DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s Amendment filed February 12, 2026 (hereinafter “02/12/26 Amendment") has been entered, and fully considered. In the 02/12/26 Amendment, claims 1-3, 5, 9, 11, 12, 14, & 16 were amended, claims 8, 10, 13, & 20 were cancelled, and claims 21 & 22 were newly added. Therefore, claims 1-7, 9, 11, 12, 14-19, 21, & 22 are now pending in the application.
3. The 02/12/26 Amendment has overcome the claim objections, and the rejections under §§ 112(b), 102, & 103 previously set forth in the Non-Final Office Action mailed 11/12/25 (“11/12/25 Action”).
4. A new claim objection, and new rejections under § 103 are set forth herein, necessitated by Applicant’s Amendment.
5. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
Claim Objections
6. Claim 22 is objected to because of the following informalities:
In claim 22, line 1, the recitation of “wherein the ECU reviews measured impedances” should instead recite --wherein the ECU is configured to review measured impedances--.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
7. 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.
8. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
9. Claims 1-7, 9, 11, 12, 14-19, 21, & 22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2016/0287136 to Condie et al. (“Condie”) in view of U.S. Patent Application Publication No. 2018/0214195 to Fraasch et al. ("Fraasch").
10. Regarding claim 1, Condie teaches a method of measuring impedance [¶¶ [0072]-[0075]] for a plurality of electrodes [one or more electrodes (24) - ¶¶ [0037], [0070]; FIGS. 2A, 2B, 8] on an intracardiac [e.g., ¶¶[0068]-[0070]] medical device [ablation catheter (12) - ¶¶ [0036], [0037], [0070]; FIGS. 2A, 2B, 8], the method comprising:
applying a first drive signal [FIG. 8] between a first electrode [electrode E1 - ¶[0072]] and a second electrode [electrode E2 - ¶[0072]] of the plurality of electrodes to measure a first impedance value [¶¶ [0072]-[0075]] between the first and second electrodes [E1, E2];
applying a second drive signal [FIG. 8] between the second electrode [electrode E2 - ¶[0072]] of the plurality of electrodes and a third electrode [electrode E3 - ¶[0072]] to measure a second impedance value [¶¶ [0072]-[0075]] between the second and third electrodes [E2, E3];
applying a third drive signal [FIG. 8] between the third electrode [electrode E3 - ¶[0072]] and a fourth electrode [see ¶[0072] (“As shown in FIG. 8, a catheter 12 may include N electrodes (depicted as E1, E2, E3 . . . EN). Bipolar impedance Zb, n may exist between electrodes E1 and E2, bipolar impedance Zb, n+1 may exist between electrodes E2 and E3, bipolar impedance Zb, N-1 may exist between electrode EN and the next lowest numbered electrode (depending on how many electrodes 24 are included on the catheter 12”)] of the plurality of electrodes to measure a third impedance value between the third and fourth electrodes [¶[0072]], wherein each drive signal of the first, second and third drive signals is applied by a separate signal generator [clearly shown in FIG. 8].
FAULTY ELECTRODE OR FAULTY CIRCUIT
While Condie teaches that the device, system, and method may also generally be used to provide intracardiac multi-frequency, multi-electrode impedance measurements for other purposes [see ¶[0068]], Condie does not teach that the method is for detecting a faulty electrode or a faulty circuit, and therefore fails to teach the following claim limitations:
detecting a faulty electrode or a faulty circuit in the plurality of electrodes based on the measured impedance values, wherein detecting a faulty electrode or a faulty circuit comprises detecting an open circuit for an electrode pair when a measured impedance of the electrode pair is more than a predetermined maximum threshold.
Fraasch, in a similar field of endeavor, teaches a system and method for the safe delivery of treatment energy to a patient, which includes verification of device and/or system integrity before, during, or after the delivery of treatment energy [e.g., ¶[0009]].
More particularly, Fraasch teaches a medical device (12) that may be coupled directly to an energy supply, such as a pulsed electric field or radiofrequency (RF) generator (14) including an energy control, delivering, and monitoring system, or indirectly through a catheter electrode distribution system (16) (CEDS). The CEDS (16) may include an impedance meter (18) for testing the integrity of the energy delivery pathway [¶[0061]]. Medical device (12) may be a treatment and mapping device, such as a catheter that is deliverable through a patient's vasculature to a tissue region for diagnosis or treatment [¶[0062]]. Device (12) may include a treatment element (34) that includes a carrier element (36) bearing a plurality of electrodes (38) which may also perform diagnostic functions, such as collection of intracardiac electrograms (EGM) and/or monophasic action potentials (MAPs) as well as performing selective pacing of intracardiac sites for diagnostic purposes [¶¶ [0063]-[0064]; FIG. 1].
Fraasch further teaches the use of device integrity checks, based on impedance measured between electrode pairs falling outside a threshold impedance range (above a maximum or below a minimum), to determine whether a fault condition exists [see, e.g., ¶[0022] (“recording an impedance measurement from each of the plurality of electrodes and determining a pre-check fault condition exists if at least one of: at least one of the recorded impedance measurements is outside a threshold impedance range; and a bipolar impedance between adjacent electrodes of the plurality of electrodes is outside a threshold bipolar impedance range”); ¶[0079] (“Impedance may be measured at each electrode 38 and the generator 14 may prevent the delivery of treatment energy to the device 12 is the measured impedance at a frequency between 4 khz and 100 khz from any electrode to patient ground is outside a predetermined impedance value range of, for example, 50-500 Ohms, and/or if the bipolar impedance between any adjacent electrodes is outside a predetermined impedance value range of, for example, 40-300 Ohms difference in bipolar impedance between different pairs”)].
Fraasch teaches detecting a faulty circuit in the plurality of electrodes based on the measured impedance values, wherein detecting a faulty circuit comprises detecting an open circuit for an electrode pair when a measured impedance of the electrode pair is more than a predetermined maximum threshold [e.g., ¶[0093] (“…the system measures the impedance between two adjacent device electrodes 38. If the device 12 or its cable are damaged, the test will resolve a very high (in the case of open conductors) or very low (in the case of shorted conductors) impedance… If the test resolves an impedance outside a range of possible tissue impedance values, it will trigger a fault state”); see also ¶[0092]].
Fraasch teaches that such checks may be performed continuously or at varying times before, during, and after the treatment energy delivery [e.g., Abstract; ¶[0077], and that delivery of treatment energy may be terminated upon determination of the existence of a fault condition [e.g., Abstract, ¶¶ [0010], [0056]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Condie to include the operation of detecting a faulty circuit in the plurality of electrodes based on the measured impedance values, wherein detecting a faulty circuit comprises detecting an open circuit for an electrode pair when a measured impedance of the electrode pair is more than a predetermined maximum threshold, since such a modification would provide the benefit/advantage of ensuring patient safety by effecting a rapid termination of the delivery of potentially harmful energy to the patient when a fault condition in the device and/or system is identified, as explicitly taught by Fraasch [e.g., ¶[0009]].
11. Regarding claim 2, the combination of Condie and Fraasch teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Condie further teaches applying additional drive signals between additional pairs of electrodes of the plurality of electrodes, wherein each electrode in the additional pairs of electrodes is connected to two drive signals [¶¶ [0072]-[0075]; FIG. 8].
12. Regarding claim 3, the combination of Condie and Fraasch teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Condie further teaches wherein 'N' is equal to a total number of the plurality of electrodes on the medical device, and an Nth drive signal is applied between the first electrode and the Nth electrode [see ¶[0072] (“Finally, bipolar impedance Zb,N may exist between electrodes EN and E1”)].
13. Regarding claim 4, the combination of Condie and Fraasch teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Condie further teaches wherein the medical device is a catheter [ablation catheter (12) - ¶¶ [0036], [0037], [0070]; FIGS. 2A, 2B] having a plurality of splines [carrier arms (30) - ¶[0039]; FIGS. 2A, 2B], and the plurality of electrodes [(24)] are arranged on the splines [¶[0040]; FIGS. 2A, 2B].
14. Regarding claim 5, the combination of Condie and Fraasch teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Condie further teaches wherein each spline [(30)] of the plurality of splines includes one or more of the plurality of electrodes [¶¶ [0039], [0040]; FIGS. 2A, 2B].
15. Regarding claim 6, the combination of Condie and Fraasch teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Condie further teaches wherein the first electrode is located on a first spline of the plurality of splines, the second electrode is located on a second spline of the plurality of splines, the third electrode is located on a third spline of the plurality of splines, and the fourth electrode is located on a fourth spline of the plurality of splines [Condie discloses that each carrier arm (30) may have one or more electrodes (24) thereon - ¶¶ [0039]-[0040]].
16. Regarding claim 7, the combination of Condie and Fraasch teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Condie further teaches wherein each drive signal of the first, second and third drive signals is applied at a different frequency [as broadly as claimed, impedance measurements for each electrode pair may be acquired at a first, low frequency and a second, high frequency - e.g., ¶¶ [0044], [0068]].
17. Regarding claim 9, the combination of Condie and Fraasch teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Fraasch further teaches wherein detecting a faulty electrode or a faulty circuit comprises detecting a short circuit for an electrode pair when a measured impedance of the electrode pair is less than a predetermined minimum threshold [e.g., ¶[0093] (“…the system measures the impedance between two adjacent device electrodes 38. If the device 12 or its cable are damaged, the test will resolve a very high (in the case of open conductors) or very low (in the case of shorted conductors) impedance… If the test resolves an impedance outside a range of possible tissue impedance values, it will trigger a fault state”); see also ¶[0092]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Condie and Fraasch such that the operation of detecting a faulty circuit comprises detecting a short circuit for an electrode pair when a measured impedance of the electrode pair is less than a predetermined minimum threshold, since such a modification would provide the benefit/advantage of ensuring patient safety by effecting a rapid termination of the delivery of potentially harmful energy to the patient when a fault condition in the device and/or system is identified, as explicitly taught by Fraasch [e.g., ¶[0009]].
18. Regarding claim 11, Condie teaches a method… for an intracardiac [e.g., ¶¶[0068]-[0070]] medical device [ablation catheter (12) - ¶¶ [0036], [0037], [0070]; FIGS. 2A, 2B, 8] having a plurality of electrodes on a distal end of the intracardiac medical device [one or more electrodes (24) - ¶¶ [0037], [0070]; FIGS. 2A, 2B, 8], the method comprising:
applying a first drive signal [FIG. 8] between a first pair of adjacent electrodes in the plurality of electrodes [electrodes E1, E2 - ¶[0072]];
applying a second drive signal [FIG. 8] between a second pair of adjacent electrodes in the plurality of electrodes [electrodes E2, E3 - ¶[0072]], the first and second pair of adjacent electrodes including a common electrode [electrode E2 is the “common electrode” - ¶[0072]];
applying additional drive signals [FIG. 8] between additional pairs of adjacent electrodes in the plurality of electrodes [see ¶[0072] (“As shown in FIG. 8, a catheter 12 may include N electrodes (depicted as E1, E2, E3 . . . EN). Bipolar impedance Zb, n may exist between electrodes E1 and E2, bipolar impedance Zb, n+1 may exist between electrodes E2 and E3, bipolar impedance Zb, N-1 may exist between electrode EN and the next lowest numbered electrode (depending on how many electrodes 24 are included on the catheter 12”)]; [and]
measuring an impedance for each pair of adjacent electrodes [¶¶ [0072]-[0075]].
FAULTY ELECTRODE OR FAULTY CIRCUIT
While Condie teaches that the device, system, and method may also generally be used to provide intracardiac multi-frequency, multi-electrode impedance measurements for other purposes [see ¶[0068]], Condie does not teach that the method is for detecting a faulty electrode or a faulty circuit, and therefore fails to teach the following emphasized claim limitations:
A method of detecting a faulty electrode or a faulty circuit for an intracardiac medical device having a plurality of electrodes on a distal end of the intracardiac medical device;
utilizing the measured impedances to detect a faulty electrode or a faulty circuit in the plurality of electrodes, including:
detecting an open circuit for an electrode pair when a measured impedance of the electrode pair is more than a predetermined maximum threshold.
Fraasch, in a similar field of endeavor, teaches a system and method for the safe delivery of treatment energy to a patient, which includes verification of device and/or system integrity before, during, or after the delivery of treatment energy [e.g., ¶[0009]].
More particularly, Fraasch teaches a medical device (12) that may be coupled directly to an energy supply, such as a pulsed electric field or radiofrequency (RF) generator (14) including an energy control, delivering, and monitoring system, or indirectly through a catheter electrode distribution system (16) (CEDS). The CEDS (16) may include an impedance meter (18) for testing the integrity of the energy delivery pathway [¶[0061]]. Medical device (12) may be a treatment and mapping device, such as a catheter that is deliverable through a patient's vasculature to a tissue region for diagnosis or treatment [¶[0062]]. Device (12) may include a treatment element (34) that includes a carrier element (36) bearing a plurality of electrodes (38) which may also perform diagnostic functions, such as collection of intracardiac electrograms (EGM) and/or monophasic action potentials (MAPs) as well as performing selective pacing of intracardiac sites for diagnostic purposes [¶¶ [0063]-[0064]; FIG. 1].
Fraasch further teaches the use of device integrity checks, based on impedance measured between electrode pairs falling outside a threshold impedance range (above a maximum or below a minimum), to determine whether a fault condition exists [see, e.g., ¶[0022] (“recording an impedance measurement from each of the plurality of electrodes and determining a pre-check fault condition exists if at least one of: at least one of the recorded impedance measurements is outside a threshold impedance range; and a bipolar impedance between adjacent electrodes of the plurality of electrodes is outside a threshold bipolar impedance range”); ¶[0079] (“Impedance may be measured at each electrode 38 and the generator 14 may prevent the delivery of treatment energy to the device 12 is the measured impedance at a frequency between 4 khz and 100 khz from any electrode to patient ground is outside a predetermined impedance value range of, for example, 50-500 Ohms, and/or if the bipolar impedance between any adjacent electrodes is outside a predetermined impedance value range of, for example, 40-300 Ohms difference in bipolar impedance between different pairs”)].
Fraasch teaches a method of detecting a faulty circuit for an intracardiac medical device comprising utilizing the measured impedances to detect a faulty circuit in the plurality of electrodes, including detecting an open circuit for an electrode pair when a measured impedance of the electrode pair is more than a predetermined maximum threshold [e.g., ¶[0093] (“…the system measures the impedance between two adjacent device electrodes 38. If the device 12 or its cable are damaged, the test will resolve a very high (in the case of open conductors) or very low (in the case of shorted conductors) impedance… If the test resolves an impedance outside a range of possible tissue impedance values, it will trigger a fault state”); see also ¶[0092]].
Fraasch teaches that such checks may be performed continuously or at varying times before, during, and after the treatment energy delivery [e.g., Abstract; ¶[0077], and that delivery of treatment energy may be terminated upon determination of the existence of a fault condition [e.g., Abstract, ¶¶ [0010], [0056]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Condie to include a method of detecting a faulty circuit for an intracardiac medical device comprising utilizing the measured impedances to detect a faulty circuit in the plurality of electrodes, including detecting an open circuit for an electrode pair when a measured impedance of the electrode pair is more than a predetermined maximum threshold, since such a modification would provide the benefit/advantage of ensuring patient safety by effecting a rapid termination of the delivery of potentially harmful energy to the patient when a fault condition in the device and/or system is identified, as explicitly taught by Fraasch [e.g., ¶[0009]].
19. Regarding claim 12, the combination of Condie and Fraasch teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Fraasch further teaches wherein utilizing the measured impedances to detect a faulty electrode or a faulty circuit comprises detecting a short circuit for an electrode pair when a measured impedance of the electrode pair is less than a predetermined minimum threshold [e.g., ¶[0093] (“…the system measures the impedance between two adjacent device electrodes 38. If the device 12 or its cable are damaged, the test will resolve a very high (in the case of open conductors) or very low (in the case of shorted conductors) impedance… If the test resolves an impedance outside a range of possible tissue impedance values, it will trigger a fault state”); see also ¶[0092]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Condie and Fraasch such that the operation of detecting a faulty circuit comprises detecting a short circuit for an electrode pair when a measured impedance of the electrode pair is less than a predetermined minimum threshold, since such a modification would provide the benefit/advantage of ensuring patient safety by effecting a rapid termination of the delivery of potentially harmful energy to the patient when a fault condition in the device and/or system is identified, as explicitly taught by Fraasch [e.g., ¶[0009]].
20. Regarding claim 14, the combination of Condie and Fraasch teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
As noted above (in the rejection of claim 11), Fraasch teaches reviewing (analyzing) measured impedances of adjacent pairs of electrodes to identify an open circuit for an electrode pair [e.g., ¶¶ [0022], [0079], [0093]].
Fraasch further teaches an embodiment wherein impedance measurements for an individual electrode may be acquired and used to indicate an open circuit or short circuit [e.g., ¶[0092]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Condie and Fraasch such that, upon reviewing (analyzing) measured impedances of adjacent pairs of electrodes to identify an electrode pair with an open circuit, an impedance measurement for each electrode of the identified electrode pair is then effectuated to determine which electrode of the electrode pair has the open circuit, since such a modification would provide the benefit/advantage of improving the efficiency, accuracy, and overall safety of a procedure by enabling a user (e.g., practitioner) to quickly identify and repair/replace the individual electrode responsible for the fault condition.
21. Regarding claim 15, the combination of Condie and Fraasch teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Fraasch further teaches generating a notification of whether a faulty electrode or a faulty circuit was detected in the utilizing step [Fraasch teaches that the system may alert a user of a potential system and/or device integrity issue - see ¶[0097]; note also ¶¶ [0065], [0079], [0083] concerning notifying a user of fault conditions].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Condie and Fraasch to include generating a notification of whether a faulty circuit was detected in the utilizing step, since such a modification would provide the benefit/advantage allowing a user (e.g., a practitioner) to then take quick, corrective action to address the faulty electrode/circuit rather than attempting to blindly troubleshoot an inoperative (or malfunctioning) energy delivery system which could result in an unduly lengthened treatment procedure.
22. Regarding claim 16, Condie teaches a system for use with an intracardiac [e.g., ¶¶[0068]-[0070]] medical device configured for insertion within a vasculature [¶[0068]] of a patient [ablation catheter (12) - ¶¶ [0036], [0037], [0070]; FIGS. 2A, 2B, 8] and having a plurality of electrodes on a distal end of the medical device one or more electrodes (24) - ¶¶ [0037], [0070]; FIGS. 2A, 2B, 8], the system comprising:
a plurality of measurement circuits [FIG. 8], each measurement circuit configured to apply a drive signal to a pair of electrodes among the plurality of electrodes and measure a response for the pair of electrodes associated with the drive signal [e.g., ¶[0072] (“As shown in FIG. 8, a catheter 12 may include N electrodes (depicted as E1, E2, E3 . . . EN). Bipolar impedance Zb, n may exist between electrodes E1 and E2, bipolar impedance Zb, n+1 may exist between electrodes E2 and E3, bipolar impedance Zb, N-1 may exist between electrode EN and the next lowest numbered electrode (depending on how many electrodes 24 are included on the catheter 12”)]; and
an electronic control unit (ECU) configured to generate an impedance value for the pair of electrodes connected to each of the measurement circuits based on the measured response [console (14) including, inter alia, one or more processors (58) - e.g., ¶¶ [0041], [0044]], [and]
wherein one or more of the electrodes in the plurality of electrodes is part of two measurement circuits such that adjacent measurement circuits have a common electrode [e.g., ¶[0072]; note that E2 is the “common electrode” between pairs E1-E2 and E2-E3].,
OPEN CIRCUIT DETECTION
While Condie teaches that the device, system, and method may also generally be used to provide intracardiac multi-frequency, multi-electrode impedance measurements for other purposes [see ¶[0068]], Condie does not teach:
wherein the ECU comprises an open circuit module configured for detecting an open circuit for an electrode in the plurality of electrodes based on the impedance value generated for each of the pairs of electrodes.
Fraasch, in a similar field of endeavor, teaches a system and method for the safe delivery of treatment energy to a patient, which includes verification of device and/or system integrity before, during, or after the delivery of treatment energy [e.g., ¶[0009]].
More particularly, Fraasch teaches a medical device (12) that may be coupled directly to an energy supply, such as a pulsed electric field or radiofrequency (RF) generator (14) including an energy control, delivering, and monitoring system, or indirectly through a catheter electrode distribution system (16) (CEDS). The CEDS (16) may include an impedance meter (18) for testing the integrity of the energy delivery pathway [¶[0061]]. Medical device (12) may be a treatment and mapping device, such as a catheter that is deliverable through a patient's vasculature to a tissue region for diagnosis or treatment [¶[0062]]. Device (12) may include a treatment element (34) that includes a carrier element (36) bearing a plurality of electrodes (38) which may also perform diagnostic functions, such as collection of intracardiac electrograms (EGM) and/or monophasic action potentials (MAPs) as well as performing selective pacing of intracardiac sites for diagnostic purposes [¶¶ [0063]-[0064]; FIG. 1].
Fraasch further teaches the use of device integrity checks, based on impedance measured between electrode pairs falling outside a threshold impedance range (above a maximum or below a minimum), to determine whether a fault condition exists [see, e.g., ¶[0022] (“recording an impedance measurement from each of the plurality of electrodes and determining a pre-check fault condition exists if at least one of: at least one of the recorded impedance measurements is outside a threshold impedance range; and a bipolar impedance between adjacent electrodes of the plurality of electrodes is outside a threshold bipolar impedance range”); ¶[0079] (“Impedance may be measured at each electrode 38 and the generator 14 may prevent the delivery of treatment energy to the device 12 is the measured impedance at a frequency between 4 khz and 100 khz from any electrode to patient ground is outside a predetermined impedance value range of, for example, 50-500 Ohms, and/or if the bipolar impedance between any adjacent electrodes is outside a predetermined impedance value range of, for example, 40-300 Ohms difference in bipolar impedance between different pairs”)].
Fraasch teaches an ECU [generator (14) including processing circuitry (44) including a processor and memory - ¶¶ [0010], [0067]; FIG. 1], comprising an open circuit module [¶¶ [0067], [0093]] configured for detecting an open circuit for an electrode in the plurality of electrodes based on the impedance value generated for each of the pairs of electrodes [e.g., ¶[0093] (“…the system measures the impedance between two adjacent device electrodes 38. If the device 12 or its cable are damaged, the test will resolve a very high (in the case of open conductors) or very low (in the case of shorted conductors) impedance… If the test resolves an impedance outside a range of possible tissue impedance values, it will trigger a fault state”); see also ¶[0092]].
Fraasch teaches that such checks may be performed continuously or at varying times before, during, and after the treatment energy delivery [e.g., Abstract; ¶[0077], and that delivery of treatment energy may be terminated upon determination of the existence of a fault condition [e.g., Abstract, ¶¶ [0010], [0056]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Condie such that the ECU comprises an open circuit module configured for detecting an open circuit for an electrode in the plurality of electrodes based on the impedance value generated for each of the pairs of electrodes, since such a modification would provide the benefit/advantage of ensuring patient safety by effecting a rapid termination of the delivery of potentially harmful energy to the patient when a fault condition in the device and/or system is identified, as explicitly taught by Fraasch [e.g., ¶[0009]].
23. Regarding claim 17, the combination of Condie and Fraasch teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Condie further teaches wherein all electrodes in the plurality of electrodes are part of two measurement circuits [¶¶ [0072]-[0075]; FIG. 8].
24. Regarding claim 18, the combination of Condie and Fraasch teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Fraasch further teaches wherein the ECU is configured for detecting at least one of a faulty electrode in the plurality of electrodes [Fraasch teaches an embodiment wherein the ECU is configured to detect a faulty electrode based on an impedance measurement for each electrode - ¶¶ [0022], [0092]] and a faulty pairing in the plurality of electrodes [as noted in the rejection of claim 16 above, Fraasch also teaches detecting a faulty pairing based on bipolar impedance measurements between adjacent electrodes (electrode pairs) - see ¶¶ [0022], [0093]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Condie and Fraasch such that the ECU is configured for detecting at least one of [or both of] a faulty electrode in the plurality of electrodes and a faulty pairing in the plurality of electrodes since such a modification would provide the benefit/advantage of ensuring patient safety by effecting a rapid termination of the delivery of potentially harmful energy to the patient when a fault condition in the device and/or system is identified, as explicitly taught by Fraasch [e.g., ¶[0009]].
25. Regarding claim 19, the combination of Condie and Fraasch teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
Fraasch further teaches wherein the ECU comprises a short circuit module [¶¶ [0067], [0093]] configured for detecting a short circuit between a pair of electrodes in the plurality of electrodes [e.g., ¶[0093] (“…the system measures the impedance between two adjacent device electrodes 38. If the device 12 or its cable are damaged, the test will resolve a very high (in the case of open conductors) or very low (in the case of shorted conductors) impedance… If the test resolves an impedance outside a range of possible tissue impedance values, it will trigger a fault state”); see also ¶[0092]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Condie and Fraasch such that the ECU comprises a short circuit module configured for detecting a short circuit between a pair of electrodes in the plurality of electrodes, since such a modification would provide the benefit/advantage of ensuring patient safety by effecting a rapid termination of the delivery of potentially harmful energy to the patient when a fault condition in the device and/or system is identified, as explicitly taught by Fraasch [e.g., ¶[0009]].
26. Regarding claim 21, the combination of Condie and Fraasch teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
As noted above (in the rejection of claim 1), Fraasch teaches reviewing (analyzing) measured impedances of adjacent pairs of electrodes to identify an open circuit for an electrode pair [e.g., ¶¶ [0022], [0079], [0093]].
Fraasch further teaches an embodiment wherein impedance measurements for an individual electrode may be acquired and used to indicate an open circuit or short circuit [e.g., ¶[0092]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Condie and Fraasch such that, upon reviewing (analyzing) measured impedances of adjacent pairs of electrodes to identify an electrode pair with an open circuit, an impedance measurement for each electrode of the identified electrode pair is then effectuated to determine which electrode of the electrode pair has the open circuit, since such a modification would provide the benefit/advantage of improving the efficiency, accuracy, and overall safety of a procedure by enabling a user (e.g., practitioner) to quickly identify and repair/replace the individual electrode responsible for the fault condition.
27. Regarding claim 22, the combination of Condie and Fraasch teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
As noted above (in the rejection of claim 16), Fraasch teaches reviewing (analyzing) measured impedances of adjacent pairs of electrodes to identify an open circuit for an electrode pair [e.g., ¶¶ [0022], [0079], [0093]].
Fraasch further teaches an embodiment wherein impedance measurements for an individual electrode may be acquired and used to indicate an open circuit or short circuit [e.g., ¶[0092]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Condie and Fraasch such that, upon the ECU reviewing (analyzing) measured impedances of adjacent pairs of electrodes to identify an electrode pair with an open circuit, an impedance measurement for each electrode of the identified electrode pair is then effectuated to determine which electrode of the electrode pair has the open circuit, since such a modification would provide the benefit/advantage of improving the efficiency, accuracy, and overall safety of a procedure by enabling a user (e.g., practitioner) to quickly identify and repair/replace the individual electrode responsible for the fault condition.
Response to Arguments
28. As noted above, the 02/12/26 Amendment has overcome the claim objections, and the rejections under §§ 112(b), 102, & 103 previously set forth in the 11/12/25 Action.
29. A new claim objection, and new rejections under § 103 are set forth herein, necessitated by Applicant’s Amendment.
30. In the 02/12/26 Amendment, independent claims 1 & 11 were amended to require that the method be for an intracardiac medical device. Independent claim 16 included a similar amendment. In the Remarks, Applicant argued the importance of this amendment as it concerns the applicability of the teaching reference, U.S. 2016/0270841 to Strobl et al. (“Strobl”), that was previously relied-upon [in the 11/12/25 Action] for the “open circuit” teachings:
In addition, claim 1 has been amended to recite "an intracardiac medical device", meaning that the plurality of electrodes are intracardiac electrodes. This is in contrast with the Strobl reference, which is described as a laparoscopic/endoscopic device that is not utilized within the vasculature of a patient (i.e., not intracardiac). This difference is important, because within the vasculature/intracardiac, current between adjacent electrodes are not open circuit if not in contact with tissue, as the blood pool provides a current path between the electrodes. This understanding clarifies that the Strobl reference will always be in an open-circuit condition in response to the jaws 144 of the end effector not being in contact with tissue, but that this will not allow for "detecting a faulty electrode or a faulty circuit in the plurality of electrodes based on the measured impedance values" as required by claim 1.
02/12/26 Amendment, pg. 9, emphasis added.
Responsive to Applicant’s amendments and Remarks, Fraasch has been applied for the teaching that, even when utilized with electrodes on an intracardiac medical device, the use of impedance measurements between electrode pairs to identify faults such as an open circuit and/or short circuit, was well known in the art before the effective filing date of the claimed invention. As such, independent claims 1, 11, & 16 are unpatentable under 35 U.S.C. 103 based on the combination of Condie and Fraasch, for the reasons set forth in detail herein.
Conclusion
31. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
32. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
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/Bradford C. Blaise/Examiner, Art Unit 3794