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 .
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.
Response to Amendment
Acknowledgement is made to the amendment received 10/30/2025.
Acknowledgement is made to the amendment of claims 1, 6-7, 10, 16-17, 20.
Acknowledgement is made to the cancellation of claims 11-15.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1-10 and 16-20 are pending. A complete action on the merits appears below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Jones (US-20080276192-A1) in view of Xiao (US-20170245928-A1) and Konings (US-20160331441-A1).
Regarding claim 1, Jones teaches a system for controlling an ablation therapy (Abstract, [0020]) comprising:
a signal generator ([0022] discusses the illustrated embodiment of Fig. 1 which controls the parameters of output of an electromagnetic energy source) adapted to provide electrical output for ablation therapy ([0020] teaches a variety of uses for the energy output devices described, such as soft tissue cutting and ablating procedures); and
a user interface ([0022]- [0023] discusses Fig. 1 as representing an embodiment of a graphical user interface having a touchscreen 15 and a control wheel 20) operatively linked to the signal generator ([0022] teaches the interface as being enabled to control several parameters of the electromagnetic energy source), the user interface configured to interact with a user ([0006]- [0009] teach this invention as accomplishing the important capability of a user to be able to easily, precisely, and accurately control aspects of electromagnetic energy generation, [0035] further discusses the operation of the graphical user interface by the user) by:
providing the user a list of available control parameters to select from ([0022]- [0023], [0037] discusses the figures in which the graphical user interface presents the user with a display which allows the user to select from a variety of parameters to control);
receiving from the user a selection of one or more control parameters ([0031], [0037]- [0038] teach the device as having a variety of parameters which may be selected, adjusted, or preset by the user); and
for at least one user selected closed loop parameter, presenting the user with an input screen for selecting or approving one or more limits for the user selected closed loop parameter ([0031], [0037]- [0038]);
further wherein the signal generator is configured to deliver a therapy regimen as follows:
generating a first electrical output having a first output parameter set ([0031], [0037] teach the energy as being delivered based of the selection made to the graphical user interface).
Jones fails to teach the control parameter as being closed loop control parameters and the therapy regimen as:
sensing a signal related to the user selected closed loop parameter and comparing the sensed signal to the user selected or approved limit for the user selected closed loop parameter;
adjusting the first output parameter set to create a second output parameter set; and
generating a second electrical output using the second output parameter set, wherein at least the second output parameter set is configured for ablating tissue.
Regarding Jones not teaching the parameter as being closed loop and generating an adjusted second output in response to sensing the first output, attention is brought to Jones as teaching the desire to control specific parameters relevant to outputting electrosurgical energy based on a user selection.
While Jones does not teach the parameter as being closed loop and generating an adjusted second output in response to sensing the first output, it is known in the art to utilize a feedback loop to control parameters relevant to an electrosurgical output for treating tissue which encompasses delivering a first electrical output, sensing a parameter of this electrical output, adjusting the output in response to this sensed parameter, and outputting a second electrical output, so as to provide an increase of accuracy to the system. This is shown by Xiao which teaches a system having increased accuracy for outputting electrosurgical energy to ablate tissue (Abstract, [0191]), this system incorporates a feedback control system for adjusting one or more characteristics of the electrosurgical output ([0011]) as a known manner of controlling an electrosurgical system for treating tissue ([0013]- [0015]). This system which utilizes a feedback loop to control specific parameters relevant to the electrosurgical output comprises producing a first output, sensing said first output and compares said parameter to the desired parameter and in response to this comparison produces a second output which it difference from the first output ([0159], [0191]- [0199] specifically in this situation the “control values” which are the values output by the controller are changes in response to the measured values so as to provide an output which is closer to the desired value, therefore in response to sensing the first electrical output, a second different electrical output is provided). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the control parameters of Jones to be closed loop/feedback loop parameters, as is taught by Xiao, to produce the predictable result of providing an increase of accuracy to the system, as is taught by Xiao, as is has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III)
Jones further fails to teach the provided therapy as being irreversible electroporation.
Jones does however teach the device as providing electromagnetic energy to perform surgical procedures ([0007], [0022]).
Konings teaches a device for providing treatment to patient tissue having a generator configured to output electromagnetic energy to a medical device (Abstract, [0043]).
Konings further teaches the known use of providing electromagnetic energy to produce irreversible electroporation ([0043]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of producing irreversible electroporation in patient tissue through the use of the application of electromagnetic energy, as is taught by Konings, into the device which provides electromagnetic energy to a patient as is taught by Jones, to produce the predictable result of treating patient tissue, as is taught by Konings, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jones (US-20080276192-A1) in view of Xiao (US-20170245928-A1) and Konings (US-20160331441-A1) further in view of Waldhauser (US-20180050206-A1), Wong (US-20020068931-A1), and Gregg (US-20110071516-A1).
Regarding claim 2, the modified teaching of Jones teaches the system of claim 1.
In view of the above provided rejection of claim 1, Xiao further teaches sensing the closed loop control parameter as comprising sensing the current, voltage, and/or impedance, including both tissue inductance and tissue capacitance ([0154], [0159]).
However, the modified device of Jones fails to teach the system of claim 1, wherein the closed loop control parameters comprise at least user selectable options for phase, and in response to receiving from the user a selection of phase, the step of sensing a signal related to the user selected closed loop parameter includes sensing a current of the first electrical output and comparing the sensed current to a voltage of the first electrical output to determine a reactive impedance and phase shift.
Waldhauser teaches a system for providing electrical stimulation to tissue, wherein the stimulation is provided by a first signal and a second signal, the first signal and the second signal differing by a magnitude of a parameter as the second signal is based at least partially on sensor data indicative of the first signal (Abstract). Waldhauser further teaches the signals as comprising one or more electrical pulses, each of which may be adjusted based of a variety of parameters including the phase ([0013]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of the parameter which is utilized to adjust the pulse delivered to tissue as being the phase, as is taught by Waldhauser, into the system of Jones as currently modified which teaches selecting pulse parameters to control the energy delivered to tissue.
Wong teaches an electrosurgical generator and a variety of real-time data measurements as being used to control the generator, such as tissue impedance, tissue reactive component, and tissue resistive component ([0063], [0068]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify Jones as currently modified to allow a user to control any parameter that is known to influence the outcome of the ablation procedure, to produce the predictable result of allowing a user to control the desired outcome of the ablation procedure.
Gregg teaches an electrosurgical generator for supplying electrosurgical energy to tissue including sensor circuitry (Abstract) and discusses the known relationship of determining the phase shift and the reactive impedance by comparing the voltage and current waveforms ([0029]- [0030]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known relationship between voltage and current waveforms to find reactance and phase shift, as is taught by Gregg into the modified teaching of Jones to produce the reactive impedance and the phase shift values. For more information on this known relationship see the conclusion section.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jones (US-20080276192-A1) in view of Xiao (US-20170245928-A1) and Konings (US-20160331441-A1) further in view of Wong (US-20020068931-A1).
Regarding claim 3, the modified teaching of Jones teaches the system of claim 1.
However, the modified teaching of Jones fails to teach the system of claim 1, wherein the closed loop control parameters comprise at least user selectable options for reactive impedance, and in response to receiving from the user a selection of reactive impedance, the step of sensing a signal related to the user selected closed loop parameter includes sensing a current of the first electrical output and comparing the sensed current to a voltage of the first electrical output to determine a reactive impedance.
Wong teaches an electrosurgical generator and a variety of real-time data measurements as being used to control the generator, such as tissue impedance, tissue reactive component, and tissue resistive component ([0063], [0068]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify Jones as currently modified to allow a user to control any parameter that is known to influence the outcome of the ablation procedure, to produce the predictable result of allowing a user to control the desired outcome of the ablation procedure.
Gregg teaches an electrosurgical generator for supplying electrosurgical energy to tissue including sensor circuitry (Abstract) and discusses the known relationship of determining the phase shift and the reactive impedance by comparing the voltage and current waveforms ([0029]- [0030]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known relationship between voltage and current waveforms to find the reactive impedance, as is taught by Gregg into the modified teaching of Jones to produce the reactive impedance and the phase shift values. For more information on this known relationship see the conclusion section.
Claims 4, 10, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US-20080276192-A1) in view of Xiao (US-20170245928-A1) and Konings (US-20160331441-A1) further in view of Essalik (US-20120041288-A1).
Regarding claim 4, the modified teaching of Jones teaches the system of claim 1.
However, the modified teaching of Jones fails to teach the system of claim 1, wherein the closed loop control parameters comprise at least user selectable options for inter-pulse or inter-burst voltage and in response to the step of receiving from the user a selection of inter-pulse or inter-burst voltage, the step of sensing a signal related to the user selected closed loop parameter includes measuring a voltage between therapy output bursts.
Essalik teaches a tissue ablation system ([0023]) and teaches ablation as being performed by varying and actuating different parameters, such as changing the voltage between pulses ([0073]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the system of Jones as currently modified to incorporate the teaching of changing the voltage between pulses to perform irreversible electroporation, as is taught by Essalik, to produce the predictable result of producing irreversible electroporation.
Further, in accordance with the previously provided modification of Xiao into Jones, this control is in response to the sensed signals as are taught by Xiao, which include the voltage sensed during a charge mode, which is the mode when a pulse is not being performed and therefore is the voltage measured between therapy output bursts ([0159]).
Regarding claim 10, Jones teaches a system for controlling an ablation therapy (Abstract, [0020]) comprising:
a signal generator ([0022] discusses the illustrated embodiment of Fig. 1 which controls the parameters of output of an electromagnetic energy source) adapted to provide electrical output for ablation therapy ([0020] teaches a variety of uses for the energy output devices described, such as soft tissue cutting and ablating procedures); and
a user interface ([0022]- [0023] discusses Fig. 1 as representing an embodiment of a graphical user interface having a touchscreen 15 and a control wheel 20) operatively linked to the signal generator ([0022] teaches the interface as being enabled to control several parameters of the electromagnetic energy source), the user interface configured to interact with a user ([0006]- [0009] teach this invention as accomplishing the important capability of a user to be able to easily, precisely, and accurately control aspects of electromagnetic energy generation, [0035] further discusses the operation of the graphical user interface by the user) by:
providing the user a list of available therapy profiles to select from ([0022]- [0023], [0037] discusses the figures in which the graphical user interface presents the user with a display which allows the user to select from a variety of parameters to control); and
receiving from the user a selection of one of the available therapy profiles ([0031], [0037]- [0041] teach the device as having a variety of parameters including therapeutic profiles which may be selected, adjusted, or preset by the user);
further wherein the signal generator is configured to deliver a therapy regimen as follows:
configuring a first output therapy parameter set using the selected therapy profile ([0031], [0037]- [0041]);
generating one or more first therapy outputs using the first output therapy parameter set ([0031], [0037]- [0041] teach the energy as being delivered based of the selection made to the graphical user interface).
Jones fails to teach the control parameter as being sensing one or more first feedback parameters;
comparing the first feedback parameters to an expected feedback parameter to generate one or more first comparison results, wherein the expected feedback parameter is associated with the selected therapy profile; and
configuring a second output therapy parameter set using the first comparison results wherein at least the second output parameter set is configured for treating tissue;
wherein the first feedback parameters and the expected feedback parameter are inter-pulse or inter-burst voltages determined by measuring voltage between pulses or between bursts.
Regarding Jones not teaching the parameter as being closed loop and generating an adjusted second output in response to sensing the first output, attention is brought to Jones as teaching the desire to control specific parameters relevant to outputting electrosurgical energy based on a user selection.
While Jones does not teach the parameter as being closed loop and generating an adjusted second output in response to sensing the first output, it is known in the art to utilize a feedback loop to control parameters relevant to an electrosurgical output for treating tissue which encompasses delivering a first electrical output, sensing a parameter of this electrical output, adjusting the output in response to this sensed parameter, and outputting a second electrical output, so as to provide an increase of accuracy to the system. This is shown by Xiao which teaches a system having increased accuracy for outputting electrosurgical energy to ablate tissue (Abstract, [0191]), this system incorporates a feedback control system for adjusting one or more characteristics of the electrosurgical output ([0011]) as a known manner of controlling an electrosurgical system for treating tissue ([0013]- [0015]). This system which utilizes a feedback loop to control specific parameters relevant to the electrosurgical output comprises producing a first output, sensing said first output and compares said parameter to the desired parameter and in response to this comparison produces a second output which it difference from the first output ([0159], [0191]- [0199] specifically in this situation the “control values” which are the values output by the controller are changes in response to the measured values so as to provide an output which is closer to the desired value, therefore in response to sensing the first electrical output, a second different electrical output is provided). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the control parameters of Jones to be closed loop/feedback loop parameters, as is taught by Xiao, to produce the predictable result of providing an increase of accuracy to the system, as is taught by Xiao, as is has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III)
Essalik teaches a tissue ablation system ([0023]) and teaches ablation as being performed by varying and actuating different parameters, such as changing the voltage between pulses ([0073]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the system of Jones as currently modified to incorporate the teaching of changing the voltage between pulses to perform irreversible electroporation, as is taught by Essalik, to produce the predictable result of producing irreversible electroporation.
Further, in accordance with the previously provided modification of Xiao into Jones, this control is in response to the sensed signals as are taught by Xiao, which include the voltage sensed during a charge mode, which is the mode when a pulse is not being performed and therefore is the voltage measured between therapy output bursts ([0159]).
Jones further fails to teach the provided therapy as being irreversible electroporation.
Jones does however teach the device as providing electromagnetic energy to perform surgical procedures ([0007], [0022]).
Konings teaches a device for providing treatment to patient tissue having a generator configured to output electromagnetic energy to a medical device (Abstract, [0043]).
Konings further teaches the known use of providing electromagnetic energy to produce irreversible electroporation ([0043]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of producing irreversible electroporation in patient tissue through the use of the application of electromagnetic energy, as is taught by Konings, into the device which provides electromagnetic energy to a patient as is taught by Jones, to produce the predictable result of treating patient tissue, as is taught by Konings, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 17, Jones teaches the system of claim 10 wherein the therapy profiles comprise a schedule of therapy output parameters to use during the duration of the therapy regimen ([0037]- [0041]).
In accordance with the above rejection of claim 10, Xiao teaches the system wherein the signal generator is adapted to configure the second output therapy parameter set as follows: if the first feedback parameters correlate with the expected feedback parameters, using the schedule of therapy output parameters for the selected therapy profile to define the second output therapy parameter set; or if the first feedback parameters do not correlate with the expected feedback parameters, modifying the schedule of therapy output parameters for the selected therapy profile in response to the first feedback parameters ([0191]- [0201]).
In accordance with the above rejection of claim 10, Konings further teaches the therapy as being irreversible electroporation ([0043]).
Regarding claim 20, Jones teaches a system for controlling an ablation therapy (Abstract, [0020]) comprising:
a signal generator ([0022] discusses the illustrated embodiment of Fig. 1 which controls the parameters of output of an electromagnetic energy source) adapted to provide electrical output for ablation therapy ([0020] teaches a variety of uses for the energy output devices described, such as soft tissue cutting and ablating procedures); and
a user interface ([0022]- [0023] discusses Fig. 1 as representing an embodiment of a graphical user interface having a touchscreen 15 and a control wheel 20) operatively linked to the signal generator ([0022] teaches the interface as being enabled to control several parameters of the electromagnetic energy source), the user interface configured to interact with a user ([0006]- [0009] teach this invention as accomplishing the important capability of a user to be able to easily, precisely, and accurately control aspects of electromagnetic energy generation, [0035] further discusses the operation of the graphical user interface by the user) by:
providing the user a list of available therapy profiles to select from ([0022]- [0023], [0037] discusses the figures in which the graphical user interface presents the user with a display which allows the user to select from a variety of parameters to control); and
receiving from the user a selection of one of the available therapy profiles ([0031], [0037]- [0041] teach the device as having a variety of parameters including therapeutic profiles which may be selected, adjusted, or preset by the user);
further wherein the signal generator is configured to deliver a therapy regimen as follows:
defining, for the selected therapy profile, at least a portion of a therapy regimen comprising a plurality of bursts of pulses, each burst comprising a plurality of pulses, each pulse comprising a plurality of pulse segments ([0026]- [0028], [0031]);
configuring a first output therapy parameter set using the selected available therapy profile ([0031], [0037]- [0041]), the first output therapy parameter set defining a first predetermined segment of a predetermined pulse of a predetermined burst ([0031], [0037]- [0041]);
generating the first predetermined segment of using the first output therapy parameters ([0031], [0037]).
However, Jones fails to teach sensing one or more first feedback parameters;
using the sensed first feedback parameters to define a second predetermined segment occurring after the first predetermined segment in the predetermined pulse of the predetermined burst;
wherein the first feedback parameters are inter-pulse or inter-burst voltages determined by measuring voltage between pulses or between bursts.
Regarding Jones not teaching the parameter as being closed loop and generating an adjusted second output in response to sensing the first output, attention is brought to Jones as teaching the desire to control specific parameters relevant to outputting electrosurgical energy based on a user selection.
While Jones does not teach the parameter as being closed loop and generating an adjusted second output in response to sensing the first output, it is known in the art to utilize a feedback loop to control parameters relevant to an electrosurgical output for treating tissue which encompasses delivering a first electrical output, sensing a parameter of this electrical output, adjusting the output in response to this sensed parameter, and outputting a second electrical output, so as to provide an increase of accuracy to the system. This is shown by Xiao which teaches a system having increased accuracy for outputting electrosurgical energy to ablate tissue (Abstract, [0191]), this system incorporates a feedback control system for adjusting one or more characteristics of the electrosurgical output ([0011]) as a known manner of controlling an electrosurgical system for treating tissue ([0013]- [0015]). This system which utilizes a feedback loop to control specific parameters relevant to the electrosurgical output comprises producing a first output, sensing said first output and compares said parameter to the desired parameter and in response to this comparison produces a second output which it difference from the first output ([0159], [0191]- [0199] specifically in this situation the “control values” which are the values output by the controller are changes in response to the measured values so as to provide an output which is closer to the desired value, therefore in response to sensing the first electrical output, a second different electrical output is provided). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the control parameters of Jones to be closed loop/feedback loop parameters, as is taught by Xiao, to produce the predictable result of providing an increase of accuracy to the system, as is taught by Xiao, as is has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III)
Essalik teaches a tissue ablation system ([0023]) and teaches ablation as being performed by varying and actuating different parameters, such as changing the voltage between pulses ([0073]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the system of Jones as currently modified to incorporate the teaching of changing the voltage between pulses to perform irreversible electroporation, as is taught by Essalik, to produce the predictable result of producing irreversible electroporation.
Further, in accordance with the previously provided modification of Xiao into Jones, this control is in response to the sensed signals as are taught by Xiao, which include the voltage sensed during a charge mode, which is the mode when a pulse is not being performed and therefore is the voltage measured between therapy output bursts ([0159]).
Jones further fails to teach the provided therapy as being irreversible electroporation.
Jones does however teach the device as providing electromagnetic energy to perform surgical procedures ([0007], [0022]).
Konings teaches a device for providing treatment to patient tissue having a generator configured to output electromagnetic energy to a medical device (Abstract, [0043]).
Konings further teaches the known use of providing electromagnetic energy to produce irreversible electroporation ([0043]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of producing irreversible electroporation in patient tissue through the use of the application of electromagnetic energy, as is taught by Konings, into the device which provides electromagnetic energy to a patient as is taught by Jones, to produce the predictable result of treating patient tissue, as is taught by Konings, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US-20080276192-A1) in view of Xiao (US-20170245928-A1) and Konings (US-20160331441-A1) further in view of Johnson (US-20150032096-A1).
Regarding claim 5, the modified teaching of Jones teaches the system of claim 1.
However, the modified teaching of Jones fails to teach the system of claim 1, wherein the closed loop control parameters comprise at least user selectable options for multi-path impedance. Johnson teaches a device for ablatively treating tumors through impedance measurements (Abstract, [0002]). These impedance measurements for detecting, locating, and identifying tumorous tissue at selected sites being from a variety of known measured impedance types ([0005]).
Johnson further teaches the ability to utilize multi-path impedance measurements, so as to monitor multiple developing ablation volumes simultaneously ([0005]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of Johnson into the device of Jones as currently modified to allow for a larger area of tissue monitoring during an ablation procedure.
Regarding claim 8, the modified teaching of Jones teaches the system of claim 1.
However, the modified teaching of Jones fails to teach the system, wherein the first and second electrical outputs differ from one another in terms of electrodes selected as anodes or cathodes for each of the outputs.
Johnson further teaches the switching of any of the positive terminal members to a return electrode which allows for the detection of a location of potential non-uniformity ([0071]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to further incorporate the teachings of Johnson into the device of Jones as currently modified, as allowing the device to more readily detect potential non-uniformity of a sample volume.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US-20080276192-A1) in view of Xiao (US-20170245928-A1) and Konings (US-20160331441-A1) further in view of Koss (US-20110238056-A1).
Regarding claim 6, the modified teaching of Jones teaches the system of claim 1, wherein the therapy regimen comprises a plurality of bursts each comprising a plurality of pulses ([0009], [0010], [0031]).
However, the modified teaching of Jones fails to teach the system wherein the first and second electrical outputs occur within the same pulse.
Koss teaches an electrosurgical instrument for applying electrical current to ablate tissue, through an application of a series of pulses (Abstract, [0004]).
Koss further teaches adjusting based on sensed impedance data, the pulse, either from an RF start to RF end value, or controlling the RF at a subsequent pulse ([0008]). The pulse profile adjusting from a start value to an end value, providing for multiple outputs to occur within the same pulse.
Therefore, it would have been obvious to a person having ordinary skill in the art at the effective filing date to incorporate the teachings of Koss into the device of Jones and Xiao so as to allow for varying electrosurgical operating consequences based on impedance data.
In accordance with the above rejection of claim 1, Konings further teaches the therapy as being irreversible electroporation ([0043]).
Regarding claim 7, Jones teaches the system of claim 1 wherein the therapy regimen comprises a plurality of bursts each comprising a plurality of pulses ([0009], [0010], [0031]).
However, the modified teaching of Jones fails to teach the system wherein the first and second electrical outputs occur within separate pulses of the same burst.
Koss further teaches adjusting based on sensed impedance data, the pulse, either from an RF start to RF end value, or controlling the RF at a subsequent pulse ([0008]). The pulse profile adjusting at a subsequent pulse providing for multiple outputs to occur between two separate pulses.
Therefore, it would have been obvious to a person having ordinary skill in the art at the effective filing date to incorporate the teachings of Koss into the device of Jones and Xiao so as to allow for varying electrosurgical operating consequences based on impedance data.
In accordance with the above rejection of claim 1, Konings further teaches the therapy as being irreversible electroporation ([0043]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jones (US-20080276192-A1) in view of Xiao (US-20170245928-A1) and Konings (US-20160331441-A1) further in view of Wham (US-20050004564-A1).
Regarding claim 9, the modified teaching of Jones teaches the system of claim 1.
However, the modified teaching of Jones fails to teach the system wherein the first and second electrical outputs differ from one another in terms of slew rate.
Wham teaches a control system for an electrosurgical generator, including an outer loop controller for generating a control signal in accordance with sensor data, and an inner loop controller for generating a setpoint control signal which is provided to an RF stage in accordance with the control signal generated by the outer loop controller and the sensor data (Abstract).
Wham further teaches the system wherein the first and second electrical outputs differ from one another in terms of slew rate ([0265]- [0266] teach the outer loop target as controlling the system based on the target slew rate).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teaching of the use of the outer loop target slew rate parameter being used to control the output of the system, as is taught by Wham, into the device of Jones as currently modified, to produce the predictable result of controlling the electrosurgical generator within the limits set by the user, such as that of the target slew rate, taught by Wham.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Jones (US-20080276192-A1) in view of Xiao (US-20170245928-A1) and Konings (US-20160331441-A1) and Essalik (US-20120041288-A1) further in view of Koss (US-20110238056-A1).
Regarding claim 16, the modified teaching of Jones teaches the system of claim 10, wherein the therapy regimen comprises a plurality of bursts each comprising a plurality of pulses ([0009]- [0010], [0031]).
However, the modified teaching of Jones fails to teach the system, wherein the first and second electrical outputs occur within separate pulses of the same burst.
Koss teaches an electrosurgical instrument for applying electrical current to ablate tissue, through an application of a series of pulses (Abstract, [0004]).
Koss further teaches adjusting based on sensed impedance data, the pulse, either from an RF start to RF end value, or controlling the RF at a subsequent pulse ([0008]). The pulse profile adjusting from a start value to an end value, providing for multiple outputs to occur within the same pulse.
Therefore, it would have been obvious to a person having ordinary skill in the art at the effective filing date to incorporate the teachings of Koss into the modified teaching of Jones so as to allow for varying electrosurgical operating consequences based on impedance data.
In accordance with the above rejection of claim 10, Konings further teaches the therapy as being irreversible electroporation ([0043]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Jones (US-20080276192-A1) in view of Xiao (US-20170245928-A1) and Konings (US-20160331441-A1) and Essalik (US-20120041288-A1) further in view of Johnson (US-20150032096-A1).
Regarding claim 18, the modified teaching of Jones teaches the system of claim 10.
In accordance with the above rejection of claim 8, Johnson further teaches the system, wherein the first and second electrical outputs differ from one another in terms of electrodes selected as anodes or cathodes for each of the outputs ([0071]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Jones (US-20080276192-A1) in view of Xiao (US-20170245928-A1) and Konings (US-20160331441-A1) and Essalik (US-20120041288-A1) further in view of Wham (US-20050004564-A1).
Regarding claim 19, the modified teaching of Jones teaches the system of claim 10.
However, the modified teaching of Jones fails to teach the system wherein the first and second electrical outputs differ from one another in terms of slew rate.
Wham teaches a control system for an electrosurgical generator, including an outer loop controller for generating a control signal in accordance with sensor data, and an inner loop controller for generating a setpoint control signal which is provided to an RF stage in accordance with the control signal generated by the outer loop controller and the sensor data (Abstract).
Wham further teaches the system wherein the first and second electrical outputs differ from one another in terms of slew rate ([0265]- [0266] teach the outer loop target as controlling the system based on the target slew rate).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teaching of the use of the outer loop target slew rate parameter being used to control the output of the system, as is taught by Wham, into the device of Jones as currently modified, to produce the predictable result of controlling the electrosurgical generator within the limits set by the user, such as that of the target slew rate, taught by Wham.
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
In response to Applicant’s argument on Page 1 of the Remarks dated 10/30/2025 that Jones is cited for “providing the user a list of available one or more values relevant to the operation of the system to select from,” the Examiner is bringing attention to the fact that this language is not provide in the claim set nor is it provided in the rejection dated 07/30/2025 and is therefore unpersuasive as an argument relevant to a rejection which is not presented.
In response to Applicant’s arguments on Page 2 of the Remarks dated 10/30/2025 that the exemplary parameters of Jones are not closed loop control parameters, the Examiner agrees and has stated in the Non-Final Rejection dated 07/30/2025, paragraph 24 “Jones does not teach the parameter as being closed loop” and for this reason, the rejection of this claim language is taught by the incorporation of the secondary reference of Xiao.
In response to Applicant’s arguments of Page 2 of the Remarks dated 10/30/2025 that “merely paraphrasing a claim phrase, and rejecting the paraphrased claim, is plainly improper,” the Examiner again brings attention to the fact that the claim language which is taught by the Jones reference is being cited under the discussion of what is taught by Jone, is this specific situation, for the claim limitation “user selected closed loop parameter,” Jones teaches the parameters as being user selected, however, it is specifically stated that the user selected parameter as taught by Jones is not a parameter which functions within a closed loop and therefore Jones is not referenced to cite a portion of the claim language which Jones is explicitly discussed as not teaching.
In response to Applicant’s arguments on Page 3 of the Remarks dated 10/30/2025 that the Examiner has interpreted “closed loop parameters” as “any value relevant to the operation of the system,” the Examiner bring attention to the Non-Final Rejection dated 07/30/2025, paragraph 126 in which this argument has been previously addressed.
Applicant’s arguments on Page 3 of the Remarks dated 10/30/2025 that does not teach the claim limitation of the feedback loop for the parameters because the parameters are not user-selected, are currently unpersuasive. This limitation of the parameters being user-selectable is taught by the base reference of Jones and is therefore not required to be taught by the secondary reference of Xiao. Additionally, the Examiner is bringing attention to the fact that the “desired or programmed values” are values which have been selected by a user of the device, as broadly as is currently claimed.
In response to Applicant’s arguments on Page 4 of the Remarks dated 10/30/2025 that Xiao does not disclose loop parameters, this argument is currently unpersuasive. While Xiao may not use the term “closed loop parameters” the system teaches using a feedback loop which measures and controls the produced parameters in response to the measured parameters so that the produced parameters match the desired or programmed values, which is a system where parameters are controlled within a closed loop as broadly as is currently claimed. For more support regarding the definition of a term closed loop, see the previously cited paragraph 126 of the Non-Final Rejection dated 7/30/2025.
Applicant’s arguments on Page 5-6 of the Remarks dated 10/30/2025 presented in a bulleted list of what Xiao does not teach these arguments are currently unpersuasive. Specifically as Applicant's arguments presented are against the references individually, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The bullet points argue that Xiao provides no teaching of user selection among the functioning of the feedback loop, such as user selection, of the parameters, the parameters being user-settable, the feedback being user-selected and the limits being user-defined, however, Xiao is not required to teach the “user selection” portion of the claim limitations as the base reference of Jones teaches this feature. Additionally, Applicant continues to argue that Xiao does not teach the user selecting temperature, which as stated in the Non-Final Rejection dated 07/30/2025 is a feature which is not claimed, or any parameter as being user selected, however, as this limitation as taught by Jones it is not required to be taught by Xiao.
Applicant’s arguments on page 9 of the Remarks dated 10/30/2025 that phase is not taught as being a user selectable feedback parameter are currently unpersuasive as phase is not taught as being a user selectable feedback parameter, the Examiner brings attention to the user selectable limitation as being taught by Jones and the feedback limitation being taught by Xiao and that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that Wong could not have been incorporated into the Jones as modified by Xiao combination as the manner of receiving the information of the system is different in Wong than that of Xiao is currently unpersuasive as the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Additionally, a person having ordinary skill in the art before the effective filing date would have an understanding that there are a variety of manners of receiving feedback information such as by the same or separate signal processing paths and that the manner of receiving that information does not necessarily constitute a teaching away from the ability to use a monitored and controlled parameter in a loop which uses monitored and controlled parameters, as is taught by Jones modified by Xiao.
In response to Applicant’s arguments on Page 11 of the Remarks dated 10/30/2025 that Johnson’s system does not teach “real-time adaptive therapy modification based on user-selected feedback control,” the Examiner again brings reference to the real-time modification taking place through feedback control as being taught by Xiao and the user-selected portion as being taught by Jones and that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, in response to Applicant’s arguments that the Johnson reference uses the measurements to determine the state of tissue for the purpose of identifying tumors in comparison to that of Jones which teaches it for determining the state of tissue during the treatment of tissue is currently unpersuasive as the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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 extension fee 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 date of this final action.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794