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 19-24 and 26-36 are currently pending in the application.
Receipt is acknowledged of amendment / response filed on July 07, 2026 and that has been entered.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 08/29/2024, which has been entered in the file.
Response to Election/Restriction
In response to the restriction requirement, Applicants have elected Group II, which includes claims 21-23 and 26-36 drawn to a method of treatment of a disorder in a patient, the method comprising administering to a patient a pharmaceutically effective amount of compound of Formula (I) or a salt thereof, without traverse, is acknowledged.
Claims 19, 20, and 24 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142 (b) as being drawn to a non-elected subject matter.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 21-23 and 26-36 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 expression a method of treatment “or prevention” [claim 21 (Currently amended), line 1, page 3 and all other occurrences of claims 21-23 and 26-36, if any] of a condition selected
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, which broadens the written description and / or enabling disclosure because it is unclear what the Applicant is intending to encompass with this broad expression “or prevention” and how all the diverse diseases are actually prevented. The above expression, which is 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 prevent all the wide range of “disorders” and “condition”, 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 “disorders” and “condition” are not defined in the claims or anywhere in the specification so as to ascertain the scope and breadth of the claimed subject matter. Therefore, it is not likely that a single compound would be predicted to be able to prevent, delay or treat the progression of diverse “disorders” and “condition”, as claimed in the instant application. Therefore, it is suggested to amend the claims within the context and scope of the claims [such as, deleting the word “or prevention” and limiting with ‘method of treatment’ only option that actually contemplated in the specification 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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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