DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is responsive to the amendment filed on 07/02/2026. As directed by the amendment: Claims 1, 8, 42, and 96 have been amended, claims 2-4, 7, 9-41, 43, 45-48, 51, 53-84, 86, and 90-92 have been cancelled, and claim 97 has been added. Thus, claims 1, 5-6, 8, 42, 44, 49-50, 52, 85, 87-89, and 93-97 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see page 7-8, filed 07/02/2026, with respect to claim objections and 35 U.S.C. 112(b) have been fully considered and are persuasive. Amendments to the claim obviate the rejection of record. The rejection and objection of the claim have been withdrawn.
Applicant's arguments, see pages 7, filed 07/02/2026, 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 8-9, filed 07/02/2026, under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant asserts on page 9 that “Grill in view of Bhadra and Mishra do not teach or suggest an apparatus that is designed to interact with these specific anatomical structures and each being subjected to a specific type of stimulation from their respective electrodes resulting in two different physiological responses.” Examiner agrees as the amendments obviate the rejection of record. Therefore, the rejection is withdrawn. See updated rejection below.
Regarding the Provisional Nonstatutory Obviousness Double Patenting rejection, filed 07/02/2026, 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 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, 93, and 97 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.
Claims 8, 52, and 93 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 8, it is unclear if the “burst pattern” parameters of the claim is for the first electrical signal, the second electrical signal, or both of claim 1.
Regarding claim 52, it is unclear if the “burst pattern” parameters of the claim is for the first electrical signal, the second electrical signal, or both of claim 44.
Regarding claim 93, it is unclear if the apparatus of claim 1 is the same or different than the “plurality of apparatuses” of claim 93.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 93 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 93 fails to further limit claim 1 because claim 93 broadens the scope by requiring multiple apparatuses to make up a system, but claim 1 only requires 1 apparatus.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Interpretation
Regarding claims 87 ad 89, the phrase “wishes” is interpreted as the intended use of the input of the subject, as the subject “wants” a result.
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, 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 Romero-Ortega et al. (US 20190290902)(Hereinafter RO).
Regarding claim 44, Grill teaches A method of treating bladder dysfunction in a subject comprising ([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.”),
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 a range of from 0.1-100Hz and wherein the first electrical signal is applied in a … pattern ([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”))
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 ([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.” [0186] “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, with a period of 0.5 s for each burst (FIG. 8G). These data clearly show increased voiding efficiency as a result of applying the low amplitude signal.” [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 [which is a compound 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 … 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,).
Although Grill teaches the left pudendal nerve is stimulated for improved bladder capacity, Grill does not teach the first electrical signal applied in a burst pattern… the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity. RO, in the same field of endeavor, teaches a neuromodulation device for bladder control to parts of the pudendal nerve (Abstract and [0012]), and further teaches wherein the first electrical signal applied in a burst pattern… the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity ([0137] “n such an embodiment, stimulation may include bursts of pulsed electrical energy for 2-20 min a day, with 1-3 applications a day and 3-7 days a week… Stimulation may be applied to the pelvic and perineal nerves [sensory branch of the pudendal nerve] including periods of activation and rest periods within a single stimulation session.” [0168] “FIG. 12 shows the normal urodynamic response of a young nulliparous rabbit (FIG. 12A) and how the bladder storage capacity and voiding efficiency in response to direct Bsm acutely in anesthetized animals. Stimulation of this nerve at 2 Hz for 10 min induced voiding and improving storage capacity by neuromodulation of nerves controlling individual pelvic floor muscles” [0053] “FIG. 12B shows the effect of stimulation of pelvic floor nerves (arrows) on the cystometrogram (CMG) and uretheral pressure (UP) in rabbits.”) to decrease the pain and discomfort of a user ([0009]). 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 applied in a burst pattern… the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity of RO, because such a modification of using burst patterns would allow to decrease the pain and discomfort of a user.
Regarding claim 49, claims 1 and 44 are obvious over RO, 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 Grill, 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 87, claims 1 and 44 are obvious over RO, 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 Grill, 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, claims 1 and 44 are obvious over RO, and Grill. Grill 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 Grill 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, claims 1 and 44 are obvious over RO, 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) 50 and 52 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 Romero-Ortega et al. (US 20190290902)(Hereinafter RO) and Bhadra et al. (US 20090254144) (IDS)(Hereinafter “Bhadra”).
Regarding claim 50, claims 1 and 44 are obvious over RO, and Grill. Grill in view of RO do 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 in view of RO, 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 RO, and Grill. Grill in view of RO do 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 in view of RO, 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.
Claim(s) 1, 5-6, and 97 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 Romero-Ortega et al. (US 20190290902)(Hereinafter RO) 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 … of the pudendal 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 first controller coupled to the at least one primary electrode(s) and configured to control the first electrical signal configured 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 … 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.” [0063] “AC waveform having a frequency of 0.1-500 Hz, optionally 0.25-100 Hz”)), 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 configured to be applied in a … 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 [which is a compound 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.” [0186] “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, with a period of 0.5 s for each burst (FIG. 8G). These data clearly show increased voiding efficiency as a result of applying the low amplitude signal.” [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 [which is a compound 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,).
Although Grill teaches the left pudendal nerve is stimulated for improved bladder capacity, Grill does not teach the wherein the first electrical signal is configured to be applied to a sensory branch of the pudendal nerve or sacral root, first electrical signal applied in a burst pattern… the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity. RO, in the same field of endeavor, teaches a neuromodulation device for bladder control to parts of the pudendal nerve (Abstract and [0012]), and further teaches wherein the first electrical signal is configured to be applied to a sensory branch of the pudendal nerve or sacral root …wherein the first electrical signal applied in a burst pattern… the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity ([0137] “n such an embodiment, stimulation may include bursts of pulsed electrical energy for 2-20 min a day, with 1-3 applications a day and 3-7 days a week… Stimulation may be applied to the pelvic and perineal nerves [sensory branch of the pudendal nerve] including periods of activation and rest periods within a single stimulation session.” [0168] “FIG. 12 shows the normal urodynamic response of a young nulliparous rabbit (FIG. 12A) and how the bladder storage capacity and voiding efficiency in response to direct Bsm acutely in anesthetized animals. Stimulation of this nerve at 2 Hz for 10 min induced voiding and improving storage capacity by neuromodulation of nerves controlling individual pelvic floor muscles” [0053] “FIG. 12B shows the effect of stimulation of pelvic floor nerves (arrows) on the cystometrogram (CMG) and uretheral pressure (UP) in rabbits.”) to decrease the pain and discomfort of a user ([0009]). 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 configured to be applied to a sensory branch of the pudendal nerve or sacral root…first electrical signal applied in a burst pattern… the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity of RO, because such a modification of using burst patterns would allow to decrease the pain and discomfort of a user.
However, Grill and RO 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 in view of RO, 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 RO, 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 RO, Mishra, and Grill. Grill in view of RO and Mishra do 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 in view of RO and Mishra, 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 97, Grill teaches wherein first electrical signal has an amplitude in the range of from 1.8 T to 3 T, and the second electrical signal has an amplitude in the range of from 1.8 T to 2.3 T (Claim 8 “the first signal has an amplitude of 2.0-10 T and the second signal has an amplitude of 0.5-3.0 T.”).
Claim(s) 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 Romero-Ortega et al. (US 20190290902)(Hereinafter RO), Mishra et al. (US 11160980) (Hereinafter Mishra),and Bhadra et al. (US 20090254144) (IDS)(Hereinafter “Bhadra”).
Regarding claim 8, claims 1 and 44 are obvious over RO, Mishra, and Grill. Grill in view of RO and Mishra do 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 in view of RO and Mishra, 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, claims 1 and 44 are obvious over RO, Mishra, and Grill. Grill in view of RO and Mishra do 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 in view of RO and Mishra, 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, claims 1 and 44 are obvious over RO, Mishra, and Grill. Grill in view of RO and Mishra do 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 in view of RO and Mishra, 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 Romero-Ortega et al. (US 20190290902)(Hereinafter RO), Mishra et al. (US 11160980) (Hereinafter Mishra), and Wei et al. (US 20120010680)(Hereinafter Wei).
Regarding claim 94, claims 1 and 44 are obvious over RO, Mishra, and Grill. Grill in view of RO and Mishra do 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 in view of RO and Mishra, 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, claims 1 and 44 are obvious over RO, Mishra, and Grill. Grill in view of RO and Mishra do 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 in view of RO and Mishra, 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 Romero-Ortega et al. (US 20190290902)(Hereinafter RO) and Yamm et al. (US 20180214691)(Hereinafter Yamm).
Regarding claim 85, claims 1 and 44 are obvious over RO, and Grill. Grill in view of RO do 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 in view RO, 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, claims 1 and 44 are obvious over RO and Grill. Grill in view of RO do 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 in view of RO, 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, 44, 50, and 52 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 apparatus of claim 1, 5, 8-11, and 14 of US 11278721 (Hereinafter ‘721) in view of Romero-Ortega et al. (US 20190290902)(Hereinafter RO) and Mishra et al. (US 11160980) (Hereinafter Mishra) requires the examination apparatus of claims 1, 6, and 8 of 17782559 to function. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of claim 1, 8-9, 11, 21, and 25 of US 11278721 (Hereinafter ‘721) in view of Romero-Ortega et al. (US 20190290902)(Hereinafter RO) requires the examination method of claims 44, 50, and 52 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.
Regarding claim 1, ‘271 teaches An apparatus for stimulating neural activity in a pudendal nerve (Claim 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 a sensory branch of the pudendal nerve or a sacral root (Claim 5 “which the at least one primary electrode is configured to apply the first electrical signal to the sensory branch of the pudendal nerve”); and
a first controller coupled to the at least one primary electrode(s) and configured to control the first electrical signal configured to be applied thereby (Claim 5 “the controller is configured to cause said at least one primary electrode to apply the first electrical signal that stimulates neural activity in the sensory branch of the pudendal nerve to produce an increase in bladder capacity”) , 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, 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 configured to be applied in a … pattern, wherein the first electrical signal is configured to be applied to a sensory branch of the pudendal nerve or sacral root (Claim 1 “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”),
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 (Claim 8 “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” Claim 11 “which the second electrical signal is to be applied to motor fibres of the pudendal nerve.”); and
a second controller coupled to the at least one secondary electrode(s) and configured to control the second electrical signal configured to be applied thereby (Claim 8 “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.”), 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 configured to improve bladder voiding, 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 configured to be applied in a burst pattern (Claim 9 “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.” Claim 8 “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” Claim 11 “which the second electrical signal is to be applied to motor fibres of the pudendal nerve.”).
Although ‘271 teaches the first electrical signal is configured to be applied to a sensory branch of the pudendal nerve or sacral root, first electrical signal applied in a burst pattern. RO, in the same field of endeavor, teaches a neuromodulation device for bladder control to parts of the pudendal nerve (Abstract and [0012]), and further teaches the first electrical signal applied in a burst pattern ([0137] “n such an embodiment, stimulation may include bursts of pulsed electrical energy for 2-20 min a day, with 1-3 applications a day and 3-7 days a week… Stimulation may be applied to the pelvic and perineal nerves [sensory branch of the pudendal nerve] including periods of activation and rest periods within a single stimulation session.” [0168] “FIG. 12 shows the normal urodynamic response of a young nulliparous rabbit (FIG. 12A) and how the bladder storage capacity and voiding efficiency in response to direct Bsm acutely in anesthetized animals. Stimulation of this nerve at 2 Hz for 10 min induced voiding and improving storage capacity by neuromodulation of nerves controlling individual pelvic floor muscles” [0053] “FIG. 12B shows the effect of stimulation of pelvic floor nerves (arrows) on the cystometrogram (CMG) and uretheral pressure (UP) in rabbits.”) to decrease the pain and discomfort of a user ([0009]). 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 ‘271, with first electrical signal is configured to be applied to a sensory branch of the pudendal nerve or sacral root, first electrical signal applied in a burst pattern of RO, because such a modification of using burst patterns would allow to decrease the pain and discomfort of a user.
However, ‘271 and RO 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 ‘271 in view of RO, 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 6, ‘271 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 (claim 10 “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.”).
Regarding claim 8, ‘271 teaches which the burst pattern comprises a signal burst repeated at an interval of from 0.1s to 2s (claim 10 “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.”).
Regarding claim 44, Grill teaches A method of treating bladder dysfunction in a subject comprising (Claim 14 “A method of treating bladder dysfunction in a subject”),
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 a range of from 0.1-100Hz and wherein the first electrical signal is applied in a … pattern (Claim 1 “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”)
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 (Claim 9 “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.” Claim 8 “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” Claim 11 “which the second electrical signal is to be applied to motor fibres of the pudendal nerve.”);
wherein applying the first electrical signal to the … pudendal nerve of the subject improves the subject's bladder capacity (Claim 1 “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”).
Although Grill teaches the left pudendal nerve is stimulated for improved bladder capacity, Grill does not teach the first electrical signal applied in a burst pattern… the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity. RO, in the same field of endeavor, teaches a neuromodulation device for bladder control to parts of the pudendal nerve (Abstract and [0012]), and further teaches wherein the first electrical signal applied in a burst pattern… the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity ([0137] “n such an embodiment, stimulation may include bursts of pulsed electrical energy for 2-20 min a day, with 1-3 applications a day and 3-7 days a week… Stimulation may be applied to the pelvic and perineal nerves [sensory branch of the pudendal nerve] including periods of activation and rest periods within a single stimulation session.” [0168] “FIG. 12 shows the normal urodynamic response of a young nulliparous rabbit (FIG. 12A) and how the bladder storage capacity and voiding efficiency in response to direct Bsm acutely in anesthetized animals. Stimulation of this nerve at 2 Hz for 10 min induced voiding and improving storage capacity by neuromodulation of nerves controlling individual pelvic floor muscles” [0053] “FIG. 12B shows the effect of stimulation of pelvic floor nerves (arrows) on the cystometrogram (CMG) and uretheral pressure (UP) in rabbits.”) to decrease the pain and discomfort of a user ([0009]). 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 applied in a burst pattern… the first electrical signal to the sensory branch of the pudendal nerve or sacral root improves bladder capacity of RO, because such a modification of using burst patterns would allow to decrease the pain and discomfort of a user.
Regarding claim 50, ‘271 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 (Claim 21 “which the burst pattern comprises a signal burst having a duration from 50 ms to 1000 ms.”).
Regarding claim 52, ‘271 teaches which the burst pattern comprises a signal burst repeated at an interval of from 0.1s to 2s (Claim 25 “wherein the burst pattern is repeated at an interval of from 0.125 s to 2 s.”).
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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