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 .
Claim Status
Applicants' response and amendments to the claims, filed 08/13/2025, are acknowledged and entered. Claims 5-8 have been cancelled by Applicant.
Claims 1-4 and 9-20 are pending.
Election/Restrictions
Claims 16-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/1 1/2023.
Duplicate Claims Warning
Applicant is advised that should claim 1 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Here, amended claims 1 and 14 require identical active method steps and cover identical subject populations, i.e., subjects in need of treating a disease or disorder, despite their slight differences in wording in the preamble of the claims.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 and 9-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Amended claims 1 and 14 require administering an amount in moles of 4-AcO-DMT necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin to treat a disease or disorder. The claims also require that the amount in moles of 4-AcO-DMT, or a salt thereof, administered is less than the amount in moles of psilocybin necessary to provide the equivalent therapeutically effective amount of psilocin.
It is entirety unclear how an amount in moles of 4-AcO-DMT necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin can be less than the amount in moles of psilocybin necessary to provide the equivalent therapeutically effective amount of psilocin. These limitations defy basic stoichiometric chemistry principles. On a molar basis, the amount in moles of 4-AcO-DMT necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin will be the same amount in moles as psilocybin. Assuming 100% conversion of 4-AcO-DMT and psilocybin to psilocin in vivo, 1 mol of 4-AcO-DMT and psilocybin will each yield 1 mol of psilocin. The amount in moles of 4-AcO-DMT cannot be less than the amount in moles of psilocybin necessary to provide the equivalent therapeutically effective amount of psilocin as required by the claims. In other words, if the therapeutically effective amount in moles of psilocin is 1 mol, it will require administering 1 mol 4-AcO-DMT or 1 mol psilocybin to yield the same 1 mol of psilocin.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 9-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amended claims recite determining an amount “in moles” of 4-AcO-DMT or a salt thereof necessary to provide an equivalent therapeutically effective amount “in moles” of psilocin as psilocybin. The amended claims also require administering “the amount of 4-AcO-DMT” determined in step (a) to the subject.
The word “moles” does not appear anywhere in the disclosure and is therefore new matter. Applicant does not disclose or describe anywhere in the originally filed disclosure determining amounts, let alone amounts “in moles” of any chemical compound.
Further, the amended claims still require “determining” steps that are not supported by the originally filed disclosure. Specifically, amended step a) of claim 1 requires “…determining an amount in moles of 4-AcO-DMT, or a salt thereof, necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin to treat the disease or disorder". Amended step a) of claim 14 now requires “…determining an amount in moles of 4-AcO-DMT, or a salt thereof, necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin to treat the disease or disorder”.
The only disclosure of “determining” any amounts of chemical compound is found in [081] and Table 1 and relate specifically to determining the ED50 psilocybin, psilocin, a psilocin prodrug of formula (I) [CT-421X] and formula (Ia) [CT-421Y] in a specific experiment [murine Head Twitch Response]. Nowhere does Applicant disclose or describe more generally “…determining an amount in moles of 4-AcO-DMT, or a salt thereof, necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin to treat the disease or disorder" as now claimed.
The amended claims require that the amount in moles of 4-AcO-DMT, or a salt thereof, administered is less than the amount in moles of psilocybin necessary to provide the equivalent therapeutically effective amount of psilocin. As already discussed in the prior Office Action, JONES ET AL. (Front. Psychiatry, 2024, 14:1303365, 8 pages) teaches that 4-acetoxy-N,N-dimethyltryptamine (psilacetin/4-AcO-DMT), which is now recited in the amended claims, requires more than, not less than an amount of psilocybin necessary to provide the equivalent therapeutically effective amount of psilocin. In this regard, Jones et al. teach that direct comparisons of the time courses for psilocin exposure arising from psilocybin and psilacetin found that psilocybin led to 10-25% higher psilocin concentrations than psilacetin at 15-min post-injection (Abstract) and it requires a dose of 1.39 mg/kg (4.89 x 10-6 mol) psilocybin and 1.77 mg/kg (4.89 x 10-6 mol) psilacetin fumarate to yield a 1 mg/kg dose (4.89 x 10-6 mol) of psilocin (Fig. 1). Thus, it clearly requires administering more psilacetin (in grams) than the amount of psilocybin necessary to provide the equivalent therapeutically effective amount of psilocin. However, based on amounts in moles, obviously the same amounts in moles of 4-AcO-DMT and psilocybin provide the same amounts in moles of psilocin.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Response to Arguments
Applicant’s arguments completely miss the mark and do not address the basis of the rejection, which is that Applicant does not disclose or describe the claimed method steps of “…determining an amount in moles of 4-AcO-DMT, or a salt thereof, necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin to treat the disease or disorder". Amending the claims to be limited to the prodrug 4-AcO-DMT does nothing to address the lack of written description of the claimed subject matter. Further, the amount in moles of 4-AcO-DMT necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin will necessarily be equal to, not less than an amount of psilocybin necessary to provide the equivalent therapeutically effective amount of psilocin as evidenced by Jones et al.
Claim Rejections - 35 USC § 112 (Enablement)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 9-15 are 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.
Amended step a) of claim 1 requires “…determining an amount in moles of 4-AcO-DMT, or a salt thereof, necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin to treat the disease or disorder". Amended step a) of claim 14 now requires “…determining an amount in moles of 4-AcO-DMT, or a salt thereof, necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin to treat the disease or disorder”. Claims 1 and 14 also require that the amount in moles of 4-AcO-DMT, or a salt thereof, administered is less than the amount in moles of psilocybin necessary to provide the equivalent therapeutically effective amount of psilocin.
On a molar basis, the amount in moles of 4-AcO-DMT necessary to provide an equivalent therapeutically effective amount in moles of psilocin as psilocybin will be the same amount in moles as psilocybin. Assuming 100% conversion of 4-AcO-DMT and psilocybin to psilocin in vivo, 1 mol of 4-AcO-DMT and psilocybin will each yield 1 mol of psilocin. The amount in moles of 4-AcO-DMT cannot be less than the amount in moles of psilocybin necessary to provide the equivalent therapeutically effective amount of psilocin as required by the claims. In other words, if the therapeutically effective amount in moles of psilocin is 1 mol, it will require administering 1 mol 4-AcO-DMT or 1 mol psilocybin to yield 1 mol of psilocin.
At bottom, the disclosure is not enabled for defying basic stoichiometric chemistry such that a lower amount in mols of 4-AcO-DMT can be administered and yield the same amount in mols of psilocin as a higher administered amount in mols of psilocybin. Put differently, if the therapeutically effective amount in moles of psilocin is 1 mol, administration of 1 mol of psilocybin would be required to yield 1 mol of psilocin. The amount in moles of 4-AcO-DMT required to be administered to also yield 1 mol of psilocin would be determined to also be 1 mol. These amounts in moles are equal and therefore the amount in moles of 4-AcO-DMT, or a salt thereof, administered cannot be “less than the amount in moles of psilocybin necessary to provide the equivalent therapeutically effective amount of psilocin” as required by the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 8:30 am - 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 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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/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
400 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038