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 .
Claim Objections
Claims 4-5, 12-13, 17, 21, and 24 objected to because of the following informalities: “and/or”. For examination purposes, examiner will interpret this as “or”. Appropriate correction is required.
Claim Interpretation
For the term “soft enough” in claim 1, the specification discloses that the portions of the invention is flexible to prevent discomfort to the subject (see [0187] of the USPGPub. version of the specification). The specification further discloses variety of shapes, tortuosity, and hardness values ([0188]-[0191]).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-6, 8-13, 17-21, 24, 25, and 27 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recite the limitation of “each of said at least two electrodes is…at opposite sides of said genital organ” in lines 11-12, which would include electrodes being positioned on a subject. Applicant is recommended to amend the limitation of “each of said at least two electrodes is…configured to be at opposite sides of said genital organ” in order to clearly exclude the subject from the claimed device and overcome this rejection.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 10-12, 17-20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et. al (US 20150032195 A1, published 01/29/2015, hereinafter known as Lin), in view of Bennett et. al, (US 20080161874 A1, published 07/03/2008, hereinafter known as Bennett).
Regarding claim 1, Lin discloses a sexual modulation device (“a desensitizing device…containing an electrical stimulation member” [0016]), comprising:
a skin patch (“two pads” [0024]) comprising a body (electricity supply element 23 in Fig. 6), wherein said skin patch has a surface configured to attach said skin patch to a skin surface of an anatomical region located near a genital organ of a subject (“two electrodes of the control circuit are configured in two pads and extended by two transmission wires so that the electrodes can be attached to the penis skin directly”, electrodes 22 in Fig. 6, [0024]);
wherein said skin patch body, comprises:
a central portion (electricity supply element 23 in Fig. 6), at least two extensions extending from said central portion, wherein said at least two extensions comprise a first extension and a second extension (as shown in annotated Fig. 6 below);
at least one opening between said first extension and said second extension shaped and sized to receive at least part of said genital organ (as shown in annotated Fig. 6 below);
at least two electrodes (“ two electrodes of the control circuit are configured in two pads and extended by two transmission wires” [0024]), suitable to transcutaneously deliver electrical impulses (“stimulating current produced by the control circuit is conducted to the electrodes and provides a low-strength subcutaneous nerve stimulation through the penis skin” [0024]), wherein each of said at least two electrodes is located at a different extension of said first extension and said second extension, and at opposite sides of said genital organ positioned within said opening; and (“the two electrodes of the control circuit are configured in two pads and extended by two transmission wires so that the electrodes can be attached to the penis skin directly”, as shown below in annotated Fig. 6 [0024])
an electronic circuitry (“two electrodes of the control circuit are configured in two pads and extended by two transmission wires” [0024]) and power supply operationally connected to the at least two electrodes (“electricity supply element has the battery chamber electrically connected to a top side of the control circuit” [0020]);
wherein said electronic circuitry and power supply are configured to deliver said electrical impulses between said at least two electrodes (“stimulating current produced by the control circuit is conducted to the electrodes and provides a low-strength subcutaneous nerve stimulation through the penis skin” [0024]).
Lin further suggests that the device as disclosed is being used during an intercourse ([0005]). Lin does not disclose wherein said central portion is soft enough to be prevent discomfort when used during sexual intercourse.
However, Bennett teaches systems and methods to screen and/or treat disorders of the body using neurostimulation (Abstract). The lead and electrode are sized and configured to be implanted percutaneously in tissue, and to be tolerated by an individual during extended use without pain or discomfort [0079].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the sexual modulation device of Lin with the prevention of pain and discomfort of Bennett because this can allow an individual to use the device over long periods of time without facing adverse or severe effects.
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Regarding claim 2, an alternative embodiment of Lin discloses at least one of, said device body, said central portion or at least an edge of said central portion is flexible (“the support member is made of a flexible material and can be configured into a C-like shape with an axially-oriented linear opening so that the linear opening can be elastically broadened” [0017]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the sexual modulation device embodiment of Lin as described in claim 1 with the flexible central portion embodiment of Lin as described in claim 2 because flexible portions of the device allow for a wider range of use on various types of individuals.
Regarding claim 3, Lin does not disclose electronic circuitry and power supply are configured to deliver said electrical impulses to a depth of at least 3 mm into the skin.
However, Bennett teaches the pulse generator is sized and configured to be implanted subcutaneously in tissue at an implant depth of between about five millimeters and about twenty millimeters [0090].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the sexual modulation device of Lin with the depth measurement of Bennett because this ensures that the electrical stimulation properly reaches the target site.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bennett and as applied to claim 1 above, and further in view of Gollan (WO 2019130311 A1, published 07/04/2019, hereinafter known as Gollan).
Regarding claim 4, the modified device of Lin does not disclose said central portion and/or said at least two extensions have a maximal thickness of up to 7mm.
However, Gollan teaches a device for electrifying perineal tissue, including: a housing shaped and sized to be attached to a perineum surface of a subject between a posterior aspect of the scrotum and the anus of the subject; and at least two electrodes in the housing configured to deliver an electric field to a perineal tissue (Abstract). A thickness of said housing is in a range between 2-8 mm… the thickness is designed to be as minimal as possible (page 3, 21).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the thickness measurement of Gollan with the modified sexual modulation device of Lin because minimal thickness allows for avoidance of any discomfort and/or pain when the device is attached to the perineum skin during sexual intercourse (Gollan, page 21).
Claims 5 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bennett as applied to claim 1 above, and further in view of Goldwasser et. al, (US 20150088224 A1, published 03/26/2015, hereinafter known as Goldwasser).
Regarding claim 5, the modified device of Lin does not discloses said central body and/or said at least two extensions have a minimal radius of tortuosity of about 2.5 mm.
However, Goldwasser teaches apparatuses (e.g., devices, systems), and methods for transdermal electrical stimulation (TES)… that can be self-contained, lightweight, and wearable (Abstract). A large central anode (radius 3 cm) is placed over premotor cortex and a thin outer electrode (inner radius 3.5 cm, outer radius 4 cm) [0238].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the radial measurement of Goldwasser with the modified sexual modulation device of Lin to create specificity in measurements for the sexual modulation device.
Regarding claim 27, in the modified device of Lin, Lin discloses at least two electrodes (“two electrodes of the control circuit are configured in two pads and extended by two transmission wires so that the electrodes can be attached to the penis skin directly”, electrodes 22 in Fig. 6, [0024]).
The modified device of Lin does not disclose electronic circuitry comprises a printed circuit board connecting said power supply to said at least two electrodes.
However, Goldwasser teaches the electrical circuit is constructed on a printed circuit board (PCB) or silicon chip [0240].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the printed circuit board of Goldwasser with the modified sexual modulation device of Lin because the PCB can control the power supply and generating and condition the current waveforms applied between the electrode in the primary unit and the electrode in the secondary unit (Goldwasser, [0161]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bennett as applied to claim 1 above, and further in view of Schoonmaker et. al, (US 20170112531 A1, published 04/27/2017, hereinafter known as Schoonmaker).
Regarding claim 6, the modified device of Lin does not disclose a hardness of at least a portion of said skin patch body or the entire skin patch body is in a range of 25-90 shore A, 15-70 shore OO, or any combination thereof.
However, Schoonmaker teaches systems and methods for measuring an analyte in a host using transcutaneous analyte sensors (Abstract). A septum is disposed, where the septum material has a relatively high durometer, e.g., silicone with a durometer of 50-70 shore A, e.g., with an exemplary thickness of, e.g., 0.062 [0363].
The specification discloses the appropriate ranges that apply to the claimed invention on page 3 as 25-90 shore A, 15-70 shore OO, or any combination thereof. However, the specification does not disclose that the specifically claimed ranges of durometer values is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Lin in view of Schoonmaker teach that the sexual modulation device can have a durometer of 50-70 shore, the prior art therefore provides teaching that the durometer value is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Because Applicants fail to disclose that the claimed ranges of durometer values provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that a relatively high durometer absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable ranges of durometer values by normal optimization procedures known in the electrical stimulation arts.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the hardness measurement of Schoonmaker with the modified sexual modulation device of Lin to create specificity in measurements for the sexual modulation device.
Claims 8 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bennett as applied to claim 1 above, and further in view of Kolb et. al, (US 20150290450 A1, published 10/15/2015, hereinafter known as Kolb).
Regarding claim 8, the modified device of Lin does not disclose at least two extensions are shaped as wings or petals.
However, Kolb teaches a skin surface electrode used in the treatment of incontinence (Abstract). The skin contacting surface includes one or more conductive regions and one or more non-conductive (i.e. insulated) regions that are similar in shape to a wing as shown in Fig. 1 [0032].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the winged shape of the extensions of Kolb with the modified sexual modulation device of Lin because it allows bodily fluid to flow past the electrode without substantially interrupting contact between the skin contacting surface and the skin (Kolb, [0032]).
Regarding claim 25, the modified device of Lin does not disclose a width of said opening between said at least two extensions is in a range of 2 cm to 20 cm and a length of said opening between said at least two extensions is in a range of 1 cm to 10 cm.
However, Kolb teaches egress has a length of 10 cm and a width of 3.3 cm, providing an egress aspect ratio of 3:1 [0055].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the egress measurements of Kolb with the modified sexual modulation device of Lin because it allows the egress to resist flow of bodily fluid along the electrode-skin interface (Kolb, [0037]).
Claims 9-13, 17-20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bennett as applied to claim 1 above, and further in view of Forsell (US 20150165197 A1, published 08/25/2014).
Regarding claim 9, the modified device of Lin does not disclose said electronic circuitry and power supply are configured to deliver said electrical impulses with parameter values selected to increase blood volume in at least one external sex organ.
However, Forsell teaches an apparatus for treating a sexual dysfunctional female patient, comprising a stimulation device adapted to stimulate an erectile blood flow passageway to increase the amount of blood in the female erectile tissue and thereby obtaining engorgement with blood of the female erectile tissue by affecting said erectile blood flow passageway (Abstract). In one embodiment there is provided an apparatus, wherein the stimulation device comprises at least one electrical electrode to stimulate the female erectile tissue to achieve engorgement of said female erectile tissue [0029].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the method of stimulating erectile blood flow of Forsell with the modified sexual modulation device of Lin because stimulation of erectile blood flow results in an increase in blood volume in an external sex organ.
Regarding claim 10, modifed Lin in view of Forsell does not disclose said genital organ comprises a Clitoris of a female subject and wherein said at least one external sex organ comprises at least one of said Clitoris, a Labia Majora, a Labia Minora, and a Vestibule of said female subject.
However, Bennett teaches positioning the electrode at a target site between the pubic symphysis and the clitoris of a female [0019].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modifed Lin in view of Forsell with the positioning of the female target site of Bennett because the stimulation waveforms conveyed to the electrode in this target area are able to affect stimulation of the left or right branches of the dorsal genital nerves (Bennett, [0020]).
Regarding claim 11, modifed Lin in view of Forsell does not disclose said skin patch surface is configured to attach said skin patch to a skin surface of a Mons Pubis of said female subject at a distance of up to 5 cm from said Clitoris, and wherein said at least one opening is shaped and sized to receive at least part of said Clitoris.
However, Bennett teaches the external pulse generator comprises a patch or carrier [0068].
The examiner considers the location of the device to be an intended use, the patch of Bennett is capable of this use and therefore meets the claim.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modifed Lin in view of Forsell with the patch design of Bennett because the patch or carrier can be readily worn on the skin, e.g., by use of a pressure-sensitive adhesive, without discomfort and without affecting body image (Bennett, [0068]).
Regarding claim 12, modifed Lin in view of Forsell does not disclose said electronic circuitry and power supply are configured to deliver said electrical impulses with parameter values selected to affect at least one nerve of an autonomic nervous system innervating said Clitoris, Labia, and/or associated tissues thereof.
However, Bennett teaches the carrier carries a removable and replaceable electronics pod, which generates the desired electrical stimulation current patterns…the pod houses microprocessor-based, programmable circuitry that generates the stimulus currents, times or sequences the stimulation pulses [0071]. The targeted tissue region comprises the left and/or right branches of the dorsal genital nerves, the pudendal nerve and/or its branches, the perineal nerves, and/or its branches, the urethral nerves, and/or its branches, and/or the sacral nerves [0029].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modifed Lin in view of Forsell with the targeting of nerves in the autonomic nervous system of Bennett because stimulation of these particular nerves helps in healing from pelvic disorders.
Regarding claim 13, the modified device of Lin does not disclose said tissues associated thereof comprise at least one smooth muscle and/or at least one blood vessel associated with the Clitoris and/or the Labia.
However, Forsell teaches the apparatus, comprises, in addition to a stimulation device, an implantable restriction device that engages the female erectile tissue or at least one venous blood vessel [0081].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the stimulation of a venous blood vessel of Forsell with the modified sexual modulation device of Lin because stimulation of a venous blood vessel associated with female genital anatomy results in an increase in blood flow and volume in the area.
Regarding claim 17, modifed Lin in view of Forsell discloses said electronic circuitry and power supply are configured to deliver said electrical impulses with a frequency in at least one of the following ranges:
0.5 Hz- 10Hz, selected to increase activity of said at least one sympathetic nerve and/or to reduce activity of said parasympathetic nerve; and
50 Hz to 200 Hz, selected to reduce activity of said at least one sympathetic nerve and/or to increase activity of said at least one parasympathetic nerve (“the stimulating current produced by the control circuit can be a low-frequency signal between 0.5 Hz and 1 KHz (preferably between 2 Hz and 30 Hz)” [0019]).
The specification discloses the appropriate ranges that apply to the claimed invention on page 4 as 0.5 Hz - 10 Hz and 50 Hz - 200 Hz. However, the specification does not disclose that the specifically claimed ranges of frequency values is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since modifed Lin in view of Forsell teach that the sexual modulation device can have frequency values of 0.5Hz-1KHz or 2Hz-30Hz, the prior art therefore provides teaching that the frequency value is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Because Applicants fail to disclose that the claimed ranges of frequency values provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that a narrower range of frequency values absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable ranges of frequency values by normal optimization procedures known in the electrical stimulation arts.
Modifed Lin in view of Forsell does not disclose at least one nerve is a sympathetic nerve and/or a parasympathetic nerve.
However, Bennett teaches in one aspect of the invention, the targeted tissue region comprises the left and/or right branches of the dorsal genital nerves, the pudendal nerve and/or its branches, the perineal nerves, and/or its branches, the urethral nerves, and/or its branches, and/or the sacral nerves.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modifed Lin in view of Forsell with the targeting of nerves in the autonomic nervous system of Bennett because stimulation of these particular nerves helps in healing from pelvic disorders.
Regarding claim 18, modifed Lin in view of Forsell does not disclose genital organ comprises a base of a Penis of a male subject, and wherein said external sex organ comprises said Penis.
However, Bennett teaches positioning the electrode at a target site between the pubic symphysis and…the base of the penis of a male [0019].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modifed Lin in view of Forsell with the positioning of the male target site of Bennett because the stimulation waveforms conveyed to the electrode in this target area are able to affect stimulation of the left or right branches of the dorsal genital nerves (Bennett, [0020]).
Regarding claim 19, modifed Lin in view of Forsell does not disclose skin patch surface is configured to attach said skin patch to a surface of a skin region superior to a base of said Penis, at a distance of up to 5 cm from said Penis base, and wherein said opening is shaped and sized to receive at least part of said Penis base.
However, Bennett teaches the external pulse generator comprises a patch or carrier…the carrier can be readily worn on the skin, e.g., by use of a pressure-sensitive adhesive, without discomfort and without affecting body image [0068].
The examiner considers the location of the device to be an intended use, the patch of Bennett is capable of this use and therefore meets the claim.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modifed Lin in view of Forsell with the patch design of Bennett because the patch or carrier can be readily worn on the skin, e.g., by use of a pressure-sensitive adhesive, without discomfort and without affecting body image (Bennett, [0068]).
Regarding claim 20, modifed Lin in view of Forsell does not disclose electronic circuitry and power supply are configured to deliver said electrical impulses with parameter values selected to affect at least one nerve of an autonomic nervous system innervating said penis, or tissues associated with said penis.
However, Bennett teaches the carrier carries a removable and replaceable electronics pod, which generates the desired electrical stimulation current patterns…the pod houses microprocessor-based, programmable circuitry that generates the stimulus currents, times or sequences the stimulation pulses [0071]. The targeted tissue region comprises the left and/or right branches of the dorsal genital nerves, the pudendal nerve and/or its branches, the perineal nerves, and/or its branches, the urethral nerves, and/or its branches, and/or the sacral nerves [0029].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modifed Lin in view of Forsell with the targeting of nerves in the autonomic nervous system of Bennett because stimulation of these particular nerves helps in healing from pelvic disorders.
Regarding claim 24, Lin discloses said electronic circuitry and power supply are configured to deliver said electrical impulses with a frequency in a range of 50 Hz- 200Hz, selected to reduce activity of said at least one sympathetic nerve and/or to increase activity of said parasympathetic nerve (“the stimulating current produced by the control circuit can be a low-frequency signal between 0.5 Hz and 1 KHz (preferably between 2 Hz and 30 Hz)” [0019]).
The specification discloses the appropriate ranges that apply to the claimed invention on page 4 as 0.5 Hz - 10 Hz and 50 Hz - 200 Hz. However, the specification does not disclose that the specifically claimed ranges of frequency values is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since modifed Lin in view of Forsell teach that the sexual modulation device can have frequency values of 0.5Hz-1KHz or 2Hz-30Hz, the prior art therefore provides teaching that the frequency value is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Because Applicants fail to disclose that the claimed ranges of frequency values provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that a narrower range of frequency values absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable ranges of frequency values by normal optimization procedures known in the electrical stimulation arts.
Modifed Lin in view of Forsell does not disclose at least one nerve is a sympathetic nerve and/or a parasympathetic nerve.
However, Bennett teaches in one aspect of the invention, the targeted tissue region comprises the left and/or right branches of the dorsal genital nerves, the pudendal nerve and/or its branches, the perineal nerves, and/or its branches, the urethral nerves, and/or its branches, and/or the sacral nerves.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modifed Lin in view of Forsell with the targeting of nerves in the autonomic nervous system of Bennett because stimulation of these particular nerves helps in healing from pelvic disorders.
Claims 21 are rejected under 35 U.S.C. 103 as being unpatentable over modifed Lin in view of Forsell as applied to claim 20 above, and further in view of Gross (US 20090198097 A1, published 08/06/2009).
Regarding claim 21, modifed Lin in view of Forsell does not disclose said tissue associated with said penis comprise at least one blood vessel and/or a Corpus Cavernosum of said penis.
Gross teaches an apparatus is provided for treating erectile dysfunction of a subject (Abstract). The apparatus includes one or more electrodes that are implanted in the vicinity of a blood vessel [0082]. Typically blood vessel is an artery that supplies the subject's penis, for example, the dorsal artery of the penis, the internal iliac artery, or the internal pudendal artery [0082].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to target the blood vessel of penis as taught by Gross using the device of modifed Lin in view of Forsell in order to treat erectile dysfunction of a subject.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/FIONA M KOWALKOWSKI/Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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