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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/19/2026 has been entered.
Response to Arguments
Applicant's arguments filed on 05/19/2026 have been fully considered but they are not persuasive.
Prior Art Rejection of claim 1
Applicant argues that the combination of Nelson in view of Hamner and Rosenbluth is improper as Hamner teaches away from the method discloses by Nelson. Examiner respectfully disagrees as Nelson is related to delivering stimulation to treat bladder dysfunction (Nelson, [0035]) and Hamner is related to delivering stimulation to treat overactive bladder dysfunction (Hamner,[0006]). Moreover, Nelson, Hamner, and the instant application share the classification of A61N1/36007 and are in the same field of endeavor. Therefore, it would have been obvious to a person having ordinary skill in the art to arrive at the claimed invention based on the combination of Nelson, Rosenbluth, and Hamner.
Applicant further argues that Hamner’s transcutaneous delivery of stimulation on the leg/foot area fails to teach delivering stimulation at the sacral or pelvic plexus which is a distinct approach from the direct, targeted, implanted stimulation taught by Nelson. Examiner notes that while invasive stimulation is a distinct approach from transcutaneous stimulation, Hamner is not being relied upon to disclose invasive stimulation at the sacral or pelvic plexus. Instead, Hamner is relied upon to disclose stimulation parameters used to treat bladder dysfunction ([0072] and [0148-0149]), and since both Nelson and Hamner are directed towards delivering electrical stimulation to treat bladder/urinary dysfunction, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to try using the parameters as taught by Hamner with the system as taught by Nelson in order to effectively treat bladder/urinary dysfunction. Hamner further discloses that tibial nerve stimulation targets the sacral plexus which contains nerves that are responsible for carrying information to the brain about bladder fullness [0064]. Therefore, it would have been obvious to one having ordinary skill in the art to apply the transcutaneous stimulation parameters taught by Hamner to the invasive stimulation method as taught by Nelson.
Applicant further argues that Rosenbluth fails to disclose the direct stimulation of the relevant autonomous nerves and the identification of the combination of specific features of the claimed stimulation pattern in the teachings of Rosenbluth can only be made based on hindsight. Examiner respectfully disagrees and notes that Rosenbluth is not relied upon to teach direct stimulation of the sacral/pelvic plexus and is instead relied upon to teach electrical stimulation parameters used to treat bladder dysfunction [0011]. Moreover, Rosenbluth discloses that electrical stimulation of target nerves including sacral verves may be beneficial to treat overactive bladder [0052] and further discloses stimulating a tibial nerve to provide input to the sacral micturition center [0258]. Therefore it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method of stimulation as taught by Nelson with the amplitude parameters as taught by Rosenbluth in order to effectively treat overactive bladder (Rosenbluth, Abstract).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Prior Art Rejection of claim 11
Applicant argues that the teaching in DeRidder of stimulation patterns consisting of five spikes with a pulse width of 1000 µseconds, as such does not provide an indication of the combinations of interburst and intraburst frequencies or amplitude of the burst pattern as specified by the claims. Examiner respectfully disagrees and notes that regarding claim 11, DeRidder was not relied upon to disclose the interburst and intraburst frequencies or amplitude of the burst pattern and was instead relied upon to disclose a pulse width of 1000 µseconds for each pulse of a group of pulses [0044]. Examiner maintains it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the method/system as taught by Nelson to apply stimulation with a pulse width of 1000 µseconds for each pulse of a group of pulses as taught by DeRidder. Such a modification would provide the predictable results of treating a neurological condition or disorder (DeRidder, Abstract).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Declaration
The declaration under 37 CFR 1.132 filed on 05/19/2026 by Prof. Dr. Klaus E. Matzel is insufficient to overcome the rejection of claims 1-4, 6-7, 9-10, 12-13, and 16 based upon 35 USC 103 as set forth in the last Office action because: the declaration lacks factual evidence as to why the stimulation parameters as taught by Hamner and Rosenbluth would not be effective when used with the system/method of treating bladder dysfunction as taught by Nelson. Furthermore, there was no factual evidence supporting the opinion that it would not have been obvious before the effective filing date to combine the teachings of Nelson with the teachings of Hamner and Rosenbluth. Therefore, the evidence is insufficient to overcome the obviousness rejection set forth in the last office action.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-7, 9-10, 12-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al (US 2019/0328303) hereinafter Nelson in view of Hamner et al (US 2021/0101007) hereinafter Hamner and further in view of Rosenbluth et al (US 2019/0001129) hereinafter Rosenbluth.
Regarding claim 1, Nelson discloses a method of ensuring pelvic health and/or treating a disease or disorder (bladder dysfunction) characterized by a dysfunctional autonomic nervous system in a human subject (patient 12) with neuromodulation by applying electric pulses (electrical stimulation therapy) to the subject through a set of one or more electrodes of an electrical lead (lead 16 containing one or more stimulation electrodes) that is operably linked to a pulse generator ([0052] electrical stimulation is delivered from IMD 14 to the target tissue site 18 via the stimulation electrodes),
wherein said method comprises applying a burst pattern (a set of burst pulses) comprising a plurality of groups of electric pulses to the subject [0072] through said set of one or more electrodes of the electrical lead ([0052] stimulation is delivered from IMD 14 via the stimulation electrodes),
wherein the one or more electrodes are implanted in a proximity of a sacral plexus (S3 sacral nerve) and/or a pelvic plexus of the human subject ([0054] lead 16 may be introduced into the S3 sacral foramen 24 of sacrum 26 to access the S3 sacral nerve).
Nelson fails to disclose wherein an interburst frequency between each group of electric pulses is between 10 and 60 Hz, wherein an intraburst frequency within each group of electric pulses is from 500 to 1000 Hz, and wherein each electric pulse of the burst pattern has an amplitude of from 0.10 to 13.0 mA and a pulse width of from 50 to 1000 µseconds.
Hamner discloses wherein the interburst frequency between each group of electric pulses is between 10 and 60 Hz ([0149] the interburst frequency can be between about 1 Hz to about 20 Hz), wherein the intraburst frequency within each group of electric pulses is from 500 to 1000 Hz, and ([0148] the intraburst frequency could be about or at least about 10 Hz, 20 Hz, 30 Hz, 40 Hz, 50 Hz, 100 Hz, 250 Hz, 500 Hz, 1 kHz, or more), and wherein each electric pulse of the burst pattern has a pulse width of from 50 to 1000 µseconds ([0072] spacing between 0 microseconds to 300 microseconds has been effective). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with wherein the interburst frequency between each group of electric pulses is between 10 and 60 Hz, wherein the intraburst frequency within each group of electric pulses is from 500 to 1000 Hz, and wherein each electric pulse of the burst pattern has a pulse width of from 50 to 1000 µseconds as taught by Hamner. Such a modification would provide the predictable results of improving comfort, reducing habituation, and/or reducing power consumption of the electrical stimulator device by varying the intraburst frequency (Hamner, [0148]) and treating an overactive bladder (Hamner, [0015]).
Rosenbluth discloses wherein each electric pulse of the burst pattern has an amplitude of from 0.10 to 13.0 mA ([0011] the first stimulus has an amplitude from about 0.1 mA to 10 mA or higher). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with each electric pulse of the burst pattern has an amplitude of from 0.10 to 13.0 mA as taught by Rosenbluth. Such a modification would provide the predictable results of treating overactive bladder (Rosenbluth, Abstract).
Regarding claim 2, Nelson discloses wherein the dysfunctional autonomic nervous system is selected from the group consisting of a muscle control disorder of the colon or bladder (bladder dysfunction), a sexual dysfunction, an inflammatory disorder of the bladder or intestines, chronic visceral pain, chronic bladder pain and chronic pelvic pain ([0037] patient 12 experiences bladder dysfunction).
Regarding claim 3, Nelson discloses wherein the muscle control disorder of the colon or bladder is a muscle disorder of one or more sphincters (urinary sphincter) of the colon or bladder ([0037] patient 12 experiences bladder dysfunction, such as, for example, a urinary sphincter).
Regarding claim 4, Nelson discloses comprising a step of positioning the one or more electrodes of the electrical lead in the proximity of the sacral and/or pelvic plexus of the subject by guiding the one or more electrodes through a third or fourth sacral foramen ([0054] lead 16 may be introduced into the S3 sacral foramen 24).
Regarding claim 6, the modified Nelson discloses the method of claim 1 as discussed above, but fails to disclose wherein the intraburst frequency is constant throughout the entire burst pattern. However, Hamner discloses wherein the intraburst frequency is constant throughout the entire burst pattern ([0146] continuous theta burst stimulation (cTBS); In the cTBS pattern, a 40 second train of uninterrupted TBS is given (600 pulses)). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with the intraburst frequency is constant throughout the entire burst pattern as taught by Hamner. Such a modification would provide the predictable results of treating an overactive bladder (Hamner, [0015]).
Regarding claim 7, the modified Nelson discloses the method of claim 1 as discussed above, but fails to disclose wherein the intraburst frequency is 500 Hz. However, Hamner discloses wherein the intraburst frequency is 500 Hz ([0148] the intraburst frequency could be about or at least about 10 Hz, 20 Hz, 30 Hz, 40 Hz, 50 Hz, 100 Hz, 250 Hz, 500 Hz, 1 kHz, or more). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with the intraburst frequency is 500 Hz as taught by Hamner. Such a modification would provide the predictable results of treating an overactive bladder (Hamner, [0015]).
Regarding claim 9, the modified Nelson discloses the method of claim 1 as discussed above, but fails to disclose wherein the amplitude of each pulse in the burst pattern is the same. However, Hamner discloses wherein the amplitude of each pulse in the burst pattern is the same ([0146] intermittent theta burst stimulation (iTBS); a burst of 3 stimuli at 50 Hz (20 ms between each stimulus) which was repeated at inter-burst intervals of 200 ms (5 Hz). In the iTBS example pattern, an about 2 second train of TBS is repeated about every 10 seconds for a total of 190 seconds (600 pulses)). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with the amplitude of each pulse in the burst pattern is the same as taught by Hamner. Such a modification would provide the predictable results of treating an overactive bladder (Hamner, [0015]).
Regarding claim 10, the modified Nelson discloses the method of claim 1 as discussed above, but fails to disclose wherein the pulse width of each pulse of each group of electric pulses is constant throughout the entire burst pattern. However, Hamner discloses wherein the pulse width of each pulse of each group of electric pulses is constant throughout the entire burst pattern ([0146] a burst of 3 stimuli at 50 Hz (20 ms between each stimulus) which was repeated at inter-burst intervals of 200 ms (5 Hz)). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with the pulse width of each pulse of each group of electric pulses is constant throughout the entire burst pattern as taught by Hamner. Such a modification would provide the predictable results of treating an overactive bladder (Hamner, [0015]).
Regarding claim 12, the modified Nelson discloses the method of claim 1 as discussed above, but fails to disclose wherein the interburst frequency between each group of electric pulses is 10 Hz and the amplitude of each pulse of each group of electric pulses is 4 mA.
Hamner discloses wherein the interburst frequency between each group of electric pulses is 10 Hz ([0149] the interburst frequency can be between about 1 Hz to about 20 Hz). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with the interburst frequency between each group of electric pulses is 10 Hz as taught by Hamner. Such a modification would provide the predictable results of treating an overactive bladder (Hamner, [0015]).
Rosenbluth discloses wherein the amplitude of each pulse of each group of electric pulses is 4 mA ([0011] the first stimulus has an amplitude from about 0.1 mA to 10 mA or higher). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with the amplitude of each pulse of each group of electric pulses is 4 mA as taught by Rosenbluth. Such a modification would provide the predictable results of treating essential tremor and other movement disorders, as well as overactive bladder (Rosenbluth, Abstract).
Regarding claim 13, Nelson discloses wherein the pulse generator is an implantable pulse generator ([0052] IMD 14 may provide electrical stimulation therapy to target tissue site 18; [0059] IMD 14 may be surgically implanted in patient 12; Figure 2: IMD 14).
Regarding claim 16, Nelson discloses determining a nature of the dysfunction of the autonomic nervous system in said patient and adjusting one or more of an application location, amplitude and interburst frequency of said burst pattern to specifically correct said dysfunction ([0095] the second therapy may be a higher stimulation amplitude or use different electrodes from the first therapy to promote urine retention as compared to the first therapy).
Claim(s) 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson (US 2019/0328303) in view of Hamner (US 2021/0101007) and Rosenbluth (US 2019/0001129) and further in view of DeRidder (US 2013/0138179).
Regarding claim 8, the modified Nelson discloses the method according to claim 1 as discussed above, but fails to disclose wherein each group of electric pulses comprises a plurality of pulses, including a first pulse, and wherein the amplitude of the first pulse of each group of electric pulses is the same, wherein the amplitude of a subsequent pulse within a group of electric pulses gradually increases compared to the preceding pulse within said group and wherein a passive charge balance occurs during each interburst interval.
However, DeRidder discloses wherein each group of electric pulses comprises a plurality of pulses (burst stimulus), including a first pulse, and wherein the amplitude of the first pulse of each group of electric pulses is the same, wherein the amplitude of a subsequent pulse within a group of electric pulses gradually increases compared to the preceding pulse within said group ([0012] FIG. 2 illustrate an exemplary burst stimulus having ramping) and wherein a passive charge balance occurs during each interburst interval ([0028] A charge balancing pulse or pulses may be applied within the burst or at the end of the burst). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with the each group of electric pulses comprises a plurality of pulses (burst stimulus), including a first pulse, and wherein the amplitude of the first pulse of each group of electric pulses is the same, wherein the amplitude of a subsequent pulse within a group of electric pulses gradually increases compared to the preceding pulse within said group and wherein a passive charge balance occurs during each interburst interval as taught by DeRidder. Such a modification would provide the predictable results of treating a neurological condition or disorder (DeRidder, Abstract).
Regarding claim 11, the modified Nelson discloses the method according to claim 1 as discussed above, but fails to disclose wherein the pulse width of each pulse of each group of electric pulses is 1000 µseconds. However, DeRidder discloses wherein the pulse width of each pulse of each group of electric pulses is 1000 µseconds ([0044] All patients underwent burst stimulation at 6, 18, or 40 Hz consisting of 5 spikes with 1 ms pulse width, 1 ms interspike interval in a charged balanced manner). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with the pulse width of each pulse of each group of electric pulses is 1000 µseconds as taught by DeRidder. Such a modification would provide the predictable results of treating a neurological condition or disorder (DeRidder, Abstract).
Claim(s) 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson (US 2019/0328303) in view of Hamner (US 2021/0101007) and Rosenbluth (US 2019/0001129) and further in view of Su (US 2012/0197336).
Regarding claim 14, Nelson discloses the method of claim 1 as discussed above, but fails to disclose wherein the method further comprises detecting or determining one or more of a bladder pressure (pves), proximal urethral pressure (pura1) and mid urethral pressure (pura2) of said subject. However, Su discloses wherein the method further comprises detecting or determining one or more of a bladder pressure (pves), proximal urethral pressure (pura1) and mid urethral pressure (pura2) of said subject ([0051] IMD 16 may sense an increased pressure of bladder). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with detecting or determining one or more of a bladder pressure (pves), proximal urethral pressure (pura1) and mid urethral pressure (pura2) of said subject as taught by Su. Such a modification would provide the predictable results of alleviating bladder dysfunction (Su, Abstract).
Regarding claim 15, Nelson discloses the method of claim 1 as discussed above, but fails to disclose wherein applying the burst pattern to the subject increases the bladder pressure, proximal urethral pressure, the mid urethral pressure, or a combination thereof. However, Su discloses wherein applying the burst pattern to the subject increases the bladder pressure, proximal urethral pressure, the mid urethral pressure, or a combination thereof ([0033] electrical stimulation delivered in bursts with varying pulse frequency variation may be selected to mimic nerve impulses to increase urethral sphincter pressure to prevent incontinence; [0051] IMD 16 may sense an increased pressure of bladder 12 with sensor 22 and initiate electrical stimulation to promote bladder voiding). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Nelson with applying the burst pattern to the subject increases the bladder pressure, proximal urethral pressure, the mid urethral pressure, or a combination thereof as taught by Su. Such a modification would provide the predictable results of preventing incontinence (Su, [0033]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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