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 .
Claims
Claims 1-20 are pending and are examined in this Office Action.
Specification
The disclosure is objected to because of the following informalities: there is “XXXX” where there should be an accession number and “[date]” where there should be a date of deposit (Spec 45).
Appropriate correction is requested.
Claim Objections
Claims 1, 5, 13 and 15 are objected to because of the following informalities: each of these claims recites “XXXX” where there should be an accession number for the deposited seeds.
Appropriate correction is requested.
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.
Lack of 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. All dependent claims are included in this rejection unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to seeds and plants of wheat variety 6PYZU31B or plants and plant parts derived from said variety and methods that utilize said variety. 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 variety is considered sufficient to ensure public availability for most plant species. The specification does not disclose a repeatable process to obtain the plant. It is noted that Applicant has deposited seeds with the National Center for Marine Algae and Microbiota (NCMA) (Spec 45) but they have not provided the accession number nor have they stated if the deposit was be made under the Budapest Treaty or not, therefore the Examiner does not know if they need to check for viability testing or not. In addition they have not stated that all restrictions to public availability will be irrevocably removed upon granting of the patent.
(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.
Inadequate Written Description
Claims 13-20 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. All dependent claims are included in these rejections unless they have a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to a wheat plant, plant part, seed, or plant cell of variety 6PYZU31B further comprising a locus conversion, or a hybrid plant produced by crossing said converted plant to a different wheat plant, or tissue culture of such a plant, or a method of using such a plant.
Each of these claims allows for a locus conversion being introduced into variety 6PYZU31B. The specification states that a locus conversion refers to wheat plants that are developed by backcrossing or genetic transformation to introduce a given locus into the wheat plant, wherein the morphological and physiological characteristics of a wheat cultivar are recovered in addition to the characteristics conferred by the locus transferred into the wheat cultivar via backcrossing or genetic transformation technique (Spec 11-12 ¶ 42). The specification also includes the following: “A single gene or locus conversion, or at least about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, or 40 or more genes or locus conversions and less than about 100, 90, 80, 70, 60, 50, 40, 30, 21, 15, or 10 genes or locus conversions, may be introduced into a plant or comprised in the genome of the wheat plant.” (Spec 18 ¶60). For this reason, claims 13-20 allow for an unlimited number of loci converted because the claims do not limit the number of loci converted. The specification even specifically suggests “less than about 100” genes or locus conversions introduced.
Wheat has 7 chromosomes, therefore, if there were 99 loci converted, there would be about 14 loci converted per chromosome. Each locus conversion can introduce flanking DNA from the donor plant that was used to introduce the specific desired trait, therefore, a very large amount of the genomic DNA on each chromosome would be altered relative to the seeds that were deposited for 6PYZU31B. Clearly Applicant was not in possession of this extremely large genus of plants derived from 6PYZU31B.
With regard to claim 18, specifically, the claim is directed to a seed produced by crossing a plant having an unlimited number of loci converted relative to 6PYZU31B with a different plant. This is a product-by-process claim, and it requires a cross-pollination, but it is not limited to the F1 produced by this cross, therefore, it encompasses distal progeny with an unlimited number of additional generations of breeding steps. Applicant was not in possession of such plants.
The plants encompassed by each of these claims have not retained a sufficient amount of genomic DNA to be described by the DNA comprised within the deposited seeds, nor are they required to retain any of the particular traits that have been described for variety 6PYZU31B in the instant specification. Therefore, the plants encompassed by these claims are not described by either structure (genomic DNA or by function (phenotype, characteristics, and/or traits).
For this reason, the instant specification does not provide an adequate written description for the wide breadth of these claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 13-20 is/are rejected under 35 U.S.C. 103 as being obvious over US 11,730,103 B2, issued on Aug. 22, 2023.
As discussed, above, the claims are broadly drawn to a wheat plant, plant part, seed, or plant cell of variety 6PYZU31B further comprising a locus conversion, or a hybrid plant produced by crossing said converted plant to a different wheat plant, or tissue culture of such a plant, or a method of using such a plant. Given the definition of locus conversion, this allows for a large amount of genomic DNA to be changed and unlimited number of traits to be changed relative to the seeds that were deposited and the traits that were reported in Table 2 (Spec 47-49).
The prior art patent is directed to wheat variety 6PLSK70B. The instant wheat variety and the prior art wheat variety share many of the same traits (Spec 47-49 and ‘103 cols 25-27). Given that the claims allow for genomic DNA and traits to be changed, the prior art variety is indistinguishable from a subset of the plants encompassed by the instant claims.
Furthermore the ‘103 patent specifically claims seeds and plants that have locus conversions relative to their particular deposited seeds, and plants produced by additional breeding steps, and methods of applying breeding techniques to such plants (‘103, claims 15-19). Any changes between these two plants can be attributed to the unlimited number of loci converted relative to either one of the seed deposits.
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 13-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-20 of US Patent No. 11,730,103 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘103 patent and the instant claims overlap substantially in scope (see rejection under 35 USC 103, above).
The claim language for claims 13-20 is identical for both applications other than the name of the variety.
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A 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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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
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