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 .
Response to Amendment
The Amendments filed January 15, 2026 has been entered. Currently, claims 4, 6-8 have been amended, claims 27-33 have been newly added, and claims 1, 3-4, 6-9, 22-33 are pending in the application.
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 32-33 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 32 recites the limitation "the current-injecting and voltage-sensing pairs are electrically distinct" in last two lines of page 6. There is insufficient antecedent basis for this limitation in the claim. Claim 33 is also rejected because they are dependent on claim 32. For examination purposes, Examiner will interpret the first external electrode of the plurality of external electrodes and the first catheter electrode as being the current-injecting pair of electrodes, and the second external electrode of the plurality of external electrodes, different from the first external electrode, and the second catheter electrode as being the voltage sensing pair of electrodes.
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, 3, 7-8, 22-28, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz (U.S. Application No. 20180125575 A1), in view of Panescu (U.S. Patent No. 5487391 A), and further in view of Cory (U.S. Application No. 20110082383 A1).
Regarding independent claim 1, Schwartz discloses a system (100) for monitoring tissue lesion development during a medical ablation process applied to a patient (pa. 0107 & Fig. 1B), the system comprising:
a catheter ablation device (111) having at least one catheter electrode (103) (pa. 0113, 0138);
the catheter ablation device connectable via an electrical feedline to a source of electrical energy (101A) and configured to apply ablation energy to ablate tissue in a target region (pa. 0107);
a plurality of external electrodes (105) for application to the body of the patient (pa. 0117, 0138);
measurement circuitry (120A, 120B, 101B) for determining an electrical impedance of a current path between the at least one catheter electrode and the external electrodes (pa. 0107, 0117, 0140); and
an electrical controller (120) arranged to control the application of an AC current source (pa. 0004, 0115) between different combinations of the catheter electrode and the plurality of external electrodes and to measure resulting voltages (i.e., the controller 120 is capable of receiving dielectric property data, such as impedance data, from catheter electrodes 103 and/or skin patch electrodes 105, by controlling the input of AC current supplied by the field generator 101A; pa. 0107, 0115-0117), the measurement of the resulting voltages providing a measure of impedance of different electrical paths through the body of the patient between the respective electrodes (pa. 0132-0138),
wherein the measurement circuitry is able to switch between different combinations of the at least one catheter electrode and the plurality of external electrodes under control of the electrical controller (pa. 0116, 0131-0138, 0140), wherein each of the different combinations comprises a pair of connected electrodes including one catheter electrode from the at least one catheter electrode and one external electrode from the plurality of external electrodes (pa. 0132-0137).
In further detail, Schwartz specifically discloses that in order to achieve accurate results of impedance measurements, they utilize numerous vector components (for example, measurements at multiple frequencies between different combinations of multiple catheter/skin patch electrode pairs using a vector formula (pa. 0137) which uses three elements: a set of frequencies, the set of catheter electrodes, and the set of skin electrodes (pa. 0132-0135) to extract strong correlations of lesion assessment.
At step 206 (pa. 0153 & Fig. 2), after applying fields of selected frequencies between the catheter electrodes and the skin electrodes, measurements of the field (for example by field measurer 101B, which is controlled by controller 120) comprise a characteristic signal at each frequency, and for each electrode selection, which is measured at block 208 to produce the set of impedance measurements Z(t). Later, these impedance measurements can be isolated in order to further understand the contributions of just the catheter electrodes or just the skin electrodes or both (pa. 0140-0142). Therefore, the device of Schwartz is able to supply current to the different sets of catheter/skin electrodes pairs and gather impedance information from either or both of the catheter/skin electrodes.
However, Schwartz does not disclose controlling the sequential application of the AC current between the different combinations of the least one catheter electrode and one external electrode via a measurement circuitry that includes a switch matrix comprising a plurality of switches.
Panescu, in the same field of endeavor, teaches a system for measuring impedance between a catheter electrode and one indifferent (e.g., external) electrode in a unipolar arrangement (Col. 4, lines 66-67 – Col. 5, lines 1-2; Col. 11, lines 19-22 & Fig. 1). The system comprises a plurality of adjacent catheter electrodes (E1-E7) electrically coupled to their own signal wires (W1 to W7), and one external electrode (EI) is electrically coupled to its own signal wire (WI) (Col. 9, lines 27-33 & Fig 11). The system further includes an interface (56) element electronically configured to a switching element (64) (i.e., a switch matrix) including an electronic switch (SM) and electronic switches (SE1 to SE7) that electrically couple a current generator (50) to the signal wires WI and W1 to W7 (Col. 9, lines 34-51). As seen in Fig. 12, when the setting switch SM in Position A, the interface configures the switching element for operation in the unipolar mode, and the interface electronically configures each individual electrode E1 to E7 to emit current by sequentially setting the associated switch SE1 to SE7. When the selected electrode E1 to E7 is so configured, it is electronically coupled to the supply of the current generator and emits current. The external electrode receives the current sequentially emitted by the selected catheter electrode E1 to E7 (Col. 10, lines 1-15).
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 interface and the switching element with its plurality of switches to the measurement circuitry of Schwartz for the purpose of providing a more efficient process that is able to render impedance measurements with high accuracy and/or repeatability.
However, Panescu only teaches the different combinations of electrodes being between at least one catheter electrode and only one external electrode, not between at least one catheter electrode and the plurality of external electrodes.
Cory, in the same field of endeavor, teaches a system and method for applying a waveform signal to tissue between two electrodes and measuring the electrical characteristics of the signal transmitted through the tissue (pa. 0143). The system comprises waveform electrodes (1), return electrodes (7). In one embodiment, there is a single, large, return electrode and a plurality of waveform electrodes 1 fashioned to form an array (pa. 0147 & Fig. 6) (this embodiment being analogous to the embodiment taught by Panescu). In a second embodiment, the waveform electrodes and return electrodes are both fashioned as electrode array assemblies (pa. 0149 & Fig. 8). In this embodiment, each electrode array is connected to a respective multiplexer circuit, wherein multiplexer circuit (52) is connected to the return electrode array (51) and multiplexer circuit (38) is connected to the waveform electrode array (18). The multiplexer circuit (38) may be an electronically controlled switch, a multiplexer, a gate array, or any suitable device that may be controlled by controller (16) to provide current waveforms or voltage waveforms from waveform generator (21) across selected, individual electrodes within the waveform electrode array assembly and one or more of the return electrodes in the return electrode array assembly (pa. 0151). The controller then calculates and stores information derived from the measured signal, e.g., impedance, resistance, reactance, admittance, conductance, and other electrical parameters based upon the plurality of different waveforms applied across the waveform electrodes and return electrodes (pa. 0154).
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 second embodiment of Cory, which includes an additional multiplexer circuit electrically connected to the plurality of return electrodes, into the system of Schwartz since it seems that either embodiment (single return electrode connected to a switch matrix vs a plurality of return electrodes connected to a switch matrix) would yield the same predictable results of allowing the system to determine/calculate impedance and other electrical parameters based on the waveforms applied across different combination of electrodes.
Regarding claim 3, Schwartz/Panescu/Cory combination discloses wherein the electrical controller is further configured to disconnect the catheter ablation device from the source of electrical energy or otherwise suspend said application of ablation energy during application of said AC current source (Schwartz, pa. 0217, 0233 & Figs. 2-3).
Regarding claim 7, Schwartz/Panescu combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, they do not disclose including multiple analogue-to-digital converters (ADC) for simultaneous measurement of different current paths.
Cory, in the same field of endeavor, teaches how sampling of signals across the electrodes may be continuous, intermittent or periodic. If continuous, it may be detected as a digital signal, e.g., via an analog-to-digital (A/D) converter that converts the received analog signal (e.g., voltage or current) into a digital value (pa. 0155).
Although Cory is silent/not explicit about having multiple A/D converters, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include more than one A/D converter for simultaneous measurement of different current paths into the system of Schwartz, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Furthermore, 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 multiple analogue-to-digital converters (ADC) for the purpose of converting raw analog signals into a usable digital form for simultaneous measurement of different current paths.
Regarding claim 8, Schwartz/Panescu/Cory combination discloses wherein the source of electrical energy is an RF generator (Schwartz, pa. 0169).
Regarding claim 22, Schwartz/Panescu/Cory combination discloses a logical unit (130) programmed to analyze the electrical impedance determined by the measurement circuitry to provide an estimate of a size of an ablation lesion in the tissue caused by the application of ablation energy by the catheter ablation device (Schwartz, pa. 0121, 0154 & Fig. 2).
Regarding claim 23, Schwartz/Panescu/Cory combination discloses wherein measuring the resulting voltages includes applying the AC current using one of the plurality of external electrodes (Schwartz, pa. 0107) and sequentially measuring voltage with the remaining external electrodes (Schwartz, pa. 0132-0138, 0140).
Regarding claim 24, Schwartz/Panescu/Cory combination discloses wherein the electrical controller is configured to, during an ablation process:
implement an initial setup phase (206, 208) including sequentially measuring an electrical impedance of each current path between the at least one catheter electrode and the plurality of external electrodes (Schwartz, pa. 0140, 0153) in order to select one or more current paths to use in monitoring tissue lesion development (Schwartz, pa. 0153 & Fig. 2). As described in paragraph 0140, multiple impedance measurements are acquired, such that the impedance Z(t) is a vector of measurements between the catheter electrode (c) and each pair of patch electrodes (p) (ci, (pi, . . . pm). At block 206, measurements of the field (by measurement circuitry 101B) comprise a characteristic signal at each frequency for each electrode selection, which is measured at block 208, to produce the set of impedance measurements Z(t) (pa. 0153). Hence, at least one, or all, current paths are monitored/selected for tissue lesion development;
implement an ablation phase (209), wherein in the ablation phase, RF energy is applied to the at least one catheter electrode to ablate the tissue to form a lesion (Schwartz, pa. 0157); and
implement a measurement phase (207, 209), wherein in the measurement phase the impedance of the selected one or more current paths is measured to monitor tissue lesion dimension (Schwartz, pa. 0159-0161, 0177).
Regarding claim 25, Schwartz/Panescu/Cory combination discloses wherein the system is configured to sequentially repeat the ablation phase and measurement phase until the lesion has reached a required size (Schwartz, pa. 0162, 0180-0181).
Regarding claim 26, Schwartz/Panescu/Cory combination discloses wherein the electrical controller is configured to select one or more current paths between the different combinations of pairs of connected electrodes to use in monitoring tissue lesion development based on the measure of impedance between the different combinations of the at least one catheter electrode and the plurality of external electrodes (Schwartz, pa. 0131-0138, 0140).
Regarding independent claim 27, Schwartz discloses a system (100) for monitoring tissue lesion development during a medical ablation process applied to a patient (pa. 0107 & Fig. 1B), the system comprising:
a catheter ablation device (111) having at least one catheter electrode (103) (pa. 0113, 0138);
the catheter ablation device connectable via an electrical feedline to a source of electrical energy (101A) and configured to apply ablation energy to ablate tissue in a target region (pa. 0107);
a plurality of external electrodes (105) for application to the body of the patient (pa. 0117, 0138);
an electrical controller (120) (pa. 0115);
measurement circuitry (120A, 120B, 101B) for determining an electrical impedance of a current path between the at least one catheter electrode and the external electrodes (pa. 0107, 0117, 0140-0141), the measurement circuitry configured to couple an AC current source (pa. 0004, 0115) to different combinations of the at least one catheter electrode and the plurality of external electrodes under control of the electrical controller (i.e., the controller 120 is capable of receiving dielectric property data, such as impedance data, from catheter electrodes 103 and/or skin patch electrodes 105, by controlling the input of AC current supplied by the field generator 101A; pa. 0107, 0115-0117), wherein each of the different combinations comprises a pair of connected electrodes including one catheter electrode from the at least one catheter electrode and one external electrode from the plurality of external electrodes (pa. 0132-0137, 0140);
wherein the electrical controller is configured to:
implement an initial setup phase (206, 208) in which the measurement circuitry is operated to sequentially couple the AC current source between the at least one catheter electrode and different ones of the plurality of external electrodes to measure the electrical impedance of each current path (pa. 0140, 0153), and, based on the measured impedances, select one or more current paths for subsequent monitoring (pa. 0153 & Fig. 2). As described in paragraph 0140, multiple impedance measurements are acquired, such that the impedance Z(t) is a vector of measurements between the catheter electrode (c) and each pair of patch electrodes (p) (ci, (pi, . . . pm). At block 206, measurements of the field (by measurement circuitry 101B) comprise a characteristic signal at each frequency for each electrode selection, which is measured at block 208, to produce the set of impedance measurements Z(t) (pa. 0153). Hence, at least one, or all, current paths are monitored/selected for tissue lesion development; and
thereafter, alternate between: (i) an ablation phase (209), in which ablation energy is delivered to the at least one catheter electrode to ablate tissue in the target region (pa. 0157), and (ii) a measurement phase (207, 209) (which is performed before during, and/or after the ablation of the target tissue, pa. 0228), in which the source of electrical energy is electrically disconnected from the catheter ablation device (at least in the step where the measurement step is performed before the ablation procedure) and the measurement circuitry is operated to measure impedance only along the selected one or more current paths to monitor tissue lesion development (pa. 0159-0161, 0177).
In further detail, Schwartz specifically discloses that in order to achieve accurate results of impedance measurements, they utilize numerous vector components (for example, measurements at multiple frequencies between different combinations of multiple catheter/skin patch electrode pairs using a vector formula (pa. 0137) which uses three elements: a set of frequencies, the set of catheter electrodes, and the set of skin electrodes (pa. 0132-0135) to extract strong correlations of lesion assessment.
At step 206 (pa. 0153 & Fig. 2), after applying fields of selected frequencies between the catheter electrodes and the skin electrodes, measurements of the field (for example by field measurer 101B, which is controlled by controller 120) comprise a characteristic signal at each frequency, and for each electrode selection, which is measured at block 208 to produce the set of impedance measurements Z(t). Later, these impedance measurements can be isolated in order to further understand the contributions of just the catheter electrodes or just the skin electrodes or both (pa. 0140-0142). Therefore, the device of Schwartz is able to supply current to the different sets of catheter/skin electrodes pairs and gather impedance information from either or both of the catheter/skin electrodes.
However, Schwartz does not disclose the measurement circuitry including a switch matrix comprising a plurality of switches, wherein the switch matrix is operated to sequentially couple the AC current source between the at least one catheter electrode and one external electrode.
Panescu, in the same field of endeavor, teaches a system for measuring impedance between a catheter electrode and one indifferent (e.g., external) electrode in a unipolar arrangement (Col. 4, lines 66-67 – Col. 5, lines 1-2; Col. 11, lines 19-22 & Fig. 1). The system comprises a plurality of adjacent catheter electrodes (E1-E7) electrically coupled to their own signal wires (W1 to W7), and one external electrode (EI) is electrically coupled to its own signal wire (WI) (Col. 9, lines 27-33 & Fig 11). The system further includes an interface (56) element electronically configured to a switching element (64) (i.e., a switch matrix) including an electronic switch (SM) and electronic switches (SE1 to SE7) that electrically couple a current generator (50) to the signal wires WI and W1 to W7 (Col. 9, lines 34-51). As seen in Fig. 12, when the setting switch SM in Position A, the interface configures the switching element for operation in the unipolar mode, and the interface electronically configures each individual electrode E1 to E7 to emit current by sequentially setting the associated switch SE1 to SE7. When the selected electrode E1 to E7 is so configured, it is electronically coupled to the supply of the current generator and emits current. The external electrode receives the current sequentially emitted by the selected catheter electrode E1 to E7 (Col. 10, lines 1-15).
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 interface and the switching element with its plurality of switches to the measurement circuitry of Schwartz for the purpose of providing a more efficient process that is able to render impedance measurements with high accuracy and/or repeatability.
However, Panescu only teaches the different combinations of electrodes being between at least one catheter electrode and only one external electrode, not between at least one catheter electrode and the plurality of external electrodes.
Cory, in the same field of endeavor, teaches a system and method for applying a waveform signal to tissue between two electrodes and measuring the electrical characteristics of the signal transmitted through the tissue (pa. 0143). The system comprises waveform electrodes (1), return electrodes (7). In one embodiment, there is a single, large, return electrode and a plurality of waveform electrodes 1 fashioned to form an array (pa. 0147 & Fig. 6) (this embodiment being analogous to the embodiment taught by Panescu). In a second embodiment, the waveform electrodes and return electrodes are both fashioned in electrode array assemblies (pa. 0149 & Fig. 8). In this embodiment, each electrode array is connected to a respective multiplexer circuit, wherein multiplexer circuit (52) is connected to the return electrode array (51) and multiplexer circuit (38) is connected to the waveform electrode array (18). The multiplexer circuit (38) may be an electronically controlled switch, a multiplexer, a gate array, or any suitable device that may be controlled by controller (16) to provide current waveforms or voltage waveforms from waveform generator (21) across selected, individual electrodes within the waveform electrode array assembly and one or more of the return electrodes in the return electrode array assembly (pa. 0151). The controller then calculates and stores information derived from the measured signal, e.g., impedance, resistance, reactance, admittance, conductance, and other electrical parameters based upon the plurality of different waveforms applied across the waveform electrodes and return electrodes (pa. 0154).
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 second embodiment of Cory, which includes an additional multiplexer circuit electrically connected to the plurality of return electrodes, into the system of Schwartz since it seems either embodiment (single return electrode connected to the switch matrix vs a plurality of return electrodes connected to the switch matrix) would yield the same predictable results of allowing the system to determine/calculate impedance and other electrical parameters based on the waveforms applied across different combination of electrodes.
Regarding claim 28, Schwartz/Cory combination discloses wherein the electrical controller is further configured to, during the initial setup phase, to connect the at least one catheter electrode with each of the selected one or more external electrodes, one at a time, such that impedance is measured individually for each pair comprising the at least one catheter electrode and a selected external electrode (Schwartz, pa. 0140).
However, they do not disclose the switch matrix being operated to sequentially couple the AC current source between the at least one catheter electrode with each of the selected one or more external electrodes.
Panescu, in the same field of endeavor, teaches a system for measuring impedance between a catheter electrode and one indifferent (e.g., external) electrode in a unipolar arrangement (Col. 4, lines 66-67 – Col. 5, lines 1-2; Col. 11, lines 19-22 & Fig. 1). The system comprises a plurality of adjacent catheter electrodes (E1-E7) electrically coupled to their own signal wires (W1 to W7), and one external electrode (EI) is electrically coupled to its own signal wire (WI) (Col. 9, lines 27-33 & Fig 11). The system further includes an interface (56) element electronically configured to a switching element (64) (i.e., a switch matrix) including an electronic switch (SM) and electronic switches (SE1 to SE7) that electrically couple a current generator (50) to the signal wires WI and W1 to W7 (Col. 9, lines 34-51). As seen in Fig. 12, when the setting switch SM in Position A, the interface configures the switching element for operation in the unipolar mode, and the interface electronically configures each individual electrode E1 to E7 to emit current by sequentially setting the associated switch SE1 to SE7. When the selected electrode E1 to E7 is so configured, it is electronically coupled to the supply of the current generator and emits current. The external electrode receives the current sequentially emitted by the selected catheter electrode E1 to E7 (Col. 10, lines 1-15).
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 interface and the switching element with its plurality of switches to the measurement circuitry of Schwartz for the purpose of providing a more efficient process that is able to render impedance measurements with high accuracy and/or repeatability.
Regarding claim 31, Schwartz/Panescu/Cory combination discloses wherein the controller is configured to sequentially repeat the ablation phase and measurement phase, using the selected one or more current paths, until the lesion has reached a required size (Schwartz, pa. 0185, 0198 & Fig. 3).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz, Panescu, and Cory, as applied to claim 1 above, and further in view of Panescu (U.S. Application No. 20150105765 A1), henceforth referred to as Panescu65.
Regarding claim 4, Schwartz/Panescu/Cory combination discloses the invention substantially as claimed in claims 1 and 3 and discussed above.
However, they do not disclose including a dummy resistive load for selective connection to the source of electrical energy during periods of operation of said measurement circuitry.
Panescu65, in the same field of endeavor, teaches including a dummy resistive load for selective connection to the source of electrical energy during periods of operation of said measurement circuitry (pa. 0085).
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 a dummy resistive load for the purpose of dissipating or absorbing excess energy supplied to the system to prevent system failure.
Claims 6 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz, Panescu, and Cory as applied to claims 1 and 27 above, and further in view of Fay (U.S. Application No. 20160242667 A1).
Regarding claim 6, Schwartz discloses the catheter ablation device comprises at least two catheter electrodes (pa. 0138), and the measurement circuitry is further configured to conduct electrical impedance sensing by applying current between one pair of external electrode and catheter electrode and measuring voltage between the same pair of electrodes (pa. 0138, 0140-0141).
Panescu teaches measuring impedance between a plurality of catheter electrodes and one indifferent (e.g., external) electrode in a unipolar arrangement (Col. 4, lines 66-67 – Col. 5, lines 1-2; Col. 11, lines 19-22 & Fig. 1) via a switching element (64) (i.e., a switch matrix) including an electronic switch (SM) and electronic switches (SE1 to SE7) that electrically couple a current generator (50) to the signal wires WI and W1 to W7 (Col. 9, lines 34-51).
Cory teaches multiple multiplexer circuits, wherein multiplexer circuit (52) is connected to the return electrode array (51) and multiplexer circuit (38) is connected to the waveform electrode array (18) (pa. 0149).
However, Schwartz/Panescu/Cory do not disclose a four-terminal electrical impedance sensing configuration.
Fay, in the same field of endeavor, teaches a four-terminal electrical impedance sensing configuration, such that the four-terminal sensing configuration drives current through a pair of “current-carrying” electrodes and measures the voltage across a different pair of “sensing” electrodes (pa. 0115, 0118).
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 four-terminal sensing because this useful configuration allows for simultaneous function of supplying current and sensing voltage, and eliminates lead/contact resistance errors by using separate pairs of wires for current injection and voltage sensing, ensuring precise measurement of low resistances.
Regarding claim 30, Schwartz discloses the measurement circuitry is configured to conduct impedance sensing, such that, for each impedance measurement, current is supplied between a pair of catheter electrode and external electrode, and voltage is sensed between the same pair of electrodes (pa. 0138, 0140-0141), with the controller selecting the electrode pairs for each measurement from among the selected one or more current paths (pa. 0121, 0140). Specifically, paragraph 0140 of Schwartz describes how multiple impedance measurements are acquired, such that the impedance Z(t) is a vector of measurements between any catheter electrode (c) and each pair of patch electrodes (p) (ci, (pi, . . . pm). At block 206, measurements of the field (by measurement circuitry 101B) comprise a characteristic signal at each frequency for each electrode selection, which is measured at block 208, to produce the set of impedance measurements Z(t) (pa. 0153). Hence, at least one, or all, current paths are monitored/selected by the controller for tissue lesion development.
Panescu teaches measuring impedance between a plurality of catheter electrodes and one indifferent (e.g., external) electrode in a unipolar arrangement (Col. 4, lines 66-67 – Col. 5, lines 1-2; Col. 11, lines 19-22 & Fig. 1) via a switching element (64) (i.e., a switch matrix) including an electronic switch (SM) and electronic switches (SE1 to SE7) that electrically couple a current generator (50) to the signal wires WI and W1 to W7 (Col. 9, lines 34-51).
Cory teaches multiple multiplexer circuits, wherein multiplexer circuit (52) is connected to the return electrode array (51) and multiplexer circuit (38) is connected to the waveform electrode array (18) (pa. 0149).
However, Schwartz/Panescu/Cory do not disclose a four-terminal impedance sensing configuration.
Fay, in the same field of endeavor, teaches a four-terminal electrical impedance sensing configuration, such that the four-terminal sensing configuration drives current through a pair of “current-carrying” electrodes and measures the voltage across a different pair of “sensing” electrodes (pa. 0115, 0118).
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 four-terminal sensing because this useful configuration allows for simultaneous function of supplying current and sensing voltage, and eliminates lead/contact resistance errors by using separate pairs of wires for current injection and voltage sensing, ensuring precise measurement of low resistances.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz, Panescu, and Cory as applied to claim 1 above, and further in view of Hauck (A.U. Application No. 2006292698 A1).
Regarding claim 9, Schwartz/Panescu/Cory combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, they do not disclose an external electrode dot harness for application across an external area of the patient's body.
Hauck, in the same field of endeavor, teaches wherein the plurality of external electrodes is provided as an electrode dot harness for application across an external area of the patient's body (pa. 0014 & Fig. 1).
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 external electrodes of Schwartz with a conventional ECG electrode system for the purpose of producing electrocardiograms used in graphing voltage versus time of the electrical activity of the heart and analyze the changes in the normal ECG pattern occurring in numerous cardiac abnormalities.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz (U.S. Application No. 20180125575 A1), in view of Panescu (U.S. Patent No. 5487391 A), in view of Cory (U.S. Application No. 20110082383 A1), and further in view of Fay (U.S. Application No. 20160242667 A1).
Regarding independent claim 32, Schwartz discloses a system (100) for monitoring tissue lesion development during a medical ablation process applied to a patient (pa. 0107 & Fig. 1B), the system comprising:
a catheter ablation device (111) having at least first and second catheter electrodes (103) (pa. 0113, 0138), the catheter ablation device connectable via an electrical feedline to a source of electrical energy (101A) and configured to apply ablation energy to ablate tissue in a target region (pa. 0107);
a plurality of external electrodes (105) for application to the body of the patient (pa. 0117, 0138);
measurement circuitry (120A, 120B, 101B) comprising a voltage sensing circuit (pa. 0107);
an electrical controller (120) (pa. 0115) configured to alternate between (i) an ablation phase (304), in which ablation energy is delivered to the at least one catheter electrodes to ablate tissue (pa. 0217, 0219), and (ii) a measurement phase (207, 209) (which is performed before, during, and/or after the ablation of the target tissue, pa. 0228), in which the source of electrical energy is electrically disconnected from the catheter ablation device (at least in the step where the measurement step is performed before the ablation procedure) and the impedance measurements are acquired (pa. 0159-0161, 0177);
wherein, during the measurement phase, the electrical controller is configured to perform impedance measurements by: (i) supplying an AC current (pa. 0004, 0115) between an external electrode and a catheter electrode (pa. 0107, 0115-0117), and (ii) sensing and recording a voltage between said electrode pair (pa. 0140).
Specifically, paragraph 0140 of Schwartz describes how multiple impedance measurements are acquired, such that the impedance Z(t) is a vector of measurements between any catheter electrode (c) and each pair of patch electrodes (p) (ci, (pi, . . . pm). At block 206, measurements of the field (by measurement circuitry 101B) comprise a characteristic signal at each frequency for each electrode selection, which is measured at block 208, to produce the set of impedance measurements Z(t) (pa. 0153).
In further detail, Schwartz specifically discloses that in order to achieve accurate results of impedance measurements, they utilize numerous vector components (for example, measurements at multiple frequencies between different combinations of multiple catheter/skin patch electrode pairs using a vector formula (pa. 0137) which uses three elements: a set of frequencies, the set of catheter electrodes, and the set of skin electrodes (pa. 0132-0135) to extract strong correlations of lesion assessment.
At step 206 (pa. 0153 & Fig. 2), after applying fields of selected frequencies between the catheter electrodes and the skin electrodes, measurements of the field (for example by field measurer 101B, which is controlled by controller 120) comprise a characteristic signal at each frequency, and for each electrode selection, which is measured at block 208 to produce the set of impedance measurements Z(t). Later, these impedance measurements can be isolated in order to further understand the contributions of just the catheter electrodes or just the skin electrodes or both (pa. 0140-0142). Therefore, the device of Schwartz is able to supply current to the different sets of catheter/skin electrodes pairs and gather impedance information from either or both of the catheter/skin electrodes.
However, Schwartz does not disclose a switch matrix having a plurality of switches, wherein the switch matrix is operated by the controller to sequentially couple the AC current source between the at least one catheter electrode and an external electrode.
Panescu, in the same field of endeavor, teaches a system for measuring impedance between a catheter electrode and one indifferent (e.g., external) electrode in a unipolar arrangement (Col. 4, lines 66-67 – Col. 5, lines 1-2; Col. 11, lines 19-22 & Fig. 1). The system comprises a plurality of adjacent catheter electrodes (E1-E7) electrically coupled to their own signal wires (W1 to W7), and one external electrode (EI) is electrically coupled to its own signal wire (WI) (Col. 9, lines 27-33 & Fig 11). The system further includes an interface (56) element electronically configured to a switching element (64) (i.e., a switch matrix) including an electronic switch (SM) and electronic switches (SE1 to SE7) that electrically couple a current generator (50) to the signal wires WI and W1 to W7 (Col. 9, lines 34-51). As seen in Fig. 12, when the setting switch SM in Position A, the interface configures the switching element for operation in the unipolar mode, and the interface electronically configures each individual electrode E1 to E7 to emit current by sequentially setting the associated switch SE1 to SE7. When the selected electrode E1 to E7 is so configured, it is electronically coupled to the supply of the current generator and emits current. The external electrode receives the current sequentially emitted by the selected catheter electrode E1 to E7 (Col. 10, lines 1-15).
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 interface and the switching element with its plurality of switches to the measurement circuitry of Schwartz for the purpose of providing a more efficient process that is able to render impedance measurements with high accuracy and/or repeatability.
However, Panescu only teaches the different combinations of electrodes being between at least one catheter electrode and only one external electrode, not between at least one catheter electrode and the plurality of external electrodes.
Cory, in the same field of endeavor, teaches a system and method for applying a waveform signal to tissue between two electrodes and measuring the electrical characteristics of the signal transmitted through the tissue (pa. 0143). The system comprises waveform electrodes (1), return electrodes (7). In one embodiment, there is a single, large, return electrode and a plurality of waveform electrodes 1 fashioned to form an array (pa. 0147 & Fig. 6) (this embodiment being analogous to the embodiment taught by Panescu). In a second embodiment, the waveform electrodes and return electrodes are both fashioned in electrode array assemblies (pa. 0149 & Fig. 8). In this embodiment, each electrode array is connected to a respective multiplexer circuit, wherein multiplexer circuit (52) is connected to the return electrode array (51) and multiplexer circuit (38) is connected to the waveform electrode array (18). The multiplexer circuit (38) may be an electronically controlled switch, a multiplexer, a gate array, or any suitable device that may be controlled by controller (16) to provide current waveforms or voltage waveforms from waveform generator (21) across selected, individual electrodes within the waveform electrode array assembly and one or more of the return electrodes in the return electrode array assembly (pa. 0151). The controller then calculates and stores information derived from the measured signal, e.g., impedance, resistance, reactance, admittance, conductance, and other electrical parameters based upon the plurality of different waveforms applied across the waveform electrodes and return electrodes (pa. 0154).
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 second embodiment of Cory, which includes an additional multiplexer circuit electrically connected to the plurality of return electrodes, into the system of Schwartz since it seems either embodiment (single return electrode connected to a switch matrix vs a plurality of return electrodes connected to a switch matrix) would yield the same predictable results of allowing the system to determine/calculate impedance and other electrical parameters based on the waveforms applied across different combination of electrodes.
However, Schwartz/Panescu/Cory combination do not teach wherein, during the measurement phase, the electrical controller is configured to sequentially perform four-terminal electrical impedance measurements by supplying an AC current between a selected electrode pair, and (ii) simultaneously sensing and recording a voltage between a selected second, different electrode pair, such that the current-injecting and voltage-sensing pairs are electrically distinct, and wherein four-terminal electrical impedance measurements are sequentially repeated for a plurality of different combinations of electrodes pairs so as to determine electrical impedance for different electrical paths through the body of the patient.
Fay, in the same field of endeavor, teaches a four-terminal electrical impedance sensing configuration, such that the four-terminal sensing configuration drives current through a pair of “current-carrying” electrodes and measures the voltage across a different pair of “sensing” electrodes, where different combinations of electrode pairs is contemplated and may be repeated (pa. 0115, 0118).
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 four-terminal sensing configuration to the measurement circuitry of Schwartz because this useful technique allows for simultaneous function of supplying current and sensing voltage, and eliminates lead/contact resistance errors by using separate pairs of wires for current injection and voltage sensing, ensuring precise measurement of low resistances.
Allowable Subject Matter
Claims 29 and 33 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject
matter: regarding claims 29 and 33, the Schwartz (U.S. Application No. 20180125575 A1), Panescu (U.S. Patent No. 5487391 A), Cory (U.S. Application No. 20110082383 A1), Fay (U.S. Application No. 20160242667 A1) references fail to teach the invention as a whole.
The Schwartz reference teaches a system (100) for monitoring tissue lesion development during a medical ablation process applied to a patient (pa. 0107 & Fig. 1B), the system comprising a catheter ablation device (111) having at least one catheter electrode (103) (pa. 0113, 0138), the catheter ablation device connectable via an electrical feedline to a source of electrical energy (101A) (pa. 0107), a plurality of external electrodes (105) (pa. 0117, 0138), a measurement circuitry (120A, 120B, 101B) for determining an electrical impedance of a current path between the at least one catheter electrode and the external electrodes (pa. 0107, 0117, 0140-0141), an electrical controller (120) arranged to control the application of an AC current source (pa. 0004, 0115) between different combinations of the catheter electrode and the plurality of external electrodes and to measure resulting voltages (i.e., the controller 120 is capable of receiving dielectric property data, such as impedance data, from catheter electrodes 103 and/or skin patch electrodes 105, by controlling the input of AC current supplied by the field generator 101A; pa. 0107, 0115-0117), the measurement of the resulting voltages providing a measure of impedance of different electrical paths through the body of the patient between the respective electrodes (pa. 0132-0138), wherein the measurement circuitry is able to switch between different combinations of the at least one catheter electrode and the plurality of external electrodes under control of the electrical controller (pa. 0116, 0131-1038), wherein each of the different combinations comprises a pair of connected electrodes including one catheter electrode from the at least one catheter electrode and one external electrode from the plurality of external electrodes (pa. 0132-0137). However, Schwartz does not teach wherein the electrical controller is further configured to, during the initial setup phase, select a subset of electrode pairs for impedance monitoring based on a criterion comprising the largest impedance change or highest sensitivity to local lesion formation, and to use only the selected subset for subsequent monitoring during the ablation process.
The Panescu reference teaches a system for measuring impedance between a catheter electrode and one indifferent (e.g., external) electrode in a unipolar arrangement (Col. 4, lines 66-67 – Col. 5, lines 1-2; Col. 11, lines 19-22 & Fig. 1). The system comprises a plurality of adjacent catheter electrodes (E1-E7) electrically coupled to their own signal wires (W1 to W7), and one external electrode (EI) is electrically coupled to its own signal wire (WI) (Col. 9, lines 27-33 & Fig 11). The system further includes an interface (56) element electronically configured to a switching element (64) (i.e., a switch matrix) including an electronic switch (SM) and electronic switches (SE1 to SE7) that electrically couple a current generator (50) to the signal wires WI and W1 to W7 (Col. 9, lines 34-51). As seen in Fig. 12, when the setting switch SM in Position A, the interface configures the switching element for operation in the unipolar mode, and the interface electronically configures each individual electrode E1 to E7 to emit current by sequentially setting the associated switch SE1 to SE7. When the selected electrode E1 to E7 is so configured, it is electronically coupled to the supply of the current generator and emits current. The external electrode receives the current sequentially emitted by the selected catheter electrode E1 to E7 (Col. 10, lines 1-15). However, Panescu does not teach wherein the electrical controller is further configured to, during the initial setup phase, select a subset of electrode pairs for impedance monitoring based on a criterion comprising the largest impedance change or highest sensitivity to local lesion formation, and to use only the selected subset for subsequent monitoring during the ablation process.
The Cory reference teaches a system and method for applying a waveform signal to tissue between two electrodes and measuring the electrical characteristics of the signal transmitted through the tissue (pa. 0143). The system comprises waveform electrodes (1), return electrodes (7). In one embodiment, there is a single, large, return electrode and a plurality of waveform electrodes 1 fashioned to form an array (pa. 0147 & Fig. 6) (this embodiment being analogous to the embodiment taught by Panescu). In a second embodiment, the waveform electrodes and return electrodes are both fashioned in electrode array assemblies (pa. 0149 & Fig. 8). In this embodiment, each electrode array is connected to a respective multiplexer circuit, wherein multiplexer circuit (52) is connected to the return electrode array (51) and multiplexer circuit (38) is connected to the waveform electrode array (18). The multiplexer circuit (38) may be an electronically controlled switch, a multiplexer, a gate array, or any suitable device that may be controlled by controller (16) to provide current waveforms or voltage waveforms from waveform generator (21) across selected, individual electrodes within the waveform electrode array assembly and one or more of the return electrodes in the return electrode array assembly (pa. 0151). The controller then calculates and stores information derived from the measured signal, e.g., impedance, resistance, reactance, admittance, conductance, and other electrical parameters based upon the plurality of different waveforms applied across the waveform electrodes and return electrodes (pa. 0154). However, Cory does not cure the deficiencies described above.
Fay teaches a four-terminal electrical impedance sensing configuration, such that the four-terminal sensing configuration drives current through a pair of “current-carrying” electrodes and measures the voltage across a different pair of “sensing” electrodes (pa. 0115, 0118). However, Fay is similarly deficient.
No other pertinent prior art references were found that would overcome the above deficiencies. Therefore, there is no motivation (either in these references or
elsewhere in the art) for making such specific and significant modifications thereto to
arrive at claims 29 and 33.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably
accompany the issue fee. Such submissions should be clearly labeled “Comments on
Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 01/15/2026 have been fully considered.
With regards to independent claim 1, Applicant argues that Examiner misinterpreted the teachings of the Panescu reference. Specifically, Applicant contends that Panescu is directed exclusively to a diagnostic probe system for cardiac mapping, not ablation, and that the previous Office Action asserted that Panescu teaches impedance measurement between an ablation electrode and an indifferent electrode. Examiner finds this argument to be persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above using a new interpretation of the Panescu reference.
The Schwartz reference is initially applied to disclose a catheter ablation device (111) having at least one catheter electrode (103) having dual ablating and sensing capabilities (pa. 00113) and a plurality of external electrodes (105) for application to the body of the patient (pa. 0117). Although the electrodes of the Panescu reference are not ablation electrodes, the reference is only being utilized to teach a sequential application of an AC current source between different combinations of the at least one catheter electrode and the plurality of external electrodes, as well as a switch matrix comprising a plurality of switches and configured to couple the AC current source to different combinations of the at least one catheter electrode and the plurality of external electrodes. The claim language is broad and not specify that the catheter electrode has to be an ablation electrode; therefore, the catheter electrode can be interpreted to be either an ablation or a sensing electrode. Regardless, such interpretation of the claim language is not necessary since the system of Schwartz reference is only modified to just include the interface and switching element with its plurality of switches of Panescu for the purpose of a more efficient process that renders impedance measurements with high accuracy and/or repeatability.
With regards to independent claim 1, Applicant argues that the technical problems addressed by Panescu, diagnostic mapping for arrhythmia, are distinct from the ablation lesion monitoring addressed by Schwartz and by the present application, and therefore the combination is based on impermissible hindsight. However, Examiner, respectfully, disagrees.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the Schwartz reference relates to systems and methods for planning, production, and/or assessment of tissue lesions. The RF ablation probe can be used for minimally invasive ablation procedures, for example, in the treatment of cardiac arrhythmia (pa. 0003-0004). Examiner argues that since the Schwartz reference provides methods of planning which include assessing the dielectric properties of tissue to allow the user to estimate in advance how to induce a lesion so that selected lesion properties are achieved (pa. 0186), and as mentioned before, the catheter electrodes of Schwartz have dual ablating and sensing modality, then it would have been obvious to combine both references as described above in order to arrive at the final product described in the claim language for the purpose of enhancing/ providing a more efficient process of impedance measuring.
Lastly, with regards to independent claim 1, Applicant argues that even if combined, the cited references cannot yield the claimed invention. Specifically, Applicant contends that while Schwartz discusses the use of multiple skin patch electrodes (e.g., see Fig. 13) and multiple catheter electrodes (see paras. [0108], [0109]), Panescu, by contrast, discloses only a single external ("indifferent") electrode, which serves as a fixed reference and is neither switched nor selected by the controller or switching element. Examiner finds this argument to be persuasive and therefore the rejection has been withdrawn. However, upon further consideration, the following
new grounds of rejection have been set forth in the action above:
Claims 1, 3, 7-8, 22-28, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz (U.S. Application No. 20180125575 A1), in view of Panescu (U.S. Patent No. 5487391 A), and further in view of Cory (U.S. Application No. 20110082383 A1).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz, Panescu, and Cory, as applied to claim 1 above, and further in view of Panescu (U.S. Application No. 20150105765 A1), henceforth referred to as Panescu65.
Claims 6 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz, Panescu, and Cory as applied to claims 1 and 27 above, and further in view of Fay (U.S. Application No. 20160242667 A1).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz, Panescu, and Cory as applied to claim 1 above, and further in view of Hauck (A.U. Application No. 2006292698 A1).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Schwartz (U.S. Application No. 20180125575 A1), in view of Panescu (U.S. Patent No. 5487391 A), in view of Cory (U.S. Application No. 20110082383 A1), and further in view of Fay (U.S. Application No. 20160242667 A1).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasoning set forth in the action above.
With regards to the additional comments on the selected dependent claims, Applicant argues that claim 6 is directed to a four-terminal electrical impedance sensing approach, using a circuit involving a first and second catheter electrode and a first and second external electrode, and that Fay simply uses four-terminal approach on four electrodes, all of which are provided on a mapping or diagnostic catheter. Furthermore, Applicant contends that implementing such a configuration described in the claim language in the ablation monitoring context of Schwartz would require substantial redesign of the hardware, switching logic, and clinical workflow, none of which is taught, suggested, or motivated by the cited art. Examiner finds these arguments to be partially persuasive.
While Examiner concedes that the previous combination of references of Schwartz, Panescu, and Fay were not sufficient to teach all the features of the claim, specifically wherein the measurement circuitry being configured to conduct a four-terminal electrical impedance sensing, since this function/technique is only possible by utilizing a switch matrix comprising a plurality of switches that is configured to provide different combinations of catheter electrodes and external electrodes.
Therefore, in new rejection set-forth above, the Schwartz reference is used to disclose the catheter ablation device comprising at least two catheter electrodes (pa. 0138), and the measurement circuitry being configured to conduct electrical impedance sensing by applying current between one pair of external electrode and catheter electrode and measuring voltage between the same pair of electrodes (pa. 0138, 0140-0141). The Panescu reference then teaches a method of measuring impedance between a plurality of catheter electrodes and one indifferent (e.g., external) electrode in a unipolar arrangement (Col. 4, lines 66-67 – Col. 5, lines 1-2; Col. 11, lines 19-22 & Fig. 1) using a switching element (64) (i.e., a switch matrix) including an electronic switch (SM) and electronic switches (SE1 to SE7) that electrically couple a current generator (50) to the signal wires WI and W1 to W7 (Col. 9, lines 34-51). The Cory reference is then utilized ameliorate the fact that the Panescu reference does not teach the different combinations of electrodes being between at least one catheter electrode and a plurality of external electrodes. Therefore, Cory is used to teach a multiplexer circuit (52) that is connected to a return electrode array (51) and a multiplexer circuit (38) that is connected to a waveform electrode array (18) (pa. 0149). Finally, the Fay references is used to teach a four-terminal electrical impedance sensing configuration, such that the four-terminal sensing configuration drives current through a pair of “current-carrying” electrodes and measures the voltage across a different pair of “sensing” electrodes (pa. 0115, 0118). Therefore, by incorporating the four-terminal sensing system of Fay into the measuring circuitry of the Schwartz reference, this allows for simultaneous function of supplying current and sensing voltage, and ensures precise measurement of low resistances.
Lastly, in response to applicant's argument that implementing such a configuration described in the claim language in the ablation monitoring context of Schwartz would require substantial redesign of the hardware, switching logic, and clinical workflow, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, based on the reasonings and new combination of references set-forth above, the claim is rejected.
With regards to the additional comments on the selected dependent claims, Applicant argues that in claim 24 neither the combination of Schwartz and Panescu teach a selection made, in an initial setup phase, of "the one or more current paths to use in monitoring tissue lesion development". Furthermore, Applicant argues that in claim 25 the Schwartz reference does not teach multiple iterations between the ablation phase and the measurement phase using the selected one or more current paths. However, Examiner disagrees.
Schwartz teaches that during the initial setup phase, multiple impedance measurements are acquired, such that the impedance Z(t) is a vector of measurements between the catheter electrode (c) and each pair of patch electrodes (p) (ci, (pi, . . . pm). At block 206, measurements of the field (by measurement circuitry 101B) comprise a characteristic signal at each frequency for each electrode selection, which is measured at block 208, to produce the set of impedance measurements Z(t) (pa. 0153). Hence, at least one, or all, current paths are being monitored/selected by the system of Schwartz for tissue lesion development. The claim language is broad and only requires the selection of one or more current paths, and does not specify any selection criteria comprising the largest diameter change or highest sensitivity to local lesion formation as detailed in claims 29 and 33. Furthermore, for claim 25 there is nothing in the Schwartz reference which prevents the system from performing multiple iterations between the ablation phase and the measurement phase. Therefore, the rejection is maintained.
Conclusion
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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