DETAILED ACTION
Claims 1-20 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The specification is objected to for the presence of blank lines in ¶253.
The terminal disclaimer filed on 1 October 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patents that issue from Application Nos. 18/542,255, 18/542,218, and 18/542,195 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The objection to the specification is withdrawn in light of Applicant’s deposit statement.
The rejection of claims 18-19 under 35 U.S.C. 101 because the claimed invention is directed to a law of nature without significantly more is withdrawn in light of recent Office guidance.
The rejection of claims 1-20 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the subject matter that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention is withdrawn in light of Applicant’s deposit statement, amendment of claim 13, and disavowal of “a plant of “soybean cultivar 28220510” as reading on the definition of “soybean plant” in ¶195 and “single locus conversion” as encompassing anything other transgenes (response pg 5-7).
The rejection of claims 1-20 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s deposit statement. Applicant is reminded that because viability testing of all deposits is required before they can be considered to meet the requirements of 37 CFR 1.801- 1.809, they are advised to perfect the deposit as early as is possible, and before the payment of the issue fee. Failure to perfect a deposit by the date of payment of the issue fee may result in abandonment of the application for failure to prosecute.
The rejections of claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of each of copending Application Nos. 18/542,255, 18/542,218, and 18/542,195 is withdrawn in light of Applicant’s filing a terminal disclaimer.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-20 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 that 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 16 July 2025. Applicant’s arguments filed 1 October 2025 have been fully considered but they are not persuasive. Part A of the previous rejection was overcome by Applicant’s overcoming the indefiniteness rejection and by amendment of claim 13.
B. 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 to conduct an examination, including search of the prior art. 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.").
The instant specification fails to satisfy the written description because it does not provide enough description to be sufficient to aid in the resolution of questions of infringement. 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. In claims 1-20, Applicant claims a new soybean cultivar. A plant cultivar is defined by both its genetics (breeding history) and its traits. In the instant application, Applicant has provided a description of the plant traits as seen in the specification. While Applicant has provided the breeding history for the instantly claimed plant cultivar, the one of the parents used to produce it is not known in the art, at least under the name provided. The instant application is thus incomplete as to the breeding history used to produce the claimed plant cultivar.
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” (USDA, “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, see 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, 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.
Moreover, a specification an incomplete 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 phenotype of the claimed plant 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. The assumption that elite cultivars are composed of relatively homogenous genetic pools is false (Haun et al, 2011, Plant Physiol. 155:645-655; see pg 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 (pg 645, right column, paragraph 2, to pg 646, left column, paragraph 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al, 2015, J. Exp. Bot. 66:5429-5440; see pg 5430 left column, paragraph 2, and right column, paragraph 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 must 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 (7.e., grandparents).
Applicant is also reminded of the 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 urges that in Ex Parte C, Enzo and Inari to assert that the written description requirement is provided by the deposit, such that they do have to provide a breeding history; the public can access their deposit and perform a molecular marker analysis that would provide structural (genetic) characteristics to distinguish the instant plant from other plants in the public domain (response pg 9-11).
This is not found persuasive.
Regarding Applicant’s argument that the public can access their deposit and perform a molecular marker analysis that would provide structural (genetic) characteristics to distinguish the instant plant with other plants, instant claims 18-19 are drawn to a method comprising detecting at least a plurality of first polymorphisms in a sample of nucleic acids from the claimed plant. So, Applicant is asking to preclude the public from performing a marker analysis that Applicant is saying the public can do to distinguish the instant plant from other plants.
Applicant needs to explain how the public can conduct a marker analysis if they have claims preventing the genotyping of the plant. If the public cannot genotype the plant, they cannot do a marker analysis Applicant says is possible to do. If a marker analysis cannot be done, then Applicant’s assertion that written description can be satisfied by way of the deposit is misleading. Applicant’s claims 18 and 19 in effect would make the public an infringer to genotype the instant variety as a means to distinguish their plant from the instant variety.
Note that in response to the obviousness and double patenting rejections below, Applicant did not provide a genetic marker analysis to show that the instant variety is not obvious over the cited plants. If genetic marker analysis can be used distinguish the instant variety, why didn’t Applicant provide marker information to show that the instant variety is not obvious over the plants cited in the obviousness and double patenting rejections? It is noted that Applicant is in the best position to do so as they own the prior art patent and the instant variety and likely have markers available. Applicant’s failure to provide this information is evidence that it is not practical to do a marker analysis to distinguish the instant plants as claimed from other plants with related phenotypes.
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).
Regarding Applicants’ arguments on the legal basis of the written description rejection and the court’s/board’s interpretations. The best starting point for a written description analysis is the law itself. The first 10 words of 35 USC 112 (a) are critical.
(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. (emphasis added)
The strict interpretation of the law is clear: Applicant must provide in the specification a written description of the invention. The only question is what an “adequate written description” is. This is a fact-based inquiry done by the factfinder (i.e., the examiner) when analyzing the nature of the instant invention.
The Office has made a finding of fact that for the instant variety the minimum description is the combination of the phenotype and genotype (breeding history). To support this finding of fact, the Office has cited other plant-related intellectual property organizations and relevant court cases dealing with plant varieties in which both the phenotype and genotype are analyzed. The Office did not cite these finding to clarify the law. They are solely to clarify the finding of fact, i.e., what is an adequate written description for the instant plant variety. Applicant’s arguments ask the Office to not consider the actual statute and base our decision solely on statements from court/board cases that do not directly decide what an adequate written description is for a plant variety.
In the obviousness and double patenting rejections below, the Office provided an example of another soybean plant that has a phenotype makes obvious a soybean plant with the phenotype of the instant variety. This plant is owned by Applicant. Because of the phenotypic similarity, the Office needs to analyze the genotype of the claimed plant more carefully. A review of the genotype provided only arbitrary/proprietary line information that is not useful to someone that is not the Applicant. These line names do not allow for the Office to have a full understanding of the instant variety.
The references cited in the rejection are evidence regarding that question of fact regarding what is considered when describing plants. They are not cited for legal analysis. The references cited, including USDA and UPOV, establish that in the plant variety art, a breeding history is part of the description of a plant variety.
Applicant has not provided evidence saying that in the plant variety art the breeding history is not considered art of the description of a plant variety. Applicant has not rebutted the evidence provided in the rejection.
Conclusion
No claim is allowed.
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 Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo (Joe) Zhou, can be reached at (571) 272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anne Kubelik/Primary Examiner, Art Unit 1662