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 05/07/2026.
Acknowledgement is made to the amendment of claims 1-2.
Acknowledgement is made to the withdrawal of claims 5, 7, and 11-13.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 1-4, 6, and 8-10 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 Wittkampf (US 20130131662 A1) in view of Weng (US 20220022934 A1).
Regarding claim 1, Wittkampf teaches an apparatus with collaborative operation between high-voltage pulse field ablation and an electrophysiological recording system (Abstract, [0051]), comprising a high-voltage power supply (Fig. 2; power supply 14), an energy storage capacitor (Fig. 2; charging unit 13 is taught as being provided with a capacitor for charging electrical energy; [0055]), a discharge circuit (Fig. 2; charging unit 13 is taught as being a capacitive-discharge unit which is arranged to be discharged; [0062]), a high-voltage pulse signal generation circuit (Fig. 2; measuring unit 12 is taught as determining the amount of electrical energy to be charged within the charging unit; [0059]- [0061]), a switch array (Fig. 2; switch 24) circuit and a control system (Fig. 2; control unit 7), wherein the energy storage capacitor is connected respectively to the high-voltage power supply, the discharge circuit and the high-voltage pulse signal generation circuit ([0055], [0059]- [0060]); the switch array circuit (Fig. 2; switch 24) is connected respectively to the high-voltage pulse signal generation circuit (Fig. 2; measuring unit 12), a catheter (Fig. 1; catheter 2) and the electrophysiological recording system (Fig. 1; EP amplifier 5); and the control system (Fig. 2; control unit 7) is connected respectively to the high-voltage power supply (Fig. 2; power supply 14), the discharge circuit (Fig. 2; charging unit 13 is taught as being a capacitive-discharge unit which is arranged to be discharged), the high-voltage pulse signal generation circuit (Fig. 2; measuring unit 12), the switch array circuit (Fig. 2; switch 24), a cardiac electrical signal monitor (Fig. 1; EP recorder 6) and a foot pedal switch (Fig. 1; foot pedal 8).
Wittkampf further teaches the system as having an element (Fig. 2; measuring unit 12 is taught as determining the amount of electrical energy to be charged within the charging unit) which controls the delivery of the electrical energy, and therefore the generation of the pulse, which is delivered to a patient between an element which delivers a specific energy (Fig. 2; charging unit 13 is taught as being a capacitive-discharge unit which is arranged to be discharged), this energy being provided by a DC power supply, and a switching element (Fig. 2; switch 24) which delivers the energy to a patient.
While Wittkampf does not teach this element as being a high-frequency high-voltage pulse signal generation circuit, instead teaching the generator as being arranged for use in direct current ablation procedures ([0013]). Wittkampf does teach that generators for use in ablation procedures using a catheter typically comprise a high-power, high-frequency generator for generating a radio-frequency between two electrodes ([0002]).
Weng teaches an electrosurgical generator and an electrosurgical system which is capable of providing energy to a high-frequency surgical instrument (Abstract- [0001]). This generator is taught as having an internal system (Fig. 4; internal system 200) which contains a DC power supply (Fig. 4; DC power supply system 210) connected to an element which delivers a specified energy (Fig. 4; DCDC converter 220; [0034]- [0035]) and a switching element (Fig. 4; switching system 240) which delivers energy to the patient.
Weng further teaches this internal system as having an element, inverter system (Fig. 4; inverter system 230) which is located between the element for delivering a specified energy and the switching element. This element of the inverter system is provided so as to chop the DC voltage into a high-frequency as is required for the procedure ([0032]- [0034]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the an inverter system in between the element which deliveries a specific energy and the switching element, as is taught by Weng, into the system which contains an element which controls the delivery of a specified energy and a switching element to deliver said energy to a patient as is taught by Wittkampf, to produce the predictable result of delivering a known typical electrosurgical energy, specifically high-frequency energy, to an electrosurgical instrument to treat a patient, as is taught by Weng, 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 Wittkampf (US 20130131662 A1) in view of Weng (US 20220022934 A1) further in view of Luo (US 20210160984 A1).
Regarding claim 2, Wittkampf as currently modified teaches the apparatus with collaborative operation between high-voltage pulse field ablation and an electrophysiological recording system of claim 1,wherein a positive pole of the high-voltage power supply is connected to a first terminal of the energy storage capacitor, and a negative pole of the high-voltage power supply is connected to a second terminal of the energy storage capacitor ([0055]- [0056]); a first terminal of the discharge circuit is connected to the first terminal of the energy storage capacitor, and a second terminal of the discharge circuit is connected to the second terminal of the energy storage capacitor (It should be understood within a broadest reasonable interpretation that all elements of an apparatus are “coupled to” all other elements, either directly, indirectly, electrically, etc. and therefore this limitation is taught as broadly as is currently claimed. However, in an attempt to forward compact prosecution, an additional reference has been provided in the conclusion section which is relevant to this claim limitation); a first input terminal of the high-frequency high-voltage pulse signal generation circuit is connected to the first terminal of the energy storage capacitor, a second input terminal of the high-frequency high-voltage pulse signal generation circuit is connected to the second terminal of the energy storage capacitor, and an output terminal of the high-frequency high-voltage pulse signal generation circuit is connected to an input terminal of the switch array circuit ([0059]- [0060], [0066]); a first output terminal of the switch array circuit is connected to the catheter, and a second output terminal of the switch array circuit is connected to the electrophysiological recording system (Fig. 2; switch 24 is shown as being connected to connector 11 which connects to catheter 2 and also to connector 25 which is connected to EP amplifier 5); the control system is connected to the high-voltage power supply by a connection (Fig. 1-2; control unit 7 is connected to power supply 14 by connector 15) and used to control an output value of an output DC voltage of the high-voltage power supply and feed the output value of the DC voltage back to the control system ([0055]- [0057]); the control system is connected to the discharge circuit and control the discharge circuit to discharge energy stored in the energy storage capacitor through a discharge control signal ([0055]- [0056]); the control system is connected to the high-frequency high-voltage pulse signal generation circuit and is used to control output and deactivation of a pulse voltage and collect signals of the pulse voltage and a pulse current ([0059]- [0060], [0062], [0064]); the control system is connected to the switch array circuit and controls the switch array circuit to operate as desired through a control signal ([0066]); the control system is connected to a cardiac electrical signal monitoring device and used to receive a trigger signal, which is sent by the cardiac electrical signal monitoring device after it detects an R wave ([0062]); and the control system is connected to the foot pedal switch and used to detect a signal from the foot pedal switch and thereby control output of high-voltage electric pulses ([0057], additionally, it should be understood within a broadest reasonable interpretation that all elements of an apparatus are “coupled to” all other elements, either directly, indirectly, electrically, etc. and therefore this limitation is taught as broadly as is currently claimed. However, in an attempt to forward compact prosecution, an additional reference has been provided in the conclusion section which is relevant to this claim limitation).
However, Wittkampf modified is silent on the connection connecting the control system to the high-voltage power supply as being by an RS232 or RS485 connection.
Luo teaches a known connection for connecting a power supply with a controller as being by a known connection interface ([0037]).
Luo further teaches the connection for connecting the power supply and the controller as being by an RS485 or RS232 connection ([0010]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of an RS485 or RS232 connection to connect a power supply and controller, as is taught by Luo, into the system where a control unit is connected to a power supply as is taught by Wittkampf, to produce the predictable result of connecting a power supply and controller, as is taught by Luo, 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 3-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf (US 20130131662 A1) in view of Weng (US 20220022934 A1) further in view of Luo (US 20210160984 A1) and Beland (US 20110002446 A1).
Regarding claim 3, Wittkampf as modified teaches the apparatus with collaborative operation between high-voltage pulse field ablation and an electrophysiological recording system of claim 2.
However, Wittkampf fails to teach the apparatus wherein the high-frequency high-voltage pulse signal generation circuit comprises two DC high-voltage source interfaces, four pulse-width modulated drive signal interfaces, four switching units and two pulse output interfaces, the two DC high-voltage source interfaces being respectively a positive power supply pole interface and a negative power supply pole interface, the four pulse-width modulated drive signal interfaces being respectively a first drive signal interface, a second drive signal interface, a third drive signal interface and a fourth drive signal interface, the four switching units being respectively a first switching unit, a second switching unit, a third switching unit and a fourth switching unit, the two pulse output interfaces being respectively a first pulse output interface and a second pulse output interface, the four switching units connected in series, i.e., one terminal of the first switching unit connected to the positive power supply pole interface, another terminal of the first switching unit connected to one terminal of the fourth switching unit and the first pulse output interface, one terminal of the second switching unit connected to the positive power supply pole interface, another terminal of the second switching unit connected to one terminal of the third switching unit and the second pulse output interface, another terminal of the third switching unit connected to the negative power supply pole interface, another terminal of the fourth switching unit connected to the negative power supply pole interface, each of the switching units comprising a switching element.
The incorporation of Weng into Wittkampf further teaches the high-frequency high-voltage pulse signal generation circuit as comprising an inverter.
Beland teaches a schematic of a high voltage inverter module for a high-voltage high frequency generator (Abstract, Fig. 7).
Beland further teaches the generator wherein the high-frequency high-voltage pulse signal generation circuit comprises two DC high-voltage source interfaces (Fig. 7; +DC POWER INPUT and -DC POWER INPUT),
four pulse-width modulated drive signal interfaces (Fig. 7; Q1-4 Drivers),
four switching units (Fig. 7; IGBT Q1-Q4) and
two pulse output interfaces (Fig. 7; points P1-P3 across diodes D1-D4 bridge),
the two DC high-voltage source interfaces being respectively a positive power supply pole interface and a negative power supply pole interface (Fig. 7; +DC POWER INPUT and -DC POWER INPUT),
the four pulse-width modulated drive signal interfaces being respectively a first drive signal interface, a second drive signal interface, a third drive signal interface and a fourth drive signal interface (Fig. 7; Q1-4 Drivers),
the four switching units being respectively a first switching unit, a second switching unit, a third switching unit and a fourth switching unit (Fig. 7; IGBT Q1-Q4),
the two pulse output interfaces being respectively a first pulse output interface and a second pulse output interface (Fig. 7; points P1-P3 across diodes D1-D4 bridge [0023]),
the four switching units connected in series, i.e., one terminal of the first switching unit connected to the positive power supply pole interface, another terminal of the first switching unit connected to one terminal of the fourth switching unit and the first pulse output interface, one terminal of the second switching unit connected to the positive power supply pole interface, another terminal of the second switching unit connected to one terminal of the third switching unit and the second pulse output interface, another terminal of the third switching unit connected to the negative power supply pole interface, another terminal of the fourth switching unit connected to the negative power supply pole interface, each of the switching units comprising a switching element ([0079]- [0080]).
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 features of an inverter, as is taught by Beland, into the inverter as is taught by Weng, to produce the predictable result of utilizing a high voltage inverter within a high-voltage high-frequency generator, as is taught by Beland, 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 4, in accordance with the above modification Beland further teaches the apparatus with collaborative operation between high-voltage pulse field ablation and an electrophysiological recording system of claim 3, wherein each switching element is an IGBT ([0079]); a gate of the IGBT serves as a control terminal of the switching unit ([0079]- [0081], [0098]); an emitter of the IGBT of the first switching unit is connected to a collector of the IGBT of the fourth switching unit ([0079]- [0081], [0098]); and an emitter of the IGBT of the second switching unit is connected to a collector of the IGBT of the third switching unit ([0079]- [0081], [0098]).
Regarding claim 8, in accordance with the above modification Beland further teaches the apparatus with collaborative operation between high-voltage pulse field ablation and an electrophysiological recording system of claim 4, wherein the first drive signal interface is connected to a control terminal of the first switching unit (Fig. 7; Q1-4 Drivers are taught as controlling each respective IGBT Q1-4); the second drive signal interface is connected to a control terminal of the second switching unit (Fig. 7; Q1-4 Drivers are taught as controlling each respective IGBT Q1-4); the third drive signal interface is connected to a control terminal of the third switching unit (Fig. 7; Q1-4 Drivers are taught as controlling each respective IGBT Q1-4); and the fourth drive signal interface is connected to a control terminal of the fourth switching unit (Fig. 7; Q1-4 Drivers are taught as controlling each respective IGBT Q1-4).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf (US 20130131662 A1) in view of Weng (US 20220022934 A1) further in view of Luo (US 20210160984 A1), Beland (US 20110002446 A1) and Zou (US 20170222641 A1).
Regarding claim 6, Wittkampf as modified teaches the apparatus with collaborative operation between high-voltage pulse field ablation and an electrophysiological recording system of claim 4.
However, Wittkampf fails to teach wherein the IGBT is an n- channel IGBT.
Zou teaches an inverter including an IGBT (Abstract).
Zou further teaches the IGBT within the inverter as being an n-channel IGBT (Abstract).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the IGBT as being an n-channel IGBT, as is taught by Zhou, into the IGBT within the inverter as is taught by Beland, to produce the predictable result of using a known type of IGBT within an inverter, as is taught by Zou, 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 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wittkampf (US 20130131662 A1) in view of Weng (US 20220022934 A1) further in view of Luo (US 20210160984 A1), Beland (US 20110002446 A1) and Weber (US 20140188095 A1).
Regarding claim 9, Wittkampf teaches the apparatus with collaborative operation between high-voltage pulse field ablation and an electrophysiological recording system of claim 8,
wherein the switch array circuit comprises at least one switch ([0066]);
the at least one switch being connected to the at least one respective channels of the electrophysiological recording system ([0066]); and
the at least one switch being connected to respective electrodes of the catheter ([0053], [0055)].
However, Wittkampf fails to teach the at least one switch as being N high voltage relay banks, and the channels being N channels, where N>2, the at least one switch being made up of two series-connected high-voltage relays, which are respectively a first high- voltage relay and a second high-voltage relay and the high-voltage relays are implemented as SPDT high-voltage vacuum relays with identical parameters.
Weber teaches an apparatus and systems for providing electrosurgical energy to a patient via an electrosurgical instrument (Abstract). The instrument being capable of function in a variety of modes and the modes being controlled based on switching circuitry ([0093]).
Weber further teaches selecting the function for the electrode to perform based on a set of multiple SPDT relays which are in series and control the electrodes based on the waveform which is delivered by the switch ([0093]- [0094]).
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 two series connected SPDT relays to control the function which is provided to an electrode, as is taught by Weber, into the switching element for controlling the function of electrodes as is taught by Wittkampf, to produce the predictable result of controlling the function of electrodes, as is taught by Weber, 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 10, Wittkampf teaches the apparatus with collaborative operation between high-voltage pulse field ablation and an electrophysiological recording system of claim 9,
the control system is connected to the switch array circuit and used to control activation and deactivation of the high-voltage relays ([0066]).
In accordance with the above rejection of Weber into the switching element of Wittkampf which teaches the electrodes as being switched out of an EP sensing mode when pulses are provided to the electrodes, Weber further teaches the apparatus wherein a normally closed contact of the first high-voltage relay is connected to the first pulse output interface (Fig. 3A-B; [0093]- [0094] teach the first switch as being used to deliver a first waveform and the second switch being used to deliver a second mode of use);
a normally open contact of the first high-voltage relay is connected to the second pulse output interface (Fig. 3A-B; [0093]- [0094]);
a common terminal of the first high-voltage relay is connected to a normally open contact of the second high-voltage relay (Fig. 3A-B; [0093]- [0094] teach the first switch as being used to deliver a first waveform and the second switch being used to deliver a second mode of use);
a normally closed contact of the second high-voltage relay is connected to one channel of the electrophysiological recording system (Fig. 3A; [0093]); and
a common terminal of the second high-voltage relay is connected to one electrode of the catheter (Fig. 3A; [0093]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20210313871 A1- Fig. 1 shows an electrical element comprising capacitive and discharging portions, also referred to as a discharge circuit, where the capacitor portion is provided in parallel with the discharging portion, which is comprised of a resistor and a switch, this citation is relevant to claim 2
US 20100094277 A1- Fig. 3 shows an electrical system for providing electrosurgical energy to a patient where the footswitch provides an effect for controlling the control section, this citation is relevant to claim 2
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/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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