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 371 of PCT/US2022/034544 06/22/2022, which claims benefit of the provisional application: 63214626 06/24/2021.
2. Claims 1-2, 5-8, 10-18, 20, 29-30, 38 and 59 are pending in the application.
Claim Rejections - 35 USC § 112
3. 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 1-2, 5-8, 10-18, 20, 29-30, 38 and 59 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 “psychedelic drug” and “anxiolytic” 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 “psychedelic drug” and “anxiolytic” without limitation (i.e., no named compounds), see claim 1, 16, and 29.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Liu et al. US 9,956,187, it discloses a compound
Ketamine for treating neuropsychiatric disorders, see column 30.
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 “psychedelic drug” and “anxiolytic” on pages 9-15 of the specification. There is no data present in the instant specification for the “psychedelic drug” and “anxiolytic” 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 “psychedelic drug” and “anxiolytic” 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 “psychedelic drug” and “anxiolytic” without limitation. There is no guidance or working examples present for constitutional any “psychedelic drug” and “anxiolytic” without limitation for the instant invention. Incorporation of the limitation of ““psychedelic drug” and “anxiolytic” supported by specification (i.e., claims 7 and 8) into claim 1, 16 and 29 would overcome this rejection.
4. 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
5. 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).
Claim 1, 5-8, 16 and 29 are rejected under 35 U.S.C. 103(a) as being obvious
over Vorsanger’s WO 2020/252384. It is noted that Vorsanger et al. ‘384 was filed
on 6/12/2020 and was designated to US.
Applicants claim a method of treating a neuropsychiatric disorder or cerebral palsy in a patient, the method comprising administering at least one psychedelic drug and at least one anxiolytic to the patient, wherein the neuropsychiatric disorder is not depression, anxiety, post-traumatic stress disorder (PTSD), opioid use disorder, cocaine use disorder, or post-partum depression, see claim 1. Dependent claims 5-8 further limit the scope of methods, i.e., administrating a first psychedelic drug and second anxiolytic to the patient, first psychedelic drug is selected from ketamine or NMDA, and anxiolytic is oxytocin.
Applicants claim a method of enhancing a therapeutic effect of a psychedelic drug in a patient with a neuropsychiatric disorder or cerebral palsy, the method comprising treating the patient with an anxiolytic in an amount sufficient to enhance the therapeutic effect, see claim 16.
Applicant claim a method of reducing an adverse effect of a psychedelic drug in a patient, the method comprises administering an anxiolytic to the patient in an amount sufficient to reduce the adverse effect, see claim 29.
Determination of the scope and content of the prior art (MPEP §2141.01)
Vorsanger’s ‘384 discloses a method of treating a neuropsychiatric condition
in a subject in need thereof, comprising administering to the subject:
a) a therapeutically effective amount of a first compound during a pretreatment step, wherein the first compound regulates an oxytocin receptor; and b) therapeutically effective amounts of the first compound and a second compound during a treatment step, wherein the second compound regulates an opioid receptor, a cocaine receptor, an adrenergic receptor, an N-methyl-D- aspartate receptor (NMD A) receptor, is MDMA, or a combination thereof; wherein the neuropsychiatric condition is selected from the group consisting of post- traumatic stress disorder (PTSD), opioid use disorder (OUD), cocaine use disorder (CUD), unipolar post-partum depression (PPD) and combinations thereof, see claim 1 on page 55. The first compound (i.e., anxiolytic) is oxytocin or cannabinoid receptor agonist CBD, and the scone compound (i.e., psychedelic drug) is selected from ketamine and NMDA. Vorsanger et al. ‘384 methods of use are for treating, preventing or reducing severity (i.e., enhancing therapeutic effect or reducing and adverse effect) of post-traumatic stress disorder (PTSD) in a subject in need thereof, comprising administering a therapeutically effective amount of oxytocin or ketamine to the subject, see claims 5, 11, 13, 65 and 82 on pages 56-62.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Vorsanger’s ‘384 is that the instant claims are embraced within the scope of Vorsanger’s ‘384. Vorsanger et al. ‘384 methods of use read on the instant claims 1, 5-8, 16 and 29.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1, 5-8, 16 and 29 prima facie obvious because one would be motivated to employ the methods of use of Vorsanger’s ‘384 to obtain instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of Vorsanger’s ‘384 would possess similar activity to that which is claimed in the reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
February 23, 2026