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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 6/11/2026 is acknowledged.
Accordingly, claims 11-29 are withdrawn for being directed to non-elected subject matter. Claims 1-10 and 30 are currently under examination.
Specification
The disclosure is objected to because of the following informalities: page 70 of specification has three statement “Error! Reference source not found.” These statements does not make sense in the context of the disclosure.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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)(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) 1-10 and 30 is/are rejected under 35 U.S.C. 102(a2) as being anticipated by He et al (US 20240417737).
He et al. teaches an AAV vector, AAV9, that comprises a nucleic acid having the sequence of SEQ ID NO: 256-257 (paragraph [0085] and [0086], [0470]), which has 100% sequence identity with SEQ ID NO: 2 and SEQ ID NO: 16 of the present application (see attached alignment). He teaches AAV vector encoding the siRNA is administered at various dosage, including 1011-1013 GC/kg (paragraph [0522] and [0524]). Claim 1 recites the AAV vector present in composition comprises 1x1011-1x1013 vg/ml with a volume of 3.0 ml or less, which means the total genome copy is at most 3x1013 GC with no lower limit, the dosage from He meets this claim limitation. Similarly, claim 9 recites the volume being 1.8 ml or less, which means the genome copy is at most 1.8x1013 with no lower limit, the dosage from He meets this claim limitation. Therefore, the disclosure from He anticipates claims 1-6, 9, 10.
Regarding claims 7 and 8, He teaches that construct #100 and construct #101 (SEQ ID NO: 256 and 257) are dual miRNA concatemer (paragraph [0157] and [0158]).
Regarding claim 30, He teaches kits comprising composition with package insert (paragraph [0528]). It is inherent the composition would need a container to hold said composition.
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 1-10 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 29 and 30 of copending Application No. 19/120,074 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the composition claimed in claims 29 and 30 anticipates the claimed invention of claims 1-10 and 30 of presently claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 255, 263, 270 of copending Application No. 18/289,921(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to nucleic acid molecule, having same sequence, SEQ ID NO: 256, as presently claimed SEQ ID NO: 2 (claims 1-6)
Having said sequence being in an AAV vector and at a particular titer (1-10 and 30) would have been obvious for formulating said nucleic acid molecule in view of the teaching available in prior art at the time the application was filed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 191-200 of copending Application No. 18/014,906 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to expression cassette that comprises nucleic acid molecule, having same sequence, SEQ ID NO: 812, as presently claimed SEQ ID NO: 2 (claims 1-6)
Having said sequence being in an AAV vector and at a particular titer (1-10 and 30) would have been obvious for formulating said nucleic acid molecule in view of the teaching available in prior art at the time the application was filed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 229-, 231-234, 236-239 of copending Application No. 18/289,921(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to nucleic acid molecule, having same sequence, SEQ ID NO: 812, as presently claimed SEQ ID NO: 2 (claims 1-6)
Having said sequence being in an AAV vector and at a particular titer (1-10 and 30) would have been obvious for formulating said nucleic acid molecule in view of the teaching available in prior art at the time the application was filed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/Primary Examiner, Art Unit 1637
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