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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lederman (US 20200383717 A1) in view of Selkee (US 8021327 B2) and Kessler (US 9943330 B2).
Regarding claim 1, Lederman teaches electrosurgical leaflet laceration device ([0002] This disclosure is related to tissue laceration using electrical energy, such as for laceration heart valve leaflets) having a delivery configuration (Fig 1; [0008]) and a deflected configuration ([0008] FIG. 1D: Once the guidewire traverses the mitral leaflet, it is ensnared and externalized. The inset depicts a kinked section of the guidewire shaft that is denuded along its inner curvature to direct electrosurgery energy to the nearby leaflet), the catheter shaft including an electrosurgical wire lumen ([0008] FIG. 1C: retrograde guiding catheters are positioned across the aortic valve into the LVOT and another across the mitral valve into the left atrium. The LVOT catheter directs an electrified guidewire across the base of the anterior mitral valve leaflet under echocardiographic guidance into a snare positioned through the left atrial guiding catheter); and an electrosurgical wire disposed within the electrosurgical wire lumen of the catheter shaft ([0004] Disclosed monopolar and bipolar tissue lacerators can comprise a wire partially covered by electrical insulation, wherein the wire has a kink defining an inner curvature, wherein the wire is exposed through the insulation at one or two exposed regions along or near the inner curvature of the kink, wherein the wire is configured to conduct electrical energy through the one or two exposed regions and through a tissue target positioned adjacent the inner curvature to lacerate the tissue target via the electrical energy), the electrosurgical wire having a cutting segment ([0004] Disclosed monopolar and bipolar tissue lacerators can comprise a wire partially covered by electrical insulation, wherein the wire has a kink defining an inner curvature, wherein the wire is exposed through the insulation at one or two exposed regions along or near the inner curvature of the kink, wherein the wire is configured to conduct electrical energy through the one or two exposed regions and through a tissue target positioned adjacent the inner curvature to lacerate the tissue target via the electrical energy), the electrosurgical wire with the electrosurgical leaflet laceration device in the deflected configuration ([0008] FIG. 1D: Once the guidewire traverses the mitral leaflet, it is ensnared and externalized. The inset depicts a kinked section of the guidewire shaft that is denuded along its inner curvature to direct electrosurgery energy to the nearby leaflet. FIG. 1E: The guidewire is electrified and the guiding catheters withdraw it to lacerate the anterior mitral leaflet lengthwise); and wherein the cutting segment of the electrosurgical wire is configured to be energized cut tissue abutting or in contact with the cutting segment ([0004]) ([0008] FIG. 1E: The guidewire is electrified and the guiding catheters withdraw it to lacerate the anterior mitral leaflet lengthwise).
Lederman fails to teach the electrosurgical leaflet laceration device comprising: a handle; a catheter shaft extending distally from the handle, and a side opening, wherein the side opening of the catheter shaft is configured to expose the cutting segment.
However, Selkee teaches the electrosurgical leaflet laceration device comprising: a handle (Fig 1; control handle 16); a catheter shaft extending distally from the handle ([32] As also shown in FIGS. 2-5, two puller wires 32 extend through the catheter 10. Each puller wire 32 extends from the control handle 16, through the central lumen 18 in the catheter body 12 (FIG. 3) and into one of the off-axis lumens 26 and 28 of the tip section 14 (FIG. 5). As described in more detail below, the proximal end of each puller wire 32 is anchored within the control handle 16 and the distal end of each puller wire 32 is anchored within the tip section). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include the electrosurgical leaflet laceration device comprising: a handle; a catheter shaft extending distally from the handle. Doing so allows the device to be controlled by an operator.
Further, Kessler teaches a side opening ([abstract] A side opening in the distal portion of the catheter body is defined by opposite first and second side edges, a proximal edge extending between the first and second side edges, and a distal edge opposite the proximal edge and extending between the first and second side edges); wherein the side opening of the catheter shaft is configured to expose the cutting segment ([abstract] The side opening window has a longitudinal axis extending between the distal and proximal edges. The tissue-removing element is configured to move between a tissue-removing position, in which the tissue-removing element is exposed through the side opening window) ([33] The cutter 28 can access target tissue through a side opening window 32 in the distal portion 26, which is typically large enough to allow the cutter 28 to protrude through and move out of the window 32 a predetermined distance). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include a side opening, wherein the side opening of the catheter shaft is configured to expose the cutting segment. Doing so allows for effective cutting of the valve when the distal end of the catheter is advanced through the valve and in place for the side to line up with the selected tissue.
Regarding claim 2 Lederman teaches the electrosurgical leaflet laceration device of claim 1, wherein the electrosurgical wire is configured to transition the electrosurgical leaflet laceration device between the delivery configuration and the deflected configuration ([0008] FIG. 1D: Once the guidewire traverses the mitral leaflet, it is ensnared and externalized. The inset depicts a kinked section of the guidewire shaft that is denuded along its inner curvature to direct electrosurgery energy to the nearby leaflet. FIG. 1E: The guidewire is electrified and the guiding catheters withdraw it to lacerate the anterior mitral leaflet lengthwise) ([0009] FIG. 2C: Initiation of laceration. The kinked guidewire cutting edge is circled in green. The transcatheter heart valve is pre-positioned at the orifice of the mitral valve. The LAMPOON guidewire is pulled outward to apply tension).
Regarding claim 3, Lederman teaches the electrosurgical leaflet laceration device of claim 2, to transition the electrosurgical leaflet laceration device between the delivery configuration and the deflected configuration ([0008] FIG. 1D: Once the guidewire traverses the mitral leaflet, it is ensnared and externalized. The inset depicts a kinked section of the guidewire shaft that is denuded along its inner curvature to direct electrosurgery energy to the nearby leaflet. FIG. 1E: The guidewire is electrified and the guiding catheters withdraw it to lacerate the anterior mitral leaflet lengthwise) ([0009] FIG. 2C: Initiation of laceration. The kinked guidewire cutting edge is circled in green. The transcatheter heart valve is pre-positioned at the orifice of the mitral valve. The LAMPOON guidewire is pulled outward to apply tension), but fails to teach wherein a proximal portion of the electrosurgical wire is coupled to an actuator in the handle and a distal portion of the electrosurgical wire is fixedly coupled to a distal end of the catheter shaft, wherein the actuator is configured to apply or release tension on the electrosurgical wire to apply or release a proximal force on the distal end of the catheter shaft to bend the catheter shaft.
However, Selkee teaches wherein a proximal portion of the electrosurgical wire is coupled to an actuator in the handle ([32] As also shown in FIGS. 2-5, two puller wires 32 extend through the catheter 10. Each puller wire 32 extends from the control handle 16, through the central lumen 18 in the catheter body 12 (FIG. 3) and into one of the off-axis lumens 26 and 28 of the tip section 14 (FIG. 5). As described in more detail below, the proximal end of each puller wire 32 is anchored within the control handle 16 and the distal end of each puller wire 32 is anchored within the tip section) and a distal portion of the electrosurgical wire is fixedly coupled to a distal end of the catheter shaft ([32] the proximal end of each puller wire 32 is anchored within the control handle 16 and the distal end of each puller wire 32 is anchored within the tip section) ([35] As shown in FIGS. 7 to 9, the puller wire 32 is preferably attached by means of an anchor 44 fixedly attached to the distal end of the puller wire 32), wherein the actuator is configured to apply or release tension on the electrosurgical wire to apply or release a proximal force on the distal end of the catheter shaft to bend the catheter shaft ([abstract] In particular, the control handle of the catheter which includes a steering assembly having a lever arm carrying a pair of pulleys for drawing corresponding puller wires to deflect the tip section of the catheter). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include wherein a proximal portion of the electrosurgical wire is coupled to an actuator in the handle and a distal portion of the electrosurgical wire is fixedly coupled to a distal end of the catheter shaft, wherein the actuator is configured to apply or release tension on the electrosurgical wire to apply or release a proximal force on the distal end of the catheter shaft to bend the catheter shaft. Doing so allows for the bending of the catheter to be controlled by the user at a proximal end.
Regarding claim 7, Lederman teaches the electrosurgical leaflet laceration device of claim 1, wherein the electrosurgical wire includes an insulative covering, and wherein the cutting segment is non-insulated ([0004] Disclosed monopolar and bipolar tissue lacerators can comprise a wire partially covered by electrical insulation, wherein the wire has a kink defining an inner curvature, wherein the wire is exposed through the insulation at one or two exposed regions along or near the inner curvature of the kink).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lederman (US 20200383717 A1) in view of Selkee (US 8021327 B2) and Kessler (US 9943330 B2), further in view of Helgeson (US 10118022 B2).
Regarding claim 4, Lederman teaches the electrosurgical leaflet laceration device of claim 1, to transition the electrosurgical leaflet laceration device from the delivery configuration to the deflected configuration ([0008] FIG. 1D: Once the guidewire traverses the mitral leaflet, it is ensnared and externalized. The inset depicts a kinked section of the guidewire shaft that is denuded along its inner curvature to direct electrosurgery energy to the nearby leaflet. FIG. 1E: The guidewire is electrified and the guiding catheters withdraw it to lacerate the anterior mitral leaflet lengthwise) ([0009] FIG. 2C: Initiation of laceration. The kinked guidewire cutting edge is circled in green. The transcatheter heart valve is pre-positioned at the orifice of the mitral valve. The LAMPOON guidewire is pulled outward to apply tension), but fails to teach wherein the catheter shaft includes a proximal portion, a distal portion, and a deflection zone portion disposed between the proximal portion and the distal portion, wherein the deflection zone portion is more flexible than the proximal portion and the distal portion, such that the catheter shaft is configured to bend or deflect at the deflection zone portion.
However, Selkee teaches wherein the catheter shaft includes a proximal portion, a distal portion ([20] FIG. 1, the catheter 10 comprises an elongated catheter body 12 having proximal and distal ends, a tip section 14 at the distal end of the catheter body 12, and a control handle 16 at the proximal end of the catheter body 12). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include wherein the catheter shaft includes a proximal portion, a distal portion. Doing so allows for a controller end and a working end of the catheter.
Further, Helgeson teaches a deflection zone portion disposed between the proximal portion and the distal portion (Fig 1; [10] Deflectable catheter shaft section 12 includes an elongated body having a distal end 13 and a proximal end 14), wherein the deflection zone portion is more flexible than the proximal portion and the distal portion ([14] The deflectable catheter shaft section 12 can be configured for deflection independent of the proximal catheter shaft section 16. The deflectable catheter shaft section 12 can be constructed of a series of polymer layer(s) and braid structure(s), which can be different than those used in the proximal catheter shaft section 16) ([14] The mechanical properties of the deflectable catheter shaft section 12 can also be varied independent of the proximal catheter shaft section 16 by varying the properties of the cylindrical braid structure(s) and the polymeric material (e.g., dimension of the cylindrical braid structure and/or durometers of the polymers)) ([10] catheter 10 further includes a tip assembly 15 located at the distal end 13 of the deflectable catheter shaft section 12) such that the catheter shaft is configured to bend or deflect at the deflection zone portion ([15] The handle assembly 17 includes an actuator that can be selectively manipulated to cause deflectable catheter shaft section 12 to deflect in one or more directions (e.g., up, down, left, and right). Deflectable catheter shaft section 12 may be configured for symmetric deflection in accordance with some embodiments and may be configured for asymmetric deflection). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include a deflection zone portion disposed between the proximal portion and the distal portion, wherein the deflection zone portion is more flexible than the proximal portion and the distal portion, such that the catheter shaft is configured to bend or deflect at the deflection zone portion. Doing so allows for the portion between the proximal end ands distal end to move in a desired direction for the treatment.
Regarding claim 5, Lederman teaches the electrosurgical leaflet laceration device of claim 4, but fails to teach wherein the side opening is disposed within the deflection zone portion of the catheter shaft.
However, Kessler teaches wherein the side opening is disposed within the deflection zone portion of the catheter shaft ([abstract] The side opening window has a longitudinal axis extending between the distal and proximal edges. The tissue-removing element is configured to move between a tissue-removing position, in which the tissue-removing element is exposed through the side opening window) (Fig 1 and 2; distal tip 42, side opening 32, proximal portion 24) ([33] The cutter 28 can access target tissue through a side opening window 32 in the distal portion 26). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include wherein the side opening is disposed within the deflection zone portion of the catheter shaft. Doing so allows for the side opening to move with the bend in the catheter for tissue access when the catheter is in the right position.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lederman (US 20200383717 A1) in view of Selkee (US 8021327 B2) and Kessler (US 9943330 B2), further in view of Atias (WO 2024006230 A1).
Regarding claim 6, Lederman teaches the electrosurgical leaflet laceration device of claim 1, but fails to teach further comprising a balloon coupled to a distal portion of the catheter shaft, the balloon having an uninflated state and an inflated state, wherein the balloon is configured to splay or open a puncture hole in a valve leaflet with the balloon in the inflated state.
However, Atias teaches further comprising a balloon coupled to a distal portion of the catheter shaft ([0009] In some aspects, the leaflet perforation tool further comprises an expansion member supported by the distal end portion of the catheter), the balloon having an uninflated state and an inflated state ([0032] the expansion member comprises an inflatable balloon, and the transitioning the expansion member from the radially compressed configuration to the radially expanded configuration comprises inflating the inflatable balloon to transition the inflatable balloon from a deflated state to an inflated state), wherein the balloon is configured to splay or open a puncture hole in a valve leaflet with the balloon in the inflated state ([0176] The expansion member 220 may include and/or be any suitable structure for expanding the pilot puncture 50 to form the leaflet opening 52. In some examples, the expansion member 220 extends at least substantially around a circumference of the catheter in order to exert an expansion force across full circumference of the pilot puncture 50). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include further comprising a balloon coupled to a distal portion of the catheter shaft, the balloon having an uninflated state and an inflated state, wherein the balloon is configured to splay or open a puncture hole in a valve leaflet with the balloon in the inflated state. Doing so allows for the balloon to hold the catheter in place and to expand the puncture hole so that the catheter can fit through.
Claim(s) 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lederman (US 20200383717 A1) in view of Kessler (US 9943330 B2) and Atias (WO 2024006230 A1), further in view of Sauter (US 20240216047 A1).
Regarding claim 8, Lederman teaches method for lacerating a valve leaflet ([0002] This disclosure is related to tissue laceration using electrical energy, such as for laceration heart valve leaflets) comprising: advancing an electrosurgical leaflet laceration device to a treatment site adjacent a valve leaflet ([0008] FIG. 1C: retrograde guiding catheters are positioned across the aortic valve into the LVOT and another across the mitral valve into the left atrium) ([0009] FIG. 2A: Left anterior oblique caudal short-axis fluoroscopic projection showing retrograde catheters positioned before anterior mitral valve leaflet traversal); positioning a distal tip of a catheter shaft of the electrosurgical leaflet laceration device adjacent a base of the valve leaflet ([0008] FIG. 1C: retrograde guiding catheters are positioned across the aortic valve into the LVOT and another across the mitral valve into the left atrium. The LVOT catheter directs an electrified guidewire across the base of the anterior mitral valve leaflet under echocardiographic guidance into a snare positioned through the left atrial guiding catheter) ([0009] FIG. 2B: A 3-dimensional transesophageal echocardiograph of the same step, with a LVOT catheter positioned at the base of the A2 scallop, and the LA catheter pointing a multiloop snare at the other side of the A2 scallop); distally advancing a guidewire through the catheter shaft and through the valve leaflet to puncture the valve leaflet to form a puncture hole ([0008] The LVOT catheter directs an electrified guidewire across the base of the anterior mitral valve leaflet under echocardiographic guidance into a snare positioned through the left atrial guiding catheter. FIG. 1D: Once the guidewire traverses the mitral leaflet, it is ensnared and externalized); proximally retracting an electrosurgical wire of the electrosurgical leaflet laceration device to transition the electrosurgical leaflet laceration device from a delivery configuration to a deflected configuration ([0009] FIG. 2C: Initiation of laceration. The kinked guidewire cutting edge is circled in green. The transcatheter heart valve is pre-positioned at the orifice of the mitral valve. The LAMPOON guidewire is pulled outward to apply tension) in which the catheter shaft is bent adjacent the side opening (Fig 2; kinked edge aligned with leaflet), energizing the electrosurgical wire ([0008] electrified guidewire); proximally retracting the electrosurgical leaflet laceration device in the deflected configuration such that the electrosurgical wire lacerates the valve leaflet ([0008] FIG. 1E: The guidewire is electrified and the guiding catheters withdraw it to lacerate the anterior mitral leaflet lengthwise).
Lederman fails to teach distally advancing the electrosurgical leaflet laceration device through the puncture hole in the valve leaflet; positioning a side opening of the catheter shaft within the puncture hole in the valve leaflet and adjacent to tissue of the valve leaflet; a cutting segment of the electrosurgical wire is longitudinally aligned with the side opening; and deenergizing the electrosurgical wire.
However, Kessler teaches positioning a side opening of the catheter shaft within the puncture hole in the valve leaflet and adjacent to tissue of the valve leaflet ([abstract] The side opening window has a longitudinal axis extending between the distal and proximal edges. The tissue-removing element is configured to move between a tissue-removing position, in which the tissue-removing element is exposed through the side opening window) ([33] The cutter 28 can access target tissue through a side opening window 32 in the distal portion 26, which is typically large enough to allow the cutter 28 to protrude through and move out of the window 32 a predetermined distance); and a cutting segment of the electrosurgical wire is longitudinally aligned with the side opening ([33] The cutter 28 can access target tissue through a side opening window 32 in the distal portion 26, which is typically large enough to allow the cutter 28 to protrude through and move out of the window 32 a predetermined distance). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include positioning a side opening of the catheter shaft within the puncture hole in the valve leaflet and adjacent to tissue of the valve leaflet; and a cutting segment of the electrosurgical wire is longitudinally aligned with the side opening. Doing so allows for the side opening to allow tissue access to the cutting element when aligned.
Further, Atias teaches distally advancing the electrosurgical leaflet laceration device through the puncture hole in the valve leaflet ([0175] the perforation tool guidewire 240 can be used to form an initial pilot puncture 50, after which the lacerating member 230 can be advanced through the leaflet to form a slightly larger pilot puncture for subsequent advancement of the expansion member 220 through the leaflet). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include distally advancing the electrosurgical leaflet laceration device through the puncture hole in the valve leaflet. Doing so allows for aligning the catheter cutting element with the desired tissue.
Further, Sauter teaches deenergizing the electrosurgical wire ([0178] the perforation is formed by applying energy and applying a slight pressure on the tissue with the guidewire. Energy delivery is stopped once a puncture is formed within the tissue). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include deenergizing the electrosurgical wire. Doing so allows for pulling out the catheter without the cutting element active to prevent unwanted cuts.
Regarding claim 9, Lederman teaches the method of claim 8, but fails to teach further comprising: after distally advancing the electrosurgical leaflet laceration device through the puncture hole in the valve leaflet and prior to positioning the side opening within the puncture hole, inflating a balloon of the electrosurgical leaflet laceration device to enlarge the puncture hole.
However, Atias teaches further comprising: after distally advancing the electrosurgical leaflet laceration device through the puncture hole in the valve leaflet and prior to positioning the side opening within the puncture hole ([0175] the perforation tool guidewire 240 can be used to form an initial pilot puncture 50, after which the lacerating member 230 can be advanced through the leaflet to form a slightly larger pilot puncture for subsequent advancement of the expansion member 220 through the leaflet), inflating a balloon of the electrosurgical leaflet laceration device to enlarge the puncture hole ([0177] In some examples, and as shown in Figs. 4A-4D, the expansion member 220 comprises an inflatable balloon 222 that is configured to be selectively inflated and deflated to transition the expansion member 220 between the radially compressed configuration and the radially expanded configuration). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include further comprising: after distally advancing the electrosurgical leaflet laceration device through the puncture hole in the valve leaflet and prior to positioning the side opening within the puncture hole, inflating a balloon of the electrosurgical leaflet laceration device to enlarge the puncture hole. Doing so allows for expanding the puncture hole to fit the catheter through and to make an accurate incision of the leaflet.
Regarding claim 10, Lederman teaches the method of claim 8, but fails to teach further comprising: after deenergizing the electrosurgical wire, proximally retracting the electrosurgical leaflet laceration device to remove the electrosurgical leaflet laceration from the treatment site.
However, Sauter teaches further comprising: after deenergizing the electrosurgical wire ([0178] the perforation is formed by applying energy and applying a slight pressure on the tissue with the guidewire. Energy delivery is stopped once a puncture is formed within the tissue), proximally retracting the electrosurgical leaflet laceration device to remove the electrosurgical leaflet laceration from the treatment site ([0180] In some embodiments, the dilator and the electrosurgical interface can be retracted and removed). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include further comprising: after deenergizing the electrosurgical wire, proximally retracting the electrosurgical leaflet laceration device to remove the electrosurgical leaflet laceration from the treatment site. Doing so allows for pulling out the catheter without the cutting element active to prevent unwanted cuts.
Regarding claim 11, Lederman teaches the method of claim 8, wherein the valve leaflet is a native heart valve leaflet (0006] The disclosed lacerators can be used in various methods disclosed herein to lacerate heart valve leaflets within the heart, including at the aortic valve and at the mitral valve for example) ([abstract] The tissue target can be a native or prosthetic heart valve leaflet in a patient's heart).
Regarding claim 12, Lederman teaches the method of claim 11, wherein the native heart valve leaflet is a native aortic valve leaflet (0006] The disclosed lacerators can be used in various methods disclosed herein to lacerate heart valve leaflets within the heart, including at the aortic valve and at the mitral valve for example).
Regarding claim 13, Lederman teaches the method of claim 8, wherein the valve leaflet is a prosthetic valve leaflet of a previously implanted heart valve prosthesis ([abstract] The tissue target can be a native or prosthetic heart valve leaflet in a patient's heart).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lederman (US 20200383717 A1) in view of Kessler (US 9943330 B2) and Atias (WO 2024006230 A1), further in view of Sauter (US 20240216047 A1) and Selkee (US 8021327 B2).
Regarding claim 14, Lederman teaches the method of claim 8, wherein proximally retracting the electrosurgical wire ([0009] FIG. 2C: Initiation of laceration. The kinked guidewire cutting edge is circled in green. The transcatheter heart valve is pre-positioned at the orifice of the mitral valve. The LAMPOON guidewire is pulled outward to apply tension), but fails to teach comprises actuating an actuator of the electrosurgical leaflet laceration device to apply a proximal force on a proximal portion of the electrosurgical wire coupled to the actuator, wherein a distal portion of the electrosurgical wire is fixedly coupled to a distal portion of the catheter shaft such that the proximal force causes the catheter shaft to bend.
However, Selkee teaches comprises actuating an actuator of the electrosurgical leaflet laceration device to apply a proximal force on a proximal portion of the electrosurgical wire coupled to the actuator ([32] As also shown in FIGS. 2-5, two puller wires 32 extend through the catheter 10. Each puller wire 32 extends from the control handle 16, through the central lumen 18 in the catheter body 12 (FIG. 3) and into one of the off-axis lumens 26 and 28 of the tip section 14 (FIG. 5). As described in more detail below, the proximal end of each puller wire 32 is anchored within the control handle 16 and the distal end of each puller wire 32 is anchored within the tip section), wherein a distal portion of the electrosurgical wire is fixedly coupled to a distal portion of the catheter shaft ([32] the proximal end of each puller wire 32 is anchored within the control handle 16 and the distal end of each puller wire 32 is anchored within the tip section) ([35] As shown in FIGS. 7 to 9, the puller wire 32 is preferably attached by means of an anchor 44 fixedly attached to the distal end of the puller wire 32) such that the proximal force causes the catheter shaft to bend [abstract] In particular, the control handle of the catheter which includes a steering assembly having a lever arm carrying a pair of pulleys for drawing corresponding puller wires to deflect the tip section of the catheter). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include comprises actuating an actuator of the electrosurgical leaflet laceration device to apply a proximal force on a proximal portion of the electrosurgical wire coupled to the actuator, wherein a distal portion of the electrosurgical wire is fixedly coupled to a distal portion of the catheter shaft such that the proximal force causes the catheter shaft to bend. Doing so allows for the bending of the catheter distal end to be controlled by the user at a proximal end.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lederman (US 20200383717 A1) in view of Kessler (US 9943330 B2) and Atias (WO 2024006230 A1), further in view of Sauter (US 20240216047 A1) and Selkee (US 8021327 B2), further in view of Prior (EP 3756598 A1).
Regarding claim 15, Lederman teaches the method of claim 14, electrosurgical leaflet laceration device ([0002] This disclosure is related to tissue laceration using electrical energy, such as for laceration heart valve leaflets) and electrosurgical wire ([0008] electrified guidewire), but fails to teach wherein the actuator comprises a first contact and the electrosurgical leaflet laceration device further comprises a second contact, wherein the first contact and the second contact must be in contact to energize the electrosurgical wire.
However, Selkee teaches wherein the actuator ([32] As also shown in FIGS. 2-5, two puller wires 32 extend through the catheter 10. Each puller wire 32 extends from the control handle 16, through the central lumen 18 in the catheter body 12 (FIG. 3) and into one of the off-axis lumens 26 and 28 of the tip section 14 (FIG. 5). As described in more detail below, the proximal end of each puller wire 32 is anchored within the control handle 16 and the distal end of each puller wire 32 is anchored within the tip section). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include the actuator. Doing so allows for control over the bending of the dial end.
Further, Prior teaches a first contact and a second contact, wherein the first contact and the second contact must be in contact to energize the electrosurgical wire ([Pg 5, Para 1] the mechanical switch of the return plug includes a plunger configured to bring at first contact into electrical communication with a second contact upon connection of the return plug with the return terminal to establish the electrical connection between the active plug and the active electrode). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Lenderman to include a first contact and a second contact, wherein the first contact and the second contact must be in contact to energize the electrosurgical wire. Doing so allows for the connection of the contacts to energize the wire and when not in contact, deenergize the wire to ensure safety of the energizing of the wire.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
Prosecution Insights