DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application claims priority to US Provisional Application No. 63/392,611 file on 07/27/2022 and is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on: 12/10/2025, 06/26/2025, 05/09/2024, 03/13/2024, 02/09/2024, 12/19/2023, and 10/11/2023 was filed prior to the mailing of the instant first Office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. A copy of Form PTO/SB/08 is attached to the instant Office action.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 – 4, 6-9, 12-13, 16, 18-19, 22, 24-25 and 44) drawn to compounds of Formula I in the reply filed on April 29, 2026 is acknowledged.
Claims 26, 43 and 46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (drawn to compounds of Formula II) and Group IV (a method of treating an inflammatory disease, neuronal disease or neurodegenerative disease at least partially mediated by ferroptosis, comprising administering to a subject in need thereof and effective amount of a compound of claim 26 comprising administration of Formula II), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 29th, 2026. Hence claims 1 – 4, 6-9, 12-13, 16, 18-19, 22, 24-25 and 44 are being examined on the merits herein.
Claim 45 was amended and claims 47-49 have been submitted with no new matter.
Applicant has cancelled claims 26, 43, and 46 in response to restriction (04/29/26) and is acknowledged.
New claims 47-49 would be included in group 3 and would be distinct for the reasons given in the restriction requirement 1/29/26. Therefore, 45 and 47-49 will be withdrawn.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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) 1-4, 6-8, 12-13, 16, 18-19, 22, 24-25 and 44 is/are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Rinsch et al. (WO 2022/162471 A1).
Claim 64 of the prior art discloses the compound core structure of Formula 1 of the instant claims and reads on claims 1-4, 6-8, 12-13, 16, 18-19, 22 and 24-25 where:
Formula 1: Claim 64 (pdf pg. 229):
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R3/R6 (instant claim 2, 7-8 and 16) are alkyl or (instant claims 12-13 and 16) as cycloalkyl (as in reference claim 64);
Y1/Y2 (instant claim 3-4 and 6) are alkyl or cycloalkyl (as in reference claim 64);
R2/R7 (instant claims 18-19, and 22) are -OH, -NH2, alkylamino and -OR10 (as in reference claim 64);
R1/R4/R5/R8 (instant claim 24) are -H (as in reference claim 64).
Regarding claim 44, and where the instant claim comprises a pharmaceutically acceptable carrier. Rinsch et al, discloses (pdf pg. 17, ¶4) where both the primary art and the instant specification uses identical common language to define the phrase “pharmaceutically acceptable carrier” to be “…acceptable material, composition or vehicle, such as a liquid or solid filler, diluent, excipient or encapsulating material, involved in carrying or transporting the subject chemical from one organ or portion of the body, to another organ or portion of the body”.
Claim(s) 1-4, 6-8, 12-13, 16, 18-19, 22, 24-25 and 44 is/are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Sun & Cama (WO 2004/073612 A2)
Claim 1 of the prior art discloses the compound core structure of Formula 1 of the instant claims and reads on claims 1-4, 6-8, 12-13, 16, 18-19, 22 and 24-25 where:
Formula 1 (instant claim): Sun & Cama:
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R3/R6 (instant claim 2, 7-8 and 16) are alkyl or (instant claims 12-13 and 16) as cycloalkyl (as in reference claim 1);
Y1/Y2 (instant claim 3-4 and 6) are alkyl or cycloalkyl (as in reference claim 1);
R2/R7 (instant claims 18-19, and 22) are -OH, -NH2, alkylamino and -OR10 (as in reference claim 1);
R1/R4/R5/R8 (instant claim 24) are selected from -H and halogen (as in reference claim 1).
Regarding claim 44, and where the instant claim comprises a pharmaceutically acceptable carrier. Sun & Cama disclose (pdf p.16-17, lines 28-04 ) where both the instant specification and the prior art define a pharmaceutically acceptable carrier as diluents, adjuvants, tablets, capsules and water.
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.
Claim 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rinsch et al. (WO 2022/162471 A1).
Rinsch et al. teaches where R2 and R7 can be independently selected from H, OH, OCH3, OAc, NH2, halogen, CN, CF3, CO2H2, NO2, NHAc, alkyl, haloalkyl, alkenyl, alkynyl, cycloalkyl, heterocycloalkyl, alkylamino, alkyl-R9, alkynyl0R9, OR10, NHR10, NR11C(o)R12, C(O)NR11R12, and NR11SO2R12 from the following reference of claim 64 (pdf pg 229). Claim 25 (instant claims) discloses an embodiment where R2= Hydroxy and R8= NH2. While Rinsch et al. does not specifically teach where R7 (R8 of the instant claim) as NH2, claim 64 (of the prior art) is a compound selected from a compound of Claim 55 (reference claims, pdf p225) where either of the R2 or R7 positions can be “are independently selected from H, OH, OCH3, OAc, NH2…”.
Instant claim 25: Reference claim 64:
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While Rinsch et al. does not expressly teach the herein claimed compound, it would be obvious for a person of ordinary skill in the art to substitute either side of the R2 or R7 (R2/R8 of the instant claims) positions, where any of the compositions could include H, OH, OCH3, OAc, NH2, etc (as listed in prior art claims) and it would be reasonable to expect that the resulting compounds would have the same functions as in the prior art because it is known and common to use bioisosteric replacements to optimize drug-target interactions.
Summary of the claims
Claim(s) 1-4, 6-8, 12-13, 16, 18-19, 22, 24-25 and 44 are pending.
Claim(s) 1-4, 6-8, 12-13, 16, 18-19, 22, 24-25 and 44 are rejected.
Claims 26, 43, and 46 are cancelled.
New claims 45 and 47-49 will be withdrawn.
No claims are in condition for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVE DROUIN whose telephone number is (571)272-5426. The examiner can normally be reached Monday- Friday 7:30am-5:00pm.
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/S.H.D./Examiner, Art Unit 1627
/SAN MING R HUI/Primary Examiner, Art Unit 1627
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