DETAILED ACTION
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 .
Status of the Application
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/11/25 has been entered.
Claims 1-35, 37-38, 40-41, 43-52 have been cancelled. Claims 36, 39, 42, 53-60 are pending and examined herein.
No arguments against the rejections of record are presented in the response filed on 12/11/25, therefore the rejections are maintained for reasons of record and repeated below for Applicant’s convenience.
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 extension fee 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
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 of carrying out his invention.
Claims 53-60 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contains 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 or joint inventor, at the time the application was filed, had possession of the claimed invention.
Claims 53 and 57 recite the limitation “wherein a level of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) upon 12 weeks of said treatment is less than 3 times the upper limit of normal value”. There is no support for this limitation in Applicant’s originally filed disclosure.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham vs John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 36, 39, 42, 53-60 are rejected under 35 U.S.C. 103(a) as being obvious over Bell et al. (“Discovery of AGN-241689: A potent, orally-acting CGRP receptor antagonist for migraine prophylaxis,” Abstract of papers; ACS National Meeting & Exposition; 253rd National Meeting of the American Chemical Society on Advanced Materials, Technologies, Systems, and Processes, San Francisco, CA, 2017, vol. 253, page 20, of record) in view of Liu et al. (US Patent Application 2018/0092899 A1, of record).
The instant claims are directed to a method of preventing migraine in a patient by administering atogepant for about three months at the claimed dosages.
Bell et al. teaches that AGN-241689 (atogepant) is a potent, orally-acting CGRP antagonist for migraine prophylaxis (title). AGN-241689 combines good oral pharmacokinetic properties with exquisite potency and selectivity.
The Examiner notes that the limitations drawn to reduction of the number of monthly migraine days, reduction of mean monthly migraine days, not more than 50% increase of baseline pretreatment levels of ALT or AST, and wherein a level of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) upon 12 weeks of said treatment is less than 3 times the upper limit of normal value are considered inherent since these in vivo processes or mechanism of action will necessarily happen because the same active agent is being administered to the same patient population.
However, Bell et al. fail to specifically disclose the claimed dosages.
Liu et al. teach methods of treating migraines with a CGRP active compound (title). Specifically, Liu et al. teaches methods of alleviating at least one symptom of acute migraine attack in a patient by administering a CGRP antagonist in an amount of 50 or 100 mg (claims 1-4) as an oral formulation (paragraph 0034) at various time intervals (paragraph 0026), which reduces pain to a level permitting the patient to engage in normal activities or reduces the severity of symptoms present in a patient within two hours of administration (paragraphs 0023 and 0025). Other dosages as low as 10 mg are taught (paragraph 0054). Symptoms of migraines include pain, aura, photophobia, phonophobia, nausea, and emesis (paragraph 0014).
The Examiner notes that the claimed dosages and treatment regimens (number of dosages per day) are obvious, absent a showing of unexpected results or criticality, given the general teachings by Liu et al. of 10, 50 or 100 mg per day. Furthermore, since CGRP antagonists, like atogepant, are known to be useful for treating migraines, it would be obvious to administer the active agent as long as needed, whether it is 3 days, 3 weeks, or 3 months.
Generally, mere optimization of ranges will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382; lt has been held that it is within the skills in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. In re Boesch, 205 USPQ 215 (CCPA 1980) MPEP 2114.04
It would have been prima facie obvious to a person of ordinary skill in the art, at the time the claimed invention was made, to have administered atogepant in the methods of preventing migraines, as taught by Bell and/or Liu et al.
A person of ordinary skill in the art would have been motivated to administer atogepant at the claimed dosages to prevent migraines in a patient because atogepant is well known for migraine prophylaxis, therefore one of ordinary skill in the art would have had a reasonable expectation of success in preventing migraines at the claimed dosages.
Response to Arguments
No arguments against the rejections of record are presented in the response filed on 12/11/25.
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 extension fee 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 Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at (866)-217-9197 (toll-free).
/Yong S. Chong/Primary Examiner, Art Unit 1623
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