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 .
Receipt and entry of the response dated 7/28/2025 is acknowledged.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10, 13, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinclair et al (US 20080194803 A1) in view of Bidasee (US 20150359862 A1). This is a new rejection necessitated by amendment of the claims.
Sinclair et al teach AAV vectors encoding and expressing, e.g., SIRT7. See the abstract, ¶’s [0016]-[0019] and [1085], Table 1. The vectors are administered in pharmaceutically effective amounts to alleviate symptoms caused by vascular disease, vascular occlusion, or vascular stenosis (abstract, ¶[1112]-[1116]) all of which are considered “vascular endothelial aging” because the inner lining of the vascular tissue, or endothelium, is affected. Regarding claims 13 and 14, such vascular occlusions, stenosis or disease are considered “related” to Hutchison-Gilford progeria because they are found in the same tissue and are considered a “dysfunction”.
Sinclair et al do not teach the use of AAV1 or the ICAM2 promoter.
Bidasee teaches the use of the ICAM2 promoter in AAV1 vectors for gene delivery applications to express transgenes in endothelial cells to the exclusion of other cells. See the abstract and ¶’s [0026]-[0027]. The vectors of Sinclair and Bidasee et al would thus express SIRT7 in vascular endothelial cells (in vitro or in vivo) absent evidence to the contrary.
The claimed methods are essentially disclosed by Sinclair et al with the exception of the ICAM2 and AAV1 limitations. The ordinary skilled artisan, seeking to express SIRT7 from AAV vectors, would have been motivated to use AAV1 and an ICAM2 promoter with the AAV vectors of Sinclair et al because Bidasee teaches them to be well-known components that have utility for expressing transgenes in endothelial cells. It would have been obvious for the skilled artisan to do this because of the known benefit of generating SIRT7-expressing AAV vectors for administration as taught by Sinclair and Bidasee et al. Given the teachings of the cited references and the level of skill of the ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Response to Arguments
Applicant's arguments filed 7/28/2025 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) Sinclair et al (US 20050171027 A1) does not teach treating vascular endothelial senescence and angiogenesis or endothelial-specific expression of Sirt-7; 2) Bidasee et al does not cure the deficiencies of Sinclair et al.
Regarding 1), “vascular endothelial senescence” and “angiogenesis” are not limitations found in the instant claims. Further, Sinclair et al (US 20050171027 A1) is not relied upon in the instant rejection. Endothelial-specific expression of Sirt-7 is addressed in the rejection above.
Regarding 2), Bidasee et al teach the endothelial-specific nature of the ICAM 2 promoter as set forth above. Applicants have presented no evidence that this would not lead to endothelial-specific expression as asserted by Bidasee et al, nor of anything unexpected or surprising about combining well-understood vector components taught by the prior art. That Bidasee et al teach a different transgene is not relevant to this rejection, as Bidasee et al is not relied upon to teach the Sirt-7 transgene.
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 Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638