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 .
Claim Status
Applicant’s election without traverse of claims 119 – 125 in the reply filed on 08/19/2026 is acknowledged.
Claims 103 – 118 and 126 – 127 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/19/2026.
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.
Claims 119 – 125 are rejected under 35 U.S.C. 103 as being unpatentable over Jentsch et al. (W.O. Patent Application Publication No. 00/44786; hereinafter Jentsch) in view of Simons et al. (U.S. Patent Application Publication No. 2021/0277417 A1; hereinafter Simons).
Regarding claims 119 and 124 – 125, Jentsch discloses/provides motivation for a construct encoding a Kv7.4 protein with an invention related to cloning and characterizing KCNQ4 (p. 3, line 1 – 5; p. 4, line 20 – 35), which is the gene that has been mapped to the DFNA2 locus for autosomal dominant hearing loss (p. 2, Summary of the Invent…).
Simons discloses/provides motivation with an invention related to methods for treating CLRN1-associated hearing loss, in which AAV vectors containing a chicken β-actin promoter (para. [0066]) and Anc80 capsids encoding Clarin (CLRN) are administered at 1.3E10 viral genomes (VG)/cochlea (para. [0092]; [0285]). Simons further discloses a pharmaceutically acceptable carrier (para. [0224], e.g. PBS).
Regarding claims 120 – 123, Jentsch and Simons teach all of the elements of the current invention as stated above except the concentrations of the dosages of claims 120 – 123. However, Simons does disclose different concentrations that fall within the range of the instant claims (para. [0092]; [0285]). The state of the art does give way to a three or four optimizable dose test for efficacy (i.e. high dose, intermediate-high dose, intermediate dose, and low dose) associated with the technique.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the motivation/concept of how to treat deafness from Jentsch and Simons to treat deafness with the KCNQ4-substituted gene therapy constructs and the optimizable formulation/dose(s) of Simons as a starting point for an efficacy test.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
