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
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.
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, 5-7, 14-17 and 19-20i s/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levi (US Pub No.: 2012/0123529).
Regarding claim 1, Levi (US Pub No.: 2012/0123529) discloses a prosthetic heart valve (in the abstract), comprising: an annular frame (shown in figure 2, annular frame disclosed in [0009]) including a plurality of strut members (the axially oriented side struts in [0012]), the frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration (as a collapsed configuration is disclosed in [0014], a collapsing and expanding is taken to be present in Levi); a leaflet structure situated at least partially within the frame (in figure 30), the leaflet structure comprising a plurality of leaflets (disclosed in [0011]), each leaflet comprising opposing commissure tab portions on opposite sides of the leaflet (disclosed in [0012] with the angularly spaced commissure with the tabs disclosed in [0099]), each commissure tab portion (being parts 366 and 368 in figure 62) being paired with an adjacent commissure tab portion of an adjacent leaflet to form a commissure (shown in figure 62 and in [0099]), the commissure tab portions of each leaflet being folded such that each commissure tab portion forms a plurality of layers (folding shown in figure 62, folding occurs at each commissure portion of the valve. Said folding forms two double layer portions in figure 65 as per [0106]); and a plurality of reinforcement members (the non-rigid reinforcing sheet in [0100]), a reinforcement member of the plurality of reinforcement members being positioned between the layers of each commissure tab portion (the sheet 378 is taken to extend between both commissure tabs of figure 62); wherein each commissure tab portion of each leaflet is positioned entirely within the frame (taken to be shown in figure 62).
Regarding claim 2, Levi discloses the prosthetic heart valve of claim 1, wherein a reinforcement member of the plurality of reinforcement members is positioned between second and third layers of each commissure tab portion (part 378 extends across the plurality of layers in figure 64).
Regarding claim 3, Levi discloses the prosthetic heart valve of claim 1, wherein a reinforcement member of the plurality of reinforcement members is positioned in a center of each folded commissure tab portion (part 378 would extend across the center of the folded commissure tab portions in figures 62 and 64).
Regarding claim 5, Levi discloses the prosthetic heart valve of claim 1, wherein the reinforcement members comprise main bodies defining longitudinal axes (the main bodies being part 378), and the longitudinal axes of the reinforcement members extend in a direction of a longitudinal axis of the prosthetic heart valve (it stands to reason that sheet 378, in [0100]-[0102] comprise a longitudinal axes in figure 63, where said longitudinal axis of the sheet 378 and the valve are the same axis).
Regarding claim 6, Levi discloses the prosthetic heart valve of claim 1, wherein the reinforcement members comprise a fabric material or a non-fabric material (fabric in [0066]).
Regarding claim 7, Levi discloses the prosthetic heart valve of claim 6, wherein the reinforcement members comprise a polymeric material (polymers in [0054] and [0100]).
Regarding claim 14, Levi discloses a prosthetic heart valve (a prosthetic heart valve is disclosed in the abstract), comprising: an annular frame (shown in figure 2, annular frame disclosed in [0009]) including a plurality of strut members (the axially oriented side struts in [0012]), the frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration (as a collapsed configuration is disclosed in [0014], a collapsing and expanding is taken to be present in Levi); a leaflet structure situated at least partially within the frame (in figure 30), the leaflet structure comprising a plurality of leaflets (disclosed in [0011]), each leaflet comprising opposing commissure tab portions on opposite sides of the leaflet (disclosed in [0012] with the angularly spaced commissure with the tabs disclosed in [0099]), each commissure tab portion(being parts 366 and 368 in figure 62) being paired with an adjacent commissure tab portion of an adjacent leaflet to form a commissure (shown in figure 62 and in [0099]), the commissure tab portions of each leaflet being folded such that each commissure tab portion forms a plurality of layers (folding shown in figure 62 to form layers. This occurs at each commissure portion of the valve); and a plurality of reinforcement members (the non-rigid reinforcing sheet in [0100]), a reinforcement member of the plurality of reinforcement members being positioned between the layers of each commissure tab portion (the sheet 378 extends between both commissure tabs of figure 62); wherein the reinforcement members comprise main bodies defining longitudinal axes (part 378 has a main body in figure 62, where it stands to reason that part 378 extends along a longitudinal axis), and the longitudinal axes of the reinforcement members extend in a direction of a longitudinal axis of the prosthetic heart valve (it stands to reason that sheet 378, in [0100]-[0102] comprise a longitudinal axes in figure 63, where said longitudinal axis of the sheet 378 and the valve are the same axis).
Regarding claim 15, Levi discloses the prosthetic heart valve of claim 14, wherein the entirety of each commissure tab portion of each leaflet is positioned within the frame (shown in figure 30 with tab portions 112).
Regarding claim 16, Levi discloses the prosthetic heart valve of claim 14, wherein a reinforcement member of the plurality of reinforcement members is positioned between second and third layers of each commissure tab portion (part 378 extends across the plurality of layers in figure 64).
Regarding claim 17, Levi discloses the prosthetic heart valve of claim 14, wherein a reinforcement member of the plurality of reinforcement members is positioned in a center of each folded commissure tab portion (part 378 extends across the center of the folded commissure tab portions in figures 62 and 64).
Regarding claim 19, Levi discloses the prosthetic heart valve of claim 14, wherein the reinforcement members comprise a fabric material or a non-fabric material (fabric in [0066]).
Regarding claim 20, Levi discloses the prosthetic heart valve of claim 19, wherein the reinforcement members comprise a polymeric material (polymers in [0054] and [0100]).
Claim Rejections - 35 USC § 103
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.
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 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi (US Pub No.: 2012/0123529) in view of Girard (US Pub No.: 2011/0295363).
Regarding claim 4, Levi discloses the prosthetic heart valve of claim 1. However, Levi does not disclose wherein the reinforcement members comprise multi-filament sutures.
Instead, Girard (US Pub No.: 2011/0295363) teaches wherein the reinforcement members comprise multi-filament sutures (multi-filament sutures to secure a valve to a stent in [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a means to secure a valve to a stent (in [0055]), where the thin diameter sutures in [0055] allow for the stent to be attached to the valve without adding too much bulk to a stent, as set out in [0031] and [0055] of Girard.
Regarding claim 18, Levi (US Pub No.: 2012/0123529) discloses the prosthetic heart valve of claim 14, wherein the reinforcement members comprise multi-filament sutures
Instead, Girard (US Pub No.: 2011/0295363) teaches wherein the reinforcement members comprise multi-filament sutures (multi-filament sutures to secure a valve to a stent in [0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a means to secure a valve to a stent (in [0055]), where the thin diameter sutures in [0055] allow for the stent to be attached to the valve without adding too much bulk to a stent, as set out in [0031] and [0055] of Girard.
Claim(s) 8-10 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levi (US Pub No.: 2012/0123529).
Regarding claim 8, Levi discloses the prosthetic heart valve of claim 1. The current embodiment of Levi does not further comprising a commissure attachment member at the commissure, and wherein the commissure tab portions of the commissure are received in the commissure attachment member.
Instead, an alternate embodiment of Levi would teach a commissure attachment member at the commissure (being the connector part 124 in [0080]), and wherein the commissure tab portions of the commissure are received in the commissure attachment member (in figure 31, part 124 is depicted as being between the leaflets and the commissure tabs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible connector of one of embodiment of Levi into the first embodiment of Levi depicted in figure 62 for the purpose of providing a means to “interconnect pairs of adjacent sides of the leaflets and to mount the leaflets to the commissure windows” in [0076], wherein said mounting is taken to be required for the leaflets in figures 62-65 (where the leaflets are part 360 when labeled). This is seen as being beneficial as this would then serve as a means to connect the presented leaflets here to a window (the window having the opening 334 in figure 60A and in [0104]) of the heart valve frame to then secure the leaflets to the frame of the presented device.
Regarding claim 9, Levi teaches the prosthetic heart valve of claim 8, wherein the commissure attachment member comprises a woven fabric (woven PET fabric in [0100] as part of a commissure 376).
Regarding claim 10, Levi teaches the prosthetic heart valve of claim 8, wherein a main body of the commissure attachment member is positioned inside the frame (as folding is shown in figures 30 and 62 and in [0106], the main body of the commissure with tab portions 112 is inside of the frame).
Regarding claim 12, Levi discloses the prosthetic heart valve of claim 10, wherein: the commissure attachment member is folded to form a central outer portion positioned along an inner surface of the frame, an inner sleeve that extends around the commissure tab portions of the commissure, and first and second side portions extending inwardly from the central outer portion (parts 148 with 126 are shown to be folded in figure 29. In figure 29, part 126 will be the central outer portion with both parts 148 being a first and second side portion); and the first and second side portions of the commissure attachment member each comprise first and second layers (the first layer will be on the leftmost side of figure 29 while the second layer will be on the rightmost side of figure 29 about the first and second sides of parts 148 and 126).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible connector of one of embodiment of Levi into the first embodiment of Levi depicted in figure 62 for the purpose of providing a means to “interconnect pairs of adjacent sides of the leaflets and to mount the leaflets to the commissure windows” in [0076], wherein said mounting is taken to be required for the leaflets in figures 62-65 (where the leaflets are part 360 when labeled). This is seen as being beneficial as this would then serve as a means to connect the presented leaflets here to a window (the window having the opening 334 in figure 60A and in [0104]) of the heart valve frame to then secure the leaflets to the frame of the presented device.
Regarding claim 13, Levi discloses the prosthetic heart valve of claim 10, wherein each side portion of the commissure attachment member is secured to a commissure tab portion of the commissure by suturing (as per [0081], a sutured attachment is disclosed). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the flexible connector of one of embodiment of Levi into the first embodiment of Levi depicted in figure 62 for the purpose of providing a means to “interconnect pairs of adjacent sides of the leaflets and to mount the leaflets to the commissure windows” in [0076], wherein said mounting is taken to be required for the leaflets in figures 62-65 (where the leaflets are part 360 when labeled). This is seen as being beneficial as this would then serve as a means to connect the presented leaflets here to a window (the window having the opening 334 in figure 60A and in [0104]) of the heart valve frame to then secure the leaflets to the frame of the presented device.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Levi (US Pub No.: 2012/0123529) in view of Bergheim (US Pub No.: 2006/0025857).
Regarding claim 11, Levi discloses the prosthetic heart valve of claim 10. However, Levi does not teach wherein the commissure attachment member comprises an outer support member that extends over apices of the frame and is secured to the outside of the frame.
Instead, Bergheim (US Pub No.: 2006/0025857) teaches wherein the commissure attachment member comprises an outer support member that extends over apices of the frame and is secured to the outside of the frame (a thin cloth covering that covers up a portion of a heart valve in [0086]. This is shown in the figures 13 and 14, wherein the cover is disclosed as part 8 (this is defined in [0151]) and is shown as covering the tabs of the heart valve. Said cover is seen as extending over an outflow end of the frame in figure 1, with the main portion being over part 8. From here the cloth part can attach itself to the outermost end of the commissure of Levi, at around part 126 in figure 31.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the outer support member of Bergheim into the device of Levi as this will provide additional support to the device of Levi. This is disclosed in [0151], where the cloth is disclosed to “distribute the lode seen by the commissural posts across the entire tab, hence reducing wear and tear on the commissural posts of the valve.” As such, a covering is disclosed to increase the durability of the artificial heart valve. From here, we also see that a cloth will promote tissue ingrowth, also disclosed in [0151], which is known to be beneficial for implants as tissue ingrowth will increase the stability of the implant and will reduce the risk of the body rejecting said implant.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rowe (US Pub No.: 2013/0317598) applied for a heart valve with part 34 appearing to be an outer support member. Benichou (US Pub No.: 2008/0154355) Applied for a folded leaflet at part 118 in figure 2.
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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