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 1-2, 6-11, 13-16, 20, 22-25, and 27-29 are currently pending in the instant application.
Receipt is acknowledged of amendment / response filed on 08/25/2026 and that has been entered.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 01/03/2025, 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 1-2 and 6-10], drawn to a pharmaceutical combination comprising a GABA(B) receptor agonist and an α2 receptor agonist thereof, without traverse, is acknowledged.
Claims 11, 13-16, 20, 22-25, and 27-29 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142 (b) as being drawn to a non-elected subject matter.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 1-2 and 6-10 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 “GABA(B)R agonist” [claim 1, line 1, page 2] and “α2 receptor agonist” [claim 1, line 2, page 2] are broad because it is not clear what kind of “GABA(B)R agonist” (such as, Baclofen, Gamma-hydroxy butyric acid, Gamma-valerolactone, Phenibut, Isovaline, Lesogaberan etc.) and “α2 receptor agonist” (such as, Agmatine, Brimonidine, Clonidine, Fadolmidine, Methyldopa etc.) the Applicant is intending to encompass with these broad expressions [since there are many and wide range of “GABA(B)R agonist” and “α2 receptor agonist” are documented and are targeted drugs that bind to and activate slow-acting GABA receptor agonists in the nervous system to calm nerve and therefore, any “GABA(B)R agonist” and “α2 receptor agonist” may fall within the broad definition of “GABA(B)R agonist” and “α2 receptor agonist” class]. 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, because the specification does not provide essential description to carry out the invention and thus lacks enablement as well. The omission of failing to describe the claimed invention renders the claims incomplete. These claims are written in functional language and therefore, broader than the enabling disclosure. Therefore, it is suggested that the expressions “GABA(B)R agonist” and “α2 receptor agonist” either be limited to the specific “GABA(B)R agonist” and “α2 receptor agonist” that actually contemplated in the specification (such as, incorporating the limitations of claim 2 into claim 1) and/or to amend the claims within the context and scope of the claims 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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