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 page 8, filed 10/20/2025, with respect to claim objections have been fully considered and are persuasive. The objection of the claim has been withdrawn.
Applicant's arguments, see pages 8-9, filed 10/20/2025, with respect to 35 U.S.C. 112(a) have been fully considered but they are not persuasive. Applicant argues that [0113]-[0114] present two different controllers because the paragraphs recite an article “a” controller which are coupled to the primary and secondary electrode, respectively, and that the paragraphs would have noted the word “the” controller for the coupled second electrodes if they were referring to the same controller. Examiner disagrees. If this were two, a clear embodiment of two separate controller would have been established in the drawings, or a specific recitation in the instant specification that recites a first controller for the first electrodes and the second controller for the second electrodes. Trying to interpret article usage in the specification makes the embodiment ambiguous at best and makes a big leap of faith conclusion that there are two separate controllers. Therefore, the rejection is maintained.
Applicant's arguments, see pages 9-14, filed 10/20/2025, under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant asserts on page 10 that “a person having ordinary skill in the art would not have found it obvious to combine Grill and Bhadra as described in the Office Action to arrive at the claimed invention… whereas the instant application teaches an apparatus configured to apply bursting stimulation to improve bladder capacity, Grill teaches an apparatus configured to apply “high amplitude stimulation” in a continuous manner (as opposed to a burst pattern) to improve bladder capacity” and argues on page 11 that “Grill, however, nowhere mentions such a problem with physical discomfort. With that in mind, a person having ordinary skill in the art would have no motivation to look for the solution solved by the subject invention… And even if a person having ordinary skill in the art were motivated to improve upon Grill’s apparatus, said person would not have looked to Bhadra’s teachings to do so. According to this methodology, “first and second series of intermittent pulse trains are concurrently applied to the first electrode and the second electrode, wherein the first and second series of intermittent pulse trains are synchronized to . . . evoke bladder contractions to expel urine from the subject.” Id. (emphasis added). Bhadra thus teaches that application of bursting stimulation triggers bladder voiding, not improved bladder capacity. And given that Grill teaches that bladder function exists in two conflicting phases (filling and voiding), the above statement from Bhadra means that the application of bursting stimulation occurs at least in part during the filling phase.” Examiner disagrees because newly amended claims recite the phrase “at least one primary electrode to apply the first electrical signal such that application of the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity” is intended use limitation because the claims fail to provide an active step of applying the burst pattern at the specific phase (filling or voiding) that Applicant is asserting is distinguishing between the prior art and the instant invention. The usage of the burst can be for any functional usage, so long the there is a first and second electrode applying burst.
Applicant then argues on pages 12-13 that “A person having ordinary skill in the art would not have considered it obvious to implement “burst patterns” from Bhadra into Grill’s apparatus. Indeed, quite the opposite. As discussed above, whereas Bhadra teaches using burst-like stimulation to “expel urine” from (i.e., cause the “voiding” in) the subject, Grill teaches using high amplitude stimulation during the filling phase to improve bladder capacity and low amplitude stimulation during the voiding phase to improve voiding efficiency. Compare Grill at [0177] & [0181], with Bhadra at [0047]. Combining Grill with Bhadra would thus render Grill unsatisfactory for its intended purpose (i.e., healthy bladder function), given that Bhadra’s disclosure regarding burst stimulation teaches an apparatus only suitable for triggering bladder voiding without the benefit of improved bladder capacity… Thus, Bhadra’s disclosure teaches that applying burst patterns during the filling phase triggers the voiding phase. The subject application, on the other hand, teaches that the application of burst patterns “when applied towards the end of the filling phase” can “delay voiding.”… modifying the apparatus of Grill to incorporate Bhadra’s burst patterns would change Grill’s principle of operation. To this end, the apparatus in Grill is designed to operate in a phase-specific manner. See Grill at [0008]. Applying the electrical signals in a phase-specific manner is an essential feature of Grills apparatus.” Examiner disagrees because Bhadra, in Fig. 10, is directed burst stimulation using the electrode for voiding following the continuous stimulation at 3 Hz, which inherently improves bladder capacity because stimulation prior to voiding allows for the bladder to expand followed by the burst stimulation for greater bladder voiding. The bladder expansion allows for improved bladder capacity. Examiner notes that this assertion can be evidenced by Chancellor et al. (US 20090036945) who also uses short burst pulses for voiding following a constant stimulation at 2 Hz for increased bladder capacity and voiding efficiency ([0176] and Fig. 32). Nevertheless, Bhadra teaches that burst stimulation for a first and second stimulation signal, which would also expand the bladder (improve bladder capacity), while also induce larger contraction of the bladder for voiding efficiency. Therefore, the rejection is maintained.
Regarding the Provisional Nonstatutory Obviousness Double Patenting rejection, filed 10/20/2025, the applicant claims that a TD will be filed at the time that allowable subject matter has been indicated. Therefore, the rejection is maintained for the reasons of record.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “a first controller coupled to the at least one primary electrode(s) and controlling the first electrical signal to be applied thereby” in lines 5-6 is grammatically inconsistent and should recite “a first controller coupled to the at least one primary electrode(s) and controlling the first electrical signal configured to be applied thereby”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity” in lines 8-9 is grammatically inconsistent and should recite “the first electrical signal to the sensory branch of the pudendal nerve or sacral root configured to improve bladder capacity”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “the first electrical signal is applied in a burst pattern” in lines 10-11 is grammatically inconsistent and should recite “the first electrical signal is configured to be applied in a burst pattern”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “the first electrical signal is applied to a sensory branch of the pudendal nerve or sacral root” in lines 11-12 is grammatically inconsistent and should recite “the first electrical signal is configured to be applied to a sensory branch of the pudendal nerve or sacral root”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “a second controller coupled to the at least one secondary electrode(s) and controlling the second electrical signal to be applied thereby” in lines 5-6 is grammatically inconsistent and should recite “a second controller coupled to the at least one secondary electrode(s) and controlling the second electrical signal configured to be applied thereby”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “the second electrical signal to the compound pudendal nerve, the sacral root, or the pudendal motor nerve improves bladder voiding” in lines 18-20 is grammatically inconsistent and should recite “the second electrical signal to the compound pudendal nerve, the sacral root, or the pudendal motor nerve configured to improve bladder voiding”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-6, 8, 42, and 93 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 has been amended to include the limitation, " a second controller coupled to the at least one secondary electrode(s) and configured to control the second electrical signal to be applied thereby ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for a single controller that controls multiple electrodes. However, the specification does not provide support for multiple controllers. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " a second controller coupled to the at least one secondary electrode(s) and configured to control the second electrical signal to be applied thereby”. Therefore, the new claim limitations introduce new matter.
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.
Claim 96 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.
The term “shortly” in claim 96 is a relative term which renders the claim indefinite. The term “shortly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Examiner notes that it is unclear if shortly before voiding can mean 1 second, 1 minute, 10 minutes, an hour, or any other time frame that may be considered short.
Claim Interpretation
Regarding claim 1, the phrase “at least one primary electrode to apply the first electrical signal such that application of the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity” is intended use limitation because the claims fail to provide an active step of applying the burst pattern at the specific phase/time (filling or voiding) that Applicant is asserting is distinguishing between the prior art and the instant invention. The usage of the burst can be for any functional usage, so long the there is a first and second electrode applying burst. If the prior art teaches the claimed structure, the prior art structure is understood to function according to the claimed intended use. See MPEP 2114.
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) 44, 49-50, 52, and 87-89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grill et al. (WO2017066572)(Hereinafter “Grill”; citations are made to related PGPUB, US20180296833) in view of Bhadra et al. (US 20090254144) (IDS)(Hereinafter “Bhadra”).
Regarding claim 1 and 44, Grill teaches An apparatus for stimulating neural activity in a pudendal nerve ([0105] “apparatus” [0123] “a signal is applied to the left and to the right pudendal nerve. In certain such embodiments, the first signal may be applied to the right nerve and the second signal applied to the left nerve, for example. Alternatively, the method may be applied bilaterally such that both the first and second signals are applied to each of the left and right nerves.”), the apparatus comprising:
at least one primary electrode configured to apply a first electrical signal to a sensory branch of the pudendal nerve or a sacral root ([0103] “The transducer 90 illustrated in FIG. 2A could be comprised of one or more electrodes” [0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0103]] and a second transducer [with its own controller, per [0097], and electrode, per [0103]], and positioning the transducers bilaterally—that is, one transducer in signalling contact with the left pudendal nerve, and one transducer in signalling contact with the right pudendal nerve. In such embodiments, the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.”); and
a first controller coupled to the at least one primary electrode(s) and configured to control the first electrical signal to be applied thereby ([0097] “The transducer 102 may be operated by a controller 104.” [0103] “The transducer 90 illustrated in FIG. 2A could be comprised of one or more electrodes” [0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0103]]…the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.”) , wherein the first controller is configured to cause the at least one primary electrode to apply the first electrical signal such that application of the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity ([0110] “the first signal is a high amplitude electrical signal and induces an increase in bladder capacity, and the second signal is a low amplitude electrical signal and induces an increase in voiding efficiency.” [0123] “a signal is applied to the left and to the right pudendal nerve. In certain such embodiments, the first signal may be applied to the right nerve and the second signal applied to the left nerve, for example. Alternatively, the method may be applied bilaterally such that both the first and second signals are applied to each of the left and right nerves.”[0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0060]] and a second transducer [with its own controller, per [0097], and electrode, per [0060]], and positioning the transducers bilaterally—that is, one transducer in signalling contact with the left pudendal nerve, and one transducer in signalling contact with the right pudendal nerve. In such embodiments, the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.”), wherein the first electrical signal comprises a AC waveform having a frequency in a range of from 0.1-100Hz, and wherein the first electrical signal is applied in a burst pattern ([0063] “AC waveform having a frequency of 0.1-500 Hz, optionally 0.25-100 Hz”))
at least one secondary electrode configured to apply a second electrical signal to a compound pudendal nerve, a sacral root, or a pudendal motor nerve ([0103] “The transducer 90 illustrated in FIG. 2A could be comprised of one or more electrodes” [0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0103]] and a second transducer [with its own controller, per [0097], and electrode, per [0103]], and positioning the transducers bilaterally—that is, one transducer in signalling contact with the left pudendal nerve, and one transducer in signalling contact with the right pudendal nerve. In such embodiments, the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.”) ; and
a second controller coupled to the at least one secondary electrode(s) and configured to control the second electrical signal to be applied thereby ([0097] “The transducer 102 may be operated by a controller 104.” [0103] “The transducer 90 illustrated in FIG. 2A could be comprised of one or more electrodes” [0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0103]]…the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.”), wherein the second controller is configured to cause the at least one secondary electrode(s) to apply the second electrical signal that stimulates neural activity in the compound pudendal nerve, sacral root, or pudendal motor nerve, wherein the second electrical signal comprises a AC waveform having a frequency in a range of from 0.1-100Hz ([0110] “the first signal is a high amplitude electrical signal and induces an increase in bladder capacity, and the second signal is a low amplitude electrical signal and induces an increase in voiding efficiency.” [0123] “a signal is applied to the left and to the right pudendal nerve. In certain such embodiments, the first signal may be applied to the right nerve and the second signal applied to the left nerve, for example. Alternatively, the method may be applied bilaterally such that both the first and second signals are applied to each of the left and right nerves.”[0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0060]] and a second transducer [with its own controller, per [0097], and electrode, per [0060]], and positioning the transducers bilaterally—that is, one transducer in signalling contact with the left pudendal nerve, and one transducer in signalling contact with the right pudendal nerve. In such embodiments, the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.” [0063] “AC waveform having a frequency of 0.1-500 Hz, optionally 0.25-100 Hz”).
wherein applying the first electrical signal to the sensory branch of the pudendal nerve of the subject improves the subject's bladder capacity ([0110] “the first signal is a high amplitude electrical signal and induces an increase in bladder capacity,).
However, Grill does not teach the first and second electrical stimulation signal applies a burst pattern. Bhadra, in the same field of endeavor, teaches a method and system for bladder control to parts of the pudendal nerve (Abstract and Fig. 5) using electrodes for stimulation ([0005]), similar to the device of Grill, and further teaches wherein the first and second electrical signal applied in a burst pattern ([0035] “Each of the individual pulses within a burst has a pulse frequency 30 between about 10 Hz to about 250 Hz.” Claim 4 “wherein said second pulse burst electrical stimulation occurs during a portion of one of said plurality of pulse burst electrical stimulations”) to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions ([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 Grill, with the first and second electrical stimulation signal applies a burst pattern of Bhadra, because such a modification of using burst patterns would allow to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions.
Regarding claim 49, claims 1 and 44 are obvious over Bhadra, and Grill. Grill teaches in which the first electrical signal has an amplitude in the range of from 0.1-20mA ([0183] “Animals in the intervention group were stimulated during voiding phase with bursts of 40 Hz pulses at amplitude to evoke robust contraction of the external urethral sphincter (0.25-0.9 mA) for 100 ms”) to increase voiding efficiency ([0081]). 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 Bhadra, with an amplitude of .1-20 mA of Grill, because such a modification would allow to stimulate (i.e. increase or induce) neural activity of a pudendal nerve.
Regarding claim 50, claims 1 and 44 are obvious over Bhadra, and Grill. Grill does not teach the duration between 20-2000 ms. Bhadra, in the same field of endeavor, teaches a method and system for bladder control to parts of the pudendal nerve (Abstract and Fig. 5) using electrodes for stimulation ([0005]), similar to the device of Grill, and further teaches wherein the burst pattern of the first electrical signal comprises a signal burst having a duration in a range of from 20ms to 2000ms ([0035] “bursts of between 2 and about 20 individual pulses 32 with pulse widths 29 of about 50 microseconds to about 300 microseconds and an inter-burst frequency 33 of about 0.25 Hz to 50 Hz.”) to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions ([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 Grill, with the duration between 20-2000 ms of Bhadra, because such a modification would allow to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions.
Regarding claim 52, claims 1 and 44 are obvious over Bhadra, and Grill. Grill does not teach the burst interval from .1-2 seconds. Bhadra, in the same field of endeavor, teaches a method and system for bladder control to parts of the pudendal nerve (Abstract and Fig. 5) using electrodes for stimulation ([0005]), similar to the device of Grill, and further teaches in which the burst pattern comprises a signal burst repeated at an interval of from 0.1s to 2s (Claim 1 “wherein said pulse burst electrical stimulations have an inter-burst frequency of about 0.25 to about 50 Hz” This conversion from hertz to seconds can be seen on instant specification page 16. The conversion of .25-50 Hz is .02-4 seconds.) to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions ([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 Grill, with the burst interval from .1-2 seconds of Bhadra, because such a modification would allow to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions.
Regarding claim 87, claim 44 are obvious over Bhadra and Grill. Grill does not explicitly teach a subject inputting their desire of a delayed void. Nevertheless, Grill does teach data entered by the user regarding desires, and specifically, wherein the first electrical signal is applied on receiving an input from the subject that the subject wishes to delay onset of a voiding phase ([0081] “the input element allows the subject to enter data regarding their behaviour and/or desires. For example, the input element may allow the subject to enter that they desire to begin bladder voiding (i.e. intend to begin urinating).” A user can desire a delayed voiding session.) to provide the best comfort the user ([0081]). 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 Bhadra, with the subject inputting their desire of a delayed void of Grill, because such a modification would allow to provide the best comfort the user.
Regarding claim 88, claim 44 are obvious over Bhadra and Grill. Bhadra does not explicitly teach a subject inputting their sensed urinary leak. Nevertheless, Grill does teach data entered by the user regarding desires, and specifically, wherein the first electrical signal is applied on receiving an input from the subject indicating that the subject has sensed a urinary leak ([0081] “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”) to provide the best comfort the user ([0081]). 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 Bhadra with the data input for the subject sensing a urinary leak of Grill, because such a modification would allow to provide the best comfort the user.
Regarding claim 89, claim 44 are obvious over Bhadra and Grill. Grill teaches wherein the first electrical signal is applied on receiving an input from the subject that the subject wishes to increase voiding efficiency ([0081] “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”).
Claim(s) 1, 5-6 , 8, 42, and 95 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grill et al. (WO2017066572)(Hereinafter “Grill”; citations are made to related PGPUB, US20180296833) in view of Bhadra et al. (US 20090254144) (IDS)(Hereinafter “Bhadra”) and Mishra et al. (US 11160980) (Hereinafter Mishra).
Regarding claim 1, Grill teaches An apparatus for stimulating neural activity in a pudendal nerve ([0105] “apparatus” [0123] “a signal is applied to the left and to the right pudendal nerve. In certain such embodiments, the first signal may be applied to the right nerve and the second signal applied to the left nerve, for example. Alternatively, the method may be applied bilaterally such that both the first and second signals are applied to each of the left and right nerves.”), the apparatus comprising:
at least one primary electrode configured to apply a first electrical signal to a sensory branch of the pudendal nerve or a sacral root ([0103] “The transducer 90 illustrated in FIG. 2A could be comprised of one or more electrodes” [0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0103]] and a second transducer [with its own controller, per [0097], and electrode, per [0103]], and positioning the transducers bilaterally—that is, one transducer in signalling contact with the left pudendal nerve, and one transducer in signalling contact with the right pudendal nerve. In such embodiments, the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.”); and
a first controller coupled to the at least one primary electrode(s) and configured to control the first electrical signal to be applied thereby ([0097] “The transducer 102 may be operated by a controller 104.” [0103] “The transducer 90 illustrated in FIG. 2A could be comprised of one or more electrodes” [0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0103]]…the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.”) , wherein the first controller is configured to cause the at least one primary electrode to apply the first electrical signal such that application of the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity ([0110] “the first signal is a high amplitude electrical signal and induces an increase in bladder capacity, and the second signal is a low amplitude electrical signal and induces an increase in voiding efficiency.” [0123] “a signal is applied to the left and to the right pudendal nerve. In certain such embodiments, the first signal may be applied to the right nerve and the second signal applied to the left nerve, for example. Alternatively, the method may be applied bilaterally such that both the first and second signals are applied to each of the left and right nerves.”[0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0060]] and a second transducer [with its own controller, per [0097], and electrode, per [0060]], and positioning the transducers bilaterally—that is, one transducer in signalling contact with the left pudendal nerve, and one transducer in signalling contact with the right pudendal nerve. In such embodiments, the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.”), wherein the first electrical signal comprises a AC waveform having a frequency in a range of from 0.1-100Hz, and wherein the first electrical signal is applied in a burst pattern ([0063] “AC waveform having a frequency of 0.1-500 Hz, optionally 0.25-100 Hz”))
at least one secondary electrode configured to apply a second electrical signal to a compound pudendal nerve, a sacral root, or a pudendal motor nerve ([0103] “The transducer 90 illustrated in FIG. 2A could be comprised of one or more electrodes” [0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0103]] and a second transducer [with its own controller, per [0097], and electrode, per [0103]], and positioning the transducers bilaterally—that is, one transducer in signalling contact with the left pudendal nerve, and one transducer in signalling contact with the right pudendal nerve. In such embodiments, the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.”) ; and
a second controller coupled to the at least one secondary electrode(s) and configured to control the second electrical signal to be applied thereby ([0097] “The transducer 102 may be operated by a controller 104.” [0103] “The transducer 90 illustrated in FIG. 2A could be comprised of one or more electrodes” [0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0103]]…the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.”), wherein the second controller is configured to cause the at least one secondary electrode(s) to apply the second electrical signal such that application of the second electrical signal to the compound pudendal nerve, the sacral root, or the pudendal motor nerve improves bladder voiding, wherein the second electrical signal comprises a AC waveform having a frequency in a range of from 0.1-100Hz ([0110] “the first signal is a high amplitude electrical signal and induces an increase in bladder capacity, and the second signal is a low amplitude electrical signal and induces an increase in voiding efficiency.” [0123] “a signal is applied to the left and to the right pudendal nerve. In certain such embodiments, the first signal may be applied to the right nerve and the second signal applied to the left nerve, for example. Alternatively, the method may be applied bilaterally such that both the first and second signals are applied to each of the left and right nerves.”[0093] “the method comprises implanting an apparatus according to the first aspect having a first transducer [with its own controller, per [0097], and electrode, per [0060]] and a second transducer [with its own controller, per [0097], and electrode, per [0060]], and positioning the transducers bilaterally—that is, one transducer in signalling contact with the left pudendal nerve, and one transducer in signalling contact with the right pudendal nerve. In such embodiments, the controller may cause each transducer to apply either the first signal or the second signal, or may cause the first transducer to apply the first signal and the second transducer to apply the second signal.” [0063] “AC waveform having a frequency of 0.1-500 Hz, optionally 0.25-100 Hz”).
wherein applying the first electrical signal to the sensory branch of the pudendal nerve of the subject improves the subject's bladder capacity ([0110] “the first signal is a high amplitude electrical signal and induces an increase in bladder capacity,).
However, Grill does not teach the first and second electrical stimulation signal applies a burst pattern. Bhadra, in the same field of endeavor, teaches a method and system for bladder control to parts of the pudendal nerve (Abstract and Fig. 5) using electrodes for stimulation ([0005]), similar to the device of Grill, and further teaches wherein the first and second electrical signal applied in a burst pattern ([0035] “Each of the individual pulses within a burst has a pulse frequency 30 between about 10 Hz to about 250 Hz.” Claim 4 “wherein said second pulse burst electrical stimulation occurs during a portion of one of said plurality of pulse burst electrical stimulations”) to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions ([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 Grill, with the first and second electrical stimulation signal applies a burst pattern of Bhadra, because such a modification of using burst patterns would allow to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions.
However, Grill and Bhadra do not teach two different controllers for applying stimulation to the pudendal nerve via the electrodes. Mishra, in the same field of endeavor, teaches multiple stimulation apparatuses with leads for delivering stimulation to the pudendal nerve (Abstract and Col. 44 lines 66), and further teaches a first and second controller, the first controller within the first implantable device for delivering stimulation energy and the second controller for delivering the second stimulation energy (Col. 15 lines 23-54) to maintain a long implant life for long term therapy (Col. 15 lines 23-54). 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 Grill, with the two different controllers for applying stimulation to the pudendal nerve via the electrodes of Mishra, because such a modification would allow to maintain a long implant life for long term therapy.
Regarding claim 5, claims 1 and 44 are obvious over Bhadra, Mishra, and Grill. Grill teaches in which the first electrical signal has an amplitude in the range of from 0.1-20mA ([0183] “Animals in the intervention group were stimulated during voiding phase with bursts of 40 Hz pulses at amplitude to evoke robust contraction of the external urethral sphincter (0.25-0.9 mA) for 100 ms”) to increase voiding efficiency ([0081]). 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 Bhadra, with an amplitude of .1-20 mA of Grill, because such a modification would allow to stimulate (i.e. increase or induce) neural activity of a pudendal nerve.
Regarding claim 6, claims 1 and 44 are obvious over Bhadra, Mishra, and Grill. Grill does not teach the duration between 20-2000 ms. Bhadra, in the same field of endeavor, teaches a method and system for bladder control to parts of the pudendal nerve (Abstract and Fig. 5) using electrodes for stimulation ([0005]), similar to the device of Grill, and further teaches wherein the burst pattern of the first electrical signal comprises a signal burst having a duration in a range of from 20ms to 2000ms ([0035] “bursts of between 2 and about 20 individual pulses 32 with pulse widths 29 of about 50 microseconds to about 300 microseconds and an inter-burst frequency 33 of about 0.25 Hz to 50 Hz.”) to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions ([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 Grill, with the duration between 20-2000 ms of Bhadra, because such a modification would allow to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions.
Regarding claim 8, claims 1 and 44 are obvious over Bhadra, Mishra, and Grill. Grill does not teach the burst interval from .1-2 seconds. Bhadra, in the same field of endeavor, teaches a method and system for bladder control to parts of the pudendal nerve (Abstract and Fig. 5) using electrodes for stimulation ([0005]), similar to the device of Grill, and further teaches in which the burst pattern comprises a signal burst repeated at an interval of from 0.1s to 2s (Claim 1 “wherein said pulse burst electrical stimulations have an inter-burst frequency of about 0.25 to about 50 Hz” This conversion from hertz to seconds can be seen on instant specification page 16. The conversion of .25-50 Hz is .02-4 seconds.) to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions ([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 Grill, with the burst interval from .1-2 seconds of Bhadra, because such a modification would allow to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions.
Regarding claim 42, claim 1 are obvious over Bhadra, Mishra, and Grill. Grill does not teach the implanting the apparatus, positioning the electrode, and activating the electrical signal to the pudendal nerve. Bhadra, in the same field of endeavor, teaches a method and system for bladder control to parts of the pudendal nerve (Abstract and Fig. 5) using electrodes for stimulation ([0005]), similar to the device of Grill, and further teaches comprising:
i. implanting in the subject an apparatus according to claim 1 ([0034] “the signal generator 28 is an implantable pulse generator.”);
ii. positioning at least one primary electrode of the apparatus according to claim 1 in signaling contact with a pudendal nerve of the subject ([0047] “a first electrode is coupled to an intradural portion of a sacral dorsal root [pudendal] of a subject”);
iii. activating the apparatus according to claim 1 to apply an electrical signal to the pudendal nerve of the subject ([0034] “the signal generator 28 is created using microcontrollers, microprocessors, or programmable logic devices with associated signal conditioning electronics.” [0047] “a first and second series of intermittent pulse trains are concurrently applied to the first electrode and the second electrode”) to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions ([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 Grill, with the implanting the apparatus, positioning the electrode, and activating the electrical signal to the pudendal nerve of Bhadra, because such a modification would allow to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions.
Regarding claim 95, claim 1 are obvious over Bhadra, Mishra, and Grill. Grill does not teach the burst pattern of the second electrical signal comprises pulses each having the same frequency. Bhadra, in the same field of endeavor, teaches a method and system for bladder control to parts of the pudendal nerve (Abstract and Fig. 5) using electrodes for stimulation ([0005]), similar to the device of Grill, and further teaches wherein the burst pattern of the second electrical signal comprises pulses each having the same frequency (Fig. 10 [0055] “The subsequent use of pulse bursting 40, using 10 pulses at 200 Hz with an inter-burst frequency of 2 Hz” Claim 4 “wherein said second pulse burst electrical stimulation occurs during a portion of one of said plurality of pulse burst electrical stimulations.”) to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions ([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 Grill, with the implanting the apparatus, positioning the electrode, and activating the electrical signal to the pudendal nerve of Bhadra, because such a modification would allow to stimulate a desired response of a user by either inducing contraction of the bladder or reducing EUS contractions.
Claim(s) 94 and 96 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grill et al. (WO2017066572)(Hereinafter “Grill”; citations are made to related PGPUB, US20180296833) in view of Bhadra et al. (US 20090254144) (IDS)(Hereinafter “Bhadra”), Mishra et al. (US 11160980) (Hereinafter Mishra), and Wei et al. (US 20120010680)(Hereinafter Wei).
Regarding claim 94, claim 1 are obvious over Bhadra, Mishra, and Grill. Grill does not teach the burst pattern of the first electrical signal comprises pulses each having the same frequency. Wei, in the same field of endeavor, teaches stimulation of the pelvic region using an implantable device with electrode leads (Abstract), and further teaches wherein the burst pattern of the first electrical signal comprises pulses each having the same frequency ([0119] “by allowing the stimulation effect between pulses or pulse bursts to decrease, or decay, to a level that is below the maximum stimulation effect but above some level that will result in incontinence or other symptoms, the stimulation time needed to stimulate the patient may be minimized.” [0105] “FIG. 10 depicts train of pulses 108 that has a higher delivery cycle than train of pulses 106 shown in FIG. 9. As seen in FIG. 10, T.sub.ON has duration T.sub.1 and T.sub.OFF has duration T.sub.2. Because T.sub.ON, having duration T.sub.1, is greater than T.sub.OFF, having duration T.sub.2, the percentage of time that IMD 14 is delivering stimulation pulses is greater than the percentage of time that IMD 14 is not delivering pulses.” See Fig. 10 where the frequency is the same for each burst.) to increase void efficiency ([0119]). 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 Grill, with the burst pattern of the first electrical signal comprises pulses each having the same frequency of Wei, because such a modification would allow to increase void efficiency.
Regarding claim 96, claim 1 are obvious over Bhadra, Mishra, and Grill. Grill does not teach the first electrical signal is applied shortly before voiding onset. Wei, in the same field of endeavor, teaches stimulation of the pelvic region using an implantable device with electrode leads (Abstract), and further teaches wherein the first electrical signal is applied shortly before voiding onset ([0119] “by allowing the stimulation effect between pulses or pulse bursts to decrease, or decay, to a level that is below the maximum stimulation effect but above some level that will result in incontinence or other symptoms, the stimulation time needed to stimulate the patient may be minimized.” [0105] “FIG. 10 depicts train of pulses 108 that has a higher delivery cycle than train of pulses 106 shown in FIG. 9. As seen in FIG. 10, T.sub.ON has duration T.sub.1 and T.sub.OFF has duration T.sub.2. Because T.sub.ON, having duration T.sub.1, is greater than T.sub.OFF, having duration T.sub.2, the percentage of time that IMD 14 is delivering stimulation pulses is greater than the percentage of time that IMD 14 is not delivering pulses.” Examiner notes that sending the burst pulses occur shortly before voiding.) to increase void efficiency ([0119]). 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 Grill, with the first electrical signal is applied shortly before voiding onset of Wei, because such a modification would allow to increase void efficiency.
Claim(s) 85 and 93 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grill et al. (US 20180296833)(WO2017066572)(Hereinafter Grill) in view of Bhadra et al. (US 20090254144) (IDS)(Hereinafter Bhadra)and Yamm et al. (US 20180214691)(Hereinafter Yamm).
Regarding claim 85, clams 1 and 44 are obvious over Bhadra and Grill. Grill does not teach detecting physiological parameters to determine micturition cycle. Yamm, in the same field of endeavor, teaches a system and method for controlling of bladder function via modulation of the pelvic nerve (Abstract), similar to the device of Grill, and further teaches further comprising detecting one or more physiological parameters in the subject to determine an ongoing phase of a micturition cycle in the subject, optionally wherein the one or more physiological parameters are selected from: nerve activity in the pudendal nerve, nerve activity in a hypogastric nerve, nerve activity in a pelvic nerve, muscle activity in a bladder detrusor muscle, muscle activity in an internal urethral sphincter, muscle activity in an external urethral sphincter, muscle activity in an external anal sphincter, and bladder pressure ([0213] “Maximum pressure: maximum bladder pressure during a micturition cycle. Also known as peak pressure, maximum voiding pressure, or maximum intravesical pressure. It should be noted that this pressure is not identical with the micturition pressure.” [0222] “External urethral sphincter electromyography: electrodes are placed into the external urethral sphincter and electromyography is recorded during bladder filling and voiding.” [0067] “The measureable physiological parameter may be muscle electromygraphic activity, wherein the electromyographic activity is indicative of the level of activity in the muscle. Such activity could typically be measured from the bladder detrusor muscle, the internal urethral sphincter, the external urethral sphincter, and the external anal sphincter.”) to increase bladder capacity and voiding efficiency ([0154]). 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 Grill, with the detecting physiological parameters to determine micturition cycle of Yamm, because such a modification would allow to increase bladder capacity and voiding efficiency.
Regarding claim 93, clams 1 and 44 are obvious over Bhadra and Grill. Grill does not teach a plurality of apparatuses. Yamm, in the same field of endeavor, teaches a system and method for controlling of bladder function via modulation of the pelvic nerve (Abstract), similar to the device of Grill, and further teaches A neuromodulation system comprising a plurality of apparatuses according to claim 1 ([0194] “a neuromodulation system, the system comprising a plurality of apparatuses”) to increase bladder capacity and voiding efficiency ([0154]). 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 Grill, with the plurality of apparatuses of Yamm, because such a modification would allow to increase bladder capacity and voiding efficiency.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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US Patent 11278721
Claims 1, 6, 8, 17, 18, 44, 50, 52, and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-11, 14, and 18-25 of Patent US 11278721. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of claim 1, 7-11, 14, and 18-25 of US 11278721 requires the examination apparatus of claims 1, 6, 8, 17, 18, 44, 50, 52, and 61 of 17782559 to function. Comparison of the claims is provided below, showing corresponding limitations in the conflicting claims.
This is a nonstatutory double patenting rejection because the patentably indistinct claims have been patented.
Claims of US 11278721
Claim 1 of 17/782559
1. An apparatus for stimulating neural activity in a pudendal nerve of a subject, the apparatus comprising: 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, wherein the first electrical signal comprises an AC waveform having a frequency in the range of from 0.1-50 Hz, wherein the first electrical signal has an amplitude in the range from 0.05 T to 10 T, wherein T is the threshold stimulation intensity required to evoke a reflex EMG response in the EUS of the subject, and wherein application of the first electrical signal is stopped at onset of a bladder voiding phase, resulting in improved voiding efficiency.
7. The apparatus according to claim 1 wherein said controller is configured to cause a second signal to be applied wherein said second signal stimulates the pudendal nerve, wherein said second electrical signal stimulates neural activity in the pudendal nerve to produce an increase in voiding efficiency and wherein the second electrical signal comprises an AC waveform having a frequency in the range of from 20 to 50 Hz.
8. The apparatus according to claim 7 wherein the second electrical signal is applied by said at least one primary electrode(s) or wherein the apparatus comprises at least one secondary electrode coupled to the controller and the second electrical signal is applied by the at least one secondary electrode(s), the controller controlling the signal to be applied thereby.
9. The apparatus according to claim 7 in which the second electrical signal is applied in a burst pattern comprising a signal burst comprising an AC waveform, wherein the signal burst is repeated at a frequency in the range of from 0.5-20 Hz.
1. An apparatus for stimulating neural activity in a pudendal nerve of a subject, the apparatus comprising:
at least one primary electrode configured to apply a first electrical signal to said pudendal 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 improve bladder function, wherein the first electrical signal comprises an AC waveform having a frequency in the a range of from 0.1-100Hz, and wherein the first electrical signal is applied in a burst pattern.
10. The apparatus according to claim 9 in which the burst pattern comprises a signal burst having a duration from 50 ms to 1000 ms repeated at an interval of from 0.125 s to 2 s.
6. The apparatus according to claim 1 wherein the burst pattern of the first electrical signal comprises a signal burst having a duration in a range of from 20ms to 2000ms.
10. The apparatus according to claim 9 in which the burst pattern comprises a signal burst having a duration from 50 ms to 1000 ms repeated at an interval of from 0.125 s to 2 s.
8. The apparatus according to claim 6 in which the burst pattern comprises a signal burst repeated at an interval of from 0.1s to 2s.
11. The apparatus according to claim 7 in which the second electrical signal is to be applied to motor fibres of the pudendal nerve.
17. The apparatus according to claim 1 in which the first electrical signal is to be applied to a sensory branch of the pudendal nerve.
18. The apparatus according claim1 wherein the first electrical signal is to be applied to the pudendal nerve or sacral root.
14. A method of treating bladder dysfunction in a subject comprising applying a first electrical signal to a pudendal nerve of the subject, wherein the first electrical signal comprises an AC waveform having a frequency in the range of from 1-50 Hz, wherein the first electrical signal has an amplitude in the range of from 0.05 T to 10 T, wherein T is the threshold stimulation intensity required to evoke a reflex EMG response in the EUS of the subject, and wherein application of the first electrical signal is stopped at onset of a bladder voiding phase, resulting in improved voiding efficiency.
18. The method according to claim 14 further comprising the application of a second electrical signal to stimulate the pudendal nerve.
19. The method according to claim 18 in which the second electrical signal applied comprises an AC waveform having a frequency in the range from 20-50 Hz.
20. The method according to claim 18 in which the second electrical signal comprises an AC waveform and is applied in a burst pattern.
44. A method of treating bladder dysfunction in a subject comprising applying a first electrical signal to a sensory branch of a pudendal nerve of the subject to stimulate activity in said sensory branch of the pudendal nerve, wherein the first electrical signal comprises an AC waveform having a frequency in a range of from 0.1-100Hz and wherein the first electrical signal is applied in a burst pattern;applying a second electrical signal to a compound pudendal nerve, a sacral root, or a pudendal motor nerve to stimulate neural activity in the compound pudendal nerve, sacral root, or pudendal motor nerve, wherein the second electrical signal comprises an AC waveform having a frequency in a range of from 0.1-100Hz and wherein the second electrical signal is applied in a burst pattern;_and wherein applying the first electrical signal to the sensory branch of the pudendal nerve of the subject improves the subject's bladder capacity.
21. The method according to claim 20 in which the burst pattern comprises a signal burst having a duration from 50 ms to 1000 ms.
50. A method according to claim44 wherein the burst pattern of the first electrical signal comprises a signal burst having a duration in a range of from 20ms to 2000ms
22. The method according to claim 18 in which the second electrical signal is to be applied to motor fibres of the pudendal nerve.
61. A method according to claim44 in which the first electrical signal is applied to a sensory branch of the pudendal nerve.
23. The method according to claim 20 in which the second electrical signal applied in a burst pattern comprises an AC waveform having a frequency in the range of from 20-50 Hz.
44. A method of treating bladder dysfunction in a subject comprising applying a first electrical signal to a pudendal nerve of the subject to stimulate activity in said pudendal nerve, wherein the first electrical signal comprises an AC waveform having a frequency in the a range of from 0.1-100Hz, and wherein the first electrical signal is applied in a burst pattern.
24. The method according to claim 20 in which the second electrical signal is applied in a burst pattern comprising a signal burst comprising the AC waveform, wherein the signal burst is repeated at a frequency in the range of from 2 to 20 Hz.
44. A method of treating bladder dysfunction in a subject comprising applying a first electrical signal to a pudendal nerve of the subject to stimulate activity in said pudendal nerve, wherein the first electrical signal comprises an AC waveform having a frequency in the a range of from 0.1-100Hz, and wherein the first electrical signal is applied in a burst pattern.
25. The method according to claim 20 wherein the burst pattern is repeated at an interval of from 0.125 s to 2 s.
52. A method according to claim44 in which the burst pattern comprises a signal burst repeated at an interval of from 0.1s to 2s
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Chancellor (US 20090036945)
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 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
/PAMELA M. BAYS/Primary Examiner, Art Unit 3796