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 .
Election/Restrictions
Applicant's election of Group II and compound 112 in the reply filed on 01/07/2026 is acknowledged. Applicant does not specifically point out supposed errors in the election of species requirement, which is treated herein as election without traverse. Regarding the restriction requirement, Applicant argues that the alleged lack of unity is obviated by amendments made to the claims, wherein claims 1 and 19-30 have been cancelled and claims 2-18 have been amended to recite a method of promoting wound repair in the heart. Per MPEP 818.02(c), “Where applicant claims two or more independent or distinct inventions and as a result of amendment to the claims, he or she cancels the claims to one or more of such inventions, leaving claims to one invention, and such claims are acted upon by the examiner, the claimed invention thus acted upon is elected.” The invention of claims 2-18 is therefore treated as the elected invention, as Applicant has cancelled claims corresponding to the invention of Group I. Additionally, while the scope of the elected invention has been amended by Applicant, this does not obviate Examiner’s arguments of lack of unity because the intended use of the compounds is not a shared technical feature between the inventions between which restriction was required.
Claims 4, 12-14, and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 2, 3, 5-11, 15, 16, and 18 are examined herein.
Priority
Examiner acknowledges that, according to the Filing receipt received 06/26/2024, that the instant application 18/546,217 filed 08/11/2023 is a 371 of PCT/US2022/70631 filed 02/11/2022 which claims benefit of U.S. provisional application 63/148,868 filed 02/12/2021. All of the claims have been awarded the effective filing date of 02/12/2021.
Information Disclosure Statement
The Information Disclosure Statement filed on 01/07/2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Claim Objections
Claim 2 is objected to because of the following informalities:
“which compound is” should read “wherein the compound is”;
The presence or absence of dashes before alternative substituents is inconsistent (“C1-C6-alkyl” vs “-(C1-C6-alkyl)-S-(C1-C6-alkyl)”);
On page 3, the following limitations are missing a closed parenthesis:
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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 2, 3, 5-11, 15, 16, and 18 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 2 recites multiple limitations that state “wherein 1-4 heteroaryl members are independently selected from N, O, and S” or “wherein 1-4 heterocycloalkyl ring members are independently selected from N, O, and S”. These limitations cause confusion as it is unclear whether (i) the heteroaryl/heterocycloalkyl only contains 1-4 heteroatoms, or (ii) the heteroaryl/heterocycloalkyl contains 1-4 heteroatoms selected from N, O, and S but can have other heteroatoms that are not N, O, or S. Clarification is required. Claims 3, 5-11, 15, 16, and 18 similarly recite and/or do not clarify the limitation at issue and are also rejected.
Claim 2 recites “form a fused C6-C10-aryl or 5- to 10-membered heteroaryl”. It is unclear whether the carbon/member count of the “fused” ring includes ring A, that a C6-C10-aryl or 5- to 10-membered heteroaryl is fused to A, or that the ring formed by R1 and R2 itself is fused in addition to being fused to ring A. Clarification is required.
Claim 2 recites “any alkyl, aryl, cycloalkyl, heteroaryl, and heterocycloalkyl is optionally substituted by… oxo”. However, aryl and heteroaryl cannot be substituted by oxo without losing aromaticity. Clarification is required.
Claim 2 recites “any alkyl, aryl, cycloalkyl, heteroaryl, and heterocycloalkyl is optionally substituted by” and “each aryl and heterocycloalkyl is optionally substituted with” and “each alkyl is optionally substituted with”. The presence of multiple definitions of substituents causes confusion. Additionally, it is unclear whether these definitions pertain to all or only some of R, R1, R2, R3, R4, RA, and/or RB. For example, the limitation “any alkyl, aryl, cycloalkyl, heteroaryl, and heterocycloalkyl is optionally substituted by” is located after the definition of R3 and R4 is set forth, but it is unclear whether this limitation also pertains to R, R1, and R2. Clarification is required.
Claims 5, 7, and 8 recite that R3 or R1 is “optionally substituted”. This limitation lacks antecedent basis because (i) it is unclear what the optional substituents are as in the above rejection, and (ii) the limitation “optionally substituted” is broader in scope than any of the lists of defined substituents as in claim 2. Claim 6 depends on claim 5 and is similarly rejected. Claim 9 depends on claim 8 and is similarly rejected. Correction is required.
Claim 15 recites “R1 is optionally substituted phenyl or 5-to-6-membered heteroaryl… with one to three substituents independently selected from…” and “R3 is optionally substituted… which optional substitution is…”. The substituent “optionally substituted phenyl” listed for R1 is not supported by claim 2. Additionally, it is unclear whether the other substituents listed in claim 15 are within the scope of claim 2 since multiple definitions for substituents of alkyl, aryl, and heterocycloalkyl are set forth in claim 2 that recite different substituents. Claim 16 depends on claim 15 and is similarly rejected. Correction is required.
Claim 18 recites the following compounds which are not within the scope of claim 2 and lack antecedent basis.
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Compound 108 depicts a substituent in R1 that is neither aryl nor heteroaryl. Compound 131 contains a heteroalkyl group substituted by heteroaryl in the R3 position. Compound 132 depicts R3 and R4 forming a heterocycloalkyl substituted by -NHC(O)-heteroaryl. Compound 149 contains a hydrogen in the R1 position and R3 is substituted by alkyl. Compound 144 contains an aryl group in the R3 position substituted by heterocycloalkyl. Compound 150 contains a moiety in the A position that is not listed in claim 2. Compound 152 contains a moiety in the A position not listed in claim 2 and R3 is substituted by alkyl. The limitations are not supported by formula (I) as in claim 2. Correction is required.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2, 3, 5-11, 15, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tait et al. (WO 2014/210159 A1; IDS filed 01/14/2026 and previously cited) in view of Uramoto et al. (Cell Physiol Biochem; 2012).
Tait et al. discloses the following compound (Compound 13; p. 16 and 111) which is identical to the elected compound 112.
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Tait et al. discloses that the above compound increases cystic fibrosis transmembrane conductance (CFTR) activity (p. 2, p. 100). Tait et al. teaches that the compounds can be used to treat dysfunction in proteostasis such as cardiovascular disease, cardiomyopathy, and impaired wound healing (p. 81).
Tait et al. does not teach a method of promoting wound healing in a subject. However, this limitation is obvious in view of Uramoto et al.
Uramoto et al. teaches that CFTR activators reduce the size of myocardial infarction in mice and ameliorate the release of myocardial-specific creatine kinase isoenzyme in vivo (Abstract, Results). Additionally, Uramoto et al. discloses that necrotic death of rat ventricular myocytes is ameliorated by CFTR activators (Abstract, Results).
As Applicant has not provided a special definition for “promoting wound healing”, the limitation has been afforded its broadest reasonable interpretation such that any effect afforded by the administration of an effective amount of the claimed compound that results in amelioration of damage or symptoms thereof is within the scope of the claims.
Therefore, it would be prima facie obvious for one of ordinary skill in the art to administer the compound of Tait et al. for the promotion of wound healing in the heart. One would have been motivated to do so, with reasonable expectation of success, as the above compound is known to enhance the activity of CFTR. As disclosed by Uramoto et al., CFTR activators have been demonstrated to ameliorate myocardial infarction and necrosis of heart tissue. One of ordinary skill in the art would therefore be apprised that the compound of Tait et al. would afford similar results due to its common function.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.E.B./Examiner, Art Unit 1624 02/04/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624