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 .
Applicant's election without traverse of Group I claims 1, 4-17, 24-29, and 36-43, drawn to a nucleic acid comprising an adeno-associated virus (AAV) expression cassette and a Rett Syndrome-associated gene in the reply filed on 01/09/2026 is acknowledged.
Claims 45-48, 52, 54, 57-59, and 64-69 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/09/2026.
Priority
This application claims the benefit of priority to U.S. Provisional Patent Application Number 63067668. This application claims the benefit of priority to Patent Application PCT/US2021/046699. Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application Number PCT/US2021/046699, filed on 08/19/2021.
Information Disclosure Statement
The IDS filed 09/21/2023 and 01/09/2026 has been considered by the Examiner.
Status of Claims
Claims 1, 4-17, 24-29, 36-43. 45-48, 52, 54, 57, 58, 59, and 64-69 are under pending.
Claims 45-48, 52, 54, 57-59, and 64-69 are withdrawn.
Claim 2-3, 18-23, 30-35, 44, 49-51, 53, 55-56, and 60-63 are cancelled.
Claim Objections
Claim 14 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 13. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 11 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claims 4-8 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claim 9 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 3 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claim 10 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 4 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claim 11 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 5 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claim 12 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 5 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claims 13 and 14 rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 4 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claim 15 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 6 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claim 16 rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 4 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claim 17 rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 6 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claim 24 rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 4 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claims 26, 28, and 29 are different length ITR Claim 13 SEQ ID No: 1 is 141 amino acids SEQ ID No: 2 is 166 amino acids which are different length ITRs as recited.
Claim 27 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 12 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claims 36 and 37 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 19 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
Claim 38 and 39 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 20 of prior U.S. Patent No. 12,104,163. This is a statutory double patenting rejection.
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.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,104,163. With regard to claim 25, upon reading claim 1 of U.S. Patent No. 12,104,163 a person of ordinary skill in the art would consult the specification of ’163 to determine suitable 5’ and 3’ ITRs. Within the specification of ’163 one of ordinary skill in the art would find that the 5' ITR could be the same length as the 3' ITR (column 13, paragraph 1). Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,104,163. Although the claims at issue are not identical, they are not patentably distinct from each other because both require the 5' ITR is the same length as the 3' ITR.
Claims 40 and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 12,104,163. Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NOs: 3 and 4 of the 163’ patent contains 100% of the stuffer sequence, SEQ ID NO: 13, recited by the present application.
Claims 42 and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,104,163 in view of Thomas et al. (WO 2020/106916 Al). Claim 1 of the 163’ patent recites a nucleic acid comprising an adeno-associated virus (AAV) expression cassette, wherein the AAV expression cassette comprises, from 5' to 3': a 5' inverted terminal repeat (ITR); a minimal human Arc gene promoter (hArcMin) set forth by SEQ ID no. 12; a Rett Syndrome-associated gene; and a 3' ITR. Thomas does not provide if the AAV contains a Kozak sequence.
Thomas et al. teach recombinant viral vectors and nucleic acids. Thomas et al. teach the Kozak sequence could be SEQ ID NOs: 17 or 18 (page 3, paragraph 0013), which are the same as SEQ ID NOs: 14 and 15 respectively of the present application. Thomas et al. teach a Kozak sequence is a short sequence centered around the translational initiation site of eukaryotic mRNAs that allows for efficient initiation of translation of the mRNA. The ribosomal translation machinery recognizes the AUG initiation codon in the context of the Kozak sequence. The Kozak sequence may enhance translation efficiency and overall expression of the transgene. The Kozak sequence may be positioned immediately 5' to the transgene sequence, or overlap with the transgene sequence (page 26, paragraph 0089).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of U.S. Patent No. 12,104,163 for a nucleic acid comprising an adeno-associated virus (AAV) expression cassette with the teachings of Thomas et al. for the addition of a Kozak sequence. Thomas et al. provide motivation by teaching that The Kozak sequence may enhance translation efficiency and overall expression of the transgene. One of skill in the art would have had a reasonable expectation of success at combining U.S. Patent No. 12,104,163 et al. and Thomas et al. because both teach AAV expression cassettes.
Conclusion
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
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