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 .
Election/Restrictions/Rejoinder
The pending claims are rejoined. The restriction requirement is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 8-12, 15-16, 19-22, 24, and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are drawn to treating cancer and neurological disease using a large range of possible products comprising the modified AAV capsid and a large range of products comprising the modified AAV capsid with the intent to treat cancer and neurological disease.
The specification does not teach treating all kinds cancer and neurological disease.
The prior art teaches treating cancer and neurological disease is unpredictable.
Burke teaches that virotherapy has been used to treat bladder cancer and has yielded mixed results (abstract, Burke Cytokine and Growth Factors Review Vol 21, pages 99-102. 2010).
Thus, there is unpredictability in the treatment of bladder cancer with viruses.
Ramaswamy et al. (Neurobiology of Disease Volume 48, Issue 2, November 2012, Pages 243-254) teach Huntington's disease (HD) is a neurodegenerative disease for which there is no cure and some therapies hold promise (abstract) as well as “Likely due to the absence of any viable treatment, the percentage of at risk patients that actually get tested is quite low” (Introduction).
Thus, the lack of viable treatments indicates the complexity and unpredictability in the art.
It would require undue experimentation to make and use the products in the methods to treat cancer and neurological disease because of the unpredictability and lack of success in the art and the lack of teaching in the specification.
Allowable Subject Matter
Claims 29-31 and 33-37 are allowed.
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 MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon, Tues, Thurs, Fri..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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