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 .
A complete action on the merits of pending claims 1-20 appears herein.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 11, 19, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation “a frequency of the temperature or the impedance” This limitation renders the scope of the claims unclear. As best understood by examiner, temperature and impedance do not have frequencies. Looking to Par. [0061]-[0067] of the present specification, and as best understood by examiner, it appears the frequency of the temperature and the frequency of the impedance refer to oscillations in the temperature and impedance. For the purpose of examination, any teaching of determining an oscillation in the temperature and/or impedance is interpreted as reading on this limitation.
Claims 11 and 19 recite the limitation “a frequency of the temperature and a frequency of the impedance.” This limitation renders the scope of the claims unclear. As best understood by examiner, temperature and impedance do not have frequencies. Looking to Par. [0061]-[0067] of the present specification, and as best understood by examiner, it appears the frequency of the temperature and the frequency of the impedance refer to oscillations in the temperature and impedance. For the purpose of examination, any teaching of determining an oscillation in the temperature and/or impedance is interpreted as reading on this limitation. Claim 20 is rejected due to its dependency on claim 19.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 8, and 9 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).
Regarding claim 1, Nabutovsky teaches
a sensor configured to detect a temperature or an impedance 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 or the impedance to a flow of blood within the vessel or an arterial pressure of the blood within the vessel, (Par. [0010] and claim 4) and
Nabutovsky, as applied to claim 1 above, is silent regarding the processor being configured to determine vasomotion of a wall of a distal 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 efficiacy 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 efficiacy of renal ablation treatment, as suggested in Zucker. (Par. [0068])
In this combination, the target blood vessel would be considered a “distal vessel” at least in that said target blood vessel would be distal to another blood vessel or other landmark in the patient.
Regarding claim 2, the combination of Nabutovsky/Zucker, as applied to claim 1 above, teaches the processor is configured to:
determine a frequency of the temperature or the impedance over the period of time; (As best understood by examiner in light of the 112b rejections discussed above, and looking to Par. [0061]-[0067] of the present application, it appears that the “frequency of the temperature or the impedance” refers to an oscillation of the temperature and/or impedance; Nabutovsky teaches measuring any changes in impedance over time, which would include any oscillations in impedance.) and
correlate the temperature or the impedance to the flow of blood within the vessel or the arterial pressure of the blood using the frequency of the temperature or the impedance. (Nabutovsky: Par. [0010] and claim 4)
Regarding claim 3, the combination of Nabutovsky/Zucker, as applied to claim 1 above, teaches an energy delivery element configured to deliver neuromodulation energy to a wall of the vessel. (Nabutovsky: Fig. 1 and Par. [0044]: ablation electrodes (16A-B))
Regarding claim 4, the combination of Nabutovsky/Zucker, as applied to claim 3 above, teaches the processor is configured to:
determine the vasomotion of the wall of the distal 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 distal 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 combination based on the rejection to claim 1 above.)
Regarding claim 5, the combination of Nabutovsky/Zucker, 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 combination based on the rejection to claim 1 above.)
Regarding claim 8, the combination of Nabutovsky/Zucker, as applied to claim 1 above, teaches to correlate the temperature or the impedance to the flow of blood or the arterial pressure of the blood the processor is configured to correlate the impedance 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, as applied to claim 8 above, teaches to correlate the impedance to the arterial pressure of the blood within the vessel the processor is configured to:
measure or detect, using the sensor, variations in the impedance at a location on a wall within the vessel over the period of time; (Nabutovsky: Par. [0047]) and
associate the variations in the impedance with the arterial pressure of the blood within the vessel, (Nabutovsky: Par. [0010] and claim 4) wherein the variations in the impedance 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.)
Claim(s) 6, 7, and 10-20 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), as applied to claim 1 above, and further in view of Cholette (US 2014/0276124 A1).
Regarding claim 6, the combination of Nabutovsky/Zucker, as applied to claim 1 above, is silent regarding to correlate the temperature or the impedance to the flow of blood or the arterial pressure of the blood the processor is configured to correlate the temperature to the flow of blood within the vessel.
Cholette, in a similar field of endeavor, teaches measuring temperature changes in blood flow prior to and after ablation; wherein said temperature changes are correlated to a blood flow rate used as an indicator of efficacy of a denervation procedure. (Par. [0072])
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 Cholette, and include the temperature sensing means of Cholette such that the processor of Nabutovsky is configured to correlate the temperature to the flow of blood within the vessel. Doing so would provide a user with more information regarding the state of the treatment zone, and would provide another method of determining/confirming the efficacy of a renal denervation procedure, as suggested in Cholette. (Par. [0072])
Regarding claim 7, the combination of Nabutovsky/Zucker/Cholette, as applied to claim 6 above, teaches to correlate the temperature to the flow of blood within the vessel the processor is configured to:
measure or detect, using the sensor, variations in the temperature at a location on a wall within the vessel over the period of time; (Cholette: Par. [0072] – it is implicit that this feature be present in the Nabutovsky/Zucker/Cholette combination based on the rejection to claim 6 above.) and
associate the variations in the temperature with the flow of blood, wherein the variations in the temperature 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.)
Regarding claim 10, Nabutovsky teaches
a second sensor configured to detect an impedance 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 to an arterial pressure of the blood within the vessel, (Par. [0010] and claim 4) and
Nabutovsky, as applied to claim 10 above, is silent regarding a first sensor configured to detect a temperature at a location on a wall of a vessel over a period of time; the processor being coupled to the first sensor; and the processor being configured to correlate the temperature to a flow of blood within the vessel, and determine vasomotion of the wall of the vessel based on the flow of blood and the arterial pressure of the blood.
Cholette, in a similar field of endeavor, teaches measuring temperature changes in blood flow prior to and after ablation; wherein said temperature changes are correlated to a blood flow rate used as an indicator of efficacy of a denervation procedure. (Par. [0072])
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 10 above, to incorporate the teachings of Cholette, and include the temperature sensing means of Cholette such that the processor of Nabutovsky is configured to correlate the temperature to the flow of blood within the vessel. Doing so would provide a user with more information regarding the state of the treatment zone, and would provide another method of determining/confirming the efficacy of a renal denervation procedure, as suggested in Cholette. (Par. [0072])
Nabutovsky, as applied to claim 10 above, is silent regarding the processor being configured to determine vasomotion of the wall of the vessel based on the flow of blood and the arterial pressure of the blood.
Zucker, in a similar field of endeavor, teaches using vasomotion to determine the efficiacy of a renal ablation treatment; (Par. [0068]) wherein vasomotion of a blood vessel is determined using a sensed blood flow rate over time and a sensed arterial blood pressure 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 the combination of Nabutovsky/Cholette, 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 arterial 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 efficiacy of renal ablation treatment, as suggested in Zucker. (Par. [0068])
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 11, the combination of Nabutovsky/Cholette/Zucker, as applied to claim 10 above, teaches the processor is configured to:
determine a frequency of the temperature and a frequency of the impedance at the location of the wall of the vessel over the period of time; (As best understood by examiner in light of the 112b rejections discussed above, and looking to Par. [0061]-[0067] of the present application, it appears that the “frequency of the temperature or the impedance” refers to an oscillation of the temperature and/or impedance; The combination of Nabutovsky/Cholette/Zucker, as applied to claim 10 above, teaches measuring any changes in impedance over time and changes in temperature over time, which would include any oscillations in impedance or temperature.)
correlate the temperature to the flow of blood based on the frequency of the temperature; (Par. [0072] - it is implicit that this feature be present in the Nabutovsky/Cholette/Zucker combination based on the rejection to claim 10 above.) and
correlate the impedance to the arterial pressure based on the frequency of the impedance. (Nabutovsky: Par. [0010] and claim 4)
Regarding method claim 19, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 11, since operation of the prior art relied on to reject apparatus claim 11 would naturally result in the step of method claim 18 being satisfied.
Regarding claim 12, the combination of Nabutovsky/Cholette/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/Cholette/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/Cholette/Zucker combination based on the rejection to claim 10 above.)
Regarding claim 14, the combination of Nabutovsky/Cholette/Zucker, as applied to claim 14 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/Cholette/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/Cholette/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 Nabutocksy/Cholette/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 Nabutocksy/Cholette/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/Cholette/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; (Fig. 5, Par. [0076]-[0077] – it is implicit that this feature be present in the Nabutovsky/Cholette/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. (Fig. 5, Par. [0076]-[0077] – it is implicit that this feature be present in the Nabutovsky/Cholette/Zucker combination based on the rejection to claim 14 above.)
Regarding claim 16, the combination of Nabutovsky/Cholette/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; (Fig. 5, Par. [0068] and [0076]-[0077] – it is implicit that this feature be present in the Nabutovsky/Cholette/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/Cholette/Zucker, as applied to claim 10 above, teaches variations in the temperature 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 impedance 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.)
Conclusion
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, Linda Dvorak can be reached at 5712724764. 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.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794