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
Response to Amendment
1. No claim amendment was submitted with the Response filed on March 20, 2026.
Claims 1, 15, 21, 25, 52 and 176 are pending in the instant application.
Claims 1, 15, 21, 25, 52 and 176 are under examination.
2. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
3. Applicant’s arguments filed on March 20, 206 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections - 35 USC § 103
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.
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 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. Claim(s) 1, 15, 21, 25, 52 and 176 stand rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0174754, June 22, 2017 (the ‘754 document, cited here by reference to the text of US patent 10,066,009, which is issued from the ‘754 document), see reasons of record in section 12 of Paper mailed on October 11, 2024, section 5 of Paper mailed on May 09, 2025 and in section 4 of Paper mailed on December 04, 2025.
Applicant argues at pp. 4-7 of the Response that MOH caused by opioids is different from other MOH, and its etiology is not associated with CGRP. Specifically, Applicant submits that, “it is known that opioid withdrawal syndrome and MOH caused by opioid use are distinct conditions and that opioid tolerance and MOH caused by opioid use are also distinct conditions and indeed act oppositely. Based on this, Applicant pointed out that if the recited antibody is able to treat conditions which are the opposite of opioid-based MoH, it would be unreasonable to expect that such antibody would effectively treat opioid-based MoH. Rather it would be entirely possible if not reasonable to expect that the antibody would even exacerbate opioid-based MoH. As provided in Applicant's response filed on April 11, 2025, opioid withdrawal syndrome is a set of symptoms caused by suddenly stopping opioid intake. Therefore, opioid withdrawal syndrome and MOH cause by opioid use are quite opposite, because, while non-use of opioid is the cause of opiate withdrawal syndrome, use of opioid is the cause of opioid-based MOH.” And further, “the description of opioid withdrawal syndrome and opioid tolerance in the '754 document teaches nothing about treatment of opioid-based MOH,” and “CGRP was not believed to be involved in MOH.” Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
As an initial matter, the instant patent application appears to suffer from the same deficiency as ‘754 document because it does not teach anything “about treatment of opioid-based MOH,” or its distinct and special etiology not related to CGPR. For example, at Brief Summary, pp. 2-7, the Medication Overuse Headache is described as overuse of any medication, see [0012], “Said medication overuse headache may comprise ergotamine-overuse headache, triptan-overuse headache, non-opioid analgesic-overuse headache, opioid-overuse headache, combination-analgesic-overuse headache, medication-overuse headache attributed to multiple drug classes not individually overused, medication-overuse headache attributed to unspecified or unverified overuse of multiple drug classes, or medication-overuse headache attributed to other medication,” emphasis added to demonstrate that, according to the specification as originally filed, opioid overuse was described as a obvious variant of any other medication. Next, the working examples at pp. 98-108, describe treatment of migraine and chronic migraine in patients who were allowed to continue using their daily acute medication, see [0696], “During the studies of chronic migraine patients described in Example 3 and episodic migraine patients described in Example 4, patients also recorded use of acute medication in a daily eDiary and were allowed to use acute medication at their own discretion. Acute medications for migraine included ergots, triptans, and analgesics (e.g., NSAIDS, opioids, and caffeine-containing combination analgesics),” emphasis added to highlight that opioids were not explained as a single novel inventive concept, as currently presented, but as an obvious variant among other medications.
Therefore, while Applicant’s explanation of possible unique etiology of opioid overuse headache is fully acknowledged, the instant specification, as originally filed, discloses overuse of opioids as an obvious variant of overuse of any other medications, and without any specific explanation of the role of CGRP in opioid overuse headache.
The Examiner maintains that it would have been obvious for one of ordinary skill in the art at the time of filing of the instant patent application to treat MOH, wherein said medication overuse comprises use of opioids, by administration of the ‘754 anti-CGRP antibody and following the protocol as fully described by the ‘754 document to treat headaches and pain in general.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
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 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 accompanied 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.
5. Claims 1, 15, 21, 25, 52 and 176 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,639,380, claims 1-15 of U.S. Patent No. 11,639,381, claims 1-31 of U.S. Patent No. 12,215,144, claims 1-28 of U.S. Patent No. 12,215,145, claims 1-22 of U.S. Patent No. 12,391,749, claims 1-12 of U.S. Patent No. 12,384,837, and claims 1-211 of U.S. Patent No. 12,384,836 for reasons of record fully explained in the previous office actions of record.
6. Claims 1, 15, 21, 25, 52 and 176 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11, 12, 35, 36, 40, 54-56 of copending Application No. 17/608,220 for reasons of record as applied to previously presented claims in earlier office actions of record.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
7. No claim is allowed.
8. 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 OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
April 14, 2026
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