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 .
Benefit of Earlier Filing Date
The instant application, filed 11 March 2024, claims the benefit of an earlier filing date to U.S. Provisional Patent Application Serial No. 63/496,815, filed 18 April 2023. Acknowledgment is made of Applicant’s claim.
Restriction/Election
Requirement for Restriction/Election was mailed 22 May 2026.
Applicant’s Response to Requirement for Restriction/Election was received 28 May 2026.
Applicant’s election of Group I (Claims 1-5) and Compound #2-18 [(S)-(6-chlorochroman-3 -yl)(1-(2-hydroxyethyl)-6-(3-methoxy-1H-pyrazol-4-yl)-1H-indol-3-yl)methanone], indicating claims 1-5 read on Compound #2-18, in the Response filed 28 May 2026 is acknowledged. Accordingly, the claims in Group II (Claims 6-10) are withdrawn.
Because Applicant did not distinctly and specifically point out the supposed errors in the Requirement for Restriction/Election, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 1-5 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 6-10, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 22 May 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Status of the Claims
The listing of claims filed 28 May 2026 has been examined.
Claims 1-10 are pending.
Claims 1-10 are amended.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 28 January 2025 is acknowledged and has been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology, specifically the term “comprising.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1 and 5 are objected to because of the following informalities:
Claim 1 recites, “…with one or more suitable substituents selected from OH, or OMe, OEt, OPri.” This appears to be a grammatical error. Examiner suggests amending to, “…with one or more suitable substituents selection from OH, OMe, OEt, and OPri.” [Emphasis added.]
Claim 1, when defining R2, recites, “…wherein heteroaryl, bicyclic heteroaryl has…” For clarity, Examiner suggests amending to, “…wherein the heteroaryl or bicyclic heteroaryl has…” [Emphasis added.]
Claim 5 recites, “…(6-Chlorochroman-3-yl)-[6-(3-chloro-1H-pyrazol-4-yl)-1-(2-hydroxyethyl)pyrrolo[3,2-b]pyridine-3-yl]methanone;;…” (p. 4, Compound 4). [Emphasis added.] Examiner suggests deleting the duplicate “;”.
Claim 5 recites, “…(6-Chlorochroman-3-yl)-[6-(3-chloro-1H-pyrazol-4-yl)-1-(2-hydroxyethyl)pyrrolo[3,2-c]pyridine-3-yl]methanone…” (p. 4, Compound 5). The “;” appears to be missing, so Examiner suggests adding a “;” after the compound name.
Claim 5 recites, “…(6-Fluorochroman-3-yl)(1-(2-hydroxyrthyl)-6-(3-methoxy-1H-pyrazol-4-yl)-1H-indazol-3-yl)methanone;;…” (p. 10, Compound 2). [Emphasis added.] Examiner suggests deleting the duplicate “;”.
Claim 5 recites, 2-(3-(6-Chlorochromane-3-carbonyl)-6-(3-methoxy-1H-pyrazol-4-yl)-1H-indazol-1-yl)acetonitrile…” (p. 10, Compound 4). The “;” appears to be missing, so Examiner suggests adding a “;” after the compound name.
Various compound names recited by claim 5 recite “1H”, but the “H” is only italicized in some instances. For consistency, Examiner requests “H” be italicized in all instances where “1H” is recited.
Appropriate correction is requested.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites R2 can be
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. However, claim 1 recites, “...the heteroaryl or bicyclic heteroaryl is optionally substituted with one or more suitable substituents selected from the group consisting of halogen, CN, CHF2, CF3, C1-C3alkyl, and amino…” [Emphasis added.] As indicated by the word “consisting,” claim 1 recites the possible R2 substituents are selected from a closed group, which fails to indicate the heteroaryl can have an alkoxy group substitution. Thus, claim 2 improperly expands the scope of claim 1 by reciting R2 can include an OMe substitution.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1-10 contain allowable subject matter. None of the prior art of record nor a search in the pertinent art area teaches a compound of Formula (I) or a pharmaceutically acceptable salt, diastereomer, enantiomer, racemate, hydrate, solvate, or prodrug thereof.
The following is a statement of reasons for the indication of allowable subject matter:
The claimed compound is:
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The closest prior art is CAS Registry Number: 1974852-21-5 (“CAS RN”) and JP2011507851 (IDS dated 28 January 2025, Cite No. 4). The structure corresponding to CAS RN and an exemplary compound disclosed by JP2011507851 are shown below:
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CAS Registry Number: 1974852-21-5
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JP2011507851 (p. 11, Compound 10)
The instantly claimed compounds differ from CAS RN and JP2011507851 in the following respects:
In the instantly claimed compounds, R2 is heteroaryl or bicyclic heteroaryl. However, CAS RN lacks a heteroaryl or bicyclic heteroaryl group in the location corresponding to R2.
In the instantly claimed compounds, a carbonyl is present between the two fused ring systems. However, the compounds disclosed by JP2011507851 lack a centrally-located carbonyl.
Thus, while CAS RN and JP2011507851’s compounds share some structural similarities with the instantly claimed compounds, a skilled artisan would not have been motivated to make the aforementioned changes as a whole to the structures which would have resulted in the instantly claimed compounds.
Conclusion
Claim 2 is rejected.
Claims 1 and 5 are objected.
Claims 2-3 are objected to for depending on an objected claim.
Claims 4 and 6-10 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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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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/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621