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
This office action is in response to applicant’s filing dated June 27, 2025.
Status of Claims
Claims 1, 5 and 52 are currently pending and are the subject of this office action.
Claims 1, 5 and 52 are presently under examination.
Priority
The present application claims priority to provisional application No. 63/666,009 filed on 06/28/2024.
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.
1) Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeLong et. al (US 2021/0363141).
For claim 1, DeLong teaches compounds that are inhibitors of both Rho kinase and of a monoamine transporter (MAT). The compounds are effective in treating several diseases like glaucoma (see abstract).
Among the compounds disclosed, the authors cite compound 175 (see page 29, Table 4):
PNG
media_image1.png
394
348
media_image1.png
Greyscale
Compound 175 is disclosed as a racemate (i.e. 50% R and 50% S), not as a pure (S) enantiomer like in instant claim 1.
However, DeLong further teaches: “when racemates exists, each enantiomer or diastereomer may be separated used, or they may be combined in any proportion” (see [0084]).
Finally, as legal authority the examiner cites In re Adamson, 125 USPQ 233 (CCPA 1960a. The case sets forth the requirements of patentability regarding enantiomers as follows: “The existence of a racemate is, in and of itself, sufficient to render obvious any individual enantiomer contained within; no express suggestion of isomer separation is needed”. See p. 235, ¶ 1. In other words, once a racemic mixture has shown some efficacy against any disease, it will be obvious to resolve the mixture and try each enantiomer individually and expect at least one of them to be efficacious.
All this will result in the practice of claim 1 with a reasonable expectation of success.
2) Claim(s) 5 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeLong et. al (US 2021/0363141) as applied to claim 1, further in view of Bastin et. al. (Organic Process Research and Development (2000) 4:427-435).
DeLong teaches all the structural limitations of claims 5 and 52, except for the monomesylate or dimesylate salts. However, DeLong further teaches making salts of the above compounds (See for example [0084]).
Further, Bastin teaches that: “the selection of an appropriate salt for a new chemical entity provides the pharmaceutical chemist the opportunity to modify the characteristics of the potential drug substance and to permit the development of dosage forms with good bioavailability, stability, manufacturability, and patient compliance (see abstract). Among the commonly used salts, Bastin discloses mesylate (see Table 1 on page428).
Before the effective filing date of the invention, it would have been prima facie obvious for the skilled in the art, to make any salt of a known biologically active compound, including the (S) enantiomer of compound 175 disclosed by DeLong, in order to improve its dosage forms, bioavailability, stability, manufacturability, and patient compliance, thus resulting in the practice of claims 5 and 52 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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, Amy L. Clark can be reached on 571 272-1310. 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.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
February 12, 2026.