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 .
Claim Objections
Claims 1, 3, 7, 12, 16, and 17 are objected to because of the following informalities:
Claim 1, line 18: –the– should be inserted before “calculated”;
Claim 1, line 11: “wherein a” should be replaced with –wherein the–;
Claim 3, line 1: –the– should be inserted before “calculated”;
Claim 7, line 1: “set” should be deleted;
Claim 12, line 3: “is” should be replaced with –are–;
Claim 16, line 10: “wherein a” should be replaced with –wherein the–;
Claim 17, line 2: “is” should be replaced with –are–.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No limitations were interpreted under 35 U.S.C. §112(f)
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 1-17 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.
Claim 1 recites “a deviation” in line 11. Claim 1 also recites “deviations” in line 9. It is unclear how the deviation of line 11 is related to the deviations in line 9. If they are the same, consistent terminology should be used. If they are different, the relationship should be defined. For the purposes of examination, the recitation in line 11 will be interpreted to be “one of the deviations”. Claim 16 recites the same limitations, so claim 16 is rejected on the same grounds. Claims 2-15 are rejected by virtue of their dependence from claim 1. Claim 17 is rejected by virtue of its dependence from claim 17.
Claim 8 recites “the calculating of the temporal length and the magnitude of the deviation event is done as a function of time”. It is unclear how temporal length and a magnitude is calculated as a function of time. The recitation suggests (A) the temporal length and the magnitude change depending on time or (B) the temporal length and the magnitude are results from time. However, temporal length and magnitude of deviation event are not understood to change depending on time or are results of time. For the purposes of examination, the recitation will be interpreted to be “the calculating of the temporal length and the magnitude of the deviation event is based on time”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0270656 A1 (Samec) (previously cited) in view of, US2014/0085608 A1 (Clopton), US 2023/0210438 A1 (Zarreii), and US 2012/0123219 A1 (Georgiev) (previously cited)
With regards to claim 1, Samec discloses a method for quantifying and diagnosing an ocular misalignment disorder (¶ [0002] discloses methods for diagnosing, monitoring, and treating health conditions and ailments; ¶¶ [1577], [1590] disclose systems and methods for identifying, treating, and/or correcting convergence deficiencies such as those caused by strabismus and/or amblyopia), comprising: securing a head mount on a user (¶ [1590] teaches use of an ophthalmic system, such as any of the augmented reality devices disclosed herein; ¶ [1575] discloses the use of a wearable augmented reality head-mounted device), the head mount having at least one camera (¶ [01576] discloses the use of an eye tracking system; ¶ [1586] discloses the eye tracking system including one or more sensors including cameras), and the head mount in communication with a device controller (¶ [1588] discloses a user interface that is not physically integrated with the device, wherein the user interface device may be a smartphone, computer, tablet, or other computational device; ¶ [1589] discloses using the interface features to control aspects of the vision testing and/or therapy); independently tracking and recording a plurality of positions of a pupil in each eye of the user over a period of time in ambient light (¶ [1591] discloses determining a difference and/or convergence point of both eyes based on eye tracking and/or gaze detection; ¶ [1586] discloses sensors for determining a gaze using the glint; ¶ [1562] discloses tracking a glint with respect to features of the eye (e.g, pupil) to determine gaze and/or convergence point of the eyes; Fig. 5 and ¶¶ [1533], [1578] depict the ophthalmic device directing ambient light from the surrounding world to the eyes); comparing the plurality of positions of the pupil in each eye of the user to detect deviations in alignment of each eye indicative of ocular misalignment (¶ [1591] discloses determining a difference in the focus and/or convergence points of both eyes; ¶ [1593] depicts detecting the eyes are becoming more or less misaligned); and using a graphical user interface (GUI) (¶ [1588] discloses a graphical user interface).
Samec is silent regarding comparing the deviations to a predetermined threshold value to determine if a deviation event has occurred, wherein a deviation event is defined by a deviation crossing the predetermined threshold value and subsequently returning below the predetermined threshold value, calculating, for each deviation event, a temporal length based on a duration between an onset of the deviation event and an offset of the deviation event.
In a system relevant to the problem of accurately detecting ocular deviations, Clopton teaches comparing the deviations to a predetermined threshold value to determine if a deviation event has occurred (¶ [0033] discloses an eye deviation condition is a deviation from a central visual axis of greater than a predetermined value (e.g., 2 degrees) with respect to that of the dominant eye), wherein a deviation event is defined by a deviation crossing the predetermined threshold value and subsequently returning below the predetermined threshold value (¶ [0033] discloses that the eye deviation condition is when the deviation is greater than a predetermined value, which indicates that the condition begins when the deviation crosses the value and ends when the deviation returns below the value), calculating, for each deviation event, a temporal length based on a duration between an onset of the deviation event and an offset of the deviation event (¶¶ [0014], [0033] depict comparing the amount of time of deviation with a predetermined amount of time to initiate treatment, which indicates that a temporal length of the deviation is calculated). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate comparing the deviations to a predetermined threshold value to determine if a deviation event has occurred, wherein a deviation event is defined by a deviation crossing the predetermined threshold value and subsequently returning below the predetermined threshold value, calculating, for each deviation event, a temporal length based on a duration between an onset of the deviation event and an offset of the deviation event, as taught by Clopton. The motivation would have been to provide a more complete diagnostic analysis of the patient.
The above combination is silent regarding calculating a magnitude based on a maximum deviation during the deviation event
In the same field of endeavor of monitoring ocular deviations, Zarreii teaches calculating a magnitude based on a maximum deviation during a deviation event (¶¶ [0105], [0107] depict calculating a maximum amount of deviation). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate, based on the teachings of Zarreii, calculating a magnitude based on a maximum deviation during a deviation event. The motivation would have been to provide a more complete diagnostic analysis of the patient.
The above combination is silent regarding displaying calculated temporal lengths and magnitudes on a graphical user interface (GUI).
In a system relevant to the problem of communicating data to a patient, Georgiev teaches displaying calculated values on a graphical user interface (GUI) (¶ [0011] discloses displaying first data display in a first graphical user interface). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the GUI of Samec to incorporate that it displays calculated values as taught by Georgiev. The motivation would have been to communicate the data with the user.
With regards to claim 8, the recitation of “the calculating of the temporal length and the magnitude of the deviation event is done as a function of time” is being interpreted to be “the calculating of the temporal length and the magnitude of the deviation event is based on time” due to the indefiniteness of the claim language.
The above combination teaches or suggests the calculating of the temporal length and the magnitude of the deviation event is based on time (¶¶ [0014], [0033] of Clopton depict comparing the amount of time of deviation with a predetermined amount of time to initiate treatment, which indicates that a temporal length of the deviation is calculated, where the temporal length is necessarily based on time; ¶¶ [0105], [0107] of Zarreii depict calculating a maximum amount of deviation during a deviation event, which is necessarily based on the time period of the deviation event).
With regards to claim 9, the above combination teaches or suggests the device controller is remote from the head mount (¶ [1588] of Samec discloses a user interface that is not physically integrated with the device, wherein the user interface device may be a smartphone, computer, tablet, or other computational device).
With regards to claim 10, the above combination teaches or suggests the method is performed outside a clinical setting (¶ [1577] of Samec discloses using the system may or may not occur at a doctor's or clinician's office).
With regards to claim 11, the above combination teaches or suggests the graphical user interface is on a display configured to be used by an operator (¶ [1588] of Samec depicts the graphical user interface being configured to allow a wearer or other person to provide input to the device; ¶ [0011] of Georgiev discloses the GUI includes interaction fields).
Claims 2, 4, 5, 7, 12, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of Clopton, Zarreii, and Georgiev, as applied to claim 1 above, and further in view of US 2019/0046029 A1 (Tomasi) (Previously cited).
With regards to claim 2, the above combination is silent regarding calibrating the plurality of positions of the pupil in each eye of the user to yield a value in a prism diopter.
In the same field of endeavor of monitoring ocular misalignment, Tomasi teaches calibrating the plurality of positions of the pupil in each eye of the user to yield a value in a prism diopter (¶ [0014] discloses measuring positions of the iris or pupil in the left and right eyes, obtaining a misalignment measurement, and converting the distance into degrees or prism diopters using a Hirschberg ratio and an internal calibration factor based on iris diameter). It would have been obvious for one of ordinary skill to have modified the above combination to incorporate calibrating the plurality of positions of the pupil in each eye of the user to yield a value in a prism diopter as taught by Tomasi. The motivation would have been to convert the detected features into real space and allow for the data to be used by the patient, doctor, or other user (¶ [0011] of Tomasi).
With regards to claim 4, the above combination is silent regarding locating centers of pupils in each eye in an image, and comparing a set of center positions over time between each eye of the user to obtain a comparison set.
In the same field of endeavor of monitoring ocular misalignment, Tomasi teaches locating centers of pupils in each eye in an image (¶¶ [0013]-[0014] discloses measuring the positions of the reflections in the left and right eyes and the positions of the reference points in the left and right eyes in image space using the acquired image. The reference points in the left and right eyes may relate to a center of an iris or a pupil of the patient), and comparing a set of center positions over time between each eye of the user to obtain a comparison set (¶¶ [0013]-[0014] and [0062]-[0064] disclose comparing the distance between the reflection point and pupil to obtain a distance d for each eye). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the deviations of the above combination to incorporate locating centers of pupils in each eye in an image, and comparing a set of center positions over time between each eye of the user to obtain a comparison set as taught by Tomasi. The motivation would have been to provide a more accurate and/or repeatable method for detecting eye deviations.
With regards to claim 5, the above combination is silent regarding using the comparison set to calculate the temporal length and the magnitude of any deviations.
In the same field of endeavor of monitoring ocular misalignment, Tomasi teaches using the comparison set to calculate the temporal length and the magnitude of the deviations (¶ [0014] discloses calculation of the degrees of prism diopters of the ocular misalignment using the images of the left and right eyes; ¶ [0080] measuring and interpreting the frequency of events of misalignment within a defined time/space span). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the determination of the temporal length and the magnitude of the deviations of the above combination such that it uses the comparison set as taught by Tomasi. The motivation would have been to provide a more accurate basis for measuring the lengths and magnitudes of the ocular misalignment.
With regards to claim 7, the above combination is silent regarding whether the predetermined threshold value set is set by a clinician or the user.
In the same field of endeavor of monitoring ocular deviations, Tomasi teaches determining deviations based on a threshold value, wherein the threshold value set is set by a clinician or the user (¶ [0015] discloses comparison of a calculated difference with a predetermined misalignment threshold; ¶ [0063] discloses the misalignment threshold may be set by the clinician or user). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that the deviation is determined based on a threshold value, wherein the threshold value set is set by a clinician or the user as taught by Tomasi. The motivation would have been to increase the accuracy of the diagnosis of the disorder by reducing excessive noise (¶ [0063] of Tomasi).
With regards to claim 12, the above combination is silent regarding emitting an alert to the user, a caregiver, and/or a clinician when the deviations in alignment of each eye are greater than the threshold value.
In the same field of endeavor of monitoring ocular deviations, Tomasi teaches determining deviations based on a threshold value (¶ [0015] discloses comparison of a calculated difference with a predetermined misalignment threshold, which indicates that a determined misalignment necessarily exceeds the threshold) and emitting an alert to the user, a caregiver, and/or a clinician when the deviations in alignment of each eye are greater than the threshold value (¶¶ [0078]-[0079] depict providing feedback and informing the patient of strabismus and the amount of misalignment in each eye, the magnitude and/or direction of misalignment). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate emitting an alert to the user, a caregiver, and/or a clinician when the deviations in alignment of each eye are greater than the threshold value as taught by Tomasi. The motivation would have been to increase the accuracy of the diagnosis of the disorder by reducing excessive noise (¶ [0063] of Tomasi) and to notify the patient of the diagnosis.
With regards to claim 13, the above combination teaches or suggests that the alert is selected from a group consisting of a tone, a vibration, a song, a verbal alert, a musical note, a sound, sensory cue, and any combination thereof (¶¶ [0078]-[0079] and Fig. 5 of Tomasi depict providing visual feedback which amounts to a sensory cue).
With regards to claim 15, the above combination is silent regarding the tracking further includes calibrating eye tracking and pixel to a prism diopter constant.
In the same field of endeavor of monitoring ocular misalignment, Tomasi teaches the tracking further includes calibrating eye tracking and pixel to a prism diopter constant (¶ [0014] discloses measuring positions in the left and right eyes, obtaining a misalignment measurement and converting the distance into degrees or prism diopters using a Hirschberg ratio and an internal calibration factor based on iris diameter. ¶¶ [0076], [0108], [0116] discloses calibrated measurements can be used to convert biometric measurements made in pixel space to physical space). It would have been obvious for one of ordinary skill to have modified the above combination to incorporate the tracking further includes calibrating eye tracking and pixel to a prism diopter constant as taught by Tomasi. The motivation would have been to convert the detected features into real space and allow for the data to be used by the patient, doctor, or other user (¶ [0011] of Tomasi).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of Clopton, Zarreii, Georgiev, and Tomasi as applied to claim 2 above, and further in view of “Effect of Viewing Conditions on Fixation Eye Movements and Eye Alignment in Amblyopia” (Murray).
With regards to claim 3, Samec further teaches treating the user by altering a setting on the head mounting system to improve an ocular misalignment disorder (¶ [1575]of Samec disclose a compensating prism correction may be applied to bring the convergence point of both eyes together, wherein the compensating prism correction may be applied by the processor, adaptable optics elements, or a combination of both).
The above combination is silent regarding whether the displaying the calculated temporal lengths and magnitudes further includes displaying a histogram of the temporal lengths and the magnitudes of all deviation events and a time plot showing changes in deviation over time.
In a system relevant to the problem of detecting ocular parameters, Murray teaches a histogram of frequency and the magnitudes of all deviation events (Fig. 4 depicts a histogram of eye deviations in degrees and the number of occurrences) and a time plot showing changes in deviation over time (Fig. 1 depicts eye movements over time). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the displaying of the above combination to incorporate, based on the teachings of Murray, displaying a histogram of the temporal lengths and the magnitudes of all deviation events and a time plot showing changes in deviation over time. The motivation would have been to convey more information to the user, thereby allowing for a more complete diagnostic picture of the ocular misalignment disorder.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of Clopton, Zarreii, and Georgiev, as applied to claim 1 above, and in view of US 2018/0214339 A1 (Levi) (previously cited)
With regards to claim 6, the above combination is silent regarding whether the tracking further includes giving real time feedback to the user or a clinician and alerting the user or the clinician to the deviations in alignment of each eye.
In the same field of endeavor of monitoring ocular parameters, Levi teaches giving real time feedback to the user wearer or a clinician and alerting the user or the clinician to any deviations in eye position (¶ [0147] discloses providing strong cues to help vergence). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate giving real time feedback to the user wearer or a clinician and alerting the user or the clinician to any deviations in eye position as taught by Levi. The motivation would have been to improve vergence in real time.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of Clopton, Zarreii, Georgiev, and Tomasi as applied to claim 12 above, and further in view of Levi
With regards to claim 14, the above combination is silent regarding the alert is emitted at various intensities related to the magnitude of the deviation events.
In the same field of endeavor of monitoring ocular misalignment deviations, Levi teaches emitting alerts at various intensities related to the magnitude of deviations (¶ [0026]; ¶ [0078] indicates that a strength of a depth cue may be related to a difficulty of the task of vergence). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the alert of the above combination to incorporate that it is emitted at various intensities related to the magnitude of any deviation as taught by Levi. The motivation would have been to communicate the magnitude of the deviation and/or difficulty to the patient, thereby providing the patient with a more tailored therapy.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of Tomasi, Clopton, Zarreii, and Georgiev,
With regards to claim 16, Samec discloses a method for therapeutic intervention of an ocular misalignment disorder (¶ [0002] discloses methods for diagnosing, monitoring, and treating health conditions and ailments; ¶¶ [1577], [1590] disclose systems and methods for identifying, treating, and/or correcting convergence deficiencies such as those caused by strabismus and/or amblyopia), comprising: providing a head mount (¶ [1590] teaches use of an ophthalmic system, such as any of the augmented reality devices disclosed herein; ¶ [1575] discloses the use of a wearable augmented reality head-mounted device); tracking and recording a plurality of positions of each eye of the user over a period of time in ambient lighting (¶ [1591] discloses determining a difference and/or convergence point of both eyes based on eye tracking and/or gaze detection; ¶ [1586] discloses sensors for determining a gaze using the glint; ¶ [1562] discloses tracking a glint with respect to features of the eye (e.g, pupil) to determine gaze and/or convergence point of the eyes; Fig. 5 and ¶¶ [1533], [1578] depict the ophthalmic device directing ambient light from the surrounding world to the eyes); comparing the plurality of positions of each eye of the user to detect deviations in alignment of each eye indicative of ocular misalignment (¶ [1591] discloses determining a difference in the focus and/or convergence points of both eyes); using a graphical user interface (GUI) (¶ [1588] discloses a graphical user interface); and emitting a sensory cue as a form of feedback to remediate or improve the ocular misalignment disorders (¶¶ [1581], [1591] discloses providing occluding an eye to re-train a lazy eye, wherein the occlusion amounts to a sensory cue).
Samec is silent regarding calibrating eye position to yield a value in prism diopters.
In the same field of endeavor of monitoring ocular misalignment, Tomasi teaches calibrating eye position to yield value in a prism diopter (¶ [0014] discloses measuring positions in the left and right eyes, obtaining a misalignment measurement and converting the distance into degrees or prism diopters using a Hirschberg ratio and an internal calibration factor based on iris diameter). It would have been obvious for one of ordinary skill to have modified the method of Samec to incorporate calibrating eye position to yield value in a prism diopter as taught by Tomasi. The motivation would have been to convert the detected features into real space and allow for the data to be used by the patient, doctor, or other user (¶ [0011] of Tomasi).
The above combination is silent regarding comparing the deviations in alignment of each eye to a predetermined threshold value to determine if a deviation event has occurred, wherein a deviation event is defined by a deviation crossing the predetermined threshold value and subsequently returning below the predetermined threshold value, calculating, for each deviation event, a temporal length based on a duration between an onset of the deviation event and an offset of the deviation event.
In a system relevant to the problem of accurately detecting ocular deviations, Clopton teaches comparing the deviations to a predetermined threshold value to determine if a deviation event has occurred (¶ [0033] discloses an eye deviation condition is a deviation from a central visual axis of greater than a predetermined value (e.g., 2 degrees) with respect to that of the dominant eye), wherein a deviation event is defined by a deviation crossing the predetermined threshold value and subsequently returning below the predetermined threshold value (¶ [0033] discloses that the eye deviation condition is when the deviation is greater than a predetermined value, which indicates that the condition begins when the deviation crosses the value and ends when the deviation returns below the value), calculating, for each deviation event, a temporal length based on a duration between an onset of the deviation event and an offset of the deviation event (¶¶ [0014], [0033] depict comparing the amount of time of deviation with a predetermined amount of time to initiate treatment, which indicates that a temporal length of the deviation is calculated). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate comparing the deviations to a predetermined threshold value to determine if a deviation event has occurred, wherein a deviation event is defined by a deviation crossing the predetermined threshold value and subsequently returning below the predetermined threshold value, calculating, for each deviation event, a temporal length based on a duration between an onset of the deviation event and an offset of the deviation event, as taught by Clopton. The motivation would have been to provide a more complete diagnostic analysis of the patient.
The above combination is silent regarding calculating a magnitude based on a maximum deviation during the deviation event
In the same field of endeavor of monitoring ocular deviations, Zarreii teaches calculating a magnitude based on a maximum deviation during a deviation event (¶¶ [0105], [0107] depict calculating a maximum amount of deviation). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate, based on the teachings of Zarreii, calculating a magnitude based on a maximum deviation during a deviation event. The motivation would have been to provide a more complete diagnostic analysis of the patient.
The above combination is silent regarding displaying calculated values on a graphical user interface (GUI).
In a system relevant to the problem of communicating data to a patient, Georgiev teaches displaying calculated values on a graphical user interface (GUI) (¶ [0011] discloses displaying first data display in a first graphical user interface). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the GUI of Samec of the above combination to incorporate that it displays calculated values as taught by Georgiev. The motivation would have been to communicate the data with the user.
With regards to claim 17, the above combination is silent regarding emitting an alert to the user when the deviations in alignment of each eye is greater than a predetermined threshold.
In the same field of endeavor of monitoring ocular deviations, Tomasi teaches determining deviations based on a threshold value (¶ [0015] discloses comparison of a calculated difference with a predetermined misalignment threshold, which indicates that a determined misalignment necessarily exceeds the threshold) and emitting an alert to the user when the deviations in alignment of each eye is greater than a predetermined threshold (¶¶ [0078]-[0079] depict providing feedback and informing the patient of strabismus and the amount of misalignment in each eye, the magnitude and/or direction of misalignment, wherein the feedback may be used for treatment). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate emitting an alert to the user when the deviations in alignment of each eye is greater than a predetermined threshold as taught by Tomasi. The motivation would have been to increase the accuracy of the diagnosis of the disorder by reducing excessive noise (¶ [0063] of Tomasi) and to notify the patient of the diagnosis.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Samec, Clopton, Zarreii, and Georgiev.
With regards to claim 18, to the extent that it can be argued that all features taught by Samec are not provided in a single embodiment, Samec discloses a variety of alternative and additional embodiments that are provided in a variety of combinations so that the benefits of these various features can be utilized. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the various features in the alternative and additional embodiments so as to derive the benefits of these features, as suggested by Samec. See at least ¶¶ [2219], [2220] of Samec.
Samec teaches a system for quantifying and treating an ocular misalignment disorder (Figs. 3 and 5 and ¶¶ [1577], [1590] disclose systems and methods for identifying, treating, and/or correcting convergence deficiencies such as those caused by strabismus and/or amblyopia), comprising: a head mount including a first camera configured to capture a first video and a second camera configured to capture a second video (¶ [1590] teaches use of an ophthalmic system, such as any of the augmented reality devices disclosed herein; ¶ [1575] discloses the use of a wearable augmented reality head-mounted device; ¶ [01576] discloses the use of an eye tracking system; ¶ [1586] discloses the eye tracking system including one or more sensors including cameras; Fig. 5 depict two cameras 24; ¶ [1473] discloses tracking of eye movements, which indicates that the cameras are sized to capture videos); and a device controller in communication with the head mount (¶ [1433] discloses a local processing and data module 70 for processing data captured from image capture devices such as cameras), the device controller including a microcomputer configured to process the first video and the second video (¶ [1433] discloses a local processing and data module 70 including a processor or computer for processing data captured from image capture devices such as cameras), wherein the device controller is configured to output data received from the microcomputer (¶ [1433] discloses local processing and data module (70) may be operatively coupled (76, 78), such as via a wired or wireless communication links, to the remote processing module (72) and remote data repository (74); ¶ [1434] discloses the remote processing module 72 analyzes and process data and/or image information), wherein the head mount is configured to independently track and record a plurality of positions of a pupil in each eye of the user over a period of time in ambient lighting (¶ [1591] discloses determining a difference and/or convergence point of both eyes based on eye tracking and/or gaze detection; ¶ [1586] discloses sensors for determining a gaze using the glint; ¶ [1562] discloses tracking a glint with respect to features of the eye (e.g, pupil) to determine gaze and/or convergence point of the eyes; Fig. 5 and ¶¶ [1533], [1578] depict the ophthalmic device directing ambient light from the surrounding world to the eyes); wherein the device controller is configured to compare the plurality of positions of the pupil in each eye of the user to detect deviations in alignment of each eye indicative of ocular misalignment (¶ [1591] discloses determining a difference in the focus and/or convergence points of both eyes)
Samec is silent regarding comparing the deviations in alignment of each eye to a predetermined threshold value to determine if a deviation event has occurred, wherein a deviation event is defined by the alignment of an eye crossing the predetermined threshold value and subsequently returning below the predetermined threshold value, calculating, for each deviation event, a temporal length based on a duration between an onset of the deviation event and an offset of the deviation event.
In a system relevant to the problem of accurately detecting ocular deviations, Clopton teaches comparing the deviations to a predetermined threshold value to determine if a deviation event has occurred (¶ [0033] discloses an eye deviation condition is a deviation from a central visual axis of greater than a predetermined value (e.g., 2 degrees) with respect to that of the dominant eye), wherein a deviation event is defined by the alignment of an eye crossing the predetermined threshold value and subsequently returning below the predetermined threshold value (¶ [0033] discloses that the eye deviation condition is when the deviation is greater than a predetermined value, which indicates that the condition begins when the deviation crosses the value and ends when the deviation returns below the value), calculating, for each deviation event, a temporal length based on a duration between an onset of the deviation event and an offset of the deviation event (¶¶ [0014], [0033] depict comparing the amount of time of deviation with a predetermined amount of time to initiate treatment, which indicates that a temporal length of the deviation is calculated). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate comparing the deviations in alignment of each eye to a predetermined threshold value to determine if a deviation event has occurred, wherein a deviation event is defined by the alignment of an eye crossing the predetermined threshold value and subsequently returning below the predetermined threshold value, calculating, for each deviation event, a temporal length based on a duration between an onset of the deviation event and an offset of the deviation event, as taught by Clopton. The motivation would have been to provide a more complete diagnostic analysis of the patient.
The above combination is silent regarding calculating a magnitude based on a maximum deviation during the deviation event
In the same field of endeavor of monitoring ocular deviations, Zarreii teaches calculating a magnitude based on a maximum deviation during a deviation event (¶¶ [0105], [0107] depict calculating a maximum amount of deviation). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate, based on the teachings of Zarreii, calculating a magnitude based on a maximum deviation during a deviation event. The motivation would have been to provide a more complete diagnostic analysis of the patient.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Samec, Clopton, Zarreii, and Georgiev, as applied to claim 18 above, and in view of Tomasi.
With regards to claim 19, the above combination is silent regarding a sensory biofeedback system for emitting a tone, a vibration, a visual indication, or any combination thereof to alert the user of an eye deviation to an amount greater than the predetermined threshold.
In the same field of endeavor of monitoring ocular deviations, Tomasi teaches determining deviations based on a threshold value (¶ [0015] discloses comparison of a calculated difference with a predetermined misalignment threshold, which indicates that a determined misalignment necessarily exceeds the threshold) and a sensory biofeedback system for emitting a tone, a vibration, a visual indication, or any combination thereof to alert the user of an eye deviation to an amount greater than a predetermined threshold (Fig. 5 and ¶¶ [0078]-[0079] depict providing feedback and informing the patient of strabismus and the amount of misalignment in each eye, the magnitude and/or direction of misalignment). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that the deviation is determined based on a threshold value, and a sensory biofeedback system for emitting a tone, a vibration, a visual indication, or any combination thereof to alert the user of an eye deviation to an amount greater than a predetermined threshold as taught by Tomasi. The motivation would have been to increase the accuracy of the diagnosis of the disorder by reducing excessive noise (¶ [0063] of Tomasi) and to notify the patient of the diagnosis.
Response to Arguments
Claim Objections
There are new grounds of claim objections.
Claim Interpreted under 35 U.S.C. §112(f)
In view of the claim amendments filed 05/11/2026, no claim limitations were interpreted under 35 U.S.C. §112(f).
Claim Rejections under 35 U.S.C. §103
Applicant's amendments and arguments filed 05/11/2026 with respect to the 35 USC 103 rejections set forth in the Non-Final Rejection mailed 02/11/2026 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US2014/0085608 A1 (Clopton) and US 2023/0210438 A1 (Zarreii). Specifically, the previously applied prior combination does not disclose comparing the deviations to a predetermined threshold value to determine if a deviation event has occurred, wherein a deviation event is defined by a deviation crossing the predetermined threshold value and subsequently returning below the predetermined threshold value, calculating, for each deviation event, a temporal length based on a duration between an onset of the deviation event and an offset of the deviation event, and a magnitude based on a maximum deviation during the deviation event but Clopton and Zarreii disclose these features. Therefore, the previously applied 103 rejection has been modified to incorporate the teachings of Clopton and Zarreii.
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.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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