DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without specifying traverse of a single method in the reply filed on 5/26/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The elected species read upon claims 1, 15, 19-20, 26-27, 29 and 31. Claims 2, 6, 10, 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Allowable Subject Matter
As indicated above, the elected species – a method of treating migraine comprising administering to a patient in need thereof the following compound species
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– reads upon claims 1, 15, 19-20, 26-27 and 29, as well as claim 31 (drafted independently).
The elected species has been searched and is deemed to be free of the prior art and non-obvious. Accordingly, the search has been expanded as called for under current Office Markush practice – a compound-by-compound search – to include a single additional species (M.P.E.P. § 803.02).
In the instant case, numerous compounds of Structure (II) were identified in the prior art. For example, Reich et al (US 2015/0376181) teach compounds of Structure (II), including the following compound species
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(Page 202, Claim 15), “as inhibitors of Mnk as well as therapeutics for the treatment of diseases such as cancer” (Abstract).
However, Reich et al does not teach the compounds for the treatment of migraine.
Jenson et al (US 2008/0039450; of record) disclose compounds “which... are inhibitors of MNK2 and MNK1... for the... treatment of disorders related to undesired activity of MNK1 and/or MNK2 kinases” (Abstract) including migraine headaches (Paragraph 0184). However, migraine headaches are listed among hundreds of diseases, including obesity and eating disorders, arthritis, menstrual cramps, cancers, and so on. No where does Jenson et al demonstrate that the MNK inhibitors can be used to treat migraine headaches.
As such, the claims are determined to be free of the art and non-obvious. Additionally, the claims contain written support and are enabled.
However, claims 1, 15 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,925,642 and U.S. Patent No. 12,329,756.
Accordingly, in the instant Action, claims 1, 15 and 29 are rejected. Dependent claims 19-20, 26-27 are objected to. And claim 31 is ALLOWED.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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, 15 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,925,642.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 is drawn to a method for treating migraine or symptoms related to a migraine, the method comprising administering to a subject in need thereof a therapeutically effective amount of a compound of Structure (II), which embraces the following compounds species:
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, wherein R1a and R1b, together with the carbon to which they are attached, join to form a cycloalkyl; R2 is -NHR3a wherein R3a is hydrogen; L is -NH-; X is CH; and Y is N – which reads on pending claims 1, 15 and 29.
US 11,925,642 claim 1 similarly recites a method of treating migraine in a human subject, comprising adminsitering to the subject an amount of eFT508 (i.e., the instantly claimed compound of Structure (II) above).
Claims 1, 15 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,329,756.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 is drawn to a method for treating migraine or symptoms related to a migraine, the method comprising administering to a subject in need thereof a therapeutically effective amount of a compound of Structure (II), which embraces the following compounds species:
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, wherein R1a and R1b, together with the carbon to which they are attached, join to form a cycloalkyl; R2 is -NHR3a wherein R3a is hydrogen; L is -NH-; X is CH; and Y is N – which reads on pending claims 1, 15 and 29.
US 12,329,756 claim 1 similarly recites a method of treating migraine in a human subject, comprising adminsitering to the subject an amount of eFT508 (i.e., the instantly claimed compound of Structure (II) above).
Claim Objections
Claims 19-20, 26-27 are objected to as depending on a rejected base claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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