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
Applicant’s election without traverse of Group II (claims 9-16) in the reply filed on 6/8/2026 is acknowledged.
Claims 1-8 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/8/2026.
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.
Claims 9, 16 are rejected under U5 U.S.C. 102(a)(1) as being anticipated by US 20020058897 Renati.
Regarding claim 9, Renati discloses an in-situ fenestration cutting staple (200, Fig. 31) comprising:
a proximal base (206);
a leading edge (distal tip of retention members 202 as seen in annotated Fig. 11 below);
a medial portion (as seen in annotated Fig. 31 below) extending from the proximal base toward the leading edge (as seen in annotated Fig. 31 below); and
a cutting edge (as seen in annotated Fig. 31 below) outwardly tapering from the leading edge toward the medial portion, the cutting edge configured to cut into a graft material at an in-situ fenestration site to form an in-situ fenestration (the limitation of the cutting edge configured to cut into a graft material at an in-situ fenestration site to form an in-situ fenestration is an intended use of the cutting edge, and the cutting edge of Renati is capable of performing the intended use as providing enough force into a graft material at an in-situ fenestration site would puncture the graft material and the cutting edge would create an in-situ fenestration or opening at the site).
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Regarding claim 16, Renati discloses the limitations of claim 9, and further discloses wherein the cutting staple is a circular cutting staple (as seen in Fig. 31), the cutting edge extends an entire circumference of the circular cutting staple to create a circular cut into the graft material at the in-situ fenestration site (as seen in annotated Fig. 31, the cutting edge goes around the entire circumference of the cutting staple).
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.
Claims 10-11, 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Renati in view of US 5791845 Fulop.
Regarding claim 10, Renati discloses the limitations of claim 9, wherein the medial portion includes longitudinal perforations (openings between the retention members 202 as seen in Fig. 31) extending between the leading edge and the proximal base (as seen in Fig. 31) and fingers (retention members 202) configured to pinch the graft material at a periphery of the in-situ fenestration in an anchored position (paragraph 109)
Renati is silent on wherein the longitudinal perforations form areas of weakness configured to tear when an opposing force is applied to the leading edge to form fingers.
However, Fulop teaches an anchoring fastener (2, Fig. 8-11) having perforations (side slit openings within the middle portion of the body of anchoring fastener 2 as seen in Fig. 8-10) that create an area of weakness (10, Fig. 8-11; slit openings stop short of the distal tip of anchoring fastener 2 to create an area of weakness 10) that tears when an opposing force is applied to the distal tip to form fingers (col. 2 line 61-62, col. 3 line 7-12, Fig. 11; an opposing force ruptures the area of weakness 10 to cause fingers 17 to spread out and anchor the fastener within a hole).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Renati with the teachings of Fulop in order to maintain the fingers in a compact fixed position prior to deployment to prevent the fingers from snagging and engaging with non-targeted areas.
Regarding claim 11, the combination of Renati and Fulop teaches the limitations of claim 10, and Renati further discloses wherein the proximal base and the fingers contact the graft material in the anchored position (paragraph 109).
Regarding claim 13, the combination of Renati and Fulop teaches the limitations of claim 10, and Renati further discloses wherein adjacent pairs of the fingers are spaced apart from each other (as seen in Fig. 31).
Regarding claim 14, the combination of Renati and Fulop teaches the limitations of claim 10, and Fulop teaches wherein the longitudinal perforations terminate short of the leading edge (as seen in Fig. 8-9, slit openings stop short of the distal tip of anchoring fastener 2 to create an area of weakness 10).
Regarding claim 15, the combination of Renati and Fulop teaches the limitations of claim 10, and Renati further discloses wherein the longitudinal perforations terminate short of the proximal base (as seen in Fig. 31, the openings between the fingers 202 stop short of the proximal base 206).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Renati in view of Fulop as applied to claim 10 above, and further in view of US 20140046347 Cully et al (hereinafter Cully).
Regarding claim 12, the combination of Renati and Fulop teaches the limitations of claim 10.
The combination is silent on wherein each of the fingers have a raised edge and an indented portion in the anchored position.
However, Cully teaches an anchoring device (110, Fig. 14-15a) having fingers (212) wherein each of the fingers have a raised edge and an indented portion in the anchored position (as seen in annotated Fig. 14 below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Renati with Fulop with the teachings of Cully in order to have the fingers assume a more concave cross section and therefore a more rounded interior opening of the staple to maximize fluid flow.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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