DETAILED ACTION
Claims 1-23, submitted on November 11, 2025, are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Withdrawn Rejections
The rejection of claims 1-18 on the ground of nonstatutory double patenting as being unpatentable over Patent No. 11,369,684 B2 is withdrawn because the claims have been amended to recite “wherein the human being does not have a history of significant cardiovascular disease.”
The rejection of claims 1-18 on the ground of nonstatutory double patenting as being unpatentable over Patent No. 11,504,429 B2 is withdrawn for the same reasons.
The rejection of claims 1-18 on the ground of nonstatutory double patenting as being unpatentable over Patent No. 12,128,052 B2 is withdrawn for the same reasons.
The provisional rejection of claims 1-18 on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 19/209,668 is withdrawn for the same reasons.
The provisional rejection of claims 1-18 on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 19/222,910 is withdrawn for the same reasons.
New Grounds for Rejection 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 1-23 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. US 10758618 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘618 Patent is directed to method of relieving migraine pain, comprising: orally administering to a human being in need thereof, a combination of: 1) a complex of meloxicam and a sulfobutylether-β-cyclodextrin, 2) a bicarbonate, and 3) a rizatriptan, wherein the combination is orally administered when the human being is suffering from moderate to severe migraine pain of an acute migraine, wherein the human being has morning migraine, wherein two hours after the combination is orally administered, the human being experiences a greater reduction in migraine pain than the human being would experience two hours after the same amount of meloxicam is orally administered alone. The accompanying specification explains that “the human being having migraine does not have a history of significant cardiovascular disease” (col. 9, ll. 45-50), which is not patentably distinct from “wherein the human being does not have a history of significant cardio vascular disease” in the recent amendment to the claims. The Tmax, Cmax, AUC, and half-life limitations of claims 2-8 and 10-18 are also disclosed in the reference patent. See, e.g., col. 16. l. 53 – col. 18, l. 12. The instant claims are therefore not patentably distinct from the claims of 10758618B2
Similar issues exist with respect to the following Patents. Claims 1-23 are also therefore rejected on the ground of nonstatutory double patenting as being unpatentable over the subject matter claimed in the following U.S. Patent Nos.:
US 10758618 B2
US 10780165 B2
US 10780166 B2
US 10799588 B2
US 10821181 B2
US 10821182 B2
US 10894053 B2
US 10905693 B2
US 10918722 B2
US 10933136 B2
US 10933137 B2
US 10940153 B2
US 10987358 B2
US 11013805 B2
US 11013806 B2
US 11020483 B2
US 11045549 B2
US 11077117 B2
US 11110173 B2
US 11123431 B2
US 11129895 B2
US 11135295 B2
US 11185550 B2
US 11207327 B2
US 11207328 B2
US 11219626 B2
US 11266657 B2
US 11285213 B2
US 11285214 B2
US 11285215 B2
US 11357854 B2
US 11369684 B2
US 11426414 B2
US 11433078 B2
US 11433079 B2
US 11471464 B2
US 11471465 B2
US 11504429 B2
US 11510927 B2
US 11571428 B2
US 11602563 B2
US 11607456 B2
US 11617755 B2
US 11617756 B2
US 11617791 B2
US 11628173 B2
US 11712441 B2
US 11738085 B2
US 11759522 B2
US 11801250 B2
US 11806354 B2
US 11826370 B2
US 11865117 B2
US 11944683 B2
US 11998552 B2
US 12005118 B2
US 12128052 B2
US 12370196 B2
Claims 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-10, 13, 15-19, 21-25, and 27-32 of copending Application No. 18065013 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the ‘013 application are directed to a method of treating migraine, comprising orally administering a combination to a human being who is experiencing an acute attack of migraine pain or migraine aura; wherein the combination comprises meloxicam or a pharmaceutically acceptable salt thereof, and about 8 mg to about 13 mg of rizatriptan or a molar equivalent amount of a salt form of rizatriptan; wherein the combination is in a single dosage form; and wherein the single dosage form is structured so that orally administering the single dosage form to healthy human subjects would result in a mean Tmax of meloxicam of 110 minutes or less, and an AUCo.24 of meloxicam of about 30 ug-hr/mL to about 50 ug-hr/mL. See claim 1 submitted on October 9, 2025. The accompanying specification (p. 15) explains that the human being “does not have a history of significant cardiovascular disease,” so the examiner concludes that at least instant claim 1 is not patentably distinct claim 1 of the ‘013 application. With respect to instant claims 2-8 and 10-19, the specification of the ‘013 application discloses this subject matter at pp. 24-27. With respect to instant claims 21-23, the ‘013 application discloses these cyclodextrins at pp. 18-19. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Similar issues exist with respect to the following co-pending applications. Claims 1-23 are also therefore provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the subject matter claimed in the following Application Nos.:
18366992
18503996
18512551
18/636,093
18/909,306
18/950,743
19/030,296
19/074,873
19/076,089
19/076,122
19/085,084
19/169,261
19/181,172
19/181,985
19/196,655
19/209,668
19/222,910
19/229,702
19/236,838
19/263,324
19/306,984
19/367,653
19/390,397
19/390,403
19/399,454
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 Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 7:00 am - 6:00 pm (Eastern Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (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
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628 December 9, 2025