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 .
Status of the Claims
This Office Action is in response to Applicant's Restriction Requirement remarks filed on January 12, 2026. Claim(s) 1-20 are pending. Claim(s) 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to a method of treating a neurodegenerative disease and election of species of Alzheimer’s disease (neurodegenerative disease) without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. Claim(s) 1-10 are examined herein insofar as they read on the elected invention and species.
Claim Rejections - 35 USC § 112, first paragraph
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 1-10 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for the treatment of Alzheimer’s disease by administering a therapeutically effective amount of cannabidiol, does not reasonably provide enablement for the treatment of any neurodegenerative disorder as recited in the instant claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The specification does not provide sufficient information that all the neurodegenerative disorders embraced by the instant claims are treatable by cannabidiol as described in the methods claimed.
The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
(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.
The breadth of the claims and nature of the invention
The breadth of the instant claims is seen to encompass methods for the treatment of any neurodegenerative disorder as recited in the instant claims.
The claims are extremely broad. Currently, there are no known agents that treat any symptom of any neurodegenerative disease all inclusively.
The state of the prior art and level of predictability in the art
Verma (Journal of Molecular Neuroscience, 2026) teaches, even as most recently, that neurodegeneration is a “systems biology” problem rather than a single-protein problem. The reference explains that because Alzheimer’s and other neurodegenerative disorders are multifactorial and complex a “one-size-fits-all” approach is insufficient to encompass the full range of disease mechanisms (page 1).
Thus, the treatment of these disorders is highly unpredictable. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The amount of direction provided by the inventor and existence of working examples
The specification does not provide guidance for the treatment of the scope of disorders embraced by umbrella terms or any symptom of any neurodegenerative disease by administering an effective amount of cannabidiol of the claims.
In the instant case, applicant demonstrates the use of CBD in treatment for improved cognitive function and ameliorated the pathophysiology of Alzheimer's disease (see Example 1).
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 27 USPQ2d 1510 (CAFC). The disclosure does not demonstrate sufficient evidence to support the Applicant's claim to the treatment/prevention. There are not sufficient working examples or data from references of the prior art to provide a nexus between those examples and a method of treating the embraced disorders with the claimed compound.
The level of one of ordinary skill
The level of skill in the art is high (MD’s, PhD’s, or those with advanced degrees). As discussed above, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which diseases would benefit from CBD activity.
The quantity of experimentation
Considering the state of the art as discussed by the reference above, particularly with regards to the alleviation of the broad scope of disorders with one compound, the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Genentech, 108 F.3d at 1366 states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable." Therefore, methods of treating any neurodegenerative disease by administering an effective amount of cannabidiol of the claims is not considered to be enabled by the instant specification.
Claim Rejections - 35 USC § 102
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.
Claims 1-10 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Small-Howard (US 2018/0098948).
At the outset, Examiner respectfully notes that the limitations of claim 2-4 and 6-10 are considered properties inherent in the disclosed active agent. "Products of identical chemical composition cannot have mutual exclusive properties." Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Small-Howard teaches a method of treating a neurodegenerative disease, wherein the neurodegenerative disease is selected from the group consisting of: Alzheimer's disease, Parkinson's disease, Lewy Body Dementia, and Huntington's disease administering a pharmaceutical composition comprising a first major cannabinoid wherein the cannabinoid is cannabidiol (abstract; claim 1, 2; claim 46).
Based on the foregoing reasons, the instant claims are deemed anticipated over the cited art.
Claims 1-10 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Koren (WO 2019/159176) of record.
At the outset, Examiner respectfully notes that the limitations of claims 2-4 and 6-10 are considered properties inherent in the disclosed active agent. "Products of identical chemical composition cannot have mutual exclusive properties." Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Koren teaches a clinical study wherein the potential synergistic effects of a cannabinoid (CBD, CBG or CBN) and eucalyptol are employed in the enhancement of cognitive performance, improvement of memory and reduction of anxiety, in healthy young volunteers, healthy elderly volunteers, and selected populations of patients suffering from mild to modest symptoms of memory decline, cognitive impairment, spatial disorientation and anxiety on the background of diagnosis of MCI (Mild Cognitive Impairment) or a neurological/neurodegenerative disorder such as Alzheimer’s disease [0095].
Conclusion
Claims 1-10 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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