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 § 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.
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 1, 4, 7-12, 16-17, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Simon (US 20120150545 A1- Cited by applicant) and further in view of Nwulia (US 20150118335 A1- Cited by applicant) and Ghajar et al. (US 20150126899), hereinafter Ghajar.
Regarding claims 1 and 16-17, Simon teaches a system for measuring neurologic function of a subject (see abstract, “The system analyzes and assesses a personalized biometric brain health signature”), the system comprising:
an odorant generator configured to deliver an odorant stimulation to the subject (see para. [0069], “An "electronic system" as used herein is intended to encompass, without limitation, hardware, software, firmware, analog circuits, DC coupled or AC coupled circuits, digital circuits, FPGA, ASICS, visual displays, audio transducers, temperature transducers, olfactory and odor generators, or any combination of the above”(emphasis added));
a plurality of electrodes configured to be attached to the subject at respective different locations, wherein the plurality of electrodes are configured to collect neural signals from the subject that are generated by the odorant stimulation (see para. [0072-75] and fig. 2, a plurality of electrodes are used to determine brain health);
a handheld control unit, with a signal processor, configured to process the neural signals from the plurality of electrodes and generate an assessment of neurologic function of the subject (see para. [0007,0078,0085,0175-177], “the systems and methods relate to assessing the brain health of a subject by applying at least one portable EEG electrode to the scalp; recording EEG signals in various brain states such as: resting states, while experiencing various standardized sensory inputs, while completing cognitive tasks, and while undergoing various other challenges, like a respiratory C0.sub.2 challenge; transferring the data directly to an electronic device, such as a cell phone, a PDA or a computer; and processing the signal to create a personalized physiological brain health biometric signature to, for a non-limiting example, monitor disease progression, optimize treatment and therapy, and/or to provide biofeedback therapy” indicating that an electronic device, e.g., handheld, phone, etc., is configured to process signals and generate an assessment).
Simon fails to teach wherein the handheld control unit configured to control the odorant generator.
Nwulia teaches a system for treating users afflicted with neuro-disorders (see abstract), the system comprising: an air source (see para. [0044,0048] and fig. 2, the system comprises an air pump/fan to provide odorless air); an odorant (see para. [0019] and fig. 3, the odorant chamber is configured to generate a stream of odorized air); and a controller configured to direct odorized air to the subject via the intranasal delivery assembly (see para. [0019] and fig. 3, a microcontroller, e.g., handheld Arduino, can control the first stream and second stream via a flowmeter, open/close the first and second solenoid valves and direct the odorized/odorless air toward to the subject via the IDA; “the device can be portable and have a user-friendly LCD screen menu options (FIG. 3, under Aim 1),”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Simon, such that the control unit is configured to control the odorant generator, as taught by Nwulia, because Simon requires an odorant generator to deliver unique odorants but fails to provide details, and Nwulia teaches that a control unit can be used to deliver odorants. Additionally, the modification is merely combining prior art elements (odorant generators) according to known methods (control unit configured to control odorant generator) to yield predictable results.
Simon-Nwulia fail to teach generating the assessment of neurologic function of the subject comprises generating a composite index from the neural signals, the composite index comprising a combination of olfactory electroencephalogram (EEG) data and epileptiform and non-epileptiform abnormal EEG data, each individually capable of assessing mild traumatic brain injury (mTBI), and then comparing the composite index to a previous baseline composite index obtained from the subject.
Ghajar teaches a system and method for provides a plurality of stimuli to a subject and records the responses to calculate a composite index (see para. [0024] and abstract). Ghajar further teaches that the index is then compared to a previous baseline composite index obtained from the subject to assess mild traumatic brain injury (see para. [0024,0082], “the system uses the recorded information to calculate a current performance index for the subject, and compares the current performance index to a baseline performance index for the subject as a diagnostic to measure the effects any of: a traumatic brain injury, intoxication, dementia, and/or fatigue”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Simon-Nwilia, such that a composite index is calculated based on a plurality of subject data, and compared to a baseline index, as taught by Ghajar, to aid in assessing mTBI and/or the subjects cognitive ability (see para. [0073,0082]).
It follows, the composite index is generated from the subject information (see para. [0073] of Ghajar) including the neural signals of Simon (see fig. 2). The neural signals being comprising a combination of olfactory EEG data, and epileptiform and non-epileptiform abnormal EEG data (see para. [0190,0215] of Simon, “Many neurological diseases are insidious and once diagnosed can progress at unpredictable rates with differential response to therapies. By allowing assessment of a wide variety of neurological circuits, the present invention can be customized to track progression and treatment response of a wide variety of disorders to include peripheral nervous system disorders such as neuropathies, retinal dysfunction, hearing disorders as well as many central nervous system disorders, which include but are not limited to multiple sclerosis, myelopathies, cranial nerve disorders, spinal cord and brain trauma, stroke, epilepsy, dementia, and schizophrenia” indicating that the EEG can comprise epileptiform and non-epileptiform data).
Regarding claims 7 and 21, Simon teaches an auditory generator configured to deliver an audible stimulation to the subject, and wherein the plurality of electrodes are configured to collect neural signals from the subject that are generated by the odorant stimulation and the audible stimulation, and wherein the composite index further comprises auditory EEG data capable of assessing mTBI (see para. [0072-75,0101], a plurality of electrodes are used to determine brain health based on a plurality inputs from audio transducers and odor generators).
Regarding claim 8, Simon teaches wherein the handheld control unit is further configured to control the auditory generator to deliver the audible stimulation to the subject, and wherein the composite index further comprises auditory EEG data capable of assessing mTBI (see para. [0098,0147,0215,0219], “Another important aspect of the present invention is its ability to be conducted remotely. Thus, because of the simplicity and portability of the headset, it is possible to collect EEG data remotely using an internet connection to control the remote data collection PC while the headset rests on the test subject far away from the data collection specialist.” and “Through a remote Internet connection and simultaneous telephone call, the data collection specialist was able to remotely collect data, controlling the local PC in Manhattan and guide the participant through the data collection paradigm” (emphasis added) indicating that the handheld control unit is capable of controlling the auditory generator/earphones).
Regarding claim 9, Simon teaches wherein the auditory generator is configured to deliver an audible stimulation to the subject via one or more earbuds worn by the subject (see para. [0219] and fig. 32).
Regarding claims 10 and 22, Simon teaches a vibrotactile generator stimulator configured to generate somatosensory stimulation to the subject, and wherein the plurality of electrodes are configured to collect neural signals from the subject that are generated by the odorant stimulation and the somatosensory stimulation, and wherein the composite index further comprises somatosensory EEG data capable of assessing mTBI. (see para. [0101,0103,0150,0176], “stimuli can be any one of the five senses, including visual or optical stimuli, auditory stimuli, olfactory stimuli, taste stimuli to the tongue or gastrological stimulation to the stomach, or touch stimuli to various components of the skin”, “sensory modalities such as vibration and proprioception can be used with the alpha attenuation paradigm to determine intactness of the specific nerve fibers and neuroanatomical pathways involved”, “sensory input approaches can also be taken for other categories of sensory information such as sound, smell, taste, touch, and balance”, and “and vibration at different frequencies, can be evaluated” (emphasis added) indicating that the invention comprises requires a vibrotactile stimulator in order to evaluate vibration (somatosensory stimulation) at different frequencies as a result ).
Regarding claim 11, Simon teaches wherein the handheld control unit is further configured to control the vibrotactile stimulator to deliver the somatosensory stimulation to the subject, and wherein the composite index further comprises somatosensory EEG data capable of assessing mTBI (see para. [0098,0101,0206,0214], cell phone/computer can be used to control the sensors/elements, remotely, to conduct brain health assessment).
Regarding claim 12, Simon teaches wherein the vibrotactile stimulator is configured to deliver the somatosensory stimulation to skin of the subject (see para. [0177], “These inputs can also be selectively applied to either of the two eyes, ears, nostrils, and various parts of the tongue and skin”(emphasis added)).
Regarding claim 20, Simon-Nwulia teach wherein the delivering the odorant stimulation comprises delivering the odorant stimulation birhinally (see fig. 3 of Nwulia, cannula goes into both nostrils). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Simon-Nwulia, because Simon requires delivering odorants, but fails to provide details, and Nwulia teaches it can be done via nostril of subject.
Claims 2 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Nwulia and Ghajar, as applied to claim 1, further in view of Hayes et al. ( US 6325475 B1- Cited by Applicant), hereinafter Hayes.
Regarding claims 2 and 18, Simon-Nwulia-Ghajar fail to teach wherein the neural signals comprise neurological measurements of olfactory evoked potentials and olfactory event related potentials. It is noted that Simon teaches “By "electrode to the scalp" we mean to include, without limitation, those electrodes requiring gel, dry electrode sensors, contactless sensors and any other means of measuring the electrical potential or apparent electrical induced potential by electromagnetic means”, “the electrical potentials are recorded and processed in the EEG hardware 42”, and “the "Sniffin' Sticks" threshold and identification test and analyzed chemosensory event-related potentials, that PTSD severity correlated significantly with odor identification scores and with parameters of event-related potentials in response to unpleasant stimuli. The results indicate preferential processing of unpleasant stimuli in PTSD patients irrespective of childhood history. With this, the systems and methods of the present invention include the use of olfactory stimulation, but rather than evaluate event-related potentials as Croy employed, the present invention aims to assess changes in state due to olfactory stimulation rather than sub second timing responses. This is very different than event related potentials. Nonetheless, Sniffin Sticks and the like are clearly important stimulants for evaluation of their effect on the PSD and other non-linear dynamics and wavelet biometrics in both healthy and disease or brain injured states” in para. [0063,0076,0123], indicating that measuring event related potentials and electrical potential, e.g., olfactory evoked potentials, can be used to assess neurologic function, e.g., PTSD).
Hayes teaches a nasal device for introducing fluids into the nostril of the user that allows for only odor to be detectable by the subject, other cues associated with delivering the fluids are not, such as pressure, temperature, sound, humidity (see ABSTRACT and column 9, 12, and 37 [lines 28-42; 40-47; 48-62]). Hayes further teaches measuring olfactory evoked potentials and olfactory event related potentials (see col. 33, 36 and 37 [lines 48-50; 60-63; 13-28]).
As such it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Simon-Nwulia-Ghajar, such that OEPs and OERPs are measured, as taught by Hayes, to aid in determining whether robust and marked electrophysiological signs of dysfunctional olfactory signal processing can be found in the brains of Alzheimer's diseased patients (see col. 36 [lines 52-55]). Additionally, the combination would merely be applying a known technique (measuring OEPs and OERPs) to a known device (assessing neurologic function system) ready for improvement to yield predictable results.
Claims 6 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Nwulia and Ghajar, as applied to claim 1, further in view of Smith et al. ( US 20160287161- Cited by Applicant), hereinafter Smith.
Regarding claim 6, Simon-Nwulia-Ghajar fail to teach wherein the odorant generator comprises an odorant cartridge configured to aerosolize a liquid odorant contained therewithin.
Smith teaches a system, method, and device for testing the user's olfactory system's odor detection ability by providing an odorant via an odor-delivery cartridge (see ABSTRACT and para. [0030]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Simon-Nwulia, such that the odorant generator comprises an odorant cartridge, as taught by Smith, to confine, preserve, and ensure quality of the aerosolized odorant (see para. [0041] of Smith). Additionaly, Simon requires an odorant generator to deliver odors, but fails to provide details, and Smith teaches it can be performed using an odorant cartridge configured to aerosolize a liquid odorant.
Regarding claim 24, Simon-Nwulia-Ghajar fail to teach comparing composite index of subject to a normative composite index of sensory and cortical measurements of known neurologic function.
Smith teaches a system for automated, standardized assessment and analysis of a human olfactory system's odor detection ability as an indicator or predictor of cognitive impairment or change in cognitive health, and other health conditions such as diabetes (see abstract). The analysis is based comparing test results of subject to a normative population’s measurements related to sensory inputs and cortex regions, neurologic function, diseases, and medical history of the population being known (see para. [0015,0082,0142-143], “Another advantage of this approach is in providing testing of a new patient and comparing their test results with a normative appropriate demographic population where all olfactory measures were collected with identical, standardized odorants”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Simon-Nwulia-Ghajar, such that comparing composite index of subject to a normative composite index of sensory and cortical measurements of known neurologic function is performed, as taught by Smith, to aid in indicating cognitive impairment or change in cognitive health, and other health conditions such as diabetes.
Response to Arguments
Applicant's arguments filed 06/04/2025 have been fully considered but they are not fully persuasive.
Applicant’s arguments with respect to rejection of independent claims have been considered but are moot because amendments require new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Greenwald teaches combining the data and/or the results into correlative measures may yield new indices that are more sensitive to the alert event. For example, the system 10 can utilize a combination of the measured parameter, the parameter result and/or the alert event to create a risk assessment index. (US 20190290201 A1)
Samec teaches as a result, among other things, the duration of the data collection, the variety of the data, the variety of locations of the data collection, and the ability to collect multiple types of data simultaneously (thereby allowing different data to be cross-referenced, e.g., using time stamps and/or location stamps applied to all of the data), may increase the accuracy of any analysis performed on a user and may reveal relationships. (US 20170365101 A1)
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791