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
The office acknowledges Applicants filing of the response dated 12/30/2025 in regards to the restriction election requirement dated 11/26/2025. Applicants have elected Group I and species (i) for examination but has not elected the species as required for examination. For the sake of compact prosecution attorney Luke Hibbeler was contacted on 1/20/2026 in regards to the species election. Attorney Hibbeler elected compound I, page 14 of the specification for examination.
Applicants have argued that the search and examination of the entire application could be made without serious burden (See MPEP §803) and should be applied in the present application in order to avoid unnecessary delay and expense to Applicant and duplicative examination by the Patent Office. In response, it is noted that this application is a 371 (national stage) application. In regards to Applicants contention that there is no serious search burden for the examination of all of the groups and/or species, these arguments have been considered but are not found persuasive as such arguments do not apply when restriction is required under 35 USC 121 and 372, as in the instantly filed application. As stated in the restriction requirement said groups deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1. Applicants arguments have been considered and the species election is withdrawn. The restriction requirement is proper and thus made final.
Claims 1-9 are pending. The group I elected by the applicants read on claims 1-3 and 5. Claims 4, 6-9 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being drawn to non-elected subject matter. Claims 1-3 and 5 are examined based on the merits herein.
Application Priority
This application filed on 8/25/2023 is a National Stage entry of PCT/CN2022/ 080255, International Filing Date: 03/11/2022, claims foreign priority to 202110267569.4, filed 03/12/2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 8/25/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Claim Rejections - 35 USC § 103
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, 5 are rejected under 35 U.S.C. 103 as being unpatentable over Baloglu et al. (WO 2014/205389).
Baloglu teaches nuclear transport modulator compounds and its uses in treatment of diseases associated with CRM1 activity (Abstract).
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(See abstract, p 110, 112). Baloglu teach pharmaceutical compositions comprising the compounds of formula I and a pharmaceutically acceptable carrier, adjuvant, vehicle (see p 40, [00139]).
From Baloglu’s teachings a person skilled in the art before the effective filing date of the invention would have found it obvious to arrive at the following compound claimed in the instant application.
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The difference between the reference compound 124 of Baloglu and the compound of instant claim 1 is a methyl group attached to the amido nitrogen (see arrows above).
A person skilled in the art would have found it obvious to add a methyl group to amido nitrogen because the reference teaches compound 124 and also teach Ra and Rb is selected from H, CONR5R6, wherein R5 and R6 are selected from H, C1-C4 alkyl in compound of formula I (see above). In addition, the reference is explicit in teaching compound 113 with methyl groups attached to amido nitrogen. “Compounds which are… homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Note also: In re Magerlein, 202 USPQ 473; In re Wood, 199 USPQ 137; In re Hoke, 195 USPQ 148; In re Lohr, 137 USPQ 548. A methyl group is considered a homolog of hydrogen these compounds are considered equivalent. The skilled artisan would have been motivated to modify the teaching of the prior art to prepare homologues because it is recognized in the art that homologues are structurally similar and would be expected to possess similar properties. Ex parte Henze (POBA 1948) 83 USPQ 167. A person skilled in the art would have been motivated to arrive at the claimed compound of claim 1 with a reasonable amount of success and obtain a compound with equivalent or better CRM1 activity. Thus claims 1, 2 are addressed. As to claim 5, a person skilled in the art would have been motivated to arrive at the claimed pharmaceutical composition of a compound of claim 1 because the Baloglu teach formulating pharmaceutical composition comprising the compounds of its invention with a pharmaceutically acceptable carrier for its use in therapeutic treatment. Hence a skilled artisan would have been motivated to arrive at the claimed pharmaceutical composition comprising the compound prepared from the teachings of Baloglu for therapeutic use with a reasonable amount of success.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 5712705239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627