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
This is a response to Applicant’s communication filed on April 27, 2023. Application No. 18/308,357, is a U.S. Nonprovisional application filed on April 27, 2023, and claims the benefit of U.S. Provisional application No. 63/335,400, filed April 27, 2022. Claims 1-40 are pending.
Claim Rejections - 35 USC § 102(a)(1)
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.
Claims 1, 2, 6-13, 16-21, 22, 26-33, and 36-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Layzell et al., US2022/0062238 A1, (publ’d March 3, 2022). Layzell discloses both a kit (Layzell et al, US ‘238 publc’n, para. [0164]) as well as a method of treating, ameliorating, or preventing depression (Id., para. [0002]; see also Id., para. [0139]-[0140]) in a subject in need thereof, the method comprising: administering parenterally (Id., para. [0018]) to the subject an effective amount of a dimethyltryptamine (DMT) compound (Id., Abstract), wherein the DMT compound is selected from the group consisting of DMT, a DMT salt, a DMT solvate, (see Id. para. [0078]) an isotopically labelled derivative of DMT (Id., para. [0056]; see also Id., para. [0086]), or any mixture thereof. (Id.)
Claims 1-3, 6-13, 16-19, 21-23, 26-33, and 36-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rands et al., US2021/0395201 A1, (publ’d Dec. 23, 2021). Rands discloses both a kit (Rands et al, US ‘201 para. [0164]) as well as a method of treating, ameliorating, or preventing depression (Id., para. [0002]; see also Id., paras. [0258]) in a subject in need thereof, the method comprising: administering parenterally (Id., para. [0247]) to the subject an effective amount of a dimethyltryptamine (DMT) compound (Id., Abstract), wherein the DMT compound is selected from the group consisting of DMT, a DMT salt, a DMT solvate, (see Id. para. [0218]) an isotopically labelled derivative of DMT (Id., para. [0253]), or any mixture thereof; as well as dosages (Id., para. 0004]).
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.
a
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.
Claims 1-40 are rejected under 35 U.S.C. 103 as being unpatentable over Layzell et al., US2022/0062238 A1 and Rands et al., US2021/0395201 A1 (cited in the 102(a)(1), rejections above), in view of Small Pharma LTD (2020), SPL026 (DMT Fumarate) in Healthy Subjects and MDD patients, (Publ’d Dec. 17, 2020), retrieved from the internet November 6, 2025 at: https://clinicaltrials.gov/study/NCT04673383, (hereafter Small Pharma Ltd (2020) study) and Leucht et al., Translating the HAM-D into the MADRS and Vice Versa with Equipercentile Linking, 226 J. of Affective Disorders 326-331 (2018). The difference between the prior art and present invention are the methods of administration and measuring outcomes (i.e., claims 4, 5, 14, 15, 24, 25, 34 and 35).
In this case, both Layzell and Rands disclose methods and kits for treating depression comprising the administration of DMT. (See the 35 U.S.C. 102(a)(1) Rejections, above.) The Small Pharma Ltd (2020) study discloses administering at least a first dose of an independently selected DMT compound and a second dose of an independently selected DMT compound, and wherein the dosage of the second dose in terms of DMT content is higher than the dosage of the first dose in terms of DMT content, wherein optionally the first dose and the second dose are at least 48 hours apart from each other. Furthermore, The Small Pharma Ltd. (2020) study discloses the results on the Montgomery Asberg Depression Rating Scale (MADRS). Leucht translate the MADRS scores of 12, 26, and 34, (resulting from the Small Pharm Ltd (2020) study) to respectively correspond to an improvement of 10, 20, 25 points on the HAM-D scale as claimed by the present invention. Accordingly, all the elements of the present invention were known in the prior art at the time of the invention. In this case, it would have been obvious to the ordinary artisan at the time of the invention to combine all the known prior art elements according to known methods to yield predictable results.
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.
Claims 1-40 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method/kit for treating depression, the specification does not reasonably provide enablement for a method of preventing depression. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
In this case, the claims include a kit/method for preventing depression. However, the specification teaches that DMT treatment may result in better depression outcomes. (See Specification, Figs. 1-29.) There is no evidence or suggestion indicating that depression is preventable. In addition, the prior art fails to provide compensatory guidance. There is no correlation between administering DMT to treat depression and preventing depression, as claimed. Accordingly, it would require undue experimentation for the artisan to practice the invention as broadly claimed.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625