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 November 24, 2025 have been entered. Currently, claims 1, 3-4, 16, 23-24, and 30 have been amended, claim 2 has been cancelled, and claims 1, 3-33 are pending in the application.
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, 3-11, 14-15, 22-26, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Behnke (U.S. Application No. 20090198230 A1), and further in view of Subramaniam (U.S. Application No. 20150141978 A1).
Regarding independent claim 1 and dependent claim 10, Behnke discloses a system for monitoring contact quality of a first body surface electrode (6) (pa. 0019, 0021 & Figs. 1-2), the system comprising:
a generator (20) configured to provide ablation energy (pa. 0021);
an electronic control unit (ECU) (24) configured to be in electrical communication with the first body surface electrode and the generator (pa. 0023);
a circuit (22) connecting the first body surface electrode to the ECU (pa. 0025-0026);
wherein the ECU is configured to send a single interrogation signal through the circuit to the first body surface electrode and receive a sense signal through the circuit in response to the interrogation signal (pa. 0019, 0026);
wherein the ECU determines the contact quality of the first body surface electrode by processing the sense signal (pa. 0027); and
wherein the ECU is further configured to provide the interrogation signal at a first frequency (e.g., 140 kHz) while the generator is providing ablation energy (pa. 0003, 0026).
However, Behnke does not disclose wherein the ECU is further configured to provide the interrogation signal at a second, different frequency while the generator is not providing ablation energy, the first frequency being below the second frequency.
Subramaniam, in the same field of endeavor, teaches a system for determining the degree of contact between an electrode and a target tissue by monitoring impedance at two different frequencies prior to the beginning of treatment (i.e., when ablation energy is not being provided), and monitoring the impedance again during the ablation procedure (i.e., when ablation energy is provided) (pa. 0066). Subramaniam teaches the measured impedance at a first frequency (e.g., 46 kHz) and at a second frequency (e.g., 460 kHz), and as shown in Fig. 2, the impedance increases/drops in a fairly linear manner as the amount of the electrode contacting the target tissue increases/decreases at both the lower frequency and the higher frequency (pa. 0070-0071). Therefore, the difference in impedance is the measured impedance at the lower frequency minus the measured impedance at the higher frequency (pa. 0072).
Examiner is interpreting a first frequency and a second frequency as not being limited to a singular frequency applied to the tissue at a given time. Hence, Examiner is interpreting the first frequency as the low frequency applied during the ablation procedure, and the second frequency as the high frequency applied before the ablation procedure. Furthermore, the claim language is still broad enough to apply prior art which references utilizing more than one frequency at a given time since the language is not limited to “only a first/second frequency”, for example.
Therefore, 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 methodology of applying the specified low and high frequencies before the application of energy, as taught by Subramaniam, into the system of Behnke in order to allow the user to calibrate system prior to ablation (Subramaniam, pa. 0072), and during the application of energy in order to obtain/continue to verify that the desired amount of contact between the electrodes is continued/maintained throughout the ablation procedure (Subramaniam, pa. 0074).
Regarding claim 3, Behnke discloses the invention substantially as claimed in claim 1 discussed above.
However, Behnke does not disclose wherein the first frequency is lower than the second frequency.
Subramaniam, in the same field of endeavor, teaches the monitored impedance prior to the beginning of treatment is measured at a low frequency (e.g., 46 kHz) (i.e., the first frequency) minus a high frequency (e.g., 460 kHz) (pa. 0072), and that the monitored the impedance during the procedure is measured using the low frequency minus the high frequency (i.e., the second frequency) (pa. 0072, 0074).Thereby, the first the first frequency is lower than the second frequency.
As explained above, Examiner is interpreting a first frequency and a second frequency as not being limited to a singular frequency applied to the tissue at a given time. Therefore, the claim language is still broad enough to apply prior art which references utilizing more than one frequency at a given time.
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 provided the low and high frequencies before ablation to allow the user to calibrate the system (Subramaniam, pa. 0072), and to have provided the low and high frequencies during in order to accurately ascertain/verify that the desired contact between the ablation electrode and the target tissue is maintained (Subramaniam, pa. 0074).
Regarding claim 4, Behnke discloses the invention substantially as claimed in claim 1 discussed above.
However, Behnke does not disclose wherein the first frequency is between 10 kHz and 20 kHz and the second frequency is between 20 kHz and 100 kHz.
Subramaniam, in the same field of endeavor, teaches using a variety of low and high frequencies, wherein different high and low ranges may be utilized, for example a low frequency (i.e., the first frequency) as low as 10 kHz and a high frequency (i.e., the second frequency) as high as 1000 kHz (pa. 0070).
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 range of the first and second frequencies to be within the ranges as taught by Subramaniam for the purpose of creating a clear linear relationship between the difference in the impedance measured at the low frequency and the high frequency that is indicative of the quality of the electrode surface contact (Subramaniam, pa. 0072).
Regarding claims 5 and 26, Behnke/Subramaniam combination discloses wherein the first body surface electrode comprises a first conductive portion (41) and a second conductive portion (42), wherein the first conductive portion is separated from the second conductive portion by a gap (Behnke, see Fig. 2), wherein the interrogation signal is sent across the gap and the sense signal has a voltage corresponding to an impedance across the gap (Behnke, pa. 0025, 0036).
Regarding claim 6, Behnke/Subramaniam combination discloses wherein the circuit provides a low contact quality signal when the sense signal is higher than a threshold (Behnke, pa. 0027).
Regarding claims 7 and 31, Behnke/Subramaniam combination discloses further comprising a trip circuit configured to shut down, disable, or prevent the provision of the ablation energy by the generator in response to the low contact quality signal (Behnke, pa. 0027).
Examiner interprets the inherent presence of a trip circuit since the system is able to shut down the generator in order to terminate the supply of RF energy to the tissue.
Regarding claim 8, Behnke/Subramaniam combination discloses further comprising a second body surface electrode, wherein the first body surface electrode and the second body surface electrode each comprise a first conductive portion and a second conductive portion, each first conductive portion being separated from each second conductive portion by a respective gap (Behnke, pa. 0021).
Regarding claim 9, Behnke/Subramaniam combination discloses wherein the circuit provides respective interrogation signals to and receives respective sense signals from each first conductive portion and each second conductive portion (Behnke, pa. 0026-0027).
Regarding claim 11, Behnke/Subramaniam combination discloses wherein the circuit provides a low contact quality signal in response to at least one of the respective sense signals being higher than a threshold (Behnke, pa. 0027).
Regarding claim 14, Behnke/Subramaniam combination discloses wherein the circuit comprises an adjustable frequency current source for providing the interrogation signal (Behnke, pa. 0037-0038).
Regarding claim 15, Behnke/Subramaniam combination discloses wherein the circuit provides a low contact quality signal when the sense signal is higher than a threshold (Behnke, pa. 0027).
Regarding claim 22, Behnke/Subramaniam combination discloses further comprising:
a catheter (2) configured to provide the ablation energy to a body;
wherein the first body surface electrode is a return electrode (Behnke, pa. 0021).
Regarding independent claim 23, Behnke discloses a method of determining contact quality of a first body surface electrode (6) (pa. 0019, 0021 & Figs. 1-3), the method comprising:
providing ablation energy from an ablation generator (20) to a body during a time interval (pa. 0021), the ablation generator comprising a return node coupled to the first body surface electrode (see Fig. 2);
providing a single interrogation signal to the first body surface electrode, the interrogation signal having a frequency related to whether the ablation energy is being provided to the body from the ablation generator (pa. 0019, 0026), wherein the interrogation signal is provided at a first frequency (e.g., 140 kHz) if the ablation energy is provided to the body (pa. 0003, 0026);
receiving a sense signal from the first body surface electrode in response to the interrogation signal, wherein the sense signal is related to an impedance between the body and the first body surface electrode (pa. 0036); and
processing the sense signal to determine the contact quality (pa. 0039).
However, Behnke does not disclose wherein the interrogation signal is provided at a second frequency if the ablation energy is not being provided to the body.
Subramaniam, in the same field of endeavor, teaches a system for determining the degree of contact between an electrode and a target tissue by monitoring impedance at two different frequencies prior to the beginning of treatment (i.e., when ablation energy is not being provided), and monitoring the impedance again during the ablation procedure (i.e., when ablation energy is provided) (pa. 0066). Subramaniam teaches the measured impedance at a first frequency (e.g., 46 kHz) and at a second frequency (e.g., 460 kHz), and as shown in Fig. 2, the impedance increases/drops in a fairly linear manner as the amount of the electrode contacting the target tissue increases/decreases at both the lower frequency and the higher frequency (pa. 0070-0071). Therefore, the difference in impedance is the measured impedance at the lower frequency minus the measured impedance at the higher frequency (pa. 0072).
Examiner is interpreting a first frequency and a second frequency as not being limited to a singular frequency applied to the tissue at a given time. Hence, Examiner is interpreting the first frequency as the low frequency applied during the ablation procedure, and the second frequency as the high frequency applied before the ablation procedure. Furthermore, the claim language is still broad enough to apply prior art which references utilizing more than one frequency at a given time since the language is not limited to “only a first/second frequency”, for example.
Therefore, 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 methodology of applying the specified low and high frequencies before the application of energy, as taught by Subramaniam, into the system of Behnke in order to allow the user to calibrate system prior to ablation (Subramaniam, pa. 0072), and during the application of energy in order to obtain/continue to verify that the desired amount of contact between the electrodes is continued/maintained throughout the ablation procedure (Subramaniam, pa. 0074).
Regarding claim 24, Behnke discloses the invention substantially as claimed in claim 23 discussed above.
However, Behnke does not disclose wherein the first frequency is lower than the second frequency.
Subramaniam, in the same field of endeavor, teaches the monitored impedance prior to the beginning of treatment is measured at a low frequency (e.g., 46 kHz) (i.e., the first frequency) minus a high frequency (e.g., 460 kHz) (pa. 0072), and that the monitored the impedance during the procedure is measured using the low frequency minus the high frequency (i.e., the second frequency) (pa. 0072, 0074).Thereby, the first the first frequency is lower than the second frequency.
As explained above, Examiner is interpreting a first frequency and a second frequency as not being limited to a singular frequency applied to the tissue at a given time. Therefore, the claim language is still broad enough to apply prior art which references utilizing more than one frequency at a given time.
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 provided the low and high frequencies before ablation to allow the user to calibrate the system (Subramaniam, pa. 0072), and to have provided the low and high frequencies during in order to accurately ascertain/verify that the desired contact between the ablation electrode and the target tissue is maintained (Subramaniam, pa. 0074).
Regarding claim 25, Behnke discloses the invention substantially as claimed in claim 24 discussed above.
However, Behnke does not disclose wherein the first frequency is between 10 kHz and 20 kHz and the second frequency is between 20 kHz and 200 kHz.
Subramaniam, in the same field of endeavor, teaches using a variety of low and high frequencies, wherein different high and low ranges may be utilized, for example a low frequency (i.e., the first frequency) as low as 10 kHz and a high frequency (i.e., the second frequency) as high as 1000 kHz (pa. 0070).
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 range of the first and second frequencies to be within the ranges as taught by Subramaniam for the purpose of creating a clear linear relationship between the difference in the impedance measured at the low frequency and the high frequency that is indicative of the quality of the electrode surface contact (Subramaniam, pa. 0072).
Regarding claim 29, Behnke/Subramaniam combination discloses wherein the sense signal is processed by comparing the sense signal to a threshold, and the method further comprises providing a low contact quality signal when the sense signal is above the threshold (Behnke, pa. 0027).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Behnke and Subramaniam, as applied to claim 1, and further in view of Winstrom (U.S. Application No. 20200323577 A1).
Regarding claims 12, Behnke/Subramaniam combination discloses providing a low contact quality signal when there is excessive peeling of the first body surface electrode (Behnke, pa. 0027).
However, they do not disclose wherein the low contact quality signal indicates more than a 40 percent reduction in an adhered area from an expected adhered area of the first body surface electrode or the second body surface electrode.
Winstrom, in the same field of endeavor, teaches a system that is able to monitor and detect when a body surface electrode is disengaged or detached if more than 25% of the surface area of one or more electrodes are not properly adhered against tissue (pa. 0025).
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 specific low contact quality indicator of 40 percent reduction in an adhered area to the system of Behnke in order to prevent an undesirable temperature rise (Winstrom, pa. 0025).
Claims 13, 20-21, 27-28, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Behnke and Subramaniam, as applied to claims 1 and 23 above, and further in view of Blaha (E.P. Application No. 1902684 B1).
Regarding claims 13 and 27, Behnke discloses further comprising:
a second body surface electrode (pa. 0021); and
a first current sensor (53) configured to sense a first current level associated with the ablation energy provided by the generator through the first body surface electrode (pa. 0025, 0032).
However, Behnke/Subramaniam combination do not disclose a variable impedance circuit nor a second current sensor.
Blaha, in the same field of endeavor, teaches a system comprising a variable impedance circuit (i.e., current monitors (43, 53, 63) and switches (44, 54, and 64)) coupled in series with at least one of a first body surface electrode (14) and a second body surface electrode (15) (pa. 0031, 0034-0035 & Fig. 4). Moreover, Blaha teaches using individual current sensors for each of the multiple body electrodes (pa. 0061), wherein a circuit (34) is coupled to the first current sensor and the second current sensor, wherein the circuit provides a control signal to the variable impedance circuit to balance the first current level through the first body surface electrode and the second current level through the second body surface electrode (pa. 0035).
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 variable impedance circuit and the additional current sensor in order to individually monitor the current load of each body electrode and evenly distribute the load if a misbalance is detected, this is will in turn prevent overheating and possible damage to the tissue (Blaha, pa. 0034-0035).
Regarding claim 20, Behnke discloses the invention substantially as claimed in claim 1 and discussed above.
However, Behnke/Subramaniam combination do not disclose an adjustable impedance circuit in series with the first body surface electrode and a return node of the generator.
Blaha, in the same field of endeavor, teaches a system comprising an adjustable impedance circuit in series with the first body surface electrode and a return node of the generator (pa. 0039).
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 adjustable impedance circuit to the system of Behnke for the purpose of properly redistributing the current load (Blaha, pa. 0039).
Regarding claim 21, Behnke/Subramaniam combination discloses the invention substantially as claimed in claims 1 and 20 and discussed above.
However, they do not disclose wherein the adjustable impedance circuit is tuned to block signals in a first frequency range while allowing signals in a second frequency range to pass.
Blaha, in the same field of endeavor, teaches a system wherein the adjustable impedance circuit is tuned to block signals in a first frequency range while allowing signals in a second frequency range to pass (pa. 0039).
Regarding claim 28, Behnke discloses the invention substantially as claimed in claim 27 and discussed above.
However, Behnke/Subramaniam combination do not disclose an adjustable impedance circuit.
Blaha, in the same field of endeavor, teaches a system comprising an adjustable impedance circuit (pa. 0039).
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 adjustable impedance circuit to the system of Behnke for the purpose of properly redistributing the current load (Blaha, pa. 0039).
Regarding claim 33, Behnke/Subramaniam combination discloses providing ablation RF energy and adjusting the power of the RF energy, waveform, and other parameters in order to achieve the desired waveform suitable for a particular task (pa. 0022).
However, they do not explicitly disclose wherein the ablation energy is delivered as a pulsed electric field.
Blaha, in the same field of endeavor, teaches delivering ablation energy as either a continuously waveform or with periodic current pulses in order to minimize the risk of damaging tissue (pa. 0006).
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 delivery of RF energy in order to minimize the risk of tissue damage.
Allowable Subject Matter
Claim 32 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 16-19, and 30 are allowed.
The following is a statement of reasons for the indication of allowable subject
matter: regarding claims 16-19, 30, and 32, the Behnke (U.S. Application No. 20090198230 A1) reference fails to teach the invention as a whole. The Behnke reference teaches a system for monitoring contact quality of a first body surface electrode (6) (pa. 0019, 0021 & Figs. 1-2), the system comprising a generator (20) configured to provide ablation energy (pa. 0021), an electronic control unit (ECU) (24) configured to be in electrical communication with the first body surface electrode and the generator (pa. 0023), a circuit (22) connecting the first body surface electrode to the ECU (pa. 0025-0026), wherein the ECU is configured to send an interrogation signal through the circuit to the first body surface electrode and receive a sense signal through the circuit in response to the interrogation signal (pa. 0019, 0026), and wherein the ECU determines the contact quality of the first body surface electrode by processing the sense signal (pa. 0027). However, Behnke does not teach the circuit being configured to dynamically adjust the threshold in response to a current level associated with the ablation energy provided by the generator through the first body surface electrode, nor wherein a magnitude of the threshold is inversely related to the current level associated with the ablation energy provided by the ablation generator through the first body surface electrode.
Other pertinent art found not previously cited in prior Office Action is Newton (U.S. Application No. 20150359584 A1). Newton teaches a system for assessing the contact quality of a return electrode by using either a fixed threshold or a variable threshold (pa. 0050). However, Newton fails to cure the above noted deficiency.
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 16-19, 30, and 32.
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 11/24/2025 have been fully considered but they are not persuasive.
With regards to newly amended independent claims 1 and 23, Applicant argues that neither the Behnke reference nor the Subramaniam reference teach, “wherein the ECU is further configured to provide the interrogation signal at a first frequency while the generator is providing ablation energy, and at a second, different frequency while the generator is not providing ablation energy." Specifically, Applicant contends that neither reference’s interrogation signal is “keyed to the generator's ablation state”, and do not “not predicate selecting which frequency to use based on whether ablation energy is being delivered”. However, Examiner respectfully disagrees.
The claim language of the independent claims 1 and 23 is broad and does not specify the that frequency of the interrogation is based on, or dependent on the state of the ablation generator. The claims may continue to be interpreted as a system/method of monitoring/determining the contact quality of a surface electrode by providing an interrogation signal at a first frequency in any instance where ablation energy is not provided to the tissue and at a second frequency in a second, different instance where ablation energy is provided to the tissue. Therefore, the rejection of Behnke in view of Subramaniam are maintained for the reasonings set-forth above.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANA VERUSKA GUERRERO ROSARIO whose telephone number is (571)272-6976. The examiner can normally be reached Monday - Thursday 7:00 - 4:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794