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 .
Priority
This application is a CONTINUATION of U.S. Patent Application No. 17/523,755, filed 10/21/2024. Acknowledgement is made of the applicant’s claim for benefit to prior-filed U.S. patent application 17/523,755 (filed 11/10/2021) and prior-filed U.S. provisional patent applications 63/112,438 (filed 11/11/2020).
Abstract
The abstract of the disclosure is objected to because the abstract has less than 50 words and does not clearly summarize the method disclosed in the invention. See MPEP 1826. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 128 and 129 are objected to because of the following informalities:
Claims 1 and 128 recite “ the first sequence of interest” in line 20 and line 18 respectively. Since there is no “second sequence of interest” appears in the claims, the word “first” needs to be deleted.
Claim 129 recite the phrase “both (j) and (k)” in (xii), there are no “(J)” and “(k)” in claim 129 or the independent claim 128. According to the context, the phrase needs to be replaced with “both (x) and (xi)”.
Appropriate correction is required.
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 1-7, 9-10, 13-14, 22, 24, 26-27, 29, 35, 37, 108-110 and 128-129 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US 12157893 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims render obvious to the instant claims.
The patent claims disclose a recombinant nucleic acid construct having the same structure as that described in instant claims. Though the patent claims are directed to the recombinant nucleic acid construct, per se, the patent specification disclosed the method of introducing the recombinant nucleic acid construct to a plant cell (see i.e., Col 6, L9-15). It has been held that a claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use. See Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86, and Sun Pharmaceutical Industries V. Eli Lilly and Co., 611 F. 3d 1381, 1387 (CAFC 2010). For this reason, the instant claims are held to be prima facie obvious over the claims of the prior patent to the same composition, wherein the currently claimed use is recited in the patent specification.
Related prior arts
Instant claims are directed to a method of editing a genome of a plant cell by introducing the cell a recombinant nucleic acid construct which comprising: (i) a left border (LB) sequence; (ii) a first recombination site and a second recombination site; (iii) a target site for a guided nuclease; (iv) a sequence of interest; (v) a right border (RB) sequence; and (vi) a single intron sequence, wherein the intron sequence is split into a 5' portion of the intron sequence and a 3' portion of the intron sequence, wherein the 5' portion of the intron sequence is positioned 5' to the RB sequence, wherein the 3' portion of the intron sequence is positioned 3' to the LB sequence, and wherein the 5' portion of the intron sequence and the 3' portion of the intron sequence are not adjacent to each other, wherein the target site for the guided nuclease and the sequence of interest are positioned between the first recombination site and the second recombination site. Krieger et al. (US 20190211344 A1, cited in IDS) is considered as the closet prior art. Krieger et al. teach an Agrobacterium-mediated transformation method for plant cells that promotes templated gene editing and site directed integration of transgenes (parag 0004). Krieger et al. teach introducing to a plant cell a vector comprising (a) a left border (LB) sequence; (b) a first recombination site and a second recombination site; (c) a target site for a guided nuclease; (d) a sequence of interest; (e) a right border (RB) sequence; wherein the target site for the guided nuclease and the sequence of interest are positioned between the first recombination site and the second recombination site (see i.e., paragraphs 0009, 0018 and 0137). Krieger et al. also teach an intron can be included (see parag 0096). However, Krieger et al. do not teach or suggest in the construct that a single intron sequence split into a 5' portion of the intron sequence and a 3' portion of the intron sequence, wherein the 5' portion of the intron sequence is positioned 5' to the RB sequence, wherein the 3' portion of the intron sequence is positioned 3' to the LB sequence, and wherein the 5' portion of the intron sequence and the 3' portion of the intron sequence are not adjacent to each other. No prior art is found to show such placement of the split intron in a vector, particular in which comprising left border and right border (i.e., binary vectors used to transfer foreign DNA into plant cells). Without the prior arts teaching of such limitation, PHOSITA would not be readily apprised of the recombinant nucleic acid construct and the method of introducing a plant cell said construct as claimed in instant invention when considering the teachings of Krieger et al..
Conclusion
No claims are allowed.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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