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 .
Status of Claims and Response to Amendments
The amendments filed December 27, 2025 have been acknowledged and entered. Claims 1, 3-14, 17 and 21-45 are pending.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Maintained Rejections
Claim Rejections - 35 USC § 112a
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The instant claim has been amended to recite a method of treatment comprising administration of a compound of claim 1. The previous rejection addressed uses of the instant compounds which are presently claimed (e.g. treatment of schizophrenia…depression). The rejection therefore still applies to the claim as amended.
The reasons for this rejection were set forth in the previous Office Action and incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed December 27, 2025 have been fully considered but they are not persuasive.
Applicant argues the claim has been amended to be limited to a subset of the specific diseases
that are known in the art to be associated with GPR52 and may therefore reasonably be expected to be treatable by GPR52 agonists as presently claimed. Several examples of such associations are described on pages 1-3 of the Background section… there is substantial teaching in the prior art demonstrating
that GPR52 agonism is associated with the treatment of the specific diseases recited in claim 21 (page 14 of 16 of remarks).
These arguments are not found persuasive for the reason that association of GPR52 with a particular condition is not evidence that there is any correlation between agonism of GPR52 and treatment of the condition. The present case is lacking any evidence which shows agonism of GPR52 has the effect in treating the claimed conditions. MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
No one has ever treated a condition of the claims by agonism of GPR52. There are no scientific studies in the prior art which show that agonism of GPR52 has any effect in treating a condition of the claims. Nor does it appear there are any models systems of disease demonstrating that agonism of GPR52 may have the claimed therapeutic effect. Moreover, it is unclear which diseases are meant to be represented by Applicant’s biological example (page 48-49, attenuation of caffeine-induced locomotor activity) or how this model could represent all the conditions claimed which are highly varied and unrelated.
Applicant is encouraged to submit evidence (e.g. scientific studies) which demonstrate the prior art was aware that the claimed conditions may be treated by agonism of GPR52. Applicant is reminded that the invention must have been enabled as of the effective filing date of the invention (see MPEP 2164.05(a)).
The rejection is still deemed proper and maintained.
Allowable Subject Matter
Claims 1, 3-14, 17 and 22-45 are allowed.
The following is an examiner’s statement of reasons for allowance: The previous rejections of the claims under 35 USC § 112a, 112b and 112d have been withdrawn in view of Applicant amendments. Reasons for allowance of Formula (1a) were set forth in the previous Office Action and are incorporated herein by reference.
Conclusion
Claims 1, 3-14, 17 and 22-45 are allowed. Claim 21 is rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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January 29, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624