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 .
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.
Election/Restrictions
Applicant's election with traverse of Group II (claims 1-4, 6-7, 9, 24, 28-31, and 37-38), in the reply filed on 17 October 2025, is acknowledged. The traversal is on the ground(s) that claim 1 of Group II does not recite a method of use of a “formulation” let alone “the Group I formulation”. This is not found persuasive because comparing Group II claim 1 with Group I claim 45, it is clear that claim 1 is drawn to a method of treating a disease or condition (this is the method of “use”) of a psychedelic compound of psilocybin or psilocin (this is equivalent to “the formulation” of Group I claim 45 comprising psilocybin”). Thus, “method of use of a formulation of claim 45 Group I” is accurately summarizing the Group II claims. Please note that claim 1 says “psilocybin or [emphasis] psilocin”.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election of “psilocybin” as a species of “psychedelic compound” AND “demoralization” as a species of “disease”, in the reply filed on 17 October 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Examiner retrieved prior art against Applicants’ elected species. Therefore, in accordance with Markush search practice, the Markush search will not be extended unnecessarily to additional species in this Office Action.
Applicants’ elected species reads on claims 1-2, 4, 9, 24, 28-31, and 37-38.
Claims 45, 47, 50-51, 55, and 65, are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention of Group I, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 17 October 2025.
Please note that the non-elected composition/formulation Group I claims cannot be rejoined per rejoinder practice. Recall that had Applicants elected the formulation of Group I, then, once Group I was put in condition for allowance, the method of use Group II claims would be automatically rejoined. However, this does not work in reverse when Applicants elect the method Group (as is the instant case) and the composition Group is withdrawn.
Please therefore cancel the non-elected Group I formulation/composition claims to expedite allowance.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 3 and 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 October 2025. Also, in contrast to Applicants’ Remarks of 17 October 2025, wherein Applicants indicate that psilocin should be examined with psilocybin since one is the metabolite of the other, the Examiner responds by indicating that Applicants did not traverse the election requirement (just the Restriction Requirement) and they did not indicate claim 3 should be examined with the elected species of psilocybin. Moreover, the Restriction Requirement and Election of Species Requirements were properly justified under 35 USC 121 practice (see, for examples, pages 3 and 5 of the previous Office Action). The withdrawn claims 3 and 6-7 will be rejoined and examined once the Markush search is extended to “psilocin” following Markush search practice.
Current Status of 18/196,567
This Office Action is responsive to the amended claims of 30 October 2023.
Claims 1-2, 4, 9, 24, 28-31, and 37-38 have been examined on the merits. Claims 1-2 are original. Claims 4, 9, 24, 28-31, and 37-38 are currently amended.
Priority
The effective filing date is 13 May 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 17 January 2025; 2 May 2024; and 7 February 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
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 1-2, 4, 9, 24, 28-31, and 37-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification and/or prior art, while being enabling for treating demoralization, depression, anxiety, death anxiety, and hopelessness (from instant claim 38) with psilocybin or psilocin, does not reasonably provide enablement for treating or preventing the scope of diseases of instant claim 1 and the dependent claims thereof, with either psilocybin or psilocin. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Wands Factors used in an (scope of) enablement rejection include (per MPEP 2164.01(a)):
1. The breadth of the claims:
The broadest reasonable interpretation (BRI) of instant claim 1 is drawn to a method to treat or prevent any disease with either psilocybin or psilocin (since the method claim 1 does not define the scope of diseases to be treated and/or prevented).
2. The Nature of the Invention:
The invention belongs to medicinals, more specifically, the administration of psychedelic compounds to patients.
The BRI of instant claim 1 does not define the scope of diseases to be treated or prevented with either psilocybin or psilocin.
3. The state of the prior art:
A review of the prior art shows that psilocybin is used to treat demoralization (see prior art rejections, below).
Furthermore, the reference PSILOCYBIN (“Psilocybin Spotlight.” Global Wellness Institute. Published: April 22, 2021. Accessed on 17 February 2026. Available from: < https://globalwellnessinstitute.org/wellnessevidence/psilocybin/psilocybin-spotlight/ > ), discloses that psilocybin is used to treat depression, anxiety, death anxiety, and hopelessness (see page 3).
However, nothing in the prior art supports preventing any of the claims 37-38 diseases by administration of psilocybin or psilocin.
Moreover, nothing in the prior art supports preventing or treating an unlimited / undefined scope of diseases (as per claims 1 and others) with either psilocybin or psilocin.
4. The Level of one of ordinary skill:
The level of one of ordinary skill includes the knowledge/skill to engage in a reasonable amount of experimentation to make and use the psychedelic compositions underlying the instant method claims.
The level of one of ordinary skill also includes knowledge in using psilocybin to treat demoralization, depression, anxiety, death anxiety, and hopelessness (per prior art, above).
However, no one has skill to engage in the undue burdensome level of experimentation required to provide guidance/enablement for treating or preventing the unlimited/undefined scope of diseases/disorders of the instant method claims 1 and others.
5. The level of predictability in the art:
The art is predictable to make the instantly claimed pharmaceutical compositions. However, the art does not provide predictability as to which diseases and disorders can be treated or prevented beyond those reported, above, as known in the prior art. To generate this level of guidance, one has to engage in undue burdensome experimentation (since no predictability in the art) to test the pharmaceutical composition against every disease known to humanity to determine if the pharmaceutical composition can treat and/or prevent said disease(s). This level of experimentation would be required to match the scope of instant claims 1 and many other claims.
6. The amount of direction provided by the inventor:
While the Specification provides pharmacokinetic and absorption data for psilocybin and psilocin in rat models (see Example 1 page 33 of Specification) and shows that Applicants formulated psilocybin and psilocin for subcutaneous injection (see Example 2 page 37) and physico-chemical stability data (Example 3 pages 43-51), the Specification does not provide direction for treating or preventing the undefined scope of diseases/disorders per the BRI of instant claim 1.
7. The existence of working examples; and
While the Specification provides pharmacokinetic and absorption data for psilocybin and psilocin in rat models (see Example 1 page 33 of Specification) and shows that Applicants formulated psilocybin and psilocin for subcutaneous injection (see Example 2 page 37) and physico-chemical stability data (Example 3 pages 43-51), the Specification does not provide direction for treating or preventing the undefined scope of diseases/disorders per the BRI of instant claim 1.
8. The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The undefined scope of diseases per the BRI of instant claim 1 would require an undue amount of experimentation to use the invention as claimed to treat or prevent any disease/disorder with either psilocybin or psilocin.
Moreover, the amount of experimentation required to prevent any of the claims 37-38 diseases would be undue as well, absent evidence in the Specification or prior art.
Therefore, claims 1-2, 4, 9, 24, 28-31, and 37-38 are rejected under 35 USC 112(a) for lacking enablement for the scope of treating or preventing all diseases (per BRI of instant claim 1) and for preventing the diseases of claims 37-38 with either psilocybin or psilocin.
To render moot this scope of enablement rejection: Applicants should delete “prevent” and/or “prevention”/”preventing” from all the claims.
Furthermore, Applicants should disclose the scope of diseases or disorders in claim 1 for which Applicants believe their specification or the prior art provides guidance/enablement. Please point to specific Examples by example number and page number in Specification or specific prior art references and explain how those example(s)/reference(s) demonstrate the guidance/enablement needed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 9, and 37-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
COMPASS (WO 2020/212952 A1, provided by Applicants-and referenced in IDS of 7 February 2024),
as evidenced by:
DEMORALIZATION (Tecuta, L., et al. “Demoralization: a systematic review on its clinical characterization.” Psychol Med. (2015 Mar); 45 (4), pp. 673-691).
The prior art reference COMPASS teaches a method of treating “helplessness”, “hopelessness”, and “sense of failure/worthlessness” (see page 14) in a patient comprising administering a therapeutically effective amount of psilocybin (Applicants’ elected species of “psychedelic compound”), or a pharmaceutically acceptable salt thereof, to a patient by subcutaneous injection (see “Abstract”; “subject” is equivalent to “patient” per page 13; and, see “Administration Routes” page 45 for “subcutaneous injection”).
The evidentiary reference DEMORALIZATION is relied upon for the beneficial teachings that “demoralization” (Applicants’ elected species of “disease or condition”) is characterized by a “psychological state” characterized by “helplessness”, “hopelessness”, and “worthlessness”/”sense of failure” (see “Abstract”: “Background”).
Thus, COMPASS as evidenced by DEMORALIZATION anticipates the method of instant claim 1 administering psilocybin to a patient to treat demoralization. This anticipates instant claims 1-2 and 37-38.
Moreover, Applicants should note that the prior art reference COMPASS teaches the above method to treat a host of additional psychological, neurological, and central nervous system disorders, such as, but not limited to: “depression”, “anxiety”, and “hopelessness” (see page 14) (not Applicants’ elected species, but alternative embodiments of instant claim 38 subject to future Markush search extension). This also would anticipate instant claims 1-2 and 37-38 during future Markush search extensions to these diseases or conditions of instant claim 38 (Examiner discloses this ahead of time for compact prosecution).
The prior art reference COMPASS teaches a plurality of alternative dosage embodiments of psilocybin, including but not limited to: 5 mg and 10 mg (page 39). Each of these dosages anticipate the plurality of alternative dosage ranges of instant claim 4.
The prior art reference COMPASS teaches that the pharmaceutical composition is a formulation selected from: a solution (see page 40), thereby anticipating instant claim 9.
Therefore, the prior art reference COMPASS as evidenced by DEMORALIZATION anticipates instant claims 1-2, 4, 9, and 37-38.
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.
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.
Claims 1-2, 4, 9, 24, 28-31, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over:
COMPASS (WO 2020/212952 A1, provided by Applicants-and referenced in IDS of 7 February 2024),
as evidenced by:
DEMORALIZATION (Tecuta, L., et al. “Demoralization: a systematic review on its clinical characterization.” Psychol Med. (2015 Mar); 45 (4), pp. 673-691),
in view of:
ANSEL (Ansel, Howard C., et al. “Pharmaceutical Dosage Forms and Drug Delivery Systems.” (1999), 7th ed. Lippincott Williams & Wilkins, pp. 48-53).
The instant claim 4 is drawn to alternative embodiments of doses. Moreover, instant claims 24 and 28-30 are drawn to varying dosing regimens. Both alternative doses and dosing regimens are variables that the artisan routinely optimizes to maximize therapeutic efficacy. Instant claim 31 is drawn to increasing patient compliance by routinely optimizing routes of administration of two doses into a single subcutaneous injection.
Determining the scope and contents of the prior art.
The prior art reference COMPASS teaches instant claims 1-2, 4, 9, and 37-38, see, above.
Moreover, the prior art reference COMPASS teaches a plurality of alternative dosages of psilocybin, including 5 mg and 10 mg (see page 39). This is useful to show that the artisan could contemplate varying dosages as a routinely optimized variable (and helps to teach instant claim 4).
The prior art reference COMPASS does teach use of “first dose” and “second dose” (see page 45). This is useful to show that the artisan could contemplate varying dosing regimens as a routinely optimized variable (helps to teach instant claims 24 and 28-31).
The prior art reference ANSEL teaches that dosages (and by logical extension—dosing regimens), are variables that are routinely optimized. ANSEL teaches that physicians may increase or decrease the dosing to meet the particular requirements of the patient (see right column on page 48).
Ascertaining the differences between the prior art and the claims at issue.
While COMPASS teaches the methods of instant claims 1-2, 4, 9, and 37-38, see, above; the plurality of alternative dosages of psilocybin, including 5 mg and 10 mg (see page 39); and use of “first dose” and “second dose” (see page 45), the COMPASS reference does not explicitly teach the dosing regimens of instant claims 24 and 28-31.
While ANSEL teaches that dosages (and by logical extension—dosing regimens), are variables that are routinely optimized; and ANSEL teaches that physicians may increase or decrease the dosing to meet the particular requirements of the patient (see right column on page 48), the ANSEL reference does not explicitly teach instant claims 1, 24, and 28-31 by itself.
Resolving the level of ordinary skill in the pertinent art.
The artisan is knowledgeable in formulating pharmaceutical compositions comprising psilocybin to treat demoralization and other disorders or conditions. The artisan is also knowledgeable in how to routinely optimize dosages and dosing regimens to maximize therapeutic efficacy of the psilocybin pharmaceutical composition.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The artisan, seeing the varying doses of psilocybin taught by COMPASS (page 39) and seeing the varying dosing regimens taught within page 45 of COMPASS, would therefore view as prima facie obvious the varying doses of psilocybin of instant claim 4 and dosing regimens (including varying dosing regimens, times, and concentrations/percentages based on first and second doses and first and second absorption ½ life) of instant claims 24 and 28-30.
The artisan would view these varying doses and dosing regimens as variables that the artisan routinely optimizes to maximize therapeutic efficacy of the psilocybin pharmaceutical composition.
The Examiner interprets dosage (for example, dosage in milligrams [mg]) and dosing regimens (inclusive of: timing of doses, and concentrations/percentages of doses of first and second doses based on first and second absorption half-lives) as variables the artisan routinely optimizes to maximize treatment efficacy. Thus, the artisan would be expected to vary the doses and dosing regimens of psilocybin in order to maximize treatment efficacy. The artisan would be motivated to vary the doses and dosing regimens of psilocybin (dosage in milligrams [mg], dosing regimens, timing of doses, and concentrations/percentages of doses of first and second doses based on first and second absorption half-lives), to optimize treatment efficacy in treating demoralization, anxiety, etc (see citations and explanations, above).
This is especially true since neither the claims nor the Specification indicate how the dosages (for example, dosage in milligrams [mg]) and dosing regimens (inclusive of: timing of doses, and concentrations/percentages of doses of first and second doses based on first and second absorption half-lives) of instant claims 4, 24, and 28-30 are critical. Moreover, the artisan would look to what is known in the pharmaceutical arts which shows that the physician routinely increases or decreases dosage and dosing regimens to meet the particular requirements of the patient (see ANSEL, page 48).
Moreover, patent law views differences in concentration (herein, the dosages and dosing regimens of claims 4, 24, and 28-30) as not supporting the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). See MPEP 2144.05(II)(A).
Moreover, the artisan would be expected to optimize treatment routes and combine the first and second doses of psilocybin as a single subcutaneous injection rather than multiple injections for convenience to the patient. The artisan would be motivated to increase convenience of dosing (especially subcutaneous injections) to the patient, and hence patient compliance with treatment, by combining first and second doses into a single subcutaneous injection, thereby teaching instant claim 31.
Thus, the prior art reference COMPASS, as evidenced by DEMORALIZATION, in view of ANSEL teaches instant claims 1-2, 4, 9, 24, 28-31, and 37-38.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4, 9, 24, 28-31, and 37-38 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7, 10, 12-20, 23, 26, 33-34, 36, and 42 of co-pending Application No. 18/865,125 in view of ROUTES (CareFirstRx. “Routes of Medication Administration.” Published: Feb 21, 2019. Accessed 17 Feb 2026. Available from: < https://www.cfspharmacy.pharmacy/blog/post/routes-of-medication-administration > ), in view of: ANSEL (Ansel, Howard C., et al. “Pharmaceutical Dosage Forms and Drug Delivery Systems.” (1999), 7th ed. Lippincott Williams & Wilkins, pp. 48-53). The instant amended claims of 30 October 2023 and the reference amended claims of 30 May 2025 were used to write this rejection.
.
Determining the scope and contents of the prior art.
The reference claim 1, drawn to a method of treating or preventing any disease or disorder in a patient by administering either psilocybin or psilocin or pharmaceutically acceptable salt thereof, to said patient, teaches the instant claim 1, drawn to similar*.
Furthermore, the dosages of reference claim 7 teach those of instant claim 4.
Reference claim 33’s “solution” helps to teach the “solution” of instant claim 9.
Reference claim 26 teaches instant claims 37-38.
The reference ROUTES teaches that subcutaneous and IV injections are commonly used routes of administration (pages 1-2).
The prior art reference ANSEL teaches that dosages (and by logical extension—dosing regimens), are variables that are routinely optimized. ANSEL teaches that physicians may increase or decrease the dosing to meet the particular requirements of the patient (see right column on page 48).
Ascertaining the differences between the prior art and the claims at issue.
*The difference between reference claim 1 and instant claim 1 is over a different route of administration: intravenous (IV) infusion in reference claims and subcutaneous injection in instant claims.
While reference ROUTES teaches that subcutaneous and IV injections are commonly used routes of administration (pages 1-2), the reference does not teach the instant claim 1 by itself.
While the prior art reference ANSEL teaches that dosages (and by logical extension—dosing regimens), are variables that are routinely optimized; and teaches that physicians may increase or decrease the dosing to meet the particular requirements of the patient (see right column on page 48), ANSEL does not teach the instant claim 1 by itself.
Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill in the art involves knowledge and skill in devising different routes of administration for the same underlying psychedelic compounds and knowledge in routinely optimizing dosing, dosing regimens, and concentrations, to maximize therapeutic efficacy.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The instant claim 1 is prima facie obvious in light of the reference claim 1.
The artisan would be expected to change routes of administration for the same underlying medicinal formulation (herein: a psychedelic compound) that is shared by reference and instant claims 1 to maximize therapeutic effect for the specific patient being treated. The artisan would be motivated to change routes of administration for the same underlying psychedelic compounds since both subcutaneous and IV injections are commonly used routes of administration (see ROUTES pages 1-2) and since doctors do this all the time to maximize therapeutic efficacy for the specific patient being treated. Thus, this teaches instant claims 1-2.
The artisan would view these varying doses and dosing regimens as variables that the artisan routinely optimizes to maximize therapeutic efficacy of the psilocybin / psilocin pharmaceutical composition.
The Examiner interprets dosage (for example, dosage in milligrams [mg]) and dosing regimens (inclusive of: timing of doses, and concentrations/percentages of doses of first and second doses based on first and second absorption half-lives) as variables the artisan routinely optimizes to maximize treatment efficacy. Thus, the artisan would be expected to vary the doses and dosing regimens of psilocybin [or psilocin] in order to maximize treatment efficacy. The artisan would be motivated to vary the doses and dosing regimens of psilocybin or psilocin (dosage in milligrams [mg], dosing regimens, timing of doses, and concentrations/percentages of doses of first and second doses based on first and second absorption half-lives), to optimize treatment efficacy in treating demoralization, anxiety, etc.
This is especially true since neither the claims nor the Specification indicate how the dosages (for example, dosage in milligrams [mg]) and dosing regimens (inclusive of: timing of doses, and concentrations/percentages of doses of first and second doses based on first and second absorption half-lives) of instant claims 4, 24, and 28-30 are critical. Moreover, the artisan would look to what is known in the pharmaceutical arts which shows that the physician routinely increases or decreases dosage and dosing regimens to meet the particular requirements of the patient (see ANSEL, page 48).
Moreover, patent law views differences in concentration (herein, the dosages and dosing regimens of claims 4, 24, and 28-30) as not supporting the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). See MPEP 2144.05(II)(A).
Moreover, the artisan would be expected to optimize treatment routes and combine the first and second doses of psilocybin or psilocin as a single subcutaneous injection rather than multiple injections for convenience to the patient. The artisan would be motivated to increase convenience of dosing (especially subcutaneous injections) to the patient, and hence patient compliance with treatment, by combining first and second doses into a single subcutaneous injection, thereby teaching instant claim 31.
This is a provisional nonstatutory double patenting rejection.
Please file a Terminal Disclaimer (TD) to render moot this rejection.
Claims 1-2, 4, 9, 24, 28-31, and 37-38 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-66 of co-pending Application No. 18/865,172, in view of ROUTES (CareFirstRx. “Routes of Medication Administration.” Published: Feb 21, 2019. Accessed 17 Feb 2026. Available from: < https://www.cfspharmacy.pharmacy/blog/post/routes-of-medication-administration > ), in view of: ANSEL (Ansel, Howard C., et al. “Pharmaceutical Dosage Forms and Drug Delivery Systems.” (1999), 7th ed. Lippincott Williams & Wilkins, pp. 48-53). The reference original claims of 12 November 2024 and the instant amended claims of 30 October 2023 were used to write this rejection.
Determining the scope and contents of the prior art.
The reference claim 1, drawn to a method of treating or preventing any disease or disorder in a patient by administering either psilocybin or psilocin or pharmaceutically acceptable salt thereof, to said patient, teaches the instant claim 1, drawn to similar*.
Furthermore, the dosages of reference claim 4 teach those of instant claim 4.
Reference claim 9 teaches instant claim 9.
Reference claims 37-38 teaches instant claims 37-38.
The reference ROUTES teaches that subcutaneous and intramuscular injections are commonly used routes of administration (pages 1-2).
The prior art reference ANSEL teaches that dosages (and by logical extension—dosing regimens), are variables that are routinely optimized. ANSEL teaches that physicians may increase or decrease the dosing to meet the particular requirements of the patient (see right column on page 48).
Ascertaining the differences between the prior art and the claims at issue.
*The difference between reference claim 1 and instant claim 1 is over a different route of administration: intramuscular injection in reference claims and subcutaneous injection in instant claims.
While reference ROUTES teaches that subcutaneous and Intramuscular injections are commonly used routes of administration (pages 1-2), the reference does not teach the instant claim 1 by itself.
While the prior art reference ANSEL teaches that dosages (and by logical extension—dosing regimens), are variables that are routinely optimized; and teaches that physicians may increase or decrease the dosing to meet the particular requirements of the patient (see right column on page 48), ANSEL does not teach the instant claim 1 by itself.
Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill in the art involves knowledge and skill in devising different routes of administration for the same underlying psychedelic compounds and knowledge in routinely optimizing dosing, dosing regimens, and concentrations, to maximize therapeutic efficacy.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The instant claim 1 is prima facie obvious in light of the reference claim 1.
The artisan would be expected to change routes of administration for the same underlying medicinal formulation (herein: a psychedelic compound) that is shared by reference and instant claims 1 to maximize therapeutic effect for the specific patient being treated. The artisan would be motivated to change routes of administration for the same underlying psychedelic compounds since both subcutaneous and Intramuscular injections are commonly used routes of administration (see ROUTES pages 1-2) and since doctors do this all the time to maximize therapeutic efficacy for the specific patient being treated. Thus, this teaches instant claims 1-2.
The artisan would view these varying doses and dosing regimens as variables that the artisan routinely optimizes to maximize therapeutic efficacy of the psilocybin / psilocin pharmaceutical composition.
The Examiner interprets dosage (for example, dosage in milligrams [mg]) and dosing regimens (inclusive of: timing of doses, and concentrations/percentages of doses of first and second doses based on first and second absorption half-lives) as variables the artisan routinely optimizes to maximize treatment efficacy. Thus, the artisan would be expected to vary the doses and dosing regimens of psilocybin [or psilocin] in order to maximize treatment efficacy. The artisan would be motivated to vary the doses and dosing regimens of psilocybin or psilocin (dosage in milligrams [mg], dosing regimens, timing of doses, and concentrations/percentages of doses of first and second doses based on first and second absorption half-lives), to optimize treatment efficacy in treating demoralization, anxiety, etc.
This is especially true since neither the claims nor the Specification indicate how the dosages (for example, dosage in milligrams [mg]) and dosing regimens (inclusive of: timing of doses, and concentrations/percentages of doses of first and second doses based on first and second absorption half-lives) of instant claims 4, 24, and 28-30 are critical. Moreover, the artisan would look to what is known in the pharmaceutical arts which shows that the physician routinely increases or decreases dosage and dosing regimens to meet the particular requirements of the patient (see ANSEL, page 48).
Moreover, patent law views differences in concentration (herein, the dosages and dosing regimens of claims 4, 24, and 28-30) as not supporting the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). See MPEP 2144.05(II)(A).
Moreover, the artisan would be expected to optimize treatment routes and combine the first and second doses of psilocybin or psilocin as a single subcutaneous injection rather than multiple injections for convenience to the patient. The artisan would be motivated to increase convenience of dosing (especially subcutaneous injections) to the patient, and hence patient compliance with treatment, by combining first and second doses into a single subcutaneous injection, thereby teaching instant claim 31.
This is a provisional nonstatutory double patenting rejection.
Please file a Terminal Disclaimer (TD) to render moot this rejection.
Conclusion
No claims are presently allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625