DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/5/26 has been entered.
Claims 15 and 21-23 are amended.
Claims 2-7, 9-15 and 21-23 are presently pending.
Notice: Improperly Marked Claim
It is noted that Claim 15 recites “the
Election/Restrictions
Applicant’s election of Invention Group II, as in present claims 15 and 21-23, in the reply filed on 4/25/25, was previously acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election was treated as an election without traverse (MPEP § 818.01(a)).
Claims 2-7 and 9-14 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/25/25.
Claims 15 and 21-23 are presently considered.
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 15 and 21-23 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,219,696. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 15: Claim 1 recites a method of treating SMA, which requires administration of an rAAV9 comprising a self-complementary genome, the CBA promoter, an SV40 intron, and a heterologous cDNA encoding SEQ ID NO: 13.
Claim 21: Claim 1 requires the CMV enhancer.
Claim 22: Claim 1 requires the BGH polyA.
Claim 23: Claim 1 requires AAV2 ITRs.
Thus, in light of the patent, the invention is obvious. The Artisan would make the invention to practice the claims of the patent. Moreover, the Artisan would expect success, as it is claimed.
Response to Argument – NSDP, US PAT NO 11,219,696
Applicant’s argument of 1/5/26 has been considered but is not found persuasive.
Applicant argues that they have filed, and the office accepted the power of attorney document of 12/5/25, and have supplied a copy of the previously submitted terminal disclaimer of 8/15/25, thus, mooting the rejection (p. 2, section I.A.).
Such is not persuasive. While the power of attorney was accepted, the decision of the Kimberly R. White, denying the original filing of a terminal disclaimer specifically states “The incorrect TD form was submitted. Please resubmit using PTO-AIA /26 (04-13). No additional fee is required with the resubmission.” Apparently the terminal disclaimer form is the incorrect form, and you are required to re-submit a terminal disclaimer using the proper form. It should be noted that these decisions are out of the Examiner’s hands and thus, there is nothing further to argue. One suggested way to overcome this issue would be just to file an electronic disclaimer. Such is always accepted.
Claims 15 and 21-23 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 119, 121-122, 124, 126-135, 137-139, 147-151, and 153-154 of copending Application No. 17/309,403 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 15: Claim 119 teaches treating SMA in a human, comprising administration of a self-complementary AAV9 genome, the genome comprising a CBA promoter, an SV40 intron, and a sequence encoding SMN1, that is SEQ ID NO: 2 and matches presently-claimed SEQ ID NO: 13.
Claim 21: Claim 119 requires a CMV enhancer.
Claim 22: Claim 119 requires the BGH polyA.
Claim 23: Claim 119 requires AAV2 ITRs.
Thus, in light of the reference, the invention is obvious. The Artisan would make the invention to practice the claims, and would expect success, as it is claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Argument – NSDP, Application No. 17/309,403
Applicant’s argument of 1/5/26 has been considered but is not found persuasive.
Applicant argues that the rejection should be held in abeyance until the ‘403 Application is under examination or withdrawn if it is the only rejection remaining in the present Application (p. 2, section I.B.).
Such is persuasive. The rejection is abeyance, but remains on the record.
Claims 15 and 21-23 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of U.S. Patent No. 12,168,777. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 15: Claim 10 adds to Claim 1, requiring cells to be transfected with a plasmid comprising a sequence coding for SMN, which may comprise the CBA promoter, CMV enhancer, SV40 intron, in Claim 11, may be self-complementary in Claim 3, may be AAV9 in Claim 1, and encode SEQ ID NO: 2 (which is presently claimed SEQ ID NO: 13). Thus, the result in the claimed AAV9.
Claim 21: Claim 10 teaches the CMV enhancer.
Claim 22: Claim 11 claims the BGH polyA.
Claim 23: As noted above, Claim 3 teaches self-complementary and Claim 11 teaches AAV2 ITRs.
Finally, it should be noted that claims are also directed to the compositions made (e.g., Claim 54).
Thus, in light of the patent, the invention is obvious. The Artisan would make the product in the process of making the claimed invention of the patent, as well as being directly claimed. The Artisan would expect success, as it is claimed.
Response to Argument – NSDP, US PAT NO 12,168,777
Applicant’s argument of 1/5/26 has been considered but is not found persuasive.
Applicant argues that though not argued again, for brevity, all previous arguments are maintained (pp. 2-3, paragraph briding).
Such is persuasive. The responses to these arguments are also maintained from the Office Action of 9/5/25.
Applicant argues that Nationwide Children’s Hospital is the assignee of the current Application, and the patent is assigned to Novartis AG, Novartis also is exclusively licensed to Novartis, and thus, the basis of harassment by multiple assignees is unlikely (p. 3). Applicant provides proof of their statements in the form of an attached article and press release (Id.).
Such is understood, but does not make a difference. The office cannot make the owner/assignee follow the patent policy in the future, without having the terminal disclaimer. Also, “unlikely” is not absolute.
Claims 15 and 21-23 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 222-265 of copending Application No. 18/940,967 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
It should be noted that Applicant has amended the claims in 18/940,967 and thus, the claims pending are different from the previously-pending claims.
Claim 15: Claim 222 teaches manufacture of AAV viral vectors, thus producing AAV viral vectors. Claim 226 teaches an AAV9, Claim 227 showing it self-complementary, Claim 234 teaches the CBA promoter (Applicant recites “chicken beta-actin (CB) promoter”) as well as an SV40 intron, and Claim 2 teaches encoding SEQ ID NO: 2, which matches Applicant’s claimed SEQ ID NO: 13. Thus, the particle is the result of the methods. Additionally the pharmaceutical compositions are claimed (e.g., Claim 254) and are utilized in the methods of treatment in, e.g., Claim 256.
Claim 21: Claim 234 teaches the CMV immediate/early enhancer.
Claim 22: Claim 234 teaches the BGH polyA.
Claim 23: While it is not clear how an AAV9 can have ITRs, each from an AAV which is NOT AAV9 is beyond the Examiner’s understanding. However, for the record, Claim 234 teaches AAV2 ITRs.
Thus, in light of the reference, the claims are obvious. The Artisan would make the compositions in practicing the methods, and they are directly claimed, and they utilized in other methods. The Artisan would also expect success, as it is claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Argument – NSDP, Application No. 18/940,967
Applicant argues to hold the rejection in abeyance (p. 4, section D.).
Such is persuasive. The rejections remain, but are not cause for finality.
Comment, Cited Patents
The present comment remains, from the previous office action, for clarity in the Examiner’s decisions.:
It is noted that Applicant’s IDS of 8/15/25 cites several patents that appear to come quite in subject matter to the presently examined claims. However, it should be noted that they do not anticipate, and the present Application has an earlier priority date, with written description for SEQ ID NO: 13, which is found in their earliest priority document as accession no NP_000335.1 in Genbank. Thus, no rejections are made against these patents.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638