DETAILED ACTION
Claims 1-19, submitted on May 8, 2025, are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
Continued Examination under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection, so the finality of the previous Office action is withdrawn. Applicant’s submission filed on May 8, 2025 has been entered.
Withdrawn Rejections
All of the rejections in the prior action are withdrawn because the claims have been amended to refer to ketoprofen and naratriptan instead of meloxicam and rizatriptan.
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are explained in MPEP 2141 et seq. They are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0207200 A1 by Plachetka et al. in view of Lipton et al., Neurology 2015;84(7):688-95 and Vargas, Continuum 2018;24(4, Headache):1032-51.
Plachetka discloses a method of treating migraine (para. 0006), including acute migraine pain (para. 0036), by orally administering a tablet (para. 0036) comprising a combination of ketoprofen (para. 0039) and naratriptan (para. 0012). It is implicit that the number of migraines varies and would include, for example, one episode per month. The reference acknowledges that migraines may have different levels of “severity of pain” (para. 0040), which suggests the subject matter of claims 5-6 and 13-14. The pharmaceutical preparation includes, among other things, disintegrants (para. 0029), which meets the limitations of claim 8.
The difference between the prior art and the claims at issue are that Plachetka does not specifically disclose using the mTOQ-4 questionnaire to monitor the therapy.
Lipton, however, discloses that mTOQ-4 is a validated questionnaire that assesses migraine treatment efficacy based on response to acute treatment (see Abstract). This reference recognizes “severe migraine” and “headache-related disability” (p. 639), which suggests the subject matter of claims 5-7 and 13-15.
Vargas similarly discloses that the four-item Migraine Treatment Optimization Question-naire (mTOQ-4) “is a validated questionnaire that can help assess treatment optimization” of migraine (p. 1045). This reference recognizes nausea (p. 1033), photophobia (p. 1035), and phonophobia (p. 1035) as symptoms of migraine, which suggests the subject matter of claims 2-4 and 10-12.
It would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date to use the mTOQ-4 questionnaire as taught by Lipton/Vargas when practicing the migraine therapy of Plachetka and thereby arrive at subject matter within the scope of the instant claims. It is routine and customary in the practice of clinical medicine to use such diagnostic tools, including mTOQ-4, in order to improve health outcomes. An mTOQ-4 score of less than 4 with a prior treatment would have indicated a need for an alternative course of therapy. So, for example, a person who is poorly responsive to treatment with an existing migraine treatment (see, e.g., Table 4-1 at p. 1036 in Vargas) would have been motivated to look to the prior art for a different course of treatment, and Plachetka suggests a solution to this problem. It would therefore have been at least prima facie obvious to try using the treatment of Plachetka when treating a person with an mTOQ-4 score of 4 or less.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Plachetka, Lipton, and Vargas, as applied to claims 1-15 above, and further in view of US 6,713,461 B1 by Billotte.
The disclosures of Plachetka, Lipton, and Vargas are relied upon as set forth above. The difference between the prior art and the claims at issue is that none of these references specifi-cally discloses using SBEβCD as an ingredient in the composition or that pain relief occurs at about two hours.
Billotte, however, discloses (see, e.g., col. 1, l. 65 – col. 2, l. 28) that SBEβCD is known to be useful as an excipient in triptan-containing migraine pharmaceutical products. Using this cyclodextrin provides for “rapid onset of action” (col. 1, ll. 41-42), which suggest the time limita-tions of instant claims 17-18. It would have been apparent to the skilled artisan that this rapid onset of action is a desirable characteristic of migraine treatments.
It therefore would have been prima facie obvious to one of ordinary skill in the art to use SBEβCD as taught by Billotte in the ketoprofen/naratriptan composition of Plachetka and thereby arrive at subject matter within the scope of the instant claims. One would have been motivated to do so in order to produce a migraine medication with a rapid onset of action. One would have had a reasonable expectation of success because Plachetka discloses that the tablets described therein “can be made in accordance with methods that are standard in the art” (para. 0029), and one would have viewed the cyclodextrin ingredients of Billotte as being “standard in the art.”
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 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 14, 2026
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