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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8, 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chiang (WO 2022192522 A1).
Regarding claim 1, Chiang teaches a catheter to detect a plurality of physiological signal from within a patient’s heart ([0251] The sensing electrode 1540 and the additional electrodes 1542, 1544 are typically used for sensing ECG signals and also for providing information to an electroanatomic mapping system. For example, when sensing ECG signals, a user can verify or confirm location of the treatment catheter 1502 in the heart based on the sensed ECG signals), the catheter comprising: an elongated shaft having a proximal region (Fig 29-30; shaft 1120 proximal end), and a distal region (Fig 29-30; shaft 1120 distal end), the elongated shaft defining a longitudinal axis (Fig 29-30; shaft 1120 longitudinal axis); a location sensor coupled to the distal region and configured to generate a plurality of location signals (Fig 30; [0227] the inner loops 1134, 1136 include a plurality of microsensors 1160) representative of a location of the catheter within the patient’s heart ([0251] The sensing electrode 1540 and the additional electrodes 1542, 1544 are typically used for sensing ECG signals and also for providing information to an electroanatomic mapping system. For example, when sensing ECG signals, a user can verify or confirm location of the treatment catheter 1502 in the heart based on the sensed ECG signals); and a plurality of sensing electrode arrays coupled to the distal region (Fig 30; [0227] the inner loops 1134, 1136 include a plurality of microsensors 1160 spaced along the rims of the overall circular shape. In some embodiments, the microsensors 1160 are configured for contact feedback, visualization under fluoroscopy or sensing for electroanatomic mapping systems. In other embodiments, the microsensors 1160 function as electrodes so as to deliver energy in the formation of a lesion), the plurality of sensing electrode arrays having a collapsed configuration and an expanded configuration (Fig 24; [0220] the supports 844 extend along at least a portion of the shaft 820, such as within longitudinal grooves 852 along the shaft 820. Likewise, in this embodiment a sheath 850 is advanceable over the shaft 820 and the grooves 852, holding the supports 844 within the grooves 852. Upon retraction of the sheath 850, the supports 844 are able to recoil toward their pre-curved configuration, moving the trowel shaped electrodes 830, 832, 834, 836 radially outwardly as shown), the plurality of sensing electrode arrays including a first sensing electrode array and a second sensing electrode array ([0226] FIG. 27 illustrates an embodiment of the treatment catheter 1112 wherein the delivery electrode 1122 comprises two semi-circular loop electrodes 1130, 1132); the first sensing electrode array, comprising: a first spline having a first end, an opposite, second end (Fig 27; loops 1130, 1132), and a first intermediate portion between the first end and the second end (Fig 27; loop 1130, 1132) ([0227] the inner loops 1134, 1136), the first spline formed as first non-planar loop in the expanded configuration wherein the first and second ends are coupled to the distal region of the shaft ([0226] The electrodes 1130, 1132 are connected to the shaft 1120 by supports 1144 which are typically insulated so as to direct the energy to the semi-circular electrodes 1130, 1132) and first intermediate portion extends from the distal region (Fig 27-30; semi-circular inner loops 1134, 1136); and a first plurality of electrodes disposed on the first intermediate portion ([0227] the inner loops 1134, 1136 include a plurality of microsensors 1160 spaced along the rims of the overall circular shape. In some embodiments, the microsensors 1160 are configured for contact feedback, visualization under fluoroscopy or sensing for electroanatomic mapping systems. In other embodiments, the microsensors 1160 function as electrodes); the second sensing electrode array ([0226] FIG. 27 illustrates an embodiment of the treatment catheter 1112 wherein the delivery electrode 1122 comprises two semi-circular loop electrodes 1130, 1132), comprising: a second spline having a third end ([0227] the inner loops 1134, 1136), an opposite, fourth end ([0227] the inner loops 1134, 1136), and a second intermediate portion between the third end and the fourth end ([0227] the inner loops 1134, 1136), the second spline formed as second non-planar loop in the expanded configuration wherein the third and fourth ends are coupled to the distal region of the shaft ([0226] The electrodes 1130, 1132 are connected to the shaft 1120 by supports 1144 which are typically insulated so as to direct the energy to the semi-circular electrodes 1130, 1132) and second intermediate portion extends from the distal region (Fig 27-30; semi-circular inner loops 1134, 1136); and a second plurality of electrodes disposed on the second intermediate portion ([0227] the inner loops 1134, 1136 include a plurality of microsensors 1160 spaced along the rims of the overall circular shape. In some embodiments, the microsensors 1160 are configured for contact feedback, visualization under fluoroscopy or sensing for electroanatomic mapping systems. In other embodiments, the microsensors 1160 function as electrodes); wherein the first intermediate portion does not contact the second intermediate portion in the expanded configuration (Fig 30).
Regarding claim 2, Chiang teaches the catheter of claim 1, wherein the plurality of sensing electrode arrays includes two sensing electrode arrays (Fig 27-30; semi-circular inner loops 1134, 1136).
Regarding claim 3, Chiang teaches the catheter of claim 1, wherein the plurality of sensing electrode arrays are deformable from the expanded configuration ([0226] the loop electrodes 1130, 1132 are comprised of a flexible material that allows the loop electrodes 1130, 1132 to bend proximally, so as to form a less concave shape (e.g. a more shallow cupped shape, a more flattened shape or a more convex shape) and conform to the target tissue area).
Regarding claim 4, Chiang teaches the catheter of claim 3, wherein the first non-planar loop includes first bends in the first spline and the second non-planar loop includes second bends in the second spline (Fig 27-30; loops 1130, 1132), the first and second bends configured to flex when deformed from the expanded configuration ([0226] the loop electrodes 1130, 1132 are comprised of a flexible material that allows the loop electrodes 1130, 1132 to bend proximally, so as to form a less concave shape (e.g. a more shallow cupped shape, a more flattened shape or a more convex shape) and conform to the target tissue area).
Regarding claim 5, Chiang teaches the catheter of claim 4, wherein the first bends include a first distal bends and first proximal bends, and the second bends include second distal bends and second proximal bends (Fig 27-30; [0226] the loop electrodes 1130, 1132 are comprised of a flexible material that allows the loop electrodes 1130, 1132 to bend proximally, so as to form a less concave shape (e.g. a more shallow cupped shape, a more flattened shape or a more convex shape) and conform to the target tissue area).
Regarding claim 6, Chiang teaches the catheter of claim 1, wherein the first non-planar loop includes a first distal planar loop section in a first plane and the second non-planar loop includes a second distal planar loop section in a second plane in the expanded configuration (Fig 27-30; loops 1130 and 1132).
Regarding claim 7, Chiang teaches the catheter of claim 6, wherein the first plane lies in the second plane in the expanded configuration, the first and second planes perpendicular to the longitudinal axis (Fig 27-30; loops 1130 and 1132) ([0226] FIG. 27 illustrates an embodiment of the treatment catheter 1112 wherein the delivery electrode 1122 comprises two semi-circular loop electrodes 1130, 1132 which together form a circular or oval shape which is perpendicular to the shaft 1120).
Regarding claim 8, Chiang teaches the catheter of claim 6, wherein the first planar loop section and second planar loop section are deflectable from an expanded configuration such that the first plane lies in the second plane, the first and second planes perpendicular to the longitudinal axis (Fig 27-30; loops 1130 and 1132) ([0226] FIG. 27 illustrates an embodiment of the treatment catheter 1112 wherein the delivery electrode 1122 comprises two semi-circular loop electrodes 1130, 1132 which together form a circular or oval shape which is perpendicular to the shaft 1120).
Regarding claim 12, Chiang teaches the catheter of claim 1, wherein the location sensor is disposed in the shaft ([[0264] It may be appreciated that any of the catheter designs described herein may include one or more sensors (e.g. microsensors), such as impedance sensors, contact sensors, contact force sensors, electroanatomic mapping sensors, etc. Such sensors may be positioned on electrodes, adjacent to electrodes, or in any suitable location along the distal portion of the catheter. For example, microsensors may be located along one or more loops of a delivery electrode or along a support structure near the delivery electrode. Alternatively or in addition, sensors may be positioned on one or more separate instruments).
Regarding claim 13, Chiang teaches the catheter of claim 1, wherein the plurality of sensing arrays are configured to tilt off axis from the shaft (Fig 27-30, sensors 1160).
Regarding claim 14, Chiang teaches an electrophysiological system, comprising: a catheter to detect a plurality of physiological signal from within a patient’s heart ([0251] The sensing electrode 1540 and the additional electrodes 1542, 1544 are typically used for sensing ECG signals and also for providing information to an electroanatomic mapping system. For example, when sensing ECG signals, a user can verify or confirm location of the treatment catheter 1502 in the heart based on the sensed ECG signals) ([0143] Cardiac mapping during an aberrant heart rhythm aims at elucidation of the mechanisms of the heart rhythm, description of the propagation of activation from its initiation to its completion within a region of interest, and identification of the site of origin or a critical site of conduction to serve as a target for treatment. Once the desired treatment locations are identified, the treatment catheter 102 is utilized to deliver the treatment energy), the catheter comprising: an elongated shaft having a proximal (Fig 29-30; shaft 1120 proximal end), and a distal region (Fig 29-30; shaft 1120 distal end), the elongated shaft defining a longitudinal axis (Fig 29-30; shaft 1120 longitudinal axis); a location sensor coupled to the distal region and configured to generate a plurality of location signals (Fig 30; [0227] the inner loops 1134, 1136 include a plurality of microsensors 1160) representative of a location of the catheter within the patient’s heart ([0251] The sensing electrode 1540 and the additional electrodes 1542, 1544 are typically used for sensing ECG signals and also for providing information to an electroanatomic mapping system. For example, when sensing ECG signals, a user can verify or confirm location of the treatment catheter 1502 in the heart based on the sensed ECG signals); and a plurality of sensing electrode arrays coupled to the distal region (Fig 30; [0227] the inner loops 1134, 1136 include a plurality of microsensors 1160 spaced along the rims of the overall circular shape. In some embodiments, the microsensors 1160 are configured for contact feedback, visualization under fluoroscopy or sensing for electroanatomic mapping systems. In other embodiments, the microsensors 1160 function as electrodes so as to deliver energy in the formation of a lesion), the plurality of sensing electrode arrays having a collapsed configuration and an expanded configuration (Fig 24; [0220] the supports 844 extend along at least a portion of the shaft 820, such as within longitudinal grooves 852 along the shaft 820. Likewise, in this embodiment a sheath 850 is advanceable over the shaft 820 and the grooves 852, holding the supports 844 within the grooves 852. Upon retraction of the sheath 850, the supports 844 are able to recoil toward their pre-curved configuration, moving the trowel shaped electrodes 830, 832, 834, 836 radially outwardly as shown), the plurality of sensing electrode arrays including a first sensing electrode array and a second sensing electrode array ([0226] FIG. 27 illustrates an embodiment of the treatment catheter 1112 wherein the delivery electrode 1122 comprises two semi-circular loop electrodes 1130, 1132); the first sensing electrode array, comprising: a first spline having a first end, an opposite, second end (Fig 27; loops 1130, 1132), and a first intermediate portion between the first end and the second end (Fig 27; loop 1130, 1132) ([0227] the inner loops 1134, 1136), the first spline formed as first non-planar loop in the expanded configuration wherein the first and second ends are coupled to the distal region of the shaft and first intermediate portion extends from the distal region ([0226] The electrodes 1130, 1132 are connected to the shaft 1120 by supports 1144 which are typically insulated so as to direct the energy to the semi-circular electrodes 1130, 1132) (Fig 27-30; semi-circular inner loops 1134, 1136); and a first plurality of electrodes disposed on the first intermediate portion ([0227] the inner loops 1134, 1136 include a plurality of microsensors 1160 spaced along the rims of the overall circular shape. In some embodiments, the microsensors 1160 are configured for contact feedback, visualization under fluoroscopy or sensing for electroanatomic mapping systems. In other embodiments, the microsensors 1160 function as electrodes); the second sensing electrode array ([0226] FIG. 27 illustrates an embodiment of the treatment catheter 1112 wherein the delivery electrode 1122 comprises two semi-circular loop electrodes 1130, 1132), comprising: a second spline having a third end ([0227] the inner loops 1134, 1136), an opposite, fourth end ([0227] the inner loops 1134, 1136), and a second intermediate portion between the third end and the fourth end ([0227] the inner loops 1134, 1136), the second spline formed as second non-planar loop in the expanded configuration wherein the third and fourth ends are coupled to the distal region of the shaft ([0226] The electrodes 1130, 1132 are connected to the shaft 1120 by supports 1144 which are typically insulated so as to direct the energy to the semi-circular electrodes 1130, 1132) and second intermediate portion extends from the distal region (Fig 27-30; semi-circular inner loops 1134, 1136); and a second plurality of electrodes disposed on the second intermediate portion ([0227] the inner loops 1134, 1136 include a plurality of microsensors 1160 spaced along the rims of the overall circular shape. In some embodiments, the microsensors 1160 are configured for contact feedback, visualization under fluoroscopy or sensing for electroanatomic mapping systems. In other embodiments, the microsensors 1160 function as electrodes); wherein the first intermediate portion does not contact the second intermediate portion in the expanded configuration (Fig 30); and an electroanatomical mapping system coupled to the catheter and configured to receive signals representative of the detected physiological signals from the plurality of sensing electrode arrays and map the patient’s heart ([0251] The sensing electrode 1540 and the additional electrodes 1542, 1544 are typically used for sensing ECG signals and also for providing information to an electroanatomic mapping system. For example, when sensing ECG signals, a user can verify or confirm location of the treatment catheter 1502 in the heart based on the sensed ECG signals) ([0143] Cardiac mapping during an aberrant heart rhythm aims at elucidation of the mechanisms of the heart rhythm, description of the propagation of activation from its initiation to its completion within a region of interest, and identification of the site of origin or a critical site of conduction to serve as a target for treatment. Once the desired treatment locations are identified, the treatment catheter 102 is utilized to deliver the treatment energy).
Regarding claim 15, Chiang teaches the electrophysiological system of claim 14, and further comprising a console coupled to the catheter, the console configured to provide ablation energy to the catheter ([0144] In this embodiment, the proximal end of the treatment catheter 102 is electrically connected with the waveform generator 108, wherein the generator 108 is software controlled with regulated energy output that creates high frequency short duration energy delivered to the catheter 102. It may be appreciated that in various embodiments the output is controlled or modified to achieve a desired voltage, current, or combination thereof. In this embodiment, the proximal end of the mapping catheter 104 is also electrically connected with the waveform generator 108 and the electronics to perform the mapping procedure are included in the generator 108. However, it may be appreciated that the mapping catheter 104 may alternatively be connected with a separate external device having the capability of providing the mapping procedure, such as electroanatomic mapping (EAM) systems (e.g. CARTO® systems by Biosense Webster/Johnson & Johnson, EnSite™ systems by St. Jude Medical/Abbott, KODEX-EPD system by Philips, Rhythmia HDX™ system by Boston Scientific).
Regarding claim 16, Chiang teaches a catheter to detect a plurality of physiological signal from within a patient’s heart, the catheter comprising: an elongated shaft having a proximal region (Fig 29-30; shaft 1120 proximal end) and a distal region (Fig 29-30; shaft 1120 distal end), the elongated shaft defining a longitudinal axis (Fig 29-30; shaft 1120 longitudinal axis); a location sensor coupled to the distal region and configured to generate a plurality of location signals (Fig 30; [0227] the inner loops 1134, 1136 include a plurality of microsensors 1160) representative of a location of the catheter within the patient’s heart ([0251] The sensing electrode 1540 and the additional electrodes 1542, 1544 are typically used for sensing ECG signals and also for providing information to an electroanatomic mapping system. For example, when sensing ECG signals, a user can verify or confirm location of the treatment catheter 1502 in the heart based on the sensed ECG signals); and a pair of sensing electrode arrays coupled to the distal region (Fig 30; [0227] the inner loops 1134, 1136 include a plurality of microsensors 1160 spaced along the rims of the overall circular shape. In some embodiments, the microsensors 1160 are configured for contact feedback, visualization under fluoroscopy or sensing for electroanatomic mapping systems. In other embodiments, the microsensors 1160 function as electrodes so as to deliver energy in the formation of a lesion), the pair of sensing electrode arrays having a collapsed configuration and an expanded configuration (Fig 24; [0220] the supports 844 extend along at least a portion of the shaft 820, such as within longitudinal grooves 852 along the shaft 820. Likewise, in this embodiment a sheath 850 is advanceable over the shaft 820 and the grooves 852, holding the supports 844 within the grooves 852. Upon retraction of the sheath 850, the supports 844 are able to recoil toward their pre-curved configuration, moving the trowel shaped electrodes 830, 832, 834, 836 radially outwardly as shown), the pair of sensing electrode arrays including a first sensing electrode array and a second sensing electrode array ([0226] FIG. 27 illustrates an embodiment of the treatment catheter 1112 wherein the delivery electrode 1122 comprises two semi-circular loop electrodes 1130, 1132); the first sensing electrode array, comprising: a first spline having a first end, an opposite, second end (Fig 27; loops 1130, 1132), and a first intermediate portion between the first end and the second end (Fig 27; loop 1130, 1132) ([0227] the inner loops 1134, 1136), the first spline formed as first non-planar loop in the expanded configuration wherein the first and second ends are coupled to the distal region of the shaft ([0226] The electrodes 1130, 1132 are connected to the shaft 1120 by supports 1144 which are typically insulated so as to direct the energy to the semi-circular electrodes 1130, 1132) and first intermediate portion extends from the distal region (Fig 27-30; semi-circular inner loops 1134, 1136); and a first plurality of electrodes disposed on the first intermediate portion ([0227] the inner loops 1134, 1136 include a plurality of microsensors 1160 spaced along the rims of the overall circular shape. In some embodiments, the microsensors 1160 are configured for contact feedback, visualization under fluoroscopy or sensing for electroanatomic mapping systems. In other embodiments, the microsensors 1160 function as electrodes); the second sensing electrode array ([0226] FIG. 27 illustrates an embodiment of the treatment catheter 1112 wherein the delivery electrode 1122 comprises two semi-circular loop electrodes 1130, 1132), comprising: a second spline having a third end ([0227] the inner loops 1134, 1136), an opposite, fourth end ([0227] the inner loops 1134, 1136), and a second intermediate portion between the third end and the fourth end ([0227] the inner loops 1134, 1136), the second spline formed as second non-planar loop in the expanded configuration wherein the third and fourth ends are coupled to the distal region of the shaft and second intermediate portion extends from the distal region ([0226] The electrodes 1130, 1132 are connected to the shaft 1120 by supports 1144 which are typically insulated so as to direct the energy to the semi-circular electrodes 1130, 1132), the second spline opposite the first spline (Fig 27-30; semi-circular inner loops 1134, 1136); and a second plurality of electrodes disposed on the second intermediate portion (Fig 27-30; semi-circular inner loops 1134, 1136) ([0227] the inner loops 1134, 1136 include a plurality of microsensors 1160 spaced along the rims of the overall circular shape. In some embodiments, the microsensors 1160 are configured for contact feedback, visualization under fluoroscopy or sensing for electroanatomic mapping systems. In other embodiments, the microsensors 1160 function as electrodes); wherein the first intermediate portion does not contact the second intermediate portion in the expanded configuration (Fig 30).
Regarding claim 17, Chiang teaches the catheter of claim 16, wherein the first non-planar loop includes a first distal planar loop section in a first plane and the second non-planar loop includes a second distal planar loop section in a second plane in the expanded configuration (Fig 27-30; loops 1130 and 1132).
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) 9-11, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiang (WO 2022192522 A1) in view of Goedeke (US 20180161577 A1).
Regarding claim 9, Chiang teaches the catheter of claim 6, but fails to fully teach wherein the first plane is parallel to the second plane in the expanded configuration, the first and second planes parallel to a reference plane including the longitudinal axis.
However, Goedeke teaches wherein the first plane is parallel to the second plane in the expanded configuration, the first and second planes parallel to a reference plane including the longitudinal axis ([0022] The elongate electrode member forming the loop can be in a plane that is co-linear with the longitudinal center axis of the elongate body. Alternatively, the elongate electrode member forming the loop is in a plane that is perpendicular to the longitudinal center axis of the elongate body). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Chiang to include wherein the first plane is parallel to the second plane in the expanded configuration, the first and second planes parallel to a reference plane including the longitudinal axis. Doing so allows for increased area that the loops can reach and a more effective treatment.
Regarding claim 10, Chiang teaches the catheter of claim 9, but fails to fully teach wherein the first non-planar loop includes a first medial planar loop section in a third plane and the second non-planar loop includes a second medial loop section in the third plane, the third plane perpendicular to the longitudinal axis in the expanded configuration.
However, Goedeke teaches wherein the first non-planar loop includes a first medial planar loop section in a third plane and the second non-planar loop includes a second medial loop section in the third plane, the third plane perpendicular to the longitudinal axis in the expanded configuration ([0635] The catheter 1784 illustrates an embodiment in which the elongate electrode member 1794 forms a loop 1705 in a plane 1707 that is perpendicular to the longitudinal center axis of the elongate body. More than one of the elongate electrode members can be used with a 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 Chiang to include wherein the first non-planar loop includes a first medial planar loop section in a third plane and the second non-planar loop includes a second medial loop section in the third plane, the third plane perpendicular to the longitudinal axis in the expanded configuration. Doing so allows for increased area that the loops can reach and a more effective treatment.
Regarding claim 11, Chiang teaches the catheter of claim 1, but fails to fully teach wherein the first non-planar loop extends from a first side to a second side of a reference plane including the axis, and the second non-planar loop extends from a second side to a first side of the reference plane in the expanded configuration.
However, Geodeke teaches wherein the first non-planar loop extends from a first side to a second side of a reference plane including the axis, and the second non-planar loop extends from a second side to a first side of the reference plane in the expanded configuration ([0471] the at least two elongate stimulation members 314 include a first elongate stimulation member 314a and a second elongate stimulation member 314b. A second plane 312 perpendicularly intersects the first plane 310 along the longitudinal axis 308 of the elongate body 302. The first plane 310 and the second plane 312 divide the first volume 316 into a first quadrant volume 332 and a second quadrant volume 334. In some embodiments (e.g., as illustrated in FIGS. 3A and 3B), the first elongate stimulation member 314a curves into the first quadrant volume 332 and the second elongate stimulation member 314b curves into the second quadrant volume 334) ([0600] It is noted that the curves of the first portion 1466 and the second portion 1474 can also all be in approximately the same plane. It is, however, possible that the curves of the first portion 1466 and the second portion 1474 are not in the same plane. For example, when the curves of the first portion 1466 and the second portion 1474 are not in the same plane the longitudinal center axis 1408 can include a helical curve through these portions of the elongate body 1402. Other shapes are also possible). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Chiang to include wherein the first non-planar loop extends from a first side to a second side of a reference plane including the axis, and the second non-planar loop extends from a second side to a first side of the reference plane in the expanded configuration. Doing so allows for increased area that the loops can reach and a more effective treatment.
Regarding claim 18, Chiang teaches the catheter of claim 17, but fails to fully teach wherein the first plane intersects the second plane in the expanded configuration.
However, Goedeke teaches wherein the first plane intersects the second plane in the expanded configuration ([0471] the at least two elongate stimulation members 314 include a first elongate stimulation member 314a and a second elongate stimulation member 314b. A second plane 312 perpendicularly intersects the first plane 310 along the longitudinal axis 308 of the elongate body 302. The first plane 310 and the second plane 312 divide the first volume 316 into a first quadrant volume 332 and a second quadrant volume 334. In some embodiments (e.g., as illustrated in FIGS. 3A and 3B), the first elongate stimulation member 314a curves into the first quadrant volume 332 and the second elongate stimulation member 314b curves into the second quadrant volume 334). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Chiang to include wherein the first plane intersects the second plane in the expanded configuration. Doing so allows for increased area that the loops can reach and a more effective treatment.
Regarding claim 19, Chiang teaches the catheter of claim 18, wherein the first planar loop section and second planar loop section are deformable from the expanded configuration ([0226] the loop electrodes 1130, 1132 are comprised of a flexible material that allows the loop electrodes 1130, 1132 to bend proximally, so as to form a less concave shape (e.g. a more shallow cupped shape, a more flattened shape or a more convex shape) and conform to the target tissue area) such that the first plane lies in the second plane, the first and second planes perpendicular to the longitudinal axis (Fig 27-30; loops 1130 and 1132). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Chiang to include wherein the first planar loop section and second planar loop section are deformable from the expanded configuration such that the first plane lies in the second plane, the first and second planes perpendicular to the longitudinal axis. Doing so allows for increased area that the loops can reach and a more effective treatment.
Regarding claim 20, Chiang teaches the catheter of claim 18, but fails to teach wherein the first non-planar loop extends from a first side to a second side of a reference plane including the axis, and the second non-planar loop extends from a second side to a first side of the reference plane in the expanded configuration.
However, Goedeke teaches wherein the first non-planar loop extends from a first side to a second side of a reference plane including the axis, and the second non-planar loop extends from a second side to a first side of the reference plane in the expanded configuration ([0471] the at least two elongate stimulation members 314 include a first elongate stimulation member 314a and a second elongate stimulation member 314b. A second plane 312 perpendicularly intersects the first plane 310 along the longitudinal axis 308 of the elongate body 302. The first plane 310 and the second plane 312 divide the first volume 316 into a first quadrant volume 332 and a second quadrant volume 334. In some embodiments (e.g., as illustrated in FIGS. 3A and 3B), the first elongate stimulation member 314a curves into the first quadrant volume 332 and the second elongate stimulation member 314b curves into the second quadrant volume 334) ([0600] It is noted that the curves of the first portion 1466 and the second portion 1474 can also all be in approximately the same plane. It is, however, possible that the curves of the first portion 1466 and the second portion 1474 are not in the same plane. For example, when the curves of the first portion 1466 and the second portion 1474 are not in the same plane the longitudinal center axis 1408 can include a helical curve through these portions of the elongate body 1402. Other shapes are also possible). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Chiang to include wherein the first non-planar loop extends from a first side to a second side of a reference plane including the axis, and the second non-planar loop extends from a second side to a first side of the reference plane in the expanded configuration. Doing so allows for increased area that the loops can reach and a more effective treatment.
Conclusion
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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