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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/19/2026 has been entered.
Response to Amendment
The amendments received 06/19/2026 have been entered. Claims 1, 3-8, 15, and 18-27 are pending. Any objection or rejection as set forth in the Office Action mailed 04/20/2026 not maintained herein has been overcome and is withdrawn.
Examiner has considered Applicant’s arguments regarding the priority dates awarded to the pending claims. Upon consideration of the specification of the 62/831,517 application, Examiner finds the arguments to be persuasive in part. Please see the below priority discussion and Examiner’s response to arguments below.
As claims 1, 3-6, 8, and 18-27 have been awarded the effective filing date of 04/09/2019, Chen et al. (Neuropsychopharmacology; October 2019) no longer qualifies as prior art against claims 1, 3-6, 8, and 18-27. The rejection under 35 U.S.C. 103 has been withdrawn for claims 1, 3-6, 8, and 18-27 but is maintained for claims 7 and 15, which have been awarded the filing date of 04/08/2020 as below.
Priority
Examiner acknowledges that, according to the Filing receipt received 10/19/2021, that the instant application 17/494,218 filed 10/05/2021 is a continuation of PCT/US2020/027321 filed 04/08/2020 which claims benefit of U.S. provisional applications 62/831,517 filed 04/09/2019, 62/857,075 filed 06/04/2019, and 62/910,859 filed 10/04/2019.
However, the limitations of the instant claims are not adequately supported or enabled in the manner provided by 35 U.S.C. 112(a) or pre-AIA U.S.C. 112, first paragraph by provisional applications 62/831,517, 62/857,075, and 62/910,859. More specifically, the agents lithium, riluzole, prazosin, lamotrigine, and ifenprodil (claim 15) and intranasal administration (claim 7) are not taught or suggested by any of the provisional applications. Therefore, claims 7 and 15 have been awarded the effective filing date of 04/08/2020 and claims 1, 3-6, 8, and 18-27 have been awarded the effective filing date of 04/09/2019.
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) 7 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Neuropsychopharmacology; October 2019; previously cited).
Chen et al. discloses a method of preventing depressive- and anxiety-like behavior in mice administered chronic corticosterone or subjected to chronic fear conditioning (Abstract; p. 543). Chen et al. discloses that a single prophylactic injection of RS-67333 protected against stress-induced hypophagia in female mice when administered 1 week prior to a stressor (p. 546). Chen et al. teaches that stress exposure is a significant risk factor in depression and PTSD and is experienced by both males and females (p. 542, col. 1). Chen et al. suggests administering resilience-enhancing drugs for prevention of PTSD in U.S. service members (p. 542, col. 1, see Reference 7 on p. 552). Chen et al. additionally teaches administering fluoxetine to the mice, which increased open-arm entries (Abstract).
Chen et al. does not explicitly teach administering RS67333 to a human (male or female). Chen et al. does not teach combining RS67333 with fluoxetine. These limitations are obvious over Chen et al.
It would have been prima facie obvious for one of ordinary skill in the art to combine RS67333 with fluoxetine. One would have been motivated to do so, with reasonable expectation of success, as Chen et al. demonstrates that fluoxetine produces anxiolytic effects. One would be apprised that combining fluoxetine with RS67333 in the method of Chen et al. could lead to improved treatment of the anxiety-related behaviors.
It would have been prima facie obvious for one of ordinary skill in the art to administer RS67333 to a human. One would have been motivated to do so, with reasonable expectation of success, as one of ordinary skill in the art would be driven to further apply a successful pre-clinical drug in a pre-clinical setting, as suggested by Chen et al. Furthermore, administering RS67333 to a female subject would be an obvious variant of a male subject, wherein both are disclosed by Chen et al. to suffer from anxiety disorders.
Response to Arguments
Applicant's arguments filed 06/19/2026 have been fully considered but they are not fully persuasive.
Regarding the priority dates awarded to the instant claims, Examiner thanks Applicant for pointing to the translated specification and statement filed 04/06/2020 and the additional drawings filed 04/09/2019. Upon consideration of these documents, Examiner has awarded the effective filing date of 04/09/2019 to claims 1, 3-6, 8, and 18-27. However, as discussed above, claims 7 and 15 are not adequately described by the provisional applications to which the instant application claims domestic benefit. While limitations discussing generic agents, or other agents such as fluoxetine, as well as other modes of administration are disclosed, the agents lithium, riluzole, prazosin, lamotrigine, and ifenprodil (claim 15) and intranasal administration (claim 7) are not taught or suggested by any of the provisional applications. One of ordinary skill in the art would not be reasonably led to any of the agents or mode of administration at issue by the species that are recited. For example, while the provisional applications describe fluoxetine and its reduction to practice, this would not reasonably lead one of ordinary skill in the art to envisage lithium, which is substantially different in structure and function. Thus, the earliest disclosure of the limitations at issue is found in PCT/US2020/27321 (see at least claims 7 and 16) which has a filing date of 04/08/2020. The rejection under 35 U.S.C. 103 over Chen et al. (Neuropsychopharmacology; October 2019) has been maintained for claims 7 and 15, as Applicant’s arguments against the rejection set forth in the Remarks filed 06/19/2026 (p. 10) are on the basis that all of the instant claims receive at least an effective filing date of 10/04/2019, which is not the case for claims 7 and 15.
Allowable Subject Matter
Claims 1, 3-6, 8, and 18-27 are allowed. The closest prior art is that of record.
Conclusion
Claims 1, 3-6, 8, and 18-27 are allowed. Claims 7 and 15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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/MADELINE E BRAUN/Examiner, Art Unit 1624
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