DETAILED ACTION
Non-Final Rejection
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 .
Claims Status
Claims 1-21 were amended in a preliminary amendment dated 6/2/2023. Claims 1-21 are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
eye tracking unit in claim 1 – this was interpred in view of this explanation in the specification: “The eyetracking may be based on any eyetracking technology, such as so-called bright and/or dark pupil measurements, iris detection, sclera movement observations or glint measurements or a combination thereof, as per se is well known in the art. It should be noted that the components of fig 2A could be integrated in a virtual reality, VR,headset 40(cf. fig 2C), for instance,which is strapped on the tested subject's head.”
analyzing unit in claim 1 – this was interpreted as a processor under the Basic Setup section.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 1 is objected to because of the following informalities:
The Office suggests amending claim 1 read as follows:
A device for visual field testing and mapping eye function of a test subject, the device comprising:
a display unit for displaying stimuli to the test subject,
an eye tracking unit configured for generating an eye tracking response by detecting eye motions in response to the displayed stimuli, and
an analyzing unit configured for determining visual field characteristics based on the displayed stimuli and the eye tracking response,
wherein the display unit is configured to display at least a first and a second peripheral stimulus at different sectors of the display in relation to a point of fixation, and in a common time frame, and
wherein the eye tracking unit or the analyzing unit is configured to determine which of the first and second stimulus is first gazed upon by the test subject.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
It is unclear whether the eye tracking unit and analyzing unit in claim 1 are configured to perform the detection and determinations or whether the units only require the ability to be programmed to do so. For purposes of examination, the Office used the former interpretation.
Claim 3 states that the first and second stimuli are located at a minimum angle theta (15-180 degress) as seen from the point of fixation. However, this would appear to depend on how far the user is located from the viewing screen. If the user is centered in front of the screen and the stimuli are off to the right and left sides of the screen, then the angle would depend on the user’s distance from the screen as shown below. It is therefore unclear how this limitation further limits the scope of the claim. For purposes of examination, the Office interpreted the limitation as indicating that a person would be capable of locating themselves in front of the screen to satisfy the angle requirement. If the claim has a different meaning, the Office suggests amending the claim as this interpretation is applicable to the claim.
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Regarding claim 12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 1-3, 5-14, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eizenman et al. (US 2014/0148728).
Regarding claim 1, Eizenman et al. disclose a device for visual field testing, mapping eye function of a test subject ([0037] discloses visual testing systems that can be used for the evaluation), the device comprising a display unit for displaying stimuli to test the subject (see monitor in Fig. 1, monitor is used to display stimuli as shown in the figure to a subject for neuropsychiatric assessment as noted in [0037]), an eye tracking unit for detecting eye motions in response to the displayed stimuli (see at least [0037] – “the eye-tracker can be used to estimate gaze position accurately” and “A second monitor is used by the VAST system (VAST is a trade mark of EL-MAR Inc.) to display the subject's fixation points on each image and provides the operator with an interface to control the experimental procedures (FIG. 2). Participants view a sequence of slides and the eye movement data is collected by a computer”), and an analyzing unit for determining a visual field characteristics based on the displayed stimuli and a corresponding eye tracking response (Fig. 5 shows an example of where the gaze starts and shifts when presented with 4 different visual stimuli at the same time), characterized by the display unit being configured to display at least a first and a second peripheral stimulus at different sectors in relation to a point of fixation (Fig. 5 shows 4 stimuli shown in 4 different sectors on the screen, Fig. 7 also shows a real example, point of fixation here interpreted as the center of the screen, the stimuli extending to the periphery of the screen), and in a common time frame ([0111] “Subjects' visual scanning patterns were recorded as they view a presentation of visual stimuli. The visual stimuli were organized as a series of slides with four images per slide”, [0085] “Visual stimuli were organized into slides that were presented on a computer monitor. Each slide had four images that were arranged in a 2.times.2 configuration (FIG. 7)”), and the eye tracking unit or the analyzing unit being configured to determine which of the first and second stimulus is first gazed upon by the test subject (Fig. 5 and 7 show where the subject’s gaze started, where it shifts over time, and where it ends).
Regarding claim 2, Eizenman et al. disclose wherein the display unit is configured to display a central stimulus at the point of fixation (Fig. 7 shows a black cross in the center).
Regarding claim 3, Eizenman et al. disclose wherein the display unit is configured to display the first and second peripheral stimuli at locations separated by a minimum angle φ in the range between 15 and 180 degrees as seen from the point of fixation ([0112] – “Participants sat at a distance of approximately 65 centimeters from the monitor so that the visual angle subtended by each of the four images on each slide is approximately (15.2.degree..times.11.4.degree”; alternatively, the screen can be moved or the user can move themselves to yield other angles in the range).
Regarding claim 5, Eizenman et al. disclose wherein the first and second peripheral stimuli are presented at least partly overlapping in time (as noted in claim 1, up to four images are presented simultaneously on each slide).
Regarding claim 6, Eizxenman et al. disclose wherein the first and second peripheral stimuli are presented to the same eye (the images in each slide are presented to the user and the same eye can see them all).
Regarding claim 7, Eizxenman et al. disclose wherein the first peripheral stimulus is presented to a first eye and the second peripheral stimulus is presented to the second (as noted above, a slide includes 4 images/stimuli that are presented simultaneously to all eyes, this would satisfy the claimed limitation as the claim does not state that the other is prevented from seeing the stimuli).
Regarding claim 8, Eizenman et al. disclose wherein the first and second peripheral stimuli have mutually different optical properties at a given point of time (optical properties were interpreted in view of the specification to include size, brightness, contrast, shape color, and variability. Eizenman et al. disclose the following information regarding the visual stimuli:
[0036] –“… wherein each visual stimulus is comprised of multiple images with specific characteristics …. iif the specific characteristics of the images are relevant to the disorder being probed, individuals with such a disorder will exhibit biases in their VSB when compared with individuals who do not suffer from the disorder.”
[0079] – “… participants view visual stimuli (slides) with images of thin body shapes alongside images of social interactions”
[0086] – “Subjects looked at 37 slides that included 16 test slides and 21 filter slides. Filler slides intended to mask the purpose of the experiment and had images that were neutral in content. The spatial position of images from each image type (e.g., thin body shapes, social interactions) were inter-mixed (i.e., for the set of 16 slides, each category of stimuli appeared in each quadrant of the slide the same number of times).”
In each of the above examples of visual stimuli, it would be inherent that characteristics such as at least size and variability are disclosed.
Regarding claim 9, Eizenman et al. disclose wherein the different optical properties are one or more in the group comprising: size, brightness, contrast, shape, and variability (see claim 8 rejection).
Regarding claim 10, Eizenman et al. disclose wherein at least one of the first and second peripheral stimuli move from a location corresponding to region with projected lower retinal sensitivity to a location corresponding to a region with higher retinal sensitivity (see [0032] where Eizenman recognizes that “fixation allows areas in the subject’s visual field to be viewed by fovea, providing the visual system with high-acuity color-rich information, while less detailed information is collected by parafoveal and peripheral retinal fields”; Fig. 4 shows exemplary visual stimuli presentation locations, in some setups it is evident that some visual stimuli will be in the subject’s peripheral vision, only to switch to a different slide where the visual stimuli are more centrally located).
Regarding claim 11, Eizenman et al. disclose wherein said at least one of the first and second peripheral stimuli move from the exterior of the visual field towards the center thereof (see claim 10 rejection and Fig. 4 where in one situation image “a” is located in a more peripheral spot only to move to a more centrally located spot).
Regarding claim 12, Eizenman et al. disclose wherein said at least one of the first and second peripheral stimuli move out of a finite region with reduced sensitivity, such as a blind spot or scotoma (see 35 USC 112 issue above where it is unclear if the locations are limited to those disclosed or may include others; in Fig. 4, the first row shows image “a” in a peripheral location while in the third row, “a” moves to a more central spot).
Regarding claim 13, Eizenman et al. disclose wherein the display is configured to increase the visibility of the first and second stimuli over time to trigger a response from the tested subject (Fig. 4 shows exemplary visual stimuli presentation locations, in the first row, stimuli “a” and “c” are located at peripheral location in the first slide; in a subsequent slide in the third row, “a” and “c” move to a more centrally located position which is more visible to the subject).
Regarding claim 14, Eizenman et al. disclose wherein three or more peripheral stimuli are provided within the common time frame (Fig. 4 shows an example with 5 visual stimuli presented to the user in the bottom row; any 3 of the outer 4 can be interpreted as satisfying this limitation).
Claim 21 is a non-transitory computer readable medium with instructions that when executed cause the method performed by the device of claim 1 to be executed. Because Eizenman’s system is computer operated, the argument in claim 1 above is used to reject the limitations of claim 21.
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Eizenman et al. (US 2014/0148728).
Regarding claim 4, Eizenman et al. do not disclose wherein the first and second peripheral stimuli are presented within a common time frame shorter than 250 ms. However, Eizenman et al. disclose:
“[0069] FIG. 6 provides a general block diagram for the processing sequence of a neuropsychiatric assessment. During the course of the assessment task, a series (N in FIG. 6) of visual stimuli (e.g., slides) is presented to the subject. The number of visual stimuli and the duration that each visual stimulus is determined by the assessment being conducted. For example, 50 slides are presented for 10.5 seconds each, for the assessment of the efficacy of treatment in depression while for the assessment of eating disorders 37 slides are presented for 12 seconds each.”
Thus, Eizenman et al. teach that the duration is a parameter that is optimizable is a result-effective variable depending on the goals of the process. MPEP 2144.05 states that, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Modifying Eizenman et al. to arrive at the claimed limitation would have been obvious in view of this section of the MPEP.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Eizenman et al. (US 2014/0148728) in view of Victor et al. (US 2007/013950).
Regarding claim 15, Eizenman et al. disclose wherein the eye tracking device is configured to detect the pupil size of at least one eye ([0045] discloses that the system can measure pupil size). However Eizenman et al. do not disclose that the device is configured to adjust optical properties of at least one stimulus based on said pupil size ([0111] and [0112] indicate that positions are changed randomly). However, other types of eye testing were known in the art at the time of the filing of the invention. Victor et al. teaches a similar vision testing system for evaluating peripheral impairment ([0002]). Victor et al. teach that peripheral sensitivity can be tested by presenting salient stimuli that elicit an orienting reflex in the form of a saccade towards the target. The stimulus could be a dot that ncreases in size, intensity, flickering, movement, and shape. “The stimulus would be presented at increasing visual angles to detect how sensitive peripheral vision is. Reaction time to detection and hit rate (misses) give an accurate measure of impairment. Reaction time to detection could be measured by either detecting an eye movement to the stimulus or by monitoring changes in pupil size” ([0087]). Thus after a reaction is detected via a measurement of pupil size, the dot is changed in at least size and position on the screen. It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Eizenman et al. to include additional testing capabilities when presenting stimuli to the patient such as that taught by Victor et al. explained above because it can increase the utility of the device bringing more value to the testers using it.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Eizenman et al. (US 2014/0148728) in view of Duffy (US 2017/0150907).
Regarding claim 18, Eizenman et al. do not disclose wherein the display device is configured to provide background, upon which the peripheral stimulus is presented, as a fluctuating pattern. However, displaying a fluctuating background with the stimulus was known in the arts. Duffy teaches a system for quantitative assessment of visual motor response. Duffy teaches that visual saliency stimuli can be presented to a subject and that for said stimuli, the background may be varied in luminance (claim 44). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Eizenman such that the visual stimuli is presented with a varying background (fluctuating pattern) as taught by Duffy in order to provide domain specific degradation in order to assess neurocognition.
Regarding claim 19, Eizenman et al. do not disclose wherein the pattern is fluctuating in a random or pseudo-random fashion. However, Eizenman et al. is modified using the same argument above in view of the teachings of Duffy. In addition, Duffy teaches that the previously mentioned degradation may be performed randomly (see at least [0183]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Eizenman et al. (US 2014/0148728) in view of Krueger (US 2018/0008141). Eizenman et al. do not disclose wherein the display unit and the eye tracking unit are included in a wearable device which is attached to the head of the test subject. However, Krueger teaches a VR/AR unit for performing visual testing that includes vision tracking and a display unit mounted on the head (see Fig. 1 and the Abstract). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Eizenman et al. to use a portable vison tracking and display system for performing the claimed functions as taught by Krueger because it can allow for offsite evaluation.
Allowable Subject Matter
Claims 16 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Closest prior art to claims 16 and 17 is Farraj et al. (Measuring pupil size and light response through closed eyelids. Biomed Opt Express. 2021 Sep 22;12(10):6485-6495) which discloses a closed-loop pupillometry method.
Conclusion
Claims 1-21 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tho Q. Tran whose telephone number is (571)270-1892. The examiner can normally be reached 7-5.
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/THO Q TRAN/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791