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 .
Claims 16-23 are under consideration in the instant Office Action.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, provisional 62/365,982 and Application Nos. 15/494,503 and 16/211,281, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The newly submitted claims on 7/2/2025 which now require a method for treating Alzheimer’s disease or it’s symptoms is not supported by any of the prior applications. The first mention of a method for treating Alzheimer’s disease is in the instant claims, file on 7/2/2025. Therefore, the claims only have priority to the filing date of 7/2/2025.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The new claim 16, files on 7/2/2025, claiming “A method for treating or reducing one or more symptoms associated with Alzheimer's disease” does not have support in the instant specification. The specification only mentions Alzheimer’s disease in one instance in page 1:
”The tragedy of aging is the loss of accumulated knowledge due to neuropathy, especially related to dementia, Alzheimer's, and other neurological disorders. The cause of these disorders is a matter of dispute, ranging from free radical damage to exposure to toxins to inability of neurons to regenerate in the numbers and quality necessary for healthy mental functioning.”
There is no mention or suggestion of treating Alzheimer’s disease or its symptoms in any form in the instant specification. Therefore, there is no proper antecedent basis for the claimed subject matter.
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 16 and 21 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 21 is indefinite because it is unclear what is the scope of pharmaceutical dosage form of 1 mg to 10 mg of psilocybin or psilocin of claim 16. Does this amount of 1 mg to 10 mg of psilocybin or psilocin refer to the total amount of psilocybin or psilocin needed to be administered in one treatment or over the total amount over the course of the treatment or the range dose per 1 to 6 times per day? Does it mean that 10mg times six times leading to a total of 60mg per day or the pharmaceutical dosage form of 10mg is the total per day divided over 6 administrations per day? Due to the different possible interpretations of the claim, the meets and bounds of the claim are unclear and therefore, indefinite.
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 16-23 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. New Matter Rejection.
There is no proper antecedent basis nor contemplation in context that is disclosed within the specification at the time of filing the instant specification for the recitation for a method of treating Alzheimer’s disease. The instant claims call for a method of treating Alzheimer’s disease or its symptoms. There is no support for the method of treating Alzheimer’s disease or its symptoms in the original set of claims or the instant specification or even in the provisional of parent applications, thereby, constituting new matter.
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 16-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (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 or unpredictability of the art and, (8) the breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The independent claims call for a method for treating or reducing one or more symptoms associated with Alzheimer's disease by administering 1-10mg up to 6 times per day of psilocybin or psilocin. It is noted that the instant specification fails to disclose this specifically claimed method. There are no examples in the instant specification that disclosed how one would treat an Alzheimer’s subject with the claimed pharmaceutical dosages of psilocybin or psilocin. The instant specification also fails to teach which, if any, symptoms of Alzheimer’s disease would be treated with this administration of psilocybin or psilocin. The general consensus in the field of endeavor is that Alzheimer’s does not have any viable treatment that is dependent of psilocybin or psilocin. There are no working examples provided in the instant specification that show how to treat Alzheimer’s disease with the administration of psilocybin/psilocin alone or with niacin. Nor is any guidance provided on when administration should take place, especially as it relates to when to start treating Alzheimer’s patients. The instant specification is towards the effects of Hericium erinaceus and how it influences neurogenesis, neural growth and differentiation but does not show how psilocybin/psilocin alone or with niacin also have the same effects in Alzheimer’s patients. There are no examples in the instant specification that supports the required scope of the instant claims of psilocybin/psilocin alone or with niacin being capable of treating AD.
The state of the art does not make up for the deficiencies of the instant specification. As recently as 2024, as evidenced by Zheng et al., 2024 (instant PTO-892), it has been shown that the ones of ordinary skill in the art have contemplated the possible use of psilocybin/psilocin as a potential therapeutic in the nuances management of Alzheimer’s disease (see abstract) but there are too many question that need to be addressed before determining what are the potential benefits in AD subjects with this type of treatment. Zheng teaches that given the potential variability in individual responses to psilocybin, particularly among AD patients, a precise calculation of personalized doses is imperative; the duration of psilocybin administration and the overall research protocol should be individualized to cater to the unique needs of each patient (see Page 14, section 6.4). Therefore, even the prior art, up until 2024, discloses that the art still is unpredictable and requires further research before determining if this type of treatment for AD would be effective.
Further, the state of the art for the effects of psilocybin compounds on neurological processes is illustrated by the teachings of Rambousek et al. 2014 (IDS 5/24/2023, #1) using an art recognized learning model system, where they demonstrated that “psilocin significantly impaired the acquisition of the Carousel maze [by rats] at both dosages (1 and 4 mg/ml)”, with “higher dosage[s] of psilocin block[ing] the learning processes even in an additional session when the rats received only saline”. Thus, learning was diminished; not improved. Therefore, neuroplasticity was not enhanced However, Rambousek did observe “no effect on memory consolidation” (e.g., see Abstract). Therefore, no “enhancement” was observed related to memory. Page 1 of Rambousek et al. then discloses that “psilocybin [alternatively] also attenuates neurocognitive parameters in humans (e.g., disrupted sustained attention and altered visual information processing) and disrupts attention sensorimotor processing…”.
In summary, either no effect or an impairment on neurological health alternatively occurs after administration of psilocybin in animals. Thus, the state of the art using psilocybin-related compounds is that cognition, solving complex challenges, motor skills and coordination, and improvement of visual/sensory processes do not occur; thereby, preventing the skilled artisan from knowing how to use the invention to treat Alzheimer’s disease without requiring undue experimentation to discover otherwise. Therefore, psilocybin or psilocin do not treat Alzheimer’s disease or its symptoms as required in the instant claims.
In conclusion, the specification fails to disclose how one of ordinary skill is expected to overcome the problem that no therapeutically effective treatment exists for treating Alzheimer’s disease and fail to specifically show how psilocybin/psilocin alone or with niacin treat the patient population as is required in the instant claims. In other words, no detailed guidance with a reasonable expectation of success has been provided within the instant specification in this currently unpredictable art for treating Alzheimer’s disease with no known effective treatment or cure. Therefore, because no universal treatment is known or accepted in the art for treating Alzheimer’s disease, one of ordinary skill in the art would not reasonably be able to successfully predict whether any particular symptom can be effectively treated through administration of psilocybin/psilocin compound, because it is unknown and not disclosed how and when the skilled artisan can successfully practice the claimed invention during the progression of any defined disorder, and importantly because it is unknown how to therapeutically and effectively treat Alzheimer’s disease, one of ordinary skill in the art would not reasonably know how to make and use the invention without requiring undue experimentation to discover such.
As set forth above, inadequate guidance is presented in the specification to overcome the obstacles in practicing the claimed invention in its full scope. The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. Given the tremendous breath of scope involving the instant claims, it would require undue experimentation for one of skill in the art to practice the claimed invention in its full scope. Therefore, the specification fails to provide enough guidance for one skilled in the art on how to practice the full scope of the instantly claimed method, thereby requiring trial and error experimentation to identify compounds meeting the functional limitations of the claims. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. One of skill in the art would neither expect nor predict the appropriate methods of treating Alzheimer’s disease in the manner claimed. Therefore, in view of the lack of guidance in the specification and in view of the discussion above, undue experimentation would indeed be required to make and use the invention commensurate with the scope of the claims.
The scope of the claims must bear a reasonable correlation with the scope of enablement. In re Fisher, 166 USPQ 18(CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
Undue experimentation would be required to produce the invention commensurate with the breadth of the claims based on the disclosure of the instant specification and the knowledge in the art. Reasonable correlation must exist between the scope of the claims and scope of enablement set forth. In view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breadth of the claims, it would take undue trial and error to practice full scope of the claimed invention.
In conclusion, the instant claims encompass an invention of tremendous breadth, and essentially call for trial and error by the skilled artisan to begin discovering how to make the claimed invention without assisting the skilled artisan in such an endeavor, which amounts to undue experimentation and is therefore insufficient to constitute adequate enablement.
Conclusion
No claims are allowed.
Advisory Information
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURORA M. FONTAINHAS whose telephone number is 571-272-2952. The examiner can normally be reached on Monday - Friday (8AM - 4PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675