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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 20 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 28-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 March 2026.
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 11, 15, and 44 are objected to because of the following informalities:
Claim 11 recites “said computer uses”; as the claim is directed to a system, the active step of the computer using something can only exist when being performed; it appears the claim should define that the computer is configured to use…; for the purposes of examination it will be treated as such. Similar language is found in claim 15, 44.
Appropriate correction is required.
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.
Claim(s) 1, 6, 8, 11, 22, 40, 42, 44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maddess (US 2010/0249532).
Regarding claim 1, Maddess discloses a system for obtaining ophthalmic electrophysiological, pupillometry and psychophysical responses from a test subject (paragraph [0157]), said system comprising:
a dichoptic stimulator for delivering a visual stimulus to the left eye of the test subject and a visual stimulus to the right eye of the test subject so as to evoke an electrophysiological response in the test subject (paragraph [0157], [0162]; elements 140a, 140b), wherein the dichoptic stimulator comprises a left eye stimulator for delivering the visual stimulus to the left eye and a right eye stimulator for delivering the visual stimulus to the right eye (paragraph [0161]-[0162], elements 140a, 140b);
a plurality of electrodes for receiving electrophysiological signals from the test subject (elements 148, 149; paragraph [0157]);
an amplifier for amplifying electrical signals received from the plurality of electrodes (element 150, paragraph [0157]);
a left eye camera for obtaining images of the left eye of the test subject, and a right eye camera for obtaining images of the right eye of the test subject (elements 156a, 156b, paragraph [0162]);
an indicator box for inputting a psychophysical response to at least one of the visual stimulus to the left eye and the visual stimulus to the right eye (paragraph [0070];
a controller for controlling operation of at least one of the dichoptic stimulator, the left eye camera, the right eye camera and the indicator box (paragraph [0157]);
a computer for processing (i) electrical signals from the amplifier, (ii) images from the left eye camera and the right -3- eye camera, and (iii) response signals from the indicator box so as to obtain the ophthalmic electrophysiological, pupillometry and psychophysical results of the test subject (paragraphs [0033], [0157], [0162]).
Regarding claim 6, Maddess further discloses that wherein said right eye stimulator and said left eye stimulator are configured to deliver stimuli to the left eye and the right eye independently of one another at different times (paragraph [0157], “presenting visual stimuli 142 to one or both eyes”).
Regarding claim 8, Maddess further discloses that said right eye stimulator and said left eye stimulator are configured to simultaneously deliver stimuli independently of one another (paragraph [0157], [0161]).
Regarding claim 11, Maddess further discloses that said computer uses the images from said left eye camera and said right eye camera to calculate the size of the pupil of the left eye of the test subject and the size of the pupil of the right eye of the test subject (paragraph [0162]).
Regarding claim 22, Maddess discloses a method for obtaining ophthalmic electrophysiological, pupillometry and psychophysical responses from a test subject, said method comprising:
providing a system for obtaining ophthalmic electrophysiological, pupillometry and psychophysical responses from a test subject, said system comprising:
a dichoptic stimulator for delivering a visual stimulus to the left eye of the test subject and a visual stimulus to the right eye of the test subject so as to evoke an electrophysiological response in the test subject (paragraph [0157], [0162]; elements 140a, 140b), wherein the dichoptic stimulator comprises a left eye stimulator for delivering the visual stimulus to the left eye and a right eye stimulator for delivering the visual stimulus to the right eye (paragraph [0161]-[0162], elements 140a, 140b);
a plurality of electrodes for receiving electrophysiological signals from the test subject (elements 148, 149; paragraph [0157]);
an amplifier for amplifying electrical signals received from the plurality of electrodes (element 150, paragraph [0157]);
a left eye camera for obtaining images of the left eye of the test subject, and a right eye camera for obtaining images of the right eye of the test subject (elements 156a, 156b, paragraph [0162]);
an indicator box for inputting a psychophysical response to at least one of the visual stimulus to the left eye and the visual stimulus to the right eye (paragraph [0070];
a controller for controlling operation of at least one of the dichoptic stimulator, the left eye camera, the right eye camera and the indicator box (paragraph [0157]);
a computer for processing (i) electrical signals from the amplifier, (ii) images from the left eye camera and the right -3- eye camera, and (iii) response signals from the indicator box so as to obtain the ophthalmic electrophysiological, pupillometry and psychophysical results of the test subject (paragraphs [0033], [0157], [0162]);
using at least one of said left eye stimulator and said right eye stimulator to deliver at least one visual stimulus to at least one of the left eye of the test subject and the right eye of the test subject over a predetermined period of time (paragraphs [0157], [0162]);
obtaining an electrical signal representative of the electrical potential present in the at least one eye of the test subject exposed to said at least one visual stimulus (paragraph [0157]);
amplifying said electrical signal using said amplifier (paragraph [0157]);
obtaining at least one of an image of the left eye from the left eye camera and an image of the right eye from the right eye camera (paragraph [0157]);
obtaining a response signal from the indicator box (paragraph [0070]); and
processing the electrical signal from the amplifier, at least one image from the left eye camera and the right eye camera, and the response signal from the indicator box so as to obtain ophthalmic electrophysiological, pupillometry and psychophysical results of the test subject (paragraphs [0033], [0157], [0162]).
Regarding claim 40, Maddess further discloses that the left eye camera and the right eye camera simultaneously obtain images of the left eye of the test subject and the right eye of the test subject; and further wherein the images obtained from the left eye of the test subject and the right eye of the test subject are processed to track at least one of pupil diameter, eye gaze direction and eyelid position (paragraph [0157], [0159]).
Regarding claim 42, Maddess further discloses that at least one of pupil diameter, eye gaze direction and eyelid position is used to confirm the quality of at least one of the electrophysiological response and the psychophysical response (paragraphs [0168]-[0170]).
Regarding claim 44, Maddess further discloses that said computer uses the images from said left eye camera and said right eye camera to determine the location of an anatomical structure of the test subject (paragraph [0056], [0137]).
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.
Claim(s) 2, 39, 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maddess in view of Doran (US 2017/0127970).
Regarding claim 2, Maddess does not specifically disclose that the plurality of electrodes comprise a left eye active electrode in contact with the left eye of the test subject, a right eye active electrode in contact with the right eye of the test subject and a ground electrode in contact with the skin of the test subject. Doran teaches an apparatus (Abstract) comprising a plurality of electrodes (corneal, reference, and ground electrodes, para. [0057]), wherein the plurality of electrodes comprise a left eye active electrode in contact with the left eye of the test subject (electrode contacting cornea of left eye, para. [0069]), a right eye active electrode in contact with the right eye of the test subject (electrode contacting cornea of right eye, para. [0069]) and a ground electrode in contact with the skin of the test subject (patient support 55 configured to be used as a ground electrode, para. [0061]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed that the system of Maddess could have been modified as claimed in view of Doran to allow for precise monitoring of the electrical responses to the dichoptic stimulation.
Regarding claim 39, Maddess does not explicitly disclose that the system is configured to stimulate one eye of the test subject while recording a pupil response in an unstimulated eye of the test subject. Doran teaches an apparatus configured to obtain ophthalmic electrophysiological and pupillometry responses from a test subject (abstract) comprising a dichoptic stimulator configured to stimulate one eye of the test subject while recording a pupil response in an unstimulated eye of the test subject (paragraph [0070]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Maddess configured to record a pupil response in an unstimulated eye while stimulating the other eye, as taught by Doran, in order to provide a background comparison.
Regarding claim 43, Maddess does not disclose that at least one of pupil diameter, eye gaze direction and eyelid position is used to modify at least one of the electrophysiological response and the psychophysical response. Doran teaches an apparatus configured to obtain ophthalmic electrophysiological and pupillometry responses from a test subject (abstract) comprising a dichoptic stimulator configured to use at least one of pupil diameter, eye gaze direction and eyelid position to modify the electrophysiological response (paragraph [0070]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Maddess and configured it to use a pupil diameter, eye gaze, or eyelid position to modify the electrophysical response, as taught by Doran, in order to provide context for the response.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maddess in view of Pardue (US 2024/0074691).
Regarding claim 7, Maddess further discloses comparing the responses from each eye (paragraph [0167], [0184]) but does not explicitly disclose wherein one of said plurality of electrodes measures the electrical potential from the eye being stimulated and generates a corresponding electrical signal and another one of said plurality of electrodes measures the electrical potential from the eye not being stimulated and generates a corresponding electrical signal, whereby to serve as a reference electrode.
Pardue teaches a device for administering an electroretinography examination (Abstract) comprising a plurality of electrodes (Abstract) wherein one of said plurality of electrodes measures the electrical potential from the eye being stimulated and generates a corresponding electrical signal (cause the stimulation light of the first compartment to flash and then cause the device 10 to store one or more signals received from the active electrode from the first compartment, para. [0054]) and another one of said plurality of electrodes measures the electrical potential from the eye not being stimulated and generates a corresponding electrical signal (electrodes can be configured to record electrical signals indicative of electrical function of the eye, para. [0046]; while left eye is being tested, right eye electrodes can still
measure electrical potential of right eye), whereby to serve as a reference electrode (reference electrode 52 of right eye, Fig. 2, para. [0051]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed that the system of Maddess could have been modified as claimed in view of Pardue to allow for precise monitoring of the electrical responses of each eye during stimulation.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maddess in view of Waldorf (US 2014/0171756).
Regarding claim 15, Maddess does not disclose that wherein said computer uses the images from said left eye camera and said right eye camera to determine the location of at least one of the left eyelid and the right eyelid of the test subject. Waldorf teaches a system comprising left and right eye cameras for obtaining images of the eyes of a test subject (elements 102B; paragraphs [0037]-[0038]), where the system is configured to use the images from the cameras to determine the location of at least one of the subject’s eyelids (paragraphs [0007], [0020], [0083]-[0084]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Maddess configured to use the camera images to determine the location of at least one eyelid, as taught by Waldorf, in order to evaluate potential physical conditions relating to the eye.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maddess in view of Monhart (US 2019/0142270).
Regarding claim 18, Maddess further discloses that the psychophysical response comprises a recorded indication that the test subject perceived at least one of the visual stimulus delivered to the left eye and the visual stimulus delivered to the right eye (paragraph [0070]); Maddess does not disclose wherein said computer is further configured to record said response signal from said indicator box and generate a graphical representation of said response signal against said delivery of the visual stimulus to the left eye and the visual stimulus to the right eye. Monhart teaches a system for obtaining ophthalmic responses to visual stimuli delivered to each eye (paragraphs [0026]-[0027]) which is further configured to obtain a psychophysical response comprising an indication of perception to the stimuli (paragraph [0036]) and to record said response signal and generate a graphical representation of said response signal against said delivery of the visual stimulus to the left eye and the visual stimulus to the right eye (paragraphs [0031]-[0032]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Maddess and configured the computer to generate a graphical representation of the response signal against the delivery of the visual stimuli, as taught by Monhart, in order to also obtain a subjective measure of the subject’s condition.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maddess, as modified by Monhart above, and further in view of Roman (Alejandro J. Roman, Sharon B. Schwartz, Tomas S. Aleman, Artur V. Cideciyan, John D. Chico, Elizabeth A.M. Windsor, Leigh M. Gardner, Gui-shuang Ying, Elaine E. Smilko, Maureen G. Maguire, Samuel G. Jacobson, Quantifying rod photoreceptor-mediated vision in retinal degenerations: dark-adapted thresholds as outcome measures, Experimental Eye Research, Volume 80, Issue 2, 2005, Pages 259-272, ISSN 0014-4835, https://doi.org/10.1016/j.exer.2004.09.008)
Regarding claim 20, Maddess, as modified, does not disclose delivering a stimulus to perform a full-field stimulus threshold test and the graphical representation comprising the results of that test. Roman teaches delivery of a visual stimulus delivered at least one eye of a test subject so as to perform a Full-field Stimulus Threshold Test (FST) on the test subject, and generation of a graphical representation comprising the results of said Full-field Stimulus Threshold Test (FST) (Abstract; sections 2.2, 2.3, 3.2; figure 3). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Maddess, as modified, configured to use the visual stimulus to perform a FST and with the results of the FST included in the graphical representation, as taught by Roman, in order to evaluate retinal degeneration.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maddess, as modified by Monhart above, and further in view of Barad (US 5822037).
Regarding claim 21, Maddess does not disclose that at least one of said visual stimulus delivered to the left eye of the test subject and said visual stimulus delivered to the right eye of the test subject is selected so as to perform a Dark Adaptometry Test on the test subject, and further wherein said graphical representation comprises the results of said Dark Adaptometry Test. Barad teaches delivering a visual stimulus to perform a Dark Adaptometry test on a test subject (abstract; column 1 line 54 to column 2 line 2; table 1) and generating a graphical representation comprising the results of the Dark Adaptometry test (figure 3). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Maddess, as modified, with at least one of said visual stimulus delivered to the left eye of the test subject and said visual stimulus delivered to the right eye of the test subject is selected so as to perform a Dark Adaptometry Test on the test subject, and further wherein said graphical representation comprises the results of said Dark Adaptometry Test, as taught by Barad, in order to evaluate the subject’s photoreceptor function.
Conclusion
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/KAREN E TOTH/ Examiner, Art Unit 3791
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