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 .
Response to Amendment
The amendments received 04/15/2026 have been entered. Any objection or rejection previously set forth in the Office Action mailed 12/16/2025 has been overcome and is withdrawn.
Examiner has considered Applicant’s arguments regarding the rejection of claim 39 under 35 U.S.C. 103 over Willwacher et al. and Patani et al. and finds them persuasive. The rejection is withdrawn.
New grounds of rejection are set forth as necessitated by amendment.
Election/Restrictions
Examiner has expanded the search scope to encompass all of formula (II) as in claim 1, formula (I) as in claim 2, formula (I) as in claim 61, formula (IA) as in claim 71, and the species of claims 39 and 40. Claims 1-20, 25-28, 30, 32-40, 61, and 67-82 are examined herein and the election of species requirement set forth in the action mailed 10/24/2025 is withdrawn. Claims 42-58 are directed to a non-elected invention and remain withdrawn, there being no allowable generic or linking claim.
Information Disclosure Statement
The Information Disclosure Statement filed on 04/15/2026 is in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
Claims 1-20, 25-28, 30, and 32-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 2 recite “wherein Y1, Y2, Y3, and Y4 are not simultaneously N”. It is unclear whether this means that all of Y1, Y2, Y3, and Y4 cannot simultaneously be N or if, for example, Y3 and Y4 cannot simultaneously be N. If the former is true, Examiner suggests amending the claim to recite “are not all simultaneously N” for clarity.
Claims 1 and 2 recite “the ring”. This limitation lacks antecedent basis as it is unclear which ring is being referred to. Claims 3-20, 25-28, 30, 32-38 do not clarify the limitation at issue and are also rejected.
Claims 1 and 2 recite “A, B and E are independently selected from C, N, O, and S”. However, A, B, and E cannot be C because its valence of 4 would not be satisfied without another substituent. Claims 3-20, 25-28, 30, 32-38 recite, require, and/or do not clarify the limitation at issue and are also rejected.
Claim 33 recites “each of R2 and R3, when present, is”. This causes confusion as, per claims 30 and 32, R2 and R3 cannot be absent.
Claim 69 recites “said fused ring” but multiple fused rings are recited in claim 61.
Claim 70 recites “said fused 5- to 6-membered heteroaryl” which lacks antecedent basis as claim 69 does not set forth a fused 5- to 6-membered heteroaryl.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-20, 25-28, 30, 32-38, 61, 78 and 80 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for pharmaceutically acceptable salts, does not reasonably provide enablement for solvates. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The claims are drawn to pharmaceutically acceptable salts and solvates of the claimed compounds. However, the numerous examples presented all failed to produce a solvate. These cannot be simply willed into existence and are considered unpredictable in the art. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity.” Hence, applicants must show that solvates can be made, or limit the claims accordingly.
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.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2024152710 A1; effectively filed 20 Jan 2023; IDS filed 08/14/2024).
Wang et al. discloses the following compound (p. 28).
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Compound 49 of claim 39 is prima facie obvious over Wang et al. because it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoeksema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.P.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Moreover, H and Me have been acknowledged by the courts to be obvious variants. In re Wood, 199 USPQ 137. Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “H” group to a “methyl” or vice versa.
Allowable Subject Matter
Claim 40 is allowed. Claims 67-77, 79, and 81-82 are objected to for depending upon a rejected base claim.
Response to Arguments
Examiner has considered Applicant’s arguments filed 04/15/2026 and does not find them persuasive.
35 U.S.C. 112(a)
In the Remarks filed 04/15/2026, Applicant stated that the instant claims were amended to remove “and/or solvate” in response to the scope of enablement rejection under 35 U.S.C. 112(a) (Remarks, p. 66). However, claim 61 has not been amended to remove “and/or solvate”. The rejection has been maintained for claim 61.
Conclusion
Claim 40 is allowed. Claims 67-77, 79, and 81-82 are objected to. Claims 1-20, 25-28, 30, 32-39, 61, 78 and 80 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.E.B./Examiner, Art Unit 1624 04/28/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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