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 .
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.
Claim(s) 1, 8 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Braido et al. 2012/0078347 (hereafter Braido ‘347) in view of Braido et al. 2016/0361161 (hereafter Braido ‘161).
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Noting figure 3-4 Braido et al. discloses a valve prosthesis comprising: a balloon-expandable stent structure (see [0025] and see 300), the stent structure comprising an inflow portion (see mark-up of proximal area) having a plurality of rows of inflow portion cells (306) and an outflow portion (see area 338) comprising a plurality of commissure posts (308), a plurality of non-commissure posts (305d), and an outflow crown ring (302) coupled to distal ends of the non-commissure posts and intersecting the commissure posts such that trident posts extend distally of a location where the distal crown ring intersects the commissure posts (see mark-up supra regarding trident post).
However, Braido ‘347 does not detail a prosthetic valve coupled to the stent frame. Braido ‘161 teaches a prosthetic heart valve 200 which may include a prosthetic valve with leaflets (262) coupled to a frame (see [0026], Fig. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify ‘347 with a prosthetic heart valve attached to the frame as taught by ‘161 in order to address patients that need total valve replacement due to diseased leaflets. Regarding claim 8 see [0046].
Regarding claims 15 and 16 and noting figure 9B (see below)
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Braido ‘347 discloses a stent structure, the stent structure comprising: an inflow portion (bottom) comprising a plurality of rows of inflow portion cells, the inflow portion (bottom) comprising outflow crowns (see peak and valleys defining a distal) defining a distalmost row of cells of the plurality of rows; an outflow portion (top) comprising commissure posts (808) comprising axial frame members and trident posts extending distally from the axial frame members (see trident below where the members extend distally); and support struts (850) extending between outflow crowns directly adjacent to the commissure posts and to intersections of the axial frame members and the trident posts (see figures above).
However, Braido ‘347 does not detail a prosthetic valve coupled to the stent frame. Braido ‘161 teaches a prosthetic heart valve 200 which may include a prosthetic valve with leaflets (262) coupled to a frame (see [0026]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify ‘347 with a prosthetic heart valve attached to the frame as taught by ‘161 in order to address patients that need total valve replacement due to diseased leaflets.
Regarding claim 17, noting figure 4 below and the rejection of claim 1 above, Braido ‘347 in view of Braido ‘161 discloses the structure as claimed and further discloses that the inflow portion comprises a plurality of rows of inflow portion cells (area 340), the inflow portion comprising outflow crowns defining a distal most row of cells of the plurality of rows (see peaks and valleys); and an outflow portion comprising: commissure posts (308); and non-commissure posts (305d) disposed circumferentially between adjacent commissure posts, wherein each outflow crown of the inflow portion is attached to a corresponding one of the commissure posts or a corresponding one of the non-commissure posts (this is interpreted as such because the claim does not require that the outflow crown be directly attached).
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Claim(s) 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Braido et al. 2012/0078347 (hereafter Braido ‘347) in view of Braido et al. 2016/0361161 (hereafter Braido ‘161) and further in view of Drasler et al. 2018/0147061.
Braido et al. ‘347 and ‘161 have been disclosed supra. Braido ‘161 teaches the use of anchoring structures on an inflow and outflow portion of a frame and further teaches spikes (6G) however does not specify that anti-migration spikes are self-expanding. Drasler et al. teaches that anchoring spike may be self-expandable (see 6G). It would have been obvious to modify the stent/frame of (347) with self-expandable anchors/spikes on the inflow and outflow end of the frame in order to secure the prosthetic valve securely to the surrounding tissue and are well-known in the art.
Allowable Subject Matter
5. Claims 4-7, 9-14 and 18-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
6. The following is a statement of reasons for the indication of allowable subject matter: The closets prior art has been disclosed supra however do not teach or disclose: that the inflow portion cells are formed by rows of struts and crowns, wherein crowns of adjacent rows of struts and crowns form nodes, and wherein the anti-migration spikes are attached to the nodes;
or that the valve prosthesis has a first diameter at an inflow end of the valve prosthesis, a second diameter at a middle region of the valve prosthesis, and a third diameter at an outflow end of the valve prosthesis, the second diameter being less than the first diameter and less than the third diameter;
or that the trident posts have an outward slant with respect to a longitudinal axis of the valve prosthesis., and wherein the prosthetic valve includes commissures attached to the trident posts;
or wherein the prosthetic valve comprises valve leaflets a valve inflow cylinder proximal to the valve leaflets, further comprising a reinforcement member collagen bonded to the valve inflow cylinder or to commissures of the valve leaflets.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 March 14, 2026