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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/17/2026 has been entered.
Claim Rejections - 35 USC § 112
The rejection of claims 150-169 is withdrawn in view of amendment of the claims and applicant’s remarks.
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 150-169 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, 9-13, 15-18, 28, 30-31 of U.S. Patent No. 11,685,909. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘909 claims recite a pharmaceutical composition comprising an expression vector encoding a polypeptide comprising an amino acid sequence that is at least 95% identical to SEQ ID NO: 120 and a recombinant guide RNA comprising a constant region comprising a first nucleotide sequence that is at least 80% identical to SEQ ID NO: 181. The composition comprises a targeting segment comprising a second nucleotide sequence complementary to a target sequence on a target strand (TS) of a double-stranded DNA molecule, wherein the double-stranded DNA molecule comprises a 5′-NTTN-3′ protospacer adjacent motif (PAM) sequence positioned 5′ of the target sequence. The composition may comprise a molecule selected from a lipid and a lipid nanoparticle. The expression vector may be an AAV vector. The protein may be fused to a nuclear localization signal (NLS), which may be SEQ ID NO: 49 or 50. Methods of using the composition in cells for gene editing are also claimed.
Claims 150-168 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8, 10, 11, 17-19, 21, 22, 24, 25, 29 of U.S. Patent No. 11,377,646. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘646 claims recite a eukaryotic cell comprising nucleic acids encoding a polypeptide comprising an amino acid sequence that is at least 98% identical to SEQ ID NO: 120 and a recombinant guide RNA comprising a constant region comprising a first nucleotide sequence that is at least 80% identical to SEQ ID NO: 181. The composition comprises a targeting segment comprising a second nucleotide sequence complementary to a target sequence on a target strand (TS) of a double-stranded DNA molecule, wherein the double-stranded DNA molecule comprises a 5′-NTTN-3′ protospacer adjacent motif (PAM) sequence positioned 5′ of the target sequence. The nucleic acids may comprise a molecule selected from a lipid and a liposome. The expression vector may be an AAV vector. The protein may be fused to a nuclear localization signal (NLS), which may be SEQ ID NO: 49 or 50.
Claims 150-153, 154-166 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 11, 13, 15-20, 28-30 of U.S. Patent No. 11,578,313. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘313 claims recite an AAV vector composition comprising an expression vector encoding a polypeptide comprising an amino acid sequence that is at least 95% identical to SEQ ID NO: 120 and a recombinant guide RNA comprising a constant region comprising a first nucleotide sequence that is at least 80% identical to SEQ ID NO: 181. The composition comprises a targeting segment comprising a second nucleotide sequence complementary to a target sequence on a target strand (TS) of a double-stranded DNA molecule, wherein the double-stranded DNA molecule comprises a 5′-NTTN-3′ protospacer adjacent motif (PAM) sequence positioned 5′ of the target sequence. The composition may comprise a molecule selected from a lipid and a lipid nanoparticle. The expression vector may be an AAV vector. The protein may be fused to a nuclear localization signal (NLS).
Claims 150-163, 165-169 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-15, 18, 22, 25, 26 of U.S. Patent No. 11,530,398. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘398 claims recite cells, vectors and methods using nucleic acids encoding a polypeptide consisting of SEQ ID NO: 120 and a recombinant guide RNA comprising a constant region comprising a first nucleotide sequence that is at least 80% identical to SEQ ID NO: 181. The composition comprises a targeting segment comprising a second nucleotide sequence complementary to a target sequence on a target strand (TS) of a double-stranded DNA molecule, wherein the double-stranded DNA molecule comprises a 5′-NTTN-3′ protospacer adjacent motif (PAM) sequence positioned 5′ of the target sequence. The composition may comprise a molecule selected from a lipid and a lipid nanoparticle. The protein may be fused to a nuclear localization signal (NLS), which may be SEQ ID NO: 49 or 50. Methods of using the composition in cells for gene editing are also claimed.
Claims 150-153, 155-169 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 7, 9, 12, 13, 15-23 of U.S. Patent No. 12,365,887. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘887 claims recite cellular methods of DNA cleavage wherein the cells comprise nucleic acids encoding a polypeptide comprising an amino acid sequence that is at least 97% identical to SEQ ID NO: 120 and a recombinant guide RNA comprising a constant region comprising a first nucleotide sequence that is at least 80% identical to SEQ ID NO: 181. The composition comprises a targeting segment comprising a second nucleotide sequence complementary to a target sequence on a target strand (TS) of a double-stranded DNA molecule, wherein the double-stranded DNA molecule comprises a 5′-NTTN-3′ protospacer adjacent motif (PAM) sequence positioned 5′ of the target sequence. The composition may comprise a molecule selected from a lipid and a lipid nanoparticle. The protein may be fused to a nuclear localization signal (NLS). Methods of using the composition in cells for gene editing are also claimed.
Claims 150-153, 155-169 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 150-152, 154-158, 161, 162, 166, 168, 169 of copending Application No. 18/313,914 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘914 claims recite a pharmaceutical composition comprising a nucleic acid encoding a polypeptide comprising an amino acid sequence that is at least 95% identical to SEQ ID NO: 120 and a recombinant guide RNA comprising a constant region comprising a first nucleotide sequence that is at least 80% identical to SEQ ID NO: 181. The composition comprises a targeting segment comprising a second nucleotide sequence complementary to a target sequence on a target strand (TS) of a double-stranded DNA molecule, wherein the double-stranded DNA molecule comprises a 5′-NTTN-3′ protospacer adjacent motif (PAM) sequence positioned 5′ of the target sequence. The composition may comprise a molecule selected from a lipid and a lipid nanoparticle. The composition may be delivered with an AAV vector into cells of a subject. The protein may be fused to a nuclear localization signal (NLS). Methods of using the composition in cells for gene editing are also claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/ Primary Examiner, Art Unit 1638
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