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 office action is in response to applicant’s reply filed on January 26, 2026.
Restrictions/Elections.
During a telephone conversation with Trevor M. Lyons on January 26, 2026, a provisional election was made without traverse to prosecute the invention of anxiety disorder. Affirmation of this election must be made by applicant in replying to this Office action.
Claim 47 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Status of Claims
Claims 40-59 are currently pending and are the subject of this office action.
Claim 47 is withdrawn since it does not encompass the elected species.
Claims 40-46 and 48-59 are presently under examination.
Priority
The present application is a CON of PCT/IB2021/000488 filed on 07/28/2021 and claims priority to provisional application No. 63/058,386 filed on 07/29/2020.
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 40-46 and 48-59 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 40-46 and 48-59 recite: “maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours”.
M.P.E.P. #2163 states: “An applicant shows possession of the claimed invention by describing the claimed invention with all its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
Claims 40-46 and 48-59 encompass a method of improving symptoms of anxiety disorders comprising the administration of therapeutically effective amounts of psilocybin or psilocin, while maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours. In other words, the claims encompass a method of treating anxiety, further limited by the Pharmacokinetic (PK) properties (achieving a certain plasma concentration after a certain period of time). Therefore, the claims encompass a genus of methods further defined by the PK outcome (achieving a certain plasma concentration after a certain period of time), which is simply a wish to know the structural limitations of such methods that will satisfy the above PK parameters (like frequency of administration, amount administered, specific pharmaceutical formulation, route of administration, etc.).
Accordingly, there is insufficient written description encompassing a: “A method for improving symptoms of a cognitive or neuropsychiatric disorder, in an individual in need thereof, comprising: a. administering to the individual a therapeutically effective amount of psilocybin or psilocin, or a pharmaceutically acceptable salt thereof; and b. maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours”, because the relevant identifying characteristics of the genus such as: frequency of administration, amount administered, specific pharmaceutical formulation, route of administration, etc., are not set forth in the specification as-filed, commensurate in scope with the claimed invention. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (see page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (see Vas-Cath at page 1116).
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddles v. Baird, 30 USPQ2d 1481, 1483. In Fiddles v. Baird, claims directed to mammalian FGF’s were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Thus, the specification fails to describe these DNA sequences. The Court further elaborated that generic statements are not adequate written description of the genus because it does not distinguish the claimed genus from others, except by function.
Per the Enzo court’s example, (Enzo Biochem., Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched “in terms of its function of lessening inflammation of tissues” which, the court stated, “fails to distinguish any steroid from others having the same activity or function” and the expression “an antibiotic penicillin” fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, “A method for improving symptoms of a cognitive or neuropsychiatric disorder, in an individual in need thereof, comprising: a. administering to the individual a therapeutically effective amount of psilocybin or psilocin, or a pharmaceutically acceptable salt thereof; and b. maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours,”, does not distinguish any particular method (like frequency of administration, amount administered, specific pharmaceutical formulation, route of administration, etc.) from other methods having the same activity or function (maintaining the plasma concentration of an active form of psilocybin or psilocin at certain level) and as such does not satisfy the written-description requirement. Applicant has not disclosed enough relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
M.P.E.P. 2163 II-A-3-a ii) states: “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i) (C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)(Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.)”.
In the instant case, Applicant discloses (see specification Example 2, pages 106-111) that the s.c. administration of different amounts of psilocybin in rats achieved the instantly claimed PK parameters. There are no examples of other conditions, like frequency of administration, amount administered, specific pharmaceutical formulation, route of administration, etc. that might result in the same or similar plasma concentration of psilocybin or psilocin. Further, there is absolutely no data for humans. So, it is not known if the plasma concentrations disclosed in claims 42-45 corresponds to rats, humans or any other individual.
Given the broad scope of the claimed subject matter (the large genus of structural limitations like frequency of administration, amount administered, specific pharmaceutical formulation, route of administration, etc.) that might satisfy certain the instant PK parameters( maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours) when administered under certain conditions, applicant has not provided sufficient written description (only Example 2 of the specification) that would allow the skilled artisan to recognize that applicant was in possession of the genus of: “methods for improving symptoms of a cognitive or neuropsychiatric disorder, in an individual in need thereof, comprising: a. administering to the individual a therapeutically effective amount of psilocybin or psilocin, or a pharmaceutically acceptable salt thereof; and b. maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours “
In the absence of structural characteristics that are shared by members of the genus of: “Methods for improving symptoms of a cognitive or neuropsychiatric disorder, in an individual in need thereof, comprising: a. administering to the individual a therapeutically effective amount of psilocybin or psilocin, or a pharmaceutically acceptable salt thereof; and b. maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours.”, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus. See University of California v. Eli Lilly and Co. 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997).
In summary, the skilled in the art will not know which conditions (like frequency of administration, amount administered, specific pharmaceutical formulation, route of administration, etc.) are required in order to satisfy the above PK limitations (maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours). In other words, the skilled in the art will not know, based on the limited information provided by Applicant, which ones of the innumerable number of possible variables (like frequency of administration, amount administered, specific pharmaceutical formulation, route of administration, etc.) are required to achieve the functional limitations of claims 40-46 and 48-59.
Applicant is trying to describe a method of treatment for what it does (maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours), rather than the structural limitations required to achieve that result (like frequency of administration, amount administered, specific pharmaceutical formulation, route of administration, etc.).
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 40-45 and 49-59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of anxiety, attention disorder and depression disorder comprising the administration of psilocybin or psilocin, does not reasonably provide enablement for the treatment of: any other type of cognitive (neurocognitive) or neuropsychiatric disorder.
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. This is a scope of enablement rejection.
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
A method for improving symptoms of a cognitive or neuropsychiatric disorder, in an individual in need thereof, comprising: a. administering to the individual a therapeutically effective amount of psilocybin or psilocin, or a pharmaceutically acceptable salt thereof; and b. maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours.
2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
Although there is prior art that suggests that the administration of psilocybin or psilocin can be effective in treating cognitive or neuropsychiatric disorders, wherein the disorder is selected from the group consisting of: anxiety, depression disorder or depression disorder (see for example Blumstock et. al. (US 2023/0113351) in the 102 rejection below and Ross et. al. (Journal of Psychopharmacology (2016) 30:1165-1180) in the 102 rejection below), a search of the literature showed no mention or suggestion that the administration of psilocybin or psilocin can be effective in treating cognitive or neuropsychiatric disorders, other than: anxiety, depression disorder or depression disorder.
In fact, a review by dos Santos et. al. (Therapeutic Advances in Psychopharmacology (2016) 6:193-213, cited by Applicant) shows that the administration of psilocybin has proven to be effective against anxiety, attention disorder and depression, and there is no mention of psilocybin being effective against any other neurocognitive or neuropsychiatric disorder.
These articles plainly demonstrate that the treatment of any cognitive or neuropsychiatric disorders (except for anxiety, depression disorder or depression disorder) comprising the administration of psilocybin or psilocin, is extremely unpredictable.
4. The breadth of the claims
Claims 40-45 and 49-59 are incredibly broad, since they encompassed almost every cognitive (neurocognitive) or neuropsychiatric disorder which includes (see specification [0084], [0108] and [0309]):
eating disorder, auditory disorder, chronic pain, bipolar disorder, post-
traumatic stress disorder (PTSD), panic disorder, phobia, schizophrenia, psychopathy, antisocial personality disorder, impulsive disorder, hyperactivity disorder (ADHD), Tourette's syndrome or autism, obsessive compulsive disorder (OCD), gambling, or aberrant sexual behavior, personality disorder (e.g., conduct disorder, antisocial personality, or aggressive behavior), autoimmune diseases, Asperger’s, inflammatory diseases, metabolic diseases such as obesity and diabetes, CNS disorders, peripheral nervous system disorders, Alzheimer’s Disease (AD), snoring, sleep apnea, restless leg syndrome, parasomnia, night terrors, sleepwalking, narcolepsy, pain, Traumatic Brain Injury (TBI), kleptomania, Friedreich’s ataxia, Parkinson’s Disease (PD), etc.
5. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 states: “The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work”.
The specification provides biological data for the effect of the administration of psilocybin on low motivation in rats (see examples 3 and 4 of the specification on pages 111 and 114 respectively), head twitch in mice (see Example 5 on page 115 of the specification) and social defeat in mice (see Example 6 on page 116).
The specification appears to be silent on a nexus between the effectiveness in these in vivo assays and the effectiveness in treating any type of neurocognitive or neuropsychiatric disorder (other than anxiety, attention and depression disorders).
As such, if there is no correlation then the examples do not constitute working examples. While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the treatment of any neurocognitive or neuropsychiatric disorder (other than anxiety, attention and depression disorders) comprising the administration of psilocybin or psilocin, is required for practice of the claimed invention.
6. The quantity of experimentation necessary
As discussed above (see: 3. the state and predictability of the art), there is a high unpredictability in the art of treating any neurocognitive or neuropsychiatric disorder (other than anxiety, attention and depression disorders) comprising the administration of psilocybin or psilocin. Based on this and in the absence of experimental evidence commensurate in scope with the claims (see: 5. The amount of direction or guidance and the presence or absence of working examples above), the skilled in the art will not accept that the administration of psilocybin or psilocin will be effective in treating any neurocognitive or neuropsychiatric disorder (except for anxiety, attention and depression disorders) as inferred by the claims and contemplated by the specification because neither the prior art nor the specification disclose a single in vitro or in vivo data that will correlate the biological activity of psilocybin or psilocin with the treatment any neurocognitive or neuropsychiatric disorder (except for anxiety, attention and depression disorders).
So, determining if the administration of psilocybin or psilocin will be effective in treating any neurocognitive or neuropsychiatric disorder (except for anxiety, attention and depression disorders)., will require assaying this compound in different assays that correlate with the treatment of different types of neurocognitive or neuropsychiatric disorders, and then further determine their efficacy in a validated animal model.
All this is undue experimentation given the limited guidance and direction provided by Applicants.
7. Conclusion
Accordingly, the invention of claims 40-45 and 49-59 does not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Claim Rejections - 35 USC § 112
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 40-46 and 48-59 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 40 recites:
“maintaining a plasma concentration of an active form of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours”.
First, what is the meaning of “maintaining”? Does “maintaining” require measuring the plasma concentration of psilocybin or psilocin, and if the plasma concentration goes below a certain value, then administer more psilocybin or psilocin in order to “maintain” the plasma concentration? If not, how is the skilled in the art supposed to “maintain” the required plasma concentrations?
Second, Applicant discloses in claims 41-45 specific psilocybin or psilocin plasma concentrations (below 10 ng/ mL or above 2 ng/mL, or above 1 ng/mL, or above 0.1 ng/mL or above 0.5 ng/mL). Do these concentrations correspond to rats? Or to humans? Or to some other species? It is obvious that the plasma concentration of a specific drug that is effective (i.e. treats anxiety) and not toxic (i.e. hallucinogenic) will depend on the species (individual) being treated. It is common knowledge that these amounts will differ from one species (i.e. human, rats, dogs, etc.) to another. So, the skilled in the art will not know to which species do these plasma concentrations correspond.
Third, claims 42-45 recite plasma concentrations “above” certain value without an upper limit. For example, claim 42 recites that the plasma concentration of psilocybin or psilocin can be “above” 2 ng/mL, which means it can be 10 ng/mL, 100 ng/mL 1000 ng/mL, etc. Are these concentrations also therapeutically effective and below a hallucinogenic threshold? It seems like high plasma concentrations of either psilocybin or psilocin (both are potent hallucinogenic) will be above the hallucinogenic threshold.
Fourth, claim 41 requires that the plasma concentration of psilocybin or psilocin be “below” 10 ng/mL. Are these plasma concentrations (“below” 10 ng/mL) effective to treat all the cognitive and neuropsychiatric disorders claimed? Except for claims 46-48, the remaining claims are very broad since essentially any cognitive or neuropsychiatric disorder is claimed (see specification [0017]-[0018], [0084], and [0108]). So, are plasma concentrations of psilocybin or psilocin “below” 10 ng/mL still effective to treat all the variety of cognitive or neuropsychiatric disorders (i.e. anxiety, Alzheimer’s disease, Parkinson disease, ADHD, bipolar disorders, pain, etc.)? It is well known in the pharmaceutical art that the effective amount of a drug (and therefore the plasma concentration) required to effectively treat a disease will vary from one disease to another.
The metes and bounds of the instant claims are not clearly defined
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 40-46 and 48-59 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Blumstock et. al. (US 2023/0113351).
The applied reference has a common Applicant/Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
For claims 40 and 49, Blumstock teaches:
A method of improving motivation or cognitive engagement in a subject in need thereof the method comprising administering to the subject a pharmaceutical composition comprising: a) a therapeutically effective and non-hallucinogenic amount of psilocybin or psilocin, wherein the psilocybin or psilocin is in an amount of about 0.1 mg to about 6 mg (a therapeutically effective amount), and b) a pharmaceutically acceptable excipient, wherein the therapeutically effective and non-hallucinogenic amount of the psilocybin or psilocin is provided to the subject in need thereof in an amount insufficient to provide a hallucinogenic experience. (see claim 1), wherein the subject is suffering from a cognitive disorder (see claim 2), and wherein the above plasma concentration lasts for more than 6 hours (i.e. more than 2 hours) (see claim 17)
For claim 41, Blumstock teaches:
The method of claim 1, wherein the therapeutically effective and non-hallucinogenic amount of the psilocybin or psilocin is provided to the subject in need thereof in an amount and/or formulation to provide a maximum plasma concentration of active form of the psilocybin or psilocin of no more than 4.5 ng/mL. (i.e. below 10 ng/mL) (See claim 13).
For claims 42-45, Blumstock teaches:
The method of claim 1, wherein the therapeutically effective and non-hallucinogenic amount of the psilocybin or psilocin is provided to the subject in need thereof in an amount and/or formulation to provide a maximum plasma concentration of active form of the psilocybin or psilocin of about 2 ng/mL to about 4.5 ng/mL (i.e. above 2 ng/mL, above 1 ng/mL, above 0.1 ng/mL and above 0.5 ng/mL) (see claim 15).
For claims 46 and 48, Blumstock teaches:
That the patient suffers from anxiety disorders (see claims 3-5).
For claims 50-53, Blumstock teaches:
The pharmaceutical composition is administered once a day (i.e. equal to 24 hours) or every alternate day (i.e. every 48 hours) (see [0095]).
For claims 54-55, Blumstock teaches:
In some embodiments the plasma concentration of psilocin will last at least 12 hours or 24 hours (see [0024]).
For claims 56-58, Blumstock teaches:
controlled released formulations (see [0109] through [0126]). And immediate release formulations (see [0127] through [0136]).
For claim 59, Blumstock teaches:
The oral administration of psilocybin or psilocin (see for example [0035]).
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 40-46, 48-50, 54-55 and 59 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ross et. al. (Journal of Psychopharmacology (2016) 30:1165-1180).
For claims 40-46, 48, 54-55 and 59, Ross teaches (see abstract and entire document) a method of treating anxiety comprising administering a composition comprising psilocybin, wherein psilocybin is orally administered at 0.3 mg/kg, which for an 80 kg adult it translates into 24 mg of psilocybin, which according to the specification corresponds to a therapeutically effective amount (see specification [0166]). The treatment results in a reduction of anxiety (i.e. improving symptoms, see page 1175 under discussion).
The prior art does not teach that the plasma concentration of psilocybin is maintained below 10 ng/mL (claim 41), or above 2 ng/mL for 2 hours or more (Claim 42), or above 0.1 ng/mL for 2 hours or more (claim 44), or above 0.5 ng/mL for 6 hours or more, or for more than or equal to 12 hours (claim 54), or for more than or equal to 24 hours (claim 55) (i.e. plasma concentration of psilocybin or psilocin (i) at or above a minimum therapeutically effective threshold in the individual and (ii) below a hallucinogenic threshold in the individual for more than or equal to two hours). However, since the treatment is effective in treating anxiety, the plasma concentration of psilocybin is considered to be above a minimum therapeutically effective threshold in the individual. Further, Ross teaches that no adverse effects (AE) were observed during treatment (see page 1176, right column, top paragraph) indicating that the plasma concentration of psilocybin is below the hallucinogenic threshold.
Further, the pharmacokinetic properties depend on the specific compound administered, the amount administered, the disease being treated among other factors, all of which are anticipated by the prior art (Ross et. al.)
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the method disclosed by Ross et. al. does not possess the same material, structural and functional characteristics of the pharmaceutical composition claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed method is different from the method taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Regarding claim 49, the prior art is silent regarding the statement: “wherein the improvement of the symptoms of the cognitive neuropsychiatric disorder ameliorates low motivation and cognitive engagement”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treating anxiety comprising the administration of 0.3 mg/kg of psilocybin ".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “improvement of the symptoms of the cognitive neuropsychiatric disorder ameliorates low motivation and cognitive engagement” appears to be the result of the process anticipated by the prior art: “a method of treating anxiety comprising the administration of 0.3 mg/kg of psilocybin ", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
For claim 50, Ross teaches the administration of 0.3 mg/kg of psilocybin at least once, which means there is always a first time.
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.
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.
Claim(s) 51-53 and 56-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross et. al. (Journal of Psychopharmacology (2016) 30:1165-1180).
The prior art teaches all the limitations of claims 51-53 (see 102(a)(1) above), except for administering psilocybin for a second time. However, dose regimen optimization is routine practice in the pharmaceutical art. Once an effective method of treatment is disclosed in the prior art (i.e. the treatment of anxiety comprising the administration of an effective amount of psilocybin) it will be obvious to optimize the dose regimen in order to achieve the best results for the patient, thus resulting in the practice of claims 51-53 with a reasonable expectation of success.
The prior art teaches all the limitations of claims 56-58 (see 102(a)(1) above), except for a controlled release formulation of psilocybin. However, controlled release formulations of active ingredients are well known in the pharmaceutical art and have been extensively used to improve the delivery of drugs and to improve the outcome of the treatment, thus resulting in the practice of claims 56-58 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
January 28, 2026.