DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 10/28/25. The claims 1-51 are pending. The claims 3-6, 9, 10, 15, 19, 21, 26, 27, 30, 31, 45, 46, 49, and 51 are amended.
Response to Arguments
Applicant’s arguments, filed 10/28/25 with respect to the rejections of claims 1-3, 11-15, 22-26, 34-44 under 103 as being unpatentable over Maimon (US2018/0153689) in view of White (US2014/0277563) have been fully considered but they are not persuasive.
Applicant argues, the office action fails to identify a distal apex formed by two first struts and a distal apex formed by two second struts. Examiner clarifies the previous office action and denotes the distal apex formed by two first struts and the distal apex formed by two second struts are referred to as the “junctions”, where the junctions and pivotal connection points that form apices at the perimeter of the frame and would be at both the inflow and outflow ends as shown in the annotated Fig. 18-1 and 18-2 of the previous rejection.
Applicant further argues, the office action fails to identify where the one or more actuators would be positioned to satisfy the limitation “one or more actuators coupled only to one or more corresponding pairs of a distal apex and a proximal apex formed by the first struts”. Applicant draws attention a supposed purpose for the claimed structure and refers to paragraph [0129]. Examiner disagrees, where the paragraph cited does not specifically recite a purpose for the limitation claimed, “one or more actuators coupled only to one or more corresponding pairs of a distal apex and a proximal apex formed by the first struts”. Rather the paragraph recites variations of the actuator coupled to different structures. There is no description of the purpose of having the actuators coupled only to one or more corresponding pairs of a distal apex and a proximal apex formed by the first struts. Furthermore, one of ordinary skill in the art would have expected the device of Maimon and the claimed invention to perform the same function of actuating and locking the device equally well with the actuators coupled only to one or more pairs of the apices or another configuration where it is coupled to the struts. Furthermore, Examiner makes notice, the limitations are overly broad. Where the one or more actuators “coupled only to” the apices, could be interpreted as any form of connection, even indirectly between the actuator and the apices.
Applicant further argues, what would be the benefit of changing the dimensions of the struts based on the implantation site. Examiner makes notice, there is diversity in patient anatomy as well as structures in the human body affected by valvular disease, see background in Maimon paragraph [0003]. Where the sizing of the struts of the implant would need correspond with the valve to be treated. Examiner makes notice, the claims of the application itself do not specify where in the body the device is to be implanted.
Applicant’s arguments with regard to independent claims 11, 22, and 34 have been addressed in the response as set forth above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
Claims 1-44 are rejected under 35 U.S.C. 103 as being unpatentable over Maimon (US2018/0153689) in view of White (US2014/0277563).
Regarding claim 1, Maimon discloses an implantable prosthetic device, comprising:
a frame (frame 604, see Fig. 18) being radially expandable and compressible between a radially compressed state and a radially expanded state ([0197]), the frame comprising a first set of first struts (series of struts as shown in annotated Fig. 18-1, [0235]) and a second set of second struts (series of struts as shown in annotated Fig. 18-2, [0235]), the frame having a distal end and a proximal end (proximal and distal ends of the frame as shown in Fig. 18);
wherein the first struts are pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame (see annotated Fig. 18-1, where junctions as shown in annotated Fig. 18 and these junctions would be at both the inflow and outflow ends at the apices of the frame, where the apices of the frame have a pivotal connection by the connection of the struts, [0197], [0122]), respectively;
wherein the second struts are pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame, respectively (see annotated Fig. 18-2, where junctions as shown in annotated Fig. 18 and these junctions would be at both the inflow and outflow ends at the apices of the frame, where the apices of the frame have a pivotal connection by the connection of the struts, [0197], [0122]);
wherein the first struts are pivotably connected to the second struts at junctions between the distal and proximal ends of the frame (see annotated Fig. 18);
one or more actuators (608, [0198]), wherein the one or more actuators are configured to apply axially directed forces to the frame to radially expand the frame from the radially compressed state to the radially expanded state ([0200]).
Maimon does not explicitly disclose the one or more actuators coupled only to one or more corresponding pairs of a distal apex and a proximal apex formed by the first struts. Maimon teaches the delivery assembly can have any number of actuator assemblies 608 and locking mechanism 610 ([0218]). Maimon further shows an arrangement of the actuator assemblies 608 in Fig. 18. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the device of Maimon to have the actuators coupled only to one or more pairs of a distal and a proximal apex formed by the first struts (the apices formed by the first struts shown in annotated Fig. 18-1, where pairs would be alternating distal and proximal apex), since Applicant has not disclosed that having the one or more actuators only to one or more pairs of a distal apex and a proximal apex formed by the first struts is used for a particular purpose or solves a stated problem. One of ordinary skill in the art, would have expected the device of Maimon and the claimed invention to perform the same function of actuating and locking the device equally well.
Maimon does not explicitly disclose wherein the first struts have a first thickness, which is measured between a radially facing inner surface and a radially facing outer surface of each first strut; wherein the second struts have a second thickness, which is measured between a radially facing inner surface and a radially facing outer surface of each second strut; wherein the first thickness is greater than the second thickness. However, White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the thickness of individual struts can differ in thickness from other individual struts in the same frame ([0078]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first struts have a greater thickness than the second struts in order to meet the needs of an intended application that required such dimensions as White teaches selecting proper dimensions of the struts based on the implantation site ([0166]).
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Regarding claim 2, Maimon/White makes obvious the implantable prosthetic device of claim 1, wherein the one or more actuators are configured to retain the frame in the radially expanded state (actuator can retain position on the frame, [0257]).
Regarding claim 3, Maimon/White makes obvious the implantable prosthetic device of claim 1; yet, does not explicitly disclose wherein the one or more actuators comprise three actuators, each of which is coupled to a corresponding pair of a distal apex and a proximal apex formed by the first struts. Maimon teaches the delivery assembly can have any number of actuator assemblies 608 and locking mechanism 610 ([0218]). Maimon further shows an arrangement of the actuator assemblies 608 in Fig. 18. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the device of Maimon to three actuators, since Applicant has not disclosed that having three actuators provides an advantage, solves any stated problem, or is used for any particular purpose and it appears the device would perform equally well with a different number of actuators.
Regarding claim 4, Maimon/White makes obvious the implantable prosthetic device of claim 1; yet, does not explicitly disclose wherein the first struts are made of a first material, the second struts are made of a second material, and the first material is more rigid than the second material. White further teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the material of individual struts can differ in material from other individual struts in the same frame ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art to have the first struts be made of a material that is less flexible than the material of the second struts in order to allow portions of the device to flex inward during a normal cardiac cycle while other portions not substantially deform ([0141]).
Regarding claim 5, Maimon/White makes obvious the implantable prosthetic device of claim1, wherein: the first struts are pivotably connected to each other at middle junctions located at midsections of the first struts (first struts would be pivotably connected at middle junctions where the first struts overlap, see annotated Fig. 18-1); and the second struts are pivotably connected to each other at middle junctions located at midsections of the second struts (second struts would be pivotably connected at middle junctions where the second struts overlap, see annotated Fig. 18-1).
Regarding claim 6, Maimon/White makes obvious the implantable prosthetic device of claim 1, wherein: the frame comprises a third set of third struts (third struts as lined in annotated Fig. 18-3), wherein the third struts are pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame, respectively (see annotated Fig. 18-3, where junctions as shown in annotated Fig. 18 and these junctions would be at both the inflow and outflow ends at the apices of the frame, where the apices of the frame have a pivotal connection by the connection of the struts, [0197], [0122]); the third struts are pivotably connected to the first and second struts at junctions between the distal and proximal ends of the frame (see annotated Fig. 18-3, where junctions as shown in annotated Fig. 18 and these junctions would be at both the inflow and outflow ends at the apices of the frame, where the apices of the frame have a pivotal connection by the connection of the struts, [0197], [0122]).
Maimon/White does not explicitly disclose the third struts have a third thickness, which is measured between a radially facing inner surface and a radially facing outer surface of each third strut; and the first thickness is greater than the third thickness.
However, White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the width (cross sectional dimension) of individual struts can differ in width from other individual struts in the same frame ([0165]). Therefore, White teaches the width of the struts is a result effective variable ([0165]). Thus, it would have been obvious to one having ordinary skill in the art to change the width (cross-sectional dimension) of the first struts to be greater than the width of the second and third struts in order to meet the needs of an intended application that required such dimensions as White teaches selecting proper dimensions of the struts based on the implantation site ([0166]).
Regarding claim 7, Maimon/White makes obvious the implantable prosthetic device of claim 6, wherein the second thickness and the third thickness are the same. However, White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the width (cross sectional dimension) of individual struts can be the same width as other individual struts in the same frame ([0165]). Therefore, White teaches the width of the struts is a result effective variable ([0165]). Thus, it would have been obvious to one having ordinary skill in the art to change the width (cross-sectional dimension) of the second struts to be the same width as the third struts in order to meet the needs of an intended application that required such dimensions as White teaches selecting proper dimensions of the struts based on the implantation site ([0166]).
Regarding claim 8, Maimon/White makes obvious the implantable prosthetic device of any previous claim; yet, does not explicitly disclose wherein the first struts have a greater resistance against deformation from axially directed forces applied to the frame than the second struts. White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the material of individual struts can differ in material from other individual struts in the same frame ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art to have the first struts be made of a material that is less flexible than the material of the second struts in order to allow portions of the device to flex inward during a normal cardiac cycle while other portions not substantially deform ([0141]).
Regarding claim 9, Maimon/White makes obvious the implantable prosthetic device of claim 6, Maimon further discloses further comprising a plurality of leaflets (48) disposed in the frame and configured to regulate a flow of blood through the frame in one direction ([0125]).
Regarding claim 10, Maimon/White makes obvious the implantable prosthetic device of claim 6, further comprising a fabric skirt (50) mounted to the frame with sutures extending through openings in the second struts ([0126], the skirt is secured to the frame with sutures and therefore would pass around the second struts through the openings).
Regarding claim 11, Maimon discloses an implantable prosthetic device, comprising:
a frame (frame 1700, see Fig. 44) being radially expandable and compressible between a radially compressed state and a radially expanded state ([0257]), the frame comprising a first set of first struts (1710) and a second set of second struts (1720), the frame having a distal end and a proximal end (proximal and distal ends of the frame as shown in Fig. 44);
wherein the first struts are pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame, respectively (see Fig. 44, where junctions as shown in annotated Fig. 44 at inflow and outflow ends would be the apices of pivotal connection for the frame with the struts);
wherein the second struts are pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame, respectively (see Fig. 44, where junctions as shown in annotated Fig. 44 at inflow and outflow ends would be the apices of pivotal connection for the frame with the struts);
wherein the first struts are pivotably connected to the second struts at junctions between the distal and proximal ends of the frame (see annotated Fig. 44);
one or more actuators (608, [0198]), wherein the one or more actuators are configured to apply axially directed forces to the frame to radially expand the frame from the radially compressed state to the radially expanded state ([0200]).
Maimon does not explicitly disclose the one or more actuators coupled only to one or more corresponding pairs of a distal apex and a proximal apex formed by the first struts. Maimon teaches the delivery assembly can have any number of actuator assemblies 608 and locking mechanism 610 ([0218]). Maimon further shows an arrangement of the actuator assemblies 608 in Fig. 18. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the device of Maimon to have the actuators coupled only to one or more pairs of a distal and a proximal apex formed by the first struts (the apices formed by the first struts shown in annotated Fig. 18-1, where pairs would be alternating distal and proximal apex), since Applicant has not disclosed that having the one or more actuators only to one or more pairs of a distal apex and a proximal apex formed by the first struts is used for a particular purpose or solves a stated problem. One of ordinary skill in the art, would have expected the device of Maimon and the claimed invention to perform the same function of actuating and locking the device equally well.
Maimon is silent regarding wherein the first struts have a greater resistance against deformation from axially directed forces applied to the frame than the second struts. White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the material of individual struts can differ in material from other individual struts in the same frame ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art to have the first struts be made of a material that is less flexible than the material of the second struts in order to allow portions of the device to flex inward during a normal cardiac cycle while other portions not substantially deform ([0141]).
Regarding claims 12 and 13, Maimon/White makes obvious the implantable prosthetic device of claim 11; yet, does not explicitly disclose wherein: the first struts have a first cross-sectional profile taken in a plane perpendicular to their length, the first cross-sectional profile having a first dimension measured in a direction; the second struts have a second cross-sectional profile taken in a plane perpendicular to their length, the second cross-sectional profile having a second dimension that is measured in the same direction as the first dimension of the first cross-sectional profile; and wherein the first dimension is greater than the second dimension; wherein: the first dimension is a first thickness, which is measured between a radially facing inner surface and a radially facing outer surface of each first strut; the second dimension a second thickness, which is measured between a radially facing inner surface and a radially facing outer surface of each second strut; and the first thickness is greater than the second thickness. However, White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the thickness (cross sectional dimension) of individual struts can differ in thickness from other individual struts in the same frame ([0078]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first struts have a greater thickness than the second struts in order to meet the needs of an intended application that required such dimensions as White teaches selecting proper dimensions of the struts based on the implantation site ([0166]).
Regarding claims 12 and 14, Maimon/White makes obvious the implantable prosthetic device of claim 11; yet, does not explicitly disclose wherein: the first struts have a first cross-sectional profile taken in a plane perpendicular to their length, the first cross-sectional profile having a first dimension measured in a direction; the second struts have a second cross-sectional profile taken in a plane perpendicular to their length, the second cross-sectional profile having a second dimension that is measured in the same direction as the first dimension of the first cross-sectional profile; and wherein the first dimension is greater than the second dimension; wherein: the first dimension is a first width, which is measured between first and second longitudinal edges of each first strut facing the distal and proximal ends of the frame, respectively; the second dimension is a second width, which is measured between first and second longitudinal edges of each second strut facing the distal and proximal ends of the frame, respectively; and the first width is greater than the second width. White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). However, White further teaches the width (cross sectional dimension) of individual struts can differ in width from other individual struts in the same frame ([0165]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first struts have a greater width than the second struts in order to meet the needs of an intended application that required such dimensions as White teaches selecting proper dimensions of the struts based on the implantation site ([0166]).
Regarding claim 15, Maimon/White makes obvious the implantable prosthetic device of any of claims 11, the modified invention fails to disclose wherein the first struts are made of a first material, the second struts are made of a second material, and the first material is more rigid than the second material. However, White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the material of individual struts can differ in material from other individual struts in the same frame ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art to have the first struts be made of a material that is less flexible than the material of the second struts in order to allow portions such as the second struts of the device to flex inward during a normal cardiac cycle while other portions such as the first struts do not substantially deform ([0141]).
Regarding claim 16, Maimon/White makes obvious the implantable prosthetic device of any of claims 11-15, Maimon further discloses wherein the first struts comprise reinforcing ribs (spacer 46).
Regarding claim 17, Maimon/White makes obvious the implantable prosthetic device of claim 16, Maimon further discloses wherein each first strut comprises one or more ribs that extend lengthwise of the first struts (spacer 46 extends along some portion of the length, see Fig. 3A).
Regarding claim 18, Maimon/White makes obvious the implantable prosthetic device of claim 16, Maimon further discloses wherein each first strut comprises a plurality of spaced-apart transverse ribs extending widthwise of the first struts (strut has multiple spacers 46 that extends along the width of the strut, see Fig. 3A).
Regarding claim 19, Maimon/White makes obvious the implantable prosthetic device of claims 11, Maimon further discloses wherein each of one or more actuators comprises first and second members (first member is 622 and second member is 618) axially moveable relative to each other ([0202]), wherein the first member is pivotably coupled to a distal apex and the second member is pivotably coupled to a proximal apex formed by the first struts (actuators are considered to be pivotably coupled by being coupled to the frame and therefore pivoting with the movement of the frame, where the first member and second member are coupled to the distal and proximal apex; respectively, at least indirectly by being coupled to the frame, see Fig. 23A).
Regarding claim 20, Maimon/White makes obvious the implantable prosthetic device of claim 19, Maimon further discloses wherein the first member is an outer member and the second member is an inner member that is partially received within the outer member ([0202]).
Regarding claim 21, Maimon/White makes obvious the implantable prosthetic device of claim 11, further comprising a plurality of leaflets (48) disposed in the frame and configured to regulate a flow of blood through the frame in one direction ([0125]).
Regarding claim 22, Maimon discloses an implantable prosthetic device, comprising:
a frame (frame 604, see Fig. 18) being radially expandable and compressible between a radially compressed state and a radially expanded state ([0197]), the frame comprising a first set of first struts (series of struts as shown in annotated Fig. 18-1 from the rejection of claim 1, [0235])), a second set of second struts (series of struts as shown in annotated Fig. 18-2 from the rejection of claim 1, [0235]), and a third set of third struts (third struts as lined in annotated Fig. 18-3), the frame having a distal end and a proximal end (proximal and distal ends of the frame as shown in Fig. 18);
wherein the first struts are pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame, respectively (see annotated Fig. 18-1, where junctions as shown in annotated Fig. 18 and these junctions would be at both the inflow and outflow ends at the apices of the frame, where the apices of the frame have a pivotal connection by the connection of the struts, [0197], [0122]);
wherein the second struts are pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame, respectively (see annotated Fig. 18-2, where junctions as shown in annotated Fig. 18 and these junctions would be at both the inflow and outflow ends at the apices of the frame, where the apices of the frame have a pivotal connection by the connection of the struts, [0197], [0122]);
wherein the third struts are pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame, respectively (see annotated Fig. 18-3, where junctions as shown in annotated Fig. 18 and these junctions would be at both the inflow and outflow ends at the apices of the frame, where the apices of the frame have a pivotal connection by the connection of the struts, [0197], [0122]);
wherein the first struts are pivotably connected to the second and third struts at junctions between the distal and proximal ends of the frame (see annotated Fig. 18-3);
wherein the second struts are pivotably connected to the first and third struts at junctions between the distal and proximal ends of the frame (see annotated Fig. 18-3);
one or more actuators (608, [0198]), wherein the one or more actuators are configured to apply axially directed forces to the frame to radially expand the frame from the radially compressed state to the radially expanded state ([0200]).
Maimon does not explicitly disclose the one or more actuators coupled only to one or more corresponding pairs of a distal apex and a proximal apex formed by the first struts. Maimon teaches the delivery assembly can have any number of actuator assemblies 608 and locking mechanism 610 ([0218]). Maimon further shows an arrangement of the actuator assemblies 608 in Fig. 18. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the device of Maimon to have the actuators coupled only to one or more pairs of a distal and a proximal apex formed by the first struts (the apices formed by the first struts shown in annotated Fig. 18-1, where pairs would be alternating distal and proximal apex), since Applicant has not disclosed that having the one or more actuators only to one or more pairs of a distal apex and a proximal apex formed by the first struts is used for a particular purpose or solves a stated problem. One of ordinary skill in the art, would have expected the device of Maimon and the claimed invention to perform the same function of actuating and locking the device equally well.
Maimon does not explicitly disclose wherein the first struts have a greater resistance against deformation from axially directed forces applied to the frame than the second and third struts. White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the material of individual struts can differ in material from other individual struts in the same frame ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art to have the first struts be made of a material that is less flexible than the material of the second and third struts in order to allow portions of the device to flex inward during a normal cardiac cycle while other portions not substantially deform ([0141]).
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Regarding claims 23 and 24, Maimon/White makes obvious the implantable prosthetic device of claim 22; yet, is silent regarding wherein: the first struts have a first cross-sectional profile taken in a plane perpendicular to their length, the first cross-sectional profile having a first dimension measured in a direction; the second struts have a second cross-sectional profile taken in a plane perpendicular to their length, the second cross-sectional profile having a second dimension that is measured in the same direction as the first dimension of the first cross-sectional profile; the third struts have a third cross-sectional profile taken in a plane perpendicular to their length, the third cross-sectional profile having a third dimension that is measured in the same direction as the first dimension of the first cross-sectional profile; and wherein the first dimension is greater than the second dimension and the third dimension; wherein the first dimension is a first thickness, which is measured between a radially facing inner surface and a radially facing outer surface of each first strut; wherein the second dimension is a second thickness, which is measured between a radially facing inner surface and a radially facing outer surface of each second strut; wherein the third dimension is a third thickness, which is measured between a radially facing inner surface and a radially facing outer surface of each third strut; and wherein the first thickness is greater than the second thickness and the third thickness.
However, White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the thickness (cross sectional dimension) of individual struts can differ in thickness from other individual struts in the same frame ([0078]). Therefore, White teaches the thickness of the struts is a result effective variable ([0078]). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to change the thickness (cross-sectional dimension) of the first struts to be greater than the thickness of the second and third struts in order to meet the needs of an intended application that required such dimensions as White teaches selecting proper dimensions of the struts based on the implantation site ([0166]).
Regarding claims 23 and 25, Maimon/White makes obvious the implantable prosthetic device of claim 22; yet, is silent regarding wherein: the first struts have a first cross-sectional profile taken in a plane perpendicular to their length, the first cross-sectional profile having a first dimension measured in a direction; the second struts have a second cross-sectional profile taken in a plane perpendicular to their length, the second cross-sectional profile having a second dimension that is measured in the same direction as the first dimension of the first cross-sectional profile; the third struts have a third cross-sectional profile taken in a plane perpendicular to their length, the third cross-sectional profile having a third dimension that is measured in the same direction as the first dimension of the first cross-sectional profile; and wherein the first dimension is greater than the second dimension and the third dimension; the first dimension is a first width, which is measured between first and second longitudinal edges of each first strut facing the distal and proximal ends of the frame, respectively; the second dimension is a second width, which is measured between first and second longitudinal edges of each second strut facing the distal and proximal ends of the frame, respectively; the third dimension is a third width, which is measured between first and second longitudinal edges of each third strut facing the distal and proximal ends of the frame, respectively; and the first width is greater than the second width and the third width.
However, White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the width (cross sectional dimension) of individual struts can differ in width from other individual struts in the same frame ([0165]). Therefore, White teaches the width of the struts is a result effective variable ([0165]). Thus, it would have been obvious to one having ordinary skill in the art to change the width (cross-sectional dimension) of the first struts to be greater than the width of the second and third struts in order to meet the needs of an intended application that required such dimensions as White teaches selecting proper dimensions of the struts based on the implantation site ([0166]).
Regarding claim 26, Maimon/White makes obvious the implantable prosthetic device of any of claims 22; yet, is silent regarding wherein the first struts are made of a first material, the second and third struts are made of a second material, and the first material is more rigid than the second material. White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the material of individual struts can differ in material from other individual struts in the same frame ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art to have the first struts be made of a material that is less flexible than the material of the second and third struts in order to allow portions of the device to flex inward during a normal cardiac cycle while other portions not substantially deform ([0141]).
Regarding claim 27, Maimon/White makes obvious the implantable prosthetic device of claim 22, Maimon further discloses wherein the first struts comprise reinforcing ribs (spacer 46).
Regarding claim 28, Maimon/White makes obvious the implantable prosthetic device of claim 27, Maimon further discloses wherein each first strut comprises one or more ribs that extend lengthwise of the first struts (spacer 46 extends along some portion of the length, see Fig. 3A).
Regarding claim 29, Maimon/White makes obvious the implantable prosthetic device of claim 27, Maimon further discloses wherein each first strut comprises a plurality of spaced-apart transverse ribs extending widthwise of the first struts (strut has multiple spacers 46 that extends along the width of the strut, see Fig. 3A).
Regarding claim 30, Maimon/White makes obvious the implantable prosthetic device of claim 22, Maimon further discloses wherein each distal and proximal apex and each junction comprise a pivot connector (fastener between pivotable connections, [0119]) that allows the first, second, and third struts to pivot relative to each other when the frame is radially expanded and compressed (fasteners between the struts described in [0119] in relation to the embodiment of frame 22, which is similar to frame 604, [0197]).
Regarding claim 31, Maimon/White makes obvious the implantable prosthetic device of claim 22, Maimon further discloses further comprising a plurality of leaflets (48) disposed in the frame and configured to regulate a flow of blood through the frame in one direction ([0125]).
Regarding claim 32, Maimon/White makes obvious the implantable prosthetic device of any of claims 22-31, Maimon further discloses wherein each of one or more actuators comprises first and second members (first member is 622 and second member is 618) axially moveable relative to each other ([0202]), wherein the first member is pivotably coupled to a distal apex and the second member is pivotably coupled to a proximal apex formed by the first struts (actuators are considered to be pivotably coupled by being coupled to the frame and therefore pivoting with the movement of the frame, where the first member and second member are coupled to the distal and proximal apex of the first struts; respectively, at least indirectly by being coupled to the frame, see Fig. 23A).
Regarding claim 33, Maimon/White makes obvious the implantable prosthetic device of claim 32, Maimon further discloses wherein the first member is an outer member and the second member is an inner member that is partially received within the outer member ([0202]).
Regarding claim 34, Maimon discloses an implantable prosthetic device, comprising:
a frame (frame 604, see Fig. 18) being radially expandable and compressible between a radially compressed state and a radially expanded state ([0197]), the frame comprising a first set of first struts (series of struts as shown in annotated Fig. 18-1 from the rejection of claim 1, [0235]) and a second set of second struts (series of struts as shown in annotated Fig. 18-2 from the rejection of claim 1, [0235]), wherein the first struts and the second struts are pivotably connected to each other by respective pivot connectors at a plurality of junctions (pivot connections between the struts, see annotated Fig. 18-3 from the rejection of claim 22, pivotable connections between the struts described in [0120] in relation to the embodiment of frame 22, which is similar to frame 604, [0197]).
one or more actuators (608, [0198]), wherein the one or more actuators are configured to apply axially directed forces to the frame to radially expand the frame from the radially compressed state to the radially expanded state ([0200]).
Maimon is silent regarding coupled only to one or more corresponding pairs of junctions formed by the first struts. Maimon teaches the delivery assembly can have any number of actuator assemblies 608 and locking mechanism 610 ([0218]). Maimon further shows an arrangement of the actuator assemblies 608 in Fig. 18. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the device of Maimon to have the actuators coupled only to one or more pairs of a distal and a proximal apex formed by the first struts (the apices formed by the first struts shown in annotated Fig. 18-1, where pairs would be alternating distal and proximal apex), since Applicant has not disclosed that having the one or more actuators only to one or more pairs of a distal apex and a proximal apex formed by the first struts is used for a particular purpose or solves a stated problem. One of ordinary skill in the art, would have expected the device of Maimon and the claimed invention to perform the same function of actuating and locking the device equally well.
Maimon is silent regarding wherein the first struts have a greater resistance against deformation from axially directed forces applied to the frame than the second struts. White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the material of individual struts can differ in material from other individual struts in the same frame ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art to have the first struts be made of a material that is less flexible than the material of the second struts in order to allow portions of the device to flex inward during a normal cardiac cycle while other portions not substantially deform ([0141]).
Regarding claim 35, Maimon/White makes obvious the implantable prosthetic device of claim 34, Maimon further discloses wherein the frame has a distal end and a proximal end (frame of 604, see Fig. 18), wherein the first struts are pivotably connected to each other at junctions forming distal and proximal apices at the distal and proximal ends of the frame (see annotated Fig. 18-1 from the rejection of claim 1), respectively. However, does not explicitly disclose wherein the one or more actuators are coupled only to corresponding pairs of junctions forming distal and proximal apices of the frame. Maimon further shows an arrangement of the actuator assemblies 608 in Fig. 18. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the device of Maimon have the actuators coupled only to pairs of junctions forming distal and proximal apieces of the frame (the apices formed by the first struts shown in annotated Fig. 18-1, where pairs would be alternating distal and proximal apex), since Applicant has not disclosed that having the one or more actuators coupled only to pairs of junctions forming distal and proximal apices of the frame is used for a particular purpose or solves a stated problem. One of ordinary skill in the art, would have expected the device of Maimon and the claimed invention to perform the same function of actuating and locking the device equally well.
Regarding claim 36, Maimon/White makes obvious the implantable prosthetic device of claim 34, however, does not explicitly disclose wherein the frame has a distal end and a proximal end, and wherein the one or more actuators are coupled only to corresponding pairs of junctions that are axially spaced from the distal and proximal ends of the frame. Maimon further shows an arrangement of the actuator assemblies 608 in Fig. 18. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the device of Maimon have the actuators coupled only to corresponding pairs of junctions that are axially spaced from the distal and proximal ends of the frame, since Applicant has not disclosed that having the one or more actuators coupled only to corresponding pairs of junctions that are axially spaced from ends of the frame is used for a particular purpose or solves a stated problem. One of ordinary skill in the art, would have expected the device of Maimon and the claimed invention to perform the same function of actuating and locking the device equally well.
Regarding claim 37, Maimon/White makes obvious the implantable prosthetic device of claim 34, Maimon further discloses wherein the frame has a distal end and a proximal end, and wherein each of the one or more actuators are coupled to corresponding pairs of junctions that includes a junction at the distal or proximal end of the frame and a junction that is axially spaced from the distal and proximal ends of the frame (608 actuators are coupled to the junctions by being connected to the frame 604, see Fig. 18).
Regarding claims 38 and 39, Maimon/White makes obvious the implantable prosthetic device of any of claims 34-37, wherein: the first struts have a first cross-sectional profile taken in a plane perpendicular to their length, the first cross-sectional profile having a first dimension measured in a direction; the second struts have a second cross-sectional profile taken in a plane perpendicular to their length, the second cross-sectional profile having a second dimension that is measured in the same direction as the first dimension of the first cross-sectional profile; and wherein an average of the first dimension along the length of the first struts is greater than an average of the second dimension along the length of the second struts; wherein: the first dimension is a first thickness, which is measured between a radially facing inner surface and a radially facing outer surface of each first strut; the second dimension a second thickness, which is measured between a radially facing inner surface and a radially facing outer surface of each second strut; and an average of the first thickness along the length of the first struts is greater than an average of the second thickness along the length of the second struts.
However, White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the thickness (cross sectional dimension) of individual struts can differ in thickness from other individual struts in the same frame ([0078]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to change the thickness (cross-sectional dimension) of the first struts to be greater than the thickness (cross-sectional dimension) of the second and third struts in order to meet the needs of an intended application that required such dimensions as White teaches selecting proper dimensions of the struts based on the implantation site ([0166]).
Regarding claim 40, Maimon/White makes obvious the implantable prosthetic device of claim 39; yet, does not explicitly disclose wherein the first thickness is constant along the length of the first struts and the second thickness is constant along the length of the second struts. White further teaches the thickness of the struts can be uniform or vary across a strut ([0078]). It would have been an obvious matter of design choice to one having ordinary skill in the art to have the first and second struts have a constant thickness, since applicant has not disclosed that having the constant thickness provides an advantage, solves any stated problem, or is used for any particular purpose and it appears the device would perform equally well with alternative designs as stated in [0078] of White.
Regarding claim 41, Maimon/White makes obvious the implantable prosthetic device of claim 39; yet, does not explicitly disclose wherein the first thickness varies along the length of the first struts and the second thickness varies along the length of the second struts. White further teaches the thickness of the struts can be uniform or vary across a strut ([0078]). It would have been an obvious matter of design choice to one having ordinary skill in the art to have the first and second struts have a varied thickness, since applicant has not disclosed that having the varied thickness provides an advantage, solves any stated problem, or is used for any particular purpose and it appears the device would perform equally well with alternative designs as stated in [0078] of White.
Regarding claims 38 and 42, Maimon/White makes obvious the implantable prosthetic device of any of claims 34-37, wherein: the first struts have a first cross-sectional profile taken in a plane perpendicular to their length, the first cross-sectional profile having a first dimension measured in a direction; the second struts have a second cross-sectional profile taken in a plane perpendicular to their length, the second cross-sectional profile having a second dimension that is measured in the same direction as the first dimension of the first cross-sectional profile; and wherein an average of the first dimension along the length of the first struts is greater than an average of the second dimension along the length of the second struts; wherein: the first dimension is a first width, which is measured between first and second longitudinal edges of each first strut facing the distal and proximal ends of the frame, respectively; the second dimension is a second width, which is measured between first and second longitudinal edges of each second strut facing the distal and proximal ends of the frame, respectively; and an average of the first width along the length of the first struts is greater than an average of the second width along the length of the second struts.
However, White teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the width (cross sectional dimension) of individual struts can differ in width from other individual struts in the same frame ([0165]). Therefore, White teaches the width of the struts is a result effective variable ([0165]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to change the width (cross-sectional dimension) of the first struts to be greater than the width than the second struts in order to meet the needs of an intended application that required such dimensions as White teaches selecting proper dimensions of the struts based on the implantation site ([0166]).
Regarding claim 43, Maimon/White makes obvious the implantable prosthetic device of claim 42; yet, does not explicitly disclose wherein the first width is constant along the length of the first struts and the second width is constant along the length of the second struts. White further teaches the thickness of the struts can be uniform or vary across a strut ([0078]). It would have been an obvious matter of design choice to one having ordinary skill in the art to have the first and second struts have a constant thickness, since applicant has not disclosed that having the constant thickness provides an advantage, solves any stated problem, or is used for any particular purpose and it appears the device would perform equally well with alternative designs as stated in [0078] of White.
Regarding claim 44, Maimon/White makes obvious the implantable prosthetic device of claim 42; yet, does not explicitly disclose wherein the first width varies along the length of the first struts and the second width varies along the length of the second struts. White further teaches the thickness of the struts can be uniform or vary across a strut ([0078]). It would have been an obvious matter of design choice to one having ordinary skill in the art to have the first and second struts have a varied thickness, since applicant has not disclosed that having the varied thickness provides an advantage, solves any stated problem, or is used for any particular purpose and it appears the device would perform equally well with alternative designs as stated in [0078] of White.
Regarding claim 45, Maimon/White makes obvious the implantable prosthetic device of claim 34; yet, does not explicitly disclose wherein the first struts are made of a first material, the second struts are made of a second material, and the first material is more rigid than the second material. White further teaches a frame 10 that can be used for a heart valve ([0076]) having struts 11 that are interconnected through pivotable joints ([0077]). White further teaches the material of individual struts can differ in material from other individual struts in the same frame ([0140]). Therefore, it would have been obvious to one having ordinary skill in the art to have the first struts be made of a material that is less flexible than the material of the second struts in order to allow portions of the device to flex inward during a normal cardiac cycle while other portions not substantially deform ([0141]).
Regarding claim 46, Maimon/White makes obvious the implantable prosthetic device of claim 34, Maimon further discloses wherein the first struts comprise reinforcing ribs (spacer 46).
Regarding claim 47, Maimon/White makes obvious the implantable prosthetic device of claim 46, Maimon further discloses wherein each first strut comprises one or more ribs that extend lengthwise of the first struts (spacer 46 extends along some portion of the length, see Fig. 3A).
Regarding claim 48, Maimon/White makes obvious the implantable prosthetic device of claim 46, Maimon further discloses wherein each first strut comprises a plurality of spaced-apart transverse ribs extending widthwise of the first struts (strut has multiple spacers 46 that extends along the width of the strut, see Fig. 3A).
Regarding claim 49, Maimon/White makes obvious the implantable prosthetic device claim 34, Maimon further discloses wherein each of one or more actuators comprises first and second members (first member is 622 and second member is 618) axially moveable relative to each other ([0202]), wherein the first member is pivotably coupled to an adjacent junction and the second member is pivotably coupled to an adjacent junction (actuators are considered to be pivotably coupled by being coupled to the frame and therefore pivoting with the movement of the frame, where the first member and second member are coupled to the distal and proximal apex; respectively, at least indirectly by being coupled to the frame, see Fig. 23A).
Regarding claim 50, Maimon/White makes obvious the implantable prosthetic device of claim 49, Maimon further discloses wherein the first member is an outer member and the second member is an inner member that is partially received within the outer member ([0202]).
Regarding claim 51, Maimon/White makes obvious the implantable prosthetic device of claim 34, further comprising a plurality of leaflets (48) disposed in the frame and configured to regulate a flow of blood through the frame in one direction ([0125]]).
Conclusion
THIS ACTION IS MADE FINAL. 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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799