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 .
Applicant’s response filed 6/12/2026 have been entered.
Claims 70-102 are pending.
Claims 80-81, 83-88 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/13/2025.
As the cited prior art ‘974 also teaches psilocin. In addition, psilacetin is a well-known pro-drug of psilocybin Therefore, both compounds (claims 78-79) will be considered and be examined herein.
Claim Rejections - 35 USC § 103
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.
Claim(s) 70-78, 82, 89-102 is/are rejected under 35 U.S.C. 103 as being unpatentable over CA 3052974 (‘974) in view US 2019/0350949 (‘949).
‘974 teaches the use of combination of psilocybin and/or terpene and/or cannabinoid derivatives for treating depression in patients suffered from diabetes and cancer (see pages 4, second paragraph, pages 56-58, claims 122 for example). ‘974 teaches one of the terpene suitable in the invention as eugenol (see page 23, last paragraph). ‘974 teaches the ratio between psilocybin and terpene as 1:100 to 100:1, 1:75 to 75:1, 1:50 to 50:1, and 1:25 to 25:1 (see page 39). ‘974 teaches the amount of the psilocybin as about 0.5% and the terpene as 8% for example (see page 6, second to last paragraph). ‘974 teaches the use of excipients for the psilocybin composition (see page 44, paragraphs 6-7). ‘974 teaches the routes of administration include oral as tablets, transdermal patches (see pages 49, line 20 bridging page 50, line 11).
‘974 does not expressly teach eugenol as the terpene. ‘974 does not expressly teach the exact dosage as claimed. ‘974 does not expressly teach the dosage form to be suppositories. ‘974 does not expressly teach the resulting reduction of the herein claimed biomarkers.
‘949 teaches a method of treating depression by using the combination of psilocybin and a terpene (see claim 30). ‘949 teaches the composition can be formulated as “tablets, capsules, powders, dispersible granules, cachets and suppository” (see [0087]).
It would have been obvious to one of ordinary skill in the art at the time of filing to adjust the dosage of the actives in the psilocybin/eugenol composition. It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the psilocybin/eugenol composition as suppository.
One of ordinary skill in the art would have been motivated to adjust the dosage of the actives in the psilocybin/eugenol composition. Employing any suitable terpene disclosed in the cited prior art including eugenol, would be reasonably expected to be effective in treating depression. In addition, the optimization of result effect parameters (dosage range, dosing regimens) is obvious as being within the skill of the artisan. The optimization of known effective amounts of known active agents to be administered, is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). It is also noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The routine optimization of the effect parameter (e.g., the dosage of the active) would be considered obvious as the adjustment of the amounts and ratio of the actives would affect the effectiveness of the herein claimed treatments.
One of ordinary skill in the art would have been motivated to formulate the psilocybin/eugenol composition as suppository is one of the dosage form that can be effectively delivery the psilocybin/terpene composition in order to treat depression.
As for the resulting reduction in biomarkers, the reduction of the herein claimed biomarkers are considered as a resulting effect after the administration of the psilocybin/terpene composition.
Claim(s) 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘974 and ‘949 as applied to claims 70-78, 82, 89-102 above, and further in view of Chadeayne et al., Acta Cryst. (2019). E75, 900–902.
‘974 and ‘949 suggest the psilocybin/eugenol composition as claimed.
‘974 and ‘949 do not expressly teach psilacetin.
Chadeayne et al. teaches psilacetin as a pro-drug of psilocybin (see page 900, first paragraph).
It would have been obvious to one of ordinary skill in the art at the time of filing to substitute psilocybin with psilacetin.
One of ordinary skill in the art would have been motivated to substitute psilocybin with psilacetin because psilacetin will be converted to psilocybin in the body. Therefore, incorporating psilacetin instead of psilocybn would be reasonably expected to be effective.
Response to Arguments
Applicant's arguments filed 6/12/2026 averring eugenol being not a terpene have been fully considered but they are not persuasive. The cited prior art ‘974 clearly teaches eugenol as one of the compounds suitable being used in the invention taught in ‘974, regardless of whether it is called terpene or not. In ‘974, eugenol is categorized as terpene. Therefore, eugenol would be considered as a suitable compound to be combined with psilocybin as taught in ‘974.
Applicant’s arguments filed 6/12/2026 averring the presence of the unexpected benefits have been considered, but are not found persuasive. The evidence demonstrated the combination of one specific combination has superior effects, however, it appears to be the an additive, expected results. It is applicant’s burden to demonstrate unexpected results over the prior art. See MPEP 716.02, also 716.02 (a) - (g). Furthermore, the unexpected results should be demonstrated with evidence that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Moreover, evidence as to any unexpected benefits must be "clear and convincing" In re Lohr, 137 USPQ 548 (CCPA 1963), and be of a scope reasonably commensurate with the scope of the subject matter claimed, In re Linder, 173 USPQ 356 (CCPA 1972). In the instant case, the claims recite more combination than what is demonstrating in the specification, therefore, the alleged unexpected results are not even commensurate with he scope the subject matter claimed, even if the alleged unexpected results being indeed unexpected.
Accordingly, the claims are considered being properly rejected under 35 USC 103a.
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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/SAN MING R HUI/ Primary Examiner, Art Unit 1627
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