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
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 2, 3, 5, 10, 12, 13, 16, 18, 20, 30, 31, 33, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (US 20200069239 A1 – Cited by Applicant), hereinafter Tsai, in view of Anson (US 20200107767 A1 – Cited by Applicant).
Regarding claim 2, and substantially similar limitations in claim 3, Tsai discloses A method of diagnosing and treating a patient afflicted with attention-deficit/hyperactivity disorder (ADHD), comprising:
(a) measuring a blink reflex in a patient suspected to be afflicted with ADHD, the measurement [to measure and/or obtain information associated with a blink reflex and/or blink period of the subject, see in ¶ 0034 and Fig. 1D] comprising:
(i) applying a non-electrical stimulus to an eye of the patient to induce a blink reflex [a reflexive blink of the subject in response to one or more different types of stimulation (e.g., electrical, mechanical, acoustic, optical, or some other type of stimulation) directly to the eye, eye lid, eye lashes, or proximity of the eye, see in ¶ 0045] and
(ii) assessing one or more blink-associated parameters [analyze a blink reflex, see in ¶ 0160];
(b) diagnosing the patient as afflicted with ADHD or not afflicted with ADHD by comparing the one or more blink-associated parameters to equivalent one or more blink-associated parameters from a patient who is not afflicted with ADHD [The metric obtained can be used to quantify deviations from population norms that will allow quantifiable measures of diagnoses that are currently described qualitatively, see in ¶ 0053; Blink reflex device 100 may be configured to compare the measured blink reflex, blink period, or a brain reflex to a baseline blink reflex, blink period, or some other brain reflex to identify an amount difference between the measured blink reflex, blink period, or brain reflex and the baseline blink reflex, blink period, or some other brain reflex, respectively … the various baseline measurements described herein may be obtained by other means, including but not limited to a population average, an average based on a subset of the population similar to the subject, an average based on a regional population, information obtained from medical journals or treatises, or a measurement taken at a time when the subject is known not to be suffering from a neurological condition. In some embodiments, multiple sources of baseline measurements may be combined to further refine one or more baseline measurements, see in ¶ 0046]; and
(c) administering an effective amount of an ADHD treatment, optionally a medication, to a patient diagnosed as afflicted with ADHD [Such an indication may enable the user, of blink reflex device 100, to decide to prohibit the subject from resuming normal activity and/or by seeking immediate medical treatment for the subject, see in ¶ 0150].
Examiner notes that although Tsai discloses a method to monitor the neurological condition of a subject, Tsai fails to explicitly disclose wherein the neurological condition of the subject is Attention-Deficit Hyperactivity Disorder (ADHD).
However, Anson discloses wherein ocular variables, such as blink reflex, can be used to assess mental dysfunction, particularly ADHD [see in ¶ 0001; see also in ¶ 0034].
Tsai and Anson are both analogous to the claimed invention because they are in the same field of assessing the neurological condition of a subject. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Tsai to incorporate the teachings of Anson to include that measuring blink reflex parameters can be used to diagnose ADHD, as ADHD is also a neurological condition that can be quantifiably assessed with ocular variables such as blink reflex
Regarding claim 5, Tsai, as modified, discloses the method of claim 2, wherein the diagnosing comprises: diagnosis of disease onset; determination of disease stage and/or severity; determination of disease progress; and/or determination of cognitive state and/or mental capacity [that identifies whether the subject suffers from a neurological condition and/or a level of severity of such a neurological condition, see in ¶ 0040].
Regarding claim 10, Tsai, as modified, discloses the method of claim 2, wherein the method measures latency until physiological response to stimulus [Blink reflex device 100 may measure a time period from when stimulation is received within the proximity of the eye of the subject to when the subject initiates or begins to blink (e.g., when one or more of the subject's eyelids, in an open state, begin to close) in response to the stimulation (hereinafter “individual latency”), see in ¶ 0043].
Regarding claim 12, and substantially similar limitations in claim 13, Tsai, as modified, discloses the method of claim 2, wherein the non-electrical stimulus is one or more physical stimuli [Stimulators 102 may provide mechanical stimuli (e.g., a puff of fluid, etc.) and/or some other type of stimuli (e.g., light, acoustic, electrical, etc.) to the subject, see in ¶ 0034; stimulator 102 may include one or more components to provide mechanical, electrical, optical, and/or acoustic stimulation to a subject, to trigger a blink reflex in the subject. The stimulation may excite certain neural pathways in the brain and/or nervous system of the subject, which may trigger the blink reflex, see in ¶ 0035].
Regarding claim 16, Tsai, as modified, discloses the method of claim 2, wherein the non-electrical stimulus is compressed air and is applied across the eye, and/or wherein the non-electrical stimulus is applied to the canthus or outer canthus [one to three air puffs over a 20 second time frame to the outer corner of either the right or left eye, see in ¶ 0160].
Regarding claim 18, Tsai, as modified, discloses the method of claim 2, wherein the blink reflex is measured with a high-speed camera, is measured by capturing and analyzing high-definition video, and/or is measured with a blink reflex monitoring device [High speed videography was employed with air puffs, see in ¶ 0159], wherein the blink reflex monitoring device is a wearable device or a handheld device [see blink reflex device 100 in Fig. 1A and ¶ 0032].
Regarding claim 20, Tsai, as modified, discloses the method of claim 2, wherein the blink reflex is not measured with an electromyoqraphy (EMG) sensor or device [a sensor 215 (shown in FIG. 1B), such as a camera, see in ¶ 0032].
Regarding claim 30, Tsai, as modified, discloses wherein the measuring of a blink reflex, comprises: providing a blink reflex monitoring device to a user [blink reflex device 100, see in ¶ 0032 and Fig. 1A], the blink reflex monitoring device having an air compression system including a compressed air source and a valve [Tubing connected to the left end of the housing unit delivers a puff of compressed air to the subject’s eyes, see in ¶ 0027]; outputting a first burst of compressed air from the compressed air source through the valve at a first pressure; detecting a presence or an absence of a blink in response to the first burst of compressed air source at the first pressure; if the blink is present, then measuring a duration between the output of the first burst of compressed air at the first pressure and the blink to determine the blink reflex [The puff of fluid may make contact with one or both eyes of the subject under sufficient velocity and/or pressure in a manner that causes a blink reflex in the subject that can be detected and measured by sensor 215 in a manner similar to that described above with respect to FIGS. 6A and 6B (e.g., by tracking the movement of upper eyelid tracking point 525 and/or lower eyelid tracking point 530, see in ¶ 0099]; and if the blink is absent, then outputting a second burst of compressed air from the compressed air source at a second pressure, the second pressure being greater than the first pressure and measuring a duration between the output of the second burst of compressed air at the second pressure and the blink to determine the blink reflex [The flow assemblies 202a and 202b may be positioned to stimulate each of the subject's eyes simultaneously or separately as further described herein, see in ¶ 0054; The first and second flow assemblies 202a and 202b may also, or alternatively, be installed in and/or attached to housing 101. Additionally, or alternatively, the air flow assemblies 202a and 202b may output the puff of air based on an instruction received from processing unit 400 and/or may output a signal to processing unit 400 indicating that the puff of air has been output by at least one of the first and second air flow assemblies 202a and 202b, see in ¶ 0099].
Regarding claim 31, and substantially similar limitations in claim 33, Tsai, as modified, discloses the method of claim 2, wherein the one or more blink- associated parameters are selected from:(a) latency, optionally in milliseconds, comprising a time differential between stimulation and eyelid movement, e.g., one or more of upper eyelid or lower eyelid;(b) differential latency, optionally in milliseconds, comprising a time differential between the start of ipsilateral eye movement and the start of contralateral eye movement [individual latency, differential latency, lid velocity, log of time to close, and log of number of oscillations (FIGS. 15 and 16). Specifically, head impacts resulted in decreased individual latency (p=0.017), increased differential latency (p=0.001), decreased log of the time to close (p=0.012); and increased oscillations (p=0.008) (FIG. 14C), see in ¶ 0181]; (c) delta 30, comprising a time difference between ipsilateral eye and contralateral eye movement;(d) eyelid excursion, optionally in pixels, comprising a distance traveled by the eyelid from the tonic lid position to closed position;(e) initial lid velocity, optionally in pixels/msec, comprising an average eyelid speed following start of eyelid movement, e.g., the first about 5 frames, the first about 7 frames, or the first about 10 frames; (f) time to close, optionally in log scale, comprising a time for lid to travel from tonic lid position to the closed position; (g) time to open, optionally in log scale, comprising a time for lid to travel from closed position back to tonic lid position; (h) time under threshold, optionally in log scale, comprising a time that the eyelid spends below the threshold position; (i) number of oscillations, comprising cycles of up and down upper eyelid movement after a stimulated blink; (j) total blink time, optionally in log scale, comprising a time from start of eyelid movement until it returns to its tonic lid position; (k) number of blinks; (I) blink rate, optionally per minute; (m) area under curve, optionally in pixels; (n) maximum closing velocity, optionally in milliseconds, comprising a maximum velocity during eyelid closure; (o) maximum opening velocity, optionally in milliseconds, comprising a maximum velocity during eyelid opening; and (p) time to first oscillation, optionally in log scale, comprising the elapsed time between the eyelid returning within threshold of a tonic position for a stimulated blink and the onset of the next unstimulated blink.
Regarding claim 49, Tsai, as modified, discloses the method of claim 2.
Tsai fails to disclose wherein the patient is experiencing symptoms associated with combined type ADHD, symptoms associated with predominantly inattentive type ADHD, and/or symptoms associated with predominantly hyperactive-impulsive type ADHD.
However, Anson discloses the patient is experiencing symptoms associated with combined type ADHD, symptoms associated with predominantly inattentive type ADHD, and/or symptoms associated with predominantly hyperactive-impulsive type ADHD [by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development, see in ¶ 0002].
Tsai and Anson are both analogous to the claimed invention because they are in the same field of assessing the neurological condition of a subject. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Tsai to incorporate the teachings of Anson to include that the patient is experiencing symptoms associated with combined type ADHD, symptoms associated with predominantly inattentive type ADHD, and/or symptoms associated with predominantly hyperactive-impulsive type ADHD, as those cover symptoms of most ADHD types.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US 20200069239 A1 – Cited by Applicant) in view of Anson (US 20200107767 A1 – Cited by Applicant), further in view of Matharu (US 20200013509 A1 – Cited by Applicant).
Regarding claim 11, Tsai, as modified, discloses the method of claim 2.
Tsai fails to disclose wherein the blink reflex correlates with functionality of one or more of the trigeminal and facial nerves.
However, Matharu discloses wherein the blink reflex correlates with functionality of one or more of the trigeminal and facial nerves [Trigeminal neuralgia, squeezing your eyelinds, question 101, see in Appendix 2, Algorithm 15].
Tsai and Matharu are both analogous to the claimed invention because they are in the same field of diagnosing neurological conditions. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified the Tsai to incorporate the teachings of Matharu and include that the blink reflex correlates with functionality of one or more of the trigeminal and facial nerves as the trigeminal nerve is responsible for sensation and blink reflexes are triggered when trigeminal nerve function is present and can register the stimulation.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US 20200069239 A1 – Cited by Applicant) in view of Anson (US 20200107767 A1 – Cited by Applicant), further in view of Walsh (US 20180279870 A1).
Regarding claim 24, Tsai, as modified, discloses wherein the blink reflex monitoring device has or comprises: a front end, a back end, a first plane extending through the front end and the back end, a second plane intersecting the first plane between the front end and the back end, the back end configured to receive a portion of a face of a user and disposed opposite the front end [front end is towards 103, back end is towards 106, where the flexible material receives a portion of a face of a user, see Fig. 1A and ¶ 0033].
Tsai, as modified, still fails to disclose wherein the blink reflex monitoring device has or comprises: a strap coupled to the blink reflex monitoring device and having a first position and a second position, wherein in the first position the strap extends away from the blink reflex monitoring device along the first plane end and is configured to secure the blink reflex monitoring device to a head of a user and in the second position the strap extends below the blink reflex monitoring device along the second plane and is configured to support the blink reflex monitoring device above a surface.
However, Walsh discloses a device that comprises a strap to be secured around the wearer’s face [the mask 100 may be removably attached to the wearer with an adhesive, an elastic band, a Velcro band, a strap, a buckle, a clip, and/or any other suitable fastener or mechanism, see in ¶ 0072; Examiner notes that one strap can also be configured to secured on the surface of a table in order to support the device].
Tsai and Walsh are both analogous to the claimed invention because they are in the same field of eye testing. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Tsai to incorporate the teachings of Walsh to include that the device comprises a strap to be able to secure to the head of the user and to the surface below the device for support in order to ensure that the device will be in proper position for further testing.
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US 20200069239 A1 – Cited by Applicant) in view of Anson (US 20200107767 A1 – Cited by Applicant), further in view of Walsh (US 20180279870 A1) and Haerich (Haerich, P. Using airpuffs to elicit the human blink reflex. Behavior Research Methods, Instruments, & Computers 30, 661–666 (1998)).
Regarding claim 25, and substantially similar limitations in claim 26, Tsai, as modified, discloses the method of claim 2, wherein the blink reflex monitoring device has or comprises: a front end and a back end, the back end configured to receive a portion of a face of a user and disposed opposite the front end [front end is towards 103, back end is towards 106, where the flexible material receives a portion of a face of a user, see Fig. 1A and ¶ 0033] and an air compression system including a source of compressed air and a valve [Tubing connected to the left end of the housing unit delivers a puff of compressed air to the subject’s eyes, see in ¶ 0027].
Tsai, as modified, still fails to disclose wherein the blink reflex monitoring device has or comprises: at least one strap coupled to the blink reflex monitoring device proximate the back end, the at least one strap configured to be secured around a head of a user; and the air compression system disposed within the blink reflex monitoring device and the valve configured to output compressed air from the back end at a pressure of about 3 PSI to about 60 PSI.
However, Walsh discloses a device that comprises a strap to be secured around the wearer’s face [the mask 100 may be removably attached to the wearer with an adhesive, an elastic band, a Velcro band, a strap, a buckle, a clip, and/or any other suitable fastener or mechanism, see in ¶ 0072; Examiner notes that one strap can also be configured to secured on the surface of a table in order to support the device].
Tsai and Walsh are both analogous to the claimed invention because they are in the same field of eye testing. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Tsai to incorporate the teachings of Walsh to include that the device comprises a strap to be able to secure to the head of the user and to the surface below the device for support in order to ensure that the device will be in proper position for further testing.
Tsai, as modified by Walsh, still fails to disclose wherein the air compression system disposed within the blink reflex monitoring device and the valve configured to output compressed air from the back end at a pressure of about 3 PSI to about 60 PSI.
However, Haerich discloses outputting compressed air at a pressure of less than about 30 PSI is sufficient to stimulate the blink reflex [selecting a regulator where the maximum outflow pressure is less than about 200 kPa or 30 psi will help to provide sufficient sensitivity in setting the stimulus intensity, see on pg. 662, Col. 2, first paragraph].
Tsai and Haerich are both analogous to the claimed invention because they are in the same field of measuring blink related parameters. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Tsai to incorporate the teachings of Haerich to include that the air compression system disposed within the blink reflex monitoring device and the valve configured to output compressed air from the back end at a pressure of about 3 PSI to about 60 PSI in order to outflow air with a pressure strong enough to elicit a blink reflex of the subject [see Haerich pg. 662, Col. 2, first paragraph].
Claims 40 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US 20200069239 A1 – Cited by Applicant) in view of Anson (US 20200107767 A1 – Cited by Applicant), further in view of Fried et al. (Fried, M., Tsitsiashvili, E., Bonneh, Y. S., Sterkin, A., Wygnanski-Jaffe, T., Epstein, T., & Polat, U. (2014). ADHD subjects fail to suppress eye blinks and microsaccades while anticipating visual stimuli but recover with medication. Vision Research, 101, 62–72.), hereinafter Fried.
Regarding claim 40, Tsai, as modified, discloses the method of claim 2.
Tsai fails to disclose wherein the patient afflicted with ADHD, in comparison to a patient that is not afflicted with ADHD, exhibits one or more of: decreased latency; decreased differential latency; decreased delta 30; increased eyelid excursion; increased initial lid velocity; increased time to close ;increased time to open; increased time under threshold; increased number of oscillations; increased total blink time ;increased number of blinks; increased blink rate; increased area under curve; increased maximum closing velocity; increased maximum opening velocity; and increased time to first oscillation.
However, Fried discloses wherein the patient afflicted with ADHD, in comparison to a patient that is not afflicted with ADHD, exhibits one or more of: decreased latency; decreased differential latency; decreased delta 30; increased eyelid excursion; increased initial lid velocity; increased time to close ;increased time to open; increased time under threshold; increased number of oscillations; increased total blink time ;increased number of blinks; increased blink rate [the average blink rate in the unmedicated ADHD group is significantly higher than in Control-1 (p=0.033,two-samplet-test), with no significant change between Control-1 and Control 2 (p=0.398) or medicated ADHD and Control-2 (p=0.255, two-sample t-test), see on pg. 65, Col. 1]; increased area under curve; increased maximum closing velocity; increased maximum opening velocity; and increased time to first oscillation.
Tsai and Fried are both analogous to the claimed invention because they are in the same field of correlating eye blink parameters to neurological conditions. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Tsai to include the teachings of Fried and include that a patient afflicted with ADHD has an increased blink rate compared to a patient not afflicted with ADHD, as blink rate can be a quantifiable indication of the presence of ADHD.
Regarding claim 47, Tsai, as modified, discloses the method of claim 2.
Tsai fails to disclose wherein the ADHD is diagnosed by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, and/or wherein the ADHD comprises one or more symptoms selected from being easily distracted, forgetful, daydreaming, disorganization, poor concentration, difficulty completing tasks, excessive fidgetiness and restlessness, hyperactivity, difficulty waiting and remaining seated, immature behavior, and/or destructive behavior.
However, Fried discloses the ADHD is diagnosed by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria [see on pg. 62 Col. 1 and pg. 63 Col. 2; Examiner notes that although DSM-5 is mentioned, the actual participants were diagnosed previously using DSM-4 criteria. However, it would be obvious to use the fifth edition of DSM to diagnose participants in present and future studies, as DSM-5 is now the most updated edition.].
Tsai and Fried are both analogous to the claimed invention because they are in the same field of correlating eye blink parameters to neurological conditions. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Tsai to include the teachings of Fried and include that the ADHD is diagnosed by Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria in order to clinically diagnose using an internationally recognized framework.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US 20200069239 A1 – Cited by Applicant) in view of Anson (US 20200107767 A1 – Cited by Applicant), further in view of Bird (US 20110207718 A1 – Cited by Applicant).
Regarding claim 54, Tsai, as modified, discloses the method of claim 2.
Although Tsai as modified discloses administering an ADHD treatment, Tsai fails to explicitly disclose wherein the method further comprises prescribing an ADHD treatment as a function of the blink reflex, and/or wherein prescribing comprises changing a prescription from a first ADHD medication to a second ADHD medication, and/or wherein the method further comprises determining a level of adherence to ADHD treatment as a function of the blink reflex.
However, Bird discloses wherein the method further comprises prescribing an ADHD treatment as a function of the blink reflex [We therefore propose that the eye blink reflex might prove to be a useful and simple clinical marker for measuring an individual's alteration in cerebral function, on commencing the therapeutic intervention of a low dose of anti-epileptic drug, see in ¶ 0324].
Tsai and Bird are both analogous to the claimed invention because they are in the same field of correlating blink parameters to neurological conditions. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Tsai to include the teachings of Bird and include that the method further comprises prescribing an ADHD treatment as a function of the blink reflex as most ADHD treatments involve prescribing some form of medication to the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m..
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/HY KHANH DOAN/ Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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