Status of the Application
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15 June 2026 has been entered.
The Examiner acknowledges Applicant’s submission of breeding history information for wheat variety PMWH80242964 in the response filed 15 June 2026 (page 7, 2nd paragraph of the Remarks).
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.
Claims 13-19 remain 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.
Claims 13-19 require a seed, plant, plant part, or plant cell of wheat variety PMWH80242964 further comprising a locus conversion.
The specification indicates that plants with a locus conversion actually encompass plants with an unlimited number of conversions at an unlimited number of loci:
[0046] A locus conversion refers to plants within a variety that have been modified in a manner that retains the overall genetics of the variety and further comprises one or more loci with a specific desired trait, such as male sterility, insect, disease or herbicide resistance. Examples of single locus conversions include mutant genes, transgenes and native traits finely mapped to a single locus. One or more locus conversion traits may be introduced into a single wheat variety.
Thus, the claims encompass plants that differ from PMWH80242964 in hundreds of undefined mutations. The only plant within the scope of the claims that is described in the specification is wheat variety PMWH80242964 itself.
One of skill in the art would not recognize that Applicant was in possession of the necessary common traits or features of the genus in view of the single disclosed species.
The structural features that distinguish wheat plants that fall within the claimed genera from those that do not are not described in the specification. The structural features that distinguish wheat plants that fall within the claimed genera from those that are one morphological and physiological characteristic outside those genera are not described in the specification.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed plants, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Applicant argues that claim 13 has been amended to recite that the plant, plant part, seed, or plant cell comprising the locus conversions otherwise (aside from locus conversions) comprises all of the physiological and morphological characteristics of wheat variety PMWH80242964 when grown under the same environmental conditions.
Applicant argues that wheat variety [PMWH80242964] is described not only by traits listed in Table 1, but also by the seed deposit which encompasses the genetics, morphological and agronomic feature of the variety, of wheat variety PMWH80242964 and thus any plant sharing them (aside from one known trait) necessarily falls within this described genus (page 5 of the Remarks).
Applicant’s argument is not found persuasive because claim 13 as presently amended reads on a mutant of wheat variety PMWH80242964. The instant Specification is specific that “a locus conversion” includes chemical or radiation-induced mutagenesis in paragraph [0007] on page 2.
8. Claims 1-19 remain 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 instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
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).
In the instant application, a full examination cannot be conducted because applicant failed to provide the breeding history for the instantly claimed plant variety. Specifically, in claims 1, 3 and 13, applicant claims a new wheat variety. A plant variety is defined by both its genetics (breeding history) and its traits. In the instant application, Applicant has only provided a description of the plant traits as seen in the specification. The instant application is silent or incomplete as to the breeding history used to produce the claimed plant variety.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. 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” by the USDA reference to Exhibit A). 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 (See UPOV EDV Explanatory Notes 14 and 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.
The breeding history is also 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. 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). 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.
Moreover, 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. Because the instant specification lacks the 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.
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 teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun et al page 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. (See Haun et al page 645 right column and page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (See Großkinsky et al page 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 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 must amend the specification/drawing to provide the breeding history used to develop the instant variety or 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 variety. 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 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 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 variety). 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 argues that the Examiner has improperly conflated the PVP and UPOV requirements to justify a breeding history requirement (page 6, 3rd paragraph of the Remarks). 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 that the Examiner conflates 35 USC 112’s focus on disclosing the invention itself with concerns about enforcement (page 6, 4th paragraph of the Remarks). 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 (pages 6-7 of the Remarks). This is not persuasive, however, because in order to perform the side-by-side testing, a practitioner would need to infringe claims 1, 5, and 13. The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted. 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. Such a deposit is not a substitute for a written description of the claimed invention. 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.
Applicant argues that they have submitted a breeding history as a Trade Secret along with a petition to expunge the information (page 7, 2nd paragraph of the Remarks). 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.
Regarding the Trade Secret submission, while Applicant provided information concerning the materials by which the instant invention was made, Applicant was silent as to what plant breeding methods were used to produce the claimed invention.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mergoum et al teach spring wheat variety ‘Faller’, a wheat variety Applicant uses as a comparison to the instant invention in Table 2 on page 32 of the instant Specification.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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 Abraham can be reached on (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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/David H Kruse/
Primary Examiner, Art Unit 1663
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