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 .
Election of Species
Applicant’s election, without traverse, of soybean variety 21776234 and soybean variety 21776245 in the reply filed on 05/12/2026 is acknowledged.
Status of the Claims
Amendments dated 05/12/2026 have been entered.
Claims 1-17 are pending and are examined in this Office action.
Information Disclosure Statement
The Information Disclosure Statements filed on 09/26/2024 and 05/12/2026 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. Signed copies of the lists of references cited are included with this Office action.
Specification
The disclosure is objected to because of the following informalities: the assigned ATCC number for soybean variety 21776234 is listed as X4 and the assigned ATCC number for soybean variety 21776245 is listed as X5; these are not recognized ATCC accession numbers. Additionally, the date(s) of the seed deposit is/are listed as “ATCC Patent Depository on DATE”, which requires an actual date of deposit (page 78, paragraphs 0280-0281 for the elected species; and also, numerous instances for the non-elected species).
Claim Objections
Claim 15 is objected to because of the following informalities: claim 15 should be amended to include the words—said method—prior to the word “comprising” in line 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Indefiniteness
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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. All dependent claims which fail to clarify the metes and bounds of the claims from which they depend are included in this rejection.
The terms “ATCC Accession Number X4” and “ATCC Accession Number X5” recited in claims 1, 13, and 17 render the claims indefinite since this is not a recognized ATCC accession number. The term is not defined by the claims or the Specification, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention since the accession number is incomplete.
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.
Written Description
Claims 2-17 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. All dependent claims which fail to clarify the metes and bounds of the claims from which they depend are included in this rejection.
Applicant has expanded the definition of “soybean plant” to include gene conversions.
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Applying the expanded definition of “soybean plant” to claim 2 (as an example) would mean that soybean variety 21776234 and soybean variety 21776245 are both, individually, a genus that encompasses conversions of the instant varieties. Applicant has not provided adequate written description for the varieties as the trait tables seem to only to be drawn to a single soybean variety 21776234 and a single soybean variety 21776245. Applicant has provided no description on what structure or function (traits) can be altered and still read on the claimed genus.
In the instant case, expanding the definition of soybean to encompass gene conversions is likely to cause substantial change to the defining traits of soybean variety 21776234 and soybean variety 21776245. Applicant has provided no information as to what traits would be conserved or changed and still count as a converted line. Without further description, it is unclear as to what applicant considers as a converted 21776234 variety and a converted 21776245 variety of the instant invention. Finally, applicant has not described any other members of either genus other than the soybean varieties represented via the trait tables in the specification.
Deposit/Enablement
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.
Since the seed and/or plant claimed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed, or seed of the claimed plant is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the 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, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) 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 enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
Applicant has indicated that Applicant intends to deposit the seeds of soybean variety 21776234 at the ATCC in accordance with 37 CFR 1.801-1.809, “ATCC number X4” deposited on “DATE”; and the seeds of soybean variety 21776245 at the ATCC in accordance with 37 CFR 1.801-1.809, “ATCC number X5” deposited on “DATE” (page 79, paragraphs 0277 and 0278, respectively). Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809 indicating that all restrictions will be irrevocably be removed upon issuance of a patent, the ATCC Accession No. and evidence of deposit to overcome this rejection.
Closest Prior Art
Claims 1-17 appear to be free of the prior art, given the failure of the prior art to teach or reasonably suggest a soybean variety having all the phenotypic characteristics of the exemplified soybean variety listed in Table 4 (soybean variety 21776234; pages 44-45) and Table 5 (soybean variety 21776245; page 46), or methods of their use.
The closest prior art in regard to Claims 1-17 can be found in GUIRALDES et al. (Pub. No.: US 2023/0172144 A1, Pub. Date: Jun. 8, 2023; see Table 18, page 46). In regard to instant soybean variety 21776234, GUIRALDES teaches soybean variety 21799942, sharing many characteristics in common (or does not significantly differ) with the instant soybean variety 21776234 including: seed coat color, hilum color, peroxidase activity, hypocotyl color, flower color, pubescence color, plant habit, stem canker (southern) resistance, soybean cyst nematode (race 3, HG type 0) resistance, and sulfonylurea resistance. However, soybean variety 21799942 differs from the instant soybean variety 21776234 in at least: cotyledon color, pod color, and salt responses.
Likewise, in regard to instant soybean variety 21776245, GUIRALDES teaches soybean variety 21799942, sharing many characteristics in common (or does not significantly differ) with the instant soybean variety 21776245 including: seed coat color, hilum color, peroxidase activity, hypocotyl color, flower color, pubescence color, plant habit, stem canker (southern) resistance, soybean cyst nematode (race 14, HG type 1.3.6.7) resistance, and sulfonylurea resistance. However, soybean variety 21799942 differs from the instant soybean variety 21776245 in at least: cotyledon color, pod color, soybean cyst nematode (race 3, HG type 0) resistance, and salt responses.
Summary
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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 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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CHRISTINA MEADOWS
Examiner
Art Unit 1663
/CHRISTINA L MEADOWS/Examiner, Art Unit 1663 /Amjad Abraham/SPE, Art Unit 1663
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