DETAILED ACTION
The amendment submitted on September 9, 2025 has been entered. Claims 1-20 are pending in the application and are rejected for the reasons set forth below. No claim is allowed, although the application would be allowable if a terminal disclaimer were to be submitted, as discussed below.
Withdrawn Rejections
The rejection of claims 1-18 for double patenting over Patent No. 11,369,684 B2 is withdrawn because the examiner is persuaded that treatment of a patient with “an mTOQ-4 score of 4 or less” would not have been prima facie obvious. See applicant’s Remarks, submitted September 9, 2025, at pp. 5-6.
The rejection of claims 1-18 for double patenting over Patent No. 11,504,429 B2 is withdrawn for the same reason.
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 appli-cation 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 Good-man, 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 applica-tions subject to examination under the first-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-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(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 that 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/terminaldisclaimer.
Claims 1-18 remain rejected and new claims 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Patent No. 12,128,052 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘052 Patent (cited in the prior action) claims a method of treating migraine, comprising orally administering one tablet daily to a human being in need thereof, wherein the tablet comprises about 20 mg of meloxicam, or a molar equivalent amount of a salt form of meloxicam, and from about 10 mg to about 15 mg of rizatriptan, or a molar equivalent amount of a salt form of rizatriptan, wherein the meloxicam is complexed with a sulfobutyl ether β-cyclodextrin (SBEβCD), wherein the human being has an mTOQ-4 score of 4 or less with respect to prior acute migraine treatments that do not include a combina-tion of melox-icam and rizatriptan before the dosage form is orally administered, wherein the Tmax of meloxicam in the human being is less than 60 minutes, and wherein the human being has acute pain. See claim 1. It would have been a matter of common sense to treat someone with 5-10 migraines per month as required by the instant claims. Applicant has not explained why this would not have been a matter of common sense, but instead suggests filing a terminal disclaimer. See applicant’s Remarks at p. 9. Until the rejection is persua-sively rebutted or a terminal disclaimer is submitted, the rejection is maintained.
Claims 1-18 remain provisionally rejected and new claims 19-20 are provision-ally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 19/209,668. Although the claims at issue are not identi-cal, they are not patentably distinct from each other. The ‘668 application (cited in the prior action) claims a method of treating migraine with substantially the same composition of the instant claims “wherein the human being has an mTOQ-4 score of 4 or less.” See the claims submitted on May 15, 2025 in the ‘668 Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented. The examiner suggests a terminal disclaimer for the reasons discussed above.
Conclusion
THIS ACTION IS MADE FINAL. See MPEP 706.07 (Final Rejection). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statu-tory 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 Theodore R. Howell whose telephone number is 571-270-5993. The examiner can normally be reached Monday through Thursday, 7:00 am - 6:00 pm (Eastern Time). The examiner is generally not available on Fridays. Examiner interviews are available via telephone and video conferencing using an Office-supplied web-based collab-oration tool. To schedule an interview, applicant is encouraged to use the USPTO Auto-mated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Theodore R. Howell/ Primary Examiner, Art Unit 1628
October 8, 2025