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 Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Errico et al (US 20140330336).
Regarding claim 1, Errico discloses stimulating a nerve within a patient (Section 0010, transcutaneous electrical stimulation of a nerve is non-invasive because it involves attaching electrodes to the skin, or otherwise stimulating at or beyond the surface of the skin or using a form-fitting conductive garment, without breaking the skin) the system comprising: a stimulator 302 comprising an electrode 340 configured for contacting the outer skin surface at, or near the target location (section 0040,contacting an outer surface of a head of the patient with a contact surface of the mobile device and applying one or more electrical impulses to the outer surface of the patient's skin such that the electrical impulses pass through the patient's skin transcutaneously to the trigeminal nerve); an energy source 320 coupled to the stimulator (Fig. 1, section 0072, device 302 may include an impulse generator 310; a power source 320 coupled to the impulse generator), wherein the energy source is configured to generate at least one electrical impulse (section 0078, the pulse generator 310 may be implemented using a power source 320 and a control unit 330 having, for instance, a processor, a clock, a memory, etc., to produce a pulse train 420 to the electrodes 340 that deliver the stimulating, blocking and/or modulating impulse 410 to the nerve) and to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the patient to a selected nerve in the patient adjacent to, or near, the target location (abstract, section 0040, contacting an outer surface of a head of the patient with a contact surface of the mobile device and applying one or more electrical impulses to the outer surface of the patient's skin such that the electrical impulses pass through the patient's skin transcutaneously to the trigeminal nerve) . One or more electrodes on the mobile device apply electrical impulses transcutaneously through the patient's skin to the targeted nerve to treat the medical condition); a sensor configured to sense a physiological parameter of the patient (Section 0194, the sensors may comprise those used in conventional Holter and bedside monitoring applications, for monitoring heart rate and variability, ECG, respiration depth and rate, core temperature, hydration, blood pressure, brain function, oxygenation, skin impedance, and skin temperature); and a software application configured for downloading onto a user interface (section 0031, The mobile phone preferably includes a software application that can be downloaded into the phone to receive the waveform from the exterior device and then provide the electrical waveform signal to the electrodes), the software application controlling parameters of the stimulator (Section 0031, the system further includes an amplifier coupled to the electrodes to amplify the signal generated by the application software and then apply the amplified signal to the electrodes).
Regarding claim 2, Errico discloses the physiological parameter includes one of blood flow associated with a nerve, heart rate or variability, ECG, respiration status, depth and rate, core temperature, hydration, blood pressure, brain function, oxygenation, skin impedance, and skin temperature, pupil diameter or dilation, galvanic skin response, selected biomarkers, a property of a voice of the patient, a laryngeal electromyographic signal, an electroglottographic signal and a property of the autonomic nervous system (Section 0194, the sensors may comprise those used in conventional Holter and bedside monitoring applications, for monitoring heart rate and variability, ECG, respiration depth and rate, core temperature, hydration, blood pressure, brain function, oxygenation, skin impedance, and skin temperature).
Regarding claim 3, Errico discloses application controls the user interface to prompt a user to enter user status information and to compare the user status information with the physiological parameter (Section 0079, Also included in the system is a measuring stage which measures and displays the electrical stimulation signal operating on the substance being treated, as well as the outputs of various sensors which sense prevailing conditions prevailing in this substance, whereby the user of the system can manually adjust the signal, or have it automatically adjusted by feedback, to provide an electrical stimulation signal of whatever type the user wishes, who can then observe the effect of this signal on a substance being treated).
Regarding claim 4, Errico discloses the user status information comprises one or more of: level of pain, satisfaction level, mood, medication use (Section 0079, Also included in the system is a measuring stage which measures and displays the electrical stimulation signal operating on the substance being treated, as well as the outputs of various sensors which sense prevailing conditions prevailing in this substance), activity level, and amount of sleep.
Regarding claim 5, Errico discloses controls the user interface to prompt a user to enter user status information and to compare the user status information to the parameters of the stimulator (section 0079, the user of the system can manually adjust the signal, to provide an electrical stimulation signal of whatever type the user wishes, who can then observe the effect of this signal on a substance being treated).
Regarding claim 6, Errico discloses the parameters include an amplitude or a duration of the electrical impulse (section 0079, the parameters of which are adjustable in regard to amplitude, duration, repetition rate and other variables).
Regarding claim 7, Errico discloses the stimulator is configured to apply a plurality of single doses (section 0036, There may be from about 1 to about 20 pulses per burst, preferably about five pulses. Each pulse within a burst has a duration from about 20 to about 1000 microseconds, preferably about 200 microseconds), wherein each single dose comprises applying the electrical impulse for a duration of between about 30 seconds and 5 minutes (section 0181, 0182, a trigeminal nerve stimulation treatment according to the present invention is conducted for continuous period of thirty seconds to thirty minutes, preferably about 90 seconds to about 5 minutes and more preferably about two minutes (each defined as a single dose). each treatment session comprises 1-3 doses administered by the patient either consecutively or separated by 5 minutes).
Regarding claim 8, Errico discloses the parameters include a number of single doses applied by the stimulator (Section 0082, each treatment session comprises 1-3 doses administered by the patient either consecutively or separated by 5 minutes).
Regarding claim 13, Errico discloses a stimulator housing 32, wherein the electrode 33 is disposed on an outer surface of the stimulator housing (Fig. 3, section 0099, the stimulator comprises a smartphone (31) with its back cover removed and joined to a housing (32) that comprises a pair of electrode surfaces (33) along with circuitry).
Regarding claim 14, Errico discloses the energy source is wirelessly coupled to the electrode (Section 0029, The energy source transmits an electrical signal comprising a plurality of electrical impulses through the interface transcutaneously through the outer skin surface of the user to a nerve of the user such that the nerve is modulated).
Regarding claim 15, Errico discloses the electrode is configured for attachment to the outer skin surface of the neck of the patient (section 0029, 0036, a system comprises a stimulator having an interface configured to contact an outer skin surface of a user and an energy source coupled to the interface. the nerve is a vagus nerve, and the outer skin surface is on a neck of the patient).
Regarding claim 16, Errico discloses a housing 30, wherein the energy source is housed within the housing (section 0033, the stimulator comprises a housing and the energy source is disposed within the housing) and the electrode is attached to, or incorporated into, the housing (Section 0092, stimulator (30) comprises two heads (31) and a connecting part that joins them. Each head (31) contains a stimulating electrode).
Regarding claim 18, Errico discloses the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz (Section 0035, the electrical impulses have a frequency of 1 kHz to 20 kHz).
Regarding claim 19, Errico discloses the electrical impulse comprises bursts of pulses, with each burst having a frequency of about 1 to about 100 bursts per second and each pulse has a duration of about 50 to about 1000 microseconds in duration (Section 0034, the electrical impulses comprise bursts of 2 to 20 pulses with each burst having a frequency of about 1 burst per second to about 100 bursts per second, wherein each of the pulses has a duration of about 50 microseconds to about 1000 microseconds).
Regarding claim 20, Errico discloses the bursts each comprise about 2 to 20 pulses (section 0034, the electrical impulses comprise bursts of 2 to 20 pulses) and the bursts are separated by an inter-burst period that comprises zero pulses (Section 0120, This is followed by a period with no signal, the inter-burst period).
Regarding claim 21, Errico discloses a stimulator comprising an electrode 340 configured for contacting the outer skin surface at, or near the target location (section 0029, a stimulator having an interface configured to contact an outer skin surface of a user and an energy source coupled to the interface. The energy source transmits an electrical signal comprising a plurality of electrical impulses through the interface transcutaneously through the outer skin surface of the user to a nerve of the user such that the nerve is modulated); an energy source 320 coupled to the stimulator 302 (Fig. 1, section 0064, device 302 may include an impulse generator 310; a power source 320 coupled to the impulse generator), wherein the energy source is configured to generate at least one electrical impulse (section 0070, the pulse generator 310 may be implemented using a power source 320 and a control unit 330 having, for instance, a processor, a clock, a memory, etc., to produce a pulse train 420 to the electrodes 340 that deliver the stimulating, blocking and/or modulating impulse 410 to the nerve) and to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the patient to a selected nerve in the patient adjacent to, or near, the target location (section 0040, contacting an outer surface of a head of the patient with a contact surface of the mobile device and applying one or more electrical impulses to the outer surface of the patient's skin such that the electrical impulses pass through the patient's skin transcutaneously to the trigeminal nerve); and a software application configured for downloading onto a user interface (section 0031, The mobile phone preferably includes a software application that can be downloaded into the phone to receive the waveform from the exterior device and then provide the electrical waveform signal to the electrodes), the software application controlling parameters of the stimulator, wherein the software application controls the user interface to prompt a user to enter user status information and to compare the user status information with the parameters of the stimulator (Section 0031, the system further includes an amplifier coupled to the electrodes to amplify the signal generated by the application software and then apply the amplified signal to the electrodes).
Regarding claim 22, Errico discloses the user status information comprises one or more of: level of pain, satisfaction level, mood, medication use (Section 0079, Also included in the system is a measuring stage which measures and displays the electrical stimulation signal operating on the substance being treated, as well as the outputs of various sensors which sense prevailing conditions prevailing in this substance), activity level, and amount of sleep.
Regarding claim 23, Errico discloses the parameters include an amplitude or a duration of the electrical impulse (section 0079, the parameters of which are adjustable in regard to amplitude, duration, repetition rate and other variables).
Regarding claim 24, Errico discloses the stimulator is configured to apply a plurality of single doses (section 0036, There may be from about 1 to about 20 pulses per burst, preferably about five pulses. Each pulse within a burst has a duration from about 20 to about 1000 microseconds, preferably about 200 microseconds), wherein each single dose comprises applying the electrical impulse for a duration of between about 30 seconds and 5 minutes (section 0181, 0182, a trigeminal nerve stimulation treatment according to the present invention is conducted for continuous period of thirty seconds to thirty minutes, preferably about 90 seconds to about 5 minutes and more preferably about two minutes (each defined as a single dose). each treatment session comprises 1-3 doses administered by the patient either consecutively or separated by 5 minutes).
Regarding claim 25, Errico discloses the parameters include a number of single doses applied by the stimulator (Section 0082, each treatment session comprises 1-3 doses administered by the patient either consecutively or separated by 5 minutes).
Regarding claim 26, Errico discloses the software application is configured to adjust the parameters of the stimulator based on the user status information (section 0178, the patient may attempt to adjust the amplitude of the stimulator as compensation for movement of the stimulator away from its optimum position).
Regarding claim 27, Errico discloses the software application is configured to provide an alert based on the user status information, the alert prompting the user to adjust the parameters of the stimulator (section 0175, 0193, Having received such preliminary information from the patient, the computer programs will perform instrument diagnostic tests and make the stimulator ready for the stimulation session. The system also receives input from the "Controller", which in this case may comprise the nerve stimulation device, as well as electronic components that may be used to select or set parameters for the stimulation protocol (amplitude, frequency, pulse width, burst number, etc.) or alert the patient as to the need to use or adjust the stimulator).
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.
Claim(s) 1-27 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Simon (US 20240316342). The applied reference has a common Assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Simon discloses stimulating a nerve within a patient (Section 0064, Devices that are used to stimulate a vagus nerve), the system comprising: a stimulator 302 comprising an electrode 340 configured for contacting the outer skin surface at, or near the target location (section 0029, a stimulator having an interface configured to contact an outer skin surface of a user and an energy source coupled to the interface. The energy source transmits an electrical signal comprising a plurality of electrical impulses through the interface transcutaneously through the outer skin surface of the user to a nerve of the user such that the nerve is modulated); an energy source 320 coupled to the stimulator (Fig. 1, section 0064, device 302 may include an impulse generator 310; a power source 320 coupled to the impulse generator), wherein the energy source is configured to generate at least one electrical impulse (section 0070, the pulse generator 310 may be implemented using a power source 320 and a control unit 330 having, for instance, a processor, a clock, a memory, etc., to produce a pulse train 420 to the electrodes 340 that deliver the stimulating, blocking and/or modulating impulse 410 to the nerve) and to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the patient to a selected nerve in the patient adjacent to, or near, the target location (abstract, section 0029, The energy source transmits an electrical signal comprising a plurality of electrical impulses through the interface transcutaneously through the outer skin surface of the user to a nerve of the user such that the nerve is modulated); a sensor configured to sense a physiological parameter of the patient (Section 0138, the sensors may comprise those used in conventional Holter and bedside monitoring applications, for monitoring heart rate and variability, ECG, respiration depth and rate, core temperature, hydration, blood pressure, brain function, oxygenation, skin impedance, and skin temperature); and a software application configured for downloading onto a user interface (section 0037, They also transmit data to and from a computer program in a patient interface device, such as a mobile phone or nearby computer), the software application controlling parameters of the stimulator (Section 0029, the system further comprises a downloadable software application downloadable onto a mobile device configured for wireless coupling to the stimulator to transmit data from the software application to the stimulator. The downloadable software application controls a duration of time in which the stimulator generates the electrical signal).
Regarding claim 2, Simon discloses the physiological parameter includes one of blood flow associated with a nerve, heart rate or variability, ECG, respiration status, depth and rate, core temperature, hydration, blood pressure, brain function, oxygenation, skin impedance, and skin temperature, pupil diameter or dilation, galvanic skin response, selected biomarkers, a property of a voice of the patient, a laryngeal electromyographic signal, an electroglottographic signal and a property of the autonomic nervous system (Section 0138, the sensors may comprise those used in conventional Holter and bedside monitoring applications, for monitoring heart rate and variability, ECG, respiration depth and rate, core temperature, hydration, blood pressure, brain function, oxygenation, skin impedance, and skin temperature).
Regarding claim 3, Simon discloses application controls the user interface to prompt a user to enter user status information and to compare the user status information with the physiological parameter (Section 0071, Also included in the system is a measuring stage which measures and displays the electrical stimulation signal operating on the substance being treated, as well as the outputs of various sensors which sense prevailing conditions prevailing in this substance, whereby the user of the system can manually adjust the signal, or have it automatically adjusted by feedback, to provide an electrical stimulation signal of whatever type the user wishes, who can then observe the effect of this signal on a substance being treated).
Regarding claim 4, Simon discloses the user status information comprises one or more of: level of pain, satisfaction level, mood, medication use (Section 0071, Also included in the system is a measuring stage which measures and displays the electrical stimulation signal operating on the substance being treated, as well as the outputs of various sensors which sense prevailing conditions prevailing in this substance), activity level, and amount of sleep.
Regarding claim 5, Simon discloses controls the user interface to prompt a user to enter user status information and to compare the user status information to the parameters of the stimulator (section 0071, the user of the system can manually adjust the signal, to provide an electrical stimulation signal of whatever type the user wishes, who can then observe the effect of this signal on a substance being treated).
Regarding claim 6, Simon discloses the parameters include an amplitude or a duration of the electrical impulse (section 0071, the parameters of which are adjustable in regard to amplitude, duration, repetition rate and other variables).
Regarding claim 7, Simon discloses the stimulator is configured to apply a plurality of single doses (section 0029, The downloadable software application controls a duration of time in which the stimulator generates the electrical signal), wherein each single dose comprises applying the electrical impulse for a duration of between about 30 seconds and 5 minutes (section 0030, the duration of time is about 5 minutes to about 30 minutes).
Regarding claim 8, Simon discloses the parameters include a number of single doses applied by the stimulator (Section 0032, The therapy regimen may comprise a duration of the electrical impulse, a parameter of the electrical impulse, such as the amplitude, duration and/or frequency of the impulses, a number of doses of the electrical impulses and/or a duration of time between doses).
Regarding claim 13, Simon discloses a stimulator housing 30, wherein the electrode 31 is disposed on an outer surface of the stimulator housing (Fig. 3, section 0092, the stimulator (30) comprises two heads (31) and a connecting part that joins them. Each head (31) contains a stimulating electrode) and the sensor is coupled to the stimulator housing (section 0114 , it is contemplated that sensors attached to the stimulator housing may also be transmitting information).
Regarding claim 14, Simon discloses the energy source is wirelessly coupled to the electrode (section 0115, the housing of the stimulator may also be joined to and/or powered by a wireless device)
Regarding claim 15, Simon discloses the electrode is configured for attachment to the outer skin surface of the neck of the patient (section 0102, Devices and methods for non-invasive electrical stimulation and their use for vagal nerve stimulation on the neck of a patient)
Regarding claim 16, Simon discloses a housing 33, 302, wherein the energy source 320 is housed within the housing (Fig. 1, section 0099, the stimulator comprises a smartphone (31) with its back cover removed and joined to a housing (32) that comprises a pair of electrode surfaces (33) along with circuitry (not shown) to control and power the electrodes and interconnect with the smartphone) and the electrode 33 is attached to, or incorporated into, the housing 32 (Fig. 3B. section 0099, the stimulator comprises a smartphone (31) with its back cover removed and joined to a housing (32) that comprises a pair of electrode surfaces (33) along with circuitry (not shown) to control and power the electrodes and interconnect with the smartphone).
Regarding claim 18, Simon discloses the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz (Section 0085, The above waveform is essentially a 1-20 KHz signal that includes bursts of pulses with each burst having a frequency of about 10-100 Hz and each pulse having a frequency of about 1-20 KHz).
Regarding claim 19, Simon discloses the electrical impulse comprises bursts of pulses, with each burst having a frequency of about 1 to about 100 bursts per second and each pulse has a duration of about 50 to about 1000 microseconds in duration (Section 0036, Each pulse within a burst has a duration from about 20 to about 1000 microseconds).
Regarding claim 20, Simon discloses the bursts each comprise about 2 to 20 pulses (section 0036, There may be from about 1 to about 20 pulses per burst) and the bursts are separated by an inter-burst period that comprises zero pulses (Section 0036, A burst followed by a silent inter-burst interval repeats from at about 1 to about 5000 bursts per second).
Regarding claim 21, Simon discloses a stimulator comprising an electrode 33 configured for contacting the outer skin surface at, or near the target location (section 0040, contacting an outer surface of a head of the patient with a contact surface of the mobile device and applying one or more electrical impulses to the outer surface of the patient's skin such that the electrical impulses pass through the patient's skin transcutaneously to the trigeminal nerve); an energy source 320 coupled to the stimulator 302 (Fig. 1, section 0072, an electrode-based nerve stimulating/modulating device 302 for delivering impulses of energy to nerves for the treatment of medical conditions. As shown, device 302 may include an impulse generator 310; a power source 320 coupled to the impulse generator 310), wherein the energy source is configured to generate at least one electrical impulse (section 0070, the pulse generator 310 may be implemented using a power source 320 and a control unit 330 having, for instance, a processor, a clock, a memory, etc., to produce a pulse train 420 to the electrodes 340 that deliver the stimulating, blocking and/or modulating impulse 410 to the nerve) and to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the patient to a selected nerve in the patient adjacent to, or near, the target location (); and a software application configured for downloading onto a user interface (section 0037, They also transmit data to and from a computer program in a patient interface device, such as a mobile phone or nearby computer), the software application controlling parameters of the stimulator, wherein the software application controls the user interface to prompt a user to enter user status information and to compare the user status information with the parameters of the stimulator (Section 0029, the system further comprises a downloadable software application downloadable onto a mobile device configured for wireless coupling to the stimulator to transmit data from the software application to the stimulator. The downloadable software application controls a duration of time in which the stimulator generates the electrical signal).
Regarding claim 22, Simon discloses the user status information comprises one or more of: level of pain, satisfaction level, mood, medication use (Section 0071, Also included in the system is a measuring stage which measures and displays the electrical stimulation signal operating on the substance being treated, as well as the outputs of various sensors which sense prevailing conditions prevailing in this substance), activity level, and amount of sleep.
Regarding claim 23, Simon discloses the parameters include an amplitude or a duration of the electrical impulse (section 0071, the parameters of which are adjustable in regard to amplitude, duration, repetition rate and other variables).
Regarding claim 24, Simon discloses the stimulator is configured to apply a plurality of single doses (section 0029, The downloadable software application controls a duration of time in which the stimulator generates the electrical signal), wherein each single dose comprises applying the electrical impulse for a duration of between about 30 seconds and 5 minutes (section 0030, the duration of time is about 5 minutes to about 30 minutes).
Regarding claim 25, Simon discloses the parameters include a number of single doses applied by the stimulator (Section 0032, The therapy regimen may comprise a duration of the electrical impulse, a parameter of the electrical impulse, such as the amplitude, duration and/or frequency of the impulses, a number of doses of the electrical impulses and/or a duration of time between doses).
Regarding claim 26, Simon discloses the software application is configured to adjust the parameters of the stimulator based on the user status information (section 0025, The patient will sense whether the nerve is being stimulated and can adjust the position of the stimulator in search for the optimum, but the patient also has the option of adjusting the amplitude of the stimulation in an attempt to compensate for a sub-optimal position).
Regarding claim 27, Simon discloses the software application is configured to provide an alert based on the user status information, the alert prompting the user to adjust the parameters of the stimulator (section 0020-0021, 0137, the level of stimulation power may be adjusted with a wheel. The position and angular orientation of the device are adjusted about a location on the neck until the patient perceives stimulation when current is passed through the stimulator electrodes. The applied current is increased gradually, first to a level wherein the patient feels sensation from the stimulation. The power is then increased, but is set to a level that is less than one at which the patient first indicates any discomfort. Alert the patient as to adjust the stimulator).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4, 9-12, 17, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al (US 20140330336) in view of Romaniw et al. (US 20230364413).
Regarding claim 4, Errico discloses in view of Romaniw, specfically Romaniw discloses the user status information comprises one or more of: level of pain, satisfaction level, mood, medication use, activity level, and amount of sleep (section 0071, the devices may be used as a bridge-therapy for alcohol dependence or opioid-use disorders to reduce opioid or alcohol cravings sufficiently to remain drug-free prior to receiving further treatment, such as prescription injection medications or other alcohol and drug recovery programs). This allows for proper treatment to addiction or opioid use disorders. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Errico by adding the user status information comprises one or more of: level of pain, satisfaction level, mood, medication use, activity level, and amount of sleep as taught by Romaniw in order to facilitate proper treatment to addiction or opioid use disorders.
Regarding claim 9, Errico discloses the invention substantially as claimed however does not show the sensor comprises a heart pulse sensor. Romaniw discloses the sensor comprises a heart pulse sensor (section 0011-0012, The heart pulse sensor may be any suitable sensor known in the art for detecting the heart pulse of a patient, such as an infrared sensor, optical sensor, tactile sensor, a photoplethysmography (PPG) sensor or the like). This indicates an optimal position for placement of the electrodes to transmit the electrical impulses through the skin surface to the underlying vagus nerve. Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Errico by adding the sensor comprises a heart pulse sensor as taught by Romaniw in order to facilitate an finding an optimal position for placement of the electrodes to transmit the electrical impulses through the skin surface to the underlying vagus nerve by using a heart pulse sensor that is configured to detect a heart pulse emanating from the carotid artery in the patient’s neck.
Regarding claim 10, Errico discloses in view of Romaniw, specfically Romaniw discloses an indicator coupled to the sensor for providing an alert when the heart pulse is detected (Section 0017, the indicator is configured to transmit an alert that is associated with the magnitude of the heart pulse. For example, the alert may comprise an audible sound that increases in decibel level as the magnitude increase). This indicates an optimal position for placement of the electrodes to transmit the electrical impulses through the skin surface to the underlying vagus nerve.
Regarding claim 11, Errico discloses in view of Romaniw, specfically Romaniw discloses the target location is a location on the outer skin surface adjacent to, near, or overlying the carotid artery (Section 0015, the sensor comprises a heart pulse sensor that is configured to detect a heart pulse emanating from the carotid artery in the patient’s neck). This indicates an optimal position for placement of the electrodes to transmit the electrical impulses through the skin surface to the underlying vagus nerve.
Regarding claim 12, Errico discloses in view of Romaniw, specfically Romaniw discloses the selected nerve is the vagus nerve (Section 0015, The vagus nerve is situated within the carotid sheath, near the carotid artery and the interior jugular vein. This indicates an optimal position for placement of the electrodes to transmit the electrical impulses through the skin surface to the underlying vagus nerve). This indicates an optimal position for placement of the electrodes to transmit the electrical impulses through the skin surface to the underlying vagus nerve.
Regarding claim 17, Errico discloses in view of Romaniw, specfically Romaniw discloses a patch having an adhesive surface for attached to the outer skin surface of the neck of the patient, wherein the electrode is housed within the patch (Fig. 12, section 0026, the device comprises a patch having at least one adhesive surface for attachment to the outer skin surface of the neck of the patient). This allows for proper secure placement of the electrode on the target area.
Regarding claim 22, Errico discloses in view of Romaniw, specfically Romaniw discloses the user status information comprises one or more of: level of pain, satisfaction level, mood, medication use, activity level, and amount of sleep (section 0071, the devices may be used as a bridge-therapy for alcohol dependence or opioid-use disorders to reduce opioid or alcohol cravings sufficiently to remain drug-free prior to receiving further treatment, such as prescription injection medications or other alcohol and drug recovery programs). This allows for proper treatment to addiction or opioid use disorders.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20220079502 Simon; Bruce J. et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796