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 .
DETAILED ACTION
This is a response to Applicant’s Communication filed on February 25, 2025. Application No. 18,768,496, filed July 10, 2024, is a Continuation of U.S. Nonprovisional application No. 17/389,223, filed on July 29, 2021, (issued U.S. Patent No. 12, 090,148) and claims the benefit of U.S. Provisional Application Nos.: 63/201,254, filed April 20, 2021; 63/129,362, filed December 22, 2020; 63/092,211, filed October 15, 2020; 63/087,175, filed October 2, 2020; 63/070,449, filed August 26,2020; and 63/103,353, filed July 29, 2020. In a preliminary amendment filed February 25, 2025, Applicant cancelled claims 3, 4, 7, 8, 10-15, 19-21, 26, 27, 29, 30, and 36-42. Claims 1, 2, 5, 6, 9, 16-18, 22-25, 28, and 31-35 are pending.
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.
Claims 1, 2, 5, 6, 9, 16-18, 22-25, 28, and 31-35 are rejected under 35 U.S.C. 103(a) as being obvious over Bell et al., MEDI 20: Discovery of AGN-241689: A potent, orally-acting CGRP receptor antagonist for migraine prophylaxis, 253 American Chemical Society, Abstract, p. 20 (April 2-6, 2017); (ACS National Meeting & Exposition; 253rd National Meeting of the American Chemical Society on Advanced Materials, Technologies, Systems, and Processes, San Francisco, CA); in view of Liu et al., US2018/0092899 A1 (see February 25, 2025, IDS).
Bell et al. discloses AGN-241689 (atogepant) as a potent, orally-acting CGRP antagonist for migraine prophylaxis. Bell et al., MEDI20, Abstract, p. 20. Atogepant combines good oral pharmacokinetic properties with exquisite potency and selectivity. Id. The difference between the prior art and present invention is that Bell does not disclose the claimed dosages.
Liu, however, teaches methods for preventing migraines with a similar CGRP active compound, ubrogepant. Liu et al., Abstract. Liu discloses dosages of ubrogepant to prevent migraines in the range of 50-100mg. See Id., claims 1-4; see also Id., paras. [0062]-[0068], for a discussion of the optimization of the dosage range. Liu further teaches using ubrogepant to reduce 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. Id., [0023]–[0025]. Symptoms of migraines include pain, aura, photophobia, phonophobia, nausea, and emesis, etc. See Id., para. [0014]
In this case, the differences in dosages does not support the patentability unless there is evidence indicating that the dosages are critical.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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 Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
(MPEP 2144.05.) In this case, Applicants have not provided evidence whether the claimed dosage ranges are critical. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to adjust the dosages as taught by Liu, to those of the claimed invention to yield the best results as a matter of routine optimization.
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 possible 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 provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 5, 6, 9, 16-18, 22-25, 28, and 31-35 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-35 of copending Application No. 16/433,298. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims recite a method of preventing migraines by administering atogepant at the same dosages.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1, 2, 5, 6, 9, 16-18, 22-25, 28, and 31-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,090,148. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are both drawn to methods of preventing migraines comprising administering atogepant at the same dosage.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625
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