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
Priority
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, is acknowledged.
Status of Claims
Claims 1-12 are currently pending in the application.
Receipt is acknowledged of amendment / response filed on July 13, 2026 and that has been entered.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 05/09/2024, which has been entered in the file.
Response to Election/Restriction
In response to the restriction requirement, Applicants have elected Group I, which includes claims 1-8 and 10 drawn to a method of treating diseases associated with mitochondrial dysfunction, the method comprising administering to a patient a therapeutically effective amount of a compound of Formula I or a pharmaceutically acceptable salt thereof, and the elected species as set forth and found to a compound, such as,
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, is acknowledged.
Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a). Therefore, the requirement for restriction is still deemed proper made it final.
Claims 9, 11, and 12 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142 (b) as being drawn to a non-elected subject matter. Therefore, the requirement for restriction is still deemed proper and made it final.
Applicants preserve their right to file a divisional on the non-elected subject 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 1-8 and 10 are rejected under 35 U.S.C. § 112, 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(s), at the time the application was filed, had possession of the claimed invention. The expressions a method for treating “diseases” (claim 1, line 1, page 2, and all other occurrences, if any) and “neurodegenerative diseases” (claim 5, line 3, page 3, and all other occurrences of claims 1-8 and 10), which broaden the enabling disclosure because it is unclear what kind of “diseases” and “neurodegenerative diseases” the Applicant is intending to encompass with these broad expressions, since any “diseases” and “neurodegenerative diseases” [such as, cognitive disorders, Alzheimer’s disease / dementia, Parkinson’s disease, Huntington’s disease, myopathy, cardiomyopathy, motor neuron dysfunction etc.] may fall within the broad definition of “diseases” and “neurodegenerative diseases” class associated with mitochondrial dysfunction. The above expressions, which are not described in such a way as to satisfy the statutory requirements within the purview of 35 U.S.C. 112 first paragraph and therefore, the specification fails to provide sufficient support to treat all the wide range of “diseases” and “neurodegenerative diseases” associated with mitochondrial dysfunction and the method comprising administering to a patient a therapeutically effective amount of a compound of Formula I or a pharmaceutically acceptable salt thereof. The type or mode of action and functionality (structure / function relationship) of preventable or treatable “diseases” and “neurodegenerative diseases” are not defined in the claims or anywhere in the specification so as to ascertain the scope and breadth of the claimed subject matter.
The recitations a method for treating “diseases” and “neurodegenerative diseases” , which are not described in such a way as to satisfy the statutory requirements within the purview of 35 U.S.C. § 112 first paragraph, because the specification does not provide essential description to carry out the invention and thus lacks enablement as well. As stated in the MPEP 2164.01 (a), there are many factors [1) The nature of the invention, 2) The state of the prior art, 3) The level of ordinary skill in the art, 4) The level of predictability in the art, 5) The amount of direction and guidance provided by the inventor, 6) The existence of working examples, 7) The breadth of the claims, and 8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure (In re Wands, 8 USPQ 2d 1400, 1404 (CAFC, 1988)] 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.” Therefore, it is not likely that a single compound would be predicted to be able to prevent, delay or treat the progression of diverse “diseases” and “neurodegenerative diseases” associated with mitochondrial dysfunction, as claimed in the instant application. Based on the unpredictable nature of the invention and state of the prior art (WO 2005/053703 A1, IDS) and the extreme breadth of the claims, one skilled in the art could not perform the claimed methods of use without undue experimentation, see In re Armbruster 185 USPQ 152 CCPA 1975. Thus, the specification fails to provide sufficient support of the broad use of the method claims 1-8 and 10 to treat all kinds of “diseases” and “neurodegenerative diseases”, associated with mitochondrial dysfunction and the method comprising administering to a patient a therapeutically effective amount of a compound of Formula I or a pharmaceutically acceptable salt thereof. Therefore, it is suggested to amend the claims within the context and scope of the claims [such as, deleting the word “diseases” and “neurodegenerative diseases” and limiting with specific type of “diseases” and “neurodegenerative diseases” that actually contemplated in the specification (e.g., incorporating the limitations of claims 6-8 into claim 1) and that have enough support] in order to overcome the rejection.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Golam Shameem, Ph.D. whose telephone number is (571) 272-0706. The examiner can normally be reached on Monday-Thursday from 7:30 AM - 6:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks, Ph.D. can be reached at (571) 270-7682.
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Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist, whose telephone number is (571) 272-1600.
/GOLAM M SHAMEEM/Primary Examiner, Art Unit 1621
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