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 .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 6/12/2026 is acknowledged. Claims 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/12/2026.
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 1-6 and 21-32 are rejected under 35 U.S.C. 103 as being unpatentable over Fraasch et al., US 20200138506, herein referred to as “Fraasch”, in view of Mishra et al., WO 2017142948, herein referred to as “Mishra”.
Regarding claim 1, Fraasch teaches a method of delivering a multiphasic ablation waveform (Abstract and Figure 29) comprising: generating a first pulse train (Figure 29: positive phase 12A); and generating a second pulse train (Figure 29: negative phase 12B), each of the second pulses having a second polarity opposite of the first polarity (Figure 29); wherein the first pulse train and second pulse train are delivered such that charge balance is achieved upon conclusion of the second pulse train (Figure 29: 12A is the first pulse train, 12B is the second pulse train, and [0106]: “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.”). Fraasch does not explicitly disclose a method comprising: generating a first pulse train comprising a plurality of first pulses each having a pulse width and an amplitude, wherein a first in time of the first pulses has a first amplitude, and each successive pulse of the first pulses has a larger amplitude than an immediately preceding pulse, each of the first pulses having a first polarity; and generating a second pulse train comprising a plurality of second pulses each having a pulse width and an amplitude, wherein a first in time of the second pulses has the first amplitude, and each successive pulse of the second pulses has a larger amplitude than an immediately preceding pulse.
However, Mishra discloses a method of delivering a multiphasic waveform (Figure 25A and [0391]) comprising: generating a first pulse train comprising a plurality of first pulses each having a pulse width and an amplitude (Figure 25A: the first pulse train is the first positive pulse through the highest amplitude positive pulse), wherein a first in time of the first pulses has a first amplitude (Figure 25A), and each successive pulse of the first pulses has a larger amplitude than an immediately preceding pulse (Figure 25A), each of the first pulses having a first polarity (Figure 25A); and generating a second pulse train comprising a plurality of second pulses each having a pulse width and an amplitude (Figure 25A: the second pulse train is the first negative pulse through the highest amplitude negative pulse), wherein a first in time of the second pulses has the first amplitude (Figure 25A), and each successive pulse of the second pulses has a larger amplitude than an immediately preceding pulse (Figure 25A), each of the second pulses having a second polarity opposite of the first polarity (Figure 25A).
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 Fraasch so that the first pulse train comprises a plurality of first pulses each having a pulse width and an amplitude, wherein a first in time of the first pulses has a first amplitude, and each successive pulse of the first pulses has a larger amplitude than an immediately preceding pulse, each of the first pulses having a first polarity; the second pulse train comprises a plurality of second pulses each having a pulse width and an amplitude, wherein a first in time of the second pulses has the first amplitude, and each successive pulse of the second pulses has a larger amplitude than an immediately preceding pulse as taught by Mishra so that the shape of the delivered pulses can be configured to influence the onset and/or patient perception (Mishra [0419]).
Regarding claim 2, Fraasch in view of Mishra discloses the method of claim 1, and Fraasch discloses a method wherein the first pulse train and second pulse train are delivered within a time window of less than about one millisecond such that the charge balance is achieved within a time window of less than about one millisecond ([0106]: “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”). Also, Mishra discloses a method wherein the first pulse train and second pulse train are delivered within a time window of less than about one millisecond such that the charge balance is achieved within a time window of less than about one millisecond ([0418]: “In some embodiments, the pulses are delivered at a high frequency, such as a frequency of at least 1kHz, such as a frequency of approximately 10kHz. In some embodiments, one or more pulses of the stimulation waveform have a pulse width between 1 μsec and 10msec, such as a duration between 10 μsec and 300 μsec.”).
Regarding claim 3, Fraasch in view of Mishra discloses the method of claim 1, and Fraasch discloses a method wherein: within the first pulse train, the first in time pulse has an amplitude that is less than an irreversible electroporation threshold ([0107]: “The voltage of these runt pulses 86 must be high enough to delivery sufficient balancing energy in a timely manner, yet must be low enough to avoid electroporative effects, both reversible and irreversible. For example, it is important to avoid causing irreversible electroporation with runt pulses so the dosing level of the PFA therapy remains constant.”), and the last in time pulse has an amplitude that is greater than an irreversible electroporation threshold (Figure 29: 12A and [0003]: “These pulses are delivered to perform reversible or irreversible electroporation via an ablation therapy delivery device of intended cardiac sites.”); and within the second pulse train, the first in time pulse has an amplitude that is less than an irreversible electroporation threshold ([0107]: “The voltage of these runt pulses 86 must be high enough to delivery sufficient balancing energy in a timely manner, yet must be low enough to avoid electroporative effects, both reversible and irreversible. For example, it is important to avoid causing irreversible electroporation with runt pulses so the dosing level of the PFA therapy remains constant.”), and the last in time pulse has an amplitude that is greater than an irreversible electroporation threshold (Figure 29: 12B and [0003]: “These pulses are delivered to perform reversible or irreversible electroporation via an ablation therapy delivery device of intended cardiac sites.”). In combination with Mishra, the first pulse in the first pulse train has the voltage of a runt pulse of Fraasch, while the last pulse in the first pulse train has the voltage of positive pulse 12A of Figure 29 of Fraasch, which is above the irreversible electroporation threshold. The second pulse train has the same amplitudes as the first pulse train.
Regarding claim 4, Fraasch in view of Mishra discloses the method of claim 1, and Fraasch discloses a method wherein the first pulse train and the second pulse train are delivered within a time window with a duration that limits muscle stimulation ([0106]: “As discussed above, biphasic pulse asymmetry during PFA energy delivery may lead to unintended muscle stimulation. Several methods are disclosed herein for correcting charge imbalance or asymmetry… 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”).
Regarding claim 5, Fraasch in view of Mishra discloses the method of claim 1, and Fraasch discloses a method wherein the first pulse train and the second pulse train are delivered to cause irreversible electroporation in a target tissue (Figure 29: 12A and 12B and [0003]: “These pulses are delivered to perform reversible or irreversible electroporation via an ablation therapy delivery device of intended cardiac sites.”).
Regarding claim 6, Fraasch in view of Mishra discloses the method of claim 5, and Fraasch discloses a method further comprising monitoring an impedance in the target tissue to determine a state of the target tissue ([0082]: “The delivery device 28 may have any suitable size, shape, or configuration, but includes at least one energy delivery electrode 32 for delivering an electrical current, and may further include one or more electrodes such as mapping electrodes and/or electrodes for measuring characteristics such as impedance (not shown).”).
Regarding claim 21, Fraasch in view of Mishra discloses the method of claim 5, and Mishra discloses a method wherein the first pulse train and the second pulse train are separated by an interval that is greater than a pulse width of any of the first pulses or the second pulses (Figure 25A: the width of the interval between all pulses is greater than a pulse width of any of the first pulses and the second pulses).
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 Fraasch so that the first pulse train and the second pulse train are separated by an interval that is greater than a pulse width of any of the first pulses or the second pulses as taught by Mishra so that the shape of the delivered pulses can be configured to influence the onset and/or patient perception (Mishra [0419]).
Regarding claim 22, Fraasch in view of Mishra discloses the method of claim 21, and Mishra discloses a method wherein the interval is at least four times the pulse width of any of the first pulses or the second pulses (Figure 25A: the width between the positive pulse with the highest amplitude and the first negative pulse is at least four times the width of any of the first pulses or second pulses).
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 Fraasch so that the interval is at least four times the pulse width of any of the first pulses or the second pulses as taught by Mishra so that the shape of the delivered pulses can be configured to influence the onset and/or patient perception (Mishra [0419]).
Regarding claim 23, Fraasch in view of Mishra discloses the method of claim 1, and Mishra discloses a method wherein the first pulse train and the second pulse train are equal and opposite to one another (Figure 25A).
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 Fraasch so that the first pulse train and the second pulse train are equal and opposite to one another as taught by Mishra so that the shape of the delivered pulses can be configured to influence the onset and/or patient perception (Mishra [0419]).
Regarding claim 24, Fraasch discloses a signal generator adapted for use in delivery of tissue ablation energy (Figure 4 and Abstract) comprising: a therapy output block (Figure 4: PFA generator 22); an input/output circuit (Figure 4: processing circuitry 50) adapted to couple to a probe (Figure 4: delivery device 28) for delivery of tissue ablation energy to direct signals from the therapy output block to the probe (Figure 4 and [0085]); a user interface allowing a user to control the signal generator (Figure 4: input means 48 and [0084]); a controller coupled to the therapy output block and the user interface (Figure 4: control unit 30); and a memory coupled to the controller and having stored instructions for the delivery of a treatment cycle ([0113]), the treatment cycle (Figure 29) comprising: a first pulse train (Figure 29: positive phase 12A); and a second pulse train (Figure 29: negative phase 12B), each of the second pulses having a second polarity opposite of the first polarity (Figure 29); wherein the first pulse train and second pulse train are delivered such that charge balance is achieved upon conclusion of the second pulse train (Figure 29: 12A is the first pulse train, 12B is the second pulse train, and [0106]: “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.”). Fraasch does not explicitly disclose a signal generator comprising a treatment cycle, the treatment cycle comprising: a first pulse train comprising a plurality of first pulses each having a pulse width and an amplitude, wherein a first in time of the first pulses has a first amplitude, and each successive pulse of the first pulses has a larger amplitude than an immediately preceding pulse, each of the first pulses having a first polarity; and a second pulse train comprising a plurality of second pulses each having a pulse width and an amplitude, wherein a first in time of the second pulses has the first amplitude, and each successive pulse of the second pulses has a larger amplitude than an immediately preceding pulse.
However, Mishra discloses a signal generator comprising a treatment cycle (Figure 25A and [0391]), the treatment cycle comprising: a first pulse train comprising a plurality of first pulses each having a pulse width and an amplitude (Figure 25A: the first pulse train is the first positive pulse through the highest amplitude positive pulse), wherein a first in time of the first pulses has a first amplitude (Figure 25A), and each successive pulse of the first pulses has a larger amplitude than an immediately preceding pulse (Figure 25A), each of the first pulses having a first polarity (Figure 25A); and a second pulse train comprising a plurality of second pulses each having a pulse width and an amplitude (Figure 25A: the second pulse train is the first negative pulse through the highest amplitude negative pulse), wherein a first in time of the second pulses has the first amplitude (Figure 25A), and each successive pulse of the second pulses has a larger amplitude than an immediately preceding pulse (Figure 25A), each of the second pulses having a second polarity opposite of the first polarity (Figure 25A).
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 signal generator disclosed by Fraasch so that the first pulse train comprises a plurality of first pulses each having a pulse width and an amplitude, wherein a first in time of the first pulses has a first amplitude, and each successive pulse of the first pulses has a larger amplitude than an immediately preceding pulse, each of the first pulses having a first polarity; the second pulse train comprises a plurality of second pulses each having a pulse width and an amplitude, wherein a first in time of the second pulses has the first amplitude, and each successive pulse of the second pulses has a larger amplitude than an immediately preceding pulse as taught by Mishra so that the shape of the delivered pulses can be configured to influence the onset and/or patient perception (Mishra [0419]).
Regarding claim 25, Fraasch in view of Mishra discloses the signal generator of claim 24, and Fraasch discloses a signal generator wherein the stored instructions define the treatment cycle such that the first pulse train and second pulse train are delivered within a time window of less than about one millisecond such that the charge balance is achieved within a time window of less than about one millisecond ([0106]: “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”). Also, Mishra discloses a signal generator wherein the first pulse train and second pulse train are delivered within a time window of less than about one millisecond such that the charge balance is achieved within a time window of less than about one millisecond ([0418]: “In some embodiments, the pulses are delivered at a high frequency, such as a frequency of at least 1kHz, such as a frequency of approximately 10kHz. In some embodiments, one or more pulses of the stimulation waveform have a pulse width between 1 μsec and 10msec, such as a duration between 10 μsec and 300 μsec.”).
Regarding claim 26, Fraasch in view of Mishra discloses the signal generator of claim 24, and Fraasch discloses a signal generator wherein the stored instructions define the treatment cycle such that: within the first pulse train, the first in time pulse has an amplitude that is less than an irreversible electroporation threshold ([0107]: “The voltage of these runt pulses 86 must be high enough to delivery sufficient balancing energy in a timely manner, yet must be low enough to avoid electroporative effects, both reversible and irreversible. For example, it is important to avoid causing irreversible electroporation with runt pulses so the dosing level of the PFA therapy remains constant.”), and the last in time pulse has an amplitude that is greater than an irreversible electroporation threshold (Figure 29: 12A and [0003]: “These pulses are delivered to perform reversible or irreversible electroporation via an ablation therapy delivery device of intended cardiac sites.”); and within the second pulse train, the first in time pulse has an amplitude that is less than an irreversible electroporation threshold ([0107]: “The voltage of these runt pulses 86 must be high enough to delivery sufficient balancing energy in a timely manner, yet must be low enough to avoid electroporative effects, both reversible and irreversible. For example, it is important to avoid causing irreversible electroporation with runt pulses so the dosing level of the PFA therapy remains constant.”), and the last in time pulse has an amplitude that is greater than an irreversible electroporation threshold (Figure 29: 12B and [0003]: “These pulses are delivered to perform reversible or irreversible electroporation via an ablation therapy delivery device of intended cardiac sites.”). In combination with Mishra, the first pulse in the first pulse train has the voltage of a runt pulse of Fraasch, while the last pulse in the first pulse train has the voltage of positive pulse 12A of Figure 29 of Fraasch, which is above the irreversible electroporation threshold. The second pulse train has the same amplitudes as the first pulse train.
Regarding claim 27, Fraasch in view of Mishra discloses the signal generator of claim 24, and Fraasch discloses a signal generator wherein the stored instructions define the treatment cycle such that the first pulse train and the second pulse train are delivered within a time window with a duration that limits muscle stimulation ([0106]: “As discussed above, biphasic pulse asymmetry during PFA energy delivery may lead to unintended muscle stimulation. Several methods are disclosed herein for correcting charge imbalance or asymmetry… 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”).
Regarding claim 28, Fraasch in view of Mishra discloses the signal generator of claim 24, and Fraasch discloses a signal generator wherein the stored instructions define the treatment cycle such that the first pulse train and the second pulse train are delivered to cause irreversible electroporation in a target tissue (Figure 29: 12A and 12B and [0003]: “These pulses are delivered to perform reversible or irreversible electroporation via an ablation therapy delivery device of intended cardiac sites.”).
Regarding claim 29, Fraasch in view of Mishra discloses the signal generator of claim 24, and Fraasch discloses a signal generator wherein the stored instructions further cause the controller to monitor an impedance in the target tissue to determine a state of the target tissue ([0082]: “The delivery device 28 may have any suitable size, shape, or configuration, but includes at least one energy delivery electrode 32 for delivering an electrical current, and may further include one or more electrodes such as mapping electrodes and/or electrodes for measuring characteristics such as impedance (not shown).”).
Regarding claim 30, Fraasch in view of Mishra discloses the signal generator of claim 24, and Mishra discloses a signal generator wherein the stored instructions define the treatment cycle ([0375]) such that the first pulse train and the second pulse train are separated by an interval that is greater than a pulse width of any of the first pulses or the second pulses (Figure 25A: the width of the interval between all pulses is greater than a pulse width of any of the first pulses and the second pulses).
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 signal generator disclosed by Fraasch so that the first pulse train and the second pulse train are separated by an interval that is greater than a pulse width of any of the first pulses or the second pulses as taught by Mishra so that the shape of the delivered pulses can be configured to influence the onset and/or patient perception (Mishra [0419]).
Regarding claim 31, Fraasch in view of Mishra discloses the signal generator of claim 30, and Mishra discloses a signal generator wherein the stored instructions define the treatment cycle ([0375]) such that the interval is at least four times the pulse width of any of the first pulses or the second pulses (Figure 25A: the width between the positive pulse with the highest amplitude and the first negative pulse is at least four times the width of any of the first pulses or second pulses).
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 signal generator disclosed by Fraasch so that the interval is at least four times the pulse width of any of the first pulses or the second pulses as taught by Mishra so that the shape of the delivered pulses can be configured to influence the onset and/or patient perception (Mishra [0419]).
Regarding claim 32, Fraasch in view of Mishra discloses the signal generator of claim 24, and Mishra discloses a signal generator wherein the stored instructions define the treatment cycle ([0375]) such that the first pulse train and the second pulse train are equal and opposite to one another (Figure 25A).
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 signal generator disclosed by Fraasch so that the first pulse train and the second pulse train are equal and opposite to one another as taught by Mishra so that the shape of the delivered pulses can be configured to influence the onset and/or patient perception (Mishra [0419]).
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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