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
Filing Receipt and Priority
The filing receipt mailed 04/17/2024 states that the instant application claims benefit of provisional application 63/487,323, filed 02/28/2023.
The provisional application supports the instant claims. Therefore, the effective filing date is 02/28/2023.
Information Disclosure Statement
The information disclosure statement submitted 03/05/2025 has been considered.
The third party submission submitted 02/27/2025 has also been considered.
Restriction and Species Election
Applicant’s election of Group II, claims 6-14 without traverse is acknowledged.
Applicant’s election of i) psilocybin and ii) mild cognitive impairment with traverse is acknowledged.
Applicant argues that the instantly claimed methods are drawn to “methods for treating dementia and mild cognitive impairment” and that “a search for publications in one of these species should reveal relevant publications for other forms of cognitive impairment.”
Applicant additionally argues that “publications relating to psilocybin should reveal publications relating to other psychedelic tryptamines” and that “psilocybin is not typically found in nature as the only psychedelic tryptamine in a natural product” and “psilocybin is typically found with other psychedelic tryptamines such as psilocin, baeocystin, and norbaeocystin.”
This is not persuasive because the claims includes methods to treat anxiety disorder, eating disorder, addiction, depression, and traumatic brain injury. Art that could be applied to dementia or Alzheimer’s disease could not be applied to any of anxiety, eating disorders, addiction, depression or traumatic brain injury.
Regarding the election psilocybin, applicant’s arguments are not persuasive as it is not clear from the remarks how the different psychedelics are alternatives of each other. Additionally, baeocystin and norbaeocystin are distinct from psilocin in that psilocin lacks the phosphate group and contains methyl groups where baeocystin and norbaeocystin have a phosphate group and hydrogens or singular methyl groups. Psilocybin itself also has a phosphate group which makes it distinct from psilocin.
Claims 1-5 and 14 are withdrawn being drawn to non-elected inventions (claims 1-5) and non-elected species (claim 14).
At examiner’s discretion, search and examination has been broaden to include “frontotemporal dementia” and “Alzheimer’s disease”.
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 6-13 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.
Indefiniteness – subject in need thereof
Claim 6 states “A method for treating a human affliction comprising administering to a human subject….”. The term “subject” is not explicitly defined within the specification. The closest that the specification comes to defining “subject” is found in para. [0036] which states “As used herein a subject is ‘treated’, or subjected to ‘treatment’, when an earnest attempt is made to alleviate a medical disorder or disease.” The specification, at least, implies that subjects to be treated are suffering from a human affliction. However, this is not reflected within the claim.
The broadest reasonable interpretation includes any human subject, even those who do not suffer from the human affliction to be treated. While the specification assumes subjects suffering from an affliction, the claim requires language that would indicate that the subject is in need of treatment.
As claims 7-13 are dependent on claim 6, they are also rejected.
Indefiniteness – time period
Claim 6 states “wherein said psychedelic tryptamine compound, or pharmaceutically acceptable salt thereof, and said D-cycloserine, or pharmaceutically acceptable salt thereof, are both administered within a 30 minute time period…”. The instant claim language is not clear as to when the 30 minute period starts. The claim language is open to interpretation and can mean “within a 30 minute time period of each other” or of another unclaimed and/or unspecified event within the method.
Examiner suggests amending the claim to specify the timing of the administration.
As claims 7-13 are dependent on claim 6, they are also rejected.
Indefiniteness – Administration
Claim 6 states “wherein neither said psychedelic tryptamine…nor said D-cycloserine…is administered more than twice within a seven day period.”
Claim 9 states “The method of claim 6, wherein said D-cycloserine or pharmaceutically acceptable salt thereof, and said psychedelic tryptamine compound or pharmaceutically acceptable salt thereof, are both administered to said human subject multiple times¸ wherein the interval between successive administering is at least 64 hours.”
A seven day period contains 168 hours. If timing of a first administration is marked as the start of the seven day period, as in claim 6, the “multiple times” can lead to a max of 3 administrations of psilocybin and D-cycloserine. The timing of administrations would be, first, at hour 0 followed a second at hour 64, and a third at hour 128. This directly contradicts the wherein clause of claim 6 which states that “neither said psychedelic tryptamine…nor said D-cycloserine…is administered more than twice within a seven day period.”
Indefiniteness – lacking unit
Claim 12 states “wherein at least one symptom of a human affliction…is alleviated for a period of at least month after said administering.” For the purpose of examination, Examiner assumes applicant intended to state “at least one month”.
Indefiniteness – “Improvement” and “Alleviation”
Claim 10 is drawn to a method of claim 6 wherein administration results in “improvement within 24 hours of a symptom of a human affliction”.
Where the specification defines “alleviate”, “improvement” is not defined. The specification outlines a method to track diseases progression and/or improvement in para. [0082]. The specific methods are Frontotemporal Dementia Rating Scale (FRS), change in Neuropsychiatric Inventory (NPI), and Clinical Global Impression of Change (CGIC). Secondary outcomes are measured via Addenbrooke’s Cognitive Examination III (ACE-III).
However, the claim lacks this language. Examiner recommends adding at least one of the methods of tracking diseases progression above to the claim.
Claim Interpretation
Applicant has elected “mild cognitive impairment”. This term is explained in the specification, para. [0064] where it states “Mild cognitive impairment, also known as incipient dementia or age-associated memory impairment, is a brain function syndrome involving the onset and evolution of cognitive impairment beyond those expected based on the age and education of the individual, but which have not yet risen to a sufficient level to significantly interfere with the daily activities of an afflicted individual. It frequently occurs as a transitional stage between the expected cognitive decline of normal aging and the more serious decline of dementia. It can present as problems with memory, language, thinking and judgment that are greater than normal age-related changes. Mild cognitive impairment increases one’s likelihood of later progression is not a certainty. Herein, mild cognitive impairment is defined as a dementia, although some prior art references refer to is a pre-dementia.”
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 6-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDevitt (US 9,877,951, published 01/30/2018, of the record) in view of Londesbrough (WO2020/212952).
Independent claim 6 is drawn to a method of treating human affliction (mild cognitive impairment) comprising administering to a human subject i) D-cycloserine in a dose range of 40 mg to 100 mg and ii) a psychedelic tryptamine compound (psilocybin) in a dose range of 0.5 mg to about 6 mg. The claim additionally requires that the amount of psychedelic tryptamine is not sufficient to induce overt hallucinogenic effects (see examiner’s comments below).
The claim also requires that both the D-cycloserine and the psilocybin be administered within a 30-minute time period and that neither D-cycloserine or psilocybin are administered more than twice within a seven-day period.
Dependent claims 7 specifies the structure of the psychedelic tryptamine compound. Dependent claim 8 specifies that the components (i) and (ii) are administered within two hours of starting a therapy session involving the subject. Dependent claim 9 specifies that the administration of the two compounds can be performed multiple times wherein the interval between administrations is at least 64 hours.
Dependent claims 10-12 are drawn to effects of practicing the claimed method and include “improvement within 24 hours of a symptom…”, “alleviation within one week of at least one symptom…”, and wherein “at least one symptom of human affliction…is alleviated for a period of at least [a] month after said administering.”
Dependent claim 13 specifies that only one tryptamine compound is administered.
McDevitt is drawn to “method…for treating dementia, including mild cognitive impairment, via administration of D-cycloserine...” (abstract).
Regarding claim 6, McDevitt in col. 9 contemplates methods of administration comprising administering 100 mg of D-cycloserine (col. 9, l. 4-6) to a subject suffering from frontotemporal dementia. McDevitt in col. 7, l. 3-22 contemplates methods of administering D-cycloserine over 7-day cycles, administered no more than one additional time within the first week, etc. This teaching embraces the general requirements of claim 6. McDevitt on col. 1, l. 39-49 states that D-cycloserine “has been widely studied in human clinical trials as a potential treatment for dementia conditions including Alzheimer’s Diseases…”.
Regarding claims 6 and 7, Londesbrough is drawn to methods of treating a subject comprising administering psilocybin (abstract). Londesbrough also contemplates treating “neurocognitive disorders” (abstract). Within the art, “neurocognitive disorders” includes Alzheimer’s disease and vascular dementia.
Londesbrough on p. 7, l. 27-29 contemplates dose amounts of psilocybin between 0.1 mg to 100 mg.
Regarding the limitations of claim 6 which state “wherein said psychedelic tryptamine compound…and said D-cycloserine…are both administered within a 30 minute time period…” and “wherein neither said psychedelic tryptamine…nor said D-cycloserine…is administered more than twice within a seven day period”, administration timing are within the skillset of one of ordinary skill in the art and it would be obvious to modify timing to embrace the claims.
Similarly, claims 8 and 9 include the limitations where the psilocybin and D-cycloserine are “administered to said human subject within two hours of commencement of a therapy session involving said subject” (claim 8) and “are both administered to said human subject multiple times, wherein the interval between successive administering is at least 64 hours.” Successive administration is similar to the limitations of claim 6 and 7. Regarding the therapy session limitation of claim 8, Londesbrough on p. 49, sec. Psychological Support During Psilocybin Sessions details the administering psilocybin during a psychotherapy session with a therapist. Therefore, similar to claims 6-7 and 9, one of ordinary skill in the art would find it obvious to combine administration of psilocybin and D-cycloserine within a therapy sessions obvious.
Regarding claims 10-13, which are drawn to effects of practicing the claimed method (similar to intended use), one of ordinary skill would find the effects obvious in view of what is taught within the art.
McDevitt teaches a method of administering D-cycloserine to treat dementia, including mild cognitive impairment. Londesbrough teaches methods of administering psilocybin to treat neurocognitive disorders, including dementia and/or Alzheimer’s disease. The MPEP section 2144.06 states:
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
While the instant claims are drawn to methods, the case law can also be applied as methods of treating dementia via administration of D-cycloserine or psilocybin are taught within the art.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to combine McDevitt with Londesbrough as both references separately teach methods of treating neurocognitive orders, such as dementia and/or mild cognitive impairment. One of ordinary skill in the art would be motivate to make the combination as both have been shown to be useful for the same purpose.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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