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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/2/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 10/2/2025.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claims 1 and 11 were rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan in view of Cao and Howard. Now, based on amendments to the claim language, claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Howard and Cao, with Govari disclosing the newly amended claim language.
Claim Objections
Claim 11 is objected to because of the following informalities: Line 4: “on the a surface” should read –on a surface--. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, 6-8, 11, 13, 15-17, 20, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al., US 20190008582, herein referred to as “Govari”, in view of Howard et al., US 20180214202, herein referred to as “Howard”, further in view of Cao et al., US 20170105793, herein referred to as “Cao”.
Regarding claim 1, Govari discloses a system (Figure 1), comprising: a catheter (Figure 2: balloon catheter 24) comprising: a balloon (Figure 2: membrane 26), coupled to a distal end of the catheter (Figure 2: proximal ring 28P), the balloon comprising a membrane (Figure 2: membrane 26) and a plurality of bare areas (Figure 2: areas of membrane 26 between leaves 30); and multiple electrodes (Figure 2: electrodes 33), which are disposed on a surface of the membrane in a radial geometry (Figure 2: leaves 30 and [0069]), each electrode of the multiple electrodes extending from a vertex of the balloon to a coupling point between the multiple electrodes and one or more electrical wires (Figure 2: electrodes 33 extend from proximal ring 28P to distal cap 28D and [0077]), wherein both the vertex and the coupling point are electrically insulating between adjacent electrodes of the multiple electrodes ([0071]: “a flexible and resilient sheet substrate 34, constructed of a suitable bio-compatible materials, for example, polyimide”), the multiple electrodes comprising a first electrode, a second electrode, and a third electrode (Figure 2: electrodes 33), and each bare area of the plurality of bare areas being positioned alternately between adjacent electrodes of the multiple electrodes so as to electrically insulate the adjacent electrodes (Figure 2: bare areas of membrane 26 are between each electrode); a switching assembly (Figure 1: switch 57 and processor 46), which is electrically connected to the catheter (Figure 1), and is configured to electrically short a first electrode group and electrically short a second electrode group ([0101] and Figure 7 and [0081]), the first and second electrode groups being disjoint from one another (Figure 7 and [0101]: “Processor 46 operates steps 208-222 of the algorithm for each given electrode 33 individually and separately,”), and electrically short a third electrode group and electrically short a fourth electrode group ([0101] and Figure 7 and [0081]), the third and fourth electrode groups being disjoint from one another (Figure 7 and [0101]: “Processor 46 operates steps 208-222 of the algorithm for each given electrode 33 individually and separately,”); a pulse generator (Figure 1: power supply 54) configured to produce at least a first set of one or more ablation pulses between the first electrode group and the second electrode group ([0118]), and a second set of one or more ablation pulses between the third electrode group and the fourth electrode group ([0118] and [0131]); and a processor (Figure 1: processor 46), which is configured to: control the switching assembly to either electrically short the first electrode group and electrically short the second electrode group or electrically short the third electrode group and electrically short the fourth electrode group ([0130] and [0132] and Figure 7); and control the pulse generator to apply the first set of one or more ablation pulses or the second set of one or more ablation pulses when the multiple electrodes are placed in contact with a target biological tissue (Figure 9). Govari does not explicitly teach a system comprising a first electrode group that comprises the first electrode and the second electrode, a second electrode group that comprises the third electrode, a third electrode group that comprises the first electrode and the third electrode, and a fourth electrode group the comprises the second electrode, or a system comprising a processor which is configured to: receive bipolar intra-cardiac electrical signals of target biological tissue from the multiple electrodes; and recommend or autonomously select electrodes of the multiple electrodes to form the first, second, third, and fourth electrode groups based at least in part on the bipolar intra-cardiac electrical signals.
However, Howard teaches a system comprising a first electrode group (Figure 14) that comprises the first electrode (Figure 14: electrode 1) and the second electrode (Figure 14: electrode 3), a second electrode group (Figure 15) that comprises the third electrode (Figure 15: electrode 2), a third electrode group (Figure 16) that comprises the first electrode (Figure 16: electrode 1) and the third electrode (Figure 16: electrode 2), and a fourth electrode group (Figure 17) the comprises the second electrode (Figure 17: electrode 3).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Govari so that a first electrode group that comprises the first electrode and the second electrode, a second electrode group that comprises the third electrode, a third electrode group that comprises the first electrode and the third electrode, and a fourth electrode group the comprises the second electrode as taught by Howard to produce deeper lesions in the adjacent tissue (Howard [0110]).
Further, Cao teaches a system (Figures 1 and 5) comprising a processor (Figure 1: controller 110) which is configured to: receive bipolar ([0032]: “Thus, energy delivery device 120 may be configured as a bipolar device whereby energy flows from one or more electrodes of the first pole, through tissues surrounding or otherwise adjacent to a body lumen, to one or more electrodes of the second pole.”) intra-cardiac electrical signals of target biological tissue from the multiple electrodes ([0052]); and recommend or autonomously select electrodes of the multiple electrodes to form the first, second, third, and fourth electrode groups based at least in part on the bipolar intra-cardiac electrical signals ([0053]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Govari so that the processor which is configured to: receive bipolar intra-cardiac electrical signals of target biological tissue from the multiple electrodes; and recommend or autonomously select electrodes of the multiple electrodes to form the first, second, third, and fourth electrode groups based at least in part on the bipolar intra-cardiac electrical signals as taught by Cao to ensure that as much cancerous tissue as possible is treated (Cao [0052]).
Regarding claim 3, Govari in view of Howard and Cao discloses the system according to claim 1, and Govari further a system wherein the switching assembly comprises a mechanical switch or an electronic switch (Figure 1: switch 57 and [0079].
Regarding claim 4, Govari in view of Howard and Cao discloses the system according to claim 1, and Govari further discloses a system wherein the electrodes (Figure 2: electrodes 33) are disposed between a vertex of the balloon (Figure 2: distal cap 28D) and a coupling point between balloon and the distal end of the catheter (Figure 2: proximal ring 28P).
Regarding claim 6, Govari in view of Howard and Cao discloses the system according to claim 1, and Howard further discloses a system wherein, when placed in contact with the target tissue, the multiple electrodes are configured to sense electrical signals from an organ ([0008]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Govari so that when placed in contact with the target tissue, the multiple electrodes are configured to sense electrical signals from an organ as taught by Howard to transmit positioning and navigation signals to or from each of the plurality of electrodes (Howard [0009]).
Regarding claim 7, Govari in view of Howard and Cao discloses the system according to claim 6, and Govari further discloses a system wherein the organ comprises a patient heart ([0055]), and Howard discloses a system wherein the sensed electrical signals comprise intra-cardiac electrical signals for mapping the patient heart ([0008]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Govari so that the sensed electrical signals comprise intra-cardiac electrical signals for mapping the patient heart as taught by Howard to transmit positioning and navigation signals to or from each of the plurality of electrodes (Howard [0009]).
Regarding claim 8, Govari in view of Howard and Cao discloses the system according to claim 1, and Howard further discloses a system wherein the one or more ablation pulses comprises one or more irreversible electroporation (IRE) pulses ([0085]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Govari so that the one or more ablation pulses comprises one or more irreversible electroporation (IRE) pulses as taught by Howard to induce the formation of microscopic defects that result in hyperpermeabilization of the cell membrane (Howard [0085]).
Regarding claim 11, Govari discloses a method (Figure 1), comprising: inserting into a patient organ ([0014]), a catheter (Figure 2: balloon catheter 24) comprising: a balloon (Figure 2: membrane 26), coupled to a distal end of the catheter (Figure 2: proximal ring 28P), the balloon comprising a membrane (Figure 2: membrane 26) and a plurality of bare areas (Figure 2: areas of membrane 26 between leaves 30) and multiple electrodes (Figure 2: electrodes 33), which are disposed on a surface of the membrane in a radial geometry (Figure 2: leaves 30 and [0069]), each electrode of the multiple electrodes extending from a vertex of the balloon to a coupling point between the multiple electrodes and one or more electrical wires (Figure 2: electrodes 33 extend from proximal ring 28P to distal cap 28D and [0077]), wherein both the vertex and the coupling point are electrically insulating between adjacent electrodes of the multiple electrodes ([0071]: “a flexible and resilient sheet substrate 34, constructed of a suitable bio-compatible materials, for example, polyimide”), the multiple electrodes comprising a first electrode, a second electrode, and a third electrode (Figure 2: electrodes 33), and each bare area of the plurality of bare areas being positioned alternately between adjacent electrodes of the multiple electrodes so as to electrically insulate the adjacent electrodes (Figure 2: bare areas of membrane 26 are between each electrode); placing at least some of the electrodes in contact with a target tissue of the organ ([0016]); selecting from the multiple electrodes a first electrode group and a second electrode group ([0101]: “Processor 46 operates steps 208-222 of the algorithm for each given electrode 33 individually and separately,”); for the first and second electrode groups that are disjoint from one another (Figure 7 and [0101]: “Processor 46 operates steps 208-222 of the algorithm for each given electrode 33 individually and separately,”), electrically shorting between electrodes within the first electrode group and electrically shorting between electrode within the second electrode group ([0101] and Figure 7 and [0081]) via a switching assembly (Figure 1: switch 57 and processor 46); applying a first set of one or more ablation pulses between the first electrode group and the second electrode group ([0118]); selecting from the multiple electrodes a third electrode group and a fourth electrode group ([0101]: “Processor 46 operates steps 208-222 of the algorithm for each given electrode 33 individually and separately,”); for the third and fourth electrode groups that are disjoint from one another (Figure 7 and [0101]: “Processor 46 operates steps 208-222 of the algorithm for each given electrode 33 individually and separately,”), electrically shorting between electrodes within the third electrode group and electrically shorting between electrode within the fourth electrode group ([0101] and Figure 7 and [0081]); and applying a second set of one or more ablation pulses between the third electrode group and the fourth electrode group ([0118] and [0131]). Govari does not explicitly disclose a method comprising a first electrode group that comprises the first electrode and the second electrode, a second electrode group that comprises the third electrode, a third electrode group that comprises the first electrode and the third electrode, and a fourth electrode group the comprises the second electrode; or a method comprising receiving intra-cardiac signals of the target tissue from the at least some of the multiple electrodes; selecting from the multiple electrodes, based at least in part on the received intra- cardiac signals from the target tissue, electrode groups.
However, Howard teaches a method comprising a first electrode group (Figure 14) that comprises the first electrode (Figure 14: electrode 1) and the second electrode (Figure 14: electrode 3), a second electrode group (Figure 15) that comprises the third electrode (Figure 15: electrode 2), a third electrode group (Figure 16) that comprises the first electrode (Figure 16: electrode 1) and the third electrode (Figure 16: electrode 2), and a fourth electrode group (Figure 17) the comprises the second electrode (Figure 17: electrode 3).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Govari so that a first electrode group that comprises the first electrode and the second electrode, a second electrode group that comprises the third electrode, a third electrode group that comprises the first electrode and the third electrode, and a fourth electrode group the comprises the second electrode as taught by Howard to produce deeper lesions in the adjacent tissue (Howard [0110]).
Further, Cao teaches a method (Figures 1 and 5) comprising receiving intra-cardiac signals of the target tissue from the at least some of the multiple electrodes ([0052]); selecting from the multiple electrodes, based at least in part on the received intra- cardiac signals from the target tissue, electrode groups ([0053]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Govari so that it includes receiving intra-cardiac signals of the target tissue from the at least some of the multiple electrodes; and selecting from the multiple electrodes, based at least in part on the received intra- cardiac signals from the target tissue, electrode groups as taught by Cao to ensure that as much cancerous tissue as possible is treated (Cao [0052]).
Regarding claim 13, Govari in view of Howard and Cao discloses the method according to claim 11, and Govari discloses a method wherein the multiple electrodes (Figure 2: electrodes 33) are disposed between a vertex of the balloon (Figure 2: distal cap 28D) and a coupling point between balloon and the distal end of the catheter (Figure 2: proximal ring 28P).
Regarding claim 15, Govari in view of Howard and Cao discloses the method according to claim 11, and Howard further discloses a method further comprising sensing electrical signals from the patient organ ([0008]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Govari so that it includes sensing electrical signals from the patient organ as taught by Howard to transmit positioning and navigation signals to or from each of the plurality of electrodes (Howard [0009]).
Regarding claim 16, Govari in view of Howard and Cao discloses the method according to claim 15, and Govari further discloses a method wherein the patient organ comprises a patient heart ([0055]), and Howard discloses a method wherein sensing the electrical signals comprises sensing intra-cardiac electrical signals for mapping the patient heart ([0008]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Govari so that sensing the electrical signals comprises sensing intra-cardiac electrical signals for mapping the patient heart as taught by Howard to transmit positioning and navigation signals to or from each of the plurality of electrodes (Howard [0009]).
Regarding claim 17, Govari in view of Howard and Cao discloses the method according to claim 11, and Howard further discloses a method wherein applying the one or more bipolar ablation pulses comprises applying, to the target tissue, one or more irreversible electroporation (IRE) pulses ([0085]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Govari so that the one or more ablation pulses comprises one or more irreversible electroporation (IRE) pulses as taught by Howard to induce the formation of microscopic defects that result in hyperpermeabilization of the cell membrane (Howard [0085]).
Regarding claim 20, Govari in view of Howard and Cao discloses the method according to claim 11, and Govari further discloses a method wherein the organ comprises heart ([0055]), and wherein applying the one or more bipolar ablation pulses comprises treating arrhythmia in the heart by applying the one or more bipolar ablation pulses to the target tissue of the heart ([0003]).
Regarding claim 27, Govari in view of Howard and Cao discloses the system according to claim 1, and Cao further discloses a system wherein the first and second electrode groups each comprising a surface area of at least approximately 10 millimeters squared (Figure 5: rows 524 of electrodes 542 have an [0054]: “electrode spacing (e.g., 1-10 mm)”; the claim language “at least approximately” is incredibly broad and the surface area of one row of electrodes is considered at minimum approximately 10 squared millimeters based on the parameters for electrode spacing), and the bare areas cumulatively comprising a surface area of at least approximately 15 millimeters squared (Figure 5: rows 524 of electrodes 542 have an [0054]: “electrode spacing (e.g., 1-10 mm)”; the claim language “at least approximately” is incredibly broad and the surface area of the bare areas is considered at minimum approximately 15 squared millimeters based on the parameters for electrode spacing).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Govari so that the first and second electrode groups each comprise a surface area of at least approximately 10 millimeters squared, and the bare areas cumulatively comprise a surface area of at least approximately 15 millimeters squared as taught by Cao to provide selective circumferential and longitudinal application of electric fields (Cao [0040]).
Regarding claim 28, Govari in view of Howard and Cao discloses the method according to claim 11, and Cao further discloses a method wherein the first and second electrode groups each comprising a surface area of at least approximately 10 millimeters squared (Figure 5: rows 524 of electrodes 542 have an [0054]: “electrode spacing (e.g., 1-10 mm)”; the claim language “at least approximately” is incredibly broad and the surface area of one row of electrodes is considered at minimum approximately 10 squared millimeters based on the parameters for electrode spacing), and the bare areas cumulatively comprising a surface area of at least approximately 15 millimeters squared (Figure 5: rows 524 of electrodes 542 have an [0054]: “electrode spacing (e.g., 1-10 mm)”; the claim language “at least approximately” is incredibly broad and the surface area of the bare areas is considered at minimum approximately 15 squared millimeters based on the parameters for electrode spacing).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Govari so that the first and second electrode groups each comprise a surface area of at least approximately 10 millimeters squared, and the bare areas cumulatively comprise a surface area of at least approximately 15 millimeters squared as taught by Cao to provide selective circumferential and longitudinal application of electric fields (Cao [0040]).
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Howard and Cao, further in view of Viswanathan et al., US 20180085160, herein referred to as "Viswanathan".
Regarding claims 2 and 12, Govari in view of Howard and Cao discloses the system according to claim 1 and the method according to claim 11, respectively, but does not disclose a system or method wherein at least one of the multiple electrodes is disposed along an axis of the catheter.
However, Viswanathan discloses a system and method wherein at least one of the multiple electrodes (Figure 2: electrodes 212) is disposed along an axis of the catheter (Figure 2: catheter 210 and [0081]: “The distal portion of the catheter (210) may include a set of electrodes (212)”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system and method disclosed by Govari with electrodes disposed along an axis of the catheter as disclosed by Viswanathan so that the electrodes can contact an inner radial surface of a lumen ([0081]).
Claims 21-22 is rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Howard and Cao, further in view of Lucke et al., US 20190298994, herein referred to as "Lucke".
Regarding claims 21 and 22, Govari in view of Howard and Cao discloses the system according to claim 1 and the method according to claim 11, respectively, but does not disclose a system or method wherein the second set has a frequency different from the first set.
However, Lucke discloses a system and method wherein the second set has a frequency different from the first set ([0098]: “second set has a frequency different from the first set”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system and method disclosed by Govari so that the second set has a frequency different from the first set as disclosed by Lucke so that the system and method can perform both high-frequency ablation, which may produce sub-surface heating at a rate that exceeds surface heating at the tissue-electrode interface, and low-frequency ablation, which may be greater in magnitude (Lucke [0082]).
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794