DETAILED ACTION
Claims 1-25, submitted on November 17, 2023, are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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.
Claim Rejections – 35 USC § 112(a)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-25 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating migraine, does not reasonably provide enablement for preventing it. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Although the claims at issue are drawn to a “method of treating migraine” (see claim 1), the term “treating” is defined in applicant’s own specification (p. 8) as “broadly includ[ing] any kind of treatment activity, including the diagnosis, cure, mitigation, or prevention of disease” (emphasis added) Even though the instant claims to not specifically include the word “prevent-ing,” it is nevertheless within the meaning of “treating.” The breadth of the claims therefore includes preventing migraines, which is not consistent with the mechanism of action understood for the active ingredients, namely, ibuprofen and rizatriptan.
As explained applicant’s specification (pp. 1-2 and 31), meloxicam is “a nonsteroidal anti-inflammatory (NSAID) drug that exhibits anti-inflammatory, analgesic, and antipyretic activities.” One of skill in the art would understand that an analgesic (as opposed to an anesthetic) affects the perception of pain; it does not prevent it. Similarly, rizatriptan is a triptan (spec. at p. 32), which Ahn et al., Pain 2005;115(1-2):1-4 explains are “serotonin receptor subtype-selective drugs have well-established efficacy in treating the pain of migraine” (see Ahn at p. 1). Importantly, Ahn et al. explicitly states that “triptans do not prevent the pain of migraine, and predicts that triptans would only be effective in experimental models of pain in which a prior stimulus has activated nociceptors and externalized the triptan receptor to the presynaptic membrane” (p. 4, emphasis added).
Applicant’s specification (p. 60) includes a working example describing the use of meloxi-cam (a NSAID, similar to ibuprofen) and a triptan (specifically, rizatriptan) in the treatment of a migraine “attack of moderate or severe intensity. The two co-primary endpoints of the trial were the proportion of patients who are free from headache pain two hours after dosing, and the proportion of patients who no longer suffered from their most bothersome migraine-associated symptom (nausea, photophobia, or phonophobia) two hours after dosing, for meloxi-cam/rizatriptan as compared to placebo. Superiority of meloxicam/rizatriptan to the rizatriptan and meloxicam arms (component contribution) was to be established based on sustained free-dom from headache pain from two to 24 hours after dosing (key secondary endpoint).” Note that this experiment describes administration of meloxicam and the triptan after a migraine has already occurred. There is no evidence in applicant’s specification that the drugs are actually useful in the prevention of migraine.
The prior art and the discussion of the mechanism of action of the active ingredients in applicant’s own specification therefore contradict the premise of the claimed invention, namely, that the NSAID and rizatriptan are useful in preventing migraine. Applicant does not provide any explanation or mechanistic rationale for a causal link between NSAID and the triptan for prevent-ing migraine, nor is this information found in the prior art. The examiner therefore concludes that one of skill in the art would be burdened with undue experimentation when attempting to practice the full scope of the invention as claimed.
Claims 2, 7-8, 17, 21, and 24 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed inven-tion. The following claim limitations are new matter:
“a complex of the ibuprofen and the SBEβCD”
“about 20 mg to about 200 mg of the ibuprofen free acid, or a molar equivalent amount of a salt of ibuprofen”
“the ibuprofen is present in a salt form”
“improves the bioavailability of ibuprofen”
“reduces the Tmax of ibuprofen”
“results in faster release or dissolution of ibuprofen”
Applicant is required to delete the new matter from the claims in response to this communica-tion. See MPEP 2163.06 (relationship of written description requirement to new matter).
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 1-25 are 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 rizatriptan and meloxicam instead of ibuprofen. The written description of the ‘255 Patent (col. 22, ll. 20-25), however, explains that avitriptan and rizatriptan are alterna-tive embodiments of the same ingredient, namely, the triptan. One would have viewed substi-tuting one triptan for another triptan as being prima facie obvious. See MPEP 2144.06(II) (substituting equivalents known for the same purpose). Similarly, the meloxicam and the ibuprofen are both NSAIDs (see the ‘225 Patent at col. 21, ll. 50-60), so one would have viewed substituting one drug in this therapeutic class for another as being prima facie obvious. The examiner therefore concludes that instant claim 1 is prima facie obvious over claim 1 of the ‘255 Patent. Instant claims 2-3. 9-13, and 18-20 are the same as claims 2-3, 7-10, and 16-18, respec-tively, of the ‘255 Patent. The dosage amounts of rizatriptan referred to in instant claims 4-6 and 15 are disclosed in the ‘255 Patent (see col. 22, ll. 30-45). Claims 1-25 are also 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 1-25 are 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 ibuprofen instead of meloxicam, 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 NSAID for another as being prima facie obvious for the reasons discussed in MPEP 2144.06(II). 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 therefore 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 1-25 are also 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 1-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 18/503,996 (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 ‘996 Application is drawn to “[a] method of treating migraine, comprising administering to a human being in need thereof a combination of a meloxicam, a donitriptan, 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 ibuprofen and rizatriptan instead of the meloxicam and donitriptan claimed in the ‘996 Application. The written description portion of the specification of the ‘996 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 rizatriptan are different triptans. As explained in the rejections above, it would have been prima facie obvious to substitute one NSAID or triptan for another drugs in the same therapeutic class. Accordingly, at least instant claim 1 would have been prima facie obvious over claim 1 of the ‘996 Application. Claims 1-25 are also 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
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, 8:00 am - 7:00 pm (Eastern Time). Exam-iner 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
March 9, 2026