CTNF 18/182,821 CTNF 96269 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of Group I, claims 1-18 in the reply filed on October 27 th , 2025 is acknowledged. Drawings 06-36 AIA The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first catheter comprising the at least one electrode; 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” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Examiner note: although Figs. 3A-B & 7A-B depict one catheter with electrodes and an ultrasound transducer, the figures do not depict two separate catheters. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-18 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 one or more characteristics” in line 10 and it is unclear if these are the same characteristics as the “one or more characteristics of the sensed neural activity” in line 9 or are different characteristics. For examination purposes, these are the same characteristics and the limitation will be interpreted as “the one or more characteristics of the sensed neural activity”. Regarding claim 1, the claim recites “the nerves” in line 11 and it is unclear whether these are the same nerves as the “nerves within tissue surrounding the biological lumen” in lines 4-5 or are different nerves. For examination purposes, these are the same nerves and the limitation will be interpreted as “the nerves within tissue surrounding the biological lumen”. Claims 2-18 are also rejected by virtue of their dependency on claim 1. Regarding claim 2, the claim recites “the nerves” in line 2 and it is unclear whether these are the same nerves as the “nerves within tissue surrounding the biological lumen” recited in claim 1, from which claim 2 depends, or are different nerves. For examination purposes, these are the same nerves and the limitation will be interpreted as “the nerves within tissue surrounding the biological lumen”. Claim 3 is also rejected by virtue of its dependency on claim 2. Regarding claim 4, the claim recites “the nerves” in line 5 and it is unclear whether these are the same nerves as the “nerves within tissue surrounding the biological lumen” recited in claim 1, from which claim 4 depends, or are different nerves. For examination purposes, these are the same nerves and the limitation will be interpreted as “the nerves within tissue surrounding the biological lumen”. Regarding claim 7, the claim recites “at least one electrode” in line 3 and it is unclear if this is the same electrode as the “at least one electrode” recited in claim 1, from which claim 7 depends, or is a different electrode. For examination purposes, these are the same electrodes and the limitation will be interpreted as “the at least one electrode”. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1-4, 10, 12-13, 15 & 17-18 are rejected under 35 U.S.C. 102( a)(1)/102(a)(2 ) as being anticipated by Fischell et al. (U.S. Pub. No. 20190008580), herein referred to as “Fischell” . Regarding claim 1, Fischell teaches 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: 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 indicative of one or more of a size, type, function or health of the nerves 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); select one or more denervation parameters based on the one or more characteristics of the sensed neural activity ([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). Regarding claim 2, Fischell discloses wherein: the sensing circuit is configured to sense the neural activity of the nerves 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 teaches 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 teaches: 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 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 teaches 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 ([0-353]: 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 teaches wherein: the sensing circuit is configured to sense the neural activity of the nerves within the tissue surrounding the biological lumen by sensing a signal indicative of the neural activity, the signal indicative of the neural activity including multiple peaks temporally spaced apart from one another ([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); and the controller is configured to determine at least one of the one or more characteristics of the sensed neural activity based on at least one of amplitudes of the multiple peaks or based on temporal spacings between the multiple 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 13, Fischell teaches 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 multiple 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 multiple 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 15, Fischell teaches wherein the controller is configured to: determine at least one of the one or more characteristics of the sensed neural activity by determining temporal spacings between at least some of the multiple 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); 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 temporal spacings between the at least some of the multiple peaks relative to the cardiac cycle ([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 teaches 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 teaches 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) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-22-aia AIA Claim s 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell 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 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 an ultrasound transducer. However, Warnking discloses 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 an 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 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 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. 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). 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 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) . 07-22-aia AIA Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell 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 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 at least one electrode. However, Coates discloses 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 at least one electrode ([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; [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 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]) . 07-22-aia AIA Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell as applied to claim 1 above, and further in view of Franke et al. (U.S. Pub. No. 20150265334), herein referred to as “Franke” . Regarding claim 8, 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 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, Franke discloses wherein the controller ([0074]: The diagnostic responses may be any suitable response and may be transmitted via the contact elements to a processor, such as a processor in the user interface module, controller, or any other processor, via a conduit connected to the medical device or via electronic signals) 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 ([0071]: At step 1020, the medical device may transfer stimulating energy to tissue portions at the location; [0072]: This cycle of stimulating energy delivery by each row of contact elements may be automatically repeated until a maximum or minimum energy amount is reached); 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 ([0075]: Based on the received diagnostic responses from each row of contact elements at each increment of stimulating energy, the processor may generate a response location profile of the tissue at the target location. The response location profile may identify which portions of the tissue exhibited the lowest threshold to the stimulating energy. These portions of tissue may be further identified as requiring treatment, such as ablation; [0077]: At step 1040, the medical device may selectively apply therapeutic energy to one or more tissue portions identified for receiving therapeutic treatment. In one embodiment, the therapeutic energy may be the same type of energy as the stimulating energy, but may be greater (e.g. double or triple) in 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 to include the controller of Franke for the purpose that only a portion of tissue having a specific size and location should receive therapeutic energy treatment, such as ablating energy (Franke: [0077]) . 07-22-aia AIA Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell as applied to claim 1 above, and further in view of Franke et al. (U.S. Pub. No. 20150202446), herein referred to as “Franke 2” . 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, Franke 2 discloses wherein the controller is configured to ([0007]: The at least one controller may be configured to communicate with the stimulator and control the depletion block stimulation and the nerve stimulation): 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 ([0050]: By way of example and not limitation, a full neurotransmitter block for intended fibers may be ensured by acquiring a recruitment curve. The recruitment curve may identify the activation threshold and saturation threshold for the neural target); 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 ([0050]: The current amplitude for the depletion block stimulation may be higher than and based on the saturation threshold of the fibers that are intended to be blocked. By way of example, the amplitude of the depletion stimulation signal may be set at approximately the saturation threshold of the fibers that are intended to be blocked, or may be set at a margin higher than the saturation threshold of the fibers, or may be set at a margin lower than the saturation threshold to provide a partial block). 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 Franke 2 for the purpose of the recruitment curve may be specific to an individual patient, may illustrate an increase in activity with increasing current amplitude, and may then illustrate a plateau where the activity does not significantly increase with increasing current amplitude (Franke 2: [0050]) . 07-22-aia AIA Claim s 11 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fischell as applied to claim 1 above, and further in view of Esteller et al. (U.S. Pub. No. 20230181909), herein referred to as “Esteller” . Regarding claim 11, Fischell 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 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 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 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]) . 07-22-aia AIA Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Fischell 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 16, Fischell 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 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). Conclusion 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ABIGAIL M ZIEGLER/Examiner, Art Unit 3794 /THOMAS A GIULIANI/Primary Examiner, Art Unit 3794 Application/Control Number: 18/182,821 Page 2 Art Unit: 3794 Application/Control Number: 18/182,821 Page 3 Art Unit: 3794 Application/Control Number: 18/182,821 Page 4 Art Unit: 3794 Application/Control Number: 18/182,821 Page 5 Art Unit: 3794 Application/Control Number: 18/182,821 Page 6 Art Unit: 3794 Application/Control Number: 18/182,821 Page 7 Art Unit: 3794 Application/Control Number: 18/182,821 Page 8 Art Unit: 3794 Application/Control Number: 18/182,821 Page 9 Art Unit: 3794 Application/Control Number: 18/182,821 Page 10 Art Unit: 3794 Application/Control Number: 18/182,821 Page 11 Art Unit: 3794 Application/Control Number: 18/182,821 Page 12 Art Unit: 3794 Application/Control Number: 18/182,821 Page 13 Art Unit: 3794 Application/Control Number: 18/182,821 Page 14 Art Unit: 3794 Application/Control Number: 18/182,821 Page 15 Art Unit: 3794 Application/Control Number: 18/182,821 Page 16 Art Unit: 3794 Application/Control Number: 18/182,821 Page 17 Art Unit: 3794 Application/Control Number: 18/182,821 Page 18 Art Unit: 3794 Application/Control Number: 18/182,821 Page 19 Art Unit: 3794 Application/Control Number: 18/182,821 Page 20 Art Unit: 3794 Application/Control Number: 18/182,821 Page 21 Art Unit: 3794 Application/Control Number: 18/182,821 Page 22 Art Unit: 3794 Application/Control Number: 18/182,821 Page 23 Art Unit: 3794 Application/Control Number: 18/182,821 Page 24 Art Unit: 3794 Application/Control Number: 18/182,821 Page 25 Art Unit: 3794 Application/Control Number: 18/182,821 Page 26 Art Unit: 3794