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 § 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 1, 3-15, 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braido (Pub. No.: US 2015/0073545).
Braido discloses a stented prosthetic heart valve comprising: an expandable stent frame 202 comprising an inflow portion 230 and an outflow portion 232, wherein the expandable stent frame further comprises an interior surface and an exterior surface (e.g. fig. 4A); a valve structure comprising a plurality of valve leaflets 208 coupled to the expandable stent frame to define a margin of attachment (para. 62); an outer wrap 206 (para. 73) encircling at least a portion of the exterior surface of the expandable stent frame (e.g., para. 73), wherein the outer wrap comprises a plurality of zones (e.g., fig. 4A, para. 72), wherein a first zone 250 of the plurality of zones comprises a different thickness than a second zone 252 of the plurality of zones (e.g., para. 74); and an inner skirt (e.g., para. 73) coupled to the interior surface of the expandable stent frame and the plurality of valve leaflets (e.g., para. 73).
For claim 3, Braido discloses the stented prosthetic heart valve of claim 1, wherein the outer wrap further comprises a proximal portion 252 adjacent to the outflow portion of the expandable stent frame and a distal portion 250 adjacent the inflow portion of the expandable stent frame, and further wherein the proximal portion of the outer wrap comprises at least the first zone and the distal portion of the outer wrap comprises at least the second zone (e.g., para. 74, fig. 4A).
For claim 4, Braido discloses the stented prosthetic heart valve of claim 3, wherein the proximal portion of the outer wrap overlaps at least a portion of the distal portion of the outer wrap (e.g., boundary stitches the two together, providing an overlap via the stitching), and further wherein the overlapping portion of the proximal portion of the outer wrap and the distal portion of the outer wrap are coupled together to define the second zone (fig. 4A).
For claim 5, Braido discloses the stented prosthetic heart valve of claim 3, wherein the proximal portion of the outer wrap abuts the distal portion of the outer wrap to define a boundary 254 (fig. 4A).
For claim 6, Braido discloses the stented prosthetic heart valve of claim 5, wherein the boundary 354 extends along one or more distal segments of the margin of attachment (e.g., para. 62), and further wherein a distal apex of the boundary overlaps a distal apex of the margin of attachment positioned on a portion of the inflow portion (fig. 5, para. 62).
For claim 7, Braido discloses the stented prosthetic heart valve of claim 5, wherein the boundary 254 is spaced a distance from a distal apex of the margin of attachment (e.g., at D2, para. 62) and along a portion of the inflow portion of the expandable stent frame (e.g., fig. 4A).
For claim 8, Braido discloses the stented prosthetic heart valve of claim 1, wherein the expandable stent frame further comprises a plurality of commissure attachment locations 216 circumferentially spaced around the outflow portion of the expandable stent frame (e.g., fig. 4A).
For claim 9, Braido discloses the stented prosthetic heart valve of claim 8, wherein the margin of attachment is defined by one or more first segments that extends from any one of the plurality of commissure attachment locations in a distal direction to adjoin a distal apex of the margin of attachment positioned on a portion of the inflow portion of the expandable stent frame, and one or more second segments that extends from any other corresponding one of the plurality of commissure attachment locations in the distal direction to adjoin the apex of the margin of attachment (e.g., fig. 4A, 5, para. 62).
For claim 10, Braido discloses the stented prosthetic heart valve of claim 9, wherein the first zone of the plurality of zones aligns with at least a portion of the one or more first segments and at least a portion of the one or more second segments (e.g., fig. 4A, 5A).
For claim 11, Braido discloses the stented prosthetic heart valve of claim 1, wherein the first zone extends from at least a portion of the outflow portion of the expandable stent frame to at least a portion of the inflow portion of the expandable stent frame (fig. 4A, first zone may be defined to be the entire cuff).
For claim 12, Braido discloses the stented prosthetic heart valve of claim 11, wherein the second zone comprises a sinusoidal band encircling at least a portion of the inflow portion of the expandable stent frame, and further wherein the sinusoidal band overlaps a portion of the first zone (fig. 4A, sinusoidal boundary line).
For claim 13, Braido discloses the stented prosthetic heart valve of claim 1, wherein the second zone comprises a sinusoidal band encircling at least a portion of the inflow portion of the expandable stent frame (fig. 4A, sinusoidal boundary line).
For claim 14, Braido discloses the stented prosthetic heart valve of claim 1, wherein each zone of the plurality of zones comprises a different material (fig. 4A, suture material, cuff material).
For claim 15, Braido discloses the stented prosthetic heart valve of claim 1, wherein the plurality of zones comprise layered materials to define each zone of the plurality of zones (suture and cuff material are layered).
For claim 17, Braido discloses the stented prosthetic heart valve of claim 1, wherein the outer wrap comprises biocompatible synthetic material (e.g., para. 73).
For claim 18, Braido discloses the stented prosthetic heart valve of claim 1, wherein the outer wrap and the inner skirt are positioned to not overlap along a length of the expandable stent frame (e.g., fig. 4A, para. 79).
For claim 19, Braido discloses the stented prosthetic heart valve of claim 1, wherein the margin of attachment is U-shaped (e.g., fig. 4B).
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 2 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Braido (Pub. No.: US 2015/0073545).
For claim 2, Braido does not specify the stented prosthetic heart valve of claim 1, wherein the first zone is about 0.1 mm thick and the second zone is about 0.3 mm thick. Instead, Braido is silent as to the thickness of each zone. However, it would have been obvious to one of ordinary skill in the art to have selected the thin material as .1mm thick and the thicker material as .3mm thick as an obvious expedient to provide a low profile thin section and a thick segment for improved sealing against the native annulus. This modification would have occurred using known methods and would have yielded predictable results.
For claim 16, Braido does not specify the stented prosthetic heart valve of claim 1, wherein the outer wrap comprises treated pericardial tissue. Instead, Braido discloses the outer wrap 206 as “tissue” (para. 64) and “any suitable biological material” (para. 73). Thus, selection of treated pericardial tissue, a known biocompatible tissue suitable for use within prosthetic valves, would have been obvious to one of ordinary skill in the art at the time the invention was filed. This modification would have occurred using known methods and would have yielded predictable results.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
