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 .
Amendment
This action is in response to the Amendment filed on 11/6/2025.
Claims 48-68 are pending.
Response to Arguments
Applicant's arguments with respect to claims 48-68 have been fully considered but are not persuasive.
Rejections Under § 102 - Fraga Da Silva (U.S. 2016/0101288).
Independent claim 48 is amended to recite "the stimulation circuit operatively coupled to the array, the microprocessor configured to execute programmed instructions stored in the memory to cause, in a bladder nerve rehabilitation stimulation mode, the stimulation circuit to activate at least one pair of electrodes of the array of electrodes to stimulate at least one nerve associated with control of the bladder sphincter to promote rehabilitation of the at least one nerve to thereby improve urinary function." Independent claim 58 is similarly amended.
Applicant argues that while the cavernous nerve is a pelvic parasympathetic nerve, the cavernous nerve is not a pelvic parasympathetic nerve associated with control of the bladder sphincter. They further argue that Fraga da Silva’s electrical stimulation parameters as taught in paragraph [0057] are much higher than the stimulation parameters for bladder nerve stimulation as taught by the current application Accordingly, as the claimed controller is programmed in a new manner to perform a different function, Applicant submits that the claimed controller is structurally distinct.
Applicant’s arguments with respect to the amended claims and Fraga Da silva’s teachings have been carefully reviewed. The examiner respectfully disagrees for the following reasons.
First, applicant’s own specifications states that the system may be used to rehabilitate the cavernous nerves, to reduce penile fibrosis, or to treat urinary incontinence (e.g. [0002], [0018] of applicant’s originally filed specifications) and also states that the nerve may be a pelvic parasympathetic nerve (e.g. claim 53, [0037] of applicant’s originally filed specifications) and also by applicant’s own admission, the cavernous nerve is a pelvic parasympathetic nerve. Thus this recitation does not preclude the cavernous nerve as a target.
Second, while the applicant argues that the stimulation parameters taught by Frago Da Silva are much higher than the stimulation parameters claimed in claim 49 of the current application, Frago Da Silva teaches a current, frequency and pulse width (i.e. 1-20mA, 10-30Hz, 0.5msec-5msec) that overlap the claimed ranges of current frequency and pulse width respectively (i.e. 0.1-2mA, 10-48Hz and 0.01msec-1msec) and thus the claims do not preclude the teachings of Frago Da Silva.
Thus since Frago da Silva teaches stimulation a pelvic parasympathetic nerve such as the cavernous nerve using stimulation parameters that overlap the claimed ranges they teach bladder nerve rehabilitation stimulation mode wherein the stimulation circuit activates at least one pair of electrodes of the array of electrodes to stimulate at least one nerve associated with control of the bladder sphincter to promote rehabilitation of the at least one nerve to thereby improve urinary function as claimed.
Therefore applicant’s arguments are not persuasive and the rejection is maintained.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 48-68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fraga Da Silva et al (U.S. Patent Application Publication Number: US 2016/0101288 A1, hereinafter “Fraga Da Silva”- APPLICANT CITED).
Regarding claims 48-50, 52, 53, 58-62 and 64, Fraga Da Silva an implantable system and method for treating urinary incontinence, comprising:
a flexible paddle one or more flexible paddles (e.g. 204, 206 Figs.1, 2C-E [0038]-[0042]) having an array of electrodes (e.g. 202 Fig.1) disposed on a first side, the flexible paddle configured to be disposed adjacent to a patient's pelvic plexus during a prostatectomy (e.g. [0014],[0021], [0037]) via laproscopic surgery (e.g. [0023],[0083]); and
a programmable controller comprising a stimulation circuit, a microprocessor, and a memory, the stimulation circuit operatively coupled to the array (e.g. 200, 300, Figs.1, 3, [0038]-[0045], [0055]),
the microprocessor configured to execute programmed instructions stored in the memory to cause, in a bladder nerve stimulation rehabilitation mode, the stimulation circuit to activate at least one pair of electrodes of the array of electrodes to stimulate (e.g.[0057]: pulse duration may be about 0.5 msec to about 10 msec, frequency may be between about 10 Hz to about 30 Hz, current may be between about 1 milliamp to about 20 milliamps) at least one nerve (i.e. cavernous nerve e.g. [0037],[0057], Note: the cavernous nerve is a pelvic parasympathetic nerve) associated with control of the bladder sphincter to promote rehabilitation of the at least one nerve to thereby improve urinary function, wherein the programmed instructions cause activation of the stimulation circuit for at least one hour daily (e.g. [0057]: automatic stimulation may occur hourly, once a day, twice a day, three times a day, four times a day, every other day, every three days, or weekly for a period of 1 hour to 2 hours). Note: As discussed above in the response to arguments section, since Fraga da Silva teaches stimulation parameters that overlap the claimed ranges that are being applied to the claimed target nerve (i.e. a pelvic parasympathetic nerve), the system and the method are used to treat urinary incontinence and improve urinary function in a bladder nerve rehabilitation stimulation mode as claimed.
Regarding claim 51, Fraga Da Silva teaches that the flexible substrates may have a flat structure designed in a suitable shape such as an oval or ellipse (e.g. [0040]) and therefore they teach that the flexible paddle has a hemispherical shape and the array of electrodes comprises at least two rows of electrodes and at least two columns of electrodes (e.g. Figs.1, 2C-E shows electrodes in at least two rows and two columns).
Regarding claims 54 and 65, Fraga Da Silva teaches that the system is configured to provide the claimed stimulation parameters as discussed above and is configured to be implanted such that electrodes disposed on at least one flexible substrate sized and shaped to abut at least a portion of a pelvic plexus of a patient (e.g. [0014]) and therefore they teach that the programmed instructions further cause , in the bladder nerve rehabilitation stimulation mode, the stimulation circuit to activate at least one pair of electrodes of the array of electrodes to stimulate a pudendal nerve to promote rehabilitation of the pudendal nerve.
Regarding claims 55 and 66, Fraga Da Silva teaches that the flexible paddle further comprises a second array of electrodes (e.g. 206, 204 Fig.1 shows two flexible substrates with electrode arrays on opposite sides) disposed on a second side, opposite the first side.
Regarding claim 56, 57 and 68, Fraga Da Silva teaches that the flexible substrates comprising electrode arrays are implanted so that they abut the pelvic plexus (e.g. [0040]) and they teach that the stimulation parameters are in the claimed ranges as discussed above, therefore they teach that the programmed instructions to cause in a bladder nerve rehabilitation stimulation mode, activation of the stimulation circuit to stimulate a pudendal nerve to promote rehabilitation of the pudendal nerve and a hypogastric sympathetic nerve to promote rehabilitation of the hypogastric sympathetic nerve as claimed.
Regarding claim 63, Fraga Da Silva teaches adjusting the programmed instructions using an external patient controller or an external physician controller (e.g. [0013],[0014]).
Regarding claim 67, Fraga Da Silva teaches that the microprocessor is further configured to execute programmed instructions stored in the memory to cause, in the bladder nerve rehabilitation stimulation mode, the stimulation circuit to activate at least one pair of electrodes of the second array of electrodes (e.g. [0039], [0054]-[0057]).
Conclusion
Applicant's amendment necessitated the new grounds 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 MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792