailed on June 5, 2026 (OA 3).
Double Patenting
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.
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
Claims 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 claims 1-19 of copending Application No. 18/536,872. Applicant’s arguments in the response received on Aug. 13, 2026, were fully considered but were not found to be persuasive.
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 a single locus conversion. 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’s Arguments
Applicant argues that the two varieties come from different pedigree and have different parents (Resp 9). This is not persuasive because Applicant has not provided any evidence to support this assertion. Applicant has submitted “Trade Secret” information in an artifact folder that they have requested to be expunged from the record; however, this information is moot because the co-pending application lacks its own written description of the variety claimed in the ‘872 application. For the “Trade Secret” information to be useful, the Examiner would need to be able to compare the breeding histories side-by-side.
Applicant argues that the varieties differ by 1.5 days for number of days to heading (heading date) and by 2 cm in height, by 1% in protein content, and by 1,000 Kernel weight (Resp 9). The difference in 1,000 Kernel weight is 30 g vs. 31 g (Spec 32, ‘872 Spec 32). This is not persuasive, however, because none of these quantitative values have been disclosed with standard deviations, and, for example, it defies credulity to believe that every wheat plant of the instant variety grows exactly 77.5 cm tall. Any numeric trait is reported as the average, and the averages cannot be compared 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 single locus conversion, so a change in a trait is encompassed by the claims.
Summary
No claim is allowed.
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.
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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
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