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 .
Claim Status
A complete action on the merits of claims 1-20 follows below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hettrick (2016/0095535)
Regarding claim 1, Hettrick teaches a method comprising analyzing a neuromodulation target site of a patient to obtain patient-specific data related to the neuromodulation target site (steps 205-220, Fig. 2);
based on the obtained patient-specific data, updating one or more parameters of an algorithm for delivering neuromodulation therapy via one or more therapy delivery elements of a catheter (evaluation/feedback algorithms 616); and
at least partially ablating nerves of the patient at the neuromodulation target site (steps 225-250, Fig. 2) via neuromodulation therapy delivered via the one or more therapy delivery elements, wherein the neuromodulation therapy is delivered via the one or more therapy delivery elements according to the updated parameters of the algorithm (electrodes 624 deliver RRF energy [0058]).
Regarding claim 2, Hettrick teaches the limitations of claim 1 as previously rejected. Hettrick teaches wherein analyzing the neuromodulation target site includes performing at least one of imaging, modeling, or mapping of the neuromodulation target site ([0065] the treatment site can be determined using IVUS, OCT, and/or other suitable image mapping modalities that can correlate the target treatment site with an identifiable anatomical structure (e.g., a spinal feature) and/or a radio paque ruler (e.g., positioned under or on the patient) before delivering the neuromodulation assembly 620).
Regarding claim 3, Hettrick teaches the limitations of claim 1 as previously rejected. Hettrick teaches wherein the one or more therapy delivery elements comprises ablation electrodes, and wherein analyzing the neuromodulation target site includes determining distances between the ablation electrodes, or impedance data of different combinations of the ablation electrodes (Claim 31 measuring impedance across the first and second electrodes caused by the first stimulus to determine a first impedance).
Regarding claim 4, Hettrick teaches the limitations of claim 1 as previously rejected. Hettrick teaches wherein the patient specific data relates to at least one of electrical properties, thermal properties, or thickness and configuration of tissue at the neuromodulation target site (vessel impedance).
Regarding claim 5, Hettrick teaches the limitations of claim 1 as previously rejected. Hettrick teaches wherein analyzing the neuromodulation target site is performed while the neuromodulation therapy is being delivered to the patient via the one or more therapy delivery elements (according to Fig. 2 after step 225, analyzing the tissue impedance continues and neuromodulation is delivered until the post neuromodulation impedance reaches a certain threshold).
Regarding claim 6, Hettrick teaches the limitations of claim 1 as previously rejected. Hettrick teaches after at least partially ablating the nerves, re-analyzing the neuromodulation target site to obtain a second set of patient-specific data related to the neuromodulation target site; based on the obtained second set of patient-specific data, further updating one or more parameters of the algorithm; and at least partially ablating the nerves of the patient at the neuromodulation target site via neuromodulation therapy delivered via the one or more of the therapy delivery elements according to the further updated parameters of the algorithm (Fig. 2 steps 230-250).
Regarding claim 7, Hettrick teaches the limitations of claim 1 as previously rejected. Hettrick teaches wherein the neuromodulation therapy comprises at least one of electrically-induced, thermally-induced, or chemically-induced ablation of the nerves ([0066] The neuromodulating effects may include denervation, thermal ablation, and/or non-ablative thermal alteration or damage (e.g., via Sustained heating and/or resistive heating).
Regarding claim 8, Hettrick teaches the limitations of claim 1 as previously rejected. Hettrick teaches wherein the neuromodulation target site comprises a renal neuromodulation target site, and wherein at least partially ablating the nerves of the patient comprises at least partially ablating renal nerves of the patient ([0066] Energy from the electrodes 624 (FIG. 6) and/or other energy delivery elements may then be applied to target tissue to induce one or more desired neuromodulating effects on localized regions of the renal artery RA and adjacent regions of the renal plexus RP, which lay intimately within, adjacent to, or in close proximity to the adventitia of the renal artery RA).
Regarding claim 9, Hettrick teaches a system comprising: a medical device (therapeutic system 600 includes console and catheter); and
circuitry (Fig 2) configured to:
analyze a neuromodulation target site of a patient to obtain patient-specific data related to the neuromodulation target site (steps 205-220, Fig. 2),
based on the obtained patient-specific data, update one or more parameters of an algorithm for delivering neuromodulation therapy via one or more therapy delivery elements of a catheter (evaluation/feedback algorithms 616), and
cause the medical device to at least partially ablate nerves of the patient at the neuromodulation target site via neuromodulation therapy (steps 225-250, Fig. 2) delivered via the one or more therapy delivery elements according to the updated parameters of the algorithm (electrodes 624 deliver RF energy [0058]).
Regarding claim 10, Hettrick teaches the limitations of claim 9 as previously rejected above. Hettrick teaches further comprising the catheter (neuromodulation catheter 102), the catheter including: an elongated shaft (elongated shaft 608) having a distal portion configured to be intravascularly positioned at the neuromodulation target site (distal portion 608a); and the one or more therapy delivery elements coupled to the elongated shaft (electrodes 624).
Regarding claim 11, Hettrick teaches the limitations of claim 9 as previously rejected above. Hettrick teaches wherein the medical device comprises the circuitry (616 and Fig. 2).
Regarding claim 12, Hettrick teaches the limitations of claim 9 as previously rejected above. Hettrick teaches wherein the circuitry is configured to receive at least one of imaging, modeling, or a mapping of the neuromodulation target site and analyze the target site based on the at least one of imaging, modeling, or a mapping of the neuromodulation target site ([0065] the treatment site can be determined using IVUS, OCT, and/or other suitable image mapping modalities that can correlate the target treatment site with an identifiable anatomical structure (e.g., a spinal feature) and/or a radio paque ruler (e.g., positioned under or on the patient) before delivering the neuromodulation assembly 620).
Regarding claim 13, Hettrick teaches the limitations of claim 9 as previously rejected above. Hettrick teaches wherein the one or more therapy delivery elements comprises ablation electrodes (electrodes 624) , and wherein to analyze the neuromodulation target site, the circuitry is configured to determine distances between the ablation electrodes, or impedance data of different combinations of the ablation electrodes (Claim 31 measuring impedance across the first and second electrodes caused by the first stimulus to determine a first impedance).
Regarding claim 14, Hettrick teaches the limitations of claim 9 as previously rejected above. Hettrick teaches wherein the patient specific data relates to at least one of electrical properties, thermal properties, or thickness and configuration of tissue at the neuromodulation target site (vessel impedance).
Regarding claim 15, Hettrick teaches the limitations of claim 9 as previously rejected above. Hettrick teaches wherein the circuitry is configured to analyze the neuromodulation target site while the medical device is delivering the neuromodulation therapy to the neuromodulation target site via the one or more therapy delivery elements (according to Fig. 2 after step 225, analyzing the tissue impedance continues and neuromodulation is delivered until the post neuromodulation impedance reaches a certain threshold).
Regarding claim 16, Hettrick teaches the limitations of claim 9 as previously rejected above. Hettrick teaches wherein the circuitry is further configured to: after the nerves are at least partially ablated, re-analyze the neuromodulation target site to obtain a second set of patient-specific data related to the neuromodulation target site; based on the obtained second set of patient-specific data, further update one or more parameters of the algorithm; and cause the medical device to at least partially ablate the nerves of the patient at the neuromodulation target site via neuromodulation therapy delivered via the one or more of the therapy delivery elements according to the further updated parameters of the algorithm (Fig. 2 steps 230-250).
Regarding claim 17, Hettrick teaches the limitations of claim 9 as previously rejected above. Hettrick teaches Wherein the medical device is configured to deliver neuromodulation therapy comprising at least one of electrically-induced, thermally-induced, or chemically-induced ablation therapy ([0066] The neuromodulating effects may include denervation, thermal ablation, and/or non-ablative thermal alteration or damage (e.g., via Sustained heating and/or resistive heating)).
Regarding claim 18, Hettrick teaches a system, comprising:
a medical device (therapeutic system 600 includes console and catheter); and
circuitry configured to:
analyze a renal neuromodulation target site of a patient to obtain patient-specific data related to the renal neuromodulation target site (steps 205-220, Fig. 2),
based on the obtained patient-specific data, update one or more parameters of an algorithm for delivering renal neuromodulation energy via a renal neuromodulation catheter (evaluation/feedback algorithms 616), and
at least partially ablate renal nerves of the patient at the renal neuromodulation target site via renal neuromodulation energy delivered via renal neuromodulation catheter according to the updated parameters of the algorithm (steps 225-250, Fig. 2 [0058]).
Regarding claim 19, Hettrick teaches the limitations of claim 18 as previously rejected above. Hettrick teaches wherein the circuitry is configured to receive at least one of imaging, modeling, or a mapping of the neuromodulation target site and analyze the target site based on the at least one of imaging, modeling, or a mapping of the neuromodulation target site ([0065] the treatment site can be determined using IVUS, OCT, and/or other suitable image mapping modalities that can correlate the target treatment site with an identifiable anatomical structure (e.g., a spinal feature) and/or a radiopaque ruler (e.g., positioned under or on the patient) before delivering the neuromodulation assembly 620).
Regarding claim 20, Hettrick teaches the limitations of claim 18 as previously rejected above. Hettrick teaches wherein the patient specific data relates to at least one of electrical properties, thermal properties, or thickness and configuration of tissue at the renal neuromodulation target site ([0066] The neuromodulating effects may include denervation, thermal ablation, and/or non-ablative thermal alteration or damage (e.g., via Sustained heating and/or resistive heating)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
/Y.E/Examiner, Art Unit 3794
