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 .
Application Status
The preliminary amendment filed on 12/17/2025 is acknowledged. Claims 1-2, 4, 6-7, 11, 15, 18, 20-22, 24-29, 35 and 47 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 7/18/2024 is acknowledged and has been considered except wherein lined through.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-2, 4, 6-7, 11, 15, 18, 20, 22, 24-29 and 35 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hansoh Bio LLC (WO2023072197A1, 2023-05-04 priority to US63263108 filed 2021-10-27).
Hansoh Bio LLC teach piperidinyl indole derivatives, pharmaceutical compositions comprising the compounds and pharmaceutical uses for the treatment of disease or disorders mediated by complement activation (Abstract). With regards to the disease or disorders mediated by complement activation, the WO document teaches that the disease or disorders include, but are not limited, age-related macular degeneration, diabetic retinopathy and macular edema (page 30, lines 10 to page 31, line 16). With regards to the piperidinyl indole derivatives, Hansoh Bio LLC teach that the compounds include, but are not limited to,
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, which read on the instant claims when X is CRX1RX2, RX1 and RX2 are F, R1 is C1-C6 alkoxyl, R2 is a C1-C6 alkyl, A is a phenyl, R5 is -CO2R5b, R5b is H, m is either 0 or 1 and n is either 0, 1 or 2 (see compounds on page 20+).
Note: The examiner did their best to determine the compounds within the priority document and should not be construed as limited to compounds which read on the claims and not identified.
Claim(s) 1-2, 4, 6-7, 11, 15, 18, 20-22, 24-29, 35 and 47 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chinook Therapeutics Inc (WO2022256586A2, 2022-18-08, IDS priority to US63196339 and US63290019 filed on 2021-06-03 and 1021-12-15).
Chinook Therapeutics teach substituted indole compound, wherein the compounds are inhibitors of the alternative pathway of the complement system, in particular, inhibitors of complement factor B (CFB) (Abstract). With regards to the substituted indole compounds, Chinook teaches that the substituted indole compounds include, but are not limited to,
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wherein the compounds read on the instant claims which read on the instant claims when X is O or CRX1RX2, RX1 and RX2 are F, alkyl, H or OH or RX1 and RX2 together for a ring, R1 is C1-C6 alkoxyl, R2 is a C1-C6 alkyl, A is a phenyl, R5 is -CO2R5b, R5b is H, m is 1 and n is either 0, 1 or 2 (see paragraph 000181 and 000182). Moreover, the WO document teaches pharmaceutical compositions comprising the substituted indole compound in combination with a pharmaceutically acceptable carrier, wherein the composition can further comprise an additional antibacterial or antifungal agent (paragraph 000310 and 000320). The WO document further teaches of method of treatment of diseases or disorders that are mediated by or otherwise affected via complement factor B (CFB) including, but not limited to, age-related macular degeneration, diabetic retinopathy and macular edema (paragraph 000328).
Note: The examiner did their best to determine the compounds within the priority documents and should not be construed as limited to compounds which read on the claims and not identified.
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626