DETAILED ACTION
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 .
Election/Restrictions
Applicants’ election without traverse of Group I (i.e., claims 1, 7-14, 16, 19-21, 25, 27 and 29-30) in the reply filed on 7/17/2026 is acknowledged.
Applicants amended of claim 27 is acknowledged. Applicant’s cancellation of claims 2-6, 15, 17-18, 22-24, 26, 28, 31-33, and 34-38 is acknowledged.
There are no new claims.
Furthermore, applicant’s election of the following species of “Compound of Formula 1” for Group I
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without traverse is acknowledged.
Since the applicant elected group I (i.e., claims 1, 7-14, 16, 19-21, 25, 27 and 29-30), therefore, based on that election, claims 31-33 are withdrawn as being drawn to a non-elected group.
Claims 1, 7-14, 16, 19-21, 25, 27 and 29-30 are under consideration in this office action and will be examined on the merits.
Status of Claims
Claims 1, 7-14, 16, 19-21, 25, 27 and 29-30 are pending. The second preliminary amendment was filed on 12/27/2024, wherein the applicant amended claims 1, 7-14, 16, 19-21, 25, 27, and 29-33, and canceled claims 2-6, 15, 17-18, 22-24, 26, 28 and 34-38. There are no new claims.
Claims 1, 7-14, 16, 19-21, 25, 27 and 29-30 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/07/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Applicant Claims
2. Determining the scope and contents of the prior art.
3. Ascertaining the differences between the prior art and the claims at issue, and 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, 7-14, 16, 19-21, 25, 27, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over SALITURO et al. (“C7 SUBSTITUTED OXYSTEROLS AND METHODS AS NMDA MODULATORS” WO2018064649 -, published 05/04/2018) herein referred to as Salituro in view of Dyck et al. (Dyck, L.E., Burden, D.A. and Boulton, A.A., 1986. Effects of Deuterium Substitution on the Catabolism of β‐Phenylethylamine: An In Vivo Study. Journal of neurochemistry, 46(2), pp.399-404), hereby known as Dyck, and Harbeson et al. (Harbeson, S.L. and Tung, R.D., 2011. Deuterium in drug discovery and development. In Annual reports in medicinal chemistry (Vol. 46, pp. 403-417). Academic Press), hereby known as Harbeson.
Regarding claims 1, 7-14, 16, 19-21, 25, 27 and 29-30, Salituro teaches substituted oxysterols useful for preventing and/or treating a broad range of disorders, including, but not limited to, NMDA-mediated disorders. Salituro teaches pharmaceutical compositions comprising the compounds of the present invention, and methods of their use and treatment. Salituro teaches
the following compound, pharmaceutically acceptable salts thereof, and pharmaceutical compositions thereof, are provided for the prevention and treatment of a variety of CNS-related conditions similar to the compounds of Formula I (see example 3, compound 71).
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Salituro’s compound 71 differs from instant compound of claim 1 as it is not deuterated, whereas the compound of claim 1 carries at least one deuterium atom. However, it is noted that Salituro indicates on pages 51-52, paragraph 274 that in the compounds of this document, ¹H (protium or "H") can be replaced ²H (deuterium or "D") with retention of activity. As such, it is an evident step for the skilled person wishing to solve the problem (of provision of agents for treating CNS diseases via modulation of the NMDA receptor) to follow this teaching of Salituro and prepare deuterated derivatives of the above-mentioned active compounds known from Salituro, which leads to the compounds of claim 1 as a solution to this problem. Consequently, the compounds of claim 1 and claims 2-29 dependent thereon represent an obvious solution to the above-mentioned problem, as do the pharmaceutical compositions, medical uses and medical indications thereof for the treatment of NMDA/CNS related conditions.
As per MPEP 2144.09, I: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)
Furthermore, Salituro’s compounds and the instant application compounds have very close structural similarities (i.e.: are isomers that only differ by deuterium substitution), with identical utilities (i.e.: used to treat CNS cancer). Salituro does not explicitly teach deuterium substitution or isotopic forms; however, deuterium substitution is commonly practiced in the pharmaceutical arts to modulate chemical properties.
For example, Dyck teaches “deuterium substitution... [as].... a useful strategy to enhance the pharmacological effects of a compound without significantly altering its basic chemical structure (page 399, column 1, lines 15-20).”
Harbeson teaches that “the incorporation of deuterium into pharmacologically active agents offers potential benefits, such as improved exposure profiles and the decreased production of toxic metabolites that could yield improvements in efficacy, tolerability, or safety (page 404, paragraph 1, lines 12-15).”
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the formula disclosed by Salituro to incorporate the teachings of Dyck to access deuterated analogues of the disclosed compounds.
A person of ordinary skill in the art would have been motivated to access deuterated analogues of Salituro such as instant invention based on the well-established benefits in the arts as explained by Harbeson of deuteration on improved pharmacological properties such as efficacy, tolerability and safety without needing to alter the compound’s structure. Additionally, both Salituro and instant invention’s compounds are directed towards the same intended use in treating CNS cancer; therefore, the similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties (i.e.: anti-cancer properties for treating CNS cancer).
Consequently, an artisan would arrive at the instant invention as a highly predictable result with a reasonable expectation of success based on the combined beneficial teachings of Salituro, Dyck and Harbeson.
Therefore, claims 1, 7-14, 16, 19-21, 25, 27, and 29-30 are rejected on grounds of obviousness.
Conclusion
Claims 1, 7-14, 16, 19-21, 25, 27 and 29-30 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHAR INAM whose telephone number is (571)272-0821. The examiner can normally be reached 7:30 am-5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAHAR INAM/
Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/
Supervisory Patent Examiner, Art Unit 1622
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