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.
Status of the Claims
The current office action is made responsive to claims filed 01/06/2026.
Acknowledgement is made to the amendment of claims 1, 7-8, 11-12, 16 and 18-19.
Acknowledgement is made to the cancellation of claims 3-4, 9-10, 14-15, 17, and 20.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1-2, 5-8, 11-13, 16, and 18-19 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.
Claims 1-2, 5, 7-8, 11-13, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Selig (US 20110202055 A1) in view of Neal (US 20180132922 A1) and Lee (US 20070049919 A1).
Regarding claim 1, Selig teaches a system (Fig. 1; HF generator system 30) for controlling delivery of current from a generator comprising a generator ([0050]), the system comprising:
a body surface electrode (Fig. 1 & 3; neutral electrode 10) comprising:
two electrodes (Fig. 1; first electrode section 11 and second electrode section 11’) for coupling with a unipolar pulse delivery electrode (Fig. 1 & 3; monopolar instrument 20) in communication with the generator ([0050]), the two electrodes in communication with skin of a patient ([0050]), the two electrodes communicating with the generator to return current to the generator ([0003]), and the two electrodes spaced apart a predetermined distance from each other along the body surface electrode ([0052]) to measure electrical impedance between the two electrodes, the measured electrical impedance corresponding to a first temperature ([0054]); and
the body surface electrode being configured to output temperature data based on the measured electrical impedance corresponding to the first temperature ([0051], [0054]); and
a processor (Fig. 2; control device 36) in communication with the at least one temperature measuring device, the processor programmed to:
receive the temperature data from the body surface electrode ([0024]- [0025]);
analyze the received temperature data to determine whether (i) a measured second temperature, by at least one thermocouple, at least meets a threshold temperature or (ii) the measured electrical impedance, between the two electrodes and corresponding to the first temperature, exceeds a threshold impedance that corresponds to the threshold temperature ([0051] discusses the temperature of the neutral electrode being determined by a measurement device and the and the system responding when the temperature reaches a temperature which could lead to burns, [0054] discusses the measurement device as measuring the impedance based on the current applied to the two electrode sections and determine the current based on this impedance); and
output a signal to terminate pulse delivery from the generator to the unipolar delivery electrode, if the threshold temperature is met ([0043], [0051]).
However, Selig fails to teach the energy being delivered from the generator as being irreversible electroporation (IRE) pulses from an IRE generator.
Neal teaches a system for ablating tissue in a treatment region of a patient’s body comprising a single-pole electrode probe for insertion into the treatment region, an external surface electrode for placement outside the patient’s body to complete the circuit with the single-pole electrode, and a device for delivering electric energy to the single-pole electrode and the skin-surface electrode to the treatment region (Abstract, [0038]).
Neal further teaches the device for delivering energy to the electrode system for treating the tissue as being a generator for delivering high-frequency irreversible electroporation pulses ([0038]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the generator for applying energy to tissue, as is taught by Selig with the generator for applying energy to tissue as is taught by Neal, to produce the predictable result of applying energy to tissue, as it 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).
Selig further fails to teach the system comprising at least one temperature measuring device configured to measure a second temperature, the at least one temperature measuring device comprising at least one thermocouple and the body surface electrode being configured to output temperature data based on the measured second temperature.
Lee teaches an ablation system having multiple ground pads which is controlled so as to reduce the risk of patient skin burns (Abstract).
Lee further teaches the use of both measured impedances at the ground pads and temperature measurements ([0050]), which are received by thermocouples ([0047]), to control the device to reduce the risk patient burns ([0009], [0045]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the thermocouple for measuring temperature to control the ablation device in addition to impedance measurements controlling the ablation device, so as to reduce patient burn risks, as is taught by Lee, into the ablation device which is controlled by impedance measurements as is taught by Selig, to produce the predictable result of controlling an ablation device using known measurements to reduce patient burn risk, as is taught by Lee, 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 2, Selig teaches the system of claim 1, wherein the body surface electrode includes a patch for adhering to the skin of the patient ([0052]).
Regarding claim 5, Selig teaches the system of claim 1, wherein the processor is programmed to transmit the signal to the generator to terminate the delivery of the current ([0051]).
In accordance with the above provided rejection of claim 1, Neal further teaches the delivery of current as being in the form of pulses.
Regarding claim 7, Selig teaches the system of claim 6, wherein the generator, the switch, the unipolar delivery electrode, and the two electrodes of the body surface electrode form an electrical circuit ([0003], [0050]- [0051]).
In accordance with the above provided rejection of claim 1, Neal further teaches the unipolar delivery electrode as being a unipolar IRE delivery electrode.
Regarding claim 8, Selig teaches the system of claim 1, wherein the generator, the unipolar delivery electrode, and the two electrodes of the body surface electrode form an electrical circuit ([0003], [0050]- [0051]).
In accordance with the above provided rejection of claim 1, Neal further teaches the unipolar delivery electrode as being a unipolar IRE delivery electrode.
Regarding claims 11-13, 16, and 18, the method steps are the same as described as the steps the system is configured to perform and therefore taught in the same way as seen in claims 1-2, 5, and 7-8.
Claims 6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Selig (US 20110202055 A1) in view of Neal (US 20180132922 A1) and Lee (US 20070049919 A1) further in view of Cohen (US 20130310829 A1).
Regarding claim 6, Selig teaches the system of claim 1, additionally comprising:
a switch for moving between a first position, where pulses are moving between the generator and the unipolar delivery electrode, and a second position, where the pulses are prohibited from moving between the generator and the unipolar delivery electrode ([0051] discusses the use of a switch for the purpose of stopping the output of energy to the monopolar instrument), and
the processor is programmed to transmit the signal to the switch to move to the second position, to terminate the delivery of the current ([0051] teaches the control device as controlling the generator, the generator being the element which is switched off).
However, Selig is silent on the position of the switch as being specifically intermediate the generator and the unipolar delivery electrode.
Cohen teaches an ablation catheter system for delivering treatment to a patient (Abstract). The ablation catheter system having a kill switch mechanism which immediately and abruptly terminates delivery of ablation treatment or therapy (Abstract).
Cohen further teaches the kill switch as being located between the generator and the ablation catheter and switching from a normally closed position to an open position in order to terminate the delivery of energy from the generator to the ablation catheter ([0059], [0196]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the teachings of the switch which terminates the delivery of ablation therapy as being located between the generator and the catheter, as is taught by Cohen, into the system having a switch which is turned off to stop ablating tissue as is taught by Selig, to produce the predictable result of terminating the delivery of ablation energy to tissue by a switch, as is taught by Cohen, 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).
In accordance with the above provided rejection of claim 1, Neal further teaches the unipolar delivery electrode as being a unipolar IRE delivery electrode.
Regarding claim 19, the method steps are the same as described as the steps the system is configured to perform and therefore taught in the same way as seen in claim 6.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the amendments have necessitated new grounds of rejection.
Specifically, applicant’s arguments of the limitations that art not taught by the Dunning in view of Neal reference are moot in view of the new rejections under Selig, Neal and Lee.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794