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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 30th, 2026, has been entered.
Response to Amendment
The amendment filed March 30th, 2026, has been entered. Claims 3, 6, & 13-16 are amended. Claims 1, 5, & 7-12 are canceled. Claims 2-4, 6, & 13-16 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 2-4, 6, & 13-16 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; as necessitate by amendment.
Claim Objections
Claim 13 is objected to because of the following informalities: “a catheter” (line 5) should be –the catheter—; as introduced already in line 2 of claim 13. Appropriate correction is required.
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 2, 6, & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Howard et al. (previously presented- US 20180214202 A1), hereinafter “Howard”, in view of Sampson et al. (US 20060135956 A1), hereinafter “Sampson”, and Byrd et al. (previously presented-US 20210161582 A1), hereinafter “Byrd”.
Regarding claims 2 & 16, Howard in view of Sampson disclose all of the limitations of claim 13, as described below.
Howard further discloses wherein the processor is further configured control the IRE power source ([0079]) (claim 2); wherein the processor is configured to select the voltage to achieve the target tissue depth of ablation ([0117] & [0140]; the lesions created are dependent on the applied voltage, the total current, and other waveform parameters) (claim 16).
Howard does not disclose wherein the processor is further configured control the IRE power source to increase a voltage of the bipolar IRE pulses, while at a same time reduce number of pulses per burst in response to user input (claim 2); wherein the processor is configured to select the voltage and the number of pulses per burst to achieve the target tissue depth of ablation (claim 16).
Byrd teaches an electroporation system wherein the processor is further configured control the IRE power source to increase a voltage of the bipolar IRE pulses, while at a same time reduce number of pulses per burst in response to user input (claim 2) ([0051] & [0056]; the electroporation generator may energize electrodes in accordance with an electroporation energization strategy which may be user-selectable; the voltage amplitude and the pulse duration needed for IRE are inversely related therefore as pulse durations are decreased the voltage amplitude must be increased to achieve electroporation); wherein the processor is configured to select the voltage and the number of pulses per burst to achieve the target tissue depth of ablation (claim 16) ([0023], [0051], [0053], & [0055]-[0056], & [0074]; the generator is configured to generate and supply a pulse signal to the electrodes that is configured to reduce, minimize, or prevent undesirable effects of IRE).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the processor and energy delivery parameters, as disclosed by Howard, to include wherein the processor is further configured to control the IRE power source to increase a voltage of the bipolar IRE pulses, while at a same time reduce number of pulses per burst in response to user input, and to select the voltage and the number of pulses per burst to achieve the target tissue depth of ablation with reduced energy delivered to the tissue, as taught by Byrd, as both references and the claimed invention are directed toward electroporation systems. As disclosed by Byrd, the electroporation generator is configured to energize electrodes in accordance with an electroporation energization strategy that may be user-selectable, the voltage amplitude and pulse duration needed for IRE are inversely related, such that as pulse durations are decreased the voltage amplitude must be increased to achieve electroporation, the electroporation generator is configured to deliver a series of DC pulses comprising pulse durations between 1 nanosecond and 100 microseconds and a voltage amplitude between 500V and 3kV, the voltage and pulse duration are selected to avoid nerve stimulation, muscle activation, and undesirable effects of IRE ([0051], [0053], & [0055]-[0056]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the processor and energy delivery parameters, as disclosed by Howard, to include wherein the processor is further configured to control the IRE power source to increase a voltage of the bipolar IRE pulses, while at a same time reduce number of pulses per burst in response to user input, and to select the voltage and the number of pulses per burst to achieve the target tissue depth of ablation with reduced energy delivered to the tissue, as taught by Byrd, as such a modification would provide for suitable and known energy delivery parameters for inducing irreversible electroporation, while also avoiding nerve stimulation, muscle activation, and other undesirable effects of IRE.
Regarding claim 6, Howard in view of Sampson and Byrd disclose all of the limitations of claim 16, as described above.
Howard further discloses wherein the processor is further configured to select an updated first group and an updated second group, wherein the updated first group and the updated second group interleave with the first group and the second group and to control the switching assembly to apply the bipolar IRE pulses in successive activations between the interleaved groups to further ablate the tissue ([0109]-[0112], & [0117]; Figures 19-20—elements 38a & 38b—a first energy delivery pattern may be delivered to the electrodes with the first group comprising electrodes 38a & the second group comprising electrodes 38b (Figure 19) and a second energy delivery patten may be delivered sequentially to produce a desired ablation pattern with the updated first group comprising electrodes 38a & the updated second group comprising electrodes 38b (Figure 20)).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Sampson and Townley et al. (previously presented-US 20160331459 A1), hereinafter “Townley”.
Regarding claim 3, Howard in view of Sampson disclose all of the limitations of claim 14, as described below.
Howard further discloses wherein the processor is further configured to monitor a measured temperature of the first group ([0083], [0086], [0111], [0132], & [0142]).
Howard does not disclose wherein the processor is further configured pause ablation based on measured temperature exceeding a threshold.
Townley teaches an ablation system wherein the processor is further configured to monitor a measured temperature of a first group of electrodes ([0111]), and wherein the processor is further configured pause ablation based on measured temperature exceeding a threshold ([0111]; energy delivery may be terminated if detected temperature reaches a predefined threshold).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the temperature feedback, as disclosed by Howard, to include wherein the processor is further configured pause ablation based on measured temperature exceeding a threshold, as taught by Townley, as both references and the claimed invention are directed toward ablation systems. As disclosed by Townley, the energy delivery via the electrodes may automatically be terminated if the detected temperature exceeds a predetermined threshold in order to avoid damage to tissue ([0111]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the temperature feedback, as disclosed by Howard, to include wherein the processor is further configured pause ablation based on measured temperature exceeding a threshold, as taught by Townley, as such a modification would halt energy delivery to the electrodes if the temperature exceeds a predefined threshold in order to prevent damage to tissue.
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Sampson and Howard et al. (previously presented-US 20180221078 A1), hereinafter “Howard078”.
Regarding claim 4, Howard in view of Sampson disclose all of the limitations of claim 13, as described below.
Howard further discloses wherein the tissue comprises cardiac tissue ([0087]).
Howard does not disclose wherein the processor is configured to gate the bipolar IRE pulses to synchronize with refractory periods of the cardiac tissue.
Howard078 teaches wherein the processor is configured to gate the bipolar IRE pulses to synchronize with refractory periods of the cardiac tissue ([0035]).
A person ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the bipolar IRE pulses, as disclosed by Howard, to include wherein the processor is configured to gate the bipolar IRE pulses to synchronize with refractory periods of the cardiac tissue, as taught by Howard078, as both references and the claimed invention are directed toward IRE systems configured to deliver bipolar IRE pulses to cardiac tissue. As disclosed by Howard078, the processor may monitor the patient’s cardiac activity to determine pulse train delivery timing at a desired portion of the cardiac cycle, for example, during the ventricular refractory period ([0035]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the bipolar IRE pulses, as disclosed by Howard, to include wherein the processor is configured to gate the bipolar IRE pulses to synchronize with refractory periods of the cardiac tissue, as taught by Howard078, as such a modification would allow the bipolar IRE pulses to be delivered to cardiac tissue during a desired portion of the cardiac cycle.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Sampson.
Regarding claim 13, Howard discloses an irreversible electroporation (IRE) system ([0079]; Figure 1—element 10), comprising: a catheter ([0080]; Figure 1—element 22) including a plurality of electrodes that are configured to be placed in contact with tissue of an organ ([0081]; Figure 1—elements 38); an IRE ablation power source configured to generate bipolar IRE pulses between a first group and a second group of the plurality of electrodes on a catheter ([0079], [0110], & [0111]; Figure 1—elements 14 & 38; the examiner is considering the first group to be the electrodes 38 that are coupled to a first polarity and the second group to be the electrodes 38 that are coupled to a second, opposite, polarity); a processor ([0086]; Figure 1—element 46), which is configured to select a number of the plurality of electrodes to be included in each of the first group and the second group based on a target tissue depth; a switching assembly which is configured to short-circuit electrodes in the first group and to short-circuit electrodes in the second group, and to connect the IRE ablation power source to each of the first group and the second group of electrodes; and wherein the processor is further configured to control the switching assembly to apply the bipolar IRE pulses between the first group and the second group of electrodes to ablate the tissue ([0079], [0086], [0092], [0109], [0110], [0111], [0117], & [0118]; Figure 16—element 38a & 38b; electrodes may be selectively connected or disconnected from first and second polarities of the generator in order to achieve desired ablation patterns and control the depth and placement of lesions in tissue, the patterns may be automated through the processor 46; the examiner is considering the first group of electrodes being electrode group 38b comprising electrodes E4-E8 which are electrically connected to each other and a first polarity to act as a single electrode; and the second group of electrodes being electrode group 38b comprising electrodes E1-E2 which are electrically connected to each other and a second polarity to act as a single electrode).
Howard does not disclose wherein the processor is configured to receive the target tissue depth of ablation, and select the number of the plurality of electrodes to be included in each of the first group and the second group based on the target tissue depth received.
Sampson teaches an ablation system comprising a processor; wherein the processor is configured to receive the target tissue depth of ablation, and select the number of the plurality of electrodes to be included in each of the first group and the second group based on the target tissue depth received ([0008], [0012], & [0043]-[0049]; Figures 5C-5D—elements 51; the controller is configured to control the delivery of energy to the one or more bipolar electrode to destroy tissue at a “known depth”; the generator may be controlled to energize the electrodes with a positive or negative polarity which will produce a desired electrode spacing and active electrode area in order to produce the desired depth of destruction).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the selection of the number of the plurality of electrodes to be included in each of the first group and the second group based on the target tissue depth, as disclosed by Howard, to include wherein the processor is configured to receive the target tissue depth of ablation, and select the number of the plurality of electrodes to be included in each of the first group and the second group based on the target tissue depth received, as taught by Sampson, as both references and the claimed invention are directed toward ablation systems comprising a plurality of electrodes configured to be selectively energized in order to achieve specific lesion characteristics. As disclosed by Howard, the selection of the electrodes in the first and second group allow for the control of the depth and placement of lesions in tissue ([0112], [0118], & [0124]) . As disclosed by Sampson, the generator may be controlled to independently energize the plurality of electrodes with positive and/or negative polarities in order to produce the desired and known depth of ablation, this allows for the system to automatically compensate for varying tissue thickness thereby facilitating proper contoured depth of ablation in the desired treatment region ([0008], [0012], [0043], & [0048]-[0049]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the selection of the number of the plurality of electrodes to be included in each of the first group and the second group based on the target tissue depth, as disclosed by Howard, to include wherein the processor is configured to receive the target tissue depth of ablation, and select the number of the plurality of electrodes to be included in each of the first group and the second group based on the target tissue depth received, as taught by Sampson, as such a modification would produce the predictable result of selecting electrodes based to control the depth of ablation and further would allow for the system to automatically compensate for varying tissue thickness thereby facilitating proper contoured depth of ablation in the desired treatment region.
Regarding claim 14, Howard in view of Sampson disclose all of the limitations of claim 13, as described above.
Howard further discloses wherein the number of electrodes in each of the first group and the second group is selected to be greater for deeper target tissue depth as compared to more shallow target tissue depth ([0110] & [0112]; the processor is configured to select the number of electrodes in each group to produce deeper lesions in adjacent tissue).
Regarding claim 15, Howard in view of Sampson disclose all of the limitations of claim 13, as described above.
Howard further discloses wherein the processor is configured to include more electrodes in the first group as compared to the second group ([0111]-[0112]; Figures 16—elements 38a & 38b; the first group of electrodes 38b comprises electrodes E4-E8, while the second group of electrodes 38a comprises electrodes E1-E2).
Conclusion
Accordingly, claims 2-4, 6, & 13-16 are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. McPherson et al. (20080249523) teaches a processor configured to select a number of electrodes to be included in a first group and a second group based on target tissue depth ([0008] & [0041]-[0042]; Figure 4B). King et al. (US 9498622 B2) teaches a processor configured to receive a target tissue depth and select a number of electrodes to be included in a first group and a second group based on target tissue depth received ([Col. 2, lines 25-40], [Col. 13, lines 20-44], [Col. 25, line 63 – Col. 26, line 3], [Col. 27, lines 20-40]; Figures 9-13).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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