DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
Applicant's election without traverse of Group I, drawn to a composition comprising a muscarinic receptor positive modulator and an NMDA receptor positive allosteric modulator, in the reply filed 7/20/26 is acknowledged.
Claims 1-8 are pending and examined herein insofar as they read on the elected invention and species.
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barlow et al. (US Patent Application 2011/0319386, of record).
Barlow et al. teach a method of treating diseases and conditions of the central and peripheral nervous system by administering a composition comprising a muscarinic receptor modulator in combination with one or more neurogenic agent (abstract and claim 1). A preferred muscarinic receptor modulator is xanomeline or oxotremorine (claim 3). In further embodiments, an agent in combination with a muscarinic agent can be pyrrolidinone (paragraphs 0457, 0466) or benzenesulfonamide (paragraph 0527).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Barlow et al. (US Patent Application 2011/0319386, of record), as applied to claims 1-4.
The instant claims are directed to a kit comprising a muscarinic receptor positive modulator, an NMDA receptor positive allosteric modulator, and a package insert containing instructions.
Barlow et al. teach as discussed above, however, fail to disclose a kit with a package insert containing instructions.
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have formulated the composition taught by Barlow et al. into a kit with a package insert containing instructions.
A person of ordinary skill in the art would have been motivated to formulate the composition taught by Barlow et al. into a kit with a package insert containing instructions because the skilled artisan would desire to safely administer the composition to effectively treat the CNS disease and to minimize potential side effects and toxicity issues related to overdose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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