DETAILED ACTION
This action is in response to preliminary amendments received on 03/31/2025. It is acknowledged that all of the originally filed claims 1-20 have been canceled and new claims 21-40 added. A complete action on the merits of claims 21-40 follows below.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 30 and 40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 30 recites the limitation “further comprising using the REA to provide radiofrequency (RF) or navigational signal injection paths, sense electrical potentials, and/or facilitate generation of an electromechanical map”. It is noted that claim 21 on which claim 30 depends on claims “receiving the ablation energy to the ablation tissue of interest at the REA … generating, at an electrode-tissue engagement (ETE) circuit, an engagement state signal that varies according to an impedance level between first and second return electrodes within the REA based on the ablation energy received by the REA”; thereby specifically claiming the embodiment of ablating tissue with radiofrequency energy. It is therefore unclear if claim 30 is reciting that in addition to the RF ablation, the REA to provide navigational signal injection paths, sense electrical potentials, and/or facilitate generation of an electromechanical map or if the claim is directed to alternative embodiments. Clarification and appropriate correction is required.
Claim 40 recites the limitation “selecting a return electrode pair of a plurality of return electrodes”. It is at most unclear how many return electrodes there are and in what arrangement they are coupled together/to the system in order to allow under control of one or more processors of the ablation power generator configured with specific executable instructions, testing and selecting a return electrode pair of a plurality of return electrodes within the REA based on the indicator generated by the level detector as claimed. Clarification and appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-22 and 30-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Behnke (US Pub. No. 2009/0234352).
Regarding Claim 21, Behnke teaches a method, comprising:
contacting a patient with a return electrode arrangement (REA) (RF energy is delivered through the active electrode to tissue and returned by “split return electrodes 52a and 52b” [0030] and Fig. 2) coupled to an ablation power generator 20 ([0033]), the REA engaging a remote tissue, at a remote location from ablation tissue of interest (Fig. 2), to provide a return path during an ablation procedure ([0033]), wherein the REA transitions between an engaged state and a disengaged state with the remote tissue ([0032]-[0035]); delivering ablation energy to the ablation tissue of interest at an active electrode coupled to the ablation power generator ([0022]-[0024]); receiving the ablation energy to the ablation tissue of interest at the REA ([0010]-[0012], [0021]-[0023]); and generating, at an electrode-tissue engagement (ETE) circuit 70, an engagement state signal that varies according to an impedance level between first and second return electrodes within the REA based on the ablation energy received by the REA (“REM system monitors the adherence of the return electrode pad to the patient by measuring the impedance and/or current between one or more split pads. Split pad designs have been incorporated into resistive return electrode pads but previously were not included in capacitive return electrode designs due to the increased impedance of these electrode pads” [0019] and “Subsequent measurements may be made after commencement of electrosurgical energy delivery to determine any degradation in contact quality or change in a characteristic of patient contact. If the capacitance is out of range, thereby indicating excessive peeling of the return electrode pad 6, the generator 20 issues an alarm (e.g., audibly, visually, etc. via the controller 24) and/or the controller 24 adjusts the output of the generator 20 (e.g., terminates RF supply)” [0035], also see general disclosure [0022]-[0029] and [0033]-[0037]).
Regarding Claim 22, Behnke teaches further comprising processing the engagement state signal at a detection circuit, wherein the detection circuit is a part of the ETE circuit (“the generator 20 includes a return electrode monitoring ("REM") system 70 having a detection circuit 22 which is coupled to the split return electrodes 52a and 52b” [0033]).
Regarding Claim 30, Behnke teaches further comprising using the REA to provide radiofrequency (RF) or navigational signal injection paths, sense electrical potentials, and/or facilitate generation of an electromechanical map (“Electrosurgical RF energy is supplied to the instrument 2 by a generator 20 via an electrosurgical cable 4, which is connected to an active output terminal, allowing the instrument 2 to coagulate, ablate and/or otherwise treat tissue. The energy is returned to the generator 20 through a return electrode pad 6 via a return cable 8” [0022] likewise “split return electrodes 52a and 52b” disclosed in [0030] and shown in Fig. 2 returns RF energy to the generator).
Regarding Claim 31, Behnke teaches a method, comprising:
contacting a patient with a return electrode arrangement (REA) (RF energy is delivered through the active electrode to tissue and returned by “split return electrodes 52a and 52b” [0030] and Fig. 2) coupled to an ablation power generator 20 (Fig. 2), the REA engaging a remote tissue, at a remote location from ablation tissue of interest (Fig. 2), to provide a return path during an ablation procedure ([0033]), wherein the REA transitions between an engaged state and a disengaged state with the remote tissue ([0032]-[0035]);
delivering ablation energy to the ablation tissue of interest at an active electrode coupled to the ablation power generator; and detecting, at an electrode-tissue engagement (ETE) circuit that includes a resonant circuit 22 coupled to the REA, when the REA is in the engaged state or disengaged state based on the ablation energy received by the REA (“Subsequent measurements may be made after commencement of electrosurgical energy delivery to determine any degradation in contact quality or change in a characteristic of patient contact. If the capacitance is out of range, thereby indicating excessive peeling of the return electrode pad 6, the generator 20 issues an alarm (e.g., audibly, visually, etc. via the controller 24) and/or the controller 24 adjusts the output of the generator 20 (e.g., terminates RF supply)” [0035], also see general disclosure [0022]-[0029] and [0033]-[0037]).
Regarding Claim 32, Behnke teaches further comprising generating, at the ETE circuit, an engagement state signal that varies based on an impedance level between first and second return electrodes within the REA (“REM system monitors the adherence of the return electrode pad to the patient by measuring the impedance and/or current between one or more split pads. Split pad designs have been incorporated into resistive return electrode pads but previously were not included in capacitive return electrode designs due to the increased impedance of these electrode pads” [0019]).
Regarding Claim 33, Behnke teaches wherein the REA further comprises a closed loop oscillator connected to a primary side of a transformer (“leads 41 and 42 are enclosed in a return cable 8 and are terminated at a secondary winding 44 of a transformer 43” [0033]), the closed loop oscillator having an oscillation frequency corresponding to a resonant frequency of the resonant circuit ([0034]); the method further comprising: generating, at the closed loop oscillator, the engagement state signal ([0034]-[0035]).
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 23-29 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Behnke as applied above, in view of Smith (US Pub. No. 2017/0135744).
Regarding Claim 23, Behnke teaches wherein the detection circuit 22 comprises a filter, an amplifier, a rectifier (“detection circuit 22 then rectifies the interrogation signal to generate a monitor signal” [0034]), and a level detector (“the detection circuit 22 determines the magnitude of the capacitance between the split return electrodes 52a and 52b by monitoring changes in amplitude of the monitor signal waveform” [0035]); however, does not teach a filter and amplifier.
In the same field of invention, Smith teaches a return electrode monitoring system comprising a detection circuit 222 comprising a filter “resonant tank filter 304” [0056], amplifier ([0056], “the current-to voltage converter 306 may include a set of high speed amplifiers (not shown in FIG. 4)”) and rectifier ([0043], “The voltage signal generated by the current-to-voltage converter 306 is provided to the second controller 220, which is configured to generate (for example, using an analog-to-digital converter (ADC)) a digital impedance value based on the voltage signal, and provide the digital impedance value to the first controller 202 by way of the isolation circuit 216”; as broadly claimed, an ADC meets the limitations of a rectifier).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a filter and amplifier in the circuit of Behnke in order to allow the resonant tank filter to filter a response signal received from the at least one of the split electrode pads and the signal to be amplified for better results.
Regarding Claim 24, Behnke in view of Smith teaches further comprising calibrating the ETE circuit for the patient (“tank voltage calibration may be obtained using the bias resistors Rbias1 and Rbias2. When the generator 104 is first powered on these resistors may be used to perform calibration before the patient-to-pad interface connector is attached” [0067] of Smith).
Regarding Claim 25, Behnke in view of Smith teaches wherein the ETE circuit is calibrated for the patient by determining the impedance level of the first and second return electrodes within the REA for the patient based on a known engaged state of the REA ([0067] of Smith).
Regarding Claim 26, Behnke teaches further comprising generating, at the level detector of the detection circuit, an error signal indicating when the REA is in the engaged state or disengaged state (“the VCP 50 may peel from the patient "P," thereby decreasing the adherence factor thereof. The decrease in adherence directly affects the capacitance between the split return electrodes 52a and 52b. Measuring the change in capacitance between the split return electrodes 52a and 52b, therefore, provides an accurate measurement of adherence of the VCP 50 to the patient "P." The amount of capacitance coupling or the change in capacitance coupling then may be used to insure positive patient contact or to determine adequate patient coverage of the VCP 50” [0032], “If the capacitance is out of range, thereby indicating excessive peeling of the return electrode pad 6, the generator 20 issues an alarm (e.g., audibly, visually, etc. via the controller 24) and/or the controller 24 adjusts the output of the generator 20 (e.g., terminates RF supply)” [0035] and display in [0023]).
Regarding Claim 27, Behnke teaches further comprising generating, at the ETE circuit, an error notification, wherein the error notification is transmitted to one or more processors of the ablation power generator and/or to a clinician (“If the capacitance is out of range, thereby indicating excessive peeling of the return electrode pad 6, the generator 20 issues an alarm (e.g., audibly, visually, etc. via the controller 24) and/or the controller 24 adjusts the output of the generator 20 (e.g., terminates RF supply)” [0035]).
Regarding Claim 28, Behnke teaches further comprising, under control of the one or more processors of the ablation power generator, directing the ablation power generator to cease delivering the ablation energy, to adjust the ablation energy supplied via the active electrode to the ablation tissue of interest, and/or to select a different pair of return electrodes of the REA that are in an engaged state (“If the capacitance is out of range, thereby indicating excessive peeling of the return electrode pad 6, the generator 20 issues an alarm (e.g., audibly, visually, etc. via the controller 24) and/or the controller 24 adjusts the output of the generator 20 (e.g., terminates RF supply)” [0035] of Behnke).
Regarding Claim 29, Behnke teaches further comprising, under control of the one or more processors of the ablation power generator, providing an alert to the clinician (a) communicating that the REA is in a disengaged state and the patient is at risk of return electrode- induced burn; and/or (b) indicating that adjustment and/or re-affixation of the return electrodes the REA is needed to avoid a risk of return-electrode induced burn ([0035] of Behnke).
Regarding Claim 34, Behnke teaches wherein the detection circuit 22 comprises a filter, an amplifier, a rectifier (“detection circuit 22 then rectifies the interrogation signal to generate a monitor signal” [0034]), and a level detector (“the detection circuit 22 determines the magnitude of the capacitance between the split return electrodes 52a and 52b by monitoring changes in amplitude of the monitor signal waveform” [0035]); however, does not teach a filter and amplifier.
In the same field of invention, Smith teaches a return electrode monitoring system comprising a detection circuit 222 comprising a filter “resonant tank filter 304” [0056], amplifier ([0056], “the current-to voltage converter 306 may include a set of high speed amplifiers (not shown in FIG. 4)”) and rectifier ([0043], “The voltage signal generated by the current-to-voltage converter 306 is provided to the second controller 220, which is configured to generate (for example, using an analog-to-digital converter (ADC)) a digital impedance value based on the voltage signal, and provide the digital impedance value to the first controller 202 by way of the isolation circuit 216”; as broadly claimed, an ADC meets the limitations of a rectifier), processing, at the ETE, the engagement state signal to form a processed state signal ([0033], “As the impedance between the split pads changes, the resonance of the REM circuit changes as well, this causes the amplitude to change. Thus, by monitoring the changes in the amplitude, the REM circuit determines the magnitude of the impedance between the split pads which is indicative of adherence of the return electrode pad to the patient”; also see [0040]-[0047] and [0055]-[0057]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a filter and amplifier in the circuit of Behnke in order to allow the resonant tank filter to filter a response signal received from the at least one of the split electrode pads and the signal to be amplified for better results.
Regarding Claim 35, Behnke teaches wherein the ETE circuit further comprises a level detector; the method further comprising: generating, at the level detector, an error signal indicating when the return electrode is in the engaged state or disengaged state based on the processed state signal (“the VCP 50 may peel from the patient "P," thereby decreasing the adherence factor thereof. The decrease in adherence directly affects the capacitance between the split return electrodes 52a and 52b. Measuring the change in capacitance between the split return electrodes 52a and 52b, therefore, provides an accurate measurement of adherence of the VCP 50 to the patient "P." The amount of capacitance coupling or the change in capacitance coupling then may be used to insure positive patient contact or to determine adequate patient coverage of the VCP 50” [0032], “If the capacitance is out of range, thereby indicating excessive peeling of the return electrode pad 6, the generator 20 issues an alarm (e.g., audibly, visually, etc. via the controller 24) and/or the controller 24 adjusts the output of the generator 20 (e.g., terminates RF supply)” [0035] and display in [0023]).
Claims 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over Behnke as applied above, in view of Cartmell (U.S. Pat. 5,830,212).
Regarding Claim 36, Behnke teaches wherein the resonant circuit 22 is connected to a secondary side of a transformer 43 and a closed loop oscillator is connected to a primary side of the transformer (“leads 41 and 42 are enclosed in a return cable 8 and are terminated at a secondary winding 44 of a transformer 43” [0033]); however, does not teach the closed loop oscillator comprising an amplifier network; the method further comprising: generating, at the amplifier network, a signal based on a resonant frequency of the resonant circuit.
In the same field of invention, Cartmell teaches a similar device and method (Figs. 1-5) comprising an oscillator coupled to a resonant tank circuit and further comprising an amplifier network (as best illustrated in Fig. 5; col. 10, ll. 31-62). The oscillator circuit is formed by a network of amplifiers (U101A, U101B). Cartmell teaches “Resistors R105, R106, R107 and amplifier U101A provide the necessary feedback gain to maintain proper oscillation. Transistors Q101 and Q102 form a push-pull amplifier circuit that buffers the oscillator and provides approximately 1.5 volts peak-to-peak to the toroidal inductor through coupling capacitor C103” (col. 10, ll. 57-62). Further, “[w]hen the electrode 10 is lifted from the patient, the amount of coupling capacitance decreases causing the natural frequency of the T101 tank circuit to increase. This increase in resonant frequency causes a corresponding increase in the tank circuit currents which are converted to a voltage signal by resistor R113…The output signal obtained as a voltage developed across R113 is detected by C105, D107, D110, C107 and R115. This output signal is applied to the non-inverting input of U101D which is configured as a comparator with the threshold voltage determined by resistor R117 and diode D113. When the electrode is lifted and the output signal increases past the threshold, U1D produces a fault signal that is sent to disable the electrosurgical generator. When the electrode is lifted beyond the half-way point, the resonant frequency of the tank circuit increases to a point beyond which the oscillator circuit can be tuned. This feature makes it impossible for the system to be properly initialized when the electrode is not correctly attached to the patient when it is first applied” (col. 10, line 63- col. 11, line 16), thereby increasing safety and accuracy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Smith to include wherein the closed loop oscillator comprising an amplifier network; the method further comprising: generating, at the amplifier network, a signal based on a resonant frequency of the resonant circuit, as taught by Cartmell in order to ensure that the electrode is correctly attached to the patient prior to initialization of the system, thereby increasing safety and accuracy.
Regarding Claim 37, Behnke in view of Cartmell teaches wherein the method further comprises a level detector, the method further comprising: outputting, at the level detector, an indicator of when the REA is in the engaged state or the disengaged state based on the signal from the amplifier network (“the detection circuit 22 determines the magnitude of the capacitance between the split return electrodes 52a and 52b by monitoring changes in amplitude of the monitor signal waveform” [0035] of Behnke, also see Col. 10, ll. 48-Col. 11, ll. 59 of Cartmell).
Regarding Claim 38, Behnke teaches further comprising, under control of one or more processors of the ablation power generator configured with specific executable instructions, stopping ablation when the level detector indicates a disengaged state (“If the capacitance is out of range, thereby indicating excessive peeling of the return electrode pad 6, the generator 20 issues an alarm (e.g., audibly, visually, etc. via the controller 24) and/or the controller 24 adjusts the output of the generator 20 (e.g., terminates RF supply)” [0035]).
Regarding Claim 39, Behnke teaches further comprising, under control of one or more processors of the ablation power generator configured with specific executable instructions, generating an alert when the level detector indicates a disengaged state (“If the capacitance is out of range, thereby indicating excessive peeling of the return electrode pad 6, the generator 20 issues an alarm (e.g., audibly, visually, etc. via the controller 24) and/or the controller 24 adjusts the output of the generator 20 (e.g., terminates RF supply)” [0035]).
Conclusion
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
