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 3, 4, 6, 13, 14, 19, 20, 31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Leonardi et al. (US 20140016097 A1 – Cited by Applicant), hereinafter Leonardi, in view of Tsai et al. (US 20200069239 A1 – Cited by Applicant), hereinafter Tsai.
Regarding claim 3, Leonardi discloses a method of diagnosing and treating a patient afflicted with a headache, comprising:
(a) measuring a blink reflex in a patient suspected to be afflicted with a headache [monitoring of these ophthalmic parameters, and in particular the monitoring of the intraocular pressure, can be used according to the invention for detecting and/or diagnosing brain diseases, like headache or intracranial hypertension for example, see in ¶ 0002], the measurement comprising:
(i) applying a stimulus to an eye of the patient to induce a blink reflex [the response of an eye to an eye blink stimulation, see in ¶ 0044] and
(ii) assessing one or more blink-associated parameters [monitoring the intraocular pressure (IOP) of the eye during at least one eye blink cycle and measuring, displaying, analyzing and/or characterizing the measured data, see in ¶ 0044]; and
(b) diagnosing the patient as afflicted with a headache or not afflicted with a headache 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 a headache [partly automatically analyzed and compared for example with typical values of a healthy eye for automatic detection of significant differences, automatic determination of the condition responsible for the detected differences, and/or automatic diagnosis of a pathology related to the determined condition, see in ¶ 0052]; and
(c) administering an effective amount of a headache treatment to a patient diagnosed as afflicted with a headache [in order to determine the suitable treatment and/or in order to follow up the patient and manage the disease with a tailored treatment, see in ¶ 0006].
Leonardi fails to explicitly disclose that the stimulus is non-electrical.
However, Tsai discloses using non-electrical stimuli to trigger a blink reflex in the subject [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].
Leonardi and Tsai are both analogous to the claimed invention because they are in the same field of measuring blink parameters to monitor neurological functional status. 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 Leonardi to incorporate the teachings of Tsai to include that non-electrical stimuli were used to trigger blink reflexes in order to target a particular neural pathway that causes a blink reflex [The different types of stimulation may trigger different neural pathways within, and/or neurological functions of, the brain to cause the blink reflex. Thus, measuring the blink reflex using different types of stimulation may enable a type of neurological impairment within the brain to be identified and/or a specific location or structure, within the brain, that has been injured or impaired, to be identified, see in Tsai ¶ 0045].
Regarding claim 4, Leonardi discloses a method of selecting a headache treatment for a patient afflicted with a headache, comprising:
(a) measuring a blink reflex in the patient afflicted with a headache [monitoring of these ophthalmic parameters, and in particular the monitoring of the intraocular pressure, can be used according to the invention for detecting and/or diagnosing brain diseases, like headache or intracranial hypertension for example, see in ¶ 0002], the measurement comprising:
(i) applying a stimulus to an eye of the patient to induce a blink reflex [the response of an eye to an eye blink stimulation, see in ¶ 0044] and
(ii) assessing one or more blink-associated parameters [monitoring the intraocular pressure (IOP) of the eye during at least one eye blink cycle and measuring, displaying, analyzing and/or characterizing the measured data, see in ¶ 0044]; and
(b) selecting a headache treatment for the patient afflicted with a headache by comparing the one or more blink-associated parameters to equivalent one or more blink-associated parameters from the patient when not experiencing symptoms of a headache and/or the patient when receiving the headache treatment [partly automatically analyzed and compared for example with typical values of a healthy eye for automatic detection of significant differences, automatic determination of the condition responsible for the detected differences, and/or automatic diagnosis of a pathology related to the determined condition, see in ¶ 0052; in order to determine the suitable treatment and/or in order to follow up the patient and manage the disease with a tailored treatment, see in ¶ 0006].
Leonardi fails to explicitly disclose that the stimulus is non-electrical.
However, Tsai discloses using non-electrical stimuli to trigger a blink reflex in the subject [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].
Leonardi and Tsai are both analogous to the claimed invention because they are in the same field of measuring blink parameters to monitor neurological functional status. 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 Leonardi to incorporate the teachings of Tsai to include that non-electrical stimuli were used to trigger blink reflexes in order to target a particular neural pathway that causes a blink reflex [The different types of stimulation may trigger different neural pathways within, and/or neurological functions of, the brain to cause the blink reflex. Thus, measuring the blink reflex using different types of stimulation may enable a type of neurological impairment within the brain to be identified and/or a specific location or structure, within the brain, that has been injured or impaired, to be identified, see in Tsai ¶ 0045].
Regarding claim 6, Leonardi, as modified, discloses the method of claim 3.
Leonardi fails to disclose 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.
However, Tsai discloses 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 [output an indication, notification, and/or sound that can be viewed or heard by the operator 109 of blink reflex device 100 that identifies whether the subject suffers from a neurological condition and/or a level of severity of such a neurological condition, see in ¶ 0040].
Leonardi and Tsai are both analogous to the claimed invention because they are in the same field of measuring blink parameters to monitor neurological functional status. 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 Leonardi to incorporate the teachings of Tsai to include that diagnosing would involve determining the severity of the condition in order to in order to determine the appropriate treatment options for the patient.
Regarding claim 11, Leonardi, as modified, discloses the method of claim 3.
Leonardi fails to disclose wherein the method measures latency until the physiological response to stimulus.
However, Tsai discloses 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].
Leonardi and Tsai are both analogous to the claimed invention because they are in the same field of measuring blink parameters to monitor neurological functional status. 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 Leonardi to incorporate the teachings of Tsai to include that the method measures latency until physiological response to stimulus as a blink parameter to monitor, as it can be used as a parameter to quantify the presence of an underlying condition.
Regarding claim 13, and substantially similar limitations in claim 14, Leonardi, as modified, discloses the method of claim 3, wherein the non-electrical stimulus is one or more physical stimuli [reference claim 3 rejection above; 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 Tsai ¶ 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 Tsai¶ 0035].
Regarding claim 17, Leonardi, as modified, discloses the method of claim 13.
Leonardi fails to disclose wherein the non-electrical stimulus is compressed air is applied across the eye, and/or wherein the non-electrical stimulus is applied to the canthus or outer canthus.
However, Tsai discloses wherein the non-electrical stimulus is compressed air 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].
Leonardi and Tsai are both analogous to the claimed invention because they are in the same field of measuring blink parameters to monitor neurological functional status. 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 Leonardi to incorporate the teachings of Tsai to include that the non-electrical stimulus is compressed air applied to the outer canthus in order to trigger corneal reflexes.
Regarding claim 19, Leonardi, as modified, discloses the method of claim 3.
Leonardi fails to disclose wherein the blink reflex is measured with a high-speed camera and/or a blink reflex monitoring device, wherein the blink reflex monitoring device is a wearable device or a handheld device.
However, Tsai discloses wherein the blink reflex is measured with a high-speed camera and/or 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] .
Leonardi and Tsai are both analogous to the claimed invention because they are in the same field of measuring blink parameters to monitor neurological functional status. 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 Leonardi to incorporate the teachings of Tsai to include that the blink reflex is measured with a high-speed camera and/or a blink reflex monitoring device, wherein the blink reflex monitoring device is a wearable device or a handheld device in order to effectively and compactly collect blink information from the subject.
Regarding claim 20, Leonardi, as modified, discloses the method of claim 3, wherein the blink reflex is not measured with an electromyography (EMG) sensor or device [pressure sensor, which allows achieving a precise and accurate measurement of the IOP, see in ¶ 0011].
Regarding claim 30, Leonardi, as modified, discloses the method of claim 3.
Leonardi fails to disclose wherein the measuring of a blink reflex, comprises: providing a blink reflex monitoring device to a user, the blink reflex monitoring device having an air compression system including a compressed air source and a valve; 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; 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.
However, Tsai 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].
Leonardi and Tsai are both analogous to the claimed invention because they are in the same field of measuring blink parameters to monitor neurological functional status. 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 Leonardi to incorporate the teachings of Tsai to include that measuring blink reflex involves an air compression system and two modes of compressed air release in order to ensure that a blink reflex is present for measurement and further analysis.
Regarding claim 31, Leonardi, as modified, discloses the method of claim 3.
Although Leonardi discloses that eye blink and rapid eye motion is captured [see in ¶ 0005], Leonardi fails to explicitly disclose 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;(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.
However, Tsai discloses 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.
Leonardi and Tsai are both analogous to the claimed invention because they are in the same field of measuring blink parameters to monitor neurological functional status. 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 Leonardi to incorporate the teachings of Tsai to include that latency and differential latency are blink associated parameters being measured , as they can be used as parameters to quantify the presence of an underlying condition.
Regarding claim 33, Leonardi, as modified, discloses the method of claim 3, wherein in comparison of a patient who is not afflicted with a headache with a patient who is afflicted with a headache: latency decreases; differential latency decreases; delta 30 decreases; eyelid excursion increases; initial lid velocity increases; time to close increases; time to open decreases; time under threshold increases; number of oscillations increases; total blink time decreases; number of blinks increases; blink rate increases; area under curve increases [the method of the invention is used for example to detect different pathologies of the eye by comparing the response to reference values. FIG. 4 shows three examples of eye responses that could be related to non-healthy eyes. Curve 20 shows a response where the negative pressure interval is big. Curve 21 shows a response where both positive pressure period and stabilization period are long. Curve 22 shows a response where the positive pressure period is very long and where there is no undershoot or negative pressure interval, see in ¶ 0047]; maximum closing velocity increases; and/or maximum opening velocity increases.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Leonardi (US 20140016097 A1 – Cited by Applicant) in view of Tsai (US 20200069239 A1 – Cited by Applicant), further in view of Yoo et al. (US 20240285202 A1), hereinafter Yoo.
Regarding claim 9, Leonardi, as modified, discloses the method of claim 3.
Leonardi fails to disclose wherein an information collected can predict correlation of ADHD to the occurrence of a future disease and/or disorder of the central nervous system.
However, Yoo discloses an information collected can predict correlation of ADHD to the occurrence of a future disease and/or disorder of the central nervous system [applying the user attention information generated using eye-tracking technology to the derived test result. According to an embodiment, it is possible to predict diagnosis and treatment response in ADHD, oppositional defiant disorder, conduct disorder, dyslexia, dyscalculia, and even autism through the comprehensive attention test, see in ¶ 0065].
Leonardi and Yoo are both analogous to the claimed invention because they are in the same field of diagnosing brain related diseases using eye related data. 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 Leonardi to incorporate the teachings of Yoo to include that an information collected can predict correlation of ADHD to the occurrence of a future disease and/or disorder of the central nervous system in order to expand treatment options for the subject.
Claims 12, 41, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Leonardi (US 20140016097 A1 – Cited by Applicant) in view of Tsai (US 20200069239 A1 – Cited by Applicant), further in view of Matharu (US 20200013509 A1 – Cited by Applicant).
Regarding claim 12, Leonardi, as modified, discloses the method of claim 3.
Leonardi 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].
Leonardi and Matharu are both analogous to the claimed invention because they are in the same field of diagnosing headaches. 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 Leonardi 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.
Regarding claim 41, Leonardi, as modified, discloses the method of claim 3.
Leonardi fails to disclose wherein the headache is diagnosed according to the third edition of the International Classification of Headache Disorders (ICHD-3).
However, Matharu discloses wherein the headache is diagnosed according to the third edition of the International Classification of Headache Disorders (ICHD-3) [improved diagnostic criteria in which phenotypic data can be tested to ascertain the value of individual International Classification of Headache Disorders (ICHD) diagnostic criteria, see in ¶ 0076; Examiner notes that the third edition of ICHD is the most updated version and notes that it would be obvious that the most updated edition of ICHD would be utilized by Matharu, even if it is not specified].
Leonardi and Matharu are both analogous to the claimed invention because they are in the same field of diagnosing headaches. 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 Leonardi to incorporate the teachings of Matharu and include that the headache is diagnosed according to the third edition of the International Classification of Headache Disorders (ICHD-3) in order to clinically diagnose using an internationally recognized framework.
Regarding claim 42, Leonardi, as modified, discloses the method of claim 3.
Leonardi failed to disclose wherein the headache is or comprises one or more of a chronic post-traumatic migraine headache, persistent post-traumatic headache, cluster headache, tension headache, sinus headache, migraine disorder or headache, hypnic headache, chronic daily headache, migraine headache, hemicrania continua headache, chronic headache, and chronic tension headache.
However, Matharu discloses wherein the headache is or comprises one or more of a chronic post-traumatic migraine headache, persistent post-traumatic headache, cluster headache, tension headache, sinus headache, migraine disorder or headache, hypnic headache, chronic daily headache, migraine headache, hemicrania continua headache, chronic headache, and chronic tension headache [cluster headache, see in ¶ 0111; hypnic headache, see in ¶ 0114].
Leonardi and Matharu are both analogous to the claimed invention because they are in the same field of diagnosing headaches. 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 Leonardi to incorporate the teachings of Matharu and include that the headache is either one of a cluster or hypnic headache in order identify the condition for proper treatment assignment
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Leonardi (US 20140016097 A1 – Cited by Applicant) in view of Tsai (US 20200069239 A1 – Cited by Applicant), further in view of Walsh et al. (US 20180279870 A1), hereinafter Walsh.
Regarding claim 24, Leonardi, as modified, discloses the method of claim 3.
Leonardi fails to disclose 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; and 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, Tsai 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].
Leonardi and Tsai are both analogous to the claimed invention because they are in the same field of measuring blink parameters to monitor neurological functional status. 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 Leonardi to incorporate the teachings of Tsai to include that 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 to establish that there is a structure to provide a stimulation to the eye.
Leonardi modified by Tsai still fail 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].
Leonardi 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 Leonardi 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.
Claim 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Leonardi (US 20140016097 A1 – Cited by Applicant) in view of Tsai (US 20200069239 A1 – Cited by Applicant) and Walsh (US 20180279870 A1), further in view of 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, Leonardi, as modified, discloses the method of claim 3.
Leonardi fails to disclose 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; 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 an air compression system including a source of compressed air and a valve, 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, Tsai discloses 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].
Leonardi and Tsai are both analogous to the claimed invention because they are in the same field of measuring blink parameters to monitor neurological functional status. 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 Leonardi to incorporate the teachings of Tsai to include that 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 and an air compression system including a source of compressed air and a valve to establish that there is a structure to provide a puff of air stimulation to the eye of the subject.
Leonardi, as modified by Tsai, 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].
Leonardi 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 Leonardi 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.
Leonardi, as modified by Tsai and 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].
Leonardi 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 Leonardi 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].
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Leonardi (US 20140016097 A1 – Cited by Applicant) in view of Tsai (US 20200069239 A1 – Cited by Applicant), further in view of Lewis (US 10962789 B1).
Regarding claim 51, Leonardi, as modified, discloses the method of claim 3.
Leonardi fails to disclose wherein the patient is experiencing symptoms associated with one or more of the prodrome stage of migraine, aura stage of migraine, attack stage of migraine, and postdrome stage of migraine.
However, Lewis discloses wherein the patient is experiencing symptoms associated with one or more of the prodrome stage of migraine, aura stage of migraine, attack stage of migraine, and postdrome stage of migraine [Migraine attack, prodome portion of migraine attack, see in Lewis, Col. 2, lines 60-67].
Leonardi and Lewis are both analogous to the claimed invention because they are in the same field of brain related illnesses. 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 Leonardi to incorporate the teachings of Lewis and include that the patient experiences symptoms of the attack stage or prodrome portion of a migraine attack in order to provide more context to blink reflex information collected and to provide a targeted treatment option.
Conclusion
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/HY KHANH DOAN/ Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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