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 .
Status of Claims
Claims 86-92 are pending in the instant application.
Claims 1-85 have been canceled.
Information Disclosure Statement
The Information Disclosure Statements received January 21st, 2026 and February 23rd, 2026 have been fully considered by the examiner, except where marked with a strikethrough.
Withdrawn Objections/Rejections
Applicant’s amended abstract is sufficient to overcome the objection to the specification. This objection is hereby withdrawn.
Applicant’s cancellation of Claims 1-48 and 52-85 renders the rejection thereof under 35 U.S.C. 112(a) moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claims 1, 23, and 37-48 renders the rejection thereof under 35 U.S.C. 112(b) moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claims 23-46 renders the rejection thereof under 35 U.S.C. 101 moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claims 1-22 and 49-85 renders the rejection thereof under 35 U.S.C. 103 moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claims 1-85 renders the rejections thereof on the grounds of nonstatutory double patenting moot. These rejections are hereby withdrawn.
The following rejections are necessitated by amendment:
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 86-92 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (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.
Nature of the invention:
The invention is drawn to a method of administering 5-MeO-DMT to a patient producing breast milk to avoid exposing an infant to 5-MeO-DMT or its metabolites.
Breadth of the invention:
The scope of the claimed invention is broad. The method is drawn to administering 5-MeO-DMT to a patient producing breastmilk to avoid exposing an infant to 5-MeO-DMT or its metabolites. Therefore, the scope of the invention includes an array of potential doses of 5-MeO-DMT that could be administered, as the dosage amount is limited only to “one or more doses”. Further, the broadest reasonable interpretation of “metabolites” includes any potential metabolite of 5-MeO-DMT. This includes a number of distinct compounds for which exposure to an infant must be avoided.
State of the prior art and predictability in the art:
With respect to metabolism of 5-MeO-DMT, Shen et. al. (“Psychedelic 5-Methoxy-N,N-dimethyltryptamine: Metabolism, Pharmacokinetics, Drug Interactions, and Pharmacological Actions”, Curr Drug Metab., 2010; hereinafter referred to as Shen) represents the state of the prior art.
At Page 4, First Paragraph under “Biotransformation of 5-MeO-DMT”, Shen teaches 5-methoxyindoloacetic acid (5-MIAA), 5-hydroxy-N,N-dimethyltryptamine glucuronide, 5-hydroxyindoleacetic acid, and bufotenine as known metabolites of 5-MeO-DMT.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
With respect to the presence of 5-MeO-DMT or metabolites thereof in breastmilk, Beginning at Page 268, Example 12 provides data acquired from patients receiving at least an initial dose of 6 mg of 5-MeO-DMT. Analysis of 5-MeO-DMT, 5-MIAA, and bufotenine levels in breastmilk is provided beginning with the table starting at Page 279 of the instant specification. It is unclear the specific dosing regimen that is represented by this table, as noted at Pages 269-272, all participants in this study take at least one 6 mg dose of 5-MeO-DMT, but then follow an individualized dosing regimen to determine if subsequent 12 mg and 18 mg doses are also taken.
Within the recited time period, 5-MeO-DMT is detected in breastmilk at 8.5 hours after administration of the final dose of 5-MeO-DMT, and 5-MIAA is detected at both 8.5 and 24.0 hours after administration of the final dose of 5-MeO-DMT. With respect to Claim 92, no data is provided from a patient that pumps and discards breast milk prior to administering one or more doses of 5-MeO-DMT.
Beyond measuring levels of 5-MeO-DMT, 5-MIAA, and bufotenine, no data have been provided with respect to levels of other known metabolites of 5-MeO-DMT, such as 5-hydroxy-N,N-dimethyltryptamine glucuronide or 5-hydroxyindoleacetic acid.
Given the presence of 5-MeO-DMT and 5-MIAA within the recited time period and the lack of data with respect to the presence of known metabolites of 5-MeO-DMT, Applicant is not enabled for the instantly claimed method.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. As referenced above, a person having ordinary skill in the art would need not only to identify and/or develop suitable protocols to evaluate the levels of metabolites beyond those already tested in breastmilk, but also must evaluate a broader range of number and dosage amounts given the broad scope of doses instantly claimed, but would also need to employ these methods, with no assurance of success.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person having ordinary skill in the art would have to engage in undue experimentation to determine whether 5-MeO-DMT or metabolites thereof can be avoided by an infant when a breastfeeding patient is administered any of the broad scope of doses that read on the instant claims.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 86-92 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The phrase “avoid exposing an infant to 5-MeO-DMT or its metabolites” renders Claim 86 indefinite. No definition has been provided that would allow a person having ordinary skill in the art to reasonably ascertain the metes and bounds of this limitation. It is not readily understood the amount of 5-MeO-DMT or metabolites thereof may be present in breastmilk and still satisfy this limitation. Dependent Claims 87-91 do not further clarify this limitation, and therefore are also included in this rejection. For the same reasons, Claim 92 is rendered indefinite for the recitation of the phrase “avoid exposing an infant to 5-MeO-DMT or its metabolites”.
The phrase “from just prior to administering the one or more doses” renders Claims 86-92 indefinite. The instant specification does not define the acceptable time frame that qualifies as “from just prior to administering the one or more doses”. A person having ordinary skill in the art would not be able to reasonably ascertain the metes and bounds of this limitation.
Conclusion
Claims 86-92 are rejected.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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