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 Arguments
Applicant’s arguments, see pages 7-8, filed 08/22/2025, with respect to 35 U.S.C. 101 have been fully considered and are persuasive. The amendments that the treatment of bladder dysfunction causing the electrode to apply stimulation signal is a practical application. Therefore, the rejection of the claims has been withdrawn.
Applicant’s arguments, see pages 8-10, filed 08/22/2025, with respect to 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Thor (US 20200222693)(Hereinafter Thor).
Applicant's arguments, see pages 10-14, filed 08/22/2025, under 35 U.S.C. 112(a) and 112(b) have been fully considered but they are not persuasive. Applicant asserts on page 13 that “WO2017066572 and WO2019023115, which the subject application incorporates by reference, physiological parameters (e.g., bladder pressure, muscle EMG activity, etc.) can indicate the stage in the bladder cycle (i.e., filling or voiding)” and argues that “the claims do not recite a “predetermined threshold value.” See MPEP 2163(II)(A)(2) (the written-description analysis “calls for the examiner to compare the scope of the claim with the scope of the description”) More to the point, Figures 2 and 3 and pages 36 and 37 of the specification demonstrate an actual reduction to practice of the claimed method by showing selective stimulation of the EUS. See Specification at 37:9-11 (“This demonstrated a clear elective effect of increasing amplitude on the urethral pressure, that correlated with EUS EMG activity, without affecting the EAS or pelvic muscle (Figure 2 & 3) on this pudendal branch.”) This alone is enough to satisfy the written-description requirement.” Examiner notes that the incorporated application fail to express what the baseline and threshold values for any of the physiological responses and further fails to show a representative number of species of when the first physiological parameter is beyond the first threshold while the second physiological response is not beyond the second threshold. Further, the instant specification of Figs. 2 and 3, and page 36-37 fail to show any physiological parameter that is not beyond the second threshold and further fails to show any representative number of species, as only urethral sphincter pressure is the only described baseline that is surpassed. Anal sphincter pressure is merely recited without describing the threshold or baseline that may be surpassed or is not passed.
Applicant then argues on page 14 that “the specification provides a specific in vivo example of how selective modulation is achieved. Further, the specification provides multiple examples in the specification of how the claimed method is to be deployed.” Examiner notes that this is not the argument is making. Applicant fails to have possession of the claimed invention because the specification fails to disclose the baseline and threshold for the physiological parameters and show a representative number of species for when a first physiological parameter is beyond the first threshold while the second physiological response is not beyond the second threshold.
Applicant lastly argues on page 14 that “the relationship between the “magnitude[s]” of the physiological responses and their corresponding predetermined thresholds is abundantly clear to a person having ordinary skill in the art. Further, as noted in the above explanation of the claimed invention, the specification (including the disclosures incorporated by reference) explains the circumstances under which the magnitude of a physiological response may be “at or below baseline” with respect to an increase in muscle activity or the like.” Examiner disagrees because Applicant has failed to show where this limitation is shown and what that set threshold may be. Therefore, the rejections are maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 7-10, 12-20, 24, and 35-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may “express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted).It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP 2163 (II)(2).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See MPEP 2163(III)(a)(ii).
Applicant' s description of the usage of the magnitude of the first and second physiological response value thresholds (claims 1, 5, 7-10, 12-20, 24, and 35-36) lacks written description support. The mere statement and recitation of the predetermined thresholds in claims 1-2, and in pages 10-11 and 15 of the instant specification provides insufficient detail to the expected first and second predetermined thresholds values for any and all of the representative physiological responses listed in claims 5 and 7 and pages 10-21 of the instant specification. Further, the instant specification fails to detail the way in which the magnitude of the first and second physiological response threshold values are or are not surpassed (depending of if EUS or EAS is present or absent).
For example, on page 11 of the instant specification, Applicant discloses that the second predetermined threshold may be the baseline or natural level of activity detectable for the second physiological response, which may be none or zero - i.e. no detectable activity or may be set as the maximum level or change of activity that is acceptable for nonspecific stimulation, for example as the threshold at which adverse effects caused by stimulation are typically experienced by a subject. For example, the second predetermined threshold may be set as a given multiple of the natural or baseline level of activity for the second physiological response, e.g. 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9 or 2 times the baseline or natural level of activity where nonspecific stimulation is indicated by an increase in the second physiological response.
The cited portions of the instant specification fail to show possession of this predetermined second threshold value for any and all of the second physiological response of claim 7 and pages 19-21. The instant specification also fails to detail what would be considered the predetermined first physiological response threshold value for all of the physiological responses of claim 5. Although page 37 only details the urethral sphincter pressure ranging between 5-37 cmH2O, there is not mention of any surpassing or being at or below a threshold. Ultimately, the specification is written generically such that it only defines the invention in functional language specifying a desired result but does not sufficiently identify how the function is performed or the result is achieved (see MPEP §2161.01).
Claims 1, 5, 7-10, 12-20, 24, and 35-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2163.05, I, B “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) “
Claim 1 recite the limitation, “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” (lines 19-23). The disclosure fails to adequately describe an adequate representative number of species this limitation. The limitation fails to have proper written description in the specification as the phrase only merely recited on pages 2-3, 5, and 8-9 which simply recites the same language. It is unknown which physiological parameter will have to be beyond a threshold and which physiological parameter is not beyond a threshold when selective modulation occurs. Further, there is not simultaneous occurring physiological parameters described when a physiological parameter is beyond a threshold while the other physiological parameter is below a threshold. Therefore, the instant claims do not comply with the written description requirement of 35 USC 112(a).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5, 7-10, 12-20, 24, and 35-36 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, it is unclear what the magnitude of the physiological response has to be to not be beyond the predetermined threshold and what this set threshold is.
Regarding claims 7 and 12, it is unclear how the presence of selective stimulation would result in the second physiological response to not be beyond the second predetermined threshold, insinuating the second physiological parameter be at or below baseline, when claim 7 and 12’s second physiological responses disclose increased anal sphincter activity, pelvic floor activity, dorsal genital nerve (DGN) activity or pelvic wall muscle activity, which all surpass baseline levels. Clarification is required.
Claim Rejections - 35 USC § 102
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 –
(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.
Claim(s) 1, 5, 7, 9-10, 12, 14, 17, 20, 24, and 35-36 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Thor (US 20200222693)(Hereinafter Thor).
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.);
(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;”).
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 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 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 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) 8, 16, and 18-19 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 8, claim 1 is anticipated over Thor. 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 16, claim 1 is anticipated over Thor. 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 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 18, claim 1 is anticipated over Thor. 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 anticipated over Thor. 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.
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thor (US 20200222693)(Hereinafter Thor) in view of 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.
Regarding claim 15, claim 1 is anticipated over Thor. However, Thor does not teach the observation by a healthcare provider. 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 wherein detecting the first physiological response and/or the second physiological response is via observation by a healthcare professional ([0039] “the clinician, (e.g., physician, technician, surgeon, electrophysiologist, or other clinician) may interact with clinician programmer 104A to communicate with IMD 102. For example, the clinician may retrieve physiological or diagnostic information from IMD 102”) to increase the efficacy of the therapy ([0039]). 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 observation by a healthcare provider of Brink, because such a modification would allow to increase the efficacy of the therapy.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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
/REX R HOLMES/Primary Examiner, Art Unit 3796