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 .
Priority
This application, filed 22 June, 2023, is a national stage application of PCT/CN2021/139649, filed 20 December, 2021, which claims foreign benefit of Application CN202111165942.1, filed 30 September, 2021, Application CN202110930084.9, filed 13 August 2021, Application CN202110749304.8, filed 1 July, 2021, and CN202011568684.7, filed 25 December, 2020.
Information Disclosure Statement
One information disclosure statement (IDS) submitted on 2 December, 2025 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 2 March, 2026, in the matter of Application N° 18/269,065. Said documents have been entered on the record.
Claim 1 is amended. No new matter was introduced.
Thus, Claims 1-14 represent all claims currently under consideration.
Terminal Disclaimer
The terminal disclaimer filed on 2 March, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 12,459,940 has been reviewed and is accepted. The terminal disclaimer has been recorded. The rejections of Claims 1-5 and 7-14 under nonstatutory double patenting have been withdrawn.
Response to Amendment
Applicant’s amendment to independent claim 1 has been considered. Specifically, Applicant revised the claim to insert the conjunction “and” between the limitation reciting that T1-T5 are independently selected from CH and N and the limitation reciting that the structural unit is selected from a set of enumerated species.
This amendment does not overcome the rejection as the claim continues to recite a genus defined by T1-T5, which encompasses a plurality of possible structures, while further reciting that the same structural unit is selected from a limited set of specific species. It remains unclear whether the claim is directed to the full genus defined by the variable substitutions or is limited to the enumerated species. The mere addition of the conjunction “and” does not resolve this ambiguity, as the claim still presents inconsistent scope by reciting both a broad genus and a narrower species selection for the same structural unit.
Therefore, the rejection under 35 U.S.C. § 112(b) is maintained.
Claim Rejections - 35 USC § 112 (MAINTAINED)
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.
Claim 1-9 and 13-14 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 1 recites the broad recitation “T1, T2, T3, T4 and T5 are independently selected from CH and N”, and the claim also recites “the structural unit
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is selected from
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” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-9, which depend upon Claim 1, and Claims 13-14 which also rely upon it, fail to cure the deficiencies as stated above.
Allowable Subject Matter
Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 10-11 are 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.
Claim 12 is allowed.
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The closest prior art appears to be Gummadi et al. (WO 2015/193846 A1, cited in IDS), which teaches substituted indazole compounds as IRAK4 inhibitors, such as Example 1 (‘846, Pg.49-51, Example 1), shown to the right, which overlaps the instantly claimed Formula IV, but differs in: (i) the position of heteroatoms within the bicyclic ring, (ii) a substituted T3, and (iii) R3 substituents.
Although additional references of record, such as those found in the related International Search Report, disclose compounds or compositions which are structurally similar, each – including Gummadi – still diverge in multiple substantive structural features (e.g., at least three substituent positions), such that the claimed compounds cannot be rendered obvious.
Conclusion
THIS ACTION IS MADE FINAL. 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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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627