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 .
Election/Restrictions
Newly submitted claim 39 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Originally claimed 1 is directed to a method of modulating a subject with EUS or EAS with bladder dysfunction or fecal incontinence by positioning an electrode for stimulating a target pudendal nerve in a subject, apply a first stimulatory electrical signal that the electrode stimulates the first target pudendal nerve, detecting a magnitude of a first physiological response and a magnitude of a second physiological response in response to the first stimulatory electrical signal, and detecting whether selective modulation of EUS or EAS is occurring or not; detecting that selective modulation of the EUS or EAS is occurring by selecting either i. selective modulation of the EUS or EAS is not occurring when the magnitude of the first physiological response is detected to be not beyond a first predetermined threshold and/or the magnitude of the second physiological response is detected to be beyond a second predetermined threshold or ii. selective modulation of the EUS or EAS is occurring when the first physiological response is detected to be beyond the first predetermined threshold while the second physiological response is detected to be not beyond the second predetermined threshold, and treating the bladder dysfunction or fecal incontinence in the subject by causing the electrode to apply a stimulatory signal, or if EAS or EUS is not occurring, apply a second stimulatory signal, wherein the second stimulatory signal differs from the first stimulatory signal by at least one parameter or by application of the second stimulatory signal to a different target pudendal nerve.
Newly added claim 39 is directed to a method of stimulating a pudendal nerve in a subject suffering fecal incontinence to modulate the EAS by determining the location of the pudendal nerve, positioning the electrode for stimulation and detecting a first physiological response and detecting no second physiological response to confirm selective modulation of the EAS where a second electrode signal treats fecal incontinence.
Claim 39 differs from claim 1 because claim 1 recites many different combinations, none of which read on claim 39. Claim 39 does not detect whether EAS is occurring based on the magnitude of a first and second response, let alone the second physiological response having to be beyond or below a second predetermined threshold. Claim 39 requires no second physiological response, which is different that claim 1. Claim 1 may not detect the selective modulation of EAS or EUS and stimulate a different target pudendal nerve. Claim 1 may treat bladder dysfunction. Claim 1 detects selective modulation of the EUS or EAS is occurring in different ways. None of these occur in claim 39.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 39 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
This Office Action is responsive to the amendment filed on 04/23/2026. As directed by the amendment: Claim 1 have been amended, claims 2-4, 6, 11, 15-16, 21-23, 25-34, and 37-38 have been cancelled, and no claims have been added. Claim 39 is withdrawn. Thus, claims 1, 5, 7-10, 12-14, 17-20, 24, and 35-36 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 7-8, filed 04/23/2026, under 35 U.S.C. 112(a) have been fully considered but they are not persuasive. Applicant argues on page 8 that “Given that individual subjects will have different base lines (i.e., a first predetermined threshold), it is not reasonable or necessary to provide specific values or a range of values for a person of ordinary skill to understand the scope of invention and that the inventors were in possession of the invention at the time of filing.” Examiner agrees. The instant specification also discloses all the conditions for which “ the steps of detecting a first physiological response compared to a first predetermined threshold and not detecting a second physiological response compared to a second predetermined threshold indicates that the electrodes are selectively and specifically stimulating a first target pudendal nerve. In other words, one disease such as EAS is being treated as opposed to EUS, or vice versa.” (remarks filed 04/23/2026). Therefore, rejection is withdrawn.
Applicant's arguments, see pages 8, filed 04/23/2026, under 35 U.S.C. 112(b) have been fully considered. Applicant argues that the arguments in section II and that claims 7 and 12 are clear because “Claim 7 as recited narrows the second physiological response indicating that the targeted pudendal nerve will modulate EAS. Claim 12 as recited narrows the second physiological response and indicates that claim 1 is directed to selectively stimulating EUS.” Examiner agrees regarding claim 7 and 12. The rejection of the claims have been withdrawn.
Applicant’s arguments, see pages 8-10, filed 04/23/2026, with respect to 35 U.S.C. 102 and 103 have been fully considered. Applicant amended claims 15 and 16 into claim 1. Applicant asserts and argues on page 10 that “The method recites steps to determine that the intended pudendal nerve is targeted and able to be stimulated and confirming that non- targeted pudendal nerves are not stimulated prior to treating the subject. In contrast, Thor does not teach targeting a specific pudendal nerve and confirming the intended pudendal nerve is targeted and that non-intended pudendal nerves are not targeted. Rather, Thor teaches stimulating a subject's pudendal nerve bundle with two electrodes to produce two signals that either "store" or "void" depending on the subject's need. There's no disclosure or suggestion in Thor to detect that the targeted pudendal nerve is stimulated before treating the subject. Neither do Grill or Brink teach this requirement.” Examiner disagrees because the claim does not require the detection of the target pudendal nerve, but does require applying a first stimulation for detecting the selective modulation of EUS or EAS and a second stimulation for treating either bladder dysfunction or fecal incontinence. Specifically, one of the combinations of the claim requires the positioning of the electrode for stimulating a pudendal nerve, detecting a first and second physiological response, and based on the selective modulation of EUS or EAS occuring, treating either bladder dysfuntion of fecal incontinence. This can be seen in Fig. 12, 13 and 14 where stimulation is turned off at certain points, which separates the multiple stimulation signals, where the Examiner interprets two stimulation signals- one stimulation is used to detect EAS or EUS with the first and second physiological responses, and another stimulation used for treatment of voiding dysfunction, as [0167] and [0165] teaches that “pudendal nerve stimulation can prevent leakage of fluid from the bladder during prolonged”, which is treating voiding dysfunction. Therefore, Thor is maintained. The rejection is updated below.
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.
Claim(s) 1, 5, 7-10, 12, 14, 17-20, 24, and 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thor (US 20200222693)(Hereinafter Thor) in view of Grill et al. (US 20200188661)(See WO2019023115A1 with publication date of 01/31/2019)(Hereinafter Grill).
Regarding claim 1, Thor teaches A method of selectively modulating an external urethral sphincter (EUS) or external anal sphincter (EAS) of a subject with bladder dysfunction or fecal incontinence ([0201] “Thus, pudendal nerve efferent fibers that exit the spinal cord in the S1 root will first pass the S1 spinal root electrode and, after branching to join the pudendal nerve, will pass the pudendal nerve electrode as they continue to the external urethral and anal sphincters.” [0254] “While the frequency of the stimulation cycles may be relatively low (less than 50 Hz), the actual active pulses applied within the stimulation cycle may include stimulation at higher frequencies for short bursts as illustrated in FIG. 4.” Examiner notes that bursts of stimulation, shown in Fig. 4, is the selective modulation of EAS or EUS, as defined on page 18 of the instant specification.), the method comprising:
(a) positioning an electrode for stimulating a first target pudendal nerve in a subject, wherein the electrode is configured to apply a stimulatory electrical signal to stimulate a first target pudendal nerve ([0201] “Thus, pudendal nerve efferent fibers that exit the spinal cord in the S1 root will first pass the S1 spinal root electrode and, after branching to join the pudendal nerve, will pass the pudendal nerve electrode as they continue to the external urethral and anal sphincters.” [0204] “While the frequency of the stimulation cycles may be relatively low (less than 50 Hz), the actual active pulses applied within the stimulation cycle may include stimulation at higher frequencies for short bursts as illustrated in FIG. 4.” );
(b) causing the electrode to apply a first stimulatory electrical signal, such that the electrode stimulates the first target pudendal nerve ([0201] “Thus, pudendal nerve efferent fibers that exit the spinal cord in the S1 root will first pass the S1 spinal root electrode and, after branching to join the pudendal nerve, will pass the pudendal nerve electrode as they continue to the external urethral and anal sphincters.”);
(c) detecting a magnitude of a first physiological response and a magnitude of a second physiological response in response to the first stimulatory electrical signal applied by an electrode (Fig. 12 showing urethral and anal pressure at 10, 20, and 30 Hz, along with a voided volume of the bladder. The phrase magnitude is interpreted as a value, which can be seen in the graph of the values of voided volume and urethral anal pressure. [0163] “FIG. 12 shows test data indicating that PUD stimulation at 20 Hz or 30 Hz allowed the bladder to fill until a bladder pressure [first physiological response (bladder pressure)] of 100 cm H20 was reached with no fluid leaking from the urethra (i.e. the slope of the voided volume [second physiological response (Fig. 12 voided volume)] tracing is zero) during pudendal nerve stimulation. At 100 cm H20 the stimulation was stopped to avoid overfilling the bladder.” [0150] “Note that, at frequencies >1 Hz, there was an elevation in baseline pressure with the onset of stimulation. This elevation in baseline pressure during stimulation was due to summation of a subsequent stimulus's response (i.e. elevation in urethral pressure) being superimposed on the preceding stimulus's response before pressure returns to baseline…The baseline pressure at 10 Hz was smaller than at 20 Hz (i.e. ˜30 cm H2O and ˜80 cm H2O).” Examiner notes that the voided volume can never surpass a given threshold as a bladder cannot hold more than a given amount of urine. For that reason, the second physiological parameter, that being the voided volume, will always have to be less than or equal to the maximum amount of volume that can be held by the bladder.);
(d) detecting whether selective modulation of the EUS or EAS is occurring, wherein (Fig. 11 showing urethral and anal pressure at .05 Hz. [0155] “A. Low frequency stimulation at 0.5 Hz elevates both anal and urethral pressure briefly, but pressure dropped to the original baseline prior to the subsequent stimulus.” Examiner notes that the presence of stimulation of EUS at 0.5 Hz.):
i. selective modulation of the EUS or EAS is not occurring when the magnitude of the first physiological response is detected to be not beyond a first predetermined threshold and/or the magnitude of the second physiological response is detected to be beyond a second predetermined threshold ( Examiner notes that selective stimulation of EUS or EAS has occurred, as shown in Fig. 11, and therefore is occurring. Therefore, this limitation is not required. )
ii. selective modulation of the EUS or EAS is occurring when the first physiological response is detected to be beyond the first predetermined threshold while the magnitude of the second physiological response is detected to be not beyond the second predetermined threshold (Fig. 12 showing urethral and anal pressure at 10, 20, and 30 Hz, along with a voided volume of the bladder. [0163] “FIG. 12 shows test data indicating that PUD stimulation at 20 Hz or 30 Hz allowed the bladder to fill until a bladder pressure [first physiological response (bladder pressure)] of 100 cm H20 was reached with no fluid leaking from the urethra (i.e. the slope of the voided volume [second physiological response (Fig. 12 voided volume)] tracing is zero) during pudendal nerve stimulation. At 100 cm H20 the stimulation was stopped to avoid overfilling the bladder.” [0150] “Note that, at frequencies >1 Hz, there was an elevation in baseline pressure with the onset of stimulation. This elevation in baseline pressure during stimulation was due to summation of a subsequent stimulus's response (i.e. elevation in urethral pressure) being superimposed on the preceding stimulus's response before pressure returns to baseline…The baseline pressure at 10 Hz was smaller than at 20 Hz (i.e. ˜30 cm H2O and ˜80 cm H2O).” Examiner notes that the voided volume can never surpass a given threshold as a bladder cannot hold more than a given amount of urine. For that reason, the second physiological parameter, that being the voided volume, will always have to be less than or equal to the maximum amount of volume that can be held by the bladder. It can be seen in Fig. 12, 13 and 14 where stimulation is turned off at certain points, which separates the multiple stimulation signals, where the Examiner interprets two stimulation signals- one stimulation is used to detect EAS or EUS with the first and second physiological responses, and another stimulation used for treatment of voiding dysfunction, as [0167] and [0165] teaches that “pudendal nerve stimulation can prevent leakage of fluid from the bladder during prolonged”, which is treating voiding dysfunction.);
(e) if selective modulation of the EUS or EAS is detected to be: (Examiner notes that the selective modulation is present, and therefore the limitation does not occur. This is because the claim is contingent on when EUS is absent. See MPEP 2111.04. “When analyzing the claimed method as a whole, the PTAB determined that giving the claim its broadest reasonable interpretation, “[i]f the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed” (quotation omitted)”. Schulhauser at 10.):
i. not occurring, then processing to step (f) (Examiner notes that the selective modulation is occurring, and therefore the limitation does not occur. This is because the claim is contingent on when EUS selective modulation is not occurring. See MPEP 2111.04. “When analyzing the claimed method as a whole, the PTAB determined that giving the claim its broadest reasonable interpretation, “[i]f the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed” (quotation omitted)”. Schulhauser at 10.); and/or
ii. occurring, then proceeding to step (g) (Examiner notes that the selective modulation is present, and therefore proceeds to step g.); and
(f) i. causing the electrode to apply a second stimulatory signal, wherein the second stimulatory signal differs from the first stimulatory signal by at least one parameter or by application of the second stimulatory signal to a different target pudendal nerve (Examiner notes that the selective modulation is present, and therefore the limitation does not occur. This is because the claim is contingent on when EUS is absent. See MPEP 2111.04. “When analyzing the claimed method as a whole, the PTAB determined that giving the claim its broadest reasonable interpretation, “[i]f the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed” (quotation omitted)”. Schulhauser at 10.)
ii. repeating steps (d) and (e) (Examiner notes that the selective modulation is present, and therefore the limitation does not occur. This is because the claim is contingent on when EUS is absent. See MPEP 2111.04. “When analyzing the claimed method as a whole, the PTAB determined that giving the claim its broadest reasonable interpretation, “[i]f the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed” (quotation omitted)”. Schulhauser at 10.); and
(g) treating the bladder dysfunction or fecal incontinence in the subject by causing the electrode to apply a stimulatory signal, where the electrode is at a position such that selective modulation of the EUS or EAS is detected to be occurring during step (d) (Abstract “METHOD OF TREATING VOIDING DYSFUNCTION [also known as bladder dysfunction]” claim 1 “reacting to the received selection of “Void” by ceasing application of the first stimulation to the pair of electrodes; ceasing application of the first stimulation allowing relaxation of: an external urethral sphincter to allow voiding of urine through the external urethral sphincter; and an external anal sphincter to allow voiding of feces through the external anal sphincter;” It can be seen in Fig. 12, 13 and 14 where stimulation is turned off at certain points, which separates the multiple stimulation signals, where the Examiner interprets two stimulation signals- one stimulation is used to detect EAS or EUS with the first and second physiological responses, and another stimulation used for treatment of voiding dysfunction, as [0167] teaches that “pudendal nerve stimulation can prevent leakage of fluid from the bladder during prolonged”, which is treating voiding dysfunction.).
However, Thor does not teach feedback provided by the subject from physiological response. Grill, in the same field of endeavor, teaches the stimulation of the pudendal nerve via an electrode to produce an increase in bladder capacity ([0009]), and further teaches wherein detecting the first physiological response and/or the second physiological response is via observation by a healthcare professional or via feedback provided by the subject ([0124] “the input element may allow the subject to enter that they desire to begin bladder voiding (i.e. intend to begin urinating). In such embodiments, the controller is configured to cause a signal to be applied that produces a physiological response appropriate to the data input—for example, in the case of the intention to urinate being indicated, the signal may increase voiding efficiency.”) to treat bladder dysfunction of a user ([0143]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Thor, with the feedback provided by the subject from physiological response of Grill, because such a modification would allow to treat bladder dysfunction of a user.
Regarding claim 5, Thor teaches when the method is a method for selectively modulating the EUS wherein the first physiological response is selected from: bladder voiding, an urgency sensation, a change in EUS activity (e.g. an increase in pulsatile EUS EMG activity, a decrease in EUS EMG activity, external urethral sphincter relaxation, optionally visually-observed external urethral sphincter relaxation), an increase in bladder detrusor activity, an increase in urethral pressure, a decrease in urethral pressure, an increase in bladder contractions, an increase in bladder pulsatile contractions, and a decrease in bladder pressure, or combinations thereof (Fig. 11 showing urethral and anal pressure at .05 Hz. [0155] “A. Low frequency stimulation at 0.5 Hz elevates both anal and urethral pressure briefly, but pressure dropped to the original baseline prior to the subsequent stimulus.” Following stimulation, the urethral pressure [first physiological response] increases/elevates/surpasses baseline and the anal sphincter pressure [second physiological response] decreases back to baseline prior to the following stimulation (not beyond baseline).).
Regarding claims 7, Thor teaches wherein the second physiological response is indicative of increased anal sphincter activity, pelvic floor activity, dorsal genital nerve (DGN) activity or pelvic wall muscle activity and is selected from: an increase in anal sphincter EMG activity, an increase in anal sphincter pressure, and anal sphincter contraction, optionally visually-observed anal sphincter contraction, an increase in pelvic floor EMG activity, pelvic floor contraction, optionally visually-observed contraction or contraction sensed by the subject, an increase in DGN neural activity, genital sensation indicative of DGN activity and reported by the subject, an increase in pelvic wall muscle EMG activity, and pelvic wall muscle twitch (Fig. 12 showing urethral and anal pressure at 10, 20, and 30 Hz, along with a voided volume of the bladder. The phrase magnitude is interpreted as a value, which can be seen in the graph of the values of voided volume and urethral anal pressure. [0163] “FIG. 12 shows test data indicating that PUD stimulation at 20 Hz or 30 Hz allowed the bladder to fill until a bladder pressure [first physiological response (bladder pressure)] of 100 cm H20 was reached with no fluid leaking from the urethra (i.e. the slope of the voided volume [second physiological response (Fig. 12 voided volume) which is a contraction sensed by the subject] tracing is zero) during pudendal nerve stimulation. At 100 cm H20 the stimulation was stopped to avoid overfilling the bladder.” [0150] “Note that, at frequencies >1 Hz, there was an elevation in baseline pressure with the onset of stimulation. This elevation in baseline pressure during stimulation was due to summation of a subsequent stimulus's response (i.e. elevation in urethral pressure) being superimposed on the preceding stimulus's response before pressure returns to baseline…The baseline pressure at 10 Hz was smaller than at 20 Hz (i.e. ˜30 cm H2O and ˜80 cm H2O).” Examiner notes that the voided volume can never surpass a given threshold as a bladder cannot hold more than a given amount of urine. For that reason, the second physiological parameter, that being the voided volume, will always have to be less than or equal to the maximum amount of volume that can be held by the bladder.).
Regarding claim 8, claim 1 is obvious over Thor and Grill. However, Thor does not teach stimulating a perineal nerve. Grill, in the same field of endeavor, teaches the stimulation of the pudendal nerve via an electrode to produce an increase in bladder capacity ([0009]), and further teaches when the method is a method for selectively modulating the EUS wherein the target pudendal nerve is a perineal nerve ([0039] “the first and/or second electronic signal is (to be) applied to perineal nerve.”) to treat bladder dysfunction of a user ([0143]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Thor, with the stimulating a perineal nerve of Grill, because such a modification would allow to treat bladder dysfunction of a user.
Regarding claim 9, Thor teaches when the method is a method for selectively modulating the EUS wherein the target pudendal nerve innervates the external urethral sphincter ([0201] “Thus, pudendal nerve efferent fibers that exit the spinal cord in the S1 root will first pass the S1 spinal root electrode and, after branching to join the pudendal nerve, will pass the pudendal nerve electrode as they continue to the external urethral and anal sphincters.” Examiner notes that the pudendal nerve supplies the EUS with stimulation as they are connected and therefore inherently there. See image showing the connection of the perineal and dorsal nerves (downstream of the pudendal as they are branched from the pudendal nerve) to the EUS.:
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Regarding claim 10, Thor teaches when the method is a method for selectively modulating the EAS wherein the first physiological response is selected from: anal sphincter contraction, an increase in anal sphincter EMG activity, and an increase in anal sphincter pressure (Fig. 11 showing urethral and anal pressure at .05 Hz. [0155] “A. Low frequency stimulation at 0.5 Hz elevates both anal and urethral pressure briefly, but pressure dropped to the original baseline prior to the subsequent stimulus.” Following stimulation, the urethral pressure [first physiological response] increases/elevates/surpasses baseline and the anal sphincter pressure [second physiological response] decreases back to baseline prior to the following stimulation (not beyond baseline).).
Regarding claim 12, Thor teaches wherein the second physiological response is indicative of increased EUS activity, pelvic floor activity, dorsal genital nerve (DGN) activity, or pelvic wall muscle activity and is selected from:
bladder voiding, an urgency sensation, an increase in pulsatile EUS EMG activity, a decrease in EUS EMG activity, external urethral sphincter relaxation, optionally visually- observed external urethral sphincter relaxation, an increase in bladder detrusor activity, an increase in urethral pressure, a decrease in urethral pressure, an increase in bladder contractions, an increase in bladder pulsatile contractions, and a decrease in bladder pressure, an increase in pelvic floor EMG activity, pelvic floor contraction, optionally visually-observed contraction or contraction sensed by the subject, an increase in DGN neural activity, genital sensation indicative of DGN activity reported by the subject, an increase in pelvic wall muscle EMG activity, and pelvic wall muscle twitch (Fig. 12 showing urethral and anal pressure at 10, 20, and 30 Hz, along with a voided volume of the bladder. The phrase magnitude is interpreted as a value, which can be seen in the graph of the values of voided volume and urethral anal pressure. [0163] “FIG. 12 shows test data indicating that PUD stimulation at 20 Hz or 30 Hz allowed the bladder to fill until a bladder pressure [first physiological response (bladder pressure)] of 100 cm H20 was reached with no fluid leaking from the urethra (i.e. the slope of the voided volume [second physiological response (Fig. 12 voided volume) which is a contraction sensed by the subject] tracing is zero) during pudendal nerve stimulation. At 100 cm H20 the stimulation was stopped to avoid overfilling the bladder.” [0150] “Note that, at frequencies >1 Hz, there was an elevation in baseline pressure with the onset of stimulation. This elevation in baseline pressure during stimulation was due to summation of a subsequent stimulus's response (i.e. elevation in urethral pressure) being superimposed on the preceding stimulus's response before pressure returns to baseline…The baseline pressure at 10 Hz was smaller than at 20 Hz (i.e. ˜30 cm H2O and ˜80 cm H2O).” Examiner notes that the voided volume can never surpass a given threshold as a bladder cannot hold more than a given amount of urine. For that reason, the second physiological parameter, that being the voided volume, will always have to be less than or equal to the maximum amount of volume that can be held by the bladder.).
Regarding claim 14, Thor teaches when the method is a method for selectively modulating the EAS wherein the target pudendal nerve innervates the external urethral sphincter ([0201] “Thus, pudendal nerve efferent fibers that exit the spinal cord in the S1 root will first pass the S1 spinal root electrode and, after branching to join the pudendal nerve, will pass the pudendal nerve electrode as they continue to the external urethral and anal sphincters.” Examiner notes that the pudendal nerve supplies the EUS with stimulation as they are connected and therefore inherently there. See image showing the connection of the perineal and dorsal nerves (downstream of the pudendal as they are branched from the pudendal nerve) to the EUS.:
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Regarding claim 17, Thor teaches wherein the subject is under anesthesia for a duration of the method ([0215] “Under sterile techniques, anesthetized animals undergo T10 transection and implantation of Synapse System Pulse Generator connected to tripolar pudendal electrodes”).
Regarding claim 18, claim 1 is obvious over Thor and Grill. However, Thor does not teach a subject being conscious for a duration. Grill, in the same field of endeavor, teaches the stimulation of the pudendal nerve via an electrode to produce an increase in bladder capacity ([0009]), and further teaches wherein the subject is conscious for a duration of the method ([0078] “the subject may perceive discomfort due to the sensation of having a full bladder, and therefore be desirous of triggering micturition.” Examiner notes that a subject must be conscious to feel discomfort.) to treat bladder dysfunction of a user ([0143]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Thor, with the subject being conscious for a duration of Grill, because such a modification would allow to treat bladder dysfunction of a user.
Regarding claim 19, claim 1 is obvious over Thor and Grill. However, Thor does not teach programming neuromodulation. Grill, in the same field of endeavor, teaches the stimulation of the pudendal nerve via an electrode to produce an increase in bladder capacity ([0009]), and further teaches further comprising programming a neurostimulation apparatus comprising the electrode to cause the electrode to apply the stimulatory electrical signal ([0009] “apparatus comprising, consisting of, or consisting essentially of : at least one primary electrode configured to apply a first electrical signal to said nerve; and a controller coupled to said primary electrode(s) and controlling the first electrical signal to be applied thereby, wherein said controller is configured to cause said at least one primary electrode to apply said first electrical signal that stimulates neural activity in the pudendal nerve to produce an increase in bladder capacity”) to treat bladder dysfunction of a user ([0143]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Thor, with the tr programming neuromodulation of Grill, because such a modification would allow to treat bladder dysfunction of a user.
Regarding claim 20, Thor teaches wherein the stimulatory electrical signal comprises a waveform having a frequency in a range of from 0.1-100 Hz (Fig. 11).
Regarding claim 24, Thor teaches wherein the stimulatory electrical signal has an amplitude in a range of from 0.1-20mA ([0184] “Physiograph tracings of anal pressure were stably maintained above baseline for over 2 hours during the course of bilateral pudendal nerve stimulation (STIM; 20 Hz, 3× threshold current (120 μA left, 150 μA right [0.15 mA]) 0.1 msec.”).
Regarding claim 35, Thor teaches wherein the stimulatory electrical signal is a continuous stimulation signal ([0134] “Initially, all pudendal stimulation parameters were evaluated across a one- or two minute period of continuous stimulation”).
Regarding claim 36, Thor teaches in which the stimulatory electrical signal comprises a waveform having a frequency in a range of from 1-50 Hz (Fig. 11).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thor (US 20200222693)(Hereinafter Thor) in view of Grill et al. (US 20200188661)(See WO2019023115A1 with publication date of 01/31/2019)(Hereinafter Grill) and Brink et al. (US 20180154144)(Hereinafter Brink).
Regarding claim 13, claim 1 is anticipated over Thor. However, Thor does not teach the selective modulation of an inferior rectal nerve. Brink, in the same field of endeavor, teaches the neurostimulation of the bladder to control pelvic disorders, similar to the method of Thor, and further teaches when the method is a method for selectively modulating the EAS wherein the target pudendal nerve is an inferior rectal nerve ([0025] “therapy system 100 includes delivery of stimulation to tissue sites proximate to lumbar or thoracic spinal nerves or their branches, such as …an inferior rectal nerve”) to influence the behavior of pelvic floor muscles ([0025]). It would have been obvious to one skilled in the art, prior to the effective filing date of the claimed invention to modify the invention of Thor, with the selective modulation of an inferior rectal nerve of Brink, because such a modification would allow to influence the behavior of pelvic floor muscles.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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