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
The Amendments under 37 CFR 1.132 filed 07/15/2025 is sufficient to overcome the rejection of independent claim 1 and 12 based upon the references failing to teach all aspects of the claims.
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/15/2025, with respect to the rejection(s) of claim(s) 1 and 12 under 35 USC 102 (a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made of Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being anticipated by Hooven (US 20050187545 A1) in view of Verin (US 20100004661 A1).
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) 1-20 is/are rejected under 35 U.S.C. 103 as being anticipated by Hooven (US 20050187545 A1) in view of Verin (US 20100004661 A1).
Regarding claim 1, Hooven teaches an apparatus (Figs 29 and 30; [0025] apparatus for ablating tissue) comprising: a procedure-specific tool for application of a procedure relative to biological tissue having a first tissue side ([0137] first body 280) and a second, opposite tissue side at which a magnetic-draw element is to be located (Fig 29; body 284 with magnet 300); a first magnetic element (Fig 29; body 286 with magnet 298) having an axis ([0084] FIG. 3, first and second bodies 12 and 14 have an exterior surface which defines an interior cavity and each body defines a corresponding axis A along its length), wherein each of the first magnetic element and the magnet- draw element includes a respective magnet (Fig 29; magnets 298 and 300); and a catheter coupled to the procedural-specific tool ([0131] The embodiment of FIGS. 29-31 is similar to the embodiment shown in FIGS. 15-16 in that it includes right and left distally curved first bodies, generally indicated at 280 and 282, only one body 280 being shown in FIGS. 29-30 and both bodies 280 and 282 being shown in FIG. 31, and further includes a flexible second body, generally indicated at 284, shown in FIGS. 29-30) ([0082] FIGS. 1-2 generally illustrate an ablation apparatus, generally indicated at 10, having first and second elongated bodies, generally indicated at 12 and 14, respectively) and having an expandable portion to transition from a first state having a first girth to or towards a second state having a second girth that is greater than the first girth ([0132] The distal end 290 of the flexible second body 284 is located on the opposite side of the myocardium MM and preferably engages the endocardial surface EN of the heart. The first body 280 further includes one or more expandible members 292, 294. The expandible member may include an inflation lumen, which fluidly communicates between a balloon and an inflation source, an expandible cage-like member or members, a spring-actuated expandible member or members or the like which is adapted for expanding and retracting as desired) ([0141] FIG. 30, the first expandible member 292 is deflated. Deflation moves the sources of magnetic force 298 in closer contact with the epicardial surface EP, and re-establishes the magnetic attraction, with the magnetically attractive elements 300 of the second body 284) ([0142] During deflation of the first expandible member 292, the second expandible member 294 may be inflated, as shown in FIG. 30. Inflation of the second expandible member 294 during deflation of the first expandible member 292 assists in maintaining a constant pressure on the epicardial surface EP and pericardium P by so as to keep the first body 280 anchored in the desired position), wherein the expandable portion is to surround the first magnetic element and facilitate movement of the procedure-specific tool, relative to the magnetic draw element ([0132]-[0143]) ([0140] FIG. 29, the increased distance between the sources of magnetic force 298 and the magnetically attractive elements 300 is sufficient to prevent movement due to magnetic attraction between the first and second bodies. The inflation thickness of the expandible member is preferably approximately 1 cm although other thicknesses are also possible and will depend on the strength of the magnetic attraction between the first and second bodies) and by magnetic attraction attributable to a magnetic force involving the magnetic-draw element ([0132]-[0143]) ([0141] FIG. 30, the first expandible member 292 is deflated. Deflation moves the sources of magnetic force 298 in closer contact with the epicardial surface EP, and re-establishes the magnetic attraction, with the magnetically attractive elements 300 of the second body 284. The magnetic attraction between the first and second bodies 280 and 284 should align the respective distal ends 286 and 290), toward an area along the first tissue side at which the magnetic- draw element is to be located for administering the procedure via the procedure-specific tool ([0132]-[0143]) ([0141] FIG. 30, the first expandible member 292 is deflated. Deflation moves the sources of magnetic force 298 in closer contact with the epicardial surface EP, and re-establishes the magnetic attraction, with the magnetically attractive elements 300 of the second body 284. The magnetic attraction between the first and second bodies 280 and 284 should align the respective distal ends 286 and 290) ([0137] Each of the first and second bodies further include respective ablation members 302 and 304 which are located on the respective distal ends or tips 286, 290).
Hooven fails to fully teach an axis about which at least one of the first magnetic element and the magnetic-draw element is to rotate, while under influence of a magnetic force involving the magnetic-draw element, along the first tissue side.
However, Verin teaches an axis about which at least one of the first magnetic element and the magnetic-draw element is to rotate ([0060] In order to control the magnitude of the magnetic force between the magnet 28 and the magnet arrangement 30,31,32,33,34,3, the magnets 30,31,32,33,34,3 will be synchronously rotated), while under influence of a magnetic force involving the magnetic-draw element, along the first tissue side ([0060] If the left column of magnets (30,31,32) is rotated in the counter-clockwise direction then the right column of magnets (33,34,3) has to be rotated in the clockwise direction or vice versa by the same angle. By this rotation of the magnets, the force of attraction between the magnet 28 and the arrangement of magnets in the head of the guiding member can be decreased down to zero or even transformed to a repulsive force if needed). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hoover to include an axis about which at least one of the first magnetic element and the magnetic-draw element is to rotate, while under influence of a magnetic force involving the magnetic-draw element, along the first tissue side. Doing so would allow control over the magnitude of the magnetic force between the magnet ([0060]).
Regarding claim 2, Hooven teaches the apparatus of claim 1, further including a first catheter assembly (Figs 29 and 30; [0082] elongated body 280) and a second catheter assembly (Figs 29 and 30; [0082] elongated body 284), wherein the first catheter assembly includes the procedure-specific tool (Figs 29 and 30; [0137] ablation electrode 302), the first magnetic element (Figs 29 and 30; [0137] magnetic force 298) and the expandable catheter (Figs 29 and 30; expandible member 292 and 294), and the second catheter assembly includes the magnetic-draw element (Figs 29 and 30; [0137] magnetically attractive elements 300).
Regarding claim 3, Hooven teaches the apparatus of claim 1, further including a first catheter assembly and a second catheter assembly, and wherein: the biological tissue includes myocardial tissue between endocardial tissue and epicardial tissue ([0132] FIGS. 29-30, the distal end 286 of the right curved first body 280 is located on one side of the myocardium MM and preferably engages the epicardial surface EP of the heart. The distal end 290 of the flexible second body 284 is located on the opposite side of the myocardium MM and preferably engages the endocardial surface EN of the heart); the first tissue side is part of either the endocardial tissue or the epicardial tissue ([0138] FIGS. 29-35 show the method for ablating a layer of tissue using the apparatus shown in FIGS. 29-31. The first body 280 is introduced and advanced to an epicardial surface EP of the heart adjacent one side of the tissue which is selected for ablation. As shown in FIG. 29, the first expandible member 292 is an elongated balloon disposed at the lower surface of the first body 280 adjacent the epicardial surface EP); the first catheter assembly includes the procedure-specific tool ([0137] Each of the first and second bodies further include respective ablation members 302 and 304 which are located on the respective distal ends or tips 286, 290 and may be made of flexible strips of conductive material or exposed sections of coil); the first magnetic element (FIGS. 29-30; 300) and the expandable catheter (FIGS. 29-30; 292, 294), the second catheter assembly includes the magnetic-draw element (FIGS. 29-30; 300) ([0137]), one of the procedure-specific tool (FIGS. 29-30; 304) ([0137]) and the magnetic-draw element is to be located nearest the first tissue side (FIGS. 29-30; magnet 298 on epicardial side) ([0137]), and the other of the procedure-specific tool and the magnetic-draw element is to be located nearest the second, opposite tissue side (FIGS. 29-30; electrode 304 and magnet 300 on endocardial side) ([0137]); and during a state in which the magnetic-draw element is physically aligned, by magnetically attraction, with the first magnetic element (FIGS. 29-30; 298, 300) ([0138]-[0143]), the procedure-specific tool is to deliver sufficient energy for transmural application relative to the myocardial tissue between endocardial tissue and epicardial tissue (FIGS. 29-30; 302, 304) ([0137]-[0143], [0163]).
Regarding claim 4, Hooven teaches the apparatus of claim 3, wherein movement of the first catheter assembly is to be moved toward a target area of the epicardial tissue-along an inner region or surface of the heart (FIGS. 29-30; catheter 280) ([0138]-[0143]), and wherein the expandable portion refers to and/or is secured to an electrode as the procedural-specific tool for an ablation procedure (FIGS. 29-30; balloons 292 and 294 connected to the catheter 280 and thus connected to the electrode 302) ([0132]-[0143]).
Regarding claim 5, Hooven teaches the apparatus of claim 1, further including a transmural tissue ablation assembly having the procedure-specific tool (FIGS. 29-30; 302) ([0137]), the first magnetic element (FIGS. 29-30; 298) ([0137]), and the expandable catheter (FIGS. 29-30; balloons 292, 294) ([0132]-[0143]), wherein at least a section of the expandable portion is configured as the procedure-specific tool (FIGS. 29-30; balloon 292 and electrode 302) ([0132]-[0143]), and wherein in response to the expandable portion moving toward or being in the second state, the expandable portion is to surround the first magnetic element and permit the application of the procedural-specific tool as an electrode in a transmural-tissue-ablation procedure (FIGS. 29-30; balloons 292, 294) ([0132]-[0143]).
Regarding claim 6, Hooven teaches the apparatus of claim 1, wherein the expandable portion is configured to rotate about an axis of the first magnetic element (FIGS. 29-30; balloons 292, 294) ([0132]-[0143]) (balloons attached to catheter 280 are capable of rotating around longitudinal axis passing through magnet 298 and catheter body 280). Hooven fails to fully teach wherein the expandable portion is configured to rotate about an axis of the first magnetic element. However, Verin teaches wherein the head portion is configured to rotate about an axis ([0057] The back and forth and/or rotational movement can be achieved manually by the surgeon when performing the intervention but preferably, the guiding member is arranged with mechanical means (pneumatic or electric motor) to achieve the back and forth or rotational movement of the head 2 of the guiding member). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hoover to include wherein the head portion is configured to rotate about an axis. Doing so allows the expandable portion on the head to gain more movement and increase the overall coverage.
Regarding claim 7, Hooven teaches the apparatus of claim 1, further including a first catheter assembly having the procedure-specific tool (FIGS. 29-30; 302) ([0137]), the first magnetic element (FIGS. 29-30; 298) ([0137]) and the expandable catheter (FIGS. 29-30; balloons 292, 294) ([0132]-[0143]), and wherein the procedure-specific tool is to perform transmural tissue ablation of the biological tissue after and/or in response to the magnetic attraction causing alignment of the first magnetic and the magnetic-draw element and causing the biological tissue to be sandwiched between the first magnetic and the magnetic-draw element (FIGS. 29-30; 302, 304) ([0137]-[0143]) ([0163] an apparatus and method for performing transmural ablation has been provided that meets all the objects of the present invention).
Regarding claim 8, Hooven teaches the apparatus of claim 1, further including a controller to adjust the magnetic force and/or cause movement of one of the first magnetic elements and the magnetic-draw element (FIGS. 29-30; balloons 292, 294) ([0131]-[0143]) ([0132] The expandible member may include an inflation lumen, which fluidly communicates between a balloon and an inflation source, an expandible cage-like member or members, a spring-actuated expandible member or members or the like which is adapted for expanding and retracting as desired) ([0139] Inflation of the first expandible member 292 minimizes or eliminates the influence of the magnetic attraction during positioning of the second body by increasing the distance through which the magnetic force acts) ([0140] FIG. 29, the increased distance between the sources of magnetic force 298 and the magnetically attractive elements 300 is sufficient to prevent movement due to magnetic attraction between the first and second bodies. The inflation thickness of the expandible member is preferably approximately 1 cm although other thicknesses are also possible and will depend on the strength of the magnetic attraction between the first and second bodies), and wherein the expandable portion further defines an area for manipulative movement of the procedural-specific tool ([0133] Each expandible member 292 and 294 preferably extends along the longitudinal axis of the first body 280 and, more preferably, extends along the distal end 286 from a tip 296 of the first body to a more proximal location. For example, each expandible member 292 and 294 preferably extends along the curved distal end to a proximal location or heel 297. The heel 297 preferably, but not exclusively corresponds to the most proximally located source of magnetic force 298) ([0137] Each of the first and second bodies further include respective ablation members 302 and 304 which are located on the respective distal ends or tips 286, 290).
Regarding claim 9, Hooven teaches the apparatus of claim 1, further including a first catheter assembly (FIGS. 29-30; 280) ([0131]-[0137]) having the procedure-specific tool (FIGS. 29-30; 302) ([0137]), the first magnetic element (FIGS. 29-30; 298) ([0137]) and the expandable catheter (FIGS. 29-30; inflatable balloons 292, 294) ([0132]-[0143]), and wherein in response to or after the transition (FIGS. 29-30; inflatable balloons 292, 294) ([0132]-[0143]), but fails to fully teach the first catheter assembly is configured to move smoothly along endocardial tissue surface. However, Verin teaches the first catheter assembly is configured to move smoothly along endocardial tissue surface ([0049] it is possible to ablate tissues in a continuous movement of the catheters and therefore to produce continuous lines of ablation instead of discrete point-by-point movements) ([0055] FIG. 14 shows another alternate embodiment of the ablating tip 14 in which the shape of the ablating tip 14 is an ovoid. This shape allows smoother displacement of the ablating tip 14 on the surface of the heart chamber by minimizing the contact zone between the ablating tip 14 and the surface 22 of the heart chamber. As the surface of the heart chambers are not perfectly flat but may present irregularities and/or obstacles, the ovoid shape is preferred as it allows easier displacement of the ablating tip. Clinical tests have shown that even when an ovoidally shaped ablating tip 14 was used the ablating tip was sometimes magnetically disengaged with the guiding member 2, because it encounters an obstacle. In order to improve the magnetic connection and therefore the guiding of the ablating tip 14, it was experimented to induce a movement to the guiding member to improve the guiding process of the ablating tip. This movement can be longitudinal as depicted by the arrow at FIG. 14 in which a back-and-forth movement is applied to the guiding member or rotational as illustrated schematically at FIG. 1). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hoover to include the first catheter assembly is configured to move smoothly along endocardial tissue surface. Doing so allows for improved navigation of obstacles.
Regarding claim 10, Hooven teaches the apparatus of claim 1, further including a first catheter assembly (FIGS. 29-30; 280) ([0131]-[0137]) having the procedure-specific tool (FIGS. 29-30; 302) ([0137]), the first magnetic element (FIGS. 29-30; 298) ([0137]) and the expandable catheter (FIGS. 29-30; inflatable balloons 292, 294) ([0132]-[0143]), and a second catheter assembly, having the magnetic-draw element (FIGS. 29-30; 284, 300) ([0131]-[0137]), but fails to fully teach wherein the expandable portion of the catheter is to rotate about an axis of the first magnetic element in response to movement of at least one of the assemblies relative to a patient and/or another of the assemblies. However, Verin teaches wherein the expandable portion of the catheter is to rotate about an axis of the first magnetic element (Fig 16; [0055] This movement can be longitudinal as depicted by the arrow at FIG. 14 in which a back and forth movement is applied to the guiding member or rotational as illustrated schematically at FIG. 1) in response to movement of at least one of the assemblies relative to a patient and/or another of the assemblies (Fig 16; [0057] one sees that thanks to the movement (either rotational or back and forth) applied on the guiding member, the ablating tip slowly rotates and is axially shifted at the same time thus rendering the progression easier of the ablating tip on the wall of the atrium especially in presence of obstacles. The back and forth and/or rotational movement can be achieved manually by the surgeon when performing the intervention but preferably, the guiding member is arranged with mechanical means (pneumatic or electric motor) to achieve the back and forth or rotational movement of the head 2 of the guiding member). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hoover to include wherein the expandable portion of the catheter is to rotate about an axis of the first magnetic element in response to movement of at least one of the assemblies relative to a patient and/or another of the assemblies. Doing so allows for improved navigation around obstacles during ablation procedures.
Regarding claim 11, Hooven teaches the apparatus of claim 1, wherein the expandable portion of the catheter includes a basket and/or a balloon that is to expand (FIGS. 29-30; balloons 292, 294) ([0132]-[0143]).
Regarding claim 12, Hooven teaches a method of administering a procedure relative to biological tissue, the method comprising: introducing a first assembly (Figs 29 and 30; [0082] elongated body 280), having an procedure-specific tool (Figs 29 and 30; [0137] ablation electrode 302), a first magnetic element (Figs 29 and 30; [0137] magnetic force 298) and a catheter ([0131] The embodiment of FIGS. 29-31 is similar to the embodiment shown in FIGS. 15-16 in that it includes right and left distally curved first bodies, generally indicated at 280 and 282, only one body 280 being shown in FIGS. 29-30), to or towards biological tissue having a first tissue side ([0137] first body 280) and a second, opposite tissue side ([0137] second body 284) at which a magnetic-draw element is to be located (FIGS. 29-30; magnet 298 on epicardial side) ([0137]), wherein the catheter is coupled to the procedural-specific tool and has an expandable portion to transition from a first state having a first girth to or towards an expanded girth that is greater than the first girth ([0132] The distal end 290 of the flexible second body 284 is located on the opposite side of the myocardium MM and preferably engages the endocardial surface EN of the heart. The first body 280 further includes one or more expandible members 292, 294. The expandible member may include an inflation lumen, which fluidly communicates between a balloon and an inflation source, an expandible cage-like member or members, a spring-actuated expandible member or members or the like which is adapted for expanding and retracting as desired) ([0141] FIG. 30, the first expandible member 292 is deflated. Deflation moves the sources of magnetic force 298 in closer contact with the epicardial surface EP, and re-establishes the magnetic attraction, with the magnetically attractive elements 300 of the second body 284) ([0142] During deflation of the first expandible member 292, the second expandible member 294 may be inflated, as shown in FIG. 30. Inflation of the second expandible member 294 during deflation of the first expandible member 292 assists in maintaining a constant pressure on the epicardial surface EP and pericardium P by so as to keep the first body 280 anchored in the desired position); wherein each of the first magnetic element and the magnet-draw element includes a respective magnet; toward an area along the first tissue side at which the magnetic-draw element is to be located ([0132]-[0143]) ([0141] FIG. 30, the first expandible member 292 is deflated. Deflation moves the sources of magnetic force 298 in closer contact with the epicardial surface EP, and re-establishes the magnetic attraction, with the magnetically attractive elements 300 of the second body 284. The magnetic attraction between the first and second bodies 280 and 284 should align the respective distal ends 286 and 290) ([0137] Each of the first and second bodies further include respective ablation members 302 and 304 which are located on the respective distal ends or tips 286, 290) ([0132]-[0143]) ([0140] FIG. 29, the increased distance between the sources of magnetic force 298 and the magnetically attractive elements 300 is sufficient to prevent movement due to magnetic attraction between the first and second bodies. The inflation thickness of the expandible member is preferably approximately 1 cm although other thicknesses are also possible and will depend on the strength of the magnetic attraction between the first and second bodies); and performing the procedure relative to the biological tissue while the magnetic force is drawing the first magnetic element and the magnetic-draw element toward one another ([0141] FIG. 30, the first expandible member 292 is deflated. Deflation moves the sources of magnetic force 298 in closer contact with the epicardial surface EP, and re-establishes the magnetic attraction, with the magnetically attractive elements 300 of the second body 284. The magnetic attraction between the first and second bodies 280 and 284 should align the respective distal ends 286 and 290).
Hooven fails to fully teach causing the procedure-specific tool and a magnetic force involving the first magnetic element and the magnetic-draw element, at least one of and the first magnetic element and the magnet-draw element to rotate, about an axis of the first magnetic element. However, Verin teaches causing the procedure-specific tool and a magnetic force involving the first magnetic element and the magnetic-draw element ([0060] If the left column of magnets (30,31,32) is rotated in the counter-clockwise direction then the right column of magnets (33,34,3) has to be rotated in the clockwise direction or vice versa by the same angle. By this rotation of the magnets, the force of attraction between the magnet 28 and the arrangement of magnets in the head of the guiding member can be decreased down to zero or even transformed to a repulsive force if needed), at least one of and the first magnetic element and the magnet-draw element to rotate, about an axis of the first magnetic element ([0060] In order to control the magnitude of the magnetic force between the magnet 28 and the magnet arrangement 30,31,32,33,34,3, the magnets 30,31,32,33,34,3 will be synchronously rotated). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hoover to include at least one of and the first magnetic element and the magnet-draw element to rotate, about an axis of the first magnetic element. Doing so would allow control over the magnitude of the magnetic force between the magnet ([0060]).
Regarding claim 13, Hooven teaches the method of claim 12, wherein during at least a second state the expandable portion facilitates positioning of the procedure-specific tool and surrounds first magnetic element (FIGS. 29-30; balloons 292, 294) ([0132]-[0143]).
Regarding claim 14, Hooven teaches the method of claim 12, wherein during at least a portion of a second state the first magnetic element and the magnetic-draw element are physically aligned with one another (Figs 29 and 30; 298, 300) ([0137]-[0143]) ([0141] The magnetic attraction between the first and second bodies 280 and 284 should align the respective distal ends 286 and 290), but fails to fully teach by way of smooth and passive movement along an inner surface of the tissue to a location for the procedure. However, Verin teaches by way of smooth and passive movement along an inner surface of the tissue to a location for the procedure ([0049] it is possible to ablate tissues in a continuous movement of the catheters and therefore to produce continuous lines of ablation instead of discrete point-by-point movements) ([0055] FIG. 14 shows another alternate embodiment of the ablating tip 14 in which the shape of the ablating tip 14 is an ovoid. This shape allows smoother displacement of the ablating tip 14 on the surface of the heart chamber by minimizing the contact zone between the ablating tip 14 and the surface 22 of the heart chamber. As the surface of the heart chambers are not perfectly flat but may present irregularities and/or obstacles, the ovoid shape is preferred as it allows easier displacement of the ablating tip. Clinical tests have shown that even when an ovoidally shaped ablating tip 14 was used the ablating tip was sometimes magnetically disengaged with the guiding member 2, because it encounters an obstacle. In order to improve the magnetic connection and therefore the guiding of the ablating tip 14, it was experimented to induce a movement to the guiding member to improve the guiding process of the ablating tip. This movement can be longitudinal as depicted by the arrow at FIG. 14 in which a back-and-forth movement is applied to the guiding member or rotational as illustrated schematically at FIG. 1). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hoover to include by way of smooth and passive movement along an inner surface of the tissue to a location for the procedure. Doing so prevents any injuries during the movement.
Regarding claim 15, Hooven teaches the method of claim 12, wherein the magnetic-draw element is part of an endocardial assembly and the first assembly with the first magnetic element magnetically attracting the magnetic-draw element of the endocardial assembly and wherein the first magnetic element and the magnetic-draw element move relative to one another for physical alignment with one another on opposite sides of myocardial tissue of a subject ([0139] After inflation, the second body 284 is preferably advanced to the endocardial surface EN on the other side of the tissue layer selected for ablation. The second body 294 is maneuvered into the desired position so as to generally align its distal end 290 with the distal end 286 of the first body 280 on the opposite side of the tissue).
Regarding claim 16, Hooven teaches the method of claim 15, further comprising: inserting the epicardial assembly to a first location relative to the heart tissue assembly (FIGS. 29-30; 280) ([0138]-[0143]), inserting the first assembly to a second location proximal to the first location and the epicardial assembly and on an opposite sides of the heart tissue compared to the first location (FIGS. 29-30; 284) ([0138]-[0137]); causing the expandable portion to transition towards the expanded girth (FIGS. 29-30; 292, 294) ([0138]-[0143]); wherein the expandable portion is configured to rotate about an axis relative to the first magnetic element of the first assembly (FIGS. 29-30; 280) ([0132]-[0143]); ablating the heart tissue while the heart tissue is sandwiched between the first magnetic element and the magnetic-draw element (FIGS. 29-30; 280) ([0138]-[0143]) ([0163]). Hoover fails to fully teach moving the epicardial assembly smoothly and passively along an inner surface of heart tissue to a location for ablation of the heart tissue. However, Verin teaches moving the epicardial assembly smoothly and passively along an inner surface of heart tissue to a location for ablation of the heart tissue ([0049] it is possible to ablate tissues in a continuous movement of the catheters and therefore to produce continuous lines of ablation instead of discrete point-by-point movements) ([0055] FIG. 14 shows another alternate embodiment of the ablating tip 14 in which the shape of the ablating tip 14 is an ovoid. This shape allows smoother displacement of the ablating tip 14 on the surface of the heart chamber by minimizing the contact zone between the ablating tip 14 and the surface 22 of the heart chamber. As the surface of the heart chambers are not perfectly flat but may present irregularities and/or obstacles, the ovoid shape is preferred as it allows easier displacement of the ablating tip. Clinical tests have shown that even when an ovoidally shaped ablating tip 14 was used the ablating tip was sometimes magnetically disengaged with the guiding member 2, because it encounters an obstacle. In order to improve the magnetic connection and therefore the guiding of the ablating tip 14, it was experimented to induce a movement to the guiding member to improve the guiding process of the ablating tip. This movement can be longitudinal as depicted by the arrow at FIG. 14 in which a back-and-forth movement is applied to the guiding member or rotational as illustrated schematically at FIG. 1). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hoover to include moving the epicardial assembly smoothly and passively along an inner surface of heart tissue to a location for ablation of the heart tissue. Doing so prevents any injuries during the movement.
Regarding claim 17, Hooven teaches the method of claim 12, further including adjusting the magnetic force to manipulate the procedural-specific tool ([0140] FIG. 29, the increased distance between the sources of magnetic force 298 and the magnetically attractive elements 300 is sufficient to prevent movement due to magnetic attraction between the first and second bodies. The inflation thickness of the expandible member is preferably approximately 1 cm although other thicknesses are also possible and will depend on the strength of the magnetic attraction between the first and second bodies), and wherein the expandable portion further defines an area for manipulative movement of the procedural-specific tool ([0133] Each expandible member 292 and 294 preferably extends along the longitudinal axis of the first body 280 and, more preferably, extends along the distal end 286 from a tip 296 of the first body to a more proximal location. For example, each expandible member 292 and 294 preferably extends along the curved distal end to a proximal location or heel 297. The heel 297 preferably, but not exclusively corresponds to the most proximally located source of magnetic force 298) ([0137] Each of the first and second bodies further include respective ablation members 302 and 304 which are located on the respective distal ends or tips 286, 290).
Regarding claim 18, Hooven teaches the method of claim 12, but ails to fully teach wherein the procedural-specific tool includes a sensor and further including using the sensor to assess the tissue. However, Verin teaches wherein the procedural-specific tool includes a sensor and further including using the sensor to assess the tissue (Fig 9; [0048] Thanks to the temperature sensor 20, the clinician may monitor the temperature at the point of contact of the inner oesophageal wall 21 and adjust the energy delivered to the ablation electrode in the ablation member tip 14 so as to prevent burning of the oesophagus wall). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Hoover to include wherein the procedural-specific tool includes a sensor and further including using the sensor to assess the tissue. Doing so monitors the tissue during ablation to prevent any damage to neighboring tissue.
Regarding claim 19, Hooven teaches the method of claim 12, wherein the expandable portion is to surround the first magnetic element and the procedure-specific tool and/or is to expand to surround the first magnetic element and to be used as part of the procedure-specific tool ([0132]-[0143]) ([0140] FIG. 29, the increased distance between the sources of magnetic force 298 and the magnetically attractive elements 300 is sufficient to prevent movement due to magnetic attraction between the first and second bodies. The inflation thickness of the expandible member is preferably approximately 1 cm although other thicknesses are also possible and will depend on the strength of the magnetic attraction between the first and second bodies), and to cause the procedure- specific tool to move, relative to the magnetic draw element and by magnetic attraction attributable to a magnetic force involving the magnetic-draw element, toward an area along the first tissue side at which the magnetic-draw element is to be located ([0132]-[0143]) ([0141] FIG. 30, the first expandible member 292 is deflated. Deflation moves the sources of magnetic force 298 in closer contact with the epicardial surface EP, and re-establishes the magnetic attraction, with the magnetically attractive elements 300 of the second body 284. The magnetic attraction between the first and second bodies 280 and 284 should align the respective distal ends 286 and 290) ([0137] Each of the first and second bodies further include respective ablation members 302 and 304 which are located on the respective distal ends or tips 286, 290).
Regarding claim 20, Hooven teaches the method of claim 12, wherein the procedure specific to the tissue includes assessing or differentiating structure nearby or associated with the tissue ([0081] The present invention provides a method and apparatus for ablating tissue, and in particular tissue associated with the heart), and wherein the procedure-specific tool is used to ablate and create a transmural lesion of the tissue ([0163] an apparatus and method for performing transmural ablation has been provided that meets all the objects of the present invention).
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 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