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 (IDS) submitted on 07/29/2025 has been considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,186,018. Although the claims at issue are not identical, they are not patentably distinct from each other because the removal of the limitations “detect a predetermined blink sequence of a plurality of blinks in succession within a pre-determined time in the first stream of images and interpret the predetermined blink sequence of a plurality of blinks in succession within a pre-determined time as a patient-induced trigger of a measurement capture” and “provide an audible sound to the patient when the stable tear film interval begins to reinforce a need to maintain fixation on the target object during the stable tear film interval” renders claims 1-20 of the instant application as broadened and obvious variants of claims 1-20 of U.S. Patent No. 12,186,018.
Examiner’s Comments
The examiner points out that while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. Limitations following "configured to," "adapted for," "designed to," "can be," and "capable of," or are statements of intended use are not positive limitations and thus are not given patentable weight. See MPEP 2111.04 and 2114.
Furthermore, it has been held that the recitation that an element is "configured to" perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138. For purposes of expediting prosecution, the Examiner has addressed all limitations following the phrase "configured to".
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 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, 4-5, 9-11 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neal et al. (US 2017/0071465).
Regarding claims 1 and 11, Neal discloses, a system (Figs. 1-18) comprising:
an ophthalmic device (10, 16, 430) configured to measure characteristics of an eye (Para. 0065-0070);
an eye tracker (Para. 0137 and 451) configured to capture a first stream of images of the eye (Para. 0066); and
a logic device (17, 19, 22, 422’) configured to:
analyze the first stream of images to determine whether the eye is fixating on a target object (Para. 0136 and see 1800);
detect a predetermined blink sequence in the first stream of images (514);
after a predetermined tear stabilization period, start a stable tear film interval (514); and
during the stable tear film interval, capture at least one measurement of the eye using the ophthalmic device when the eye is fixating on the target object (Para. 0153, 0162 and see 502, 510).
Regarding claim 4, Neal discloses, the logic device is further configured to: determine an eye fixation position and orientation relative to an optical axis of the eye tracker based at least in part on the first corresponding image coordinates and/or the second corresponding image coordinates (Para. 0136 and 0154).
Regarding claim 5, Neal discloses, the logic device is further configured to: estimate eye fixation parameters based at least in part on the determined eye fixation position and orientation (Para. 0136 and 0154); receive the first stream of images (Para. 0066 and 0136) from the eye tracker (Para. 0137); and track a current eye position and orientation by analyzing at least one image from the first stream of images to determine the current eye position and orientation relative to the eye fixation parameters (Para. 0066, 0136-0137 and 0154); wherein the eye fixation parameters comprise a reference position and orientation of the eye when fixated (Para. 0015, 0110 and 0151).
Regarding claim 9, Neal discloses, the logic device is further configured to perform an eye diagnostic procedure and track eye position using the eye tracker during the eye diagnostic procedure (Para. 0074, 0131 and 0176).
Regarding claims 10 and 20, Neal discloses, a diagnostic device configured to perform an eye diagnostic procedure while tracking a position and orientation of the eye using the eye tracker (Para. 0074, 0131 and 0176); wherein the diagnostic device is configured to modify the eye diagnostic procedure based, at least in part, on data representative of eye fixation parameters and a tracked eye position (Para. 0074, 0131 and 0176).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Neal et al. (US 2017/0071465) as applied to claims 1 and 11 above, in view of Khadari et al. (US 2017/0293356).
Neal remains as applied to claims 1 and 11 above.
Neal does not disclose the blink sequence comprises a plurality of blinks in succession; and wherein detect the predetermined blink sequence in the first stream of images comprises processing the images through neural network trained to detect an open eye and/or a closed eye, and training a neural network to receive the stream of images and output a determination of an eye position.
Khadari teaches, from the same field of endeavor that in a system and method that it would have been desirable to make the blink sequence comprises a plurality of blinks in succession; and wherein detect the predetermined blink sequence in the first stream of images comprises processing the images through neural network trained to detect an open eye and/or a closed eye (Para. 0438, 0504 and 06220), and training a neural network to receive the stream of images and output a determination of an eye position (Para. 0438, 0443 and 0504).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the blink sequence comprises a plurality of blinks in succession; and wherein detect the predetermined blink sequence in the first stream of images comprises processing the images through neural network trained to detect an open eye and/or a closed eye, and training a neural network to receive the stream of images and output a determination of an eye position as taught by the system and method of Khadari in the system and method of Neal since Khadari teaches it is known to include these features in a system and method for the purpose of providing an accurate and efficient system and method.
Claims 3, 7, 13-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Neal et al. (US 2017/0071465) as applied to claims 1 and 11 above, in view of Deering et al. (US 2009/0189830).
Neal remains as applied to claims 1 and 11 above.
Furthermore, Neal discloses, the eye tracker is configured to capture a first image of the eye from a first location and a second image of the eye from a second location (Para. 0084-0091); and wherein the logic device is further configured to: detect a first plurality of eye characteristics from the first image (Para. 0084-0091), the eye characteristics having first corresponding image coordinates (Para. 0084-0091); detect a second plurality of eye characteristics from the second image (Para. 0084-0091), the eye characteristics having second corresponding image coordinates (Para. 0084-0091).
Neal does not disclose the logic device is further configured to: determine a calibration offset and a calibration gain based at least in part on the first corresponding image coordinates, the second corresponding image coordinates, the first location and the second location.
Deering teaches, from the same field of endeavor that in a system and method that it would have been desirable to make the logic device is further configured to: determine a calibration offset and a calibration gain based at least in part on the first corresponding image coordinates, the second corresponding image coordinates, the first location and the second location (Para. 0181 and 0337).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the logic device is further configured to: determine a calibration offset and a calibration gain based at least in part on the first corresponding image coordinates, the second corresponding image coordinates, the first location and the second as taught by the system and method of Deering in the system and method of Neal since Deering teaches it is known to include these features in a system and method for the purpose of providing an accurate and efficient system and method.
Regarding claims 7 and 18, Neal in view of Deering discloses and teaches as set forth above, and Deering further teaches, from the same field of endeavor that in a system and method that it would have been desirable to include a retina imaging system comprising an optical coherence tomography (OCT) scanner configured to perform a retinal scan (Para. 0139); wherein the eye tracker is further configured to capture a stream of images of the eye during the retinal scan (Para. 0172-0177 and 0180-0181); wherein the retina imaging system is further configured to: capture a plurality of retinal images of the eye (Para. 0172-0177 and 0180-0181); detect whether a fovea is present in one or more of the plurality of retinal images of the eye (Para. 0172-0177 and 0180-0181); and identify a first retinal image from the plurality of retinal images of the eye having the detected fovea (Para. 0172-0177 and 0180-0181); and wherein the logic device is further configured to: determine a corresponding image from the stream of images having a temporal proximity to the first retinal image (Para. 0172-0177 and 0180-0181); and analyze the corresponding image to determine eye fixation parameters (Para. 0172-0177 and 0180-0181).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the system and method of Deering in the system and method of Neal since Deering teaches it is known to include these features in a system and method for the purpose of providing an accurate and efficient system and method.
Regarding claim 14, Neal in view of Deering discloses and teaches as set forth above, and Deering further teaches, from the same field of endeavor that in a system and method that it would have been desirable to include capturing a stream of images of the eye (Para. 0181 and 0337); detecting an eye position and orientation in the stream of images based at least in part on coordinates of the detected eye characteristics, the calibration offset and the calibration gain (Para. 0181 and 0337); and determining an eye fixation position and orientation relative to an optical axis (Para. 0181 and 0337).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the system and method of Deering in the system and method of Neal since Deering teaches it is known to include these features in a system and method for the purpose of providing an accurate and efficient system and method.
Regarding claim 15, Neal in view of Deering discloses and teaches as set forth above, and Neal further discloses, the logic device is further configured to: estimate eye fixation parameters based at least in part on the determined eye fixation position and orientation (Para. 0136 and 0154); receive the first stream of images (Para. 0066 and 0136) from the eye tracker (Para. 0137); and track a current eye position and orientation by analyzing at least one image from the first stream of images to determine the current eye position and orientation relative to the eye fixation parameters (Para. 0066, 0136-0137 and 0154); wherein the eye fixation parameters comprise a reference position and orientation of the eye when fixated (Para. 0015, 0110 and 0151).
Claims 6, 8, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Neal et al. (US 2017/0071465) as applied to claims 1 and 11 above, in view of S. et al. (US 2013/0010096).
Neal remains as applied to claims 1 and 11 above.
Neal does not disclose the logic device is further configured to determine the fixation position relative to an optical axis of the eye tracker by constructing and analyzing a histogram of detected eye positions and orientations; wherein analyzing the histogram further comprises determining whether coordinates of a relative maximum value comprise a fixation position and orientation; and wherein determining whether coordinates of the relative maximum value comprise a fixation position and orientation further comprise comparing the relative maximum value with a threshold and/or an average coordinate value of the histogram.
S. teaches, from the same field of endeavor that in a system and method that it would have been desirable to make the logic device is further configured to determine the fixation position relative to an optical axis of the eye tracker by constructing and analyzing a histogram of detected eye positions and orientations (Para. 0042-0046 and 0053-0073); wherein analyzing the histogram further comprises determining whether coordinates of a relative maximum value comprise a fixation position and orientation (Para. 0042-0046 and 0053-0073); and wherein determining whether coordinates of the relative maximum value comprise a fixation position and orientation further comprise comparing the relative maximum value with a threshold and/or an average coordinate value of the histogram (Para. 0042-0046 and 0053-0073).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the logic device is further configured to determine the fixation position relative to an optical axis of the eye tracker by constructing and analyzing a histogram of detected eye positions and orientations; wherein analyzing the histogram further comprises determining whether coordinates of a relative maximum value comprise a fixation position and orientation; and wherein determining whether coordinates of the relative maximum value comprise a fixation position and orientation further comprise comparing the relative maximum value with a threshold and/or an average coordinate value of the histogram as taught by the system and method of S. in the system and method of Neal since S. teaches it is known to include these features in a system and method for the purpose of providing a simple, low cost and accurate system and method.
Regarding claims 8 and 19, Neal in view of S. discloses and teaches as set forth above, and S. further teaches, from the same field of endeavor that in a system and method that it would have been desirable to make the logic device is configured to track the eye position and orientation and calculate an offset from eye fixation parameters and determine if the offset is less than a threshold value (Para. 0042-0046 and 0053-0073); wherein when the offset is less than the threshold value the eye is determined to be fixated and the logic device generates an indication of fixation (Para. 0042-0046 and 0053-0073); and wherein when the offset is greater than the threshold value the eye is determined to be out of alignment and the control processor generates an indication of no fixation (Para. 0042-0046 and 0053-0073).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the system and method of S. in the system and method of Neal since S. teaches it is known to include these features in a system and method for the purpose of providing a simple, low cost and accurate system and method.
Regarding claim 17, Neal in view of S. discloses and teaches as set forth above, and S. further teaches, from the same field of endeavor that in a system and method that it would have been desirable to include detecting the fixation position relative to an optical axis of a device by constructing and analyzing a histogram of detected eye positions and orientations (Para. 0042-0046 and 0053-0073); wherein analyzing the histogram further comprises determining a relative maximum value (Para. 0042-0046 and 0053-0073).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the system and method of S. in the system and method of Neal since S. teaches it is known to include these features in a system and method for the purpose of providing a simple, low cost and accurate system and method.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Warden et al. (US 2005/0225725), Hacker et al. (US 2011/0261320) and Neal et al. (US 2011/0149239) disclose a system and method that includes an ophthalmic device configured to measure characteristics of an eye, an eye tracker and a logic device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWAYNE A PINKNEY whose telephone number is (571)270-1305. The examiner can normally be reached M-F 7:00-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached on 571-272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAWAYNE PINKNEY/Primary Examiner, Art Unit 2872 08/04/2026
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