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 .
Response to Arguments
Applicant’s arguments, filed on September 30, 2025 with respect to the rejection(s) of claim(s) 17-20 under 35 U.S.C. 102(a)(1) and claim(s) 21-29 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the previous rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments as can be further seen below.
Election/Restrictions
Applicant’s election without traverse of Group II and Species 1B in the reply filed on June 6, 2025 is acknowledged. Claim 30 is withdrawn as being directed to non-elected Species 1A. The requirement to elect between species 2A-2C is withdrawn.
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.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0172041 A1 to Draghici et al. (hereinafter “Draghici”) in view of US 8,939,919 B2 to Barlow et al. (hereinafter “Barlow”).
Regarding claim 17, Draghici teaches a cranial nerve stimulation system (abstract, line 1) comprising:
at least one stimulating electrode configured to attach adjacent to a cranial nerve (see abstract, fig. 1, 30 below, and para 0046);
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at least one switch/switch fabric electrically connected to the at least one stimulating electrode/each electrode in the electrode array (para 0050);
and at least one stimulating unit (signal driver unit containing a microcontroller—see annotated fig. 1 above) electronically connected to the at least one stimulating electrode and the at least one switch/switch fabric (para 0050- para 0051);
wherein the at least one switch/switch fabric is configured to activate the at least one stimulating electrode to stimulate the cranial nerve (para 0050), and wherein the at least one stimulating unit (signal driver unit containing a microcontroller) is configured to modulate at least one stimulation parameter (para 0046-0047 and 0049-0051), but does not explicitly disclose where the at least one switch electrically connected to the at least one stimulation electrode is a trigger switch, and does not disclose where at least one stimulating unit electronically connected to the at least one stimulating electrode and at least one trigger switch.
However, Barlow teaches a therapeutic systems and methods for assessing and entraining neuromuscular patterns and/or behaviors in a patient (see abstract- “The present invention relates to a therapeutic system and methods of using the therapeutic system. In particular, the present invention relates to systems having hardware, software, and appliance components for assessing and entraining a neuromuscular pattern or behavior in a patient.”), and configured to provide stimulation to the brain in order to influence brain responses and brain development (including brain repair, respiration control, non-nutritive suck patterns, mastication, etc.) (col. 1, lines 14-20: “ The invention relates generally to systems and methods for stimulating a central pattern generator and a trigeminal nerve in a brain of a human subject. Specifically, the present invention relates to stimulation that influences brain response or brain development including repair of the brain, control of respiration, control of a non-nutritive suck pattern, mastication, and combinations thereof.”).
Furthermore, the system (figs. 6-8B) contains an orofacial stimulator appliance (see fig. 8B, 108) containing at least one push-button switch (see figs. 1, 108 and 816, fig. 8B – 816, and col. 3, lines 5-8) electrically connected to at least one stimulating unit/pulse generation system (See fig. 1, 106 and 108, and col. 5: “The therapeutic stimulus system 100 includes a computing device 102 to process data and execute one or more applications, a data source 104 to store data, a pulse generation system 106 to generate pneumatic pulses in response to input signals, and an orofacial stimulator appliance 108 to transfer the pneumatic pulses to a patient as a tactile stimulus.
(29) According to one aspect, the therapeutic stimulus system 100 can be used for assessing a patient's natural non-nutritive suck (NNS) pattern and for providing a tactile stimulus that will stimulate the suck central pattern generator (sCPG) and trigeminal nerve of the patient's brain to entrain a proper NNS pattern”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Draghici with the trigger/push-button switch of Barlow to arrive at the claimed invention. Such modification would improve the system by allowing more precise and reliable control when activating therapeutic stimulation treatment to the patient.
Regarding claim 18, Draghici as modified teaches the system of claim 17, wherein the at least one cranial nerve is selected from the group consisting of:
the trigeminal nerve, the facial nerve, the accessory nerve, the hypoglossal nerve, the auricular branch of the Vagus nerve, and the main bundle of the Vagus nerve (para 0008). This device provides stimulation through cranial nerve selected from the group of Hypoglossal nerve (nerves associated with the tongue).
Regarding claim 19, Draghici as modified teaches the system of claim 17, further comprising an impedance sensor/ touchpad sensors (para 0011 and para 0014) indicating to the user whether the at least one stimulating unit has good, fair or poor contact with the patient (para 0014). The feedback loop signal is able to provide a signal indicating if the contact between the tissue and electrodes is good or bad.
Regarding claim 20, Draghici as modified teaches the system of claim 17, further comprising a sensing electrode configured to attach adjacent to at least one muscle, power source, a transmitter (para 0045 and fig. 1, 30), and a processor/microcontroller (para 0066) communicatively connected to a non-transitory computer-readable memory with instructions store thereon, which when executed by the processor, initiates a closed- loop synchronization between activation and deactivation of the at least one stimulating electrode when the at least one sensing electrode measures electrical energy in the at least one muscle that passes a minimum threshold (para 0072).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Draghici in view of Barlow, and further in view of US 2018/0197629 A1 to Zhou.
Regarding claim 21, Draghici as modified teaches the system of claim 17 containing sensors (see para 0014: “The device may further comprise sensors that operate as buttons for the touch pad by providing a signal to the microcontroller, and may further comprise predetermined sections of the electrodes, wherein the sections are assigned specific actions.”), but does not disclose wherein the system further comprises a feeding bottle comprising at least one sensor, a power source, and a transmitter.
However, Zhou teaches a digital content processing system for monitoring and analyzing baby feeding habits (abstract, lines 1-2 and para 0001). The system (figs. 2 and 7) comprises a feeding bottle comprising at least one sensor (abstract: “The baby feeding habits data, e.g., feeding times, types of content consumed (milk, water, juice or baby formula) and volume of intakes, are collected through a variety of electronic sensors, e.g., a temperature sensor, a motion sensor, a color sensor and an electronic field imaging sensor, attached to a baby feeding bottle.”) and a power source/ wireless charger (para 0036), but does not disclose wherein the system also comprises a transmitter.
However, Barlow teaches a therapeutic system and method for assessing and entraining a neuromuscular behavior of a patient (abstract, lines 1-5). The system (figs. 7-8) contains a pacifier in communication with a receiver tube) (col. 2, lines 45-52), a sensor (col. 3, lines 9-13), and a research module/ transmitter that is designed to transmit data (col. 10, lines 58-65).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Draghici with the bottle and sensor of Zhou and the transmitter system of Barlow to arrive at the claimed invention. Such modification would improve the system by ensuring a baby’s feeding habits can be monitored and treated if the infant’s feeding habits are not favorable, ultimately preventing long-term health issues and feeding habits from developing over time.
Regarding claim 22, Draghici as modified teaches the system of claim 21, wherein the at least one sensor is selected from the group consisting of a flow sensor, a pressure sensor, a suction sensor, a gyroscope, an accelerometer, a temperature sensor, and a volume sensor (para 0062, last sentence: “As shown in FIG. 6, sensors 320 that are activated by pressure from the tongue, lips, or teeth, can be placed on the ISB, as can accelerometers 330 that gather data regarding the tilting of the head.”).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Draghici in view of Barlow, and further in view of US 10,130,809 B2 to Cartledge et al. (hereinafter “Cartledge”).
Regarding claim 23, Draghici as modified teaches the system of claim 17, but does not disclose wherein the stimulating electrode comprises an earpiece and a conductive element.
However, Cartledge teaches an electrostimulation device (abstract, line 1) containing a stimulating electrode comprising an earpiece and a conductive element (conductive surface) ( col. 3, lines 41-67, col. 4, lines 1-19, and col. 13, lines 45-51).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Draghici with the teachings of Cartledge to arrive at the claimed invention. Such modification would improve the system by providing another non-invasive stimulation method that is able to target the vagus nerve, ultimately providing effective treatment for the patient without adversely effecting healthy tissue.
Claims 24 is rejected under 35 U.S.C. 103 as being unpatentable over Draghici in view of Zhou and Barlow, and further in view of Cartledge.
Regarding claim 24, Draghici as modified teaches the system of claim 21, but does not disclose wherein the earpiece comprises at least one outer surface conductive region positioned to directly contact a region of an ear.
However, Cartledge teaches wherein the earpiece comprises at least one outer surface conductive region positioned to directly contact a region of an ear (col. 13, lines 45-51).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Draghici with the teachings of Cartledge to arrive at the claimed invention. Such modification would improve the system by allowing for proper signal transmission/stimulation treatment.
Claims 25 is rejected under 35 U.S.C. 103 as being unpatentable over Draghici in view of Zhou and Barlow, and further in view of US 2016/0346530 A1 to Jeffery et al. (hereinafter “Jeffery”).
Regarding claim 25, Draghici as modified teaches the system of claim 21, but does not disclose wherein the earpiece is an anode and the conductive element/portion is a cathode.
However, Jeffery teaches a method and apparatus for transdermal electrical stimulation (abstract, lines 1-2). The system (fig. 1A and fig. 1C-1D) teach wherein the earpiece-type device (fig. 1D, 177) has an anode electrode portion of the earpiece positioned on the right temple area, and a conductive portion is a cathode (para 0157).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Draghici with the teachings of Jeffery to arrive at the claimed invention. Such modification would improve the system by achieve for proper stimulation treatment.
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0106338 A1 to Errico in view of Draghici and Barlow.
Regarding claim 26, Errico teaches a method of enhancing muscle rehabilitation (abstract, lines 1-3), comprising the steps of:
providing a cranial nerve stimulation system and at least one stimulating electrode (abstract, last two sentences and para 0084), setting at least one stimulating parameter using the at least one stimulating electrode (para 0084);
but does not disclose wherein the method further comprises at least one switch electrically connected to the at least one stimulating electrode, and at least one stimulating unit electronically connected to the at least one stimulating electrode and the at least one switch;
securing the at least one stimulating electrode to a subject's cranial nerve;
; and administering stimulation using the at least one stimulating electrode to the cranial nerve.
However, Draghici teaches a cranial nerve stimulation system (abstract, line 1) containing at least one switch/switch fabric electrically connected to the at least one stimulating electrode/each electrode in the electrode array (para 0050);
and at least one stimulating unit (signal driver unit containing a microcontroller) electronically connected to the at least one stimulating electrode and the at least one switch/switch fabric (para 0050- para 0051);
securing the at least one stimulating electrode to a subject's cranial nerve (see fig.1,30);
and administering stimulation using the at least one stimulating electrode to the cranial nerve (abstract). However, Errico nor Draghici teach wherein the at least one switch is a trigger switch.
However, Barlow teaches a therapeutic systems and methods for assessing and entraining neuromuscular patterns and/or behaviors in a patient (see abstract- “The present invention relates to a therapeutic system and methods of using the therapeutic system. In particular, the present invention relates to systems having hardware, software, and appliance components for assessing and entraining a neuromuscular pattern or behavior in a patient.”), and configured to provide stimulation to the brain in order to influence brain responses and brain development (including brain repair, respiration control, non-nutritive suck patterns, mastication, etc.) (col. 1, lines 14-20: “ The invention relates generally to systems and methods for stimulating a central pattern generator and a trigeminal nerve in a brain of a human subject. Specifically, the present invention relates to stimulation that influences brain response or brain development including repair of the brain, control of respiration, control of a non-nutritive suck pattern, mastication, and combinations thereof.”).
Furthermore, the system (figs. 6-8B) contains an orofacial stimulator appliance (see fig. 8B, 108) containing at least one push-button switch (see figs. 1, 108 and 816, fig. 8B – 816, and col. 3, lines 5-8) electrically connected to at least one stimulating unit/pulse generation system (See fig. 1, 106 and 108, and col. 5: “The therapeutic stimulus system 100 includes a computing device 102 to process data and execute one or more applications, a data source 104 to store data, a pulse generation system 106 to generate pneumatic pulses in response to input signals, and an orofacial stimulator appliance 108 to transfer the pneumatic pulses to a patient as a tactile stimulus.
(29) According to one aspect, the therapeutic stimulus system 100 can be used for assessing a patient's natural non-nutritive suck (NNS) pattern and for providing a tactile stimulus that will stimulate the suck central pattern generator (sCPG) and trigeminal nerve of the patient's brain to entrain a proper NNS pattern”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Errico with the method of Draghici and the trigger/push-button switch of Barlow to arrive at the claimed invention. Such modification would improve the system by applying proper signal transmission/stimulation treatment that is able to enhance muscle function for the patient through the use of direct stimulation, ultimately improving unhealthy smooth muscle tissue while preventing neurological disfunction.
Regarding claim 27, Errico as modified teaches the method of claim 26, wherein the cranial nerve is selected from the group consisting of: the trigeminal nerve, the facial nerve, the accessory nerve, the hypoglossal nerve, the auricular branch of the vagus nerve, and the main bundle of the vagus nerve (para 0045 - the vagus nerve).
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Errico in view of Draghici and Barlow, and further in view of US 2007/0067004 A1 to Boveja et al. (hereinafter “Boveja”).
Regarding claim 28, Errico as modified teaches the method of claim 26, but does not disclose wherein the administering step is performed manually in an open loop by activating the at least one switch.
However, Boveja teaches methods and systems for neuromodulating the vagus nerve for neurological therapy (abstract, lines 1-2). The system (fig. 13) where the administering step is performed manually in an open loop by activating at least one ON/Off switch or trigger switch (para 0066-0067 and para 0293-0294).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Errico with the teachings of Boveja to arrive at the claimed invention. Such modification would improve the system by allowing the physician to alter the stimulation parameter in the case where the stimulation parameters are not providing effective therapy for the patient, ultimately providing more accurate and effective stimulation therapy for each patient.
Regarding claim 29, Errico as modified teaches the method of claim 26, but does not disclose wherein the method further comprises a step of indicating to the user whether the at least one stimulating unit has good, fair or poor contact with the patient.
However, Draghici teaches an impedance sensor/ touchpad sensors (para 0011 and para 0014) indicating to the user whether the at least one stimulating unit has good, fair or poor contact with the patient (para 0014). The feedback loop signal is able to provide a signal indicating if the contact between the tissue and electrodes is good or bad.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Errico with the teachings of Draghici to arrive at the claimed invention, since such modification would improve the system by ensuring the patient is receiving effective stimulation treatment, ultimately providing more accurate and effective stimulation therapy for each patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Acrot-Krishnamurthy et al. (US 2012/0271382 A1) teaches a method for performing neural stimulation test for stimulating the cervical region of a patient.
Simon et al. (US 8, 914, 122 B2) teaches a non-invasive electrical stimulation device used to stimulate the vagus nerve of a patient.
THIS ACTION IS MADE FINAL. 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.
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/K.J.W./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792