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 .
Application Status
The Amendments and remarks filed 11 August 2025 in response to the office action dated 10 April 2025 has been entered. Claims 1, 24, 26, and 72 are amended. Claims 2-6, 8-23, 27-28, 30-39, 41, 44-48, 51, 53-71, and 73-75 are canceled. Claims 76-81 are newly added. Claims 1, 7, 24-26, 29, 40, 42-43, 49-50, 52, 72, and 76-81 are pending.
It is noted that the amendment to the claims filed on 11 August 2025 does not comply with the requirements of 37 CFR 1.121(c) because the additional limitation added to claim 1 is not underlined. However, in the interest of compact prosecution, the amendment to the claims has been entered.
Any objection or rejection not reiterated herein has been withdrawn in view of applicant’s claim amendments.
Priority
This application claims priority to application 63/236,215 filed 08/23/2021.
Information Disclosure Statement
The information disclosure statements filed 10/28/2022 and 12/17/2024 have been 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 1, 7, 24, 29, 49-50, 52, 77, and 79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32, 48-50, and 54 of copending Application No. 17821359 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 48 of the copending application anticipates claims 1, 24, 29, 77, and 79 of the current application.
Regrading claim 1, 24, 29, 77, and 79, the copending application is drawn to an isolated nucleic acid molecule comprising a nucleotide sequence at least 85% identical to SEQ ID NO: 9, wherein the nucleotide sequence encodes a polypeptide with factor VIII (FVIII) activity and further comprising a first ITR and a second ITR flanking the genetic cassette, wherein the first ITR comprises a polynucleotide sequence at least 75% identical to SEQ ID NO: 1, and the second ITR comprises a polynucleotide sequence at least about 75% identical to SEQ ID NO: 2. SEQ ID Nos: 1, 2, and 9 are 100% identical to the current application’s SEQ ID Nos: 1, 2, and 9, respectively.
Regarding claim 7, 49-50, and 52, the copending application teach these limitations. It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention to formulate the nucleic acid molecule with the components of claim 7 and in a vector, host cell, and pharmaceutical composition as claimed by the copending application. The combination of prior art elements according to known methods to yield predictable results supports can support a conclusion of obviousness. See MPEP 2143(I). One of ordinary skill in the art would have a reasonable expectation of success since both application teach a nucleic acid molecule formulated with a clotting factor flanked by two ITRs of the same nucleotide sequence.
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 11 August 2025 have been fully considered however the copending claims, as discussed above, anticipate and render obvious the claims of the current application.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Claim 1, 72 and 76 are free of the prior art. The closest prior art is Beer (previously cited) as discussed in the office action dated 10 April 2025 on pages 5-10. Beer teaches all the limitation of the claimed invention except where a heterologous polynucleotide sequence comprises a nucleotide sequence at least 95% identical to SEQ ID NO: 9, 33, 14, or 35. Reed nor the prior art teaches a sequence that is at least 95% identical to SEQ ID NOs: 3, 9, 14, 33, or 35 or why those sequences would be in a nucleic acid molecule with flanking ITRs.
Claims 24-26, 40, 42-43, and 81 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 TIFFANY N GROOMS whose telephone number is (571)272-3771. The examiner can normally be reached M-F 830-530.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached on 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.N.G./Examiner, Art Unit 1637 /Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637