DETAILED ACTION
The amendment submitted on April 28, 2026 has been entered. Claims 23-48 are pending in the application and are rejected for the reasons set forth below. No claim is allowed. Any rejections in the prior action that are not reiterated herein are withdrawn.
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 .
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 possi-ble 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 provi-sions 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 accompa-nied 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 23-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,219,626 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘626 Patent claims a method of treating migraine, comprising administering an oral dosage form comprising an inclu-sion complex of sulfobutyl ether β-cyclodextrin (SBEβCD) with about 15 mg to about 25 mg of a meloxicam, about 400 mg to about 600 mg of sodium bicarbonate, and about 8 mg to about 13 mg of a rizatriptan to a human being suffering from migraine; wherein the Tmax of meloxicam in the human being after administering the oral dosage form is shorter than the Tmax of meloxicam that would result from orally administering a reference dosage form comprising a) the same amount of the meloxicam; b) no rizatriptan; c) no SBEβCD; and d) no bicarbonate; and wherein the human being achieves a reduction in migraine pain that lasts for about 8 hours to about 24 hours. The claims of the ‘626 Patent do not specifically require that the composition has the claimed properties “under simulated gastric conditions” as required by the instant claims, but this characteristic would have been prima facie obvious over the corresponding teachings of, for example, Example 2 (col. 34-35) and Example 4 (col. 36) in the Patent. These two Examples in the written description of the Patent describe compositions having essentially the same ingredi-ents as those of the instant claims, so it would have been apparent that they have essentially the same properties. It is therefore a reasonable inference that the compositions referred to in the claims of the ‘626 Patent are also within the scope of the instant claims. The claims of the ‘626 Patent also do not specifically identify the human as having “acute migraine pain” as required by the instant claims. The claims of the ‘626 Patent, however, are drawn to treating a “human” with migraine. The written description of the ‘626 Patent (see, e.g., col. 3, ll. 1-6) explains that the method is also useful for “the acute treatment of migraine in patients,” i.e., subjects within the meaning of the instant claims. One would have therefore have viewed using the treatment meth-ods claimed in the ‘626 Patent in the treatment of acute migraine as required by the instant claims as being prima facie obvious.
Claims 23-48 are also rejected on the ground of nonstatutory double patenting as being unpatentable over the corresponding claims of the following US Patent Nos. for substantially the same reasons explained above.
10,758,618 B2 10,780,165 B2 10,780,166 B2 10,799,588 B2
10,821,181 B2 10,821,182 B2 10,894,053 B2 10,905,693 B2
10,918,722 B2 10,933,136 B2 10,933,137 B2 10,940,153 B2
10,987,358 B2 11,013,805 B2 11,013,806 B2 11,020,483 B2
11,045,549 B2 11,077,117 B2 11,110,173 B2 11,123,431 B2
11,129,895 B2 11,135,295 B2 11,185,550 B2 11,207,327 B2
11,207,328 B2 11,266,657 B2 11,285,213 B2 11,285,214 B2
11,285,215 B2 11,357,854 B2 11,369,684 B2 11,426,414 B2
11,433,078 B2 11,433,079 B2 11,471,464 B2 11,471,465 B2
11,504,429 B2 11,510,927 B2 11,571,428 B2 11,602,563 B2
11,607,456 B2 11,617,755 B2 11,617,756 B2 11,617,791 B2
11,628,173 B2 11,712,441 B2 11,738,085 B2 11,759,522 B2
11,801,250 B2 11,806,354 B2 11,826,370 B2 11,865,117 B2
11,944,683 B2 11,998,552 B2 12,005,118 B2 12,128,052 B2
12,370,196 B2 12,472,255 B2 12,472,258 B2 12,551,488 B2
12,551,489 B2 12,611,413 B2 12,685,736 B2 12,691,123 B2
Claims 23-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the corresponding claims of the following copending Application Nos. (reference applications). Although the claims at issue are not identical, they are not patent-ably distinct from each other for substantially the same reasons discussed above. This is a provi-sional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/909,306 18/950,743 19/076,089 19/181,985
19/306,984 19/367,653 19/390,403 19/390,405
19/399,454 19/423,882 19/515,441 19/519,879
19/569,243 19/641,965 19/646,069 19/656,103
19/682,183 19/697,885 19/724,680 19/726,732
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 statu-tory 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 exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, 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
August 26, 2026
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