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 .1
Status of Claims
Claims 1-5,7-19 and 24-28 are pending.
Election/Restrictions
Claims 3-4,8-11,17 and 24-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention/Group II and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 20, 2026 (Group I) and species (June 12, 2026).
Applicant’s election without traverse of Group I in the reply filed on May 20th is acknowledged.
Applicant’s election of the compound species of formula I in the Telephone Interview and email forwarded to the Examiner on June 12th is acknowledged.
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2 (identified as Example 31 in the specification)
Because applicant did not distinctly and specifically point out the supposed errors when electing the species, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-2,5,7,12-16, 18 and 19 are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on December 7, 2023, August 1, 2025, and April 29, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
State of the Art
Note, the STN Structure Search by the USPTO STIC Search Professional dated on or about April 29, 2026 demonstrates the claimed TAK1 inhibitor compounds are free of the prior art.
The Examiner notes US 20220380382A1 (aka US Pub 382, the U.S. national stage of PCT/EP2020/067451), discloses macrocyclic kinase (EGFR) inhibitors. The International equivalent publication to US Pub 382, WO 2020260252, was cited on Applicant’s IDS dated December 7, 2023 (For. Ref. 3) and corresponding International Search Report (ISR) as reference D3. The ISR determined the claimed compounds were novel and possess inventive step over the compounds of D3 as follows.
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The ISR noted that D3 exemplifies macrocyclic kinase inhibitors in the state of the art, “However, they [the compounds of D3] have an additional ring integrated in the macrocycle and they target the kinase EGFR instead of TAK1.” See page 9 of the ISR.
Claim Rejections - 35 USC § 112 (Written Description)
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 1-2,5,7,12-16 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. --------------
The instant Application’s claims are directed to a compound of formula I,
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wherein R1, R2, R3, W1, W2, W3, Ring A, X and Y are broadly defined therein.
Claim 1 recites that Ring A is defined as a 6 membered aromatic ring or 5 to 6 membered heteroaromatic ring comprising 1 or 2 atoms selected from the group consisting of N, S and O;
X is defined as a linear C2-8-alkylene substituted with various groups, including the formation of spiro type rings with the carbons of X;
R1 is broadly defined as
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and R3 is broadly defined as
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Dependent claims 2,5,7,12-16 and 19 are similarly rejected as their scope is not supported by the specification.
The specification does not teach or disclose the full scope of the rejected
compound claims to demonstrate that the inventors had possession of the clamed
scope of compounds.
Examples 1-147 of the specification, at best, support a scope of compounds where
Ring A is phenyl or thiazole only;
R1 is hydrogen;
R3 is hydrogen and
X is substituted just once by methyl, ethyl or forms a cycloalkyl (spiro) with a carbon of X.
Examples 1-147 cannot support the claimed subject matter because the compounds of formula I are limited to the definitions of Ring A, R1, R3 and X detailed above.
Claim Rejections - 35 USC § 112
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 2 and 12-16 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 2 and 12-16 recite the term “preferably” and/or “more preferably” in the second to last line, or last line of each claim.
Regarding claims 2 and 12-16, the phrases “preferably” or “more preferably” render the claims indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
Allowable Subject Matter
Claim 18 is 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 and Correspondence
In summary no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 CONTINUING DATA
This application is a 371 of PCT/EP2022/067990 06/29/2022
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