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 .
Response to Amendment
The amendment filed March 20, 2025 has been entered. Claims 1-5, 7-8, 10, 12, 17, 21-25 and 28-31 remain pending in the application.
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 1-4, 8, 17, 21-22, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Thorpe (WO 2004084117) (previously cited) in view of Wood (U.S. Patent Pub. No. 20130128223) (previously cited), Townsley (U.S. 3598478) (previously cited).
Regarding claim 1, Thorpe teaches (Figures 1, 4) a device for measuring ocular microtremor (saccadic-motion) of a patient’s eye comprising a housing (17) containing; a light source (12) for illuminating a target area of the eye with a light beam; a detector (light sensor 16, 18) arranged to detect scattered light from the interaction of the light beam with the target area of the eye (Page 7, lines 4-7, 26-27); and a focusing lens (14) arranged to collect the scattered light for the detector. (Page 7, lines 26-27).
However, Thorpe does not teach “and a port in a wall of the housing, wherein the port is configured such that at least one of: the light beam can exit the device and the scattered light can enter the device; and one or more support portions configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilise and support the device on or against the patient's head; and wherein the device comprises a ball joint configured to permit the housing is to move relative to each of the one or more support portions for aligning the device to the target area of the eye, wherein the housing is pivotably coupled to each of the one or more support portions via the ball joint, and wherein the one or more support portions are removable from the housing.”
Wood, in a related field of endeavor, teaches (Figures 9-10) a digital device for measuring detecting maladies related to the eye, comprising a port in a wall (opening of eye cup) of the housing (Paragraph [0079]), wherein the port is configured such that at least one of: the light beam can exit the device and the scattered light can enter the device (Paragraph [0083]); and wherein one or more support portions (eye cup) are configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilize and/or support the device on or against a patient's head (Paragraphs [0019], [0113]), wherein the one or more support portions are removable from the housing (Paragraph [0113] a patient interface 2050 in the form of an eye cup is releasably attached to the distal end 2006 of the housing 2004).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “a port in a wall of the housing, wherein the port is configured such that at least one of: the light beam can exit the device and the scattered light can enter the device; and wherein one or more support portions are configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilize and/or support the device on or against a patient's head, wherein the one or more support portions are removable from the housing” of Wood. Doing so enables light to be aimed at and illuminate the target area of interest of the eye according to the dimensions of a patient’s face. (Paragraph [0083]).
Townsley, in a related field of endeavor, teaches an apparatus for determining the contour of the human cornea wherein the device comprises a ball joint (126, 128, 130, 132) configured to permit the housing (Col. 4, lines 31-33, tubular housing 82) to move relative to each of the one or more support portions (Col. 3, lines 38-40, eyepiece 100) for aligning the device to the target area of the eye, wherein the housing is pivotably coupled to each of the one or more support portions via the ball joint. (Abstract, adjusting housing means comprise double joint ball and socket means which permit the operator to make finite adjustments for accurate alignment while viewing the eye; a ball and socket joint inherently forms a pivotable connection).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “wherein the device comprises a ball joint configured to permit the housing is to move relative to each of the one or more support portions for aligning the device to the target area of the eye, wherein the housing is pivotably coupled to each of the one or more support portions via the ball joint” as taught by Townsley. Doing so enables the operator to make finite adjustments for accurate alignment while viewing the eye. (Abstract).
Regarding claim 2, Thorpe illustrates (Figure 1) wherein the focusing lens (14) is positioned a predefined position from the detector (light sensor 16) and the detector is positioned in a Fourier plane (focal plane) of the focusing lens.
Regarding claim 3, Thorpe as modified teaches of all of the elements of the claimed invention except “wherein the one or more support portions are configured to conform to the one or more locations on a patient's head or face”.
Wood teaches (Figure 10) an embodiment wherein the one or more support portions (eye cup) are configured, to conform to one or more locations on a patient's head or face. (Paragraphs [0019], [0113]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “wherein the one or more support portions are configured, to conform to one or more locations on a patient's head or face” of Wood. Doing so allows the device to be adapted for contacting a region of a patient's face surrounding an eye of the patient according to the dimensions of a patient’s face. (Paragraph [0019]).
Regarding claim 4, Thorpe as modified teaches of all of the elements of the claimed invention except “wherein the one or more support portions are configured, in use, to position the port at a predetermined distance from said eye during a measurement and within a predetermined volume of space with respect to said eye”.
Wood teaches (Figures 10-11) wherein the one or more support portions (eye cup) are configured, in use, to position the port at a predetermined distance from said eye during a measurement and, within a predetermined volume of space with respect to said eye. (Paragraphs [0013], [0019]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “wherein the one or more support portions are configured, in use, to position the port at a predetermined distance from said eye during a measurement and, within a predetermined volume of space with respect to said eye” of Wood. Doing so enables a preselected area of the person's retina to be visible to the imaging system. (Paragraph [0013]).
Regarding claim 8, Thorpe as modified teaches of all of the elements of the claimed invention except “wherein each of the one or more support portions comprises an interface portion at a distal end of each of the one or more support portions, and wherein each of the one or more support portions or the interface portion is ergonomically shaped to conform to the one or more locations on a patient's head or face”.
Wood teaches (Figures 9-10) wherein each support portion comprises an interface portion (1020) at a distal end of each support portion (eye cup); and, wherein each support portion or the interface portion is ergonomically shaped to conform to one or more locations on a patient's head or face. (Paragraphs [0019], [0113]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “wherein each support portion comprises an interface portion at a distal end of each support portion; and, wherein each support portion or the interface portion is ergonomically shaped to conform to one or more locations on a patient's head or face” of Wood. Doing so allows the device to be adapted for contacting a region surrounding an eye of the patient. (Paragraph [0019]).
Regarding claim 17, Thorpe teaches wherein the device is a handheld device. (Page 4, lines 10-15).
Regarding claim 21, Thorpe teaches (Figure 1) an illumination optical path by which the light beam reaches the port from the light source (12), and a detection optical path by which the scattered light reaches the detector (16, 18). (Page 7, lines 4-7, 26-27).
Regarding claim 22, Thorpe as modified teaches of all of the elements of the claimed invention except “a beam splitter arranged in at least one of the illumination optical path to direct the light beam towards the port and in the detection optical path to direct the scattered light to the detector”.
Wood teaches (Figure 1A) a beam splitter (41) arranged in at least one of the illumination optical path to direct the light beam towards the port and in the detection optical path to direct the scattered light to the detector. (Paragraphs [0093]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “a beam splitter arranged in at least one of the illumination optical path to direct the light beam towards the port and in the detection optical path to direct the scattered light to the detector” of Wood. Doing so directs a portion of the illuminating light as reflected from the target of interest to a second viewing location. (Paragraph [0009]).
Regarding claim 32, Thorpe teaches (Figures 1, 4) a device for measuring ocular microtremor (saccadic-motion) of a patient’s eye a housing (17) containing; a light source (12) for illuminating a target area of the eye with a light beam; a detector (light sensor 16, 18) arranged to detect scattered light from the interaction of the light beam with the target area of the eye (Page 7, lines 4-7, 26-27); and a focusing lens (14) arranged to collect the scattered light for the detector. (Page 7, lines 26-27).
However, Thorpe does not teach “and a port in a wall of the housing, wherein the port is configured such that at least one of: the light beam can exit the device and the scattered light can enter the device; and one or more support portions configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilise and support the device on or against the patient's head; and wherein the device comprises a ball joint configured to permit the housing is to move relative to each of the one or more support portions for aligning the device to the target area of the eye, wherein the housing is pivotably coupled to each of the one or more support portions via the ball joint.”
Wood, in a related field of endeavor, teaches (Figures 9-10) a digital device for measuring detecting maladies related to the eye, comprising a port in a wall (opening of eye cup) of the housing (Paragraph [0079]), wherein the port is configured such that at least one of: the light beam can exit the device and the scattered light can enter the device (Paragraph [0083]); and wherein one or more support portions (eye cup) are configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilize and/or support the device on or against a patient's head (Paragraphs [0019], [0113]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “a port in a wall of the housing, wherein the port is configured such that at least one of: the light beam can exit the device and the scattered light can enter the device; and wherein one or more support portions are configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilize and/or support the device on or against a patient's head” of Wood. Doing so enables light to be aimed at and illuminate the target area of interest of the eye according to the dimensions of a patient’s face. (Paragraph [0083]).
Townsley teaches a ball joint (126, 128, 130, 132) configured to permit the housing (Col. 4, lines 31-33, tubular housing 82) is to move relative to each of the one or more support portions (Col. 2, lines 42-46, target structure which consists of opening 36, shells 38, 40) for aligning the device to the target area of the eye, (Col. 3, lines 41-47 the ball 130 is internally threaded and the rod 124 is externally threaded to enable movement of the target structure for the distance permitted by the slot 140. The rod 124 is fixed in position relative to the ball 126 by means of clips 147 and the target structure moves with the rod due to the connection between the socket 128 and extension 149 of the target), wherein the housing is pivotably coupled to each of the one or more support portions via the ball joint. (Abstract, adjusting housing means comprise double joint ball and socket means which permit the operator to make finite adjustments for accurate alignment while viewing the eye; a ball and socket joint inherently forms a pivotable connection).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “wherein the device comprises a ball joint configured to permit the housing is to move relative to each of the one or more support portions for aligning the device to the target area of the eye, wherein the housing is pivotably coupled to each of the one or more support portions via the ball joint,” as taught by Townsley. Doing so enables the operator to make finite adjustments for accurate alignment while viewing the eye. (Abstract).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Thorpe in view of Wood and Townsley, further in view of Fink (WO 2016179370) (previously cited).
Regarding claim 5, Thorpe as modified teaches of all of the elements of the claimed invention except “wherein a position of the light source, the detector and the focusing lens relative to each of the one or more support portions is adjustable”.
Fink teaches a handheld ophthalmological examination device (Figure 6A) wherein the position of the light source, the detector and the focusing lens relative to each of the one or more support portion is adjustable. (Paragraph [0062] a hinged arm-mount can be used to allow for adjustment of the light source position, and thus illumination of the eye. The arm-mount can be located in the horizontal plane of the top face of the casing, to allow the light source to swing forward and to turn inwards to illuminate the eye. In some implementations, arm-mount segments can be length adjustable. Note that the entire smartphone/light source assembly can be rotated and/or translocated by the user with respect to the eye).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe as modified to provide “wherein the position of the light source, the detector and the focusing lens relative to each support portion is adjustable” of Fink. Doing so enables the device to image the eye from different positions or angles.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Thorpe in view of Wood and Townsley, further in view of Dal Santo (U.S. 6022109) (previously cited).
Regarding claim 7, Thorpe as modified teaches of all of the elements of the claimed invention except “wherein the housing is additionally slidably coupled to each support portion, and wherein the device is configured to move the housing in one or more directions in response to an operator input”.
Dal Santo, in a related field of endeavor, teaches (Figures 1 and 5) a handheld pupilometer (10) wherein the housing (12) is additionally slidably coupled to each support portion (eye cups 15A and 15B), and wherein the device is configured to move the housing in one or more directions in response to an operator input (Figure 5; Col. 5, lines 43-63 in the embodiment shown, the eyecups are connected to eyepieces 18A and 18B at spaced eyepiece locations. The eyepieces are held in openings in the back of the housing 12 with threaded nuts 19, and the eyecups are secured to the eyepieces with threaded nuts 21, washers 23 being disposed between the nut and a forward flange of each eyecup to enable tightening of the nuts 21 against the rubber flanges. In this instance, the spacing between the eyepieces may be adjusted by manually sliding eyepiece 18B along slot 25 (FIG. 5) in the back of the housing, a spring-type washer 27 imparting spring-load induced friction against the housing wall surrounding the slot 25 for maintaining the eyepiece in position during normal handling vibrations, but which may be manually overcome for sliding adjustment of the eyepiece 18B. It will be apparent that the two eye-cups 15A, 15B may be of other configurations such as merged into a single goggle-type rubber eyecup shaped to generally surround both eyes at said eyepiece locations and assist in positioning of the pupilometer; and/or the eyecup(s) may be connected other than as shown such as directly to the back of the housing 12.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “wherein the housing is additionally slidably coupled to each support portion, and wherein the device is configured to move the housing in one or more directions in response to an operator input” of Dal Santo. Doing so enables the device to adjustment of the eyepiece to a desired position. (Col. 5, lines 62-64).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Thorpe in view of Wood and Townsley, further in view of Bhatt (WO 2016151368) (previously cited).
Regarding claim 10, Thorpe as modified does not teach “wherein, the detector is arranged and configured, in use, to image an interference pattern in the Fourier plane of the focusing lens formed from the scattered light.”
Bhatt in a related field of endeavor, teaches (Figure 1A) an apparatus for imaging of the eye wherein the detector (145) is arranged and configured, in use, to image an interference pattern in the Fourier plane of the focusing lens (127) formed from the scattered light. (Page 4, lines 3-14; Page 6, lines 15-25).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe as modified by Wood and Fink to provide “wherein, the detector is arranged and configured, in use, to image an interference pattern in the Fourier plane of the focusing lens formed from the scattered light” of Bhatt. Doing so provides a mechanism that enables multi-mode imaging of the eye. (Page 3, lines 3-14).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Thorpe in view of Wood and Townsley, further in view of Bolger (WO 0243613) (previously cited).
Regarding claim 12, Thorpe teaches (Figures 1, 4) an apparatus for monitoring eye tremors configured to determine one or more ocular microtremor properties (saccadic-motion) of said eye based on an output signal of the detector (light sensor 16, 18). (Page 10, lines 22-27).
However, Thorpe does not teach “wherein the one or more ocular microtremor properties include at least one of a microtremor frequency and a micro tremor amplitude”.
Bolger, in a related field of endeavor, teaches an apparatus for monitoring eye tremors wherein the one or more ocular microtremor properties include at least one of a microtremor frequency and a micro tremor amplitude. (Page 12, lines 3-7).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe as modified by Wood and Fink to provide “wherein the one or more ocular microtremor properties include at least one of a microtremor frequency and a micro tremor amplitude” of Bolger. Doing so provides data indicative of a patient's level of consciousness for proper administration of anesthetics, which reduces the risk of over or under dosage. (Page 6, line 26-29; Page 7, line 1; Page 8).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Thorpe in view of Wood and Slawson, further in view of Sternal (U.S. 20140063450) (previously cited).
Regarding claim 23, Thorpe as modified does not teach “a mirror arranged in the illumination optical path to direct the light beam towards the port, wherein a position and/or orientation of the mirror is adjustable.”
Wood teaches (Figure 1A) a mirror (34) arranged in the illumination optical path to direct the light beam towards the port, but does not teach wherein the position and/or orientation of the mirror is adjustable.
Sternal, in a related field of endeavor, teaches (Figure 2B) an imaging apparatus wherein the position and/or orientation of the mirror (132-4) is adjustable. (Paragraph [0035]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “a mirror arranged in the illumination optical path to direct the light beam towards the port” of Wood “wherein the position and/or orientation of the mirror is adjustable” of Sternal. Doing so allows the optical path length of the reference light to be adjusted to the optical path length of the measuring light that varies depending on the eye to be inspected. (Paragraph [0035] of Sternal).
Claims 24-25 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Thorpe in view of Wood and Townsley, further in view of Kempinski (U.S. Patent Pub. No. 20160132726) (previously cited) and Everett (U.S. 20060228011) (previously cited).
Regarding claim 24, Thorpe as modified teaches of all of the elements of the claimed invention except “wherein the processor is configured to: receive an output signal from the detector, the output signal comprising a stream of image data comprising a series of image frames captured over a period of time at a frame rate; reject or delete one or more image frames from the series of image frames in the image data having one or more image frame quality metrics falling outside one or more predefined threshold values; and determine an OMT signal from a remaining stream of the image data representative of eye movement over time; wherein the one or more image frame quality metrics include at least one of a total integrated signal across a respective image frame, a height and a width of an auto correlation peak obtained from the respective image frame”.
Kempinski teaches wherein the processor (112) is configured to: receive an output signal from the detector (camera 104), the output signal comprising a stream of image data comprising a series of image frames captured over a period of time at a frame rate (Paragraph [0028]-[0029]); reject or delete one or more image frames from the series of image frames in the image data having one or more image frame quality metrics falling outside one or more predefined threshold values, (Paragraph [0062] if the movement vector is larger than a predefined threshold, the summing may be performed again for example by: remove or discount large movements from the movement vector since they may be noise movements); and determine an OMT signal from a remaining stream of the image data representative of eye movement over time (Paragraphs [0060]. [0063]-[0064] eye movement patterns, e.g., microsaccade, saccade, are determined from predefined image data).
However, Kempinski does not teach “wherein the one or more image frame quality metrics include at least one of a total integrated signal across a respective image frame, a height and a width of an auto correlation peak obtained from the respective image frame.”
Everett, in a related field of endeavor, a line scan imager to determine motion of a subject, which can be applied to track the human eye to facilitate measurement, imaging, or treatment with a beam of optical radiation. (Abstract).
Everett teaches wherein the one or more image frame quality metrics include a total integrated signal across a respective image frame (Paragraph [0043] from the velocity estimate given by this median, one can integrate to form position estimates for the first frame, and correct the data stream D(t) for the effects of motion during the first frame.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “wherein the one or more image frame quality metrics include at least one of a total integrated signal across a respective image frame, a height and a width of an auto correlation peak obtained from the respective image frame” of Everett. Doing so provides a position-corrected image data from all N frames, which can be combined to form a reference frame free from motion artifacts. (Paragraph [0043]).
Regarding claim 25, Thorpe teaches of all of the elements of the claimed invention except “wherein the processor is configured to: receive an output signal from the detector, the output signal comprising a stream of image data comprising a series of image frames captured over a period of time at a frame rate; reject or delete pairs of image frames from the series of image frames in the image data having one or more inter-frame correlation quality metrics falling outside one or more predefined threshold values; and determine an OMT signal from a remaining stream of the image data representative of eye movement over time, wherein the one or more inter-frame correlation quality metrics include one or more signal-to-noise parameters extracted from a cross-correlation of a respective pair of image frames”.
Kempinski teaches wherein the processor (112) is configured to: receive an output signal from the detector (camera 104), the output signal comprising a stream of image data comprising a series of image frames captured over a period of time at a frame rate (Paragraph [0028]-[0029]); and reject or delete image frames from the series of image frames in the image data having one or more image frame quality metrics falling outside one or more predefined threshold values, (Paragraph [0062] if the movement vector is larger than a predefined threshold, the summing may be performed again for example by: remove or discount large movements from the movement vector since they may be noise movements); and determine an OMT signal from a remaining stream of the image data representative of eye movement over time (Paragraphs [0060]. [0063]-[0064] eye movement patterns, e.g., microsaccade, saccade, are determined from predefined image data).
However, Kempinski does not teach “wherein the one or more inter-frame correlation quality metrics include one or more signal-to-noise parameters extracted from a cross-correlation of a respective pair of image frames.”
Everett teaches wherein the one or more inter-frame correlation quality metrics include one or more signal-to-noise parameters extracted from a cross-correlation of a respective pair of image frames (Abstract, a line scan imager is used to determine the motion of a subject. Each line of image data from the line scan imager is compared with a reference image; Paragraphs [0037]-[0038] one can cross-correlate each line with local lines within the same frame. Cross-correlation of neighboring lines gives mainly information on motion along the length of these lines. Due to the pattern noise in typical line-scan cameras and the general uncertainty in the estimate of motion, this information can then provide an ‘inter-frame correlation quality metric’ that includes a signal-to-noise parameter from a cross-correlation of the image frames).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “wherein the one or more inter-frame correlation quality metrics include one or more signal-to-noise parameters extracted from a cross-correlation of a respective pair of image frames” of Everett. Doing so provides position information and uncertainty estimates that can be monitored to indicate to the operator the current quality of the tracking data, and the current state of the subject, such as indicating when the patient may be beginning to tire. (Paragraph [0041]).
Regarding claim 31, Thorpe teaches of all of the elements of the claimed invention except “a processor configured to: receive an output signal from the detector, the output signal comprising a stream of image data comprising a series of image frames captured over a period of time at a frame rate, reject or delete one or more image frames from the series of image frames in the image data having an inter-frame velocity exceeding a predefined threshold value, and determine an OMT signal from a remaining stream of the image data representative of eye movement over time, wherein the inter-frame velocity is based on a change in cross-correlation peak position between successive pairs of cross-correlated image frames.”
Kempinski, in a related field of endeavor, teaches a processor (112) configured to: receive an output signal from the detector (camera 104), (Paragraph [0025]), the output signal comprising a stream of image data comprising a series of image frames captured over a period of time at a frame rate, (Paragraph [0028]-[0029]), reject or delete one or more image frames from the series of image frames in the image data having an inter-frame velocity exceeding a predefined threshold value, (Paragraph [0062] if the movement vector is larger than a predefined threshold, the summing may be performed again for example by: remove or discount large movements from the movement vector since they may be noise movements), and determine an OMT signal from a remaining stream of the image data representative of eye movement over time, (Paragraphs [0060]. [0063]-[0064] eye movement patterns, e.g., microsaccade, saccade, are determined from predefined image data),
Everett teaches wherein the inter-frame velocity is based on a change in cross-correlation peak position between successive pairs of cross-correlated image frames (Paragraph [0043] tracking method makes use of reference frames to form a stream of estimates of displacement D(t). For example, the first time derivative of D(t) yields a velocity V(t) that will have peaks corresponding to each saccade of the eye. If one plots the estimated velocity V(t) as a function of position on the eye, then the resulting N-1 plots will show common features due to motion during the first frame; Fig. 2, Paragraph [0029] the comparisons of the reference frame 200 can be done using a cross-correlation, forming a cross-correlation function C(d) where the vector d represents the shift).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “wherein the inter-frame velocity is based on a change in cross-correlation peak position between successive pairs of cross-correlated image frames” of Everett. Doing so provides a measure of the likelihood of actual eye shift. (Paragraph [0039]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Thorpe in view of Wood and Townsley, further in view of Zhao (U.S. Patent Pub. No. 20150042955) (previously cited).
Regarding claim 28, Thorpe as modified does not teach “a first sub-system comprising the detector and the focusing lens, the first sub-system configured to provide a first signal representing angular movements or displacements of said eye relative to the device based on an output signal of the detector; and a second sub-system comprising a second detector arranged to detect scattered light from the interaction of the light beam with a reference target at or on the patient's head and a second focusing lens arranged to collect the scattered light for the second detector, the second sub- system configured to provide a second signal representing angular movements or displacements of said head relative to the device based on an output signal of the second detector, and wherein the device is configured to provide an OMT signal representing angular movements or displacements of said eye relative to said head based on the first and second signals.”
Zhao, in a related field of endeavor, teaches (Figure 5) a first sub-system comprising the detector (504) and the focusing lens (510), the first sub-system configured to provide a first signal representing angular movements or displacements of said eye relative to the device based on an output signal of the detector; (Paragraphs [0040]-[0041]); and a second sub-system comprising a second detector (506) arranged to detect scattered light from the interaction of the light beam with a reference target at or on the patient's head and a second focusing lens (520) arranged to collect the scattered light for the second detector, the second sub- system configured to provide a second signal representing angular movements or displacements of said head relative to the device based on an output signal of the second detector, and wherein the device is configured to provide an OMT signal representing angular movements or displacements of said eye relative to said head based on the first and second signals (Figure 6; Paragraph [0044] the first data and second data used to determine a measure of ocular scattering).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe as modified by Wood and Fink to provide “a first sub-system comprising the detector and the focusing lens, the first sub-system configured to provide a first signal representing angular movements or displacements of said eye relative to the device based on an output signal of the detector; and a second sub-system comprising a second detector arranged to detect scattered light from the interaction of the light beam with a reference target at or on the patient's head and a second focusing lens arranged to collect the scattered light for the second detector, the second sub- system configured to provide a second signal representing angular movements or displacements of said head relative to the device based on an output signal of the second detector, and wherein the device is configured to provide an OMT signal representing angular movements or displacements of said eye relative to said head based on the first and second signals” of Zhao. Doing so provides a stable basis for measuring the scattering, and thus provides an objective measurement indicative of ocular scattering. (Paragraph [0044]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Thorpe in view of Wood, Townsley, and Kempinski.
Regarding claim 29, Thorpe, as previously discussed, teaches (Figures 1, 4) an apparatus that teaches a method for monitoring eye tremors (saccadic-motion), comprising a housing (17) containing a light source (12) for illuminating a target area of the eye with a light beam; a detector (light sensor 16) arranged to detect scattered light from the interaction of the light beam with the target area of the eye (Page 7, lines 4-7); a focusing lens (14) arranged to collect the scattered light for the detector (Page 7, lines 26-27); and detecting scattered light from the interaction of the light beam with the target area of the eye. (Page 7, lines 26-27).
However, Thorpe does not teach “a port in a wall of the housing, through which the light beam can exit the device and/or through which the scattered light can enter the device, and one or more support portions configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilise and support the device on or against a patient's head, wherein the housing is pivotally coupled to each of the one or more support portions; supporting or stabilising the device on or against the patient's head; and aligning the device to a target area of the eye” and “determining one or more microtremor properties of the eye based on an output signal of the detector.”
Wood, as previously discussed, teaches (Figures 9-10) a digital device for measuring detecting maladies related to the eye, comprising a port in a wall (opening of eye cup) of the housing (Paragraph [0079]), through which the light beam can exit the device and/or through which the scattered light can enter the device and one or more support portions (eye cup) configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilise and support the device on or against a patient's head; wherein the one or more support portions are removable from the housing (Paragraph [0113] a patient interface 2050 in the form of an eye cup is releasably attached to the distal end 2006 of the housing 2004); supporting or stabilising the device on or against the patient's head (Paragraphs [0019], [0113]); and aligning the device to a target area of the eye. (Paragraph [0081]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “a port in a wall of the housing, through which the light beam can exit the device and/or through which the scattered light can enter the device and one or more support portions configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilise and support the device on or against a patient's head; wherein the one or more support portions are removable from the housing; supporting or stabilising the device on or against the patient's head; and aligning the device to a target area of the eye” of Wood. Doing so enables light to be aimed at and illuminate the target area of interest of the eye according to the dimensions of a patient’s face. (Paragraph [0083]).
Townsley, in a related field of endeavor, teaches an apparatus for determining the contour of the human cornea wherein the device comprises a ball joint (126, 128, 130, 132) configured to permit the housing (Col. 4, lines 31-33, tubular housing 82) to be pivotably coupled to each of the one or more support portions (Col. 3, lines 38-40, eyepiece 100; Abstract, adjusting housing means comprise double joint ball and socket means which permit the operator to make finite adjustments for accurate alignment while viewing the eye; a ball and socket joint inherently forms a pivotable connection).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide “wherein the device comprises a ball joint configured to permit the housing is to move relative to each of the one or more support portions” as taught by Townsley. Doing so enables the operator to make finite adjustments for accurate alignment while viewing the eye. (Abstract).
Kempinski, as previously discussed, teaches determining one or more microtremor properties of the eye based on an output signal of the detector (Paragraphs [0060]. [0063]-[0064] eye movement patterns, e.g., microsaccade, saccade, are determined from predefined image data).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide the steps of “determining one or more microtremor properties of the eye based on an output signal of the detector” of Kempinski. Doing so provides the ability to determine if the detected eye movement between the first frame and the second frame corresponds to either an actual movement of the eye, or to falsely detected, irrelevant movements, noise or other non-reliable detections of movements.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Thorpe in view of Wood, Townsley, and Kempinksi, further in view of Fink.
Regarding claim 30, Thorpe does not teach “placing the one or more support portions in contact with the one or more locations on the patient's head or face; and adjusting a position of the light source, detector and focusing lens to align the device to the target area of the eye.”
Wood teaches placing the one or more support portions (eye cup) in contact with one or more locations on a patient's head or face. (Paragraph [0019]).
However, Wood does not teach “adjusting a position of the light source, detector and focusing lens to align the device to the target area of the eye.”
Fink, in a related field of endeavor, teaches (Figure 6A) a handheld ophthalmological examination device wherein the position of the light source, the detector and the focusing lens relative to each support portion is adjustable and that the housing is moveable relative to each support portion for aligning the device to the target area of the eye. (Paragraph [0043]). Hence, Fink teaches the step of adjusting the position of the light source, detector and focusing lens to align the device to the target area of the eye.
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Thorpe to provide the step of “placing the one or more support portions in contact with one or more locations on a patient's head or face” of Wood and the step of “adjusting the position of the light source, detector and focusing lens to align the device to the target area of the eye” of Fink. Doing so enables alignment of the device according to the dimensions of a patient’s face.
Response to Arguments
Applicant’s arguments, see Remarks, filed 3/20/2025, with respect to the rejections of claim(s) 1-5, 7-8, 10, 12, 17, 21-25 and 28-31 under U.S.C. 103 have been fully considered and acknowledged.
Applicant argues that Townsley does not disclose “one or more support portions configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilise and
support the device on or against the patient's head; and a ball joint configured to permit the housing to move relative to each of the one or more support portions for aligning the device to the target area of the eye, wherein the housing is pivotably coupled to each of the one or more support
portions via the ball joint.”
As discussed in the rejection, and contrary to Applicant’s argument above, Wood discloses wherein one or more support portions (eye cup) are configured, in use, to be placed in contact with one or more locations on a patient's head or face to stabilize and/or support the device on or against a patient's head (Paragraphs [0019], [0113]), wherein the one or more support portions are removable from the housing (Paragraph [0113] a patient interface 2050 in the form of an eye cup is releasably attached to the distal end 2006 of the housing 2004).
Applicant further argues that the eyepiece 100 in Townsley is for the operator of the device, rather than for the patient and therefore cannot be considered as a supporting portion. While this may be persuasive, Applicant’s assertion that the supporting portion in Townsley is the head rest arrangement including the chin rest bar 14 and supporting cylinder 28, is not persuasive. Instead, the support portions include the target structure which consists of opening 36, and shells 38, 40 (Fig. 1; Col. 2, lines 42-46) for aligning the device to the target area of the eye (Col. 3, lines 41-47 the ball 130 is internally threaded and the rod 124 is externally threaded to enable movement of the target structure for the distance permitted by the slot 140. The rod 124 is fixed in position relative to the ball 126 by means of clips 147 and the target structure moves with the rod due to the connection between the socket 128 and extension 149 of the target), wherein the housing is pivotably coupled to each of the one or more support portions via the ball joint. (See Abstract, the target structure comprises a pair of hollow plastic shells; the shells are mounted at one end of an adjustable housing; the adjusting means comprise double joint ball and socket means which permit the operator to make finite adjustments for accurate alignment while viewing the eye.)
Conclusion
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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791