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 .
Status of Claims
Claims 9-10, 15-18 and 66-67 are pending in the instant application. Claims 9-10 and 15-18 are amended and claims 1-8, 11-14 and 19-65 are cancelled via the amendment filed January 27th, 2026.
Priority
This is a 35 U.S.C. 371 National Stage filing of Application No. PCT/US2021/053864 filed October 6th, 2021 which claims priority to provisional application 63/088,876, filed October 7th, 2020.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed January 27th, 2026 was considered by the Examiner.
Withdrawn Objections
Applicant’s arguments and amendments, filed January 27th, 2026, with respect to the objection of claims 17 and 18 have been fully considered and are persuasive. The objection of claims 17-18 has been withdrawn.
Applicant has overcome this objection by amending the claims to recite “The compound, tautomer, deuterated derivative or pharmaceutically acceptable salt according to claim 9, selected from the group consisting of” in lines 1-2, insert “and” before the last compound and amend the end of the claim to recite “or a tautomer, deuterated derivative, or pharmaceutically acceptable salt thereof.”
Withdrawn Rejections
Applicant’s arguments and amendments, filed January 27th, 2026, with respect to 102 rejection of claims 9-10, 15-16 and 66 as being anticipated by Ohmoto been fully considered and are persuasive. The objection of claims 17-18 has been withdrawn.
Applicant has overcome this rejection by amending claim 9 to recite that “R1 is selected from -O-phenyl, -C1-4 alkoxy and phenyl substituted with 1-3 groups independently selected from -C1-3 alkyl”.
Response to Remarks
Applicant’s arguments with respect to the claim objections have been considered but are moot as Applicant’s amendments have overcome the objection.
Applicant’s arguments with respect to the 102 rejection of claim(s) 9-10, 15-16 and 66 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s amendments have necessitated a new grounds rejection presented below.
Restriction/Election
Applicant’s election without traverse of “Compound 142” to prosecute the invention of Group II, a compound of Formula II, in the reply filed on October 3rd, 2025 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of the Compound 142 appears allowable. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claims 17 and 18, as well as structural species:
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Since a non-elected species has been found not allowable, examination has been limited to claims directed to the elected species, which are presently claims 9-10, 15-18 and 66. Claims 9-10, 15-18 and 66 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claim 67 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention or species. Election was made without traverse in reply filed October 3rd, 2025.
New Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 9-10 and 66 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Changunda et al (Tetrahedron 73 (2017) 137-147).
Changunda teaches the following compound (page 146, compound 19e):
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Regarding claim 9, this compound is embraced by instant Fomrula (II), wherein W, X and Y are C, Z is phenyl, R1 is C4 alkoxy and R2-R4 are hydrogen.
Regarding claim 10, this compound is embraced by formula IIa.
Regarding claim 66, Changunda teaches that the compounds above, was in a reaction with NaHCO3 (pages 144-146). Regarding the preamble of the instant claim “A pharmaceutical composition”, MPEP 2111.02(II) notes “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In this situation, the preamble is not considered limiting since it does not affect the structure of the compound of formula (I).
Claim(s) 9, 15-16 and 66 are newly rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by William et al (US 3082206 A, published March 19th, 1963).
William teaches the following compound (claim 2):
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Regarding claim 9, this compound is embraced by instant Formula (II), wherein W is N, X and Y are C, Z is phenyl substituted with NH2, R1 is -O-phenyl, R2 is absent, R3 is -O-phenyl and R4 is hydrogen.
Regarding claim 15, as seen above, R1 is -O-phenyl.
Regarding claim 16, as seen above, R3 is -O-phenyl.
Regarding claim 66, William teaches that the compound above, was in a reaction with water (Examples 1-10). Regarding the preamble of the instant claim “A pharmaceutical composition”, MPEP 2111.02(II) notes “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In this situation, the preamble is not considered limiting since it does not affect the structure of the compound of formula (I).
Allowable Subject Matter
Claims 17 and 18 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
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.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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