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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 16-17 objected to because of the following informalities:
Claim 16 recites the acronyms “HIPAA” and “GDPR”. Before the use of acronyms, the word/phrase should be fully written followed by the acronym. The claim should read “Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR)”.
Claim 17 recites the acronym “EMR”. Before the use of acronyms, the word/phrase should be fully written followed by the acronym. The claim should read “Electronic medical record (EMS)”.
Appropriate correction is required.
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 6 and 8-9 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 claim 6, the claim recites “vision tests typically lasts 15-30 minutes” The term “typically” in claim 6 is a relative term which renders the claim indefinite. The term “typically” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the length of the series of vision tests is rendered indefinite. Clarification is requested.
Further regarding claim 6, the claim recites “wherein the series of vision tests typically lasts 15-30 minutes depending on test battery”. This recitation renders the claim indefinite as it unclear what capacity of the battery necessary to power the electronic device for 15-30 minutes. It is further unclear what the power requirements for the vision tests are. Further, it is unclear if the series of vision tests are truncated in order to accommodate the smaller test battery, or if the series of vision tests are lengthened in order to accommodate the larger test battery. Clarification is requested.
For the purposes of examination, the claim is interpreted as “wherein a test battery can support the series of vision tests lasting 15-30 minutes.”
Regarding claim 8, the claim recites “wherein tracking saccadic velocity comprises”. The term “tracking saccadic velocity” lacks antecedent basis in the claims. Clarification is requested.
For the purposes of examination, the claim is interpreted as being dependent on claim 7, where proper antecedent basis is present for the claim limitations.
Further regarding claim 8, the claim recites “eye movement speeds typically ranging from 300-700 degrees per second.” The term “typically” in claim 8 is a relative term which renders the claim indefinite. The term “typically” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the range of eye movement speeds is rendered indefinite. Clarification is requested.
For the purposes of examination, the claim is interpreted as “eye movement speeds ranging from 300-700 degrees per second.”
Regarding claim 9, the claim recites “wherein tracking fixation duration comprises”. The term “tracking fixation duration” lacks antecedent basis in the claims. Clarification is requested.
For the purposes of examination, the claim is interpreted as being dependent on claim 7, where proper antecedent basis is present for the claim limitations.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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 1, 3, 5, 10-11, 14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2023/0233076 by Serafini et al., hereinafter “Serafini” in view of US Patent Publication 2022/0230749 by Ianchulev et al., hereinafter “Ianchulev” in view of US Patent Publication 2010/0056935 by McKinley et al., hereinafter “McKinley”.
Regarding claim 1, Serafini teaches a method of implementing a virtual reality (VR) system for vision testing and eye health monitoring (Abstract; The method of using and implementing the modular screening platform enables comprehensive ocular evaluations), comprising: at an electronic device including a high-resolution VR headset (The most basic display includes a left and right screen at a 4K resolution) with eye-tracking sensors ([0012, 0065]; the interchangeable module can contain components such as eye tracking cameras) and wearable devices for measuring intraocular pressure ([0065]; the interchangeable module may include devices for performing examinations of intraocular pressure); generating a VR user interface corresponding to a three-dimensional virtual environment; rendering the VR user interface on the VR headset; conducting a series of vision tests in the VR environment ([0061, 0071, 0079]; Functional and oculomotor testing are completed through virtual reality, and can create a three-dimensional effect. To use this vision screening tests, stimuli must be presented (i.e., rendered) to the user within the 3D environment); continuously monitoring, using the eye-tracking sensors and wearable devices, eye movements and vitals during the vision tests ([0013]; The optical devices are used for the monitoring of vision health during the optical evaluations.); and evaluating the monitored data for visual performance and eye health assessment ([0103, 0107]; the examination of vision health is evaluated by the outcomes of the interchangeable modules and vision tests).
Serafini does not teach wherein the electronic device includes wearable devices for measuring tear film stability.
Ianchulev teaches a method of assessing the stability of the tear film of a subject by displaying a placido disk on a screen in front of the subject and using a camera to assess the breaking of the tear film via the reflection from the cornea ([0105, 0142]). Assessed tear film stability can be used to assess dry eye, in addition to other corneal and ocular surface abnormalities ([0104]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Serafini such that the wearable devices include devices configured to assess tear film stability, in order to assess dry eye and other corneal and ocular surface abnormalities, as taught by Ianchulev ([0104]). The assessment of dry eye would provide a more comprehensive understanding of the vision health of the user.
The combination of Serafini and Ianchulev does not teach wherein the electronic device includes wearable devices for measuring ocular blood flow.
McKinley teaches a method of determining ocular blood flow in the eye by making instantaneous velocity measurements using near-infrared spectroscopy ([0080]). McKinley teaches that determining a ocular blood flow provides a baseline evaluation of perfusion of the optic disk and the optic nerve head. As such, determining ocular blood flow provides a simple measure of the function and general health of the eye and can also be used in preventing the possibility of iatrogenically induced ischemic optic neuropathy ([0079]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Serafini in view of Ianchulev such that the wearable devices include devices configured to measure ocular blood flow, in order to provide a simple measure of the function and general health of the eye and prevent the possibility of iatrogenically induced ischemic optic neuropathy, as taught by McKinley ([0079]).
It is noted that the wearable device of Serafini comprises infrared illumination sources, and the device is configured to have interchangeable modules for the assessment of multiple aspects of vision health of the user. Therefore, one of ordinary skill in the art would modify the method of Serafini to be capable of assessing more aspects of health of the user as taught by Ianchulev and McKinley.
Regarding claim 3, the combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, wherein the wearable devices measure intraocular pressure (Serafini, see the rejection of claim 1), tear film stability by assessing break-up time (Ianchulev, [0142], The speed of the tear film breaking defines the tear film stability), and ocular blood flow using near-infrared spectroscopy (McKinley, see the rejection of claim 1).
The combination of Serafini, Ianchulev, and McKinley does not teach measuring intraocular pressure with an accuracy of ±1 mmHg or measuring ocular blood flow with an accuracy of ±5%. Serafini teaches that the development of an interchangeable module allows for the accurate diagnosis of a wide range of ophthalmic pathologies [0017], suggesting that the accuracy of these assessments are important to the use of device. However, where the general conditions of a claim are disclosed in the prior art ([0017] of Serafini discloses the objective of accuracy of optical testing), it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, Applicant has failed to provide details of criticality or unexpected results with regard to the claimed accuracy ranges. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum accuracy of intraocular pressure and ocular blood flow taught by the combination of Serafini, Ianchulev, and McKinley.
Regarding claim 5, the combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, wherein conducting a series of vision tests comprises performing tests for visual acuity, contrast sensitivity, and color vision (Serafini, [0021]). The combination of Serafini, Ianchulev, and McKinley does not teach wherein the series of vision tests comprises performing tests for stereopsis.
Serafini teaches that many commercially available VR headsets can be implemented in research for stereopsis ([0006]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Serafini, Ianchulev, and McKinley such that the series of vision tests includes performing tests for stereopsis, as taught by Serafini ([0006]). The inclusion of screening tests for stereopsis would create a method capable of assessing more aspects of health of the user, providing a more comprehensive understanding of the user’s vision health.
Regarding claim 10, the combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, wherein evaluating the monitored data comprises correlating intraocular pressure (Serafini, [0077]; intraocular pressure is correlated with glaucoma, which affect visual performance), tear film stability (Ianchulev, [0118, 0142]; tear film stability correlates to dry eye which affects clarity of the image at the cornea when dry) and ocular blood flow (McKinley, [0079]; ocular blood flow provides a measure of function (i.e., performance) of the eye) with visual performance metrics.
Regarding claim 11, the combination of Serafini, Ianchulev, and McKinley teaches the method of claim 10, wherein correlating comprises associating elevated intraocular pressure with decreased visual field sensitivity (Serafini, [0077]; intraocular pressure is correlated with glaucoma, which affect visual performance. Specifically, glaucoma can result in tunnel vision, or the inability to see in the peripheries, which can be considered decreased visual field sensitivity), unstable tear film with fluctuating vision quality (Ianchulev, [0118, 0142]; tear film stability correlates to dry eye which affects clarity of the image at the cornea when dry and therefore the vision quality of a user fluctuates between vision with an intact and broken tear film), and reduced ocular blood flow with potential issues in visual acuity under stress (McKinley, [0079]; reduced ocular blood flow can potentially cause iatrogenically induced ischemic optic neuropathy, which results in temporary vision loss, thereby affecting visual acuity. This effect on visual acuity would be present if the user is emotionally stressed or not.).
Regarding claim 14, the combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, further comprising comparing monitored data against established clinical thresholds to flag potential issues (Serafini, [0077-0078]; The diagnosis of pathologies such as glaucoma and astigmatism are based on comparing derived parameters to diagnostic thresholds), such as intraocular pressure exceeding 21 mmHg for glaucoma risk.
Regarding claim 19, the combination of Serafini, Ianchulev, and McKinley teaches a virtual reality (VR) system for vision testing and eye health monitoring (Serafini, [0061]; screening platform 100 utilizes a display with eye tracking for functional and oculomotor testing through virtual reality), comprising: a high-resolution VR headset with eye-tracking sensors and wearable devices configured to measure intraocular pressure, tear film stability, and ocular blood flow (See the rejection of claim 1); one or more processors (Serafini, [0051-0052]; the screening platform includes three CPUs); and memory storing one or more programs configured to be executed by the one or more processors (Serafini, [0012]; “the CPU(s) may contain the microprocessor(s) and graphics processor(s) for operating the display, memory for running programs”), the one or more programs including instructions for (The parts of the screening platform must be controlled to present visual stimuli and operate the sensors, therefore the stored programs must govern these operations): generating a VR user interface corresponding to a three-dimensional virtual environment (See the rejection of claim 1); rendering the VR user interface on the VR headset (See the rejection of claim 1); conducting a series of vision tests in the VR environment (See the rejection of claim 1); continuously monitoring eye movements and vitals during the vision tests (See the rejection of claim 1); and evaluating the monitored data for visual performance and eye health assessment (See the rejection of claim 1).
Regarding claim 20, the combination of Serafini, Ianchulev, and McKinley teaches a non-transitory computer-readable storage medium storing one or more programs configured to be executed by one or more processors of an electronic device (See the memory of the rejection of claim 19) including a high-resolution VR headset with eye-tracking sensors and wearable devices for measuring intraocular pressure, tear film stability, and ocular blood flow (See the rejection of claims 1 and 19), the one or more programs including instructions for: generating a VR user interface corresponding to a three-dimensional virtual environment (See the rejection of claims 1 and 19); rendering the VR user interface on the VR headset; conducting a series of vision tests in the VR environment (See the rejection of claims 1 and 19); continuously monitoring eye movements and vitals during the vision tests (See the rejection of claims 1 and 19); and evaluating the monitored data for visual performance and eye health assessment (See the rejection of claims 1 and 19).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Serafini in view of Ianchulev in view of McKinley, as applied to claim 1, in view of US Patent Publication 2024/0293022 by Powers et al., hereinafter “Powers”.
Regarding claim 2, the combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, wherein the high-resolution VR headset has a resolution of at least 60 pixels per degree (PPD) (Each of the two screens comprise 3480x2160 pixels ([0015]) and the visual field is at least 110 degrees ([0074]). This would result in 13600 pixels per degree.), and a field of view of 100-120 degrees (the field of view of the display is at least 110 degrees ([0074]).
The combination of Serafini, Ianchulev, and McKinley is silent regarding the refresh rate of the electronic device.
Powers teaches a VR headset configured to present stimuli based on the requirements of a vision test ([0046]). Powers teaches that a refresh rate of 90Hz or more can be used in virtual environments in order to ensure a smooth and responsive experience, reducing motion blur and minimizing the risk of motion sickness ([0043]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Serafini, Ianchulev, and McKinley such that the electronic device comprises a refresh rate of 90-120 Hz, in order to ensure a smooth and responsive experience, reducing motion blur and minimizing the risk of motion sickness, as taught by Powers ([0043]).
Claims 4, 6, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Serafini in view of Ianchulev in view of McKinley, as applied to claim 1, in view of US Patent Publication 2022/0301669 by Gross et al., hereinafter “Gross”.
Regarding claim 4, the combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, but does not teach wherein the eye-tracking sensors have an accuracy within 0.1 mm of eye movement and a latency of less than 10 milliseconds.
Gross teaches a method of performing multiple vision assessments and evaluating user performance on the assessments (Abstract). Gross teaches that the quality of the received data may consist of latency, accuracy, and precision, and specifically, the latency of eye movements ([0051]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of the combination of Serafini, Ianchulev, and McKinley to comprise monitoring the latency of eye movements, as this is indicative of the quality of the received data, as taught by Gross ([0051]).
As the method of Serafini, Ianchulev, McKinley, and Gross uses eye tracking cameras (e.g. eye movements), Serafini suggests the importance of the accuracy of the captured eye movements and the latency of the eye movements. Where the general conditions of a claim are disclosed in the prior art ([0017] of Serafini discloses the objective of accuracy of optical testing, including eye movements and [0051] of Gross teaches that the latency of eye movements is indicative of the quality of those movements), it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, Applicant has failed to provide details of criticality or unexpected results with regard to the claimed accuracy ranges. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum accuracy and latency of eye movements taught by the combination of Serafini, Ianchulev, McKinley, and Gross.
Regarding claim 6, the combination of Serafini, Ianchulev, McKinley, and Gross teaches the method of claim 4, but does not teach wherein the series of vision tests typically lasts 15-30 minutes depending on test battery.
Serafini teaches that electronic device comprises a battery pack, and that the battery pack should be sized such that the device should be capable of being used for 1 hour of continuous use. The device is capable of performing a wide range of vision tests ([0021]). It would be prima facie obvious to one of ordinary skill in the art to size the battery pack in order to perform multiple vision tests during the continuous use of the device. Where the general conditions of a claim are disclosed in the prior art ([0021] of Serafini discloses the objective of using the device for a period of time), it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, Applicant has failed to provide details of criticality or unexpected results with regard to the claimed accuracy ranges. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum time of use of the device taught by the combination of Serafini, Ianchulev, McKinley, and Gross.
Regarding claim 18, the combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, but does not teach the method further comprising: establishing baseline visual performance and eye health metrics for the user; comparing real-time monitored data to the baseline metrics; and providing personalized recommendations when deviations from the baseline exceed predetermined thresholds.
Gross teaches a method of displaying the results of the vision assessments to the user at a web portal. The results can comprise the eye evaluation data, and comparing ongoing (i.e., real-time) assessments with previous baselines, and recommending training based on comparisons to predetermined thresholds (i.e. target scores) ([0090, 0097]). This method provides feedback and tailored recommendations to the user based on their eye evaluations.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Serafini, Ianchulev and McKinley such that the method further comprising: establishing baseline visual performance and eye health metrics for the user; comparing real-time monitored data to the baseline metrics; and providing personalized recommendations when deviations from the baseline exceed predetermined thresholds, as taught by Gross ([0090, 0097]), in order to provide feedback and tailored recommendations to the user based on their eye evaluations.
Claims 7-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Serafini in view of Ianchulev in view of McKinley, as applied to claim 1, in view of US Patent Publication 2021/0330185 by Krukowski et al., hereinafter “Krukowski”.
Regarding claims 7-9 and 12, the combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, the method further comprising using algorithms to process data related to visual clarity (Serafini, [0021]; the device is capable of determining visual acuity (i.e., clarity). The pathologies are determined based on sensor measurements, and therefore the data must be processed via an algorithm).
The combination of Serafini, Ianchulev, and McKinley does not teach wherein monitoring eye movements comprises tracking saccadic velocity, wherein tracking saccadic velocity comprises eye movement speeds ranging from 300-700 degrees per second, and fixation duration, wherein tracking fixation duration comprises measuring eye focus durations ranging from 200 milliseconds to several seconds, depending on task complexity; or the method further comprising using algorithms to process data related to reaction time, and stability of vision.
Krukowski teaches a method of operating a diagnostic device for performing eye evaluations via a head-mounted display unit in a virtual reality environment. Krukowski further teaches that eye tracking can comprise of many different measured variables, including velocity of saccades ([0156, 0230]) and fixations ([0156, 0226-0227]). Saccades are the quick movements of the eyes to fixate on a target, and can occur up to 350ms after the presentation of the target ([0232]). Therefore, when determining fixation strategies between multiple targets the fixation duration must be at least 350ms to define the fixation and differentiate the fixation from a saccade. The medium amplitude saccades are around 5-10 degrees ([0232]) and are complete within a few tens of milliseconds ([0231]). Assuming a few tens of milliseconds represents 10-100ms, this would result in a range of saccadic velocities of 50-1000 degrees/second. Krukowski teaches that other measures of interest include fixation stability (i.e., stability of vision) and saccade latency (i.e., reaction time).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Serafini, Ianchulev, and McKinley, such that monitoring eye movements comprises tracking saccadic velocity, wherein tracking saccadic velocity comprises eye movement speeds ranging from 300-700 degrees per second, and fixation duration, wherein tracking fixation duration comprises measuring eye focus durations ranging from 200 milliseconds to several seconds, depending on task complexity, and the method further comprising using algorithms to process data related to reaction time, and stability of vision, as taught by Krukowski ([0156, 0226-0232]). The modification merely comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A. It is noted that Serafini teaches tracking eye movements to monitor the health of the eye, and Krukowski is directed towards a method for tracking eye movements.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Serafini in view of Ianchulev in view of McKinley, as applied to claim 1, in view of Gross in view of Non-Patent Literature The severity of dry eye symptoms… (2024) by Alqurashi et al., hereinafter “Alqurashi”.
The combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, but does not teach further comprising generating a detailed report including insights on intraocular pressure trends, tear film stability, visual performance metrics, and recommendations for eyewear adjustments, screen settings, and vision exercises.
Gross teaches a display of evaluations of individuals’ eye movements and recommended training/therapy tasks for individuals to improve, maintain, or rehabilitate their vision and health issues, as shown in Figs. 8-9 ([0106-0107]). Figs. 8-9 show assessment scores, trend data related to visual assessments, and correlations to other scores and statistics.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by the combination of Serafini, Ianchulev, and McKinley such that the method further comprises generating a detailed report including insights on intraocular pressure trends, tear film stability, visual performance metrics, and recommendations for eyewear adjustments and vision exercises. It is noted that the combination of Serafini, Ianchulev, and McKinley assesses intraocular pressure and tear film stability, therefore it would be obvious to also output this data and relevant comparisons within the display. It is further noted that one of the vision tests of Serafini includes refractive errors, and therefore displaying the results of refractive errors are comprises a recommendation on eyewear adjustments, as refractive errors govern the prescriptions of eyewear.
The combination of Serafini, Ianchulev, McKinley, and Gross does not teach the method comprising generating recommendations for screen settings.
Alqurashi teaches that dry eye syndrome is a tear film disorder caused by increased tear evaporation or decreased production (Abstract). Alqurashi teaches that reducing the screen brightness (i.e., a screen setting) can be an effective method to lower the risk of developing dry eye and may decrease eye strain and tear evaporation (Discussion, Pg. 4, par. 1).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by the combination of Serafini, Ianchulev, McKinley, and Gross such that the method comprises generating recommendations for screen settings, as recommendations for reducing screen brightness can decrease eye strain and the symptoms of dry eye, as taught by Alqurashi (Discussion, Pg. 4, par. 1). It is noted that the combination of Serafini, Ianchulev, McKinley, and Gross teaches that tear film stability is indicative of dry eye syndrome, therefore it would be obvious to provide recommendations for treating dry eye.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Serafini in view of Ianchulev in view of McKinley, as applied to claim 1, in view of US Patent Publication 2022/0160223 by Bradley et al., hereinafter “Bradley”.
Regarding claim 15, the combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, but does not teach further comprising calibrating the system using a diverse control group of 30-50 individuals with a range of visual conditions.
Bradley teaches a method of using a head-worn device for diagnosing a user’s vision by administering a plurality of vision tests (Abstract). The optotypes used in the vision tests are calibrated by a sufficiently large population size before use in visual acuity tests ([0226]). This allows for a calibrated optotype having improved display resolution, thereby allowing for an accurate assessment of a viewer's visual acuity ([0225]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by the combination of Serafini, Ianchulev, and McKinley such that the method further comprises calibrating the system using a diverse control group, in order to enable an accurate assessment of a viewer's visual acuity, as taught by Bradley ([0225-0226]).
The combination of Serafini, Ianchulev, McKinley, and Bradley does not teach wherein the control group comprises of 30-50 individuals. However, where the general conditions of a claim are disclosed in the prior art ([0226] of Bradley discloses the a sufficiently large group for the calibration of the optical system), it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, Applicant has failed to provide details of criticality or unexpected results with regard to the claimed control group size. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum size of the control group of the method taught by the combination of Serafini, Ianchulev, McKinley, and Bradley. It is noted that the sufficiently large group must have some differences in their vision, and therefore would be a diverse group with a range of visual conditions.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Serafini in view of Ianchulev in view of McKinley, as applied to claim 1, in view of US Patent Publication 2019/0183330 by Schiffman et al., hereinafter “Schiffman”.
The combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, but does not teach further comprising encrypting all visual health data at rest and in transit and ensuring compliance with HIPAA and GDPR standards for handling health data.
Schiffman teaches a method of using an electronic device to perform vision tests wherein the device stores evaluation results and transmits the evaluation results to a server for storage and further transmission. The server is a HIPAA and GDPR compliant server, providing secure, anonymized storage of the User’s personal health information (PHI) via encryption and hashing techniques with PHI-secure transmission links ([0076-0077]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by the combination of Serafini, Ianchulev, and McKinley such that the method further comprising encrypting all visual health data at rest and in transit and ensuring compliance with HIPAA and GDPR standards for handling health data, in order to provide secure, anonymized storage of the User’s PHI, as taught by Schiffman ([0076-0077]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Serafini in view of Ianchulev in view of McKinley, as applied to claim 1, in view of US Patent Publication 2016/0166201 by Stein et al., hereinafter “Stein”.
The combination of Serafini, Ianchulev, and McKinley teaches the method of claim 1, but does not teach further comprising providing more detailed reporting and integration with EMR systems for clinical settings, and providing a simpler interface with recommendations tailored for non-clinical personal use.
Stein teaches a device for monitoring medical data from a patient. The monitored medical data can be communicated to an Electronic Medical Records (EMR) system to implement health information technology practices ([0273]). The monitored data can also be communicated as a report, wherein the report can be a simple status report for the patient or a detailed report listing of all the parameters measured, trends, and analysis of the data sent to a health care provider such as a doctor, surgeon, or hospital ([0259]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by the combination of Serafini, Ianchulev, and McKinley such that the method further comprising providing more detailed reporting and integration with EMR systems for clinical settings, and providing a simpler interface with recommendations tailored for non-clinical personal use, enabling the sharing of medical data at the appropriate levels of detail for each user, as taught by Stein ([0259, 0273]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2025/0090014 by Baldwin et al. teaches method of using an electronic device with wearable devices for measuring the tear film in the eye.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON A GLOVER whose telephone number is (571)270-0971. The examiner can normally be reached Mon-Fri 8:00-5:00 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, Jason Sims can be reached at 571-272-7540. 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.
/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
Prosecution Insights