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 .
Specification
The disclosure is objected to because of the following informalities:
1. Element 401.
Appropriate correction is required.
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.
Claim(s) 1-4, 10 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowe (2008/0208327) "Rowe".
Regarding Claim 1, Rowe discloses a heart valve assembly (Abstract), comprising;
a valve frame (FIG. 1, frame 14) having a leaflet assembly (FIG. 1, valve member 16) sutured to the valve frame (FIG. 1, valve 12, par. [0027]), the leaflet assembly having a plurality of leaflets (FIGS. 1-2, leaflets 28, par. [0030]);
an annulus frame (FIGS. 1 and 4D, frame 32) having an annulus skirt (FIG. 1, sealing member) sutured to the annulus frame (pars. [0032] and [0037]);
and wherein the annulus frame is connected to the valve frame (par. [0005]), and the valve frame and the annulus frame are made from different materials (pars. [0029] and [0032]).
Regarding Claim 2, Rowe discloses the assembly of claim 1, wherein the valve frame is made from a self-expanding material and the annulus frame is made from a balloon expandable material (pars. [0029] and [0032]).
Regarding Claims 3 and 13, Rowe further discloses that the annulus frame can be made from any of various suitable ductile and/or elastic materials and is typically made of a metal, such as stainless steel, titanium, or other biocompatible metals, such as cobalt-chromium (par. [0032]).
Regarding Claim 4, Rowe discloses the assembly of claim 3, wherein the valve frame is made from Nitinol (par. [0029]).
Regarding Claim 10, Rowe discloses a system, comprising:
a heart valve assembly (FIG. 1) comprising:
a valve frame (FIG. 1, frame 14) having a leaflet assembly (FIG. 1, valve member 16) sutured to the valve frame (FIG. 1, valve 12, par. [0027]), the leaflet assembly having a plurality of leaflets (FIGS. 1-2, leaflets 28, par. [0030]);
an annulus frame (FIGS. 1 and 4D, frame 32) having an annulus skirt (FIG. 1, sealing member) sutured to the annulus frame (pars. [0032] and [0037]);
and wherein the annulus frame is connected to the valve frame (par. [0005]), and the valve frame and the annulus frame are made from different materials (pars. [0029] and [0032]);
a delivery system having:
a ballon catheter (FIG. 3, catheter 70) having a shaft (FIG.3, shaft 72), having a distal end (par. [0038]), a balloon provided on the shaft adjacent the distal end (par. [0038]), and a valve frame seat located on the shaft directly proximal to the balloon (at spaced-apart balloon 74, Fig. 3, par. [0044]);
a sheath assembly (shaft 92 plus outer sheath 94) having a capsule (outer sheath 94) that slidably covers the balloon and the valve frame seat (par. [0029]);
and wherein the valve frame is seated around the valve frame seat and the annulus frame is seated over the balloon (spaced-apart balloon 76, FIG. 3, par. [0044]).
Regarding Claim 12, Rowe discloses the system of claim 10 and describes wherein the valve frame is made from a self-expanding material and the annulus frame is made from a balloon expandable material (pars. [0029] and [0032]).
Regarding Claim 14, Rowe discloses the system of claim 13 and describes wherein the valve frame is made from Nitinol (par. [0029]).
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) 5-9, 15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rowe (2008/0208327) "Rowe" in view of Von Segesser et al. (2017/0189178) "Von Segesser".
Regarding Claim 5, Rowe does not disclose the assembly with an inflow side, and an outflow side, and the valve frame has a flared inflow end that is configured to be positioned below the native aortic leaflets to provide an effective securing mechanism to prevent the assembly from moving towards the inflow side. However, Von Segesser discloses a stent valve (See Annotated FIG. 2A, below, stent component 200), wherein the assembly has an inflow side (See Annotated FIG. 2A, below), and an outflow side (See Annotated FIG. 2A, below), and the valve frame (See Annotated FIG. 2A, below) has a flared inflow end (See Annotated FIG. 2A, below, located at 202 and area below) that is configured to be positioned below the native aortic leaflets to provide an effective securing mechanism to prevent the assembly from moving towards the inflow side (pars. [0067] and [0071]- [0073]). It would have been obvious to one skilled in the art, before the effective filing date of the claimed invention, to modify the assembly disclosed by the first embodiment of Rowe to include a valve frame with an inflow side, outflow side, and a flared inflow end in the assembly, as disclosed by Von Segesser, in order to secure the assembly.
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Regarding Claim 6, Rowe does not disclose an annulus frame with an inflow side that is flared to prevent that the annulus frame from moving towards the outflow side of the assembly. However, Von Segesser discloses a stent valve (See Annotated FIG. 3A, below, stent component 300), wherein the annulus frame (See Annotated FIG. 3A, below, fixation element 302) has an inflow side that is flared (See Annotated FIG. 3A, below) to prevent the annulus frame from moving towards the outflow side (See Annotated FIG. 3A, below) of the assembly (par. [0072]). It would have been obvious to one skilled in the art, before the effective filing date of the claimed invention, to modify the assembly disclosed by the first embodiment of Rowe to include an annulus frame with a flared inflow side, as disclosed by Von Segesser, in order to help secure the stent component in the implantation site.
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Regarding claim 7, Rowe does not disclose the valve frame with a flared inflow end and the annulus frame with an outflow end having a plurality of posts, with each of the plurality of posts having an outflow tip that is adapted to engage a connection location on the flared inflow end of the valve frame. However, Von Segesser discloses a stent valve (See Annotated FIG. 2A, above, stent component 200), wherein the valve frame has a flared inflow end (See Annotated FIG. 2A, above) and the annulus frame (See Annotated FIG. 3A, above, stent component 300) has an outflow end (See Annotated FIG. 3A) having a plurality of posts (See Annotated FIG. 3A, above), with each of the plurality of posts having an outflow tip (par. [0067], describes that various mating configurations may be used, including where the inner component has post tips (FIG. 8E, locking elements 828, par. [0082])), that is adapted to engage a connection location on the flared inflow end of the valve frame (FIG. 4, par. [0067]). It would have been obvious to one skilled in the art, before the effective filing date of the claimed invention, to modify the assembly disclosed by the first embodiment of Rowe to reverse said parts (provide the tips on the annulus frame) as a simple design choice, as disclosed by Von Segesser, in order to provide optimal structural integrity.
Regarding claim 8, Rowe does not disclose the plurality of posts extending inside the valve frame. However, Von Segesser describes a stent valve (FIG. 8A, stent component 800) wherein the plurality of posts (FIG. 8E, locking elements 828) extends inside the valve frame (FIG. 8E, par. [0082]; see how 828 would extend into the opposing frame). It would have been obvious to one skilled in the art, before the effective filing date of the claimed invention, to modify the assembly disclosed by the first embodiment of Rowe to extend the plurality of posts inside the valve frame, as disclosed by Von Segesser, so that the posts can form a crown that may engage an element such as a failed biological valve or calcified native annulus from the outflow side (par. [0082]).
Regarding claim 9, Rowe does not disclose a flared inflow end of the valve frame with a concave configuration, and the connection locations are positioned at a base of the concavity, with the connection locations defining a ring that has the smallest diameter of the valve frame. However, Von Segesser discloses a stent valve (See Annotated FIG. 2A, above, stent component 200), wherein the flared inflow end of the valve frame (See Annotated FIG. 2A, above) has a concave configuration (See Annotated FIG. 2A, above, located at fixation element 202, also referred to as annular groove, par. [0067]), and the connection locations (par. [0067]: may attach to fixation element 302, See Annotated Fig. 3A, above, Fig. 4) are positioned at a base of the concavity (FIGS. 21B-D, par. [0096]: stents 2112 and 2114), which connect to form fixation element 2116 (analogous to fixation element 202), may have a crown shape, and thus form a ring at their connection), with the connection locations defining a ring (FIGS. 21B and 21C, par. [0096)) that has the smallest diameter of the valve frame (FIGS. 21B-D, par. [0096]: conical stents 2112 and 2114 make up a double-conical stent 2108).
It would have been obvious to one skilled in the art, before the effective filing date of the claimed invention, to modify the valve frame disclosed in the first embodiment of Rowe to provide the fixation location anywhere along the stent, including at the base of the fixation concavity, as to place the two fixation elements at the same location (the location for fixation at the native valve), as disclosed by Von Segesser, to provide a stronger fixation.
Regarding claim 15, Rowe further discloses a method of delivering a heart valve assembly (FIG. 1) to an aortic annulus (par. [0040]) which has native aortic leaflets (FIGS. 4-5, par. [0040]), comprising:
providing a heart valve assembly (FIG. 1) comprising:
a valve frame (FIG. 1, frame 14) having a leaflet assembly (FIG. 1, valve member 16) sutured to the valve frame (FIG. 1, valve 12, par. [0027]), the leaflet assembly having a plurality of leaflets (FIGS. 1-2, leaflets 28, par. [0030]);
an annulus frame (FIGS. 1 and 4D, frame 32) having an annulus skirt (FIG. 1, sealing member) sutured to the annulus frame (pars. [0032] and [0037]);
wherein the annulus frame is connected to the valve frame (par. [0005]), and the valve frame and the annulus frame are made from different materials (pars. [0029] and [0032]);
providing a delivery system (pars. [0006] and [0026]) having:
a balloon catheter (FIG. 3, catheter 70) having a shaft (FIG.3, shaft 72), having a distal end (par. [0038]), a balloon provided on the shaft adjacent the distal end (par. [0038]), and a valve frame seat located on the shaft directly proximal to the balloon (at spaced-apart balloon 74, Fig. 3, par. [0044]);
a sheath assembly (FIG. 5, shaft 92 plus outer sheath 94) having a capsule (FIG. 5, outer sheath 94, pars. [0029] and [0045]);
and crimping the heart valve assembly on to the balloon catheter by seating the valve frame around the valve frame seat and the annulus frame over the balloon (spaced-apart balloon 76, FIG. 3, pars. [0026] and [0044]);
sliding the capsule (FIG. 5, outer sheath 94) to cover the balloon (FIG. 3, balloon catheter 70) and the valve frame seat (FIG. 5, pars. [0045]- [0046]);
advancing the delivery system with the heart valve assembly ensheathed by the capsule to the location of an aortic annulus in a human heart with the annulus frame at the location of the aortic annulus (pars. [0040], [0044] - [0046], FIGS. 4A-4B);
inflating the balloon to expand the annulus frame (FIG. 4C, pars. [0044]- [0046]);
deflating the balloon (FIG. 4D); and
withdrawing the balloon catheter (FIG. 4G, pars. [0045]- [0046]);
but fails to disclose:
withdrawing the capsule such that the capsule does not cover the valve frame, and such that the valve frame begins to self-expand while the annulus frame remains crimped.
However, Von Segesser further discloses withdrawing the capsule (par. [0011] and [0012]: attachment member (commissural post) serves capsule function, FIG. 9B, stem 906 (or commissural post)) such that the capsule does not cover the valve frame (See Annotated Fig. 2A, above, stent component 200), and such that the valve frame begins to self-expand while the annulus frame remains crimped (par. [0011]).
Accordingly, it would have been obvious to one skilled in the art, before the effective filing date of the claimed invention, to modify the assembly disclosed in Rowe to include withdrawing the capsule in the appropriate manner, as disclosed by Von Segesser, so as to expand the valve as disclosed and test proper positioning.
Regarding Claim 17, Rowe further discloses that the valve frame is made from a self-expanding material and the annulus frame is made from a balloon expandable material (pars. [0029] and [0032]).
Regarding Claim 18, Rowe further discloses that the annulus frame can be made from any of various suitable ductile and/or elastic materials and is typically made of a metal, such as stainless steel, titanium, or other biocompatible metals, such as cobalt-chromium (par. [0032]).
Regarding Claim 19, Rowe further discloses that the valve frame is made from Nitinol (par. [0029]).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rowe (2008/0208327) "Rowe" in view of Braido et al. (2014/0107767) "Braido".
Regarding Claim 11, Rowe does not disclose an eyelet provided on the valve frame; an ear hub provided on the shaft immediately proximal to the valve frame seat; and the eyelet engages the ear hub when the valve frame is seated around the valve frame seat and the annulus frame is seated over the balloon.
However, Braido discloses an eyelet (FIGS. 1 and 2, eyelet 210, retaining element 118, par. [0040]) provided on the valve frame (FIG. 1, frame 102); an ear hub (ring 500 serving as the ear hub, FIG. 4) provided on the shaft (placed on top of a jar, FIG. 4, jar 450) immediately proximal to the valve frame seat (pars. [0043] and [0045], stent 400, FIGS. 4 and 7F); and the eyelet (eyelet 210) engages the ear hub (ring 500) when the valve frame (frame 102, FIG. 1) is seated around the valve frame seat (stent 400, FIG. 4) and the annulus frame (annulus section 110, FIG. 1) is seated over the balloon (par. [0047]: struts 114 that include retaining elements 118 (serving as eyelet) can be guided into channels 530 of ring 500 (ear hub), par. [0004]: the stent may be balloon-expandable).
It would have been obvious to one skilled in the art, before the effective filing date of the claimed invention, to modify the assembly disclosed in the first embodiment of Rowe, to provide an eyelet on the valve frame to adjust the position of the stent, provide an ear hub or ring near the valve frame seat, and have the eyelet engage the ear hub or ring, as disclosed by Braido, to secure the stent structure for transport/delivery and use.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Rowe (2008/0208327) "Rowe" in view of Von Segesser et al. (2017/0189178) "Von Segesser," as applied to claim 15 above, and further in view of Braido et al. (2014/0107767) "Braido".
Regarding Claim 16, Rowe in view of Von Segesser does not disclose an eyelet provided on the valve frame; an ear hub provided on the shaft immediately proximal to the valve frame seat; and the eyelet engages the ear hub when the valve frame is seated around the valve frame seat and the annulus frame is seated over the balloon.
However, Braido discloses an eyelet (FIGS. 1 and 2, eyelet 210, retaining element 118, par. [0040]) provided on the valve frame (FIG. 1, frame 102); an ear hub (ring 500 serving as the ear hub, FIG. 4) provided on the shaft (placed on top of a jar, FIG. 4, jar 450) immediately proximal to the valve frame seat (pars. [0043] and [0045], stent 400, FIGS. 4 and 7F); and the eyelet (eyelet 210) engages the ear hub (ring 500) when the valve frame (frame 102, FIG. 1) is seated around the valve frame seat (stent 400, FIG. 4) and the annulus frame (annulus section 110, FIG. 1) is seated over the balloon (par. [0047]: struts 114 that include retaining elements 118 (serving as eyelet) can be guided into channels 530 of ring 500 (ear hub), par. [0004]: the stent may be balloon-expandable).
It would have been obvious to one skilled in the art, before the effective filing date of the claimed invention, to modify the assembly disclosed in the first embodiment of Rowe, to provide an eyelet on the valve frame to adjust the position of the stent, provide an ear hub or ring near the valve frame seat, and have the eyelet engage the ear hub or ring, as disclosed by Braido, to secure the stent structure for transport/delivery and use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774