DETAILED ACTION
This office action is in response to applicant’s filing dated April 30, 2026.
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 .
Status of claims
Claims 1 -20 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1 – 19, drawn to a compound of Formula (I) and a pharmaceutical composition thereof, in the reply filed on April 30, 2026 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 30, 2026.
Since written response to restriction/election requirement, filed on April 30, 2026 was incomplete as it did not contain the election of species, a provisional species election was made during a telephone conversation with Qionghua Weng on May 13, 2026, election was made without traverse to prosecute the invention of species, compound ex. 1:
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, claims 1, 2, 6 – 11, 13 – 15 and 17 - 19. Affirmation of this election must be made by applicant in replying to this Office action. Claims 3 – 5, 12 and 16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Upon performing the search of prior art Examiner detected compounds related to non-elected species. Hence, the examination will be expanded to include non-elected species compound of Formula (III).
Claims 1, 2, 6 – 11, 13 – 15 and 17 – 19 are under consideration in the present office action, as being related to an elected species, compound ex. 1 and expanded species, compound of Formula (III).
Priority
The present application is a CON of PCT/CN2022/135152, filed on November 29, 2022, which the benefits of priority to Chinese Patent Application No. 202210307006.8, filed on March 25, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/28/2024, 04/12/2024 and 06/26/2025 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 § 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.
Claims 1, 2, 6 – 11, 13 – 15 and 17 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 2024/0216357 A1, cited in IDS, filed 06/26/2025).
Instant claims are drawn to a compound of Formula (I)
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, such as a compound of Formula (II):
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or (III):
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, where X is N; X1, X2, X3, and X4 are respectively C or N, X1 is different from X2, X1 is different from X4, and X2 is different from X3; R3 is C6-10 aryl, unsubstituted or substituted with 1 – 4 R", R" is H, deuterium, F, Cl, Br, -ORa (Ra is H, C1-6 alkyl); R4 is H, deuterium, F; ring A is a heterocyclic ring composed of 3-6 atoms; ring B is a bridge ring composed of 6-8 atoms; m is 0 – 5, R’ is -NRbRc (Rb, and Rc are independently H, deuterium, C1-6 alkyl). One of the exemplary compounds of Formula (II) is
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(ex. 1). The compounds of instant claims act as Lysine specific demethylase 1 (LSD1) inhibitors. Instant claims are further drawn to a pharmaceutical composition comprising an effective amount of a compound of Formula (I).
Chen teaches compound of formula (I-1b)
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, where fragment
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is
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, (page 6, [0053] and [0054]), m=0; ring B is
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or e.g.
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(page 20, [0222]); R1 and/or R2 is
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and
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(page 23, [0235]). Exemplary compounds taught by Chen are:
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(page 120. Ex. 117) or
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(page 132, ex. 169). The compounds, taught by Chen are capable to inhibit Lysine specific demethylase 1 (LSD1). Chen further teaches a pharmaceutical composition comprising therapeutically effective amount of the above compounds or the tautomer, the mesomer, the racemate, the enantiomer, the diastereoisomer, or the mixture thereof, or the deuterated isotope derivative (page 57, [0243]). Although the exemplary structures of compounds taught Chen are not identical to instantly claimed exemplary structures, they represent positional isomers, where identical structural fragments occupy different positions of the molecular core, and presented herein for illustrative purposes (see examples above).
Thus, since Chen teaches compounds of equivalent and similar structure and functionality as instantly claimed compounds, where all structural elements, taught by Chen, are equivalent to the same of instantly claimed compounds, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify known compounds and make various structural analogs, by selecting known structural fragments and combining them with known core, to arrive at claimed compounds. The one of ordinary skills would be motivated to do so in search of an active agent, Lysine specific demethylase 1 (LSD1) inhibitor, possessing improved desired properties, with the reasonable expectation of success.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
Claims 1, 2, 6 – 11, 13 – 15 and 17 – 19 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691