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 .
FINAL ACTION
Priority
Instant application 17/607,577 filed on 10/29/2021 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1-3, 13-14, 16-17, 19-20, 24-25, 29-31, 33-34, 41-42 and 44 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/23/2025 has been entered.
Information Disclosure Statement
All references from IDS documents received 10/15/2025, 07/10/2023, 01/23/2023 and 10/29/2021 have been considered unless marked with strikethrough
Response to Arguments/Amendments
The amendment filled on 10/16/2025 has been entered.
Applicant amended claims 1, 13, 24 and 25.
As submitted by Applicants:
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715
715
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113
563
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Applicant’s arguments and Applicant’s amendment overcome the 102 rejections of record, therefore the 102 rejections are withdrawn.
However, Applicant’s amendment necessitated new grounds of rejections presented in this office action.
Examiner has moved onto alternative species embodied within the general formula recited in the amended claim 1, and subsequent examination is based on this species expansion.
Election/Restrictions
Applicant elected without traverse of Group (products claims) in the reply filed on 10/09/2024.
Claims 41 and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/09/2024.
With regard to species election Applicant elected:
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As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Species Election
A careful review of the prior art has indicated that elected species is free of the prior art. A claim directed to the elected species in independent form would be free of the prior art.
Please note that the elected species does not fall under the general formula recited in claim 1 (the instant general formula require nitrogen in a position adjacent to the piperidine ring).
Examiner has moved onto alternative species embodied within the general formula recited in the amended claim 1, and subsequent examination is based on this species expansion.
The whole scope of claim 1 has not been searched.
The examined species are:
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.
Claims 33 and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as not reading on the expanded species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/09/2024.
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.
Claims 1-3, 14, 17, 29-31 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN (CAS Registry Number 1249903-07-8 (entered STN 11/01/2010)) evidenced by UkrOrgSyntez website (printed 02/23/2025).
STN discloses the following compound - CAS Registry 1249903-07-8:
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The above compound (CAS RN 1249903-07-8) falls under the general formula recited in the instant claim 1:
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143
188
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wherein X is N, Y is CR40, R40 is hydrogen, Z is CR50, R50 is hydrogen, R1 is hydrogen, R6a is hydrogen, R6b is hydrogen, R5a is C1 hydroxyalkyl, R5b hydrogen.
Regarding claim 17, R5a is -CH2OH.
Regarding claim 29, the above compound falls under the first formula recited in claim 29:
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93
128
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wherein X is N, Y is CR40, R40 is hydrogen, Z is CR50, R50 is hydrogen, R1 is hydrogen, R6a is hydrogen, R6b is hydrogen, and R5b hydrogen.
Regarding claim 30, the above compound falls under the first structure recited in claim 30:
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wherein R1 is hydrogen, R40 is hydrogen, R50 is hydrogen R6a is hydrogen, R6b is hydrogen, and R5b hydrogen.
Regarding instant claim 31, as evidenced by UkrOrgSyntez website (printed 02/23/2025), UkrOrgSyntez is a screening library that provides “screening libraries and building blocks for small molecule drug discovery.”
Since the above compound is registered in the screening library, one of ordinary skill in the art would ‘at once envisage’ formulating compound 1249903-07-8 into a pharmaceutical composition comprising said compound and the pharmaceutically acceptable carrier DMSO in order to test the efficacy of said screening library compound on a variety of diseases. (See also MPEP 2131.02 III).
Claims 1-3, 13, 14, 17, 31 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by (CAS Registry Number 1490246-08-6 (entered STN 12/08/2013)) evidenced by Aurora Fine Chemicals website (printed 7/11/2025),
STN 1490246-08-6 discloses the following compound:
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The above compound (1490246-08-6) falls under the general formula recited in the instant claim 1:
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wherein X is N, Y is CR40, Z is CR50, wherein R40 and R50 are covalently bonded and together with the intermediate carbon, comprise 6-membered aryl, R1 is halogen (chloro), R6a is hydrogen, R6b is hydrogen, R5a is CF3, R5b hydrogen.
Regarding claim 17, R5a is -CF3.
Regarding instant claim 31, as evidenced by Aurora Fine Chemicals website (printed 7/11/2025), “Aurora's chemical library is a collection of stocked chemicals used in high throughput screening, medicinal chemistry, common drug design as well as in chemical research.”
Since the above compound is registered in the screening library, one of ordinary skill in the art would ‘at once envisage’ formulating compound 1490246-08-6 into a pharmaceutical composition comprising said compound and the pharmaceutically acceptable carrier DMSO in order to test the efficacy of said screening library compound on a variety of diseases. (See also MPEP 2131.02 III).
Claims 1-3, 14, 17, 31 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN (CAS Registry Number 1339671-89-4 (entered STN 11/02/2011)) evidenced by UkrOrgSyntez website (printed 02/23/2025).
STN discloses the following compound - CAS Registry 1339671-89-4:
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765
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The above compound (CAS RN 1339671-89-4) falls under the general formula recited in the instant claim 1:
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wherein X is N, Y is CR40, R40 is hydrogen, Z is CR50, R50 is hydrogen, R1 is hydrogen, R6a is hydrogen, R6b is hydrogen, R5a is -CH2Cl, R5b hydrogen.
Regarding claim 17, R5a is -CH2Cl.
Regarding instant claim 31, as evidenced by UkrOrgSyntez website (printed 02/23/2025), UkrOrgSyntez is a screening library that provides “screening libraries and building blocks for small molecule drug discovery.”
Since the above compound is registered in the screening library, one of ordinary skill in the art would ‘at once envisage’ formulating compound 1339671-89-4 into a pharmaceutical composition comprising said compound and the pharmaceutically acceptable carrier DMSO in order to test the efficacy of said screening library compound on a variety of diseases. (See also MPEP 2131.02 III).
Claims 1, 2, 3, 14, 16, 17, 19, 20, 24, 25, 29, 30, 31 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN (CAS RN 1332217-43-2 entered to STN 09/14/2011) evidenced by ChemBridge website (printed 02/23/2025).
STN discloses the following compound (CAS Registry 1332217-43-2):
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The above compound (RN 1332217-43-2) falls under the general formula recited in the instant claim 1:
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wherein X is N, Y is CR40, R40 is C1 alkyl (methyl), Z is CR50, R50 is C1 alkyl (methyl), R1 is hydrogen, R6a is hydrogen, R6b is hydrogen, R5b is C3 alkanediyl-aryl, R5a is C1 hydroxyalkyl.
Regarding claim 16, the aryl is phenyl.
Regarding claim 17, R5a is -CH2OH.
Regarding claim 19, R5b is C3 alkanediyl-aryl.
Regarding claim 20, R5b is C3 alkanediyl-phenyl.
Regarding claims 24 and 25, R40 is C1 alkyl (methyl) and R50 is C1 alkyl (methyl).
Regarding claim 29, the above compound falls under the second formula recited in claim 30:
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wherein X is N, Y is CR40, R40 is C1 alkyl (methyl), Z is CR50, R50 is C1 alkyl (methyl), R1 is hydrogen, R6a is hydrogen, R6b is hydrogen, R5a is C1 hydroxyalkyl.
Regarding claims 30, the above compound falls under the last formula recited in claim 30:
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247
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wherein R40 is C1 alkyl (methyl), R50 is C1 alkyl (methyl), R1 is hydrogen.
Regarding instant claim 31, as evidenced by ChemBridge website (printed 02/23/2025), ChemBridge is a screening library that provides “small molecule, lead-like and drug-like screening compounds.” Since the above compound is registered in the screening library, one of ordinary skill in the art would ‘at once envisage’ formulating compound 1332217-43-2 into a pharmaceutical composition comprising said compound and the pharmaceutically acceptable carrier DMSO in order to test the efficacy of said screening library compound on a variety of diseases. (See also MPEP 2131.02 III).
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A 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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/I.S./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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