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 amendment filed February 3rd, 2026 has been entered.
Response to Arguments
Applicant’s arguments, see pages 8-10, filed February 3rd, 2026, with respect to the rejection(s) of claim(s) 1, 8 & 15 under 35 U.S.C. 103 have been fully considered and are persuasive in view of the amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a new interpretation of the current prior art of record and newly found prior art that teaches the claims’ limitations.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-12, 15-17 & 21 are rejected under 35 U.S.C. 103 as being unpatentable over Howard et al. (U.S. Pub. No. 20180214202, previously cited), herein referred to as “Howard” in view of Altmann et al. (U.S. Pub. No. 20220000543, earliest effective filing date), herein referred to as “Altmann” and Selkee et al. (U.S. Pub. No. 20180177547, previously cited), herein referred to as “Selkee”.
Regarding claim 1, Howard discloses an ablation system ([0003]: The present invention relates to methods, systems, and devices for enhancing the efficiency and efficacy of ablation energy delivery) comprising:
a catheter (medical device 12; [0079]: a medical device 12, such as a catheter) comprising a plurality of electrodes (plurality of electrodes 38; [0081]: the device 12 may include a treatment element 32, such as that shown in FIGS. 1-12, that includes a carrier element 36 bearing a plurality of electrodes 38) arranged along a variable diameter spiral ([0081]: The carrier element 36 may be transitionable between a linear configuration and an expanded configuration in which the carrier element 36 has an arcuate or substantially circular configuration. For example, the carrier element 36 may form a loop in the expanded configuration; where Figs. 1A & 1B in the instant application’s Drawings show a circular/loop catheter and this is being interpreted as variable diameter spiral); and
a controller (generator 14 & CEDS 16) coupled to the catheter ([0079]: an energy supply, such as a pulsed electric field or radiofrequency (RF) generator 14 including an energy control, delivering, and monitoring system or indirectly through a device electrode distribution system 16 (which may also be referred to herein as a catheter electrode distribution system or CEDS); [0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle), the controller programmed to:
select at least one pair of non-adjacent electrodes of the plurality of electrodes, wherein each of the at least one pair of non-adjacent electrodes comprises two electrodes separated by at least one other electrode of the plurality of electrodes along the variable diameter spiral ([0098]: A first delivery pattern is shown in FIG. 7, in which ablation energy is delivered only to the odd electrodes (that is, electrodes E1, E3, E5, E7, E9, E11, E13, E15, and E17). Further, electrodes E1, E5, E9, E13, and E17 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E3, E7, E11, and E15 are connected to a second polarity of the generator 14 (for example, the positive polarity); where E1 & E3 are seen as a pair & vice versa for the following electrodes, see Fig. 7 where E1 is separated from E3 by E2 such that E1 & E3 are non-adjacent); and
sequentially apply bipolar stimulation using the at least one selected pair of non-adjacent electrodes ([0098]: After a train of biphasic pulses has been delivered using only the odd electrodes, the device electrode distribution system 16 may then switch to using only the even numbered electrodes (that is, electrodes E2, E4, E6, E8, E10, E12, E14, and E16) for a similar train of pulses. This second delivery pattern is shown in FIG. 8. Specifically, electrodes E2, E6, E10, and E14 are connected to the negative polarity of the generator 14 while electrodes E4, E8, E12, and E16 are connected to the positive polarity of the generator 14. The two pulse train deliveries (that is, delivery by odd electrodes only then delivery by even electrodes only) may be automated by the generator 14 and device electrode distribution system 16, such that the two patterns would be delivered in rapid succession).
But Howard fails to disclose wherein the controller is programmed to select the at least one pair of non-adjacent electrodes to prevent arcing between electrodes
However, Altmann discloses wherein the controller is programmed to select the at least one pair of non-adjacent electrodes to prevent arcing between electrodes ([0026]: the proximal end of catheter 21 is connected to a control console 24 (also referred to herein as a console 24) comprising an ablative power source, in the present example an IRE pulse generator (IPG) 45, which is configured to deliver peak power in the range of tens of kW. Console 24 comprises a switching box 46, which is configured to switch the power applied by IPG 45 to one or more selected pairs of electrodes 50. A sequenced IRE ablation protocol, also referred to herein as an ablation plan or a predefined pattern, may be defined in advance by physician 30, or by processor 41, or by a combination thereof, and stored in a memory 48 of console 24; [0036]: To make the generated electric field as spatially uniform as possible over a large tissue region it is best to have pairs of electrodes 50 selected with overlapping fields, or at least fields adjacent to each other. However, there is a Joule heating component that occurs with the IRE generated fields, and this heating may cause uncontrolled damage to tissue and undesired damage to the electrodes when multiple pairs of electrodes 50 are continuously used for applying the predefined the IRE pulses in accordance with a pattern of time slots; [0049]: In some embodiments, at least some of electrodes 50 are used more than one time in different time slots of the same predefined pattern, but is paired with a different electrode in different time slots. For example, electrode 50C is paired with electrode 50A in time slot 1, and with electrode 50E in time slot 9. Moreover, as shown in Table 1, at least one time slot is positioned, in the predefined pattern, between two time slots having a common electrode; see Table 1 after [0046] & wherein arcing is known to cause a high energy discharge that includes heat and light such that prevention of the Joule heating component from two electrodes being too close is seen as a prevention of arcing). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Howard to include the controller of Altmann for the purpose of preventing uncontrolled damage to the section of tissue located between the electrodes of the respective pair (Altmann: [0054], [0015], [0036]).
While Altmann discloses a variable diameter spiral ([0029]: lasso of tip section, see Fig. 2) Howard in view of Altmann fails to disclose a variable diameter spiral that is selectively transitionable between i) an expanded spiral having a first outermost diameter and ii) a retracted spiral having a second outermost diameter smaller than the first outermost diameter, wherein the second diameter is fifteen millimeters (mm), wherein, in the expanded spiral, i) a first electrode of the plurality of electrodes proximate a base of the expanded spiral is spaced from a second electrode of the plurality of electrodes proximate a free end of the expanded spiral in a direction parallel to a longitudinal axis of the catheter, and ii) the first electrode of the plurality of electrodes proximate the base and the second electrode of the plurality of electrodes proximate the free end are located a same radial distance from a center of the expanded spiral, and wherein the plurality of electrodes are substantially evenly spaced around an entire circumference of the expanded spiral.
However, Selkee discloses a variable diameter spiral (distal assembly 17; [0049]: a resilient three-dimensional (3-D) arcuate distal assembly 17 which is advantageously constructed for significantly greater and more uniform loop contraction) that is selectively transitionable ([0049]: the distal assembly 17 is responsive to operator manipulation of a control handle 16 in decreasing its radius and increasing its coiling, as shown in FIG. 2B) between i) an expanded spiral having a first outermost diameter ([0060]: the distal assembly 17 in its neutral, unconstrained configuration may be used for circumferential contact with an ostium having a larger radius) and ii) a retracted spiral having a second outermost diameter smaller than the first outermost diameter ([0060]: the distal assembly 17 in its neutral, unconstrained configuration may be used for circumferential contact with an ostium having a larger radius, and then be adjusted into its contracted configuration for circumferential contact within the PV of the ostium with a significantly smaller radius), wherein the second diameter is fifteen millimeters (mm) ([0073]: where a radius R3 of the arc of distal portion 15 is about 17 mm when the distal assembly 17 is unconstrained, the distal assembly 17 can be contracted into a tighter coil such that the arcs of the distal curve portion 21D and the distal portion 15 are both defined by a radius of about 10 mm, for a reduction in the radius R3 of the arc of the distal portion 15 by about 60% or more; wherein the flexible structure is capable of having a diameter of 15 mm), wherein, in the expanded spiral, i) a first electrode of the plurality of electrodes proximate a base of the expanded spiral is spaced from a second electrode of the plurality of electrodes proximate a free end of the expanded spiral in a direction parallel to a longitudinal axis of the catheter ([0083]: The electrodes can be approximately evenly spaced along the distal portion 15; see Fig. 7 where all of the electrodes are capable of being spaced apart in a direction parallel to the longitudinal axis of the catheter), and ii) the first electrode of the plurality of electrodes proximate the base and the second electrode of the plurality of electrodes proximate the free end are located a same radial distance from a center of the expanded spiral, and wherein the plurality of electrodes are substantially evenly spaced around an entire circumference of the expanded spiral ([0083]: The electrodes can be approximately evenly spaced along the distal portion 15; see Fig. 7 where all of the electrodes are capable of being spaced a same radial distance from a center of the expanded spiral & are capable of being evenly spaced).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the variable diameter spiral of Howard in view of Altmann to the variable diameter spiral of Selkee for the purpose of enabling the distal assembly to be used for circumferential contact with an ostium having a larger radius, and then be adjusted into its contracted configuration for circumferential contact within the PV of the ostium with a significantly smaller radius (Selkee: [0060]).
It would have been an obvious matter of design choice for the second outermost diameter to be fifteen millimeters (mm), since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise: wherein, in the expanded spiral, i) a first electrode of the plurality of electrodes proximate a base of the expanded spiral is spaced from a second electrode of the plurality of electrodes proximate a free end of the expanded spiral in a direction parallel to a longitudinal axis of the catheter, and ii) the first electrode of the plurality of electrodes proximate the base and the second electrode of the plurality of electrodes proximate the free end are located a same radial distance from a center of the expanded spiral, and wherein the plurality of electrodes are substantially evenly spaced around the entire circumference of the expanded spiral, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 2, Howard discloses wherein to select the at least one pair of non-adjacent electrodes, the controller is programmed to select a pair of electrodes that are separated by one electrode of the plurality of electrodes along the variable diameter spiral ([0098]: A first delivery pattern is shown in FIG. 7, in which ablation energy is delivered only to the odd electrodes (that is, electrodes E1, E3, E5, E7, E9, E11, E13, E15, and E17). Further, electrodes E1, E5, E9, E13, and E17 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E3, E7, E11, and E15 are connected to a second polarity of the generator 14 (for example, the positive polarity) … The two pulse train deliveries (that is, delivery by odd electrodes only then delivery by even electrodes only) may be automated by the generator 14 and device electrode distribution system 16, such that the two patterns would be delivered in rapid succession; where E1 & E3 are seen as a pair & vice versa for the following electrodes, see Fig. 7 where E1 is separated from E3 by E2 such that E1 & E3 are non-adjacent).
Regarding claim 3, Howard discloses wherein to select the at least one pair of non-adjacent electrodes, the controller is programmed to select a pair of electrodes that are separated by at least two electrodes of the plurality of electrodes along the variable diameter spiral ([0089]: Further, the delivery patterns discussed herein are not necessarily mutually exclusive, and may be combined during an ablation procedure; [0101]: The first delivery pattern is shown in FIG. 9, in which ablation energy is delivered through a set of active electrodes that includes only every third electrode (that is, E1, E4, E7, E10, E13, and E16). Further, electrodes E1, E7, and E13 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E4, E10, and E16 are connected to a second polarity of the generator 14 (for example, the positive polarity); where E1 & E4 are seen as a pair and are separated by E2 & E3, see [0102] for the delivery pattern with each pair where the pair comprises electrodes separated by 2 electrodes).
Regarding claim 4, Howard in view of Selkee discloses wherein the first outermost diameter is twenty seven millimeters (Selkee: [0073]: For example, where a radius R3 of the arc of distal portion 15 is about 17 mm when the distal assembly 17 is unconstrained, the distal assembly 17 can be contracted into a tighter coil such that the arcs of the distal curve portion 21D and the distal portion 15 are both defined by a radius of about 10 mm, for a reduction in the radius R3 of the arc of the distal portion 15 by about 60% or more; wherein the distal assembly is capable of having a first diameter of 27 mm).
Additionally, it would have been an obvious matter of design choice for the first diameter to be twenty seven millimeters, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 5, Howard discloses wherein to select the at least one pair of non-adjacent electrodes, the controller is programmed to:
measure impedances between a plurality of different pairs of electrodes of the plurality of electrodes ([0086]: The generator 14 may be configured to deliver a sampling pulse prior to delivery of a full series or “pulse train” of pulsed electric field ablative therapy pulses. Such a preliminary sampling pulse may provide measurements of relative electrical impedance between electrodes); and
select the at least one pair of non-adjacent electrodes based on the measured impedances ([0086]: Additionally, such preliminary pulses may be used to evaluate such conditions as relative proximity of individual electrodes to ensure an appropriate voltage is to be applied to the electrodes during subsequent energy delivery. These preliminary pulses may also be applied to assess whether the electrodes in positioned properly relative to the target tissue. The preliminary pulses may be delivered with or without automated, immediate, subsequent delivery of one or more therapeutic pulse trains).
Regarding claim 6, Howard discloses wherein to select the at least one pair of non-adjacent electrodes, the controller is programmed to select the at least one pair of non-adjacent electrodes based on a user input received at the controller ([0140]: By selectively connecting or disconnecting the neutral electrodes 38c, 38d from each other, the user may modify energy delivery by concentrating and/or redirecting the energy. The ability to more precisely control energy delivery may enhance patient safety by allowing the user to avoid delivering energy to sensitive areas).
Regarding claim 7, Howard discloses wherein to select the at least one pair of non-adjacent electrodes, the controller is programmed to select the at least one pair of non-adjacent electrodes to achieve a target lesion depth ([0097]: Energizing every other electrode 38 may allow for a greater separation distance of approximately 5 mm between active electrodes, thereby driving the electric field deeper into the underlying tissue and creating a deeper ablation lesion; [0098]: The two pulse train deliveries (that is, delivery by odd electrodes only then delivery by even electrodes only) may be automated by the generator 14 and device electrode distribution system 16, such that the two patterns would be delivered in rapid succession; where the energy delivery pattern is enabled by the controller/electrode distribution system within the generator for a deeper electric field penetration and this is seen as selection for achieving a target lesion depth).
Regarding claim 8, Howard discloses a method for ablating tissue ([0003]: The present invention relates to methods, systems, and devices for enhancing the efficiency and efficacy of ablation energy delivery), the method comprising:
coupling a controller (generator 14) to a catheter (medical device 12; [0079]: an energy supply, such as a pulsed electric field or radiofrequency (RF) generator 14 including an energy control, delivering, and monitoring system or indirectly through a device electrode distribution system 16 (which may also be referred to herein as a catheter electrode distribution system or CEDS); [0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle), wherein the catheter (medical device 12) includes a plurality of electrodes (electrodes 38; [0081]: the device 12 may include a treatment element 32, such as that shown in FIGS. 1-12, that includes a carrier element 36 bearing a plurality of electrodes 38)) arranged along a variable diameter spiral ([0081]: The carrier element 36 may be transitionable between a linear configuration and an expanded configuration in which the carrier element 36 has an arcuate or substantially circular configuration. For example, the carrier element 36 may form a loop in the expanded configuration; where Figs. 1A & 1B in the instant application’s Drawings show a circular/loop catheter and this is being interpreted as variable diameter spiral);
selecting, using the controller coupled to the catheter (generator 14 & CEDS 16; [0079]: an energy supply, such as a pulsed electric field or radiofrequency (RF) generator 14 including an energy control, delivering, and monitoring system or indirectly through a device electrode distribution system 16 (which may also be referred to herein as a catheter electrode distribution system or CEDS); [0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle), at least one pair of non- adjacent electrodes of the plurality of electrodes, wherein each of the at least one pair of non-adjacent electrodes comprises two electrodes separated by at least one other electrode of the plurality of electrodes along the variable diameter spiral ([0098]: A first delivery pattern is shown in FIG. 7, in which ablation energy is delivered only to the odd electrodes (that is, electrodes E1, E3, E5, E7, E9, E11, E13, E15, and E17). Further, electrodes E1, E5, E9, E13, and E17 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E3, E7, E11, and E15 are connected to a second polarity of the generator 14 (for example, the positive polarity); where E1 & E3 are seen as a pair & vice versa for the following electrodes, see Fig. 7 where E1 is separated from E3 by E2 such that E1 & E3 are non-adjacent), and
sequentially applying bipolar stimulation using the at least one selected pair of non-adjacent electrodes ([0098]: After a train of biphasic pulses has been delivered using only the odd electrodes, the device electrode distribution system 16 may then switch to using only the even numbered electrodes (that is, electrodes E2, E4, E6, E8, E10, E12, E14, and E16) for a similar train of pulses. This second delivery pattern is shown in FIG. 8. Specifically, electrodes E2, E6, E10, and E14 are connected to the negative polarity of the generator 14 while electrodes E4, E8, E12, and E16 are connected to the positive polarity of the generator 14. The two pulse train deliveries (that is, delivery by odd electrodes only then delivery by even electrodes only) may be automated by the generator 14 and device electrode distribution system 16, such that the two patterns would be delivered in rapid succession).
But Howard fails to disclose wherein the controller is programmed to select the at least one pair of non-adjacent electrodes to prevent arcing between electrodes.
However, Altmann discloses wherein the controller is programmed to select the at least one pair of non-adjacent electrodes to prevent arcing between electrodes ([0026]: the proximal end of catheter 21 is connected to a control console 24 (also referred to herein as a console 24) comprising an ablative power source, in the present example an IRE pulse generator (IPG) 45, which is configured to deliver peak power in the range of tens of kW. Console 24 comprises a switching box 46, which is configured to switch the power applied by IPG 45 to one or more selected pairs of electrodes 50. A sequenced IRE ablation protocol, also referred to herein as an ablation plan or a predefined pattern, may be defined in advance by physician 30, or by processor 41, or by a combination thereof, and stored in a memory 48 of console 24; [0036]: To make the generated electric field as spatially uniform as possible over a large tissue region it is best to have pairs of electrodes 50 selected with overlapping fields, or at least fields adjacent to each other. However, there is a Joule heating component that occurs with the IRE generated fields, and this heating may cause uncontrolled damage to tissue and undesired damage to the electrodes when multiple pairs of electrodes 50 are continuously used for applying the predefined the IRE pulses in accordance with a pattern of time slots; [0049]: In some embodiments, at least some of electrodes 50 are used more than one time in different time slots of the same predefined pattern, but is paired with a different electrode in different time slots. For example, electrode 50C is paired with electrode 50A in time slot 1, and with electrode 50E in time slot 9. Moreover, as shown in Table 1, at least one time slot is positioned, in the predefined pattern, between two time slots having a common electrode; see Table 1 after [0046] & wherein arcing is known to cause a high energy discharge that includes heat and light such that prevention of the Joule heating component from two electrodes being too close is seen as a prevention of arcing). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Howard to include the controller of Altmann for the purpose of preventing uncontrolled damage to the section of tissue located between the electrodes of the respective pair (Altmann: [0054], [0015], [0036]).
While Altmann discloses a variable diameter spiral ([0029]: lasso of tip section, see Fig. 2) Howard in view of Altmann fails to disclose a variable diameter spiral that is selectively transitionable between i) an expanded spiral having a first outermost diameter and ii) a retracted spiral having a second outermost diameter smaller than the first outermost diameter, wherein the second outermost diameter is fifteen millimeters (mm), wherein, in the expanded spiral, i) a first electrode of the plurality of electrodes proximate a base of the expanded spiral is spaced from a second electrode of the plurality of electrodes proximate a free end of the expanded spiral in a direction parallel to a longitudinal axis of the catheter, and ii) the first electrode of the plurality of electrodes proximate the base and the second electrode of the plurality of electrodes proximate the free end are located a same radial distance from a center of the expanded spiral, and wherein the plurality of electrodes are substantially evenly spaced around an entire circumference of the expanded spiral.
However, Selkee discloses a variable diameter spiral (distal assembly 17; [0049]: a resilient three-dimensional (3-D) arcuate distal assembly 17 which is advantageously constructed for significantly greater and more uniform loop contraction) that is selectively transitionable ([0049]: the distal assembly 17 is responsive to operator manipulation of a control handle 16 in decreasing its radius and increasing its coiling, as shown in FIG. 2B) between i) an expanded spiral having a first outermost diameter ([0060]: the distal assembly 17 in its neutral, unconstrained configuration may be used for circumferential contact with an ostium having a larger radius) and ii) a retracted spiral having a second outermost diameter smaller than the first outermost diameter ([0060]: the distal assembly 17 in its neutral, unconstrained configuration may be used for circumferential contact with an ostium having a larger radius, and then be adjusted into its contracted configuration for circumferential contact within the PV of the ostium with a significantly smaller radius), wherein the second outermost diameter is fifteen millimeters (mm) ([0073]: where a radius R3 of the arc of distal portion 15 is about 17 mm when the distal assembly 17 is unconstrained, the distal assembly 17 can be contracted into a tighter coil such that the arcs of the distal curve portion 21D and the distal portion 15 are both defined by a radius of about 10 mm, for a reduction in the radius R3 of the arc of the distal portion 15 by about 60% or more; wherein the flexible structure is capable of having a diameter of 15 mm), wherein, in the expanded spiral, i) a first electrode of the plurality of electrodes proximate a base of the expanded spiral is spaced from a second electrode of the plurality of electrodes proximate a free end of the expanded spiral in a direction parallel to a longitudinal axis of the catheter ([0083]: The electrodes can be approximately evenly spaced along the distal portion 15; see Fig. 7 where all of the electrodes are capable of being spaced apart in a direction parallel to the longitudinal axis of the catheter), and ii) the first electrode of the plurality of electrodes proximate the base and the second electrode of the plurality of electrodes proximate the free end are located a same radial distance from a center of the expanded spiral, and wherein the plurality of electrodes are substantially evenly spaced around an entire circumference of the expanded spiral ([0083]: The electrodes can be approximately evenly spaced along the distal portion 15; see Fig. 7 where all of the electrodes are capable of being spaced a same radial distance from a center of the expanded spiral & are capable of being evenly spaced).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the variable diameter spiral of Howard in view of Altmann to the variable diameter spiral of Selkee for the purpose of enabling the distal assembly to be used for circumferential contact with an ostium having a larger radius, and then be adjusted into its contracted configuration for circumferential contact within the PV of the ostium with a significantly smaller radius (Selkee: [0060]).
It would have been an obvious matter of design choice for the second outermost diameter to be about fifteen millimeters (mm), since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise: wherein, in the expanded spiral, i) a first electrode of the plurality of electrodes proximate a base of the expanded spiral is spaced from a second electrode of the plurality of electrodes proximate a free end of the expanded spiral in a direction parallel to a longitudinal axis of the catheter, and ii) the first electrode of the plurality of electrodes proximate the base and the second electrode of the plurality of electrodes proximate the free end are located a same radial distance from a center of the expanded spiral, and wherein the plurality of electrodes are substantially evenly spaced around the entire circumference of the expanded spiral, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 9, Howard discloses wherein selecting the at least one pair of non-adjacent electrodes comprises selecting a pair of electrodes that are separated by one electrode of the plurality of electrodes along the variable diameter spiral ([0098]: A first delivery pattern is shown in FIG. 7, in which ablation energy is delivered only to the odd electrodes (that is, electrodes E1, E3, E5, E7, E9, E11, E13, E15, and E17). Further, electrodes E1, E5, E9, E13, and E17 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E3, E7, E11, and E15 are connected to a second polarity of the generator 14 (for example, the positive polarity) … The two pulse train deliveries (that is, delivery by odd electrodes only then delivery by even electrodes only) may be automated by the generator 14 and device electrode distribution system 16, such that the two patterns would be delivered in rapid succession; where E1 & E3 are seen as a pair & vice versa for the following electrodes, see Fig. 7 where E1 is separated from E3 by E2 such that E1 & E3 are non-adjacent).
Regarding claim 10, Howard discloses wherein selecting the at least one pair of non-adjacent electrodes comprises selecting a pair of electrodes that are separated by at least two electrodes of the plurality of electrodes along the variable diameter spiral ([0089]: Further, the delivery patterns discussed herein are not necessarily mutually exclusive, and may be combined during an ablation procedure; [0101]: The first delivery pattern is shown in FIG. 9, in which ablation energy is delivered through a set of active electrodes that includes only every third electrode (that is, E1, E4, E7, E10, E13, and E16). Further, electrodes E1, E7, and E13 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E4, E10, and E16 are connected to a second polarity of the generator 14 (for example, the positive polarity); where E1 & E4 are seen as a pair and are separated by E2 & E3, see [0102] for the delivery pattern with each pair where the pair comprises electrodes separated by 2 electrodes).
Regarding claim 11, Howard discloses wherein selecting the at least one pair of non-adjacent electrodes comprises selecting a pair of electrodes wherein each electrode of the pair are substantially across from one another on the variable diameter spiral ([0116]: FIG. 25 shows a group of two adjacent electrodes 38c (electrodes E5 and E6) of the third plurality of electrodes being between the first and second pluralities of electrodes 38a, 38b … The first plurality of electrodes 38a may be at a first location on the carrier element 36 and the second plurality of electrodes 38b may be at a second location on the carrier element 36 that is approximately 180° from the first location; see Fig. 25 where the opposite polarity electrodes are opposite each other & where a pair is seen as one electrode from 38a and one electrode from 38b).
Regarding claim 12, Howard discloses wherein selecting the at least one pair of non-adjacent electrodes further comprises:
measuring impedances between a plurality of different pairs of electrodes of the plurality of electrodes ([0086]: The generator 14 may be configured to deliver a sampling pulse prior to delivery of a full series or “pulse train” of pulsed electric field ablative therapy pulses. Such a preliminary sampling pulse may provide measurements of relative electrical impedance between electrodes); and
selecting the at least one pair of non-adjacent electrodes based on the measured impedances ([0086]: Additionally, such preliminary pulses may be used to evaluate such conditions as relative proximity of individual electrodes to ensure an appropriate voltage is to be applied to the electrodes during subsequent energy delivery. These preliminary pulses may also be applied to assess whether the electrodes in positioned properly relative to the target tissue. The preliminary pulses may be delivered with or without automated, immediate, subsequent delivery of one or more therapeutic pulse trains).
Regarding claim 15, Howard discloses a controller (generator 14, [0079]: an energy supply, such as a pulsed electric field or radiofrequency (RF) generator 14 including an energy control, delivering, and monitoring system or indirectly through a device electrode distribution system 16 (which may also be referred to herein as a catheter electrode distribution system or CEDS)) for use in an ablation therapy system ([0003]: The present invention relates to methods, systems, and devices for enhancing the efficiency and efficacy of ablation energy delivery), the controller coupled to a catheter (medical device 12; [0079]: an energy supply, such as a pulsed electric field or radiofrequency (RF) generator 14 including an energy control, delivering, and monitoring system or indirectly through a device electrode distribution system 16 (which may also be referred to herein as a catheter electrode distribution system or CEDS)), wherein the controller comprises:
a memory device ([0086]: As such, the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure); and
a processor (processor 46) coupled to the memory device ([0086]: As such, the generator 14 may include processing circuitry including a processor 46 in communication with one or more controllers and/or memories; [0114]: the generator 14 may be programmed and configured to deliver ablation energy according to a predefined cycle), the processor programmed to:
select at least one pair of non-adjacent electrodes of a plurality of electrodes, wherein each of the at least one pair of non-adjacent electrodes comprises two electrodes separated by at least one other electrode of a plurality of electrodes ([0098]: A first delivery pattern is shown in FIG. 7, in which ablation energy is delivered only to the odd electrodes (that is, electrodes E1, E3, E5, E7, E9, E11, E13, E15, and E17). Further, electrodes E1, E5, E9, E13, and E17 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E3, E7, E11, and E15 are connected to a second polarity of the generator 14 (for example, the positive polarity); where E1 & E3 are seen as a pair & vice versa for the following electrodes, see Fig. 7 where E1 is separated from E3 by E2 such that E1 & E3 are non-adjacent), along a variable diameter spiral of the catheter ([0081]: The carrier element 36 may be transitionable between a linear configuration and an expanded configuration in which the carrier element 36 has an arcuate or substantially circular configuration. For example, the carrier element 36 may form a loop in the expanded configuration; where Figs. 1A & 1B in the instant application’s Drawings show a circular/loop catheter and this is being interpreted as variable diameter spiral), and
control the catheter to sequentially apply bipolar stimulation using the at least one selected pair of non-adjacent electrodes ([0098]: After a train of biphasic pulses has been delivered using only the odd electrodes, the device electrode distribution system 16 may then switch to using only the even numbered electrodes (that is, electrodes E2, E4, E6, E8, E10, E12, E14, and E16) for a similar train of pulses. This second delivery pattern is shown in FIG. 8. Specifically, electrodes E2, E6, E10, and E14 are connected to the negative polarity of the generator 14 while electrodes E4, E8, E12, and E16 are connected to the positive polarity of the generator 14. The two pulse train deliveries (that is, delivery by odd electrodes only then delivery by even electrodes only) may be automated by the generator 14 and device electrode distribution system 16, such that the two patterns would be delivered in rapid succession).
But Howard fails to disclose wherein the processor is programmed to select the at least one pair of non-adjacent electrodes to prevent arcing between electrodes.
However, Altmann discloses wherein the processor is programmed to select the at least one pair of non-adjacent electrodes to prevent arcing between electrodes ([0026]: the proximal end of catheter 21 is connected to a control console 24 (also referred to herein as a console 24) comprising an ablative power source, in the present example an IRE pulse generator (IPG) 45, which is configured to deliver peak power in the range of tens of kW. Console 24 comprises a switching box 46, which is configured to switch the power applied by IPG 45 to one or more selected pairs of electrodes 50. A sequenced IRE ablation protocol, also referred to herein as an ablation plan or a predefined pattern, may be defined in advance by physician 30, or by processor 41, or by a combination thereof, and stored in a memory 48 of console 24; [0036]: To make the generated electric field as spatially uniform as possible over a large tissue region it is best to have pairs of electrodes 50 selected with overlapping fields, or at least fields adjacent to each other. However, there is a Joule heating component that occurs with the IRE generated fields, and this heating may cause uncontrolled damage to tissue and undesired damage to the electrodes when multiple pairs of electrodes 50 are continuously used for applying the predefined the IRE pulses in accordance with a pattern of time slots; [0049]: In some embodiments, at least some of electrodes 50 are used more than one time in different time slots of the same predefined pattern, but is paired with a different electrode in different time slots. For example, electrode 50C is paired with electrode 50A in time slot 1, and with electrode 50E in time slot 9. Moreover, as shown in Table 1, at least one time slot is positioned, in the predefined pattern, between two time slots having a common electrode; see Table 1 after [0046] & wherein arcing is known to cause a high energy discharge that includes heat and light such that prevention of the Joule heating component from two electrodes being too close is seen as a prevention of arcing). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Howard to include the processor of Altmann for the purpose of preventing uncontrolled damage to the section of tissue located between the electrodes of the respective pair (Altmann: [0054], [0015], [0036]).
While Altmann discloses a variable diameter spiral ([0029]: lasso of tip section, see Fig. 2) Howard in view of Altmann fails to disclose wherein the variable diameter spiral is selectively transitionable between i) an expanded spiral having a first outermost diameter and ii) a retracted spiral having a second outermost diameter smaller than the first outermost diameter, wherein the second outermost diameter is fifteen millimeters (mm), wherein, in the expanded spiral, i) a first electrode of the plurality of electrodes proximate a base of the expanded spiral is spaced from a second electrode of the plurality of electrodes proximate a free end of the expanded spiral in a direction parallel to a longitudinal axis of the catheter, and ii) the first electrode of the plurality of electrodes proximate the base and the second electrode of the plurality of electrodes proximate the free end are located a same radial distance from a center of the expanded spiral, and wherein the plurality of electrodes are substantially evenly spaced around an entire circumference of the expanded spiral.
However, Selkee discloses wherein the variable diameter spiral (distal assembly 17; [0049]: a resilient three-dimensional (3-D) arcuate distal assembly 17 which is advantageously constructed for significantly greater and more uniform loop contraction) is selectively transitionable ([0049]: the distal assembly 17 is responsive to operator manipulation of a control handle 16 in decreasing its radius and increasing its coiling, as shown in FIG. 2B) between i) an expanded spiral having a first outermost diameter ([0060]: the distal assembly 17 in its neutral, unconstrained configuration may be used for circumferential contact with an ostium having a larger radius) and ii) a retracted spiral having a second outermost diameter smaller than the first outermost diameter ([0060]: the distal assembly 17 in its neutral, unconstrained configuration may be used for circumferential contact with an ostium having a larger radius, and then be adjusted into its contracted configuration for circumferential contact within the PV of the ostium with a significantly smaller radius), wherein the second outermost diameter is fifteen millimeters (mm) ([0073]: where a radius R3 of the arc of distal portion 15 is about 17 mm when the distal assembly 17 is unconstrained, the distal assembly 17 can be contracted into a tighter coil such that the arcs of the distal curve portion 21D and the distal portion 15 are both defined by a radius of about 10 mm, for a reduction in the radius R3 of the arc of the distal portion 15 by about 60% or more; wherein the flexible structure is capable of having a diameter of 15 mm), wherein, in the expanded spiral, i) a first electrode of the plurality of electrodes proximate a base of the expanded spiral is spaced from a second electrode of the plurality of electrodes proximate a free end of the expanded spiral in a direction parallel to a longitudinal axis of the catheter ([0083]: The electrodes can be approximately evenly spaced along the distal portion 15; see Fig. 7 where all of the electrodes are capable of being spaced apart in a direction parallel to the longitudinal axis of the catheter), and ii) the first electrode of the plurality of electrodes proximate the base and the second electrode of the plurality of electrodes proximate the free end are located a same radial distance from a center of the expanded spiral, and wherein the plurality of electrodes are substantially evenly spaced around an entire circumference of the expanded spiral ([0083]: The electrodes can be approximately evenly spaced along the distal portion 15; see Fig. 7 where all of the electrodes are capable of being spaced a same radial distance from a center of the expanded spiral & are capable of being evenly spaced).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the variable diameter spiral of Howard in view of Altmann to the variable diameter spiral of Selkee for the purpose of enabling the distal assembly to be used for circumferential contact with an ostium having a larger radius, and then be adjusted into its contracted configuration for circumferential contact within the PV of the ostium with a significantly smaller radius (Selkee: [0060]).
It would have been an obvious matter of design choice for the second outermost diameter to be about fifteen millimeters (mm), since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise: wherein, in the expanded spiral, i) a first electrode of the plurality of electrodes proximate a base of the expanded spiral is spaced from a second electrode of the plurality of electrodes proximate a free end of the expanded spiral in a direction parallel to a longitudinal axis of the catheter, and ii) the first electrode of the plurality of electrodes proximate the base and the second electrode of the plurality of electrodes proximate the free end are located a same radial distance from a center of the expanded spiral, and wherein the plurality of electrodes are substantially evenly spaced around the entire circumference of the expanded spiral, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 16, Howard discloses wherein to select the at least one pair of non-adjacent electrodes, the controller is programmed to select a pair of electrodes that are separated by one electrode of the plurality of electrodes along the variable diameter spiral ([0098]: A first delivery pattern is shown in FIG. 7, in which ablation energy is delivered only to the odd electrodes (that is, electrodes E1, E3, E5, E7, E9, E11, E13, E15, and E17). Further, electrodes E1, E5, E9, E13, and E17 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E3, E7, E11, and E15 are connected to a second polarity of the generator 14 (for example, the positive polarity) … The two pulse train deliveries (that is, delivery by odd electrodes only then delivery by even electrodes only) may be automated by the generator 14 and device electrode distribution system 16, such that the two patterns would be delivered in rapid succession; where E1 & E3 are seen as a pair & vice versa for the following electrodes, see Fig. 7 where E1 is separated from E3 by E2 such that E1 & E3 are non-adjacent).
Regarding claim 17, Howard disclose wherein to select the at least one pair of non-adjacent electrodes, the controller is programmed to select a pair of electrodes that are separated by at least two electrodes of the plurality of electrodes along the variable diameter spiral ([0089]: Further, the delivery patterns discussed herein are not necessarily mutually exclusive, and may be combined during an ablation procedure; [0101]: The first delivery pattern is shown in FIG. 9, in which ablation energy is delivered through a set of active electrodes that includes only every third electrode (that is, E1, E4, E7, E10, E13, and E16). Further, electrodes E1, E7, and E13 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E4, E10, and E16 are connected to a second polarity of the generator 14 (for example, the positive polarity); where E1 & E4 are seen as a pair and are separated by E2 & E3, see [0102] for the delivery pattern with each pair where the pair comprises electrodes separated by 2 electrodes).
Regarding claim 21, Howard in view of Selkee discloses wherein to select the at least one pair of non-adjacent electrodes, the controller is programmed to select the first electrode of the plurality of electrodes and a third electrode of the plurality of electrodes, wherein the second electrode of the plurality of electrodes is evenly spaced between the first and third electrodes of the plurality of electrodes around the circumference of the expanded spiral (Howard: [0098]: A first delivery pattern is shown in FIG. 7, in which ablation energy is delivered only to the odd electrodes (that is, electrodes E1, E3, E5, E7, E9, E11, E13, E15, and E17). Further, electrodes E1, E5, E9, E13, and E17 are connected to a first polarity of the generator 14 (for example, the negative polarity) while electrodes E3, E7, E11, and E15 are connected to a second polarity of the generator 14 (for example, the positive polarity); wherein the first electrode is seen as E17, the second electrode is seen as E9, and the third electrode is seen as E1 such that E9 is equidistant between E17 & E1 and in Howard Fig. 7, wherein in this combination, Howard teaches the electrode selection/connectivity for energy application while also showing evenly spaced electrodes and Selkee teaches the equidistant electrode spacing relative to the circumference of the spiral such that the combination teaches the claim’s limitations).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794