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 .
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.
Election/Restrictions
Applicant’s election without traverse in the reply filed on 3 March 2026, is acknowledged.
Applicants provided a compliant species election of:
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, wherein: X1 is S; R1 is
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; R2 and R3 are each H; “n” is 1; “Y” is N; R4 is -SO2-ethyl; Ra is H; and R5 is pyridine (a “heteroaryl”).
Applicants’ elected species has prior art.
Therefore, the Markush search will not be extended unnecessarily to additional species of genus formula I of claim 2.
The elected species reads on claims 2, 13-17, 19-27, and 31-36.
Claims 4, 6-7, and 37-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3 March 2026.
Current Status of 18/556,657
This Office Action is responsive to the amended claims of 3 March 2026.
Claims 2, 13-17, 19-27, and 31-36 have been examined on the merits. Claim 2 is currently amended. Claims 13-17, 19-27, and 31-36 are previously presented.
Priority
The effective filing date is 23 April 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3 March 2026; 5 March 2025; 20 August 2024; and 1 February 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claims 31-34 and 36 are 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.
Dependent claim 31 adds a limitation “or a pharmaceutically acceptable salt thereof” which is not seen in parent claim 2. Therefore, the scope of claim 31 is different (more broad) than that of parent claim 2 and hence claim 31 does not narrow the scope of parent claim 2. Thus, claim 31 is rejected under 35 USC 112(d).
Claims 32-34 and 36 are similarly rejected as these claims refer back to claim 31 but do not remedy the rationale underpinning the basis for rejecting claim 31.
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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2, 13, and 31-36 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by:
PATEL (WO 2021/127643 A1, provided by Applicants and referenced in IDS of 1 February 2024). Although published on 24 June 2021, which is after the instant application’s effective filing date of 23 April 2021, this reference is effectively filed 20 December 2019, which is before the instant application’s effective filing date of 23 April 2021.
The applied reference has a common inventor (Mandegar, Mohammad A.) and assignee (Tenaya Therapeutics) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The prior art reference PATEL, which is “by another”, teaches the compound I-6:
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(page 226; see, also, Example 4 page 142), or a pharmaceutically acceptable salt thereof (para [0005]), which maps to the instant claim 2 genus formula I in the following manner: R1 is
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; X1 is S; “n” is 1; Ra is H; R2 and R3 are each H; “Y” is N; R4 is -S(O)2-ethyl; R5 is pyridyl (a “heteroaryl”).
Furthermore, PATEL teaches a method of use thereof to treat (para [0004]) dilated cardiomyopathy (para [0012]) in a subject by administering to the subject a therapeutically effective amount of said compound (para [0004] and “Abstract”). The PATEL reference describes the compound, above, as an HDAC6 inhibitor (see “Abstract”). This anticipates instant claims 2, 31-34, 35 (first row left cell page 9), and 36.
The Examiner interprets “dilated cardiomyopathy”, above, as inclusive of “familial dilated cardiomyopathy” thereby anticipating instant claim 13.
Conclusion
Claims 14-17 and 19-27 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.
Claims 2, 13, and 31-36 are not presently allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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