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) 1-12 and 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Calomeni (US Pub No.: 2018/0353294).
Regarding claim 1, Calomeni (US Pub No.: 2018/0353294) teaches a transcatheter heart valve prosthesis comprising (heart valve in the abstract, catheter delivery in [0003]): a frame having a central longitudinal axis (being the device of figure 4, where the frame will have a central longitudinal axis through the openings of said frame, being line 20 in figure 4 as per [0066]), the frame including an inflow portion, an outflow portion (ends 24 and 22, defined as a downstream end and upstream end in [0053]), and a plurality of commissure bars extending from the outflow portion towards the inflow portion (being the commissure parts 52 and 62, with commissure crowns 42); and a prosthetic valve operatively connected to the plurality of commissure bars (valve part 16 with leaflets 60 forming/defining commissures 62 in [0063]), wherein: in a radially compressed configuration (as an expanding occurs in [0021]-[0023], a radially compressed configuration is implied to be present. A compressed state is shown in figure 6), each of the plurality of commissure bars is disposed within a respective opening of a plurality of openings in the frame, and the inflow portion, the outflow portion (commissure parts shown in figures 5-8, which are disposed in downstream end part 24 and upstream end 22), and the plurality of commissure bars are spaced a first distance from a central longitudinal axis of the frame (it stands to reason that, before part 30 expands, commissure crowns 44 and parts 52 and 62 are still spaced apart from a central longitudinal axis. In figures 6-7, as the frame part 30 is expanded, the cells are depicted as being larger, which causes a change in distance from central axis 20); and in a radially expanded configuration, the inflow portion is spaced a second distance from the central longitudinal axis greater than the first distance (as an expansion of part 30 occurs, the distance of the inflow portion will be greater than the distance when the device is not expanded. Distance details in [0020] and [0057]), and the plurality of commissure bars are spaced a third distance from the central longitudinal axis of the frame less than the second distance (the commissure parts 52 and 62 are spaced toward end 24 but are not at the topmost end of figure 4. As such, the distance from the longitudinal axis is shorter than a second distance and the distance from the longitudinal axis 20 is shorter than a second distance, where the inner axial strut is part 52 in figures 4-5).
Regarding claim 2, Calomeni discloses the transcatheter heart valve prosthesis of claim 1, wherein the plurality of commissure bars extends substantially parallel to the central longitudinal axis (shown in figure 4 and 5 with parts 52 and 62).
Regarding claim 3, Calomeni discloses the transcatheter heart valve prosthesis of claim 1, wherein each commissure bar includes a distal portion and a proximal portion (being shown in figures 4-5), wherein the prosthetic valve is operably coupled to the distal portion (in figure 5, where part 62 is attached to valve leaflet 60 as per [0063]), and wherein the proximal portion (Part 52 is depicted as being proximal in figure 9) in the radially compressed configuration includes a first strut and a second strut separated by a slot (being the parts of part 42 and 46 separated by part 44 in figure 8).
Regarding claim 4, Calomeni discloses the transcatheter heart valve prosthesis of claim 3, wherein in the radially expanded configuration, the first strut and the second strut extend circumferentially in opposite directions from the distal portion of the commissure bar (in figure 8 of Calomeni, different strut members that comprise part 30 extend in different directions with respect to commissure crown 44, where parts 42 and 46 are strut parts that extend in different directions with respect to part 44).
Regarding claim 5, Calomeni discloses the transcatheter heart valve prosthesis of claim 1, wherein in the radially expanded configuration, the outflow portion is spaced the third distance from the central longitudinal axis (the outflow portion part 24 can be defined to be a third distance from a central longitudinal axis).
Regarding claim 6, Calomeni discloses the transcatheter heart valve prosthesis of claim 1, wherein the plurality of commissure bars comprises three commissure bars (being the three commissure elements 52 and 62 shown in figures 5 and 9).
Regarding claim 7, Calomeni discloses the transcatheter heart valve prosthesis of claim 1, wherein the prosthetic valve comprises a plurality of leaflets (three leaflet configuration in [0056]).
Regarding claim 8, Calomeni discloses the transcatheter heart valve prosthesis of claim 5, wherein respective commissures of the plurality of leaflets are coupled to respective commissure bars of the frame (the leaflets 60 are attached to the leaflet commissure in 62).
Regarding claim 9, Calomeni discloses the transcatheter heart valve prosthesis of claim 5, wherein the third distance is greater than the first distance (as a first distance is in a compressed configuration and the third distance is the distance between the outflow end and the same longitudinal axis, the first distance is smaller due to the compressed configuration of the device).
Regarding claim 10, Calomeni discloses the transcatheter heart valve prosthesis claim 5, further comprising a transition portion coupling the inflow portion to the outflow portion (being the portion between parts 22 and 24), wherein in the radially compressed configuration the transition portion is spaced the first distance from the central longitudinal axis (as the device is expandable, the portion between parts 22 and 24 will be at least partially along a first distance when the device is compressed), and in the radially expanded configuration, the transition portion tapers from the second distance from the central longitudinal axis to the third distance from the longitudinal axis (as per the definition of the second and third distance, the portions of the space between parts 22 and 24 make up the second and third distance).
Regarding claim 11, Calomeni discloses the transcatheter heart valve prosthesis of claim 1, further comprising connectors coupling the commissure bars to the inflow portion (parts 50 and 54, shown in figures 4-5, connect to the commissure bars).
Regarding claim 12, Calomeni discloses the transcatheter heart valve prosthesis of claim 11, wherein the connectors include an undulation region (being lobes part 54 shown in figure 4).
Regarding claim 15, Calomeni discloses a transcatheter heart valve prosthesis comprising (heart valve in the abstract, catheter delivery in [0003]): a frame having a central longitudinal axis (being the device of figure 4, where the frame will have a central longitudinal axis through the openings of said frame), the frame a plurality of inner axial struts, a plurality of outer axial struts (being parts 52 and 62 respectively in figure 5), and a plurality of connectors coupling the inner axial struts to the outer axial struts (as part 52 is disclosed as a commissure attachment location in [0064] with part 64 being a leaflet commissure in [0069], a connection between parts 52 and 64 is present); and a prosthetic valve operatively connected at least some of the inner axial struts (valve part 16 with leaflets 60 forming/defining commissures 62 in [0063]); wherein: in a radially compressed configuration (as an expanding occurs in [0021]-[0023], a radially compressed configuration is implied to be present), the plurality of inner axial struts, the plurality of outer axial struts, and the connectors are spaced a first distance from the central longitudinal axis (it stands to reason that, before part 30 expands, commissure crowns 44 and parts 52 and 62 of figure 6 are still spaced apart from a central longitudinal axis part 20 in figure 4), and in a radially expanded configuration, the plurality of outer axial struts are spaced a second distance from the central longitudinal axis greater than the first distance (as an expansion of part 30 occurs, the distance of the inflow portion will be greater than the distance when the device is not expanded. Distance details in [0020] and [0057]), and the plurality of inner axial struts are spaced a third distance from the central longitudinal axis smaller than the second distance (the commissure parts 52 and 62 are spaced toward end 24 but are not at the topmost end of figure 4. As such, the distance from the longitudinal axis 20 is shorter than a second distance, where the inner axial strut is part 52 in figures 4-5).
Regarding claim 16, Calomeni discloses the transcatheter heart valve prosthesis of claim 15, wherein the frame further comprises an inflow portion coupled to the plurality outer axial struts (ends 24 and 22, defined as a downstream end and upstream end in [0053]), wherein in the radially compressed configuration, the inflow portion is spaced the first distance from the central longitudinal axis (it stands to reason that the inflow position is spaced a distance away from the central longitudinal axis, with a longitudinal axis defined in [0019], [0064], and figure 4), and wherein in the radially expanded configuration, the inflow portion is spaced the second distance from the central longitudinal axis (as the device is expanded, it stands to reason a different distance is present between the outflow portion and the central axis 20 between a compressed configuration in figure 6 to an expanded configuration in figure 7).
Regarding claim 17, Calomeni discloses the transcatheter heart valve prosthesis of claim 15, wherein the frame further comprises an outflow portion coupled to the plurality inner axial struts (ends 24 and 22, defined as a downstream end and upstream end in [0053]), wherein in the radially compressed configuration, the outflow portion is spaced the first distance from the central longitudinal axis (it stands to reason that the outflow position is spaced a distance away from the central longitudinal axis, with a longitudinal axis defined in [0019], [0064], and figure 4), and wherein in the radially expanded configuration, the outflow portion is spaced the third distance from the central longitudinal axis (as the device is expanded, it stands to reason a different distance is present between the outflow portion and the central axis 20 between a compressed configuration in figure 6 to an expanded configuration in figure 7).
Regarding claim 18, Calomeni discloses the transcatheter heart valve prosthesis of claim 16, wherein the inflow portion comprises a plurality of generally diamond shaped cells (the cells shown in figure 8, about labeled part 30, are depicted as diamond shaped cells).
Regarding claim 19, Calomeni discloses a transcatheter heart valve prosthesis (heart valve in the abstract, catheter delivery in [0003]) comprising: a frame including a central longitudinal axis (being the device of figure 4, where the frame will have a central longitudinal axis through the openings of said frame); and a prosthetic valve coupled to the frame (valve part 16 with leaflets 60 forming/defining commissures 62 in [0063]), wherein: in a radially expanded configuration (as an expanding occurs in [0021]-[0023], a radially expanded configuration is implied to be present), the frame comprises an outer structure and an inner structure (part 62 is an inner structure with respect to commissure part 52 in figure 5), wherein the prosthetic valve is attached to the inner structure (the inner structure being the commissure part 62 in figure 5), and wherein the outer structure surrounds the inner structure and is spaced from the inner structure by a gap (part 52 interfaces with part 62 in [0069] and figures 6-7, where there is a gap between part 52 and 62 in figure 6), and in a radially compressed configuration (as an expanding occurs in [0021]-[0023], a radially compressed configuration is implied to be present), the outer structure and the inner structure are spaced about the same distance from the central longitudinal axis such that the gap disappears (in figure 7, parts 52 and 62 are viewed as being in line with each other, implying that they are spaced the same distance away from a longitudinal direction in the arrangement of figure 7, which is a deployed position as per [0069]).
Regarding claim 20, Calomeni discloses the transcatheter heart valve prosthesis of claim 19, wherein in the radially compressed configuration, the frame is a single layer tube (as the device of Calomeni is compressed as shown in figure 6 and is implanted into the body via the device of figure 1 with delivery sheath 12).
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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calomeni (US Pub No.: 2018/0353294) in view of Levi (US Pub No.: 2021/0393398).
Regarding claim 13, Calomeni discloses the transcatheter heart valve prosthesis of claim 1. However, Calomeni does not teach wherein each commissure bar includes holes and/or longitudinal slots.
Instead, Levi (US Pub No.: 2021/0393398) teach wherein each commissure bar includes holes and/or longitudinal slots (being parts 308 on a support member 302 of commissures 310 and 312, defined in [0160]). 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 commissure bar with holes of Levi into Calomeni for the purpose of providing a means to secure a commissure with sutures 322 that pass through openings 308 that act as a means to secure the commissure as per [0160].
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calomeni (US Pub No.: 2018/0353294) in view of Morriss (US Pub No.: 2013/0310928).
Regarding claim 14, Calomeni discloses the transcatheter heart valve claim 1. However, Calomeni does not further comprise cleats extending radially outwardly and proximally from the inflow portion.
Instead, Morriss teaches a further comprising of cleats (in [0252]) extending radially outwardly and proximally from the inflow portion (the cleats extend from valve 185 to wall 158 as per [0252] to secure the valve to the wall. As the valve is proximal to the inflow portion, a placement proximal to the inflow portion and radially outward to connect the valve and part 30 of Calomeni is possible). 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 cleats of Morriss into Calomeni for the purpose of providing an additional means to attach the valve to the frame of the device, as presented in [0252].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nir (US Pub No.: 2023/0051890) considered for commissure details to connect a leaflet to a frame in the abstract. Neuberger (US Pub No.: 2023/0028648) considered for a transcatheter valve prosthesis with Commissures 126A and struts 126B.
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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