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 .
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.
Claims 1-9, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Charles (E.P. Application No. 1599146 B1), and further in view of Friedrichs (U.S. Application No. 20170209202 A1).
Regarding independent claim 1, Charles discloses an electrosurgical generator, comprising:
a first radio frequency (RF) source (74) and a second RF source (74’) (pa. 0031 & Fig. 9);
a first controller (72) configured to output a first control signal to the first RF source to generate a first RF waveform (i.e., a cutting RF waveform) (pa. 0017-0018, 0032 & Fig. 2);
a second controller (72’) configured to output a second control signal to the second RF source to generate a second RF waveform (i.e., a coagulating RF waveform) (pa. 0031), with the first RF source and the second RF source configured to simultaneously generate the respective first RF waveform and second RF waveform (pa. 0032); and
a first output port (10S) configured to provide the respective first RF waveform and the second RF waveform for treatment of tissue (pa. 0016, 0032).
However, Charles does not disclose a second output port configured to provide an RF waveform.
Friedrichs, in the same field of endeavor, teaches a generator (200) comprising a controller (224), a power supply (227), and a dual frequency inverter (228) (pa. 0037 & Fig. 3). The generator includes a plurality of ports (250-262) to accommodate various types of electrosurgical instruments (e.g., monopolar electrosurgical instrument 20, electrosurgical forceps 30, ultrasonic surgical instrument 40, etc.) (pa. 0031 & Fig. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the number of output ports on the generator of Charles to include a second output port, as taught by Friedrichs, for the purpose of helping accommodate for various types of electrosurgical instruments.
Regarding claim 2, Charles/Friedrichs combination discloses wherein the first RF source comprises a first power supply (66) coupled to a first RF inverter (60), and the second RF source comprises a second power supply (66’) coupled to a second RF inverter (60’) (Charles, pa. 0017, 0031).
Regarding claim 3, Charles/Friedrichs combination discloses wherein the first controller is configured to controllably operate at least one of the first RF inverter or the first power supply to generate the first RF waveform having at least one property comprising at least one of a carrier frequency, a phase, an amplitude, a duty cycle, a peak voltage, a crest factor, a continuous waveform, or a discontinuous waveform (Charles, pa. 0031-0032).
Regarding claim 4, Charles/Friedrichs combination discloses wherein the second controller is configured to controllably operate at least one of the second RF inverter or the second power supply to generate the second RF waveform having at least one property comprising at least one of a carrier frequency, a phase, an amplitude, a duty cycle, a peak voltage, a crest factor, a continuous waveform, or a discontinuous waveform (Charles, pa. 0031-0032).
Regarding claim 5, Charles/Friedrichs combination discloses further comprising a common return terminal (see inside the output stage 73, input connections 47 and 47' are both connected to output connection 49) coupled to each of the first RF inverter and the second RF inverter (Charles, pa. 0032).
Regarding claim 6, Charles discloses the invention substantially as claimed in claims 1-2 discussed above.
However, Charles does not disclose further comprising an isolation transformer having a primary winding coupled to one of the first RF inverter or the second RF inverter, and having a secondary winding coupled to the corresponding first output port or the second output port.
Friedrichs, in the same field of endeavor, teaches a generator (200) comprising a controller (224), a power supply (227), and a dual frequency inverter (228). The electrical energy for a medical instrument (40) is delivered through an active and return terminals (234, 236) and electrosurgical energy for energizing a second medical instrument (20) is delivered through an active and return terminals (230, 232). The active terminals and the return terminals are coupled to the dual-frequency inverter through an isolation transformer (229) (pa. 0037). The isolation transformer (229) comprises a primary winding (229a) coupled to the inverter, and having a secondary winding (229b, 229c) coupled to a high pass filter (306) and a low pass filter (304), which are electrically coupled to the active terminals and the return terminals (pa. 0038 & Figs. 3-4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the isolation transformer, including the low-pass and the high-pass filters taught by Friedrichs, to be coupled to one of the first RF inverter or the second RF inverter of Charles, for the purpose preventing unwanted electrical noise from traveling between the RF circuitry of the generator.
Regarding claims 7 and 16, Charles/Friedrichs combination discloses wherein the first RF waveform is one of monopolar or bipolar, and wherein the second RF waveform is one of monopolar or bipolar (Charles, abstract, pa. 0032 & Fig. 3).
Regarding claim 8, Charles/Friedrichs combination discloses further comprising a clock source (switch device 51) coupled to each of the first controller and the second controller and configured to synchronize operation of the first controller and the second controller (Charles, pa. 0023).
Regarding claim 9, Charles/Friedrichs combination discloses further comprising a plurality of sensors (68, 68’) communicatively coupled to the first controller and the second controller and configured to output sensor signals corresponding to the first RF waveform and the second RF waveform (Charles, pa. 0017, 0031).
For further clarification, the Charles reference discloses voltage threshold detectors (68, 68’), each coupled to their respective power supplies and controllers. Examiner determines that the voltage threshold detector must inherently contain at least one sensor that is able to measure/sense voltage from the RF waveforms in order to adjust the output power supply to be within a specific threshold.
Regarding independent claim 15, Charles discloses an electrosurgical system, comprising:
an electrosurgical generator, comprising:
a first radio frequency (RF) source (74) and a second RF source (74’) (pa. 0031 & Fig. 9);
a first controller (72) configured to output a first control signal to the first RF source to generate a first RF waveform (i.e., a cutting RF waveform) (pa. 0017-0018, 0032 & Fig. 2);
a second controller (72’) configured to output a second control signal to the second RF source to generate a second RF waveform (i.e., a coagulating RF waveform) (pa. 0031); and
a first output port (10S) configured to provide the respective first RF waveform and the second RF waveform for treatment of tissue (pa. 0016, 0032);
a first electrosurgical instrument coupled to the first output port for delivering electrosurgical energy based on the first RF waveform and for delivering electrosurgical energy based on the second RF waveform (pa. 0032);
wherein the electrosurgical generator is configured to simultaneously provide the first RF waveform and the second RF waveform to the first electrosurgical instrument (pa. 0032).
However, Charles does not disclose a second electrosurgical instrument, nor a second port configured to provide an RF waveform.
Friedrichs, in the same field of endeavor, teaches a system comprising a generator (200) used in monopolar and/or bipolar electrosurgical procedures, including, for example, cutting, coagulation, ablation, and vessel sealing procedures. The generator includes a plurality of output ports (250-262) for interfacing with one or more electrosurgical instruments (10, 40) (pa. 0027, 0029, 0031 & Figs. 2-3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the number of output ports on the generator of Charles to include a second output port, as taught by Friedrichs, for the purpose of helping accommodate for various types of electrosurgical instruments. Moreover, it would have been obvious to add an additional electrosurgical instrument to the electrosurgical system of Charles since it seems the invention would work equally well with either one or more of electrosurgical instruments given that both variations would lead to the same predictable results of providing a plurality of RF waveforms to treat tissue.
Regarding claim 17, Charles/Friedrichs combination discloses wherein at least one of the first electrosurgical instrument or the second electrosurgical instrument comprises at least one of a tissue sealing device, a tissue cutting device, or a tissue grasping device (Charles, pa. 0032).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Charles and Friedrichs as applied to claim 1 above, and further in view of Friedrichs (U.S. Application No. 20170312005 A1), henceforth referred to as Fried’005.
Regarding claims 11, Charles discloses wherein the first RF waveform has a first carrier frequency and the second RF waveform has a second carrier frequency (pa. 0031-0032).
However, Charles/Friedrichs combination does not disclose wherein at least one of the first controller or the second controller is configured to perform a frequency domain analysis of the corresponding first RF waveform or second RF waveform based on the corresponding first carrier frequency or the second carrier frequency; and determine a presence of cross-conductance between the first RF source and the second RF source based on the frequency domain analysis.
Fried’005, in the same field of endeavor, teaches an electrosurgical
generator (200) including a power supply (227) configured to output a DC waveform, an inverter (228) coupled to the power supply, the inverter including a plurality of switching elements, and a controller (224) coupled to the inverter (abstract, pa. 0029, 0033 & Fig. 3). As seen in Figs. 8-9, harmonic frequency plots (600, 700) illustrate the frequency domain spectrum of RF waveforms (402, 502), respectively (pa. 0043). To eliminate undesired harmonics of the RF waveforms, the present disclosure utilizes an elective harmonic elimination (SHE) modulation method, which allows for fundamental and certain harmonics to be independently controlled. This also allows for individual power regulation and elimination of undesired harmonics, which reduces leakage of current, energy losses, and electro-magnetic interference (pa. 0044).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the SHE modulation method taught by Fried’005 in order to allow either the first controller or the second controller of Charles to be able to perform a frequency domain analysis of the corresponding RF waveform and determine a presence of cross-conductance for the purpose of more efficiently regulating power and eliminating undesired harmonics, which reduces leakage of current, energy losses, and electro-magnetic interference (Fried’005, pa. 0044).
Claims 10, 12-14, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Charles and Friedrichs as applied to claims 1 and 15 above, and further in view of Heckel (U.S. Application No. 20190132062 A1).
Regarding claim 10, Charles/Friedrichs combination discloses the plurality of sensors (68, 68’) communicatively coupled to the first controller and the second controller and configured to output sensor signals corresponding to the voltage of the first RF waveform and the second RF waveform (Charles, pa. 0017, 0031).
However, they do not disclose wherein at least one of the first controller or the second controller is configured to discriminate measurement data, based on the corresponding first RF waveform or second RF waveform, from the sensor signals.
Heckel, in the same field of endeavor, teaches an electrosurgical system (410) comprising an electrosurgical generator (430) (e.g., an RF signal/energy generator), a voltage monitoring circuit (VMC) (440), a current monitoring circuit (CMC) (450), and a controller (480) to control operation of electrosurgical generator (pa. 0051 & Fig. 4). The controller receives voltage samples and/or current samples from VMC and/or from CMC. Another type of information that the electrosurgical system obtains is from the output of multiple band pass filters, such as Goertzel filters, to independently filter voltage samples and current samples at specific frequencies. This leads to a more accurate electrosurgical system because the controller is able to select a frequency that, among the candidate frequencies, is the least susceptible to (including minimal) RF interferences (pa. 0058).
Examiner notes that the method taught by Heckel to discriminate measurement data using a Goertzel filter is similar to the method taught by the instant application (see pa. [0045]) which describes how the controllers 204 and 304 analyze their respective first and second RF waveforms using any suitable band pass technique or any technique which transforms the measurement data to the frequency domain, such as discrete Fourier transform (DFT) and fast Fourier transform (FFT), or Goertzel filters.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the controller’s ability to use Goertzel filters, as taught by Heckel, to the controller of Charles for the purpose of discriminating/selecting the most suitable waveform frequencies that are least susceptible to RF interferences (Heckel, pa. 0058).
Regarding claim 12, Charles/Friedrichs combination discloses the invention substantially as claimed in claims 1 and 9 discussed above.
However, they do not disclose wherein at least one of the first controller or the second controller is further configured to controllably operate the corresponding first RF source or the second RF source to generate an interrogation waveform, nor receive sensor signals from the plurality of sensors corresponding to the interrogation waveform, the sensor signals indicative of a measured impedance for an electrosurgical instrument coupled to the corresponding first output port or the second output port; and determine tissue contact by the electrosurgical instrument based on the measured impedance.
Heckel, in the same field of endeavor, teaches an electrosurgical system comprising a first electrosurgical generator (110) and a second electrosurgical generator (120) (pa. 0030 & Fig. 1A). Controlling the operation of the electrosurgical system includes determining a state or an operational mode of the electrosurgical system, for example determining, during therapeutic RF energy delivery, whether or when to transition the electrosurgical system from a treatment mode in which the electrosurgical system outputs (high power) therapeutic RF energy, to an interrogation mode in which the electrosurgical system outputs a low power interrogation signal (e.g., to measure impedance at the system's output in order to determine whether or when to transition the electrosurgical system to the treatment mode), and, while operating in the interrogation mode, whether or when to transition the electrosurgical system back to the treatment mode (pa. 0012).
When the treatment device touches the treated tissue (e.g., when the electrosurgical system’s electrical circuitry is closed via the tissue), the electrosurgical system senses impedance (Z1), and when the treatment device does not touch the treated tissue (i.e., when the electrosurgical system's output circuitry is open), the impedance sensed is infinite (Z∞), or, in practice, at least in the order of tens of kilo ohms (pa. 0039). The electrosurgical system receives continuous feedback signal (340) to continually control the system's output electrical current, voltage or output power, and to determine whether the system is to transition from the treatment mode to the interrogation mode. The feedback signal may be derived from current samples and/or voltage samples that are continuously read to reflect the electrical condition or state of the electrosurgical system at any time (pa. 0049). The electrosurgical system’s controller (480) is able to calculate, during an impedance interrogation phase, the system's instantaneous output impedance, Zout, by applying an interrogation voltage, Vin. The controller is able to compute the output impedance Zout in order to determine the next operation mode or state of electrosurgical system. By knowing the output voltage (Vout) and output current (Tout) at treatment electrode (418), the controller is able to determine and control the therapeutic RF energy actually provided to the treated site when the electrosurgical system operates in the treatment mode (pa. 0060).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the interrogation waveform as well as the functionalities of the controller taught by Heckel, including the controller’s ability to receive signals corresponding to the interrogation waveform in order to determine tissue contact for the purpose of allowing the user to properly determine when therapeutic RF energy should actually be provided to the treated site.
Regarding claim 13, Charles/Friedrichs combination discloses wherein the at least one of the first controller or the second controller is further configured to output the corresponding first control signal or the second control signal, for generating the corresponding first RF waveform or the second RF waveform (Charles, pa. 0017, 0031-0032).
However, they do not explicitly disclose determining tissue contact.
Heckel, in the same field of endeavor, teaches controlling the operation of the electrosurgical system by determining a state or an operational mode using interrogation signal (e.g., to measure impedance at the system's output) (pa. 0012). Specifically, Heckel teaches using impedance values to determine when the treatment device touches the treated tissue (pa. 0039, 0060).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the interrogation waveform as well as the functionalities of the controller taught by Heckel, including the controller’s ability to receive signals corresponding to the interrogation waveform in order to determine tissue contact for the purpose of allowing the user to properly determine when therapeutic RF energy should actually be provided to the treated site.
Regarding claim 14, Charles/Friedrichs combination discloses the invention substantially as claimed in claims 1 and 12 discussed above.
However, they do not disclose wherein a power level of the interrogation waveform is less than a power level of the corresponding first RF waveform or the second RF waveform.
Heckel, in the same field of endeavor, teaches wherein a power level of the interrogation waveform is less than a power level of an RF waveform (pa. 0052).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the low interrogation waveform and the higher RF waveform taught by Heckel, in order to ensures patient safety, optimize energy delivery, and prevent unwanted tissue damage.
Regarding claim 18, Charles/Friedrichs combination discloses further comprising a plurality of sensors (68, 68’) communicatively coupled to the first controller and the second controller and configured to output sensor signals corresponding to the first RF waveform and the second RF waveform (Charles, pa. 0017, 0031).
For further clarification, the Charles reference discloses voltage threshold detectors (68, 68’), each coupled to their respective power supplies and controllers. Examiner determines that the voltage threshold detector must inherently contain at least one sensor that is able to measure/sense voltage from the RF waveforms in order to adjust the output power supply to be within a specific threshold.
However, they do not disclose wherein the first controller is configured to discriminate first measurement data, corresponding to the first RF waveform, from the sensor signals, and wherein the second controller is configured to discriminate second measurement data, corresponding to the second RF waveform, from the sensor signals.
Heckel, in the same field of endeavor, teaches an electrosurgical system (410) comprising an electrosurgical generator (430) (e.g., an RF signal/energy generator), a voltage monitoring circuit (VMC) (440), a current monitoring circuit (CMC) (450), and a controller (480) to control operation of electrosurgical generator (pa. 0051 & Fig. 4). The controller receives voltage samples and/or current samples from VMC and/or from CMC. Another type of information that the electrosurgical system obtains is from the output of multiple band pass filters, such as Goertzel filters, to independently filter voltage samples and current samples at specific frequencies. This leads to a more accurate electrosurgical system because the controller is able to select a frequency that, among the candidate frequencies, is the least susceptible to (including minimal) RF interferences (pa. 0058).
Examiner notes that the method taught by Heckel to discriminate measurement data using a Goertzel filter is similar to the method taught by the instant application (see pa. [0045]) which describes how the controllers 204 and 304 analyze their respective first and second RF waveforms using any suitable band pass technique or any technique which transforms the measurement data to the frequency domain, such as discrete Fourier transform (DFT) and fast Fourier transform (FFT), or Goertzel filters.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the controller’s ability to use Goertzel filters, as taught by Heckel, to the first controller and the second controller of Charles for the purpose of discriminating/selecting the most suitable waveform frequencies that are least susceptible to RF interferences (Heckel, pa. 0058).
Regarding claim 20, Charles/Friedrichs combination discloses the invention substantially as claimed in claims 1 and 18 discussed above.
However, they do not disclose wherein at least one of the first controller or the second controller is further configured to controllably operate the corresponding first RF source or the second RF source to generate an interrogation waveform, nor receive sensor signals from the plurality of sensors corresponding to the interrogation waveform, the sensor signals indicative of a measured impedance for the corresponding first electrosurgical instrument or the second electrosurgical instrument; and determine tissue contact, based on the measured impedance, by the corresponding first electrosurgical instrument or the second electrosurgical instrument.
Heckel, in the same field of endeavor, teaches an electrosurgical system comprising a first electrosurgical generator (110) and a second electrosurgical generator (120) (pa. 0030 & Fig. 1A). Controlling the operation of the electrosurgical system includes determining a state or an operational mode of the electrosurgical system, for example determining, during therapeutic RF energy delivery, whether or when to transition the electrosurgical system from a treatment mode in which the electrosurgical system outputs (high power) therapeutic RF energy, to an interrogation mode in which the electrosurgical system outputs a low power interrogation signal (e.g., to measure impedance at the system's output in order to determine whether or when to transition the electrosurgical system to the treatment mode), and, while operating in the interrogation mode, whether or when to transition the electrosurgical system back to the treatment mode (pa. 0012).
When the treatment device touches the treated tissue (e.g., when the electrosurgical system’s electrical circuitry is closed via the tissue), the electrosurgical system senses impedance (Z1), and when the treatment device does not touch the treated tissue (i.e., when the electrosurgical system's output circuitry is open), the impedance sensed is infinite (Z∞), or, in practice, at least in the order of tens of kilo ohms (pa. 0039). The electrosurgical system receives continuous feedback signal (340) to continually control the system's output electrical current, voltage or output power, and to determine whether the system is to transition from the treatment mode to the interrogation mode. The feedback signal may be derived from current samples and/or voltage samples that are continuously read to reflect the electrical condition or state of the electrosurgical system at any time (pa. 0049). The electrosurgical system’s controller (480) is able to calculate, during an impedance interrogation phase, the system's instantaneous output impedance, Zout, by applying an interrogation voltage, Vin. The controller is able to compute the output impedance Zout in order to determine the next operation mode or state of electrosurgical system. By knowing the output voltage (Vout) and output current (Tout) at treatment electrode (418), the controller is able to determine and control the therapeutic RF energy actually provided to the treated site when the electrosurgical system operates in the treatment mode (pa. 0060).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the interrogation waveform as well as the functionalities of the controller taught by Heckel, including the controller’s ability to receive signals corresponding to the interrogation waveform in order to determine tissue contact for the purpose of allowing the user to properly determine when therapeutic RF energy should actually be provided to the treated site.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Charles, Friedrichs, and Heckel as applied to claims 1 and 18 above, and further in view of Friedrichs (U.S. Application No. 20170312005 A1), henceforth referred to as Fried’005.
Regarding claims 19, Charles discloses wherein the first RF waveform has a first carrier frequency and the second RF waveform has a second carrier frequency (pa. 0031-0032).
However, Charles/Friedrichs/Heckel combination does not disclose wherein at least one of the first controller or the second controller is configured to perform a frequency domain analysis of the corresponding first RF waveform or second RF waveform based on the corresponding first carrier frequency or the second carrier frequency; and determine a presence of cross-conductance between the first RF source and the second RF source based on the frequency domain analysis.
Fried’005, in the same field of endeavor, teaches an electrosurgical
generator (200) including a power supply (227) configured to output a DC waveform, an inverter (228) coupled to the power supply, the inverter including a plurality of switching elements, and a controller (224) coupled to the inverter (abstract, pa. 0029, 0033 & Fig. 3). As seen in Figs. 8-9, harmonic frequency plots (600, 700) illustrate the frequency domain spectrum of RF waveforms (402, 502), respectively (pa. 0043). To eliminate undesired harmonics of the RF waveforms, the present disclosure utilizes an elective harmonic elimination (SHE) modulation method, which allows for fundamental and certain harmonics to be independently controlled. This also allows for individual power regulation and elimination of undesired harmonics, which reduces leakage of current, energy losses, and electro-magnetic interference (pa. 0044).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the SHE modulation method taught by Fried’005 in order to allow either the first controller or the second controller of Charles to be able to perform a frequency domain analysis of the corresponding RF waveform and determine a presence of cross-conductance for the purpose of more efficiently regulating power and eliminating undesired harmonics, which reduces leakage of current, energy losses, and electro-magnetic interference (Fried’005, pa. 0044).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
“Frequency Oscillator”, chapter on “Fundamentals of microwave engineering”, section 1.7.3 “Oscillators: Oscillator Structures, Phase Noise” describes how in the most general sense, an oscillator is a nonlinear circuit that converts DC power to an AC waveform.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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