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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/29/2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
[0002]: As written it reads “The present disclosure is drawn to psychopharmacology, and specifically to using computer-based eyelid tracking technology to assist in identifying correct medication dosing for patients with neurodeviate conditions, such as autism spectrum disorder, ADHD, and schizophrenia”. However, this is the first indication of the term “ADHD”, therefore, the term should be spelled out to provide clarity.
Appropriate correction is required.
Claim Objections
Claims 1, 3-5, 12, 16-17 are objected to because of the following informalities:
Regarding claims 1 and 12, as written they read “performing three of more tests of a startle response of a user, each test utilizing a mobile device having a camera, display, and optionally a speaker, each test occurring a different time after the user has been administered a medication” (Claim 1); “perform three of more tests of a startle response of a user, each test utilizing the display, the speaker, or both, and each test occurring a different time after the user has been administered a medication” (Claim 12). However, the examiner believes “of” (underlined) is a typo which should read “or”.
Regarding claim 3, as written it reads “wherein the mobile device sends the plurality of images to a remote processor, the remote processor being configured to calculate the one or more amplitudes, determine the correlation, and determining whether the correct dose has been achieved”. However, the examiner believes “determining” should be “determine”.
Regarding claims 4 and 16, as written they read “wherein the one or more amplitudes are positively correlated with a plasma concentrations of the medication” (Claim 4); “wherein the one or more amplitudes is positively correlated with a plasma concentrations of the medication” (Claim 16). However, to be grammatically correct, the examiner believes “a plasma concentrations” in claims 4 and 16 should be “a plasma concentration”. Additionally, in claim 16, the phrase “the one or more amplitudes is” should be changed to “the one or more amplitudes are”.
Regarding claims 5 and 17, as written they read “wherein the one or more amplitudes are negatively correlated with a plasma concentrations of the medication” (Claims 5 and 17).
However, to be grammatically correct, the examiner believes “a plasma concentrations” in claims 5 and 17 should be “a plasma concentration”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea, specifically a mental process, without significantly more.
Regarding claims 1 and 12, the examiner notes that these claims are directed to: 1) a method for identifying correct dosing in patients being treated with a medication for neurodeviate conditions (Claim 1) and 2) a system (Claim 12) Therefore, the claims fall within the statutory categories of invention.
With reference to Step 2A, Prong One, the claim recites “calculating one or more amplitudes of a closure of an eyelid of the at least one eye for each test; determining a value of a correlation between predetermined plasma concentrations of the medication and the one or more amplitudes of the closure of the eyelid at the different time of each test after the user has been administered the medication; and determining whether a correct dose has been achieved based on the value of the correlation” (Claim 1); “calculate one or more amplitudes of a closure of an eyelid of the at least one eye for each test; and determine a correlation between predetermined plasma concentrations of the medication with a curve formed by the one or more amplitudes of the closure of the eyelid at different times after the user has been administered the medication” (Claim 12).
The limitations, under broadest reasonable interpretation, cover performance of the limitation in the mind and/or read on counting the number of eyelid closures, identifying a correlation between predetermined plasma concentrations and the amplitude of eyelid closures and deciding whether a correct dose has been achieved, which represent steps, which can be practically performed in the human mind by a user. If a claim limitation under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components (i.e. a processor), then it falls within the “mental processes” grouping of abstract ideas.
Following step 2A, Prong Two of the two-prong analysis, the claim recites the following additional elements: “performing three of more tests of a startle response of a user, each test utilizing a mobile device having a camera, display, and optionally a speaker, each test occurring a different time after the user has been administered a medication; receiving a plurality of images of at least one eye of the user from a camera during each test;” (Claim 1); “comprising one or more processors, a display operably coupled to a first processor of the one or more processors; a camera operably coupled to the first processor; optionally a speaker coupled to the first processor; and a non-transitory computer-readable medium containing instructions that, when executed, configure the one or more processors to: perform three of more tests of a startle response of a user, each test utilizing the display, the speaker, or both, and each test occurring a different time after the user has been administered a medication; receive a plurality of images of at least one eye of the user from the camera during each test” (Claim 12). These additional elements do not integrate the judicial exception into a practical application because the claim as written does not include elements to 1) improve the functioning of a computer (See MPEP 2106.05(a)); 2) effect a particular treatment or prophylaxis (See MPEP 2106.04(d)(2)); 3) use a particular machine (See MPEP 2106.05(b)); 4) use the judicial exceptions in a meaningful way beyond generally linking the use to a particular technological environment (See MPEP 2106.05(h)). Furthermore, these receiving steps do not integrate the judicial exception into a practical application because they add insignificant extra-solution activity, in the form of data gathering and pre-solution activity, to the judicial exception using a well-known device (i.e. sensor coils) (See MPEP 2106.05(g)).
Following step 2B, the additional element(s) (i.e. “performing three of more tests of a startle response of a user, each test utilizing a mobile device having a camera, display, and optionally a speaker, each test occurring a different time after the user has been administered a medication; receiving a plurality of images of at least one eye of the user from a camera during each test;” (Claim 1); “comprising one or more processors, a display operably coupled to a first processor of the one or more processors; a camera operably coupled to the first processor; optionally a speaker coupled to the first processor; and a non-transitory computer-readable medium containing instructions that, when executed, configure the one or more processors to: perform three of more tests of a startle response of a user, each test utilizing the display, the speaker, or both, and each test occurring a different time after the user has been administered a medication; receive a plurality of images of at least one eye of the user from the camera during each test” (Claim 12) do not amount to significantly more than the judicial exception the these limitations represent data gathering steps which utilize conventional tools (i.e. one or more processors, a display, a camera) to perform well understood, routine and conventional activity (i.e. performing three or more tests of startle response, receiving a plurality of images) in the field, to perform the abstract idea.
Regarding claims 2-11 and 3-21, the claims add additional limitations that append the judgement of claim 1 and/or do not include additional elements that are sufficient to amount to significantly more than the judicial exception, nor a practical application of the judicial exception because they:
provide additional information about how data gathering/processing is performed (i.e. “wherein all steps are performed on the mobile device” (Claim 2); “wherein the mobile device sends the plurality of images to a remote processor, the remote processor being configured to calculate the one or more amplitudes, determine the correlation, and determining whether the correct dose has been achieved” (Claim 3); “further comprising repeating, at a same medication dosage, steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved” (Claim 7); “further comprising adjusting a dosage of the medication and repeating steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved” (Claim 8); “further comprising receiving input indicating when the medication was administered” (Claim 9); “further comprising receiving input indicating what dosage was administered” (Claim 10); “wherein the first processor is present on a mobile device and all steps are performed on the mobile device” (Claim 14); “wherein the first processor is present on a mobile device, a second processor of the one or more processors is present on a remote device, the first processor is configured to send the plurality of images to the second processor, the second processor being configured to calculate the one or more amplitudes, determine the correlation, and determining whether a correct dose has been achieved” (Claim 15); “wherein the instructions, when executed, further configure the one or more processors to receive input indicating when the medication was administered” (Claim 19); “wherein the instructions, when executed, further configure the one or more processors to receive input indicating what dosage was administered” (Claim 20)).;
provide additional information about the data that is obtained (i.e. “wherein the one or more amplitudes are positively correlated with a plasma concentrations of the medication” (Claim 4); “wherein the one or more amplitudes are negatively correlated with a plasma concentrations of the medication” (Claim 5); “wherein the one or more amplitudes is positively correlated with a plasma concentrations of the medication” (Claim 16); “wherein the one or more amplitudes is negatively correlated with a plasma concentrations of the medication” (Claim 17)).;
and/or constitute insignificant extra-solution activity (i.e. “further comprising recommending a modified dosage of the medication based on the correlation” (Claim 6); “further comprising storing information in a database, the information including a user code, a dose, a time of administration, and the one or more amplitudes and times each of the plurality of images was captured” (Claim 11); “wherein the instructions, when executed, further configure the one or more processors to determine whether a correct dose has been achieved based on a value of the correlation” (Claim 13); “wherein the instructions, when executed, further configure the one or more processors to recommend a modified dosage of the medication based on the correlation” (Claim 18); “wherein the instructions, when executed, further configure the one or more processors to store information in a database, the information including a user code, a dose, a time of administration, and the one or more amplitudes and times each of the plurality of images was captured” (Claim 21).).
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.
Claim(s) 1-3, 6, 12-15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over White et al. US 2005/0079636 A1 “White” and further in view of Fryar-Williams et al. US 2020/0049722 A1 “Fryar-Williams”.
Regarding claims 1 and 12, White teaches “A method for identifying correct dosing in patients being treated with a medication for neurodeviate conditions, the method comprising:” (Claim 1) (“The inventors have devised a method and apparatus for diagnosing schizophrenia, or a schizophrenic disorder subtype, or predisposition thereto. The present invention may have an advantage of significantly reduce misdiagnosis of schizophrenia. The diagnostic method may be useful in genetic linkage studies for identifying molecular defect(s) that may be associated with schizophrenia” [0011]; “In fifth aspect the invention provides a method of treating a patient with schizophrenia or schizophrenic disorder subtype including the steps of:--[0057] (1) measuring a dichoptic reversal rate whereby the subject is capable of perceiving that binocular rivalry persists; [0058] (2) comparing said measured dichoptic reversal rate with a corresponding reference dichoptic reversal rate to diagnose presence or absence of schizophrenia or schizophrenic disorder subtype; and [0059] (3) administering to said patient a pharmaceutically-effective dosage of a drug for treating schizophrenia or a schizophrenic disorder subtype, when said measured dichoptic reversal rate is in said range” [0056-0059]; “The invention also extends to a process for identifying a candidate therapeutic agent for alleviating schizophrenia, including the steps of measuring first perceptual rivalry rate in a test subject, administering or applying a test compound to the test subject, measuring second perceptual rivalry rate in the test specimen, and identifying a candidate therapeutic agent if said second perceptual rivalry rate is faster than said first perceptual rivalry rate. Preferably, said perceptual rivalry is binocular rivalry. Suitably, the test specimen is a human or animal” [0168]; “The invention further provides a method of treating a patient with schizophrenia, said method comprising the steps of determining an interhemispheric switch rate of the patient, comparing said interhemispheric switch rate with a range of reference interhemispheric switch rates associated with schizophrenia; and administering to said patient a pharmaceutically-effective dosage of a schizophrenia treating drug when said interhemispheric switch rate is in said range” [0170].
Therefore, White describes at least one method for identifying correct dosing (i.e. pharmaceutically-effective dosage of schizophrenia treating drug) in patients being treated with a medication for neurodeviate conditions (i.e. schizophrenia or schizophrenic disorder subtype).);
“A system, comprising: one or more processors; a display operably coupled to a first processor of the one or more processors; a camera operably coupled to the first processor; optionally a speaker coupled to the first processor; and a non-transitory computer-readable medium containing instructions that, when executed, configure the one or more processors to:” (Claim 12) (See [0011] above and “FIG. 1 shows one embodiment of a diagnostic apparatus useful for diagnosing schizophrenia as herein described. Shown is a psychophysical set-up used to examine binocular rivalry” [0089]; “The monitoring means may incorporate a liquid crystal shutter before each eye. The liquid crystal shutters allow the field of view of each eye to be superimposed so that the different viewing images are presented at the same retinal location of each eye. Alternatively, the monitoring means may comprise a 3D head mounted display as described in Example 2” [0156]. “Display. PC compatible computers equipped with ATI mach 64 video chipsets (eMachines eTower 333cs) ran custom software (written by KDW) to generate the rivalry stimuli in a frame sequential format, to measure responses, and to provide user interfaces […] The observer wore a head-mounted display (iGlasses) with SVHS resolution, which was synchronized to the frames generated in an SVGA graphics mode (1024.times.768.times.256 at 60 Hz non-interlaced) by an AverMedia Averkey scan converter. The Virtual I-O iGlasses 3D head-mounted display has separately driven LCD displays (180,000 pixels) for each eye, giving resolutions of 225.times.266.” [0200]; “An apparatus shown in FIG. 1 may also be used for measuring a rate of binocular rivalry. Binocular rivalry is tested with a subject 1 seated three metres from a computer monitor 2 and wearing liquid crystal shutter goggles 3 to enable the presentation of vertical moving lines 4 to the left eye and horizontal moving lines 5 to the right eye. The stimuli subtend 1.5 degrees of visual angle with a spatial frequency of 8 cycles/degree moving at 4 cycles/second. The subject 1 presses one of three response buttons 6 to indicate their perceptual state (horizontal, vertical or mixed/indeterminate percepts). The response buttons 6 may be located on a computer mouse” [0201]; “PC compatible computers equipped with ATI mach 64 video chipsets (eMachines eTower 333cs) run locally written software to generate the rivalry stimuli, measure the subject's responses, and provide user interfaces. One of these PCs provides a display for the subject to view on a 14-inch XGA resolution monitor (0.25 mm dot pitch Triniton), which the subject views through Nuvision liquid crystal shutter glasses” [0202].
Therefore, since the system shown in FIG. 1 includes ATI mach 64 video chipsets (eMachines eTower 333cs) (i.e. one or more processors) which run custom software, and includes a monitoring means may in the form of a 3D head mounted display (i.e. with liquid crystal shutters, see [0201], thus, representing a camera) to measure the subject’s responses, White describes a system comprising: one or more processors (i.e. ATI mach 64 video chipsets); a display operably coupled to a first processor of the one or more processors (i.e. monitor 2 and/or 3D head mounted display); a camera operably coupled to the first processor (i.e. liquid crystal shutters within the 3D head mounted display/goggles 3); optionally a speaker coupled to the first processor; and a non-transitory computer-readable medium containing instructions (i.e. software) that, when executed, configure the one or more processors to perform specific functions.);
“performing three of more tests of a startle response of a user, each test utilizing a mobile device having a camera, display, and optionally a speaker, each test occurring a different time after the user has been administered a medication” (Claim 1); “perform three of more tests of a startle response of a user, each test utilizing the display, the speaker, or both, and each test occurring a different time after the user has been administered a medication” (Claim 12) (See [0200] and [0201] above and “Quantifiable measures provided by binocular rivalry may be linked to clinical parameters such as reading and cognitive measures, symptomatology, course of illness, treatment resistance, side effects from, and response to, medication. Since thousands of data points can be collected in a short time from a procedure with potentially high patient acceptance. It is possible that binocular rivalry, once linked to other clinical parameters by the investigations proposed herein, could provide a useful adjunct to more protracted assessments with less patient acceptability” [0129]; “The recordal means for recording perceived change is suitably a subjective device in the form of an indicator means activated by the test subject when a change is perceived. Preferably, the recordal means is an objective device that records eye movements as an indicator of which image is being perceived. Alternatively, steady state visual evoked potentials may be measured to provide an objective indication of the perceptual alternation” [0157]; “The processing means suitably includes timing means and means for receiving signals from the recordal means indicative of perceptual change. Interhemispheric switch rate is calculated by dividing the number of perceptual switches by the total time of perceptual rivalry” [0158].
Therefore, since the ATI mach 64 video chipsets can run custom software to generate rivalry stimuli in a frame sequential format in order to measure patient eye responses and thus measure a rate of binocular rivalry (see [0200]-[0201]), wherein binocular rivalry is linked to clinical parameters such as side effects from and response to medication (i.e. taken in the course of a procedure) and thousands of data points are collected in a short time from a procedure in order to measure binocular rivalry (see [0129]), the method carried out by the system involves performing three or more tests of a startle response of a user (i.e. by providing rivalry stimuli, see [0200]-[0201]), each test utilizing a mobile device having a camera, display, and optionally a speaker, (i.e. 3D head mounted display, see FIG. 1, and [0200]) each test occurring a different time after the user has been administered a medication (i.e. each of the thousands of data points being associated with a distinct time).);
“receiving a plurality of images of at least one eye of the user from a camera during each test” (Claim 1); “receive a plurality of images of at least one eye of the user from the camera during each test“ (Claim 12) (“Binocular rivalry may provide a quantifiable measurement for diagnosis and understanding schizophrenia, schizophrenia subtypes and predisposition thereto” [0010]; “Preferably, the rate of perceptual rivalry is determined by measuring a rate of binocular rivalry” [0017]; “In another embodiment, an image is presented to each respective eye via a 3D head mounted display” [0070]; “The recorder for recording perceived change may be a subjective device in the form of an indicator activated by the test subject when a change is perceived” [0071]; “Preferably, the recorder is an objective device that records eye movements as an indicator of which image is being perceived. Alternatively, steady state visual evoked potentials may be measured to provide an objective indication of the perceptual alternation” [0072]; “In this way, it is possible to track the "waxing" and "waning" of the VEP amplitudes for each eye's image simultaneously during spontaneous rivalry, permitting an analysis of the relative dominance of each eye's image in real-time and to determine alternation rate” [0138]; and “Reference also may be made to Sweeney et al (1998, Biol. Psychiatry 43:584-594, incorporated herein by reference) who disclose the use of infrared recordings to monitor eye movements. Such procedures that monitor eye movements have particular utility in binocular rivalry methods that rely on moving dichoptic stimuli, such as moving vertical and horizontal gratings” [0139].
Therefore, in order to measure the rate of binocular rivalry, an image is presented to each respective eye and an objective device (i.e. camera) or infrared recordings (i.e. infrared camera) is used to record eye movements. Thus, the method carried out by the system involves receiving a plurality of images of at least one eye of the user from a camera during each test.);
“calculating one or more amplitudes of a closure of an eyelid of the at least one eye for each test” (Claim 1); “calculate one or more amplitudes of a closure of an eyelid of the at least one eye for each test” (Claim 12) (“Alternatively, a perceptual alternation may be signaled by a suitable detection means. For example, the detection means may be adapted to measure visually evoked potentials (VEP) […] In this way, it is possible to track the "waxing" and "waning" of the VEP amplitudes for each eye's image simultaneously during spontaneous rivalry, permitting an analysis of the relative dominance of each eye's image in real-time and to determine alternation rate” [0138]. Therefore, since it is possible to track the “waxing” and “waning” of the VEP amplitudes for each eye’s image simultaneously, the method carried out by the system involves calculating one or more amplitudes of a closure of an eyelid of at least one eye for each test.); […]
“determining whether a correct dose has been achieved based on the value of the correlation” (Claim 1) (“(c) administering to said patient a pharmaceutically-effective dosage of a drug for treating schizophrenia or a schizophrenic disorder subtype, when said measured interhemispheric switch rate is in said range” [0050]; “The invention further provides a method of treating a patient with schizophrenia, said method comprising the steps of determining an interhemispheric switch rate of the patient, comparing said interhemispheric switch rate with a range of reference interhemispheric switch rates associated with schizophrenia; and administering to said patient a pharmaceutically-effective dosage of a schizophrenia treating drug when said interhemispheric switch rate is in said range” [0170].
Therefore, since the measured interhemispheric switch rate is compared with a reference interhemispheric switch rate (i.e. associated with schizophrenia) and is used to administer a pharmaceutically-effective dosage of a schizophrenia treating drug to a patient, the method involves determining whether a correct dose has been achieved based on the value of the correlation (i.e. when the interhemispheric switch rate corresponds to the reference interhemispheric switch rate associated with schizophrenia).).
White does not teach “determining a value of a correlation between predetermined plasma concentrations of the medication and the one or more amplitudes of the closure of the eyelid at the different time of each test after the user has been administered the medication” (Claim 1); “determine a correlation between predetermined plasma concentrations of the medication with a curve formed by the one or more amplitudes of the closure of the eyelid at different times after the user has been administered the medication” (Claim 12).
Fryar-Williams is within the same field of endeavor as the claimed invention because it involves methods for diagnosing a psychotic disorder, such as schizophrenia, schizoaffective disorder or psychosis (see [Abstract]).
Fryar-Williams teaches “determining a value of a correlation between predetermined plasma concentrations of the medication and the one or more amplitudes of the closure of the eyelid at the different time of each test after the user has been administered the medication” (Claim 1); “determine a correlation between predetermined plasma concentrations of the medication with a curve formed by the one or more amplitudes of the closure of the eyelid at different times after the user has been administered the medication” (Claim 12) (“In diagnosing schizophrenia, schizoaffective disorder and psychosis, including schizophrenic and schizoaffective psychosis, and psychosis phenotype, and predicting association with schizophrenia or risk of an individual developing schizophrenia, schizoaffective disorder or psychosis, including schizophrenic and schizoaffective psychosis, in accordance with embodiments disclosed herein, determination of markers as disclosed herein may be used in conjunction with a range of other sensory-based, cognitive and behavioural tests known and available to those skilled in the art including, for example, […] eye blink rate” [0183], “In particular embodiments of the present disclosure, analysis of biomarker levels, values or ratios are subjected to one or more statistical analyses. For example, in particular embodiments, methods of the present disclosure comprise conducting one or more statistical analyses of determined values of markers derived from a subject, in combination, and diagnosing schizophrenia, schizoaffective disorder or psychosis in the subject on the basis of the combined analysis. Such statistical analyses may include receiver operating characteristic (ROC) analysis, logistical regression analysis, Spearman's rank-order correlation analysis and the Mann-Whitney U test. ROC analysis may comprise determining ROC ranges for individual ROC variables, cut off limits, compound ROC variables and/or continuous variables, equations involving ROC variables and/or continuous variables” [0184]; “Methods may also comprise comparing individual measures or values of visual and/or auditory processing relative to ROC measures, values, percentage cut-off levels or values or percentages typical of control subjects, optionally in the same population area, of the same MTHFR 677 genotype, who do not suffer from schizophrenia or a schizoaffective disorder or psychosis. From this comparison, one can determine the number of abnormal variables, relative to controls and from this number determine a diagnostic psychosis risk index relative to controls and note type of abnormal variables compared with controls” [0204]; “Embodiments of the present disclosure contemplate the employment of one or more additional biomarkers to those described elsewhere herein to aid in diagnosis and risk predictions. Such additional biomarkers may, for example, be used to validate or extend diagnoses made in accordance with the present disclosure” [0216]; “Antipsychotic medication remained stable during the assessment period and DSM IV-R criteria case diagnoses were made by trained staff and checked by consensus opinion and DSM IV-R symptom-checklist. Patients and controls were rated for clinical and sub-clinical symptoms respectively, and had biological samples taken prior to auditory and visual processing assessments” [0276].
Therefore, since the methods for diagnosing schizophrenia, schizoaffective disorder and psychosis involves the determination of markers and sensory-based, cognitive and behavioral tests including the calculation of eye blink rate and may perform receiver operating characteristic (ROC) analysis on determined biomarkers present within a patient (see [0184]) and involves comparing individual measures or values of visual processing relative to ROC measures, values, percentage cut-off levels or values, or percentages typical of control subjects, the method carried out by the system involves determining a value of a correlation between predetermined plasma concentrations of the medication (i.e. biomarkers) and the one or more amplitudes of the closure of the eyelid at the different time of each test after the user has been administered the medication.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and system of White such that it involves determining a value of a correlation between predetermined plasma concentrations of the medication and the one or more amplitudes of the closure of the eyelid at the different time of each test after the user has been administered the medication as disclosed in Fryar-Williams in order to effectively diagnose a patient’s risk for schizophrenia. Analyzing biomarkers markers (i.e. with an ROC curve, for example), performing sensory-based, cognitive and behavioral tests and performing a comparison between individuals who do and do not suffer from schizophrenia (see Fryar-Williams: [0204]) are three of a finite number of techniques which can be used to effectively diagnose a patient with schizophrenia with a reasonable expectation of success. Thus, modify the method and system of White such that it involves determining a value of a correlation (i.e. comparison) between predetermined plasma concentrations of the medication (i.e. biomarker) and the one or more amplitudes of the closure of the eyelid at the different time of each test after the user has been administered the medication (i.e. eye blink rate) as disclosed in Fryar-Williams would yield the predictable result of effectively diagnosing a patient’s risk for schizophrenia.
Regarding claims 2 and 14, White in view of Fryar-Williams discloses all features of the claimed invention as discussed with respect to claims 1 and 12 above, and White further teaches “wherein all steps are performed on the mobile device” (Claim 2); “wherein the first processor is present on a mobile device and all steps are performed on the mobile device” (Claim 14) (See [0201] as discussed in claims 1 and 12 above, and “Display. PC compatible computers equipped with ATI mach 64 video chipsets (eMachines eTower 333cs) ran custom software (written by KDW) to generate the rivalry stimuli in a frame sequential format, to measure responses, and to provide user interfaces” [0200]; “Experimental Sequence. The test subject was presented traditional binocular rivalry for 4 to 9 min (in six epochs) to obtain the endogenous perceptual alternation rate, and presented dichoptic reversal stimuli at 3.75, 7.5, 15, and 30 reversals per sec for 2 min at each rate in two .about.1 min epochs (14 epochs per observer). Order of presentation of traditional rivalry and the four reversal rates was counterbalanced within observer. At the end of each epoch a graph of the responses was displayed. The experimenter described in words the general features shown in the graph in order to verify that these recorded responses were representative of the observer's perceptions” [0208]. Therefore, since the ATI mach 64 video chipsets run custom software to generate the rivalry stimuli in a frame sequential format, to measure responses (i.e. which are subsequently displayed, see [0208]) and to provide user interfaces, all the steps are performed on the mobile device (see FIG. 1). Furthermore, the first processor is present on a mobile device and all steps are performed on the mobile device.).
Regarding claims 3 and 15, White in view of Fryar-Williams discloses all features of the claimed invention as discussed with respect to claims 1 and 12 above, and White further teaches “wherein the mobile device sends the plurality of images to a remote processor, the remote processor being configured to calculate the one or more amplitudes, determine the correlation, and determining whether the correct dose has been achieved” (Claim 3); “wherein the first processor is present on a mobile device, a second processor of the one or more processors is present on a remote device, the first processor is configured to send the plurality of images to the second processor, the second processor being configured to calculate the one or more amplitudes, determine the correlation, and determining whether a correct dose has been achieved” (Claim 15) (“PC compatible computers equipped with ATI mach 64 video chipsets (eMachines eTower 333cs) run locally written software to generate the rivalry stimuli, measure the subject's responses, and provide user interfaces. One of these PCs provides a display for the subject to view on a 14 inch XGA resolution monitor (0.25 mm dot pitch Triniton), which the subject views through Nuvision liquid crystal shutter glasses” [0202]. Therefore, multiple PC compatible computers (i.e. each containing a respective processor) are present. Since the PC compatible computers generate rivalry stimuli, measure the subject’s responses and provide user interfaces, and one of these PCs provides a display for the subject to view through Nuvision liquid crystal shutter glasses, the mobile device (i.e. containing a first processor) must be configured to send the plurality of images to a remote/second processor (i.e. present in one of the PC compatible computers), the remote/second processor being configured to calculate the one or more amplitudes, determine the correlation and determine whether the correct dose has been achieved.).
Regarding claims 6 and 18, White in view of Fryar-Williams discloses all features of the claimed invention as discussed with respect to claims 1 and 12 above, and White further teaches “further comprising recommending a modified dosage of the medication based on the correlation” (Claim 6) and “wherein the instructions, when executed, further configure the one or more processors to recommend a modified dosage of the medication based on the correlation” (Claim 18) (“(a) measuring an interhemispheric switch rate of the patient; [0049] (b) comparing said measured interhemispheric switch rate with a range of reference interhemispheric switch rates associated with schizophrenia or schizophrenia disorder subtype; and [0050] (c) administering to said patient a pharmaceutically-effective dosage of a drug for treating schizophrenia or a schizophrenic disorder subtype, when said measured interhemispheric switch rate is in said range” [0050].
Therefore, since the method involves administering a pharmaceutically-effective dosage of a drug for treating schizophrenia or a schizophrenic disorder subtype based on whether the measured interhemispheric switch rate is in the range of reference interhemispheric switch rates associated with schizophrenia or a schizophrenic disorder subtype, the method further comprises recommending a modified dosage of the medication (i.e. to be administered) based on the correlation (i.e. comparison of measured interhemispheric switch rate with a range of reference interhemispheric switch rates). Additionally, the instructions, when executed, further configure the one or more processors to recommend a modified dosage (i.e. pharmaceutically-effective dosage) of the medication based on the correlation (i.e. comparison of measured interhemispheric switch rate with a range of reference interhemispheric switch rates).
Regarding claim 13, White in view of Fryar-Williams discloses all features of the claimed invention as discussed with respect to claim 12 above, and White further teaches “wherein the instructions, when executed, further configure the one or more processors to determine whether a correct dose has been achieved based on a value of the correlation” (“In fourth aspect the invention provides a method of treating a patient with schizophrenia or a schizophrenic disorder subtype including the steps of:--[0048] (a) measuring an interhemispheric switch rate of the patient; [0049] (b) comparing said measured interhemispheric switch rate with a range of reference interhemispheric switch rates associated with schizophrenia or schizophrenia disorder subtype; and [0050] (c) administering to said patient a pharmaceutically-effective dosage of a drug for treating schizophrenia or a schizophrenic disorder subtype, when said measured interhemispheric switch rate is in said range” [0047]-[0050]; “Type and amount of medication at the time of scanning and testing is important for several reasons. Different medications produce differential responses and side effects. Medications with anticholinergic side effects may affect performance on memory tests. These measures will be collected for two reasons: (1) to determine if any of these factors affect the probability of abnormal binocular rivalry; (2) to train graduate and postdoctoral fellows in the methodology of research diagnoses” [0214].
Therefore, since the method carried out by the system involves measuring an interhemispheric switch rate, comparing the measured interhemispheric switch rate with a range of reference interhemispheric switch rates associated with schizophrenia or schizophrenia disorder subtypes (i.e. to determine a correlation between them) and administering a pharmaceutically- effective dosage of a drug to the patient (i.e. a correct dose), the instructions, when executed, further configure the one or more processors to determine whether a correct dose has been achieved based on a value of the correlation.).
Claim(s) 4 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over White et al. US 2005/0079636 A1 “White” and Fryar-Williams et al. US 2020/0049722 A1 “Fryar-Williams” as applied to claims 1 and 12 above, and further in view of Tejima et al. US 2024/0159780 A1 “Tejima”.
Regarding claims 4 and 16, White in view of Fryar-Williams discloses all features of the claimed invention as discussed with respect to claims 1 and 12 above, however, the combination does not teach “wherein the one or more amplitudes are positively correlated with a plasma concentrations of the medication” (Claim 4); “wherein the one or more amplitudes is positively correlated with a plasma concentrations of the medication” (Claim 16).
Tejima is within the same field of endeavor as the claimed invention because it involves methods of evaluating therapeutic or prophylactic agents or other medical technologies for patients with Parkinson's disease being treated with L-DOPA or L-DOPA-related compounds or dopamine agonists, the method involving a step of obtaining ocular information of the patient, and B) a step of calculating an estimated effective amount or effective level of the therapeutic or prophylactic agent or other medical technology from the ocular information (see [Abstract]).
Tejima teaches “wherein the one or more amplitudes are positively correlated with a plasma concentrations of the medication” (Claim 4); “wherein the one or more amplitudes is positively correlated with a plasma concentrations of the medication” (Claim 16) (“The blink frequency peaked around 30 to 60 minutes after administration of L-DOPA (FIG. 12A). […] Considering that the dopaminergic function in the brain is overactivated in dyskinesias, these cannot be explained by the knowledge that blink frequency simply shows a positive correlation with dopamine function in the brain, as previously reported, suggesting that dyskinesia cannot be detected simply by measuring the blink frequency alone” [0405]. In this case, since blink frequency (i.e. amplitude) peaked (i.e. increased) 30-60 minutes after administration of L-DOPA, there is a positive correlation between the amplitudes of the eyelid closures (i.e. blinks) with a plasma concentration of the medication (i.e. L-DOPA).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and system of White in view of Fryar-Williams such that the one or more amplitudes [of a closure of an eyelid] are positively correlated with a plasma concentration of the medication in order to allow a user to better characterize the effect of the administration of a medication. When a positive correlation exists between blink frequency (i.e. amplitude of eyelid closure) and the concentration of medication, a user can more easily assess the propagation of a medication through a patient with a reasonable expectation of success. Thus, modifying the method and system of White in view of Fryar-Williams such that the one or more amplitudes [of a closure of an eyelid] are positively correlated with a plasma concentration of the medication would yield the predictable result of allowing a user to better characterize the effect of the administration of a medication.
Claim(s) 5 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over White et al. US 2005/0079636 A1 “White” and Fryar-Williams et al. US 2020/0049722 A1 “Fryar-Williams” as applied to claims 1 and 12 above, and further in view of Krill et al. US 2022/0265686 A1 “Krill”.
Regarding claims 5 and 17, White in view of Fryar-Williams discloses all features of the claimed invention as discussed with respect to claims 1 and 12 above, however the combination does not teach “wherein the one or more amplitudes are negatively correlated with a plasma concentrations of the medication”.
Krill is within a related field of endeavor to the claimed invention because it involves the use of fospropofol to treat diseases or disorders (see [Abstract]).
Krill teaches “wherein the one or more amplitudes are negatively correlated with a plasma concentrations of the medication” (“The purpose of Study No. 15-3 (GLP) was to determine the potential toxicity of fospropofol in Sprague-Dawley rats when administered once daily by oral gavage for 14 days Administration of fospropofol disodium by once daily oral gavage to Sprague-Dawley rats at fospropofol dose levels of 0, 50, 100, and 250 mg/kg/day for 14 consecutive days resulted in treatment-related mortalities at 250 mg/kg/day. […] Clinical observations during the dosing period for these animals included labored breathing, prostrate, splayed hindlimbs, uncoordinated movement, decreased activity, and eyes closed” [2444].
Therefore, as the amount of fospropofol accumulates within the plasma of the rats over the course of the 14-day study, the Sprague-Dawley rats experience decreased activity and their eyes remain closed (i.e. amplitude of eyelid closure decreases since eyes remain closed). Thus, this indicates that a negative correlation exists between the plasma concentrations of the medication (i.e. fospropofol) and the one or more amplitudes of closure of an eyelid.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and system of White in view of Fryar-Williams such that the one or more amplitudes are negatively correlated with a plasma concentrations of the medication as disclosed in Krill in order to assess whether the administration of the medication is negatively impacting the subject to which it is being administered, as evidenced by a decrease in the amplitude of eyelid closure (i.e. eyes remain closed). When a negative correlation exists between the amplitude of eyelid closure and the plasma concentration of medication, this could be representative of a negative response to the medication (i.e. subject becomes drowsier, for example). Therefore, modifying the method and system of White in view of Fryar-Williams such that the one or more amplitudes are negatively correlated with a plasma concentrations of the medication as disclosed in Krill would yield the predictable result of assessing whether the administration of the medication is negatively impacting the subject to which it is being administered, as evidenced by a decrease in the amplitude of eyelid closure (i.e. eyes remain closed).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over White et al. US 2005/0079636 A1 “White” and Fryar-Williams et al. US 2020/0049722 A1 “Fryar-Williams” as applied to claim 1 above, and further in view of Hammer, JR, et al. US 2005/0171139 A1 “Hammer”.
Regarding claim 7, White in view of Fryar-Williams discloses all features of the claimed invention as discussed with respect to claim 1 above, however, the combination does not teach “further comprising repeating, at a same medication dosage, steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved”.
Hammer is within the same field of endeavor as the claimed invention because it involves compositions and methods for treating a human diagnosed as having, or at risk for developing, a psychotic symptom by administering a full agonist of a dopamine D2-like receptor to the human (see [Abstract]).
Hammer teaches “further comprising repeating, at a same medication dosage, steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved” (“The invention also features methods for identifying a full D2-receptor agonist that includes administering a test compound to a test subject, such as a mammalian subject (e.g., a mouse, rat, or other laboratory animal) and then testing the subject for Prepulse Inhibition (PPI) (e.g., PPI of the acoustic startle response). […] The test compound can be administered (and preferably is administered) more than one time and the test subject tested for PPI on enough occasions to determine that PPI is attenuated in the subject after a certain number of repetitions. For example, the administration and testing steps can be repeated at least two, three, four, six or ten times or more. The test subject can be tested for PPI after every administration of the D2 receptor agonist, or PPI can be tested after only some administrations” [0011]; “For example, in specific embodiments, the patient can receive about 0.4 mg/kg of the agonist. This dosage can be administered daily or several times daily, and treatment can continue for days, weeks, months, or years. We know that high doses of D2 agonists can cause psychotic symptoms; clearly, therapeutic doses must be lower than these doses. The dosage can remain constant over the course of the treatment regimen. In some embodiments, the amount of the agonist administered and the frequency with which it is administered are such that a certain low level of the agonist (e.g., the level of circulating agonist) is maintained […] As in other therapies, a patient and his or her physician can work together toward an optimal personalized dose” [0034].
Therefore, since the test compound (i.e. D2-receptor agonist) is administered to a test subject and testing (i.e. Prepulse Inhibition (PPI), PPI of the acoustic startle response) is performed repeatedly (i.e. at least two, three, four, six or ten times or more, see [0011]), and the dosage can remain constant over the course of the treatment regimen, the method further comprises repeating, at a same medication dosage (i.e. dosage remains constant, low level agonist is maintained, see [0034]), steps of performing tests of a startle response (i.e. PPI of the acoustic startle response) receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose (i.e. optimal personalized dose) has been achieved.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of White in view of Fryar-Williams such that it further comprises repeating, at a same medication dosage, steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved as disclosed in Hammer in order to allow for accurate assessment of the impact of medication administration. By maintaining the same dosage of a medication and repeating the testing is one of a finite number of techniques which can be used to assess the impact of the medication with a reasonable expectation of success. Thus, modifying the method of White in view of Fryar-Williams such that it further comprises repeating, at a same medication dosage, steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved as disclosed in Hammer would yield the predictable result of allowing for accurate assessment of the impact of medication administration.
Regarding claim 8, White in view of Fryar-Williams discloses all features of the claimed invention as discussed with respect to claim 1 above, however the combination does not teach “further comprising adjusting a dosage of the medication and repeating steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved”.
Hammer teaches “further comprising adjusting a dosage of the medication and repeating steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved” (“Where a patient has developed a tolerance, a higher dose of the agonist can be administered without causing an adverse reaction (or without causing an adverse reaction that is as significant as it would have been had the patient's treatment been initiated at the higher dosage). Thus, regardless of the initial treatment regime, dosages can be adjusted. As in other therapies, a patient and his or her physician can work together toward an optimal personalized dose. Adjustment (e.g., dosage increase or decrease over time) is contemplated and will preferably be such that the patient experiences an improvement in their psychotic symptoms but does not experience an external effect of the drug or significant EPSs. The low dosages stated above notwithstanding, full agonists of a D2-like receptor can be administered at higher dosages (e.g., by increasing dosage over time)” [0034]. Therefore, since a patient who has developed a tolerance for the agonist (i.e. drug) can be administered a higher dose and the dosage can be adjusted to achieve an optimal personalized dose (i.e. resulting in an improvement in the patient’s psychotic symptoms), the method, further comprises adjusting a dosage of the medication and repeating steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of White in view of Fryar-Williams such that it further comprises adjusting a dosage of the medication and repeating steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved as disclosed in Hammer in order to allow the impact of different doses of medication to be assessed. When a patient has built up a tolerance to a dosage of a medication, often times it is necessary to alter the dosage in order to achieve a desired treatment outcome Thus, modifying the method of White in view of Fryar-Williams such that it further comprises adjusting a dosage of the medication and repeating steps of performing tests of a startle response, receiving images, calculating amplitudes, determining values of correlations, and determining whether the correct dose has been achieved as disclosed in Hammer would yield the predictable result of allowing the impact of different doses of medication to be assessed, such that the optimal personalized dose can be determined and thus provided to the patient.
Claim(s) 9-11 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over White et al. US 2005/0079636 A1 “White” and Fryar-Williams et al. US 2020/0049722 A1 “Fryar-Williams” as applied to claims 1 and 12 above, and further in view of Shluzas et al. US 2022/0301666 A1 “Shluzas”.
Regarding claims 9 and 19, White in view of Fryar-Williams discloses all features of the claimed invention as discussed with respect to claims 1 and 12 above, however the combination does not teach “further comprising receiving input indicating when the medication was administered” (Claim 9); “wherein the instructions, when executed, further configure the one or more processors to receive input indicating when the medication was administered” (Claim 19).
Shluzas is within a related field of endeavor to the claimed invention because it involves an efficient, hands-free system and method for capturing and recording patient treatment and physiological data in critical care environments (see [Abstract]).
Shluzas teaches “further comprising receiving input indicating when the medication was administered” (Claim 9); “wherein the instructions, when executed, further configure the one or more processors to receive input indicating when the medication was administered” (Claim 19) (“A head mounted display (HMD) may refer to one or more apparatus and/or one or more systems that are capable of accepting input from the user via a variety of input methods. Touch, voice, head tilt/motion, eye tracking are all examples of input methods into HMD systems. A head mounted display integrates visual display of images and text to the user, a microprocessor capable of executing instructions via software programs also known as apps or app. A head mounted display may also include computer memory, a digital camera, a motion sensor, and communicate with networks via wireless communication protocols.” [0071]; “The term patient data refers to any background information, physiological data, or patient history data that may be useful in classifying, diagnosing and/or treating a patient's medical condition. […] Examples of patient history may be injury type, injury location, injury time, medications administered, medication dosage and time of administration, medication interactions, tourniquet administration, blood loss, ATMIST data, MARCH data, PAWS data, or other patient history or treatment data” [0081]; “The HMD is the interface between the user and the data tag. The data tag is configured to contain a data storage microchip, a microprocessor, and a battery. The data transmitted to the data tag from the HMD is stored in the data tag on internal non-volatile storage such as flash memory, hard drive, or other non-volatile memory methods. The data tag is further configured to contain a display 302, which will display selected patient information on the external surfaces of the data tag. […] The display of patient information is to inform clinicians, transportation EMTs or other care givers who are not wearing an HMD. The patient's vital signs, triage status, injury location, treatments given, drugs or other medications administered, time of drug administration, tourniquets applied, time of tourniquet application, and or time of next tourniquet change and/or loosening are selectively displayed so the caregivers have the critical patient information clearly and easily at hand. The tag may also display patient allergies, drug combination errors, and/or clinical decision support recommendations. The tag may contain physical buttons 303, dials, touch screen, or other user input methods to collect user input” [0134].
Therefore, since the head mounted display and the data tag are both configured to receive a user input corresponding to patient data and patient data includes patient history including medications administered, medication dosage and time of administration, the method carried out by the system further comprises receiving input indicating when the medication was administered.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and system of White in view of Fryar-Williams such that it further comprises receiving input indicating when the medication was administered as disclosed in Shluzas in order to ensure that a subject is administered medications at appropriate times. Receiving a user input regarding the time a medication was administered is one of a finite number of techniques which can be used to ensure that a subject is not administered a medication too frequently, and thus risk adverse side effects, with a reasonable expectation of success. Thus, modifying the method and system of White in view of Fryar-Williams such that it further comprises receiving input indicating when the medication was administered as disclosed in Shluzas would yield the predictable result of ensuring that a subject is administered medication(s) at appropriate times, thereby minimizing the risk of developing adverse side effects associated with taking the medication(s) too frequently.
Regarding claims 10 and 20, White in view of Fryar-Williams and Shluzas discloses all features of the claimed invention as discussed with respect to claims 9 and 19 above, and Shluzas further teaches “further comprising receiving input indicating what dosage was administered” (Claim 10); “wherein the instructions, when executed, further configure the one or more processors to receive input indicating what dosage was administered” (Claim 20) (See Shluzas [0071]; [0081] and [0134] as discussed in claims 9 and 19 above. Therefore, since the head mounted display and the data tag are both configured to receive a user input corresponding to patient data and patient data includes patient history including medications administered, medication dosage and time of administration, the method carried out by the system further comprises receiving input indicating what dosage [of medication] was administered.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and system of White in view of Fryar-Williams such that it further comprises receiving input indicating what dosage [of medication] was administered as disclosed in Shluzas in order to ensure that a subject is administered medications at appropriate amounts. Receiving a user input regarding the dosage of medication administered is one of a finite number of techniques which can be used to ensure that a subject is not administered additional medication at a detrimental dosage, and thus reduce the risk of adverse side effects, with a reasonable expectation of success. Thus, modifying the method and system of White in view of Fryar-Williams such that it further comprises receiving input indicating what dosage [of medication] was administered as disclosed in Shluzas would yield the predictable result of ensuring that a subject is administered medication(s) at [an] appropriate amount(s).
Regarding claims 11 and 21, White in view of Fryar-Williams discloses all features of the claimed invention as discussed with respect to claims 1 and 12 above, however the combination does not teach “further comprising storing information in a database, the information including a user code, a dose, a time of administration, and the one or more amplitudes and times each of the plurality of images was captured” (Claim 11); “wherein the instructions, when executed, further configure the one or more processors to store information in a database, the information including a user code, a dose, a time of administration, and the one or more amplitudes and times each of the plurality of images was captured” (Claim 21).
Shluzas teaches “further comprising storing information in a database, the information including a user code, a dose, a time of administration, and the one or more amplitudes and times each of the plurality of images was captured” (Claim 11); “wherein the instructions, when executed, further configure the one or more processors to store information in a database, the information including a user code, a dose, a time of administration, and the one or more amplitudes and times each of the plurality of images was captured” (Claim 21) (See Shluzas: [0081] as discussed in claims 9 and 19 above and “This disclosure provides an individual, cloud-based and on-device, patient monitoring system where a patient specific physiological monitoring device communicates with an electronic medical records tag to capture and report patient data to a mobile computer that is used by the caregiver. The mobile computer provides the caregiver with a hands-free solution to improve the interface between clinician providers and the EHR” [0012]; “The additional sensor(s) 204 can include an infra-red sensor, optical sensor, ultrasound sensor, acoustic sensor, a laser, a thermal sensor, gyroscopic position and orientation sensors, eye tracking sensors, eye blink sensors, touch sensitive sensors, speakers, vibratory haptic feedback transducers, stereoscopic cameras, or the like. The additional sensor(s) can be used to provide additional information to the processor for processing image data from the camera or for storing patient data or photographs/video onto the data tag” [0125].
Therefore, since additional sensors, such as eye tracking and blink sensors, can be used to obtain and provide additional information for processing image data or for storing patient data, including patient history such as medication dosage and time of administration, and the electronic medical record tag provides an interface between clinical providers and EHR (i.e. electronic health record/database), the method further comprises storing information in a database, the information including a user code, a dose, a time of administration and the one or more amplitudes and times each of the plurality of images (i.e. photographs, see [0125]) was captured. Furthermore, the instructions, when executed, further configure the one or more processors to store information in a database, the information including a user code, a dose, a time of administration, and the one or more amplitudes and times each of the plurality of images (i.e. photographs, see [0125]) was captured.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and system of White in view of Fryar-Williams such that it involves storing information in a database, the information including a user code, a dose, a time of administration, and the one or more amplitudes and times each of the plurality of images was captured as disclosed in Shluzas in order to allow patient data to be accessed at a later time when assessing the status of a patient. Storing information in a database is one of a finite number of techniques which can be used to allow patient information to be accessed at a later time when performing as assessment thereof with a reasonable expectation of success. Thus, modifying the method and system of White in view of Fryar-Williams such that it involves storing information in a database, the information including a user code, a dose, a time of administration, and the one or more amplitudes and times each of the plurality of images was captured as disclosed in Shluzas would yield the predictable result of allowing patient data to be accessed at a later time when assessing the status of a patient.
Conclusion
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
