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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 5th, 2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 11-14, filed September 5th, 2025, with respect to the rejection(s) of claim(s) 1, 17 & 33 under 35 U.S.C. 103 have been fully considered and are persuasive in view of Olson’s disclosure. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the other current prior art of record.
Regarding Applicant’s arguments on pages 12-13 that the current prior art of record (namely, Viswanathan and Stewart) does not disclose the above discussed features (with respect to the spline geometry and their configuration), the Examiner respectfully disagrees on the grounds that Viswanathan, Stewart and Howard do disclose this as detailed in the updated rejection, below.
Claim Rejections - 35 USC § 112
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the claim recites “a proximal end of the basket assembly” in line 3 and it is unclear if this is the same proximal end of the basket assembly as recited in claim 1, from which claim 2 depends or is a different proximal end. For examination purposes, these are the same proximal ends and the limitation will be interpreted as “the proximal end of the basket assembly”.
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 1-2, 4-8, 10, 13, 16-18, 20-24, 26, 29, 32-33, 36-44 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan et al. (U.S. Pub. No. 20190231421, previously cited), herein referred to as “Viswanathan” in view of Stewart et al. (U.S. Pub. No. 20190030328, cited in IDS), herein referred to as “Stewart”.
Regarding claim 1, Viswanathan discloses a medical apparatus (Abstract: Systems, devices, and methods for electroporation ablation therapy), comprising:
a probe (ablation device 3800, Fig. 38A), comprising:
an insertion tube (outer shaft 3810) configured for insertion into a body cavity of a patient ([0267]: The ablation device (3800) as described herein may be disposed in the first configuration prior to delivering a pulse waveform and transformed to the second configuration to make contact with a tissue surface (e.g., an inner wall of the left atrium or ventricle, and/or the like));
a basket assembly (set of splines 3830) having a proximal end that is connected distally to the insertion tube ([0253]: A proximal end of the set of splines (3830) may be coupled to a distal end of the outer shaft (3810)) and comprising a plurality of resilient spines (splines 3830), which are (i) configured, in an expanded state, to bow radially outward around a longitudinal axis of the basket assembly ([0256]: a second configuration (e.g., expanded configuration, basket configuration, deployed configuration) shown in FIG. 38B, where a distal portion (3804) of each spline of the set of splines (3830) bows radially outward from the longitudinal axis (3824)) and in a collapsed state, extend parallel to the longitudinal axis ([0256]: the set of splines (3830) may be configured to transform between a first configuration shown in FIG. 38A, where the set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800); see also Fig. 38C) and (ii) are conjoined at a distal end of the basket assembly ([0253]: A distal end of each spline of the set of splines (3830) may be tethered to and/or coupled to a distal portion of the inner shaft (3820)) and
a plurality of electrodes (electrodes 3832, 3834), which are configured to contact tissue in the body cavity ([0254]: The ablation device/apparatus may include a plurality of electrodes configured to generate an electric field for ablating tissue. Each spline of the set of splines (3830) may include a set of electrodes (3832, 3834)) and comprise radial electrodes (electrodes 3832, 3834), each radial electrode disposed on a respective resilient spine of the plurality of resilient spines about the longitudinal axis ([0254]: Each of the distal electrodes (3832) are the nearest to the distal portion (3822) relative to other electrodes (e.g., the set of proximal electrodes (3834)) of its corresponding set of electrodes on the same spline) such that each radial electrode is disposed on a section of the respective resilient spines that extends parallel to the longitudinal axis in the collapsed state ([0256]: set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800); see Fig. 38A where this includes electrodes 3832, 3834), each radial electrode bulging beyond a surface boundary of the respective resilient spine of the plurality of resilient spines and extending around the respective resilient spine of the plurality of resilient spines ([0254]: the set of electrodes (3832, 3834) may each extend around a circumference of its spline. For example, the distal electrodes (3832) may be constructed from metallic rings that encircle a circumference of its spline; wherein the electrodes comprising metallic rings wrapped around a circumference of the spline is seen as bulging from a surface boundary (the circumference) of a given spline), the radial electrodes comprising (i) first radial electrodes that are disposed on a first set of different, non-adjacent resilient spines of the plurality of resilient spines (every other electrode 3832, Fig. 38A) and (ii) second radial electrodes that are disposed on a second set of different, non-adjacent resilient spines of the plurality of resilient spines (every other electrode 3834, Fig. 38A);
an electrical signal generator (signal generator 122) configured to apply to the plurality of electrodes, including the axial electrode, pulses in a bipolar mode having an amplitude sufficient to cause irreversible electroporation (IRE) in the tissue contacted by the plurality of electrodes ([0075]: The signal generator (122) may be configured to generate pulse waveforms for irreversible electroporation of tissue, such as, for example, pulmonary vein ostia. For example, the signal generator (122) may be a voltage pulse waveform generator and deliver a pulse waveform to the ablation device (110); [0246]: In some embodiments, the cap electrode (3322) and the set of electrodes (3332, 3334) may be configured in anode-cathode sets; [0265]: In some embodiments, the set of electrodes (3832, 3834) may be configured in anode-cathode sets; see explanation, below of Viswanathan’s teachings that include an axial electrode), the pulses being configured to be applied in accordance with a predefined protocol comprising sequentially:
applying the pulses between pairs of the first radial electrodes ([0265]: For example, a particular activation sequence may include activating distal electrodes (3432) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D));
after applying the pulses between the pairs of the first radial electrodes, applying the pulses between pairs of the second radial electrodes ([0265]: For example, a particular activation sequence may include activating distal electrodes (3432) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D) and activating proximal electrodes (3834) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D)).
But Viswanathan fails to disclose: an axial electrode disposed on the longitudinal axis of the basket assembly.
However, Viswanathan in a different embodiment discloses an axial electrode (cap electrode 3322, Fig. 33A) disposed on the longitudinal axis of the basket assembly ([0240]: distal cap electrode (3322) may be formed at the distal end of the catheter device (3300); see Fig. 33A where this is along axis 3324). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the embodiment of Viswanathan to include an axial electrode, as taught by another embodiment of Viswanathan, for the purpose of the combination of closely-placed distal electrodes having outward-facing windows and a cap electrode allows the distal end of the ablation device to generate and project a stronger electric field, and to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one of these electrodes alone (Viswanathan: [0239]).
But Viswanathan fails to disclose the pulses being configured to be applied in accordance with a predefined protocol comprising sequentially:
after applying the pulses between the pairs of the second radial electrodes, applying the pulses between the first radial electrodes and the axial electrode; and
after applying the pulses between the first radial electrodes and the axial electrode, applying the pulses between the second radial electrodes and the axial electrode.
However, Stewart discloses a medical apparatus (Abstract: A method, system, and device for electroporation; [0078]: That is, even though the figures show an expandable element 30 that is inflatable, it will be understood that the expandable element 30 may include one or more splines 41 in addition to or instead of the inflatable expandable element) and the pulses being configured to be applied in accordance with a predefined protocol comprising sequentially ([0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially … These patterns may be repeated and/or further be immediately followed by one or more other patterns; wherein the following patterns are seen as being part of a predefined protocol comprising the following steps occurring in sequence):
applying the pulses between pairs of the first radial electrodes ([0081]: In the energy delivery pattern shown in FIGS. 7 and 8, every other electrode 18A may be active and connected to the generator 14 (electrodes E1, E3, E5, E7, E9, E11, E13, and E15). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E1, E5, E9, and E13) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E3, E7, E11, and E15) … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E1 and E3, between electrodes E3 and E5, between electrodes E5 and E7, and so on);
after applying the pulses between the pairs of the first radial electrodes, applying the pulses between pairs of the second radial electrodes ([0082]: In the energy delivery pattern shown in FIGS. 9 and 10, every other electrode 18A may be active and connected to the generator 14 (electrodes E2, E4, E6, E8, E10, E12, E14, and E16). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E2, D6, E10, and E14) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E4, E8, E12, and D16). … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E2 and E4, between electrodes E4 and E6, between electrodes E6 and E8, and so on; [0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially);
after applying the pulses between the pairs of the second radial electrodes, applying the pulses between the first radial electrodes and the axial electrode ([0081]: In the energy delivery pattern shown in FIGS. 7 and 8, every other electrode 18A may be active and connected to the generator 14 (electrodes E1, E3, E5, E7, E9, E11, E13, and E15). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E1, E5, E9, and E13) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E3, E7, E11, and E15) … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E1 and E3, between electrodes E3 and E5, between electrodes E5 and E7, and so on; [0080]: electrodes 18A are also shaded in the figures, and inactive electrodes (electrodes that are uncoupled from both polarities of the generator 14) are referred to with reference number 18B in FIGS. 5-21; [0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially … These patterns may be repeated and/or further be immediately followed by one or more other patterns; see Figs. 7-8 where distal electrode 18’’ is also shaded as an active electrode); and
after applying the pulses between the first radial electrodes and the axial electrode, applying the pulses between the second radial electrodes and the axial electrode ([0082]: In the energy delivery pattern shown in FIGS. 9 and 10, every other electrode 18A may be active and connected to the generator 14 (electrodes E2, E4, E6, E8, E10, E12, E14, and E16). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E2, D6, E10, and E14) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E4, E8, E12, and D16). … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E2 and E4, between electrodes E4 and E6, between electrodes E6 and E8, and so on; [0080]: electrodes 18A are also shaded in the figures, and inactive electrodes (electrodes that are uncoupled from both polarities of the generator 14) are referred to with reference number 18B in FIGS. 5-21; [0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially … These patterns may be repeated and/or further be immediately followed by one or more other patterns; see Figs. 9-10 where distal electrode 18’’ is also shaded as an active electrode).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the pulse application of Viswanathan to the protocol of Stewart for the purpose of a sequence of a plurality of energy delivery patterns to enhancing lesion formation, customized energy delivery patterns creating specific lesion sizes, shapes, and depths and such that an increased distance between active electrode pairs may help drive the electroporation energy deeper into the target tissue (Stewart: Abstract, [0076], [0081]).
Regarding claim 2, Viswanathan discloses wherein the plurality of resilient spines (splines 3830) comprise respective proximal and distal tips, wherein the proximal tips of the plurality of resilient spines are joined proximate a proximal end of the basket assembly, and the distal tips of the plurality of resilient spines are joined to the distal end of the basket assembly ([0253]: A distal end of each spline of the set of splines (3830) may be tethered to and/or coupled to a distal portion of the inner shaft (3820). Proximal portions of the set of splines (3830) may be attached to and/or coupled to the outer shaft (3810)), and the plurality of resilient spines bow radially outward away from the longitudinal axis when the basket assembly is deployed in the body cavity so that the radial electrodes contact the tissue in the body cavity ([0256]: In some embodiments, the set of splines (3830) may be configured to transform between a first configuration shown in FIG. 38A, where the set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800), and a second configuration (e.g., expanded configuration, basket configuration, deployed configuration) shown in FIG. 38B, where a distal portion (3804) of each spline of the set of splines (3830) bows radially outward from the longitudinal axis (3824); [0267]: The ablation device (3800) as described herein may be disposed in the first configuration prior to delivering a pulse waveform and transformed to the second configuration to make contact with a tissue surface (e.g., an inner wall of the left atrium or ventricle, and/or the like)).
Regarding claim 4, Viswanathan discloses the body cavity comprising a chamber of a heart of the patient and the tissue comprising myocardial tissue, wherein the insertion tube comprises a flexible catheter configured for insertion into the chamber of a heart of the patient and the plurality of electrodes are configured to contact and apply the pulses to the myocardial tissue within the chamber ([0267]: The ablation device (3800) as described herein may be disposed in the first configuration prior to delivering a pulse waveform and transformed to the second configuration to make contact with a tissue surface (e.g., an inner wall of the left atrium or ventricle, and/or the like)).
Regarding claim 5, Viswanathan discloses wherein the first radial electrodes and the second radial electrodes comprise a single respective radial electrode on each respective resilient spine of the plurality of resilient spines ([0266]: For example, a particular activation sequence may include activating distal electrodes (3432) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D) and activating proximal electrodes (3834) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D); wherein this limitation is seen as active electrodes).
Regarding claim 6, Viswanathan discloses wherein the first radial electrodes and the second radial electrodes comprise multiple radial electrodes on each respective resilient spine of the plurality of resilient spines in respective locations that are longitudinally staggered among the plurality of resilient spines ([0266]: In some embodiments, the set of distal electrodes (3832) may be separated from the distal portion (3822) by at most 6 mm from the distal end of each spline (3830). In some embodiments, the set of distal electrodes (3832) may be separated from the set of proximal electrodes (3834) by between about 1 mm and about 20 mm … For example, a particular activation sequence may include activating distal electrodes (3432) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D) and activating proximal electrodes (3834) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D); wherein this limitation is seen as active electrodes).
Regarding claim 7, Viswanathan discloses wherein the pulses configured to be applied by the electrical signal generator ([0342]: FIG. 24 provides an example of a biphasic waveform sequence with a hierarchical structure; [0344]: A variety of hierarchical waveforms can be generated with a suitable pulse generator) comprise a sequence of the pulses having an amplitude of at least approximately 200 V ([0342]: The amplitude of each pulse or the voltage amplitude of the biphasic pulse can be anywhere in the range from 500 volts to 7,000 volts or higher, including all values and sub ranges in between), and a duration of each pulse of the pulses is less than approximately 20 µs ([0342]: The pulse width/pulse time duration can be in the range from nanoseconds or even sub-nanoseconds to tens of microseconds).
Regarding claim 8, Viswanathan discloses wherein the sequence of the pulses comprises biphasic pairs of the pulses, wherein each biphasic pair comprises a positive pulse and a negative pulse ([0342]: biphasic pulses such as (2400) have a positive voltage portion as well as a negative voltage portion to complete one cycle of the pulse).
Regarding claim 10, Viswanathan discloses wherein the electrical signal generator is configured to apply the pulses in a unipolar mode between one or more of the plurality of electrodes on the basket assembly, including the axial electrode, and a common electrode that is separate from the probe ([0074]: The apparatus (120) may be coupled to an ablation device (110), and optionally to a pacing device (130) and/or an optional return electrode (140) (e.g., a return pad, illustrated here with dotted lines); [0075]: the signal generator (122) may be a voltage pulse waveform generator and deliver a pulse waveform to the ablation device (110). The return electrode (140) may be coupled to a patient (e.g., disposed on a patient's back) to allow current to pass from the ablation device (110) through the patient and then to the return electrode (140) to provide a safe current return path from the patient (not shown)).
Regarding claim 13, Viswanathan in view of Stewart discloses wherein in accordance with the predefined protocol, the pulses are configured to be applied simultaneously between two or more of the radial electrodes and the axial electrode (Stewart: [0080]: electrodes 18A are also shaded in the figures, and inactive electrodes (electrodes that are uncoupled from both polarities of the generator 14) are referred to with reference number 18B in FIGS. 5-21; see Figs. 7-10 where distal electrode 18’’ is also shaded as an active electrode).
Regarding claim 16, Viswanathan discloses wherein the radial electrodes comprise at least proximal and distal radial electrodes on each respective resilient spine of the plurality of resilient spines ([0254]: Each spline of the set of splines (3830) may include a set of electrodes (3832, 3834) from the plurality of electrodes formed on the surface of that spline), and wherein in accordance with the predefined protocol, the pulses are configured to be applied to only one of the proximal or distal radial electrodes on each respective resilient spine of the plurality of resilient spines ([0265]: the set of electrodes (3832, 3834) may be configured in anode-cathode sets … the set of electrodes (3832, 3834) of one or more splines of the set of splines (3830) may be activated together to deliver pulse waveforms for irreversible electroporation. In other embodiments, the pulse waveform delivery may be repeated sequentially over predetermined subsets of the set of electrodes (3832, 3834)).
Regarding claim 17, Viswanathan discloses a method for medical treatment (Abstract: Systems, devices, and methods for electroporation ablation therapy), comprising:
providing a basket assembly (set of splines 3830) for insertion into a body cavity of a patient ([0267]: The ablation device (3800) as described herein may be disposed in the first configuration prior to delivering a pulse waveform and transformed to the second configuration to make contact with a tissue surface (e.g., an inner wall of the left atrium or ventricle, and/or the like)), the basket assembly comprising a plurality of resilient spines (set of splines 3830), which are (i) configured to, in an expanded state, bow radially outward around a longitudinal axis of the basket assembly (set of splines 3830) and, in a collapsed state, extend parallel to the longitudinal axis ([0256]: the set of splines (3830) may be configured to transform between a first configuration shown in FIG. 38A, where the set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800); see also Fig. 38C) and (ii) are conjoined at a distal end of the basket assembly ([0253]: A distal end of each spline of the set of splines (3830) may be tethered to and/or coupled to a distal portion of the inner shaft (3820)), and a plurality of electrodes (electrodes 3832, 3834), which are configured to contact tissue in the body cavity ([0254]: The ablation device/apparatus may include a plurality of electrodes configured to generate an electric field for ablating tissue. Each spline of the set of splines (3830) may include a set of electrodes (3832, 3834)) and comprise radial electrodes (electrodes 3832, 3834), each radial electrode disposed on a respective resilient spine of the plurality of resilient spines ([0254]: Each of the distal electrodes (3832) are the nearest to the distal portion (3822) relative to other electrodes (e.g., the set of proximal electrodes (3834)) of its corresponding set of electrodes on the same spline) such that each radial electrode is disposed on a section of the respective resilient spines that extends parallel to the longitudinal axis in the collapsed state ([0256]: set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800); see Fig. 38A where this includes electrodes 3832, 3834), each radial electrode bulging beyond a surface boundary of the respective resilient spine of the plurality of resilient spines and extending around the respective resilient spine of the plurality of resilient spines ([0254]: the set of electrodes (3832, 3834) may each extend around a circumference of its spline. For example, the distal electrodes (3832) may be constructed from metallic rings that encircle a circumference of its spline; wherein the electrodes comprising metallic rings wrapped around a circumference of the spline is seen as bulging from a surface boundary (the circumference) of a given spline), the radial electrodes comprising (i) first radial electrodes that are disposed on a first set of different, non-adjacent resilient spines of the plurality of resilient spines (every other electrode 3832, Fig. 38A) and (ii) second radial electrodes that are disposed on a second set of different, non-adjacent resilient spines of the plurality of resilient spines (every other electrode 3834, Fig. 38A); and
applying to the plurality of electrodes, including the axial electrode, pulses in a bipolar mode having an amplitude sufficient to cause irreversible electroporation (IRE) in the tissue contacted by the plurality of electrodes ([0075]: The signal generator (122) may be configured to generate pulse waveforms for irreversible electroporation of tissue, such as, for example, pulmonary vein ostia. For example, the signal generator (122) may be a voltage pulse waveform generator and deliver a pulse waveform to the ablation device (110); [0246]: In some embodiments, the cap electrode (3322) and the set of electrodes (3332, 3334) may be configured in anode-cathode sets; [0265]: In some embodiments, the set of electrodes (3832, 3834) may be configured in anode-cathode sets; see explanation, below of Viswanathan’s teachings that include an axial electrode), the pulses being applied in accordance with a predefined protocol comprising sequentially:
applying the pulses between pairs of the first radial electrodes ([0265]: For example, a particular activation sequence may include activating distal electrodes (3432) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D));
after applying the pulses between the pairs of the first radial electrodes, applying the pulses between pairs of the second radial electrodes ([0265]: For example, a particular activation sequence may include activating distal electrodes (3432) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D) and activating proximal electrodes (3834) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D)).
But Viswanathan fails to disclose: an axial electrode disposed on the longitudinal axis of the basket assembly.
However, Viswanathan in a different embodiment discloses an axial electrode (cap electrode 3322, Fig. 33A) disposed on the longitudinal axis of the basket assembly ([0240]: distal cap electrode (3322) may be formed at the distal end of the catheter device (3300); see Fig. 33A where this is along axis 3324). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the embodiment of Viswanathan to include an axial electrode, as taught by another embodiment of Viswanathan, for the purpose of the combination of closely-placed distal electrodes having outward-facing windows and a cap electrode allows the distal end of the ablation device to generate and project a stronger electric field, and to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one of these electrodes alone (Viswanathan: [0239]).
But Viswanathan fails to disclose the pulses being configured to be applied in accordance with a predefined protocol comprising sequentially:
after applying the pulses between the pairs of the second radial electrodes applying the pulses between the first radial electrodes and the axial electrode; and
applying the pulses between the second radial electrodes and the axial electrode.
However, Stewart discloses a method (Abstract: A method, system, and device for electroporation; [0078]: That is, even though the figures show an expandable element 30 that is inflatable, it will be understood that the expandable element 30 may include one or more splines 41 in addition to or instead of the inflatable expandable element) and the pulses being configured to be applied in accordance with a predefined protocol comprising sequentially ([0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially … These patterns may be repeated and/or further be immediately followed by one or more other patterns):
applying the pulses between pairs of the first radial electrodes ([0081]: In the energy delivery pattern shown in FIGS. 7 and 8, every other electrode 18A may be active and connected to the generator 14 (electrodes E1, E3, E5, E7, E9, E11, E13, and E15). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E1, E5, E9, and E13) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E3, E7, E11, and E15) … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E1 and E3, between electrodes E3 and E5, between electrodes E5 and E7, and so on);
after applying the pulses between the pairs of the first radial electrodes, applying the pulses between pairs of the second radial electrodes ([0082]: In the energy delivery pattern shown in FIGS. 9 and 10, every other electrode 18A may be active and connected to the generator 14 (electrodes E2, E4, E6, E8, E10, E12, E14, and E16). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E2, D6, E10, and E14) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E4, E8, E12, and D16). … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E2 and E4, between electrodes E4 and E6, between electrodes E6 and E8, and so on; [0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially);
after applying the pulses between the pairs of the second radial electrodes, applying the pulses between the first radial electrodes and the axial electrode ([0081]: In the energy delivery pattern shown in FIGS. 7 and 8, every other electrode 18A may be active and connected to the generator 14 (electrodes E1, E3, E5, E7, E9, E11, E13, and E15). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E1, E5, E9, and E13) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E3, E7, E11, and E15) … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E1 and E3, between electrodes E3 and E5, between electrodes E5 and E7, and so on; [0080]: electrodes 18A are also shaded in the figures, and inactive electrodes (electrodes that are uncoupled from both polarities of the generator 14) are referred to with reference number 18B in FIGS. 5-21; [0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially … These patterns may be repeated and/or further be immediately followed by one or more other patterns; see Figs. 7-8 where distal electrode 18’’ is also shaded as an active electrode); and
after applying the pulses between the first radial electrodes and the axial electrode, applying the pulses between the second radial electrodes and the axial electrode ([0082]: In the energy delivery pattern shown in FIGS. 9 and 10, every other electrode 18A may be active and connected to the generator 14 (electrodes E2, E4, E6, E8, E10, E12, E14, and E16). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E2, D6, E10, and E14) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E4, E8, E12, and D16). … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E2 and E4, between electrodes E4 and E6, between electrodes E6 and E8, and so on; [0080]: electrodes 18A are also shaded in the figures, and inactive electrodes (electrodes that are uncoupled from both polarities of the generator 14) are referred to with reference number 18B in FIGS. 5-21; [0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially … These patterns may be repeated and/or further be immediately followed by one or more other patterns; see Figs. 9-10 where distal electrode 18’’ is also shaded as an active electrode).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the pulse application of Viswanathan to the protocol of Stewart for the purpose of a sequence of a plurality of energy delivery patterns to enhancing lesion formation, customized energy delivery patterns creating specific lesion sizes, shapes, and depths and such that an increased distance between active electrode pairs may help drive the electroporation energy deeper into the target tissue (Stewart: Abstract, [0076], [0081]).
Regarding claim 18, Viswanathan discloses wherein the plurality of resilient spines (splines 3830) have respective proximal and distal tips, wherein the proximal tips of the plurality of resilient spines are coupled together at a at a proximal end of the basket assembly, and the distal tips of the plurality of resilient spines are coupled together at the distal end of the basket assembly ([0253]: A distal end of each spline of the set of splines (3830) may be tethered to and/or coupled to a distal portion of the inner shaft (3820). Proximal portions of the set of splines (3830) may be attached to and/or coupled to the outer shaft (3810)), and the plurality of resilient spines bow radially outward when the basket assembly is deployed in the body cavity, whereby the radial electrodes contact the tissue in the body cavity ([0256]: In some embodiments, the set of splines (3830) may be configured to transform between a first configuration shown in FIG. 38A, where the set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800), and a second configuration (e.g., expanded configuration, basket configuration, deployed configuration) shown in FIG. 38B, where a distal portion (3804) of each spline of the set of splines (3830) bows radially outward from the longitudinal axis (3824); [0267]: The ablation device (3800) as described herein may be disposed in the first configuration prior to delivering a pulse waveform and transformed to the second configuration to make contact with a tissue surface (e.g., an inner wall of the left atrium or ventricle, and/or the like)).
Regarding claim 20, Viswanathan discloses the body cavity comprising a chamber of a heart and the tissue comprising myocardial tissue within the chamber, and the method further comprising providing an insertion tube that comprises a flexible catheter configured for insertion into the chamber of the heart of the patient, and the plurality of electrodes are configured to contact and apply the pulses to the myocardial tissue within the chamber ([0267]: The ablation device (3800) as described herein may be disposed in the first configuration prior to delivering a pulse waveform and transformed to the second configuration to make contact with a tissue surface (e.g., an inner wall of the left atrium or ventricle, and/or the like)).
Regarding claim 21, Viswanathan discloses wherein the first radial electrodes and the second radial electrodes comprise a single respective radial electrode on each respective resilient spine of the plurality of resilient spines ([0266]: For example, a particular activation sequence may include activating distal electrodes (3432) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D) and activating proximal electrodes (3834) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D); wherein this limitation is seen as active electrodes).
Regarding claim 22, Viswanathan discloses wherein the first radial electrodes and the second radial electrodes comprise multiple radial electrodes on each respective resilient spine of the plurality of resilient spines in respective locations that are longitudinally staggered among the plurality of resilient spines ([0266]: In some embodiments, the set of distal electrodes (3832) may be separated from the distal portion (3822) by at most 6 mm from the distal end of each spline (3830). In some embodiments, the set of distal electrodes (3832) may be separated from the set of proximal electrodes (3834) by between about 1 mm and about 20 mm … For example, a particular activation sequence may include activating distal electrodes (3432) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D) and activating proximal electrodes (3834) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D); wherein this limitation is seen as active electrodes).
Regarding claim 23, Viswanathan discloses wherein applying the pulses ([0342]: FIG. 24 provides an example of a biphasic waveform sequence with a hierarchical structure; [0344]: A variety of hierarchical waveforms can be generated with a suitable pulse generator; [0345]: In some embodiments, the ablation pulse waveforms described herein are applied during the refractory period of the cardiac cycle) comprises applying a sequence of the pulses having an amplitude of at least approximately 200 V ([0342]: The amplitude of each pulse or the voltage amplitude of the biphasic pulse can be anywhere in the range from 500 volts to 7,000 volts or higher, including all values and sub ranges in between), and wherein a duration of each pulse of the pulses is less than approximately 20 µs ([0342]: The pulse width/pulse time duration can be in the range from nanoseconds or even sub-nanoseconds to tens of microseconds). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the generator of Olson in view of Howard and Stewart to the generator of Viswanathan for the purpose that the pulsed waveforms may enhance the safety, efficiency and effectiveness of the energy delivery by reducing the electric field threshold associated with irreversible electroporation, yielding more effective ablative lesions with reduced total energy delivered (Viswanathan: [0338]).
Regarding claim 24, Viswanathan discloses wherein the sequence of the pulses comprises biphasic pairs of the pulses, wherein each biphasic pair comprises a positive pulse and a negative pulse ([0342]: biphasic pulses such as (2400) have a positive voltage portion as well as a negative voltage portion to complete one cycle of the pulse).
Regarding claim 26, Viswanathan discloses wherein the predefined protocol further comprises applying the pulses comprises applying the pulses in a unipolar mode between one or more electrode of the plurality of electrodes on the basket assembly, including the axial electrode, and a common electrode that is separate from the basket assembly ([0074]: The apparatus (120) may be coupled to an ablation device (110), and optionally to a pacing device (130) and/or an optional return electrode (140) (e.g., a return pad, illustrated here with dotted lines); [0075]: the signal generator (122) may be a voltage pulse waveform generator and deliver a pulse waveform to the ablation device (110). The return electrode (140) may be coupled to a patient (e.g., disposed on a patient's back) to allow current to pass from the ablation device (110) through the patient and then to the return electrode (140) to provide a safe current return path from the patient (not shown)).
Regarding claim 29, Viswanathan in view of Stewart discloses wherein in accordance with the predefined protocol, the pulses are applied simultaneously between two or more of the radial electrodes and the axial electrode (Stewart: [0080]: electrodes 18A are also shaded in the figures, and inactive electrodes (electrodes that are uncoupled from both polarities of the generator 14) are referred to with reference number 18B in FIGS. 5-21; see Figs. 7-10 where distal electrode 18’’ is also shaded as an active electrode).
Regarding claim 32, Viswanathan discloses wherein the radial electrodes comprise at least proximal and distal radial electrodes on each respective resilient spine of the plurality of resilient spines ([0254]: Each spline of the set of splines (3830) may include a set of electrodes (3832, 3834) from the plurality of electrodes formed on the surface of that spline), and wherein in accordance with the predefined protocol, the pulses are applied to only one of the proximal or distal radial electrodes on each respective resilient spine of the plurality of resilient spines ([0265]: the set of electrodes (3832, 3834) may be configured in anode-cathode sets … the set of electrodes (3832, 3834) of one or more splines of the set of splines (3830) may be activated together to deliver pulse waveforms for irreversible electroporation. In other embodiments, the pulse waveform delivery may be repeated sequentially over predetermined subsets of the set of electrodes (3832, 3834)).
Regarding claim 33, Viswanathan discloses a medical apparatus (Abstract: Systems, devices, and methods for electroporation ablation therapy), comprising:
a probe (ablation device 3800, Fig. 38A), comprising:
an insertion tube (outer shaft 3810) configured for insertion into a body cavity of a patient ([0267]: The ablation device (3800) as described herein may be disposed in the first configuration prior to delivering a pulse waveform and transformed to the second configuration to make contact with a tissue surface (e.g., an inner wall of the left atrium or ventricle, and/or the like));
a basket assembly (set of splines 3830) having a proximal end that is connected distally to the insertion tube ([0253]: A proximal end of the set of splines (3830) may be coupled to a distal end of the outer shaft (3810)) and comprising a plurality of resilient spines (splines 3830), which are (i) configured to, in an expanded state, bow radially outward around a longitudinal axis of the basket assembly ([0256]: a second configuration (e.g., expanded configuration, basket configuration, deployed configuration) shown in FIG. 38B, where a distal portion (3804) of each spline of the set of splines (3830) bows radially outward from the longitudinal axis (3824)) and, in a collapsed state, extend parallel to the longitudinal axis ([0256]: the set of splines (3830) may be configured to transform between a first configuration shown in FIG. 38A, where the set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800); see also Fig. 38C) and (ii) are conjoined at a distal end of the basket assembly ([0253]: A distal end of each spline of the set of splines (3830) may be tethered to and/or coupled to a distal portion of the inner shaft (3820)); and
a plurality of electrodes (electrodes 3832, 3834), which are configured to contact tissue in the body cavity ([0254]: The ablation device/apparatus may include a plurality of electrodes configured to generate an electric field for ablating tissue. Each spline of the set of splines (3830) may include a set of electrodes (3832, 3834)) and comprise (i) first radial electrodes that are disposed on a first set of different, non-adjacent resilient spines of the plurality of resilient spines (every other electrode 3832, Fig. 38A) such that each first radial electrode is disposed on a section of the respective resilient spines that extends parallel to the longitudinal axis in the collapsed state ([0256]: the set of splines (3830) may be configured to transform between a first configuration shown in FIG. 38A, where the set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800); see Fig. 38A where this includes electrodes 3832), (ii) second radial electrodes that are disposed on a second set of different, non-adjacent resilient spines of the plurality of resilient spines (every other electrode 3834, Fig. 38A) such that each second radial electrode is disposed on a section of the respective resilient spines that extends parallel to the longitudinal axis in the collapsed state ([0256]: the set of splines (3830) may be configured to transform between a first configuration shown in FIG. 38A, where the set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800); see Fig. 38A where this includes electrodes 3834); and
an electrical signal generator (signal generator 122) configured to apply to the plurality of electrodes, including the axial electrode, pulses having an amplitude sufficient to cause irreversible electroporation (IRE) in the tissue contacted by the plurality of electrodes, the pulses being applied in a bipolar mode between different pairs of the plurality of electrodes sequentially with a predefined protocol ([0075]: The signal generator (122) may be configured to generate pulse waveforms for irreversible electroporation of tissue, such as, for example, pulmonary vein ostia. For example, the signal generator (122) may be a voltage pulse waveform generator and deliver a pulse waveform to the ablation device (110); [0246]: In some embodiments, the cap electrode (3322) and the set of electrodes (3332, 3334) may be configured in anode-cathode sets; [0265]: In some embodiments, the set of electrodes (3832, 3834) may be configured in anode-cathode sets; see explanation, below of Viswanathan’s teachings that include an axial electrode), the predefined protocol comprising:
applying the pulses between pairs of the first radial electrodes ([0265]: For example, a particular activation sequence may include activating distal electrodes (3432) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D));
applying the pulses between pairs of the second radial electrodes ([0265]: For example, a particular activation sequence may include activating distal electrodes (3432) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D) and activating proximal electrodes (3834) of half of the splines (3830) (e.g., two of the four splines (3830) depicted in FIGS. 38A-38D)).
But Viswanathan fails to disclose (iii) an axial electrode disposed on the longitudinal axis of the basket assembly.
However, Viswanathan in a different embodiment discloses an axial electrode (cap electrode 3322, Fig. 33A) disposed on the longitudinal axis of the basket assembly ([0240]: distal cap electrode (3322) may be formed at the distal end of the catheter device (3300); see Fig. 33A where this is along axis 3324). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the embodiment of Viswanathan to include an axial electrode, as taught by another embodiment of Viswanathan, for the purpose of the combination of closely-placed distal electrodes having outward-facing windows and a cap electrode allows the distal end of the ablation device to generate and project a stronger electric field, and to thereby more effectively generate focal ablation lesions of tissue at a desired depth compared to any one of these electrodes alone (Viswanathan: [0239]).
but Viswanathan fails to disclose the pulses being applied in a bipolar mode between different pairs of the plurality of electrodes sequentially with a predefined protocol, the predefined protocol comprising:
applying the pulses between the first radial electrodes and the axial electrode; and
applying the pulses between the second radial electrodes and the axial electrode.
However, Stewart discloses a medical apparatus (Abstract: A method, system, and device for electroporation; [0078]: That is, even though the figures show an expandable element 30 that is inflatable, it will be understood that the expandable element 30 may include one or more splines 41 in addition to or instead of the inflatable expandable element) and the pulses being applied in a bipolar mode between different pairs of the plurality of electrodes sequentially with a predefined protocol (Abstract: The energy generator may also be configured to deliver electroporation energy in a sequence of a plurality of energy delivery patterns to enhance lesion formation; [0022]: the energy generator is configured to deliver bipolar electroporation energy; [0077]: These patterns may be repeated and/or further be immediately followed by one or more other patterns … the processing circuitry 50 may be configured to automatically deliver a sequence of two or more energy delivery patterns in rapid succession by selectively activating or deactivating each of the plurality of electrodes; wherein the following patterns are seen as being part of a predefined protocol comprising the following steps occurring in sequence), the predefined protocol comprising:
applying the pulses between pairs of the first radial electrodes ([0081]: In the energy delivery pattern shown in FIGS. 7 and 8, every other electrode 18A may be active and connected to the generator 14 (electrodes E1, E3, E5, E7, E9, E11, E13, and E15). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E1, E5, E9, and E13) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E3, E7, E11, and E15) … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E1 and E3, between electrodes E3 and E5, between electrodes E5 and E7, and so on);
applying the pulses between pairs of the second radial electrodes ([0082]: In the energy delivery pattern shown in FIGS. 9 and 10, every other electrode 18A may be active and connected to the generator 14 (electrodes E2, E4, E6, E8, E10, E12, E14, and E16). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E2, D6, E10, and E14) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E4, E8, E12, and D16). … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E2 and E4, between electrodes E4 and E6, between electrodes E6 and E8, and so on; [0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially);
applying the pulses between the first radial electrodes and the axial electrode ([0081]: In the energy delivery pattern shown in FIGS. 7 and 8, every other electrode 18A may be active and connected to the generator 14 (electrodes E1, E3, E5, E7, E9, E11, E13, and E15). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E1, E5, E9, and E13) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E3, E7, E11, and E15) … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E1 and E3, between electrodes E3 and E5, between electrodes E5 and E7, and so on; [0080]: electrodes 18A are also shaded in the figures, and inactive electrodes (electrodes that are uncoupled from both polarities of the generator 14) are referred to with reference number 18B in FIGS. 5-21; [0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially … These patterns may be repeated and/or further be immediately followed by one or more other patterns; see Figs. 7-8 where distal electrode 18’’ is also shaded as an active electrode); and
applying the pulses between the second radial electrodes and the axial electrode ([0082]: In the energy delivery pattern shown in FIGS. 9 and 10, every other electrode 18A may be active and connected to the generator 14 (electrodes E2, E4, E6, E8, E10, E12, E14, and E16). Of these, every other active electrode 18A may be connected to the negative polarity of the generator 14 (electrodes E2, D6, E10, and E14) and the intervening active electrodes may be connected to the positive polarity of the generator 14 (electrodes E4, E8, E12, and D16). … In this configuration, bipolar energy may be delivered between adjacent pairs of active electrodes 18A with opposite polarities, such as between electrodes E2 and E4, between electrodes E4 and E6, between electrodes E6 and E8, and so on; [0080]: electrodes 18A are also shaded in the figures, and inactive electrodes (electrodes that are uncoupled from both polarities of the generator 14) are referred to with reference number 18B in FIGS. 5-21; [0077]: processing circuitry 50 may be programmed and configured to automatically or semi-automatically switch electrode connections (for example, through the CEDS 16) multiple times during a medical procedure to deliver two or more energy delivery patterns sequentially … These patterns may be repeated and/or further be immediately followed by one or more other patterns; see Figs. 9-10 where distal electrode 18’’ is also shaded as an active electrode).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the pulse application of Viswanathan to the protocol of Stewart for the purpose of a sequence of a plurality of energy delivery patterns to enhancing lesion formation, customized energy delivery patterns creating specific lesion sizes, shapes, and depths and such that an increased distance between active electrode pairs may help drive the electroporation energy deeper into the target tissue (Stewart: Abstract, [0076], [0081]).
Regarding claim 36, Viswanathan discloses wherein, in the collapsed state, each resilient spine of the plurality of resilient spines straightens along an axial direction that is parallel to the longitudinal axis ([0256]: the set of splines (3830) may be configured to transform between a first configuration shown in FIG. 38A, where the set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800); see also Fig. 38C).
Regarding claim 37, Viswanathan discloses wherein, in the collapsed state, each resilient spine of the plurality of resilient spines straightens along an axial direction that is parallel to the longitudinal axis ([0256]: the set of splines (3830) may be configured to transform between a first configuration shown in FIG. 38A, where the set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800); see also Fig. 38C).
Regarding claim 38, Viswanathan discloses wherein, wherein, in the collapsed state, each resilient spine of the plurality of resilient spines straightens along an axial direction that is parallel to the longitudinal axis ([0256]: the set of splines (3830) may be configured to transform between a first configuration shown in FIG. 38A, where the set of splines (3830) are arranged generally parallel to the longitudinal axis (3824) of the ablation device (3800); see also Fig. 38C).
Regarding claim 39, Viswanathan discloses wherein, in the expanded state, the section of each resilient spine of the plurality of resilient spines is non-overlapping with the sections of adjacent resilient spines of the plurality of resilient spines along an axial direction that is parallel to the longitudinal axis ([0256]: a second configuration (e.g., expanded configuration, basket configuration, deployed configuration) shown in FIG. 38B, where a distal portion (3804) of each spline of the set of splines (3830) bows radially outward from the longitudinal axis (3824); see Fig. 38B where the splines do not overlap with each other & are non-overlapping in an axial direction parallel to the longitudinal axis).
Regarding claim 40, Viswanathan discloses wherein, in the expanded state, the section of each resilient spine of the plurality of resilient spines is non-overlapping with the sections of adjacent resilient spines of the plurality of resilient spines along an axial direction that is parallel to the longitudinal axis ([0256]: a second configuration (e.g., expanded configuration, basket configuration, deployed configuration) shown in FIG. 38B, where a distal portion (3804) of each spline of the set of splines (3830) bows radially outward from the longitudinal axis (3824); see Fig. 38B where the splines do not overlap with each other & are non-overlapping in an axial direction parallel to the longitudinal axis).
Regarding claim 41, Viswanathan discloses wherein, in the expanded state, the section of each resilient spine of the plurality of resilient spines is non-overlapping with the sections of adjacent resilient spines of the plurality of resilient spines along an axial direction that is parallel to the longitudinal axis ([0256]: a second configuration (e.g., expanded configuration, basket configuration, deployed configuration) shown in FIG. 38B, where a distal portion (3804) of each spline of the set of splines (3830) bows radially outward from the longitudinal axis (3824); see Fig. 38B where the splines do not overlap with each other & are non-overlapping in an axial direction parallel to the longitudinal axis).
Regarding claim 42, Viswanathan discloses wherein, in the expanded state, each radial electrode of each resilient spine of the plurality of resilient spines is non-overlapping with each radial electrode of adjacent resilient spines of the plurality of resilient spines along an axial direction that is parallel to the longitudinal axis ([0256]: a second configuration (e.g., expanded configuration, basket configuration, deployed configuration) shown in FIG. 38B, where a distal portion (3804) of each spline of the set of splines (3830) bows radially outward from the longitudinal axis (3824); see Fig. 38B where the electrodes do not overlap with each other & are non-overlapping in an axial direction parallel to the longitudinal axis).
Regarding claim 43, Viswanathan discloses wherein, in the expanded state, each radial electrode of each resilient spine of the plurality of resilient spines is non-overlapping with each radial electrode of adjacent resilient spines of the plurality of resilient spines along an axial direction that is parallel to the longitudinal axis ([0256]: a second configuration (e.g., expanded configuration, basket configuration, deployed configuration) shown in FIG. 38B, where a distal portion (3804) of each spline of the set of splines (3830) bows radially outward from the longitudinal axis (3824)).
Regarding claim 44, Viswanathan discloses wherein, in the expanded state, each first radial electrode of each resilient spine of the plurality of resilient spines is non-overlapping with each second radial electrode of an adjacent resilient spine of the plurality of resilient spines along an axial direction that is parallel to the longitudinal axis ([0256]: a second configuration (e.g., expanded configuration, basket configuration, deployed configuration) shown in FIG. 38B, where a distal portion (3804) of each spline of the set of splines (3830) bows radially outward from the longitudinal axis (3824); see Fig. 38B where the electrodes do not overlap with each other & are non-overlapping in an axial direction parallel to the longitudinal axis).
Claims 15 & 31 are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan in view of Stewart as applied to claims 1 & 17, above, and further in view of Howard et al. (U.S. Pub. No. 2018/0214202, previously cited), herein referred to as “Howard”.
Regarding claim 15, Viswanathan in view of Stewart fails to disclose wherein in accordance with the predefined protocol, the pulses are configured to be applied to the radial electrodes on different ones of the plurality of resilient spines in a predefined sequence in which the pulses are not applied in immediate succession to the radial electrodes on mutually adjacent spines of the plurality of resilient spines.
However, Howard discloses wherein in accordance with the predefined protocol, the pulses are configured to be applied to the radial electrodes on different ones of the plurality of resilient spines in a predefined sequence in which the pulses are not applied in immediate succession to the radial electrodes on mutually adjacent spines of the plurality of resilient spines ([0094]: as shown in FIG. 5, ablation energy may be delivered through only the second electrode pair 38a, 38b (Electrodes 3 and 4), the fourth electrode pair 38a, 38b (Electrodes 7 and 8), the sixth electrode pair 38a, 38b (Electrodes 11 and 12), and the eighth electrode pair 38a, 38b (Electrodes 15 and 16); while Howard does not disclose a basket assembly, since the claims only describe electrodes on spines such that they would be interpreted as forming a circumferential lesion, Howard’s patterning on a catheter loop is seen as a functional equivalent to a basket structure when the lesion is presumed to be a circumferential lesion). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the predefined protocol of Viswanathan in view of Stewart to the pattern of Howard for the purpose of creating a larger ablative effect by delivering energy through every other electrode pair (Howard: [0094]).
Regarding claim 31, Viswanathan in view of Stewart fail to disclose wherein in accordance with the predefined protocol, the pulses are applied to the radial electrodes on different ones of the plurality of resilient spines in a predefined sequence in which the pulses are not applied in immediate succession to the radial electrodes on mutually adjacent spines of the plurality of resilient spines.
However, Howard discloses wherein in accordance with the predefined protocol, the pulses are applied to the radial electrodes on different ones of the plurality of resilient spines in a predefined sequence in which the pulses are not applied in immediate succession to the radial electrodes on mutually adjacent spines of the plurality of resilient spines ([0094]: as shown in FIG. 5, ablation energy may be delivered through only the second electrode pair 38a, 38b (Electrodes 3 and 4), the fourth electrode pair 38a, 38b (Electrodes 7 and 8), the sixth electrode pair 38a, 38b (Electrodes 11 and 12), and the eighth electrode pair 38a, 38b (Electrodes 15 and 16); while Howard does not disclose a basket assembly, since the claims only describe electrodes on spines such that they would be interpreted as forming a circumferential lesion, Howard’s patterning on a catheter loop is seen as a functional equivalent to a basket structure when the lesion is presumed to be a circumferential lesion). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the predefined protocol of Viswanathan in view of Stewart to the pattern of Howard for the purpose of creating a larger ablative effect by delivering energy through every other electrode pair (Howard: [0094]).
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794