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
Claims 16-35 are pending in the present application.
Election/Restrictions
Applicant’s election of Group I (claims 16-24; drawn to a pharmaceutical composition or kit of parts comprising N,N-dimethyltryptamine (DMT) and harmine) without traverse in the reply filed October 29, 2025 is acknowledged by the Examiner.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected invention is not allowable over the prior art as indicated below in the rejections under 35 U.S.C 102 and 103.
As the Applicant’s elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 16-24 have been examined to the extent that they embrace and are readable on the elected embodiment and the above identified nonelected species. Claims 16-24 have been found to be not allowable over the prior art.
Claims 25-35 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Priority
The following continuity data is acknowledged in the present application file:
PNG
media_image1.png
92
663
media_image1.png
Greyscale
Information Disclosure Statement
The Information Disclosure Statements filed 08/04/2023, 09/06/2023, 11/20/2023, 12/14/2023, 06/11/2024 and 07/29/2025 have been acknowledged by the Examiner. The submissions 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16 and 20-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite mixtures of naturally occurring compounds. This judicial exception is not integrated into a practical application because the claims do not require more than the natural products themselves. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims only narrow based on weight percentages and do not require materials besides naturally occurring compounds.
Applicant is directed to MPEP 2106 regarding criteria for subject matter eligibility.
Step 1
Step 1 in the analysis is “Is the claim to a process, machine, manufacture or composition of matter?” In this situation, the claims are directed to compositions of matter (Step 1: YES).
Step 2A: Prong One
The next step (2A) is a two-prong inquiry where prong one is “Does the claim recite an abstract idea, law of nature, or natural phenomenon?” In this situation, the claims embrace mixtures of naturally occurring compounds, i.e. nature-based products. The instant claims are being examined according to MPEP 803.02 regarding the product where each claim under consideration embraces a product comprising DMT, which is naturally occurring and found in nature, including plants, mammalian organisms, human brains and body fluids, and harmine, which is also found in nature.
There is no indication or requirement of the instant claims that the materials contained in the claimed compositions are different structurally from the components as found in their natural environment.
The specification states:
In order for DMT to become bioavailable, peroral formulations usually contain plant-based sources of DMT (e.g. from Psychotria viridis) combined with B-carbolines (e.g. from Banisteriopsis caapi) that act as selective reversible monoamine oxidase A (MAO-A) inhibitors to prevent degradation of DMT in the body […] DMT is a structural analogue of serotonin and is widely found in nature, including plants, mammalian organisms, human brains and body fluids (In last paragraph, page 2)
Harmine (7-methoxy-1-methyl-9H-pyrido[3, 4-b]-indole), also known as banisterine or as telepathine, is an alkaloid that occurs in a number of different plants, including harmel (Peganum harmala) or Banisteriopsis caapi. (In last paragraph, page 13)
For the reasons above, the instant claims are directed to mixtures of nature-based products. As noted in MPEP 2106.04(b)(II):
When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. […]
Furthermore, MPEP 2106.04(c)(I)(A) states:
Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. For instance, for the probiotic composition example, the mixture of Lactobacillus and milk should be analyzed for markedly different characteristics, rather than the Lactobacillus separately and the milk separately.
MPEP 2106.04(c)(II) sets forth the process for performing the markedly different characteristic analysis including the steps of “selecting the appropriate counterpart(s),” “identifying appropriate characteristics for analysis,” and “evaluating characteristics to determine whether they are ‘markedly different’”.
Each of the appropriate counterparts would be the DMT and harmine as they occur in nature.
MPEP 2106.04(c)(II)(A) notes:
Although the selected counterpart should be in its natural state, examiners should take care not to confuse the counterpart with other material that may occur naturally with, or adjacent to, the counterpart. For example, assume that applicant claims a nucleic acid having a nucleotide sequence derived from naturally occurring gene B. Although gene B occurs in nature as part of a chromosome, the closest natural counterpart for the claimed nucleic acid is gene B, and not the whole chromosome. See, e.g., Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972, 1979-81 (2013)
Accordingly, even though DMT and harmine occur in plants, the counterparts are not the entire plants. Since the instance claims embrace materials that are structurally unchanged from their natural state, the appropriate counterparts are the DMT and harmine as they occur naturally.
MPEP 2106.04(c)(II)(B) outlines identifying appropriate characteristics that can include “Biological or pharmacological functions or activities;” “Chemical and physical properties;” and “Structure and form, whether chemical, genetic or physical.”
In this situation, the only properties disclosed by Applicant appear to be the utility of the combination of DMT and harmine as suitable for treating a psychiatric, psychosomatic and/or somatic disorder. See pages 17-19.
As noted in MPEP 2112.01:
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.’ Since the structure of the naturally occurring compound is identical, the properties observed by Applicant are inherent to the compound as it occurs in nature.
MPEP 2106.04(c)(II)(C) outlines evaluating characteristics and notes:
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.
In this situation since there are no required changes relative to the naturally occurring counterpart, the instant claims lack markedly different characteristics.
For the reasons above, the instantly claimed methods do not possess markedly different characteristics relative to the naturally occurring counterpart since they have the same structures and properties of the materials that occur in nature and/or follow the steps that occur during natural eating processes. (STEP 2A, Prong One: YES).
Step 2A: Prong Two
The second prong of step 2A is (MPEP 2106.04(d)) to determine whether the claim as a whole integrates (or does not integrate) the judicial exception into a practical application. In the instant situation, the claims are generally only compositions that do not require application to any particular condition or any specific type of formulation. In the instant situation, the claims are generally only compositions that do not require application to any particular condition or any specific type of formulation. Dependent claims 20-22 specify that the combination is not formulated for peroral administration, where the DMT is formulated for intranasal administration, or where harmine is formulated buccal or sublingual administration. These limitations, however, do not require any particular characteristics since a composition or kit or parts containing DMT and harmine which is largely an oil extract could be formulated as drops for intranasal, buccal or sublingual administration.
The only significant feature otherwise part of the instant claims is the dosage requirements of instant claims 23-24; however, these limitations do not represent an integration into a practical application but rather a function of combining multiple naturally occurring components into a singular composition. A composition could be administered at a smaller dosage, multiple times throughout a period, to a subject to meet the requirements of the instant claims.
Step 2B
The final step (MPEP 2106.05(II)) is “Does the claim recite additional elements that amount to significantly more than the judicial exception?” The same section instructs:
Examiners should answer this question by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)).
The instant claims are drawn to a “composition or kit of parts” comprising DMT and harmine, each with a pharmaceutically acceptable carrier. instant claims 23-24 includes dosage requirements and Dependent claims 20-22 specify that the combination is not formulated for peroral administration, where the DMT is formulated for intranasal administration, or where harmine is formulated buccal or sublingual administration. These limitations, however, do not require any particular characteristics since a composition or kit or parts containing DMT and harmine which is largely an oil extract could be formulated as drops for intranasal, buccal or sublingual administration. Similarly, the present claims require a pharmaceutically acceptable carrier but the carrier could simply be water or another naturally occurring material that would not materially affect the properties of the compositions.
As such, neither of these claims require anything beyond the naturally occurring components.
For these reasons, the claims do not require significantly more than the exception itself. (STEP 2B: NO).
Based on the analysis above, the instant claims are deemed to be drawn to subject matter that is ineligible under 35 USC 101.
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.
Claims 16 and 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/081764 A1 (Published: 05/02/2019; Internation Filing Date: 10/26/2018).
WO ‘764 discloses provides a pharmaceutical combination product comprising DMT and harmine for the treatment and/or prevention of psychiatric and/or neurological disorders. See abstract, page 18, lines 21-29 and page 27, lines 22-33. See also page 18, lines 10-14 where WO ‘764 discloses where the combination product may also include a pharmaceutically acceptable carrier. The combination product comprises (i) a compound which promotes neurogenesis and has hallucinogenic or psychedelic side effects, and (ii) a 5-HT2A receptor antagonist which prevents, alleviates and/or removes the hallucinogenic or psychedelic side effects caused by the first compound.
WO ‘764 also discloses various forms of administration for the combination product. From page 33, lines 26-29 of WO ‘764:
In a preferred embodiment, the combination product is prepared for oral, sublingual, buccal, intranasal, intravenous, intramuscular, subcutaneous, rectal, transdermal, topical and/or inhalation-mediated administration routes, preferably oral, sublingual, inhalation-mediated and/or intranasal routes.
See the routes of administration claimed in present claims 20-22.
WO ‘764 discloses where the dosage of DMT is the combination product is provided in a range from 0.5 mg -1000 mg. See present claim 23.
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 16-24 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/081764 A1 (Published: 05/02/2019; Internation Filing Date: 10/26/2018), in view of SHROOMERY (SHROOMERY, “Re: Ayahuasca failure (Syrian Rue and MImosa) [Re: thoraxx]” March 19, 2016; retrieved from Shroomery. https://www.shroomery.org/forums/showflat.php/Number/23022449; retrieved March 19, 2016) and Ott (JONATHAN OTT: "Pharmahuasca: Human Pharmacology of Oral DMT Plus Harmine", JOURNAL OF PSYCHOACTIVE DRUGS., vol. 31, no. 2, 1 April 1999 (1999-04-01), pages 171-177, XP055842648.).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
WO ‘764 discloses provides a pharmaceutical combination product comprising DMT and harmine for the treatment and/or prevention of psychiatric and/or neurological disorders. See abstract, page 18, lines 21-29 and page 27, lines 22-33. See also page 18, lines 10-14 where WO ‘764 discloses where the combination product may also include a pharmaceutically acceptable carrier. The combination product comprises (i) a compound which promotes neurogenesis and has hallucinogenic or psychedelic side effects, and (ii) a 5-HT2A receptor antagonist which prevents, alleviates and/or removes the hallucinogenic or psychedelic side effects caused by the first compound.
WO ‘764 also discloses various forms of administration for the combination product. From page 33, lines 26-29 of WO ‘764:
In a preferred embodiment, the combination product is prepared for oral, sublingual, buccal, intranasal, intravenous, intramuscular, subcutaneous, rectal, transdermal, topical and/or inhalation-mediated administration routes, preferably oral, sublingual, inhalation-mediated and/or intranasal routes.
See the routes of administration claimed in present claims 20-22.
WO ‘764 discloses where the dosage of DMT is the combination product is provided in a range from 0.5 mg -1000 mg. See present claim 23.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
WO ‘764 does not disclose a composition of kit of parts comprising N,N-dimethyltryptamine (DMT) fumarate and harmine hydrochloride. See present claims 17-19.
WO ‘764 also does not disclose where the composition comprising harmine and a pharmaceutically acceptable carrier is formulated so that a dose of harmine is between 75 mg to 300 mg per administration. See present claim 24.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
From SHROOMERY webpage:
Aya is elusive. I struggled a lot to get a successful experience. It came down to extracting the MAOI from caapi, and converting some DMT to the salt form, mixed together in 1 capsule down the hatch.
When using plain rue and root bark, you're throwing darts. If you wanna get serious, order a gram of Harmine hcl + Harmaline hcl, and mix that with some DMT fumarate. You can dial in your dose more easily and it has always been effective that way for me and others. I use about 200mg harmalas + 150mg dmt.
This forum webpage discloses a formulation comprising a composition comprising DMT fumarate as well as harmine hydrochloride, where the formulation provides DMT fumarate in a dosage of 150 mg and harmine hydrochloride in a dosage of 200 mg.
Ott discloses combinations of different amounts of DMT and harmine hydrochloride (see page 173, Ic, 2nd par.; p. 174, Ic, 1st par) for oral administration.
Ott further discloses intravenous administration of DMT fumarate as the most effective route of administration on page 174, rc, 2nd par..
WO ‘764 discloses a composition comprising DMT and harmine for oral administration for provides a combination product for the treatment and/or prevention of psychiatric and/or neurological disorders. SHROOMERY and Ott further disclose combination compositions comprising DMT fumarate and harmine hydrochloride for oral administration. It would have been obvious to one of ordinary skill in the art to substitute DMT of WO ‘746 for DMT fumarate of SHROOMERY and/or Ott for the purpose of the treatment and/or prevention of psychiatric and/or neurological disorders. Similarly, it would have been obvious for one of skill in the art to substitute the harmine of WO ‘746 for harmine hydrochloride of SHROOMERY and/or Ott. As WO ‘764, SHROOMERY and Ott disclose working examples for demonstrating the effects of a composition comprising DMT and harmine for oral administration, there would be a reasonable expectation of success.
Therefore, the present claims are prima facie obvious.
Conclusion
Claims 16-24 are rejected.
Claims 25-35 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph McKane can be reached at 5712720699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUINCY A. MCKOY/
Patent Examiner
Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626