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 .
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.
Claim Objections
Claim 78 is objected to because of the following informalities: the limitations reciting “when assessing changes in eye state using apparatus covering” and “self-administrating” contain typographical errors. The first limitation would be more accurately recited as “when assessing changes in eye state using an apparatus covering” (emphasis added). The second limitation would be more accurately recited as “self-administering” (emphasis added). Appropriate correction is required.
Applicant is advised that should Claim 81 be found allowable, Claim 114 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. The same goes for if Claim 85 should be found allowable, Claim 115 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. The same goes for if Claim 89 should be found allowable, Claim 116 will be objected to under 37 CFR 1.75 as being substantially duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 78-89 and 91-117 are 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.
Regarding Claims 78 and 117, the limitation “wherein the method includes at least one of the following calibration or compensation features” recites a structural limitation instead of a method step. A method claim should recite method steps, therefore the limitation could be written similar to “wherein the method includes at least one calibration or compensation feature performing at least one of the following steps:”.
Additionally, the limitation “of the eye” recited in lines 18 and 20 of Claim 78 and lines 17 and 19 of Claim 117 lacks proper antecedent basis. It is unclear what “eye” this limitation is referring to given that the claims recite “at least one of the eyes” earlier within the claims. These limitations are being interpreted to mean “of the at least one of the eyes”.
Furthermore, the limitations “the apparatus” recited in lines 24 and 30 of Claim 78 and lines 23 and 29 of Claim 117 are indefinite. It is unclear what “apparatus” these limitations are reciting. Are these recitations referring to the “portable eye motion capture apparatus” recited earlier in the claims, the “image recording apparatus” recited earlier in the claims, or different apparatuses altogether. For this examination, the phrase is being interpreted that the “apparatuses” recited within the claims do not all have to be the same “apparatus”. It should be noted that the continuous use of the word “apparatus” to describe multiple elements makes it confusing/indefinite to differentiate or understand if each of these “apparatuses” are the same apparatus, if there are multiple “apparatuses” built into a singular apparatus, or if there are more than one individual apparatuses being used for the different elements.
Regarding Claim 96, the limitation recited in lines 3-5 of the claim is unclear. The specification fails to clarify what this limitation is meant to mean and therefore cannot be interpreted.
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
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 78-89 and 91-117 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 78 follows.
STEP 1
Regarding Claim 78, the claim recites a series of steps or acts, including a self-administered portable eye motion capture apparatus used to cover the eyes of a user; capturing eye motion data of the user during an episode or event of dizziness or imbalance; providing frame positioning; providing gaze alignment; detecting head movement and/or head orientation; processing or semi-processing captured eye motion data; transmitting eye motion data to a remote location; and creating analytics based on the eye motion data to be used by a clinician in order to provide a medical diagnosis, produce a treatment regime, or report on the symptoms. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of creating analytics based on the eye motion data to be used by a clinician in providing a medical diagnosis, producing a treatment regime, or reporting of symptoms sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 78 fails to recite any application of the created analytics in a manner that imposes a meaningful limitation on the Abstract Idea. The Abstract Idea alone does not provide an improvement to the technological field, the method does not affect a particular treatment or effect a particular change based on the created analytics, nor does the method use a particular machine to perform the Abstract Idea. It is noted that while the claim recites that the created analytics are “for use by a clinician in providing the medical diagnosis, or producing the treatment regimen, or reporting on the symptoms, for said user”, this limitation is intended use language; the claimed invention does not positively recite a step of providing a medical diagnosis, producing a treatment regimen, or reporting on symptoms of the user based on the created analytics. Furthermore, were the claim amended to positively recite performing one or a combination of the aforementioned steps, each of these steps is also directed to a concept performed in the human mind, making each step drawn to a Mental Process, which is an Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 78 recites additional steps of capturing eye motion data of the user during an episode or event of dizziness or imbalance, providing frame positioning, providing gaze alignment, detecting head movement and/or orientation, processing or semi-processing the captured eye motion data, and transmitting the eye motion data to a remote location. The capturing, providing, detecting, processing, and transmitting steps are recited at a high level of generality such that they amount to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea, as well as post-solution activity. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering or processing activity engaged in by medical professionals prior to Applicant's invention. Additionally, the “frame positioning” step utilizes a processor which is a generic computer program configured to perform “removed/cut down electronically through processing” as well as perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the capturing, processing, and transmitting steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The same analysis breakdown as addressed for method claim 78 above applies to method claim 117 given that Claim 78 is narrower and encompasses every feature outlined in Claim 117.
Dependent Claims 79-89 and 91-116 fail to add something more to the abstract independent claims as they generally recite steps pertaining to data gathering and processing as well as steps that could be performed by a clinician looking at data and making a mental observation/judgment. Steps that can be performed by a clinician in this manner present steps that can be performed mentally which is an Abstract idea.
The capturing, providing, detecting, processing, transmitting, and creating steps recited in the independent claims, Claim 78 and 114, maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 78-82, 85, 87-89, 91-95, 99, 106-110, and 112-117 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krueger'141 (U.S. Patent Publication 20180008141).
Regarding Claim 78, Krueger'141 discloses a method of accurately measuring or detecting eye or pupil movements when assessing changes in eye state using apparatus covering a user's eyes that omits ambient/exterior light from reaching the eyes of the user so that the user cannot fixate their eyes on any specific feature/object (Paragraph [0087] - In order for the person's eyes to be able to focus on the displays (306 and 307), there are typically two lenses 322 (left eye lens) and 323 (right eye lens) between the person's eyes and the displays, 306 and 307, when the VR device 300 is worn normally by the person 98. Because the interior of the VR device 300 is not exposed to external light, there can be one or more illumination source(s) 330 to provide light that can be used by the video camera(s) 210 and 211 to sense ocular parameters such as eye or eyelid position or eye motion or any of the other ocular parameters described in other parts of this document), the method including:
self-administering a portable eye motion capture apparatus by the user to cover their eyes prior to onset of, at an onset of, during, or after, an episode or event of dizziness or imbalance (Paragraph [0090] - The eye sensors could be used to image one or both retinas of the person 98, to capture anatomic features of a retina, to capture motion and/or orientation of a retina, and/or to determine retinal image stability and/or foveal fixation; Paragraph [0276] - An example of a portable and wearable computing and head mounted display system can include an eye tracking and measuring system, a connected head mounted display tracking and measuring system, an optical system, peripherals, a power supply, a micro-processor, a memory, and a user interface; Paragraph [0306] - If the device does not need to be completely portable and self-contained);
capturing eye motion data of the user with the portable eye motion capture apparatus during or after their episode or event of dizziness or imbalance (Paragraph [0305] - This can be done with passive head movements or active head movements and an alarm in the device can trigger the timing event of head movement, rather than having another person move the user's head for more of an “active head movement test”. Specifically, the electronic circuit can be triggered or turned on by verbal command (auditory input), by visual means (such as prolonged eyelid closure or other specific eyelid movement); Paragraph [0325] - Similarly, any person with a motion sensitivity disorder (such as motion sickness, vection induced motion sickness, or visually induced motion sickness) or a balance problem, either of a central or peripheral origin, will have a VOR/DVA abnormality…express symptoms of dizziness, disorientation, difficulty with focusing, nausea, fuzziness, and such other complaints as not being clear headed. Embodiments of the present invention can be useful to people who have experienced a vestibular insult, vestibular dysfunction or labyrinthine dysfunction such as those caused by infection, concussive injury, traumatic brain injury, vascular disease, ototoxic or vestibulotoxic medication use, surgical complications, Meniere's disease, people experiencing chronic imbalance, such as, but not limited to, stroke victims, people with systemic illnesses, the elderly and other people who have experienced head injuries, especially those who have experienced cerebral or labyrinthine (inner ear) concussions. It can be used in physician offices to see if a gaze stabilization problem exists and can be useful in the treatment of such an abnormality when it is present);
wherein the method includes at least one of the following calibration or compensation features a) to c) (Paragraph [0095] - a vestibulo-ocular performance calibration test that can be implemented using a head-worn AR/VR unit. This test comprises the following configuration and steps);
a). providing frame positioning including detecting at least one of the eyes of the user as an object of interest is within a frame of reference covered by at least one image recording apparatus, and unnecessary frame/field outside of the eye is removed/cut down electronically through processing or the image capture apparatus is zoomed/focused to the eye to remove extraneous areas to increase definition by the resultant smaller field/frame area of interest and/or to ensure capture of the eyes/pupils of the user (Paragraph [0099] - Display: The display background is subdued, plain, solid, and/or non-distracting; Paragraph [0186] -comprises a light beam projector, shown at 1910, and a forward-facing camera, shown at 1920. The light beam projector 1920 can be a laser pointer or any other source of a light that can be projected from the head-worn device into the user's field of view, as depicted by the scene 96. The projected light can produce a spot or shape in the user's field of view that can serve as a reference point, a projected object that the user can focus on, as shown at 1912. The reference point or projected object generated by the light beam projector 1912 can be used as a target that the user is asked to follow or focus on as part of an ocular performance test; Paragraph [0187] - The forward-facing camera 1920 can be configured to adjust its field of view, focal length, or to zoom in or out in response to an eye sensor);
b). providing gaze alignment whereby, if the pupils of the eyes of the user are not aligned on a horizontal plane relative to the apparatus applied to their face, applying a misalignment correction factor by either realigning eye images of the eye image data relative to the horizontal plane or adjusting eye alignment in later eye image data post processing and analysis of the images (Paragraph [0079] - For example, in an AR/VR environment, tracking can easily be done not only in a purely horizontal or vertical direction, but also using any pattern combining horizontal (i.e. x-direction), vertical (i.e. y-direction), or depth (i.e. z-direction) movement; Paragraph [0083] - The eye sensor can be responsive to any eye position, including vertical movement of the eyes (which represents pitch), rotation of the eyes (which represents roll), and horizontal movement of eyes (which represents yaw); Paragraph [0098] - Eyes: The subject is asked to track a visual target element of interest by moving his/her eyes. The eye sensor (typically a video camera) measures the subject's eye movement 642 as visual elements are displayed; Paragraph [0200] - Eye tracking using binocular horizontal and vertical eye position estimates can be derived from the relative positions of multiple corneal reflections and the center of the pupil. By using two eye landmarks (corneal surface reflections and pupil center) whose relative position are invariant under translation, the angular position of the eye independently of lateral motion of the video system relative to the head is able to be estimated; Paragraph [0311] - Specifically, when there is an abnormal VOR in the horizontal plane, specific algorithms of eye fixation on a target object, while the head is moving horizontally can be used to rehabilitate the abnormality. When the abnormal VOR is seen in the vertical plane, specific algorithms of eye fixation on a target object, while the head is moving in a vertical manner can be used to rehabilitate the abnormality. As the VOR is enhanced or improved, the DVA or RIS will be enhanced);
c). detecting head movement and/or head orientation of the user by the apparatus, the head movement and/or orientation detection used in synchronisation with eye or pupil position/movement recording or correlated as a precursor before the episode prior to commencing recording the eye or pupil position/movement (Paragraph [0096] - comprises a display 604, a head orientation sensor 606, and an eye tracking video camera 608; Paragraph [0097] - Head: In this test, the subject is asked to keep his/her head motionless or the head is constrained to keep it motionless. The head orientation sensor 640 is used to verify that the head is stationary; Paragraph [0188] - The video camera(s) 2010 could be connected to a video processor for eye orientation video processor 124 and a head orientation video processor 2022, both of which can be connected to a central processing unit 132 in the electronic module 2020);
processing or semi-processing for additional processing to take place the captured eye motion data onboard the portable eye motion capture apparatus, or processing or semi-processing for additional processing to take place the captured eye motion data at a remote location remote from the portable eye motion capture apparatus, or a combination of processing or semi-processing for additional processing to take place the captured eye motion data onboard the portable eye motion capture apparatus and remotely at the remote location (Paragraph [0224] - The remote device could also be used to process the data from head orientation sensors and eye tracking sensors and convert this information into the desired visual data for review); and
transmitting the processed, semi-processed eye motion data or transmitting unprocessed eye motion data to the remote location (Paragraph [0224] - The remote device could also be used to process the data from head orientation sensors and eye tracking sensors and convert this information into the desired visual data for review); and
creating analytics based on the processed, semi-processed, or unprocessed eye motion data (Paragraph [0193] - The aggregated data can be stored and written to a file that is compatible with eye-tracking analysis software. Graphics can be generated to visualize such findings. Beyond the analysis of visual attention, stored eye data can be examined to measure the cognitive state or other information).
Regarding Claim 117, the sections of Krueger'141 cited above in Claim 78 disclose a method comprising the steps set forth in the claim.
Regarding Claim 79, Krueger'141 discloses a method outlined in Claim 78 above as well as including detecting nystagmus eye movements or patterns of nystagmus eye movements (Paragraph [0220] - A linear filter may be used when processing eye-tracking data to approximate eye movement signals, at least well enough to recognize a pattern).
Regarding Claim 80, Krueger'141 discloses a method outlined in Claim 79 above as well as including detecting nystagmus eye movements or patterns of nystagmus eye movements (Paragraph [0079] - In embodiments of the present invention, vestibular ocular performance (VOP), saccades, visual pursuit performance, nystagmus, vergence, eyelid closure, dynamic visual acuity, dynamic visual stability, retinal image stability, foveal fixation stability, and focused position of the eyes could be measured in a VR, AR or synthetic 3D environment; Paragraph [0235] - the eyes can be observed and measured at rest to see if there are any abnormalities such as spontaneous nystagmus).
Regarding Claim 81, Krueger'141 discloses a method outlined in Claim 80 above as well as determining speed and direction of nystagmus eye movements and/or determining speed and direction of patterns of the nystagmus eye movements (Paragraph [0028] - [0028] Nystagmus is a description of abnormal involuntary or uncontrollable eye movement, characterized by jumping (or back and forth) movement of the eyes, which results in reduced or limited vision. It is often called “dancing eyes”. Nystagmus can occur in three directions: (1) side-to-side movements (horizontal nystagmus), (2) up and down movements (vertical nystagmus), or (3) rotation of the eyes as seen when observing the front of the face (rotary or torsional nystagmus); Paragraph [0079] - Peak velocity, amplitude, latency, duration, and inhibition of saccades can additionally be measured. The remote distractor effect can be detected. The slow component velocity (SCV) with optokinetic and gaze testing can also be measured. Smooth pursuit accuracy movements, velocity, acceleration and latency can also be measured; Paragraph [0267] - Measuring the slow component velocity of nystagmus takes into account the directional influence of responses according to the vector projection of eye movements).
Regarding Claim 114, the sections of Krueger'141 cited above in Claim 81 disclose a method comprising the steps set forth in the claim.
Regarding Claim 82, Krueger'141 discloses displaying pattern, speed and/or direction of the nystagmus eye movements or patterns of eye movements as at least one graphic representation and/or on an electronic display (Paragraph [0088] - For example, the position of one or both of the eyes (or the orientation or movement of the eyes or eyelids) could be used to determine which of a plurality of choices a user has selected in a menu of options presented on a display; Paragraph [0287] - The device can measure the relationship between motion of the head in this environment and VOP. The data acquired can be uploaded to a remote position from the user for display and interpretation or transmitted wirelessly to a smart phone, wearable display device or other hand held device or other pc computer source).
Regarding Claim 85, Krueger'141 discloses a method outlined in Claim 78 above as well as wherein the eye motion data includes or is augmented by eye movement video sequences, 3Dorientation and position of the user's head during the episode or event of dizziness or imbalance, eye kinematics and tracking data, other eye feature information, patient history, questionnaire data, information pertinent to diagnosis, or a combination of any two or more thereof (Paragraph [0036] - The goal of oculomotor compensation is not retinal image stabilization, but rather controlled retinal image motion adjusted to be optimal for visual processing over the full range of natural motions of the body or with head movement; Paragraph [0192] - Eye tracking is the process of measuring either the point of gaze (where one is looking) or the motion of an eye relative to the head position).
Regarding Claim 115, the sections of Krueger'141 cited above in Claim 85 disclose a method comprising the steps set forth in the claim.
Regarding Claim 87, Krueger'141 discloses a method outlined in Claim 78 above as well as instructing the user when and how to self-administer and use the eye motion capture apparatus (Paragraph [0110] - The subject is instructed to keep his/her eyes focused on the target visual element as the head moves. The eye sensor (typically a video camera) measures eye movement 642 relative to head movement 640; Paragraph [0111] - Cues are provided to tell the subject when to move the head. These cues can be audio cues. The cues could be haptic (i.e. tap on the hand). The cues could be visual (i.e. change of color or intensity of the visual target element of interest). The cues are typically timed randomly so the subject doesn't try to anticipate the timing; Paragraph [0112] - The test sequence is as follows; Paragraph [0113] - 1. The subject is instructed to move the head about 20-25 degrees in one direction when a first cue is given, and to hold the head in this new position 622; Paragraph [0114] - 2. The subject is instructed to move the head back about 20-25 degrees when the second cue is given 624; Paragraph [0115] - 3. The subject is instructed to move the head the first direction a second time when the third cue is given; Paragraph [0116] - 4. The process is repeated as many times as needed 626).
Regarding Claim 88, Krueger'141 discloses a method outlined in Claim 78 above as well as wherein episode capture and/or recording is monitored in real or near real time by at least one clinician following automatic detection and transmission of recorded or direct image data as the episode or event occurs (Paragraph [0312] - The head/eye worn device or method could also collect the data, which could then be uploaded to a medical doctor, trainer, coach or other person at a remote location. This remote location could then provide verbal or visual feedback to the user and this feedback could be integrated with other information provided to the user).
Regarding Claim 89, Krueger'141 discloses a method outlined in Claim 78 above as well as wherein the eye motion capture apparatus performs on-board processing that occurs during or after video capture of the eye motion data, wherein the on-board processing detects if the user closes their eyes during a recording and/or after the captured eye motion data, compresses video data and/or logs particular eye and head movements (Paragraph [0201] - The collected data from the eye tracking system can be used to measure the movement features of the eyes or eyelids or rotation of the eye, acceleration/velocity of the eye movement, duration of the eyelid closure, rate of the eyelid closure).
Regarding Claim 116, the sections of Krueger'141 cited above in Claim 89 disclose a method comprising the steps set forth in the claim.
Regarding Claim 91, Krueger'141 discloses a method outlined in Claim 78 above as well as wherein a starting point and a finishing point of a user’s pupil(s) is used to determine direction and magnitude of eye or pupil movement and/or other eye kinematics (Paragraph [0169] - The saccade eye position 1701 changes during this duration 1709 to reach a new position that differs from the initial eye position by a distance that can be defined as a saccade amplitude; Paragraph [0201] - The collected data from the eye tracking system can be used to measure the movement features of the eyes or eyelids or rotation of the eye, acceleration/velocity of the eye movement, duration of the eyelid closure, rate of the eyelid closure and the direction of gaze).
Regarding Claim 92, Krueger'141 discloses a method outlined in Claim 78 above as well as including capturing rotational motion of the eye(s) and/or a user’s pupil(s); and/or determining speed and/or rate of rotation and/or other eye kinematics from time taken for a full or partial rotation (Paragraph [0193] - The information can then be analyzed to extract eye rotation and ultimately the direction of gaze from changes in reflections).
Regarding Claim 93, Krueger'141 discloses a method outlined in Claim 78 above as well as including using at least one of pixel count, pixel size and/or pixel pattern, of a sensor of a camera or each said camera of the portable eye motion capture apparatus to determine angle of gaze of the user, the method including determining angle of gaze from captured image data and/or image data recordings of eye/pupil position/movement, and/or the method including determining and/or displaying a rate of change of the angle of gaze with respect to time (Paragraph [0201] - In this case, each eye data observation is translated into a set of pixel coordinates. From there, the presence or absence of collected eye data points in different screen areas can be examined; [0280] - For example, a relative position of a center and corners of an HMD screen with respect to a gaze direction or a gaze angle of the eye pupil of the wearer may be stored. Also, locations or coordinates of starting and ending points, or waypoints, of a path of a moving object displayed on the HMD, or of a static path (e.g., semicircle, Z-shape etc.) may be stored on the memory unit).
Regarding Claim 94, Krueger'141 discloses a method outlined in Claim 78 above as well as including determining frame position by detecting that one or both eyes of the user of the portable eye motion capture apparatus is/are within a frame of reference covered by at least one image capture/recording apparatus of the portable eye motion capture apparatus (Paragraph [0141] - The test shown in FIG. 7. or FIG. 8 could be run with the target visual element not being stationary. This would make the overall test more similar to a natural environment in which the head, the eyes, and the visual world are all moving relative to one another and relative to a stationary reference frame at all times).
Regarding Claim 95, Krueger'141 discloses a method outlined in Claim 78 above as well as including identifying pupil position and/or pupil diameter in a reference region (Paragraph [0289] - In one embodiment, the eye-tracker uses the center of the pupil and infrared and/or near-infrared non-collimated light to create corneal reflections (CR). The vector between the pupil center and the corneal reflections can be used to compute the point of regard on surface or the gaze direction).
Regarding Claim 99, Krueger'141 discloses a method outlined in Claim 78 above as well as including: using one or more of pupil center, pupil shape or pupil position relative to a horizontal plane/reference for calibration/position determination; and/or including calibrating or compensating for incorrect position of the portable eye motion capture apparatus or an image capture means of the portable eye motion capture apparatus, such as by frame positioning/windowing, apparatus positioning and/or gaze positioning/pupil position, and/or correcting for misalignment in recordings due to incorrect portable eye motion capture apparatus placement (Paragraph [0200] - Eye tracking using binocular horizontal and vertical eye position estimates can be derived from the relative positions of multiple corneal reflections and the center of the pupil. By using two eye landmarks (corneal surface reflections and pupil center) whose relative position are invariant under translation, the angular position of the eye independently of lateral motion of the video system relative to the head is able to be estimated).
Regarding Claim 106, Krueger'141 discloses a method outlined in Claim 78 above as well as detecting one or more of head movement, head orientation and/or eye orientation or pupil orientation relative to the head and/or the portable eye motion capture apparatus (Paragraph [0080] - Optionally, the system may include one or more of a multi-axis accelerometer to monitor head movements).
Regarding Claim 107, Krueger'141 discloses a method outlined in Claim 78 above as well as including detection and/or imaging presence of and/or location of at least one glint in a pupil or eye relative to center and/or edge of the respective pupil or a respective iris (Paragraph [0199] - Eye sensors to track reference locations on the surface of one or both eyes to determine gaze-tracking locations, utilizing multiple illumination sources and/or multiple cameras to generate and observe glint/reflections from multiple directions can be used improve the accuracy of gaze tracking; Paragraph [0214] - When the eye is panned horizontally or vertically, the relative positioning of the glint and the center of the bright-eye change accordingly, and the direction of gaze can be calculated from these relative positions).
Regarding Claim 108, Krueger'141 discloses a method outlined in Claim 107 above as well as wherein, for a given light source position within the apparatus, position of the glint is used to determine eye, iris and/or pupil center position and/or angle of gaze, and/or wherein distance and/or position of the glint(s) from the respective pupil center is used to determine position and/or orientation of the apparatus or of a camera of the portable eye motion capture apparatus relative to the face of the user and/or determine the angle of gaze (Paragraph [0214] - The first Purkinje image is also called the glint, and this together with the reflection of light off the retina, the so-called bright-eye, can be video-recorded using an infrared sensitive camera as a very bright spot and a less bright disc, respectively. When the eye is panned horizontally or vertically, the relative positioning of the glint and the center of the bright-eye change accordingly, and the direction of gaze can be calculated from these relative positions).
Regarding Claim 109, Krueger'141 discloses a method outlined in Claim 107 above as well as wherein distance between two said glints and/or between at least one said glint and the center of the pupil or other reference is used to compensate for non-ideal apparatus placement/orientation on the user's head/face with respect to eye position or to compensate for non-ideal positioning of at least one camera of the portable eye motion capture apparatus relative to eye position (Paragraph [0214] - The first Purkinje image is also called the glint, and this together with the reflection of light off the retina, the so-called bright-eye, can be video-recorded using an infrared sensitive camera as a very bright spot and a less bright disc, respectively. When the eye is panned horizontally or vertically, the relative positioning of the glint and the center of the bright-eye change accordingly, and the direction of gaze can be calculated from these relative positions).
Regarding Claim 110, Krueger'141 discloses a method outlined in Claim 78 above as well as including using one or more of environmental metrics, body metrics or head metrics, in addition to information/data obtained or derived from image capture information/data from the apparatus, to assess neurological and/or vestibular condition or activity of the user (Paragraph [0082] - a person 98 wearing a head-worn augmented reality system for measuring and/or improving vestibular performance, ocular performance, and/or vestibulo-ocular performance. Referring in more detail to FIG. 1, the person is wearing a headband head worn unit 100, which comprises a headband 104, a see-through display 106, a head orientation sensor 108, and an eye measuring sensor 110…The head orientation sensor 108 can use one or more accelerometers, gyroscopes, magnetometers, or any other relative or absolute position, velocity, or acceleration sensing device capable of being understood by anyone skilled in the art; Paragraph [0234] - The comparison of the smallest image, visual image or optotypes correctly identified or the comparison of the correct numbers of images, visual elements or optotypes in both the DVA and SVA tests can determine if the person has a defect in his or her vestibulo-ocular reflex functions), wherein: when part of the method as herein claimed:
the body metrics is sensed, measured and/or used in combination with eye kinematics/eye state measured by or derived from the apparatus to determine/assess changes in the body that occur before and/or during neuro-vestibular dysfunction or changes in neuro-vestibular function (Paragraph [0078] - For example, all six semi-circular canals can be evaluated for normal function, hypofunction, hyperfunction, for the presence of abnormalities such as BPPV, and to help determine if a person has a peripheral vestibular disorder or central disorder; Paragraph [0130] - The processor in the AR/VR system then compares head movement and eye movement to determine vestibulo-ocular performance 644. Performance could be measured as accuracy, gain, phase, symmetry, velocity, saccades, and/or visual acuity).
Regarding Claim 112, Krueger'141 discloses a method outlined in Claim 78 above as well as determining general health, personal health, stress, fatigue or illness by detection/measurement of eye state or changes in eye state (Paragraph [0078] - Ocular measurements using VR, AR, or synthetic 3D images can be used to predict human performance, to determine candidacy for specific jobs or tasks, or for neurologic health status assessment (such as alcohol and drug usage, the need for rehabilitation, or for the detection, assessment, or management of concussions and/or traumatic brain injury)); and/or
assessing data relating to head movement and eye or pupil motion, optionally the assessing further including assessing data relating to at least one measured body function and/or at least one environmental factor, such as at least one body function includes at least one of heart rate, blood pressure, body temperature, oxygen level, wherein, optionally, the at least one environmental factor includes at least one of ambient temperature, air pressure, humidity, location, gravity; and/or assessing data including determining at least one threshold, safe range, cut-off, optionally the at least one threshold, safe-range or cut-off including determining one or more of a safe threshold for a person conducting an activity, a threshold for time spent in or presence in a particular gravity or change of gravity (Paragraph [0035] - In this document, DVA will be used to assess impairments in a person's ability to perceive objects accurately while actively moving the head, or the ability to track a moving object. It is an eye stabilization measurement while the head is in motion; Paragraph [0078] - Ocular measurements using VR, AR, or synthetic 3D images can be used to predict human performance, to determine candidacy for specific jobs or tasks, or for neurologic health status assessment (such as alcohol and drug usage, the need for rehabilitation, or for the detection, assessment, or management of concussions and/or traumatic brain injury); Paragraph [0221] - The velocity detection method uses an empirically determined velocity threshold).
Regarding Claim 113, Krueger'141 discloses a method outlined in Claim 78 above as well as the user capturing their nystagmus eye motion data at their home, residence, place of work, or place of recreation (Paragraph [0314] - Additionally, this portable hand held device or limb worn device can provide a software rehabilitative eye tracking program, if an abnormality is present. This can then enable the person to develop normal or enhanced eye or foveal fixation stability on a target of interest with head rotation or head movement, while performing their occupational activities), the method including:
the user self-administering the apparatus, the apparatus being a portable eye motion capture apparatus, to cover their eyes prior to onset of, at an onset of, during, or after, an episode or event of dizziness or imbalance (Paragraph [0090] - The eye sensors could be used to image one or both retinas of the person 98, to capture anatomic features of a retina, to capture motion and/or orientation of a retina, and/or to determine retinal image stability and/or foveal fixation; Paragraph [0276] - An example of a portable and wearable computing and head mounted display system can include an eye tracking and measuring system, a connected head mounted display tracking and measuring system, an optical system, peripherals, a power supply, a micro-processor, a memory, and a user interface; Paragraph [0306] - If the device does not need to be completely portable and self-contained);
the portable eye motion capture apparatus configured for capturing eye motion data of the user during the episode or event of dizziness or imbalance (Paragraph [0305] - This can be done with passive head movements or active head movements and an alarm in the device can trigger the timing event of head movement, rather than having another person move the user's head for more of an “active head movement test”. Specifically, the electronic circuit can be triggered or turned on by verbal command (auditory input), by visual means (such as prolonged eyelid closure or other specific eyelid movement); Paragraph [0325] - Similarly, any person with a motion sensitivity disorder (such as motion sickness, vection induced motion sickness, or visually induced motion sickness) or a balance problem, either of a central or peripheral origin, will have a VOR/DVA abnormality…express symptoms of dizziness, disorientation, difficulty with focusing, nausea, fuzziness, and such other complaints as not being clear headed. Embodiments of the present invention can be useful to people who have experienced a vestibular insult, vestibular dysfunction or labyrinthine dysfunction such as those caused by infection, concussive injury, traumatic brain injury, vascular disease, ototoxic or vestibulotoxic medication use, surgical complications, Meniere's disease, people experiencing chronic imbalance, such as, but not limited to, stroke victims, people with systemic illnesses, the elderly and other people who have experienced head injuries, especially those who have experienced cerebral or labyrinthine (inner ear) concussions. It can be used in physician offices to see if a gaze stabilization problem exists and can be useful in the treatment of such an abnormality when it is present);
processing or part-processing the captured eye motion data onboard the portable eye motion capture apparatus or remote from the portable eye motion capture apparatus or a combination of onboard and remotely (Paragraph [0224] - The remote device could also be used to process the data from head orientation sensors and eye tracking sensors and convert this information into the desired visual data for review); and
transmitting the respective processed, part processed or unprocessed eye motion data to a remote location creating analytics based on the processed, part processed or unprocessed eye motion data (Paragraph [0224] - The remote device could also be used to process the data from head orientation sensors and eye tracking sensors and convert this information into the desired visual data for review).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 83-84 are rejected under 35 U.S.C. 103 as being unpatentable over Krueger'141 (U.S. Patent Publication 20180008141) as applied to Claim 78 above, in view of Lewkowski’304 (WO Patent Publication 2007128034 – cited by applicant).
Regarding Claim 83, Krueger'141 discloses the method outlined in Claim 81 above, but fails to disclose including determining at least one driver or origin of the nystagmus eye movements from the pattern speed or direction of the nystagmus eye movements. Lewkowski’034 teaches determining which ear or which part of an ear of a patient may cause the patient to experience nystagmus eye movements (Page 1 lines 22-26 - The presence of nystagmus (very specific, rapid, involuntary eye movements) during a dizziness attack can suggest to a clinician that there is a vertiginous component to it and the direction of the nystagmus may provide some evidence to a specialist in the field, of more specific information, such as which ear (or which part of the ear) has the active disease; Page 23 lines 11-17 - In particular the analysis may involve the identification of nystagmus during the time of a vestibular attack, as well as the intensity and direction of the nystagmus. Analysing eye movements during an attack of dizziness can be a key diagnostic tool in vestibular disorders. It may help determine whether the cause of a patient's imbalance problems is vestibular (inner ear) or otherwise, and if vestibular they may point towards a specific diagnosis). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger'141 to include determining if the nystagmus is caused by a vestibular issue or something else in order to more clearly identify a diagnosis based on where the problem occurs as seen in Lewkowski’034.
Regarding Claim 84, Krueger'141 discloses the method outlined in Claim 80 above, but fails to disclose including analyzing at least one component of the nystagmus eye movements or analyzing eye kinematics of the nystagmus eye movements during sub-periods or intervals of time during a phase of the nystagmus eye movements or analyzing at least one component of at least one slow phase of the nystagmus eye movements or analyzing transition(s) of one or more phases of the nystagmus eye movements or analyzing between the phases of nystagmus eye movements, or analyzing a combination of any two or more thereof to determine drivers of the nystagmus eye movements, origin of the nystagmus eye movements and/or physiological pathways contributing to the nystagmus eye movements. Lewkowski’034 teaches (Page 20 lines 13-18 - In the case of nystagmography the analysis concentrates on recorded eye movements during the dizzy attack. The analysis may make use of already existing eye tracking processing software which is able to analyse the eye images for vertical, horizontal or tortional eye movements, pupil diameter and other eye attribute parameters; Page 23 lines 11-17 - In particular the analysis may involve the identification of nystagmus during the time of a vestibular attack, as well as the intensity and direction of the nystagmus. Analysing eye movements during an attack of dizziness can be a key diagnostic tool in vestibular disorders. It may help determine whether the cause of a patient's imbalance problems is vestibular (inner ear) or otherwise, and if vestibular they may point towards a specific diagnosis). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger'141 to include determining if the nystagmus is caused by a vestibular issue or something else in order to more clearly identify a diagnosis based on where the problem occurs as seen in Lewkowski’034.
Claims 86 and 104-105 are rejected under 35 U.S.C. 103 as being unpatentable over Krueger'141 (U.S. Patent Publication 20180008141) as applied to Claim 78 above, in view of Tsai et. al.'245 (WO Patent Publication 2018213245 – previously cited).
Regarding Claim 86, Krueger'141 discloses the method outlined in Claim 78 above, but fails to disclose including identifying severity, timing and location of the episode or event. Tsai et. al.’245 teaches identifying severity, time, and location of neurological conditions (Paragraph [0046] - Device 100 may also, or alternatively, be configured to determine whether the subject suffers from a neurological condition and/or the severity…Device 100 may also, or alternatively, enable the type of neurological condition and/or specific locations or structures of the brain that have been injured to be identified based on differences in the blink reflex and/or blink period between the left and right eye. Over time, device 100 may be configured to track changes in the baseline blink reflex, blink period, and/or brain reflex as a subject ages or is repeatedly exposed to brain or neurological trauma). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger'141 to include identifying severity, time, and location of an episode or event in order to get a baseline that can be used to compare similar episodes or events over time as well as getting a better understanding of what is occurring as seen in Tsai et. al.’245.
Regarding Claim 104, Krueger'141 discloses the method outlined in Claim 78 above as well as tracking duration and rate of eyelid closure (Paragraph [0201] - The collected data from the eye tracking system can be used to measure the movement features of the eyes or eyelids or rotation of the eye, acceleration/velocity of the eye movement, duration of the eyelid closure, rate of the eyelid closure), but fails to disclose detecting partial eye closure or full eye closure occurring within a threshold time. Tsai et. al.’245 teaches discarding or ignoring blink-related data wherein an amount of time that a user’s eyes are closed is compared to a threshold amount of time during imaging (Paragraph [0044] - Blink reflex device 100 may also, or alternatively, be configured to detect when the subject exhibits an abnormal blink and may reject, discard, and/or ignore any data associated with a blink reflex measurement of the abnormal blink or other non-reflex closure or movement of the eye. An abnormal blink may occur when the eye of the subject does not fully return to the open state, does not fully close, remains closed for a prolonged time period (e.g., greater than 2 times, 5 times, 10 times, 15 times, etc. of a normal blink period) (sometimes referred to as a “micro-sleep”)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger'141 to include discarding or ignoring periods of time whenever the user’s eyes are closed for longer than a threshold amount of time in order to discount abnormal data as a way to filter and observed desired data as seen in Tsai et. al.’245.
Regarding Claim 105, Krueger'141 discloses the method outlined in Claim 104 above, but fails to disclose using the threshold time to allow for a user blinking, such as if eye full or partial eye closure is within the threshold time; and/or if eye full or partial closure is beyond the threshold time, providing an alert and/or stop recording and/or apparatus shut down/go into sleep mode occurs. Tsai et. al.’245 teaches applying a threshold amount of time wherein a user’s eyes remain closed (Paragraph [0044] - An abnormal blink may occur when the eye of the subject does not fully return to the open state, does not fully close, remains closed for a prolonged time period (e.g., greater than 2 times, 5 times, 10 times, 15 times, etc. of a normal blink period) (sometimes referred to as a “micro-sleep”)); and providing an alert to the user (Paragraph [0112] - In the event that the received information does not match the stored information, blink reflex may output a notification that alerts the user that a tracking point cannot be identified). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger'141 to include an alert to a user whose eyes remain closed beyond a threshold amount of time in order to notify the user that the device cannot perform its function as it is supposed to so that a user can make adjustments as needed as seen in Tsai et. al.’245.
Claims 96 and 97 are rejected under 35 U.S.C. 103 as being unpatentable over Krueger'141 (U.S. Patent Publication 20180008141) as applied to Claim 95 above, in view of Ronnecke et. al.'541 (EP Patent Application 2712541 – previously cited).
Regarding Claims 96 and 97, Krueger'141 discloses the method outlined in Claim 95 above, but fails to disclose wherein at least one zone outside of the reference region is ignored or rejected or treated as unwanted or unnecessary, or wherein a previsualisation/detection field is used within which is captured the eye as the object of interest to ensure capturing the eye in image data and unnecessary frame/field beyond the eye is removed/reduced. Paul Lewkoski’034 also fails to disclose wherein a portion/window of an overall sensor area of the portable eye motion capture apparatus is used for windowing such that captured image data is derived from the portion of the overall sensor area. Ronnecke et. al.'541 teaches using a region of interest (ROI) around a user’s eyes that track only movements within that region – window - and reduces tracking movements that occur outside of the ROI (Column 1 lines 15-18 - It then creates an ROI around the eye or eyes to track the eye within this region only. This results in reduced bandwidth requirements and can thus be used to increase camera readout frame rate). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger'141 to include a region of interest (ROI) that tracks eye motion within the ROI while ignoring/rejecting eye motion outside of ROI in order to gather information within a desirable frame and increase the efficacy of the device as seen in Ronnecke et. al.’541.
Claim 98 is rejected under 35 U.S.C. 103 as being unpatentable over Krueger'141 (U.S. Patent Publication 20180008141) as applied to Claim 95 above, in view of Tomasi et. al.'091 (WO Patent Publication 2017143091 - previoulsy cited).
Regarding Claim 98, Krueger'141 discloses the method outlined in Claim 78 above as well as identifying position of the eye(s)/pupil(s) relative to one another and/or to a reference (Paragraph [0080] - Such systems and methods can include eyewear or headwear that comprise one or more eye-tracking cameras for monitoring the position and geometry of at least one eye and its components of the user; Paragraph [0250] - When coupled with eye gaze direction and the tracking of vestibulo-ocular eye movements, absolute head position and movements referenced to viewed objects can be discerned. Within a wearable display system object position, direction, distance, speed and acceleration can be plotted. These display devices, with eye and head tracking sensors, provide a method to integrate head gestures with eye-signal control), but fails to disclose wherein position of the eye(s)/pupil(s) relative to one another and/or to a reference is used for positioning the portable eye motion capture apparatus on/relative to the user. Tomasi et. al.’091 teaches setting boundaries pertaining to eye(s)/pupil(s) positioning to assist in positioning an eye motion capture device on a user (Page 8 Paragraph 3 - The method may further include displaying a graphic on a display screen of the mobile device for assisting in aligning the eyes of the patient with the image acquisition unit. In this regard, the graphic may include a boundary surrounding both of the eyes of the patient or boundaries surrounding each of the eyes of the patient, respectively). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger’141 to include boundaries used to assist in positioning the eye motion capture device relative to the user in order to align the eyes of the user with the eye motion capture device as seen in Tomasi et. al.’091.
Claim 100 is rejected under 35 U.S.C. 103 as being unpatentable over Krueger'141 (U.S. Patent Publication 20180008141) as applied to Claim 99 above, in view of Vlaskamp'672 (WO Patent Publication 2020023672 - cited by applicant).
Regarding Claim 100, Krueger'141 discloses the method outlined in Claim 99 above, but fails to disclose wherein, if the pupils are not aligned on a horizontal plane, degree of pupil misalignment is calculated and used to either realign eye images to a true horizontal plane or as an adjustment parameter in later image post processing and analysis. Vlaskamp'672 teaches realigning horizontal planes to account for misalignment of a user’s eyes based on a processor’s alignment reading (Paragraph [0020] - wherein the processor is configured to receive user input to adjust at least one of the left-eye and right-eye alignment markers in the form of user input to raise or lower at least one of the first and second horizontal lines; Paragraph [0232] - the display alignment process may check (e.g., automatically or by providing a user with alignment markers that highlight any misalignment to the user and receiving user feedback on any misalignment)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger'141 to include identifying misalignment of the eyes and adjusting the horizontal plane in order to assist the device in obtaining aligned readings of eye movement as seen in Vlaskamp’672.
Claim 101 is rejected under 35 U.S.C. 103 as being unpatentable over Krueger'141 (U.S. Patent Publication 20180008141) as applied to Claim 78 above, in view of Klingstrom et. al.'543 (WO Patent Publication 2019050543 – previously cited).
Regarding Claim 101, Krueger'141 discloses the method outlined in Claim 78 above, but fails to disclose including measuring/imaging variation in pupil shape from circular to ovoid/ellipsoid and compensating for non-circular irregularity via image capture means and/or processing means. Klingstrom et. al.'543 teaches determining a confidence value based on a spherical shape of a user’s pupil towards its center and different confidence values as the shape of the user’s pupil becomes less spherical (Paragraph [0028] - The cornea of the eye is typically approximately spherical in a central region around the pupil, but deviates more from the spherical shape further away from the center of the cornea and thus also from the center of the pupil. The optical properties of the eye may therefore be more difficult to model in these regions, which makes glints located far out on the cornea (or even as far out as the sclera) less reliable for computation of gaze directions; Paragraph [0029] - Determining the first confidence value may for example comprise associating a first value of the distance (that is, the distance between the one or more glints and the cornea center of the left eye) with a lower reliability than a reliability associated with a second value of the distance). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger'141 to include a confidence value assigned to a user’s pupil shape ranging from being spherical to not spherical in order to better observe and understand variations/trends caused by pupil shape that can occur in optical models whenever they are processed and analyzed as seen in Klingstrom et. al.’543.
Claims 102 and 103 are rejected under 35 U.S.C. 103 as being unpatentable over Krueger'141 (U.S. Patent Publication 20180008141) as applied to Claim 78 above, in view of Hay et. al.'638 (U.S. Patent 6419638 – previously cited).
Regarding Claim 102, Krueger’141 discloses the method outlined in Claim 78 above as well as identifying accuracy of eye fixations (Paragraph [0079] - Accuracy of the shift of the eyes from target fixation to another can be measured), but fails to disclose determining a confidence factor in the accuracy of eye kinematics, wherein the confidence factor is used during analysis to accept, modify or reject eye kinematic measurements. Hay et. al.'638 teaches confidence levels used to accept or reject eye movement when compared to a threshold (Column 26 lines 61-67 to column 27 lines 1-2 - The results of each test may either add to or subtract from the overall confidence and subsequent acceptance or rejection of the peak as a candidate eye location. Once the results of multiple tests have achieved a threshold level of confidence, the location of the peak, specifically the location of the estimated center of the pupillary aperture, is accepted as being the location of the eye for that search boundary and the logic moves on to find the other eye or to the next task). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger’141 to include confidence levels used to accept or reject eye movements when compared to a threshold in order to focus the user’s or clinician’s focus on observing eye movements that are within a frame of reference or boundary rather than those that fall outside a given threshold as seen in Hay et. al.’638.
Regarding Claim 103, Krueger’141 discloses the method outlined in Claim 102 above, but fails to disclose wherein the confidence factor includes one or more of pixel count, pixel size or pixel pattern, representing a shape of a pupil image, percentage of eyelid closure obstructing a view of a pupil, size of the pupil, angle of the pupil from a portable eye motion capture apparatus center. Hay et. al.'638 teaches using a confidence value derived from pixels in order to give information regarding pupil image (Column 34 lines 9-23 - As summarized earlier, the Find_Eyes_2 subroutine implements an eye pupil location strategy which attempts to locate and discriminate the eye pupils by implementing a single pass raster scan (box 435 of FIG. 13c) within search boundaries (rectangular boxes) established separately within the overall ST-7 image for the right and left eyes, and performing multiple tests within a given region of the image when pixels are encountered which have an intensity level which exceeds the basic screening criteria. The tests are designed to reject regions which are not good candidates for the eye pupil location (e.g., intensity peaks caused by hot pixels, reflections from eyeglass frames and lens, reflections from tear ducts) with minimal computational effort while applying sufficient tests to establish confidence for the selection of the "true" eye pupil locations). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger’141 to include confidence values inspired by pixels in order to provide an additional screening parameter with a value that may be more sensitive towards identifying pupil shape and location as seen in Hey et. al.’638.
Claim 111 is rejected under 35 U.S.C. 103 as being unpatentable over Krueger'141 (U.S. Patent Publication 20180008141) as applied to Claim 78 above, in view of Krueger'792 (U.S. Patent Application 2014152792 – previously cited).
Regarding Claim 111, Krueger’141 discloses the method outlined in Claim 78 above, but fails to disclose including assessing effects on a person of high altitude, space flight, off-earth time, low/reduced gravity relative to earth, by detecting/measuring eye position/changes in eye position relative to head position with change in environmental metrics/conditions. Krueger'792 teaches an eye movement capture device used by individuals in space travel – flight (Paragraph [0066] - This remote physiologic biosensor detection could track head movement, head velocity, or abnormal eye movements, or prolonged eyelid closure, physical monitoring and physiologic measurements of the vital signs as discussed previously; Paragraph [0237] - The modular and miniature design of the eye glass subsystem allows the use in a much larger field of use, including vehicular travel (land, sea and air), medical rehabilitation, space travel). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Krueger’141 to include a device that can be used by those in space flight as a way to combat their disorientation early on as seen in Krueger’792 (Paragraph [0251] - The only remedy at this moment is drug therapy while stationed in space, a decidedly non-optimal solution. Additionally during training for space flight students aboard the zero-G flight simulator routinely experience motion sickness. It is expected our technology will remedy space sickness and by providing visual cues to offset the loss of proprioception and orientation due to loss of gravitation).
Response to Arguments
Applicant's arguments filed 14 April 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior claim objections. However, additional claim objections have been addressed in Paragraph 3 above as well as a previously addressed objection in Paragraph 4 above pertaining to Claims 85, 115, 89, and 116.
Applicant’s amendments have overcome some of the prior 35 U.S.C. 112b rejections, but remaining rejections have been addressed in Paragraph 5 above.
Application’s amendments and reasons regarding overcoming the prior 35 U.S.C. 101 rejections were considered, but were found not to be persuasive. The applicant had amended the claims to include “providing” and “detecting” limitations, but as addressed in the Paragraphs above, the examiner notes that these additional limitations amount to pre-solution data gathering performed by a computer program such as a processing unit. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. Additionally, the examiner notes that the current “improvement” argument is geared towards a controller using calibration techniques to obtain data, but this is not an improvement to the controller itself. Arguing “improvement” via calibration is not enough to overcome the judicial exception without evidence as to how these said improvements would enable the controller comprising the calibration techniques to work or control better. The full analysis of the 101 rejection is in Paragraph 6 above.
Claims 78-82, 85, 87-89, 91-95, 99, 106-110, and 112-117 are rejected under 35 U.S.C. 102(a)(1) as necessitated by amendments, as discussed in Paragraph 7 above. It is further noted that Claim 84 that once was rejected under 35 U.S.C. 102(a)(1) is now rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraph 8 above.
Claims 83-84, 86, 96-98, 100-105, and 111 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 8-15 above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
Prosecution Insights