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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted February 12th, 2026 and April 27th, 2026 have been considered by the Examiner.
Response to Amendment
The amendment filed April 28th, 2026 has been entered. Applicant’s amendments to the claims have overcome the 112(b) rejection previously set forth in the Non-Final Rejection mailed January 27th, 2026.
Response to Arguments
Applicant’s arguments, see pages 14-18, filed April 28th, 2026, 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 the submitted amendment reciting in part “a plurality of ablation electrodes… and a plurality of strip electrodes…”. Therefore, the rejection has been withdrawn.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 15-18 that Viswanathan does not suggest or disclose “each ablation electrode bulging beyond the spine width of the respective resilient spine”, the Examiner respectfully disagrees on the grounds that Viswanathan does disclose this as ring electrodes disposed on a spline does bulge beyond the spine width of the respective resilient spine, as detailed in the original rejection and in the updated rejection, below. Viswanathan in [0254] discloses “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” such that the spine width is the spine circumference and ring electrodes wrapping around the spine circumference are seen as bulging beyond a spine width. Additionally, while Viswanathan’s Figures show the electrodes as flush with the surface of the splines, the claim does not require the spine width to extend along the entire length of the spine such that the spine circumference/width may only be a portion of the spine underneath the ablation electrode. The Examiner agrees that Viswanathan and/or Stewart fails to disclose a plurality of strip electrodes in combination with a plurality of ablation electrodes (as in, the electrodes are distinct), however, the ablation electrodes remain disclosed by Viswanathan.
Regarding Applicant’s arguments on page 17 with respect to typographical errors in the Viswanathan disclosure, the Examiner notes that Viswanathan does have errors, however, the distinction between electrodes being labeled as 3432 and 3832 in Figs. 38A-D are minor errors and it can still be understood what Viswanathan is referencing.
Applicant argues that the additional references relied upon for dependent claims fail to remedy the deficiencies of those used for independent claim 1 (and/or 17 and 33), the Examiner respectfully disagrees on the grounds laid out above for independent claim 1, in which the rejection for claim 1 is also maintained and therefore the rejection for all dependent claims are also updated and maintained.
The following new grounds of rejection are set forth:
Claim Rejections - 35 USC § 112
Claims 1-2, 4-8, 10, 13, 15-18, 20-24, 26, 29, 31-33 & 36-44 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 1, the claim recites “each respective resilient spine” in line 13 and it is unclear if this is the same resilient spine as the plurality of resilient spines recited in line 5 or is a different resilient spine. For examination purposes, these are the same spines and the limitation will be interpreted as “each respective resilient spine of the plurality of resilient spines”.
Regarding claim 1, the claim recites “a respective resilient spine” in line 23 and it is unclear if this is the same resilient spine as the plurality of resilient spines recited in line 5 or is a different resilient spine. For examination purposes, these are the same spines and the limitation will be interpreted as “a respective resilient spine of the plurality of resilient spines”. Line 24 has a similar recitation (“the respective resilient spine”) and will be interpreted similarly: “the respective resilient spine of the plurality of resilient spines”.
Claims 2, 4-8, 10, 13, 15-16, 36, 39 & 42 are also rejected by virtue of their dependency on claim 1.
Regarding claim 17, the claim recites “each respective resilient spine” in line 10 and it is unclear if this is the same resilient spine as the plurality of resilient spines recited in line 3 or is a different resilient spine. For examination purposes, these are the same spines and the limitation will be interpreted as “each respective resilient spine of the plurality of resilient spines”.
Regarding claim 17, the claim recites “a respective resilient spine” in line 19 and it is unclear if this is the same resilient spine as the plurality of resilient spines recited in line 3 or is a different resilient spine. For examination purposes, these are the same spines and the limitation will be interpreted as “a respective resilient spine of the plurality of resilient spines”. Line 21 has a similar recitation (“the respective resilient spine”) and will be interpreted similarly: “the respective resilient spine of the plurality of resilient spines”.
Claims 18, 20-24, 26, 29, 31-32, 37, 40 & 43 are also rejected by virtue of their dependency on claim 17.
Regarding claim 33, the claim recites “each respective resilient spine” in lines 16-17 and it is unclear if this is the same resilient spine as the plurality of resilient spines recited in line 5 or is a different resilient spine. For examination purposes, these are the same spines and the limitation will be interpreted as “each respective resilient spine of the plurality of resilient spines”.
Regarding claim 33, the claim recites “the respective resilient spine” in line 20 and it is unclear if this is the same resilient spine as the plurality of resilient spines recited in line 5 or is a different resilient spine. For examination purposes, these are the same spines and the limitation will be interpreted as “a respective resilient spine of the plurality of resilient spines”.
Regarding claim 33, the claim recites “a respective resilient spine” in line 22 and it is unclear if this is the same resilient spine as the plurality of resilient spines recited in line 5 or is a different resilient spine. For examination purposes, these are the same spines and the limitation will be interpreted as “a respective resilient spine of the plurality of resilient spines”. Line 24 has a similar recitation (“the respective resilient spine”) and will be interpreted similarly: “the respective resilient spine of the plurality of resilient spines”.
Claims 38, 41 & 44 are also rejected by virtue of their dependency on claim 33.
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” and Harlev et al. (U.S. Pub. No. 20090171274, cited in IDS), herein referred to as “Harlev”.
Regarding claim 1, Viswanathan discloses a medical system (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 ablation 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)), each ablation 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 ablation 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 respective resilient spine comprising a spine width perpendicular to the longitudinal axis ([0264]: The thickness of each spline (3830) may vary based on the number of electrodes (3832, 3834) formed on each spline (3830) which may correspond to the number of insulated electrical leads in the spline (3830). The splines (3830) may have the same or different materials, thickness, and/or length; wherein the spines each have a thickness that may be the same amongst all of the splines), each ablation electrode bulging beyond a spine width 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; [0266]: each electrode of the set of electrodes (3832, 3834) may include a diameter of between about 0.5 mm to about 3 mm; wherein the electrodes wrapping around a circumference of the spline is seen as bulging from a spine width (the circumference) of a given spline), the ablation electrodes comprising (i) first ablation 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 ablation 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);
one or more processors (processor 124); and
a memory (memory 126) storing instructions that, when executed by the one or more processors (0075]: The processor (124) may incorporate data received from memory (126), cardiac stimulator (128), and pacing device (130) to determine the parameters (e.g., amplitude, width, duty cycle, etc.) of the pulse waveform to be generated by the signal generator (122). The memory (126) may further store instructions to cause the signal generator (122) to execute modules, processes and/or functions associated with the system (100), such as pulse waveform generation and/or cardiac pacing synchronization), are configured to cause the system to:
cause an electrical signal generator (signal generator 122) 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) … memory (126) may further store instructions to cause the signal generator (122) to execute modules, processes and/or functions associated with the system (100), such as pulse waveform generation and/or cardiac pacing synchronization; [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 ablation 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 ablation electrodes, applying the pulses between pairs of the second ablation 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 ablation electrodes, applying the pulses between the first ablation electrodes and the axial electrode; and
after applying the pulses between the first ablation electrodes and the axial electrode, applying the pulses between the second ablation 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 ablation 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 ablation electrodes, applying the pulses between pairs of the second ablation 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 ablation electrodes, applying the pulses between the first ablation 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 ablation electrodes and the axial electrode, applying the pulses between the second ablation 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]).
But Viswanathan in view of Stewart fail to disclose a plurality of strip electrodes, each comprising a strip electrode width disposed on a respective resilient spine, the strip electrode width being no greater than the spine width of the respective resilient spine; and
one or more processors; and a memory storing instructions that, when executed by the one or more processors, are configured to cause the system to: receive electrical signals from at least some of the plurality of strip electrodes and generate an electro-anatomical map responsive to the received electrical signals.
However, Harlev discloses a plurality of strip electrodes (electrodes 54), each comprising a strip electrode width (see width of electrodes 54 in Fig. 6B) disposed on a respective resilient spine ([0059]: The individual splines may carry several types of electrodes. The array of sensing electrodes typified by spline electrode 54), the strip electrode width being no greater than the spine width of the respective resilient spine (see Fig. 6B where the electrode 54 is inset relative to the width of the total spine thickness); and
one or more processors (processing unit 24); and a memory storing instructions that, when executed by the one or more processors ([0048]: The signal conditioning hardware 20 performs various interface functions applicable to the mapping, tracking, and registration procedures that are performed in conjunction with the workstation class computer-processing unit 24), are configured to cause the system to:
receive electrical signals from at least some of the plurality of strip electrodes and generate an electro-anatomical map responsive to the received electrical signals ([0048]: Each catheter is coupled to signal conditioning hardware 20 with appropriate catheter cabling typified by catheter cable 17. The signal conditioning hardware 20 performs various interface functions applicable to the mapping, tracking, and registration procedures that are performed in conjunction with the workstation class computer-processing unit 24; [0049]: In use, the physician looks at a computer display 26. Present on the display is a substantial amount of information. A large window presents an image of the heart chamber 13 along with an image of the catheter 10. The physician will manipulate and control the catheter 10 based in part on the images and other data presented on the display 26. The image 27 seen in FIG. 1 is schematic and depicts the distal array of the catheter 10 deployed, occupying a small portion of the heart chamber 13 volume. The representation of the heart chamber 13 may use color, wire frame, or other techniques to depict the structure of the heart chamber 13 and to simultaneously portray electrical activity of the patient's heart). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Viswanathan in view of Stewart to include the plurality of strip electrodes and the processor of Harlev for the purpose of the plurality of strip electrodes enabling non-contact mapping via receiving and detecting very small voltages from the blood pool and because it is useful to display chamber geometry, catheter location, and electrical activity in an integrated fashion (Harlev: [0059], [0049]).
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 the 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 ablation 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 ablation 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 ablation electrodes and the second ablation electrodes comprise a single respective ablation 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 ablation electrodes and the second ablation electrodes comprise multiple ablation 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 ablation 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 ablation 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 ablation electrodes comprise at least proximal and distal ablation 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 ablation 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 ablation 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 ablation electrodes (electrodes 3832, 3834), each ablation 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 ablation 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 respective resilient spine comprising a spine width perpendicular to the longitudinal axis ([0264]: The thickness of each spline (3830) may vary based on the number of electrodes (3832, 3834) formed on each spline (3830) which may correspond to the number of insulated electrical leads in the spline (3830). The splines (3830) may have the same or different materials, thickness, and/or length; wherein the spines each have a thickness that may be the same amongst all of the splines), each ablation electrode bulging beyond the spine width 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; [0266]: each electrode of the set of electrodes (3832, 3834) may include a diameter of between about 0.5 mm to about 3 mm; wherein the electrodes wrapping around a circumference of the spline is seen as bulging from a spine width (the circumference) of a given spline), the ablation electrodes comprising (i) first ablation 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 ablation 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 ablation 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 ablation 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 ablation electrodes, applying the pulses between pairs of the second ablation 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 ablation electrodes applying the pulses between the first ablation electrodes and the axial electrode; and
applying the pulses between the second ablation 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 ablation 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 ablation electrodes, applying the pulses between pairs of the second ablation 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 ablation electrodes, applying the pulses between the first ablation 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 ablation electrodes and the axial electrode, applying the pulses between the second ablation 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]).
But Viswanathan in view of Stewart fail to disclose disposing a plurality of strip electrodes on a respective resilient spine, each of the plurality of strip electrodes comprising a strip electrode width being no greater than the spine width of the respective resilient spine;
receiving electrical signals from at least some of the plurality of strip electrodes;
generating an electro-anatomical map responsive to the received electrical signals.
However, Harlev discloses disposing a plurality of strip electrodes (electrodes 54) on a respective resilient spine ([0059]: The individual splines may carry several types of electrodes. The array of sensing electrodes typified by spline electrode 54), each of the plurality of strip electrodes comprising a strip electrode width being no greater than the spine width of the respective resilient spine (see Fig. 6B where the electrode 54 is inset relative to the width of the total spine thickness);
receiving electrical signals from at least some of the plurality of strip electrodes ([0048]: Each catheter is coupled to signal conditioning hardware 20 with appropriate catheter cabling typified by catheter cable 17. The signal conditioning hardware 20 performs various interface functions applicable to the mapping, tracking, and registration procedures that are performed in conjunction with the workstation class computer-processing unit 24);
generating an electro-anatomical map responsive to the received electrical signals ([0049]: In use, the physician looks at a computer display 26. Present on the display is a substantial amount of information. A large window presents an image of the heart chamber 13 along with an image of the catheter 10. The physician will manipulate and control the catheter 10 based in part on the images and other data presented on the display 26. The image 27 seen in FIG. 1 is schematic and depicts the distal array of the catheter 10 deployed, occupying a small portion of the heart chamber 13 volume. The representation of the heart chamber 13 may use color, wire frame, or other techniques to depict the structure of the heart chamber 13 and to simultaneously portray electrical activity of the patient's heart). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Viswanathan in view of Stewart to include the plurality of strip electrodes and the steps of Harlev for the purpose of the plurality of strip electrodes enabling non-contact mapping via receiving and detecting very small voltages from the blood pool and because it is useful to display chamber geometry, catheter location, and electrical activity in an integrated fashion (Harlev: [0059], [0049]).
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 ablation 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 ablation electrodes and the second ablation electrodes comprise a single respective ablation 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 ablation electrodes and the second ablation electrodes comprise multiple ablation 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 in a unipolar mode between one or more electrode of the plurality of ablation 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 ablation 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 ablation electrodes comprise at least proximal and distal ablation 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 ablation 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 system (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 ablation 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 ablation 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 ablation 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 ablation 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 ablation 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); each respective resilient spine comprising a spine width perpendicular to the longitudinal axis ([0264]: The thickness of each spline (3830) may vary based on the number of electrodes (3832, 3834) formed on each spline (3830) which may correspond to the number of insulated electrical leads in the spline (3830). The splines (3830) may have the same or different materials, thickness, and/or length; wherein the spines each have a thickness that may be the same amongst all of the splines), each ablation electrode bulging beyond the spine width of the respective resilient spine ([0254]: the set of electrodes (3832, 3834) may each extend around a circumference of its spline; [0266]: each electrode of the set of electrodes (3832, 3834) may include a diameter of between about 0.5 mm to about 3 mm; wherein the electrodes wrapping around a circumference of the spline is seen as bulging from a spine width (the circumference) of a given spline), and
an electrical signal generator (signal generator 122) configured to apply to the plurality of ablation electrodes, including the axial electrode, pulses having an amplitude sufficient to cause irreversible electroporation (IRE) in the tissue contacted by the plurality of ablation electrodes, the pulses being applied in a bipolar mode between different pairs of the plurality of ablation 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 ablation 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 ablation 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 ablation electrodes and the axial electrode; and
applying the pulses between the second ablation 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 ablation 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 ablation 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 ablation 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 ablation 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]).
But Viswanathan in view of Stewart fail to disclose a plurality of strip electrodes each disposed on a respective resilient spine, each of the plurality of strip electrodes comprising a strip electrode width no greater than the spine width of the respective resilient spine.
However, Harlev discloses a plurality of strip electrodes (electrodes 54) each disposed on a respective resilient spine ([0059] The individual splines may carry several types of electrodes. The array of sensing electrodes typified by spline electrode 54), each of the plurality of strip electrodes comprising a strip electrode width (see width of electrodes 54 in Fig. 6B) no greater than the spine width of the respective resilient spine (see Fig. 6B where the electrode 54 is inset relative to the width of the total spine thickness).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Viswanathan in view of Stewart to include the plurality of strip electrodes of Harlev for the purpose of the plurality of strip electrodes enabling non-contact mapping via receiving and detecting very small voltages from the blood pool and because it is useful to display chamber geometry, catheter location, and electrical activity in an integrated fashion (Harlev: [0059], [0049]).
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 ablation electrode of each resilient spine of the plurality of resilient spines is non-overlapping with each ablation 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 ablation electrode of each resilient spine of the plurality of resilient spines is non-overlapping with each ablation 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 ablation electrode of each resilient spine of the plurality of resilient spines is non-overlapping with each second ablation 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 and Harlev 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 and Harlev fails to disclose wherein in accordance with the predefined protocol, the pulses are configured to be applied to the ablation 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 ablation 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 ablation 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 ablation 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 and Harlev 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 and Harlev fail to disclose wherein in accordance with the predefined protocol, the pulses are applied to the ablation 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 ablation 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 ablation 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 ablation 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 and Harlev 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
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
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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