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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the source of polarized light, optical detector disposed to receive polarized light from the source upon being reflected from a left retina of the patient… and to receive polarized light from the source upon being reflected from a right retina of the patient, and the electronic processor must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 8, 10, 18, and 20 are objected to because of the following informalities: “the correspondence” should read “the correlation”. 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.
Claims 1-2, 4-5, 7-12, 14-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guyton (US20170014026A1, of record in the IDS dated 12/04/2024).
With respect to Claim 1, Guyton discloses a system for determining an alignment status ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned) of a patient's eyes (Fig. 3-- eye alignment monitor; [0052]), the system comprising:
a source of polarized light (Fig. 3—element 11, IRED; [0052]);
an optical detector (Fig. 3—elements 36 and 37, analog position sensors; [0053]) disposed to receive polarized light from the source (Fig. 3—element 11, IRED; [0052]) upon being reflected from a left retina (Fig. 3-- element 10, left eye; [0052]) of the patient and produce a corresponding left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) for circular scans ([0013]: retinal birefringence scanning detects the anatomic fovea directly by sensing centration of the circular scan on the radial nerve fibers) of the left retina (Fig. 3-- element 10, left eye; [0052]) and to receive polarized light from the source (Fig. 3—element 11, IRED; [0052]) upon being reflected from a right retina (Fig. 3-- element 30, right eye; [0052]) of the patient and produce a corresponding right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]) for circular scans ([0013]: retinal birefringence scanning detects the anatomic fovea directly by sensing centration of the circular scan on the radial nerve fibers) of the right retina (Fig. 3-- element 30, right eye; [0052]);
an electronic processor ([0055]: 36 and 37 are connected via an analog-to-digital converter to computing means) communicatively coupled to the optical detector (Fig. 3—elements 36 and 37, analog position sensors; [0053]); and
persistent electronic memory ([0055]: computer memory) comprising instructions that, when executed by the electronic processor ([0055]: 36 and 37 are connected via an analog-to-digital converter to computing means), configure the electronic processor ([0055]: 36 and 37 are connected via an analog-to-digital converter to computing means) to perform actions comprising:
determining a correlation ([0055]: The variability within this set of relative positions is then calculated as a measure of the variability over time of the alignment between the two eyes) of a signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) with a signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]);
determining an alignment status ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned) of the patient's eyes based on the correlation ([0055]: The variability within this set of relative positions is then calculated as a measure of the variability over time of the alignment between the two eyes); and
providing the alignment status ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned).
With respect to Claim 2, Guyton discloses the system of claim 1, and further discloses wherein the alignment status ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned) comprises an indication of one of:
the right eye and the left eye are aligned, or the right eye and the left eye are misaligned ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned).
With respect to Claim 4, Guyton discloses the system of claim 1, and further discloses wherein the correlation ([0055]: The variability within this set of relative positions is then calculated as a measure of the variability over time of the alignment between the two eyes) comprises a magnitude- squared coherence ([0044]: various statistical methods may be utilized to determine variability in the relative positions of the two pupils' images with one another over time) of the signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) and the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]).
With respect to Claim 5, Guyton discloses the system of claim 1, and further discloses wherein the correlation ([0055]: The variability within this set of relative positions is then calculated as a measure of the variability over time of the alignment between the two eyes) comprises a linear fit ([0044]: various statistical methods may be utilized to determine variability in the relative positions of the two pupils' images with one another over time) of a one of the signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) or the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]) to another of the signal derived from left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) or the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]).
With respect to Claim 7, Guyton discloses the system of claim 1, and further discloses wherein the alignment status ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned) comprises an identification of a misaligned eye ([0056]: if a deficit of binocular function is present, the normalized position of the pupil image of one eye will show more variability over time than the normalized position of the pupil image of the other eye, thus identifying the eye with the more variable normalized position to be the amblyopic or strabismic eye).
With respect to Claim 8, Guyton discloses the system of claim 7, and further discloses wherein the actions further comprise:
determining a time of misalignment based on the correspondence ([0055]: difference values between the left and right eye are taken at multiple time points); and
identifying the misaligned eye based on a comparison of the signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) and the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]) at the time of misalignment ([0056]: if a deficit of binocular function is present, the normalized position of the pupil image of one eye will show more variability over time than the normalized position of the pupil image of the other eye, thus identifying the eye with the more variable normalized position to be the amblyopic or strabismic eye).
With respect to Claim 9, Guyton discloses the system of claim 8, and further discloses wherein the actions further comprise, prior to identifying the misaligned eye:
linearly fitting ([0044]: various statistical methods may be utilized to determine variability in the relative positions of the two pupils' images with one another over time) of one of the signal derived from left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) or the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]) to another of the signal derived from left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) or the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]).
With respect to Claim 10, Guyton discloses the system of claim 7, and further discloses wherein the actions further comprise:
determining a time of relative alignment based on the correspondence ([0055]: difference values between the left and right eye are taken at multiple time points); and
identifying the misaligned eye based on a comparison of the signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) and the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]) at the time of relative alignment ([0056]: if a deficit of binocular function is present, the normalized position of the pupil image of one eye will show more variability over time than the normalized position of the pupil image of the other eye, thus identifying the eye with the more variable normalized position to be the amblyopic or strabismic eye).
With respect to Claim 11, Guyton discloses a method of determining an alignment status ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned) of a patient's eyes (Fig. 3-- eye alignment monitor; [0052]), the method comprising:
directing (Fig. 3—light from element 11 is directed at the patient’s eyes) polarized light to a left retina (Fig. 3-- element 10, left eye; [0052]) of the patient and directing polarized light to a right retina (Fig. 3-- element 30, right eye; [0052]) of the patient;
obtaining a left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) corresponding to polarized light reflected from the left retina (Fig. 3-- element 10, left eye; [0052]) for circular scans ([0013]: retinal birefringence scanning detects the anatomic fovea directly by sensing centration of the circular scan on the radial nerve fibers) of the left retina (Fig. 3-- element 10, left eye; [0052]) and obtaining a right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]) corresponding to polarized light reflected from the right retina (Fig. 3-- element 30, right eye; [0052]) for circular scans ([0013]: retinal birefringence scanning detects the anatomic fovea directly by sensing centration of the circular scan on the radial nerve fibers) of the right retina (Fig. 3-- element 30, right eye; [0052]);
determining a correlation ([0055]: The variability within this set of relative positions is then calculated as a measure of the variability over time of the alignment between the two eyes) of a signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) with a signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]);
determining an alignment status ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned) of the patient's eyes based on the correlation ([0055]: The variability within this set of relative positions is then calculated as a measure of the variability over time of the alignment between the two eyes); and providing the alignment status ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned).
With respect to Claim 12, Guyton discloses the method of claim 11, and further discloses wherein the alignment status ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned) comprises an indication of one of: the right eye and the left eye are aligned, or the right eye and the left eye are misaligned ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned).
With respect to Claim 14, Guyton discloses the method of claim 11, and further discloses wherein the correlation ([0055]: The variability within this set of relative positions is then calculated as a measure of the variability over time of the alignment between the two eyes) comprises a magnitude- squared coherence ([0044]: various statistical methods may be utilized to determine variability in the relative positions of the two pupils' images with one another over time) of the signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) and the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]).
With respect to Claim 15, Guyton discloses the method of claim 11, and further discloses wherein the correlation ([0055]: The variability within this set of relative positions is then calculated as a measure of the variability over time of the alignment between the two eyes) comprises a linear fit coherence ([0044]: various statistical methods may be utilized to determine variability in the relative positions of the two pupils' images with one another over time) of a one of the signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) or the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]) to another of the signal derived from left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) or the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]).
With respect to Claim 17, Guyton discloses the method of claim 11, and further discloses wherein the alignment status ([0056]: elements 36 and 37 will indicate a probable deficit of binocular function if the two eyes are not aligned) comprises an identification of a misaligned eye ([0056]: if a deficit of binocular function is present, the normalized position of the pupil image of one eye will show more variability over time than the normalized position of the pupil image of the other eye, thus identifying the eye with the more variable normalized position to be the amblyopic or strabismic eye).
With respect to Claim 18, Guyton discloses the method of claim 11, and further discloses further comprising:
determining a time of misalignment based on the correspondence ([0055]: difference values between the left and right eye are taken at multiple time points); and
identifying the misaligned eye based on a comparison of the signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) and the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]) at the time of misalignment ([0056]: if a deficit of binocular function is present, the normalized position of the pupil image of one eye will show more variability over time than the normalized position of the pupil image of the other eye, thus identifying the eye with the more variable normalized position to be the amblyopic or strabismic eye).
With respect to Claim 19, Guyton discloses the method of claim 18, and further discloses further comprising, prior to the identifying the misaligned eye:
linearly fitting ([0044]: various statistical methods may be utilized to determine variability in the relative positions of the two pupils' images with one another over time) of one of the signal derived from left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) or the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]) to another of the signal derived from left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) or the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]).
With respect to Claim 20, Guyton discloses the method of claim 11, and further discloses further comprising:
determining a time of relative alignment based on the correspondence ([0055]: difference values between the left and right eye are taken at multiple time points); and
identifying the misaligned eye based on a comparison of the signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) and the signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]) at the time of relative alignment ([0056]: if a deficit of binocular function is present, the normalized position of the pupil image of one eye will show more variability over time than the normalized position of the pupil image of the other eye, thus identifying the eye with the more variable normalized position to be the amblyopic or strabismic eye).
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 3, 6, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Guyton (US20170014026A1, of record in the IDS dated 12/04/2024) in view of Hanaki (US20050174536A1, of record in the IDS dated 12/04/2024).
With respect to Claim 3, Guyton discloses the system of claim 1, and further discloses the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) and the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]).
However, Guyton does not disclose wherein the signal derived from the left eye electrical signal comprises a fast Fourier transform power of at least one frequency characteristic of central fixation, and wherein the signal derived from the right eye electrical signal comprises a fast Fourier transform power of at least one frequency characteristic of central fixation.
Guyton and Hanaki are related as both pertaining to the field of eye examination apparatuses. Hanaki discloses wherein the signal derived from the left eye electrical signal ([0044]: data from the left eye is picked up by 54L) comprises a fast Fourier transform power of at least one frequency characteristic of central fixation ([0047]: a frequency analysis is performed by means of a fast Fourier transform to calculate a power spectrum), and wherein the signal derived from the right eye electrical signal ([0044]: data from the right eye is picked up by 54R) comprises a fast Fourier transform power of at least one frequency characteristic of central fixation ([0047]: a frequency analysis is performed by means of a fast Fourier transform to calculate a power spectrum).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Guyton with the signal analysis of Hanaki in order to create a device which may efficiently and precisely examiner an accommodative function of an eye (Hanaki, [0005]).
With respect to Claim 6, Guyton discloses the system of claim 1, and further discloses the correlation ([0055]: The variability within this set of relative positions is then calculated as a measure of the variability over time of the alignment between the two eyes), a signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]), and a signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052])
However, Guyton does not disclose wherein the correlation comprises a spectral correlation coefficient for a signal derived from the left eye electrical signal and a signal derived from the right eye electrical signal.
Guyton and Hanaki are related as both pertaining to the field of eye examination apparatuses. Hanaki discloses wherein the correlation comprises a spectral correlation coefficient for a signal derived from the left eye electrical signal and a signal derived from the right eye electrical signal ([0047]: a frequency analysis is performed by means of a fast Fourier transform (FFT) to calculate a power spectrum. The calculated power spectrum is converted to common logarithms and analyzed. Based on this power spectrum, a mean power spectrum (in dB) in the intervals for high frequency components of 1.0 to 2.3 Hz is determined and evaluated). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Guyton with the signal analysis of Hanaki in order to create a device which may efficiently and precisely examiner an accommodative function of an eye (Hanaki, [0005]).
With respect to Claim 13, Guyton discloses the method of claim 11, and further discloses the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]) and the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052]).
However, Guyton does not disclose wherein the signal derived from the left eye electrical signal comprises a fast Fourier transform power of at least one frequency characteristic of central fixation, and wherein the signal derived from the right eye electrical signal comprises a fast Fourier transform power of at least one frequency characteristic of central fixation.
Guyton and Hanaki are related as both pertaining to the field of eye examination apparatuses. Hanaki discloses wherein the signal derived from the left eye electrical signal ([0044]: data from the left eye is picked up by 54L) comprises a fast Fourier transform power of at least one frequency characteristic of central fixation ([0047]: a frequency analysis is performed by means of a fast Fourier transform to calculate a power spectrum), and wherein the signal derived from the right eye electrical signal ([0044]: data from the right eye is picked up by 54R) comprises a fast Fourier transform power of at least one frequency characteristic of central fixation ([0047]: a frequency analysis is performed by means of a fast Fourier transform to calculate a power spectrum).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Guyton with the signal analysis of Hanaki in order to create a device which may efficiently and precisely examiner an accommodative function of an eye (Hanaki, [0005]).
With respect to Claim 16, Guyton discloses the method of claim 11, and further discloses the correlation ([0055]: The variability within this set of relative positions is then calculated as a measure of the variability over time of the alignment between the two eyes), a signal derived from the left eye electrical signal (Fig. 3-- element 21, left pupil image; [0052]), and a signal derived from the right eye electrical signal (Fig. 3-- element 22, right pupil image; [0052])
However, Guyton does not disclose wherein the correlation comprises a spectral correlation coefficient for a signal derived from the left eye electrical signal and a signal derived from the right eye electrical signal.
Guyton and Hanaki are related as both pertaining to the field of eye examination apparatuses. Hanaki discloses wherein the correlation comprises a spectral correlation coefficient for a signal derived from the left eye electrical signal and a signal derived from the right eye electrical signal ([0047]: a frequency analysis is performed by means of a fast Fourier transform (FFT) to calculate a power spectrum. The calculated power spectrum is converted to common logarithms and analyzed. Based on this power spectrum, a mean power spectrum (in dB) in the intervals for high frequency components of 1.0 to 2.3 Hz is determined and evaluated). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Guyton with the signal analysis of Hanaki in order to create a device which may efficiently and precisely examiner an accommodative function of an eye (Hanaki, [0005]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Krall (US 20210169322 A1) discloses aspects of the instant invention, see Fig. 5 and [0050]-[0056].
Jarc (US 10432922 B2) discloses aspects of the instant invention, see Fig. 1A and Col. 5, Line 35- Col. 7, Line 61.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MACKENZI BOURQUINE whose telephone number is (571)272-5956. The examiner can normally be reached Monday - Friday 8:30 - 4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached at (571) 270-1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MACKENZI BOURQUINE/Examiner, Art Unit 2872
/WILLIAM R ALEXANDER/Primary Examiner, Art Unit 2872
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