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 11/19/2025.
Acknowledgement is made to the amendment of claims 1, 14, and 30.
Acknowledgement is made to the cancellation of claims 10-13 and 21-29 .
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Claims 1-9, 14-20, and 30 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 1-6, 9, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Davalos (US 20180161086 A1) in view of Fähsing (US 20200000506 A1), Danziger (US 20170189096 A1), and Ayati (US 5904706 A).
Regarding claim 1, Davalos teaches an electroporation system ([0033]) comprising:
a catheter shaft ([0085]);
at least one electrode ([0085], [0113]) coupled to the catheter shaft at a distal end thereof ([0151]); and
an electroporation generator coupled in communication with the at least one electrode ([0033]), the electroporation generator configured to supply a plurality of biphasic pulse signals to the at least one electrode ([0109]), each biphasic pulse signal comprising:
a first phase having a first polarity and a first pulse duration ([0073] teaches a first pulse being initiated); and
a second phase having a second polarity opposite to the first polarity ([0073] teaches a first pulse being initiated followed by a second pulse which is equal in magnitude but opposite in charge), and a second pulse duration, each of the first phase and second phase having a voltage amplitude of at least 500 volts ([0129] teaches the electrodes as having a separation distance of 5 cm and [0024] teaches the energy based therapy as having a voltage-to-distance ratio of 200 V/cm, providing for a 1000 V pulse, discussion of the relationship between the voltage of a pulse, the separation distance between electrodes, and the voltage-to-distance ratio can be found in [0052]) and a pulse duration of less than 20 microseconds ([0067] teaches a pulse length of 1 microsecond),
wherein the second phase is generated at a non-zero interval following the first phase ([0073] teaches the second pulse being initiated at a desired time following the administration of the first pulse, [0074]- [0075] teaches a delay being included between the pulses),
wherein the non-zero interval is more than zero ([0076] teaches the time delay between pulses as being equal to 1 time the pulse length),
wherein the plurality of biphasic pulse signals repeat at a pulse period that is greater than 5 milliseconds (ms) and no more than 10 ms ([0072] teaches the rate that the pulses are applied as being 100 Hz, which converts to a 10 millisecond period), and wherein the pulse period is a period of time between i) the occurrence of a first biphasic pulse signal and ii) the occurrence of a second, consecutive biphasic pulse signal.
Davalos fails to teach the electroporation generator comprising:
a microcontroller;
a plurality of switching elements; and
an opto-isolator configured to prevent noise generated by switching of the plurality of switching elements from reaching the microcontroller.
Fähsing teaches a generator for the delivery of high frequency alternating current to a medical instrument (Abstract).
Fähsing further teaches the generator comprising: a controller (Fig. 1; control unit 16); a plurality of switching elements (Fig. 1; relays 26); and an opto-isolator (Fig. 1; optocouplers 36) configured to prevent noise generated by switching of the plurality of elements from reaching the controller (noise reduction between electrical elements is a known function of an opto-isolator, for further information on this function of this element, see the references provided in the conclusion section).
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 a generator comprising: a controller, a plurality of switching elements; and an opto-isolator, as is taught by Fähsing, into the generator of Davalos, to produce the predictable result of transmitting control signals to a medical instrument, as is taught by Fähsing.
Danziger teaches an electrosurgical system including a generator for supplying electroporation energy to tissue (Abstract).
Danziger further teaches the generator for supplying electroporation as having a control circuit which allows for information to be relayed from one entity to another entity, such as a microcontroller ([0103]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to substitute the control circuit being a microcontroller, as is taught by Danziger, for the control as is taught by Fähsing, to produce the predictable result of providing a controlling component within a generator.
However, Davalos as currently modified fails to teach the plurality of switching elements as being a first plurality of semi-conductor switching elements in a bridge configuration, the first plurality of semi-conductor switching elements selectably connecting a first conductor of the catheter to one of: positive voltage supply; or a negative voltage supply; and a second plurality of semi-conductor switching elements in a bridge configuration, the second plurality of semi-conductor switching elements selectable connecting a second conductor of the catheter to one of: positive voltage supply; or a negative voltage supply.
Ayati teaches a known circuit for forming an electrotherapy current waveform, specifically a biphasic waveform which passes through the patient’s body (Abstract, Col. 4, Lines 50-65).
Ayati further teaches the circuit as for producing biphasic waveforms from a voltage source as comprising an H-bridge which allows the electric charge to pass through the electrodes and the body of the patient, specifically by allowing the electric current to pass through the patient’s body in one direction and then through the patient’s body in the opposite direction based on the electronic semi-conductor switches of the bridge opened or closed to control the production of the current flow (Abstract, Col. 4, Lines 50-65 & Col. 7, Lines 60-67).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the bridge configuration as being a known configuration for forming a biphasic waveform from a source of a voltage through the electrodes of a catheter to a patient’s body, as is taught by Ayati, into the circuity which produces a biphasic pulse which is delivered through a patient’s body as is taught by Davalos, to produce the predictable result of producing a biphasic waveform by a known circuitry as is taught by Ayati, 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, Davalos teaches the electroporation system of claim 1, wherein each of the first and second phase has a voltage amplitude of at least 600 volts ([0024], [0129]) and a pulse duration of less than 3 microseconds ([0067]).
Regarding claim 3, Davalos teaches the electroporation system of claim 1, wherein each of the first and second phase has a voltage amplitude of at least 600 volts ([0024], [0129]) and a pulse duration of less than 1.5 microseconds ([0067]).
Regarding claim 4, Davalos teaches the electroporation system of claim 1, wherein each of the first pulse duration, the second pulse duration, and the non-zero interval is less than 3 microseconds ([0067], [0076]).
Regarding claim 5, Davalos teaches the electroporation system of claim 4, wherein each of the first phase and second phase has a voltage amplitude of at least 600 volts ([0024], [0129]).
Regarding claim 6, Davalos teaches the electroporation system of claim 1, wherein the pulse period is 10 ms ([0072]).
Regarding claim 9, Davalos teaches the electroporation system of claim 8, wherein each of the first and second phase has a voltage amplitude in the range of 600 volts to 1.4 kV ([0024], [0129]), and a pulse duration in the range of 1 microsecond to 1.5 microseconds ([0067], [0076]).
Regarding claim 14, Davalos teaches a method, performed by an electroporation generator ([0033]) comprising:
supplying ([0033]) a first phase of a biphasic pulse signal of a plurality of biphasic pulse signals to at least one electrode coupled at a distal end of a catheter shaft, the first phase having a first polarity and a first pulse duration ([0076]);
supplying a second phase of the biphasic pulse signal to the at least one electrode, the second phase having a second polarity opposite to the first polarity, and a second pulse duration ([0073]), wherein each of the first phase-and second phase-has a voltage amplitude of at least 500 volts ([0129] teaches the electrodes as having a separation distance of 5 cm and [0024] teaches the energy based therapy as having a voltage-to-distance ratio of 200 V/cm, providing for a 1000 V pulse, discussion of the relationship between the voltage of a pulse, the separation distance between electrodes, and the voltage-to-distance ratio can be found in [0052]) and a pulse duration of less than 20 microseconds ([0067] teaches a pulse length of 1 microsecond); and
wherein the second phase is generated at a non-zero interval following the first phase ([0073] teaches the second pulse being initiated at a desired time following the administration of the first pulse, [0074]- [0075] teaches a delay being included between the pulses), and
wherein the non-zero interval is more than zero ([0076] teaches the time delay between pulses as being equal to 1 time the pulse length); and
wherein the plurality of biphasic pulse signals repeat at a pulse period that is greater than 5 milliseconds (ms) and no more than 10 ms ([0072] teaches the rate that the pulses are applied as being 100 Hz, which converts to a 10 millisecond period), and wherein the pulse period is a period of time between i) the occurrence of a first biphasic pulse signal and ii) the occurrence of a second, consecutive biphasic pulse signal.
Davalos further fails to teach preventing noise generated by switching of the plurality of switching elements from reaching the microcontroller.
Fähsing teaches a generator for the delivery of high frequency alternating current to a medical instrument (Abstract).
Fähsing further teaches the generator comprising: a controller (Fig. 1; control unit 16); a plurality of switching elements (Fig. 1; relays 26); and an opto-isolator (Fig. 1; optocouplers 36) configured to prevent noise generated by switching of the plurality of elements from reaching the controller (noise reduction between electrical elements is a known function of an opto-isolator, for further information on this function of this element, see the references provided in the conclusion section.
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 a generator comprising: a controller, a plurality of switching elements; and an opto-isolator, as is taught by Fähsing, into the generator of Davalos, to produce the predictable result of transmitting control signals to a medical instrument, as is taught by Fähsing.
Danziger teaches an electrosurgical system including a generator for supplying electroporation energy to tissue (Abstract).
Danziger further teaches the generator for supplying electroporation as having a control circuit which allows for information to be relayed from one entity to another entity, such as a microcontroller ([0103]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to substitute the control circuit being a microcontroller, as is taught by Danziger, for the control as is taught by Fähsing, to produce the predictable result of providing a controlling component within a generator.
However, Davalos as modified further fails to teach the switching elements as being a first plurality of switching elements in a bridge configuration, the first plurality of semi-conductor switching elements selectably connecting a first conductor of a catheter to one of: positive voltage supply, or a negative voltage supply, a second plurality of semi-conductor switching elements in a bridge configuration, the second plurality of semi-conductor selectably connecting a second conductor of the catheter to one of: positive voltage supply, or a negative voltage supply and controlling the first plurality of switching elements to connect to the positive voltage supply and the second plurality of switching elements to connect to the negative voltage supply.
Ayati teaches a known circuit for forming an electrotherapy current waveform, specifically a biphasic waveform which passes through the patient’s body (Abstract, Col. 4, Lines 50-65).
Ayati further teaches the circuit as for producing biphasic waveforms from a voltage source as comprising an H-bridge which allows the electric charge to pass through the electrodes and the body of the patient, specifically by allowing the electric current to pass through the patient’s body in one direction and then through the patient’s body in the opposite direction based on the electronic semi-conductor switches of the bridge opened or closed to control the production of the current flow (Abstract, Col. 4, Lines 50-65 & Col. 7, Lines 60-67).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the bridge configuration as being a known configuration for forming a biphasic waveform from a source of a voltage through the electrodes of a catheter to a patient’s body, as is taught by Ayati, into the circuity which produces a biphasic pulse which is delivered through a patient’s body as is taught by Davalos, to produce the predictable result of producing a biphasic waveform by a known circuitry as is taught by Ayati, 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 15, Davalos teaches the method of claim 14, wherein each of the first and second phase has a voltage amplitude of at least 600 volts ([0024], [0129]) and a pulse duration of less than 3 microseconds ([0067]).
Regarding claim 16, Davalos teaches the method of claim 14, wherein each of the first and second phase has a voltage amplitude of at least 600 volts ([0024], [0129]) and a pulse duration of less than 1.5 microseconds ([0067]).
Regarding claim 17, Davalos teaches the method of claim 14, wherein each of the first pulse duration, the second pulse duration, and the non-zero interval is less than 3 microseconds ([0067], [0076]).
Regarding claim 18, Davalos teaches the method of claim 17, wherein each of the first phase and second phase has a voltage amplitude of at least 600 volts ([0024], [0129]).
Regarding claim 19, Davalos teaches the method of claim 14, wherein the pulse period is 10 ms ([0072] teaches the rate that the pulses are applied as being 100 Hz, which converts to a 10 millisecond period).
Claims 7-8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Davalos (US 20180161086 A1) in view of Fähsing (US 20200000506 A1), Danziger (US 20170189096 A1), and Ayati (US 5904706 A) further in view of Viswanathan (US 20170189097 A1).
Regarding claim 7, Davalos teaches the electroporation system of claim 1 further comprising an electrode assembly coupled at the distal end of the catheter shaft ([0151]).
However, Davalos fails to teach the method wherein the electrode assembly is configured as one of an electrode loop assembly, a basket electrode assembly, a planar electrode assembly, and an expandable electrode assembly comprising an expandable isolation member.
Viswanathan teaches a system including a pulse waveform generator and an ablation device having an electrode assembly which provides a set of biphasic pulses (Abstract, [0021]).
Viswanathan further teaches the electrode assembly as being looped ([0040]).
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 electrode assembly being a looped assembly, as is taught by Viswanathan, into the distal catheter electrode assembly of Davalos as having an electrode assembly for providing a biphasic pulse to tissue during use.
Regarding claim 8, Viswanathan further teaches the electroporation system of claim 7, wherein the electrode assembly is configured as a bipolar electrode loop assembly ([0040], [0048]).
In accordance with the above rejection of claim 7, Davalos further teaches the electroporation system wherein each of the first and second phase has a voltage amplitude of at least 600 volts ([0024], [0129]) and a pulse duration of less than 3 microseconds ([0067], [0076]).
Regarding claim 20, Davalos teaches the method of claim 14, wherein the at least one electrode is part of an electrode assembly coupled at the distal end of the catheter shaft ([0151]).
However, Davalos fails to teach the method wherein the electrode assembly is configured as one of an electrode loop assembly, a basket electrode assembly, a planar electrode assembly, and an expandable electrode assembly comprising an expandable isolation member.
Viswanathan teaches a system including a pulse waveform generator and an ablation device having an electrode assembly which provides a set of biphasic pulses (Abstract, [0021]).
Viswanathan further teaches the electrode assembly as being looped ([0040]).
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 electrode assembly being a looped assembly, as is taught by Viswanathan, into the distal catheter electrode assembly of Davalos as having an electrode assembly for providing a biphasic pulse to tissue during use.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Davalos (US 20180161086 A1) in view of Ayati (US 5904706 A).
Regarding claim 30, Davalos teaches an electroporation system ([0033]) comprising:
a catheter shaft ([0085]);
at least one electrode ([0085], [0113]) coupled to the catheter shaft at a distal end thereof ([0151]); and
an electroporation generator coupled in communication with the at least one electrode ([0033]), the electroporation generator configured to supply a plurality of biphasic pulse signals to the at least one electrode ([0109]), each biphasic pulse signal comprising:
a first phase having a first polarity and a first pulse duration ([0073] teaches a first pulse being initiated); and
a second phase having a second polarity opposite to the first polarity ([0073] teaches a first pulse being initiated followed by a second pulse which is equal in magnitude but opposite in charge), and a second pulse duration, each of the first phase and second phase having a voltage amplitude of at least 500 volts ([0129] teaches the electrodes as having a separation distance of 5 cm and [0024] teaches the energy based therapy as having a voltage-to-distance ratio of 200 V/cm, providing for a 1000 V pulse, discussion of the relationship between the voltage of a pulse, the separation distance between electrodes, and the voltage-to-distance ratio can be found in [0052]) and a pulse duration of less than 20 microseconds ([0067] teaches a pulse length of 1 microsecond),
wherein the second phase is generated at a non-zero interval following the first phase ([0073] teaches the second pulse being initiated at a desired time following the administration of the first pulse, [0074]- [0075] teaches a delay being included between the pulses),
wherein the non-zero interval is more than zero ([0076] teaches the time delay between pulses as being equal to 1 time the pulse length),
wherein the plurality of biphasic pulse signals repeat at a pulse period that is greater than 5 milliseconds (ms) and less than 10 ms, and wherein the pulse period is a period of time between i) the occurrence of a first biphasic pulse signal and ii) the occurrence of a second, consecutive biphasic pulse signal ([0072] teaches the rate that the pulses are applied as being 100 Hz, which converts to a 10 millisecond period).
However, Davalos fails to teach the generator as comprising a first plurality of semi-conductor switching elements in a bridge configuration, the first plurality of semi-conductor switching elements selectably connecting a first conductor of the catheter to one of: positive voltage supply; or a negative voltage supply; and a second plurality of semi-conductor switching elements in a bridge configuration, the second plurality of semi-conductor switching elements selectably connecting a second conductor of the catheter to one of: positive voltage supply; or a negative voltage supply.
Ayati teaches a known circuit for forming an electrotherapy current waveform, specifically a biphasic waveform which passes through the patient’s body (Abstract, Col. 4, Lines 50-65).
Ayati further teaches the circuit as for producing biphasic waveforms from a voltage source as comprising an H-bridge which allows the electric charge to pass through the electrodes and the body of the patient, specifically by allowing the electric current to pass through the patient’s body in one direction and then through the patient’s body in the opposite direction based on the electronic semi-conductor switches of the bridge opened or closed to control the production of the current flow (Abstract, Col. 4, Lines 50-65 & Col. 7, Lines 60-67).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the bridge configuration as being a known configuration for forming a biphasic waveform from a source of a voltage through the electrodes of a catheter to a patient’s body, as is taught by Ayati, into the circuity which produces a biphasic pulse which is delivered through a patient’s body as is taught by Davalos, to produce the predictable result of producing a biphasic waveform by a known circuitry as is taught by Ayati, 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).
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 Davalos as previously provided reference are moot in view of the new rejections under the incorporation Ayati.
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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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794