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 .
Claim Status
Claims 1-9 are pending and under examination.
Information Disclosure Statement
The listing of references in the specification (see [0009]-[0010]) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 6-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (I-SceI-mediated scarless gene modification via allelic exchange in Clostridium. J Microbiol Methods. 2015 Jan;108:49-60).
Regarding Claim 1, Zhang et al. teach a plasmid for transformation (see pg. 50, 2.3 Plasmid construction; Fig. 1), comprising a site into which a gene of interest is to be incorporated (see Fig. 1, site between H1 & H2), a pair of homologous recombination sequences sandwiching the site (see Fig. 1, H1 & H2 sites), and a pair of endonuclease target sequences sandwiching the pair of homologous recombination sequences (see Fig 1, I-SceI sites surrounding Hi & H2 sites).
Regarding Claims 6-9, Zhang et al. teach transformation methods utilizing the plasmid (see pg. 50-51, 2.4-2.6; Fig. 1, target gene integration).
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Gorsuch et al. (WO 2020/146807 A1; published 16 July 2020).
Regarding Claim 1, Gorsuch et al. teach a plasmid for transformation (see pg. 103-105, Example 3; Fig. 7A & B), comprising a site into which a gene of interest is to be incorporated (see Fig. 7A & B, site between HA sites), a pair of homologous recombination sequences sandwiching the site (see Fig. 7A & B, HA sites), and a pair of endonuclease target sequences sandwiching the pair of homologous recombination sequences (see Fig. 7A & B, TFN sites).
Regarding Claims 2 and 5, Gorsuch et al. teach an endonuclease under the control of a promoter (see Fig. 7A & B, TFN nuclease).
Regarding Claims 3 and 4, Gorsuch et al. teach homing endonucleases under the control of a promoter (see pg. 52, I-CreI, I-Tev1). Applicant’s specification characterizes “homing endonucleases” as including endonucleases encoded by an intron (with the prefix “I-“) (see [0027]).
Regarding Claims 6-9, Gorsuch et al. teach transformation methods utilizing the plasmid (see pg. 103-105, Example 3).
Claim Rejections - 35 USC § 103
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.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (I-SceI-mediated scarless gene modification via allelic exchange in Clostridium. J Microbiol Methods. 2015 Jan;108:49-60) as applied to claim 1 above, and further in view of Gorsuch et al. (WO 2020/146807 A1; published 16 July 2020).
The teachings of Zhang et al. have been outlined above (see 102 rejection). In addition, Zhang et. al teaches a homing endonuclease (see Fig 1, I-SceI sites surrounding Hi & H2 sites). Zhang et al. does not appear to teach a single plasmid including both the endonuclease target sites and the endonuclease under control of a promoter.
The teachings of Gorsuch et al. have been outlined above (see 102 rejection).
It would have been prima facie obvious to a skilled artisan at the time filing to incorporate the particular endonuclease under the control of a promoter into the plasmid of Zhang et al. for clear simplicity reasons. A skilled artisan would have recognized that incorporation of the endonuclease under the control of a promoter would reduce experimental time and materials by negating the need for a separate plasmid carrying the endonuclease. A skilled artisan would have expected the modified plasmid construct to function successfully because Gorsuch et al. demonstrated successful transformation with a similar plasmid construct.
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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-21 of copending Application No. 18/258799.
The reference claims encompass essentially the same plasmid product as the instant claims, including: a site into which a gene of interest is to be incorporated, a pair of homologous recombination sequences sandwiching the site, a pair of endonuclease target sequences sandwiching the pair of homologous recombination sequences, and a homing endonuclease under the control of a promoter. The reference claims also include a counter selection marker. Thus, while being different scope, the reference claims nonetheless anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of copending Application No. 18/258909.
The reference claims encompass essentially the same plasmid product (and methods thereof) as the instant claims, including: a site into which a gene of interest is to be incorporated, a pair of homologous recombination sequences sandwiching the site, a pair of endonuclease target sequences sandwiching the pair of homologous recombination sequences, and a homing endonuclease under the control of a promoter. The reference claims also include a counter selection marker. Thus, while being slightly different in scope, the reference claims nonetheless anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhang and Li et al. (Efficient precise knockin with a double cut HDR donor after CRISPR/Cas9-mediated double-stranded DNA cleavage. Genome Biol. 2017 Feb 20;18(1):35). This reference also teaches a plasmid construct encompassed by Claim 1, using the CRISPR/Cas system (see Fig 2(a), pD-mCherry-sg).
Conclusion
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/CHRISTOPHER M BABIC/ Supervisory Patent Examiner, Art Unit 1633