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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 1, 2026 has been entered.
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Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-6, 12 and new claims 21-25 are under consideration in this office action.
Terminal Disclaimer
The terminal disclaimer filed on July 1, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 12,529,056 (application No. 18/660,147) has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections/Rejections
Any objection or rejection of record pertaining to cancelled claims 7-11 is rendered moot by applicant' s cancellation of said claims.
The rejections of claims 1-6 and 12 on the ground of nonstatutory double patenting for being unpatentable over claims 1-5 of U.S. Patent No. 12,157,774 and over claims 1, 3, and 7-12 of U.S. Patent No. 12,071,485 are withdrawn in view of applicant’s amendment to remove polynucleic acid molecules of SEQ ID NOs: 142, 146, 196, 201-202, and 204-206.
Modified 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 1-6, 12 and new claims 21-25 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 7 of ‘779 are comprised of nucleic acid sequences of SEQ ID NOs: 2, 6, 56, and 61-62, 64-66, which are identical to nucleic acid sequences for the sense strand of instant claims 1-2 (same SEQ ID NOs). 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 claim 5-6 and new claims 21-22 (same SEQ ID NOs). Because the claims of ‘779 satisfy all the structural limitations of instant claim 12, it necessarily follows that the peptide polynucleic acid inherently possesses the ability to downregulate one or more DUX4 regulated genes selected from the group consisting of MDB3L2, TRIM43, PRAMEF1, ZSCAN4, KHDC1L, and LEUTX.
Claims 1-6, 12 and new claims 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent 12,486,328 (previously provisionally rejected over Application No. 19/267,411). 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 sequence of SEQ ID NO: 146 of ‘328 claim 1 is identical to instant nucleic acid sequence of SEQ ID NO: 6 of claims 1-2 and new claims 23 and25. The polynucleotide sequence of SEQ ID NO: 413 of ‘328 claim 1 is comprised of instant nucleic acid sequence of SEQ ID NO: 76, as in the double stranded polyucleic acid of instant claims 5 and new claims 21 and 22. Because the claims of ‘328 satisfy all the structural limitations of instant claim 12, it necessarily follows that the peptide polynucleic acid inherently possesses the ability to downregulate one or more DUX4 regulated genes selected from the group consisting of MDB3L2, TRIM43, PRAMEF1, ZSCAN4, KHDC1L, and LEUTX.
Claims 1-6, 12 and new claims 21-25 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 they are directed to overlapping embodiments: a double stranded polynucleic acid molecule that mediates RNA interference against DUX4. The polynucleotide sequences of claim 2 of ‘215 are comprised of nucleic acid sequences of SEQ ID NOs: 146 and 202, which are identical to nucleic acid sequences for the sense strand of instant claims 1-2 of SEQ ID NOs: 6 and 62. The polynucleotide sequences of claim 1 of ‘215 are comprised of nucleic acid sequences of SEQ ID NOs: 413 and 417, which are identical to nucleic acid sequences for the antisense strand of instant claim 5-6 and new claims 21-22 of SEQ ID NOs: 76 and 132. Because the claims of ‘215 satisfy all the structural limitations of instant claim 12, it necessarily follows that the peptide polynucleic acid inherently possesses the ability to downregulate one or more DUX4 regulated genes selected from the group consisting of MDB3L2, TRIM43, PRAMEF1, ZSCAN4, KHDC1L, and LEUTX.
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 July 1, 2026 regarding the nonstatutory double patenting rejections over Patents 11,912,779 and 12,486,328 have been fully considered.
Applicant asserts that Patents ‘779 and ‘328 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 7). Thus, the later-filed reference patents are not proper obviousness-type double patenting references. Applicant points to a PTAB decision in Ex parte Baurin, Appeal 2024-002920, 2024 WL 4921, Ex parte Chung, Appeal 2024-001838, and Ex parte Mates, Appeal 2025-001500, 2025 WL 3923901, and contra Ex Parte Baumeister, Appeal 2026-000193, 2025 WL 3515282.
Applicant’s arguments are not convincing. First, PTAB decisions are not precedential. Second, the cited cases have not been patented are still under review. Third, 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).
In response to examiner’s assertion that PTAB decisions are not precedential, applicant submits new arguments in view of Allergan USA, Inc. v. MSN Laboratories Private Ltd. (“Allergan”), a precedential Federal Circuit decision decided after In re Cellect (remarks, pg 9). It is the examiner’s position that the fact pattern and procedural posture of that particular case, however, are not the same as the application under consideration. Allergan establishes that a patent with Patent Term Adjustment (PTA) cannot be invalidated for Obviousness-Type Double Patenting (ODP) based on later-filed, later-issued, and earlier-expiring child patents sharing a common priority date. This fact pattern is distinct from the instant application, wherein the reference patents are later filed, first issued, and later expiring and the application under consideration is earlier filed, potentially later issued, and earlier expiring. The holding of Allergen is expressly tied to a first-filed, first-issue patent whose later expiration resulted from patent term adjustment (PTA). The Federal Circuit’s rationale centered on preserving the PTA awarded to the first-filed patent. Allergan reinforces the importance of filing order, but because the holding of Allergan is limited within the context of PTA, there is not clear Federal Circuit precedent resolving whether the anti-harassment rationale alone supports an ODP rejection against a first-filed application when there is not PTA.
Applicant is reminded that double patenting serves both preventing the unjustified extension of exclusivity and preventing separate ownership and enforcement of patentably indistinct inventions. If the instant applicant issues and there is no terminal disclaimer, the patents could potentially be separately assigned or licensed, creating the very multiple-enforcement concern that obvious type double patenting is intended to prevent. Filing a terminal disclaimer addresses this issue by requiring common ownership for the enforceable life of the patents.
The ODP rejections are maintained because the claims are not patentably distinct and the rejection serves the policy against separate ownership and enforcement. Applicant arguments that Allergan supports the position that the first-filed application should not be subject to ODP over a later filed patent have been considered, but it is the examiner’s position that Allergan does not address the specific fact pattern under review here.
Regarding the provisional ODP rejection over the claims of Application No. 18/809,215, 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 ‘779 and ‘328 are maintained, the provisional nonstatutory double patenting rejection of Application No. 18/809,215 is also maintained.
Conclusion
No claim is allowed.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
Prosecution Insights