DETAILED ACTION
The amendment submitted on June 16, 2026 has been entered. Claims 1-26 are pending in the application and remain 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.
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Withdrawn Rejections
The rejection of claim 6 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of applicant’s corrective amendment.
The rejection of claims 1-26 under 35 U.S.C. 112(a) for lack of enablement is withdrawn because the independent claim has been amended to refer to “therapeutically” administering.
Response to Arguments
Applicant argues that “[t]he reference claims of the reference patents and reference patent applications do not recite the limitations that the Office Action alleges are found in the present specification. Using the specification of the reference patents and reference patent applications to introduce these limitations when they are otherwise absent from the claims of the reference patents and reference patent applications is clearly not permitted, as it represents a use of the disclosure of the cited patent application as though it were prior art. As the reference claims of the reference patents and reference patent applications themselves do not recite the above limitations alleged by the Office Action to be taught in the present specification, Applicant respectfully submits that the double patenting rejections are improper.” See applicant’s Remarks, submitted June 16, 2026, at pp. 6-7. Applicant’s arguments have been fully considered but are not persuasive for the following reasons.
The law as it applies to double patenting that the Office follows is explained in In re Vogel, 422 F.2d 438 (C.C.P.A. 1970), which states as follows (emphasis added, internal citations omitted):
Does any claim in the application define merely an obvious variation of an invention disclosed and claimed in the patent? In considering the question, the patent disclosure may not be used as prior art. This does not mean that the disclosure may not be used at all. As pointed out above, in certain instances it may be used as a dictionary to learn the meaning of terms in a claim. It may also be used as required to answer the second analysis question above. We recognize that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim. A claim is a group of words defining only the boundary of the patent monopoly. It may not describe any physical thing and indeed may encompass physical things not yet dreamed of. How can it be obvious or not obvious to modify a legal boundary? The disclosure, however, sets forth at least one tangible embodiment within the claim, and it is less difficult and more meaningful to judge whether that thing has been modified in an obvious manner. It must be noted that this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. § 103, since only the disclosure of the invention claimed in the patent may be examined.
See also MPEP 804. The use of the written description of the cited reference Patents and Applications is therefore proper in the limited circumstances explained in In re Vogel. In the present situation, the ‘255 Patent claims a method of treating migraine comprising administering a combination of a meloxicam and avitriptan. It is therefore proper to look to the rest of the ‘255 Patent to understand what is meant of avitriptan. The written description of the ‘255 Patent (col. 22, ll. 20-25) explains that avitriptan and donitriptan are alternative embodiments of the same ingredient, namely, the triptan. One would therefore have viewed substituting one triptan for another triptan as being prima facie obvious. See MPEP 2144.06(II) (substituting equivalents known for the same purpose). The examiner therefore maintains that the rejections are proper and they are accordingly maintained.
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 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 1-26 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,472,255 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘255 Patent is drawn to “[a] method of treating migraine in a human being in need thereof, comprising admin-istering to the human being a combination of a meloxicam, an avitriptan, a bicarbonate, and a sulfobutylether-β-cyclodextrin (SBEβCD), wherein the human being is suffering from migraine pain or aura” (emphasis added). This claim is identical to instant claim 1, except that it refers to avitriptan instead of donitriptan. The written description of the ‘255 Patent (col. 22, ll. 20-25), however, explains that avitriptan and donitriptan are alternative embodiments of the same ingredient, namely, the triptan. One would have viewed substituting one triptan for another triptan as being prima facie obvious. See MPEP 2144.06(II) (substituting equivalents known for the same purpose). The examiner therefore concludes that instant claim 1 is prima facie obvious over claim 1 of the ‘255 Patent. Instant claims 2-3, 7, 9-11, 13-22, and 25 are the same as claims 2-3, 6, 7-9, 10-19, and 20, respectively, of the ‘255 Patent. Claims 1-26 also remain rejected for double patenting over the corresponding claims of the following U.S. Patents for substantially the same reasons: 10,780,166 B2; 10,821,182 B2; 10,918,722 B2; 10,933,137 B2; 11,013,805 B2; 11,013,806 B2; 11,020,483 B2; 11,045,549 B2; 11,357,854 B2; 11,369,684 B2; 11,433,078 B2; 11,4330,79 B2; 11,471,465 B2; 11,504,429 B2; 11,607,456 B2; 11,617,755 B2; 11,617,791 B2; 11,826,354 B2; 12,268,693 B2; and 12,357,640 B2.
Claims 1-26 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,471,014 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘014 Patent is directed to “[a] method of treating migraine, comprising administering a solid oral dosage form comprising a complex of meloxicam with a sulfobutyl ether β-cyclodextrin (SBEβCD), at least 400 mg of a bicarbonate, and rizatriptan to a human being suffering from migraine.” This meets the limitations of instant claims 1-2, 10-12, and 14, except for two differences: first, the instant claims require donitriptan instead of rizatriptan, and second, the instant claims require that “the human being is suffering from migraine pain or aura,” which is not specifically recited in the claims of the ‘014 Patent. Both of these claim limitations, however, would have been apparent when the claims of the ‘014 are read in light of the accompanying written description. As explained in the rejection above, one would have viewed substituting one triptan for another as being prima facie obvious for the reasons discussed in MPEP 2144.06(II). The ‘014 Patent describes (col. 2, ll. 63-64) rizatriptan and donitriptan as being equivalents, so one would have viewed substituting donitriptan for rizatriptan in claim 1 of the ‘014 Patent as being prima facie obvious. Second, even though the ‘014 Patent does not specifically claim that “the human being is suffering from migraine pain or aura,” the written description of the Patent (see, e.g., col. 4, ll. 1-10) acknowledges that pain and aura were known symptoms of migraines. One would there-fore have been motivated to extend the method of claim 1 of the ’014 Patent to the treatment of persons with pain or aura in order to alleviate the suffering caused by these symptoms. One would have had a reasonable expectation of success because, by treating the migraine itself in the manner prescribed in claim 1 of the ‘014 Patent, one would reasonably expect to alleviate the pain and aura referred to in instant claims 1, 13, and 21. Claims 5-11 and 18-19 of the ‘014 Patent are drawn to subject matter within the scope of instant claims 7-12, 15-16, 22-23, and 25. Claims 1-26 also remain rejected for double patenting over the corresponding claims of the following U.S. Patents for substantially the same reasons: 10,029,010 B1; 10,058,614 B2; 10,195,278 B2; 10,195,279 B2; 10,265,399 B2; 10,265,400 B2; 10,307,484 B2; 10,322,181 B2; 10,363,312 B2; 10,369,224 B2; 10,369,225 B2; 10,426,839 B2; 10,456,471 B2; 10,463,736 B2; 10,485,871 B2; 10,512,692 B2; 10,517,950 B1; 10,532,101 B1; 10,537,642 B1; 10,583,088 B2; 10,583,144 B2; 10,653,777 B2; 10,688,185 B2; 10,695,429 B2; 10,695,430 B2; 10,702,602 B2; 10,722,583 B2; 10,729,773 B2; 10,729,774 B1; 10,758,617 B2; 10,758,618 B2; 10,780,165 B2; 10,821,181 B2; 10,933,136 B2; 10,987,358 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; 11,219,626 B2; 11,285,213 B2; 11,285,214 B2; 11,331,323 B2; 11,471,464 B2; 11,510,927 B2; 11,571,428 B2; 11,617,756 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; 12,128,052 B2; 12,472,256 B2; 12,472,257 B2; 12,472,258 B2; 12,478,678 B2; 12,485,176 B2; 12,551,488 B2; and 12,551,489 B2.
Claims 1-26 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 18/512,551 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 (submitted on November 17, 2023) of the ‘551 Application is drawn to “[a] method of treating migraine, comprising administering to a human being in need thereof a combination of [an] ibuprofen, a rizatriptan, a bicarbonate, and a sulfobutylether-β-cyclodextrin (SBEBCD), wherein the human being is suffering from migraine pain or aura.” Note that instant claim 1 requires meloxicam and donitriptan instead of the ibuprofen and rizatriptan claimed in the ‘551 Application. The written description portion of the specification of the ‘551 Application, however, explains that meloxicam and ibuprofen are within the same class of drugs, namely, NSAIDS (pp. 31-32). Similarly, the specification (p. 32) explains that donitriptan and rizatriptans are different triptans. As explained in the rejections above, it would have been prima facie obvious to substitute one NSAID or triptan for another drug in the same therapeutic class. Accordingly, at least instant claim 1 would have been prima facie obvious over claim 1 of the ‘551 Application. Claims 1-26 also remain rejected for double patenting over the corresponding claims of the following copending Applications for substantially the same reasons: 18/065,013 (see especially claim 2, submitted on February 17, 2026); 18/636,093 (see claim 38); 18/950,743 (see claims 6-8); 19/030,296 (see claim 12); 19/074,873; 19/085,084; 19/169,261; 19/196,655; 19/236,838; 18/366,992; 18/909,306; 19/076,089 (see claim 12); 19/181,172; 19/076,122; 19/181,985; 19/263,324; 19/306,984; 19/367,653; 19/399,454; 19/423,882; and 19/458,316. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
September 21, 2026
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