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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 16, 2025 has been entered.
Information Disclosure Statement
The information disclosure statement(s) filed June 16, 2025 has/have been considered by the Examiner.
Terminal Disclaimer
The terminal disclaimer filed on November 18, 2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,433,231 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
This action is in response to the reply filed August 11, 2025. Claim 1 is amended. Claims 8-15 are canceled. Claims 1-7 are pending in this action.
Specification
Applicant’s arguments, filed August 11, 2025, with respect to the objection to the Specification have been fully considered and are persuasive. The Specification objection of July 15, 2025 has been withdrawn.
Claim Rejections - 35 USC § 102/103
Applicant's arguments filed August 11, 2025 regarding the prior art have been fully considered but they are not persuasive. The previously cited reference as taught by Gollan (WO 2017089887 A2 – hereinafter Gollan) does not explicitly teach the amplitude range of 100 µA to 500µA as required, however as stated in the rejection below, Gollan teaches the bioelectric signal range starting from 1 mA (Gollan paragraph 00030 – “In one embodiment, the current of the electrical impulses is from 1 to 60 mA”, further detailed in paragraph 000100), where 500 µA converts to 0.5 mA and is within 0.5 mA of 1 mA as taught by Gollan above, and furthermore a prima facie case of obviousness would exist over Gollan since although the claimed ranges or amounts do not overlap with the prior art, they are merely close, see MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation amplitudes of Gollan try the 0.5 mA amplitude since such modification would have been routine optimization to deliver stimulation treatment to the groin in order to treat, for example, premature ejaculation or other forms of sexual dysfunction (Gollan paragraph 0002).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gollan (WO 2017089887 A2 - hereinafter Gollan).
Re. claims 1, Gollan discloses a method of treating a subject for erectile dysfunction (ED) (paragraph 0005 – “…the present invention provides a device, wherein the device comprises a skin patch, configured to attach to the skin surface of the perineum of a subject suffering from erectile dysfunction, wherein the skin patch contains electrodes configured to deliver electrical impulses transcutaneously to the ischiocavernosus and bulbospongiosus muscles of the subject, wherein the transcutaneously delivered electrical impulses are configured to treat the erectile dysfunction”), the method comprising:
applying an electrode to tissue at or near the subject's groin area so as to provide a bioelectric signal that increases expression of Sonic hedgehog (SHH) in the tissue (paragraph 0065 – “…the electrode pad (26) is further configured to conform with the subject's thigh-groin crease”, the thigh-groin crease shown in figure 8; paragraph 00081 –“In some embodiments, the scrotum fitting curved cuts (22) are designed to fit to the posterior aspect of the scrotum, thus enabling the patient to precisely position the device (30) and to stimulate specifically the bulbospongiosus muscle and the neuromuscular junction of the bulbospongiosus muscle and the muscular branch of the perineal nerve.”),
wherein the bioelectric signal as measured at the cellular level of the tissue comprises:
a biphasic pulse (paragraph 0026 – “…the electrical impulses are a biphasic symmetrical wave”) with/at a frequency/amplitude range of 40 Hz to 100 Hz (paragraph 00097 – “In some embodiments, the frequency of the electrical impulses are from 1 to 100Hz…In some embodiments, the frequency is 90 Hz. In some embodiments, the frequency is 80 Hz. In some embodiments, the frequency is 70 Hz. In some embodiments, the frequency is 60 Hz. In some embodiments, the frequency is 50 Hz. In some embodiments, the frequency is 40 Hz); Gollan does not explicitly teach the biphasic pulse amplitude range from at from 100 µA to 500µA.
Gollan however teaches biphasic stimulation amplitudes starting from 1 mA (Gollan paragraph 00030 – “In one embodiment, the current of the electrical impulses is from 1 to 60 mA”, further detailed in paragraph 000100), where 500 µA converts to 0.5 mA and is within 0.5 mA of 1 mA as taught by Gollan above, and furthermore a prima facie case of obviousness would exist over Gollan since although the claimed ranges or amounts do not overlap with the prior art, they are merely close, see MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation amplitudes of Gollan try the 0.5 mA amplitude since such modification would have been routine optimization to deliver stimulation treatment to the groin in order to treat, for example, premature ejaculation or other forms of sexual dysfunction (Gollan paragraph 0002).
Gollan does not explicitly teach that the bioelectric signal increases expression of Sonic hedgehog (SHH) in the tissue, and wherein the application of the bioelectric signal increases expression of SHH by the tissue and thus treats the ED. The recited limitations however are considered to comprise intended results of the stimulation and not to comprise positively recited steps of the method (see MPEP 2111.04. I). Therefore, since Gollan teaches application of the bioelectric signal as stated above, Gollan as stated above meets all the positively recited steps of the claimed invention and thus should inherently yield any intended results, unless the claims are incomplete for failing to include aspects that are essential to achieving the claimed intended results.
Re. claim 2, Gollan further teaches wherein the electrode is a gel electrode (paragraph 00073 – “The electrodes can be made from any suitable material, such as, for example, metal, carbon, a conductive gel, and the like”).
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gollan (WO 2017089887 A2 - hereinafter Gollan) [previously cited] in view of Dirk (US 9555583 B1 – hereinafter Dirk) [previously cited].
Re. claim 3, Gollan teaches the claimed invention as stated above, but does not explicitly teach wherein the gel electrode comprises a gel comprising SHH.
Dirk teaches a neural interface 10 used for stimulation to a target muscle (Dirk figure 1A shows the neural interface 10 placed on a target muscle 18; column 8, lines 23-25: “To provide selectivity of neural recording and/or stimulation…”).
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Dirk further teaches that the neural interface 10 is a gel electrode, which can be made of composite polymer materials such as an oligo (PEG fumarate) hydrogel, or OPF (Dirk column 8, lines 46-47 and column 9, lines 5-6: “The neural interface can be made of composite polymer materials that are tuned via molecular formulation and the addition of small particles to have mechanical properties that are compatible with the mechanical properties of nerve tissue while also having selective electrical conductivity to enable the transmission of electrical signals to and from the neurons…For example, the base polymer can comprise…oligo[PEG fumarate] [OPF, a hydrogel]”, among listings of other hydrogel materials).
Lastly, Dirk teaches that the neural interface 10 and/or polymer mats 11 can further include one or more therapeutic agents (Dirk column 12, lines 20-22: “The neural interface and/or polymer mats of the invention can further include one or more therapeutic agents.”), such as Sonic Hedgehog, or SHH (column 12, line 27 and column 13, lines 27-28: “Exemplary non-limiting agents include…a morphogen (e.g., Wnt or Sonic Hedgehog (SHH))”).
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Both Gollan and Dirk are within the field of gel electrodes. Gollan teaches gel electrodes made of any suitable material such as a conductive gel as stated in claim 2 above (Gollan paragraph 00073 – “The electrodes can be made from any suitable material, such as, for example, metal, carbon, a conductive gel, and the like.”), and Dirk teaches gel electrodes as stated above (Dirk column 8, lines 46-47 and column 9, lines 5-6: “The neural interface can be made of composite polymer materials that are tuned via molecular formulation and the addition of small particles to have mechanical properties that are compatible with the mechanical properties of nerve tissue while also having selective electrical conductivity to enable the transmission of electrical signals to and from the neurons…For example, the base polymer can comprise…oligo[PEG fumarate] [OPF, a hydrogel]”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gel electrodes as taught by Gollan to incorporate the sonic hedgehog (SHH) therapeutic agent to the gel electrode as taught by Dirk since such modification would predictably result in, for example, promoting nerve regeneration and growth, reducing inflammatory responses to implantation of a neural interface, and/or minimizing scar tissue formation (Dirk column 12, lines 20-26).
Re. claim 5, Gollan teaches the method further comprising:
applying an electrode gel to the electrode (Gollan paragraph 00073 – “The electrodes can be made from any suitable material, such as, for example, metal, carbon, a conductive gel, and the like”)
or
to the groin area before application of the electrode to the groin area.
Gollan does not explicitly teach wherein the electrode gel comprises SHH.
Dirk teaches a neural interface 10 used for stimulation to a target muscle (Dirk figure 1A shows the neural interface 10 placed on a target muscle 18; column 8, lines 23-25: “To provide selectivity of neural recording and/or stimulation…”).
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Dirk further teaches that the neural interface 10 is a gel electrode, which can be of composite polymer materials such as an oligo (PEG fumarate) hydrogel, or OPF (Dirk column 8, lines 46-47 and column 9, lines 5-6: “The neural interface can be made of composite polymer materials that are tuned via molecular formulation and the addition of small particles to have mechanical properties that are compatible with the mechanical properties of nerve tissue while also having selective electrical conductivity to enable the transmission of electrical signals to and from the neurons…For example, the base polymer can comprise…oligo[PEG fumarate] [OPF, a hydrogel]”, among listings of other hydrogel materials).
Lastly, Dirk teaches that the neural interface 10 and/or polymer mats 11 can further include one or more therapeutic agents (Dirk column 12, lines 20-22: “The neural interface and/or polymer mats of the invention can further include one or more therapeutic agents.”), such as Sonic Hedgehog, or SHH (column 12, line 27 and column 13, lines 27-28: “Exemplary non-limiting agents include…a morphogen (e.g., Wnt or Sonic Hedgehog (SHH))”).
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Both Gollan and Dirk are within the field of gel electrodes. Gollan teaches gel electrodes made of any suitable material such as a conductive gel as stated in claim 2 above (Gollan paragraph 00073 – “The electrodes can be made from any suitable material, such as, for example, metal, carbon, a conductive gel, and the like.”), and Dirk teaches gel electrodes as stated above (Dirk column 8, lines 46-47 and column 9, lines 5-6: “The neural interface can be made of composite polymer materials that are tuned via molecular formulation and the addition of small particles to have mechanical properties that are compatible with the mechanical properties of nerve tissue while also having selective electrical conductivity to enable the transmission of electrical signals to and from the neurons…For example, the base polymer can comprise…oligo[PEG fumarate] [OPF, a hydrogel]”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gel electrodes as taught by Gollan to incorporate the sonic hedgehog (SHH) therapeutic agent to the gel electrode as taught by Dirk since such modification would predictably result in, for example, promoting nerve regeneration and growth, reducing inflammatory responses to implantation of a neural interface, and/or minimizing scar tissue formation (Dirk column 12, lines 20-26).
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gollan (WO 2017089887 A2 - hereinafter Gollan) [previously cited] in view of Dirk (US 9555583 B1 - hereinafter Dirk) [previously cited], and in further view of Yuzhakov (US 6565532 B1 – hereinafter Yuzhakov) [previously cited].
Re. claim 4, the combined invention of Gollan and Dirk (hereinafter the combined invention), specifically Gollan of the combined invention, teaches a transdermal/skin patch 30 in figure 1 (Gollan paragraph 0005 - “…the present invention provides a device, wherein the device comprises a skin patch, configured to attach to the skin surface of the perineum of a subject suffering from erectile dysfunction…”) with gel electrodes (Gollan paragraph 00073 – “The electrodes can be made from any suitable material, such as, for example, metal, carbon, a conductive gel, and the like”).
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The combined invention does not explicitly teach wherein the gel electrode gel further comprises glyceryl trinitrate.
Yuzhakov teaches a similar transdermal system 700 (Yuzhakov figure 30) with hydrogel pad 500 (Yuzhakov column 28, line 8: “…hydrogel pads 500…”) which can function as a transdermal patch, and teaches the known element of a transdermal patch made of nitroglycerin, or a GTN patch, which can be used as system 700, which includes the hydrogel pad 500 (Yuzhakov column 28, lines 34-45: “More specifically, the closed-loop system 700 of the present invention can be used as a portable high-accuracy painless sensor for outpatient blood glucose-level monitoring, as a portable system for continuous or rate controlled outpatient chemotherapy, as a temporary and rate controlled nicotine patch, as a site-specific controlled analgesic patch, as an externally attached artificial pancreas, as externally attached artificial endocrine glands, as temperature-controlled fever-reducing patches, as heart rate-controlled nitroglycerin high-rate transdermal patches…); Yuzhakov further mentions the system 700 can be used as an erectile dysfunction treatment high-rate transdermal patch (Yuzhakov column 28, lines 34-45).
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Since the combined invention and Yuzhakov teach within the field of transdermal gel patches AND treating erectile dysfunction (Yuzhakov column 28, lines 34-45), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the transdermal gel electrode patch of the combined invention to incorporate the nitroglycerin in the transdermal gel patch as taught by Yuzhakov since such modification would predictably result in treating angina chest pains through the nitroglycerin.
Re. claim 6, the combined invention of Gollan and Dirk (hereinafter the combined invention), specifically Gollan of the combined invention, teaches a transdermal/skin patch 30 (Gollan paragraph 0005 - “…the present invention provides a device, wherein the device comprises a skin patch, configured to attach to the skin surface of the perineum of a subject suffering from erectile dysfunction…”) with gel electrodes (Gollan paragraph 00073 – “The electrodes can be made from any suitable material, such as, for example, metal, carbon, a conductive gel, and the like”).
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The combined invention does not explicitly teach wherein the gel electrode gel further comprises glyceryl trinitrate.
Yuzhakov teaches a similar transdermal system 700 (Yuzhakov figure 30) with hydrogel pad 500 (Yuzhakov column 28, line 8: “…hydrogel pads 500…”) which can function as a transdermal patch, and teaches the known element of a transdermal patch made of nitroglycerin, or a GTN patch, which can be used for system 700, which includes the hydrogel pad 500 (Yuzhakov column 28, lines 34-45: “More specifically, the closed-loop system 700 of the present invention can be used as a portable high-accuracy painless sensor for outpatient blood glucose-level monitoring, as a portable system for continuous or rate controlled outpatient chemotherapy, as a temporary and rate controlled nicotine patch, as a site-specific controlled analgesic patch, as an externally attached artificial pancreas, as externally attached artificial endocrine glands, as temperature-controlled fever-reducing patches, as heart rate-controlled nitroglycerin high-rate transdermal patches…); Yuzhakov further mentions the system 700 can be used as an erectile dysfunction treatment high-rate transdermal patch (Yuzhakov column 28, lines 34-45).
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Since the combined invention and Yuzhakov teach within the field of transdermal gel patches AND treating erectile dysfunction (Yuzhakov column 28, lines 34-45), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the transdermal gel electrode patch of the combined invention to incorporate the nitroglycerin in the transdermal gel patch as taught by Yuzhakov since such modification would predictably result in treating angina chest pains through the nitroglycerin.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gollan (WO 2017089887 A2 - hereinafter Gollan) [previously cited] in further view of Yuzhakov (US 6565532 B1 – hereinafter Yuzhakov) [previously cited].
Re. claim 7, Gollan teaches a transdermal/skin patch 30 in figure 1 (Gollan paragraph 0005 - “…the present invention provides a device, wherein the device comprises a skin patch, configured to attach to the skin surface of the perineum of a subject suffering from erectile dysfunction…”) with gel electrodes (Gollan paragraph 00073 – “The electrodes can be made from any suitable material, such as, for example, metal, carbon, a conductive gel, and the like”).
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Gollan further teaches the method further comprising:
applying an electrode gel to the electrode (Gollan paragraph 00073 – “The electrodes can be made from any suitable material, such as, for example, metal, carbon, a conductive gel, and the like”)
or
to the groin area before application of the electrode to the groin area.
Gollan does not explicitly teach wherein the gel electrode gel further comprises glyceryl trinitrate.
Yuzhakov teaches a similar transdermal system 700 (Yuzhakov figure 30) with hydrogel pad 500 (Yuzhakov column 28, line 8: “…hydrogel pads 500…”) which can function as a transdermal patch, and teaches the known element of a transdermal patch made of nitroglycerin, or a GTN patch, which can be used for system 700, which includes the hydrogel pad 500 (Yuzhakov column 28, lines 34-45: “More specifically, the closed-loop system 700 of the present invention can be used as a portable high-accuracy painless sensor for outpatient blood glucose-level monitoring, as a portable system for continuous or rate controlled outpatient chemotherapy, as a temporary and rate controlled nicotine patch, as a site-specific controlled analgesic patch, as an externally attached artificial pancreas, as externally attached artificial endocrine glands, as temperature-controlled fever-reducing patches, as heart rate-controlled nitroglycerin high-rate transdermal patches…); Yuzhakov further mentions the system 700 can be used as an erectile dysfunction treatment high-rate transdermal patch (Yuzhakov column 28, lines 34-45).
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Since the combined invention and Yuzhakov teach within the field of transdermal gel patches AND treating erectile dysfunction (Yuzhakov column 28, lines 34-45), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the transdermal gel electrode patch of the combined invention to incorporate the nitroglycerin in the transdermal gel patch as taught by Yuzhakov since such modification would predictably result in treating angina chest pains through the nitroglycerin.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796