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 .
Claims 2, 11, and 19 are cancelled. A complete action on the merits of pending claims 1, 3-10, 12-18, and 21-23 appears herein.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/01/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nabutovsky (US 2014/0276746 A1) in view of Zucker (US 2019/0261866 A1) in view of Gross (US 2017/0007158 A1).
Applicant’s arguments, see Remarks, filed 06/01/2026, with respect to the rejection(s) of claim(s) 10 and 18 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nabutovsky (US 2014/0276746 A1), in view of Gross (US 2017/0007158 A1), in view of Hughes (US 5,620,002), in view of Zucker (US 2019/0261866 A1).
Claim Objections
Claims 7 and 9 are objected to because of the following informalities:
Regarding claim 7, the limitation “wherein to correlate the temperature signal to the arterial pressure of the blood within the vessel the processor” should read --wherein, to correlate the temperature signal to the arterial pressure of the blood within the vessel, the processor--
Regarding claim 9, the limitation “wherein to correlate the impedance signal to the arterial pressure of the blood within the vessel the processor” should read --wherein, to correlate the impedance signal to the arterial pressure of the blood within the vessel, the processor--
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-5, 8, 9, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Nabutovsky (US 2014/0276746 A1) in view of Zucker (US 2019/0261866 A1) in view of Gross (US 2017/0007158 A1).
Regarding claim 1, Nabutovsky teaches a therapeutic assembly for renal denervation, (Fig. 1) comprising:
a sensor configured to detect a temperature signal or an impedance signal at a location within a vessel over a period of time; (Fig. 1 and Par. [0047]: impedance electrodes (18A-C) and
a processor coupled to the sensor (Claim 4: processor) and configured to:
correlate the temperature signal or the impedance signal to a flow of blood within the vessel or an arterial pressure of the blood within the vessel (Par. [0010] and claim 4)
Nabutovsky, as applied to claim 1 above, is silent regarding the processor being configured to: determine a frequency domain parameter of the temperature signal or the impedance signal over the period of time; the correlation of the temperature signal or the impedance signal to a flow of blood within the vessel or an arterial pressure of the blood within the vessel being made using the frequency domain parameter of the temperature signal or the impedance signal to determine a correlation; and the processor being configured to: determine vasomotion of a wall of a vessel based on the flow of blood or the arterial pressure of the blood.
Zucker, in a similar field of endeavor, teaches using vasomotion to determine the efficacy of a renal ablation treatment; (Par. [0068]) wherein vasomotion of a blood vessel is determined using a sensed blood flow rate over time; (Claim 1 and Par. [0008])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Nabutovsky, as applied to claim 1 above, to incorporate the teachings of Zucker, and configure the processor of Nabutovsky to determine the vasomotion of a target blood vessel using the calculated blood flow rate. Doing so would provide a user with more information regarding the state of the target treatment zone, and would provide another method for determining the efficacy of renal ablation treatment, as suggested in Zucker. (Par. [0068])
The combination of Nabutovsky/Zucker, as applied to claim 1 above, is silent regarding the processor being configured to: determine a frequency domain parameter of the temperature signal or the impedance signal over the period of time; and the correlation of the temperature signal or the impedance signal to a flow of blood within the vessel or an arterial pressure of the blood within the vessel being made using the frequency domain parameter of the temperature signal or the impedance signal to determine a correlation.
Gross, in a similar field of endeavor, teaches control circuitry configured to calculate the level of correlation between at least one time-varying component of an electrode impedance and a periodic hemodynamic signal by calculating the level of correlation in the frequency domain. (Par. [0179])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Nabutovsky/Zucker, as applied to claim 1 above, to incorporate the teachings of Gross, and configure the processor of Nabutovsky to calculate the correlation between the impedance signal to a flow of blood within the vessel or an arterial pressure of the blood within the vessel by calculating the level of correlation in the frequency domain. Doing so would be a simple substitution of one correlation method for another for the predictable result of determining the correlation between the impedance signal and the flow of blood within the vessel or an arterial pressure of the blood within the vessel.
In this combination, by calculating the correlation in the frequency domain, a frequency parameter of the impedance signal over time would have to be determined and used in said calculation.
Regarding claim 3, the combination of Nabutovsky/Zucker/Gross, as applied to claim 1 above, teaches an energy delivery element configured to deliver neuromodulation energy to the wall of the vessel. (Nabutovsky: Fig. 1 and Par. [0044]: ablation electrodes (16A-B))
Regarding claim 4, the combination of Nabutovsky/Zucker/Gross, as applied to claim 3 above, teaches the processor is configured to:
determine the vasomotion of the wall of the vessel based on the flow of blood or the arterial pressure of the blood prior to the delivery of the neuromodulation energy; and determine the vasomotion of the wall of the vessel after the delivery of the neuromodulation energy. (Nabutovsky: Par. [0047]; and Zucker: Par. [0068] – it is implicit that this feature be present in the Nabutovsky/Zucker/Gross combination based on the rejection to claim 1 above.)
Regarding claim 5, the combination of Nabutovsky/Zucker/Gross, as applied to claim 4 above, teaches the processor is configured to:
compare the vasomotion of the wall prior to the delivery of the neuromodulation energy and the vasomotion of the wall after the delivery of the neuromodulation energy; and determine a success or failure of renal neuromodulation based on the comparison. (Nabutovsky: Par. [0051]; and Zucker: Par. [0068] – it is implicit that this feature be present in the Nabutovsky/Zucker/Gross combination based on the rejection to claim 1 above.)
Regarding claim 8, the combination of Nabutovsky/Zucker/Gross, as applied to claim 1 above, teaches to correlate the temperature signal or the impedance signal to the flow of blood or the arterial pressure of the blood the processor is configured to correlate the impedance signal to the arterial pressure of the blood within the vessel. (Nabutovsky: Par. [0010], [0047] and claim 4)
Regarding claim 9, the combination of Nabutovsky/Zucker/Gross, as applied to claim 8 above, teaches to correlate the impedance signal to the arterial pressure of the blood within the vessel the processor is configured to:
measure or detect, using the sensor, variations in the frequency domain parameter of the impedance signal at a location on the wall within the vessel over the period of time; (Nabutovsky: Par. [0047] and Gross: Par. [0179]: Changes in the impedance measured by the sensors of Nabutovsky would be reflected in the frequency domain of the impedance signal – it is implicit that this feature be present in the Nabutovsky/Zucker/Gross combination based on the rejection to claim 1 above.) and
associate the variations in the frequency domain parameter of the impedance signal with the arterial pressure of the blood within the vessel, (Nabutovsky: Par. [0010] and claim 4; Gross: Par. [0179]) – it is implicit that this feature be present in the Nabutovsky/Zucker/Gross combination based on the rejection to claim 1 above.) wherein the variations in the frequency domain parameter of the impedance signal are inversely proportional to a diameter of the vessel that corresponds to the arterial pressure of the blood. (The relationship between arterial pressure and impedance is a known natural phenomenon, and one of ordinary skill in the art would expect to see results similar to what’s claimed given that the changes in impedance and arterial blood pressure in both Nabutovsky and the present application are due to ablation procedures directed towards renal denervation.)
Regarding claim 21, the combination of Nabutovsky/Zucker/Gross, as applied to claim 1 above, teaches the frequency domain parameter of the temperature signal or the impedance signal over the period of time comprises one or more of: a Fourier transform, a power spectral density, or a coherence. (Gross: Par. [0319]: the control circuitry derives the time-varying frequency component using an FFT – it is implicit that this feature be present in the Nabutovsky/Zucker/Gross combination based on the rejection to claim 1 above.)
Claim(s) 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Nabutovsky (US 2014/0276746 A1) in view of Zucker (US 2019/0261866 A1), in view of Gross (US 2017/0007158 A1), as applied to claim 1 above, and further in view of Hughes (US 5,620,002).
Regarding claim 6, the combination of Nabutovsky/Zucker/Gross, as applied to claim 1 above, is silent regarding to correlate the temperature signal or the impedance signal to the flow of blood or the arterial pressure of the blood, the processor is configured to correlate the temperature signal to the flow of blood within the vessel.
Hughes, in a similar field of endeavor, teaches a temperature sensor configured to output a signal indicative of a blood temperature; (Claim 15; The temperature of the blood would be the same temperature as the arterial wall at least at the point of contact between said blood and said wall.) and determining a volumetric blood flow rate using a frequency domain temperature signal produced from the temperature sensor output signal. (Col. 1, Lines 14-18; and Claim 6)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Nabutovsky/Zucker/Gross, as applied to claim 1 above, to incorporate the teachings of Hughes, and include the temperature sensor of Hughes, such that the processor of Nabutovksy determines the volumetric blood flow rate using a frequency domain temperature signal produced from the temperature sensor output signal. Doing so would be a simple substitution of one blood flow rate calculation for another for the predictable result of determining the blood flow rate through the artery.
Regarding claim 7, the combination of Nabutovsky/Zucker/Gross/Hughes, as applied to claim 6 above, teaches to correlate the temperature signal to the flow of blood within the vessel the processor is configured to:
measure or detect, using the sensor, variations in the frequency domain parameter of the temperature signal at a location on the wall within the vessel over the period of time; (Hughes: Claim 15; The temperature of the blood would be the same temperature as the arterial wall at least at the point of contact between said blood and said wall; Any changes in the frequency domain parameter of the temperature signal would be reflected in the cardiac output determination – it is implicit that this feature be present in the Nabutovsky/Zucker/Gross/Hughes combination based on the rejection to claim 6 above.) and
associate the variations in the frequency domain parameter of the temperature signal with the flow of blood, wherein the variations in the frequency domain parameter of the temperature signal are inversely proportional to the flow of the blood. (The relationship between blood flow and temperature is a well-known natural phenomenon, and one of ordinary skill in the art would expect to see results similar to what’s claimed given that the changes in temperature and blood flow in both Nabutovsky and the present application are due to ablation procedures directed towards renal denervation.)
Claim(s) 10, and 12-18, 20, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Nabutovsky (US 2014/0276746 A1), in view of Gross (US 2017/0007158 A1), in view of Hughes (US 5,620,002), in view of Zucker (US 2019/0261866 A1).
Regarding claim 10, Nabutovsky teaches therapeutic assembly for renal denervation, (Fig. 1) comprising:
a second sensor configured to detect an impedance signal at the location on the wall of the vessel over the period of time; (Fig. 1 and Par. [0047]: impedance electrodes (18A-C) and
a processor coupled to the second sensor (Claim 4: processor) and configured to:
correlate the impedance signal to an arterial pressure of the blood within the vessel; (Par. [0010] and claim 4) and
Nabutovsky further teaches determining a change in blood flow rate (Par. [0082]) and an arterial pressure of the blood. (Par. [0062])
Nabutovsky, as applied to claim 10 above, is silent regarding a first sensor configured to detect a temperature signal at a location on a wall of a vessel over a period of time; the processor being coupled to the first sensor; determine a frequency domain parameter of the temperature signal over the period of time; correlate the temperature signal to a flow of blood within the vessel using the frequency domain parameter of the temperature signal to generate a first correlation; determine a frequency domain parameter of the impedance signal over the period of time; the correlation of the impedance signal to the arterial pressure of the blood within the vessel being performed using the frequency domain parameter of the impedance signal to generate a second correlation; and determine vasomotion of the wall of the vessel based on the flow of blood and the arterial pressure of the blood and based on the first correlation and the second correlation.
Gross, in a similar field of endeavor, teaches control circuitry configured to calculate the level of correlation between at least one time-varying component of an electrode impedance and a periodic hemodynamic signal by calculating the level of correlation in the frequency domain. (Par. [0179])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Nabutovsky, as applied to claim 10 above, to incorporate the teachings of Gross, and configure the processor of Nabutovsky to calculate the correlation between the impedance signal to a flow of blood within the vessel or an arterial pressure of the blood within the vessel by calculating the level of correlation in the frequency domain. Doing so would be a simple substitution of one correlation method for another for the predictable result of determining the correlation between the impedance signal and the flow of blood within the vessel or an arterial pressure of the blood within the vessel.
In this combination, by calculating the correlation in the frequency domain, a frequency parameter of the impedance signal over time would have to be determined and used in said calculation.
The combination of Nabutovsky/Gross, as applied to claim 10 above, is silent regarding a first sensor configured to detect a temperature signal at a location on a wall of a vessel over a period of time; the processor being coupled to the first sensor; determine a frequency domain parameter of the temperature signal over the period of time; correlate the temperature signal to a flow of blood within the vessel using the frequency domain parameter of the temperature signal to generate a first correlation; and determine vasomotion of the wall of the vessel based on the flow of blood and the arterial pressure of the blood and based on the first correlation and the second correlation.
Hughes, in a similar field of endeavor, teaches a temperature sensor configured to output a signal indicative of a blood temperature; (Claim 15; The temperature of the blood would be the same temperature as the arterial wall at least at the point of contact between said blood and said wall.) and determining a volumetric blood flow rate using a frequency domain temperature signal produced from the temperature sensor output signal. (Col. 1, Lines 14-18; and Claim 6)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Nabutovsky/Gross, as applied to claim 10 above, to incorporate the teachings of Hughes, and include the temperature sensor of Hughes, such that the processor of Nabutovksy determines the volumetric blood flow rate using a frequency domain temperature signal produced from the temperature sensor output signal. Doing so would be a simple substitution of one blood flow rate calculation for another for the predictable result of determining the blood flow rate through the artery.
In this combination, by calculating the frequency domain temperature signal, a frequency parameter of the temperature signal over time would have to be determined and used in said calculation.
The combination of Nabutovsky/Gross/Hughes, as applied to claim 10 above, is silent regarding determine vasomotion of the wall of the vessel based on the flow of blood and the arterial pressure of the blood and based on the first correlation and the second correlation.
Zucker, in a similar field of endeavor, teaches using vasomotion to determine the efficacy of a renal ablation treatment; (Par. [0068]) wherein vasomotion of a blood vessel is determined using a time-based series of blood pressure readings and a time-based series of blood flow readings. (Claim 21)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Nabutovsky/Gross/Hughes, as applied to claim 10 above, to incorporate the teachings of Zucker, and configure the processor of Nabutovsky to determine the vasomotion of a target blood vessel using the calculated blood flow rate and blood pressure. Doing so would provide a user with more information regarding the state of the target treatment zone, and would provide another method for determining the efficacy of renal ablation treatment, as suggested in Zucker. (Par. [0068])
In this combination, the determination of the vasomotion of the wall would be based on the first and second correlation at least in that the determined flow rate and blood pressure are based on said first and second correlations.
Regarding method claim 18, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 10, since operation of the prior art relied on to reject apparatus claim 10 would naturally result in the step of method claim 18 being satisfied.
Regarding claim 12, the combination of Nabutovsky/Gross/Hughes/Zucker, as applied to claim 10 above, teaches an energy delivery element configured to deliver neuromodulation energy to the location of the wall of the vessel. (Nabutovsky: Fig. 1 and Par. [0044]: ablation electrodes (16A-B))
Regarding claim 13, the combination of Nabutovsky/Gross/Hughes/Zucker, as applied to claim 12 above, teaches the processor is configured to:
determine the vasomotion of the wall of the vessel based on the flow of blood and the arterial pressure of the blood prior to the delivery of the neuromodulation energy; and determination the vasomotion of the wall of the vessel after the delivery of the neuromodulation energy. (Zucker: Par. [0077] – it is implicit that this feature be present in the Nabutovsky/Gross/Hughes/Zucker combination based on the rejection to claim 10 above.)
Regarding claim 14, the combination of Nabutovsky/Gross/Hughes/Zucker, as applied to claim 13 above, teaches the processor is configured to:
compare the vasomotion of the wall prior to the delivery of the neuromodulation energy and the vasomotion of the wall after the delivery of the neuromodulation energy; (Zucker: Par. [0077] – it is implicit that this feature be present in the Nabutovsky/Gross/Hughes/Zucker combination based on the rejection to claim 10 above.)
determine a success or failure of renal neuromodulation based on the comparison; (Zucker: Par. [0068] – it is implicit that this feature be present in the Nabutovsky/Gross/Hughes/Zucker combination based on the rejection to claim 10 above; Nabutovsky: Par. [0051]: Comparing measured values to a threshold value to determine the success of a renal denervation procedure).
The combination of Nabutovsky/Gross/Hughes/Zucker, as applied to claim 14 above, is silent regarding the processor being configured to provide an indication of the success or failure of the renal neuromodulation.
Zucker further teaches a display configured to display one or more quantifications of vasomotion and a quality metric. (Fig. 5, Par. [0076]-[0077])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified combination of Nabutovsky/Gross/Hughes/Zucker, as applied to claim 14 above, to further incorporate the teachings of Zucker, and include the display of Zucker, such that the processor of Nabutovsky uses said display to show indication of the success or failure of the renal neuromodulation. Doing so would allow a user to easily and quickly view and determine the progress/success of the ablation procedure.
Regarding method claim 20, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 14, since operation of the prior art relied on to reject apparatus claim 14 would naturally result in the step of method claim 20 being satisfied.
Regarding claim 15, the combination of Nabutovsky/Gross/Hughes/Zucker, as applied to claim 14 above, teaches a display configured to output the indication of the success or failure of the renal neuromodulation to an operator; (Zucker: Fig. 5, Par. [0076]-[0077] – it is implicit that this feature be present in the Nabutovsky/Gross/Hughes/Zucker combination based on the rejection to claim 14 above.) wherein the processor is configured to: cause the display to output the indication of the success or failure of the renal neuromodulation to the operator. (Zucker: Fig. 5, Par. [0076]-[0077] – it is implicit that this feature be present in the Nabutovsky/Gross/Hughes/Zucker combination based on the rejection to claim 14 above.)
Regarding claim 16, the combination of Nabutovsky/Gross/Hughes/Zucker, as applied to claim 14 above, teaches to determine the success or failure of the renal neuromodulation based on the comparison the processor is configured to: determine a difference between the vasomotion of the wall prior to the delivery of the neuromodulation energy and the vasomotion of the wall after the delivery of the neuromodulation energy; (Zucker: Fig. 5, Par. [0068] and [0076]-[0077] – it is implicit that this feature be present in the Nabutovsky/Gross/Hughes/Zucker combination based on the rejection to claim 14 above.) and determine whether the difference is greater than or equal to a threshold amount. (Nabutovsky: Par. [0051]: There would have to be some threshold value used by the processor to differentiate between a successful procedure and an unsuccessful procedure.)
Regarding claim 17, the combination of Nabutovsky/Gross/Hughes/Zucker, as applied to claim 10 above, teaches variations in the frequency domain parameter of the temperature signal over the period of time are inversely proportional to the flow of the blood (The relationship between blood flow and temperature is a well-known natural phenomenon, and one of ordinary skill in the art would expect to see results similar to what’s claimed given that the changes in temperature and blood flow in both Nabutovsky and the present application are due to ablation procedures directed towards renal denervation.) and variations in the frequency domain parameter of the impedance signal over the period of time are inversely proportional to a diameter of the vessel that corresponds to the arterial pressure of the blood. (The relationship between arterial pressure and impedance is a known natural phenomenon, and one of ordinary skill in the art would expect to see results similar to what’s claimed given that the changes in impedance and arterial blood pressure in both Nabutovsky and the present application are due to ablation procedures directed towards renal denervation.)
Regarding claim 22, the combination of Nabutovsky/Gross/Hughes/Zucker, as applied to claim 10 above, teaches the frequency domain parameter of the temperature signal comprises one or more of: a Fourier transform of the temperature signal, a power spectral density of the temperature signal, or a coherence of the temperature signal, (Hughes: Col. 5, Lines 51-56 – it is implicit that this feature be present in the Nabutovsky/Gross/Hughes/Zucker combination based on the rejection to claim 10 above.) and wherein the frequency domain parameter of the impedance signal comprises one or more of: a Fourier transform of the impedance signal, a power spectral density of the impedance signal, or a coherence of the impedance signal. (Gross: Par. [0319]: the control circuitry derives the time-varying frequency component using an FFT – it is implicit that this feature be present in the Nabutovsky/Gross/Hughes/Zucker combination based on the rejection to claim 10 above.)
Regarding method claim 23, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 22, since operation of the prior art relied on to reject apparatus claim 22 would naturally result in the step of method claim 23 being satisfied.
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 NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM 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, Joanne Rodden can be reached at 3032974276. 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.
/N.S.B./Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
Prosecution Insights