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 .
Claims 1-20 are pending in this application and are examined on the merits.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Information Disclosure Statement
Initialed and dated copy of Applicant’s information disclosure statements (IDS) filed on 4/10/2025 is attached to the instant Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the assigned NCMA Deposit No. is listed as “XXXX”; this is not a recognized NCMA accession number. Additionally, the date(s) of the seed deposit is/are listed as “NCMA on [date]”, which requires an actual date of deposit (page 44, paragraph [0121]).
Appropriate correction is required.
Claim Objections
Claims 1, 5, 13 and 15 are objected to for missing the NCMA accession number. Appropriate correction is required.
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.
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 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.
Claims 1, 5, 13 and 15 refer to “NCMA Accession No. XXXX”. While it is acknowledged that Applicant will/has made a deposit of wheat variety 6PNUQ24B seed in compliance with 37 C.F.R. § 1.801-1.809 (page 44, paragraph [0121]), because the Accession Number information is incomplete within the claims, it is unclear what wheat variety 6PNUQ24B refers to. The metes and bounds are not clear.
In claim 2, the recitation “An F1 hybrid wheat seed” renders the claim indefinite. It is unclear to which variety F1 hybrid is in reference to. The metes and bounds are not clear. It is suggested to specify that it is drawn to an F1 hybrid wheat seed of wheat variety 6PNUQ24B.
Enablement
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 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 650 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 at the NCMA in accordance with 37 CFR 1.801-1.809, (Specification, page 44, paragraph 0121). 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 NCMA Accession No. and evidence of deposit to overcome this rejection.
Written description
Claims 3, 5-9 and 13-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIJA), 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
First claim 3 reads on a wheat plant part by growing a hybrid seed of claim 2, Given that plant part reads on a seed, the claim thus reads on a F2 seed of wheat variety 6PNUQ24B. Given genetic information for the parents to produce F2 seed is unknow. It is unclear what genotypic and phenotypic features are correlated to the F2 seeds as well as the plant produced by growing such F2 seed. Therefore, Applicants are not in possession of F2 seeds and the plant produced thereby.
Further, claims 13-20 are broadly drawn to a seed, plant, plant part, or plant cell of wheat variety 6PNUQ24B further comprising a locus conversion. According to the specification [0042], a locus conversion refers to plants within a variety that have been modified and retains the genome specific of the variety and further comprises one or more loci for desired traits. Therefore, the claims read on a genus of a seed, plant, plant part, or plant cell of wheat variety 6PNUQ24B with an unlimited number of loci conversions and that substantially differs from the wheat variety 6PNUQ24B. The specification does not describe a single species of wheat variety 6PNUQ24B further comprising a locus conversion that retains the original genome of the variety. No specific structural features that would distinguish said a seed, plant, plant part, or plant cell of wheat variety 6PNUQ24B further comprising any number of locus conversion. Consequently, the specification does not provide sufficient written description for claims 13-20.
Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
Amending the claims to specify that the plant has the locus conversion and otherwise comprises all of the physiological and morphological characteristics of the wheat variety 6PNUQ24B would obviate the rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18,598,890 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other, because the disclosed varieties are full siblings with one another that do not appear to differ by any traits significantly.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Remarks
The claims are deemed free of the prior art of record. The closest prior art is the wheat cultivar 6PDLD01B of Laskar et al (US 11,191,233 B1), which exhibit similar features such as glume color and anther color. However, wheat cultivar 6PDLD01B exhibits distinct leaf wax, disease resistance profiling and genetic background.
No claim is allowed.
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/LI ZHENG/Primary Examiner, Art Unit 1662