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 .
DETAILED ACTION
Priority and Status of Claims
1. This application is a 371of PCT/US2021/051005 09/18/2021, which claims benefit of 63/080,679 with a filing date 09/18/2020.
2. Claims 45-56 and 60-64 are pending in the application.
Responses to Election/Restriction
3. Applicant’s election without traverse of claims 45-56 and 60-64, in the reply filed on November 13, 2025 is acknowledged. Election of a compound psilocin as a single species is also acknowledged.
Claims 45-56 and 60-64 are pending in the application, and are prosecuted in the case.
The requirement is still deemed proper and therefore is made FINAL.
Claim Rejections - 35 USC § 112
4. 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.
Claims 45-56 and 60-64 are rejected under 35 U.S.C. 112(a) or 35 U.S.C.
112, first paragraph (pre-AIA ), because the specification does not reasonably provide
enablement of the instant “serotonin agonist”, “indirect serotonin receptor antagonist” and
“entactogen” without limitation (i.e., no named compounds). The specification does not
enable any person skilled in the art to which it pertains, or with which it is most nearly
connected, to make the invention commensurate in scope with these claims.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is a method of use using “serotonin agonist” and “entactogen” without limitation (i.e., no named compound), see claims 45, 51 and 60.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Ameri et al. US 2023/0210762 A, it discloses that
psilocybin as serotonin agonist, see column 14.
The amount of direction or guidance present and the presence or absence
of working examples
The only direction or guidance present in the instant specification is the description of a number of “serotonin agonist” and “entactogen” on pages 2-4 of the specification. There is no data present in the instant specification for “serotonin agonist”, “indirect serotonin receptor antagonist” and “entactogen” without limitation (i.e., no named compound).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “serotonin agonist”, “indirect serotonin receptor antagonist” and “entactogen” are without limitation (i.e., no named compound).
The quantity or experimentation needed and the Ievel of skill in the art
While the level of the skill in the chemical arts is high, it would require
undue experimentation of one of ordinary skill in the art to resolve any “serotonin agonist” and “entactogen” without limitation. There is no guidance or working examples present for constitutional any “serotonin agonist” and “entactogen” without limitation for the instant invention. Incorporation of the limitation of “serotonin agonist”, “indirect serotonin receptor antagonist” and “entactogen” (i.e., claims 47-48) supported by specification into claims 45, 51 and 60 would overcome this rejection.
5. 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.
Claims 47-48, 53-54 and 62 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 pre-AIA the applicant regards as the invention.
Claims 47-48, 53-54 and 62 independently recite the limitation “comprises” is ambiguous and indefinite, i.e., see line 1 in claim 45. A compound claim cannot use open-ended language when defining the parameters of the gene or compound, see M.P.E.P. 2111.03. Replacement of the limitation “comprises” with a limitation “is” would overcome this rejection.
6. 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 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.
Claim Rejections - 35 USC § 103
7. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 45, 47-48, 50-51, 53-54, 60 and 62 are rejected under 35 U.S.C. 103(a)
as being obvious over Ameri et al. US 2023/0210762 A1, and Russ et al. US
2020/0147038 A1 It is noted that both Ameri et al. ‘762 and Russ et al. ‘038 are 102
(a)(2) references.
Applicant claim a composition for treating a serotonin receptor related disease or condition, comprising a therapeutically effective amount of a direct receptor serotonin agonist compound and an entactogen, wherein said direct serotonin agonist and entactogen modulate activity of the 5-HT2A serotonin receptor in said subject, wherein said serotonin receptor is activated to approximately the same level as the activation by said direct receptor serotonin agonist without said entactogen, and at least one pharmaceutically acceptable carrier, see claim 45. Dependent claims 47-48 and 50 further limit the scope of composition, i.e., the direct serotonin receptor agonist is psilocybin, or psilocin in claim 47, entactogen is MDMA in claim 48, and the diseases or conditions are selected from eating disorder, post- traumatic stress disorder (PTSD), anxiety or deficit-hyperactivity disorder in claim 50 .
Applicants claim a composition for treating a serotonin receptor related disease or condition, comprising a therapeutically effective amount of a direct receptor serotonin agonist compound and an indirect serotonin receptor agonist compound, wherein said direct serotonin agonist and said indirect serotonin receptor agonist modulate activity of the 5-HT2A serotonin receptor in said subject, wherein said serotonin receptor is activated to approximately the same level as the activation by said direct receptor serotonin agonist without said indirect serotonin receptor agonist, and at least one pharmaceutically acceptable carrier, see claim 51. Dependent claims 53-54 further limit the scope of composition, i.e., the direct serotonin receptor agonist is psilocybin, or psilocin in claim 53, indirect serotonin receptor agonist is MDMA in claim 54.
Applicants claim a composition for treating a serotonin receptor related disease or condition, comprising the step of: a therapeutically effective amount of a psilocybin, or psilocin compound and an indirect serotonin receptor agonist compound, wherein said psilocybin, or psilocin compound and an indirect serotonin receptor agonist compound modulate activity of the 5-HT2A serotonin receptor in said subject; wherein said 5-HT2A serotonin receptor is activated to approximately the same level as the activation by said psilocybin, or psilocin compound without said indirect serotonin receptor agonist; and at least one pharmaceutically acceptable carrier, see claim 60.
Dependent claims 62 further limit the scope of composition, i.e., the indirect serotonin receptor agonist is MDMA.
Determination of the scope and content of the prior art (MPEP §2141.01)
Ameri et al. ‘762 disclose a composition comprising psilocin, psilocybin and
MDMA, and it is used for treating depression, anxiety, cluster headache and post-
traumatic stress disorder (PTSD), see claim 1 and Examples 1-4 in column 16, and
section [0145] in column 14.
Russ et al. ‘038 discloses a composition comprising psilocybin and MDMA, and
it is used for treating mental disorders selected from depressed mood, weight gain,
anxiety, eating disorder, post- traumatic stress disorder (PTSD), see column 2, sections
[0081] and [0083] in column 10, and claims 1, 53-54 and 92 in columns 34 and 36-37.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Ameri et al. ‘762 and Russ et al. ‘038 is that the instant claims are embraced within the scope of Ameri et al. ‘762 and Russ et al. ‘038. Ameri et al. ‘762 and Russ et al. ‘038 compositions and methods of use read on the instant compositions in claims 45, 47-48, 50-51, 53-54, 60 and 62.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 45, 47-48, 50-51, 53-54, 60 and 62 prima facie obvious because one would be motivated to employ the compositions and methods of use of Ameri et al. ‘762 and Russ et al. ‘038 to obtain instant invention.
The motivation to make the claimed compositions and methods of use derived from the known compositions and methods of use of Ameri et al. ‘762 and Russ et al. ‘038 would possess similar activity to that which is claimed in the reference.
Claim Objections
Claims 48-49, 54-55 and 62-63 are objected to because of the following
informalities: replacement of the term “MDMA” with a term “ 3,4-Methylene-dioxymethamphetamine” would obviate the objection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1629
December 01, 2025