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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted May 26th, 2026 has been considered by the Examiner.
Response to Amendment
The amendment filed May 26th, 2026 has been entered. Applicant’s amendments to the claims have overcome the 112(b) rejections and Applicant’s arguments have overcome the Drawings objection previously set forth in Non-Final Office Action mailed December 23rd, 2025.
Response to Arguments
Applicant’s arguments, see pages 15-18, filed May 26th, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art that teaches the newly disclosed claim limitations.
Applicant’s arguments with respect to claim(s) 8-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 15-16 & 37 objected to because of the following informalities:
Claim 15, line 4: “peak” should read --peaks--,
Claim 16 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 36,
Claim 37 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 38.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 & 36-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim recites “the signal including a plurality of temporally spaced peaks corresponding to neural firing events; identify the plurality of temporally spaced peaks as discrete events within the signal” in lines 9-11 but there is not adequate support in the Specification for this limitation. Paragraph [0034] of the instant Specification recites “The temporal locations or timing of the peaks are indicative of when various nerves fired, and their respective amplitudes may also be indicative of how far the firing nerves are from the sensing electrode(s). Presuming for simplicity that each individual different peak corresponds to a different individual nerve firing, the amplitude of an individual peak may be indicative of an axial radial distance between sense electrode(s) and a nerve, and thus, how deep or shallow the nerve is relative to the lumen wall of the biological lumen within which the catheter is located” and paragraphs [0048]-[0049] discuss average or median amplitudes, but do not explicitly disclose “the controller comprising one or more processors and configured to” carry out the claimed limitation requiring identification of discrete events.
Regarding claim 1, the claim recites “determine one or more characteristics of the sensed neural activity of the nerves within the tissue surrounding the biological lumen by determining amplitudes of the plurality of peaks and determining a distribution of the amplitudes across at least two amplitude ranges” in lines 14-16 but there is not adequate support in the Specification for this limitation. Paragraph [0048] of the instant Specification recites “In certain embodiments, characteristic(s) of the sensed neural activity is/are determined at step 106 (e.g., by the controller 422) based on amplitudes of the multiple peaks and/or based on temporal spacings between the multiple peaks of the sensed signal indicative of the neural activity. For example, an average amplitude of the multiple peaks can be determined and one or more denervation parameters can be selected (e.g., by the controller 422) based on the average amplitude of the multiple peaks” but this does not provide explicit support for the claimed limitation requiring two ranges.
Claims 2-18 & 36-40 are also rejected by virtue of their dependency on claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 & 36-40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites “the plurality of peaks” in line 13 and it is unclear if these are the same plurality of peaks as the plurality of temporally spaced peaks recited in line 9 or are different peaks. For examination purposes, these are the same peaks and the limitation will be interpreted as “the plurality of temporally spaced peaks”.
Claims 2-18 & 36-40 are also rejected by virtue of their dependency on claim 1.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 10, 12-13 & 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al. (U.S. Pub. No. 20190008580, previously cited), herein referred to as “Fischell” in view of Schepis et al. (U.S. Pub. No. 20170215758), herein referred to as “Schepis”.
Regarding claim 1, Fischell discloses a tissue treatment system ([0003]: This invention relates in some aspects to the field of devices that monitor, stimulate, and/or ablate tissue and nerve fibers primarily in the adventitial and/or periadvential area surrounding a blood vessel; [0463]: Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed inventions), comprising:
a signal generator (stimulation sub-system 580; [0361]: stimulation module 504 provides control of the stimulation sub-system 580 for providing electrical stimulation and/or energy based ablation through the electrodes);
a sensing circuit (sensing & assessment 505) coupleable to at least one electrode of a catheter that is insertable into a biological lumen, the sensing circuit configured to sense neural activity of nerves within tissue surrounding the biological lumen using the at least one electrode of the catheter while the catheter is inserted into the biological lumen ([0362]: The 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); [0181]: FIG. 1 is a schematic view of the distal portion of a Nerve Sensing Catheter (NSC) 10 that is designed to sense electrical energy (currents or voltages) from extra-vascular tissue within a human body … The NSC includes three conduits 20 with outer insulation 22, and sharpened wire 24, with 2 of the three guide tubes and conduits shown in their fully deployed positions (the third is not shown). Ideally the sharpened wires 24 are made from or coated with a radiopaque material such as gold or platinum; [0182]: The conduits 20 run all the way to the proximal end of the NSC 10 where they interface with electronic equipment 500 that provides sensing (as shown in FIG. 21)); and
a controller (processor 540) communicatively coupled to the signal generator and the sensing circuit (see Figs. 21-22);
the controller comprising one or more processors (processor 540) and configured to:
receive a signal indicative of the sensed neural activity, the signal including a plurality of temporally spaced peaks corresponding to neural firing events ([0378]: One measure of neural activity that may be assessed, is peak burst height (or maximum voltage) which can reflect the number of active fibers in renal sympathetic nerve activity (RSNA) or synchronized RSNA. This measure may reflect residual nerve activity better than any post-ablation changes in average rhythm/burst rate/frequency over time, or peak frequency of the nerve activity. Nonetheless both amplitude and frequency of the activity (e.g., bursts) may be used to assess post-ablation nerve activity change relative to the pre-ablation baseline or relative to a threshold which defines successful therapy; wherein amplitude is the peak and the frequency is the spacing therebetween);
determine one or more characteristics of the sensed neural activity of the nerves within the tissue surrounding the biological lumen, the one or more characteristics of the sensed neural activity indicative of one or more of a size, type, function or health of the nerves within tissue surrounding the biological lumen and/or indicative of proximity of the nerves relative to the at least one electrode of the catheter ([0303]: Configuring sensing components and obtaining sensed data in step 276 which may include attaching the connector 360 to the external nerve activity measurement equipment 500 of FIG. 21 and measuring the amplitude or level of sympathetic nerve activity between at least one pair of electrodes 117 of FIGS. 6-8; [0317]: Additionally, the NSC 100 can be used as a screening device to screen candidate ablation locations. This may occur by obtaining a baseline of sensed data and evaluating the sensed data in order to determine if sufficient nerve activity is sensed at that location. For example, nerve density may vary with respect to how far the catheter is positioned within the arterial vessel. For example, the nerve density/distribution may vary as a function of the circumference of the artery, which tends to get bigger as one moves proximally along the renal artery. Further the target nerves may be clumped on one side of the artery rather than surrounding it in a relatively balanced manner);
select one or more denervation parameters based on the one or more characteristics of the sensed neural activity, the one or more denervation parameters including at least one parameter that controls delivery of denervation energy to the nerves ([0362]: 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]: The sensing and assessment module 505 can also be used to calculate various quantitative measurements that can be derived from sensed data … 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); and
control the signal generator to generate, using the selected one or more denervation parameters, signals for performing a denervation procedure intended to denervate at least some of the nerves for which the neural activity was sensed ([0365]: The protocols module 506 can include, for example, a subroutine for processing data as part of steps such as step 288 of FIG. 20a. For example, sensed data can be evaluated according to at least one treatment criterion, and if the criterion is passed then the ablation procedure is finalized, and if the treatment criterion is not passed, then ablative stimulation is adjusted, repeated, or otherwise provided, as defined by the treatment protocol as per step 286 of FIG. 20a).
Fischell fails to explicitly disclose the controller configured to:
identify the plurality of temporally spaced peaks as discrete events within the signal;
determine one or more characteristics of the sensed neural activity of the nerves within the tissue surrounding the biological lumen, by determining amplitudes of the plurality of peaks and determining a distribution of the amplitudes across at least two amplitude ranges;
However, Schepis discloses a controller (controller 150) comprising one or more processors ([0094]: The computer operates software designed to record signals passed from the controller, and to drive the controller's output. Possible software includes Cambridge Electronic Design's (UK) SPIKE program. The software is programmable, can record and analyze electrophysiological signals such as EPs, EEG signals, ECG signals, and EMG signals, and can direct the controller to deliver stimulation) and configured to:
receive a signal indicative of the sensed neural activity, the signal including a plurality of temporally spaced peaks corresponding to neural firing events ([0096]: The patient monitoring system can acquire, amplify, and filter physiological signals, and can also output them to the controller 150 … EEG measurements of in any of area of the brain can be recorded to measure the amplitude of the corresponding evoked potential activity, the latency between the application of the electrical nerve stimulation and the onset of a first EPs, the latency between the end of one EP and the start of subsequent EPs, the frequency of each of the EPs when bursts of multiple EPs are present, and as the shape of the EPs; [0099]: FIG. 4(b) demonstrates multiple evoked potentials activated by a single stimulation. It is thought that chronic pain may be discernible from acute pain by the existence of repeating potentials);
identify the plurality of temporally spaced peaks as discrete events within the signal ([0099] FIG. 4(b) demonstrates multiple evoked potentials activated by a single stimulation. It is thought that chronic pain may be discernible from acute pain by the existence of repeating potentials … Plot B demonstrates a phenomenon known as “wind-up”, where evoked potentials occur repetitiously, but each occurrence demonstrates a new number of potentials and activation frequencies; [0096]: Through a quantitative analysis of this information at the low frequency electrical nerve stimulation, a target nerve associated with the neural pathway that is the source of chronic pain can be identified, after which the target nerve can be blocked and impaired to treat the chronic pain);
determine one or more characteristics of the sensed neural activity of the nerves within the tissue surrounding the biological lumen by determining amplitudes of the plurality of peaks ([0096]: Through a quantitative analysis of this information at the low frequency electrical nerve stimulation, a target nerve associated with the neural pathway that is the source of chronic pain can be identified, after which the target nerve can be blocked and impaired to treat the chronic pain; [0097]: FIG. 4(a) is graph showing the amplitude, latency and shape of several evoked potentials (1-4). The potentials are elicited by an electrical stimulation that is indicated in time as a vertical dashed line. If the stimulation intensity is constant, then the evoked potential amplitude of an individual burst will increase as the distance between the probe and nerve decreases, helping the physician drive the probe towards the painful circuitry. Alternatively, the amplitude of the evoked potential will decrease with increasing distance between the probe and nerve) and determining a distribution of the amplitudes across at least two amplitude ranges ([0106]: First, in order to elicit a chronic pain response in a target nerve that is suspected of or could be associated with a neural pathway that is the source of a patient's chronic pain, as determined by the presence of or a change in EP activity observed via EEG during brain wave monitoring (i.e., an increase in amplitude of the EPs, a decrease in latency, an increase in frequency, or a sufficient change in shape)), the one or more characteristics of the sensed neural activity indicative of one or more of a size, type, function or health of the nerves, and/or indicative of proximity of the nerves within tissue surrounding the biological lumen relative to the at least one electrode of the catheter ([0097]: FIG. 4(a) is graph showing the amplitude, latency and shape of several evoked potentials (1-4). The potentials are elicited by an electrical stimulation that is indicated in time as a vertical dashed line. If the stimulation intensity is constant, then the evoked potential amplitude of an individual burst will increase as the distance between the probe and nerve decreases, helping the physician drive the probe towards the painful circuitry. Alternatively, the amplitude of the evoked potential will decrease with increasing distance between the probe and nerve; [0122]: For example, the method can involve a user … advancing a percutaneous probe through the surface of the skin and towards a target nerve, which is a nerve that is suspected of being the source of a patient's chronic pain. Next, once the tip of the probe is close to the target nerve, a first (low frequency) electrical nerve stimulation (see parameters described above) can be delivered to the target nerve via a pulse generator or other suitable means through the probe. At this time, EEG signals can be recorded via electrodes to monitor evoked potential activity in one or more predetermined regions of the brain);
select one or more denervation parameters based on the one or more characteristics of the sensed neural activity, the one or more denervation parameters including at least one parameter that controls delivery of denervation energy to the nerves ([0124]: If the stimulation characteristics of the second (high frequency) electrical nerve blocking stimulation are sufficient to verify that the source of the chronic pain has been correctly identified, then, in one particular embodiment, the volume of nerve tissue that can be impaired or ablated at the probe's current setting can then be determined. If the nerve falls within that volume, then EPs and spontaneous or baseline activity carrying the chronic pain signals to the area of the brain being monitored can be silenced upon impairment or ablation through a third (ultra-high frequency) electrical nerve stimulation, and the patient will not feel any chronic pain post-ablation; see also [0064]); and
control the signal generator to generate, using the selected one or more denervation parameters, signals for performing a denervation procedure intended to denervate at least some of the nerves for which the neural activity was sensed ([0030]: the controller can transmit the third nerve stimulation to the probe via a pulse generator connected to the probe via an electrical lead; [0124]: If the nerve falls within that volume, then EPs and spontaneous or baseline activity carrying the chronic pain signals to the area of the brain being monitored can be silenced upon impairment or ablation through a third (ultra-high frequency) electrical nerve stimulation, and the patient will not feel any chronic pain post-ablation).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell to include the controller of Schepis, for the purpose of indicating that the target nerve is in close enough proximity to a part of the neural pathway associated with chronic pain so that the chronic pain can be treated (Schepis: [0062]).
Regarding claim 2, Fischell discloses wherein:
the sensing circuit is configured to sense the neural activity of the nerves within tissue surrounding the biological lumen using the at least one electrode ([0362]: The 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); [0181]: FIG. 1 is a schematic view of the distal portion of a Nerve Sensing Catheter (NSC) 10 that is designed to sense electrical energy (currents or voltages) from extra-vascular tissue within a human body … The NSC includes three conduits 20 with outer insulation 22, and sharpened wire 24, with 2 of the three guide tubes and conduits shown in their fully deployed positions (the third is not shown). Ideally the sharpened wires 24 are made from or coated with a radiopaque material such as gold or platinum; [0182]: The conduits 20 run all the way to the proximal end of the NSC 10 where they interface with electronic equipment 500 that provides sensing (as shown in FIG. 21)); and
the signal generator is configured to generate the signals for performing the denervation procedure (stimulation module 504; [0361]: stimulation module 504 provides control of the stimulation sub-system 580 for providing electrical stimulation and/or energy based ablation through the electrodes).
Regarding claim 3, Fischell discloses wherein:
the sensing circuit is configured to sense evoked neural activity of the nerves within the tissue surrounding the biological lumen using the at least one electrode of the catheter ([0182]: The conduits 20 run all the way to the proximal end of the NSC 10 where they interface with electronic equipment 500 that provides sensing (as shown in FIG. 21); [0250]: sensing evoked nerve activity can be accomplished by using two electrodes on different conduits (or an electrode 117 and sensor tube 116) for stimulation and the other electrode 117 on the third conduit for sensing (the sensing would typically occur after the stimulation is provided)); and
the evoked neural activity is responsive to electrical stimulation delivered using at least one other electrode of the catheter ([0250]: sensing evoked nerve activity can be accomplished by using two electrodes on different conduits (or an electrode 117 and sensor tube 116) for stimulation and the other electrode 117 on the third conduit for sensing (the sensing would typically occur after the stimulation is provided)).
Regarding claim 4, Fischell discloses:
a first catheter comprising the at least one electrode (NSC 100); and
a second catheter comprising at least one electrode configured to emit radio frequency (RF) energy and/or an ultrasound transducer configured to emit ultrasound energy ([0310]: Perform a renal denervation in step 286 on one (unilateral) or both (bilateral) arteries using energy based devices such as the Simplicity™ catheter from Medtronic or the PTAC of Fischell et al U.S. Pat. No. 8,740,849 and then remove the treatment device from the body; [0356]: The electrical energy delivered to a patient may take different forms. In a preferred configuration, the stimulation sub-system 580 may generate RF energy as is now used by devices such as the Medtronic Simplicity device);
wherein the sensing circuit is configured to sense the neural activity of the nerves within tissue surrounding the biological lumen using the at least one electrode of the first catheter ([0182]: The conduits 20 run all the way to the proximal end of the NSC 10 where they interface with electronic equipment 500 that provides sensing (as shown in FIG. 21)); and
wherein the signal generator is configured to generate the signals for performing the denervation procedure using the at least one electrode of the second catheter ([0356]: In a preferred configuration, the stimulation sub-system 580 may generate RF energy as is now used by devices such as the Medtronic Simplicity device), or the ultrasound transducer of the second catheter.
Regarding claim 10, Fischell discloses wherein the controller is configured to select at least one of the one or more denervation parameters using one or more tables accessed by the controller from a memory ([0353]: The RAM 542 can also contain as well as program protocols (for providing stimulation, sensing, or ablation), parameter values, criterion used during the treatment, and other values for settings that are used during screening, processing sensed data, and assessment of sensed data as can occur for the detection of significant changes in nerve activity indicative of effective denervation. The values of the RAM can be accessed by the stimulation subsystem 580 or the sensing subsystem which is realized, at least in part, by the combination of amplifiers, A-to-D converters, FIFO buffers, and CPU; [0361]: The stimulation module 504 control of the stimulation sub-system 580 of FIG. 21 controls the generation of stimulation signals which can include RF signals, pulses, or arbitrary waveforms for output including alternating current (AC) and/or direct current (DC) signals to be used by electrical, stored in the protocols and parameters module 506; wherein this is seen as using one or more tables since it is data stored in a memory).
Regarding claim 12, Fischell in view of Schepis discloses wherein:
the controller is configured to determine at least one additional characteristic of the sensed neural activity based on temporal spacings between at least some of the plurality of temporally spaced peaks (Schepis: [0096]: The patient monitoring system can acquire, amplify, and filter physiological signals, and can also output them to the controller 150 … EEG measurements of in any of area of the brain can be recorded to measure the amplitude of the corresponding evoked potential activity, the latency between the application of the electrical nerve stimulation and the onset of a first EPs, the latency between the end of one EP and the start of subsequent EPs, the frequency of each of the EPs when bursts of multiple EPs are present, and as the shape of the EPs; [0099]: FIG. 4(b) demonstrates multiple evoked potentials activated by a single stimulation. It is thought that chronic pain may be discernible from acute pain by the existence of repeating potentials. In Plot A, the stimulation elicited evoked potential has a latency of Δt.sub.0, and, as shown, the same neuron continues to fire at regular intervals (e.g., Δt.sub.1=Δt.sub.2=Δt.sub.3), approximating a long-lasting neural oscillation or volley. Plot B demonstrates a phenomenon known as “wind-up”, where evoked potentials occur repetitiously, but each occurrence demonstrates a new number of potentials and activation frequencies).
Regarding claim 13, Fischell discloses wherein the controller is configured to:
determine at least one of the one or more characteristics of the sensed neural activity by determining an average amplitude or a median amplitude of the plurality of temporally spaced peaks ([0068]: Of these nerve measurements, the average voltage would be a preferred measurement; [0308]: The summary statistic related to the baseline dataset can include values such as mean, median, and standard deviation of a measure; variance, peak amplitude, average amplitude, peak frequency, average frequency, burst duration, guard-bands, and other measures as disclosed herein); and
select the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the average amplitude or the median amplitude of the plurality of temporally spaced peaks ([0363]: The sensing and assessment module 505 can also be used to calculate various quantitative measurements that can be derived from sensed data … 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; [0365]: The protocols module 506 can include, for example, a subroutine for processing data as part of steps such as step 288 of FIG. 20a. For example, sensed data can be evaluated according to at least one treatment criterion, and if the criterion is passed then the ablation procedure is finalized, and if the treatment criterion is not passed, then ablative stimulation is adjusted, repeated, or otherwise provided, as defined by the treatment protocol as per step 286 of FIG. 20a).
Regarding claim 17, Fischell discloses wherein the biological lumen comprises a renal artery and the nerves comprise renal nerves innervating a kidney ([0022]: The PNASC also includes sensors for sensing the activity of nerves, such as the sympathetic nerves that lie outside of the external elastic lamina of the renal artery … PNASC embodiments also are disclosed that use, RF or ultrasonic energy to provide for perivascular nerve ablation, such as renal nerve ablation).
Regarding claim 18, Fischell discloses wherein the sensing circuit is configured to sense spontaneous neural activity of the nerves within the tissue surrounding the biological lumen using the at least one electrode of the catheter ([0308]: a8. Measure nerve activity outside of the second renal artery in step 282 by repeating steps a1 through a7).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Schepis as applied to claim 1 above, and further in view of Warnking (U.S. Pat. No. 9943666, cited in IDS), herein referred to as “Warnking”.
Regarding claim 5, Fischell discloses an ultrasound transducer configured to emit ultrasound energy ([0189]: Providing an ultrasound transducer either within the body of the PNASC or in the distal portion of the conduits 20 to provide energy based ablation, such as ablation at perivascular sites that is delivered by the conduits 20), but fails to disclose wherein the one or more denervation parameters selected by the controller comprise one or more of amplitude, power, duration, frequency, and duty cycle of ultrasound energy emitted by the ultrasound transducer.
However, Warnking discloses an ultrasound transducer (transducer 30) configured to emit ultrasound energy (Col. 10, lines 15-20: the ultrasound system 20 may control the transducer 30 to transmit ultrasound energy in a pulsed function during application of therapeutic ultrasonic energy), wherein the one or more denervation parameters selected by the controller comprise one or more of amplitude, power, duration, frequency, and duty cycle of ultrasound energy emitted by the ultrasound transducer (Cols. 7-8, lines 65-67 & 1-3: In step 60, the ultrasound system 20 uses the measured artery size to set the acoustic power to be delivered by transducer 30 during application of therapeutic ultrasonic energy in later steps. For example, control board 42 may use a lookup table correlating a particular echo delay (and thus artery diameter) with a particular power level; Col. 10, lines 15-20: the ultrasound system 20 may control the transducer 30 to transmit ultrasound energy in a pulsed function during application of therapeutic ultrasonic energy. The pulsed function causes the ultrasound transducer 30 to emit the ultrasound energy at a duty cycle of, for example, 50%). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Warnking for the purpose of adjusting the power level based on artery diameter and/or the pulse modulation of the ultrasound energy is helpful in limiting the tissue temperature (Warnking: Col 8, lines 4-10; Col. 10, lines 20-23).
Regarding claim 6, Fischell in view of Schepis fails to disclose wherein the ultrasound transducer is located within a balloon that is at least partially filled with a cooling fluid that is circulated through the balloon in order to cool at least a portion of the tissue surrounding the biological lumen proximate the balloon, and wherein the one or more denervation parameters selected by the controller also comprise at least one of a flow rate or a temperature associated with the cooling fluid and wherein the controller is configured to select and vary the at least one of the flow rate or the temperature based on the one or more characteristics of the sensed neural activity to control a depth of cooling protection provided by the cooling fluid and thereby control a depth of ablation produced by ultrasound energy emitted by the ultrasound transducer.
However, Warnking discloses wherein the ultrasound transducer (ultrasound transducer 30) is located within a balloon (balloon 24) that is at least partially filled with a cooling fluid that is circulated through the balloon in order to cool at least a portion of the tissue surrounding the biological lumen proximate the balloon, and wherein the one or more denervation parameters selected by the controller also comprise at least one of a flow rate or a temperature associated with the cooling fluid (Col. 6, lines 29-36: The circulation device 48 may include elements such as a tank for holding the circulating coolant 35, pumps 37, a refrigerating coil (not shown), or the like for providing a supply of liquid to the interior space of the balloon 24 at a controlled temperature, desirably at or below body temperature. The control board 42 interfaces with the circulation device 48 to control the flow of fluid into and out of the balloon 24) and wherein the controller is configured to select and vary the at least one of the flow rate or the temperature (Col. 6, lines 34-39: The control board 42 interfaces with the circulation device 48 to control the flow of fluid into and out of the balloon 24. For example, the control board 42 may include motor control devices linked to drive motors associated with pumps for controlling the speed of operation of the pumps 37) based on the one or more characteristics of the sensed neural activity to control a depth of cooling protection provided by the cooling fluid and thereby control a depth of ablation produced by ultrasound energy emitted by the ultrasound transducer (Col. 7, lines 45-47: the circulation device 48 maintains a flow of cooled aqueous liquid into and out of balloon 24, so as to cool the transducer 30; Col. 9, lines 5-14: The power level desirably is selected so that throughout the impact volume, solid tissues are heated to about 42° C. or more for at several seconds or more, but desirably all of the solid tissues, including the intima of the renal artery remain well below 65° C. Thus, throughout the impact region, the solid tissues (including all of the renal nerves) are brought to a temperature sufficient to inactivate nerve conduction but below that which causes rapid necrosis of the tissues; lines 40-47: the circulation of cooled liquid through the balloon 24 containing the transducer 30 may also help reduce the heat being transferred from the transducer 30 to the intimal layer 3 and to the blood flowing past the transducer. Hence, the transmitted therapeutic unfocused ultrasound energy does not damage the intima and does not provoke thrombus formation, providing a safer treatment; wherein this limitation is interpreted as the temperature being controlled since it is a temperature associated with the cooling fluid & is interpreted broadly to be a result of the cooling fluid and selection of ultrasound parameters).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Fischell in view of Schepis to include a balloon and cooling system, as taught by Warnking, for the purpose of the transmitted therapeutic unfocused ultrasound energy does not damage the intima and does not provoke thrombus formation, providing a safer treatment (Warnking: Col. 9, lines 44-47).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Schepis as applied to claim 1 above, and further in view of Coates et al. (U.S. Pub. No. 20210000543, cited in IDS), herein referred to as “Coates”.
Regarding claim 7, Fischell discloses wherein the catheter further comprises at least one radio frequency (RF) electrode configured to emit radio frequency (RF) energy ([0061] It is also envisioned that the wires leading to two or more of the distal needle/electrodes could be attached at the proximal end of the PNASC to an electrical or RF source to deliver electric current or RF energy to perform tissue and/or nerve ablation) but fails to disclose wherein the denervation parameters selected by the controller comprise one or more of amplitude, power, duration, frequency, and duty cycle of radio frequency (RF) energy emitted by the at least one RF electrode.
However, Coates discloses wherein the catheter further comprises at least one radio frequency (RF) electrode configured to emit radio frequency (RF) energy ([0116]: For example, the therapy delivery device may include radiofrequency (RF) electrodes on a catheter introduced and advanced along a blood vessel of the patient) and wherein the denervation parameters selected by the controller comprise one or more of amplitude, power, duration, frequency, and duty cycle of radio frequency (RF) energy emitted by the at least one RF electrode ( [0145]: Generator 14 is configured to receive one or more therapy programs 34 from programmer 24, and apply the denervation therapy parameter values specified by the received one or more therapy programs 34, such as amplitude, duty cycle, and frequency, to generate a denervation stimulus; [0168]: processor 25 may generate a GUI 26 that orders the therapy programs 34 based on determined efficacy (e.g., resulting in lesioning of a target nerve and/or avoiding lesioning of an adverse-effect region, or a clinician may otherwise select one of therapy programs 34; wherein based on the methods shown in Figs. 4-7, the determined efficacy is determined based on measured characteristics).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Coates for the purpose of having multiple therapy programs/denervation parameters may provide efficacious results for a particular patient, e.g., due to similar targeting of the renal nerve or other nerve or target tissue site of interest by denervation stimuli (Coates: [0103]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Schepis as applied to claim 3 above, and further in view of Gross et al. (U.S. Pat. No. 10478249, cited in IDS), herein referred to as “Gross”.
Regarding claim 8, Fischell in view of Schepis fails to disclose wherein the controller is configured to:
determine at least one of the one or more characteristics of the sensed neural activity by determining a minimal amount of stimulation energy needed to evoke a neural response by the nerves within tissue surrounding the biological lumen; and
select the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the minimal amount of stimulation energy needed to evoke the neural response by the nerves within tissue surrounding the biological lumen.
However, Gross discloses wherein the controller (control unit 32) is configured to:
determine at least one of the one or more characteristics of the sensed neural activity by determining a minimal amount of stimulation energy needed to evoke a neural response by the nerves within tissue surrounding the biological lumen (Col. 57, lines 12-17: Step 108 comprises (1) initiating action potentials in the nerve by applying an excitatory current to the nerve and (2) after the start of the application of the excitatory current, detecting a value of the parameter (i.e., an “excited” value), e.g., as described with reference to FIG. 2C; see “min/max” achievable when excited in steps 108-114 Fig. 4; see also Col. 81, lines 36-52, lines 47-49: by varying the amplitude of the stimulating current, the approximate distance of the nerve may be determined) and
select the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the minimal amount of stimulation energy needed to evoke the neural response by the nerves within tissue surrounding the biological lumen (Col. 57, lines 30-31: Step 112 comprises ablating the nerve tissue by applying ablative energy; lines 46-51: If it is decided to continue ablating, steps 112, 114, 116, and 118 are repeated, optionally after an adjustment step 120 in which one or more characteristics (e.g., the intensity) of the ablation energy is adjusted. This part of the technique thereby represents an iterative routine 122 (e.g., a cycle), which may comprise the ablate-excite-detect cycle; Col. 69, lines 30-36: step 642 comprises, or represents, an iterative routine in which the excitatory current is applied and adjusted until a desired detection of the factor is achieved (e.g., until a threshold defined at least in part based on a target excited value of the factor is crossed). For some applications, this iterative routine comprises, or corresponds to, steps 108 and 110 described with reference to FIG. 4).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Gross for the purpose of varying the amplitude of the stimulating current, the approximate distance of the nerve may be determined and facilitating controlled ablation of autonomic nerve tissue (e.g., tissue of an autonomic nerve) of a subject (Gross: Col. 81, lines 47-49, Col. 69, lines 47-49).
Regarding claim 9, Fischell fails to disclose wherein the controller is configured to:
determine at least one of the one or more characteristics of the sensed neural activity by determining an amount of stimulation energy needed to cause saturation of an evoked neural response of the nerves within tissue surrounding the biological lumen; and
select the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the amount of stimulation energy needed to cause saturation of the evoked neural response of the nerves within tissue surrounding the biological lumen.
However, Gross discloses wherein the controller is configured to (control unit 32):
determine at least one of the one or more characteristics of the sensed neural activity by determining an amount of stimulation energy needed to cause saturation of an evoked neural response of the nerves within tissue surrounding the biological lumen (Col. 57, lines 12-17: Step 108 comprises (1) initiating action potentials in the nerve by applying an excitatory current to the nerve and (2) after the start of the application of the excitatory current, detecting a value of the parameter (i.e., an “excited” value), e.g., as described with reference to FIG. 2C; see “min/max” achievable when excited in steps 108-114 Fig. 4; see also Col. 81, lines 36-52, lines 47-49: by varying the amplitude of the stimulating current, the approximate distance of the nerve may be determined); and
select the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the amount of stimulation energy needed to cause saturation of the evoked neural response of the nerves within tissue surrounding the biological lumen (Col. 57, lines 30-31: Step 112 comprises ablating the nerve tissue by applying ablative energy; lines 46-51: If it is decided to continue ablating, steps 112, 114, 116, and 118 are repeated, optionally after an adjustment step 120 in which one or more characteristics (e.g., the intensity) of the ablation energy is adjusted. This part of the technique thereby represents an iterative routine 122 (e.g., a cycle), which may comprise the ablate-excite-detect cycle; Col. 69, lines 30-36: step 642 comprises, or represents, an iterative routine in which the excitatory current is applied and adjusted until a desired detection of the factor is achieved (e.g., until a threshold defined at least in part based on a target excited value of the factor is crossed). For some applications, this iterative routine comprises, or corresponds to, steps 108 and 110 described with reference to FIG. 4; see also Col 81, lines 53-62).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Gross for the purpose of varying the amplitude of the stimulating current, the approximate distance of the nerve may be determined and facilitating controlled ablation of autonomic nerve tissue (e.g., tissue of an autonomic nerve) of a subject (Gross: Col. 81, lines 47-49, Col. 69, lines 47-49).
Claims 11, 14 & 36 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Schepis as applied to claim 1 above, and further in view of Esteller et al. (U.S. Pub. No. 20230181909, previously cited), herein referred to as “Esteller”.
Regarding claim 11, Fischell in view of Schepis fails to disclose wherein the controller is configured to select at least one of the one or more denervation parameters using a machine learning model implemented by at least one of the one or more processors of the controller.
However, Esteller discloses wherein the controller is configured to select at least one of the one or more denervation parameters using a machine learning model implemented by at least one of the one or more processors of the controller ([0072]: Detected feature(s) from the feature detector 321 may be fed into a control algorithm 322, which may use relationship(s) 323 between the feature(s) and waveform parameter(s) to determine feedback for closed-loop control 324 of the therapy. By way of example, these relationships may be determined using machine learning processes and training data. More than one algorithm may be used to provide the closed-loop control. The algorithm(s) may be selected from a plurality of algorithms that are available to be used to implement the closed-loop control. The different algorithms may use different feature(s) and/or control different waveform parameter(s), and/or have different transfer functions or sensitivity for adjusting the parameter(s) in response to changes in the feature(s). The closed-loop control 324 may be used by the stimulation control 317 to adjust the stimulation (e.g., parameter(s)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Esteller for the purpose of machine learning enabling to determination of the relationships between the extracted features and the stimulation therapy (Esteller: [0080]).
Regarding claim 14, Fischell in view of Schepis fails to disclose wherein the controller is configured to:
determine at least one of the one or more characteristics of the sensed neural activity by fitting a curve to a portion of the signal indicative of the neural activity, and determining an area under the curve; and
select the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the area under the curve.
However, Esteller discloses wherein the controller ([0072]: The controller 316 may include a signal sampler 319 configured for use to sample a signal produced by the sensing circuitry 315) is configured to:
determine at least one of the one or more characteristics of the sensed neural activity by fitting a curve to a portion of the signal indicative of the neural activity, and determining an area under the curve ([0070]: The modulation device 302 may include sensing circuitry 315 configured to receive sensed electrical energy from the electrode(s), such as may be used to sense local field potentials in the spinal cord and/or sense other electrical activity in neural tissue or muscle tissue; [0072]: The controller 316 may include a signal sampler 319 configured for use to sample a signal produced by the sensing circuitry 315. The controller 316 may further include a feature detector 320 configured to detect one or more features in the sampled signal. A few examples of features that may be detected include peaks (e.g., minimum and/or maximum peaks including local peaks/inflections), range between minimum/maximum peaks, local minima and/or local maxima, area under the curve (AUC)); and
select the one or more denervation parameters based on the one or more characteristics of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the area under the curve ([0072]: The feature detector may include a feature selection 321 for determining or otherwise providing the selected closed-loop sensed feature. Detected feature(s) from the feature detector 321 may be fed into a control algorithm 322, which may use relationship(s) 323 between the feature(s) and waveform parameter(s) to determine feedback for closed-loop control 324 of the therapy).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Esteller for the purpose of providing feedback for closed-loop control such that sensing electrophysiological data while providing a therapy provides a plausible closed-loop feedback mechanism by which to regulate the therapy (Esteller: [0070], [0006]).
Regarding claim 36, Fischell in view of Schepis fails to disclose wherein the controller is further configured to diagnose a disease state by comparing the sensed neural activity to a neural activity signature stored in a memory and associated with the disease state.
However, Esteller discloses wherein the controller is further configured to diagnose a disease state by comparing the sensed neural activity to a neural activity signature stored in a memory and associated with the disease state ([0074]: These extracted feature(s) 431 may be compared using comparator 432 to setpoint(s) for the extracted feature(s) 433. The therapy may be controlled or adjusted at 434 based on the comparison; [0093]: FIG. 15 illustrates, by way of example and not limitation, epidural oscillation signals in the time domain representing a healthy state, a disease state and effective spinal cord stimulation … Setpoints, as illustrated in FIGS. 4 and 5, may represent the “state” of the spinal cord, and the spinal cord state may represent a healthy, pain-free condition or a distressed condition associated with worse symptoms or outcomes, as may inferred through measured or analyzed oscillations. Multiple such states and their features can be compared; [0068]: Control circuitry within the therapy device may be used to control the therapy based on the sensed biological signal(s). The control circuitry may include a controller/processor and/or may include other hardware, firmware and/or software). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Esteller, for the purpose of providing feedback for closed-loop control such that sensing electrophysiological data while providing a therapy provides a plausible closed-loop feedback mechanism by which to regulate the therapy (Esteller: [0070], [0006]).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Schepis as applied to claim 1 above, and further in view of Shah (U.S. Pat. No. 10543037, cited in IDS), herein referred to as “Shah”.
Regarding claim 15, Fischell discloses wherein the controller is configured to:
determine at least one additional characteristic of the sensed neural activity by determining temporal spacings between at least some of the plurality of temporally spaced peaks relative to a cardiac cycle ([0068]: Further measurements may be categorized, sorted, time-locked, correlated, normalized or otherwise evaluated in relation to measures such as blood pressure, a component of the cardiac cycle; [0135]: configured to provide non-ablative stimulation in order to provide a stimulus for obtaining sensing of evoked data to measure the health of the sympathetic nerve that is time-locked to the stimulus);
but Fischell in view of Schepis fail to disclose wherein the controller is configured to:
select at least one of the one or more denervation parameters based on the additional characteristic of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the temporal spacings between the at least some of the plurality of temporally spaced peaks relative to the cardiac cycle.
However, Shah discloses wherein the controller (controller 1539) is configured to:
select at least one of the one or more denervation parameters based on the additional characteristic of the sensed neural activity by selecting at least one of the one or more denervation parameters based on the temporal spacings between the at least some of the plurality of temporally spaced peaks relative to the cardiac cycle (Col. 11, lines 32-35: the control algorithm 132 includes monitoring one or more of the temperature, time, impedance, power, flow velocity, volumetric flow rate, blood pressure, heart rate; lines 43-46: If monitored parameters fall outside the ranges set by the predetermined parameter profiles, the control algorithm 132 adjusts the commanded power output accordingly).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Shah for the purpose of enabling the power control to be automated (Shah: Col. 11, lines 4-6).
Regarding claim 16, Fischell in view of Schepis fails to disclose wherein the controller is further configured to diagnose a disease state based on at least one of the one or more characteristics of the sensed neural activity.
However, Shah discloses wherein the controller is further configured to diagnose a disease state based on at least one of the one or more characteristics of the sensed neural activity (Col. 6, lines 25-29: The console 106 can also be configured to deliver the neuromodulation energy via an automated control algorithm 132 and/or under the control of a clinician. In addition, one or more diagnostic algorithms 134 may be executed on a processor (not shown) of the system 100; lines 39-46: The feedback from the diagnostic information may allow a clinician to better position the device at the treatment site and/or determine the effectiveness of the applied energy during the treatment and/or shortly thereafter (e.g., while the patient is still catheterized). Likewise, while the patient is still catheterized, a clinician may decide to repeat a treatment based on feedback from the diagnostic information; wherein diseased state is seen as any tissue necessitating treatment or any unhealthy tissue). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Shah for the purpose of the feedback may be useful in helping the clinician increase the likelihood of success of the current or subsequent treatments (Shah: Col. 6, lines 46-48).
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Schepis as applied to claim 1 above, and further in view of Wang (U.S. Pub. No. 2019/0110704, cited in IDS), herein referred to as “Wang”.
Regarding claim 37, Fischell in view of Schepis fails to disclose wherein the controller is configured to determine the minimal amount of stimulation energy needed to evoke the neural response by:
comparing neural activity sensed within a temporal window following electrical stimulation to a baseline of spontaneous neural activity sensed prior to the electrical stimulation; and
determining that an evoked neural response has occurred when the neural activity sensed within the temporal window differs from the baseline of spontaneous neural activity by at least a threshold.
However, Wang discloses wherein the controller (computing unit 104) is configured to determine the minimal amount of stimulation energy needed to evoke the neural response by:
comparing neural activity sensed within a temporal window following electrical stimulation to a baseline of spontaneous neural activity sensed prior to the electrical stimulation ([0170]: At step 1, physiological signals from sensor 103 are continuously recorded by device 104 to produce a reliable baseline reflective of any instantaneous changes in the signals; [0171]: Energy is then delivered by one of the electrodes in device 101 to the area on the arterial wall that this electrode is in contact with (step 2). Sensor 103 detects any physiological change caused by the energy delivered, and the change is recorded as signals which are then sent to device 104. (step 3); [0172]: In step 4, device 104 determines the deviation of the physiological signals from the baseline of step 1; [0174]: In an embodiment, the dosage of energy delivered in step 2 is adjustable to induce different interactions with a targeted nerve such as nerve stimulation or nerve ablation); and
determining that an evoked neural response has occurred when the neural activity sensed within the temporal window differs from the baseline of spontaneous neural activity by at least a threshold ([0172]: step 5, determines the type of nerves innervating the area on the arterial wall based on the deviation from the baseline information; [0173]: In one embodiment, the physiological signals detected by sensor 103 comprises one or more of … muscle activity, skeletal nerve activity, action potential of cells; see threshold determining nerve type in Fig. 2).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Wang for the purpose of identifying the presence of functional sympathetic or parasympathetic nerves innervating a selected area on the arterial wall based on changes in physiological parameters induced by a dose of energy (Wang: [0168]).
Regarding claim 38, Fischell in view of Schepis fails to disclose wherein the controller is configured to determine the minimal amount of stimulation energy needed to evoke the neural response by:
comparing neural activity sensed within a temporal window following electrical stimulation to a baseline of spontaneous neural activity sensed prior to the electrical stimulation; and
determining that an evoked neural response has occurred when the neural activity sensed within the temporal window differs from the baseline of spontaneous neural activity by at least a threshold.
However, Wang discloses wherein the controller (computing unit 104) is configured to determine the minimal amount of stimulation energy needed to evoke the neural response by:
comparing neural activity sensed within a temporal window following electrical stimulation to a baseline of spontaneous neural activity sensed prior to the electrical stimulation ([0170]: At step 1, physiological signals from sensor 103 are continuously recorded by device 104 to produce a reliable baseline reflective of any instantaneous changes in the signals; [0171]: Energy is then delivered by one of the electrodes in device 101 to the area on the arterial wall that this electrode is in contact with (step 2). Sensor 103 detects any physiological change caused by the energy delivered, and the change is recorded as signals which are then sent to device 104. (step 3); [0172]: In step 4, device 104 determines the deviation of the physiological signals from the baseline of step 1; [0174]: In an embodiment, the dosage of energy delivered in step 2 is adjustable to induce different interactions with a targeted nerve such as nerve stimulation or nerve ablation); and
determining that an evoked neural response has occurred when the neural activity sensed within the temporal window differs from the baseline of spontaneous neural activity by at least a threshold ([0172]: step 5, determines the type of nerves innervating the area on the arterial wall based on the deviation from the baseline information; [0173]: In one embodiment, the physiological signals detected by sensor 103 comprises one or more of … muscle activity, skeletal nerve activity, action potential of cells; see threshold determining nerve type in Fig. 2).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis to include the controller of Wang for the purpose of identifying the presence of functional sympathetic or parasympathetic nerves innervating a selected area on the arterial wall based on changes in physiological parameters induced by a dose of energy (Wang: [0168]).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Schepis and Wang as applied to claim 38 above, and further in view of Franke et al. (U.S. Pub. No. 20150202446, previously cited), herein referred to as “Franke”.
Regarding claim 39, Fischell in view of Schepis and Wang fails to disclose wherein the controller is further configured to:
begin the electrical stimulation at a low stimulation level;
incrementally increase the electrical stimulation level until the evoked neural response is detected; and
store the stimulation level at which the evoked neural response is first detected as the minimal amount of stimulation energy needed to evoke the neural response.
However, Franke discloses wherein the controller (controller 1539) is further configured to:
begin the electrical stimulation at a low stimulation level; incrementally increase the electrical stimulation level until the evoked neural response is detected; and store the stimulation level at which the evoked neural response is first detected as the minimal amount of stimulation energy needed to evoke the neural response ([0073]: The controller 1539 may further include a titration control module 1546. The titration control module may be used to adjust the depletion block stimulation to control the axons that are captured by the depletion block stimulation, to adjust the nerve stimulation to control the axons that a captured by the nerve stimulation, or to adjust both the depletion block stimulation and the nerve stimulation. The amplitude of the stimulation may be adjusted, or the pulse width may be adjusted, or both the amplitude and pulse width may be adjusted to control the axons that are captured; [0077]: The memory may include a plurality of neural stimulation parameter sets, where each set includes a unique combination of parameter values for the neural stimulation and wherein each unique combination of parameter values is defined to provide neural stimulation therapy at an intensity level. The instructions include instructions for stepping through the plurality of neural stimulation parameter sets according to a schedule to change (increase or decrease) the intensity of the therapy until the therapy is at the desired long term intensity). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Fischell in view of Schepis and Wang to include the controller of Franke for the purpose of capturing as many nerve fibers in the vagus nerve as possible by titrating amplitude up as high as tolerable (Franke: [0035]).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell in view of Schepis as applied to claim 1 above, and further in view of Franke et al. (U.S. Pub. No. 20150265334, previously cited), herein referred to as “Franke 2”.
Regarding claim 40, Fischell in view of Schepis disclose fail to disclose wherein the one or more processors are further configured to:
select the one or more denervation parameters to create a deeper lesion when the determined distribution of amplitudes indicates a prevalence of peaks having lower amplitudes; and
select the one or more denervation parameters to create a shallower lesion when the determined distribution of amplitudes indicates a prevalence of peaks having higher amplitudes.
However, Franke 2 discloses wherein the one or more processors (controller 165; [0046]: controller 165 may include a processor having similar characteristics as the processor described above in reference to the processor of the user interface module 135. The processor of the controller 165 may be generally configured to accept information from the system 100, and process the information according to various algorithms to produce control signals for controlling the energy generator 170) are further configured to:
select the one or more denervation parameters to create a deeper lesion when the determined distribution of amplitudes indicates a prevalence of peaks having lower amplitudes ([0078]: Steps 1020 and 1030 may be repeated to evaluate if the therapeutic step 1040 was effective … If the treated tissue is identified as still eliciting any or an undesired level of response to the stimulating energy, this may indicate that the previous treatment step 1040 was not yet effective. In this case, the treatment step 1040 may be repeated at the same, less, or greater level than the original therapeutic treatment energy along with steps 1020 and 1030 until the identified tissue no longer elicits a response; wherein until specified relative to a threshold (for both the lesion depth and amplitude), anything adjusting a therapeutic dose in response to stimulation is seen as meeting the limitation); and
select the one or more denervation parameters to create a shallower lesion when the determined distribution of amplitudes indicates a prevalence of peaks having higher amplitudes ([0078]: Steps 1020 and 1030 may be repeated to evaluate if the therapeutic step 1040 was effective …If the treated tissue is identified as still eliciting any or an undesired level of response to the stimulating energy, this may indicate that the previous treatment step 1040 was not yet effective. In this case, the treatment step 1040 may be repeated at the same, less, or greater level than the original therapeutic treatment energy along with steps 1020 and 1030 until the identified tissue no longer elicits a response; wherein until specified relative to a threshold (for both the lesion depth and amplitude), anything adjusting a therapeutic dose in response to stimulation is seen as meeting the limitation).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Fischell in view of Schepis to include the processor of Franke for the purpose of allowing for a practitioner to determine whether a treatment was successful, reduce treatment procedure times, reduce energy used, reduce healing time, and provide for a treatment with fewer complications (Franke 2: [0093]).
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 Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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