DETAILED ACTION
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
To expedite the compact prosecution, the Examiner is pursuing the amended claims dated 25 April 2024, in which applicant canceled claims 10-14.
Therefore, claims 1-9, and 15-30 are pending in the application.
Priority
This application was filed 03/14/2024 and is a 371 application of PCT/US2023/025435 filed on 06/15/2023, which claims benefit to provisional application 63352935 filed on 06/16/2022.
Thus, the earliest possible priority for the instant application is 06/16/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/14/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
Title Objection
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. See MPEP 606.01
The following title is suggested:
“Recombinant Vector Comprising Nucleic Acid Sequence of enhancer Element 14 for Treating Wiskott-Aldrich Syndrome.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, and 15-30 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 is recited the term “an effective fragment” in line 3. The limitation “an effective fragment” is not indefinite if the specification provides examples or teachings regarding the nature of the effective fragment or the effective fragment is comprising specific nucleic acid sequence. However instant specification is not specifically defined the “effective fragment.” Therefore, POSITA at the time of the invention would not know the “effective fragment” is considered for in this claim. See MPEP 2173.05(b). Dependent claims 2-9, and 15-30 are rejected as being dependent upon rejected base claim 1.
Subject Matter Free of Art
In the closest prior art, Neitz et al. (US20180344197; cited in IDS filed 03/14/2024; hereinafter “Neitz”) discloses a recombinant vector [0004] comprising: a nucleic acid sequence of an enhancer comprising a nucleic acid sequence of enhancer element or an effective fragment thereof [0009]; the vectors further comprise an enhancer element upstream of the promoter, wherein the gene is operatively linked to the enhancer element, [0011]. However, Neitz does not fairly teach or suggest an enhancer element nucleic acid sequence consisting of 100% sequence identity to SEQ ID NO: 1, as recited in the instant claim 1.
Furthermore, according to ABSS search result, none of the prior teach or reasonably suggest the SEQ ID NO: 1 of claim 1 (see ABSS report filed Jul 15, 2026).
Claims 2-9, and 16-17, 21-23 are objected because art does not teach or reasonably suggest the SEQ ID NOs: 2,3,7,8,9,10,14,17,32,20,21,11,12 (see ABSS report filed Jul 15, 2026). Since claims 2-9, and 16-17, 21-23 depend from rejected base independent claim 1. Claims 2-9, and 16-17, 21-23 would be free of the art, if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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