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 .
Priority
Applicant’s claim to priority from Provisional Application No. 63/236,225 filed 08/23/2021 is hereby acknowledged.
Application Status
Amendments filed on 12/19/2025 have been received and are hereby acknowledged.
Claims 2-4, 6, 8-9, 11-31, 34-45, 47-48, 51-52, and 55-60 are cancelled. Claims 1, 5, 7, 10, 32, 33, 46, 49-50 and 53-54 are pending. Claim 10 is withdrawn for further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Therefore, claims 1, 5, 7, 32, 33, 46, 49-50, and 53-54 are under examination in current office action.
Any rejection or objection not reiterated herein has been overcome by Applicant’s amendments and therefore has been withdrawn. Applicant’s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 12/19/2025 was filed after the mailing date of the Office Action on 09/19/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The following rejections are modified as necessitated by Applicant’s amendments, but are maintained from previous Office Action dated 09/19/2025:
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, 5, 7, 32, 46, 49, 50 and 54 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 7, 24, 26, 29, 49-50, 52 , and 76-77 of co-pending Application No. 17/821,356 (US2023009132-A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, reciting “An isolated nucleic acid molecule comprising a nucleotide sequence at least 85% identical to SEQ ID NO: 9”, claims 1 and 77 of co-pending app.’356 have SEQ ID NO: 9 that is 100% identical to instant application’s SEQ ID NO: 9. Claims 26 and 76 of co-pending application ‘356 are drawn to a nucleotide sequence set forth in SEQ ID NO: 14 or SEQ ID NO: 35. SEQ ID NO: 9 is 100% identical to SEQ ID NO:35. SEQ ID NO: 9 is also contained within SEQ ID NO: 14 with 100% sequence homology. Claim 29 of co-pending app.’356 is drawn to a heterologous polynucleotide sequence encoding a clotting factor.
Regarding claim 5, claim 1 of co-pending app.’356 is drawn to a SEQ ID NO: 33 that is 100% identical to nucleotides 58-4824 of SEQ ID NO: 9.
Regarding claim 32, claims 1 and 24 of co-pending application ‘562 are drawn to a first and second inverted repeat (ITR) flanking the genetic cassette. Claim 1’s of co-pending app.’356 is drawn to SEQ ID NOs: 1 and 2 encoding for ITRs.
Regarding claims 32 and 46, claim 7 of co-pending app.’356 is drawn to all elements a, b, c, d, e and f.
Regarding claim 49, claim 49 of co-pending app.’356 is drawn to same elements, i.e. a vector comprising the nucleic acid molecule of claim 1.
Regarding claim 50, claim 50 of co-pending app. ‘356 is drawn to a host cell comprising the nucleic acid molecule of claim 1.
Regarding claim 54, claim 52 of co-pending app.’356 is drawn to a pharmaceutical composition comprising the nucleic acid molecule of claim 1.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claims 33 and 53 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.
Response to Arguments
Applicant's arguments filed 05/28/2025 have been fully considered but they are not persuasive.
In response, Benefit claims under 35 U.S.C. 119(e) and foreign priority claims under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) or (b) are not taken into account when determining the term of an issued patent (see 35 U.S.C. 154(a)(2) and (a)(3) ), and therefore, are not taken into account in determining the patent term filing date of an application.
Regarding Applicant’s argument stating: “there is no rationale for applying a double patenting rejection in the instant case”, Examiner respectfully disagrees.
In response, MPEP 1490(VI)(D)(2)(b) states :
“(b) Application under Examination Has the Same Patent Term Filing Date
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application or includes a compliant terminal disclaimer in the application under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.”
Therefore, the rejections are maintained.
Allowable Subject Matter
The following is an examiner’s statement of reasons for the indication of allowable subject matter:
Claim 1 contains elements that appear to be allowable over prior art: SEQ ID NO: 9 or a sequence at least 85% identical to SEQ ID NO: 9 does not appear to be found in prior art.
Other reasons for indicating allowable subject matter have been disclosed in the previous Office Action dated 09/19/2025.
Conclusion
No claims are allowed.
Claims 33 and 53 are objected to.
THIS ACTION IS MADE FINAL. 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 ALEXANDRA G DACE DENITO whose telephone number is (703)756-4752. The examiner can normally be reached Monday-Friday, 8:30-5:00EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached on 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.D./Examiner, Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636