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 .
Information Disclosure Statement
The information disclosure statement filed on January 30, 2026 has been considered.
Response to Amendment
The amendment filed on January 30, 2026 has been entered. Claims 1, 4, 6, 8, and 11-13 have been amended in the present application. Claims 13-20 are withdrawn from consideration. Claims 1-12 are under consideration in the present application. Applicant’s amendments to the specification have overcome each and every objection previously set forth in the Non-Final Office Action mailed August 1, 2025.
Response to Arguments
Applicant's arguments filed January 30, 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on pages 12-15 that Shalon fails to teach “determining an expected location, the expected location being indicative of where the dot indicative of the reflected radiation is expected to be captured; determining a difference between the location of the dot the dot indicative of the reflected radiation and the expected location,” Examiner respectfully disagrees.
Applicant argues that Shalon merely teaches using a “set of known reference positions… corresponding to stationary pixel positions of the described imager” and “positions of each pixel are known and correlated in memory and therefor distances between the reflected images of the projected lights can be derived electronically” and as such do not constitute “an expected location indicative of where the dot indicative of the reflected radiation is expected to be captured.” However, Shalon describes that the instrument is calibrated by measuring the position of the reflected images of the light beams using a reference sphere in place of the cornea (Col. 11 lines 41-45). The spot measurements determined from the calibration and those reflected from the cornea are then used to compute a corneal curvature (Col. 11 lines 48-50). Using the reference sphere to calibrate the instrument constitutes “determining an expected location, the expected location being indicative of where the dot indicative of the reflected radiation is expected to be captured” since reference positions are determined based on reflections from the sphere and are thus the expected locations of the reflected radiation if the cornea was shaped like a sphere. The curvature of the curvature of the cornea is then determined based on the reference positions determined from the calibration sphere and the reflected radiation from the cornea. Therefore, Applicant’s arguments are not persuasive and Examiner maintains the 102 rejections of claims 1 and 8 over Shalon.
Claim Rejections - 35 USC § 102
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 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 1-6 and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shalon et al. (U.S. Patent No. 5,585,873 – cited by Applicant – hereinafter referred to as “Shalon”).
Regarding claim 1, Shalon teaches a system (Figure 1 keratometer 10), comprising: a processing unit (Col. 8 lines 49-50 keratometer 10 has a processor);
one or more light sources (Figure 8 LEDs 64, Col. 8 lines 28-32 four light sources) operatively connected to the processing unit (Figure 17 LED out puts are connected to the processor);
a light sensor (Figure 3 imaging device 84, Col. 8 lines 38-52 CCD imager connected to processor) operatively connected to the processing unit; and
non-transitory computer-readable media storing instructions (Col. 8 lines 46-52 instructions executed by processor are stored in memory) that, when executed by the processing unit, cause the processing unit to perform operations comprising:
causing the one or more light sources (Col. 8 lines 28-32 four light sources (LEDs 64) are projected onto eye) to direct radiation to a cornea of a patient in a predetermined pattern (Figure 8 LEDs 64 are arranged in a pattern);
causing the light sensor to capture a portion of the radiation that is reflected from the cornea of the patient (Col. 9 lines 42-51 CCD image sensor captures image of beam reflected from eye);
generating an image based on the portion of the radiation, the image illustrating a dot indicative of reflected radiation (Col. 9 lines 42-51 CCD image sensor captures image of beam reflected from eye, Figures 13A and B spots 200a-d Col. 11 lines 39-62 reflected spots 200a-d are indicative of spots where keratometer readings are taken);
determining a location within the image of the dot indicative of the reflected radiation (Col. 8 lines 39-52 location of the reflected light is measured);
determining an expected location, the expected location being indicative of where the dot indicative of the reflected radiation is expected to be captured (Col. 11 lines 41-45 instrument is calibrated by measuring the position of the reflected images of the light beams using a reference sphere in place of the cornea which are the expected locations of light reflected from the cornea if the cornea was shaped like a sphere);
determining a difference between the location of the dot indicative of the reflected radiation and an expected location within the expected return image (Col. 11 lines 39-53, Col. 12 lines 41-48 radii of curvature determined from location of spots 200a-d and calibration spot data); and
determining, based at least in part on the difference, a curvature of the cornea (Col. 11 lines 48-50 spot positions from cornea reflection and calibration are used to determine curvature of the cornea; Col. 12 lines 41-48 radii of curvature determined from location of spots 200a-d and calibration spot data; Col. 67 I.B. curvature calculated using position of measured spots with respect to known reference positions).
Regarding claim 2, Shalon teaches all the limitations of the claimed invention with respect to claim 1. Shalon further teaches the one or more light sources (Figure 8 LEDs 64) are disposed within a housing (Figure 1 housing 24) of a vision screening device (Figure 1 keratometer 10) and arranged in a predetermined pattern, the predetermined pattern comprising one of a grid pattern, a diamond pattern, a circular pattern, a placido ring pattern, a dot matrix pattern, or a spot matrix pattern (Figure 8 LEDs 64 are arranged in a substantially grid or diamond pattern).
Regarding claim 3, Shalon teaches all the limitations of the claimed invention with respect to claim 1. Shalon further teaches the one or more light sources comprise one or more light emitting diodes (LEDs) (Figure 8 four LEDs 64, Col. 8 lines 28-32 four light sources).
Regarding claim 4, Shalon teaches all the limitations of the claimed invention with respect to claim 1. Shalon further teaches the expected locations associated with the expected location is determined based at least partly on locations of the light sources and the predetermined pattern (Col. 11 lines 39-53, measuring position of reflected spots 200a-d from reference sphere which are based on the location and pattern of LEDs 64).
Regarding claim 5, Shalon teaches all the limitations of the claimed invention with respect to claim 1. Shalon further teaches determining, based at least partly on the curvature of the cornea, a prescription for the patient (Col. 7 lines 39-52 prescription (diopter or refractive power) calculated from curvature); and displaying the prescription on a display of a vision screening device (Figure 2 display 32, Col. 7 lines 53-59 readings are displayed).
Regarding claim 6, Shalon teaches all the limitations of the claimed invention with respect to claim 1. Shalon further teaches generating an expected return image based at least partly on the predetermined pattern of the one or more light sources (Col. 11 lines 39-53, measuring position of reflected spots 200a-d from reference sphere which are based on the location and pattern of LEDs 64) and an angle of the one or more light sources relative to the patient (Col. 8 lines 33-37 angle of light beams are used to measure spacing of reflected light); and
determining the expected location based on the generated expected return image (Col. 11 lines 39-53, measuring position of reflected spots 200a-d from reference sphere are used to determine the expected return image).
Regarding claim 8 Shalon teaches a vision screening device (Figure 1 keratometer 10), comprising: a processing unit (Col. 8 lines 49-50 keratometer 10 has a processor);
a housing (Figure 1 housing 24);
one or more light sources (Figure 8 LEDs 64, Col. 8 lines 28-32 four light sources) disposed within the housing (Figure 8 LEDs 64 are in projection portion 14 which comprises part of housing 24, Col. 6 lines 38-39), and operatively connected to the processing unit (Figure 17 LED out puts are connected to the processor);
a light sensor (Figure 3 imaging device 84, Col. 8 lines 38-52 CCD imager connected to processor) disposed within the housing (Figure 3 imaging device 84 is within housing 24) and operatively connected to the processing unit; and
memory storing instructions (Col. 8 lines 46-52 instructions executed by processor are stored in memory) that, when executed by the processing unit, cause the vision screening device to:
cause the one or more light sources (Col. 8 lines 28-32 four light sources (LEDs 64) are projected onto eye) to direct radiation to a cornea of a patient in a predetermined pattern (Figure 8 LEDs 64 are arranged in a pattern);
cause the light sensor (Figure 3 imaging device 84) to capture a portion of the radiation that is reflected from the cornea of the patient (Col. 9 lines 42-51 CCD image sensor captures image of beam reflected from eye);
generate an image based on the portion of the radiation, the image illustrating a dot indicative of reflected radiation (Col. 9 lines 42-51 CCD image sensor captures image of beam reflected from eye, Figures 13A and B spots 200a-d Col. 11 lines 39-62 reflected spots 200a-d are indicative of spots where keratometer readings are taken);
determine a location within the image of the dot indicative of the reflected radiation (Col. 8 lines 39-52 location of the reflected light is measured);
determine an expected location, the expected location being indicative of where the dot indicative of the reflected radiation is expected to be captured (Col. 11 lines 41-45 instrument is calibrated by measuring the position of the reflected images of the light beams using a reference sphere in place of the cornea which are the expected locations of light reflected from the cornea if the cornea was shaped like a sphere);
determine a difference between the location of the dot indicative of the reflected radiation and an expected location within the expected return image (Col. 11 lines 39-53, Col. 12 lines 41-48 radii of curvature determined from location of spots 200a-d and calibration spot data); and
determine, based at least in part on the difference, a curvature of the cornea (Col. 11 lines 48-50 spot positions from cornea reflection and calibration are used to determine curvature of the cornea; Col. 12 lines 41-48 radii of curvature determined from location of spots 200a-d and calibration spot data; Col. 67 I.B. curvature calculated using position of measured spots with respect to known reference positions).
Regarding claim 9, Shalon teaches all the limitations of the claimed invention with respect to claim 8. Shalon further teaches a display unit (Figure 2 display 32);
the memory further storing instructions (Col. 8 lines 46-52 instructions executed by processor are stored in memory) that, when executed by the processing unit, cause the vision screening device to:
determine, based at least partly on the curvature of the cornea, a prescription for the patient (Col. 7 lines 39-52 prescription (diopter or refractive power) calculated from curvature); and
display the prescription on the display unit (Figure 2 display 32, Col. 7 lines 53-59 readings are displayed).
Regarding claim 10, Shalon teaches all the limitations of the claimed invention with respect to claim 8. Shalon further teaches the one or more light sources (Figure 8 LEDs 64) are configured to emit the radiation according to the predetermined pattern, the predetermined pattern comprising one of a grid pattern, a diamond pattern, a circular pattern, a placido ring pattern, a dot matrix pattern, or a spot matrix pattern (Figure 8 LEDs 64 are arranged in a substantially grid or diamond pattern).
Regarding claim 11, Shalon teaches all the limitations of the claimed invention with respect to claim 8. Shalon further teaches a range finder (Col. 9 line 57- col. 10 line 14 fixation LED 90 functions as a range finder) since it is used to accurately position keratometer 10 at an appropriate distance from the eye and determine the distance from eye piece 34 to the eye), the range finder being used for determining a distance of the patient from the vision screening device finder (Col. 9 line 57- col. 10 line 14 fixation LED 90 functions as a range finder since it is used to accurately position keratometer 10 at an appropriate distance from the eye and determine the distance from eye piece 34 to the eye), wherein the expected location is determined based on the predetermined pattern and the distance (Col. 11 lines 39-53 measuring position of reflected spots 200a-d from reference sphere which are based on the location and pattern of LEDs 64 and distance from the patient’s eye to the keraometer).
Regarding claim 12, Shalon teaches all the limitations of the claimed invention with respect to claim 8. Shalon further teaches the memory further storing instructions (Col. 8 lines 46-52 instructions executed by processor are stored in memory) that, when executed by the processing unit, cause the vision screening device to: generate an expected return image based at least partly on the predetermined pattern of the one or more light sources (Col. 11 lines 39-53, measuring position of reflected spots 200a-d from reference sphere which are based on the location and pattern of LEDs 64), the expected return image illustrating expected locations of the returned radiation (Col. 11 lines 41-45 instrument is calibrated by taking reflected images of the light beams using a reference sphere in place of the cornea); and determine the expected location based on the generated expected return image (Col. 11 lines 41-45 instrument is calibrated by measuring the position of the reflected images of the light beams using a reference sphere in place of the cornea which are the expected locations of light reflected from the cornea if the cornea was shaped like a sphere).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shalon (U.S. Patent No. 5,585,873) as applied to claim 1 above, in view of Brown et al. (U.S. Patent Application Publication No. 2018/0160899 – hereinafter referred to as “Brown”).
Regarding claim 7, Shalon teaches all the limitations of the claimed invention with respect to claim 1. Shalon fails to teach sending to a remote server, information associated with the patient, the information including a recommendation associated with the patient. However, Brown teaches a portable device for keratometry (Figure 1A device 100) that includes sending to a remote server, information associated with the patient, the information including a recommendation associated with the patient (Figure 3 server 304, [0153] results are sent to server 304). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the keratometer taught by Shalon by connecting it to a remote server as taught by Brown in order to store results outside the device and send results to other clients or medical professionals (Brown [0153]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Grierson et al. (U.S. Patent No. 8,192,023) discloses a similar device to the instant invention for measuring corneal curvature by comparing reflections from the cornea to a reference image.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX PARK RICKEL whose telephone number is (703)756-4561. The examiner can normally be reached Monday-Friday 8:30 a.m. - 6 p.m. ET.
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Alex Rickel
Examiner
Art Unit 2872
/A.P.R./Examiner, Art Unit 2872
/BUMSUK WON/Supervisory Patent Examiner, Art Unit 2872
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