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
Claims 55-76 are pending in the application. Claims 55-60, 62 and 65-73 are rejected. Claims 55, 67 and 73 are objected to. Claims 61, 63, 64 and 74-76 are withdrawn.
Restriction/Election of Species
Applicant’s election without traverse of Group I, claims 55-73, and further elected species of “Compound 16” having the structure below in the reply filed on April 14, 2026 is acknowledged.
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Claims 61, 63, 64 and 74-76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 14, 2026.
As per MPEP § 803.02(III), the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species appears to be free of the prior art. Therefore, according to MPEP § 803.02(III): should the elected species be found allowable over the prior art, the examination of the Markush claim will be extended. The prior art search will be extended to cover non-elected species or group of species that fall within the scope of a proper Markush grouping which includes the elected species. The prior art search will not be extended unnecessarily to cover all nonelected species, and need not be extended beyond a proper Markush grouping. However, if prior art is found that anticipates or renders obvious the Markush claims with respect to a nonelected species, the Markush claims shall be rejected and claims to the nonelected species held withdrawn from further consideration. Consequently, the prior art search was extended to include the following non-elected species:
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Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/022524, filed on March 30, 2022, which claims benefit of Provisional Application No. 63/168,548, filed on March 31, 2021.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on April 14, 2026 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Claim Objections
Claims 55, 67 and 73 are objected to because of the following informalities:
Claim 55 should be amended to recite the expression “a pharmaceutically acceptable salt thereof” preceding the wherein clause for variable definitions (i.e., but after the recited generic formula). The aforementioned expression which is currently recited at the end of the claim should subsequently be canceled.
Claim 55 should be amended to recite, “...wherein Ar2 is phenyl or six membered heteroaryl wherein the phenyl and six membered heteroaryl are optionally substituted with one to three halo...” for sake of clarity. See page 3 of 10.
Claim 55 should be amended to recite, “...heterocyclylamino (wherein the heterocyclyl ring in heterocyclyl, heterocyclyloxy, and heterocyclylamino is optionally substituted with Ri, Rj and/or Rk each independently selected from...” for sake of clarity and consistency. See page 3 of 10.
Claim 55 should be amended to cancel the word “and” appearing immediately after the recited definition for variable “R4” for proper Markush language.
Claim 67 should be amended to replace “-P(=O)(Ra)(Rb)is” with “-P(=O)(OH)2 is” for sake of consistency and clarity.
Claim 67 should be amended to recite, “...attaching the phenyl ring to the remainder of Formula (Ic), (Ie), [[and]] or (Ig)” for sake of clarity and consistency (i.e., claim is drawn to a single compound).
Claim 73 should be amended to recite, “[[a]] the compound of claim 55” for sake of consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION — The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 56-60, 62 and 65-73 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 56-58 and 60 each recite the expression “having a structure” and are rejected as indefinite. The term “having” is open-ended; therefore, it is unclear what additional, unrecited elements- if any- Applicant intended claims 56-58 and 60 to encompass. It is suggested Applicant replace the aforementioned open-ended expression in each of claims 56-58 and 60 with a closed-ended transitional phrase which limits each claim to the recited formula/structure. Dependent claims 59, 62 and 65-73 do not correct this issue of indefiniteness and are hence rejected.
Claim 68 recites the limitation “alk1” and is rejected as indefinite. There is insufficient antecedent basis for this limitation in claim 68 as parent claim 58 is drawn towards Formulas (Ic), (Ie), and (Ig), wherein “alk1” is absent in each formula. It is suggested that Applicant cancel the aforementioned limitation from the claim to overcome this issue of indefiniteness.
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.
Claims 55, 56 and 73 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Li et al. (PCT Publication No. WO 2019/051269 A1; March 14, 2019).
Li et al. teach Compound No. 68 having the following chemical structure on e.g., page 44:
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Regarding instant claim 55, the above prior art Compound No. 68 is encompassed by variable definitions of the instantly claimed compound of Formula (I), wherein ---- is a bond between y and z; b and e are N, and d is C; R3 and R4 are independently absent; x is NH; z is N; y is CH; R5 is absent; R6 is absent; G is a bond; n is 0; Ar is heterocyclyl; R1 and R2 are independently absent; alk1 is alkylene; m is 1; and Ra and Rb are each hydroxy.
Regarding instant claim 56, the above prior art Compound No. 68 is encompassed by variable definitions of the instantly claimed compound of Formula (Ib), wherein ---- is a bond between y and z; b and e are N, and d is C; R3 and R4 are independently absent; x is NH; z is N; y is CH; R5 is absent; R6 is absent; G is a bond; Ar is heterocyclyl; R1 and R2 are independently absent; alk1 is alkylene; and Ra and Rb are each hydroxy.
Regarding instant claim 73, Li et al. teach “combining the subject compound with a pharmaceutically acceptable carrier or diluent.” See e.g., paragraph [00215].
Allowable Subject Matter
Claims 57-60, 62 and 65-72 are free of the prior art and would otherwise be allowable if amended to overcome the claim objection(s) and/or rejection(s) under 35 U.S.C. § 112 discussed above and rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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