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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Specification
The disclosure is objected to because of the following informalities:
In paragraph 64, line 25, "pins 3114 similar to pins 3114" is repetitive and not clear.
Appropriate correction is required.
Claim Objections
Claims 3, 4, and 8 objected to because of the following informalities:
In claim 3 lines 2 and 3, claim 4 line 3 and claim 8 line 4, “central” should be “center”.
Appropriate correction is required.
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 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ratz et al. (US 2014/0277390).
Regarding claim 1, Ratz discloses a prosthetic heart valve (see Fig. 1) for replacing a native atrioventricular valve, the prosthetic heart valve comprising: a self-expanding stent (10; see paragraph [0019]) formed as a monolithic structure (see paragraph [0021]; the wire frame of a metal tube can be cut or etched to removed but the desired metal skeleton), the stent including an atrial disk (formed of proximal anchors 22), a ventricular disk (formed of distal anchors 24), and a center portion (frame 20) extending between the atrial disk and the ventricular disk (see Fig. 1); a plurality of prosthetic leaflets directly coupled to the center portion of the stent (see paragraph [0040] and Fig. 6, valve 60 comprising a plurality of leaflets); and an outer fabric coupled to the stent (outer skirt 30’ or 30’’; see Figs. 3 and 4), wherein in an implanted condition of the prosthetic heart valve, the atrial disk is sized to contact an atrial side of the native atrioventricular valve (proximal anchors 22; see Fig. 6), the ventricular disk is sized to contact a ventricular side of the native atrioventricular valve (distal anchors 24; see Fig. 6), the center portion (20) is sized to be positioned radially inside the native atrioventricular valve without pressing against the native atrioventricular valve (see Fig. 6), and the outer fabric (30’ or 30’’) is configured to directly contact the native atrioventricular valve (see Fig. 6 illustrating similar fabric 30).
Regarding claim 3, Ratz discloses the prosthetic heart valve of claim 1, wherein in an expanded condition of the stent (10), the center portion (20) has a diameter, and the ventricular disk (formed of distal anchors 24) has a diameter that is between 1.5 and 2.5 times larger than the diameter of the central portion (see paragraph [0034], where the outermost tip diameter of the stent may range from 40-60 mm when the stent is expanded while the frame diameter may range from 20-40 mm when the stent is expanded).
Regarding claim 13, Ratz discloses the prosthetic heart valve of claim 1 but fails to disclose wherein the ventricular disk (formed of distal anchors 24) includes a plurality of diamond-shaped ventricular cells that extend substantially parallel to a center longitudinal axis of the stent in an expanded condition of the stent (see Fig. 6, tip 28 is substantially parallel to the longitudinal axis of the frame, and paragraph [0029], the ends can be parallel or substantially parallel with the longitudinal axis of the frame).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz as applied to claim 1 above, and further in view Morriss et al. (US 9763780).
Regarding claim 2, Ratz discloses the prosthetic heart valve as claimed in claim 1 but fails to disclose the prosthetic heart valve is sized to be received within a delivery catheter for delivery to the patient, the delivery catheter having an inner diameter of between 22 French and 32 French.
Morriss also discloses a prosthetic heart valve device (100). Morriss teaches that a prosthetic heart valve device (100) has an outer diameter of no larger than about 8-10 mm when in the delivery configuration (see col. 15, lines 3-5) which is about 24-30 French and thereby sized to be received within a delivery catheter for delivery to the patient, the delivery catheter having an inner diameter of between 22 French and 32 French. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz to be of no larger than about 24-30 French when in the delivery configuration, as taught by Morriss, so that it is sized to be received within a delivery catheter having an inner diameter between 22 French and 32 in order to position the prosthetic heart valve in the heart using less invasive approaches (see col. 8 lines 1-6).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz as applied to claim 1 above, and further in view of Kovalsky et al. (US 2014/0222142).
Regarding claim 4, Ratz discloses the prosthetic heart valve as claimed in claim 1 and further discloses the outer fabric (outer skirt 30’ or 30’’) includes a first outer fabric (portion of outer skirt 30’ or 30’’ covering frame 20) and a second outer fabric (portions of outer skirt 30’ or 30’’ covering 22 and 24) where the first outer fabric is not directly coupled to the center portion of the stent (see Figs. 3-4 and [0052-0053], in which the outer skirt 30’ or 30’’ is attached to the proximal 22 and distal 24 anchors, thereby interpreted as not directly coupled to the central portion 20 of the stent) and the second outer fabric includes a first portion directly coupled to the atrial disk (see Figs. 3-4, fabric is directly coupled to the proximal anchors 22) and a second portion directly coupled to the ventricular disk (see Figs. 3-4, fabric is also coupled to the distal anchors 24).
Ratz fails to disclose wherein the first outer fabric is formed as a knitted fabric and the second outer fabric is formed as a woven fabric.
Kovalsky also discloses prosthetic heart valve (200; see Fig. 2) comprising a first outer fabric (tent portion 228) and a second outer fabric (graft material portion 226). Kovalsky teaches the first outer fabric (228) is formed as a knitted fabric (see paragraph [0163] describing the tent portion may be made of a knitted PTFE fabric) and the second outer fabric (226) is formed as a woven fabric (see paragraph [0218] describing the graft material may be made of a low-porosity woven fabric). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first outer fabric of Ratz to be formed as a knitted fabric and the second outer fabric of Ratz to be formed as a woven fabric, as taught by Kovalsky, in order to provide cushioning to the native chordae, distribute the tension and load placed on the chordae, provide a medium for tissue ingrowth, and provide the ability for the fabric to stretch to conform to a curved surface (see paragraphs [0163] and [0218]).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Kovalsky et al. as applied to claim 4 above, and further in view of Schwartz et al. (WO 2019/144036).
Regarding claim 5, Ratz in view of Kovalsky, discloses the prosthetic heart valve as claimed in claim 4 but fails to disclose wherein a first end of the first outer fabric is coupled to the first portion of the second outer fabric at a first seam, and a second end of the first outer fabric is coupled to the second portion of the second outer fabric at a second seam.
Schwartz also discloses a prosthetic heart valve (400, see Figs. 20 and 23) comprising first (414) and second (first portion 436 and second portion 424) outer fabrics. Schwartz teaches that a first end of the first outer fabric (414) is coupled to the first portion (436) of the second outer fabric at a first seam (see Figs. 20 and 22-24 upper dotted line), and a second end of the first outer fabric (414) is coupled to the second portion (424) of the second outer fabric at a second seam (see Figs. 20 and 22-24, lower dotted line). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer skirt of Ratz in view of Kovalsky to have the first end of the first outer fabric coupled to the first portion of the second outer fabric at a first seam, and a second end of the first outer fabric coupled to the second portion of the second outer fabric at a second seam, as taught by Schwartz, as the modification merely requires a combination of prostheses that obtains the predictable result of easily attaching an outer covering to a stent frame (see paragraph [0138]).
Regarding claim 6, Ratz in view of Kovalsky and Schwartz teaches the first seam and the second seam are formed via sutures or ultrasonic welding (see Ratz paragraph [0052] suggesting that when the outer skirt 30’ is formed from multiple pieces, the multiple pieces are stitched or otherwise connected together).
Regarding claim 7, Ratz in view of Kovalsky discloses the prosthetic heart valve as claimed in claim 4 but fails to disclose wherein as the prosthetic heart valve transitions from an expanded condition to a collapsed condition, the first outer fabric stretches to increase in length by a factor of greater than 1 and less than 3.
Schwartz teaches a further embodiment wherein as the prosthetic heart valve transitions from an expanded condition to a collapsed condition, the first outer fabric stretches to increase in length by a factor of greater than 1 and less than 3 (see paragraph [0024]; the sealing members (outer fabrics) can be heat shrunk to achieve a stretchability between 80-160%). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer skirt of Ratz in view of Kovalsky, wherein the outer fabric stretches to increase in length by a factor of greater than 1 and less than 3, as taught by Schwartz, to better distribute forces applied by the prosthetic heart valve on the native atrioventricular valve tissue and reduce damage caused by the relative motion of the prosthetic heart valve (see paragraph [0003]).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz as applied to claim 1 above, and further in view of Kovalsky and Qi et al. (US 2020/0289261).
Regarding claim 8, Ratz discloses the prosthetic heart valve as claimed in claim 1 and further discloses the outer fabric (outer skirt 30’ or 30’’) includes a single outer fabric having a first end being directly coupled to the atrial disk (see Figs. 3-4, end attached to the proximal anchors 22) and a second end of the fabric being directly coupled to the ventricular disk (see Figs. 3-4, end attached to the distal anchors 24). Ratz fails to disclose wherein the single outer fabric is woven.
Kovalsky also discloses prosthetic heart valve (200; see Fig. 2) comprising an outer fabric (graft material portion 226). Kovalsky teaches the outer fabric being formed as a woven fabric (see paragraph [0218], the graft material or portions thereof may be a low-porosity woven fabric). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer skirt of Ratz to be made from a woven fabric, as taught by Kovalsky, in order to provide a medium for tissue ingrowth and provide the ability for the fabric to stretch to conform to a curved surface (see paragraph [0218]).
Ratz also fails to disclose the outer fabric includes a central portion forming at least one pleat.
Qi also discloses a prosthetic heart valve (1) having an outer fabric (skirt 2, see Fig. 1d). Qi teaches the outer fabric (2) including a central portion forming at least one pleat (see paragraph [0380] and Fig. 1d, vertical lines on the skirt). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer skirt of Ratz to have a central portion forming at least one pleat, as taught by Qi, in order to control the position of a peripheral leakage occluder and form a double-layered structure that is capable of preventing paravalvular leakage (see paragraph [0114]).
Regarding claim 9, Ratz in view of Kovalsky and Qi discloses the prosthetic heart valve as claimed in claim 8, and further discloses wherein as the prosthetic heart valve transitions from an expanded condition to a collapsed condition, the at least one pleat unfolds so that the outer fabric does not prevent the prosthetic heart valve from transitioning from the expanded condition to the collapsed condition (see Qi’s [0371] describing the skirt in an unfolded configuration before the stent is released, or in other words in the collapsed condition).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz, Kovalsky, and Qi et al. as applied to claim 9 above, and further in view of Schwartz.
Regarding claim 10, Ratz in view of Kovalsky, and Qi discloses the prosthetic heart valve as claimed in claim 9, but fails to teach the prosthetic heart valve further comprising at least one suture extending radially between the outer fabric and the stent, a first end of the at least one suture being coupled to the outer fabric, a second end of the at least one suture being coupled to the stent.
Schwartz also discloses a prosthetic heart valve (430, see Fig. 22) comprising an outer fabric (414) attached to a stent (402). Schwartz teaches at least one suture (434, 435, 442, etc.) extending radially between the outer fabric (414) and the stent (402), a first end of the at least one suture being coupled to the outer fabric, a second end of the at least one suture being coupled to the stent (see Fig. 22). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Ratz in view of Kovalsky and Qi to further comprise at least one suture extending radially between the outer fabric and the stent, a first end of the at least one suture being coupled to the outer fabric, a second end of the at least one suture being coupled to the stent, as taught by Schwartz, in order to sufficiently secure the outer fabric to the stent (see paragraph [0139]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz as applied to claim 1 above, and further in view Lane et al. (US 9241790).
Regarding claim 11, Ratz discloses the prosthetic heart valve as claimed in claim 1, and further discloses wherein the stent (10) includes a plurality of cells (16, 18; see Fig. 1). Ratz fails to disclose selected ones of the cells having a free end hooking radially outwardly adjacent the center portion of the stent in an expanded condition of the stent, the free end configured to press the outer fabric radially outwardly.
Lane also discloses a stent (valve 800, see Fig. 8a) that includes a plurality of cells. Lane teaches selected ones of the cells having a free end hooking radially outwardly adjacent the center portion of the stent in an expanded condition of the stent (the cells having barbs 823, see Fig. 8a), the free end configured to press the outer fabric radially outwardly (due to hooking radially outwardly).Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz such that selected ones of the cells have a free end hooking radially outwardly adjacent the center portion of the stent in an expanded condition of the stent, the free end configured to press the outer fabric radially outwardly, as taught by Lane, in order to better secure the prosthetic heart valve in the native atrioventricular valve (see col 15-16, lines 49-51, 1-8).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz as applied to claim 1 above, and further in view Quadri et al. (US 9333074).
Regarding claim 12, Ratz discloses the prosthetic heart valve as claimed in claim 1 and further discloses the stent includes a plurality of cells (16, 18; see Fig. 1). Ratz fails the disclose selected ones of the cells having protrusion extending radially outwardly adjacent the center portion of the stent in an expanded condition of the stent, the protrusion configured to press the outer fabric radially outwardly.
Quadri also discloses a stent (stent 140a, see Fig. 6) with a plurality of cells (see Fig. 6). Quadri teaches selected ones of the cells having a protrusion (outward flare 196, see Fig. 6) extending radially outwardly adjacent the center portion of the stent in an expanded condition of the stent, the protrusion configured to press the outer fabric radially outwardly (due to the protrusion extending radially outwardly). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz to provide selected ones of the cells having a protrusion extending radially outwardly adjacent the center portion of the stent in an expanded condition of the stent, the protrusion configured to press the outer fabric radially outwardly, as taught by Quadri, in order to better anchor the stent to the native atrioventricular valve (see col 15, lines 15-18).
Claims 14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Kovalsky, Schwartz, and Alferness et al. (US 20040111006).
Regarding claim 14, Ratz discloses a prosthetic heart valve (see Fig. 1) for replacing a native atrioventricular valve, the prosthetic heart valve comprising: a self-expanding stent (see paragraph [0021]) including an atrial disk (formed proximal anchors 22), a ventricular disk (formed of distal anchors 24), and a center portion extending between the atrial disk and the ventricular disk (frame 20); a plurality of prosthetic leaflets coupled to the stent (see paragraph [0040]); a fabric coupled to the atrial disk (outer skirt 30’ or 30’’) and extending toward the ventricular disk (see paragraph [0052], the outer skirt at the proximal anchors can form an annular ring) and a fabric coupled to the ventricular disk (outer skirt 30’ or 30’) and extending towards the atrial disk (see paragraph [0052], the distal end of the outer skirt can attach and/or cover the distal anchors).
Ratz fails to disclose the fabric coupled to the atrial disk is a first non-extensible sealing fabric.
Alferness discloses a blood flow regulator cuff that is a related implanted device to help stabilize a person’s blood flow. Alferness teaches the use of a non-extensible woven fabric to make up a non-stretchable casing (see Fig. 3, outer casing 34) that aids in directing fluid to flow through the prosthesis (see paragraph [0036]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer skirt of Ratz to be formed from a first non-extensible sealing fabric in a similar manner, as taught by Alferness, to direct fluid flow through the central passage and improve the ability of the prosthetic heart valve to prevent paravalvular leakage.
Ratz in view of Alferness fails to discloses the fabric coupled to the ventricular disk of the prosthetic heart valve is a second extensible fabric.
Kovalsky also discloses a prosthetic heart valve (200; see Fig. 2) that comprises a first outer fabric (graft material portion 226) and a second outer fabric (tent portion 228). Kovalsky teaches the second outer fabric (tent portion 228) is made from elastic materials which is best understood to mean extensible (see paragraph [0163], the tent portion can be made of any suitable material, such as, but not limited to, native or artificial valve tissue, fabric, mesh, and/or elastic materials). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified outer skirt (which forms a second outer fabric when modified by Kovalsky) of Ratz in view of Alferness to be formed as an extensible fabric, as taught by Kovalsky, in order to provide cushioning to the native chordae and distribute the tension and load placed on the chordae (see Kovalsky’s paragraph [0163]).
Ratz in view of Kovalsky and Alferness fails to disclose the first non-extensible sealing fabric being coupled to the second extensible fabric at a coupling location.
Schwartz also discloses an embodiment of a prosthetic heart valve (600, see Fig. 32-36) with a first fabric (see paragraph [0165], first covering 614) and a second fabric (see paragraph [0165], second covering or layer 616). Schwartz teaches a further embodiment where the first fabric (backing layer 114, see Fig. 12) is attached to the second fabric (cushioning layer 116, see Fig.12) at a coupling location (dashed lines 142, 144, see Fig. 12, where the cushioning layer meets the backing layer for attachment). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz in view of Kovalsky and Alferness to have a first and second outer fabric that are attached at a coupling location, as taught by Schwartz, to protect native tissue from damage due to being in contact with the heart valve (see paragraph [0115]) and prevent perivalvular leakage (see paragraph [0129], forming inflow and outflow protective portions).
Regarding claim 16, Ratz in view of Kovalsky, Alferness, and Schwartz discloses the prosthetic heart valve as claimed in claim 14, and further discloses wherein the coupling location is at or adjacent a terminal end of the first non-extensible sealing fabric (see Schwartz’ Fig. 12 and paragraph [0128], distal edge 148 of backing layer can have an offset distance of about 3.5mm in some embodiments).
Regarding claim 17, Ratz in view of Kovalsky, Alferness, and Schwartz discloses the prosthetic heart valve as claimed in claim 14 but fails to disclose wherein the first non-extensible sealing fabric includes an overlapping portion extending a distance toward the ventricular disk beyond the coupling location.
Schwartz also discloses a further embodiment of a prosthetic heart valve (900, see Fig. 45) that comprises a first fabric (second portion 926, which become non-extensible sealing fabric when modified by Alferness) and a second fabric (first portion 924). Schwartz teaches the first non-extensible sealing fabric includes an overlapping portion extending a distance towards the ventricular disk beyond the coupling location (see paragraph [0190], the first and second portions 924, 926 can be configured to overlap each other). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz in view of Kovalsky, Alferness, and Schwartz to have the first non-extensible sealing fabric to include an overlapping portion extending a distance towards the ventricular disk beyond the coupling location, as taught by Schwartz, to protect the tissue from damage due to the stent and help maintain the structural integrity of the outer cover (see paragraphs [0115] and [0190]).
Regarding claim 18, Ratz in view of Kovalsky, Alferness, and Schwartz discloses the prosthetic heart valve as claimed in claim 17 but fails to disclose wherein the overlapping portion is positioned radially inward of the second extensible fabric.
Schwartz further teaches that the overlapping portion is position radially inward of the second extensible fabric (see paragraph [0190], the first portion is a fabric with a plush pile layer 924 that goes over the second portion that is a fabric without a plush pile layer 926 so the non-extensible fabric is under the extensible fabric). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz in view of Kovalsky, Alferness, and Schwartz to have the overlapping portion positioned radially inward of the second extensible fabric, as taught by Schwartz, to help maintain the structural integrity of the outer cover (see paragraph [0190]).
Regarding claim 19, Ratz in view of Kovalsky, Alferness, and Schwartz discloses the prosthetic heart valve as claimed in claim 17 but fails to disclose wherein the second extensible fabric includes a first layer and a second layer, the overlapping portion being sandwiched between the first layer and the second layer of the second extensible fabric.
Schwartz discloses a further embodiment of a prosthetic heart valve (200, see Fig. 15) with an outer fabric (202). Schwartz teaches the outer fabric comprising multiple layers (see paragraph [0133], cover member can comprise a first layer 206, a second layer 208, and a spacer layer 210 extending between the first and second layers). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz in view of Kovalsky, Alferness, and Schwartz to create a prosthetic heart valve with a non-extensible sealing fabric and an extensible fabric with two layers wherein there is an overlapping portion which is sandwiched between the first and second layer of the extensible fabric, as taught by Schwartz, to maintain the structural integrity of the fabric cover and stent (see paragraph [0135]).
Regarding claim 20, Ratz in view of Kovalsky, Alferness, and Schwartz discloses the prosthetic heart valve as claimed in claim 14 but fails to disclose wherein the first non-extensible sealing fabric is formed as a woven fabric, and the second extensible fabric is formed as a knitted fabric.
Kovalsky also discloses a prosthetic heart valve (200; see Fig. 2) that comprises a first outer fabric (graft material portion 226) and a second outer fabric (tent portion 228). Kovalsky further teaches wherein the first non-extensible sealing fabric (graft material portion 226 when modified by Alferness) is formed as a woven fabric (see paragraph [0218], low-porosity woven fabric which creates a one-way fluid passage) and the second extensible fabric (tent portion 228) is formed as a knitted fabric (see paragraph [0163]), the tent portion can be a knitted PTFE fabric). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified prosthetic heart valve of Ratz in view of Kovalsky, Alferness, and Schwartz to have a non-extensible sealing fabric be formed as a woven fabric and an extensible fabric be formed as a knitted fabric, as taught by Kovalsky, to provide a medium for tissue ingrowth and create a fluid passage which prevents perivalvular leakage (Kovalsky, see paragraph [0218]) and to provide cushioning to the native chordae and distribute the tension and load placed on the chordae (Kovalsky, see paragraph [0163]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Kovalsky, Alferness, Schwartz and Noe et al. (US 2018/0206983).
Regarding claim 15, Ratz in view of Kovalsky, Alferness, and Schwartz discloses the prosthetic heart valve as claimed in claim 14 and the prosthetic heart valve being formed as a monolithic structure (see Ratz’ paragraph [0021], the wire frame of a metal tube can be cut or etched to removed but the desired metal skeleton) but fails to disclose wherein the stent includes an inner frame and an outer frame coupled to the inner frame, the prosthetic leaflets being coupled directly to the inner frame.
Noe also discloses a prosthetic heart valve (100, see Fig. 1A-1C). Noe teaches a stent that includes an inner frame (see Fig. 1A, element 105) and an outer frame (see Fig. 1A, element 101) coupled to the inner frame with the prosthetic leaflets being coupled directly to the inner frame (see paragraph [0080], replacement leaflets can be secured to the strut frame). Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Ratz in view of Kovalsky, Alferness, and Schwartz to have an inner and an outer frame coupled to the inner frame with the prosthetic leaflets being coupled directly to the inner frame, as taught by Noe, such that it would be easier to match the valve to the size of the native valve and easier to retrieve the prosthetic heart valve if initially place incorrectly (see paragraph [0007]).
Conclusion
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/JUSTIN ZHI-DE YAO/Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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