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 1-4, 6, 8, 10, 14, 16, 21, 23, 30, 32, 36-38, 40-42, 67, and 69 are pending in the instant application.
Claims 40-42, 67 and 69 are withdrawn from consideration.
Claims 1-4, 6, 8, 10, 14, 16, 21, 23, 30, 32, and 36-38 are examined herein.
Priority
The instant application is a CON of PCT/US2020/062627 filed on 30 November 2020, and claims benefit of priority to U.S. Provisional Application No. 63112609, filed on 11 November 2020. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 11 November 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 15 September 2023 and 09 June 2026, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Election/Restrictions
Applicant’s election of Group I, claims 1-4, 6, 8, 10, 14, 16, 21, 23, 30, 32, 36-38, and 69, without traverse, in the reply filed on 09 June 2026 is acknowledged. In addition, the specie election of Formula(I), compound 30 (pictured below), which reads on claims 1-4, 6, 23, 30, and 36-38, is acknowledged.
PNG
media_image1.png
200
256
media_image1.png
Greyscale
Claims 40-42, 67 and 69 are withdrawn from consideration for not reading on the elected group.
If the elected species is not identified in the art, the search will be expanded to additional species per MPEP 802.03.
The elected species was not found in the art, and the search was expanded to include all species of Formula(I).
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 1-4, 6, 8, 10, 14, 16, 21, 23, 30, 32, and 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crews et al. (WO2013106646A2; cited by Applicant on 1449 IDS) in view of Bondani et al. (Drug Discov Today. 2017;22(10):1572-1581).
Regarding claims 1, 6, 8, 10, 16, and 21 Crews teaches compound of Formula (I) (pictured below) which overlaps with the instant Formula (I) when:
R1’ is –(CH2)nOH or –(CH2)n-O-(C1-C6)alkyl, wherein n is 0
X is C=O
X’ is C=O
R2’ is -NR1-(CH2)n-(C=O)u(NR1)v- Aryl, optionally substituted; wherein n is 0-6; u is 0; and v is 0; or
R2’ is -NR1-(CH2)n-(C=O)u(NR1)v- Alkyl, optionally substituted; wherein n is 0-6; u is 0; v is 0; and alkyl is cyclic
R3’ is (CH2)n-C(O)u(NR1)v(SO2)w-Heteroaryl, optionally substituted; wherein n is 1; u is 0; v is 0; and w is 0.
PNG
media_image2.png
172
248
media_image2.png
Greyscale
PNG
media_image3.png
194
316
media_image3.png
Greyscale
Crews does not disclose a preferred embodiment of the instant genus. The closest compound contains a 1,2,4 triazole and not a 1,2,3 triazole (pictured below from STN search). Crew’s definition of heteroaryl provides examples including triazole (page 40), but does not specifiy the exact substitution of the three nitrogens. However, 1,2,4 triazoles are the only embodiments disclosed.
PNG
media_image4.png
222
494
media_image4.png
Greyscale
Bondani et al. teaches 1,2,3 triazoles are bioisosteres for 1,2,4 triazoles (page 1578, column 2, paragraph 4).
It would be prima facie obvious to one of ordinary skill in the art to substitute the 1,2,4 triazole for a 1,2,3 triazole as Bondani teaches there are isosteric substitutions. The skilled artisan would have a reasonable expectation of success and would be guided to making this substitution as Bondani provides an example in which the isosteric substitution was carried out resulting in reduced toxicity and increased efficacy.
Regarding claim 2, Crews teaches R2’ which corresponds to the instant L, in particular the alkylene group of -NR1-(CH2)n-(C=O)u(NR1)v- Aryl.
Regarding claim 3, Crews teaches R2’ which corresponds to the instant A, in particular the aryl group of -NR1-(CH2)n-(C=O)u(NR1)v- Aryl. Crews provides no limit as to the number of carbons within the aromatic moiety (page 39).
Regarding claim 4, Crews teaches R2’ can be optionally substituted which corresponds to the instant (Re)n. Optional substitutions include optionally substituted heteroaryl groups (page 39).
Regarding claim 23, Crews teaches R3’ which corresponds to the instant 1,2,3 triazole, in particular the heteroaryl group of (CH2)n-C(O)u(NR1)v(SO2)w-Heteroaryl. Crews teaches the heteroaryl can be substituted. Substitutions include, halo, cyano, C1-6 alkyl, aryl, or heteroaryl (page 38). Additionally, Crews defines alkyl to include cyclic alkyl croups (page 36).
Regarding claim 30, Crews teaches R3’ which corresponds to the instant R1, in particular the alkylene group of (CH2)n-C(O)u(NR1)v(SO2)w-Heteroaryl. Crews teaches this alkylene group may be optionally substituted with C1-6 alkyl.
Regarding claim 32, Crew teaches which corresponds to the instant R1, in particular the alkylene group of (CH2)n-C(O)u(NR1)v(SO2)w-Heteroaryl. Crews teaches this alkylene group may be optionally substituted with C1-6 alkyl, which includes cyclic alkyl.
Regarding claims 36 and 37, compound 2 (pictured below) is a species of the reference genus, however Crews does not teach the exact embodiment. Crews teaches the compound pictured below. Modification of the 1,2,4 triazole, as guided by Bondani and the addition of the 1-ethynyl-1-methylcyclopropane to the triazole results in the instant elected species.
PNG
media_image4.png
222
494
media_image4.png
Greyscale
PNG
media_image5.png
209
274
media_image5.png
Greyscale
Regarding claim 38, Crews teaches a pharmaceutical composition of a compound of Formula (I) (claim 45).
Conclusion
Claims 1-4, 6, 8, 10, 14, 16, 21, 23, 30, 32, and 36-38 are rejected.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights