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 I (claims 1-16) in the reply filed on 4/30/2026 is acknowledged. Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the protective covering members attached to and covering an inside of each of the frame portions ad an outside of each of the frame portions (claim 8) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuval et al. (Pub. No.: US 2008/0071366).
Tuval et al. (hereinafter, Tuval) discloses a prosthetic heart valve comprising:
a stent frame 12 that is reconfigurable between a low-profile delivery configuration (e.g., fig. 5B-5C) and an expanded operable configuration (e.g., fig. 1); and
a valve member 104 attached to commissure posts 30 of the stent frame 12 (e.g., fig. 4A, 4B) and comprising multiple leaflets 105 made of collagen-based biomaterial (e.g., para. 584, pericardium sheet), wherein each leaflet has a free edge and is molded and cross-linked to retain a three-dimensional shape comprising a concave region (e.g., fig. 10B, examiner notes the claim terms “molded” and “cross-linked” are product-by-process limitations which are not limited to the manipulations of the recited steps, only the structure implied by the steps, see MPEP 2113, here, as the leaflets have the same structure, the Tuval leaflets meet the claim).
wherein the prosthetic heart valve includes an inflow end and an outflow end (fig. 1, 14), wherein the valve member is reconfigurable between: (i) an open configuration that allows blood flow from the inflow end to the outflow end (e.g., fig. 10A) and (ii) a closed configuration that prevents blood flow from the outflow end to the inflow end (e.g., fig. 10B), and
wherein, while the valve member is in the open configuration, no portion of the valve member directly touches the stent frame other than at the commissure posts (fig. 1, 4C).
For claim 2, Tuval discloses the prosthetic heart valve of claim 1, wherein the concave region of each leaflet has a vertex at a central location of the free edge of the leaflet (fig. 10B, at central coaptation point).
For claim 3, Tuval discloses the prosthetic heart valve of claim 1, wherein each leaflet further comprises:
a first planar region comprising a first free edge portion that terminates at a central location of the free edge of the leaflet; and
a second planar region comprising a second free edge portion that terminates at the central location of the free edge of the leaflet, and
wherein the concave region is disposed between the first and second planar regions (fig. 10B).
For claim 4, Tuval discloses the prosthetic heart valve of claim 3, wherein the first free edge is linear and the second free edge is linear (fig. 10B).
For claim 5, Tuval discloses the prosthetic heart valve of claim 4, wherein the first free edge and the second free edge are non-parallel in relation to each other (fig. 10B).
For claim 6, Tuval discloses the prosthetic heart valve of claim 4, wherein an angle defined between the first free edge and the second free edge is between 80° and 120° (fig. 10B, leaflets are evenly spaced about the circular perimeter).
For claim 7, Tuval discloses the prosthetic heart valve of claim 3, wherein the first and second planar regions are non-coplanar (angled, see fig. 10B).
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 8-14, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (Pub. No.: US 2008/0071366).
Tuval discloses a prosthetic heart valve (abstract) comprising:
a valve member 104 comprising flexible leaflets 105;
a metal framework 12, 14 comprising: (i) multiple cells (fig. 1, 3B), (ii) commissure posts 20 to which the valve member is attached (e.g., fig. 4A), and (iii) frame portions 122 (fig. 3B), wherein each of the frame portions is positioned between two of the commissure posts (fig. 3B);
a skirt 106 attached to an inflow end of the metal framework (e.g., fig. 1); and
protective covering members 124 attached to and covering an inside of each of the frame portions and an outside (not expressly disclosed) of each of the frame portions 122, wherein the protective covering members are separate from the skirt (fig. 1, 3B).
As provided in italicized text above, Tuval lacks specific disclosure that covering member 124 covers an inside of each of the frame portions and an outside of each of the frame portions. Instead, covering 124 is described as “In the configuration shown in FIG. 3A, the area defined by engagement arms 22 and support elements 122 is open, while in the configuration shown in FIG. 3B, a covering 124 is provided in this area.” No mention is provided as to how the covering is attached to the support elements; however, it would have been obvious to one of ordinary skill in the art to have wrapped the covering member around support element 122 such that it covers an inside and an outside of each frame portion as an obvious attachment mechanism known in the art to secure the covering to the support element 122. This attachment would have occurred using known methods and would have yielded predictable results.
For claim 9, Tuval discloses the prosthetic heart valve of claim 8, wherein the each of the frame portions 122 is directly connected to two adjacent commissure posts 20 by two individual elongate members 22 of the metal framework that extend in opposite directions like arches (fig. 3B).
For claim 10, Tuval discloses the prosthetic heart valve of claim 8, wherein the skirt 106 defines a cylinder (fig. 1), and wherein the commissure posts 20 and the frame portions 122 all extend from the cylinder toward an outflow end of the metal framework (fig. 1, fig. 3B).
For claim 11, Tuval discloses the prosthetic heart valve of claim 10, wherein the multiple cells comprise multiple small cells (fig. 1) and multiple larger cells (fig. 3B), wherein skirt is attached to the multiple small cells to define the cylinder (fig. 1), and wherein each of the frame portions 122 are located between two of the commissure posts 20 to thereby define two larger cells of the multiple larger cells (fig. 3B).
For claim 12, Tuval discloses the prosthetic heart valve of claim 10, wherein the multiple larger cells are not covered by the skirt (fig. 1, 3B).
For claim 13, Tuval discloses the prosthetic heart valve of claim 8, wherein the protective covering members comprise three separate protective covering members 124 comprising bovine pericardium (not disclosed) and PET (polyester, para. 590) sutured (e.g., fig. 3C) to the frame portions.
As provided in italicized text, Tuval lacks disclosure of bovine pericardium and PET covers, instead teaching the covers comprise polyester. Elsewhere, Tuval teaches engagement arms 22 may be covered in polyester and pericardium (para. 579) and discloses bovine pericardium as a known source for prosthetic material (para. 17). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the protective covering members 124 as comprising bovine pericardium and PET as suggested elsewhere in the Tuval disclosure as an obvious selection of a known biocompatible material suitable for covering the cell defined by support element 122. This selection would have occurred using known methods and would have yielded predictable results.
For claim 14, Tuval discloses the prosthetic heart valve of claim 8, wherein the skirt abuts against the protective covering members (fig 1, 3D).
For claim 16, Tuval discloses the prosthetic heart valve of claim 8, wherein each of the frame portions are located equidistant between two of the commissure posts (fig. 3D).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (Pub. No.: US 2008/0071366) in view of Hoang et al. (Pub. No.: US 2019/0365530
Tuval discloses the prosthetic heart valve of claim 8, wherein the skirt 106 comprises: a first skirt material attached to an inside of the metal framework (fig. 4C, para. 599); and a second skirt material attached to an outside of the metal framework (not disclosed), and wherein the first and second skirt materials are differing types of materials (not disclosed).
As provided in italicized text, Tuval lacks a second skirt material on the outside of the metal framework of a differing type of material. Hoang teaches inner skirt 16 and outer skirt 18 of differing materials (para. 86, 101), with the outer skirt selected to have a plush exterior for the purpose of sealing against native tissue. It would have been obvious to one of ordinary skill in the art to have provided an outer skirt of a different material as taught by Hoang with the Tuval frame for the purpose of providing a plush exterior for sealing against native tissue to thereby prevent perivalvular leakage. 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
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