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 § 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) 1-2, 5-8, 13-16, 18-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Errico et al (US 20140330336) in view of Simon (US 20220079502), both cited previously.
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).
However, Errico does not specifically discloses 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 physiological parameter. Simon discloses 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 physiological parameter (abstract, page 37, claim 10). This allows to monitor compliance and the effectiveness of the therapy being delivered. 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 software 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 as taught by Simon in order to facilitate monitor compliance and the effectiveness of the therapy being delivered.
Regarding claim 2, Errico in view of Simon, specifically 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 5, Errico in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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).
However, Errico does not specifically discloses 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. Simon discloses 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 (abstract, page 37, claim 10). This allows to monitor compliance and the effectiveness of the therapy being delivered. 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 software 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 as taught by Simon in order to facilitate monitor compliance and the effectiveness of the therapy being delivered.
Regarding claim 22, Errico in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically 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 in view of Simon, specifically Simon discloses the software application is configured to adjust the parameters of the stimulator based on the user status information (abstract, 0127).
Regarding claim 27, Errico in view of Simon, specifically 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).
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 Simon (US 20220079502) and in view of Romaniw et al. (US 20230364413), all cited previously.
Regarding claim 4, Errico in view of Simon 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 in view of Simon 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 in view of Simon 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 in view of Simon 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 in view of Simon 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 in view of Simon 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 in view of Simon 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4-27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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
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