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 1, 2, 12, 13, 38, 40 ,43, 44, 54, 75, 80, 85 and 87 in the reply filed on 07/02/2026 is acknowledged.
Claims 95 – 96, 106, 111, 130, 132 – 133 and 152 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/02/2026.
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.
Claim 40 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 40, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 2 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lupski et al. (NIH, Mammalian Gene Collection ABSS (EST) result for Sequence 6, 2002; hereinafter Lupski).
Regarding claims 1 – 2 and 12, Lupski discloses a nucleic acid comprising a human Enh98 enhancer sequence that is 92.5% identical to SEQ ID NO: 6 and a pCMV-SPORT6 vector comprising a CMV promoter that contains the nucleic acid.
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 13, 38, 40, 43, 44, 54, 75, 80, 85 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Lupski in view of Schauer et al. (W.O. Patent Publication Application No. 2018089527; hereinafter Schauer).
Regarding claims 13, 38, 40, 43, 44, 54 and 75, Lupski teaches all of the elements of the current invention as stated above except a heterologous gene for the vector. However, Schauer discloses an invention that provides polynucleotides, vectors (AAV5; paras. [0006], [00065]) and viruses expressing frataxin (FXN, gene) and methods of treating Friedreich’s Ataxia (Abstract).
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 adopt the method and AAV (Adeno-Associated Virus) capsid of Schauer for treating a neurodegenerative disorder by engineering Lupski’s vector (e.g. creating a recombinant AAV vector) to express FXN.
Regarding claims 80, 85 and 87, Schauer discloses (para. [00025]) that the method comprises administering to a subject a therapeutically effective amount of a pharmaceutical composition, in which the recombinant virions transduce the cells in the subject. Schauer further discloses (para. [00038]) neurons transduced with AAV5-FXN.
Also, Schauer discloses (para. [00010]) that the invention provides a composition comprising a viral vector, wherein the viral vector comprises a nucleic acid molecule encoding FXN operably linked to control elements; and a pharmaceutically acceptable excipient (para. [00016]).
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 transduce the recombinant AAV vector of Lupski and Schauer into a cell of interest (e.g. a neuron). Schauer provides the motivation for the technique by stating that the aim of the study was for the composition/nucleic acid molecule to be expressed by the transduced cells at a level sufficient to ameliorate at least one symptom of Friedreich’s Ataxia in the subject (para. [00025]).
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.
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, 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
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