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.
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 1-2, 5-7, 11-13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallace et al. (US 20170325948 A1).
Regarding claim 1, Wallace discloses a prosthetic heart valve for replacing a native atrioventricular valve (the Abstract discloses a prosthetic mitral valve), the prosthetic heart valve comprising: a collapsible and expandable frame (3201), the frame including an atrial disk, a ventricular disk, and a center portion extending between the atrial disk and the ventricular disk (see fig. 6b), the frame including a plurality of commissure attachment features that include struts that extend from the center portion of the frame (¶ 0018 discloses that commissure attachment features 3236 include struts 3261 that extend from a center portion of the frame 3201 as the aperture 3265 is configured to attach to the aperture 3246 on the central portion of the frame 3201 in which the strut 3261 is configured to extend from and attach to a strut frame 3215 to an attachment feature 3205; see fig. 6a-6d); a plurality of prosthetic leaflets mounted to the plurality of commissure attachment features (¶0087/¶ 0108 disclose and fig. 6a illustrates a plurality of replacement/prosthetic leaflets mounted to the plurality of commissure attachment features 3236); a sealing fabric coupled to an outer surface of the frame (¶ 0135 and fig. 6a); and a commissure support ring coupled to and extending around the plurality of commissure attachment features (see fig. 6a; commissure support ring comprising a central portion 3206 and a strut frame 3215), wherein in an expanded condition of the prosthetic heart valve, the atrial disk and the ventricular disk each flare outwardly from the center portion of the frame, the center portion of the frame defining a minimum diameter of the frame (see fig. 6b below), each of the plurality of commissure attachment features being spaced from adjacent ones of the plurality of commissure attachment features so that gaps in the frame are present between adjacent ones of the plurality of commissure attachment features (see fig. 6a below).
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Regarding claim 2, Wallace discloses the invention as claimed as discussed with respect to claim 1. Wallace further discloses that the commissure support ring is a collapsible and expandable structure that has a circular shape in an expanded condition of the commissure support ring (fig. 6d illustrates an expanded commissure support ring 3206/3215 with a circular shape).
Regarding claim 5, Wallace discloses the invention as claimed as discussed with respect to claim 1. Wallace further discloses that the commissure support ring (3206/3215) includes a first circumferential row of generally diamond-shaped cells (see fig. 6a).
Regarding claim 6, Wallace discloses the invention as claimed as discussed with respect to claim 5. Wallace further discloses that the commissure support ring (3206/3215) includes a second circumferential row of generally diamond-shaped cells adjacent the first circumferential row (see cropped fig. 6a below).
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Regarding claim 7, Wallace discloses the invention as claimed as discussed with respect to claim 6. Wallace further discloses that the commissure support ring (3206/3215) includes a plurality of connectors integrally formed with the commissure support ring (fig. 6a illustrates a plurality of connectors and 6d illustrates that the connector 3205), the plurality of connectors each having a shape that is complementary to a shape of each of the plurality of commissure attachment features (fig. 6a illustrates that the connectors have a shape complimentary to each of the commissure attachment features 3236 given that their apertures are aligned and attached to secure the frame to the commissure support ring 3206/3215).
Regarding claim 11, Wallace discloses the invention as claimed as discussed with respect to claim 1. Wallace further discloses that the struts (3261) that extend from the center portion of the frame include at least one aperture (3236; see fig. 6c).
Regarding claim 12, Wallace discloses the invention as claimed as discussed with respect to claim 11. Wallace further discloses that the commissure support ring is coupled to the plurality of commissure attachment features via mechanical fasteners extending through the at least one aperture (¶ 0025 discloses that the commissure support ring 3206/3215 can be attached to the frame 3201 with a plurality of couplers/rivets that extend through the plurality of apertures - also see fig. 6a).
Regarding claim 13, Wallace discloses the invention as claimed as discussed with respect to claim 1. Wallace further discloses that in the expanded condition of the prosthetic heart valve, the ventricular disk of the frame is bell-shaped (fig. 6a illustrates a prosthetic heart valve 3200 in which the ventricular disk 3204 of the frame 3201 is bell-shaped).
Regarding claim 16, Wallace discloses the invention as claimed as discussed with respect to claim 1. Wallace further discloses that the plurality of commissure attachment features extend from the center portion of the frame in an outflow direction (figs. 6a-d illustrate commissure attachment features 3261 that extend from a center portion, as discussed in claim 1, in an outflow direction/ventricular direction), and the commissure support ring is positioned in the outflow direction relative to the center portion of the frame (figs. 6a-d also illustrate a commissure support ring 3206/3215 that is positioned in the outflow direction/ventricular direction relative to the center portion 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.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 20170325948 A1) as applied to claim 1 above, and further in view of Yohanan et al. (US 9168131 B2).
Regarding claim 3, Wallace discloses the invention as claimed as discussed with respect to claim 1. Wallace fails to disclose that the commissure support ring is a collapsible and expandable structure that has a lobed shape in an expanded condition of the commissure support ring.
Yohanan also discloses a prosthetic heart valve (Abstract; 10) comprising: a commissure support ring (12). Yohanan teaches that the commissure support ring is a collapsible and expandable structure (col. 4 lines 52-57) that has a lobed shape in an expanded condition of the commissure support ring (see figs. 2-3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified/replaced the commissure support ring of Wallace so that the commissure support ring that is a collapsible and expandable structure has a specifically lobed shape in an expanded condition of the commissure support ring as taught by Yohanan as they serve the same function of providing commissural support to prosthetic leaflets (Yohanan - Abstract/col. 5 lines 1-7).
Regarding claim 4, Wallace in view of Yohanan discloses the invention as claimed as discussed with respect to claim 3. Yohanan further discloses a structure that in the expanded condition of the commissure support ring, the first portions of the commissure support ring are capable of aligning with the plurality of commissure attachment features of Wallace (as seen in claim 1) and have a minimum diameter of the commissure support ring (see fig. 3 below), and second portions of the commissure support ring aligned with middle portions of free edges of the plurality of prosthetic leaflets have a maximum diameter of the commissure support ring (see fig. 3 below).
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Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 20170325948 A1) as applied to claim 1 above, and further in view of Quijano et al. (US 20200155307 A1).
Regarding claim 8, Wallace discloses the invention as claimed as discussed with respect to claim 1. Wallace further discloses that the frame includes a plurality of tines on the ventricular disk (3222a; fig. 6e). Wallace fails to disclose that each of the plurality of tines extending to a free end pointing toward the atrial disk in a collapsed condition of the frame.
Quijano also discloses a prosthetic heart valve (10) for replacing a native atrioventricular valve (¶ 0029), the prosthetic heart valve comprising: a collapsible and expandable frame (¶ 0029; 11), the frame including an atrial portion, ventricular portion, and center portion extending between the atrial portion and ventricular portion (see fig. 5a below). Quijano teaches that the frame (11) includes a plurality of tines (18) on the ventricular portion and further that that each of the plurality of tines extending to a free end pointing toward the atrial portion in a collapsed condition of the frame (¶ 0102 discloses that the tines 18 proceed toward an expanded configuration as shown in fig. 6a when deployed i.e. pointed towards atrial portion when collapsed and pointed radially outwards when expanded).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the commissure support ring of Wallace to include plurality of tines extending to a free end pointing toward the atrial disk in a collapsed condition of the frame as taught by Quijano in order to engage tissue of the native valve annulus to anchor the assembly (Quijano ¶ 0084).
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Regarding claim 9, Wallace in view of Quijano disclose the invention as claimed as discussed with respect to claim 8. Quijano further discloses that in the expanded condition of the prosthetic heart valve (10), at least some of the plurality of tines (18) extend at an acute angle relative to a central longitudinal axis of the prosthetic heart valve (see fig. 5a below).
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Regarding claim 10, Wallace in view of Quijano disclose the invention as claimed as discussed with respect to claim 8. Quijano further discloses that in the expanded condition of the prosthetic heart valve (10), at least some of the plurality of tines (18) extend at an acute angle relative to a central longitudinal axis of the prosthetic heart valve (see fig. 5a below).
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Claims 14-15, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 20170325948 A1) in view of Cartledge et al. (US 10226335 B2).
Regarding claim 14, Wallace discloses the invention as claimed as discussed with respect to claim 13. Wallace further discloses that the sealing fabric extends over the ventricular disk and over the center portion of the frame (see fig. 6a annotated below). Wallace fails to disclose an inflow edge of the sealing fabric being positioned a spaced distance from a terminal end of the atrial disk.
Cartledge also discloses a prosthetic heart valve (200) for replacing a native atrioventricular valve (Abstract), the prosthetic heart valve comprising: a collapsible and expandable frame (col. 17 lines 52-63), the frame including an atrial disk, a ventricular disk, and a center portion extending between the atrial disk and the ventricular disk (see fig. 13 below); a sealing fabric (240) coupled to an outer surface of the frame (col. 18 lines 64-67; see figs. 4 and 13); wherein in an expanded condition of the prosthetic heart valve, the atrial disk and the ventricular disk each flare outwardly from the center portion of the frame, the center portion of the frame defining a minimum diameter of the frame (see fig. 13 below). Cartledge teaches that an inflow edge of the sealing fabric is positioned a spaced distance from a terminal end of the atrial disk (see fig. 13 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sealing fabric of Wallace such that the inflow edge is positioned a spaced distance from a terminal end of the atrial disk as taught by Cartledge in order to create a tight seal, i.e. prevent leakage, at the valve annulus (Cartledge Col. 22 lines 50-52).
Regarding claim 15, Wallace discloses the invention as claimed as discussed with respect to claim 13. Wallace fails to disclose that that in an implanted condition of the prosthetic heart valve, at least a portion of the sealing fabric is configured to parachute into contact with structure of the native atrioventricular valve during ventricular systole.
Cartledge also discloses a prosthetic heart valve (200) for replacing a native atrioventricular valve (Abstract), the prosthetic heart valve comprising: a collapsible and expandable frame (col. 17 lines 52-63), the frame including an atrial disk, a ventricular disk, and a center portion extending between the atrial disk and the ventricular disk (see fig. 13 below); a sealing fabric (240) coupled to an outer surface of the frame (col. 18 lines 64-67; see figs. 4 and 13); wherein in an expanded condition of the prosthetic heart valve, the atrial disk and the ventricular disk each flare outwardly from the center portion of the frame, the center portion of the frame defining a minimum diameter of the frame (see fig. 13 below). Cartledge teaches that an inflow edge of the sealing fabric is positioned a spaced distance from a terminal end of the atrial disk (see fig. 13 below). Cartledge teaches that in an implanted condition of the prosthetic heart valve, at least a portion of the sealing fabric is capable of parachuting into contact with structure of the native atrioventricular valve during ventricular systole due to its ability to its flexible and self-expandible structure (col. 22 lines 23-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified at least a portion of the sealing fabric of Wallace to be configured to parachute into contact with structure of the native atrioventricular valve during ventricular systole as taught by Cartledge in order to create a tight seal, i.e. prevent leakage, at the valve annulus (Cartledge Col. 22 lines 50-52).
Regarding claim 17, Wallace discloses a method of implanting a prosthetic heart valve (the Abstract discloses a prosthetic mitral valve), the method comprising: loading the prosthetic heart valve into a delivery device (¶ 0070 discloses loading a prosthetic/replacement heart valve into a delivery device), the prosthetic heart valve including a collapsible and expandable frame (3201) having an atrial disk, a ventricular disk, a center portion extending between the atrial disk and the ventricular disk (see fig. 6b above), a plurality of commissure attachment features that include struts that extend from the center portion of the frame (¶ 0018 discloses that commissure attachment features 3236 include struts 3261 that extend from a center portion of the frame 3201 as the aperture 3265 is configured to attach to the aperture 3246 on the central portion of the frame 3201 in which the strut 3261 is configured to extend from and attach to a strut frame 3215 to an attachment feature 3205; see fig. 6a-6d), and a plurality of prosthetic leaflets mounted to the plurality of commissure attachment features (¶0087/¶ 0108 disclose and fig. 6a illustrates a plurality of replacement/prosthetic leaflets mounted to the plurality of commissure attachment features 3236); advancing the delivery device to a native heart valve of a patient while the prosthetic heart valve is maintained in a collapsed condition by the delivery device (¶ 0068 discloses a PHV configured to be placed in a mitral valve and ¶0070 discloses maintaining a PHV collapsed in a delivery device before deployment); while the delivery device is positioned in or adjacent to the native heart valve (¶ 0070 discloses delivering a PHV to a treatment site i.e. the native heart valve/mitral valve as disclosed in the Abstract), starting to deploy the prosthetic heart valve in a ventricle of the patient so that the ventricular disk begins to expand (¶ 0070 discloses deploying/placing the PHV in the mitral valve annulus and ¶ 0068 discloses expanding/placing a ventricular disk in the ventricle side of the mitral valve annulus); and continuing to deploy the prosthetic heart valve so that the center portion is positioned against an annulus of the native heart valve and the atrial disk expands within an atrium of the patient, wherein while starting to deploy the prosthetic heart valve (¶ 0068 discloses that the frame comprises a central portion in between the ventricular and atrial disks and that the atrial disk that is placed in the atrial side of the mitral valve annulus i.e. the center portion is against the native mitral valve annulus), a commissure support ring coupled to and extending around the plurality of commissure attachment features limits the distance which the plurality of commissure attachment feature can splay outwardly (Figs. 6a-d illustrate a commissure support ring 3215 that extends around a plurality of attachment features 3261. ¶ 0118 discloses that the commissure attachment features 3261 angle/splay inward connecting the frame 3201 to the commissure support ring 3215 and ¶ 0025 discloses that rivets may be utilized to secure commissure support ring 3215 to the commissure attachment features 3261 i.e. limiting distance in which the commissure attachment features may move further inward).
Wallace fails to disclose that a sealing fabric coupled to an outer surface of the frame moves toward the native heart valve when starting to deploy the prosthetic heart valve in a ventricle of the patient.
Cartledge also discloses a method of implanting a prosthetic heart valve (col. 1 lines 25-28), the method comprising: a prosthetic heart valve (200) including a collapsible and expandable frame (col. 17 lines 52-63) having an atrial disk, a ventricular disk, a center portion extending between the atrial disk and the ventricular disk (see fig. 13 above), advancing the delivery device to a native heart valve of a patient while the prosthetic heart valve is maintained in a collapsed condition by the delivery device (col. 17 lines 52-57; fig. 1); while the delivery device is positioned in or adjacent to the native heart valve (see fig. 14); and continuing to deploy the prosthetic heart valve so that the center portion is positioned against an annulus of the native heart valve and the atrial disk expands within an atrium of the patient (see figs. 19-21). Cartledge teaches a sealing fabric (240) coupled to an outer surface of the frame (as seen in fig. 13) moves toward the native heart valve when starting to deploy the prosthetic heart valve in a ventricle of the patient (col. 22 lines 23-27 discloses that upon deployment the sealing fabric/skirt 240 self-expands towards the sub-valvular structures below the mitral valve annulus i.e. deployment in the ventricle as seen in transapical approaches illustrated in figs. 14-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the prosthetic heart valve of Wallace to include a sealing fabric coupled to an outer surface of the frame that moves toward the native heart valve when starting to deploy the prosthetic heart valve in a ventricle of the patient as taught by Cartledge in order to create a tight seal, i.e. prevent leakage, at the valve annulus (Cartledge Col. 22 lines 50-52).
Regarding claim 19, Wallace in view of Cartledge discloses the invention as claimed as discussed with respect to claim 17. Wallace further discloses that the commissure support ring is a collapsible and expandable structure that has a circular shape after the prosthetic heart valve is fully deployed within the native heart valve (fig. 6d illustrates an expanded commissure support ring 3215 with a circular shape and ¶ 0068 discloses a valve assembly comprising a commissure support ring 3206/3215 to be deployed in the native mitral valve annulus).
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 20170325948 A1) in view of Cartledge et al. (US 10226335 B2) as applied to claim 17 above, and further in view of Quijano et al. (US 20200155307 A1).
Regarding claim 18, Wallace in view of Cartledge discloses the invention as claimed as discussed with respect to claim 17. Wallace over Cartledge fail to disclose that while starting to deploy the prosthetic heart valve, at least one of a plurality of tines on the ventricular disk frictionally engage tissue of the native heart valve.
Quijano also discloses a method of implanting a prosthetic heart valve (10; ¶ 0066), the method comprising: loading the prosthetic heart valve into a delivery device (¶ 0068), the prosthetic heart valve including a collapsible and expandable frame (¶ 0029; 11) having an atrial disk, a ventricular disk, and a center portion extending between the atrial disk and the ventricular disk (see fig. 5a above). Quijano teaches that while starting to deploy the prosthetic heart valve (10), at least one of a plurality of tines on the ventricular disk frictionally engage tissue of the native heart valve (¶ 0084 discloses that upon deployment the ventricular tines extend and engage tissue of the native valve annulus). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the commissure support ring of Wallace in view of Cartledge to include that while starting to deploy the prosthetic heart valve, having at least one of a plurality of tines on the ventricular disk frictionally engage tissue of the native heart valve as taught by Quijano in order to engage tissue of the native valve annulus to anchor the assembly (Quijano ¶ 0084).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 20170325948 A1) in view of Cartledge et al. (US 10226335 B2) as applied to claim 17 above, in further view of Yohanan et al. (US 9168131 B2).
Regarding claim 20, Wallace in view of Cartledge discloses the invention as claimed as discussed with respect to claim 17. Wallace discloses that the commissure support ring is a collapsible and expandable structure (fig. 6d illustrates an expanded commissure support ring 3215). Wallace fails to disclose that has a lobed shape after the prosthetic heart valve is fully deployed within the native heart valve.
Yohanan also discloses a prosthetic heart valve (Abstract; 10) comprising: a commissure support ring (12). Yohanan teaches discloses that the commissure support ring is a collapsible and expandable structure (col. 4 lines 52-57) that has a lobed shape after the prosthetic heart valve is fully deployed within the native heart valve (see figs. 2-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified/replaced the commissure support ring of Wallace so that the commissure support ring is a collapsible and expandable structure that has a specifically lobed shape after the prosthetic heart valve is fully deployed within the native heart valve as taught by Yohanan as they serve the same function of providing commissural support to prosthetic leaflets (Yohanan - Abstract/col. 5 lines 1-7).
Regarding claim 21, Wallace over Cartledge discloses the invention as claimed as discussed with respect to claim 17. Wallace further discloses that after the prosthetic heart valve is fully deployed within the native heart valve, first portions of the commissure support ring aligned with the plurality of commissure attachment features and the second portions of the commissure support ring aligned with middle portions of free edges of the plurality of prosthetic leaflets (see fig. 6a below).
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Wallace fails to disclose that first portions of the commissure support ring aligned with the plurality of commissure attachment features specifically have a minimum diameter of the commissure support ring, and that the second portions of the commissure support ring aligned with middle portions of free edges of the plurality of prosthetic leaflets specifically have a maximum diameter of the commissure support ring, such that as the plurality of prosthetic leaflets open during atrial systole, the middle portions of the free edges of the plurality of prosthetic leaflets reach a position radially outward of the first portions of the commissure support ring and radially inward of the second portions of the commissure support ring.
Yohanan also discloses a prosthetic heart valve (Abstract; 10) comprising: a commissure support ring (12). Yohanan teaches discloses that the commissure support ring is a collapsible and expandable structure (col. 4 lines 52-57) that has a lobed shape after the prosthetic heart valve is fully deployed within the native heart valve (see figs. 2-3).
Yohanan teaches a lobed commissure support ring (12). By modifying the shape of Wallace’s commissure support ring to that of Yohanan’s commissure support ring, the support ring’s lobed shape would allow the first portions of the commissure support ring to align with the plurality of commissure attachment features and have a specifically minimum diameter of the commissure support ring, and the second portions of the commissure support ring aligned with middle portions of free edges of the plurality of prosthetic leaflets having a specifically a maximum diameter of the commissure support ring, such that as the plurality of prosthetic leaflets open during atrial systole, the middle portions of the free edges of the plurality of prosthetic leaflets reach a position radially outward of the first portions of the commissure support ring and radially inward of the second portions of the commissure support ring. This is due to Yohanan’s lobed commissure support ring’s shape allowing the free edges of leaflets (40) to open towards the lobed portions of a commissure support ring/frame (12) as can be seen in figs. 2-3 annotated below.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified/replaced the commissure support ring of Wallace so that the commissure support ring is a collapsible and expandable structure that has shape which would allow first portions of the commissure support ring to align with the plurality of commissure attachment features and have a specifically have a minimum diameter of the commissure support ring, and that the second portions of the commissure support ring align with middle portions of free edges of the plurality of prosthetic leaflets to have a specifically maximum diameter of the commissure support ring, such that as the plurality of prosthetic leaflets open during atrial systole, the middle portions of the free edges of the plurality of prosthetic leaflets reach a position radially outward of the first portions of the commissure support ring and radially inward of the second portions of the commissure support ring as taught by Yohanan as they serve the same function of providing commissural support to prosthetic leaflets (Yohanan - Abstract/col. 5 lines 1-7).
Conclusion
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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