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 .
Withdrawn Rejections/Objections
The objections to claims 8, 39, 45-46, and 48 are withdrawn. The amendments to the claims adopt the suggested amendments that overcome the objections.
The rejection of claim 47, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn. The amendments overcome the rejection.
The rejection of claims 40-42, under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn. The amendments overcome the rejection.
The objection to nucleic acid/amino acid sequence disclosure contained in this application for not comply with the requirements for such a disclosure as set forth in 37 C.F.R. 1.821 - 1.825 is withdrawn. The new sequence listing and amendments to the specification filed 2/9/2026 and 2/11/2026 overcome the objection.
The rejection of claims 8, 39, 43, 44, on the ground of nonstatutory double patenting as being unpatentable over amended claims 28, 30, 31 and 40 of copending Application No. 18/862,490 (reference application), is withdrawn. The subject matter of the claims are no longer overlapping due to the amendments in both the instant and copending claim.
The following new rejection is necessitated by the amendments to the claims:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8, 39-41, and 43-48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claim 8 as amended recites, “at least 95% identical to the amino acid sequence of the AAV2.7m8 capsid”. The amendment to the claims removed the reference SEQ ID NO. Claims reciting “at least 95% identical to the amino acid sequence” are reference to a comparison of sequences. However, the claim no longer recites any particular reference sequence. As such, the metes and bound of the above recitation are not apparent. Further there are multiple AAV2.7m8 capsid amino acid sequences. As such it is not apparent which one would be considered “the amino acid sequence”. As such the claim as amended is indefinite.
The remainder of the pending claims are dependent upon claim 8. As such, they also comprise the above indefinite subject matter.
The following rejections of record are modified to take into consideration the amendments to the claims:
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.
Claim 8, as amended, is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over amended claim 24 of copending Application No. 18/034,039 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and copending claims have overlapping, non-mutually exclusive subject matter.
Regarding claim 8, copending claim 24 discloses a pharmaceutical composition comprising an AAV comprising an AAV capsid, wherein the AAV capsid is at least 95% identical to AAV2.7m8, AAV8, or AAV9, and an artificial genome comprising an expression cassette flanked by AAV ITRs, wherein the expression cassette comprises a transgene encoding a heavy and light chain of a substantially full or full length anti-TNFα mAb, anti-IL6 mAb, or anti-IL6R mAb, or an antigen-binding fragment thereof, operably linked to one or more regulatory sequences that promoter expression of the transgene in human ocular tissue cells. Claim 8 more narrowly a regulatory sequence that controls expression of the transgene in human retinal cells, whereas the copending claim more broadly recites a promoter controlling expression in human ocular tissue. However, retinal expression is one of a finite number of known desired cites for expression of such therapeutics in the eye. As such, it would have been obvious to an artisan of ordinary skill to use a promoter that expresses in human retinal cells in the copending claim. The copending claims does not teach that claimed anti-TNFalpha mAb species of adalimumab, infliximab, or golimumab. However, these are all art established anti-TNFalpha mAb species that were available and could be predictable used in copending claim 24. Thus copending claim 24 and instant claim 8 have overlapping, non-mutually exclusive subject matter and are thus obvious variants of each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 2/9/2026 have been fully considered but they are not persuasive.
Regarding copending application 18/034,039, Applicant submits that the copending application is filed after the instant application and is therefore not an appropriate application for use in an obvious-type double patenting rejection against instant application. Applicant refers to the Federal Circuit holdings of Allergan USA, Inc v. MSN Labs Private LTD as evidence.
In response, Applicant is referred to MPEP § 804.02(I)(B)(1), which states, “If two (or more) pending applications are filed, in each of which a rejection of one claimed invention over the other on the ground of provisional nonstatutory double patenting (NSDP) is proper, the provisional NSDP rejection will be made in each application.”. As such, the MPEP dictates that regardless of effective filing date, the rejection with be made in both the copending applications. As such, the rejection of record is maintained.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632
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