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 .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's After-Final submission filed on 05/06/26 (“05/06/26 Amendment") has been entered, and fully considered [by the filing of the 06/08/26 RCE].
Response to Amendment
3. In the 05/06/26 Amendment, claims 1, 11, & 16 were amended, and claims 7, 14, & 22 were cancelled (claims 8, 10, 13, & 20 were previously cancelled). No claims were newly added. Accordingly, claims 1-6, 9, 11, 12, 15-19, & 21 are now pending in the application.
4. The 05/06/26 Amendment has overcome the claim objection, and the rejections under § 103 previously set forth in the Final Office Action mailed 03/06/26 (“03/06/26 Action”).
5. New grounds of rejection under §§ 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 16-19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
8. Claim 16 recites the limitation “a common electrode” in line 14. This recitation renders the claim indefinite, as it is not clear whether the recited “a common electrode” is intended to be the same “a common electrode” previously recited in line 10 of the claim, or a separate/additional “common electrode.” As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
9. Claims 17-19 are rejected as ultimately depending from a claim (claim 16) rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 103
10. 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.
11. 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.
A. INDEPENDENT CLAIM 1(& DEPENDENT CLAIMS 2-6, 9, & 21)
12. Claims 1-6, 9, & 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2016/0287136 to Condie et al. (“Condie”) in view of U.S. 2019/0117113 to Curran (“Curran”), and further in view of U.S. 2018/0214195 to Fraasch et al. ("Fraasch")
13. 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]].
A. UNIQUE FREQUENCIES
While Condie teaches that impedance measurements for each electrode pair may be acquired at a first, low frequency and a second, high frequency - e.g., ¶¶ [0044], [0068]], Condie does not teach the following emphasized claim limitations:
applying a first drive signal at a first frequency… ;
applying a second drive signal at a second frequency… ;
applying a third drive signal at a third frequency…; [and]
wherein the first, second, and third frequencies are different.
Curran, in a similar field of endeavor, relates to electrical impedance-based measurement of electrodes of a medical device to determine, among other things, contact between tissue and the electrodes of the medical device [¶[0002]].
More particularly, Curran teaches measuring impedances between electrodes of a connected medical device [e.g., ¶[0010]], including applying drive signals between electrode pairs at unique frequencies [e.g., Abstract [(“The present disclosure is directed to measuring impedance across a plurality of electrode pairs. The disclosed systems and methods may simultaneously provide drive signals between electrode pairs and then sense the voltage signals that develop at the electrodes. Digital signal processing may be used to synchronously demodulate the voltage signal at each electrode to determine impedances at the electrodes. Each electrode pair may be driven at a unique frequency to allow for significantly increasing a number of electrode pairs and/or increasing drive current magnitudes”); see also ¶’s [0007], [0012], [0045], [0048], [0049]].
Curran recognizes that, as catheters are configured with increasing numbers of electrodes to improve mapping accuracy and/or ablation control [e.g., ¶[0044] (“[i]n the case of such a 128 electrode catheter, impedance of 64 electrode pairs may be sequentially determined”)], challenges arise concerning current limits/thresholds and noise levels [¶[0044] (“[a]s the number of electrodes increases, the magnitude of the drive current must decrease to maintain the sum current below threshold auxiliary current limits. As will be appreciated, lowering the magnitude of the drive current applied across each bi-pole reduces the signal-to-noise ratio of its response. Accordingly, for medical devices with high numbers of electrodes, the response of the bi-pole pairs of electrodes may be overwhelmed by noise”)].
Curran’s approach of using unique frequencies addresses these drawbacks [e.g., ¶[0048] (“Higher unique frequencies also assist in increasing the maximum number of channels possible while maintaining safe sum current limits… use of unique frequencies allows for increasing the magnitude of a drive current applied to the bi-poles while maintaining auxiliary current limits for a patient below a predetermined threshold”); & ¶[0049] (“Another important aspect of the present disclosure is that driving each electrode pair/bi-pole at a unique frequency not only allows for significantly increasing a number of electrodes that may be interrogated and/or increasing drive current magnitudes but also minimizes crosstalk between channels”)].
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 first, second, and third drive signals are applied at first, second, and third frequencies, respectively, and wherein the first, second, and third frequencies are different, since such a modification would provide the benefits/advantages of allowing for the use of an increased number of electrodes to improve mapping accuracy and/or ablation control, while increasing drive current magnitudes and also minimizing crosstalk between channels, as explicitly taught by Curran.
B. 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]], the combination of Condie & Curran does not teach:
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 further modify the combination of Condie and Curran 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]].
14. Regarding claim 2, the combination of Condie, Curran, 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].
15. Regarding claim 3, the combination of Condie, Curran, 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”)].
16. Regarding claim 4, the combination of Condie, Curran, 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].
17. Regarding claim 5, the combination of Condie, Curran, 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].
18. Regarding claim 6, the combination of Condie, Curran, 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]].
19. Regarding claim 9, the combination of Condie, Curran, 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, Curran, 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 21, the combination of Condie, Curran, 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, Curran, 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.
B. CLAIMS 11, 12, & 15-19
21. Claims 11, 12, & 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Condie in view of Fraasch.
22. 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]].
A. 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]].
B. COMMON ELECTRODE
Claim 11 further requires the limitation:
determining that the common electrode includes the open circuit when the first pair of adjacent electrodes and the second pair of adjacent electrodes include an impedance indicative of an open circuit.
While the combination of Condie and Fraasch does not explicitly teach this limitation, it is the Examiner’s position that such a modification would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention.
The test for obviousness is not 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). “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). Moreover, it is noted that "[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). Office personnel may… take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396.
In the instant case, Fraasch clearly teaches reviewing (analyzing) measured impedances of adjacent pairs of electrodes to identify an open circuit for an electrode pair [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] (“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…”); & ¶[0093] (“In this test, 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”)].
As such, the system/method of Fraasch is clearly capable of identifying an instance wherein immediately adjacent electrode pairs (sharing a common electrode) each include an impedance indicative of an open circuit. In the event of such an occurrence, it would have been entirely routine (and logical) for a skilled artisan to then surmise that the electrode common to the immediately adjacent electrode pairs is responsible for the fault condition. It is further noted that the limitation at issue comprises a step that is capable of being performed by a person, as the claimed determination is not linked to, e.g., a processor.
In view of the foregoing, it is the Examiner’s position that the combined teachings of Condie and Fraasch would have plainly suggested to one of ordinary skill in the art that 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 determining that the common electrode includes the open circuit when the first pair of adjacent electrodes and the second pair of adjacent electrodes include an impedance indicative of an 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.
23. 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]].
24. 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.
25. 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].,
A. 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]].
B. COMMON ELECTRODE
Claim 16 further requires the limitation:
wherein the ECU is configured to determine that a common electrode between adjacent electrode pairs includes the open circuit when a first pair of adjacent electrode pairs and a second pair of adjacent electrode pairs include an impedance indicative of an open circuit.
While the combination of Condie and Fraasch does not explicitly teach this limitation, it is the Examiner’s position that such a modification would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention.
The test for obviousness is not 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). “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). Moreover, it is noted that "[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). Office personnel may… take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396.
In the instant case, Fraasch clearly teaches reviewing (analyzing) measured impedances of adjacent pairs of electrodes to identify an open circuit for an electrode pair [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] (“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…”); & ¶[0093] (“In this test, 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”)].
As such, the system of Fraasch is clearly capable of identifying an instance wherein immediately adjacent electrode pairs (sharing a common electrode) each include an impedance indicative of an open circuit. In the event of such an occurrence, it would have been entirely routine (and logical) to then surmise that the electrode common to the immediately adjacent electrode pairs is responsible for the fault condition.
In view of the foregoing, it is the Examiner’s position that the combined teachings of Condie and Fraasch would have plainly suggested to one of ordinary skill in the art that 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 to determine that a common electrode between adjacent electrode pairs includes the open circuit when a first pair of adjacent electrode pairs and a second pair of adjacent electrode pairs include an impedance indicative of an 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.
26. 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].
27. 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]].
28. 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]].
Response to Arguments
29. As noted above, the 05/06/26 Amendment has overcome the claim objection, and the rejections under § 103 previously set forth in the 03/06/26 Action.
30. New grounds of rejection under §§ 112(b) & 103 are set forth herein, necessitated by Applicant’s Amendment.
31. Further, the rejection of independent claims 11 & 16 under § 103 has been updated to address Applicant's arguments [05/06/26 Amendment, pgs. 7-8] concerning the combination of Condie and Fraasch.
Conclusion
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, 8:30 AM - 4:30 PM MST.
Examiner Interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Joanne M. Rodden, can be reached at telephone number 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
Prosecution Insights