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 5/13/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 and 15 objected to because of the following informalities: the preamble of these claims recite “using combination” and should recite “using a combination”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 1, at the time the invention was filed the applicant was not in possession of the following limitations:
Claim 1: “automated eye image evaluation performed with minimal subjective intervention on the part of the clinician”. The specification mentions “automated eye image evaluation” as sub feature of a confirmation step. It separately mentions the goal “minimal operator intervention” and “minimal subjective intervention (see direct quotes below). The specification never explicitly described the automated eye image evaluation as a mechanism that achieves or is performed with minimal subjective intervention. The claim links these two concepts as a specific requirement, but the specification treats them as independent attributes of the system. Therefore, the claim limitation of “evaluation” is not linked to the concept of “minimal subjective intervention”.
Claim 1: “to calculate a composite test protocol score for the subject with minimal subjective intervention on the part of the clinician”. The specification mentions calculating the score as a statistical task involving variables and weighing and it separately discussed “minimizing operator intervention” as broad objectives for the testing platform (see direct quotes below). While the specification describes what a score is and that the system should have minimal intervention, the specification treats these as two separate goals rather than a single, integrated functional step. Therefore, the claim limitation of “calculate[ing]” is not linked to the concept of “minimal subjective intervention on the part of the clinician”.
Claim 15: “Automatically establishing a region of interest for the camera-based eye tracker in the goggle based system in which the region of interest is centered on the subject's pupils without clinician input”. The specification describes the technical process where the ROI is self-positioning on a pupil and separately discusses the objective to “minimize subjective intervention on the part of the clinician” and “effectively eliminate subjective manipulation”. While the specification describes how the camera self-positions, such self-positioning is treated as an independent feature rather than an integrated process that functions specifically through the total exclusion of clinician input. The claim requires the centering to occur “without clinician input”, which is an absolute negative limitation, yet, the specification fails to disclose a technical “lock-out” mechanism or a purely autonomous logic that specifically prevents or operates in the total absence of human agency. While the specification states that automatic ROI is “potentially more reliable than human adjustment”, it does not describe a system where the clinician is technically incapable of providing input or where the centering is specifically defined by the exclusion of input. Because the specification describes a technician who still reviews results and monitors for errors, it does not demonstrate that the inventor had possession of a centering process that functions entirely without human input at the time of filing.
Claim 15: “automated eye image evaluation performed with minimal subjective intervention on the part of the clinician”. The specification mentions “automated eye image evaluation” as sub feature of a confirmation step. It separately mentions the goal “minimal operator intervention” and “minimal subjective intervention (see direct quotes below). The specification never explicitly described the automated eye image evaluation as a mechanism that achieves or is performed with minimal subjective intervention. The claim links these two concepts as a specific requirement, but the specification treats them as independent attributes of the system. Therefore, the claim limitation of “evaluation” is not linked to the concept of “minimal subjective intervention”.
Claim 15: “calculate a composite test protocol score for the subject with minimal subjective intervention on the part of the clinician”. The specification mentions calculating the score as a statistical task involving variables and weighing and it separately discussed “minimizing operator intervention” as broad objectives for the testing platform. While the specific describes what a score is and that the system should have minimal intervention, the specification treats these as two separate goals rather than a single, integrated functional step. Therefore, the claim limitation of “calculate[ing]” is not linked to the concept of “minimal subjective intervention on the part of the clinician”.
For reference, specification regarding minimizing operator input:
para [0029] “For OVRT testing this necessitates the acquisition of objective, reliable data that minimizes subjective intervention on the part of the clinician.”
para. [0032] “…automated analysis of test metrics (latency, accuracy, gain relative to stimulus, etc.) with minimal operator intervention.”
para. [0033] “The present invention enhances acquisition software and simplifies its use as an important step in minimizing the influence of operator variability…”
par. [0036] “…The Automated setup in the eye tracking aspects will decrease setup time and create an interface usable by a technician or medic with minimal training which decreases opportunities for user errors.”
para. [0038] “Further, using pre-programmed/ automated voice instructions for each test removes variability between the tests due to clinician/technician error, and minimizes error due to subject misconception of testing protocol 40.”
para. [0039] “Adding an automated confirmation of correct eye tracking settings provides a simple automated assurance that the specific tests are being performed within the desired settings again minimizes erroneous results due to clinician/technician error.”
para [0041] “Streamlining the data analysis will decrease testing time, create an interface that can be used by an inexperienced technician or medic with minimal training, and limit opportunities for clinician/technician errors.”
para. [0042] “By automating pupil detection and removal of remaining artifacts, acquired data are to have sufficient reliability to minimize, possibly obviate, the need for operator filtering and extraction.”
Of note, the claims as originally filed in the 15/233,845 parent application do not set forth any mention of any claim to minimization nor do the address clinician input of the minimization or lack thereof.
Claims 1-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 15 recites the limitation "the quantified camera based eye tracker obtained data". There is insufficient antecedent basis for this limitation in the claim because the claim previously sets forth quantifying eye movement velocity data, and not quantification based on a camera based eye tracker data. For purposes of examination the indefinite limitation has been deemed to claim that the quantified camera based eye tracker obtained data is the quantified eye movement velocity data.
Claims 1 and 15 recite the limitation " analytic variables obtained from camera based eye tracker ". There is insufficient antecedent basis for this limitation in the claim because it is unclear if this camera based eye tracker is the same camera as previously recited (i.e., a/the “camera based eye tracker”). For purposes of examination the indefinite limitation has been deemed to claim “the camera based eye tracker”.
Claims 1 and 15 recite “wherein this step includes…”, and while the preamble sets forth “the steps of”, the instance of “wherein this step includes…” is the only reference to a step in Claims 1 and 15. It is therefore unclear which limitations of Claims 1 and 15 are steps and which are not steps. For purposes of examination the indefinite limitation has been deemed to claim “automatically confirming that the oculomotor, vestibular and reaction time testing protocol is performed within preset parameters”, because the limitation “the step” does not seem to impart any actual limitation.
The term “minimal subjective intervention on the part of the clinician” in claims 1 and 15 is a relative term which renders the claim indefinite. The term “minimal” and “subjective” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination the indefinite limitation has been deemed to claim that the process of testing protocol is at least somehow/somewhat automated in order to minimize operator error with respect to testing protocol.
Regarding Claims 1 and 15, the limitation “wherein this step includes automatically confirming that the oculomotor, vestibular and reaction time testing protocol is performed within preset parameters including automated eye image evaluation performed with minimal subjective intervention on the part of the clinician” renders the claim indefinite. As addressed above, it is unclear what limitation “this step” imparts on the claim. Furthermore, there are grammatical issues with the claim which make the metes and bounds of the claim unclear. For instance, there appears to be a step or action being performed, but there is no claim to what is being done. There is a confirmation that the oculomotor, vestibular and reaction time testing protocol is performed within preset parameters, but there are no parameters claimed. It is further unclear what is meant by preset parameters “including” automated eye image evaluation performed. For purposes of examination the indefinite limitation has been deemed to claim that a testing protocol is performed which is at least somewhat automated in order to minimize operator error with respect to testing protocol, but does not explicitly exclude the operator for performing steps for the testing protocol.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140327880 A1 to Kiderman et al. (hereinafter, Kiderman) in view of US 2015/0245766 A1 to Rennaker et al. (hereinafter, Rennaker).
Regarding Claims 1 and 15, Kinderman discloses a process for automatic data acquisition, appraisal and analysis in noninvasive rapid screening of neuro-otologic condition using combination of subject's objective oculomotor, vestibular and reaction time analytic variables obtained by a camera based eye tracker, comprising the steps of:
Establishing an oculomotor (para. [0054] “In the Horizontal random saccade (HS) the subject is directed to follow (or jump to) a target… as it is displayed at a fixed location on the screen. … The unit 10 will obtain values for at least eye peak velocity, latency, accuracy for both main saccade, and combined main and secondary corrective saccade.”),
vestibular (para. [0067] “In the subjective visual vertical (SVV) testing the subject is presented with a red line on the display and directed to use control left and right buttons… to manipulate the displayed line into the vertical (upright). … The unit 10 measures the mean and standard deviation from subjective vertical position and the true vertical position.”) and
reaction time testing protocol (para. [0069] “[0069] In the Visual reaction time (VRT) test 20 random time center lights or stimulus are presented. The subject is directed to signal their recognition by pressing a button, or other input. The system 10 measures the Average visual reaction time and the standard deviation (SD) of the reaction time.”)
for a specific neuro-otologic condition (para. [0003] “The present invention relates to Traumatic Brain Injury (TBI including mild Traumatic Brain Injury or mTBI) and psychological health, and more specifically to quantitative, noninvasive, clinical diagnosis of traumatic brain injury…”) which protocol includes (para. [0015] “One implementation of the present invention includes the establishment of a protocol…”, ) eye tracking aspects (para. [0021] “Small cameras, mounted in goggles, track the center of the pupil to provide the location of the eye.") and which protocol obtains a combination of a subject's objective oculomotor, vestibular and reaction time analytic variables (para. [0073] “The I-Portal® system based neuro-otologic tests are neuro-physiologic; measuring the eye's response to various motion, oculomotor, and optokinetic stimuli.”) from a camera based eye tracker (para. [0021] “VOG technology, however, uses infrared cameras to measure the eye's position. Small cameras, mounted in goggles, track the center of the pupil to provide the location of the eye.”) capable of capturing and quantifying
eye movement velocity data (para. [0058] “… the unit 10 will obtain values for at least eye peak velocity, latency, accuracy for both main saccade, and combined main and secondary corrective saccade.”),
eye movement latency data (para. [0056] “The main latency during the HS testing is the time duration from the initial display of the subject target or stimulus and the beginning of the main saccadic eye movement…”),
eye movement smoothness data (para. [0062] “In SPH testing the unit 10 measures the percent of saccade, which is the percent of saccadic eye movement components that comprise the whole of the smooth pursuit test.”) and
eye movement precision data (para. [0058] “As with HS testing, in VS testing the unit 10 will obtain values for at least eye peak velocity, latency, accuracy for both main saccade, and combined main and secondary corrective saccade.”);
Coupling the camera based eye tracker in a goggle based system to the subject (para. [0012] “… providing a stimulus generating eye tracking unit, such as a head mounted goggle based eye tracking unit coupled to the subject…”) (para. [0023] “The VOG/VNG unit 10 coupled to the subject; presenting a plurality of virtual reality based visual stimulus to the subject…”);
Automatically establishing a region of interest for the camera based eye tracker in the goggle based system in which the region of interest is centered on the subject's pupils (para. [0021] “VOG technology, however, uses infrared cameras to measure the eye's position. Small cameras, mounted in goggles, track the center of the pupil to provide the location of the eye.”) without clinician input (para. [0053] “… the unit 10 allows for the testing to progress in an almost fully automated method making it particularly easy for technicians. The technician merely needs to explain the upcoming or current test and review the results for testing abnormalities (e.g., results indicating the goggles have slipped off the patient, or the power has been interrupted, etc).”);
Conducting the oculomotor, vestibular and reaction time testing protocol to obtain a combination of a subject's objective oculomotor, vestibular and reaction time analytic variables (para. [0012] “… obtaining objective physiologic response of the subject from the eye tracking unit based upon each of neurologic test associated with each visual stimulus presented to the subject…”) based upon the quantified camera based eye tracker obtained data (para. [0021] “VOG technology, however, uses infrared cameras to measure the eye's position. Small cameras, mounted in goggles, track the center of the pupil to provide the location of the eye.”), wherein this step includes automatically confirming that the oculomotor, vestibular and reaction time testing protocol is performed within preset parameters including automated eye image evaluation (para. 0014 “… determining whether at least one post-trauma objective physiologic responses of the subject differs from an associated objective physiologic response of a normative database of similar subjects by greater than a preset threshold for that response.”) performed with minimal subjective intervention on the part of the clinician (para. [0053] “… the unit 10 allows for the testing to progress in an almost fully automated method making it particularly easy for technicians.”);
Analyzing the combination of a subject's objective oculomotor, vestibular and reaction time analytic variables obtained from camera based eye tracker (para. [0022] “… obtaining objective physiologic response of the subject from the eye tracking unit based upon each of neurologic test associated with each visual stimulus presented to the subject; and using the objective physiologic responses to the neurologic tests to diagnose the presence of traumatic brain injury.”) to calculate a composite test protocol score for the subject (para. [0074] “The abnormal results, based upon an individual baseline or a normative group, to the above battery of tests presents a effective screening tool for an increased likelihood of the presence of mTBI.”) with minimal subjective intervention on the part of the clinician ([0053] “The total test battery time is less than 15 minutes per patient (approximately 13 minutes 30 seconds) and the unit 10 allows for the testing to progress in an almost fully automated method making it particularly easy for technicians. The technician merely needs to explain the upcoming or current test and review the results for testing abnormalities (e.g., results indicating the goggles have slipped off the patient, or the power has been interrupted, etc).”); and
sharing composite test protocol score for screening of a neuro-otologic condition of the subject (para. [0022] “A VNG unit is typically a diagnostic system for recording, analyzing and reporting (generally) involuntary eye movements, called nystagmus for involuntary movements, using video imaging technology.”) (para. [0026] “Remote data access from forward deployed facilities to other medical personnel for triage can be implemented.”).
(Claim 2) wherein the conducting the oculomotor, vestibular and reaction time testing protocol uses automated pre-programmed instructions to the subject (para. [0029] “The combination of the eye tracking and the display of simulated distanced visual targets allow the VOG/VNG unit 10 to automatically run a number of preprogrammed neurologic tests and to record the physiologic responses thereto.”).
(Claim 3) advising a clinician of testing which is outside of present parameters (para. [0053] “The technician merely needs to explain the upcoming or current test and review the results for testing abnormalities (e.g., results indicating the goggles have slipped off the patient, or the power has been interrupted, etc)”).
(Claims 6, 7, 14, 16, 19) wherein the specific neuro-otologic condition is mild traumatic brain injury (para. [0003] “The present invention relates to Traumatic Brain Injury (TBI including mild Traumatic Brain Injury or mTBI)…”).
(Claims 10, 11, 18) the step of advising a clinician of testing which is outside of present parameters (paragraph [0053] “The technician merely needs to explain the upcoming or current test and review the results for testing abnormalities (e.g., results indicating the goggles have slipped off the patient, or the power has been interrupted, etc)”).
Kinderman further discloses (Claims 5, 8, 9, 13, 17, 20) where wherein the composite test protocol score is a normalized test score (paras. [0035, 0074] discuss abnormal test results based upon an “individual baseline or normative group” and differing from responses of a “normative database of similar subjects), (Claims 6 and 14) wherein the specific neuro-otologic condition is mild traumatic brain injury (para. [0003] “The present invention relates to Traumatic Brain Injury (TBI including mild Traumatic Brain Injury or mTBI)…”), (Claim 10) the step of advising a clinician of testing which is outside of present parameters (paragraph [0053] “The technician merely needs to explain the upcoming or current test and review the results for testing abnormalities (e.g., results indicating the goggles have slipped off the patient, or the power has been interrupted, etc)”).
Kinderman discloses the claim invention as set forth and cited above except for expressly disclosing (Claims 4, 8, 12, 17, 20) where the composite/normalized test score is displayed on a graphical progressive background.
Rennaker teaches (a) the use of a battery of visual tests to measure the severity of traumatic brain injury (using a housing that fits over the users eyes and uses light and cameras operable to detect pupil orientations in paras. [0003, 0015, 0016]). Rannaker teaches a display that returns a numeric score that indicates the level of neurological impairment (para. [0015]). Especially as broadly claimed, and lacking further description within the instant specification of what a “graphical progressive background” is, the display in Rennaker is considered a graphical progressive background as it has the capability of changing the numeric score on the display depending on the level of neurological impairment. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the composite test score of Kinderman to be displayed numerically on a progressive background as set forth in Rennaker as Rennaker teaches at para. [0006] that there is a critical need to identify brain injury in individuals to prevent everything from cognitive impairments to suicide. A skilled artisan would have recognized that the ability to display the score of a test would have enabled treatment to address such cognitive impairments. Also, displaying results for diagnostic tests is notoriously obvious in the art.
Conclusion
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791