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 .
Current Status of 17/799,597
This Office Action is responsive to the amended claims filed 05/20/2026.
Claims 1, 5-13, and 16-17 are examined on the merits.
Claims 2-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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Claims 18-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II, there being no allowable generic or linking claim.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.
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.
Response to Arguments
Applicants’ claim amendments and Remarks of 05/20/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
The instant claims have not been amended.
In regard to the 103 rejection, this rejection is maintained. Applicants remarks with Examiner’s reply is summarized below:
Applicants submit that the cited references fail to teach treating abnormal MeCP2 expression in a subject with a nootropic agent and/or alpha-7 acetylcholine receptor agonist as claimed.
Applicants submit that the CODA references teaching drug delivery and does not teach treating any neuronal disease.
Examiner disagrees. In the abstract (on the first page of the pdf), CODA teaches methods of treating neurological disorder and modulating the activity of neurons in a subject.
Applicants submit that there is no teaching in the CODA reference for an artisan to combine any ligands as a treatment for any physical condition and there is no motivation provided to make any combination.
CODA does not necessarily have to have a teaching for combine any ligands as a treatment. Via Kerkhoven logic, combining any two compounds known to be used for the same purpose is well known in the art.
Applicants urge the Office to not engaged in hindsight reasoning.
Applicants have not addressed the underlying rationale (e.g. Kerkhoven logic) underpinning the rejection.
Response to Amendment
Claim Rejections - 35 USC § 103-Maintained
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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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