DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s arguments and amendments filed on 6/13/2025 have been entered.
Claims 9, 21 and 22 have been amended.
In view of Applicant’s amendments to the claims the enablement rejection is withdrawn.
Claims 9-13, 21 and 22 are examined in the instant application.
Claim Objections
Claim 22 is objected to because of the following informalities: claim 22 is not grammatically correct. The acronym for the intraflagellar transport 88 gene should be “ift88” and not uft88. Appropriate correction is required.
Claim Rejections - 35 USC § 103-Necessitated by Amendment
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 9-13, 21 and 22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chung et al. (May 2007, Molecular Therapy, Vol 15, Supplement 1, pg. S314) in view Collier et a. (WO 2005/014634 A1) and Li et al. (January 2007, PLoS Genetics, Vol. 3(1), pgs. 9-20).
The instant rejection is applied to the breadth of the claimed invention regarding delivering an AAV 2/8 encoding a transgene and not necessarily to treat any condition.
Regarding claims 9-11, Chung et al. teach a method of delivering an AAV 2/8 encoding EGFP to the renal collecting duct via retrograde ureteral delivery in a mouse. Chung continues to teach that their method could be used as a treatment for polycystic kidney diseases such as Bardet-Biedel (See Abstract).
Chung does not teach:
Treating a subject having a kidney disease,
Treating Alport syndrome,
ADPKD; and
The pkd1, pkd2 and ift88 transgenes.
Regarding treating a kidney disease, Collier et al. teach a gene therapy method of delivering a viral vector encoding a therapeutic transgene for the treatment of Alport syndrome and APKD (pgs. 6 parag. 2, 48, 51, 113 parag. 2, 258).
Regarding pkd1, pkd2 and ift88, Li et al. teach that the transgenes pkd1, pdk2 and IFT88 are all involved in the pathogenesis of PKD and APKD (pg. 10 col. 2 parag. 2 and pg. 15 col. 2 parag. 2 bridge pg. 17 parag. 1).
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Chung regarding an AAV2/8 encoding a transgene to the renal collecting duct with the teachings of Collier regarding using gene therapy to treat PKD and the teachings of Li regarding genes involved in PKD to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make such a combination since Chung teaches that their AAV delivery could be used to deliver transgenes for the treatment of PKD and Collier teaching that delivering viral vectors to treat disease such as Alport syndrome and APKD can provide a therapeutic benefit. Further motivation is provided by Li teaching the role of genes such as pdk1, pdk2 and itf88 in the pathogenesis of PKD.
There would have been a reasonable expectation of success that the EGFP of Chung could be substituted with a gene such as pkd1 or ift88 since Chung taught successful transgene delivery via retrograde ureteral delivery.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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DAVID A. MONTANARI
Examiner
Art Unit 1632
/ANOOP K SINGH/ Primary Examiner, Art Unit 1632