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 7/7/2026.
Claims 1-15 and 17-24 are pending.
Claims 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 on 1/9/2026.
Claims 1-15 and 17-20 are examined.
Response to Arguments
Applicant's arguments filed 7/7/2026 have been fully considered but they are not persuasive.
Rejections Under § 102/103 - Fraga Da Silva
Independent claim 1 has been amended to incorporate the subject matter of claim 16 and recite, "wherein the stimulation circuit applies, in the nerve rehabilitation mode, a current amplitude in a range of to 2 mA at a frequency between 10 to 48 Hz with a pulse width between 0.01 to 1.0 milliseconds."
Applicant’s arguments have been considered however they are not persuasive for the following reasons.
Independent claim 1 as amended now recites
A system for treating erectile dysfunction, the system comprising:
a flexible paddle having an array of electrodes, the flexible paddle configured to be implanted adjacent to one or more cavernous nerves; and
a programmable controller comprising a stimulation circuit, a microprocessor and a memory, 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,
wherein the stimulation circuit applies, in the nerve rehabilitation mode, a current amplitude in a range of 0.1 to 2 mA at a frequency between 10 to 48 Hz with a pulse width between 0.01 to 1.0 milliseconds.
Fraga Da Silva teaches:
A system for treating erectile dysfunction (e.g. Abstract: Systems and methods are provided for treating a sexual disorder such as erectile dysfunction (ED)), 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.[0022]: In addition to providing sexual arousal, the electrical stimulation may promote nerve regeneration. [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).
Fraga Da Silva further teaches the stimulation circuit applies stimulation that may cause and maintain an erection and may promote and/or improve nerve (e.g., nerve(s) of the pelvic plexus and/or cavernous nerve(s)) regeneration over time and provides a current amplitude in a range of 1 to 20 mA (overlapping the claimed 0.1mA-2mA) at a frequency between 10 to 30 Hz (thus overlapping the claimed 10 to 48 Hz) with a pulse width between 0.5-5milliseconds (thus overlapping 0.01 to 1.0 milliseconds).
The claim does not recite any additional limitations regarding the “nerve rehabilitation mode” and the specifications do not recite any special definition for nerve rehabilitation that precludes the teachings of Fraga Da Silva that teaches nerve regeneration, and/or to improve nerve regeneration to treat sexual disorders such as erectile dysfunction to be considered as nerve rehabilitation. The nerve rehabilitation mode (claim 1) and erection mode (claim 8) are only defned by stimulation parameters that overlap the teachings of Fraga Da Silva. Applicant’s arguments are not persuasive because Fraga Da silva teaches stimulation parameters that at least partially overlap the claimed ranges.
Fraga da Silva also clearly states that the stimulation parameters are selected to “promote nerve regeneration, and to improve nerve regeneration to treat sexual disorders such as erectile dysfunction” (e.g. [0057]) and therefore the stimulation parameters clearly are selected to promote rehabilitation of the one or more cavernous nerve to improve an erectile response as claimed. Therefore, the prior art discloses the claimed range with sufficient specificity and also establishes the same functions since they teach all of the claimed limitations as well as stimulation parameters to promote nerve regeneration, and/or to improve nerve regeneration to treat sexual disorders such as erectile dysfunction and thus nerve rehabilitation. The claim does not recite any additional steps that preclude the teachings of Fraga da Silva.
Additionally, Applicant’s originally filed specifications in the current application do not provide any support for the at least partially overlapping ranges as taught by Fraga da Silva to not result in the claimed rehabilitation of the nerves to improve an erectile response as claimed. No additional steps that preclude the teachings of Fraga Da Silva are claimed and therefore, the rejection has been maintained.
Nonstatutory Double Patenting Rejections
Applicant requests that this rejection be held in abeyance until the claims are determined to be in condition for allowance. Therefore, the rejection is maintained.
Response to Amendment
The declaration under 37 C.F.R. 1.132 filed 7/7/2026 is insufficient to overcome the rejection of claims1-15 and 17-20 based upon 35 U.S.C 102 and 103 as set forth in the last Office action because: the points presented do not overcome the rejections.
Fraga da Silva teaches a system with the same structural elements as the claimed invention as discussed previously and reiterated below. They further teach that the system is used to promote nerve regeneration, and/or to improve nerve regeneration to treat sexual disorders such as erectile dysfunction by stimulating the carvernous nerves using stimulation parameters that overlap the claimed ranges. The overlapping stimulation ranges thus would necessarily result in nerve stimulation to promote rehabilitation of the cavernous nerve to improve erectile response. The affidavit states that the ordinarily skilled person would have understood that the data points within the 1-20mA range current intensity range disclosed by Fraga Da Silva aren’t equivalent as stimulation at different sub-ranges within the 1-20mA are expected to provdie different functions. The claim recites a stimulation intensity of 0.1-2mA, a frequency of 10-48Hz and a pulse width of 0.01-1 milliseconds. So if 1 mA or 1.25mA or 1.5mA or 1.6mA or 1.7mA… or 2 mA current, 10-30 Hz frequency and 0.5msec or 0.75msec or 1 msec pulse width current as taught by Fraga Da Silva is applied for stimulating the cavernous nerve using the flexible paddles as taught by Fraga Da Silva, would necessarily result in the same function as claimed. The originally filed specifications and claims do not preclude these parameters.
The originally filed specification do not recite any special definition for “nerve rehabilitation” and also do not recite any reasons why one or ordinary skill in the art would not choose the overlapping ranges.
Further Fraga Da Silva teaches a system with the same structural elements as the claimed invention and teach that the system is used to promote nerve regeneration, and/or to improve nerve regeneration to treat sexual disorders such as erectile dysfunction (and therefore nerve rehabilitation) by stimulating the cavernous nerves using stimulation parameters that overlap the claimed ranges, they teach that the prior art establishes the same functions or properties within the prior art range and at least some of the data points in the prior art range are equivalent to one another and the claimed range can be readily envisaged by one or ordinary skill in the art.
With regards to the “modes” the only differentiation between the modes are the stimulation levels, Fraga Da Silva teaches overlapping stimulation parameters with the stimulation parameters in the nerve rehabilitation mode as claimed and also teaches stimulation parameters that overlap with the erection mode as claimed in claim 12 of the current application.
Further with regards to the obviousness rejection, the prior art range is a results effective variable since Fraga Da silva clearly teaches that In addition to providing sexual arousal, the electrical stimulation may promote nerve regeneration (e.g. [0022]) and that the stimulation parameters are selected to promote nerve regeneration, and/or to improve nerve regeneration to treat sexual disorders such as erectile dysfunction and that for nerve regeneration, it may be preferable to stimulate at predetermined intervals over time (e.g. [0057]). 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 Rejections - 35 USC § 102/103
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 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.
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.
Claims 1-15, 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, 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” - PREVIOUSLY 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).
Fraga da Silva further teaches that the stimulation circuit applies, in the nerve rehabilitation mode (e.g. [0057]: stimulation parameters are selected to provide sexual arousal, to promote nerve regeneration, and/or to improve nerve regeneration to treat sexual disorders such as erectile dysfunction, [0022]: In addition to providing sexual arousal, the electrical stimulation may promote nerve regeneration), a current amplitude in a range 1 mA to 20mA (overlapping the 0.1-2mA claimed range), a frequency of 10Hz to 30Hz (with the claimed 10-48Hz range) and a pulse width of 0.5msec to 5 msec (overlapping 0.1-2msec) (e.g. [0057]) and therefore they teach the claimed stimulation parameters
In the alternative, Fraga da Silva does not teach the specific 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).
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 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” - PREVIOUSLY CITED) in view of Whitehurst et al (U.S. Patent Number: US 6650943 B1, hereinafter “Whitehurst” - PREVIOUSLY 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- PREVIOUSLY CITED) in view of Whitehurst et al (U.S. Patent Number: US 6650943 B1, hereinafter “Whitehurst” - PREVIOUSLY CITED) and further in view of Edgerton et al (U.S. Patent Application Publication Number: US 2014/0316484 A1, hereinafter “Edgerton”- PREVIOUSLY CITED).
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- 15 and 17-20 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 claim 1 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Boggs, II et al (U.S. Patent Application Publication Number: US 2008/0065167 A1, hereinafter “Boggs”) teaches systems and methods for neuromodulation stimulation for the restoration of erectile function via electrical stimulation of peripheral nerves and/or spinal nerve roots where in the nerve comprise cavernous nerve (e.g. abstract, claim 13).
THIS ACTION IS MADE FINAL. 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
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