DETAILED ACTION
The Amendment filed November 13, 2025 has been entered.
Claims 13-15 are currently amended.
Claims 1-19 are pending.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
All previous objections and rejections not set forth below have been withdrawn.
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 .
Withdrawn Claim Rejection
The rejection of claims 1-19 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s response.
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 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 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 1-19 are drawn to a plant, plant part, or seed of wheat variety PMWH102204613, 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.
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. Applicant specifically claims a new wheat plant 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 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, www.ams.usda.gov/services/pvpo/application-help/apply). 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, www.upov.int/edocs/expndocs/en/upov_exn_edv.pdf). 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. (Haun et al. The Composition and Origins of Genomic Variation among Individuals of the Soybean Reference Cultivar Williams 82. Plant Physiol. 2010 Nov 29;155(2):645–655, see 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. (Haun Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al. Plant phenomics and the need for physiological phenotyping across scales to narrow the genotype-to-phenotype knowledge gap. J. Exp. Bot. 2015 Sep;66(18):5429-40. Epub 2015 Jul 10, see 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).
Response to Arguments
Applicant's arguments filed November 13, 2026 have been fully considered but they are not persuasive.
Applicant maintains that the written description provided in the instant application along with reference to the seed deposit in a public depository is sufficient to meet the written description requirement under 35 USC §112. Applicant would like to rely on Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 965 (Fed. Cir. 2002) where the Court held that "that reference in the specification to a deposit in a public depository, which makes its contents accessible to the public when it is not otherwise available in written form, constitutes an adequate description of the deposited material sufficient to comply with the written description requirement of § 112, ¶ 1. Applicant also points out that the Supreme Court explicitly recognized that "[t]he description requirement for plants includes a deposit of biological material, for example, seeds, and mandates that such material be accessible to the public." J.E.M. Ag Supply, Inc. V. Pioneer Hi-Bred International, Inc., 534 U.S. at 142-143. Applicant submits that the written description as submitted along with the reference in the specification to a deposit in a public depository is sufficient to meet the written description requirement under 35USC § 112.
Applicant's arguments are not persuasive.
Applicant's arguments are not persuasive because Applicant appears to be capable of describing how the instant invention was made. Enzo Biochem, Inc., relied upon by Applicant, also states that [a] reference in specification to deposit of biological material in public depository, which makes its contents accessible to public when it is not otherwise available in written form, constitutes adequate written description of deposited material sufficient to comply with the written description requirement. Unlike Enzo where the inventor had not described the nucleotide sequences inserted into the plasmids contained in the deposited bacteria, Applicant appears to be capable of describing, in written form, the parental plants and breeding method(s) used to produce the claimed wheat variety PMWH102204613. 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. Accordingly, the rejection is maintained.
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 are drawn to a plant, plant part, seed, or plant cell of wheat variety PMWH102204613 further comprising a locus conversion.
Because the claim language of “comprising” is understood to be open, there is no limit to the number of loci in wheat variety PMWH102204613 that may be converted in the claimed plant, plant part, seed, or plant cell. Additionally, because it is understood that a locus conversion can alter a trait, there is no limit to the number of traits of the wheat variety PMWH102204613 that may be altered in the claimed plant, plant part, seed, or plant cell. Further, the claims do not require that any specific traits of the wheat variety PMWH102204613 be retained by the claimed plant, plant part, seed, or plant cell. Accordingly, the genus encompassed by these claims is nearly infinite, and such plants were not in possession of the Applicant at the time of filing, since they have not been adequately described either by their structure (genetics) or by their function (required traits).
Response to Arguments
Applicant's arguments filed November 13, 2026 have been fully considered but they are not persuasive.
Applicant maintains that the amendment of the claims to clarify that the locus conversion is a “single locus conversion” should overcome the rejection.
Applicant's arguments are not persuasive.
Applicant's arguments are not persuasive because the recitation that the locus conversion is a “single” locus conversion does not limit to the number of loci in wheat variety PMWH102204613 that may be converted in the claimed plant, plant part, seed, or plant cell exclude given that the claim language of “comprising” is understood to be open. Additionally, even if the number of locus conversions were limited to one, there is no definition of “locus conversion” or “single locus conversion” in the specification that would restrict the number and type of changes made to the genome. Further, the claims do not require that any specific traits of the wheat variety PMWH102204613 be retained by the claimed plant, plant part, seed, or plant cell. Accordingly, the rejection is maintained.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-19 remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 13-19 are indefinite because the meets and bounds of the genus encompassed by the claimed plants and seed are not clear. Given that the claim language of “comprising” is understood to be open, there is no limit to the number of loci in wheat variety PMWH102204613 that may be converted in the claimed plant, plant part, seed, or plant cell. Additionally, because it is understood that a locus conversion can alter a trait, there is no limit to the number of traits of the wheat variety PMWH102204613 that may be altered in the claimed plant, plant part, seed, or plant cell. Further, the claims do not require that any specific traits of the wheat variety PMWH102204613 be retained by the claimed plant, plant part, seed, or plant cell. The meets and bounds of the genus encompassed by the claimed plants and seed are therefore not clear.
Response to Arguments
Applicant's arguments filed November 13, 2026 have been fully considered but they are not persuasive.
Applicant maintains that the amendment of the claims to clarify that the locus conversion is a “single locus conversion” should overcome the rejection.
Applicant's arguments are not persuasive.
Applicant's arguments are not persuasive because the recitation that the locus conversion is a “single” locus conversion does not limit to the number of loci in wheat variety PMWH102204613 that may be converted in the claimed plant, plant part, seed, or plant cell exclude given that the claim language of “comprising” is understood to be open. Additionally, even if the number of locus conversions were limited to one, there is no definition of “locus conversion” or “single locus conversion” in the specification that would restrict the number and type of changes made to the genome. Further, the claims do not require that any specific traits of the wheat variety PMWH102204613 be retained by the claimed plant, plant part, seed, or plant cell. Accordingly, the rejection is maintained.
Conclusion
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.
Remarks
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662