DETAILED ACTION
This action is pursuant to the claims filed on August 29, 2024. Claims 21-40 are pending. Claims 1-20 is/are canceled. A first action on the merits of claims 21-40 is as follows.
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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-40 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Sun et al. (hereinafter ‘Sun’, U.S. Pat. No. 6,391,024, see IDS).
In regard to independent claim 21, Sun discloses a system (apparatus 10 in Fig. 1) for assessing a contact state between a medical device (col. 17, ln. 18-22: apparatus 10 comprises a microprocessor configured to analyze the assessment impedance and the reference impedance and provide an indication of the state of the electrode/tissue contact of a catheter 18), wherein the medical device comprises a catheter having a distal portion and a plurality of electrodes disposed within the distal portion (col. 8, ln. 63- col. 9, ln. 12: the apparatus 10 comprises the catheter 18 comprising a plurality of electrodes 46 at its distal end which is used to determine electrode/tissue contact), the system comprising:
a signal generator (power generator 26 in Fig. 1) operably coupled to the plurality of electrodes (the generator 26 is coupled to the catheter 18 comprising the electrodes 46 as shown in Fig. 1);
a detection amplifier operably coupled to the plurality of electrodes (col. 11, ln. 4-7 & col. 11, ln. 19-26: ECG signal 38 of electrodes 46 that is free from the high frequency interference and the ECG signal is fed into the ECG filter system 36 and to an ECG amplifier as shown in Fig. 1); and
an electronic control unit (ECU) operably coupled to the signal generator and the detection amplifier (various components of the system including the controller 30 in power control system 12 in Fig. 1; the controller 30 is operably coupled to the generator 26 and the ECG amplifier (not shown) as shown in Fig. 1; col. 9, ln. 55-63: the catheter system 12 comprises a plurality of band electrodes 46 is connected to a power control system (PCS) microprocessor 58 is part of the controller 30), wherein the ECU is configured to:
cause the signal generator to generate an excitation signal for delivery to the plurality of electrodes (col. 8, ln. 40-50 & col. 12, ln. 8-16: a controller 30 controls the signals 32 to the power generator 26 and monitors the power 28 provided by the power generator 26; the power output signal 28 of respective electrode leads controls the duty cycle and phase of each of the channel for ECG and impedance measurements);
cause the detection amplifier to measure electrical potentials at the plurality of electrodes (col. 11, ln. 4-7 & col. 11, ln. 19-26: the power 28 passes through a temperature filter (“FL”) 104 and is sent to the PCS microprocessor 58 to filter out any RF noise present in the power 28 so that the it provides an ECG signal 38 that is free from the high frequency interference and the ECG signal is fed into the ECG filter system 36 and to an ECG amplifier as shown in Fig. 1);
determine the contact state between the catheter and the tissue from the measured electrical potentials (col. 10, ln. 58-64: the power output signal 28 is monitored and provided to the PCS microprocessor 58 to determine the impedance at each of the electrodes 46 via the current and voltage monitor); and
output an indication of the contact state between the catheter and the tissue (col. 17, ln. 18-28: the PCS microprocessor 58 analyzes the assessment impedance at each of the electrodes 46 and provides an indication of the state of the electrode/tissue contact and the indication may be provided on the front panel of the power control system through a display device).
In regards to claims 22-23, Sun further discloses wherein the ECU is further configured to cause the detection amplifier to measure electrophysiology data from the tissue using the plurality of electrodes (col. 12, ln. 7-16: the PCS microprocessor 58 controls the duty cycle and the phase of each of the channels of the plurality of electrodes 46 for measuring ECG signal and impedance), wherein the ECU is further configured to cause the detection amplifier to measure the electrophysiology data from the tissue using the plurality of electrodes when the contact state between the catheter and the tissue is that the catheter is in contact with tissue (col. 13, ln. 35-45 & col. 23, ln. 18-41: the tissue contact during ablation is sensed and fed back into the microprocessor 58 and the microprocessor 58 controls the duty cycle of each of the leads of the plurality of electrodes for ECG measurements).
In regards to claim 24-25, Sun further discloses wherein the excitation signal drives a current between a pair of electrodes of the plurality of electrodes (col. 12, ln. 7-16: the PCS microprocessor 58 controls the duty cycle and the phase of each of the channels of the plurality of electrodes 46 for measuring ECG signal and impedance; broadly, the PCS microprocessor 58 which controls the power output signal 28 is used to drive the CAD; col. 12, ln. 18-54: the output signal 28 controls the CAD to provide a signal to one of the electrodes 46 in a bipolar operation to provide impedance measurement between a pair of the electrodes), wherein the ECU is further configured to determine impedances at the plurality of electrodes from the measured electrical potentials at the plurality of electrodes and to determine the contact state between the catheter and the tissue from the impedances at the plurality of electrodes (col. 12, ln. 47-53: impedance measurement between any pair of electrodes to assess the adequacy of electrode/tissue contact).
In regards to claim 26, Sun further discloses wherein the contact state comprises a binary contact state (col. 17, ln. 18-40: the display device indicates a degree of confidence of electrode/tissue contact where a percentage of 5% indicates no tissue contact with the electrode; note that anything above 5% indicates tissue contact; therefore, when the threshold is 5%, there are two states: no contact and tissue contact to provide for the claimed binary contact state).
In regards to claim 27-28, Sun further discloses wherein the measured electrical potentials are measured with reference to an additional electrode that is not amongst the plurality of electrodes within the distal portion of the catheter, wherein the additional electrode comprises a patch electrode applied to a body surface of a patient, wherein the additional electrode comprises a patch electrode applied to a body surface of a patient (col. 12, ln. 47-53: impedance can be measured between any one of the electrodes 46 and backplates 16 to assess the adequacy of electrode/tissue contact).
In regards to independent claim 29, Sun discloses a system (apparatus 10 in Fig. 1)
a catheter having a distal portion and including a plurality of electrodes disposed within the distal portion (catheter 18 comprising electrodes 46 at a distal end as shown in Fig. 1);
an electronic control unit (ECU) (power control system 12 in Fig. 1) coupled to the catheter (see Fig. 1), wherein the ECU is configured to:
drive one or more electrodes of the plurality of electrodes with an electrical signal (col. 8, ln. 37-41: power generator 26 outputs power output signal 28 to both ECG filter system 36 and contact assessment device 14, col. 8, ln. 40-50 & col. 12, ln. 8-16);
detect respective electrical potentials on the plurality of electrodes while the one or more electrodes of the plurality of electrodes are driven with the electrical signal (col. 11, ln. 4-7 & col. 11, ln. 19-26: the power 28 passes through a temperature filter (“FL”) 104 and is sent to the PCS microprocessor 58 to filter out any RF noise present in the power 28 so that the it provides an ECG signal 38 that is free from the high frequency interference and the ECG signal is fed into the ECF filter system 36 and to an ECG amplifier as shown in Fig. 1);
determine a contact state between the catheter and a tissue (col. 10, ln. 58-64: the power output signal 28 is monitored and provided to the PCS microprocessor 58 to determine the impedance at each of the electrodes 46 via the current and voltage monitor); and
output an indication of the contact state between the catheter and the tissue (col. 17, ln. 18-28: the PCS microprocessor 58 analyzes the assessment impedance at each of the electrodes 46 and provides an indication of the state of the electrode/tissue contact and the indication may be provided on the front panel of the power control system through a display device).
In regards to claim 30, Sun further discloses wherein the ECU is configured to drive the electrical signal from a first electrode of the plurality of electrodes to a second electrode of the plurality of electrodes (col. 12, ln. 47-53: impedance can be measured between any pair of the electrodes 46 to assess the adequacy of electrode/tissue contact; this is inherent based upon a bipolar impedance measurement).
In regards to claim 31, see the rejection claim 26 above.
In regard to claims 32-33, see the rejection of claims 27 and 28 above.
In regards to claims 33-34, Sun discloses wherein the ECU is further configured to measure an electrophysiology data from the tissue using the plurality of electrodes, wherein the electrophysiology data is measured when the catheter is in contact with the tissue (col. 13, ln. 35-45 & col. 23, ln. 18-41: the tissue contact during ablation is sensed and fed back into the microprocessor 58 and the microprocessor 58 controls the duty cycle of each of the leads of the plurality of electrodes for ECG measurements).
In regards to independent claim 35, Sun discloses a method of assessing a contact state between a medical device and a tissue (col. 3, ln. 34-43), wherein the medical device comprises a catheter having a distal portion and a plurality of electrodes within the distal portion (apparatus 10 comprising a catheter 18 having a plurality of electrodes 46 at its distal tip in Fig. 1), the method comprising:
causing an electronic control unit (ECU) (power control system 12 in Fig. 1) to command a signal generator (power generator 26) to generate an excitation signal for delivery to the plurality of electrodes (col. 8, ln. 47-50: “The power 28 is input to the CAD 14 and to an electrocardiogram (ECG) filter system 36 contained within the power control system 12”; The operation of the power generator 26 is controlled by a controller 30 which outputs control signals 32 to the power generator 26; the power is supplied to the band electrodes 46 for ablation purposes and ECG monitoring and contact assessment);
causing the ECU to command a detection amplifier to measure electrical potentials at the plurality of electrodes (col. 8, ln. 37-41: power generator 26 outputs power output signal 28 to both ECG filter system 36 and contact assessment device 14; col. 8, ln. 40-50 & col. 12, ln. 8-16; col. 11, ln. 4-7 & col. 11, ln. 19-26: the power 28 passes through a temperature filter (“FL”) 104 and is sent to the PCS microprocessor 58 to filter out any RF noise present in the power 28 so that the it provides an ECG signal 38 that is free from the high frequency interference and the ECG signal is fed into the ECF filter system 36 and to an ECG amplifier as shown in Fig. 1);
determining, in the ECU, the contact state between the catheter and the tissue from the measured electrical potentials ls (col. 10, ln. 58-64: the power output signal 28 is monitored and provided to the PCS microprocessor 58 to determine the impedance at each of the electrodes 46 via the current and voltage monitor); and
outputting, from the ECU, an indication of the contact state between the catheter and the tissue (col. 17, ln. 18-28: the PCS microprocessor 58 analyzes the assessment impedance at each of the electrodes 46 and provides an indication of the state of the electrode/tissue contact and the indication may be provided on the front panel of the power control system through a display device).
In regards to claim 36, Sun further discloses wherein the indication of the contact state comprises one of an indication that the catheter is in contact with the tissue and an indication that the catheter is not in contact with the tissue (col. 17, ln. 18-40: the display device indicates a degree of confidence of electrode/tissue contact where a percentage of 5% indicates no tissue contact with the electrode; note that anything above 5% indicates tissue contact; therefore, when the threshold is 5%, there are two states: no contact and tissue contact).
In regards to claim 37, see the rejection of claim 22 above.
In regards to claim 38, see the rejection of claim 23 above.
In regards to claim 39, Sun further discloses determining, in the ECU, impedances at the plurality of electrodes from the measured electrical potentials at the plurality of electrodes, and wherein determining, in the ECU, the contact state between the catheter and the tissue comprises determining, in the ECU, the contact state between the catheter and the tissue from the impedances at the plurality of electrodes (col. 12, ln. 47-53: impedance can be measured between any pair of the electrodes 46 to assess the adequacy of electrode/tissue contact).
In regards to claim 40, Sun further discloses wherein the plurality of impedances comprises a plurality of bipolar impedances measured between pairs of electrodes of the plurality of electrodes (col. 12, ln. 47-53: impedance can be measured between any pair of the electrodes 46 to assess the adequacy of electrode/tissue contact).
Conclusion
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 5/22/2026
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