Prosecution Insights
Last updated: October 02, 2026
Application No. 18/915,196

METHOD AND APPARATUS FOR USING STIMULATION AND SENSING DISTANCES IN NEUROSTIMULATION CONTROL

Final Rejection §103
Filed
Oct 14, 2024
Priority
Oct 23, 2023 — provisional 63/545,289
Examiner
CIRULNICK, EMILY NICOLE
Art Unit
3792
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Boston Scientific Corporation
OA Round
2 (Final)
25%
Grant Probability
At Risk
3-4
OA Rounds
12m
Est. Remaining
25%
With Interview

Examiner Intelligence

Grants only 25% of cases
25%
Career Allowance Rate
1 granted / 4 resolved
-45.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
29 currently pending
Career history
28
Total Applications
across all art units

Statute-Specific Performance

§101
8.1%
-31.9% vs TC avg
§103
51.7%
+11.7% vs TC avg
§102
14.0%
-26.0% vs TC avg
§112
20.4%
-19.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 4 resolved cases

Office Action

§103
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 . Response to Amendment The amendment filed Jul. 20, 2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112 and 101 rejections previously set forth in the Non-Final Office Action mailed May 5, 2026. Response to Arguments 35 U.S.C. § 101: Applicant amended claims and addressed previous 35 USC 101 rejections and the rejections have been withdrawn. 35 U.S.C. § 112: Applicant amended claims and addressed previous 35 USC 112 rejections and the rejections have been withdrawn. 35 U.S.C. § 103: Applicant's arguments filed Jul. 20, 2026 have been fully considered but they are not persuasive. On page 9 of Applicant’s response, applicant argues that Zhang and Bittner do not teach the added limitation, specifically “without using one or more additional electrodes”. As Bittner discloses that one or more electrodes can be used for both stimulation and sensing, and Zhang teaches the use of two electrodes for sensing and stimulation, this would cover only two electrodes with no additional electrodes being used. For example, the sensing electrode and the stimulation electrode of Zhang can be the two electrodes and they can swap functionality to accomplish the task as taught by Bittner. This combination allows determining or adjusting the stimulation therapy for optimal results based on lead placement. The rejection still applies and has been updated below in light of the amendments to the claim. Information Disclosure Statement The information disclosure statement (IDS) submitted on July 26, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20220266027 A1, published Aug. 25, 2022, hereinafter referred to as “Zhang”) in view of Bittner et al. (US 20220331589 A1, published Oct. 20, 2022, hereinafter referred to as “Bittner”). Regarding claims 1, 11, and 20, Zhang teaches a system and a non-transitory computer-readable storage medium (“One skilled in the art will understand that the feature extraction algorithm 140 can comprise instructions that can be stored on non-transitory machine-readable media, such as magnetic, optical, or solid-state memories within the IPG 100 (e.g., stored in association with control circuitry 102).” ¶[0067]) including instructions, which when executed by a system, cause the system to perform a method for delivering neurostimulation to a neural target in a patient using a plurality of electrodes (“Implantable Pulse Generator (IPG) 10 shown in FIG. 1… The IPG 10 is coupled to tissue-stimulating electrodes 16” ¶[0004]), the system comprising: a stimulation output circuit (Fig. 1 “stimulation circuitry 28” ¶[0004]) configured to deliver neurostimulation pulses to the neural target using a stimulation electrode selected from the plurality of electrodes (“Stimulation in IPG 10 is typically provided by pulses … FIG. 2A.” ¶[0007] and Fig. 1 “IPG 10 is coupled to tissue-stimulating electrodes 16” ¶[0004]), the stimulation electrode configured to be positioned at a stimulation distance from the neural target (“Referring to FIG. 6 A, assume that a patient has been implanted with an electrode lead 17 placed at a distance D near the patient's spinal cord” ¶[0098]); a sensing circuit (Fig. 1 “IPG 100 also includes sensing circuitry 115, and one or more of the electrodes 16 can be used to sense signals the ESG signal” ¶[0064]) configured to sense neural signals from the neural target using a sensing electrode selected from the plurality of electrodes (“the waveform sensed at the sensing electrode may be referred to as an ElectroSpinoGram (ESG) signal, which comprises the ECAP, the stimulation artifact 134, and other background signals that may be produced by neural tissue even absent stimulation” ¶[0058]), the sensing electrode configured to be positioned at a sensing distance from the neural target (“In FIG. 7A, the stimulating electrodes are still at the original calibrated distance D from the spinal cord. The same amount of neural elements are activated as in FIG. 6 A. However, the distance between the sensing electrodes and the spinal cord is increased because of movement of the spinal cord (new distance D″).” ¶[0101]), the neural signals including neural responses each evoked by the delivery of a pulse of the neurostimulation pulses; and a stimulation control circuit configured to control the delivery of the neurostimulation pulses, the stimulation control circuit (“FIG. 4 shows various external devices that can wirelessly communicate data with the IPG 10 and/or the ETS 80, including a patient, hand-held external controller 45, and a clinician programmer 50. Both of devices 45 and 50 can be used to wirelessly send a stimulation program to the IPG 10 or ETS 80—that is, to program their stimulation circuitries 28 and 44 to produce pulses with a desired shape and timing described earlier. Both devices 45 and 50 may also be used to adjust one or more stimulation parameters of a stimulation program that the IPG 10 or ETS 80 is currently executing. Devices 45 and 50 may also receive information from the IPG 10 or ETS 80, such as various status information, etc.” ¶[0017] and Fig. 5 “The IPG 100 includes control circuitry 102… to produce currents or voltages of prescribed amplitudes (I) for the stimulation pulses, and with the correct timing (PW, F) at selected electrodes” ¶[0062]) including: a test controller configured to control performance of an electrode distance test including sensing a first neural signal of the neural signals using the sensing electrode while delivering the neurostimulation pulses using the stimulation electrode and sensing a second neural signal of the neural signals using an electrode while delivering the neurostimulation pulses using another electrode (“according to some embodiments, testing may be performed with a patient to determine which features are best suited for implementing closed-loop feedback. For example, a patient implanted with an electrode lead may undergo a testing procedure, whereby stimulation parameters (amplitude, pulse width, frequency, etc.) and/or the center point of stimulation (i.e., which electrodes are used to provide the stimulation) are varied” ¶[0140]; therefore, multiple signals are acquired); and a test processor configured to analyze the stimulation distance and the sensing distance using the first neural signal and the second neural signal (“The impact of changes in stimulation geometry and/or the stimulation waveform can thereby be tied to changes in the neural response features to determine which neural response features are most sensitive to stimulation for that patient.” ¶[0140]; “Once the feature extraction algorithm 140 determines one or more of these features, it may then be used to any useful effect in the IPG 100, and specifically may be used to adjust the stimulation that the IPG 100 provides, for example by providing new data to the stimulation circuitry 28 via bus 118. For example, if the distance between the stimulation electrode(s) and the patient's spinal cord changes (for example, because of postural changes, coughing, movement, etc.), the stimulation may be adjusted based on the extracted features to maintain optimum therapeutic stimulation.” ¶[0096]; the closed-loop feedback algorithm on Fig. 9 ¶[0106]-[0111] and “if it is determined to adjust the stimulation, adjusting the stimulation based on one or more of the first value and the second value.” ¶[0025]; and Fig. 14 “The third column 1406 shows the behavior at the sensing electrode for the given event, expressed as a change in the amount of CSF between the electrode(s) and the spinal cord (dCSF). A decrease in dCSF (down-arrow) indicates that the electrode is closer to the spinal cord; and increase in dCSF (up-arrow) indicates that the electrode is further from the spinal cord. The fourth column 1408 shows the behavior at the stimulating electrode(s).” ¶[0127]). Zhang does not disclose swapping between the sensing electrode and the stimulation electrode for sensing the neural signals and delivering the neurostimulation pulses without using one or more additional electrodes, wherein the sensing a second neural signal of the neural signal is using the stimulation electrode while delivering the neurostimulation pulses using the sensing electrode. Bittner’s invention relates to medical devices, and more specifically, electrical stimulation (¶[0002]). Sensing circuitry 206 in Fig. 2A may be configured to monitor signals from any combination of electrodes 232A, 232B and/or sensor(s) 222 (this includes only two electrodes). Sensing circuitry 206 may be used to sense stimulation-evoked and/or physiological signals, such as ECAP signals, EMG signals, and the like. In some examples, sensing circuitry 206 detects ECAP and/or EMG signals from a particular combination of electrodes 232A, 232B. In some cases, the particular combination of electrodes used for sensing ECAP and/or EMG signals includes at least one of the same electrodes as a set of electrodes used to deliver stimulation pulses to patient 14 (sensing a second neural signal of the neural signal is using the stimulation electrode while delivering the neurostimulation pulses using the sensing electrode) (¶[0088]). This step 74 in Fig. 12 may involve a sweep in which one or more electrode is used to stimulate and either the same and/or one or more other electrode is used to sense a composite signal evoked by the stimulation (swapping between the sensing electrode and the stimulation electrode for sensing the neural signals and delivering the neurostimulation pulses without using one or more additional electrodes as this shows that only one electrode can be used to do both the sensing and the stimulation so only one electrode is needed but more can be used). The sweep may be sequentially starting at the most distal electrode to the most proximal electrode. The sweep may include electrode configurations that are randomized or that block certain stimulation or sensing electrodes together (similar to the sweeps shown in FIGS. 11A-11C). In step 79, the processing circuitry 352 sets a stimulation level based on the one or more composite signals (analyze using the first neural signal and the second neural signal) (¶[0112]). As indicated in FIGS. 11A-11C, the different composite signals were evoked by different stimulation configurations, and features from the different composite signals can be used in accordance with aspects of this disclosures, including but not limited to: assess, for example but not limited to, efficacy of response to stimulation, determine or adjust stimulation settings (e.g. stimulation parameters, timing, lead activation); determine or adjust stimulation therapy (e.g., timing and duration of stimulation), lead placement and efficacy (e.g. positioning or repositioning during trial stimulation (external/implant) or chronic implantation). For example, the quantity of the composite signals in FIGS. 11A-11C may indicate that positioning of the stimulations of the electrodes to elicit the response indicates positioning is sufficient to elicit therapeutic response, positioning is inconclusive, or positioning is insufficient to elicit therapeutic response (¶[0151]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to swap between the sensing electrode and the stimulation electrode for sensing the neural signals and delivering the neurostimulation pulses without using one or more additional electrodes and to deliver stimulation using the sensing electrode and send the second neural signal using the stimulation electrode and analyze the information using the first and second neural signal as taught by Bittner in the system and method of Zhang as each electrode switches between sensing and stimulation. Further, only one electrode (but more can be used) is needed for the process, and therefore, when the teachings of Bittner are combined with Zhang, the stimulation and sensing electrodes in Zhang would be able to swap functionality without the use of additional electrodes in order to determine or adjust the stimulation therapy for optimal results based on lead placement. Regarding claims 2 and 12, Zhang teaches wherein the stimulation control circuit comprises a control adjuster configured to adjust the control of the delivery of the neurostimulation pulses using an outcome of the analysis (“According to some embodiments, adjusting the stimulation comprises using a feedback control algorithm to adjust the stimulation… in some embodiments, the method further comprises: using one or more of the sensing electrodes to sense a stimulation artifact, monitoring for a change in the stimulation artifact, and upon detection of a change in the stimulation artifact, determining whether to adjust the stimulation using the at least one second feature of the sensed neural responses to determine whether to adjust the stimulation.” ¶[0025] and Fig. 12 “control system 1200 includes a control algorithm 1202 for adjusting stimulation parameters based on neural features extracted from recorded neural signals” ¶[0123]). Regarding claim 3, Zhang teaches the system further comprising an implantable neurostimulator (“Implantable Pulse Generator (IPG) 10 shown in FIG. 1” ¶[0004] and “FIG. 5 shows an IPG 100 that includes stimulation and sensing functionality.” ¶[0054]) including the stimulation output circuit (Fig. 1 and 5 “stimulation circuitry 28 in the IPG 10” ¶[0007]), the sensing circuit (Fig. 1 “IPG 100 also includes sensing circuitry 115, and one or more of the electrodes 16 can be used to sense signals the ESG signal” ¶[0064]), and the stimulation control circuit (Fig. 5 “The IPG 100 includes control circuitry 102… to produce currents or voltages of prescribed amplitudes (I) for the stimulation pulses, and with the correct timing (PW, F) at selected electrodes” ¶[0062]). Regarding claim 4, Zhang teaches wherein the test controller is configured to control the delivery of the neurostimulation pulses during the electrode distance test using stimulation parameters determined to minimize perception of stimulation by the patient (“The disclosed methods and systems are particularly useful during the provision of sub-perception therapy. Sub-perception (also known as sub-threshold or paresthesia-free) therapy involves providing stimulation that the patient does not readily perceive. Sub-perception therapy involves providing stimulation with lower stimulation amplitudes that do not evoke paresthesia and correspond to amplitudes below perception threshold or at sub-threshold stimulation amplitudes.” ¶[0097]). Regarding claims 5 and 13, Zhang and Bittner do not explicitly teach wherein the test processor is configured to determine a first magnitude being a magnitude of the neural responses in the first neural signal, to determine a second magnitude being a magnitude of the neural responses in the second neural signal, and to analyze the stimulation distance and the sensing distance using the first magnitude and the second magnitude. Referring to Fig.’s 6-7, Zhang teaches the change in sensing responses when the distance between either the stimulating or sensing electrodes changes with respect to the target spinal cord. The change in the distance between the stimulating electrodes and the spinal cord causes an increase in the thickness of the cerebrospinal fluid (dCSF) between the stimulating electrodes and the target neural elements, which may impact the effectiveness of the stimulation. Specifically, since the stimulating electrodes are further from the spinal cord, the stimulation may activate fewer neural elements. Since fewer neural elements are activated, the patient's therapy may be degraded. Also, since fewer neural elements are activated, the magnitude of sensed neural response features will decrease. Thus, the sensed neural response intensity (e.g., peak-to-peak amplitude) can be used for closed-loop feedback to increase the stimulation intensity at the new distance D′, so as to activate the desired amount of neural elements, thereby maintaining the patent's therapy (¶[0099]). FIG. 6 C illustrates a similar situation where the stimulation environment has changed, this time due to the stimulating electrodes moving further from the spinal cord (new distance D′). Again, fewer neural elements are activated since the stimulating electrodes have moved further from the spinal cord. The patient's therapy may suffer, and the magnitude of the sensed neural response will be reduced. Thus, the sensed neural response intensity/amplitude can be used for closed loop feedback to increase the stimulation intensity at the new distance D′, so as to activate the desired amount of neural elements, thereby maintaining the patent's therapy. It should also be appreciated that similar changes in the stimulation environment can occur wherein the stimulating electrodes move closer to the spinal cord. In that case, the stimulation may activate a greater number of neural elements than desired, which may cause discomfort or other side effects for the patient. Such changes may be reflected as an increase in the sensed magnitude of the neural response and the neural response intensity/amplitude can be used for closed-loop feedback to decrease the stimulation to maintain the appropriate baseline therapy (¶[0100]). The situations illustrated in FIGS. 7 A and 7B illustrate problems with assuming that changes in sensed neural response intensity (and features derived based only on the sensed neural response intensity) all originate from changes to the stimulation environment and therefore need to be corrected using closed-loop feedback to adjust the stimulation parameters. The goal is to maintain stimulation of the correct neural fibers to maintain the patient's therapy. If the stimulating environment changes, then stimulation may need to be adjusted. However, if the sensing environment changes, then stimulation may not need to be adjusted, even though a change in the neural response intensity is observed (¶[0102]). Methods and systems for closed-loop adjustment of stimulation parameters based on neural response measurements that are able to discern between changes in the stimulation environment (when closed-loop adjustment is warranted) and changes in the sensing environment (when closed-loop adjustment may not be warranted) are presented. As used herein, changes in the stimulation environment may be expressed in terms of stim-dCSF, meaning the width of dCSF between the stimulating electrode(s) and the spinal cord. An increase in stim-dCSF means that the stimulating electrode-spinal cord distance has increased; a decrease in stim-dCSF means that the stimulating electrode-spinal cord distance has decreased. Likewise, changes in the sensing environment may be expressed in terms of sense-dCSF. An increase in sense-dCSF means that the stimulating electrode-spinal cord distance has increased; a decrease in sense-dCSF means that the stimulating electrode-spinal cord distance has decreased (¶[0103]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to determine a first magnitude being a magnitude of the neural responses in the first neural signal, to determine a second magnitude being a magnitude of the neural responses in the second neural signal, and to analyze the stimulation distance and the sensing distance using the first magnitude and the second magnitude as taught by Zhang in the device of Zhang and Bittner since the magnitude of the sensed neural signals tells us if there has been a change in the sensing or stimulating sensors and the sensed magnitude of the neural response and the neural response intensity/amplitude can be used for closed-loop feedback to increase or decrease the stimulation to maintain the appropriate baseline therapy. Regarding claims 6, 14, and 15, Zhang teaches wherein the test processor is configured to determine, as an outcome of the analysis: whether the stimulation distance and the sensing distance are approximately equal, and, if the stimulation distance and the sensing distance are not approximately equal, at least one of: which of the stimulation and sensing electrodes is closer to the neural target (“changes in the stimulation environment may be expressed in terms of stim-dCSF, meaning the width of dCSF between the stimulating electrode(s) and the spinal cord. An increase in stim-dCSF means that the stimulating electrode-spinal cord distance has increased; a decrease in stim-dCSF means that the stimulating electrode-spinal cord distance has decreased. Likewise, changes in the sensing environment may be expressed in terms of sense-dCSF. An increase in sense-dCSF means that the stimulating electrode-spinal cord distance has increased; a decrease in sense-dCSF means that the stimulating electrode-spinal cord distance has decreased” ¶[0103] and Fig. 14 “The third column 1406 shows the behavior at the sensing electrode for the given event, expressed as a change in the amount of CSF between the electrode(s) and the spinal cord (dCSF). A decrease in dCSF (down-arrow) indicates that the electrode is closer to the spinal cord; and increase in dCSF (up-arrow) indicates that the electrode is further from the spinal cord. The fourth column 1408 shows the behavior at the stimulating electrode(s).” ¶[0127] and this figure also shows a condition where the distances do not change indicating the stimulating electrode and sensing electrode are equal). Regarding claims 7 and 16, Zhang teaches wherein the test processor comprises: a detection module configured to detect the neural responses including morphological features of the neural responses from each of the first neural signal and the second neural signal (“the decision to (or to what extent to) implement closed-loop feedback can be based on morphological (i.e., shape) changes in the neural response” ¶[0105] and ¶[0112]-[0113] show ways to determine the morphological change and this is done between two signals); a measurement module configured to determine a first neural response parameter using the morphological features detected from the first neural and a second neural response parameter using the morphological features detected from the second neural signal (“FIG. 8 illustrates neurological modeling that shows how ECAPs recorded in a true positive (change in stim-dCSF) and a false positive (change in sense-dCSF) may differ from each other. Note, however, that the morphology (i.e., the shape of the curve) of true positive ECAP curve changes compared to the baseline ECAP curve. By contrast, the morphology of the false positive ECAP curve is largely preserved, even though the amplitude of the curve is decreased.” ¶[0104]; this can be applied to the two signals as taught in claim 1); and an analysis module configured to analyze the stimulation distance and the sensing distance using the first neural response parameter and the second neural response parameter (Fig. 14 “The third column 1406 shows the behavior at the sensing electrode for the given event, expressed as a change in the amount of CSF between the electrode(s) and the spinal cord (dCSF). A decrease in dCSF (down-arrow) indicates that the electrode is closer to the spinal cord; and increase in dCSF (up-arrow) indicates that the electrode is further from the spinal cord. The fourth column 1408 shows the behavior at the stimulating electrode(s).” ¶[0127]; the comparison is done between two signals including a baseline and can be applied to two signal). Regarding claims 8 and 17, Zhang teaches wherein the neural signals include evoked compound action potentials (ECAPs) each evoked by the delivery of a pulse of the neurostimulation pulses (Fig. 5 “it can be beneficial to sense a neural response in neural tissue that has received stimulation from the IPG 100. One such neural response is an Evoked Compound Action Potential (ECAP)” ¶[0055]), the detection module is configured to detect ECAPs including ECAP features each being a morphological feature of the ECAPs from each of the first neural signal and the second neural signal (“the morphology (i.e., the shape of the curve) of true positive ECAP curve changes compared to the baseline ECAP curve. By contrast, the morphology of the false positive ECAP curve is largely preserved, even though the amplitude of the curve is decreased.” ¶[0104]; “An ECAP is shown in isolation in FIG. 5, and comprises a number of peaks that are conventionally labeled with P for positive peaks and N for negative peaks, with P1 comprising a first positive peak, N1 a first negative peak, P2 a second positive peak, N2 a second negative peak, and so on” ¶[0055]; “The feature extraction algorithm 140 analyzes the digitized sensed signals to determine one or more ECAP features” ¶[0067]), and the measurement module is configured to determine the first neural response parameter using the ECAP features detected from the first neural signal and the second neural response parameter using the ECAP features detected from the second neural signal (Fig. 14 “In the illustrated embodiment, the extracted neural feature is an amplitude change, for example, N1-P2 amplitude, or other amplitude-related feature of the neural response.” ¶[0127]). Regarding claims 9 and 18, Zhang teaches wherein the stimulation control circuit further comprises a test initiator configured to initiate the electrode distance test in response to at least one of: a change in the sensed neural signal exceeding a specified sensing threshold (Fig. 9 “At step 906, assume that a change in the neural response compared to the baseline neural response is detected. For example, assume that the amplitude of the sensed neural response has decreased. Upon a change in the sensed neural response, a closed-loop feedback algorithm may be implemented (step 908), which may adjust the stimulation parameters in an attempt to bring the neural response back into agreement with the baseline neural response” ¶[0107] and in 9B and 9C, step 908 initiates steps 910 or 914 to check for changes from the baseline). Regarding claims 10 and 19, Zhang does not teach wherein the stimulation control circuit further comprises a notification generator to produce a notification using an outcome of the analysis. Bittner teaches the external device 24 of Fig. 1 may provide a notification to patient 14 when the electrical stimulation is being delivered or notify patient 14 of the prospective termination of the electrical stimulation. In addition, notification of termination may be helpful so that patient 14 knows that a voiding event may be more probable and/or the end of the fill cycle is nearing such that the bladder should be emptied (e.g., the patient should visit a restroom). In such examples, external device 24 may display a visible message, emit an audible alert signal or provide a somatosensory alert (e.g., by causing a housing of external device 24 to vibrate). In other examples, the notification may indicate when therapy is available (e.g., a countdown in minutes, or indication that therapy is ready) during the physiological cycle. In this manner, external device 24 may wait for input from patient 14 prior to terminating the electrical stimulation that reduces bladder contraction or otherwise promotes urine retention. Patient 14 may enter input that either confirms termination of the electrical stimulation so that the therapy stops for voiding purposes, confirms that the system should maintain therapy delivery until patient 14 may void, and/or confirms that patient 14 is ready for another different stimulation therapy that promotes voiding during the voiding event (¶[0058]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to produce a notification as taught by Bittner in the system of Zhang in order to indicate when the therapy is available. Conclusion THIS ACTION IS MADE FINAL. 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 Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-Th 8-5:30 and every other F 8-4:30ET. 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, Unsu Jung can be reached at (571) 272-8506. 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. /E.N.C./Patent Examiner, Art Unit 3792 /ALLEN PORTER/Primary Examiner, Art Unit 3796
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Prosecution Timeline

Oct 14, 2024
Application Filed
May 05, 2026
Non-Final Rejection mailed — §103
Jul 20, 2026
Response Filed
Aug 24, 2026
Final Rejection mailed — §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
25%
Grant Probability
25%
With Interview (+0.0%)
2y 11m (~12m remaining)
Median Time to Grant
Moderate
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