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
As required by M.P.E.P. 609, the applicant’s submissions of the Information Disclosure Statement dated 10/03/2023 and 8/08/2025 is acknowledged by the examiner and the cited references have been considered in the examination of the claims now pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-10 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites the limitation “secured to a portion of the head of the pediatric patient” in line 4. The current claim language positively recites a body part of a human being, thus claiming non-statutory subject matter. In order to overcome this rejection, the claimed subject matter should be “adapted to” or “configured to” be affixed to, be employed to be positioned, and be positioned.
Claims 2-10 inherit the deficiencies of independent claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Donaldson (20170049316) in view of Huang (WO 2018107108).
Regarding claim 1, Donaldson discloses a system to administer a Visual Field test (Fig 1, [0010], method for testing a patient's visual field using testing apparatus having a display and a patient input device) to a “…” patient (7), the system comprising: a display unit (3) configured to display visual information ([0060], a retinal display unit that projects light directly into a patient's eye or eyes such at an image of the visual field test display screen is formed on their retina) to the “…” patient (7), wherein the display unit (3) is secured to a portion of the head of the “…” patient and depicts one or more visual ([0062], a visual field test screen similar that which would be visualized as being displayed on the display 3 to the patient 7 wearing the head mounted display unit 5) elements (19); a control device, configured to control the one or more visual elements depicted on the display unit ([0047], control unit configured to (a) present a home target on the display; (b) display a cursor on the display, the cursor being moveable by the patient using the patient input device; and (c) present, once the cursor is moved to the home target, a visual field target on the display at a first position); and one or more sensors configured to track movement of the “…” patient during administration of the visual field test ([0086], eye tracker may be provided for tracking the eye being tested and stopping the test when it detects the eye gaze has been moved from the cursor) but does not teach a pediatric patient and one more sensors configured to track movement of the pediatric during administration of the visual field test.
Furthermore, in a related field endeavor, Huang teaches one more sensors configured to track movement of the “…” during administration of the visual field test ([0042], determination of a subject's visual field perimetry using virtual reality; [0051], head motion sensor 115 which may include a gyroscope 116 and an accelerometer 117, head motion sensor 115 provides the data to establish head orientation so the VR display can be adjusted to produce an immersive visual environment). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine one or more sensors configured to track movement of the patient during administration of the visual field test of Huang with the system of Donaldson to enhance readability of the system (Huang, [0005]).
It would have been obvious to one of ordinary skill in the art to administer a pediatric patient, based on routine experimentation, since testing on patients of all ages would have been obvious to one of ordinary skill in the art. Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the testing conditions for any age, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co , 193 USPQ 8. See MPEP § 2144.
Regarding claim 2, Donaldson discloses wherein the one or more sensors is disposed within the goggles (5) and configured to track one or more eye- movements of the “…” patient (Fig 1, [0060], display 3 is part of a head mounted display; [0086], eye tracker provided for tracking eye being tested and stopping the test when it detects the eye gaze has moved from the cursor); and further comprising: at least one data processor ([0043], software program provide on a non-transient computer readable medium containing program instructions, when executed by a computer); and at least one memory storage device ([0043], software program provide on a non-transient computer readable medium containing program instructions, when executed by a computer) but does not teach the display unit is a virtual, augmented or mixed reality goggles configured to provide the visual field test; and the one or more sensors are configured to monitor the pediatric patient during administration of the visual test.
Huang teaches the display unit is a virtual, augmented or mixed reality goggles configured to provide the visual field test ([0043], current disclosure enables the presentation of both background graphics and a fixation target to both eyes to create a 3-dimensional stereoscopic immersive VR visual environment); and the one or more sensors are configured to monitor the “…” patient during administration of the visual test ([0042], determination of a subject’s visual field perimetry using virtual reality; [0051], head motion sensor 115 which may include a gyroscope 116 and an accelerometer 117, head motion sensor 115 provides the data to establish head orientation so the VR display can be adjusted to produce an immersive visual environment). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine one or more sensors configured to track movement of the patient during administration of the visual field test of Huang with the system of Donaldson to enhance readability of the system (Huang, [0005]).
Furthermore, it would have been obvious to one of ordinary skill in the art to administer a pediatric patient, based on routine experimentation, since testing on patients of all ages would have been obvious to one of ordinary skill in the art. Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the testing conditions for any age, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co , 193 USPQ 8. See MPEP § 2144.
Regarding claim 3, Donaldson discloses wherein the processor ([0043], computer) is configured to: (i) show a fixation target that simulates (Fig 2, [0068], software generates a first visual field target 11 on the display 2 at a first known position) a stationary object (11); (ii) provide a mobile cursor (21) that simulates a mobile object capable of independent motion and that is controllable in response to input received from the “…” patient (Fig 1, [0021], patient input device is a computer device , patient input device may be a joystick, touch screen, or drawing tablet; [0063], circular cursor 21 is also displayed and moveable by patient 7 by operating the patient input device 9) by a control device (9); (iii) receive from the “…” patient at least one first response, wherein the at least one first response comprises moving (Fig 2, [0067], home target spot 19 and moveable cursor 21 is displayed on display 3. The patient is prompted to begin the test by moving the cursor 21 to the home target spot 19 using the user input device 9) the mobile object (21), using the control device, in the direction ([0021], patient input device is a computer device , patient input device may be a joystick, touch screen, or drawing tablet and pen; [0063], presentation of the first visual field target 11 establishes a notional linear path 13 between the home target 19 and the presented visual field target 11) of the stationary object (11); (iv) provide instructions to move the mobile object to be superimposed over the stationary object ([0017], rather than requiring the patient to move the cursor the whole way to the target, which would be time consuming, once the patient has moved the cursor a predetermined distance from the home target toward the presented visual field target, the presented target is recorded as detected); (v) has a specified (a) size, (b) shape, (c) contrast and (d) luminance, wherein the luminance of each stimulus is greater than the luminance of a background ([0035], visual characteristics of each visual field target vary depending on the position of the visual field target on the display, the visual characteristics comprising at least one of the size, shape, color and/or contrast; [0036], step of presenting a visual field target on the display comprises increasing the brightness of the visual field target and/or the contrast of the visual field target relative to the background display); (vi) receive from the “…” patient at least one second response ([0019], test functions like an interactive game in which the patient's responses prompt progression through the sequence of presented visual field targets), wherein the at least one second response comprises moving the mobile object, using the control device, in the direction of ([0050], presenting a test sequence of peripheral target spots at different positions on the display, where each peripheral target spot in the sequence is presented in response to the cursor being moved to the centre of field target) the one stimulus; (vii) repeat steps (ii) to (vi) at least y times, where y is greater than 2, until the patient indicates that a lowest stimulus intensity has been seen ([0037], step d) further comprises recording the brightness and/or contrast level of a visual field target at the time of detection. In this way, it can be determined if there is a threshold level of visibility for visual field targets in different regions of a patient's visual field; [0074], steps are repeated until a number of patient responses have been recorded for a number visual field targets at various positions across the display) but does not teach provide a set of n stimuli, wherein n is greater than or equal to 2 wherein each stimulus in the set of n stimuli; when the “…” patient views at least one stimulus; calculate a visual field score if a percentage of responses in step (vii) labeled as correct is greater than or equal to the percentage expected to be correct based on a historical value for the patient's retinal sensitivity score or an estimated percentage of correct choices based on a probability score.
However, Huang teaches provide a set of n stimuli, wherein n is greater than or equal to 2 wherein each stimulus in the set of n stimuli ([0075], This provides the opportunity to briefly present visual stimulus 250 within a time window; [0093], full threshold test requires a series of visual stimuli to be shown at each location to bracket in the threshold); when the “…” patient views at least one stimulus ([0044], presentation of visual stimulus could be varied between the right and left eye in rapid alternation since the left and right eye displays are separately controlled); calculate a visual field score if a percentage of responses in step (vii) labeled as correct is greater than or equal to the percentage expected to be correct based on a historical value for the patient's retinal sensitivity score or an estimated percentage of correct choices based on a probability score ([0075], score board 211 indicates that one or more dragon has been slayed; [0077], scoreboard 211 indicated that one more dragon has escaped; [0093], retinal sensitivity is the inverse of the minimum stimulus strength needed for the eye to perceive it at the particular location in the VF). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine one or more sensors configured to track movement of the patient during administration of the visual field test of Huang with the system of Donaldson to enhance readability of the system (Huang, [0005]).
Furthermore, it would have been obvious to one of ordinary skill in the art to administer a pediatric patient, based on routine experimentation, since testing on patients of all ages would have been obvious to one of ordinary skill in the art. Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the testing conditions for any age, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co , 193 USPQ 8. See MPEP § 2144.
Regarding claim 4, Donaldson discloses wherein the control device (9) is a connected handpiece (Fig 1, [0061], rather than using a pen and tablet, different patient input devices 9 may also be used, such as a computer mouse, joystick, or touch screen) and the mobile object is controlled by the connected handpiece and is used by the system to receive the at least one response from the “…” patient ([0030], step of recording visual field target as not detected if, after a period of time, the cursor has not been moved in response to presentation of a visual field target; [0063], circular cursor 21 displayed and movable by patient 7 by operating the patient input device 9) but does not teach a wireless connection.
However, Huang teaches a wireless connection [0056], mobile computing device 110 is directly connected with one or more devices via the direct wireless connection using Bluetooth and/or BLE protocols, WIFI protocols). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a wireless connected system of Huang with the system of Donaldson to enhance readability of the system (Huang, [0005]).
Furthermore, it would have been obvious to one of ordinary skill in the art to administer a pediatric patient, based on routine experimentation, since testing on patients of all ages would have been obvious to one of ordinary skill in the art. Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the testing conditions for any age, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co , 193 USPQ 8. See MPEP § 2144.
Regarding claim 5, Donaldson in view of Huang discloses the invention as described within claim 3 and Donaldson further teaches wherein the at least one first response of moving the mobile object is used by the system to understand whether the subject is fixating in the stationary object or not (Fig 2, [0068], software generates a first visual field target 11 on display 2 at a first known position; [0086], eye tracker may be provided for tracking eye being tested and stopping the test when it detects the eye gaze has moved from the cursor).
Regarding claim 6, Donaldson in view of Huang discloses the invention as described within claim 3 and Huang further teaches wherein said stimuli are presented in several locations throughout the “…” patient's visual field ([0075], stimulus 250 takes the form of a checker board with moderate contrast between the light and dark squares within. The checker board is animated by light-dark partem reversal at several Hz (cycles per second) to activate the retinal motion sensing system and enhance stimulus perception).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine one or more sensors configured to track movement of the patient during administration of the visual field test of Huang with the system of Donaldson to enhance readability of the system (Huang, [0005]).
Furthermore, it would have been obvious to one of ordinary skill in the art to administer a pediatric patient, based on routine experimentation, since testing on patients of all ages would have been obvious to one of ordinary skill in the art. Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the testing conditions for any age, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co , 193 USPQ 8. See MPEP § 2144.
Regarding claim 7, Donaldson in view of Huang discloses the invention as described within claim 3 and Huang further teaches wherein said movement of the mobile object toward the stimuli is recorded and is a vector movement and is used by the system to confirm whether the subject did or did not see the stimulus (Fig 13, [0080], player rotates his/her head and thereby moves sight 220 toward the recent location of the stimulus 261. The motion of sight 220 is described by vector 270. Perception of the visual stimulus is detected if the motion vector 270 exceeds a magnitude threshold Theta).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine one or more sensors configured to track movement of the patient during administration of the visual field test of Huang with the system of Donaldson to enhance readability of the system (Huang, [0005]).
Regarding claim 8, Donaldson in view of Huang discloses the invention as described within claim 7 and Donaldson further teaches wherein knowing the vector of the mobile object movement detects potential false positives or negatives ([0026], the act of the cursor being moved to intersect with the target region of the boundary thereby indicates that the movement vector for the cursor meets the requirement for recording the visual field target as detected; [0029], step of recording the visual field target as not detected if the cursor is moved into contact with a portion of the boundary that is not the target region for that respective visual field target. This may be recorded as a false positive).
Regarding claim 9, Donaldson in view of Huang discloses the invention as described within claim 2 and Huang further teaches wherein said eye tracking system is used to control a gaze fixation ([0018], patient is prompted to focus their gaze back to the home target at the start of each iteration of the test sequence through the requirement for them to move the cursor back to the home target; [0086], an eye tracker may be provided for tracking the eye being tested and stopping the test when it detects the eye gaze has moved from the cursor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine one or more sensors configured to track movement of the patient during administration of the visual field test of Huang with the system of Donaldson to enhance readability of the system (Huang, [0005]).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Donaldson (20170049316) in view of Huang (WO 2018107108) and in further view of Monhart (20190142270).
Regarding claim 10, Donaldson in view of Huang discloses the invention as described within claim 3 but does not teach wherein one of the said sensors is an eye tracking system configured to:(i) turn ON the eye tracking sensors at a time in the range of from 1 to 5 milliseconds before providing the set of n stimuli, wherein the eye tracking sensors produce a fixation status ;(ii) analyze the fixation status before providing the set of n stimuli; (iii) detect eye fixation on the fixation target; (iv) continue the Visual Field test without modifications, if the eye tracking system detects eye fixation on the fixation target; and (v) adjust the position of the set of n stimuli a before presenting the set of n stimuli if the eye tracking system detects eye fixation on a position other than fixation target, to match the said new detected position of the eye.
However, Monhart teaches wherein one of the said sensors is an eye tracking system (Fig 3, [0024], eye tracking system 300) configured to: (i) turn ON the eye tracking sensors (302) at a time in the range of from 1 to 5 milliseconds before providing the set of n stimuli (Fig 3, [0041], this verification is done without using an eye camera (e.g., eye sensor 302) or a gaze tracker. This may be achieved by first presenting visual stimuli, it can be concluded that the subject response was given to the blind spot test stimuli instead of the regular visual stimuli and the subject was not looking at the predefined fixation target due to malfixation), wherein the eye tracking sensors (302) produce a fixation status ([0025], eye sensor 302 tracks the subject's eyes and gaze direction, gaze direction may be calculated based on the pupil position and the positions of the corneal reflexes of infrared LEDs used for the illumination of the eye with invisible light. Based on the gaze direction, one can calculate the IPD and therefore the individual offset for the fixation position as needed in subsequent testing); (ii) analyze the fixation status before providing the set of n stimuli ([0027], horizontal and/or vertical inter-eye distance measurements are processed by a processor 316 to generate visual stimuli and fixation targets on a display screen); (iii) detect eye fixation on the fixation target ([0035], method 400 can verify whether the subject's eye is looking at a fixation target without using a camera or gaze tracker); (iv) continue the Visual Field test without modifications, if the eye tracking system detects eye fixation on the fixation target ([0035], display screen is split into two regions, namely a left display region that displays a fixation target and visual stimuli specific to the left eye of the subject and a right display region that displays a fixation target and visual stimuli specific to the right eye of the subject, method 400 can verify whether the subject's eye is looking at a fixation target without using a camera or gaze tracker); and (v) adjust the position of the set of n stimuli a before presenting the set of n stimuli if the eye tracking system detects eye fixation on a position other than fixation target, to match the said new detected position of the eye ([0031], response-capturing device 314 is a traditional clicker or button (e.g., the button 107 in FIG. 1) that is clicked by the subject 314 to indicate whether he/she has seen a stimulus or not. In yet some other embodiments, the response-capturing device 314 is the eye sensor 302 that tracks eye movements for determining subject responses to the visual stimuli).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Donaldson and Huang with eye tracking features of Monhart to enhance testing accuracy within a system for testing visual field of a subject (Monhart, [0004]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Baha (20190150727), Donaldson (20170245753), and Julian (20130265227) are examples of methods for use in testing a patient's visual field.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sharrief I Broome whose telephone number is (571)272-3454. The examiner can normally be reached Monday-Friday 8am-5pm, EST.
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Sharrief I. Broome
Primary Examiner
Art Unit 2872
/SHARRIEF I BROOME/ Primary Examiner, Art Unit 2872