Prosecution Insights
Last updated: April 19, 2026
Application No. 17/930,303

SYSTEMS AND METHODS FOR MONITORING AND EVALUATING NEUROMODULATION THERAPY

Final Rejection §103
Filed
Sep 07, 2022
Examiner
KUO, JONATHAN T
Art Unit
3792
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Medtronic Ireland Manufacturing Unlimited Company
OA Round
6 (Final)
73%
Grant Probability
Favorable
7-8
OA Rounds
2y 10m
To Grant
99%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allow Rate
332 granted / 457 resolved
+2.6% vs TC avg
Strong +27% interview lift
Without
With
+27.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
43 currently pending
Career history
500
Total Applications
across all art units

Statute-Specific Performance

§101
4.5%
-35.5% vs TC avg
§103
45.4%
+5.4% vs TC avg
§102
16.7%
-23.3% vs TC avg
§112
21.1%
-18.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 457 resolved cases

Office Action

§103
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 This office action is responsive to the amendment filed on 8/25/2025. As directed by the amendment, the status of the claim(s) are: Claim(s) 26, 32-35, 41-42, 44-47 has/have been amended; Claim(s) 1-25, 28-29, 37-38 is/are cancelled; Claim(s) 26-27, 30-36, 39-48 is/are presently pending. The amendment(s) to the claim(s) is sufficient to overcome the claim objection(s) from the previous office action. Response to Arguments Applicant remarks/amendments with respect to 101 overcome the previous 101 rejection(s). In addition to claim amendments and applicant remarks, the claim(s) would seem to integrate the elements into a practical application in light of the memorandum of 8/4/2025, “Reminders on evaluating subject matter eligibility of claims under 35 U.S.C. 101”; https://www.uspto.gov/sites/default/files/documents/memo-101-20250804.pdf. Applicant argues on p. 9-10 of remarks that the prior art of record does not teach the amended limitations of “at a target site at which no neuromodulation has been previously delivered within a blood vessel of a patient, prior to delivering a prospective neuromodulation therapy to the patient at the target site determining, by a controller, prior to delivering the prospective neuromodulation therapy to the patient at the target site, a determined value of a physiological parameter indicative of patient responsiveness to the prospective neuromodulation therapy at the target site based on the measurement”. However, after review, this is not persuasive. As is claim mapped in the rejection below, Toth teaches evaluating and mapping nerves in blood vessel prior to neuromodulation and delivering ablation only after it is determined that the location is suitable for surgical intervention ([0374] “Once determined, such information may be used to selectively ablate such tissues”; [0375] “find a more ideal location at which to ablate it”; [0378] “The method may include assessing the result set to decide if the location is suitable for performing a surgical procedure, if it is not then the system may move and/or assess an alternative location in the body. If the location is suitable for a surgical procedure then the method may include performing at least a portion of a surgical procedure thereupon”; [0376] “monitoring a physiologic signal at a first monitoring location…to generate a first signal set, and monitoring a physiologic signal at a second monitoring location…and/or the first monitoring location to generate a second signal set. The method includes analyzing the signal sets to generate a result…The result may be compared against criteria to determine if a procedure should be performed or not”; [0385] “step of monitoring to determine an updated signal may be performed before, during, and/or after the step of performing at least a portion of the surgical procedure”). Applicant additionally argues on p. 10 that the prior art of record does not teach “predetermined threshold value of a physiological parameter” because it is impossible for the first signal set or the second signal set to be predetermined before it is measured, comparing a first signal to the second signal set, whether at the same location or at different location, is not a teaching or suggestion of comparing a determined value of a physiological parameter to a predetermined threshold value and Toth’s alleged comparison of a signal to “itself” is not comparing a determined value of a physiological parameter to a predetermined threshold value. After review, this is not persuasive, Toth teaches (emphasis added) [0376] “monitoring a physiologic signal at a first monitoring location…to generate a first signal set, and monitoring a physiologic signal at a second monitoring location…and/or the first monitoring location to generate a second signal set. The method includes analyzing the signal sets to generate a result…The result may be compared against criteria to determine if a procedure should be performed or not”; [0385] “step of monitoring to determine an updated signal may be performed before, during, and/or after the step of performing at least a portion of the surgical procedure”. Toth is teaching that first monitoring location is the same location in order to measure first and second signal sets to be compared against a criteria in order to determine whether to perform the procedure which is a neural modulation. The Mirraim-Webster dictionary definition of “criteria” is (https://www.merriam-webster.com/dictionary/criterion) “a standard on which a judgment or decision may be based” and so would read on the recited predetermined threshold value on which the comparing is made. Toth teaches that the physiologic signal can be various physiological parameters ([0049]). Note that Toth’s teaching of “result” from signal sets in [0376] “analyzing the signal sets to generate a result (e.g. a difference between the signal sets, a change in set compared with a previous result, a patient population, etc.”) means that “result” is a physiologic signal since measured physiologic signal is being compared to itself or equivalent from a patient population. Applicant further argues on p. 10 last paragraph that Toth does not specifically describe a comparison of a value of a physiological parameter and that Toth’s teaching of comparing change or a difference without any reference to comparing a determined value [itself] with a predetermined threshold value of the physiological parameter would not meet the claim limitation of “predetermined threshold value of a physiological parameter”. This is not persuasive because Toth’s teaching of comparing against criteria would mean that there is a standard or predetermined value that is being compared to. Toth [0376]’s teaching of “analyzing the signal sets to generate a result (e.g. a difference between the signal sets, a change in a set compared with a previous result, a patient population, etc.” would also be equivalent to comparison of a determined value of the physiological parameter to a predetermined threshold value of the physiological parameter. For example, comparing to patient population would mean that the average signal from patent population would be the “predetermined threshold” as claimed. Having a criteria be based on how much difference there is between signal sets or how much of a change in signal sets occurs would be equivalent to comparing to a ”predetermined threshold value”; e.g. a difference/change of 50% to determine whether to ablate is no different than comparing to a predetermined threshold value set at 50% of the physiological parameter to determine whether to ablate. Applicant is reminded that the pre-appeal or appeal process is available should they feel that they are at an impasse with Examiner. 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. Claim(s) 26, 30-35, 39-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth (US 20160029960 A1; PCT 371 filed 9/25/2015; cited in IDS; cited in previous office action) in view of Edwards (US 20130116737 A1; 5/9/2013; cited in previous office action). Regarding claim 26, Toth teaches a method comprising: obtaining, by a sensing element at a target site at which no neuromodulation has been previously delivered within a blood vessel of a patient, (Fig. 2k-2m; Fig. 3a-3d; [0008] "guidewire for monitoring physiologic signals"; [0018]; [0027] "delivery catheter"; [0374] “Once determined, such information may be used to selectively ablate such tissues”; [0375] “find a more ideal location at which to ablate it”; [0378] “The method may include assessing the result set to decide if the location is suitable for performing a surgical procedure, if it is not then the system may move and/or assess an alternative location in the body. If the location is suitable for a surgical procedure then the method may include performing at least a portion of a surgical procedure thereupon”), prior to delivering a prospective neuromodulation therapy to the patient at the target site (Fig. 1c; [0376] “monitoring a physiologic signal at a first monitoring location…to generate a first signal set, and monitoring a physiologic signal at a second monitoring location…and/or the first monitoring location to generate a second signal set. The method includes analyzing the signal sets to generate a result…The result may be compared against criteria to determine if a procedure should be performed or not”; [0385] “step of monitoring to determine an updated signal may be performed before, during, and/or after the step of performing at least a portion of the surgical procedure”), a measurement related to a hemodynamic parameter of the patient (Fig. 1a; Fig. 1c; Fig. 2o; [0049]; [0054]; [0098]; [0155]; [0268]); determining, by a controller (Fig. 1b, controller 120), prior to delivering the prospective neuromodulation therapy to the patient at the target site, a determined value of a physiological parameter indicative of patient responsiveness to the prospective neuromodulation therapy at the target site based on the measurement ([0057]; [0376]; [0385]); determining, by the controller (Fig. 1b, controller 120) and based on the determined value of the physiological parameter, prior to delivering the prospective neuromodulation therapy to the patient at the target site, a likelihood of the patient benefitting from the prospective neuromodulation therapy being delivered to the patient at the target site; ([0376] "The result may be compared against criteria to determine if a procedure should be performed or not"; [0205] "for predicting the outlook of a subject after a surgery or a procedure"; [0213]); and indicating, by the controller, prior to delivering the prospective neuromodulation therapy to the patient at the target site, the likelihood of the patient benefitting from the prospective neuromodulation therapy being delivered to the patient at the target site (Fig. 1b-1c; [0376] "The result may be compared against criteria to determine if a procedure should be performed or not"; [0205] "for predicting the outlook of a subject after a surgery or a procedure"; [0213]), wherein the blood vessel comprises a renal blood vessel (Fig. 2o; [0049]). Toth does not teach wherein the physiological parameter comprises a renal vascular resistance. Note that Toth does teach measuring various physiological parameters which include “vessel wall stiffness” ([0049]). However, Edwards teaches in the same field of endeavor (Fig. 1-2) wherein the physiological parameter comprises a renal vascular resistance ([0047] “renal vascular resistance may be measured”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Toth to include this feature as taught by Edwards because this enables measuring this parameter to evaluate neuromodulation effect or “likely success” (Fig. 3; [0049]). In the combination of Toth and Edwards, Toth teaches wherein determining the likelihood of the patient benefitting from the prospective neuromodulation therapy being delivered to the patient at the target site comprises comparing the determined value of the physiological parameter to a predetermined threshold value of the physiological parameter ([0376] "analyzing the signal sets to generate a result…The result may be compared against criteria"). Regarding claim 30, in the combination of Toth and Edwards, Toth teaches wherein the sensing element comprises at least one of an electrocardiogram sensor ([0084] “electrocardiographic signal”), a pressure sensor ([0084] “pressure sensor”), a temperature sensor ([0084] “temperature sensor”), a flow sensor ([0057] “blood flow”), an impedance sensor ([0084] “bioimpedance”), a flow rate sensor ([0057] “blood flow…blood flow differential signal”), a chemical sensor ([0057]; “analyte level”; [0085]), a bio-sensing element ([0084]-[0085]), an electrochemical sensor([0084] “extracellular potential electrode”; [0085] “electrochemical”), a hemodynamic sensor ([0041]; [0057]; [0084]), or an optical sensor ([0085] “electro-optical”; [0103]). Regarding claim 31, in the combination of Toth and Edwards, Toth teaches wherein a guidewire comprises the sensing element (Fig. 2k-2m; Fig. 3a-3d; [0008] "guidewire for monitoring physiologic signals"; [0018]; [0027]). Regarding claim 32, in the combination of Toth and Edwards, Toth teaches wherein a catheter assembly comprises the sensing element (Fig. 2k-2m; Fig. 3a-3d; [0008] "guidewire for monitoring physiologic signals"; [0018]; [0027] "delivery catheter"), and wherein the catheter assembly is configured to deliver the prospective neuromodulation therapy to the target site as an actual neuromodulation therapy (Fig. 2j; [0245]; Fig. 21; Fig. 3B; [0259] "over which an additional catheter ... may be deployed"; [0280] ablation/stimulation tool 327 ... allowing the second tool 327 to take on a deployed shape (in this case a helical shape)"; [0262] "catheter electrode(s)"). Regarding claim 33, in the combination of Toth and Edwards, Toth teaches wherein the catheter assembly is configured to deliver the actual neuromodulation therapy by at least delivering energy, a chemical, or cryogenic cooling to the target site ([0046]). Regarding claim 34, in the combination of Toth and Edwards, Toth teaches wherein determining the likelihood of the patient benefitting from the prospective neuromodulation therapy comprises determining the patient will likely benefit from the prospective neuromodulation therapy ([0376] "The result may be compared against criteria to determine if a procedure should be performed or not"; [0205]; [0378] "if the location is suitable for a surgical procedure"), the method further comprising causing a medical device to apply the prospective neuromodulation therapy as an actual neuromodulation therapy to the target site to at least partially ablate nerves proximate to a wall of the blood vessel based on determining the patient will likely benefit from the prospective neuromodulation therapy ([0015] "ablation"; [0026]-[0027]; Fig. 2j; [0075] "nerve ablation"; [0175]; [0245] neuromodulation"; [0352] "ablate the nerves"). Regarding claim 35, Toth teaches a system comprising: a sensing element (Fig. 2k-2m; Fig. 3a-3d; [0008] "guidewire for monitoring physiologic signals"; [0018]; [0027] "delivery catheter") configured to sense a hemodynamic parameter at a target site at which no neuromodulation has been previously delivered within a blood vessel of a patient (Fig. 1a; Fig. 1c; Fig. 2o; [0049]; [0054]; [0098]; [0155]; [0268]; [0374] “Once determined, such information may be used to selectively ablate such tissues”; [0375] “find a more ideal location at which to ablate it”; [0378] “The method may include assessing the result set to decide if the location is suitable for performing a surgical procedure, if it is not then the system may move and/or assess an alternative location in the body. If the location is suitable for a surgical procedure then the method may include performing at least a portion of a surgical procedure thereupon”); and a controller (Fig. 1b, controller 120) configured to: receive, from the sensing element, prior to a prospective neuromodulation therapy being delivered to the patient at the target site, a measurement related to the hemodynamic parameter ([0057]; [0376] “monitoring a physiologic signal at a first monitoring location…to generate a first signal set, and monitoring a physiologic signal at a second monitoring location…and/or the first monitoring location to generate a second signal set. The method includes analyzing the signal sets to generate a result…The result may be compared against criteria to determine if a procedure should be performed or not”; [0385] “step of monitoring to determine an updated signal may be performed before, during, and/or after the step of performing at least a portion of the surgical procedure”), determine, prior to the prospective neuromodulation therapy being delivered to the patient at the target site, a determined value of the physiological parameter indicative of patient responsiveness to the neuromodulation therapy being delivered to the patient at the target site based on the measurement ([0057]; [0376]), determine, based on the determined value of the physiological parameter, prior to the prospective neuromodulation therapy being delivered to the patient at the target site, a likelihood of the patient benefitting from the prospective neuromodulation therapy being delivered at the target site ([0376] "The result may be compared against criteria to determine if a procedure should be performed or not"; [0205] "for predicting the outlook of a subject after a surgery or a procedure"; [0213]), and indicate, prior to the prospective neuromodulation therapy being delivered to the patient at the target site, the likelihood of the patient benefitting from the prospective neuromodulation therapy being delivered to the patient at the target site (Fig. 1b-1c; [0376] "The result may be compared against criteria to determine if a procedure should be performed or not"; [0205] "for predicting the outlook of a subject after a surgery or a procedure"; [0213]), wherein the blood vessel comprises a renal blood vessel (Fig. 2o; [0049]). Toth does not teach wherein the physiological parameter comprises a renal vascular resistance. Note that Toth does teach measuring various physiological parameters which include “vessel wall stiffness” ([0049]). However, Edwards teaches in the same field of endeavor (Fig. 1-2) wherein the physiological parameter comprises a renal vascular resistance ([0047] “renal vascular resistance may be measured”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Toth to include this feature as taught by Edwards because this enables measuring this parameter to evaluate neuromodulation effect or “likely success” (Fig. 3; [0049]). In the combination of Toth and Edwards, Toth teaches wherein the controller is configured to determine the likelihood of the patient benefitting from the prospective neuromodulation therapy being delivered to the patient at the target site by at least comparing the determined value of the physiological parameter to a predetermined threshold value of the physiological parameter ([0376] "analyzing the signal sets to generate a result…The result may be compared against criteria"). Regarding claim 39, in the combination of Toth and Edwards, Toth teaches wherein the sensing element comprises at least one of an electrocardiogram sensor ([0084] “electrocardiographic signal”), a pressure sensor ([0084] “pressure sensor”), a temperature sensor ([0084] “temperature sensor”), a flow sensor ([0057] “blood flow”), an impedance sensor ([0084] “bioimpedance”), a flow rate sensor ([0057] “blood flow…blood flow differential signal”), a chemical sensor ([0057]; “analyte level”; [0085]), a bio-sensing element ([0084]-[0085]), an electrochemical sensor([0084] “extracellular potential electrode”; [0085] “electrochemical”), a hemodynamic sensor ([0041]; [0057]; [0084]), or an optical sensor ([0085] “electro-optical”; [0103]). Regarding claim 40, in the combination of Toth and Edwards, Toth teaches further comprising a guidewire, wherein the guidewire comprises the sensing element (Fig. 2k-2m; Fig. 3a-3d; [0008] "guidewire for monitoring physiologic signals"; [0018]; [0027]). Regarding claim 41, in the combination of Toth and Edwards, Toth teaches further comprising a catheter assembly configured to deliver the prospective neuromodulation therapy to the target site as an actual neuromodulation therapy, (Fig. 2j; [0245]; Fig. 21; Fig. 3B; [0259] "over which an additional catheter ... may be deployed"; [0280] ablation/stimulation tool 327 ... allowing the second tool 327 to take on a deployed shape (in this case a helical shape)"; [0262] "catheter electrode(s)"), wherein the catheter assembly comprises the sensing element (Fig. 2k-2m; Fig. 3a-3d; [0008] "guidewire for monitoring physiologic signals"; [0018]; [0027] "delivery catheter"). Regarding claim 42, in the combination of Toth and Edwards, Toth teaches wherein the catheter assembly is configured to deliver the actual neuromodulation therapy by at least delivering energy to the target site ([0046]). Regarding claim 43, in the combination of Toth and Edwards, Toth teaches wherein the energy comprises at least one of radiofrequency energy ([0046]), pulsed electrical energy ([0162] “ablation pulses”), microwave energy ([0261] “microwave”), optical energy ([0139] “laser ablation”), ultrasound energy ([0046]), direct heat energy ([0046]), or radiation. Regarding claim 44, in the combination of Toth and Edwards, Toth teaches wherein the catheter assembly is configured to deliver the actual neuromodulation therapy by at least delivering a chemical to the target site ([0139] “chemical”). Regarding claim 45, in the combination of Toth and Edwards, Toth teaches wherein the catheter assembly is configured to deliver the actual neuromodulation therapy by at least applying cryogenic cooling to the target site ([0046] “cryoablation”). Regarding claim 46, in the combination of Toth and Edwards, Toth teaches further comprising a catheter assembly configured to deliver neuromodulation therapy to the target site (Fig. 2j; [0245]; Fig. 21; Fig. 3B; [0259] "over which an additional catheter ... may be deployed"; [0280] ablation/stimulation tool 327 ... allowing the second tool 327 to take on a deployed shape (in this case a helical shape)"; [0262] "catheter electrode(s)"), wherein the controller is configured to determine the patient will likely benefit from the prospective neuromodulation therapy ([0376] "The result may be compared against criteria to determine if a procedure should be performed or not"; [0205]; [0378] "if the location is suitable for a surgical procedure") and, based on determining the patient will likely benefit from the prospective neuromodulation therapy, cause the delivery of the prospective neuromodulation therapy as an actual neuromodulation therapy via the catheter assembly to at least partially ablate nerves proximate to a wall of the blood vessel ([0015] "ablation"; [0026]-[0027]; Fig. 2j; [0075] "nerve ablation"; [0175]; [0245] neuromodulation"; [0352] "ablate the nerves"). Regarding claim 47, Toth teaches a system comprising: a catheter assembly configured to be positioned at a target site at which no neuromodulation has been previously delivered ([0374] “Once determined, such information may be used to selectively ablate such tissues”; [0375] “find a more ideal location at which to ablate it”; [0378] “The method may include assessing the result set to decide if the location is suitable for performing a surgical procedure, if it is not then the system may move and/or assess an alternative location in the body. If the location is suitable for a surgical procedure then the method may include performing at least a portion of a surgical procedure thereupon”) within a renal blood vessel of a patient (Fig. 2o; Fig. 3A-3D; [0275] “renal artery”), wherein the catheter assembly is configured to deliver renal neuromodulation therapy to the target site (Fig. 2j; [0245]; Fig. 21; Fig. 3B; [0259] "over which an additional catheter ... may be deployed"; [0280] ablation/stimulation tool 327 ... allowing the second tool 327 to take on a deployed shape (in this case a helical shape)"; [0262] "catheter electrode(s)"); a sensing element (Fig. 2k-2m; Fig. 3a-3d; [0008] "guidewire for monitoring physiologic signals"; [0018]; [0027] "delivery catheter"); and a controller (Fig. 1b, controller 120) configured to: receive, from the sensing element, prior to the prospective renal neuromodulation therapy being delivered to the patient the target site, a measurement related to the hemodynamic parameter ([0057]; [0376] “monitoring a physiologic signal at a first monitoring location…to generate a first signal set, and monitoring a physiologic signal at a second monitoring location…and/or the first monitoring location to generate a second signal set. The method includes analyzing the signal sets to generate a result…The result may be compared against criteria to determine if a procedure should be performed or not”; [0385] “step of monitoring to determine an updated signal may be performed before, during, and/or after the step of performing at least a portion of the surgical procedure”), determine, prior to the prospective renal neuromodulation therapy being delivered to the patient at the target site, a determined value of a physiological parameter indicative of patient responsiveness to the prospective renal neuromodulation therapy at the target site based on the measurement ([0057]; [0376]), determine, based on the determined value of the physiological parameter, prior to the prospective renal neuromodulation therapy being delivered to the patient at the target site, the patient will likely benefit from the prospective renal neuromodulation therapy being delivered to the patient at the target site ([0376] "The result may be compared against criteria to determine if a procedure should be performed or not"; [0205] "for predicting the outlook of a subject after a surgery or a procedure"; [0213]), and based on determining the patient will likely benefit from the prospective renal neuromodulation therapy, cause delivery of the prospective renal neuromodulation therapy as an actual renal neuromodulation therapy via the catheter assembly to at least partially ablate nerves proximate to a wall of the renal blood vessel ([0015] "ablation"; [0026]-[0027]; Fig. 2j; [0075] "nerve ablation"; [0175]; [0245] neuromodulation"; [0352] "ablate the nerves"). Toth does not teach wherein the physiological parameter comprises a renal vascular resistance. Note that Toth does teach measuring various physiological parameters which include “vessel wall stiffness” ([0049]). However, Edwards teaches in the same field of endeavor (Fig. 1-2) wherein the physiological parameter comprises a renal vascular resistance ([0047] “renal vascular resistance may be measured”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Toth to include this feature as taught by Edwards because this enables measuring this parameter to evaluate neuromodulation effect or “likely success” (Fig. 3; [0049]). In the combination of Toth and Edwards, Toth teaches wherein the controller is configured to determine the likelihood of the patient benefitting from the prospective renal neuromodulation therapy being delivered to the patient at the target site by at least comparing the determined value of the physiological parameter to a predetermined threshold value of the physiological parameter ([0376] "analyzing the signal sets to generate a result…The result may be compared against criteria"). Allowable Subject Matter Claims 27, 36, 48 are 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. The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of dependent claim 27 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the blood vessel comprises a renal blood vessel, and wherein physiological parameter comprises a renal wave speed. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of dependent claim 36 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the blood vessel comprises a renal blood vessel, and wherein the physiological parameter comprises a renal wave speed. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of dependent claim 48 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the physiological parameter comprises a renal wave speed. 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 Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT. 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, Niketa Patel can be reached at 571-272-4156. 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. /JONATHAN T KUO/Primary Examiner, Art Unit 3792
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Prosecution Timeline

Sep 07, 2022
Application Filed
Nov 15, 2023
Examiner Interview (Telephonic)
Nov 17, 2023
Non-Final Rejection — §103
Feb 05, 2024
Examiner Interview Summary
Feb 05, 2024
Applicant Interview (Telephonic)
Feb 22, 2024
Response Filed
Mar 27, 2024
Final Rejection — §103
May 14, 2024
Examiner Interview Summary
May 14, 2024
Applicant Interview (Telephonic)
May 30, 2024
Response after Non-Final Action
Jun 27, 2024
Response after Non-Final Action
Jun 27, 2024
Examiner Interview (Telephonic)
Aug 02, 2024
Request for Continued Examination
Aug 06, 2024
Response after Non-Final Action
Aug 26, 2024
Non-Final Rejection — §103
Dec 02, 2024
Response Filed
Jan 24, 2025
Final Rejection — §103
Mar 31, 2025
Response after Non-Final Action
Apr 28, 2025
Request for Continued Examination
Apr 29, 2025
Response after Non-Final Action
May 23, 2025
Non-Final Rejection — §103
Aug 25, 2025
Response Filed
Sep 08, 2025
Final Rejection — §103 (current)

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Prosecution Projections

7-8
Expected OA Rounds
73%
Grant Probability
99%
With Interview (+27.4%)
2y 10m
Median Time to Grant
High
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