DETAILED ACTION
Claims 1-24, submitted on December 8, 2025, are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
The suggestion of allowable subject matter in the prior action is withdrawn.
This communication includes at least one new rejection that was not necessitated by amendment on an information disclosure statement. This Office action is therefore non-final.
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 .
Withdrawn Rejections
The rejection for double patenting over Patent No. 12, 128,052 B2 is withdrawn in view of the terminal disclaimer submitted on December 8, 2025.
The provisional rejection for double patenting over co-pending Application No. 19/209,668 is withdrawn for the same reason.
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 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,561,664 B1. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘664 Patent is directed to a pharmaceutical dosage form comprising: 1) about 0.0285 mmol to about 0.0854 mmol of meloxicam in a free acid form or a salt form, 2) about 0.0186 mmol to about 0.0557 mmol of rizatriptan in a free base form or a salt form, 3) about 100 mg to about 175 mg of a sulfobutylether-β-cyclodextrin (SBEβCD), and 4) about 400 mg to about 600 mg of sodium bicarbonate. The accompanying specification explains that 20 mg is an appropriate dosage amount of meloxicam (col. 11, ll. 60-65). The specification also explains that 10-15 mg is an appropriate dosage amount of rizatriptan (col. 19, ll. 25-30). The specification also discloses treating patients with “a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire (mTOQ-4)” (col. 28, ll. 45-50). The dosage form claimed in the ‘664 Patent (see, e.g., col. 14, l. 10 – col. 16, l. 35) has substantially the same pharmacokinetic properties recited in the instant claims. The dosage form claims in the ‘664 Patent is used in the treatment of migraine (col. 4, ll. 55-65). The examiner therefore concludes that the instant claims are drawn to subject matter that is not patentably distinct from the subject matter of the claims of the ‘664 Patent. See MPEP 804(II)(B)(1) (Construing the Claim Using the Reference Patent or Application Disclosure).
Claims 1-24 are also rejected on the ground of nonstatutory double patenting as being unpatentable over the corresponding claims of the following U.S. Patent Nos. for substantially the same reasons:
10583144 B2
10653777 B2
10688185 B2
10695429 B2
10695430 B2
10702535 B2
10702602 B2
10729774 B1
10758617 B2
10758618 B2
10780165 B2
10780166 B2
10799588 B2
10821181 B2
10821182 B2
10894053 B2
10905693 B2
10918722 B2
10933136 B2
10933137 B2
10940153 B2
10987358 B2
11013805 B2
11013806 B2
11020483 B2
11045549 B2
11077117 B2
11110173 B2
11123431 B2
11129895 B2
11135295 B2
11185550 B2
11207327 B2
11207328 B2
11219626 B2
11266657 B2
11285213 B2
11285214 B2
11285215 B2
11357854 B2
11369684 B2
11426414 B2
11433078 B2
11433079 B2
11471464 B2
11471465 B2
11504429 B2
11510927 B2
11571428 B2
11602563 B2
11607456 B2
11617755 B2
11617756 B2
11617791 B2
11628173 B2
11712441 B2
11738085 B2
11759522 B2
11801250 B2
11806354 B2
11826370 B2
11865117 B2
11944683 B2
11998552 B2
12005118 B2
12370196 B2
Claims 1-24 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. 18/065,013 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘013 Application is 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; 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 AUC0-24 of meloxicam of about 30 μg·hr/mL to about 50 μg·hr/mL. The accompanying specification (pp. 21 and 32) explains that 20 mg is a suitable dosage amount of meloxicam, and 10-15 mg is a suitable dosage amount for rizatriptan. The dosage form claimed in the ‘013 Application may also include SBEβCD (p. 19 of the specification of the ‘013 Application). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-24 are also provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the corresponding claims of the following copending Application Nos. for substantially the same reasons:
18/366,992
18/503,996
18/512,551
18/636,093
18/909,306
18/950,743
19/030,296
19/074,873
19/076,089
19/076,122
19/085,084
19/181,172
19/181,985
19/196,655
19/222,910
19/229,702
19/236,838
19/263,324
19/306,984
19/367,653
Conclusion
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 17, 2025
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