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 .
Status of Claims
Claims 1-3, 5, 9-14, and 22-26 are pending in this application. Claims 22-26 are withdrawn, Claims 4 and 6-8 are cancelled, and Claims 1-3, 5, and 9-14 have been examined on the merits.
Election/Restrictions
Claims 22-26 are withdrawn from consideration because Invention I was constructively elected by original presentation for prosecution on the merits, accordingly withdrawing Claims 22-26 as being directed to a non-elected invention (37 CFR 1.142(b) and MPEP § 821.03). An Interview was held with David Le on 06/02/2026 to confirm the withdrawal of claims (see attached interview summary).
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 (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 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, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Auerbach (US20170367625A1) in view of Ryle (“Simultaneous drift, microsaccades, and ocular microtremor measurement from a single noncontact far-field optical sensor”, 2015, Journal of Biomedical Optics, Vol 2 Issue 2) and in further view of Brown (US20140323897A1).
Regarding Claim 1,
Auerbach teaches a system comprising: an image capture device (corresponding disclosure in at least [0026], where there is an image capture device (camera) “an imaging device, which can be for example a CMOS video camera, a 3D camera, a thermal imager, a light field camera or a depth camera”);
a patch configured to be placed in an eye region of a patient and comprising a visible pattern;
a light emitting diode (LED) carried by the patch configured to be disposed in an eye region (corresponding disclosure in at least [0047], where there is a marker that can be disposed in the eye region “A marker can be adhered to the eyelid, such as a thin retro-reflective adhesive sticker or else IR reflective polish can be applied to eyelids or eyelashes” and further in [0087], where the marker can be an LED “The markers can be for example patches made from retro-reflective material, geometric patterns on the blanket or nightgown, or low voltage LED lights embedded or attached to clothing or patches”),
wherein the image capture device is configured to view the LED at a view-angle (corresponding disclosure in at least [0146], where the camera is positioned at an angle to view the LED “The video sensor continuously tracks the markers that are positioned on the subject. The field of view should be set to include the markers from a perspective that most pronouncedly reveals the breathing movement”)
and processing circuitry (corresponding disclosure in at least [0025], where there is processing circuitry “power supply elements and circuitry for operating the signal generating elements”) configured to:
receive, from the image capture device, an image signal comprising a sequence of images of the eye region of the patient; (corresponding disclosure in at least [0096], where the camera captures a sequence of images “The following relates to the detection and tracking of the markers using 2D video images… Detection on the intensity image (or sequence of images) can proceed in the following steps”);
and generate a motion signal from motion of the visible pattern in the image signal (corresponding disclosure in at least [0104], where the motion from the markers with patterns are tracked for the signal) “The tracking of the markers can proceed by calculating the optical flow patterns in order to identify the local motion within the image”),
and determine a depth of anesthesia based on the motion signal motion (corresponding disclosure in at least [0109]-[0110], where the patient’s motion (i.e. eye movement) is tracked, which determines the depth of anesthesia (subject’s awakening is quantified) “the tracking can be used as a filter as follows: the single frame detection method may be set to produce an abundance of objects some of which are not actual markers on the subject's body... Movement of non-marker features can also be tracked. For example, using IR illumination, the subject eyes are visible and can be tracked in a similar manner as an artificial marker. In this way, subject's awakenings [from anesthesia] can be quantified through measurement and recording of the times the subject's eyes are open”).
Auerbach does not teach that is offset from an angle of far-field intensity maximum of the LED and based on the determined depth of anesthesia, determining a depth of anesthesia index score.
Ryle, in a similar field of endeavor, teaches a similar concept (OMT measurements), of wherein the image capture device is offset from an angle of far-field intensity maximum of the LED (corresponding disclosure in at least [pg. 11, “4.2 “Light Sources and Far-Field Correlation: Image Interpolation”], where a far-field angle was used to capture an LED source “a number of light sources were tested to illuminate a portion of the sclera in attempts to measure OMT using the far-field sensor”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated where the image capture device is offset from an angle of far field intensity as taught by Ryle. One of the ordinary skill in the art would have been motivated to incorporate this because angling the capturing device and positioning as far from the flash/target ensures that the light does not reflect back, which minimizes possible glare and distortion in images.
Auerbach and Ryle do not teach determining a depth of anesthesia index score.
Brown, in a similar field of endeavor, teaches a similar concept (monitoring depth of anesthesia) of determining a depth of anesthesia index score (corresponding disclosure in at least [0091], where a motion signal (the harmonic components) are determined and based on such characterization, a score (index between 0 and 100) is determined “The harmonic components might also be used as an input for later processing for a characterization of overall level of anesthesia, summarized by a single scaled number (e.g., an index between 0 and 100)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated determining a depth of anesthesia based on a signal and determining a depth of anesthesia index score as taught by Brown. One of the ordinary skill in the art would have been motivated to incorporate this because the scaling of numbers provides a grading or scale to objectively measure the level of consciousness during anesthesia.
Regarding Claim 2, the combined references teach the limitations of Claim 1, and Auerbach further teaches wherein the processing circuitry is further configured to:
filter the motion signal (corresponding disclosure in at least [0109], where
the motions are filtered “Once they are tracked, criteria for filtering them can be used based on characteristics of their movement. For example, markers that remain static for a long time even when subject makes some position change can be filtered. Furthermore, if one is concerned with tracking only breathing motion, non-static markers with a different frequency of motion (or uncorrelated motion) than the identified breathing markers are filtered”);
determine a depth of anesthesia based on the determined motion (corresponding disclosure in at least [0109]-[0110], where the patient’s motion (i.e. eye movement) is tracked, which determines the depth of anesthesia (subject’s awakening is quantified) “the tracking can be used as a filter as follows: the single frame detection method may be set to produce an abundance of objects some of which are not actual markers on the subject's body... Movement of non-marker features can also be tracked. For example, using IR illumination, the subject eyes are visible and can be tracked in a similar manner as an artificial marker. In this way, subject's awakenings [from anesthesia] can be quantified through measurement and recording of the times the subject's eyes are open.”).
Regarding Claim 3, the combined references of Auerbach and Greivenkamp teach the limitations of Claim 1, and Auerbach further teaches wherein the processing circuitry is further configured to: determine a region of interest including the feature (corresponding disclosure in at least [0096], where there is a region of interest (marked pixels) “only pixels which surpass this value by a set number of standard deviations are marked. The standard deviation is calculated from the image histogram”);
sum the pixels of the region of interest along a direction in each of the images of the sequence of images to obtain a one-dimensional sum signal (corresponding disclosure in at least [0096], where the pixels are summed (clustered) “The marked pixels are clustered to connected components using chain clustering for example. Two pixels belong to the same cluster if there is a path of marked pixels that connect them, each within distance d of each other”)
determine a difference between the values of the summed pixels at two points along the one-dimensional sum signal for each of the images of the sequence of images (corresponding disclosure in at least [0101], where the displacement (difference) between the marker pixels are determined “Successful tracking means that the positions of all the detected markers were determined in each frame, that the frame to frame displacement of each marker does not surpass a predefined threshold and that this displacement is consistent across the marker pixels. The threshold is set using the maximal expected speed of the breathing motion. It can be later adjusted per patient during the baseline setting per patient described below”); and
determine the motion signal based on the determined differences for each of the images of the sequence of images (corresponding disclosure in at least [0101], where the motion is determined “. The threshold is set using the maximal expected speed of the breathing motion. It can be later adjusted per patient during the baseline setting per patient described below”).
Regarding Claim 5, the combined references teach the limitations of Claim 1, and Auerbach further teaches wherein the visible pattern disposed in the eye region is disposed on the patch comprising an adhesive to be attached to a person's eyelid (corresponding disclosure in at least [0087], where the pattern is on a patch “Markers are applied either directly to the subject's body or integrated to a covering of the subject such as his clothing, his blanket, an elastic strap, or a bandage for example. The markers can be for example patches made from retro-reflective material, geometric patterns on the blanket or nightgown, or low voltage LED lights embedded or attached to clothing or patches”
Regarding Claim 9, the combined references teach the limitations of Claim 1, and Auerbach further teaches a power source electrically coupled to the LED (corresponding disclosure in at least [0131], where the LED has a power source (some method of power as there needs to be a way to limit the power consumptions of the light) “in order to limit power consumption the extra LEDs are turned off during regular monitoring or flash in some time dependent way to reduce power consumption” and further in [0170] “Electrical contact can be provided from the power supply located in disposable part 602, through buttons 608 and 608′, although of course many alternative ways exist of conveying power from the batteries to the LED assembly 601”).
Regarding Claim 10, the combined references teach the limitations of Claim 1, and Auerbach further teaches wherein the LED is placed within a transparent area in a patch (corresponding disclosure in at least [0171], where the LED is placed on a transparent material “Of course, the top portion 612 of LED assembly 601 is made of material of a transparency sufficient to allow the required amount of light generated by the LED to be viewed from the outside”).
Regarding Claim 11, the combined references teach the limitations of Claim 1, and Auerbach further teaches wherein the processing circuitry is further configured to track the feature and to cause the image capture device to keep the feature within the field of view of the image capture device (corresponding disclosure in at least [0047], where the device will maintain a proper field of view to keep the feature in view “The choice of camera sensor should be made accordingly and also the placement should be closer to narrow the field of view. One possibility is to attach the camera to an eyeglass frame rather than to the bed”).
Regarding Claim 12, the combined references teach the limitations of Claim 1, and Auerbach further teaches wherein the visible pattern comprises a high contrast object added to the eye region (corresponding disclosure in at least [0047], where there is a high contrast object (the thin retro-reflective adhesive or the reflective polish, which is a contrasting object that can easily be detected “A marker can be adhered to the eyelid, such as a thin retro-reflective adhesive sticker or else IR reflective polish can be applied to eyelids or eyelashes”).
Regarding Claim 13, the combined references teach the limitations of Claim 1, and Auerbach further teaches wherein the visible pattern is located in a plurality of regions of interest within each image of the sequence of images (corresponding disclosure in at least [0101], where the frames (sequence of images) track the feature (the clusters), which is the region of interest “Once the clusters in a frame are detected, they are tracked over the following frames (as described below). If the tracking was not successful for all the detected markers, the detection is reinitialized on the new current frame”).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Auerbach (US20170367625A1), Ryle (“Simultaneous drift, microsaccades, and ocular microtremor measurement from a single noncontact far-field optical sensor”, 2015, Journal of Biomedical Optics, Vol 2 Issue 2) and Brown (US20140323897A1) as applied in Claim 1 and in further view of Lesmy (WO2010045724A1)
Regarding Claim 14, the combined references teach the limitations of Claim 1, and Auerbach further teaches the processing circuitry and the motion signals from a plurality of regions of interest (corresponding disclosure in at least), but does not teach generating a composite signal.
Lesmy, in a similar field of endeavor, teaches generating a composite signal (corresponding disclosure in at least [0086], where composite signals focused around a region of interest is generated “The extracted rhythmic signal and spikes are shown in Figure 7B, as well as their recombination to form a noise-reduced composite signal containing the restored action potentials”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated generating a composite signal as taught by Lesmy. One of the ordinary skill in the art would have been motivated to incorporate this because it incorporates the multiple types of information into a single signal for further image analysis.
Response to Arguments
Applicant’s arguments regarding the Claim objections filed 04/10/2026 have been considered and the objections are withdrawn in light of the amendments.
Applicant’s arguments regarding the rejection under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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