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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-20) in the reply filed on 1/9/2026 is acknowledged.
Claims 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on1/9/2026.
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 1-20 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 claim 1, Fraga Da Silva teaches a system (e.g. Fig.1) for treating erectile dysfunction (e.g. Abstract), the system comprising:
a flexible paddle (e.g. 204, 206 Figs.1, 2C-E [0038]-[0042]) having an array of electrodes(e.g. 202 Fig.1), the flexible paddle configured to be implanted adjacent to one or more cavernous nerves (e.g.[0037],[0040], [0056], [0057]); and
a programmable controller (e.g. 400, 500 Fig. 1, 300 Fig.3, [0058]), comprising a stimulation circuit (e.g. 312 Fig.3), a microprocessor (e.g. 302 Fig.3), and a memory (e.g. 304, Fig.3, [0054]-[0057]), the stimulation circuit operatively coupled to the array of electrodes, the microprocessor configured to execute programmed instructions stored in the memory to:
cause the stimulation circuit to, in a nerve rehabilitation mode, activate the array of electrodes in accordance with preferred stimulation parameters stored in the memory to stimulate the one or more cavernous nerves to promote rehabilitation of the one or more cavernous nerves to improve an erectile response (e.g. [0057]:stimulation parameters are selected to promote nerve regeneration, and to improve nerve regeneration to treat sexual disorders such as erectile dysfunction and female sexual arousal disorders, stimulation may promote and improve nerve (e.g., nerve(s) of the pelvic plexus and/or cavernous nerve(s)) regeneration over time). (Note: the claim does not recite what is meant by a “nerve rehabilitation mode” and since Fraga Da Silva teaches stimulation parameters that overlap the ranges disclosed in the current application (and as claimed in dependent claim 16) for nerve regeneration and improvement of nerve regeneration, it is considered as nerve rehabilitation mode).
Regarding claim 2, Fraga Da Silva teaches that the programmable controller is disposed within an implantable pulse generator configured to be operatively coupled to the array of electrodes via one or more leads (e.g. 208 Fig.1, [0039], [0044], [0053]).
Regarding claim 3, Fraga Da Silva teaches that the programmable controller is configured to cause the stimulation circuit to activate the array of electrodes responsive to a command received from at least one of an external patient controller or an external physician controller (e.g. 400, 500 Fig.1 [0058]).
Regarding claim 4-6, Fraga Da Silva teaches that the programmable controller is disposed within at least one of an external patient controller (e.g. 400 Fig.1) or an external physician controller (e.g.500 Fig.1), and wherein the flexible paddle comprises an antenna configured to communicate with the at least one of the external patient controller or the external physician controller and that the flexible paddle comprises a controller (e.g. 302 Fig. 3) comprising the antenna (e.g. 306 Fig.3) , the controller having a memory(e.g. 304 Fig.3) configured to store one or more operational parameters associated with the array of electrodes, wherein the programmable controller is configured to cause the stimulation circuit to cause the controller to activate the array of electrodes responsive to user input received by the at least one of the external patient controller or the external physician controller (e.g. [0058]).
Regarding claims 7-9, Fraga Da Silva teaches providing electrical stimulation to one or more cavernous nerves (e.g. [0037],[0040], [0056], [0057]) as discussed above and they further teach providing electrical stimulation to provide sexual arousal to treat sexual disorders such as erectile dysfunction (e.g. [0057], [0063],[0064]) having a current amplitude in a range of 1 to 50 mA (which overlaps the claimed range of 0.5-25mA) at a frequency between 10-30 Hz (which overlaps the claimed range of 10-48 Hz) with a pulse width between 0.5msec - 5 msec) (which overlaps the claimed range of 0.1 to 1.0 milliseconds) and therefore they teach that the programmable controller is configured to cause the stimulation circuit to, in an erection mode, selectively activate a preferred set of excitation electrodes of the array of electrodes to elicit a rapid erectile response to cause an erection sufficient for sexual performance (e.g. [0023], [0084]). Note: The claims are directed to an apparatus and since Fraga Da Silva teaches selectively activating electrodes with stimulation parameters that overlap the claimed ranges they teach that the stimulation is sufficient to elicit a rapid erectile response to cause an erection sufficient for sexual performance as claimed.
Regarding claims 10-12, Fraga Da Silva teaches providing electrical stimulation to one or more cavernous nerves (e.g. [0037],[0040], [0056], [0057]) as discussed above and they further teach providing electrical stimulation to provide sexual arousal to treat sexual disorders such as erectile dysfunction (e.g. [0057], [0063],[0064]) having a current amplitude in a range of 1 to 10mA (which overlaps the claimed range of 1-6mA) at a frequency between 10-30 Hz (which overlaps the claimed range of 6 to 100 Hz) with a pulse width between 0.5msec - 5 msec) (which overlaps the claimed range of 0.1 to 1.0 milliseconds) and therefore they teach that the programmable controller is configured to cause the stimulation circuit to, in an erection mode, selectively activate a preferred set of excitation electrodes of the array of electrodes to elicit a rapid erectile response to cause an erection sufficient to facilitate a medical procedure (e.g. [0084]) wherein the medical procedure comprises application of a urinary catheter. Note: The claims are directed to an apparatus and since Fraga Da Silva teaches selectively activating electrodes with stimulation parameters that overlap the claimed ranges they teach that the stimulation is sufficient to elicit a rapid erectile response to facilitate a medical procedure. The medical procedure is intended use since the claims are directed to an apparatus.
Regarding claims 13 and 14, Fraga Da Silva teaches that the erectile response promotes rehabilitation of neural transmission via the one or more cavernous nerves (e.g. [0004], [0036], [0037] : restore function by electrostimulating the cavernosal nerve) and that the programmable controller is configured to automatically activate the stimulation circuit to activate all of the electrodes of the array of electrodes at least once per day to rehabilitate neural transmission day (e.g.[0056], [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 10 min to 2 hours, 10 min to 1 hour, 10 min to 30 min, 10 min to 20 min, or 1 hour to 2 hours).
Regarding claim 15, Fraga Da Silva teaches that the programmable controller is configured to automatically activate the stimulation circuit to activate the array of electrodes at least one hour per day (e.g.[0056], [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 10 min to 2 hours, 10 min to 1 hour, 10 min to 30 min, 10 min to 20 min, or 1 hour to 2 hours).
Regarding claim 17, Fraga Da Silva teaches the stimulation circuit applies, in the nerve rehabilitation mode, applies oscillating or low-frequency electrical stimulation (e.g. [0057: stimulation for nerve regeneration occurs using oscillating current or low-frequency electrical stimulation.)
Regarding claim 20, Fraga Da Silva teaches that the flexible paddle is sized and shaped to be implanted at a pelvic plexus (e.g. [0014]), the limitation regarding implanting the flexible paddle in at a pelvic plexus via a laproscopic surgery is intended use since the claims are directed to an apparatus.
Claim Rejections - 35 USC § 103
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 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 16 is rejected under 35 U.S.C. 103 as obvious over Fraga Da silva et al (U.S. Patent Application Publication Number: US 2016/0101288 A1, hereinafter “Fraga Da Silva”- APPLICANT CITED).
Regarding claim 16, Fraga da Silva teaches the claimed invention as discussed above and further teaches that the stimulation circuit applies, in the nerve rehabilitation mode, a current amplitude in a range of 1 mA to 20mA, a frequency of 10Hz to 30Hz and a pulse width of 0.5msec to 5 msec (e.g. [0057]). They do not specifically teach the claimed ranges of current as being 0.1 to 2 mA at a frequency between 10 to 48 Hz with a pulse width between 0.01 to 1.0 milliseconds.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Fraga Da Silva with the stimulation parameters in the claimed ranges, 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).
Claim 18 is rejected under 35 U.S.C. 103 as obvious over Fraga Da silva et al (U.S. Patent Application Publication Number: US 2016/0101288 A1, hereinafter “Fraga Da Silva”- APPLICANT CITED) in view of Whitehurst et al (U.S. Patent Number: US 6650943 B1, hereinafter “Whitehurst” - APPLICANT CITED).
Regarding claim 18, Fraga da Silva teaches the claimed invention as discussed above except for the one or more electrodes of the array of electrodes being configured to measure neural activity of the one or more cavernous nerves.
In a similar field of endeavor, Whitehurst teaches an implantable system for cavernous nerve stimulation and further teaches electrodes being configured to measure neural activity of the one or more cavernous nerves (e.g. Col. 10 line 11-30). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the electrodes of teachings of Fraga da Silva to be configured to measure neural activity as taught by Whitehurst in order to provide the predictable results of providing a more effective therapy using closed loop stimulation with adjusted stimulation parameters.
Claim 19 is rejected under 35 U.S.C. 103 as obvious over Fraga Da silva et al (U.S. Patent Application Publication Number: US 2016/0101288 A1, hereinafter “Fraga Da Silva”- APPLICANT CITED) in view of Whitehurst et al (U.S. Patent Number: US 6650943 B1, hereinafter “Whitehurst”) and further in view of Edgerton et al (U.S. Patent Application Publication Number: US 2014/0316484 A1, hereinafter “Edgerton”).
Regarding claim 19, Fraga da Silva in view of Whitehurst teaches the claimed invention of adjusting stimulation parameters in a closed loop algorithm programmed in the system based on sensed data as discussed above except for the microprocessor being configured to execute a machine learning algorithm stored in the memory to adjust the preferred stimulation parameters based on the measured neural activity of the one or more cavernous nerves.
Edgerton teaches a neuromodulation system for recovery sexual function and teaches that it is well known to used machine learning methods that such as a gaussian process optimization to determine a set of neurostimulation parameters based on sensed signals (e.g. [0089]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the algorithm as taught by Fraga Da Silva in view of Whitehust with machine learning method of implementing a gaussian process optimization as taught by Edgerton in order to provide the predictable results of providing a more effective therapy.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1- 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12, 17 and 18 of Copending application 19/264402. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 1 and 7 of Copending application 19/264402 are obvious over the claims 1 and 16 of the instant application as shown below. Additionally dependent claims 2, 3, 5, 6, 9, 10 and 15-17 of the current also recite similar limitations as claims 2-10,12,17 and 18 of Copending application 19/264402.
Additionally dependent claims 4, 7, 8, 11-14 and 18-20 of the current application are obvious in view of the teachings of Fraga Da silva as discussed above.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792