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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/2025 has been entered.
Response to Arguments
Applicant’s arguments and amendments filed 10/29/2025 have been fully considered. The applicant has amended claims 16, 24, and 27; canceled claim 21.
Under remarks on page 5 state, “Claims 31 and 32 are new,” but the claims submitted on 10/29/2025 do not contain the alleged new claims. The last page on amendments to the claims is “Page 4” and the first page of the Remarks is “Page 5.” Per the Electronic Filing System Acknowledgement, the claim set filed is only 3 pages (2-4) and the Remarks are 10 pages (5-14). The last claim present on the last page of the amendments to the claims on page 4 is claim 30. Therefore, any remarks towards those non-filed claims, claims 31 and 32, will not be considered and claims 31 and 32 are not examined since they do not exist.
Regarding the 35 USC 112d Rejection, the amended claims have overcome the rejection.
Regarding 35 USC 103 rejection, applicant argues about the following: I.) Hyde’s embodiments do not render the claimed micro-controller as obvious; II.) Hyde does not disclose the claimed micro-controller transmission; III.) Hyde does not disclose the claimed synchronization; IV.) Hyde’s Clock/Timer 816 does not disclose the claimed temporal tag.
I.) Hyde’s embodiments do not render the claimed micro-controller as obvious & II.) Hyde does not disclose the claimed micro-controller transmission
The examiner agrees with the applicant that Hyde’s embodiments do not render the claimed micro-controller as obvious and does not disclose the microcontroller transmission. Additionally, the amended claim 1 now states the microcontroller, not the system, receives, generates, and transmits at least one stimulus of the sensory stimulation. Hyde discloses the neural stimulation system to comprise of a microcontroller, but is silent specifically in teaching the microcontroller performing those functions.
Tyler teaches, in Paragraphs 0086, 0088-0089, and 0125, in the transcranial electrical stimulation (TES) system, a controller or processor manages computational modeling to determine optimal electrode parameters and positioning for targeted stimulation. This processor component, which can be a microcontroller or microprocessor, may reside on a remote server or within a portable TES system controller, receiving data about head anatomy and desired brain regions to target via a communication system. It then generates stimulation signals according to the computed parameters, delivering electrical stimuli with specified timing, duration, frequency, and intensity through each electrode. The system also includes hardware and software for controlling the waveform and other stimulation parameters.
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the neural stimulation system of Hyde to incorporate the teachings of the microcontroller containing the functions of receiving, generating, and transmitting at least one stimulus of the sensory stimulation from Tyler because the microcontroller can then serve as a compact tool for real-time analysis of physiological data, which greatly improves feedback regarding targeted electrical stimulation within the brain (Tyler | Paragraphs 0019, 0022).
III.) Hyde does not disclose the claimed synchronization and IV.) Hyde’s Clock/Timer 816 does not disclose the claimed temporal tag
The examiner agrees with the applicant that Hyde does not disclose the claimed synchronization and the temporal tag. However, Simon teaches of the synchronization signal as temporal tag (Simon | reaction time – elements 640 and 648) configured to time-locking an onset of the at least one stimulus of the sensory stimulation with the related physiological signal (Simon | biosensor signal (EEG Signal) – elements 646 and 650; Figure 10; Paragraph 0088; [Examiner’s note, Figure 10 demonstrates the synchronized physiological signal, EEG signal, and reaction time of the user when interacting with the presented stimulus.]) and based on the starting time of the at least one stimulus of the sensory stimulation (Simon | Figure 10; Paragraph 0088).
In Simon, Figure 10 illustrates the user’s interaction when the stimulus is present with the corresponding physiological signal. One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Hyde in view of Tyler to incorporate the teachings of synchronization signals with time-locking because doing so would allow analyzing the timing of the patient's response to a stimulus, which will offer their physician valuable insights for diagnostic evaluations. This performance data helps the physician make an accurate diagnosis and determine the appropriate treatment plan to assist the patient (Simon | Paragraphs 0003, 0040).
Response to Amendment
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 is: “to generate the sensory stimulation comprising at least one stimulus according to the stimulation paradigm by means of the at least one sensory stimulation element” in claims 16 and 22.
Claim 16 and 22 recites “to generate the sensory stimulation comprising at least one stimulus according to the stimulation paradigm by means of the at least one sensory stimulation element.” The limitation has been interpreted under 112f as a means plus function limitation because of the combination of a non-structural generic placeholder term “at least one sensory stimulation element” and functional language “to generate the sensor stimulation comprising at least one stimulus” without reciting sufficient structure to achieve the function.
Because this claim limitation is 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.
Claims 16 and 22 regarding “at least one sensory stimulation element” is being interpreted as a device that provides a stimulation to the user, where it can be a visual (e.g. LED matrix on a display for a visual stimuli; [Examiner’s note, specifically discussed on Page 13 lines 24-27.]), auditory (e.g. stereo; [Examiner’s note, specifically discussed on Page 14 lines 8-13.]), or haptic (e.g. haptic motor controller; [Examiner’s note, specifically discussed on Page 14 lines 1-3.]) stimulation.
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
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 16, 20, 22-30 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.
In Claim 16, the claim limitation “the acquisition of a physiological signal” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “an acquisition of a physiological signal.”
In Claim 16, the claim limitation “a device for the acquisition of a physiological signal so as to synchronize said system for stimulation with the device for the acquisition of a physiological signal during an acquisition” renders the claim indefinite because the limitation is unclear. The claim recites “acquisition of a physiological signal” twice and is unclear whether the physiological signals are the same or different. For purposes of examination, the claim limitation is interpreted as to mean the same signal. The examiner recommends the following correction: “a device for the acquisition of a physiological signal so as to synchronize said system for stimulation with the device for the acquisition of the physiological signal during an acquisition.”
In Claim 16, the claim limitation “during an acquisition” renders the claim indefinite because the limitation is unclear. It is unclear whether the “during the acquisition” refers to the previously cited “acquisition of a physiological signal.” For purposes of examination, the claim limitation is interpreted as to mean the same thing.
In Claim 16 and 27, the claim limitation “the related physiological signal” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “a related physiological signal.”
In Claim 16 and 27, the claim limitation “acquisition of a physiological signal” and “related physiological signal” renders the claim indefinite because the limitation is unclear. It is unclear whether the same physiological signal is being references or not. For purposes of examination, the claim limitation is interpreted as referencing the same physiological signal.
In Claim 26, the claim limitation “the electrical stimulation device” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “an electrical stimulation device.”
In Claim 26, the claim limitation “electrical stimulation device” renders the claim indefinite because the limitation is unclear. It is unclear whether the “electrical stimulation device” and the “device,” as previously recited in claim 16, are the same or different. For purposes of examination, the claim limitation is interpreted as the same device.
In Claim 29, the claim limitation “clinical database” renders the claim indefinite because the limitation is unclear. It is unclear whether the “clinical database” and the “database,” as previously recited in claim 27, are the same or different. For purposes of examination, the claim limitation is interpreted as the same database.
In Claim 30, the claim limitation “the results of the analysis step and the information concerning the stimulation paradigm selected” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “a result of the analysis step and an information concerning the stimulation paradigm selected.”
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16, 20, 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US 20170027812) in view of Tyler et al. (US 20150174418 A1), and Simon et al. (US 20170177023 A1).
Regarding Claim 16, Hyde teaches a system (neural stimulation system – element 4200) for automatic evaluation of cognition and consciousness of a subject through external stimulations, said system comprising a micro-controller (wireless microcontroller – element 4280), a digital-to- analog converter (digital-to-analog converter (DAC) – element 4270) and at least one sensory stimulation element (Paragraph 0011, a neural stimulation system includes, but is not limited to, a neural signal sensor adapted to sense a neural signal from a subject, the neural signal indicative of a physiological status of the subject, a neural stimulator adapted to produce a stimulus responsive to the sensed neural signal, the stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of a pinna of the subject, and a securing member configured to secure the neural stimulator to the pinna),
wherein the system is configured:
to receive as an input comprising an information concerning a stimulation paradigm comprising at least one pattern of a sensory stimulation configured to induce a cognitive process in a stimulated subject (Paragraph 0013, 0015);
to generate, as output a stimulation digital output (Paragraph 0227, The digital stimulus signal generator 4020 may generate a digital stimulus signal based, at least in part, on the one or more stimulation parameters received from the personal computing device 4045) comprising at least one synchronization signal (Paragraph 0229, The DAC 4025 may include two or more output channels in some embodiments. One or more of the output channels may produce an inverted signal relative to another of the output channels.); and
to transmit, through a cable (communication link – element 210), said at least one synchronization signal determined by the stimulation paradigm to a device for the acquisition of a physiological signal so as to synchronize said system for stimulation with the device for the acquisition of a physiological signal during an acquisition (Paragraph 0016, a system includes, but is not limited to, a personal computing device comprising circuitry for receiving a neural activity signal, the neural activity signal indicative of a physiological status of a subject, circuitry for determining a neural stimulus control signal based at least in part on the neural activity signal, and circuitry for outputting the neural stimulus control signal to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna); and
wherein the digital-to-analog converter (DAC – element 4270) is configured to receive the stimulation digital output and to generate the sensory stimulation comprising at least one stimulus according to the stimulation paradigm by means of the at least one sensory stimulation element (Paragraph 0245),
and wherein the physiological signal is at least one of an electrocardiographic signal, an electroencephalographic signal (Paragraph 0243, The physiological sensor 4245 may include at least one of an electroencephalogram (EEG) sensor, a heart rate sensor, a moisture sensor, a temperature sensor, a bio sensor, a chemical sensor, electrocardiograph (ECG), motion sensor (e.g., accelerometer and/or gyroscope), electromyogram (EMG), pulse oximeter, galvanic response sensor, or a photoplethysmograph probe. Other physiological sensors may also be used to implement the physiological sensor 4245. In some embodiments, the nerve stimulation earpiece 4201 may include multiple physiological sensors 4245), an electroencephalographic signal, a respiratory rate, or a pupil diameter measurement [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.].
Hyde is silent in teaching the microcontroller which comprises receiving, generating, and transmitting at least one stimulus of the sensory stimulation;
Tyler teaches the microcontroller comprises receiving, generating, and transmitting at least one stimulus of the sensory stimulation (Tyler | Paragraphs 0086, 0088-0089, 0125). Hyde teaches the system and Tyler teaches the microcontroller which comprises receiving, generating, and transmitting at least one stimulus of the sensory stimulation (Tyler | Paragraphs 0086, 0088-0089, 0125). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Hyde to incorporate the teachings of the microcontroller containing the functions of receiving, generating, and transmitting at least one stimulus of the sensory stimulation from Tyler because the microcontroller can then serve as a compact tool for real-time analysis of physiological data, which greatly improves feedback regarding targeted electrical stimulation within the brain (Tyler | Paragraphs 0019, 0022).
Additionally, Hyde in view of Tyler is silent in teaching the at least one synchronization signal is a temporal tag configured to time-locking an onset of the at least one stimulus of the sensory stimulation with the related physiological signal and based on the starting time of the at least one stimulus of the sensory stimulation;
Simon teaches at least one synchronization signal is a temporal tag (Simon | reaction time – elements 640 and 648) configured to time-locking an onset of the at least one stimulus of the sensory stimulation with the related physiological signal (Simon | biosensor signal (EEG Signal) – elements 646 and 650; Figure 10; Paragraph 0088; [Examiner’s note, Figure 10 demonstrates the synchronized physiological signal, EEG signal, and reaction time of the user when interacting with the presented stimulus.]) and based on the starting time of the at least one stimulus of the sensory stimulation (Simon | Figure 10; Paragraph 0088). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Hyde in view of Tyler to incorporate the teachings of synchronization signals with time-locking because doing so would allow analyzing the timing of the patient's response to a stimulus, which will offer their physician valuable insights for diagnostic evaluations. This performance data helps the physician make an accurate diagnosis and determine the appropriate treatment plan to assist the patient (Simon | Paragraphs 0003, 0040).
Regarding Claim 20, Hyde in view of Tyler and Simon teaches the invention as discussed above in Claim 16. Tyler in view of Simon is silent in teaching an electroencephalogram (EEG) device or electrocardiogram (EKG) device;
Another embodiment of Hyde teaches the device for the acquisition of a physiological signal is an electroencephalogram device (Hyde | EEG – element 754) or an electrocardiogram device (Hyde | heart rate sensor – element 760; Paragraph 0081, a heart rate sensor 760 (which may be used to heart rhythm variability, as well as heart rate, and may include, but is not limited to, and EKG or pulse-oximeter based heart rate sensor). The neural signal sensor comprises the EEG and the EKG, which provides a neural signal. One having ordinary skill in the art at the time the invention was filed would have found it obvious to combine the neural stimulation system of Hyde in view of Tyler and Simon to incorporate EEG and EKG of another embodiment from Hyde because doing so would allow the collection of additional data, such as heart rate or brain wave activity, while the patient responds to a stimulus. The additional data allows for a more comprehensive analysis of their performance, which facilitates an accurate diagnosis and the creation of an appropriate treatment plan (Hyde | Paragraph 0111).
Regarding Claim 22, Hyde in view of Tyler and Simon teaches the system according to claim 16, wherein the at least one sensory stimulation element is configured to provide auditory stimulation (Hyde | auditory stimulus source – element 828), visual stimulation (Hyde | visual stimulus source – element 834) and/or haptic stimulation (Hyde | haptic stimulator – element 838).
Regarding Claim 23, Hyde in view of Tyler and Simon teaches the system according to claim 16, wherein the micro-controller is pre- programmed and programmable (Hyde | Paragraph 0091, personal computing device 208 can be an audio player, a mobile phone, a computer, or any of various other devices having computing capability (e.g., microprocessor based devices) and including application software and/or suitable hardware for controlling operation of wearable neural stimulation device 202; [Examiner’s note, the device is controlled by hardware and software. For the user to operate the device, it is preprogrammed and also programmable.]).
Regarding Claim 24, Hyde in view of Tyler and Simon teaches the system according to claim 16, wherein the information concerning the stimulation paradigm comprises information concerning a type of stimulation paradigm (Hyde | treatment regimen information – element 2574) and at least one stimulation paradigm parameter (Hyde | Paragraph 0148, secondary input signal may be representative of a physiological parameter of the subject or an environmental parameter of the subject, and may include a signal sensed from a sensor on or associate with neural stimulation device 1314, or a sensor in the environment of the subject, and/or parameters or values derived from such sensed signals).
Regarding Claim 25, Hyde in view of Tyler and Simon teaches the system according to claim 16, further comprising a proprietary non-volatile memory (Hyde | Paragraph 0121, a data processing system generally includes one or more of a system unit housing, a video display, memory such as volatile or non-volatile memory) and a user interface (Hyde | user interface – element 867), notably a screen touch (Hyde | Paragraph 0118, user interface 894, which may include one or more input devices such as a keyboard, button, switch, computer mouse, or touchscreen), through which a user selects the stimulation paradigm to be generated (Hyde | Paragraphs 0015, 0021).
Regarding Claim 26, Hyde in view of Tyler and Simon teaches the system according to claim 16, wherein the stimulation digital output of the microcontroller (Hyde | wireless microcontroller – element 4280) is received by an external stimulation device (Hyde | nerve stimulation earpiece – element 4201), notably the electrical stimulation device configured to deliver somatosensory stimulation (Hyde | Paragraph 0013, a wearable neural stimulation device includes, but is not limited to, a vibratory mechanical stimulator adapted to produce a vibratory stimulus of sufficient frequency and amplitude to modulate the activity of at least one mechanoreceptor with a receptive field on at least a portion of a pinna of a subject, and a securing member configured to secure the vibratory mechanical stimulator to the pinna; [Examiner’s note, mechanical vibration is a form of somatosensory stimulation.]).
Claims 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US 20170027812 A1) in view of Tyler et al. (US 20150174418 A1), Simon et al. (US 20170177023 A1), and Maschino et al. (US 20070179557 A1).
Regarding Claim 27, Hyde teaches a method for the stimulation of a subject (Paragraph 0012, a method includes, but is not limited to, sensing with a neural signal sensor a neural signal indicative of a physiological status of a subject, the neural signal sensor located in or on a portion of a body of the subject, determining with signal analysis circuitry at least one parameter of the sensed neural signal, and delivering a neural stimulus with a neural stimulation device worn on a pinna of the subject responsive to the sensed neural signal, wherein the neural stimulus is configured to modulate the activity of at least one sensory nerve fiber innervating at least a portion of the pinna of the subject) for cognitive evaluation comprising the steps of:
receiving a clinical information concerning a patient (Paragraph 0111, data drawn from one or more neural signals, physiological signals, environmental signals, or other secondary signals (e.g. obtained with secondary sensor 750 in FIG. 7) or secondary inputs (e.g. secondary signal input 800 in FIG. 7), as well as clock or timer information, can be correlated with a mental or emotional state of the subject, reported to a medical care provider or other party, and/or stored in the subject's medical or health records);
receiving a selection of at least one stimulation paradigm obtained on the basis of the clinical information concerning the patient (Paragraph 0110, parameters that are indicative of worsening mental or physical/physiological status of the subject can be reported to a medical care provider so that an appropriate intervention can be made, and/or used as a basis for modulating the delivery of neural stimulation, Paragraph 0203, the therapeutic secondary stimulus is provided via digital media, in the form of a therapy application that provides cognitive training and therapy. The therapy application also performs mental health monitoring. In an aspect, the therapy application includes an interactive survey 2924 displayed on touchscreen 2926 of mobile phone 2906), the stimulation paradigm comprising at least one pattern of a sensory stimulation configured to induce a cognitive process in a stimulated subject (Paragraph 0013, 0015);
receiving an input comprising information concerning the selected stimulation paradigm so as to generate a sensory stimulation comprising at least one stimulus according to said stimulation paradigm and at least one synchronization signal determined by the stimulation paradigm (Paragraph 0016, a system includes, but is not limited to, a personal computing device comprising circuitry for receiving a neural activity signal, the neural activity signal indicative of a physiological status of a subject, circuitry for determining a neural stimulus control signal based at least in part on the neural activity signal, and circuitry for outputting the neural stimulus control signal to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna);
transmitting (first analog output connector – element 4255 and second analog output connector – element 4260) the at least one synchronization signal to a device (nerve stimulation earpiece – element 4201) for acquisition of a physiological signal (physiological signal input – element 4295) acquiring a physiological signal of the patient during a generation of the stimulation (personal computing device – element 4290) wherein the physiological signal is at least one of an electrocardiographic signal, an electroencephalographic signal (Paragraph 0243, The physiological sensor 4245 may include at least one of an electroencephalogram (EEG) sensor, a heart rate sensor, a moisture sensor, a temperature sensor, a bio sensor, a chemical sensor, electrocardiograph (ECG), motion sensor (e.g., accelerometer and/or gyroscope), electromyogram (EMG), pulse oximeter, galvanic response sensor, or a photoplethysmograph probe. Other physiological sensors may also be used to implement the physiological sensor 4245. In some embodiments, the nerve stimulation earpiece 4201 may include multiple physiological sensors 4245), an electroencephalographic signal, a respiratory rate, or a pupil diameter measurement [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]; and
transferring the information concerning the selected stimulation paradigm (personal computing device – element 4290), the physiological signal acquired and the at least one synchronization signal to a database for storage (Paragraph 0016, a system includes, but is not limited to, a personal computing device comprising circuitry for receiving a neural activity signal, the neural activity signal indicative of a physiological status of a subject, circuitry for determining a neural stimulus control signal based at least in part on the neural activity signal, and circuitry for outputting the neural stimulus control signal to a neural stimulation device including an external neural stimulator configured to be carried on a pinna of the subject, wherein the neural stimulus control signal is configured to control delivery of a neural stimulus by the external neural stimulator, the neural stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of the pinna). By broadest reasonable interpretation, one can determine the stimulation paradigm is selected from the personal computing device and a signal is determined.
Hyde is silent in teaching the microcontroller which comprises receiving, generating, and transmitting at least one stimulus of the sensory stimulation;
Tyler teaches the microcontroller comprises receiving, generating, and transmitting at least one stimulus of the sensory stimulation (Tyler | Paragraphs 0086, 0088-0089, 0125). Hyde teaches the system and Tyler teaches the microcontroller which comprises receiving, generating, and transmitting at least one stimulus of the sensory stimulation (Tyler | Paragraphs 0086, 0088-0089, 0125). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Hyde to incorporate the teachings of the microcontroller containing the functions of receiving, generating, and transmitting at least one stimulus of the sensory stimulation from Tyler because the microcontroller can then serve as a compact tool for real-time analysis of physiological data, which greatly improves feedback regarding targeted electrical stimulation within the brain (Tyler | Paragraphs 0019, 0022).
Additionally, Hyde in view of Tyler is silent in teaching the at least one synchronization signal is a temporal tag configured to time-locking an onset of the at least one stimulus of the sensory stimulation with the related physiological signal and based on the starting time of the at least one stimulus of the sensory stimulation;
Simon teaches at least one synchronization signal is a temporal tag (Simon | reaction time – elements 640 and 648) configured to time-locking an onset of the at least one stimulus of the sensory stimulation with the related physiological signal (Simon | biosensor signal (EEG Signal) – elements 646 and 650; Figure 10; Paragraph 0088; [Examiner’s note, Figure 10 demonstrates the synchronized physiological signal, EEG signal, and reaction time of the user when interacting with the presented stimulus.]) and based on the starting time of the at least one stimulus of the sensory stimulation (Simon | Figure 10; Paragraph 0088). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Hyde in view of Tyler to incorporate the teachings of synchronization signals with time-locking because doing so would allow analyzing the timing of the patient's response to a stimulus, which will offer their physician valuable insights for diagnostic evaluations. This performance data helps the physician make an accurate diagnosis and determine the appropriate treatment plan to assist the patient (Simon | Paragraphs 0003, 0040).
Lastly, Hyde in view of Tyler and Simon is silent in teaching the information, concerning the selected stimulation paradigm, is transferred to a database for storage. However, Maschino teaches a database for storage (database - element 240). One having ordinary skill in the art at the time the invention was filed would have found it obvious to modify the neural stimulation device of Hyde in view of Tyler and Simon to incorporating the teachings of the database from Maschino because Maschino teaches in Paragraph 0066, a stimulation parameter module 230 in FIG. 2, may be capable of accessing data from the database 240 based upon data received from the neuro-response analysis module 220. When data can be accessed from a database, then data can be stored within the same database.
Regarding Claim 28, Hyde in view of Tyler, Simon, and Maschino teaches the method according to claim 27, further comprises a step of analyzing the physiological signal acquired and the at least one synchronization signal (Hyde | Paragraph 0143, neural activity signal 1306 may be an unprocessed neural signal, or neural activity signal 1306 may have been subjected to various types and amounts of signal processing, and/or analysis (including, but not limited to filtering, amplification, analog to digital conversion, signal averaging, conversion from time to frequency domain, feature extraction, and so forth).
Regarding Claim 29, Hyde in view of Tyler, Simon, and Maschino teaches the method in Claim 27. Hyde in view of Tyler and Simon is silent in teaching the clinical information is provided by either: a clinical database, or a user, the clinical information being further saved in the clinical database;
Maschino teaches the clinical information is provided by either: a clinical database (database – element 240), or by a user, the clinical information being further saved in the clinical database [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]. One having ordinary skill in the art at the time the invention was filed would have found it obvious to modify the neural stimulation system of Hyde in view of Tyler, Simon, and Maschino to incorporate the teaching of the database from Maschino because Maschino teaches in Paragraph 0066, the system 205 may also comprise a database 240 that may provide a tabulation of various patient characteristics to particular neuro-transmission parameters. Consultation into the database 240 may provide correlation between the types of internal stimulation that may be desirable based upon various physiological parameters of a particular patient. A stimulation parameter module 230 in FIG. 2, may be capable of accessing data from the database 240 based upon data received from the neuro-response analysis module 220. It would have been notoriously obvious to a skilled artisan to incorporate a database where clinical information can be provided by the user, through the medical device, or through the database. The clinical information would need to obviously be included, within the database, for the device to function. Thus, allowing for the clinic to provide support for the user’s needs.
Regarding Claim 30, Hyde in view of Tyler, Simon, and Maschino teaches the method according to claim 27, further comprising a step of generating a report (Hyde | report – element 2576) comprising the results of the analysis step and the information concerning the stimulation paradigm selected (Hyde | Paragraph 0184, report 2576 is generated by reporting circuitry 2578 and stored in data storage circuitry 2566 in addition to, or as an alternative to, providing report 2576 to a recipient).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SRISTI DIVINA GOMES whose telephone number is (571)272-1356. The examiner can normally be reached Monday-Thursday: 7:30-4:30 & Friday 7:30-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
Prosecution Insights