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 1, 10, 13, 16, 17, 20, 22, 25, 26, 29-31, 33, 34, 37, 39, 42, 45, 48, 50-53, 57, 60, 61, 63, 64, 67, 68 and 69 are pending in the application. Claims 1, 10, 22, 25, 45, 48, 50 and 64 are rejected. Claims 1, 10, 16, 17, 22, 25, 45, 48, 50 and 64 are objected to. Claims 63 and 69 are allowed. Claims 13, 20, 26, 29-31, 33, 34, 37, 39, 42, 51-53, 57, 60, 61, 67 and 68 are withdrawn.
Restriction/Election of Species
Applicant’s election without traverse of Group I, claims 1, 10, 13, 16, 17, 20, 22, 25, 26, 29-31, 33, 34, 37, 39, 42, 45, 48, 50-53, 57, 60, 61, 63, 64, 67 and newly added claim 69, and the following further elected species in the reply filed on February 13, 2026 is acknowledged (note: canceled claim 32 was improperly included in Group I in the Restriction Requirement mailed December 16, 2025):
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Claims 1, 10, 16, 17, 22, 25, 45, 48, 50, 63, 64 and 69 read on Applicant’s elected species. Claims 13, 20, 26, 29-31, 33, 34, 37, 39, 42, 51-53, 57, 60, 61, 67 and 68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Note: although Applicant asserts otherwise (see page 31 of Applicant’s Remarks dated February 13, 2026), claim 13 does not read on Applicant’s elected species and is, therefore, withdrawn by the Examiner. Election was made without traverse in the reply filed on February 13, 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 which is NOT allowable:
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Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/EP2022/057820, filed on March 24, 2022, which claims priority to UK Application No. GB2104097.7, filed on March 24, 2021.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on September 20, 2023, December 19, 2025 and January 26, 2026 are 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
Claim 1, 10, 16, 17, 22, 25, 45, 48, 50 and 64 are objected to because of the following informalities:
Claim 1 should be amended to replace the word “include” in the instances shown below with the word “with” for sake of consistency.
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Claim 1 should be amended to replace “C3-6 heterocycloalkyl” in the instances shown below with “C3-C6 heterocycloalkyl” for sake of clarity and consistency.
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Claim 1 should be amended to cancel the word “and” where indicated below for proper Markush language.
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Claim 1 should be amended to include the word “and” before “C2-C6 alkyne” in the second line of the following:
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Claims 10, 16, 17, 22, 25, 45 and 48 should be amended to replace “The compound, stereoisomer, tautomer, hydrate, N-oxide derivative or pharmaceutically acceptable salt of claim 1” with “The compound of claim 1 or a stereoisomer, tautomer, hydrate, N-oxide derivative or pharmaceutically acceptable salt thereof” for sake of clarity and consistency.
Claim 17 should be amended to include a period at the end of the claim.
Claim 50 should be amended to replace “The compound, stereoisomer, tautomer, hydrate, N-oxide derivative or pharmaceutically acceptable salt of claim 48” with “The compound of claim 48 or a stereoisomer, tautomer, hydrate, N-oxide derivative or pharmaceutically acceptable salt thereof” for sake of clarity and consistency.
Claim 64 should be amended to replace “a compound according to claim 1” with “the compound according to claim 1” 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 1, 10, 16, 17, 22, 25, 45, 48, 50 and 64 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.
Claim 1 does not define the dotted lines present within the claimed generic compound of formula (I) (partially reproduced below) and is, therefore, rejected as indefinite.
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It is suggested Applicant amend claim 1 to recite a definition(s) for the dotted lines. For instance, see page 26, line 20 of the instant specification for support. For the purposes of examination, a dotted line depicted between two vertices (e.g., A and D, D and E, E and G, etc.) within the instantly claimed compound of formula (I) is being interpreted as a single bond, a double bond, or being absent. Dependent claims 10, 16, 17, 22, 25, 45, 48, 50 and 64 do not correct this issue of indefiniteness and are hence rejected.
Claim 10 recites “wherein the heterocycle” and is rejected as indefinite. It is unclear whether Applicant intended “the heterocycle” to be in reference to a) the “C3-C9 heterocycle” recited hitherto in the claim; b) the amino-thietane dioxide recited hitherto in the claim; or c) an unrecited and undefined heterocycle. Regarding interpretation a), it is further unclear whether Applicant intended the “C3-C9 heterocycle” to be limited by either of the two recited list of alternatives in the claim or both recited list of alternatives (i.e., further substitution).
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 1, 10, 22, 25, 45, 48, 50 and 64 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by CAS Registry No. 2380140-66-7 (entered STN on November 20, 2019).
CAS Registry No. 2380140-66-7 corresponds to the following chemical structure:
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Regarding instant claims 1, 10, 22, 25, 45, 48, 50, the above prior art structure is encompassed by variable definitions of the instantly claimed compound of formula (I), wherein R0 is H; R1 is NRaRb and wherein Ra and Rb together form an optionally substituted C6 heterocycle together with the N to which they are attached; R2 is H; R3 is H; X is C; Y is C; Z is N; M is CH; A is CH; D is CH; G is CH; and E is CH.
Regarding instant claim 64, the prior art teaches the above compound in unbuffered water (i.e., a pharmaceutically acceptable carrier or diluent).
Allowable Subject Matter
Claims 63 and 69 are allowable over the prior art. Claims 16 and 17 would be allowable if a) rewritten in independent form including all of the limitations of the base claim and any intervening claims and b) amended to address the claim objections and 35 U.S.C. § 112 issues as discussed above.
Conclusion
Claims 1, 10, 22, 25, 45, 48, 50 and 64 are rejected. Claims 1, 10, 16, 17, 22, 25, 45, 48, 50 and 64 are objected to. Claims 63 and 69 are allowed. Claims 13, 20, 26, 29-31, 33, 34, 37, 39, 42, 51-53, 57, 60, 61, 67 and 68 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST.
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/D.M.S./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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