DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
2. Claims 1-17 are pending.
3. Claims 1-17 are examined herein.
Specification
4. The specification is objected to because on page 59 it is missing the deposit information for the claimed variety. Appropriate correction is required.
Claim Objections
5. Claims 1, 10, 13, and 17 are objected to for reciting “X6” in place of the deposit accession number. Appropriate correction is required.
Election/Restrictions
6. Applicant’s election without traverse of soybean variety “22148807” in the reply filed on November 24, 2025 is acknowledged. It is noted that Applicant canceled all of the other species.
Claim Rejections - 35 USC § 112(b)
7. 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.
8. Claims 1-17 are 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 pre-AIA the applicant regards as the invention.
In claims 1, 10, 13, and 17, the variety name “22148807” without the corresponding deposit information, renders the claims indefinite. The term “22148807” is not otherwise known in the art and one of ordinary skill in the art would not be apprised of its metes and bounds. In addition, one or ordinary skill in the art would recognize that common variety names can and do change over time. Because claims 2-9, 11, 12, 14-16 depend from claim 1, and fail to obviate its indefiniteness, these claims are indefinite as well.
Claim Rejections - 35 USC § 112(a)
9. 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.
Deposit of Biological Material
10. Claims 1-17 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ a novel soybean plant. Since the plant is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the plant. A deposit of 625 seeds of each of the claimed embodiments is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the plant and it is not apparent if the plant is readily available to the public.
It is noted that on page 86 of the specificaiton, Applicant provides a statement indicating that the seeds have been deposited with the ATCC, but the deposit does not appear to have been actually made, as no accession number or the date are supplied. It is also unclear under what terms the deposit will be made. It is noted that pursuant to MPEP 2409, where a statement is merely an indication that a deposit has been made (with no indication as to whether it has been accepted), there is no assurance that the requirements under 35 U.S.C. 112 have been satisfied. Given that in the instant case, there is no indication that the deposit has been made and accepted, the deposit requirement is not met.
(a) If a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
See MPEP 2404.01: The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b)), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
Written Description
11. Claims 1-17 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.
Applicant claims plants and seeds of soybean variety 22148807, plants and seeds derived from said variety, and methods of using said variety.
35 U.S.C. § 112(a) states that “ The specification shall contain a written description of the invention…”. The instantly claimed invention is a plant, and as such, the inquiry here is a fact-based inquiry on what constitutes an “adequate” written description of a plant. To assess what an adequate written description is, the Office has reviewed the following literature, wherein the Office citations are not for legal precedence, but rather are for the fact-based inquiry of what is an adequate disclosure.
A plant variety is defined by both its genetics (breeding history) and its traits. 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”, 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; IDS Document). 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; IDS Documents). 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 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.
As seen 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; IDS Document). 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 Groβkinsky et al., 2015, J. Exp. Bot. 66: 5429-5440; see pg. 5430, left column, paragraph 2, and right column, paragraph 2; IDS Document). 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.
In the instant application, a full examination cannot be conducted. Applicant claims a new soybean variety, 22148807. Applicant has provided a description of the plant traits as seen in Table 6 on pgs. 51-52 of the instant specification. The instant disclosure appears entirely silent as to the breeding history (parental genetics) used to produce the claimed plant variety. As such, the breeding history information provided is insufficient. For this reason, the instant application is incomplete as to the breeding history used to produce the claimed plant variety. If both of the parents were never in the public domain, then the Applicant must state clearly for the record that the parents are internal soybean lines that have never been made publicly available.
The satisfaction of the written description requirement also provides value to the disclosure for the following reasons:
MPEP 2163 (1) 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(1) 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).
Additionally, some of the policy reasons why an adequate written description is needed includes, assisting with search and examination and assisting with infringement verification. However, that does not change the fact that the basal understanding of a plant requires an understanding of the trait and genetics of said plant.
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 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 any 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 (i.e., grandparents).
Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should also note 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).
Conclusion
12. No claims are allowed.
13. The claims appear to be free from the prior art. The closest prior art is Guiraldes et al (US Patent Publication 2020/0288663, published on September 17, 2020) that teaches soybean variety 3446437 that shares a number of characteristics with the instantly claimed soybean but differs at least with regard to relative maturity (see Table 1 of Guiraldes).
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
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/MYKOLA V. KOVALENKO/ Primary Examiner, Art Unit 1662