DETAILED ACTION
Claims 1-66 are currently pending in the instant application.
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 .
Election/Restrictions
Applicant’s election without traverse of Group III, drawn to claims 49-66 and election of species 5-MeO-DMT in the reply filed on 02/13/2026 is acknowledged.
Claims 1-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/13/2026.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Applicants' elected species of 5-MeO-DMT does not appear allowable, therefore the search and examination of the claims has not been extended beyond the elected species (see the following 35 USC 103(a) rejection). Claim 64 does not read on the elected embodiment and is therefore considered a withdrawn claim. Since the elected embodiment is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration. It has been determined the entire scope claimed is not patentable.
Priority
PNG
media_image1.png
46
336
media_image1.png
Greyscale
Information Disclosure Statement
Applicant's Information Disclosure Statements filed on 06/22/2023, 08/06/2025, 09/16/2025 and 02/18/2026 have been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 49-63 and 65-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barrow et al (see WO 2022/235529, pub. 11/10/2022, which claims priority to 63/183,579, filed 05/03/2021, hereafter referred to as ‘579, cited in IDS filed 06/22/2023) and WITOWSKI (see WIPO Pub No. 2021/226416, published 11/11/2021 and filed 05/07/2021, which claims priority to US Prov. Appl. No, 63/021,866, filed 05/08/2020, cited in IDS filed 06/22/2023).
Barrow et al teaches a method for dosing psychedelics and teaches 5-MeO-DMT can be dosed at 1-20 mg and effects of the drug can last 1-12 hours after administration (see paragraph [0018], p. 4 of ‘579). The doses may be single doses or multiple doses or continuous dose over a period of several hours, days, weeks or months (see paragraph [0022], p. 6 of ‘579). Taking such compounds is taught to treat headache disorder, including cluster headaches and migraine headaches (see paragraph [0029], p. 8 of ‘579). Further, Barrow et al teach that the dosing regimen can include administering a starting dose to the individual, and at a set amount of time, increasing the dose a set amount and administering the increased dose to the individual, and repeating these steps over a period of time (see paragraph [0012], p. 3-4 of ‘579). Barrow et al teaches using a sub-perceptual dose and then tapering up over time (see paragraph [0013], p. 4 of ‘579). As sub-perceptual refers to effects that occur below threshold of conscious perception, this reads on the limitation that starting dose may not alleviate the patient’s symptoms.
WITOWSKI teaches compounds listed in Table (2) which includes the elected species,
PNG
media_image2.png
27
465
media_image2.png
Greyscale
, (see p. 17 and p. 28, line 22) as an active pharmaceutical ingredient in pharmaceutical compositions to treat a disease (see p. 18). These compositions are used for treating or preventing neurological, mood and abuse disorders, which includes migraine, cluster headaches and other headache disorders (see p. 21). WITOWSKI teaches formulations comprising active pharmaceutical ingredients may be in different forms (sprayable liquids, gels, creams, lotions, ointments, or transdermal patch for the dermal delivery of the active pharmaceutical ingredient) and the different forms are useful in methods relating to differing dosage amounts and/or dosage periods; providing alternative pharmacokinetic profiles, pharmacodynamic profiles, and/or safety profiles; permitting long term maintenance therapies; providing for the testing of new indications; and other potential advantageous benefits (see p. 40). WITOWSKI recites different dosages may be administered between 1 mg and up to 100 mg (see p. 40-42). Further, WITOWSKI teaches duration of therapeutic or prophylactic effect of compositions may last for at least 5 min, at least 15 min, at least 30 min, at least 60 min…at least 1 day, etc. (see p. 51). WITOWSKI also teaches that a first agent can be administered 30 min prior to administration of a second therapeutic agent
PNG
media_image3.png
548
691
media_image3.png
Greyscale
(see p. 26, which reads on claims 50-52).
WITOWSKI teaches that these compositions or compounds may be used in a method of treating or preventing a disease, including migraine, cluster headaches and other headache disorders (see p. 21). Treating refers to the eradication or amelioration of a disease or disorder, or of one or more symptoms associated with the disease or disorder and that in some embodiments the terms refer to the administration of a compound or dosage form provided herein, with or without one or more additional active agent(s), after the onset of symptoms of a particular disease (see p. 20). As preventing means inhibition or reduction of a symptom of the particular disease so subjects with familial history of a disease are candidates for preventive regimes. Further subjects who have a history of recurring symptoms are potential candidates for prevention (see p. 21). Prevention may be interchangeably with the term prophylactic treatment. As pain is a symptom of a migraine, WITOWSKI teaches that treating would also eliminate or ameliorate one or more symptoms associated with the disease, this would read on claim 66.
WITOWSKI teaches that subjects who have a history of recurring symptoms are potential candidates for prevention. Thus, it would be obvious to one of ordinary skill in the art to administer 5-MeO-DMT as therapeutic agent in a composition to treat migraine, cluster headaches and other headache disorders to a patient having at least 2 migraine headaches a month during the 3 months prior to administration. Regarding the limitations of claims 53-55, the teachings of WITOWSKI would encompass said patients as having at least 2, 3, 4 or 5 migraine headaches a month during the 3 months prior to administration as said patient would be considered a subject having a history of recurring symptoms of a headache disorder.
Regarding the limitations of claims 50-52, as Barrow et al using a sub-perceptual dose teach and the effects of the drug may last 1-12 hours after administration, so it would be obvious to administer a second dose following a set amount of time when the action of the first dose would be considered complete. Additionally WITOWSKI teaches the duration of therapeutic or prophylactic effect of compositions may last for at least 5 min, at least 15 min, at least 30 min, at least 60 min…at least 1 day, etc. (see p. 51). WITOWSKI also teaches that a first agent can be administered 30 min, 1 hr, 24 hr prior to administration of a second therapeutic agent (see p. 26). Further DAVIS (see Journal Psychopharmacology, 2018, Vol. 32, No. 7, p. 779-792, cited in IDS filed 08/06/2025) teaches range of subjective effects of 5-MeO-DMT that vary depending on the dose and route of administration with peak effects between 35 and 40 minutes after insufflation or within seconds -to-minutes when smoked. Furthermore, current unpublished reports of 5-MeO-DMT use describe inhalation as commons means of consumption with initial onset of effects within 60 sec and peak total duration of effect between 5 and 20 minutes (see 1st col. 2nd full paragraph, p. 780). Thus, it would be obvious to one of ordinary skill in the art to vary the time between first and second dose being administered as effects of the administered drug can vary based on the dose and route of administration.
Regarding claims 59-63, Barrow et al teach that 5-MeO-DMT can be dosed at 1-20 mg. Barrow et al also teach using a sub-perceptual dose and then tapering up over time. Further WITOWSKI teaches that different dosages may be administered between 1 mg and up to 100 mg (see p. 40-42) depending on alternative pharmacokinetic profiles, pharmacodynamic profiles, and/or safety profiles; permitting long term maintenance therapies; providing for the testing of new indications for the psilocybin analogues; and other potential advantageous benefits (see p. 40). Thus, it would be obvious to vary the dose of tryptamine used depending on the method through which the compound is administered and desired effects.
MPEP 2144.05, Section I teaches that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005). A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). Further regarding the dosage taught in claims 59-64, MPEP 2144.05, Section II, A also states that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
It would be obvious to one of ordinary skill in the art to try different dose of tryptamine to obtain desired results. As a range of dosing of 5-MeO-DMT is taught by the prior art, depending on the desired effects of 5-MeO-DMT and route of administration, it would be obvious to change the dosage of 5-MeO-DMT administered.
Regarding claim 56, the limitations of claim 49 are taught by the prior art of Barrow et al and WITOWSKI as discussed above. Artisans of ordinary skill may not recognize inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer. See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347-49 (Fed. Cir. 1999); accord Toro Co. v. Deere & Co., 355 F.3d 1313, 1320-21 (Fed. Cir. 2004). Thus, “wherein the patient exhibits a 30% reduction in a mean monthly number of migraines after administration of the tryptamine” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compound (5-MeO-DMT) is being administered to the same subjects (patients having acute headaches). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. Although the prior art is silent regarding “wherein the patient exhibits a 30% reduction in a mean monthly number of migraines after administration of the tryptamine” by practicing the method made obvious by the prior art: "A method of treating an acute headache and prophylactically preventing reoccurrence of acute headaches in a patient in need thereof comprising administering a first dose of tryptamine to the patient… wherein the tryptamine is 5-MeO-DMT", one will also be meeting the limitations of “wherein the patient exhibits a 30% reduction in a mean monthly number of migraines after administration of the tryptamine”, even though the prior art was silent as to these parameters.
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Although Barrow et al and WITOWSKI do not provide a single embodiment that incorporates all the limitations of the instant claims, within Barrow et al and WITOWSKI, all the limitations of the rejected claims are taught. At the timing of filing of the instant application, one of ordinary skill in the art would have a reasonable expectation of success in utilizing the compound 5-MeO-DMT in treating an acute headache, including a migraine or cluster and one of ordinary skill in the art would be motivated to use the cited compound, which is taught as an active pharmaceutical ingredient, which are used to treat or prevent said disease, which includes neurological, mood, and abuse disorders or disease (see p. 19, first paragraph of WITOWSKI) with migraine, cluster headaches specifically named as a neurological disorder (see p. 21 of WITOWSKI). Further, both Barrow et al and WITOWSKI teach administering more than one dose of 5-MeO-DMT with the second dose being administered at various time periods following the first dose. Barrow et al teaches using a sub-perceptual dose and then tapering up over time (see paragraph [0013], p. 4 of ‘579). As sub-perceptual refers to effects that occur below threshold of conscious perception, this reads on the limitation that starting dose does not alleviate the patient’s symptoms. As WITOWSKI teaches administering said compound to a patient with history of recurring symptoms, this would include patients having at least 2 migraine headaches a month during the 3 months prior to administration.
According to MPEP 2143.02, a rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). Since this is the case with the prior art cited, the instant claims have been rejected.
Conclusion
None of the claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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, Adam Milligan can be reached at 571-270-7674. 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.
/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
Prosecution Insights