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 .
Continued Examination Under 37 CFR 1.114
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 6/30/2026 has been entered.
Status of the Claims
Claims 1, 5, 8, 10, 12, 15-16, 25-32, and 38-42 are pending. Claims 1, 12, 15, 16, 25, 26, 27, 29, 31 and 32 are rejected. Claims 5, 8, 10, 28, 30, and 38-42 are withdrawn.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 6/30/2026 was considered by the Examiner.
Election/Restriction
**Per the rejections below on new prior art, the 7/14/2025 restriction requirement is valid.
Applicant’s election without traverse of Group I and the species of compound 4ET-03-063:
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, in the reply filed on 10/21/2025 is acknowledged.
Claims 1, 12, 15, 16, 25, 26, 27, 29, 31 and 32 embrace the elected species and are therefore under examination. The elected species was free of the prior art but is rejected below under double patenting. As per MPEP 803.02, “Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability.” Found incidental to the search was the non-elected species rejected below under 35 USC 102 and 103.
Claims 5, 8, 10, 28, 30, and 38-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Note from Examiner
The indicated allowability of claims 1, 5, 8, 10, 12, 15-16, 25-32 and 38 is withdrawn in view of the newly discovered reference(s) to US20180228803, US20170266185, and Yuan et al. (Bioorganic & Medicinal Chemistry, 27, 2019, 1211-1225). Rejections based on the newly cited reference(s) follow.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan et al. (Bioorganic & Medicinal Chemistry, 27, 2019, 1211-1225).
Regarding instant claim 31, Yuan teaches the following structure 42h on p. 1216:
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, R =
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, which is identical to a compound on p. 7, right column of instant claims.
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 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.
Claim(s) 1, 12, 25, 26, 27, 29, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ernst et al. (US20180228803).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Ernst et al. teach the following compounds, arrows added by Examiner, (3A and 3O of para. [0133]):
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and
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. Both compounds are similar to an instant compound of formula (II):
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, wherein X = CH; Y = N; L = -NH-; R2 = -NH2; R1a and R1b, together with the carbon to which they are both attached, join to form heterocyclyl.
Ernst et al. additionally teach that the invention is directed to compositions containing the compounds in combination with a pharmaceutically acceptable carrier (see para. [0011] and [0013]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art compounds differ from the instant compounds with a hydrogen to methyl substitution.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1, 12, 25, 26, 27, 29, and 32,
prior art compound 3A differs from the instant claims because of the following proviso at the end of claim 1:
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However, the instant claims still allow for -N(CH3)H (instead of -NH2), for example, in the R2 location when R3a = C1 alkyl;
prior art compound 3B differs from the instant claims by the location of a methyl by the arrow added supra, wherein the instant compounds have a hydrogen.
The compounds as taught by the prior art and the compounds in the instant claims are considered structural analogs and hydrogen and methyl are deemed obvious variants. It is well established that the substitution of hydrogen for methyl on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, Whittaker, Stirling, and Ohta, 582 F.2d 638, 199 U.S.P.Q 137 (C.C.P.A. 1978). In the instant case, a person having ordinary skill in the art at the time the invention was filed would have been motivated to synthesize the instantly claimed analogs with the reasonable expectation that it would have the same utility as the closest structurally related compounds taught by the prior art and with the motivation of obtaining additional useful compounds. A person of ordinary skill in the art would have expected them to be useful in the same utilities and been motivated to apply them in the same methods.
Claim(s) 1, 15, 16, 25-27, 29, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reich et al. (US20170266185).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Reich et al. teach compounds as MNK inhibitors (see title).
REJECTION A: Reich et al. teach the following compound on p. 83, left column (arrow added by Examiner):
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, which is similar to an instant compound of formula (II):
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, wherein X = CH; Y = N; L = -NH-; R2 = -NH2; R1a and R1b, together with the carbon to which they are both attached, join to form 5 membered cycloalkyl; n = 0 (claims 15 and 16).
Reich et al. additionally disclose compositions comprising a compound and pharmaceutically acceptable carrier (see para. [0014]).
REJECTION B: Reich et al. teach the following compound on p. 79, right column (arrow added by Examiner):
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, which is similar to an instant compound of formula (II):
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, wherein X = CH; Y = N; L = -NH-; R2 = -NH2; R1a= methyl and R1b= aryl (phenyl). This position in the prior art corresponds to “R2” of the prior art genus which the prior art teaches may be alkyl (see para. [0082]). Regarding alkyl, the prior art recites the following:
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.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
REJECTION A: The prior art compound differs from the instant compounds with hydrogen to methyl substitution.
REJECTION B: The prior art compound differs from a methyl to a propyl of the instant claims.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
REJECTION A: Regarding instant claims 1, 15, 16, 25-27, 29, and 32, the prior art compound differs from the instant claims because of the following proviso at the end of claim 1:
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However, the instant claims still allow for -N(CH3)H, for example, in the R2 location when R3a = C1 alkyl. The compounds as taught by the prior art and the compounds in the instant claims are considered structural analogs and hydrogen and methyl are deemed obvious variants. It is well established that the substitution of hydrogen for methyl on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, Whittaker, Stirling, and Ohta, 582 F.2d 638, 199 U.S.P.Q 137 (C.C.P.A. 1978). In the instant case, a person having ordinary skill in the art at the time the invention was filed would have been motivated to synthesize the instantly claimed analogs with the reasonable expectation that it would have the same utility as the closest structurally related compounds taught by the prior art and with the motivation of obtaining additional useful compounds. A person of ordinary skill in the art would have expected them to be useful in the same utilities and been motivated to apply them in the same methods.
REJECTION B: Regarding instant claims 1, 25-27, and 29, the prior art compound is a homolog of the instant claims. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its
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homologs because
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homologs
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often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).” A skilled artisan would have been motivated to synthesize the instantly claimed compounds with a reasonable expectation of success in arriving at an MNK inhibitor.
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.
Claims 1, 12, 15, 16, 25, 26, 27, 29, 31 and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 8, 10, 15, 17, 18, 19, 20, 26, 27, 29, and 31 of copending Application No. 18294823 (reference application), in view of Biondi (Current Pain and Headache Reports, 2006, 10:167-178). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 12, 15, 16, 25, 26, 27, 29, and 31, copending Application No. 18294823 teaches a method for treating a migraine or symptoms related to a migraine using the following in claim 31:
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, which is the elected species and is embraced by a compound of instant Structure (II):
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, wherein R2 =
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; X = CH and Y = N; L = -NH-; R1a and R1b =
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(aryl); R4 = -OH; n = 1. Regarding the pharmaceutical composition of instant claim 32, “It is obvious to add a carrier to an obvious compound.” Ex parte Douros, 163 USPQ 667 (PTO Bd. App. 1968).
Regarding copending application 18294823 teaching a method for treating a migraine or symptoms related to a migraine, the instant claims are drawn to compounds that are useful for the treatment of neuropathic pain. Biondi teaches “There is evidence to suggest that the early phase of migraine pain results from neurogenic inflammation affecting cranial blood vessels and dura” (see abstract). It would have been obvious to a skilled artisan to explore the use of the instant claims in the treatment of migraine pain, which is related to neurogenic issues, with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy 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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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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