DETAILED ACTION
Status of Application
The amendments and response filed 06 July 2026 are acknowledged and have been considered in their entireties. Claims 8-11 are new and dependent upon examined claim 1, thus, claims 1-11 are pending; Claims 2-7 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 1 and 8-11 are subject to examination on the merits.
Withdrawal of Previous Rejections
The rejection of claim 1 under 35 U.S.C. 112(a), written description, is withdrawn in view of the amendment to the claim to define the proteolysis tag.
US20170073670
Maintained 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 and 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12139730. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘730 necessarily anticipate the instant claim.
Instant claim 1 is drawn to: A complex comprising a nucleic acid sequence-recognizing module and a proteolysis tag, wherein the module is linked to the proteolysis tag, the module specifically binds to a target nucleotide sequence in a double stranded DNA, wherein the complex is further bound with a nucleic acid altering enzyme that converts one or more nucleotides in the target nucleotide sequence to a different nucleotide, wherein the nucleic acid altering enzyme is a deaminase, wherein the nucleic acid sequence-recognizing module is Cas nickase and wherein the proteolysis tag of a peptide at the C-terminus of the module containing three hydrophobic amino acid residues, wherein the three hydrophobic amino acid residues are leucine-valine-alanine (LVA), leucine-alanine-alanine (LAA), alanine-alanine- valine (AAV), or alanine-serine-valine (ASV).
The claims to the ‘730 patent in their broadest are drawn to: A complex comprising a nucleic acid sequence-recognizing module and a proteolysis tag,
wherein the module is linked to the proteolysis tag, the module specifically binds to a target nucleotide sequence in a double stranded DNA, and the tag consists of a peptide at the C-terminal of the module containing 3 hydrophobic amino acid residues, wherein the 3 hydrophobic amino acid residues are leucine-valine-alanine, leucine-alanine-alanine, alanine-alanine-valine, or alanine-serine-valine, wherein the complex is further bound with a nucleic acid altering enzyme that converts one or more nucleotides in the target nucleotide sequence to a different nucleotide, deletes one or more nucleotides in the target nucleotide sequence, or inserts one or more nucleotides in the target nucleotide sequence, wherein the nucleic acid altering enzyme is a deaminase or a DNA glycosylase, and wherein the nucleic acid sequence-recognizing module is selected from the group consisting of CRISPR-mutant Cas, zinc finger motif, TAL effector and PPR motif. Dependent claim 2 recites that Cas protein is either dead or is a nickase. Dependent claims 6-15 are methods of using the complex and dependent claim 13 further recites the complex is bound nucleic acid altering enzyme which is a deaminase.
Thus, once the scope of the claims of the complex utilized in the method claims in the ‘730 patent are combined (e.g. claims 6, 7, 13), then the complex as recited in the claims will necessarily anticipate the instant claims.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 26 August 2026
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