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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 7/11/2025 is acknowledged.
Applicants elected Group I (claims 1-13 and 16-17) and the species of compound of claim 1 (an alpha7-nAChR agonist called PHA-543613).
This election reads on claims 1, 5-13, and 16-17.
Claims 2-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/11/2025.
Claims 18-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/11/2025.
Current Status of 17/799,597
This Office Action is responsive to the amended claims filed 8/12/2022.
Claims 1, 5-13, and 16-17 are examined on the merits.
Priority
This application is a national stage entry of PCT/US21/18573, and claims priority to US Provisional application 62/979,223.
The instant claims find support from the US provisional application. Therefore, the effective filing date is 2/20/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/12/2022 and 10/10/2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 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 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.
Claim(s) 1, 5-13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over CAL (WO 2013/163455A2), in view of UMAM (WO 2012055826), and CODA (US 20190161529). These references were all cited in the IDS.
CAL teaches a method for treating defects caused by abnormal MeCP2 expression (page 2 lines 21-23) and teaches a method for screening candidate drugs that inhibit a neurological disease or disorder associated with a MeCP2 mutation (page 12, In 4-9; Figure 14). CAL shows bar graphs showing two readouts for a drug screening platform (Figure 14). The first two graphs show the quantification of protein levels using infrared detection (in cell western) in neurons derived from a control (WT83), a RTT patient (Q83X) and a patient with MePC2 duplication (2M). This helps teach claim 1.
CAL teaches Rett syndrome and autism as examples of neurological diseases or orders (page 16 lines 3-6). This helps teach claims 11-13.
CAL teaches that in embodiments where more than one agent is administered, administration may be concurrent or sequential (page 15 lines 15-20). This helps teach claims 7-9.
CAL teaches the composition may be formulated as an oral dosage form, such as tablet or capsule (page 32 lines 19-22). This helps teach claim 10.
CAL fails to teach using an Alpha-7 nicotinic acetylcholine receptor agonist.
UMAM teaches a method for treating defects caused by abnormal MeCP2 expression in a subject in need thereof (page 1 lines 5-12). This helps teach claim 1.
UMAM teaches Rett syndrome and autism as examples of such disorders of MeCP2 associated disordered (page 9 lines 25-33). This helps teach claims 11-13.
UMAM fails to teach using an Alpha-7 nicotinic acetylcholine receptor agonist.
CODA teaches methods of treating neurological disorder and modulating the activity of neurons in a subject (abstract). This helps teach claim 1.
CODA teaches the reference’s composition and methods are utilized to treat Rett syndrome and autism (page 35 right col). This helps teach claims 11-13.
CODA teaches the elected alpha-7 nicotinic acetylcholine receptor agonist, PHA-543613 (table 5). This teaches claims 5 and 6.
CODA teaches further administering a nootropic agent (paragraph [0136]). This helps teach claim 7.
Given that methods for screening drugs that affect neural cells having MeCp2 overexpression was known in the art, as taught by CAL (page 12, In 4-9; Figure 14), it would have been obvious to one of ordinary skill in the art to apply the screening method CAL to identify effective compounds, further disclosed by CODA (abstract), for use in the treatment methods, which are known to be MeCP2 caused by abnormal MeCP2 expression in a subject (e.g. for Rhett syndrome of UMAM page 1 lines 5-12 and page 9 lines 25-33). Thus, treating or diminishing overexpression of a gene (e.g.MeCP2) in a neural cell in vivo or ex vivo with an agent or drug would have been obvious to one of ordinary skill in the art. This teaches claims 1, 5-6, 11-13.
The artisan would have been motivated to add a second additional agent (nootropic agent) for use for the same purpose (CODA paragraph [0136]). “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from them having been individually taught in the prior art.” In re Kerkhoven. This teaches claim 7.
The artisan would have expected to administer PHA-543613 and nootropic agent either sequentially or concurrently from the natural conclusion that there are physically only two ways to administer two compounds, together at the same time or one after another. This teaches claims 8-9.
Furthermore, CAL teaches the composition may be formulated as an oral dosage form, such as tablet or capsule (page 32 lines 19-22). This teaches the limitations of a pharmaceutical composition for oral delivery of claim 10.
The artisan would have been motivated to administer PHA-543613 and a nootropic agent (known to treat Rett syndrome) to a subpopulation of Rett syndrome patients (specifically less than 25 years old and 10 years old). It is obvious to administer the combination treatment to any Rett Syndrome patient, including that sub-population, because nothing precludes them from the treatment. This teaches claims 16-17.
Conclusion
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625