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 .
Status of Claims
Claims 1-20 are pending and examined below.
Claim Objections
Regarding claim 14, the claim reads “wherein the outflow edge has a length corresponding to a diameter of the outer skirt”. Examiner believes this should instead read “wherein the outflow edge has a length corresponding to a circumference of the outer skirt” based on paragraph ¶0041 of the specification.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2017/0128209 (Morris)
Regarding claim 1, Morris discloses a heart valve prosthesis (Fig. 72, 1700, ¶0381) comprising:
a frame having expanded and contracted configurations (¶0382, “self-expanded”) and including
an inner frame (Fig. 72, 120) configured to support a prosthetic valve component (Fig. 72, 130, ¶0381), and
an outer frame (Fig. 72, 110) coupled to the inner frame (see Fig. 72), the outer frame being sized to surround the inner frame (see Fig. 72, wherein 110 surrounds 120) and configured to anchor the heart valve prosthesis (¶0382, “anchoring member 110”), the outer frame including a plurality of first crowns positioned around an outflow end of the outer frame (see annotated Fig. 75 below) and a plurality of second crowns positioned inward of the plurality of first crowns (see annotated Fig. 75 below, wherein the second crowns are positioned inwardly to the heart relative to the first crowns); and
a single-layer skirt (Fig 140a, ¶0381, “integral portions of a single sealing member”) disposed within and coupled to the outer frame (¶0381, “coupled to an inner wall of 110) and consisting of a single piece of material with minimal overlap of itself or another piece of skirt material when the heart valve prosthesis is in an expanded configuration (Fig. 43, see also ¶0381, wherein the described embodiment comprises an integral sealing member 140a + 140B coupled to the inner wall of 110 and the outer wall of 120 – which corresponds to a minimal overlap configuration)
PNG
media_image1.png
619
819
media_image1.png
Greyscale
Regarding claim 2, Morris further discloses wherein the skirt (Fig. 73, 140a) is coupled to the outer frame by at least one suture (¶0256, wherein sealing member 140 can be sutured to a wall of the heart valve prosthesis, see also Fig. 73, wherein sutures are shown)
PNG
media_image2.png
539
1039
media_image2.png
Greyscale
Regarding claim 3, Morris further discloses wherein the skirt further comprises a ring portion and a conical portion (see annotated Fig. 77 below), ring portion having an inflow edge and being located at an inflow side of the heart valve prosthesis (see Fig. 73) and the conical portion having an outflow edge and being located at an outflow side of the heart valve prosthesis (see Fig. 73)
Regarding claim 14, as best understood (see claim objections above), Morris further discloses wherein the outflow edge has a length corresponding to a diameter of an outflow end of the outer skirt (see Figs 72-77, wherein the valve is arranged as a circle – therefore the length of the outflow edge is equal to the circumference)
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) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0128209 (Morris) in view of US 2016/0278922 (Braido)
Regarding claim 4, Morris discloses a skirt comprising an inflow edge (see rejection of claim 3) but doesn't explicitly teach or disclose wherein the inflow edge is configured with a plurality of slits.
Braido discloses a heart valve prosthesis (Fig. 8B + 8C) comprising a skirt configured with a plurality of slits (Fig. 8A, 812, ¶0049)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the inflow edge of the skirt of Morris with a plurality of slits, as taught by Braido, in order to accommodate the changing diameter of the frame (¶0049)
Regarding claim 5, Morris discloses a skirt with a conical portion with an outflow edge (see rejection of claim 3) but doesn't explicitly teach or disclose a plurality of notches in the outflow edge.
Braido discloses a skirt (Fig. 10, 1000) configured with a plurality of notches (Fig. 10, wherein 1030a and 1030b form a notch)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the outflow edge of the skirt of Morris with a plurality of notches, as taught by Braido, in order to reduce puckering at the seams (¶0051)
Regarding claim 6, Morris discloses a conical portion with an outflow edge (see rejection of claim 3) but doesn't explicitly teach or disclose a plurality of notches that, when sutured together, cause the conical portion to form a conical shape
Braido discloses a skirt (Fig. 10, 1000) comprising a plurality of notches (Fig. 10, 1030a +1030b) configured with a plurality of notch edges that, when sutured together (¶0051, “when fully assembled, see also ¶0052, “suture pattern”) cause the conical portion to form a conical shape (¶0051, wherein “flared portion” corresponds to conical shape)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the outflow edge of the skirt of Morris with a plurality of notches that form a conical shape when sutured together as taught by Braido, in order to reduce puckering at the seams (¶0051)
Regarding claim 7, Morris discloses a skirt with an outflow edge (see rejection of claim 3) but doesn't explicitly teach or disclose wherein, in a flat arrangement, the outflow edge is interrupted by the notches (see Fig. 10, wherein the notches interrupt the outflow edge) and, when the notch edges are sutured together, the outflow edge is continuous (¶0051, “form a continuous layer”)
Braido discloses a skirt (Fig. 10, 1000) with an outflow edge wherein, in a flat arrangement, the outflow edge is interrupted by the notches and, when the notch edges are sutured together (¶0051, “when fully assembled, see also ¶0052, “suture pattern”), the outflow edge is continuous.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the outflow edge of the skirt of Morris with notches that form a continuous edge when sutured together, as taught by Braido, in order to reduce puckering at the seams (¶0051)
Claim(s) 8-13, 15, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0128209 (Morris) in view of US 2018/0271651 (Christianson)
Regarding claim 8, Morris discloses a skirt with an inflow edge (See rejection of claim 3) but doesn't explicitly teach or disclose wherein, in a flat arrangement, the inflow edge is a first arc section of a first circle having a first diameter and the outflow edge 48is a second arc section of a second circle, concentric to the first circle, having a second diameter smaller than the first diameter
Christensen discloses a skirt (Fig. 19, wherein the skirt is cut to according to template 534) wherein, in a flat arrangement (see Fig. 19), the inflow edge is a first arc section of a first circle having a first diameter (Fig. 19, wherein the outer edge corresponds to the inflow edge) and the outflow edge is a second arc section of a second circle, concentric to the first circle (¶0088, wherein 536a and 536b are sewn together such that the edges form two concentric circles), having a second diameter smaller than the first diameter (see Fig. 19, wherein the inner edge corresponds to the outflow edge and has a smaller diameter)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the skirt of Morris with an inflow edge and outflow edge geometry, as taught by Christensen, to order to attach to the frame while still easily folding for collapsing and deployment of the heart valve prosthesis.
Regarding claim 9, Morris discloses wherein the ring portion includes ring connection edges disposed at ends of the inflow edge and the conical portion includes conical connection edges disposed at the ends of the outflow edge and intersecting the ring connection edges (¶0381, wherein the skirt forms an integral sealing member therefore the conical connection edges and the ring connection edges intersect)
PNG
media_image3.png
539
1039
media_image3.png
Greyscale
Regarding claim 10, Morris discloses wherein the ring connection edges and the conical connection edges intersect at an angle (¶0381, wherein the skirt forms an integral sealing member therefore the conical connection edges and the ring connection edges intersect at some angle)
Regarding claim 11, Morris discloses ring connection edges and conical connection edges (see rejection of claim 9) that are connected by an edge (see rejection of claim 10) Morris doesn't explicitly teach or disclose that the edge is an arcuate edge. Christensen doesn't explicitly teach or disclose wherein the ring connection edges are connected to the conical connection edges by an arcuate edge.
However, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the edge between the ring connection edge and the conical connection edge to be an arcuate edge in order to reduce stress concentrations on the skirt material as blood flow through the valve (see also MPEP 2144.04)
Regarding claim 12, Morris doesn't explicitly teach or disclose wherein the ring connection edges are collinear with the conical connection edges.
Christenson discloses wherein the ring connection edges are collinear with the conical connection edges (see annotated Fig. 19 below)
PNG
media_image4.png
555
597
media_image4.png
Greyscale
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the skirt of Morris such that the ring connection edges are collinear with the conical connection edges, as taught by Christensen, in order to prevent paravalvular leakage.
Regarding claim 13, Morris discloses a skirt with a ring connection edges and an inflow edge but doesn't explicitly teach or disclose wherein the ring connection edges intersect the inflow edge at obtuse angles. Christenson doesn't explicitly teach or disclose but doesn't explicitly teach or disclose wherein the ring connection edges intersect the inflow edge at obtuse angles
However, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the edge between the ring connection edge and the conical connection edge to be an arcuate edge in order to reduce stress concentrations on the skirt material as blood flow through the valve (see also MPEP 2144.04)
Regarding claim 15, Morris discloses a method of assembling a heart valve prosthesis (Fig. 72, 1700) including an inner frame (Fig. 72, 120), an outer frame disposed around the inner frame (Fig. 72, outer frame 110 disposed around 120), a valve component supported by the inner frame (Fig. 72, valve 130 supported by 120), and a skirt consisting of a single piece of material (Fig. 72, 140a + 140b, ¶0381, wherein 140a and 140b can form an integral sealing member - hereinafter 140ab), the method comprising:
disposing the skirt within the outer frame (see Fig. 77, wherein 140ab is disposed within the outer frame 110), wherein a ring portion of the skirt including an inflow edge corresponds to a ring section of the outer frame and a conical portion of the skirt including an outflow edge corresponds to a tapered portion of the outer frame (see annotated Fig.77 below); and
PNG
media_image5.png
539
1039
media_image5.png
Greyscale
coupling the skirt to the outer frame (¶0381, wherein 140ab Is coupled to the inner wall of 110)
Morris doesn't explicitly teach or disclose forming the skirt into a three-dimensional configuration by securing a plurality of connection edges to one another
Christenson discloses forming the skirt (¶0088, inner skirt 510 and outer skirt 532) into a three-dimensional configuration (¶0088, “assembled configuration”) by securing a plurality of connection edges to one another (¶0088, wherein the two ends of each skirt are sewn together and attached to the frame at locations 536a and 536b)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Morris with a step to form the skirt into a three-dimensional structure by securing a plurality of connection edge to another, as taught by Christenson, in order to prevent paravalvular leakage.
Regarding claim 16, Morris discloses wherein the skirt is coupled to the outer frame by at least one suture (¶0256, wherein sealing member 140 can be sutured to a wall of the heart valve prosthesis, see also Fig. 73, wherein sutures are shown)
Regarding claim 18, Morris discloses wherein each of the plurality of connection edges includes ring connection edges disposed at ends of the ring portion (see annotated Fig. 19) and cone connection edges disposed at ends of the conical portion (see annotated Fig. 19)
PNG
media_image6.png
539
1039
media_image6.png
Greyscale
Regarding claim 19, Morris discloses wherein the ring connection edges intersect the cone connection edges at an angle (¶0381, wherein the skirt forms an integral sealing member therefore the conical connection edges and the ring connection edges intersect at some angle)
Regarding claim 20, Morris doesn't explicitly teach or disclose an arcuate edge connecting the ring connection edge to the cone connection edges. Christianson doesn't explicitly teach or disclose an arcuate edge connecting the ring connection edge to the cone connection edges.
However, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the edge between the ring connection edge and the conical connection edge to be an arcuate edge in order to reduce stress concentrations on the skirt material as blood flow through the valve (see also MPEP 2144.04)
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0128209 (Morris) in view of US 2018/0271651 (Christianson), as applied to claims above, and further in view of US 2016/0278922 (Braido)
Regarding claim 17, Morris doesn't explicitly teach or disclose wherein forming the skirt into the three-dimensional configuration includes securing together a plurality of opposing notch edges, the notch edges being configured to interrupt the outflow edge of the skirt. Christianson doesn't explicitly teach or disclose wherein forming the skirt into the three-dimensional configuration includes securing together a plurality of opposing notch edges, the notch edges being configured to interrupt the outflow edge of the skirt.
Braido discloses wherein forming the skirt (Fig. 10, 1000) into the three-dimensional configuration includes securing together a plurality of opposing notch edges (¶0051, “when fully assembled, edges of first and second wedges 1010 and 1020 adjoin to one another”), the notch edges being configured to interrupt the outflow edge of the skirt (Fig. 10, wherein notches 1030a and 1030b interrupt the outflow edge)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Morris in view of Christianson to include securing together a plurality of opposing notch edges, as taught by Braido, to order to accommodate changes in the diameter of the frame.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAXIMILIAN TOBIAS SPENCER whose telephone number is (571)272-8382. The examiner can normally be reached M-F 8am-5pm.
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://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408.918.7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights