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 .
DETAILED ACTION
Claims 1-11, 16-19, 21, 23-24, and 26-27 are pending in the instant application.
Claims 3-7, 9-11, 16-19, 21, 23-24, and 26-27 are withdrawn.
Claims 1, 2, and 8 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 63/048829, filed on 07 July 2020, and PCT/US2021/040637, filed on 07 July 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 07 July 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 20 January 2023, 16 July 2024, ,25 July 2024, 10 September 2024, 30 April 2025, and 04 August 2025, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 05 November 2025 has been entered.
With respect to the 103 rejection, Applicant amendment has been considered but is not found persuasive for at least the following reasons. Applicant argues that no explanation was set forth as to why one skilled in the art would be guided to modifying the compounds of Rawat. As set forth in the previous office action and reproduced below, both Rawat and the instant invention share utility as Nurr1 agonists, this would immediately guide the skilled artisan to the work of Rawat. Additionally, reference compound A of Rawat needs one modification to arrive at the instantly claimed compound; the chloro substituent at R11 needs to be modified to an ethyl piperazine substituent. This substituent is already seen at R10 of reference compound A, so the skilled artisan would be guided to this substituent as it is already found within a preferred embodiment. As to why the skilled artisan would choose to have R10 and R11 as the same substituent, in looking at reference compound B, where R10 and R11 are the same substituent, the skilled artisan would be motivated to make the modification to reference compound A where R10 and R11 would be the same. Applicant further argues that the instant compounds show and EC50 value ten times lower than that of chloroquine and that this result could not have been expected from the work of Rawat. Examiner respectfully disagrees as Rawat reports EC50 values one-tenth of chloroquine (paragraph [0036]). For these reasons the rejection is maintained.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
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.
Claim(s) 1, 2, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rawat et al. (WO2013134047A2; cited by Applicant on 1449 IDS).
Regarding claims 1 and 2, Rawat teaches compounds of Formula (I) (pictured below)(claim 1). Instant compound (I) is a species of Formula (I) when
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X is CR18, wherein R18 is H
Y is N
Z is N
Z1 is N
Z2 is CR14, wherein R14 is H
L is an alkyl linker
R10 is a substituted heterocycle
R11 is a substituted heterocycle
R12 is H
R13 is H
R15 is H
R16 is Cl
R17 is H
Rawat does not teach a preferred embodiment of compound (I).
Rawat does teach the two embodiments below (claim 10). The compound below will be referred to as reference compound A (left) and reference compound B ( right).
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Reference compound A Reference Compound B Instant Compound (I)
It would be prima facie obvious to modify reference compound A in light of reference compound B to arrive at the instant compound (I). Reference compound A requires one modification to arrive at the instant compound; the chloro substituent at R11 needs to be modified to an ethyl piperazine substituent. A substituted heterocycle is one of the options for R11, however it is amongst a long list of possible substituents. Reference compound A already has the ethyl piperazine at R10, which would guide one skilled in the art to choosing this substituent. Reference compound B shows the same substituent for R10 and R11 which would further guide the skilled artisan to replacing the chloro R11 substituent of reference compound A with the ethyl piperazine R10 substituent, leading to the instant compound (I). Additionally, the instant and reference compounds share the same utility as a Nurr1 agonists, therefore the skilled artisan would be directed to modifying the reference compound to arrive at the instant compound (I).
Regarding claim 8, Rawat teaches the pharmaceutical composition of a compound of Formula (I) and a pharmaceutically acceptable carrier (claim 11).
Conclusion
Claims 1, 2, and 8 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621