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 .
Status of Claims
This office action is in response to the filing of the application on 2/28/2024. Since the initial filing, no claims have been amended, added, or canceled. Thus claims 1-20 are pending in the application.
Drawings
The drawings are objected to for the following:
FIG 2B and FIG 3A/B depicts reference character “138”, lack the corresponding specification detail
FIG 3A depicts reference character “146”, lack the corresponding specification detail
FIG 3A depicts reference character “150”, lack the corresponding specification detail
FIG 4 depicts reference character “250”, lack the corresponding specification detail
FIG 4 depicts reference character “246”, lack the corresponding specification detail
FIG 6 depicts reference character “438” lack the corresponding specification detail
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 20 are objected to because of the following informalities:
Claim 1 reads “a pelvic region of the human subject based on an identified location” (ln 3) and should read --a pelvic region of the human subject based on the identified location--
Claim 20 reads “comprising a controller operatively coupled to the vibratory element” and should be corrected to -- comprising a controller operatively coupled to the vibratory mechanism--
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore,
Secondary vibration element in claim 18
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“Vibration Mechanism” in claims 1, 8, 11, and 13-20
This phrase utilizes the generic placeholder “mechanism”, and is not being modified by sufficient structure for performing the claimed function of “applying vibrations”. The specifications [0054-0055], states “The vibration mechanism 16 includes a housing 32, a vibratory element 34, a battery 38, and a controller 42. The vibratory element 34, battery 38, and controller 42 are disposed in the housing 32 and are electrically connected so that the controller 42 can operate the vibratory element 34 (e.g., via transmitters and receivers) and the battery 38 can provide power to the vibratory element 34 and the controller 42 The vibratory element 34 is a DC motor that generates vibrations, such as an Eccentric Rotating Mass (“ERM”) vibration motor, which uses an unbalanced load to generate vibrations. However, in other examples, the vibratory element 34 may be a pancake or shaftless motor, a piezoelectric vibration generator, or other suitable means for producing vibrations.” Therefore, "a vibration mechanism" is a motor, piezoelectric vibration generators, or “other suitable means for producing vibrations”
“Second Vibration Mechanism” in claims 9 and 12
This phrase utilizes the generic placeholder “mechanism”, and is not being modified by sufficient structure for performing the claimed function of “applying vibrations”. The specifications [0054-0055], states “The vibration mechanism 16 includes a housing 32, a vibratory element 34, a battery 38, and a controller 42. The vibratory element 34, battery 38, and controller 42 are disposed in the housing 32 and are electrically connected so that the controller 42 can operate the vibratory element 34 (e.g., via transmitters and receivers) and the battery 38 can provide power to the vibratory element 34 and the controller 42 The vibratory element 34 is a DC motor that generates vibrations, such as an Eccentric Rotating Mass (“ERM”) vibration motor, which uses an unbalanced load to generate vibrations. However, in other examples, the vibratory element 34 may be a pancake or shaftless motor, a piezoelectric vibration generator, or other suitable means for producing vibrations.” Therefore "a vibration mechanism" is a motor, piezoelectric vibration generators, or “other suitable means for producing vibrations”
“Vibratory Element” in claims 16, 17, 18, and 20
This phrase utilizes the generic placeholder “mechanism”, with no transition word and is not being modified by sufficient structure for performing the claimed function of “applying vibrations”. The specifications [0054-0055], states “The vibratory element 34 is a DC motor that generates vibrations, such as an Eccentric Rotating Mass (“ERM”) vibration motor, which uses an unbalanced load to generate vibrations. However, in other examples, the vibratory element 34 may be a pancake or shaftless motor, a piezoelectric vibration generator, or other suitable means for producing vibrations.” Therefore, a "vibratory element" is considered a motor, a piezoelectric vibration generator, or other suitable means for producing vibrations.
“Second Vibratory Element” in claim 18
This phrase utilizes the generic placeholder “mechanism”, and is not being modified by sufficient structure for performing the claimed function of “applying vibrations”. The specifications [0054-0055], states “The vibratory element 34 is a DC motor that generates vibrations, such as an Eccentric Rotating Mass (“ERM”) vibration motor, which uses an unbalanced load to generate vibrations. However, in other examples, the vibratory element 34 may be a pancake or shaftless motor, a piezoelectric vibration generator, or other suitable means for producing vibrations.” Therefore, a "vibratory element" is considered a motor, a piezoelectric vibration generator, or other suitable means for producing vibrations.
“Remote Communication device” in claim 16 and 20
This phrase utilizes the generic placeholder “device and is not being modified by sufficient structure for performing the claimed function of “remote communication”. The specifications [0077], states “The stimulation device 210 can be operated using a personal electronic device 252, such as a smartphone, smartwatch, laptop, or other remote computer, as shown Fig. 4. An application stored on the personal electronic device 252 can be used to program and operate the device 210. Using wireless communication, such as via Wi-Fi, the subject 14 can control the device 210 remotely via wireless communication signals 200 rather than operating the device 210 manually (e.g., pressing buttons 254 through the housing 232). In the illustrated example of Fig. 4, the subject 14 can use an application stored on the personal electronic device 252 to operate the stimulation device 210.” Therefore, “remote communication device” is any wireless communication device such as a phone or personal electronic device capable of remote connections.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 14 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim limitation of “comprising a garment” (claim 11, ln 3) and “an undergarment” (claim 14, ln 2) is not detailed within the specifications. The specification does not list both the use of a garment and an undergarment in tandem with the claimed device and instead lists that underwear is a garment and not an undergarment. Further clarification is required.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 14, the limitation “wherein applying the vibration device comprises dressing the human subject with an undergarment” lacks antecedent basis and therefore the scope of the claim is indefinite because it is unclear if the undergarment is meant to be the same as the garment claimed in claim 11 or if the undergarment is a separate piece of clothing that is worn in tandem with a separate garment layered over top of the undergarment and both are required for the method of the application. For examination purposes, the undergarment will be interpreted as the same as any kind of garment worn under another garment. Additionally, the garment is separate and not required to be worn with an additional garment.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 8-14, and 16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by John et al. (US 20220016413 A1).
Regarding claim 1, John discloses a wearable neurostimulation device and method of treating testicular pain, the method comprising:
identifying a location of testicular pain in a human subject (The user and or the doctor is able to identify and locate the area of pain and the best location for treatment, [0409] discloses treating Orchialgia (persistent pain in the scrotum));
coupling a vibration mechanism (FIG 1a, device/neurostimulator 12) to a pelvic region of the human subject based on an identified location of testicular pain and
applying vibrations to the pelvic region to alleviate testicular pain. (The neurostimulation system 10 can be placed in any location picked by the user and/or a doctor for any type of pain treatment, FIG 10e shows the user the most opportune locations for treatment of specific pain. The neurostimulation system 10 can be designed to serve as a “mask” so that the nerve ending become confused and can mask the user’s pain (i.e. treating Orchialgia [0409]) through different machinations. [0262] “In embodiments, the sensory mask is provided by non-electrical modalities such as, vibration”).
Regarding claim 3, John discloses the method of claim 1, wherein applying vibrations comprises applying vibrations to a cremasteric muscle of the human subject. (John discloses that the device can be placed in a multitude of places as to ease the patient’s pain and the user’s interface program may be configured to teach the users where to specifically place the device as to allow the best mode of pain treatment depending on the location of the originating pain. This includes telling the user about specific nerves and how to place the device in order to block the pain radiating from specific nerve endings, [0369]. As John shows that the vibrations can be placed upon the pelvic area and can be used to treat pain within the scrotum, the application of the device upon the pelvic area would therefore either vibrate the cremasteric muscles or the corresponding nerves and muscles around it which would in turn vibrate the cremasteric muscles. This would there for teach the user to apply the vibrations to the cremasteric muscle (considered a part of the scrotum and pelvic floor area) for treatment of pain, FIGs 9-10).
Regarding claim 8, John discloses the method of claim 1, wherein coupling the vibration mechanism comprises engaging the vibration mechanism with a scrotum of the human subject. (John discloses that the device can be placed near the scrotum to treat orchialgia and the user’s interface program may be configured to teach the users where to specifically place the device as to allow the best mode of pain treatment. This includes telling the user about specific nerves and how to place the device in order to block the pain radiating from specific nerve endings that cause persistent pain in the scrotum, [0409 and 0369]. This would there for teach the user to apply the device to or around the scrotum for treatment of pain within the pelvic floor/testicular area, [0409] FIGs 9-10).
Regarding claim 9, John discloses the method of claim 8, comprising coupling a second vibration mechanism to another area of the pelvic region of the human subject. (John discloses that the device can be placed anywhere and in multitudes; user’s interface program may be configured to give the user control over multiple devices, [0205]. The user is also able to place the device in any location of their choosing, including over the pelvic area to treat pain within the area. As noted by John, utilizing multiple stimulation devices can also greatly contribute to the reduction of pain signals coming from multiple nerves that cause pain around the same location, [0086]).
Regarding claim 10, John discloses the method of claim 1, comprising adjusting a frequency of the vibrations being applied, wherein the frequency is in a range of approximately 15 Hz to approximately 55 Hz. (John discloses a method of blood flow therapy by utilizing the neurostimulation device at specific frequencies. [0450] states that vibration simulation can occur at a frequency between 20-50 Hz. Additionally, FIG 1b and [0071] show the buttons on the simulation device that causes the simulation of the device 12to be adjusted to the user’s preference).
Regarding claim 11, John discloses a wearable neurostimulation device that is able to treat testicular pain in a human subject, the method comprising:
applying a vibration device (stimulation matrix 14) to a pelvic region of the human subject (FIG 1a, wrap 18 being applied to the pelvic area of the user) and, the vibration device comprising a garment a vibration mechanism (FIG 1a, device/neurostimulator 12, configured to deliver vibrations, [0262]) coupled to the garment;
identifying a target location to treat testicular pain in the pelvic region, wherein the target location is adjacent to one or more of a iliohypogastric nerve, a ilioinguinal nerve, and a genitofemoral nerve (a user or physician identifying the best place for pain treatment, FIG 9c and 9e. The user interface directs the user where to place the device for pain relief, [0072]; including locations to treat scrotal pain [0409] which include locating nerve endings (i.e an iliohypogastric nerve, an ilioinguinal nerve, and a genitofemoral nerve) for pain treatment and targeted nerve stimulation [0016]);
positioning the vibration mechanism adjacent to the target location of the human subject (placement refining for best pain treatment location (i.e. place near or next to a nerve or pain center), FIG 10e); and
delivering vibrations to the pelvic region at the target location of the human subject to treat testicular pain. (The neurostimulation system 10 can be placed in any location picked by the user and/or a doctor for any type of pain treatment including the scrotum [0409], FIG 10e shows the user the most opportune locations for treatment of specific pain, including placing the device on or near a target location. The neurostimulation system 10 can be designed to serve as a “mask” so that the nerve ending become confused and can mask the user’s pain through different machinations. [0262] “In embodiments, the sensory mask is provided by non-electrical modalities such as, vibration”).
Regarding claim 12, John discloses the method of claim 11, wherein applying the vibration device comprises positioning a second vibration mechanism of the vibration device in a second target location of the pelvic region of the human subject. (John discloses that the device can be placed anywhere and in multitudes; user’s interface program may be configured to give the user control over multiple devices, [0205]. The user is also able to place the device in any location of their choosing, including over the pelvic area to treat pain within the area. As noted by John, utilizing multiple stimulation devices can also greatly contribute to the reduction of pain signals coming from multiple locations, [0086]).
Regarding claim 13, John discloses the method of claim 11, wherein applying the vibration device (device 12) comprises fastening a strap (wrap 18) around the human subject, wherein the vibration mechanism is supported by the strap (FIG 1). (John discloses the device is composed of a large fabric piece as a strap that contains the neurostimulator device situated in place as well as wraps around a user’s preferred location, [0079]. The strap is therefore supporting the device and keeping it in its optimal position).
Regarding claim 14, John discloses the method of claim 11, wherein applying the vibration device comprises dressing the human subject with an undergarment, wherein the undergarment is configured to support to the vibration mechanism. (Examiner’s note: Applicant defines in paragraph [0081] wherein the wearable device 310 (i.e. the vibration device) comprises the garment 330 and then further defines the garment 330 as the claimed "undergarment" thereby equating the garment as the "undergarment" as claimed. Therefore, this Examiner is equating the wrap 18, a garment, as the undergarment because the wrap 18 is capable of being worn under another garment thereby making it an undergarment.) As disclosed by John [0074], the device 12 is attached to the body using the wrap 18, the wrap containing magnets 36 to hold the device 12 in place upon the wrap 18; therefore, the wrap 18 (i.e. the garment / undergarment ) is supporting the device 12. Additionally, the wrap 18 is wound tightly to its location (For example: FIG 10 shows the device securely and tightly wrapped around a user leg) for pain treatment, allowing clothing to be placed over top to allow the user to use the device while going out walking/running, the wrap 18 supporting the device 12 throughout the activity and keeping the device in its designated location, [0079]).
Regarding claim 16, John discloses the method of claim 11, comprising communicating with a controller using a remote communication device (user device 20, FIG 3b) to adjust a frequency of a vibratory element of the vibration mechanism (adjustment to intensity or frequency can be seen in FIG 5a-5f, where the user’s mobile device contains the required programing to adjust the device 12 through sliders and toggles), wherein the controller is communicatively coupled to the vibratory element. (John discloses a method of blood flow therapy by utilizing the neurostimulation device at a variety of frequencies. [0450] “Microcirculation therapy: stimulation such as vibration, sonic, or ultrasonic energy is provided to increase microcirculation. Treatment may include short (e.g., 10-sec) bursts of vibration at a selected frequency (e.g., 20-50 Hz) and amplitude (e.g., 1-2 mm) followed by a pause (e.g., 5 to 10 sec) to increase skin blood flow.” This allows the user and/or doctor to adjust the vibrational frequency of the stimulation therapy to a frequency that works best for each user).
Claims 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Branch et al. (US 10172762 B1).
Regarding claim 17, Branch discloses a wearable device for treating testicular pain in a human subject, (Stated within the abstract and [4] the device can be used to treat various forms of pain including those around the pelvis and specific parts of the body; this would then include testicular pain) the wearable device comprising:
a garment (V-wrap pad 120, FIG 3);
a vibration mechanism comprising a vibratory element (vibrator 146, FIG 3), a battery coupled to the vibratory element (D/C power battery 149, FIG 3), and a controller (User’s mobile device) operatively coupled to the vibratory element (rotary vibration motor 901, FIG 9),
wherein the vibration mechanism is configured for applying vibrations to a pelvic region of the human subject. ([col 14 ln 24-26] a firmware board (903) controlling vibration velocity, intensity, and speeds; and a remote-control mechanism. As shown in FIG 3, the garment is depicted as being worn around the pelvic region of a subject, thus applying the vibrational mechanism to the pelvic region).
Regarding claim 18, Branch discloses the wearable device of claim 17, wherein the vibration mechanism comprises a second vibratory element, and wherein the controller is configured to separately operate the vibratory element and the second vibratory element at different frequencies. (Branch’s device discloses the ability to add multiple vibrators to the pocket enclosed upon the VBand system. As mentioned in [col 5 ln 39-55] the VBand is equipped with 2-3 vibrators and the user may use them together at one time or as individual s/replacement components. Furthermore, the vibration components all have their own on/off and vibration settings for the user to control, further detailed within col 5 lines 31-35 and 41, allowing the user to have different vibration frequencies going at the same time as to confuse the nerve endings for pain relief. As mentioned by Branch, the controller would be the User’s mobile device which connects to the vibrators and controls the intensity and pattern of the output vibrations).
Regarding claim 19, Branch discloses the wearable device of claim 17, wherein the garment comprises a flexible band arranged for removably attaching to a pelvic region of the human subject, wherein the vibration mechanism is coupled to the flexible band. (Branch discloses a VBand that may be wrapped around a multitude of different locations on the body, allowing the wrap to be flexible and removable, [col 8 ln 19-37]. Branch also mentions that the vibrators may be placed in any of the pockets scattered across the band, [col 9 ln 17-20] “These vibration modules are connected to the brace by hook and loop tabs attached to the actual module or inserted into removable/attachable pockets affixed by hook & Loop Velcro or stationary pockets”).
Regarding claim 20, Branch discloses the wearable device of claim 17, comprising a controller operatively coupled to the vibratory element, the controller comprising a processor, a memory communicatively coupled to the processor and storing executable instructions that, when executed by the processor, causes the processor to:
receive data transmitted by a remote communication device (data received by a user’s mobile device);
send a signal to the vibratory element (signal sent by control programing on the user’s mobile device);
adjust an intensity parameter of a vibration applied by the vibratory element (the sliders depicted within the controller’s app on the user’ mobile device that adjusts the intensity of the vibrations.
As detailed within [col 7 ln 62-67 and col 8 ln 1-5], Branch allows the vibrators of the VBand to be connected and managed through a control device. Branch specifies the use of a Bluetooth chipset [col 15 lines 1-7] as to allow the User to use their mobile device as a controller for better and easier control of the vibration mechanism and the vibration intensities. [col 3 ln 49-53] “The V-Pods can be controlled remotely individually or in unison using a number of known methods, arrangements, and mechanisms, including computer applications software on a remote-control unit or smart phone.” As it is commonly known, a mobile phone has a processor that is able to receive and send signals; as the vibrator is able to connect to a remote control and/or a mobile phone the vibrator therefore must have a processor and the ability to execute instructions and communicate with the control device. The device would also be able to control the type of vibrations that the vibrators are able to produce as to give the user a better pain relief. [col 7 ln 50-57] details that the sliders; which are a part of the controller; are used to turn on/off the vibrators, change vibration patter (off, pulse, wave, steady) as well as to modify the intensity of the vibrations).
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.
Claims 2 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over John et al. as applied to claim 1 above, and further in view of Linden et al (US 20200306528 A1).
Regarding claim 2, John discloses the method of claim 1.
John is silent on applying vibrations comprises applying vibrations to a testicular cord of the human subject.
However, Linden teaches of a stimulation device that is used to treat testicular pain that can occur after hernia surgery, [0336]. Linden utilizes a stimulation device to block the nerves around the groin area in order to block the pain signals being generated by the nerves. As taught by Linden, the stimulation of the testicular cord (tubular connecting tissue that is a part of the inguinal ring, [0337]) and can relieve pain in the testicular area.
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filling date to modify the method and device of John to incorporate applying vibrations to the testicular cord as taught by Linden. It would be obvious to one with ordinary skill in the art to utilize the methods of stimulating the testicular cord either by stimulating the pelvic area which in turn would stimulate the testicular cord or by stimulating the inguinal ring (Linden [0337]) which would also stimulate the nerves and muscles around it (i.e. stimulating the testicular cord which is located near and around the inguinal ring) and incorporate them with the methods of scrotal pain treatment depicted by John (John [0369]); thus applying a vibrating stimulation device that stimulates the testicular cord.
Regarding claim 4, John discloses the method of claim 1.
John is silent on applying vibrations comprises applying vibrations to an inguinal canal of the human subject.
Linden teaches of a stimulation device that is used to treat testicular pain that can occur after hernia surgery, [0336]. Linden utilizes a stimulation device to block the nerves around the groin area in order to block the pain signals being generated by the nerves. As taught by Linden, the stimulation of the inguinal canal [0337] and can relieve pain in the testicular area.
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filling date to modify the method and device of John to incorporate applying vibrations to the inguinal canal as taught by Linden. It would be obvious to one with ordinary skill in the art to utilize the idea of stimulating the inguinal canal as a means of pain treatment depicted by Linden and incorporate them with the methods of pain treatment via vibrational stimulation in the pelvic area disclosed by John.
Regarding claim 5, John discloses the method of claim 1.
John is silent on applying vibrations comprises applying vibrations to an ilioinguinal nerve of the human subject.
Linden teaches of a stimulation device that is used to treat testicular pain that can occur after hernia surgery, [0336]. Linden utilizes a stimulation device to block the nerves around the groin area in order to block the pain signals being generated by the nerves. As taught by Linden [0337] “The apparatus of the present inventive concepts can be configured to stimulate the ilioinguinal nerve, genitofemoral nerve and/or iliohypogastric nerves, such as to ameliorate pain”.
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filling date to modify the method and device of John to incorporate applying vibrations to the ilioinguinal nerve as taught by Linden. It would be obvious to one with ordinary skill in the art to utilize the idea of stimulating the ilioinguinal nerve as a means of pain treatment depicted by Linden and incorporate them with the methods of pain treatment via vibrational stimulation in the pelvic area disclosed by John.
Regarding claim 6, John discloses the method of claim 1.
John is silent on applying vibrations comprises applying vibrations to an iliohypogastric nerve of the human subject.
Linden teaches of a stimulation device that is used to treat testicular pain that can occur after hernia surgery, [0336]. Linden utilizes a stimulation device to block the nerves around the groin area in order to block the pain signals being generated by the nerves. As taught by Linden [0337] “The apparatus of the present inventive concepts can be configured to stimulate the ilioinguinal nerve, genitofemoral nerve and/or iliohypogastric nerves, such as to ameliorate pain”.
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filling date to modify the method and device of John to incorporate applying vibrations to the iliohypogastric nerve as taught by Linden. It would be obvious to one with ordinary skill in the art to utilize the idea of stimulating the iliohypogastric nerve as a means of pain treatment depicted by Linden and incorporate them with the methods of pain treatment via vibrational stimulation in the pelvic area disclosed by John.
Regarding claim 7, John discloses the method of claim 1.
John is silent on applying vibrations comprises applying vibrations to one or more of a genitofemoral nerve and a pudendal nerve of the human subject.
Linden teaches of a stimulation device that is used to treat testicular pain that can occur after hernia surgery, [0336]. Linden utilizes a stimulation device to block the nerves around the groin area in order to block the pain signals being generated by the nerves. As taught by Linden, the stimulation of the pundendal nerve [0295 and 0337] and can relieve pain in the testicular area. [0341] “In some embodiments, apparatus 10 is configured to treat pelvic, bladder and/or bowel disorders, such as by stimulating sacral, pudendal and/or tibial nerves.”
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filling date to modify the method and device of John to incorporate applying vibrations to the one or more of a genitofemoral nerve and a pudendal nerve as taught by Linden. It would be obvious to one with ordinary skill in the art to utilize the idea of stimulating one or more of a genitofemoral nerve and a pudendal nerve as a means of pain treatment depicted by Linden and incorporate them with the methods of pain treatment via vibrational stimulation in the pelvic area disclosed by John.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over John et al. as applied to claims 1-13 and 16 above, and further in view of Branch et al. (US 10172762 B1).
Regarding claim 15, John discloses the method of claim 14.
John is silent on inserting the vibration mechanism inside a pocket of the undergarment.
However, Branch teaches of a band that can wrap around any part of the body with a vibrator for pain management. This VBand garment that goes around an area of pain for treatment includes a pocket in which to place a vibrational element.
Therefore, it would be obvious to one of ordinary skill in the art prior to the effective filling date to modify the wrap and vibration mechanism of John to incorporate the pockets of Branch to give the vibration mechanism better stability when the user is in motion. As the neurostimulation device is large and heavy, it would be beneficial for the wrap to apply more than one stabilization agent to allow the device to stay in place. John employs a series of magnetic snap connects in order to maintain stabilization and placement of the device upon the wrap; utilizing a pocket in tandem with this magnetic snap connects would prevent gravity or the gravitational force that occurs during movement by the user from disconnecting the magnetic snaps or breaking them during long stretches of movement. The pocket allows the device a secondary stabilization agent to prevent any breaking or damage to the magnetic snap connectors.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Forward (US 20130144357 A1) teaches of a method and device to increase testosterone production in males. This device consists of electrodes places along specific parts of the pelvic region with a controller attached to the user’s clothing as to allow the user to hide the device under their clothing’s.
Podrazhansky (US 20090005713 A1) teaches of a vibroacoustic device that can be places anywhere along the body as to stimulate the nerves and tissues underneath. The device is attaches to the skin of a user in their desired location and a controller generates various vibrations along the transducers attached to the user in order to treat various diseases.
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/DANIELLE B RESTAINO/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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