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 .
Claim Status
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 August 13, 2025.
Claims 1-12 are under consideration in this office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 20, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on February 11, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patents 12,049,629, 11,999,955, 11,555,190, and 11,525,137 and Application No. 18/660,147 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections/Rejections
The objections to the drawings and specification regarding Figure 4 were made in error and are withdrawn.
The rejection of claim 1, 3-5, and 7-12 under 35 U.S.C. 112(a) for failing to comply with the written description requirement are withdrawn in view of applicant’s amendment to remove the percent identity language from the claims.
The rejections of claims 1-12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,049,629, over claims 1, 5-13, and 15 of U.S. Patent No. 11,999,955, over claims 1, 3-10, and 16 of U.S. Patent No. 11,555,190, and over claims 1, 5, and 11-21 of U.S. Patent No. 11,525,137 are withdrawn, and over claims 1, 4-5, and 7-33 of copending Application No. 18/660,147 are withdrawn. A terminal disclaimer was filed.
Maintained Rejections
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,157,774. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to overlapping embodiments: a double-stranded polynucleic acid molecule that mediates RNA interference against DUX4. The nucleic acid sequences of the sense strands of SEQ ID NOs: 142, 196, 201, 202, 204, 205, and 206 of instant claims 1-2 are identical to those of claim 4 of ‘774 (same SEQ ID NOs), and the sense strands of instant SEQ ID NO: 6 and instant SEQ ID NO: 62 are identical to SEQ ID NO: 146 and SEQ ID NO: 202 of ‘774, respectively. Further, claims 2-3 of ‘774 are directed to 5’-terminal modifications that read on the modifications of instant claims 7-12.
The claims of ‘774 anticipate the instant claims.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 7-12 of U.S. Patent No. 12,071,485. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to a method of treating muscular dystrophy in a subject in need thereof using an anti-transferrin antibody conjugated to an siRNA against DUX4, which anticipates the double-stranded polynucleic acid molecule that mediates RNA interference against DUX4 of the instant claims. The nucleic acid sequences of ‘485 claim 14 for the sense strand of SEQ ID NOs: 142, 146, 196, and 201-206 are identical to those of instant claims 1-2 (same SEQ ID NOs). Further, claims 7-12 of ‘485 are directed to 2’-terminal modifications that read on the modifications of instant claims 7-12. The claims of ‘485 anticipate the instant claims.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-15 of U.S. Patent No. 11,912,779. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to overlapping embodiments: a double stranded polynucleic acid molecule that mediates RNA interference against DUX4. The polynucleotide sequences of claim 1 of ‘779 are comprised of nucleic acid sequences of SEQ ID NOs: 72, 76, 126, and 131-136, which are identical to nucleic acid sequences for the antisense strand of instant claims 5-6 (same SEQ ID NOs). Further, claims 4-7 and 10 of ‘779 are directed to 2’-terminal modifications that read on the modifications of instant claims 7-12. The claims of ‘779 anticipate the instant claims.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, and 7-33 of copending Application No. 18/660,147. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to a composition that is identical to that instantly claimed, thereby anticipating the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20, of copending Application No. 18/809,215. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to a composition that is identical to that instantly claimed and a method of use thereof, thereby anticipating the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19/267,411. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed to a composition that is identical to that instantly claimed. siRNA of SEQ ID NO: 146 of ‘411 is identical to instant sense strand of SEQ ID NO: 6, and SEQ ID NO: 413 of ‘411 is identical antisense strand of SEQ ID NO: 216, thereby anticipating the instant claims.
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 February 9, 2026 regarding the nonstatutory double patenting rejections over Patents 12,157,774, 12,071,485, and 11,912,779 have been fully considered.
Applicant asserts that Patents ‘774, ‘485, and ‘779 do not qualify as reference patents for purposes of nonstatutory double patenting because the filing date of the instant application is earlier than that of the reference patents (remarks, pg 10). Thus, a patent issuing from the instant application will expire earlier than Patents ‘774, ‘485, and ‘799 and will not extend a period of exclusivity on the claimed subject matter (remarks, pg 11). Applicant points to a PTAB decision in Application No. 17/135,529.
Applicant’s arguments are not convincing. First, PTAB decisions are not precedential. Second, according to MPEP 1701, improper time-wise extension is not the only reason for requiring a terminal disclaimer. 37 CFR 1.321(c)(3) requires that a terminal disclaimer filed to obviate a nonstatutory double patenting rejection based on commonly owned conflicting claims must also include a provision that any patent granted on that application be enforceable only for and during the period that the patent is commonly owned with the application or patent which formed the basis for the rejection. A terminal disclaimer to ensure common ownership at present is a requirement, and one which the Federal Circuit in In re Cellect, LLC, 81 F.4th 1216, 2023 U.S.P.Q.2d 1011 (Fed. Cir. 2023) commented upon favorably ("We also agree with the USPTO that the Board did not err in determining that a risk of separate ownership existed and, even in the absence of separate ownership, that a terminal disclaimer would have been required to ensure common ownership." Id. at 1230).
Regarding the provisions ODP rejections, MPEP 822.01 states that a ‘provisional” double patenting rejection should continue to be made by the examiner in each application as long as there are conflicting claims in more than one application unless that “provisional” double patenting rejection is the only rejection remaining in one of the applications. Since the rejections over ‘774, ‘485, and ‘779 are maintained, the provisional nonstatutory double patenting rejections of Application Nos. 18/660,147, 18/809,215, and No. 19/267,411 are also maintained.
Conclusion
No claim is 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 JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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