Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/11/24 has been considered by the examiner.
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.
Claims 1-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a medical system for measuring visual evoked potentials (VEP) of a person. Thus, the claim is directed to a machine, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“the image generating module (1) being configured to cause the display (2) to display a sequence of images comprising a first image and a second image, the first and the second image being displayed alternately, wherein the first image comprises a windmill pattern (30) consisting of a number N of equidistantly spaced light circular sectors (31), and a number of N equidistantly spaced dark circular sectors (32), wherein the number N is selected from the set comprised of 4, 8, 16, 32, and wherein the light and the dark circular sectors (31,32) each extend outwards in a radial direction from a common central point (33), wherein each dark circular sector (32) is arranged between two light circular sectors (3 t),wherein the second image corresponds to the first image, but with the order of the light circular sectors (31) and the dark circular sectors (32) being reversed, or wherein the second image corresponds to an all-dark area having the same color and luminance as the dark circular sectors (32), detect EEG signals indicative of electrical activity in the brain of the person in response to observing said sequence of images displayed by the display (2), the EEG recording module (4) being configured to record said EEG signals, the analyzing module (8) being configured to derive from said EEG signals recorded by the EEG recording module (4) at least one visual evoked potential (VEP)”
These limitations describe a mental process as the skilled artisan is capable of performing the judicial exception mentally, or using pen and paper. Furthermore, nothing from the claims or applicant’s accompanying specification shows that the skilled artisan would not be able to perform the judicial exception mentally, or using pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a display (2) for displaying images to be observed by the person with a single eye; a plurality of electrodes (3) configured to be attached to the scalp of the person. an EEG recording module (4) connected to said plurality of electrodes (3), an analyzing module (8)”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity, e.g., merely using a processor to collect, store, and organize data to convey meaning to a user – i.e. the user takes the tabulated data and decides on a course of action or treatment. The claim as a whole is directed to conveying a message or meaning to a human reader independent of the intended computer system, and/or the computer-readable medium merely serves as a support for information or data, no functional relationship exists. See MPEP 2111.05.
Claims 17 and 36 recite the additional limitations:
“camera (5) configured for tracking movement of the eye of the person, wherein the image generation module (1) is configured to only display images of said sequence in case the person fixates said common central point (33) with said eye; computer, computer program”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity e.g., mere generic camera, tracker, receiving data, outputting data.
Furthermore, the additional limitations recite well-known structural limitations (generically recited camera and computer components, etc.) and as such, do not amount to significantly more than the identified judicial exception.
Dependent claims 2-16 and 18-35 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-36 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-16, 18, 20-32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Grose-Fifer (“Temporal tuning and the development of lateral interactions in the human visual system." Investigative ophthalmology & visual science 35.7 (1994): 2999-3010) and in further view of Atilla (“Pattern electroretinography and visual evoked potentials in optic nerve diseases." Journal of clinical neuroscience 13.1 (2006): 55-59).
Regarding claim 1, Grose-Fifer teaches a medical system (20) for measuring visual evoked potentials (VEP) of a person [Abstract, p. 3002, col. 1, par. 3], comprising:
- a display (2) for displaying images [p. 3000, col. 2, par. 5-p. 3001, col. 1, par. 1 “visual stimuli were generated by the VENUS visual stimulator and were displayed on a Tekronix 608 oscilloscope”]
- an image generating module (1) [p. 3000, col. 2, par. 5 “visual stimuli were generated by the VENUS visual stimulator”], the image generating module (1) being configured to cause the display (2) to display a sequence of images [p. 3000, col. 2, par. 5-p. 3001, col. 1, par. 1 “visual stimuli were generated by the VENUS visual stimulator and were displayed on a Tekronix 608 oscilloscope… the stimuli appeared as either a windmill-dartboard (Figs. 1A, 1B)”] comprising a first image [fig. 1A] and a second image [fig. 1B], the first and the second image being displayed alternately [Fig. 1 (A,B) description “The windmill-dartboard stimulus has two distinct phases: windmill, shown in (A), and dartboard, shown in (B)”], wherein the first image comprises a windmill pattern (30) consisting of a number N of equidistantly spaced light circular sectors (31), and a number of N equidistantly spaced dark circular sectors (32), wherein the number N is selected from the set comprised of 4, 8, 16, 32, and wherein the light and the dark circular sectors (31,32) each extend outwards in a radial direction from a common central point (33), wherein each dark circular sector (32) is arranged between two light circular sectors (3 t) [fig. 1A; p. 3001, col. 1, par. 1 “The radial spatial pattern used consisted of a central disk (which subtended a visual angle of 2.3°) surrounded by three contiguous annuli, all radially divided into dark and light segments.”], wherein the second image corresponds to the first image, but with the order of the light circular sectors (31) and the dark circular sectors (32) being reversed [fig. 1B; fig. 1A; p. 3001, col. 1, par. 1 “The segments in the central disk and in the second annulus were contrast reversed” Examiner notes the inner disc of fig. 1B comprises the reversed windmill pattern of fig. 1A], or wherein the second image corresponds to an all-dark area having the same color and luminance as the dark circular sectors (32),
- a plurality of electrodes (3) configured to be attached to the scalp of the person and to detect EEG signals indicative of electrical activity in the brain of the person in response to observing said sequence of images displayed by the display (2) [p. 3001, col. 1, par. 2 “Gold-cup EEG electrodes were fixed with paste at Oz (active) and Cz (reference)”],
- an EEG recording module (4) connected to said plurality of electrodes (3), the EEG recording module (4) being configured to record said EEG signals [p. 3001, col. 1, par. 2 “A differential amplifier with a gain set at 20,000 and a bandpass filter set at 1 to 100 Hz was used… analog-to-digital (A/D) converter”], and
- an analyzing module (8), the analyzing module (8) being configured to derive from said EEG signals recorded by the EEG recording module (4) at least one visual evoked potential (VEP) [p. 3001, col. 2, par. 3 “VEPS were recorded in response to the 4 Hz windmill-dartboard stimulus”, p. 3002, col. 1, par. 3 “The first stage in the analysis of the data was a visual inspection of the VEP waveforms”, p. 3003, col. 1, par. 1 “After inspection of the VEP waveforms, each VEP was analyzed by means of a discrete Fourier transform”]
However, Grose-Fifer does not teach the image is to be observed by the person with a single eye
Atilla teaches the image is to be observed by the person with a single eye [Table 1; p. 56, col. 2, par. 6; Examiner notes the affected eyes were compared to unaffected eyes]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Grose-Fifer, to incorporate the image is to be observed by the person with a single eye, for comparing the affected eye to the unaffected eye, as evidence by Atilla [p. 56, col. 2, par. 6].
Regarding claims 2 and 21, Grose-Fifer further teaches the light circular sectors (31) are white circular sectors and/or that the dark circular sectors (32) are black circular sectors [fig. 1A, B; p. 3001, col. 1, par. 1 “all radially divided into dark and light segments… Michelson contrast of segments was 100%”]
Regarding claim 3, Grose-Fifer further teaches the light circular sectors (31) comprise a luminance of about 167cd/m2, and/or wherein the dark circular sectors (32) comprise a luminance of about 0.015 cd/m2, and/or wherein the Michelson contrast between light and dark circular sectors (31, 32) is at least 40 [fig. 1A, B; p. 3001, col. 1, par. 1 “all radially divided into dark and light segments… Michelson contrast of segments was 100%”].
Regarding claims 4 and 22, Grose-Fifer further teaches each light circular sector (31) is delimited by two radii (31a) extending from the common central point (33) in the radial direction and an arc (31b) extending in a circumferential direction [fig. 1A, light sectors]
Regarding claims 5 and 23, Grose-Fifer further teaches the arcs (31b) of the light circular sectors (31) are of equal length [fig. 1A, light sectors].
Regarding claims 6 and 24, Grose-Fifer further teaches wherein the light and dark circular sectors (31,32) define a circle [fig. 1A, light sectors].
Regarding claims 7 and 25, Grose-Fifer further teaches the first image comprises a region (35) adjacent the circle, said region (35) having the same color and luminance as the dark circular sectors (32) so that the dark circular sectors (32) seamlessly blend into said region (35) of the first image [fig. 1A]
Regarding claims 8 and 26, Grose-Fifer further teaches the light circular sectors (31) make up a percentage of the area of the circle, wherein preferably this percentage is one of: 12.5%, 25%, 37.5%, 50%, 75% [fig. 1A, light sectors; Examiner notes there are the same amount of light sectors as dark sectors and are the same size]
Regarding claim 9, Grose-Fifer further teaches the image generating module (1) is configured to cause the display (2) to display a series of sequences for different percentages of the area of the circle [fig. 1C, Examiner notes the percentage of the area of the circle of the light sectors is different than fig. 1A].
Regarding claims 10 and 27, Grose-Fifer further teaches each first image and each second image in the sequence is displayed over a constant period of time, starting with an onset of the respective image and ending with an offset of the respective image [fig. 2B, 3A, 3B; p. 3002, col. 2, par. 1].
Regarding claims 11 and 28, Grose-Fifer further teaches said constant period of time from onset to offset of the respective image is at least 400 ms, preferably 500ms [fig. 3A]
Regarding claims 12 and 29, Grose-Fifer further teaches the analyzing module (8) is configured to determine a visual evoked potential (VEP) by averaging a pre-defined number of EEG signal segments following onset of the first and/or second images in the sequence [p. 3001, col. 1, par. 1 “for each stimulus condition 61 recordings were averaged.”, p. 3001, col. 2, par. 3 “VEPS were recorded in response to the 4 Hz windmill-dartboard stimulus, the 4 Hz partial windmill stimulus”].
Regarding claims 13 and 30, Grose-Fifer further teaches the analyzing module (8) is configured to determine a visual evoked potential (VEP) by averaging a pre-defined number of EEG signal segments following onset of the first images in the sequence, and/or wherein the analyzing module (8) is configured to determine a visual evoked potential (VEP) by averaging a pre-defined number of EEG signal segments following offset of the first images in the sequence [p. 3001, col. 1, par. 1 “for each stimulus condition 61 recordings were averaged.”, p. 3001, col. 2, par. 3 “VEPS were recorded in response to the 4 Hz windmill-dartboard stimulus, the 4 Hz partial windmill stimulus”]
Regarding claims 14 and 31, Atilla further teaches the analyzing module (8) is configured to compare an amplitude of at least one deflection of the visual evoked potential (VEP) with an amplitude of a corresponding deflection of a reference curve [Table 1; p. 56, col. 2, par. 2-3]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Grose-Fifer, to incorporate the analyzing module (8) is configured to compare an amplitude of at least one deflection of the visual evoked potential (VEP) with an amplitude of a corresponding deflection of a reference curve, for comparing the affected eye to the unaffected eye, as evidence by Atilla [p. 56, col. 2, par. 6].
Regarding claims 15 and 32, Atilla further teaches the analyzing module (8) is configured to compare a latency of at least one deflection of the visual evoked potential (VEP) with a latency of a corresponding deflection of a reference curve [Table 1; p. 56, col. 2, par. 2-3]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Grose-Fifer, to incorporate the analyzing module (8) is configured to compare a latency of at least one deflection of the visual evoked potential (VEP) with a latency of a corresponding deflection of a reference curve, for comparing the affected eye to the unaffected eye, as evidence by Atilla [p. 56, col. 2, par. 6].
Regarding claim 16, Atilla further teaches amplitude and latency are measured in diseased retinas and compared to retinas that are not diseased [Table 1; p. 56, col. 2, par. 2-3]
Although Ailla does not explicitly teach the analyzing unit (8) is configured to detect that the person has a diseased retina (10) and to provide a corresponding information to an operator of the system, if the amplitude of said at least one deflection of the visual evoked potential deviates from the amplitude of a corresponding deflection of the reference curve by more than a pre-determined amount, and/or if the latency of said at least one deflection of the visual evoked potential deviates from the latency of a corresponding deflection of the reference curve by more than a pre-determined amount, Atilla does suggest measuring amplitude and latency of affected and unaffected eyes and performing a comparison, indicating there is evidence of a difference between amplitude and latency in unaffected and affected eyes [Table 1; p. 56, col. 2, par. 2-3; p. 57, col. 2, par. 3]. Therefore, incorporating that the analyzing unit (8) is configured to detect that the person has a diseased retina (10) and to provide a corresponding information to an operator of the system based on the amplitude or latency, would be obvious to one skilled in the art.
Regarding claims 18 and 34, Atilla further teaches comparing amplitudes of unaffected and affected eyes of a P100 deflection of the visual evoked potential (VEP)obtained from displaying a series of sequences for different percentages of the area of the circle to be observed by the person with a reference curve [Table 1; p. 56, col. 2, par. 2-3; p. 57, col. 2, par. 3]
Although Atilla does not explicitly teach the analyzing unit (8) is configured to detect that the person has a diseased retina (10) based on comparing amplitudes of a P100 deflection of the visual evoked potential (VEP)obtained from displaying a series of sequences for different percentages of the area of the circle to be observed by the person with a reference curve, Atilla suggests comparing amplitudes of unaffected and affected eyes of a P100 deflection of the visual evoked potential (VEP)obtained from displaying a series of sequences for different percentages of the area of the circle to be observed by the person with a reference curve [Table 1; p. 56, col. 2, par. 2-3; p. 57, col. 2, par. 3]. Therefore, incorporating the analyzing unit (8) is configured to detect that the person has a diseased retina (10) based on comparing amplitudes of a P100 deflection of the visual evoked potential (VEP), would be obvious to one skilled in the art
Regarding claim 20, Grose-Fifer teaches method for measuring visual evoked potentials (VEP) of a person [Abstract, p. 3002, col. 1, par. 3], preferably using a system according to claim 1, the method comprising the steps of:
a) Causing a display (2) [p. 3000, col. 2, par. 5-p. 3001, col. 1, par. 1 “visual stimuli were generated by the VENUS visual stimulator and were displayed on a Tekronix 608 oscilloscope”] to display a sequence of images to be observed by the person [p. 3000, col. 2, par. 5-p. 3001, col. 1, par. 1 “visual stimuli were generated by the VENUS visual stimulator and were displayed on a Tekronix 608 oscilloscope… the stimuli appeared as either a windmill-dartboard (Figs. 1A, 1B)”], the sequence of images comprising a first image [fig. 1A] and a second image [fig. 1B], the first and the second image being displayed alternately [Fig. 1 (A,B) description “The windmill-dartboard stimulus has two distinct phases: windmill, shown in (A), and dartboard, shown in (B)”], wherein the first image comprises a windmill pattern (30) consisting of a number N of equidistantly spaced light circular sectors (31), and a number N of equidistantly spaced dark circular sectors (32), wherein the number N is selected from the set comprised of 4, 8, 16, 32, and wherein the light and the dark circular sectors (31,32) each extend outwards in a radial direction from a common central point (33), wherein each dark circular sector (32) is arranged between two light circular sectors (31) [fig. 1A; p. 3001, col. 1, par. 1 “The radial spatial pattern used consisted of a central disk (which subtended a visual angle of 2.3°) surrounded by three contiguous annuli, all radially divided into dark and light segments.”], wherein the second image corresponds to the first image, but with the order of the light circular sectors (31) and the dark circular sectors (32) being reversed [fig. 1B; fig. 1A; p. 3001, col. 1, par. 1 “The segments in the central disk and in the second annulus were contrast reversed” Examiner notes the inner disc of fig. 1B comprises the reversed windmill pattern of fig. 1A], or wherein the second image corresponds to an all- dark area having the same color and luminance as the dark circular sectors (32),
b) Detecting EEG signals via electrodes (3) attached to the scalp of the person and recording said EEG signals, the EEG signals being indicative of electrical activity in the brain of the person in response to observing said sequence of images [p. 3001, col. 1, par. 2 “Gold-cup EEG electrodes were fixed with paste at Oz (active) and Cz (reference)”], and
c) Deriving at least one visual evoked potential (VEP) of the person from said EEG signals [p. 3001, col. 1, par. 2 “A differential amplifier with a gain set at 20,000 and a bandpass filter set at 1 to 100 Hz was used… analog-to-digital (A/D) converter”]
However, Grose-Fifer does not teach the image is to be observed by the person with a single eye
Atilla teaches the image is to be observed by the person with a single eye [Table 1; p. 56, col. 2, par. 6; Examiner notes the affected eyes were compared to unaffected eyes]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Grose-Fifer, to incorporate the image is to be observed by the person with a single eye, for comparing the affected eye to the unaffected eye, as evidence by Atilla [p. 56, col. 2, par. 6].
Claims 17 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Grose-Fifer and Atilla and in further view of Zerlaut (“Modeling mesoscopic cortical dynamics using a mean-field model of conductance-based networks of adaptive exponential integrate-and-fire neurons." Journal of computational neuroscience 44.1 (2018): 45-61.)
Regarding claims 17 and 33, Grose-Fifer and Atilla teach a medical system (20) for measuring visual evoked potentials (VEP) of a person
However, Grose-Fifer and Atilla do not teach the medical system comprises a camera (5) configured for tracking movement of the eye of the person, wherein the image generation module (1) is configured to only display images of said sequence in case the person fixates said common central point (33) with said eye.
Zerlaut teaches the medical system comprises a camera (5) configured for tracking movement of the eye of the person, wherein the image generation module (1) is configured to only display images of said sequence in case the person fixates said common central point (33) with said eye [p. 51, col. 2, par. 2, 3 “Stimuli were presented during fixation”]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Grose-Fifer and Atilla, to incorporate the medical system comprises a camera (5) configured for tracking movement of the eye of the person, wherein the image generation module (1) is configured to only display images of said sequence in case the person fixates said common central point (33) with said eye, for presenting the stimuli while the user is fixating, as evidence by Zerlaut [p. 51, col. 2, par. 2, 3].
Claims 19 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Grose-Fifer and Atilla and in further view of Marcar (“Stimuli to differentiate the neural response at successive stages of visual processing using the VEP from human visual cortex”, Journal of Neuroscience Methods, Volume 293, 2018, Pages 199-209, ISSN 0165-0270)
Regarding claims 19 and 35, Grose-Fifer and Atilla teach a medical system (20) for measuring visual evoked potentials (VEP) of a person
However, Grose-Fifer and Atilla do not teach the reference curve is a linear function of the percentage of the area of the circle
Marcar teaches the reference curve is a linear function of the percentage of the area of the circle [fig. 3 “A shows the spatial frequency spectra from the windmill, dartboard and RMS-dartboard stimuli. B depicts the value of the function f(0) of the three images. C shows the sum of the energy in the high spatial frequencies (3–7 cpd) of the three images”]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Grose-Fifer and Atilla, to incorporate the reference curve is a linear function of the percentage of the area of the circle, for investigating the independ+ence of the neural processes selective to temporal – and spatial luminance contrast, as evidence by Marcar [p. 205, col. 2, par. 1].
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Grose-Fifer and Atilla and in further view of Jayaraman (“Multifocal visual evoked potential in optic neuritis, ischemic optic neuropathy and compressive optic neuropathy." Indian Journal of Ophthalmology 62.3 (2014): 299-304.)
Regarding claim 36, Grose-Fifer and Atilla teach a medical system (20) for measuring visual evoked potentials (VEP) of a person
However, Grose-Fifer and Atilla do not teach a computer program, the computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out step a) of the method according to claim 20
Jayaraman teaches a computer program, the computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out step a) of the method according to claim 20 [p. 300, col. 1, par. 4 “The first slice of second order kernel responses with highest signal-to-noise ratio (log SNR) was extracted from three recorded and three additional derived channels using mfVEP processing program”, p. 300, col. 2, par. 2 “The amplitude and latency probability plots of 60 sectors were obtained for each subject in comparison with normative database[21] built in Multifocal VEP processing program”]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Grose-Fifer and Atilla, to incorporate a computer program, the computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out step a) of the method, for processing the signals, as evidence by Jayaraman [p. 300, col. 1, par. 4, p. 300, col. 2, par. 2].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791