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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/19/2026 has been entered.
Amendment
This action is in response to the Amendment filed on 3/19/2026.
Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed 3/19/2026 have been fully considered but they are not persuasive.
Rejections Under §102/103- Fraga Da Silva.
The claim 1 as recited is directed to a system that comprises:
one or more flexible paddles comprising an array of electrodes, the one or more flexible paddles configured to be implanted adjacent to one or more cavernous nerves;
a pulse generator operatively coupled to the array of electrodes; and
a controller operatively coupled to the pulse generator, the controller having instructions that, when executed by a processor, cause the controller to cause, in a “nerve rehabilitation mode”, the pulse generator to activate the array of electrodes in accordance with predefined stimulation parameters to stimulate the one or more cavernous nerves “to promote rehabilitation of neural transmission of the one or more cavernous nerves without activating the one or more cavernous nerves that cause a physiological response that results in an erection”, wherein the predefined stimulation parameters comprise low current intensity in a range between 0.1 to 2 mA.
As discussed in the previous office and reiterated below, Fraga Da Silva teaches a system that comprises the one or more flexible paddles comprising an array of electrodes, the one or more flexible paddles configured to be implanted adjacent to one or more cavernous nerves; a pulse generator operatively coupled to the array of electrodes; and a controller operatively coupled to the pulse generator as claimed.
They further teach applying a current of 1-20mA (e.g. [0057]) which overlaps the claimed 0.1-2mA in the 1-2mA range. The “nerve stimulation mode” to activate the array of electrodes in accordance with predefined stimulation parameters to stimulate the one or more cavernous nerves “to promote rehabilitation of neural transmission of the one or more cavernous nerves without activating the one or more cavernous nerves that cause a physiological response that results in an erection” as recited has not been defined as anything more than providing a stimulation of 0.1-2mA. Therefore, in the claims, as recited, the “nerve rehabilitation mode” comprises stimulating the nerve at 0.1-2mA. The limitation “to promote rehabilitation of neural transmission of the one or more cavernous nerves without activating the one or more cavernous nerves that cause a physiological response that results in an erection” is interpreted as a result of the application of the stimulation current in the range of 0.1-2mA.
With regards to the arguments regarding the 102 rejection with respect to the ranges, the overlap in the current range between the prior art and the claimed range is not just an endpoint overlap, the ranges instead partially overlap. Further in [0057], Fraga Da Silva states:
[0057] The 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 and female sexual arousal disorder. For example, stimulation 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. As an example, pulse duration may be programmed to be between about 0.5 msec to about 10 msec, about 0.5 msec to about 5 msec, about 1 msec to about 4 sec, or about 1 msec to about 3 msec. Frequency of alternating current may be programmed to be between about 10 Hz to about 30 Hz, about 10 Hz to about 25 Hz, about 10 Hz to about 20 Hz, or about 15 Hz to about 25 Hz. Voltage may be programmed to be between about 1 V to about 15 V, about 5 V to about 10V, about 1 V to about 5 V, or about 10 V to about 15V. Current may be programmed to be between about 1 milliamp to about 100 milliamps, about 1 milliamp to about 50 milliamps, about 1 milliamp to about 20 milliamps, about 20 milliamps to about 50 milliamps, about 50 milliamps to about 100 milliamps, or about 75 milliamps to about 100 milliamps. Period of stimulation may be programmed to automatically stimulate during predetermined times or may stimulate responsive to user input, e.g., at user interface 402. For example, stimulation may be maintained during a portion or during the entire period of desired erection. For nerve regeneration, it may be preferable to stimulate at predetermined intervals over time. For example, 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. Preferably, stimulation for nerve regeneration occurs using oscillating current or low-frequency electrical stimulation.
Therefore Fraga Da Silva discloses that the stimulation parameters are selected to promote nerve regeneration, and/or to improve nerve regeneration and may promote and/or improve nerve (e.g., nerve(s) of the pelvic plexus and/or cavernous nerve(s)) regeneration over time and they also teach that for nerve regeneration, it may be preferable to stimulate at predetermined intervals over time and that stimulation for nerve regeneration occurs using oscillating current or low-frequency electrical stimulation.
In the declaration (paragraph 7) and the applicant’s own specifications in the current application “nerve rehabilitation mode” is described as: “For example, the nerve rehabilitation mode may apply current amplitude in the range of 0.1 to 2 mA, frequency in the range of 10 to 48 Hz, and pulse width in the range of 0.01 to 1 milliseconds.”
Therefore, Fraga Da Silva teaches overlapping applied stimulation parameters ranges for current (as well as frequency and pulse duration as seen in [0057]) with the claimed range and therefore they do establish same functions or properties within the claimed prior art range (including frequency and pulse duration) relative to the functions or properties of the claimed range. Further while applicant argues that the overlap is only over part of the claimed range, and Fraga Da Silva establishes different functions, the argument is not persuasive since Fraga Da Silva clearly also teaches that stimulation for nerve regeneration occurs using oscillating current or low-frequency electrical stimulation as described in [0057]. The “nerve rehabilitation mode” as claimed does not preclude the teachings of Fraga Da Silva. Further since Fraga Da Silva teaches a substantial overlap in not only current but also frequency and pulse width ranges, they teach a nerve stimulation mode to promote rehabilitation of neural transmission of the one or more cavernous nerves without activating the one or more cavernous nerves that cause a physiological response that results in an erection as claimed.
Further with regards the obviousness rejections under 35 U.S.C. 103, Fraga Da Silva clearly teaches that the stimulation parameters including current are adjusted (e.g. claim 23, [0014], [0046], [0048],[0084]: external physician controller 500 may be used to program and adjust parameters such as pair(s) of electrodes to be used for stimulation, pulse duration, frequency of alternating current, voltage, current, and period of stimulation may be adjusted). 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 teachings to adjust the stimulation to include the lower range of stimulation current (i.e. 0.1 upto 1 mA) to be able to provide the current in the ranges as claimed.
Thus, the prior art of Fraga Da Silva teaches the flexible paddles, electrodes, pulse generator and controller as the structural elements of the system as claimed. They also teach the location of stimulation since they teach that the paddles are configured to be implanted adjacent to one or more cavernous nerves as claimed. Further they teach at least a partially overlapping current stimulation range as well as frequency and pulse duration ranges. They also teach that the stimulation parameters are adjustable. It would have bene obvious to a person having ordinary skill in the art to modify the teachings of Fraga Da Silva to provide current stimulation in the claimed range due to the reasons discussed above. Therefore, Fraga Da Silva’s teachings teach the claimed invention as recited.
Therefore, the rejection is maintained.
Response to Amendment
The affidavit under 37 CFR 1.132 filed on 3/19/2026 is insufficient to overcome the rejection of claims 1-20 based upon the rejection under 35 U.S.C. 102(a)(1) as being 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”- APPLICANT CITED) as set forth in the last Office action because the showing is not commensurate in scope with the claims.
As discussed above, the claims as recited are directed to a system that comprises one or more flexible paddles comprising an array of electrodes, the one or more flexible paddles configured to be implanted adjacent to one or more cavernous nerves; a pulse generator operatively coupled to the array of electrodes; and a controller operatively coupled to the pulse generator, the controller having instructions that, when executed by a processor, cause the controller to cause, in a “nerve rehabilitation mode”, the pulse generator to activate the array of electrodes in accordance with predefined stimulation parameters to stimulate the one or more cavernous nerves “to promote rehabilitation of neural transmission of the one or more cavernous nerves without activating the one or more cavernous nerves that cause a physiological response that results in an erection”, wherein the predefined stimulation parameters comprise low current intensity in a range between 0.1 to 2 mA.
With regards to paragraph 18-20 of the declaration, that Fraga da Silva does not distinguish between functions (e.g. between causing erections and nerve regeneration), the “nerve stimulation mode” to activate the array of electrodes in accordance with predefined stimulation parameters to stimulate the one or more cavernous nerves “to promote rehabilitation of neural transmission of the one or more cavernous nerves without activating the one or more cavernous nerves that cause a physiological response that results in an erection” as recited has not been defined as anything more than providing a stimulation of 0.1-2mA. Therefore, in the claims, as recited, the “nerve rehabilitation mode” is only defined as a limitation that comprises stimulating the nerve at 0.1-2mA. The limitation “to promote rehabilitation of neural transmission of the one or more cavernous nerves without activating the one or more cavernous nerves that cause a physiological response that results in an erection” is interpreted as a result of the application of the stimulation current in the range of 0.1-2mA. The prior art of Fraga da Silva teaches a current of 1-20mA (e.g. [0057]). This is range that partially overlaps the claimed range and is not just an end point overlap. Further in the declaration (paragraph 7) and the applicant’s own specifications in the current application “nerve rehabilitation mode” is described as: “For example, the nerve rehabilitation mode may apply current amplitude in the range of 0.1 to 2 mA, frequency in the range of 10 to 48 Hz, and pulse width in the range of 0.01 to 1 milliseconds.”
In paragraph [0057] of the prior art of Fraga da Silva (reproduced below), additional stimulation parameters of frequency and pulse duration are described with substantial overlap with the “nerve stimulation mode” as described.
[0057] The 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 and female sexual arousal disorder. For example, stimulation 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. As an example, pulse duration may be programmed to be between about 0.5 msec to about 10 msec, about 0.5 msec to about 5 msec, about 1 msec to about 4 sec, or about 1 msec to about 3 msec. Frequency of alternating current may be programmed to be between about 10 Hz to about 30 Hz, about 10 Hz to about 25 Hz, about 10 Hz to about 20 Hz, or about 15 Hz to about 25 Hz. Voltage may be programmed to be between about 1 V to about 15 V, about 5 V to about 10V, about 1 V to about 5 V, or about 10 V to about 15V. Current may be programmed to be between about 1 milliamp to about 100 milliamps, about 1 milliamp to about 50 milliamps, about 1 milliamp to about 20 milliamps, about 20 milliamps to about 50 milliamps, about 50 milliamps to about 100 milliamps, or about 75 milliamps to about 100 milliamps. Period of stimulation may be programmed to automatically stimulate during predetermined times or may stimulate responsive to user input, e.g., at user interface 402. For example, stimulation may be maintained during a portion or during the entire period of desired erection. For nerve regeneration, it may be preferable to stimulate at predetermined intervals over time. For example, 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. Preferably, stimulation for nerve regeneration occurs using oscillating current or low-frequency electrical stimulation.
Fraga da Silva in paragraph [0057] above also describes the nerve stimulation for nerve regeneration occurs using oscillating current or low-frequency electrical stimulation. Therefore the prior art of Fraga da Silva establishes the same functions or properties within the prior art range relative to the functions or properties of the claimed range. Further as discussed above, there is a partial overlap for the current stimulation parameters and a substantial overlap for the with the claimed ranges for the frequency and pulse duration parameters and in view of the disclosure that stimulation for nerve regeneration occurs using oscillating current or low-frequency electrical stimulation, the prior art range not limited and therefore the claimed range can be readily envisaged by a person having ordinary skill in the art.
With regards to the statements regarding obviousness in paragraph 21, the prior art of Fraga da Silva teaches additional stimulation parameters of frequency and pulse duration which have a substantial overlap with the frequency and pulse duration disclosed in the current application for nerve rehabilitation mode. Fraga da Silva teaches that for nerve generation a low frequency oscillating current may be useful. Fraga da Silva also teaches that the stimulation parameters including current are adjusted (e.g. [0014], [0046], [0048],[0084] claim 23 : external physician controller 500 may be used to program and adjust parameters such as pair(s) of electrodes to be used for stimulation, pulse duration, frequency of alternating current, voltage, current, and period of stimulation may be adjusted). Therefore since the prior art of Fraga da silva teaches overlapping current intensity values in the 1-2mA range as discussed above, 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 teachings to adjust the stimulation to also include the lower range of stimulation current (i.e. 0.1 upto 1 mA) as claimed.
Further with regards to paragraph 22 of the declaration regarding unexpected results. Fraga da silva teaches overlapping current (as well as frequency and pulse duration) parameters as discussed above. They also teach that the stimulation parameters of current, frequency and pulse duration are adjustable and 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 teachings to adjust the stimulation to also include the lower range of stimulation current (i.e. 0.1 upto 1 mA). Thus, the statement of unexpected results is inadequate to overcome the obviousness rejection.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
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 1-18 are rejected under 35 U.S.C. 102(a)(1) as being 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”- APPLICANT CITED).
Regarding claims 1 and 2, Fraga Da Silva teaches a system (e.g. Fig.1) for rehabilitating cavernous nerves of a patient, the system comprising:
one or more flexible paddles (e.g. 204, 206 Figs.1, 2C-E [0038]-[0042]) comprising an array of electrodes (e.g. 202 Fig.1), the one or more flexible paddles configured to be implanted adjacent to one or more cavernous nerves (e.g. [0037],[0057]);
an implantable pulse generator (e.g. 200, 300, Fig.1, [0038]-[0045]) operatively coupled to the array of electrodes; and
a controller operatively coupled to the pulse generator (e.g. 300, Fig.1, [0038], [0039,[0045]), the controller having instructions that, when executed by a processor, cause the controller to cause, in a nerve rehabilitation mode, the pulse generator to activate the array of electrodes in accordance with predefined stimulation parameters to stimulate the one or more cavernous nerves to promote rehabilitation of neural transmission of the one or more cavernous nerves without activating the one or more cavernous nerves that cause a physiological response that results in an erection (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),
wherein the predefined stimulation parameters comprise low current intensity in a range between 0.1 to 2 mA (e.g. [0057]: Current may be programmed to be between about 1 milliamp to about 100 milliamps, about 1 milliamp to about 50 milliamps, about 1 milliamp to about 20 milliamp).
In the alternative, Fraga Da Silva teaches that the predefined stimulation parameters comprise a low current intensity between about 1 milliamp to about 100 milliamps, about 1 milliamp to about 50 milliamps, about 1 milliamp to about 20 milliamp (e.g. [0057]) but does not teach the specific current intensity range of between 0.1 to 2 mA. 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 predefined stimulation parameter comprising a low current intensity of 0.1 to 2 milliamps, 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 claims 3 and 4, Fraga Da Silva teaches the implantable pulse generator is configured to be subcutaneously implanted in the patient's lower abdomen between umbilicus and iliac crest lines (e.g. [0083] Figs.6, 7) Note: the claims are directed to an apparatus and the location of implantation of the implantable pulse generator is intended use).
Regarding claims 5 and 6, Fraga Da Silva teaches the controller is configured to cause, in the nerve rehabilitation mode, the pulse generator to activate all electrodes of the array of electrodes at least once per day and 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 7, Fraga Da Silva teaches the predefined stimulation parameters comprise a frequency between 10 to 48 Hz and a pulse width between 0.01 to 1.0 milliseconds (e.g. [0057]: pulse duration may be programmed to be between about 0.5 msec to about 10 msec, about 0.5 msec to about 5 msec, about 1 msec to about 4 sec, or about 1 msec to about 3 msec. Frequency of alternating current may be programmed to be between about 10 Hz to about 30 Hz).
In the alternative, Fraga Da silva teaches that the wherein the predefined stimulation parameters comprise a pulse duration between about 0.5 msec to about 10 msec, about 0.5 msec to about 5 msec, about 1 msec to about 4 sec, or about 1 msec to about 3 msec, frequency of between about 10 Hz to about 30 Hz (e.g. [0057]) but does not teach the specific frequency between 10 to 48 Hz and a specific 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 predefined stimulation parameter comprising a specific frequency between 10 to 48 Hz and a specific pulse width between 0.01 to 1.0 milliseconds, 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 8, Fraga Da Silva teaches the controller is configured to cause, in the nerve rehabilitation mode, the pulse generator to apply oscillating or low-frequency electrical stimulation (e.g. [0057: stimulation for nerve regeneration occurs using oscillating current or low-frequency electrical stimulation.)
Regarding claim 9, Fraga Da Silva teaches the controller is configured to cause the pulse generator 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 10, Fraga Da Silva teaches the one or more flexible paddles comprise an antenna (e.g. 400, 500 Fig.1 [0058], [0060]) configured to communicate with the at least one of the external patient controller or the external physician controller.
Regarding claim 11, Fraga Da Silva teaches the controller is configured to cause, in the nerve rehabilitation mode, the pulse generator to activate the array of electrodes in accordance with predefined stimulation parameters to stimulate the one or more cavernous nerves to improve an erectile response (e.g. [0014], [0050], [0056]).
Regarding claim 12, Fraga Da Silva teaches the controller is configured to cause, in an erection mode, the pulse generator to selectively activate a preferred set of excitation electrodes of the array of electrodes in accordance with second predefined stimulation parameters to elicit a rapid erectile response to cause an erection sufficient for sexual performance (e.g. [0014]-[0016], [0050],[0056]).
Regarding claim 13, Fraga Da Silva teaches the controller is configured to: cause the pulse generator to selectively activate a predetermined pattern of electrodes of the array of electrodes to elicit one or more penile responses; and determine the preferred set of excitation electrodes of the array of electrodes based on a comparison of the one or more penile responses (e.g. [0014]-[0016], [0050],[0056],[0058]).
Regarding claim 14, Fraga Da Silva teaches the controller is configured to: cause the pulse generator to selectively activate the preferred set of excitation electrodes of the array of electrodes in accordance with a plurality of different predefined stimulation parameters to elicit a corresponding plurality of penile responses; and determine the second predefined stimulation parameters based on a comparison of the corresponding plurality of penile responses (e.g. [0014]-[0016], [0050],[0056],[0058]).
Regarding claim 15, Fraga Da Silva teaches wherein the controller is configured to cause the pulse generator to selectively activate electrodes of the predetermined pattern of electrodes in an interpulsed manner (e.g. [0016],[0049]).
Regarding claim 16, Fraga Da Silva teaches the invention as claimed and they teaches that the it may be preferable to stimulate at predetermined intervals over time by providing automatic stimulation for example on an hourly basis and that the stimulation is an oscillating current or low-frequency electrical stimulation (e.g. [0057]), they do not specifically teach that the pulse generator selectively activates electrodes of the predetermined pattern of electrodes for a period of one to two minutes, with a period of two to five minutes rest between activation of the electrodes of the predetermined pattern of electrodes. 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 electrodes being activated to provide stimulation with a period of one to two minutes and with a period of two to five minutes rest between activation, 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 17, Fraga Da Silva teaches the stimulation parameters to promote an erectile response as comprising a frequency between of 0.5 to 25 mA, a frequency between 10 to 48 Hz, and a pulse width between 0.1 to 1.0 milliseconds (e.g. [0057]: Current may be programmed to be between about 1 milliamp to about 100 milliamps, about 1 milliamp to about 50 milliamps, about 1 milliamp to about 20 milliamps, pulse duration may be programmed to be between about 0.5 msec to about 10 msec, about 0.5 msec to about 5 msec, about 1 msec to about 4 sec, or about 1 msec to about 3 msec. Frequency of alternating current may be programmed to be between about 10 Hz to about 30 Hz).
In the alternative, Fraga Da silva teaches stimulation parameters comprises a current between about 1 milliamp to about 100 milliamps, about 1 milliamp to about 50 milliamps, about 1 milliamp to about 20 milliamps, pulse duration between about 0.5 msec to about 10 msec, about 0.5 msec to about 5 msec, about 1 msec to about 4 sec, or about 1 msec to about 3 msec and frequency to be between about 10 Hz to about 30 Hz (e.g. [0057]) but does not teach the specific ranges of current as 0.5 to 25 mA, frequency between 10 to 48 Hz, and a pulse width between 0.1 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 predefined stimulation parameter comprising a specific ranges as claimed, 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 18, Fraga Da Silva teaches the controller is configured to cause, in an erection mode, the pulse generator to selectively activate a preferred set of excitation electrodes of the array of electrodes in accordance with second predefined stimulation parameters to elicit a rapid erectile response to cause an erection sufficient to facilitate a medical procedure (e.g. [0049], [0050]).
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 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 Epstein et al (U.S. Patent Number: US 6259945, hereinafter “Epstein”- PREVIOUSLY CITED).
Regarding claim 19, Fraga da Silva teaches the claimed invention as discussed above, except for one or more external pulse generators configured to be operatively coupled to the array of electrodes during an intraoperative stimulation mode.
In a similar field of endeavor, Epstein teaches an external pulse generator (e.g. 104, 106 Fig.1) configured to be operatively coupled to an array of electrodes (e.g. 102 Fig.1) during an intraoperative stimulation mode (e.g. Col. 4 lines 34-67). 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 teachings of Fraga Da Silva to have an external pulse generator configured to be operatively coupled to the array of electrodes of Fraga Da Silva during an intraoperative stimulation mode in order to provide the predictable results of allowing the clinician to be able to accurately locate and optimize the stimulation parameters.
Claim 20 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 Epstein et al (U.S. Patent Number: US 6259945, hereinafter “Epstein”- PREVIOUSLY CITED) and further in view of Keravel et al (U.S. Patent Application Publication Number: US 2004/0243205A1 hereinafter “Keravel”- PREVIOUSLY CITED).
Regarding claim 20, Fraga da Silva in view of Epstein teaches the claimed invention as discussed above, except for the controller being configured to: cause, in the intraoperative stimulation mode, the pulse generator to selectively activate a predetermined pattern of electrodes of the array of electrodes to elicit one or more penile responses; and determine a preferred orientation of the one or more flexible paddles based on a comparison of the one or more penile responses.
Keravel teaches an implantable paddle lead comprising an array of electrodes (e.g. Fig.1, claim 28) and further teaches selectively activating the electrodes to elicit one or more responses during an intraoperative procedure and determining a preferred orientation of the paddle lead at the target location based on a comparison of the responses (e.g. Claims 28, 39-42). 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 teachings of Fraga da Silva in view of Epstein to be used intraoperatively to determine a proper orientation of the paddle lead based on evoked response from the underlying nerve tissue as taught by Keravel in order to provide the predictable results of properly and accurately implanting the paddle lead in the target tissue for a more efficient therapy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gill et al (U.S. Patent Application Publication Number: US 2017/0281945 A1 hereinafter “Gill”) teaches providing sub-threshold stimulation to a cavernous nerve that provides a regenerative effect but does not stimulate the nerve to a level that triggers the nerve's physiological effect, such as a muscle contraction (or an erection in the case of injury to the cavernous nerve) (e.g. [0013], claims 1, 9).
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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