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 .
Status of the Claims
Amendments dated 01/27/2026 are entered.
Claims 1-20 are pending.
Claims 1-20 are examined herein.
The objections to Claims 9 and 12 have been withdrawn in view of Applicant’s amendments to the claim.
The rejections to Claims 18-19 under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (Frontiers in plant science 9 (2018): 1-16) have been withdrawn in view of Applicant’s amendments to the claims.
Specification
The disclosure is objected to because of the following informalities: on pg. 54, paragraph [00253], there is a blank line where there should be an Accession number and a blank line where there should be a date of deposit. The paragraph with the deposit information states that the “deposit has been accepted under the Budapest Treaty… ”, however, without an Accession Number and a date of deposit, it appears that the deposit has not, yet, been made. It is unclear how it can already be accepted under the Budapest Treaty if it has not, yet, been made.
Appropriate correction is required.
Response to Arguments
Applicant’s Remarks on pg. 5 in the reply filed on 01/27/2026 are acknowledged but do not overcome the objections to the specification because the specification still remains unamended in regard to the deposit information for the claimed cultivar and the date of the deposit and the application is not in condition for allowance.
Claim Objections
Claims 1, 9, and 11-13 are objected to because of the following informalities:
Claims 1, 11, and 13 each have a blank line where there should be an Accession number.
Response to Arguments
Applicant’s Remarks on pg. 5 in the reply filed on 01/27/2026 are acknowledged but do not overcome the objections to the claims because the claims still remain unamended in regard to the deposit information for the claimed cultivar and the date of the deposit and the application is not in condition for allowance.
Claim Rejections - 35 USC § 112
Indefiniteness
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 1-20 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 1, 6, 10-11, 13, and 16-17 are indefinite in their recitation of soybean cultivar “24190311” because the recitation does not clearly identify the claimed soybean cultivar and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “24190311” is not known in the art, the use of said same does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with the denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of the soybean plant that encompasses all of its traits. This rejection can be obviated by amending the claims to recite the NCMA deposit number.
Dependent claims are also rejected because they fail to overcome the deficiencies of the parent claims.
Response to Arguments
Applicant’s Remarks on pg. 5 in the reply filed on 01/27/2026 are acknowledged but do not overcome the 35 U.S.C. 112(b) rejections to the claims because the claims still remain unamended in regard to the deposit information for the claimed cultivar and the application is not in condition for allowance.
Claim Rejections - 35 USC § 112
Enablement
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 1-20 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 enablement requirement. The claims 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 claims are directed to seeds and plants of soybean cultivar 24190311 or plants and plant parts derived from said cultivar, and methods that utilize said cultivar. 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 seeds. A deposit of 625 seeds of the cultivar is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the plant. It is noted that Applicant states that a deposit of seeds has been made (See pg. 53 of the instant specification) but there is no accession number or date of deposit.
(a) If a deposit is ACCEPTED 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.
Response to Arguments
Applicant’s Remarks on pg. 6 in the reply filed on 01/27/2026 are acknowledged but do not overcome the 35 U.S.C. 112(a) enablement rejections above because Applicant only affirms that a deposit of at least 625 seeds of the claimed cultivar will be made with a Budapest Treaty approved depository after allowance of the claimed invention, not that the deposit has actually been made. As such, the rejection remains because the claims are not in condition for allowance.
Claim Rejections - 35 USC § 112
Written Description
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 1-20 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 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.
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).”
The instant invention is a new soybean variety (24190311). So, the examiner will evaluate what is an adequate written description for a new soybean 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).
In reviewing Applicant’s specification, there is a phenotypic description of the plant traits as seen in Table 1 (pg. 10) of the instant specification. While Applicant has provided the breeding method for the instantly claimed plant cultivar in the instant specification (pg. 9, paragraph 0069) and via the IDS dated 05/02/2024, one of the parents used to produce soybean cultivar 24190311 is not known in the art, at least under the name provided (6008-19) As such, the breeding history information provided is insufficient; thus, the instant application is incomplete as to the breeding history used to produce the claimed plant variety. If one of the parents (6008-19) was never in the public domain, then the Applicant must state clearly for the record that the parent is internal soybean line that has never been made publicly available.
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, (U)).
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 (V)).
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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). 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 (Y)) 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 (p. 645, right column and p. 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 (Z), 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 an applicant’s 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 U.S.C. § 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 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 siblings or parents of the instant plant are claimed, the serial numbers and names of the siblings 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”. In the instant application, Applicant included some breeding history for cultivar 24190311 in the specification and additional names for two of the three parents in a separate IDS. This disclosure is insufficient because it does not address all the issues set forth above, and the information provided in the IDS with regard to additional names of two of the parents should be set forth in the specification. Absent the disclosure in the IDS, one skilled in the art would not have known that the 15XT327740-15 and MK1111B3-B2BAH-10-12 parents are known by other names and are prior art cultivars. An IDS is not part of the specification and cannot provide the written description required to be in the Specification. Thus, the breeding history for the claimed cultivar as disclosed in the specification is incomplete.
Response to Arguments
Applicant’s Remarks on pgs. 7-15 in the reply filed on 01/27/2026 are acknowledged but do not overcome the maintained rejection in regard to the instant soybean cultivar’s breeding history as disclosed in the instant specification (pg. 9, paragraph 0069) and via the IDS dated 05/02/2024.
It is noted in the Applicant’s Remarks on pgs. 7-15 that Applicant has argued both law and legal court cases in the reply, wherein that position is noted as being off-base from the Office’s position which is that, the law that governs written description is a statute, wherein there is no need to look at court cases, and further wherein the question is a factual question only. The Office has reviewed the public domain and a breeding history is a minimum requirement for a complete understanding what is considered a plant. In the instant case, we have the plant traits as described in Table 1 (pg. 10) and 66% of the breeding history (pg. 9, paragraph 0069), which does not constitute a complete breeding history. Due to Applicant’s inadequate disclosure of the breeding history, three questions still need to be resolved: Is 6008-19 a proprietary line? Has 6008-19 ever been publicly available? Are there any other names for 6008-19? As such, Claims 1-20 remain rejected under 35 U.S.C. 112 (a).
Closest Prior Art
Claims 1-20 appear to be free of the prior art, given the failure of the prior art to teach or reasonably suggest a soybean cultivar having all the phenotypic characteristics of the exemplified soybean cultivar listed in Table 1 (pg. 10), or methods of its use. The closest prior art in regard to Claims 1-17 and 20 and be found in Mason et al. (US Patent No. 11083158 B2, issued 08/10/2021) which teaches soybean cultivar 80361023, sharing many traits in common with (or does not significantly differ) instant soybean cultivar 24190311, including seed coat color, seed coat luster, cotyledon color, leaflet shape, growth habit, flower color, plant pubescence color, pod wall color, maturity group, and relative maturity. However, soybean cultivar 80361023 differs from the instant soybean cultivar in at least breeding history, parental genetics, disease resistances, and herbicide resistances.
Conclusion
No claims are 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 KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, AMJAD 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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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663