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
Status of 17/734,098
Claims 16 and 25-38 are currently pending.
Priority
Instant application 17/734,098, filed 5/1/2022, does not claim priority. Claims 16 and 25-38 are thus granted the effective filing date of 5/1/2022.
Information Disclosure Statement
All references from the IDS’s submitted on 7/10/2025 and 3/10/2026 have been considered unless marked with a strikethrough.
Response to Arguments/Amendments
The amendment filed 3/10/2026 has been entered. Claims 16, 25, 26, and 37 have been amended. Claim 17 has been cancelled and claim 38 has been added, but is not considered new matter.
In the Non-Final dated 9/11/2025, claims 16-17 and 25-38 were rejected under 35 U.S.C. 112(b). In response, Applicant has cancelled claim 17, and struck through the term “about”, which overcomes one of the 112(b) rejections. However, Applicant did not address the 112(b) rejection of claim 27 and dependent claims thereof, and thus the rejection of claims 27-30 is maintained.
Claims 16 and 25-36 were rejected under 35 U.S.C. 112(a) in the Non-Final dated 9/11/2025. In response, Applicant has amended instant claim 16 to define the condition or disease being treated and specifically recite the conditions or diseases treated, which overcomes the rejection. Thus, the rejection is withdrawn.
Claims 16-17, 25, and 37 were rejected under 35 U.S.C. 102(a)(1) in the Non-Final dated 9/11/2025. In response, Applicant has amended instant claim 16 to recite where the titrating dose regimen includes a starting dose, one or more additional increased doses, and one or more therapeutic doses. This amendment overcomes the anticipation rejection because Kuypers discloses a titrating dose regimen with only two doses. Thus, the rejection is withdrawn.
In the Non-Final dated 9/11/2025, claims 26 and 31-36 were rejected under 35 U.S.C. 103. In response, Applicant has amended instant claim 16 as stated above, which also overcomes the 103 rejections. Thus, the rejections are withdrawn.
However, Applicant’s amendments necessitated the new ground(s) of rejection presented in this Office Action.
Election/Restriction
Applicant’s election of Group I, claims 1-8 and 16-24, drawn to methods of dosing a psychedelic and treating an individual with psychedelics in the reply filed 7/10/2025 is acknowledged. The Examiner notes that claims 1-15 and 18-24 are cancelled, and claims 25-38 have been added but are not considered new matter. Claims 25-38 are also method claims and have thus been added to Group I. Applicant’s election of lysergic acid diethylamide (LSD), or a salt thereof, as the single disclosed species of psychedelic and generalized anxiety disorder as the single disclosed species of condition or disease to treat in the reply filed 7/10/2025, is also acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Examination will begin with the elected species. In accordance with MPEP § 803.02, 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, the search of the Markush-type claim will be extended. 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 examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
In the Non-Final dated 9/11/2025, the elected species was searched and prior art was identified, but was overcome upon amendment to instant claim 16. Subsequent examination is based on the elected species with the additional titrating dosage limitations. See the 103 rejections below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 16 and 25-38 read on the elected species.
Claim Interpretation
Claim 16 recites the limitation, “patient”, which is defined in the instant specification as a warm-blooded animal and, in particular, mammals including man (page 5, para [0025]). Because the instant disclosure does not contain any further definition and solely contains prophetic examples without defining a patient population, the limitation is currently being interpretated in its broadest sense.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 112(b)
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 27-30 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.
Claim 27 recites a table with dosing regimens Scenarios 1, 2, and 3. The limitations of the table are unclear because the scenario and daily administration requirements are not separated for clarification nor clearly defined. It is unknown how many times a day the dosage is given in Scenarios 1 and 3. Dependent claims 28-30 do not resolve the issue and are therefore also rejected. Appropriate correction is required.
NEW OBJECTIONS AND REJECTIONS NECESSITATED BY AMENDMENT
Claim Objections
Claim 16 is objected to for a minor informality. Specifically, claim 16 recites the limitation, “eating disorder”, twice. Appropriate correction is required.
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.
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 16, 25-36, and 38 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 claims contain 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 use the invention commensurate in scope with these claims.
The instant specification does not reasonably provide enablement for treating all conditions or diseases from the group consisting of anxiety disorders, depression, headache disorder, obsessive compulsive disorder (OCD), personality disorders, stress disorders, drug disorders, gambling disorder, eating disorder, body dysmorphic disorder, pain, neurodegenerative disorders, movement disorders, autism spectrum disorder, and neurological disorders. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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 methods of treating conditions or diseases with LSD in a titrating dosing regimen, wherein the starting dose is 10 μg to 20 μg and the therapeutic dose is 100 μg or 200 μg.
Breadth of the Claims
The claims are broadly directed to the use of LSD to treat a laundry list of conditions or diseases selected from the group consisting of anxiety disorders, depression, headache disorder, obsessive compulsive disorder (OCD), personality disorders, stress disorders, drug disorders, gambling disorder, eating disorder, body dysmorphic disorder, pain, neurodegenerative disorders, movement disorders, autism spectrum disorder, and neurological disorders. The genus of conditions or diseases Applicant claims to be able to be treated by titrating doses of LSD disclosed in the instant application embodies claim 1 and is further elucidated in para [00033] of the instant specification:
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Level of Ordinary Skill in the Art
The artisans using Applicant’s method would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical arts, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
For example, the conditions or diseases from the group affect different organs and have different methods of growth and/or harm to the body, and different vulnerabilities. The skill thus depends on the condition or disease. There are some diseases where the skill level is high and there are multiple successful therapeutic treatments. The mechanism of action in these situations, however, is not necessarily the same as is alleged for these compounds.
State of the Prior Art and Predictability in the Art
There are different types of treatments available for the conditions and diseases recited in instant claim 16, such as anxiety disorders, including talk therapy, medications, and lifestyle adjustments. Not every treatment option is effective for every patient, and for some patients, combinations of the above treatment options are necessary to manage their symptoms. Therefore, the ability to treat the conditions and diseases of the instant disclosure is unpredictable, much less the ability to anticipate which patients are at risk for the conditions and diseases.
A review of the prior art identifies Kuypers (Kuypers, K. P. C. Ther. Adv. Psychopharmacol. 2020, 10, 1-15) as close prior art, which discloses an analysis of studies on microdosing psychedelics, including lysergic acid diethylamide (LSD) (abstract). Specifically, Kuypers teaches the treatment of people suffering from affective disorders, which are defined as depression and anxiety disorders (page 2, right column, top paragraph). Moreover, Kuypers teaches that patients reported an increase in anxiety with a 20 ug dose of LSD, and a decrease in anxiety with a 200 ug crossover dose of LSD, indicating treatment at low dosages of LSD does not treat anxiety and in fact worsens it. No other evidence of treating conditions or diseases selected from headache disorder, obsessive compulsive disorder, personality disorders, stress disorders, drug disorders, gambling disorder, eating disorder, body dysmorphic disorder, pain, neurodegenerative disorders, movement disorders, autism spectrum disorder, and neurological disorders was provided in Kuypers.
Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Furthermore, there is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the numerous conditions or disease claimed herein. That a single compound can be used to treat all of the conditions and diseases embraced by the claims is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating any or all the diseases or disorders by administering the instant claimed compounds.
Amount of Direction Provided and Working Examples The only direction or guidance present in the instant specification is the listing of diseases applicant considers as treatable by the claimed compounds and prophetic examples of oral and patch dosing schedules. No examples of treating a disease, working or prophetic, are present in the instant disclosure, let alone examples of treating the conditions or diseases recited in the instant claims. The disclosure merely provides prophetic dosing schedules. (See MPEP 2164.02 (“Compliance with enablement requirement of 35 USC 112, first paragraph, does not turn on whether an example is disclosed… Lack of a working example, however is a factor to be considered, especially in a case involving an unpredictable and undeveloped art”.)
Quantity of Experimentation Needed to Make or Use the Invention Based on the Content of the Disclosure
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what conditions or diseases, out of all conditions or diseases embodied by the instant claims, would be benefited and would furthermore then have to determine which of the titrating dosing schedules would treat each claimed condition or disease.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
The specification fails to provide enough support of the broad use of the methods of administering LSD in a titrating dose of the claims in the treatment of conditions or diseases selected from the group of anxiety disorders, depression, headache disorder, obsessive compulsive disorder (OCD), personality disorders, stress disorders, drug disorders, gambling disorder, eating disorder, body dysmorphic disorder, pain, neurodegenerative disorders, movement disorders, autism spectrum disorder, and neurological disorders as a result necessitation one of skill to perform an exhaustive search for which diseases can be treated by what titration of the invention to practice the claimed invention.
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 an 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 of skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compounds encompassed in the instant claims, with no assurance of success.
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, 25-26, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Kuypers (Kuypers, K. P. C. Ther. Adv. Psychopharmacol. 2020, 10, 1-15) further in view of Gasser (Gasser, P. Archives Suisses de Neurologie et de Psychiatrie. 1996, 147, 59-66). This rejection applies to the elected species.
Determining the scope and contents of the prior art
The reference Kuypers teaches an analysis of studies on microdosing psychedelics, including lysergic acid diethylamide (LSD) (abstract). Specifically, Kuypers teaches the oral administration of LSD free base to patients with anxiety in a 20 μg dosage or a crossover 200 μg dosage (Table 1, Entry 5). It was reported that the low dose increased anxiety; however, anxiety decreased with the high dosage, indicating treatment. This helps teach claims 16, 25, and 37.
With respect to claim 26, Kuypers teaches multiple other studies administering LSD tartrate to patients (Table 1) and the conversion of LSD free base to LSD tartrate (page 12, 1st paragraph).
Regarding claim 38, Kuypers teaches typical oral doses of LSD in humans are 100-200 μg (page 1, Introduction).
The reference Gasser teaches a study of psycholytic psychotherapy, which is talk therapy supplemented by experiences in an altered state of consciousness by LSD (title, abstract). Specifically, Gasser teaches administration of LSD to patients over 1 to 16 sessions, the average being 6.8 sessions, with LSD dosages of 100-400 μgs (page 61, bottom left column and Table II, translated document). Approximately 14.9% of patients had anxiety (page 62, first paragraph, translated document) and six out of ten patients felt less fear of death and dying after treatment (page 64, Table VIII, translated document).
Ascertaining the differences between the prior art and the claims at issue
Kuypers fails to teach a titrating dose with more than two doses of LSD to treat anxiety and fails to teach LSD tartrate in the specific anxiety study above.
Gasser fails to teach the starting dose of 10 μg to 20 μg and fails to teach LSD tartrate to treat anxiety.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development methods of treatment of anxiety with LSD. An artisan possess the technical knowledge necessary to make adjustments to the methods to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said methods of treatment of anxiety with LSD and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to one of ordinary skill in the art to combine the methods of Kuypers and Gasser because they both teach methods for the same purpose with the same drug. One of ordinary skill in the art would be motivated before the effective filing date to combine the teachings of Kuypers and Gasser in order to develop additional anxiety treatments and explore the scope of LSD administration. A skilled artisan would have readily predicted that the combination of the methods would improve known anxiety treatments.
Claims 31-33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Kuypers (Kuypers, K. P. C. Ther. Adv. Psychopharmacol. 2020, 10, 1-15) in further view of Gasser (Gasser, P. Archives Suisses de Neurologie et de Psychiatrie. 1996, 147, 59-66) and “What are Medication Blister Packs?” Drug Package LLC, Oct. 26, 2021, herein after “Drug Package LLC”. This rejection applies to the elected species.
Determining the scope and contents of the prior art
The references Kuypers and Gasser teach as disclosed above, and at least those teachings are incorporated herein.
The reference Drug Package LLC teaches information about medication blister packs, and specifically teaches doses of medication within plastic bubbles and backed by foil (page 2, line 2) in single dose and multi-dose options (page 2, line 15). Further, the blister packs can be organized by day and time of day (page 2, lines 14 and 15) and can accommodate varying sizes of pills (page 2, line 17).
Ascertaining the differences between the prior art and the claims at issue
The references Kuypers and Gasser fail to teach as disclosed above, and at least those teachings are incorporated herein. Additionally, Kuypers and Gasser fail to teach the doses separated in packaging, whereas Drug Package LLC fails to teach the treatment of anxiety with LSD.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development dosing during treatment of anxiety with LSD. An artisan possess the technical knowledge necessary to make adjustments to the dosing to enhance its effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said dosing during treatment of anxiety with LSD and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to one of ordinary skill in the art to combine the methods of treatment of anxiety with LSD of Kuypers and Gasser with the blister pack separated dosages of Drug Package LLC because blister packaging is known in the pharmaceutical arts as a common drug dispersal method. One of ordinary skill in the art would have been motivated before the effective filing date to combine the teachings of Kuypers, Gasser, and Drug Package LLC to expand the treatment options available for anxiety by increased adherence to a dosing schedule. A skilled artisan would have reasonably predicted that such a combination would result in successful, or improved, treatment of anxiety with LSD in light of the teachings of Kuypers, Gasser, and Drug Package LLC.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Kuypers (Kuypers, K. P. C. Ther. Adv. Psychopharmacol. 2020, 10, 1-15) in further view of Gasser (Gasser, P. Archives Suisses de Neurologie et de Psychiatrie. 1996, 147, 59-66), “What are Medication Blister Packs?” Drug Package LLC, Oct. 26, 2021, Date Accessed: Aug. 27, 2025, herein after “Drug Package LLC”, and Universitatsspital Basel (WO 2021/225796, cited in the IDS of 7/10/2025, herein after “Basel”). This rejection applies to the elected species.
Determining the scope and contents of the prior art
The references Kuypers, Gasser, and Drug Package LLC teach as disclosed above, and at least those teachings are incorporated herein.
The reference Basel teaches methods of treatment with MDMA and psychedelics, such as LSD (abstract), and specifically teaches that administration can be in separate dosage forms or in the same dosage form in order to achieve the desired effects (page 9, para [00043]).
Ascertaining the differences between the prior art and the claims at issue
The references Kuypers, Gasser, and Drug Package LLC fail to teach as disclosed above, and at least those teachings are incorporated herein.
Additionally, Kuypers and Gasser fail to teach the doses separated in packaging and the multiple dosage forms and Drug Package LLC fails to teach the treatment of anxiety with LSD and the multiple dosage forms, whereas Basel fails to teach the treatment of anxiety with LSD and dosages in separate packaging.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development dosing during treatment of anxiety with LSD. An artisan possess the technical knowledge necessary to make adjustments to the dosing to enhance its effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said dosing during treatment of anxiety with LSD and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (A), it would have been prima facie obvious to one of ordinary skill in the art to combine the treatments of Kuypers, Gasser, and Drug Package LLC, as stated above, with the multiple dosage forms of Basel because psychedelics are known to be administered in multiple dosage forms to expand the scope of anxiety treatments and increase adherence to regimens. One of ordinary skill in the art would have been motivated before the effective filing date to combine the teachings of Kuypers, Gasser, Drug Package LLC, and Basel to expand the treatment options available for anxiety by increased adherence to a dosing schedule by offering additional dosage forms. A skilled artisan would have reasonably predicted that such a combination would result in successful, or improved, treatment of anxiety with LSD in light of the teachings of Kuypers, Gasser, Drug Package LLC, and Basel.
Conclusion
No claims are 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.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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