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 April 29, 2026. Claim(s) 1, 3, 6, 8, 10, 14, 16-18, 21, 24, 30, 32-33, 37-38, 41, 47, 74-76, and 81-83 are pending. Applicant's election of election of species of compound
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and postpartum depression (disease) without traverse of the restriction requirement in the reply is acknowledged. The elected species was found free of the art, therefore the search was expanded to a genus encompassing Formula I in its entirety. The species requirement is hereby withdrawn. Claim(s) 1, 3, 6, 8, 10, 14, 16-18, 21, 24, 30, 32-33, 37-38, 41, 47, 74-76, and 81-83 are examined herein insofar as they read on the elected invention.
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 81-83 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 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. Pursuant to In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (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. Some experimentation is not fatal; the issue is whether the amount of experimentation is "undue"; see In re Vaeck, 20 USPQ2d 1438, 1444. The analysis is as follows:
Breadth of claims 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 term of any neurodegenerative disease by administering an effective amount of Formula I of the claims. In the instant case, applicant examines the solubility and control release profiles of the pharmaceutical formulations, namely extended-release formulations, delayed-release formulations, and pulsatile-release formulations (pages 452-458).
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. There are any 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 of Formula I.
Skill of those in the art
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 compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
The quantity of experimentation needed
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 a compound of Formula I of the claims is not considered to be enabled by the instant specification.
Conclusion
Claims 1, 3, 6, 8, 10, 14, 16-18, 21, 24, 30, 32-33, 37-38, 41, 47, and 74-76 are allowed.
Claims 81-83 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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