DETAILED ACTION
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 .
Claim Status
Claims 1-3, 7, 9-10, 12-13, 17-25, 32-33, and 64 were previously pending.
A Non-Final Office Action was mailed 29 August 2025 rejecting claims 1-3, 7, 9-10, 12-13, 17-25, 32-33, and 64.
In response to the 29 August 2025 Non-Final Office Action, Applicant filed an Amendment/Request for Reconsideration received 27 February 2026.
Applicant’s 27 February 2026 Amendment/Request for Reconsideration cancelled claims 2-3 and 33, amended claims 1, 7, and 18-25, and added claims 65-67. Therefore, claims 1, 7, 9-10, 12-13, 17-25, 32, and 64-67 are now pending and currently under examination.
Priority
Acknowledgment is made of applicant's claim for priority based on the following:
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Information Disclosure Statement (IDS)
The IDS (1) filed on 27 February 2026 has been considered by the examiner. Signed copies are enclosed.
Withdrawn Claim Rejections
Applicant has amended claims 1, 7, and 18-25 and cancelled claims cancelled claims 2-3 and 33. Therefore, the previous claim rejections as follows are hereby withdrawn:
Duplicate claim warning – claim 33: withdrawn.
35 USC 112(b) rejection of claims 17-25: withdrawn.
35 USC 103 rejection of claims 1-3, 7, 9-10, 12, 18, and 33: withdrawn; 35 USC 103 rejection of claims 32 and 64 is maintained.
Double patenting rejections of: co-pending application 18/004,546 and co-pending application 18/257,014: withdrawn.
New/Maintained Claim Rejections
Applicant has amended claim 1 from a method to treat any disease to a method to treat addiction, attention deficit/hyperactivity disorder (ADHD), bipolar disorder, or depression. Therefore, the following claim rejections are necessitated by Applicant’s amendment:
35 USC § 112(a) – Scope of Enablement
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 1-3, 7, 9-10, 12-13, and 17-25 were previously rejected under 35 USC § 112(a) – Scope of Enablement. However, Applicant has amended the scope of claim 1 and cancelled claims 2-3 and 33, thereby warranting the following modification to the previously held rejection under 35 U.S.C. 112(a):
Claims 1, 7, 9-10, 12-13, 17-25, and 65-66 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 treatment of multiple sclerosis (MS) and autoimmune encephalomyelitis (EAE), does not reasonably provide enablement for treatment of addiction, ADHD, bipolar disorder, or depression as claimed.
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.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)).
These include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based
on the content of the disclosure
All of the Wands factors have been considered with regard to the instant claims
as discussed below:
(A)/(B) The breadth of the claims/The nature of the invention:
The claims are directed to a method of treating addiction, ADHD, bipolar disorder, or depression by administering a therapeutically effective amount of a pharmaceutical composition comprising:
A CNS homing peptide with an amino acid sequence selected from SEQ ID NO: 1-22; associated with,
Psilocybin, or a pharmaceutically acceptable salt, co-crystal, polymorph, hydrate, solvate, stereoisomer, or pro-drug thereof; and
Wherein the CNS homing peptide is covalently or non-covalently attached with, or is conjugated to psilocybin.
The specification defines ‘treating’ as: “includ[ing] partially or completely delaying, alleviating, mitigating or reducing the intensity of one or more attendant symptoms of a disorder or condition and/or alleviating, mitigating or impeding one or more causes of a disorder or condition ([0042]).”
The specification defines ‘a therapeutically effective amount’ as: “a compound or material or amount of the compound or material when administered is sufficient or effective to prevent, alleviate, or ameliorate one or more symptoms of a disease, disorder or medical condition being treated, and/or to prolong the survival of the subject being treated ([0041]).”
In order to practice the full scope of the invention, the claims require: 1) selecting one of the 22 CNS homing peptides from SEQ ID NOs: 1-22; 2) selecting psilocybin, or a pharmaceutically acceptable salt, co-crystal, polymorph, hydrate, solvate, stereoisomer, or pro-drug thereof; and selecting a means of attaching the homing peptide to the psilocybin or broadly claimed forms thereof that includes 3) non-covalent or covalent interactions or conjugation. One of ordinary skill must perfectly select the correct combination of 1), 2), and 3), in addition to a therapeutically effective amount, to arrive at the treatment of diseases, addiction, ADHD, bipolar disorder, and depression, which share some broad, overlapping neurobiological features, but are not generally understood to involve the same disease pathway. For instance, it is widely accepted there are three recognized types of ADHD and bipolar disorder and 6 distinct biological subtypes of depression. Addiction, not defined in the specification, is a beast of its own and can include the wide sweeping categories of: various types of substance addiction whereby ingestion of the substance chemically alters brain chemistry (alcohol, drugs, caffeine, etc.); various types of behavioral addiction (gambling, shopping, food, pornography, exercise, kleptomania, etc.); and various types of emotional/mental addiction (chemical or behavioral addiction to cope with another mental health issue or issues).
Thus, scope of the claims is astronomical.
(C)/(E) The state of the prior art/The level of predictability in the art:
The necessary steps to make and use the invention, as claimed, are to identify every subcategory that would respond to treatment or be prevented by administration of the claimed CNS homing peptide in association with psilocybin or its broadly-claimed derivatives.
The examiner recognizes that Applicant has amended claim 1 in an attempt to overcome the previous 35 USC 112(a) rejection. Furthermore, in their arguments, Applicant contends the examiner has failed to properly articulate the rationale for the enablement rejections. As proof of examiner’s failure, Applicant provides “exemplary references” reflecting the state of the prior art regarding psilocybin:
1) Ziff (Ziff, Shawn, et al. “Analysis of psilocybin-assisted therapy in medicine: A narrative
review.” Cureus 14.2 (2022));
2) Van Der Meer, P. B., et al. “Therapeutic effect of psilocybin in addiction: a systematic
review.” Front Psych. 2023; 14: 1134454." (2023);
3) Johnson, Matthew W., and Roland R. Griffiths. “Potential therapeutic effects of
psilocybin.” Neurotherapeutics 14.3 (2017): 734-740;
4) De Veen, Bas TH, et al. “Psilocybin for treating substance use disorders?” Expert review
of neurotherapeutics 17.2 (2017): 203-212; and
5) Barrett, Frederick S., and Katrin H. Preller, eds. Disruptive psychopharmacology. Springer, 2022.
Applicant is reminded the relevant “state of the prior art” is the knowledge available to a person of ordinary skill in the art as of the effective filing date of the claimed invention, which is 03 August 2020. Therefore, references 1), 2), and 5) are not applicable as evidence supporting enablement. See MPEP 2124: “it is impermissible to use a later factual reference showing the state of the art existing after the effective filing date of the claimed invention to determine whether the application is enabled or described as required under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Koller, 613 F.2d 819, 823 n. 5, 204 USPQ 702, 706 n.5 (CCPA 1980).”
3) Johnson (2017) provides the following:
- treatment-resistant major depression: a small, open-label pilot study of 12 individuals were given 10 mg oral psilocybin (session one) and 25 mg oral psilocybin (session two, one week after session one). Five of the 12 individuals were in remission at the final three-month follow-up (p. 736).
- addiction: author admits “these studies were conducted with relatively limited resources and were designed to establish safety and determine if efficacy results are encouraging enough to warrant the effort and funding required to conduct larger, randomized clinical trials.”
Smoking addiction (substance-related addiction): 15 participants were administered ~0.29 mg/kg oral psilocybin on their target quit date. A second and third optional dose of psilocybin at ~0.43 mg/kg was administered 2 and 8 weeks after the participant’s target quit date (p. 737).
Alcohol addiction (substance-related addiction): 10 participants were administered psilocybin in the context of a 12-week program of motivational enhancement therapy (p. 737). Participants were given 0.3 mg/kg psilocybin orally (p. 737). For some participants, an optional second session occurred four weeks later where psilocybin was administered orally at 0.4 mg/kg (p. 737).
Johnson does not specifically address ADHD or bipolar disorder.
4) de Veen (2017) contemplates use of psilocybin on substance abuse disorders and concludes preliminary data on ongoing alcohol and smoking addiction studies in humans shows promising effects of psilocybin administration on substance use (abstract).
De Veen addresses psilocybin the context of alcohol, drug, and tobacco dependence and depressive symptoms in terminally ill cancer patients (p. 205). Further, de Veen addresses psilocybin use and mood (p. 207).
De Veen does not specifically address ADHD or bipolar disorder.
It is reasonable to draw the limited conclusion that, as of the effective filing date of the claimed invention, administering psilocybin to treat substance-abuse disorders and depression was contemplated and put into practice. However, prior art does not contemplate the full-scope of what is claimed and is limited to very small subsets of each disorder (e.g., substance abuse is only a fraction of each and every disorder encompassed by addiction). Moreover, references as recently as February 2026 show treatment of bipolar disorder using psilocybin led to the development or worsening of manic symptoms, sleep disruptions, and anxiety (abstract).1 This post-filing evidence is used for the limited purpose of showing the art remains, up to only three months ago, extremely unpredictable.
More importantly, Applicant’s cited prior art does not contemplate anything other than psilocybin use alone. The relevant enablement question is whether the specification enables the claimed peptide-associated psilocybin compositions for treating addiction, ADHD, bipolar disorder, or depression, not whether free psilocybin administration is generally known to have psychiatric effects.
As discussed in the previous office action, Moudgil does not disclose administering CNS homing peptides with psychedelic drugs. Furthermore, Moudgil discloses these peptides are used to treat certain diseases, limited to those diseases related to the central nervous system and characterized by neuroinflammation (abstract). Moudgil produces experimental data pertaining to EAE (see Examples 1 and 2, pp. 26-29). From this, Moudgil extrapolates the CNS homing peptides, which are identical to those currently claimed, are used in treating explicitly named CNS conditions such as MS, Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, etc. (claim 49, p. 35). Moudgil is wholly silent on administering the CNS homing peptides to cure any psychiatric disorder and fails to either expressly or impliedly name addiction, ADHD, bipolar disorder, or major depressive disorder.
In conclusion, one having ordinary skill would have found it impossible to predict a priori which disease and its subtypes could be effectively treated by administering psilocybin associated with a CNS homing peptide comprising SEQ ID NOs: 1-22, and this would have been drastically more difficult considering the extremely broad scope of the instant claims.
The level of unpredictability in the art of drug development and patient treatment for any condition, including the vast spectrum of psychological disorders as claimed, is very high. In order to identify a pharmaceutical as both safe and effective for use in the general population, the skilled Artisan must validate the drug in pre-clinical testing, followed by phase I-III clinical trials to evaluate the drug's safety and efficacy in humans. Each stage of this process is fraught with complexity. With regard to both practicing the invention for the full scope effectively treating or preventing any disease by administering a composition comprising a CNS homing peptide comprising SEQ ID NOs: 1-22 that is associated with psilocybin, MPEP 2164.03 indicates that the physiological art in general is unpredictable. “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.”
(D) The level of one of ordinary skill:
One having ordinary skill in the art would have an advanced degree in biomedical research and/or clinical practice such as a Ph.D. and/or an M.D., therefore the level of skill is high.
(F) The amount of direction provided by the inventor/(G) The existence of working examples:
The specification does not provide a single working example demonstrating treatment of addiction, ADHD, bipolar disorder, or depression using the claimed pharmaceutical composition. Furthermore, there are limited details regarding the disorders the claimed method purportedly treats. For instance, addiction is not defined in the specification and mentioned only three times within a list of many other CNS diseases in 42 pages. The only detailed example is not a working example at all, but an experimental plan directed to peptide-guided delivery of psilocybin in the context of multiple sclerosis (MS) and experimental autoimmune encephalomyelitis (EAE) ([0101] and [0102]). The pathways of MS and EAE have little to no overlap with psychiatric/behavioral disorders apart from the shared similarity of involving the brain, and therefore, the disclosed MS/EAE experimental plan is not commensurate in scope with the amended claims. EAE is described as a relapsing-remitting model that mimics MS, involving PLP-induced autoimmune disease and demyelination ([0102]). The specification is silent as to why these results in an MS/EAE model would predict treatment of addiction, ADHD, bipolar disorder, or depression, nor does it provide diseases-specific endpoints, dosing regiments, patient-selection criteria, specific routes of administration, specific schedules, biomarkers, behavioral assays, or efficacy data for the claimed psychiatric/behavioral disorders.
Accordingly, the disclosure provides, at most, a prophetic plan for evaluating peptide-guided liposomal psilocybin in an MS/EAE model. It does not provide sufficient guidance for one of ordinary skill in the art to determine, without undue experimentation, which of the 22 claimed CNS-homing peptides, which type of association with psilocybin, which psilocybin form, which does, which route, which treatment schedule, and which disease-specific endpoints would successfully treat addiction, ADHD, bipolar disorder, and depression. The specification does not provide further guidance on readily identifiable properties of a disease that would allow one of ordinary skill to readily discern susceptibility to the claimed method of effective treatment. Thus, given the unpredictability in the art, the amount of guidance in the specification regarding making/using the claimed composition for effective treatment of the claimed diseases is not sufficient to enable one of ordinary skill to practice the full scope of the claimed invention.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
In view of the foregoing analysis, the quantity of experimentation to practice the full scope of the invention would be undue. The skilled artisan would be required to design and perform separate studies for each claimed disease; determine whether CNS-targeted psilocybin or its derivatives are effective for treatment; determine whether the peptide association preserves or alters psilocybin activity; determine whether each peptide or representative peptide subset provides therapeutically useful CNS delivery; determine disease-appropriate dosing and safety parameters; and establish therapeutic efficacy across the full scope of the claimed diseases. The specification does not provide sufficient working examples, representative data, or disease-specific technical guidance to reduce this experimentation to routine optimization.
Claim Rejections - 35 USC § 112(a) – Written Description
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 1, 7, 9-10, 12-13, 17-25, and 65-66 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is referred to the Guidelines on Written Description published at FR 66(4) 1099-1111 (January 5, 2001) (also available at www.uspto.gov). The following passage is particularly relevant:
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 structure and function, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
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 a genus, one must describe a sufficient number of species to reflect the variation within the genus. What constitutes a “representative number” is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. In an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
For example, MPEP 2163 states, in part,
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that “[w]ithout such disclosure, the claimed methods cannot be said to have been described.”).
The claims are directed to a method of treating addiction, ADHD, bipolar disorder, or depression by administering a therapeutically effective amount of a pharmaceutical composition comprising:
A CNS homing peptide with an amino acid sequence selected from SEQ ID NO: 1-22; associated with,
Psilocybin, or a pharmaceutically acceptable salt, co-crystal, polymorph, hydrate, solvate, stereoisomer, or pro-drug thereof; and
Wherein the CNS homing peptide is covalently or non-covalently attached with, or is conjugated to psilocybin.
With respect to the genus embraced by the claims, the phrase “treating a disease in a subject in need thereof comprising administering to the subject a therapeutically effective amount” is interpreted in view of the specification. The specification defines “treating” as “includ[ing] partially or completely delaying, alleviating, mitigating or reducing the intensity of one or more attendant symptoms of a disorder or condition and/or alleviating, mitigating or impeding one or more causes of a disorder or condition.” The specification defines the term “therapeutically effective” or “effective amount” as indicating “that a compound or material or amount of the compound or material when administered is sufficient or effective to prevent, alleviate, or ameliorate one or more symptoms of a disease, disorder or medical condition being treated, and/or to prolong the survival of the subject being treated.” Thus, the full scope of the claims requires effective treatment of addiction, ADHD, bipolar disorder, or depression by administering the composition recited in the claims. In order to practice the full scope of the invention, one having ordinary skill would need to know every subcategory of the claimed psychiatric or behavioral disorder that would be susceptible to treatment by administration of psilocybin in association with the CNS homing peptide. These disorders encompass many different molecular mechanisms driving pathology and different responsiveness to therapies. Especially exemplifying this is the broad scope of ‘addiction’ involving behavioral, substance, and/or emotional/mental subsets and no other further guidance from the specification, the claims therefore embrace treating a broad spectrum of psychiatric/behavioral disorders with not a single disclosure of one representative species.
With respect to disclosure of a representative number of species, the level of skill of an artisan in the field of disease treatment and prevention as well as the level of knowledge in the prior art and the predictability of the prior art must be considered. The artisans of skill in the field disease prevention and treatment would be a collaborative team of materials scientists, physicians, and/or biologists possessing an advanced degree in biomedicine and/or a doctor of medicine degree, thus the level of skill is high. The level of unpredictability in the art is also very high as discussed above.
In conclusion, one having ordinary skill would have found it impossible to predict a priori 1) which combination of CNS homing peptide and psilocybin and 2) at which amount would effectively treat a subject having addiction disorder, ADHD, bipolar disorder, or depression. The level of unpredictability in the art of drug development and patient treatment for any condition is very high. In order to identify a pharmaceutical as both safe and effective for use in the general population, the skilled Artisan must validate the drug in pre-clinical testing, followed by phase I-III clinical trials to evaluate the drug's safety and efficacy in humans. Each stage of this process is fraught with complexity.
Thus, one having ordinary skill would again need to empirically delineate which diseases could be effectively treated by administration of psilocybin associated with CNS homing peptides having SEQ ID NOs: 1-22. The state of the art fails to remedy the deficiencies under 35 USC 112(a) in terms of establishing applicant was in possession of the full scope of the claimed invention. In summary, the field of treating addiction, ADHD, bipolar disorder, or depression by administering psilocybin, targeted to the brain or otherwise, was highly unpredictable, and the biological arts are unpredictable in general.
As noted above, in order to satisfy the written description requirement under 35 USC 112(a), the original disclosure may provide 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 structure and function, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
In the instant case, no drawings have been made of record. The specification describes the composition in detail and states that the composition can achieve a pain-relieving effect, a psychedelic effect, or a combination thereof ([0010]). Several examples of diseases that could be treated by the composition are listed and the disease is described as follows:
The cell(s), the tissue(s), and/or organ(s) of the CNS can comprise damaged or inflamed cell(s), tissue(s), and/or organ(s). In some embodiments, the cell(s), tissue(s), and/or organ(s) of the CNS comprise the brain, the white matter, the gray matter, the brainstem, the cerebellum, the diencephalon, the cerebrum, the spinal cord, the cranial nerve, cell(s) of any of the preceding, tissue(s) of any of the preceding, or a combination thereof ([0013]).
The description above reads on any disease and does not provide further guidance as to which types of addiction, ADHD, bipolar disorder, or depression would be respond to treatment with the claimed composition comprising a CNS homing peptide in association with psilocybin. The specification provides one example that is merely prophetic in nature and does not reduce the invention to actual practice. Therefore, no examples of effective treatment of addiction, ADHD, bipolar disorder, or depression have been provided. Thus, given the unpredictability in the art, the amount of guidance in the specification regarding making/using the claimed composition for effective treatment of the claimed diseases is not sufficient to enable one of ordinary skill to practice the full scope of the claimed invention.
The description of a single species of composition used to treat a single disease (MS), which does not even fall under the scope of the claimed diseases, as well as the low predictability regarding which disease might even respond to such a composition, supports the conclusion that Applicant has not provided sufficient written description to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed invention. This is also the case because although multiple sclerosis was described, no data was presented showing that the claimed composition has any effect on this condition, let alone that it could effectively treat addiction, ADHD, bipolar disorder, or depression. The intended outcome recited in instant claim 1, “treating” by administering an “effective amount,” appears to be merely a wish or plan for obtaining the invention as claimed, consistent with the patent at issue in University of Rochester vs. G.D. Searle & Co. In view of the foregoing, the claims are rejected under 35 USC 112(a) as failing to satisfy the written description requirement.
Claim Rejections - 35 USC § 103
Claims 1-3, 7, 9, 10, 12, 18, 32, 33, and 64 were previously rejected under 35 USC § 103. However, Applicant has amended the scope of claim 1 and cancelled claims 2-3 and 33, thereby warranting the following modification to the previously held rejection:
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.
Claims 32, 64, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Moudgil (cited in prior office action as: WO 2018/132467 A1, published: 19 July 208) in further view of Idell (cited in prior office action as: “The fibrinolytic system: A new target for treatment of depression with psychedelics,” available online: 23 January 2017).
Moudgil discloses central nervous system homing peptides and uses thereof (title).
Regarding instant claims 32 and 64, Moudgil discloses isolated central nervous system (CNS)-homing peptides (p. 2) that comprise an amino acid motif selected from SEQ ID NOs: 1-21 (p. 2 and p. 3). Moudgil further discloses a scramble of SEQ ID NO: 14, represented by SEQ ID NO: 22, that shows significantly lower binding to spinal cord and brain cerebellum in EAE mice (p. 7 and Fig. 9). The CNS-homing peptides disclosed by Moudgil in SEQ ID NOs: 1-22 are identical to those sequences disclosed in the instant application represented by SEQ ID NOs: 1-22. Furthermore, Moudgil discloses the CNS-homing peptide is capable of application in a kit that includes a pharmaceutical composition ([0098]).
Regarding instant claim 67, Moudgil specifically contemplates use of the CNS homing peptide comprising any one of SEQ ID NOs: 1-22 to treat neuroinflammation associated with multiple sclerosis (p. 20, lines 19-28). Moudgil discloses a composition comprising the CNS-homing peptide covalently or non-covalently associated with a therapeutically active agent such as a drug or prodrug (p. 21 and 22). Moudgil also discloses the composition comprising the CNS-homing peptide and therapeutically active agent may be used to treat a variety of conditions associated with inflammation of the CNS, including MS (p. 22). Finally, Moudgil discloses the embodiments of the invention are used as a method to treat neuroinflammation in a subject by administering a composition comprising a CNS-homing peptide in combination with a therapeutic agent wherein the homing peptide facilitates the delivery of the therapeutic agent to inflamed CNS tissue (p. 36, claim 53).
Idell teaches the potential use of psilocybin as a 5-ht2a receptor agonist, which can improve mood and treat depression through anti-inflammatory and pro-fibrinolytic effects that include the blockage of TNF-α activity leading to decreased PAI-1 activity and increased clearance (abstract and p. 47). Idell further teaches that serotonergic classic psychedelics such as psilocybin demonstrate therapeutic effects on the brain including normalization of changes that occur as a result of chronic stress and disruption of the fibrinolytic system (p. 48). Idell hypothesizes that psilocybin may decrease PAI-1 activity via reduction of TNF-α levels, leading to disinhibition of tPA, increased mBDNF production, normalized synaptic plasticity, and resolution of depression (p. 48). Because there is an established link between peripheral and central inflammation in the pathogenesis of depression, the teachings of Idell hypothesize that the anti-inflammatory properties of psilocybin make it a candidate for depression treatment (p. 48 and 51). Finally, Idell teaches the psychedelic effects of psilocybin that include perceptual changes, labile moods vacillating from joy to anxiety, and cognitive changes (p. 50).
Therefore, regarding instant claims 34, 64, and 67, Idell makes obvious substituting the anti-inflammatory therapeutic agent in the CNS-homing peptide + therapeutic agent composition taught by Moudgil with psilocybin.
In terms of instant claims 32, 64, and 67 it would have been prima facie obvious, before the effective filing date of the claimed invention, to use the combined teachings of the references to arrive at the claimed invention. Moudgil discloses identical CNS-homing peptides as what is currently claimed in the instant invention. Furthermore, Moudgil discloses these CNS-homing peptides combined with and therapeutically active agent are used to treat a variety of conditions associated with inflammation of the CNS. Finally, Moudgil discloses the limitations of the above rejected claims in the form of a therapeutic agent associated with the CNS-homing peptide. While Moudgil does not specifically disclose the therapeutically active agent is psilocybin, Idell teaches psilocybin, its anti-inflammatory properties, and a potential use as a therapeutic to treat depression by reducing neuroinflammation. Therefore, one of ordinary skill in the art would anticipate success in substituting the generic anti-inflammatory disclosed by Moudgil with psilocybin, which is taught by Idell as a therapeutic to treat depression because of its ability to reduce neuroinflammation. A simple substitution of one known equivalent element for another obtains predictable results and a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation, but of ordinary skill and common sense (KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
Conclusion
Claims 1, 7, 9-10, 12-13, 17-25, 32, and 64-67 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.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
1 Do et al., Psilocybin use in bipolar disorder: A comprehensive review, Journal of Affective Disorders, Volume 394, Part B, 2026, 120485. DOI: https://doi.org/10.1016/j.jad.2025.120485.
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