DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Acknowledgment is made to the amendment received 3/18/2026.
Response to Arguments
Applicant’s arguments with respect to claims 1, 9, and 14 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, 9, and 14 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koop. Now, based on amendments to the claim language, claims 1, 9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Koop in view of Fraasch.
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, 5-6, 9-11, 14-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Koop et al., US 20220022952, herein referred to as “Koop”, in view of Fraasch et al., US 20200138506, herein referred to as “Fraasch”.
Regarding claim 1, Koop discloses a pulse generator for use with an electroporation system (Figure 1: electroporation generator 130), the pulse generator configured to be coupled to a catheter (Figure 1: electroporation catheter 105) including a plurality of electrodes (Figure 2A: electrodes 201a, 201b, 201c, 201d, 201e, and 201f) and configured to generate a waveform to be delivered using at least one of the plurality of electrodes (Figure 3F), the waveform including: a pulse train having positive and negative pulses (Figure 3F: non-alternating pulse sequence 301f), wherein an average charge over the pulse train is zero ([0092]: “FIG. 3F. is a diagram illustrating two pulse sequences 305f, one non-alternating (301f) and the other alternating (302f), of charge-and-energy balanced, asymmetric triphasic pulses (311t) to be delivered to electrodes in an electroporation electrode arrangement of the catheter.”), and wherein each positive pulse in the pulse train has a greater amplitude and shorter pulse width than each negative pulse in the pulse train (Figure 3F: 301f and [0094]: “And each triphasic pulse may have a first voltage pulse length and a second voltage pulse length, the first voltage pulse length being less than or equal to the second voltage pulse length. The illustrated triphasic pulses have asymmetric voltage amplitudes (v) and varied pulse lengths such that d1 is less than d2 and are therefore charge-and-energy balanced while having a higher voltage amplitude than symmetric triphasic pulses (such as those shown in FIG. 3E).”). Koop does not explicitly disclose a pulse generator for use with an electroporation system wherein a pulse width of the positive and negative pulses in the pulse train compensates for switching time of the electroporation system while preserving the average charge of zero over the pulse train.
However, Fraasch teaches a pulse generator (Figure 4: PFA generator 22) for use with an electroporation system (Figure 4 and [0083]: “The PFA generator 22 is configured to deliver high-frequency, non-ablative pulses for causing reversible and/or non-reversible electroporation in targeted tissue cells.”) wherein a pulse width of the positive and negative pulses in the pulse train compensates for switching time of the electroporation system while preserving the average charge of zero over the pulse train (Figure 29 and [0070] and [0106]: “To compensate for the resulting charge imbalance, the controller increases the pulse width T by a target amount to effectively balance charge delivery. The pulse width T of the negative phase 12B in FIG. 29 is increased to 5.25 μs, or 250 ns over the pulse width T of 5 μs shown in FIG. 28, resulting in a net charge of zero or approximately zero.”).
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 pulse generator of Koop so that a pulse width of the positive and negative pulses in the pulse train compensates for switching time of the electroporation system while preserving the average charge of zero over the pulse train as taught by Fraasch to avoid unintended muscle stimulation (Fraasch [0106]).
Regarding claim 2, Koop in view of Fraasch discloses the pulse generator in accordance with claim 1, and Koop further discloses a pulse generator wherein the pulse train includes a first pulse (Figure 3F: 301f, first pulse with v1 and d-1), a last pulse (Figure 3F: 301f, last pulse in Figure, also v1 and d-1), and at least one intermediate pulse between the first pulse and the last pulse (Figure 3F: 301f, there are many intermediate pulses, including many with v2 and d2), and wherein a polarity of the first pulse is the same as a polarity of the last pulse (Figure 3F: 301f, the last and first pulse have the same polarity and [0092]).
Regarding claim 3, Koop in view of Fraasch discloses the pulse generator in accordance with claim 2, and Koop further discloses a pulse generator wherein the at least one intermediate pulse has a first pulse width (Figure 3F: 301f, d2), and wherein the first pulse and the last pulse have a second pulse width that is different than the first pulse width (Figure 3F: 301f, d1 and [0094]: “And each triphasic pulse may have a first voltage pulse length and a second voltage pulse length, the first voltage pulse length being less than or equal to the second voltage pulse length. The illustrated triphasic pulses have asymmetric voltage amplitudes (v) and varied pulse lengths such that d1 is less than d2 and are therefore charge-and-energy balanced while having a higher voltage amplitude than symmetric triphasic pulses (such as those shown in FIG. 3E).”).
Regarding claim 5, Koop in view of Fraasch discloses the pulse generator in accordance with claim 2, and Koop further discloses a pulse generator wherein positive pulses of the at least one intermediate pulse have a different pulse width and a different amplitude (Figure 3F: 301f, d1 and v1) than negative pulses of the at least one intermediate pulse (Figure 3F: 301f, d2 and v2).
Regarding claim 6, Koop in view of Fraasch discloses the pulse generator in accordance with claim 2, and Koop further discloses a pulse generator wherein the at least one intermediate pulse has a first pulse amplitude (Figure 3F: 301f, v2), and wherein the first pulse and the last pulse have a second pulse amplitude that is different than the first pulse amplitude (Figure 3F: 301f, v1).
Regarding claim 9, Koop discloses a pulse generator for use with an electroporation system (Figure 1: electroporation generator 130), the pulse generator configured to be coupled to a catheter (Figure 1: electroporation catheter 105) including a plurality of electrodes (Figure 2A: electrodes 201a, 201b, 201c, 201d, 201e, and 201f) and configured to generate a waveform to be delivered using at least one of the plurality of electrodes (Figure 3F), the waveform including: a single, asymmetrical pulse train having positive and negative pulses (Figure 3F: alternating pulse sequence 302f), wherein the pulse train includes a first pulse (Figure 3F: 302f, first pulse with v1 and d-1), a last pulse (Figure 3F: 302f, last pulse in Figure, also v1 and d-1), and at least one intermediate pulse between the first pulse and the last pulse (Figure 3F: 302f, there are many intermediate pulses, including many with v2 and d2), and wherein, to facilitate reducing a maximum absolute charge of the pulse train, the first and last pulses have at least one of a different amplitude and a different pulse width than the at least one intermediate pulse (Figure 3F: 321f and [0094]: “And each triphasic pulse may have a first voltage pulse length and a second voltage pulse length, the first voltage pulse length being less than or equal to the second voltage pulse length. The illustrated triphasic pulses have asymmetric voltage amplitudes (v) and varied pulse lengths such that d1 is less than d2 and are therefore charge-and-energy balanced while having a higher voltage amplitude than symmetric triphasic pulses (such as those shown in FIG. 3E).”), wherein an average charge over the pulse train is zero ([0092]: “FIG. 3F. is a diagram illustrating two pulse sequences 305f, one non-alternating (301f) and the other alternating (302f), of charge-and-energy balanced, asymmetric triphasic pulses (311t) to be delivered to electrodes in an electroporation electrode arrangement of the catheter.”), and wherein each positive pulse in the single, asymmetrical pulse train has a greater amplitude and shorter pulse width than each negative pulse in the single, asymmetric pulse train (Figure 3F: 302f and [0094]: “And each triphasic pulse may have a first voltage pulse length and a second voltage pulse length, the first voltage pulse length being less than or equal to the second voltage pulse length. The illustrated triphasic pulses have asymmetric voltage amplitudes (v) and varied pulse lengths such that d1 is less than d2 and are therefore charge-and-energy balanced while having a higher voltage amplitude than symmetric triphasic pulses (such as those shown in FIG. 3E).”). Koop does not explicitly disclose a pulse generator for use with an electroporation system wherein a pulse width of the positive and negative pulses in the pulse train compensates for switching time of the electroporation system while preserving the average charge of zero over the pulse train.
However, Fraasch teaches a pulse generator (Figure 4: PFA generator 22) for use with an electroporation system (Figure 4 and [0083]: “The PFA generator 22 is configured to deliver high-frequency, non-ablative pulses for causing reversible and/or non-reversible electroporation in targeted tissue cells.”) wherein a pulse width of the positive and negative pulses in the pulse train compensates for switching time of the electroporation system while preserving the average charge of zero over the pulse train (Figure 29 and [0070] and [0106]: “To compensate for the resulting charge imbalance, the controller increases the pulse width T by a target amount to effectively balance charge delivery. The pulse width T of the negative phase 12B in FIG. 29 is increased to 5.25 μs, or 250 ns over the pulse width T of 5 μs shown in FIG. 28, resulting in a net charge of zero or approximately zero.”).
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 pulse generator of Koop so that a pulse width of the positive and negative pulses in the pulse train compensates for switching time of the electroporation system while preserving the average charge of zero over the pulse train as taught by Fraasch to avoid unintended muscle stimulation (Fraasch [0106]).
Regarding claim 10, Koop in view of Fraasch discloses the pulse generator in accordance with claim 9, and Koop further discloses a pulse generator wherein the first pulse and the last pulse have different polarities (Figure 3F: 302f, the last and first pulse have opposite polarities and [0092]).
Regarding claim 11, Koop in view of Fraasch discloses the pulse generator in accordance with claim 9, and Koop further discloses a pulse generator wherein the first pulse and the last pulse have the same polarity (Figure 3F: 301f, the last and first pulse have the same polarities and [0092]).
Regarding claim 14, Koop discloses a method for controlling an electroporation system (Figure 1), the method comprising: generating, using a pulse generator (Figure 1: electroporation generator 130), a waveform (Figure 3F) including a single, asymmetrical pulse train having positive and negative pulses (Figure 3F: alternating pulse sequence 301f), wherein an average charge over the pulse train is zero ([0092]: “FIG. 3F. is a diagram illustrating two pulse sequences 305f, one non-alternating (301f) and the other alternating (302f), of charge-and-energy balanced, asymmetric triphasic pulses (311t) to be delivered to electrodes in an electroporation electrode arrangement of the catheter.”), and wherein each positive pulse in the single, asymmetrical pulse train has a greater amplitude and shorter pulse width than each negative pulse in the single, asymmetric pulse train (Figure 3F: 301f and [0094]: “And each triphasic pulse may have a first voltage pulse length and a second voltage pulse length, the first voltage pulse length being less than or equal to the second voltage pulse length. The illustrated triphasic pulses have asymmetric voltage amplitudes (v) and varied pulse lengths such that d1 is less than d2 and are therefore charge-and-energy balanced while having a higher voltage amplitude than symmetric triphasic pulses (such as those shown in FIG. 3E).”); and delivering, using one or more electrodes (Figure 2A: electrodes 201a, 201b, 201c, 201d, 201e, and 201f) on a catheter (Figure 1: electroporation catheter 105) coupled to the pulse generator, the generated waveform to target tissue ([0060]). Koop does not explicitly disclose a method for controlling an electroporation system, the method comprising: determining a pulse width of the positive and negative pulses to compensate for switching time of the electroporation system while preserving the average charge of zero over the single, asymmetrical pulse train.
However, Fraasch teaches a method for controlling an electroporation system (Figure 4 and Abstract), the method comprising: determining a pulse width of the positive and negative pulses to compensate for switching time of the electroporation system while preserving the average charge of zero over the single, asymmetrical pulse train (Figure 29 and [0070] and [0106]: “To compensate for the resulting charge imbalance, the controller increases the pulse width T by a target amount to effectively balance charge delivery. The pulse width T of the negative phase 12B in FIG. 29 is increased to 5.25 μs, or 250 ns over the pulse width T of 5 μs shown in FIG. 28, resulting in a net charge of zero or approximately zero.”).
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 of Koop so it includes determining a pulse width of the positive and negative pulses to compensate for switching time of the electroporation system while preserving the average charge of zero over the single, asymmetrical pulse train as taught by Fraasch to avoid unintended muscle stimulation (Fraasch [0106]).
Regarding claim 15, Koop in view of Fraasch discloses the method of claim 14, and Koop further discloses a method wherein the pulse train includes a first pulse (Figure 3F: 301f, first pulse with v1 and d-1), a last pulse (Figure 3F: 301f, last pulse in Figure, also v1 and d-1), and at least one intermediate pulse between the first pulse and the last pulse (Figure 3F: 301f, there are many intermediate pulses, including many with v2 and d2), and wherein a polarity of the first pulse is the same as a polarity of the last pulse (Figure 3F: 301f, the last and first pulse have the same polarity and [0092]).
Regarding claim 16, Koop in view of Fraasch discloses the method of claim 15, and Koop further discloses a method wherein the at least one intermediate pulse has a first pulse width (Figure 3F: 301f, d2), and wherein the first pulse and the last pulse have a second pulse width that is different than the first pulse width (Figure 3F: 301f, d1 and [0094]: “And each triphasic pulse may have a first voltage pulse length and a second voltage pulse length, the first voltage pulse length being less than or equal to the second voltage pulse length. The illustrated triphasic pulses have asymmetric voltage amplitudes (v) and varied pulse lengths such that d1 is less than d2 and are therefore charge-and-energy balanced while having a higher voltage amplitude than symmetric triphasic pulses (such as those shown in FIG. 3E).”).
Regarding claim 18, Koop in view of Fraasch discloses the method of claim 15, and Koop further discloses a method wherein positive pulses of the at least one intermediate pulse have a different pulse width and a different amplitude (Figure 3F: 301f, d1 and v1) than negative pulses of the at least one intermediate pulse (Figure 3F: 301f, d2 and v2).
Regarding claim 19, Koop in view of Fraasch discloses the method of claim 15, and Koop further discloses a method wherein the at least one intermediate pulse has a first pulse amplitude (Figure 3F: 301f, v2), and wherein the first pulse and the last pulse have a second pulse amplitude that is different than the first pulse amplitude (Figure 3F: 301f, v1).
Claims 4, 12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Koop (Figure 3F) in view of Fraasch, further in view of Embodiment B of Koop (Figure 3E).
Regarding claim 4, Embodiment A of Koop in view of Fraasch discloses the pulse generator in accordance with claim 3 but does not explicitly disclose a pulse generator wherein the second pulse width is half of the first pulse width.
However, Embodiment B of Koop teaches a pulse generator wherein the second pulse width is half of the first pulse width (Figure 3E and [0093]: “The illustrated triphasic pulses have symmetric voltage amplitudes (v) and varied pulse lengths such that d1 is approximately equal to one half of d2 and are therefore charge-and-energy balanced.”).
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 pulse generator disclosed by Embodiment A of Koop so that the second pulse width is half of the first pulse width as taught by Embodiment B of Koop to ensure that the pulse train is both charge and energy balanced ([0093]).
Regarding claim 12, Embodiment A of Koop in view of Fraasch discloses the pulse generator in accordance with claim 9, including wherein the at least one intermediate pulse has a first pulse width (Figure 3F: d2), but does not explicitly disclose a pulse generator wherein the first pulse and the last pulse have a second pulse width that is half of the first pulse width.
However, Embodiment B of Koop in view of Fraasch teaches a pulse generator wherein the first pulse and the last pulse have a second pulse width that is half of the first pulse width (Figure 3E and [0093]: “The illustrated triphasic pulses have symmetric voltage amplitudes (v) and varied pulse lengths such that d1 is approximately equal to one half of d2 and are therefore charge-and-energy balanced.”).
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 pulse generator disclosed by Embodiment A of Koop so that the second pulse width is half of the first pulse width as taught by Embodiment B of Koop to ensure that the pulse train is both charge and energy balanced ([0093]).
Regarding claim 17, Embodiment A of Koop in view of Fraasch discloses the method of claim 16 but does not explicitly disclose a method wherein the second pulse width is half of the first pulse width.
However, Embodiment B of Koop teaches a method wherein the second pulse width is half of the first pulse width (Figure 3E and [0093]: “The illustrated triphasic pulses have symmetric voltage amplitudes (v) and varied pulse lengths such that d1 is approximately equal to one half of d2 and are therefore charge-and-energy balanced.”).
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 Embodiment A of Koop so that the second pulse width is half of the first pulse width as taught by Embodiment B of Koop to ensure that the pulse train is both charge and energy balanced ([0093]).
Claims 7, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Koop in view of Fraasch.
Regarding claim 7, Koop in view of Fraasch discloses the pulse generator in accordance with claim 6 but does not explicitly disclose a pulse generator wherein the second pulse amplitude is half of the first pulse amplitude.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second pulse amplitude so that it is half of the first pulse amplitude since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)
Regarding claim 13, Koop in view of Fraasch discloses the pulse generator in accordance with claim 9 but does not explicitly disclose a pulse generator wherein the at least one intermediate pulse has a first pulse amplitude, and wherein the first pulse and the last pulse have a second pulse amplitude that is half of the first pulse amplitude.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second pulse amplitude so that it is half of the first pulse amplitude, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)
Regarding claim 20, Koop in view of Fraasch discloses the method of claim 19 but does not explicitly disclose a method wherein the second pulse amplitude is half of the first pulse amplitude.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second pulse amplitude so that it is half of the first pulse amplitude, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 8 is under 35 U.S.C. 103 as being unpatentable over Koop in view of Fraasch, further in view of Forsyth et al., US 20200289185, herein referred to as “Forsyth”.
Regarding claim 8, Koop in view of Fraasch discloses the pulse generator in accordance with claim 1 but does not explicitly disclose a pulse generator wherein the pulse train is a subset of pulses within a longer burst waveform, and wherein the average charge over the burst waveform is non-zero.
However, Forsyth teaches a pulse generator (Figure 5: power supply 108) wherein the pulse train is a subset of pulses (Figure 16: first output 910) within a longer burst waveform (Figure 16: second output 912), and wherein the average charge over the burst waveform is non-zero ([0140]: “The method then includes making an adjustment, as indicated at 924, to the charge balance that results from the first and second outputs 910, 912.”).
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.
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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