DETAILED ACTION
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
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 .
Application Status
The Amendment filed on 2/17/2026 is acknowledged and has been entered. Claims 1-3, 8-22 and 24-30 are currently pending and under consideration.
Rejections Withdrawn in view of Applicants arguments/amendments:
The rejection of Claims 1-2, 8-22 and 30 on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,325,726B2 to Vanover et al. (2025-06-10) in view of Hogenkamp, Derek (US 2004/0034002 A1, 2004-02-19) referred to herein as Hogenkamp is withdrawn in view of the approval of the terminal disclaimer
The rejection of claims Claim(s) 1-2, 8, 17-22 and 30 under 35 U.S.C. 102(a)(1) as being anticipated by Hogenkamp, Derek (US 2004/0034002 A1, 2004-02-19) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 1, 3, 14, 17-22, 24 and 30 under 35 U.S.C. 103 as being unpatentable over Sage Therapeutics (WO2019/126741A1, 2019-06-27) is withdrawn in view of Applicants amendments and reconsideration.
The rejection of Claim(s) 14, 16 and 26-29 under 35 U.S.C. 103 as being unpatentable over Sage Therapeutics (WO2019/126741A1, 2019-06-27), as applied above to claims 1, 3, 14, 17-22, 24 and 30, Salituro et al. (US2020/0291059A1, 2020-09-17, filed 2018-12-08, IDS) is withdrawn in view of Applicants arguments and reconsideration. Specifically, the examiner reconsidered the obviousness of making two modifications to the compound of Salituro to arrive at the non-deuterated methyl and methoxy as described previously in the 103 of Salituro alone set forth above and/or previously, followed by making a 3rd modification for the deuteration.
Rejections Maintained, but amended in view of Applicants Amendments
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 8, 10-14, 16-22 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hogenkamp, Derek (US 2004/0034002 A1, 2004-02-19) in view of Salituro et al. (US2020/0291059A1, 2020-09-17, filed 2018-12-08, IDS).
The combination of Hogenkamp and Salituro et al. have been discussed previously in the Final rejection of 12/17/2025 and are incorporated herein.
In response to the rejection, Applicants contend that the deuterated neurosteroids of Salituro do not have the same core structure as either Applicant’s compounds or the Hogenkamp compounds, e.g. pyrazole-based neurosteroids vs. imidazole-based neurosteroids. In view of this, Applicants content that the Examiner has not demonstrated that a person of ordinary skill in the art would have had any reasonable expectation of success, or motivation, in applying the teachings of Salituro to the compounds of Hogenkamp. In particular, Applicants contend that the Examiner has not shown that the pyrazole compounds and imidazole compounds bind to their target receptors the same way, or metabolizes the same way. Thus, Applicants contend that the present claims are not obvious over Hogenkamp in view of Salituro.
These arguments have been carefully considered, but are not found persuasive.
Regarding Applicants assertion that the compounds of do not have the same core structure, the Examiner disagrees. While the Examiner acknowledges that the neurosteroids have different heteroaryl rings off of the oxo, the Examiner recognizes that the two compounds appear substantially similar in that both contain the pregnan-20-one steroid ring system:
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. Accordingly, it would appear that each has the same core structure. Moreover, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Thus, as noted in the Final Office action, Salituro et al teaches deuteration of structurally similar compounds acting as neurosteroids which are used for the same purpose as Hogenkamp. Obviousness does not require absolute predictability, but at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (see MPEP 2143.02). Note: The specification (example 6) provides an in vivo mouse pharmacokinetics of deuterated compounds of Examples 2 and 3 compared to the non-deuterated compound of Formula A (Example 1). However, there does to appear to be any data which is provided to show the differences in pharmacokinetics between the claimed deuterated compounds compared to the non-deuterated.
New Rejections upon Reconsideration
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.
Claim(s) 1-2, 8-22 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Praxis Precision Medicines INC. (WO2021/168106A1, 2021-08-26, Priority to US62/97813 filed on 2020-02-18) referred to herein as Praxis in view of Hogenkamp, Derek (US 2004/0034002 A1, 2004-02-19) referred to herein as Hogenkamp.
Praxis teaches deuterated derivatives of the compound of Formula (I), pharmaceutical salts thereof and method of use, wherein the compound of Formula I has the following formula
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(paragraph 0004). Specifically, Praxis teaches compounds including, but not limited to,
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,
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and pharmaceutically acceptable salts thereof(paragraph 0006). Regarding the deuterium enrichment, Praxis teach that is to be understood that the position can contain hydrogen at its natural abundance or can be enriched in deuterium with an isotopic enrichment factor of, for example, 90% deuterium incorporation (paragraph 0010). Regarding the method of use, Praxis teaches methods of administering the compounds for the treatment of disorders including, but are not limited, method of inducing anesthesia in a subject and treating sleep disorders such as insomnia, wherein the compound is administered orally or by injection (paragraph 0026, 0035, 0038 and 0115). Lastly, Praxis teach a pharmaceutical composition comprising the deuterated compound or pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent (Claim 3).
Praxis does not specifically teach the alternative diastereomer at the identified area
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. While Praxis teaches many of the deuterated compounds claimed in claim 14, the WO document does not specifically teach all the potential deuterated variations as specifically claimed 14.
Hogenkamp teaches steroids referred to as 3α-hydroxy-3β-methoxymethyl-21-substituted-5α- (and 5β-)pregnan-20-ones with properties desirable for use as sedative/hypnotics and anesthetics, wherein the steroids have the following generic structure of formula I:
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(paragraph 0002). Specifically, Hogenkamp teaches a steroid having the chemical formula 3α-hydroxy-21-(1′-imidazolyl)-3β-methoxymethyl-5β-pregnan-20-one which has the structure:
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and reads on the instantly claimed compound of Formula 1 wherein X is H, R1 is OCH3, R2-R3 are H, R2-9 are H as well at its diasteromer 3α-hydroxy-21-(1′-imidazolyl)-3β-methoxymethyl-5α-pregnan-20-one (claim 7 of the PGPUB, CAS RN: 304910-80-3 for structure). In particular, the PG Pub teaches that both the 5α and 5β pregnan-20-one had similar invitro activities and biological duration of action (Table 1). Moreover, the publication teaches a method of alleviating insomnia or inducing anesthesia in an animal comprising administering an effective amount of a compound of formula I (see claims 12-13 for example).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to change the diastereomer of the hydrogen in the compound taught by Praxis in view of the teachings of Hogenkamp. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Hogenkamp teaches that both the 5α and 5β pregnan-20-one had similar invitro activities and biological duration of action and,
-each stereoisomer has been taught in the prior art to be effective for inducing sedation and treating disorders such as sleep disorders.
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) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990).
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the deuterium pattern to a variety of different locations in the compound taught by Praxis. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Praxis teaches that there is a need for derivatives of the compound of Formula (I) with improved properties (such as improved pharmacokinetic properties).
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) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990).
Conclusion
Claims 3 and 24-29 are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626