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 .
Status of Claims
Claims 1-22 are presently pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 09/18/2024, 02/26/2024, and 07/15/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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) 1 and 3-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava (US 2015/0066007 A1), hereinafter Srivastava in view of Himmelstein et al. (US 2014/0012251 A1), hereinafter Himmelstein, and further in view of Shimada et al. (US 2022/0095979 A1), hereinafter Shimada.
Regarding claim 1, Srivastava discloses a method for use in evaluating neural electrical activity of renal nerves in tissue surrounding a renal artery of a patient for which a renal denervation procedure has been or is going to be performed ([0001] “the present technology are related to neuromodulation catheters having nerve monitoring features for transmitting digital neural signals”, [0023] “Neuromodulation catheters configured in accordance with at least some embodiments of the present technology can include contacts that record neural signals before and/or after neuromodulation and a digitizer that digitizes the recorded neural signals and transmits the digitized neural signals to an extracorporeal device.”), the method comprising:
inserting a distal portion of a guide catheter (guide catheter 135) through an abdominal aorta (view Figures 2 and 3D) of a patient such that the distal portion of the guide catheter is positioned adjacent to a renal artery ostium located along a lateral aspect of the abdominal aorta ([0133] “A catheter may be inserted percutaneously into the femoral artery through this access site, passed through the iliac artery and aorta, and placed into either the left or right renal artery.”)
using the guide catheter to insert a distal portion of a mapping catheter (neuromodulation assembly 120, [0025] “a neuromodulation assembly 120 operably connected to the shaft 108 at the distal portion 108b”, view Figure 1) through a distal most end of the guide catheter such that the distal portion of the mapping catheter is positioned within the renal artery of the patient (view Figure 3A and 3D: the neuromodulation assembly 120 is located in the renal artery RA, [0026] “the neuromodulation catheter 102 can be configured for delivery via a guide catheter or sheath (not shown).”) ;
while the distal portion of the mapping catheter is positioned within the renal artery of the patient (view Figure 3D: the neuromodulation assembly 120 is located in the renal artery RA),
using a stimulation electrode to deliver one or more electrical stimulation pulses to thereby evoke a neural electrical response from at least some of the renal nerves in tissue surrounding the renal artery ([0049] “the contacts 124 can be configured to deliver energy to nerves proximate to a treatment site in a blood vessel or other body lumen. For example, the contacts 124 can be electrodes that deliver therapeutic levels of RF energy and/or other forms of electrical energy to nerves proximate to the target site.”), wherein the stimulation electrode is located on the mapping catheter, on the distal portion of the guide catheter, or on a guidewire (view Figure 3A: the contacts 124 are on the neuromodulation assembly 120); and
using a sense electrode positioned in the renal artery, downstream from the stimulation electrode, to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses ([0050] “In certain embodiments, one or more of the contacts 124 along the support member 122 can record electrical activity from the nerves proximate to the vessel wall, and in other embodiments contacts 124.sub.i integrated with the digitizer 128 can perform the recording function. The neural activity can be recorded from the nerves at their natural state and/or after applying nontherapeutic and/or therapeutic levels of stimulation.”), wherein the sense electrode is located on the mapping catheter (view Figure 3A: the contacts 124 are on the neuromodulation assembly 120); and using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as a pre-denervation or post-denervation measurement associated with a renal denervation procedure ([0050] “The neural activity can be recorded from the nerves at their natural state and/or after applying nontherapeutic and/or therapeutic levels of stimulation.”)
Srivastava fails to disclose the stimulation electrode is positioned in abdominal aorta within 10 mm of the renal artery ostium and that the sense electrode positioned in the renal artery, downstream from the stimulation electrode.
However, Himmelstein teaches an ablation device for denervation including a catheter delivery mechanism wherein the stimulation electrode is positioned in abdominal aorta within 10 mm of the renal artery ostium ([0028] “The device is advanced longitudinally through the blood vessel, e.g., over a guide wire, to the relevant location within the body lumen, such as within the aorta, and into the desired position within the inner circumference of the vessel, such as at the renal artery ostium of the aorta.”, [0140] “The purpose of positioning the electrodes 408 on one side of the wire frame 403 is so that, when the wire frame 403 is expanded within the aorta and the against the insides of the aorta, the electrodes 408 would be situated on one specific side of the aorta, e.g., the side that branches off to the renal artery for more effective ablation of, e.g., the renal nerve, called the renal artery ostium”, [0158] “For example, when denervation is desired for the renal artery, which is approximately 6-7 mm in diameter at the ostium of the aorta, the diameter of the circular RF electrodes 408 must be at least that distance, i.e., 7 mm, in order to properly provide ablation at the renal artery ostium.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava to incorporate the teachings of Himmelstein to have the stimulation electrode positioned in abdominal aorta within 10 mm of the renal artery ostium, as these prior art references are directed to renal denervation devices. One would be motivated to do this as the renal artery ostium allows for the desired effects of denervation of the kidney without affecting blood flow from the aorta, as recognized by Himmelstein ([0016]).
Srivastava and Himmelstein, alone or in combination, fail to teach the sense electrode positioned in the renal artery, downstream from the stimulation electrode.
However, Shimada teaches a system for use in analyzing neural activity of nerves surrounding a biological lumen wherein a sense electrode positioned in the renal artery, downstream from the stimulation electrode ([0072] “FIG. 3 illustrates one example of use of such a probe, in which a probe 302 such as that shown in FIG. 1 or FIG. 2 (or FIGS. 17A and 17B discussed below) is introduced into a blood vessel, such as an artery 304, in a location near a body organ such as kidney 306. The probe is introduced via a sheath in some examples, such as where a sheath is advanced to the intended probe location in the artery, and then withdrawn sufficiently to expose the probe 302 to the artery 304. The probe 302 here comprises a stimulation electrode such as electrodes 104 and 204 of FIGS. 1 and 2, and a sense electrode such as electrodes 106 and 206 of the same Figures.”, [0075] “FIG. 4 shows an intraluminal microneurography probe and sheath assembly coupled to associated instrumentation, consistent with an example. Here, a probe body 402 has an expandable sense electrode 404 and an expandable stimulation electrode 406, couple via wires to instrumentation. A sheath 408 is used to introduce the probe into an artery or other biological lumen or suitable location,”)).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Himmelstein to incorporate the teachings of Shimada to have a sense electrode positioned in the renal artery, downstream from the stimulation electrode, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as so the sensor may measure the downstream neural activity, as recognized by Shimada ([0095]).
Regarding claim 3, Srivastava in view of Himmelstein in view of Shimada teaches the method of claim 1 (as shown above). Srivastava and Himmelstein, alone or in combination, fail to teach wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 1.5 centimeters.
However, Shimada teaches wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 1.5 centimeters ([0164] “The center-to-center axial distance between the two mesh electrodes E2 and E3 (aka the mesh electrodes 1706 and 1704), when they are both deployed, can be referred to as the distance d23. In accordance with certain embodiments, the distance d23 is within the range of 1 cm to 10 cm (which distance should be selected such that the evoked action potential of the neural response do not reach the electrode E3 until any stimulus artifact effect has subsided), with the d23 distance preferably being about 3 cm”, [0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bi-polar nerve stimulation. In accordance with certain embodiments, the electrodes E3, E4, and E5 are used for sensing nerve activity.”, view Figure 17).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Himmelstein to have the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 1.5 centimeters, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as at these distances stimulus artifact effects may have subsided, as recognized by Shimada ([0165]).
Regarding claim 4, Srivastava in view of Himmelstein in view of Shimada teaches the method of claim 1 (as shown above). Srivastava and Himmelstein, alone or in combination, fail to teach wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 1.5 centimeters.
However, Shimada teaches wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 2.0 centimeters ([0164] “The center-to-center axial distance between the two mesh electrodes E2 and E3 (aka the mesh electrodes 1706 and 1704), when they are both deployed, can be referred to as the distance d23. In accordance with certain embodiments, the distance d23 is within the range of 1 cm to 10 cm (which distance should be selected such that the evoked action potential of the neural response do not reach the electrode E3 until any stimulus artifact effect has subsided), with the d23 distance preferably being about 3 cm”, [0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bi-polar nerve stimulation. In accordance with certain embodiments, the electrodes E3, E4, and E5 are used for sensing nerve activity.”, view Figure 17).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Himmelstein to have the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 2.0 centimeters, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as at these distances stimulus artifact effects may have subsided, as recognized by Shimada ([0165]).
Regarding claim 5, Srivastava in view of Himmelstein in view of Shimada teaches the method of claim 1 (as shown above). Srivastava and Himmelstein, alone or in combination, fail to teach wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 3.0 centimeters.
However, Shimada teaches wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 3.0 centimeters ([0164] “The center-to-center axial distance between the two mesh electrodes E2 and E3 (aka the mesh electrodes 1706 and 1704), when they are both deployed, can be referred to as the distance d23. In accordance with certain embodiments, the distance d23 is within the range of 1 cm to 10 cm (which distance should be selected such that the evoked action potential of the neural response do not reach the electrode E3 until any stimulus artifact effect has subsided), with the d23 distance preferably being about 3 cm”, [0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bi-polar nerve stimulation. In accordance with certain embodiments, the electrodes E3, E4, and E5 are used for sensing nerve activity.”, view Figure 17).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Himmelstein to have the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 3.0 centimeters, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as at these distances stimulus artifact effects may have subsided, as recognized by Shimada ([0165]).
Regarding claim 6, Srivastava in view of Himmelstein in view of Shimada teaches the method of claim 1 (as shown above). Srivastava and Himmelstein, alone or in combination, fail to teach wherein the one or more electrical stimulation pulses are delivered between the stimulation electrode and a return electrode.
However, Shimada teaches wherein the one or more electrical stimulation pulses are delivered between the stimulation electrode and a return electrode ([0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bipolar nerve stimulation”, Examiner would like to make note of [0040] of the instant application’s specification which states “the stimulation electrode can also be referred to as stimulation cathode, while the return electrode can also be referred to as the stimulation anode.).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Himmelstein to incorporate the teachings of Shimada to have the one or more electrical stimulation pulsed be delivered between the stimulation electrode and a return electrode, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as this allows for the entire duration of the desired pulse shape be used for stimulation purposes, as recognized by Shimada ([0150]).
Additionally, Himmelstein further teaches the stimulation electrode and a return surface electrode that is also positioned in the abdominal aorta within 10 millimeters (mm) ([0028],[0140], [0158], [0280]-[0281] “A bipolar operation is possible when two or more electrodes are used, such as two concentric electrodes. The one or more electrodes 1316/1316' may be attached to an electrode delivery member… For example, when aortic denervation is desired at the level of the renal artery ostium, which is approximately 6-7 mm in diameter at the ostium of the aorta, the diameter of the circular or ring-shape of the electrodes 1316/1316' should be at least that distance, i.e., 7 mm, in order to properly provide ablation surrounding the renal artery ostium. The diameter of the circular or ring-shape of the electrodes 1316/1316' may be calculated with reference to the renal artery ostium. For example, if it is desired that the RF energy be applied at least approximately 2 mm from each edge of the renal artery ostium, the diameter of the circular or ring-shape of the electrodes 1316/1316' that surround the imaging catheter may have a 10 mm to about a 15 mm diameter.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava to incorporate the teachings of Himmelstein to have the stimulation electrode and the return electrode positioned in abdominal aorta within 10 mm of the renal artery ostium, as these prior art references are directed to renal denervation devices. One would be motivated to do this as the renal artery ostium allows for the desired effects of denervation of the kidney without affecting blood flow from the aorta, as recognized by Himmelstein ([0016]).
Regarding claim 7, Srivastava in view of Himmelstein in view of Shimada teaches the method of claim 1 (as shown above). Srivastava and Himmelstein, alone or in combination, fail to teach wherein the one or more electrical stimulation pulses are delivered between the stimulation electrode and a return surface electrode that is positioned on skin of the patient.
Shimada teaches wherein the one or more electrical stimulation pulses are delivered between the stimulation electrode and a return surface electrode that is positioned on skin of the patient ([0111] “FIG. 12A, the probe comprises a first electrode and a second electrode. Such a system can further include a third electrode applied on the patient's skin (not shown). A first electrode mounted on the probe can be used to deliver an electrical stimulus to the surrounding tissue in a monopolar fashion, with the electrode placed on the person's skin being used as the return electrode during stimulation.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Himmelstein to incorporate the teachings of Shimada to have the one or more electrical stimulation pulsed be delivered between the stimulation electrode and a return surface electrode that is positioned on skin of the patient, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as these positions of the sense electrodes provides best sensing fidelity and best signal-to-noise ratio (SNR), as recognized by Shimada ([0170]).
Regarding claim 8, Srivastava in view of Himmelstein in view of Shimada teaches the method of claim 1 (as shown above). Srivastava fails to disclose wherein the stimulation electrode comprises a deployable stimulation electrode that is deployed such that an outer circumference of the deployable stimulation electrode is in contact with an inner wall of the abdominal aorta within 10 mm of the renal artery ostium.
However, Himmelstein teaches disclose wherein the stimulation electrode comprises a deployable stimulation electrode that is deployed such that an outer circumference of the deployable stimulation electrode is in contact with an inner wall of the abdominal aorta within 10 mm of the renal artery ostium ([0027] “The wire frame is contacted against the inner surface of the aorta at the renal artery ostium, such that the circular electrodes ablate the nerve activity circumferentially around the renal artery ostium.”, [0032], [0033] “When the device is so positioned, the wire frame can be expanded to the inner surface of the aorta, allowing the RF electrodes to be centered about the renal artery ostium while they perform their ablative function.”, [0057], [0158] “For example, when denervation is desired for the renal artery, which is approximately 6-7 mm in diameter at the ostium of the aorta, the diameter of the circular RF electrodes 408 must be at least that distance, i.e., 7 mm, in order to properly provide ablation at the renal artery ostium.”, [0261] “The one or more positioning elements 1318 are deployable from the delivery catheter 1312 at a target region from a position of the delivery catheter 1312 further distal than the one or more electrodes 1316. In use, this allows the positioning elements 1318 to position and secure device 1300 at the desired location within a vessel, e.g., the aorta in the area of the renal artery ostium. The one or more positioning elements 1318 may be used so that the one or more electrodes 1316 may operate at the precise location, namely around the renal artery ostium.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Shimada to incorporate the teachings of Himmelstein to have the stimulation electrode comprises a deployable stimulation electrode that is deployed such that an outer circumference of the deployable stimulation electrode is in contact with an inner wall of the abdominal aorta within 10 mm of the renal artery ostium, as these prior art references are directed to renal denervation devices. One would be motivated to do this as the renal artery ostium allows for the desired effects of denervation of the kidney without affecting blood flow from the aorta and to be able to properly provide ablation to the surrounding ostium, as recognized by Himmelstein ([0016], [0221]).
Regarding claim 9, Srivastava in view of Himmelstein in view of Shimada teaches the method of claim 8 (as shown above). Himmelstein further teaches where “Action potentials may be measured from the segment of the catheter 111 situated within the more distal portion of the renal artery. The quantity of downstream electrical activity as well as the time delay of electrical activity from the proximal to distal electrodes 115,216 provides a measure of residual nerve activity post nerve ablation.”([0107]), however, Srivastava and Himmelstein, alone or in combination, fail to explicitly teach wherein the sense electrode comprises a deployable sense electrode that is deployed such that an outer circumference of the deployable sense electrode is in contact with an inner wall of the renal artery, downstream of the deployable stimulation electrode.
However, Shimada teaches wherein the sense electrode comprises a deployable sense electrode that is deployed such that an outer circumference of the deployable sense electrode is in contact with an inner wall of the renal artery ([0015] “An expandable sense electrode is fixed to the probe body at one end of the sense electrode and is movable relative to the probe body at a second end of the sense electrode such that movement of the movable end toward the fixed end causes the sense electrode to expand from the probe body toward a wall of the artery”, [0032] “at least one of the electrodes of the second pair of electrodes comprises a deployable unitary electrode that can be selectively transitioned between a non-deployed position and a deployed position and is configured as a sense electrode to sense neural activity by the nerves that surround the biological lumen. In accordance with certain embodiments, the deployable unitary electrode, that is configured to be used as the sense electrode, has an outer periphery that simultaneously contacts multiple contiguous and/or non-contiguous locations, spaced about a 360 degree segment of an inner wall of the biological lumen), downstream of the deployable stimulation electrode (view Figure 1 and 2, [0072] “The probe 302 here comprises a stimulation electrode such as electrodes 104 and 204 of FIGS. 1 and 2, and a sense electrode such as electrodes 106 and 206 of the same Figures.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Himmelstein to incorporate the teachings of Shimada to have the sense electrode comprise a deployable sense electrode that is deployed such that an outer circumference of the deployable sense electrode is in contact with an inner wall of the renal artery, downstream of the deployable stimulation electrode, as these prior art references are directed to denervation process. One would be motivated to do this as the deployed sense electrodes can provide electrical contact with the surrounding biological tissue of the lumen which provides better sensing of evoker of intrinsic neural signal from the nerves surround the lumen of the blood vessel, as recognized by Shimada ([0027]).
Regarding claim 10, Srivastava in view of Himmelstein in view of Shimada teaches the method of claim 9 (as shown above). Srivastava and Himmelstein, alone or in combination, fail to teach wherein the deployable sense electrode is used together with another sense electrode to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, wherein the other sense electrode is also located on the mapping catheter downstream of the stimulation electrode or is a surface electrode that is positioned on skin of the patient.
However, Shimada teaches the deployable sense electrode is used together with another sense electrode to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, wherein the other sense electrode is also located on the mapping catheter downstream of the stimulation electrode or is a surface electrode that is positioned on skin of the patient ([0170] “three electrodes E3, E4, and E5 form part of a nerve activity (action potential) sensing circuit (SENS). The SENS circuit should be able to detect the voltage signature of the action potential within the spectrum of bioelectrical activity within the human body”, [0175] “Tests have shown that including all of the electrodes E1-E5 on the probe body 1702 provides for the best sensing fidelity, including the best signal-to-noise ratio (SNR), compared to embodiments where one or more of the electrodes that are used for sensing are located on the human body, i.e., is/are skin electrode(s). However, in an alternative embodiment the electrode E4 is located on the human body, i.e., is a skin electrode.”)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Himmelstein to incorporate the teachings of Shimada to have the deployable sense electrode is used together with another sense electrode to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, wherein the other sense electrode is also located on the mapping catheter downstream of the stimulation electrode or is a surface electrode that is positioned on skin of the patient, as these prior art references are directed to renal denervation devices. One would be motivated to do this as these positions of the sense electrodes provides best sensing fidelity and best signal-to-noise ratio (SNR), as recognized by Shimada ([0170]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava in view of Himmelstein in view of Shimada as applied to claim 1 above, and further in view of Fischell et al. (US 2019/0008580 A1), hereinafter Fischell.
Regarding claim 2, Srivastava in view of Himmelstein in view of Shimada teaches the method of claim 1 (as shown above). Srivastava further discloses where “the neural signals can be detected by recording electrical activity via the contacts, filtering the recorded analog signals to distinguish the neural signals from other electrical activity, and digitizing the analog neural signals…The digitizer can transmit the digitized neural signals to the extracorporeal read/write module, and the post-neuromodulation ENG signals can then be compared with the ENG signals taken before neuromodulation (block 540)… Using this information, the method 500 can then determine whether the nerves have been adequately modulated (block 545). For example, if the amplitude observed in ENG is below a threshold value, then the neuromodulation step may have effectively modulated or stopped conduction of the adjacent nerves and the neuromodulation process can be considered complete. However, if nerve activity is detected above a threshold value, the process of neuromodulating (block 530) and monitoring the resultant nerve activity (block 535) can be repeated until the nerves have been effectively modulated.” ([0066]-[0067]), but Srivastava, Himmelstein, and Shimada, alone or in combination, fail to explicitly teach wherein the using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as the pre- denervation or post-denervation measurement associated with the renal denervation procedure, comprises using the sensed neural electrical activity to select one or more renal denervation parameters and performing renal denervation using the one or more renal denervation parameters selected.
However, Fischell teaches an intravascular catheter for nerve activity ablation and or sensing, specifically, for sensing of nerve activity before and after attempted renal denervation (Abstract) wherein the using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as the pre- denervation or post-denervation measurement associated with the renal denervation procedure, comprises using the sensed neural electrical activity to select one or more renal denervation parameters and performing renal denervation using the one or more renal denervation parameters selected ([0362] “he sensing and assessment module 505 controls the comparison of current nerve activity stored in the RAM 542 (e.g., in the RAM portion 546) with reference values or data such as previously recorded baseline nerve activity (e.g., stored in RAM location 544). The module 505 can determine if one or more selected treatment criteria have been met or not and therefore determine whether one of effective nerve ablation or ineffective nerve ablation has occurred. The Control module 502 can operate both stimulation module 504 and sensing module 505 according to treatment protocols and parameters and parameters module 506 can include nerve stimulation protocols, sensing protocols, ablation protocols, and evaluation protocols that enable the electronics system 500 to allow a medical practitioner to responsively adjust the catheter system operation in relation to the evaluation of sensed data, doctor input, time intervals, detection of events, and other triggers that can cause the selection, provision, and adjustment of therapy. In one embodiment, the control module can operate in a semi-automatic or fully automatic closed-loop manner to adjust the ablation treatment provided based upon the assessment of sensed data.”, [0363] “Assessment of data and modification of the ablation treatment may occur in a closed loop manner in which the stimulation is adjusted in relation to an evaluation of sensed data”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed inventio to have modified Srivastava, Himmelstein, and Shimada to incorporate the teachings of Fischell to have using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as the pre- denervation or post-denervation measurement associated with the renal denervation procedure, comprises using the sensed neural electrical activity to select one or more renal denervation parameters and performing renal denervation using the one or more renal denervation parameters selected, as these prior art references are directed to renal denervation systems and methods. One would be motivated to do this as this adjustment based on the sensed data improves efficacy of the treatment and reduced the need for the patient to need additional procedures at additional costs and risks to the patient, as recognized by Fischell ([0008]).
Claim(s) 11 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava in view of Behar et al. (US 2015/0223877 A1), hereinafter Behar, and further in view of Shimada.
Regarding claim 11, Srivastava discloses a method for use in evaluating neural electrical activity of renal nerves in tissue surrounding a renal artery of a patient for which a renal denervation procedure has been or is going to be performed ([0001] “the present technology are related to neuromodulation catheters having nerve monitoring features for transmitting digital neural signals”, [0023] “Neuromodulation catheters configured in accordance with at least some embodiments of the present technology can include contacts that record neural signals before and/or after neuromodulation and a digitizer that digitizes the recorded neural signals and transmits the digitized neural signals to an extracorporeal device.”), the method comprising:
inserting a distal portion of a guide catheter (guide catheter 135) through an abdominal aorta of a patient (view Figure 2 and 3D) such that the distal portion of the guide catheter is positioned adjacent to a renal artery ostium located along a lateral aspect of the abdominal aorta ([0133] “A catheter may be inserted percutaneously into the femoral artery through this access site, passed through the iliac artery and aorta, and placed into either the left or right renal artery.”)
using the guide catheter to insert a distal portion of a mapping catheter (neuromodulation assembly 120, [0025] “a neuromodulation assembly 120 operably connected to the shaft 108 at the distal portion 108b”, view Figure 1) through a distal most end of the guide catheter such that the distal portion of the mapping catheter is positioned within the renal artery of the patient (view Figure 3A and 3D: the neuromodulation assembly 120 is located in the renal artery RA, [0026] “the neuromodulation catheter 102 can be configured for delivery via a guide catheter or sheath (not shown).”);
while the distal portion of the mapping catheter is positioned within the renal artery of the patient (view Figure 3D: the neuromodulation assembly 120 is located in the renal artery RA),
using a stimulation electrode to deliver one or more electrical stimulation pulses thereby evoking a neural electrical response from at least some of the renal nerves in tissue surrounding the renal artery ([0049] “the contacts 124 can be configured to deliver energy to nerves proximate to a treatment site in a blood vessel or other body lumen. For example, the contacts 124 can be electrodes that deliver therapeutic levels of RF energy and/or other forms of electrical energy to nerves proximate to the target site.”), wherein the stimulation electrode is located on the mapping catheter, on the distal portion of the guide catheter, or on a guidewire (view Figure 3A: the contacts 124 are on the neuromodulation assembly 120); and
using a sense electrode positioned in the renal artery, to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses ([0050] “In certain embodiments, one or more of the contacts 124 along the support member 122 can record electrical activity from the nerves proximate to the vessel wall, and in other embodiments contacts 124.sub.i integrated with the digitizer 128 can perform the recording function. The neural activity can be recorded from the nerves at their natural state and/or after applying nontherapeutic and/or therapeutic levels of stimulation.”), wherein the sense electrode is located on the mapping catheter (view Figure 3A: the contacts 124 are on the neuromodulation assembly 120); and using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as a pre-denervation or post-denervation measurement associated with a renal denervation procedure ([0050] “The neural activity can be recorded from the nerves at their natural state and/or after applying nontherapeutic and/or therapeutic levels of stimulation.”).
Srivastava fails to disclose a stimulation electrode positioned in the abdominal aorta to deliver one or more electrical stimulation pulses to an aorticorenal ganglia and a sense electrode positioned in the renal artery, downstream from the stimulation electrode.
However, Behar teaches a system and method for treating nerve structures and, more particularly but not exclusively, so systems and methods for ablating nerve structures ([0002]) wherein a stimulation electrode is positioned in the abdominal aorta to deliver one or more electrical stimulation pulses to an aorticorenal ganglia ([0244], [0248]: “vascular position of electrodes include: aorta and/or renal artery (left or right) for ablation (part thereof or entirely) of the corresponding aorticorenal ganglion”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava to incorporate the teachings of Behar to have the stimulation electrode positioned in the abdominal aorta to deliver one or more electrical stimulation pulses to an aorticorenal ganglia, as these prior art references are directed to nerve ablation/stimulation. One would be motivated to do this as the stimulation being formed within a large blood vessel (i.e. aorta) prevents significant damage caused by the stimulation and ablating/stimulating the aorticorenal ganglia can reduce sympathetic tone preventing diseases such as hypertension, diabetes and obesity, as recognized by Behar ([0102], [0110], [0112]).
Srivastava and Behar, alone or in combination, fail to teach the sense electrode positioned in the renal artery, downstream from the stimulation electrode.
However, Shimada teaches a system for use in analyzing neural activity of nerves surrounding a biological lumen wherein a sense electrode positioned in the renal artery, downstream from the stimulation electrode ([0072] “FIG. 3 illustrates one example of use of such a probe, in which a probe 302 such as that shown in FIG. 1 or FIG. 2 (or FIGS. 17A and 17B discussed below) is introduced into a blood vessel, such as an artery 304, in a location near a body organ such as kidney 306. The probe is introduced via a sheath in some examples, such as where a sheath is advanced to the intended probe location in the artery, and then withdrawn sufficiently to expose the probe 302 to the artery 304. The probe 302 here comprises a stimulation electrode such as electrodes 104 and 204 of FIGS. 1 and 2, and a sense electrode such as electrodes 106 and 206 of the same Figures.”, [0075] “FIG. 4 shows an intraluminal microneurography probe and sheath assembly coupled to associated instrumentation, consistent with an example. Here, a probe body 402 has an expandable sense electrode 404 and an expandable stimulation electrode 406, couple via wires to instrumentation. A sheath 408 is used to introduce the probe into an artery or other biological lumen or suitable location,”)).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Behar to incorporate the teachings of Shimada to have a sense electrode positioned in the renal artery, downstream from the stimulation electrode, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as so the sensor may measure the downstream neural activity, as recognized by Shimada ([0095]).
Regarding claim 13, Srivastava in view of Behar in view of Shimada teaches the method of claim 11 (as shown above). Srivastava and Himmelstein, alone or in combination, fail to teach wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 1.5 centimeters.
However, Shimada teaches wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 1.5 centimeters ([0164] “The center-to-center axial distance between the two mesh electrodes E2 and E3 (aka the mesh electrodes 1706 and 1704), when they are both deployed, can be referred to as the distance d23. In accordance with certain embodiments, the distance d23 is within the range of 1 cm to 10 cm (which distance should be selected such that the evoked action potential of the neural response do not reach the electrode E3 until any stimulus artifact effect has subsided), with the d23 distance preferably being about 3 cm”, [0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bi-polar nerve stimulation. In accordance with certain embodiments, the electrodes E3, E4, and E5 are used for sensing nerve activity.”, view Figure 17).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Behar to have the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 1.5 centimeters, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as at these distances stimulus artifact effects may have subsided, as recognized by Shimada ([0165]).
Regarding claim 14, Srivastava in view of Behar in view of Shimada teaches the method of claim 11 (as shown above). Srivastava and Himmelstein, alone or in combination, fail to teach wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 1.5 centimeters.
However, Shimada teaches wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 2.0 centimeters ([0164] “The center-to-center axial distance between the two mesh electrodes E2 and E3 (aka the mesh electrodes 1706 and 1704), when they are both deployed, can be referred to as the distance d23. In accordance with certain embodiments, the distance d23 is within the range of 1 cm to 10 cm (which distance should be selected such that the evoked action potential of the neural response do not reach the electrode E3 until any stimulus artifact effect has subsided), with the d23 distance preferably being about 3 cm”, [0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bi-polar nerve stimulation. In accordance with certain embodiments, the electrodes E3, E4, and E5 are used for sensing nerve activity.”, view Figure 17).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Behar to have the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 2.0 centimeters, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as at these distances stimulus artifact effects may have subsided, as recognized by Shimada ([0165]).
Regarding claim 15, Srivastava in view of Behar in view of Shimada teaches the method of claim 11 (as shown above). Srivastava and Behar, alone or in combination, fail to teach wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 3.0 centimeters.
However, Shimada teaches wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 3.0 centimeters ([0164] “The center-to-center axial distance between the two mesh electrodes E2 and E3 (aka the mesh electrodes 1706 and 1704), when they are both deployed, can be referred to as the distance d23. In accordance with certain embodiments, the distance d23 is within the range of 1 cm to 10 cm (which distance should be selected such that the evoked action potential of the neural response do not reach the electrode E3 until any stimulus artifact effect has subsided), with the d23 distance preferably being about 3 cm”, [0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bi-polar nerve stimulation. In accordance with certain embodiments, the electrodes E3, E4, and E5 are used for sensing nerve activity.”, view Figure 17).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Behar to have the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 3.0 centimeters, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as at these distances stimulus artifact effects may have subsided, as recognized by Shimada ([0165]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava in view of Behar in view of Shimada as applied to claim 11 above, and further in view of Fischell et al. (US 2019/0008580 A1), hereinafter Fischell.
Regarding claim 12, Srivastava in view of Behar in view of Shimada teaches the method of claim 11 (as shown above). Srivastava further discloses where “the neural signals can be detected by recording electrical activity via the contacts, filtering the recorded analog signals to distinguish the neural signals from other electrical activity, and digitizing the analog neural signals…The digitizer can transmit the digitized neural signals to the extracorporeal read/write module, and the post-neuromodulation ENG signals can then be compared with the ENG signals taken before neuromodulation (block 540)… Using this information, the method 500 can then determine whether the nerves have been adequately modulated (block 545). For example, if the amplitude observed in ENG is below a threshold value, then the neuromodulation step may have effectively modulated or stopped conduction of the adjacent nerves and the neuromodulation process can be considered complete. However, if nerve activity is detected above a threshold value, the process of neuromodulating (block 530) and monitoring the resultant nerve activity (block 535) can be repeated until the nerves have been effectively modulated.” ([0066]-[0067]), but Srivastava, Behar, and Shimada, alone or in combination, fail to explicitly teach wherein the using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as the pre- denervation or post-denervation measurement associated with the renal denervation procedure, comprises using the sensed neural electrical activity to select one or more renal denervation parameters and performing renal denervation using the one or more renal denervation parameters selected.
However, Fischell teaches an intravascular catheter for nerve activity ablation and or sensing, specifically, for sensing of nerve activity before and after attempted renal denervation (Abstract) wherein the using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as the pre- denervation or post-denervation measurement associated with the renal denervation procedure, comprises using the sensed neural electrical activity to select one or more renal denervation parameters and performing renal denervation using the one or more renal denervation parameters selected ([0362] “he sensing and assessment module 505 controls the comparison of current nerve activity stored in the RAM 542 (e.g., in the RAM portion 546) with reference values or data such as previously recorded baseline nerve activity (e.g., stored in RAM location 544). The module 505 can determine if one or more selected treatment criteria have been met or not and therefore determine whether one of effective nerve ablation or ineffective nerve ablation has occurred. The Control module 502 can operate both stimulation module 504 and sensing module 505 according to treatment protocols and parameters and parameters module 506 can include nerve stimulation protocols, sensing protocols, ablation protocols, and evaluation protocols that enable the electronics system 500 to allow a medical practitioner to responsively adjust the catheter system operation in relation to the evaluation of sensed data, doctor input, time intervals, detection of events, and other triggers that can cause the selection, provision, and adjustment of therapy. In one embodiment, the control module can operate in a semi-automatic or fully automatic closed-loop manner to adjust the ablation treatment provided based upon the assessment of sensed data.”, [0363] “Assessment of data and modification of the ablation treatment may occur in a closed loop manner in which the stimulation is adjusted in relation to an evaluation of sensed data”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed inventio to have modified Srivastava, Behar, and Shimada to incorporate the teachings of Fischell to have using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as the pre- denervation or post-denervation measurement associated with the renal denervation procedure, comprises using the sensed neural electrical activity to select one or more renal denervation parameters and performing renal denervation using the one or more renal denervation parameters selected, as these prior art references are directed to renal denervation systems and methods. One would be motivated to do this as this adjustment based on the sensed data improves efficacy of the treatment and reduced the need for the patient to need additional procedures at additional costs and risks to the patient, as recognized by Fischell ([0008]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava in view of Behar in view of Shimada as applied to claim 11 above, and further in view of Himmelstein.
Regarding claim 16, Srivastava in view of Behar in view of Shimada teaches the method of claim 11 (as shown above). Srivastava and Behar, alone or in combination, fail to teach wherein the one or more electrical stimulation pulses are delivered between the stimulation electrode and a return electrode.
However, Shimada teaches wherein the one or more electrical stimulation pulses are delivered between the stimulation electrode and a return electrode ([0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bipolar nerve stimulation”, Examiner would like to make note of [0040] of the instant application’s specification which states “the stimulation electrode can also be referred to as stimulation cathode, while the return electrode can also be referred to as the stimulation anode.).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava and Himmelstein to incorporate the teachings of Shimada to have the one or more electrical stimulation pulsed be delivered between the stimulation electrode and a return electrode, as these prior art references are directed to sensing neural electrical activity from a denervation procedure. One would be motivated to do this as this allows for the entire duration of the desired pulse shape be used for stimulation purposes, as recognized by Shimada ([0150]).
Srivastava, Behar, and Shimada, alone or in combination, fail to teach the stimulation electrode and a return surface electrode that is also positioned in the abdominal aorta within 10 millimeters (mm).
However, Himmelstein further teaches the stimulation electrode and a return surface electrode that is also positioned in the abdominal aorta within 10 millimeters (mm) ([0028],[0140], [0158], [0280]-[0281] “A bipolar operation is possible when two or more electrodes are used, such as two concentric electrodes. The one or more electrodes 1316/1316' may be attached to an electrode delivery member… For example, when aortic denervation is desired at the level of the renal artery ostium, which is approximately 6-7 mm in diameter at the ostium of the aorta, the diameter of the circular or ring-shape of the electrodes 1316/1316' should be at least that distance, i.e., 7 mm, in order to properly provide ablation surrounding the renal artery ostium. The diameter of the circular or ring-shape of the electrodes 1316/1316' may be calculated with reference to the renal artery ostium. For example, if it is desired that the RF energy be applied at least approximately 2 mm from each edge of the renal artery ostium, the diameter of the circular or ring-shape of the electrodes 1316/1316' that surround the imaging catheter may have a 10 mm to about a 15 mm diameter.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava, Behar, and Shimada to incorporate the teachings of Himmelstein to have the stimulation electrode and the return electrode positioned in abdominal aorta within 10 mm of the renal artery ostium, as these prior art references are directed to renal denervation devices. One would be motivated to do this as the renal artery ostium allows for the desired effects of denervation of the kidney without affecting blood flow from the aorta, as recognized by Himmelstein ([0016]).
Claim(s) 17 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimada in view of Behar.
Regarding claim 17, Shimada discloses a method for use in evaluating neural electrical activity of renal nerves in tissue surrounding a renal artery of a patient for which a renal denervation procedure has been or is going to be performed (Abstract: “Certain embodiments described herein relate to a system for use in analyzing neural activity of nerves surrounding a biological lumen.”, [0095] “The clinician can then compare renal nerve activity pre- and post-denervation to determine the degree of nerve ablation incurred, thereby more accurately achieving the desired degree of nerve ablation during treatment of the patient.”), the method comprising:
using a stimulation electrode to deliver one or more electrical stimulation pulses thereby evoking a neural electrical response from at least some of the renal nerves in tissue surrounding the renal artery ([0034] “In accordance with certain embodiments, a system includes a probe body configured to be introduced into a renal artery, wherein the probe body includes a distal end and a proximal end, with the distal end being configured to be placed closer to a kidney than the proximal end. The system also includes a plurality of electrodes supported by the probe body and electrically isolated from one another. A stimulator is electrically coupled to and configured to deliver electrical stimulation via a first pair of the electrodes to evoke neural activity by the nerves that surround the biological lumen”);
using a sense electrode positioned in the renal artery, downstream from the stimulation electrode, to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses ([0034] “An amplifier is configured to produce a sensed signal indicative of evoked neural activity and/or indicative of intrinsic neural activity by renal nerves that surround the renal artery. The amplifier includes a pair of input terminals, an output terminal, and a ground reference terminal. A second pair of the electrodes is electrically coupled to the pair of input terminals of the amplifier to thereby enable the amplifier to produce the sensed signal indicative of the evoked and/or intrinsic neural activity by the renal artery nerves.); and
using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as a pre-denervation or post-denervation measurement associated with a renal denervation procedure ([0106] “The expandable stimulation electrode is excited at 1108, inducing an electrical signal into the nerves adjacent to the arterial wall. The nerves propagate the signal from the stimulation electrode, which can be observed at 1110 as nerve activity as a result of exciting the stimulation electrode. The observed nerve activity can then be measured, characterized, stored, viewed, etc., to determine whether the nerve activity exceeds a desired level at 1112. If a desired level of nerve activity is exceeded, nerves proximate the probe are ablated at 1114, such as using an radio frequency or microwave ablation element comprising a part of the probe located between the sense electrode and the stimulation electrode, as shown in FIGS. 5 and 6. Steps 1108-1112 are then repeated and the nerve is optionally ablated again, until the nerve activity is determined not to exceed the desired level at 1112. At that point, the measurement and nerve ablation is complete, and the probe and sheath can be withdrawn at 1116.”, [0095] “a clinician can measure nerve activity such as renal nerve activity by emitting an electrical pulse through stimulation electrodes in the probe, and recording propagation along renal nerve fibers using the sense electrode or electrodes on the probe. The clinician can then compare renal nerve activity pre- and post-denervation to determine the degree of nerve ablation incurred, thereby more accurately achieving the desired degree of nerve ablation during treatment of the patient.”).
Although Shimada discloses “a system includes a probe body configured to be introduced into a renal artery…A stimulator is electrically coupled to and configured to deliver electrical stimulation via a first pair of the electrodes to evoke neural activity by the nerves that surround the biological lumen.” ([0034]), Shimada fails to explicitly disclose a stimulation electrode positioned in an abdominal aorta of the patient to deliver one or more electrical stimulation pulses to an aorticorenal ganglia.
However, Behar teaches a system and method for treating nerve structures and, more particularly but not exclusively, so systems and methods for ablating nerve structures ([0002]) wherein a stimulation electrode is positioned in the abdominal aorta to deliver one or more electrical stimulation pulses to an aorticorenal ganglia ([0244], [0248]: “vascular position of electrodes include: aorta and/or renal artery (left or right) for ablation (part thereof or entirely) of the corresponding aorticorenal ganglion”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Srivastava to incorporate the teachings of Behar to have the stimulation electrode positioned in the abdominal aorta to deliver one or more electrical stimulation pulses to an aorticorenal ganglia, as these prior art references are directed to nerve ablation/stimulation. One would be motivated to do this as the stimulation being formed within a large blood vessel (i.e. aorta) prevents significant damage caused by the stimulation and ablating/stimulating the aorticorenal ganglia can reduce sympathetic tone preventing diseases such as hypertension, diabetes and obesity, as recognized by Behar ([0102], [0110], [0112]).
Regarding claim 19, Shimada in view of Behar teaches the method of claim 17 (as shown above). Shimada further discloses wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 1.5 centimeters ([0164] “The center-to-center axial distance between the two mesh electrodes E2 and E3 (aka the mesh electrodes 1706 and 1704), when they are both deployed, can be referred to as the distance d23. In accordance with certain embodiments, the distance d23 is within the range of 1 cm to 10 cm (which distance should be selected such that the evoked action potential of the neural response do not reach the electrode E3 until any stimulus artifact effect has subsided), with the d23 distance preferably being about 3 cm”, [0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bi-polar nerve stimulation. In accordance with certain embodiments, the electrodes E3, E4, and E5 are used for sensing nerve activity.”, view Figure 17).
Regarding claim 20, Shimada in view of Behar teaches the method of claim 17 (as shown above). Shimada further discloses wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 2.0 centimeters ([0164] “The center-to-center axial distance between the two mesh electrodes E2 and E3 (aka the mesh electrodes 1706 and 1704), when they are both deployed, can be referred to as the distance d23. In accordance with certain embodiments, the distance d23 is within the range of 1 cm to 10 cm (which distance should be selected such that the evoked action potential of the neural response do not reach the electrode E3 until any stimulus artifact effect has subsided), with the d23 distance preferably being about 3 cm”, [0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bi-polar nerve stimulation. In accordance with certain embodiments, the electrodes E3, E4, and E5 are used for sensing nerve activity.”, view Figure 17).
Regarding claim 21, Shimada in view of Behar teaches the method of claim 17(as shown above).
Shimada further discloses wherein the sense electrode, which is used to sense the neural electrical activity evoked in response to the one or more electrical stimulation pulses, is positioned downstream of the stimulation electrode by at least 3.0 centimeters ([0164] “The center-to-center axial distance between the two mesh electrodes E2 and E3 (aka the mesh electrodes 1706 and 1704), when they are both deployed, can be referred to as the distance d23. In accordance with certain embodiments, the distance d23 is within the range of 1 cm to 10 cm (which distance should be selected such that the evoked action potential of the neural response do not reach the electrode E3 until any stimulus artifact effect has subsided), with the d23 distance preferably being about 3 cm”, [0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bi-polar nerve stimulation. In accordance with certain embodiments, the electrodes E3, E4, and E5 are used for sensing nerve activity.”, view Figure 17).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimada in view of Behar as applied to claim 17 above, and further in view of Fischell et al. (US 2019/0008580 A1), hereinafter Fischell.
Regarding claim 18, Shimada in view of Behar teaches the method of claim 17 (as shown above). Shimada further discloses “The observed nerve activity can then be measured, characterized, stored, viewed, etc., to determine whether the nerve activity exceeds a desired level at 1112. If a desired level of nerve activity is exceeded, nerves proximate the probe are ablated at 1114, such as using an radio frequency or microwave ablation element comprising a part of the probe located between the sense electrode and the stimulation electrode, as shown in FIGS. 5 and 6. Steps 1108-1112 are then repeated and the nerve is optionally ablated again, until the nerve activity is determined not to exceed the desired level at 1112. At that point, the measurement and nerve ablation is complete, and the probe and sheath can be withdrawn at 1116” ([0106]), but Shimada and Behar, alone or in combination, fail to explicitly teach wherein the using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as the pre- denervation or post-denervation measurement associated with the renal denervation procedure, comprises using the sensed neural electrical activity to select one or more renal denervation parameters and performing renal denervation using the one or more renal denervation parameters selected.
However, Fischell teaches an intravascular catheter for nerve activity ablation and or sensing, specifically, for sensing of nerve activity before and after attempted renal denervation (Abstract) wherein the using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as the pre- denervation or post-denervation measurement associated with the renal denervation procedure, comprises using the sensed neural electrical activity to select one or more renal denervation parameters and performing renal denervation using the one or more renal denervation parameters selected ([0362] “he sensing and assessment module 505 controls the comparison of current nerve activity stored in the RAM 542 (e.g., in the RAM portion 546) with reference values or data such as previously recorded baseline nerve activity (e.g., stored in RAM location 544). The module 505 can determine if one or more selected treatment criteria have been met or not and therefore determine whether one of effective nerve ablation or ineffective nerve ablation has occurred. The Control module 502 can operate both stimulation module 504 and sensing module 505 according to treatment protocols and parameters and parameters module 506 can include nerve stimulation protocols, sensing protocols, ablation protocols, and evaluation protocols that enable the electronics system 500 to allow a medical practitioner to responsively adjust the catheter system operation in relation to the evaluation of sensed data, doctor input, time intervals, detection of events, and other triggers that can cause the selection, provision, and adjustment of therapy. In one embodiment, the control module can operate in a semi-automatic or fully automatic closed-loop manner to adjust the ablation treatment provided based upon the assessment of sensed data.”, [0363] “Assessment of data and modification of the ablation treatment may occur in a closed loop manner in which the stimulation is adjusted in relation to an evaluation of sensed data”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed inventio to have modified Shimada and Behar to incorporate the teachings of Fischell to have using the sensed neural electrical activity, evoked in response to the one or more electrical stimulation pulses, as the pre- denervation or post-denervation measurement associated with the renal denervation procedure, comprises using the sensed neural electrical activity to select one or more renal denervation parameters and performing renal denervation using the one or more renal denervation parameters selected, as these prior art references are directed to renal denervation systems and methods. One would be motivated to do this as this adjustment based on the sensed data improves efficacy of the treatment and reduced the need for the patient to need additional procedures at additional costs and risks to the patient, as recognized by Fischell ([0008]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimada in view of Behar as applied to claim 17 above, and further in view of Himmelstein.
Regarding claim 22, Shimada in view of Behar teaches the method of claim 17 (as shown above). Shimada further discloses wherein the one or more electrical stimulation pulses are delivered between the stimulation electrode and a return electrode ([0165] “the electrodes E1 and E2 are used for stimulating nerves to evoke a nerve response, with the electrode E1 serving as the stimulation anode and the deployable electrode E2 serving as the stimulation cathode, wherein such nerve stimulation can be referred to more specifically as bipolar nerve stimulation”, Examiner would like to make note of [0040] of the instant application’s specification which states “the stimulation electrode can also be referred to as stimulation cathode, while the return electrode can also be referred to as the stimulation anode.).
Behar and Shimada, alone or in combination, fail to teach the stimulation electrode and a return surface electrode that is also positioned in the abdominal aorta within 10 millimeters (mm).
However, Himmelstein further teaches the stimulation electrode and a return surface electrode that is also positioned in the abdominal aorta within 10 millimeters (mm) ([0028],[0140], [0158], [0280]-[0281] “A bipolar operation is possible when two or more electrodes are used, such as two concentric electrodes. The one or more electrodes 1316/1316' may be attached to an electrode delivery member… For example, when aortic denervation is desired at the level of the renal artery ostium, which is approximately 6-7 mm in diameter at the ostium of the aorta, the diameter of the circular or ring-shape of the electrodes 1316/1316' should be at least that distance, i.e., 7 mm, in order to properly provide ablation surrounding the renal artery ostium. The diameter of the circular or ring-shape of the electrodes 1316/1316' may be calculated with reference to the renal artery ostium. For example, if it is desired that the RF energy be applied at least approximately 2 mm from each edge of the renal artery ostium, the diameter of the circular or ring-shape of the electrodes 1316/1316' that surround the imaging catheter may have a 10 mm to about a 15 mm diameter.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Behar, and Shimada to incorporate the teachings of Himmelstein to have the stimulation electrode and the return electrode positioned in abdominal aorta within 10 mm of the renal artery ostium, as these prior art references are directed to renal denervation devices. One would be motivated to do this as the renal artery ostium allows for the desired effects of denervation of the kidney without affecting blood flow from the aorta, as recognized by Himmelstein ([0016]).
Conclusion
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/ATTIYA SAYYADA HUSSAINI/ Examiner, Art Unit 3792
/William J Levicky/ Primary Examiner, Art Unit 3796
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