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 . Claims 1-9, 12, 14-19, 21-22, 24-25, 30-33, 36, 39-40, 47, 49-53, 60-61, & 63-73 are pending and examined below.
Response to Arguments
Applicant's arguments filed 06/27/2026 have been fully considered but they are not persuasive.
Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 1-4) and that the dependent claims rise and fall with the same arguments (pages 4-5).
Applicant's arguments are moot due to the additional references applied to the newly added limitations, as detailed in the rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “the expanding member exerts a fixation-free pushing force, the expanding member being fixation-free of one or more of the native valve leaflets”. It appears this limitation does not further limit the subject matter of claim 1 as it is claiming the same limitations of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braido (US 20190060064 A) in view of Arcaro et al. (US 20190091014 A1) hereinafter, Arcaro.
Regarding claim 1, Braido teaches
a valve (100, Fig. 1 or 200, Fig. 6, Braido) comprising: a tubular frame (102, Fig. 1, Braido) having a porous outer surface (112, Fig. 1, Braido) and length (L1, Fig. 3B, Braido) extending from a first end (130, Fig. 3A, Braido) to a second end (132, Fig. 3A, Braido) of the tubular frame (102, Fig. 3A, Braido);
valve leaflets (108, Fig. 3A, Braido) disposed within the tubular frame (102, Fig. 3A, Braido); and
the porous outer surface (112, Fig. 1, Braido) of the tubular frame (102, Fig. 3A, Braido) creates an area of cross flow for blood through the tubular frame (improved flow path, ¶0068, Braido), decreasing a risk of thrombosis between the valve leaflets and the tubular frame (prevent regurgitation and other inefficiencies that may reduce cardiac performance, ¶0068, Braido).
Braido does not teach an expanding member. However, Arcaro teaches prosthetic valves having a frame (abstract, Arcaro)
an expanding member (5700, Fig. 39, Arcaro) extending radially outward from the tubular frame (1102, Fig. 39, Arcaro) at a position along a longitudinal axis of the tubular frame (1102, Fig. 39, Arcaro); wherein:
the expanding member (5700, Fig. 39, Arcaro) is configured to exert a fixation-free pushing force on one or more native valve leaflets in a direction away from the tubular frame when the valve is deployed (to engage and displace native leaflets, ¶0219, Arcaro),
the expanding member (5700, Fig. 39, Arcaro) being fixation-free of the one or more native valve leaflets such that the expanding member does not penetrate, pinch, grasp or clamp to the one or more native valve leaflets (engage the base of the native leaflets and the native sinuses of a native valve, ¶0219, Arcaro);
and the expanding member (5700, Fig. 39, Arcaro) is expandable independently of the tubular frame (free to project outwardly, ¶0220, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
The phrase “…configured to exert a fixation-free pushing force” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
In this case, the Arcaro device discloses all the claimed structural features and is considered to be capable of exerting a fixation-free pushing force.
Regarding claim 2, Braido teaches
wherein: the tubular frame (102, Fig. 1, Braido) defines an inner lumen (lumen of 102, Fig. 1, Braido);
the tubular frame length (L1, Fig. 3B, Braido) is along the longitudinal axis of the tubular frame (102, Fig. 3A, Braido);
the valve leaflets (108, Fig. 3A, Braido) are disposed within the inner lumen (lumen of 102, Fig. 1, Braido);
the valve leaflets (108, Fig. 3A, Braido) have a first end (end opposite 109, Fig. 1, Braido) proximate the first end (130, Fig. 3A, Braido) of the tubular frame (102, Fig. 3A, Braido);
the valve leaflets (108, Fig. 3A, Braido) have a second end (109, Fig. 1, Braido) that extends partially between the first end (130, Fig. 3A, Braido) and the second end (132, Fig. 3A, Braido) of the tubular frame (102, Fig. 3A, Braido).
Braido does not teach an expanding member. However, Arcaro teaches
the expanding member (5700, Fig. 39, Arcaro) exerts a fixation-free pushing force (to engage and displace native leaflets, ¶0219, Arcaro),
the expanding member (5700, Fig. 39, Arcaro) being fixation-free of one or more of the native valve leaflets (engage the base of the native leaflets and the native sinuses of a native valve, ¶0219, Arcaro); and
the expanding member (5700, Fig. 39, Arcaro) extends from the tubular frame (1102, Fig. 39, Arcaro) at a position proximate the second end of the valve leaflets (Figs. 37& 39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Regarding claim 3, Braido does not teach an expanding member. However, Arcaro teaches
wherein the expanding member (5700, Fig. 39, Arcaro) is further configured to transition between a collapsed configuration (5700, Fig. 38, Arcaro) and an expanded configuration (5700, Fig. 39, Arcaro) where the expanding member curves toward the second end of the tubular frame (see annotated Fig. 39 below, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to facilitate a more compact design. (¶0218, Arcaro).
Regarding claim 4, Braido teaches
wherein the porous outer surface (112, Fig. 1, Braido) is defined by a lattice network (102 is lattice shaped, Fig. 1, Braido).
Claim(s) 5-9, 12, 14-19, 21-22, 24-25, 30-33, 36, 39-40, 47, 49-50, 60-61, & 63-73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braido in view of Arcaro and further in view of Hacohen (US 20110224785 A1).
Regarding claim 5, Braido teaches
a valve (100, Fig. 1 or 200, Fig. 6, Braido) comprising:
a tubular frame (102, Fig. 1, Braido) comprising a porous outer surface (112, Fig. 1, Braido) and defining an inner lumen (lumen of 102, Fig. 1, Braido),
the tubular frame (102, Fig. 1, Braido) having a length (L1, Fig. 3B, Braido) along a longitudinal axis of the tubular frame, the length (L1, Fig. 3B, Braido) extending from a first end (130, Fig. 3A, Braido) to a second end (132, Fig. 3A, Braido) of the tubular frame (102, Fig. 1, Braido);
valve leaflets (108, Fig. 3A, Braido) disposed within the inner lumen (lumen of 102, Fig. 1, Braido); and
the porous outer surface (112, Fig. 1, Braido) of the tubular frame (102, Fig. 3A, Braido) creates an area of cross flow for blood through the tubular frame (improved flow path, ¶0068, Braido), decreasing a risk of thrombosis between the valve leaflets and the tubular frame (prevent regurgitation and other inefficiencies that may reduce cardiac performance, ¶0068, Braido).
Braido does not teach an expanding member. However, Arcaro teaches
an expanding member (5700, Fig. 39, Arcaro) having a collapsed configuration (5700, Fig. 38, Arcaro) and an expanded configuration (5700, Fig. 39, Arcaro), wherein, in the collapsed configuration (5700, Fig. 38, Arcaro), the expanding member is folded towards the second end of the tubular frame (5700, Fig. 38, Arcaro), and wherein,
the expanding member is configured to:
extend from the tubular frame at a position proximate the second end of the valve leaflets (see annotated Fig. 39 below, Arcaro); and
exert a fixation-free pushing force away from the valve and on an entire length of an outer surface of a native valve leaflet when the valve is deployed (to engage and displace native leaflets, ¶0219, Arcaro), such that the expanding member does not penetrate, pinch, grasp or clamp to the native valve leaflet (engage the base of the native leaflets and the native sinuses of a native valve, ¶0219, Arcaro);
the expanding member comprises a shape memory material (¶0217, Arcaro) and is expandable independently of the tubular frame (free to project outwardly, ¶0220, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Braido in view of Arcaro does not teach the expanding member extends radially outward from 5 mm to 15 mm from the porous outer surface of the tubular frame. However, Hacohen teaches a prosthetic atrioventricular valve (abstract, Hacohen) wherein
in the expanded configuration, the expanding member (120, Fig. 5A, Hacohen) extends radially outward from 5 mm to 15 mm from the porous outer surface of the tubular frame (2 and 7 mm, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 6, Braido teaches
a valve (100, Fig. 1 or 200, Fig. 6, Braido) comprising:
a tubular frame (102, Fig. 1, Braido) comprising a porous outer surface (112, Fig. 1, Braido) and defining an inner lumen (lumen of 102, Fig. 1, Braido),
the tubular frame (102, Fig. 1, Braido) having a length (L1, Fig. 3B, Braido) extending from a first end (130, Fig. 3A, Braido) to a second end (132, Fig. 3A, Braido) along a longitudinal axis of the tubular frame (102, Fig. 1, Braido);
valve leaflets (108, Fig. 3A, Braido) disposed within the inner lumen (lumen of 102, Fig. 1, Braido); and wherein
the valve leaflets (108, Fig. 3A, Braido) have a first end (end opposite 109, Fig. 1, Braido) proximate the first end (130, Fig. 3A, Braido) of the tubular frame and a second end (109, Fig. 1, Braido) that extends partially between the first end and the second end (132, Fig. 3A, Braido) of the tubular frame (102, Fig. 3A, Braido); and
the porous outer surface (112, Fig. 1, Braido) of the tubular frame (102, Fig. 3A, Braido) creates an area of cross flow for blood through the tubular frame (improved flow path, ¶0068, Braido), decreasing a risk of thrombosis between the valve leaflets and the tubular frame (prevent regurgitation and other inefficiencies that may reduce cardiac performance, ¶0068, Braido).
Braido does not teach an expanding member. However, Arcaro teaches
the expanding member (5700, Fig. 39, Arcaro):
extends from the tubular frame at a position proximate the second end of
the valve leaflets (see annotated Fig. 39 below, Arcaro);
conforms to a shape of a vessel wall (engage the base of the
native leaflets and the native sinuses of a native valve, ¶0219, Arcaro); and
is configured to exert a fixation-free force on a native valve leaflet when the valve is deployed, pushing the native valve leaflet against the vessel wall, such that the expanding member (5700, Fig. 39, Arcaro) does not penetrate, pinch, grasp or clamp to the native valve leaflet (to engage and displace native leaflets, ¶0219, Arcaro);
the expanding member (5700, Fig. 39, Arcaro) comprises a shape memory (¶0217, Arcaro) material and is expandable independently of the tubular frame (free to project outwardly, ¶0220, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
The phrase “…configured to exert a fixation-free pushing force” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
In this case, the Arcaro device discloses all the claimed structural features and is considered to be capable of exerting a fixation-free pushing force.
Braido in view of Arcaro does not teach the expanding member extends radially outward from 5 mm to 15 mm from the porous outer surface of the tubular frame. However, Hacohen teaches
an expanding member (120, Fig. 5A, Hacohen) extending radially outward from 5 mm to 15 mm from the porous outer surface of the tubular frame at a position along the longitudinal axis of the tubular frame (2 and 7 mm, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 7, Braido does not teach the expanding member comprises a plurality of arms. However, Arcaro teaches
wherein: the expanding member (5700, Fig. 39, Arcaro) comprises a plurality of arms (plurality of 5700, Fig. 39, Arcaro) sufficiently spaced around the tubular frame so that coronary arteries are avoided when implanted in an aorta (Fig. 40, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Braido in view of Arcaro does not teach the dimensions of the plurality of arms. However, Hacohen teaches
wherein each arm of the plurality of arms one or more:
has a width less than or equal to 3.0 mm; has a width less than or equal to 1.0 mm; has a diameter of less than or equal to 3.0 mm; has a diameter of less than or equal to 1.0 mm (Hacohen discloses the length of the anchoring elements to be 2 and 7 mm, therefore, based on the figures and the length dimensions, it would be obvious that the width and diameter is between 2 and 7 mm, ¶0095, Hacohen); and
is a cylindrical wire (rod shaped, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 8, Braido does not teach the expanding member. However, Arcaro teaches
wherein the expanding member (5700, Fig. 39, Arcaro) is a continuous flange configured to prevent perivalvular leakage such that blood must pass through the valve leaflets (the leaflets open and blood flows therethrough (of the prosthetic valve), ¶0005, Figs. 38-40, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
The phrase “…configured to prevent perivalvular leakage such that blood must pass through the valve leaflets” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
In this case, the Arcaro device discloses all the claimed structural features and is considered to be capable of preventing perivalvular leakage.
Regarding claim 9, Braido does not teach the expanding member. However, Arcaro teaches
wherein the extension of the expanding member from the porous outer surface of the tubular frame provides sufficient radial force to push the native valve leaflet against the vessel wall (engage the base of the native leaflets and the native sinuses of a native valve, ¶0219, Fig. 40, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Braido in view of Arcaro does not teach the expanding member from 5 mm to 15 mm from the porous outer surface of the tubular frame. However, Hacohen
wherein the extension of the expanding member from 5 mm to 15 mm from the porous outer surface of the tubular frame (2 and 7 mm, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 12, Braido
wherein the second end (109, Fig. 1, Braido) of the valve leaflets (108, Fig. 3A, Braido) is positioned approximately halfway between the first end (130, Fig. 3A, Braido) and the second end (132, Fig. 3A, Braido) of the tubular frame (102, Fig. 3A, Braido).
Regarding claim 14, Braido does not teach the expanding member. However, Arcaro teaches
wherein the expanding member (5700, Fig. 39, Arcaro) is further configured to transition between a collapsed configuration (Fig. 38, Arcaro) and an expanded configuration (Figs. 39-40, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to facilitate a more compact design. (¶0218, Arcaro).
Regarding claim 15, Braido does not teach the expanding member. However, Arcaro teaches
wherein, when the expanding member (5700, Fig. 39, Arcaro) is in the expanded configuration (Figs. 39-40, Arcaro), the expanding member curves toward the second end of the tubular frame (see annotated Fig. 39 below, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Regarding claim 16, Braido does not teach the expanding member. However, Arcaro teaches
wherein the expanding member comprises one or more radiopaque markers (radiopaque marker bands, ¶0088, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to have a variety of features with such types of prostheses (¶0088, Arcaro).
Regarding claim 17, Braido teaches
wherein the porous outer surface of the tubular frame is defined by a lattice network (102 is lattice shaped, Fig. 1, Braido).
Regarding claim 18, Braido teaches
a sleeve for a valve (100, Fig. 1 or 200, Fig. 6, Braido) comprising:
a tubular frame (102, Fig. 1, Braido) comprising a porous outer surface (112, Fig. 1, Braido) and an inner surface (lumen of 112, Fig. 1, Braido), the tubular frame (102, Fig. 1, Braido) having a length along a longitudinal axis of the tubular frame, the length (L1, Fig. 3B, Braido) extending from an upstream first end (130, Fig. 3A, Braido) to a downstream second end (132, Fig. 3A, Braido) of the tubular frame (102, Fig. 1, Braido); and
the porous outer surface (112, Fig. 1, Braido) of the tubular frame (102, Fig. 3A, Braido) creates an area of cross flow for blood through the tubular frame (improved flow path, ¶0068, Braido), decreasing a risk of thrombosis (prevent regurgitation and other inefficiencies that may reduce cardiac performance, ¶0068, Braido);
and the inner surface (lumen of 112, Fig. 1, Braido) is configured to contact an exterior surface of the valve when the sleeve is deployed (Fig. 1, Braido).
Braido does not teach an expanding member. However, Arcaro teaches
wherein the expanding member is configured to:
exert a fixation-free pushing force in a direction away from the tubular frame on a native defective valve leaflet when the sleeve is deployed (to engage and displace native leaflets, ¶0219, Arcaro), so that the defective valve leaflet does not contact the porous outer surface of the tubular frame, and the fixation-free pushing force does not penetrate, pinch, grasp or clamp to the native defective valve leaflet (engage the base of the native leaflets and the native sinuses of a native valve, ¶0219, Arcaro); and
transition between a collapsed configuration (Fig. 38, Arcaro) and an expanded configuration (Figs. 39-40, Arcaro);
the expanding member comprises a shape memory material (¶0217, Arcaro) and is expandable independently of the tubular frame;
in the collapsed configuration, the expanding member is folded towards the downstream second end of the tubular frame; in the expanded configuration, the expanding member curves toward the downstream second end of the tubular frame (see annotated Fig. 39 below, Arcaro);
an expanding member (5700, Fig. 39, Arcaro) extending radially from the porous outer surface of the tubular frame (100, Fig. 39, Arcaro) at a position along the longitudinal axis of the tubular frame between the upstream first end and the downstream second end of the tubular frame (see annotated Fig. 39 below, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
The phrase “…configured to exert a fixation-free pushing force” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
In this case, the Arcaro device discloses all the claimed structural features and is considered to be capable of exerting a fixation-free pushing force.
Braido in view of Arcaro does not teach the expanding member extends radially outward from 5 mm to 15 mm. However, Hacohen teaches
from the porous outer surface of the tubular
an expanding member (120, Fig. 5A, Hacohen) extending radially outward from 5 mm to 15 mm (2 and 7 mm, ¶0095, Hacohen) from the porous outer surface of the tubular frame.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 19, Braido does not teach the expanding member comprises a plurality of arms. However, Arcaro teaches
wherein the expanding member (5700, Fig. 39, Arcaro) comprises a plurality of arms (plurality of 5700, Fig. 39, Arcaro) sufficiently spaced around the tubular frame so that coronary arteries are avoided when implanted in an aorta (Fig. 40, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Regarding claim 21, Braido in view of Arcaro does not teach the dimensions of the plurality of arms. However, Hacohen teaches
wherein a width of each arm of the plurality of arms is less than or equal to 3.0 mm (Hacohen discloses the length of the anchoring elements to be 2 and 7 mm, therefore, based on the Figures and the length dimensions, it would be obvious that the width and diameter is between 2 and 7 mm, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 22, Braido in view of Arcaro does not teach the plurality of arms are cylindrical wires. However, Hacohen teaches
wherein each arm of the plurality of arms (120, Fig. 5A, Hacohen) are cylindrical wires (rod shaped, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 24, Braido in view of Arcaro does not teach the dimensions of the plurality of arms. However, Hacohen teaches
wherein each arm of the plurality of arms has a diameter of less than or equal to 3.0 mm (Hacohen discloses the length of the anchoring elements to be 2 and 7 mm, therefore, based on the Figures and the length dimensions, it would be obvious that the width and diameter is between 2 and 7 mm, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 25, Braido does not teach the expanding member. However, Arcaro teaches
wherein the expanding member (5700, Fig. 39, Arcaro) is a continuous flange configured to prevent perivalvular leakage such that blood must pass through a valve disposed within the sleeve (the leaflets open and blood flows therethrough (of the prosthetic valve), ¶0005, Figs. 38-40, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
The phrase “…configured to prevent perivalvular leakage such that blood must pass through the valve leaflets” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
In this case, the Arcaro device discloses all the claimed structural features and is considered to be capable of preventing perivalvular leakage.
Regarding claim 30, Braido does not teach the expanding member. However, Arcaro teaches
wherein the expanding member (5700, Fig. 39, Arcaro) comprises one or more radiopaque markers (radiopaque marker bands, ¶0088, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to have a variety of features with such types of prostheses (¶0088, Arcaro).
Regarding claim 31, Braido teaches
wherein the porous outer surface (112, Fig. 1, Braido) of the tubular frame (102, Fig. 1, Braido) is defined by a lattice network (102 is lattice shaped, Fig. 1, Braido).
Regarding claim 32, Braido teaches
wherein the inner surface (lumen of 112, Fig. 1, Braido) of the tubular frame (102, Fig. 1, Braido) comprises an interior attachment (116, Fig. 1, Braido) configured to contact the exterior surface of the valve (100, Fig. 1, Braido) and prevent the tubular frame from moving with respect to the valve (116 may include one or more eyelets that facilitate the suturing of the leaflet commissures to the stent, ¶0050, Braido).
Regarding claim 33, Braido teaches
a valve system (100, Fig. 1 or 200, Fig. 6, Braido) comprising:
a stent (102, Fig. 1, Braido) comprising:
a stent frame (struts forming 102, Fig. 1, Braido) comprising an outer surface (outer of 102, Fig. 1, Braido) and defining an inner lumen (lumen of 102, Fig. 1, Braido), the stent frame having a length (L1, Fig. 3B, Braido) along a longitudinal axis of the stent frame (struts forming 102, Fig. 1, Braido), the length extending from an upstream first end (130, Fig. 3A, Braido) to a downstream second end (132, Fig. 3A, Braido) of the stent frame; and
a plurality of valve leaflets (108, Fig. 3A, Braido) disposed within the inner lumen (lumen of 102, Fig. 1, Braido); and
a tubular frame (102, Fig. 1, Braido) defined by a lattice network (102 is lattice shaped, Fig. 1, Braido) having pores (112, Fig. 1, Braido) and configured to contact the outer surface of the stent frame (Fig. 1, Braido),
the tubular frame (102, Fig. 1, Braido) defined by the lattice network creates an area of cross flow for blood to flow from the inner lumen of the stent frame to a position outside of the tubular frame (improved flow path, ¶0068, Braido), and
decreasing a risk of thrombosis between the plurality of valve leaflets and the tubular frame (prevent regurgitation and other inefficiencies that may reduce cardiac performance, ¶0068, Braido).
Braido does not teach an expanding member. However, Arcaro teaches wherein:
the expanding member (5700, Fig. 39, Arcaro) comprises a plurality of (cylindrical wires) that are circumferentially spaced apart at intervals sufficient to avoid obstruction of coronary arteries when the valve is implanted in an aortic position;
the expanding member (5700, Fig. 39, Arcaro) is configured to:
conform to a shape of a respective vessel wall (engage the base of the
native leaflets and the native sinuses of a native valve, ¶0219, Arcaro); and
exert a pushing force in a direction away from the tubular frame on an entire length of one or more native defective valve leaflets when the valve system is implanted (to engage and displace native leaflets, ¶0219, Fig. 40, Arcaro), both:
pushing the one or more native defective valve leaflets against the respective vessel wall (to engage and displace native leaflets, ¶0219, Fig. 40, Arcaro); and
avoiding contact of the one or more native defective valve leaflets from the lattice network of the tubular frame (to engage and displace native leaflets, ¶0219, Fig. 40, Arcaro);
the expanding member exerts a fixation-free pushing force (to engage and displace native leaflets, ¶0219, Arcaro),
the expanding member being fixation-free of the one or more defective native valve leaflets, such that the expanding member does not penetrate, pinch, grasp or clamp to the one or more defective native valve leaflets (engage the base of the native leaflets and the native sinuses of a native valve, ¶0219, Arcaro);
the expanding member comprises a shape memory (¶0217, Arcaro) material and is expandable independently of the tubular frame (free to project outwardly, ¶0220, Arcaro); and
one or more of:
the tubular frame is positioned on the outer surface of the stent frame at a position such that the expanding member (5700, Fig. 39, Arcaro) extends from the tubular frame proximate the downstream second end of the plurality of valve leaflets (see annotated Fig. 39 below); or
the expanding member is further configured to transition between a collapsed configuration (5700, Fig. 38, Arcaro) and an expanded configuration (5700, Fig. 39, Arcaro), wherein, when the expanding member is in the expanded configuration and the tubular frame is in contact with the outer surface of the stent frame, the expanding member (5700, Fig. 39, Arcaro) curves toward the downstream second end of the stent frame (see annotates Fig. 39 below);
the extension of the expanding member (5700, Fig. 39, Arcaro) from the lattice network of the tubular frame provides sufficient radial force to push the native valve leaflet against the vessel wall (engage the base of the native leaflets and the native sinuses of a native valve, ¶0219, Fig. 40, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Braido in view of Arcaro does not teach the expanding member comprises a plurality of cylindrical wires. However, Hacohen teaches
the expanding member (120, Fig. 5A, Hacohen) comprises a plurality of cylindrical wires (rod shaped, ¶0095, Hacohen);
the tubular frame comprising an expanding member extending radially outward from 5 mm to 15 mm (2 and 7 mm, ¶0095, Hacohen) from the lattice network of the tubular frame;
the extension of the expanding member from 5 mm to 15 mm (2 and 7 mm, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 36, Braido in view of Arcaro does not teach the dimensions of the plurality of arms. However, Hacohen teaches
wherein a width of each cylindrical wire is less than or equal to 3.0 mm (Hacohen discloses the length of the anchoring elements to be 2 and 7 mm, therefore, based on the figures and the length dimensions, it would be obvious that the width and diameter is between 2 and 7 mm, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 39, Braido in view of Arcaro does not teach the dimensions of the plurality of arms. However, Hacohen teaches
wherein each cylindrical wire has a diameter of less than or equal to 3.0 mm (Hacohen discloses the length of the anchoring elements to be 2 and 7 mm, therefore, based on the Figures and the length dimensions, it would be obvious that the width and diameter is between 2 and 7 mm, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 40, Braido does not teach the expanding member. However, Arcaro teaches
wherein the expanding member (5700, Fig. 39, Arcaro) is a continuous flange configured to prevent perivalvular leakage such that blood must pass through the plurality of valve leaflets (the leaflets open and blood flows therethrough (of the prosthetic valve), ¶0005, Figs. 38-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
The phrase “…configured to prevent perivalvular leakage such that blood must pass through the valve leaflets” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
In this case, the Arcaro device discloses all the claimed structural features and is considered to be capable of preventing perivalvular leakage.
Regarding claim 47, Braido does not teach the expanding member. However, Arcaro teaches
wherein the expanding member comprises one or more radiopaque markers (radiopaque marker bands, ¶0088, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to have a variety of features with such types of prostheses (¶0088, Arcaro).
Regarding claim 49, Braido teaches
wherein an inner surface (lumen of 112, Fig. 1, Braido) of the tubular frame (102, Fig. 1, Braido) comprises an interior attachment (116, Fig. 1, Braido) configured to contact the outer surface of the stent frame (struts forming 102, Fig. 1, Braido) and prevent the tubular frame from moving with respect to the stent frame (116 may include one or more eyelets that facilitate the suturing of the leaflet commissures to the stent, ¶0050, Braido).
Regarding claim 50, Braido teaches
a method for replacing a native defective valve (method of expanding a prosthetic heart valve between native leaflets of a native aortic annulus, ¶0024, Braido) comprising:
delivering the valve of claim 6 proximate to the native defective valve (Fig. 3B, Braido) such that the second end of the tubular frame is proximate the native defective valve;
expanding the expanding member from the collapsed configuration (collapsing the prosthetic heart valve into a catheter, ¶0024, Braido) to the expanded configuration (Fig. 3B, Braido);
advancing the second end of the tubular frame between defective leaflets of the native defective valve (Fig. 3B, Braido), and
a porous outer surface (112, Fig. 1, Braido) of the tubular frame (102, Fig. 3A, Braido) creates an area of cross flow for blood through the tubular frame (improved flow path, ¶0068, Braido), decreasing a risk of thrombosis between the valve leaflets and the tubular frame (prevent regurgitation and other inefficiencies that may reduce cardiac performance, ¶0068, Braido).
Braido does not teach an expanding member. However, Arcaro teaches
wherein the expanding member (5700, Fig. 39, Arcaro) contacts the defective leaflets as the tubular frame is advanced between the defective leaflets (to engage and displace native leaflets, ¶0219, Arcaro); and
pushing the defective leaflets against the vessel wall via the expanding member (engage the base of the native leaflets and the native sinuses of a native valve, ¶0219, Arcaro); wherein:
the expanding member is expandable independently of the tubular frame (free to project outwardly, ¶0220, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Regarding claim 60, Braido does not teach the expanding member. However, Arcaro teaches
wherein the expanding member (5700, Fig. 39, Arcaro) is a continuous flange configured to prevent perivalvular leakage such that blood must pass through the valve leaflets (the leaflets open and blood flows therethrough (of the prosthetic valve), ¶0005, Figs. 38-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
The phrase “…configured to prevent perivalvular leakage such that blood must pass through the valve leaflets” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the implantation device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to delivery such an implant in order to meet the claim requirements.
In this case, the Arcaro device discloses all the claimed structural features and is considered to be capable of preventing perivalvular leakage.
Regarding claim 61, Braido in view of Arcaro does not teach the expanding member extends from 5 mm to 15 mm. However, Hacohen teaches
wherein the expanding member (120, Fig. 5A, Hacohen) extends from 5 mm to 15 mm from the porous outer surface of the tubular frame (2 and 7 mm, ¶0095, Hacohen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido and Arcaro by incorporating the teaching above as taught by Hacohen in order to anchor the prosthetic valve at the native valve (¶0095, Hacohen).
Regarding claim 63, Braido teaches
wherein: the valve leaflets (108, Fig. 3A, Braido) have a first end (end opposite 109, Fig. 1, Braido) and a second end (109, Fig. 1, Braido),
the first end (end opposite 109, Fig. 1, Braido) of the valve leaflets is proximate the first end (130, Fig. 3A, Braido) of the tubular frame (102, Fig. 1, Braido); and
the second end (109, Fig. 1, Braido) of the valve leaflets extends partially between the first (130, Fig. 3A, Braido) and second end (132, Fig. 3A, Braido) of the tubular frame (102, Fig. 1, Braido).
Regarding claim 64, Braido teaches
wherein the second end (109, Fig. 1, Braido) of the valve leaflets (108, Fig. 3A, Braido) is positioned approximately halfway between the first (130, Fig. 3A, Braido) and second end (132, Fig. 3A, Braido) of the tubular frame (102, Fig. 3A, Braido).
Regarding claim 65, Braido does not teach the expanding member. However, Arcaro teaches
wherein the expanding member (5700, Fig. 39, Arcaro) extends from the tubular frame (1102, Fig. 39, Arcaro) at a position proximate the second end of the valve leaflets (Figs. 37& 39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Regarding claim 66, Braido does not teach an expanding member. However, Arcaro teaches
wherein, when the expanding member (5700, Fig. 39, Arcaro) is in the expanded configuration (5700, Fig. 39, Arcaro), the expanding member curves toward the second end of the tubular frame (see annotated Fig. 39 below, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to facilitate a more compact design. (¶0218, Arcaro).
Regarding claim 67, Braido does not teach an expanding member. However, Arcaro teaches
wherein the expanding member comprises one or more radiopaque markers (radiopaque marker bands, ¶0088, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to have a variety of features with such types of prostheses (¶0088, Arcaro).
Regarding claim 68, Braido teaches
wherein the porous outer surface (112, Fig. 1, Braido) of the tubular frame is defined by a lattice network (102 is lattice shaped, Fig. 1, Braido).
Regarding claim 69, Braido does not teach an expanding member. However, Arcaro teaches
further comprising: partially unsheathing the valve such that the expanding member is unsheathed, thereby allowing the expanding member to expand into its expanded configuration (1272b is optionally used to constrain the anchor members 5700 until the intermediate constraint 1272b is released, ¶0218, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Regarding claim 70, Braido teaches
wherein: the tubular frame is configured to transition between a collapsed configuration (collapsed condition, ¶0051, Braido) and an expanded configuration (Fig. 3B, Braido);
in the expanded configuration, the porous outer surface of the tubular frame expands to contact the vessel wall (Fig. 3B, Braido); and
the method further comprises fully unsheathing (unsheathe, ¶0046, Braido) the valve to allow the tubular frame to expand and contact the vessel wall (Fig. 3B, ¶0055, Braido).
Regarding claim 71, Braido teaches
wherein: the valve comprises an expandable balloon (¶0004, Braido) disposed between the valve leaflets;
the tubular frame is configured to transition between a collapsed configuration (collapsed condition, ¶0051, Braido) and an expanded configuration (Fig. 3B, Braido);
in the expanded configuration (Fig. 3B, Braido), the porous outer surface of the tubular frame expands to contact the vessel wall (Fig. 3B, ¶0055, Braido); and
the method further comprises:
unsheathing (unsheathe, ¶0046, Braido) the valve, thereby allowing the expanding member to expand into its expanded configuration (Fig. 3B, Braido);
expanding the expandable balloon such that the valve expands and contacts the vessel wall (Fig. 3B, ¶0055, Braido); and
removing the expandable balloon from the valve (¶0005, Braido).
Regarding claim 72, Braido teaches
further comprising: decreasing a risk of thrombosis between the valve leaflets and the tubular frame (prevent regurgitation and other inefficiencies that may reduce cardiac performance, ¶0068, Braido).
Regarding claim 73, Braido teaches
further comprising: increasing a flow of blood to a coronary artery (better blood flow to the coronary sinus ostia and improved flow path to the coronary sinus ostia, ¶0068, Braido).
Claim(s) 51-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braido (US 20190060064 A) in view of Arcaro and Hacohen and further in view of Wilson et al. (US 8163008 B2) hereinafter, Wilson.
Regarding claim 51, Braido does not teach the expanding member. However, Arcaro teaches
advancing the valve between the defective leaflets until the expanding member is approximately perpendicular to the tubular frame (5700, Fig. 40, alternative or additional locations for the anchor members 5700 (e.g., more proximally- or distally-located positions on the frame 1102 of the prosthetic valve 100) are contemplated, ¶0221, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to engage the base of the native leaflets and the native sinuses of a native valve (¶0219, Arcaro).
Braido in view of Arcaro and Hacohen does not teach taking a fluorographic image. However, Wilson teaches a device and method for improving flow through a native blood vessel valve (abstract, Wilson)
taking a fluorographic image of the valve to confirm the expanding member is approximately perpendicular to the tubular frame (radiopaque material such that monitoring can be accomplished using X-ray equipment, col. 15 lines 4-5, Wilson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido, Arcaro and Hacohen by incorporating the teaching above as taught by Wilson in order to monitor (the device) using X-ray equipment (col. 15 lines 4-5, Wilson).
Regarding claim 52, Braido does not teach taking a fluorographic image of the valve. However, Wilson teaches
further comprising; taking a fluorographic image of the valve to confirm the expanding member is approximately parallel to an annular plane (radiopaque material such that monitoring can be accomplished using X-ray equipment, col. 15 lines 4-5, Wilson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido, Arcaro and Hacohen by incorporating the teaching above as taught by Wilson in order to monitor (the device) using X-ray equipment (col. 15 lines 4-5, Wilson).
Regarding claim 53, Braido does not teach repositioning the valve. However, Arcaro teaches
further comprising; repositioning the valve when the expanding member is not approximately parallel to the annular plane (facilitating repositioning, ¶0117, Arcaro).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Braido by incorporating the teaching above as taught by Arcaro in order to facilitate repositioning and also help with retraction and/or reorientation of the prosthetic valve 100, including when the prosthetic valve 100 is diametrically compacted and/or partially or fully deployed (¶0117, Arcaro).
PNG
media_image1.png
434
400
media_image1.png
Greyscale
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
Prosecution Insights