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 filed on 10/23/2025 have been fully considered but they are not persuasive. Applicant argues that the cited prior art fails to disclose the limitations recited in newly amended claim 1. Specifically, Applicant argues that since Hamner discloses dual transcutaneous peripheral neuromodulation, it would not have been obvious to one having ordinary skill in the art to modify the teachings of Nelson with the stimulation parameters as taught by Hamner. Examiner respectfully disagrees as Hamner is directed towards providing stimulation to treat overactive bladder [0006] and Nelson is directed towards delivering stimulation to treat bladder dysfunction [0035], therefore, both Nelson and Hamner are in the same field of endeavor and it would have been obvious to one having ordinary skill in the art to modify the method/system as taught by Nelson with the stimulation parameters as taught by Hamner in order to treat symptoms of bladder dysfunction such as overactive bladder.
Applicant further argues that Hamner does not disclose the specific combination of an interburst frequency between 10 and 60 Hz and an intraburst frequency of 500 to 1000 Hz. Examiner respectfully disagrees as Hamner discloses and interburst frequency between about 1Hz to about 20Hz [0149] and an intraburst frequency being about or at least 10Hz to about 1KHz [0148]. Hamner also discloses a pulse width between 50 to 1000 µseconds ([0072] spacing between 0 microseconds to 300 microseconds). It would have been obvious to one having ordinary skill in the art at the time the invention was made to further modify the method as taught by the modified Nelson with the interburst frequency between about 1Hz to about 20 Hz, the intraburst frequency of about 500 to 1000Hz, and a pulse width between 50 to 1000 µseconds since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Applicant further argues that Hamner does not disclose an amplitude between 0.10 to 13.0 mA and a pulse width between 50 to 1000 µseconds. Examiner notes that Hamner does disclose a pulse width between about 50 to 1000 µseconds as discussed above and is not being relied upon to teach an amplitude between 0.10 to 13.0 mA. Applicant argues that Rosenbluth discloses a broad amplitude range from 0.1mA to 10mA and a broad frequency range between 10 Hz and 20 Hz, but fails to provide any teaching to apply an electrical stimulus with an interburst frequency between 10 and 60 Hz and an intraburst frequency of 500 to 1000 Hz, in combination with an amplitude between 0.10 to 13.0 mA and a pulse width between 50 to 1000 µseconds. Examiner notes Rosenbluth is not being relied upon to teach an interburst frequency between 10 and 60 Hz and an intraburst frequency of 500 to 1000 Hz, only an amplitude between 0.10 to 13.0 mA ([0011] 0.1mA to 10mA 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/system as taught by Nelson with an amplitude between 0.10 to 13.0 mA as taught by Rosenbluth. Such a modification would provide the predictable results of treating overactive bladder (Abstract).
It also would have been obvious to one having ordinary skill in the art at the time the invention was made to further modify the method as taught by the modified nelson with an amplitude between 0.10 to 13.0 mA, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Applicant further argues that Rosenbluth is directed toward treating tremors using neuromodulation so it would not have been obvious to modify Nelson with the teachings of Rosenbluth. Examiner respectfully disagrees as Nelson is directed towards treating bladder dysfunction [0035] and Rosenbluth is directed towards treating overactive bladder (Abstract). Therefore, both Nelson and Rosenbluth are in the same field of endeavor and it would have been obvious to one having ordinary skill in the art to modify the method/system as taught by Nelson with the stimulation amplitude as taught by Rosenbluth in order to treat symptoms of bladder dysfunction such as overactive bladder.
Claim Objections
Claims 1 and 16 is objected to because of the following informalities:
Claim 1, lines 6-7 recite, “one or more electrodes of an electrical lead”. Examiner suggests amending the claim to recite, “one or more electrodes of the electrical lead” in order to avoid indefiniteness and improve clarity. Otherwise “an electrical lead” could be interpreted to be a different lead from the previously recited lead. In order to further advance prosecution, Examiner is interpreting “an electrical lead” recited in lines 6-7 to be referring to the same electrical lead that was previously recited.
Claim 16, line 2 recites, “…nature of the dysfunction of the of said autonomic…”. Examiner suggests amending the claim to recite, “…nature of the dysfunction of the [[of said]] autonomic…”.
Appropriate correction is respectfully requested.
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 an electrical lead ([0052] stimulation is delivered from IMD 14 via the stimulation electrodes),
wherein said one or more electrodes are located 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 [0148] and treating an overactive bladder [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 essential tremor and other movement disorders, as well as overactive bladder (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 [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 [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 [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 [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 [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 (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 of said 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 (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 (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 (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 [0033].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights