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 .
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18/217,688 (and 16/768,738) and Provisional Application No. 63/393,025, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Regarding claim 1, the limitations “d. presenting to the subject the chart without including the stimulus image presented in step c, where the subject is requested to fixate in a zone that is where the stimulus image of step c appeared”; “d. binocular disparity by the while visual exploring and target visualization; e. target hit by the subject fixate where the usual visual stimulus was present previously; f. number of consecutive target hits by the subject when considering a trial “are not supported in the disclosure as originally filed.
The disclosure at the time of the effective filing date of Application No. 18/217,688 and 16/768,738 discloses on page 14 presenting an empty screen [520] and presenting targets and requesting a subject to identify if the targets are exactly the same that were viewed before (Recognition). If the targets are exactly the same an answer saying "same" must be given. If are not exactly the same, an answer saying "different” must be given. Both answers must be collected using a keyboard or similar support [525]. Further page 23, discloses that for a number of repetitions, presenting a stimulus image in one of a plurality of zones on the chart to the subject [315]; the subject is requested to remember which zone each stimulus image appeared and in what order; d. presenting to the subject a cue corresponding to one of the presented stimulus images [320]. However, this does not disclose or provide adequate support for presenting to the subject the chart without including the stimulus image presented in step c, where the subject is requested to fixate in a zone that is where the stimulus image of step c appeared. Furthermore, the disclosure as originally filed does not recite “binocular disparity”, “target hit by the subject fixate where the usual visual stimulus was present previously”, and “number of consecutive target hits”.
The disclosure at the time of the effective filing date of Provisional Application No. 63/393,025 does disclose “binocular disparity”, “target hit by the subject fixate where the usual visual stimulus was present previously”, and “number of consecutive target hits” on page 4. The disclosure at the time of the effective filing date of Provisional Application No. 63/393,025 further discloses on pages 3 & 15 for a number of repetitions, presenting a stimulus image in one of the zones to the subject, the subject is requested to remember which zone each stimulus image appeared and in what order, presenting to the subject a cue corresponding to one of the presented stimulus images; on pages 23 & 32 presenting an empty screen [520] and presenting targets and requesting a subject to identify if the targets are exactly the same that were viewed before (Recognition). However, this does not disclose or provide adequate support for presenting to the subject the chart without including the stimulus image presented in step c, where the subject is requested to fixate in a zone that is where the stimulus image of step c appeared.
Accordingly claims 1-3 are not entitled to the benefit to the prior applications and will be treated with an effective filing date of July 28, 2023.
Regarding claims 6-7, the limitations “calculating, modelling and reporting one or more effects of drugs or treatments that … lymphocyte B” and “wherein the drugs … Ofatumumab” are not supported in the disclosure as originally filed. The disclosure at the time of the effective filing date of Application No. 18/217,688 does not disclose drugs or treatments and does not disclose calculating, modelling, and reporting one or more effects of drugs or treatments. However, Provisional Application No. 63/393,025 does disclose the limitations “calculating, modelling and reporting one or more effects of drugs or treatments that … lymphocyte B” and “wherein the drugs … Ofatumumab”.
Accordingly claims 6-7 are not entitled to the benefit to Application No. 18/217,688. However, claims 6-7 are entitled to the benefit to Provisional Application No. 63/393,025, and will be treated with an effective filing date of July 28, 2022.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “25” & “35” in fig. 1; “33” in fig. 2. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/269,302 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of copending Application No. 18/269,302.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 4 of the instant application corresponds to the claim of the copending Application No. 18/269,302 as follows:
Instant application 18/227,577
Regarding claim 4. A system for detecting one or more neurological disorders and/or measuring, fine- motor skills, processing speed, decision making, and cognitive processes in a subject by measuring eye movements, oculomotor features or pupil behaviour, comprising:
a. an eye tracker, configured to monitor eye movements of a subject while the subject is visualizing, recognizing, maintaining, controlling, fixating and analyzing targets;
b. a processor configured to receive data from the eye tracker while the subject is visualizing, recognizing, maintaining, controlling, fixating and analyzing the targets; and
c. a display configured to display a test report received from the processor,
wherein the processor is further configured to analyze the eye-tracking data for evidence of one or more neurological disorders or general cognitive performance and to report, in the test report, a detection of the one or more neurological disorders or a measure of cognitive performance of the subject.
Copending Application No. 18/269,302
Regarding claim 1. A system for detecting one or more neurological disorders and/or measuring cognitive performance in a subject by measuring eye movements, oculomotor features or pupil behaviour; said measuring of eye movements performed while said subject is visualizing, recognizing, maintaining, controlling, inhibiting, sequencing, following and analyzing targets; said system comprising a. an eye tracker [10], configured to monitor eye movements of a subject [5] while the subject [5] is visualizing, recognizing, maintaining, controlling, sequencing, following and analyzing targets [15]; b. a processor [20], configured to receive data from said eye tracker [10] while said subject [5] is visualizing, recognizing, maintaining, controlling, sequencing, following and analyzing said targets [15]; and c. a display means [40] configured to display a test report [50] received from said processor [20]; wherein said processor [20] is further configured to analyze the eye-tracking data for evidence of one or more neurological disorders or general cognitive performance and to report, in said test report [50], a detection of said one or more neurological disorders or a measure of cognitive performance of said subject [5].
Claim 1 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 11 of U.S. Patent No. US 11,694,803 B2 in view of Martucci (US 20160262680 A1), and further in view of Berme (US 11033453 B1). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are obvious over claim 1 of U.S. Patent No. 11,694,803 B2 in view of Martucci (US 20160262680 A1), and further in view of Berme (US 11033453 B1).
Instant application 18/227,577
Regarding claim 1, 1.A method for evaluating compromises in neurological disorders, fine-motor skills, executive processes, decision making, processing speed and cognitive capabilities associated with Multiple Sclerosis (MS), the method comprising a. providing a system for evaluating compromises in neurological disorders, fine-motor skills, executive processes, decision making, fine motor skills and cognitive capabilities associated with MS; b. requesting a subject to fixate on a reference target of a chart, where the chart includes multiple regions (e.g., rectangles) placed in different zones; c. for a number of repetitions, presenting a stimulus image in one of the zones to the subject, the subject being requested to remember which zone each stimulus image appeared and in what order; d. presenting to the subject the chart without including the stimulus image presented in step c, where the subject is requested to fixate in a zone that is where the stimulus image of step c appeared; e. measuring a saccade of the subject in response to the presenting of step d who is requested to look at the zone in which was presented the stimulus image presented in step c; f. repeating steps d and e of presenting a chart and measuring a saccade; g. repeating steps b-f for a number of trials modifying a time in which the stimulus images are shown; h. calculating one or more of: i. a WM effect, wherein the WM effect is a measure that increases when WM demand increases. For each stimulus image fixated, the WM effect is represented by the ratio between the number of errors reported by the subject through all the trials, and a number of trials); and iv. an average saccadic latency, saccadic latency defined as an amount of time for the subject to initiate a saccade to the zone; and reporting one or more of v. a degree of compromise in working memory, with increased the WM effect; and
l. a degree of compromise in executive processes, with increased saccadic latency; m. wherein the method further comprises additional steps comprising measurements performed during the step of presenting a stimulus image, during which the subject is further requested to look at the stimulus image; the measurements comprising measuring one or more of a. an amplitude of pupillary dilatation of the subject; b. a number of fixations made by the subject on the stimulus image; c. a gaze duration by the subject on the stimulus image; d. binocular disparity by the while visual exploring and target visualization; e. target hit by the subject fixate where the visual stimulus was present previously; f. number of consecutive target hits by the subject when considering a trial; g. Number of blinks coming from the left eye, the right eye or from both eyes; h. an intelligent algorithm with ocolumotor behaviour as income for classifying person's performance; i. Microsaccades' Factors of Form (FF):i) HEWI: shows the microsacade's height / width relationship. ii) AREA: shows the area of the rectangle in which the microsaccade is inscribed; ii) LONG: is the longitude of the horizontal-vertical plane trajectory of the microsaccade. iii) ANG: is the sum of all the angles in the plane horizontal - vertical plane of the microsaccade; iv) AANG: is the sum of all the absolute values of angles in radians in the plane horizontal - vertical plane of the microsaccade; v) MOD and THETA: are the modulus and the angle of the polar coordinates of the sum of the cartesian coordinates; i) TIME: is the time duration in milliseconds of the microsaccade. vii) VMIN and VMAX: are the minimum and maximum velocities of the microsaccades in degrees per second; viii) Microsaccade rate: is the instantaneous rate in each time bin; ix) Directional congruency: is the congruency between the microsaccade direction and the location of the stimulus; j. Obtaining eye position information coming from the left eye, the right eye or from both eyes while performing visual exploration.
U.S. Patent No. 11,694,803 B2
Regarding claim 11. A method for evaluating compromises in neurological functions associated with Multiple Sclerosis [MS], said method comprising steps of: a. providing a system for evaluating compromises in neurological functions associated with MS; b. requesting a subject to fixate on a central fixation cross surrounded by boxes in an upper right, lower right, upper left and lower left zones; c. for a number of repetitions, presenting a stimulus image in one of the zones to the subject; the subject is requested to remember which zone each stimulus image appeared and in what order; d. presenting to the subject a cue corresponding to one of the presented stimulus images e. measuring a saccade of the subject in response to said step of presenting a cue; the subject is requested to look at the zone in which was the presented said stimulus image corresponding to said cue; f. repeating steps of presenting a cue and measuring a saccade; g repeating steps b-e for a number of trials; h. calculating at least one of the following: i. a WM effect, wherein the WM effect is a measure that increases when WM demand increases such that for each cue number, the WM effect is represented by the ratio between a number of errors reported by the subject through all trials, and a number of trials; and ii. an average saccadic latency, saccadic latency defined as an amount of time for said subject to initiate a saccade to said zone; iii. reporting one or more of iv. a degree of compromise in working memory, with increased said WM effect; and ii. a degree of compromise in executive processes, with increased said saccadic latency; h. wherein said method further comprises additional steps comprising measurements performed during said step of presenting a stimulus image, during which said subject is further requested to look at said stimulus image; said measurements comprising measuring at least one of the following: i. a lack in an amplitude of pupillary dilatation of the subject as the cognitive load increases; ii. a number of fixations made by the subject on said stimulus image; and iii a gaze duration by said subject on said stimulus image; and k. said additional steps further comprising calculating and reporting at least one of the following: i. a degree of compromise of subcortical brain areas, with a lack in the amplitude of pupillary dilatation as the cognitive load increases; ii. a degree of compromise of executive processes, with increased said number of fixations; and iii. a degree of compromise of executive processes and working memory, with increased said gaze duration.
U.S. Patent No. 11,694,803 B2 does not recite evaluating compromises in fine-motor skills, executive processes, decision making, processing speed and cognitive capabilities associated with MS.
However, Martucci (US 20160262680 A1) directed to computer-implemented cognitive assessment tool discloses method/system (Abstract, para. [0002]) for evaluating compromises in fine-motor skills, executive processes, decision making, processing speed and cognitive capabilities (“motor”, “executive function”, “decision-making”, “processing speed”; “cognitive abilities”, para. [0094-0095, 0173]) associated with MS (“cognitive losses … multiple sclerosis”, para. [0094-0095, 0147, 0173]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 11 of U.S. Patent No. 11,694,803 B2 such that such that the method/system evaluates compromises in fine-motor skills, executive processes, decision making, processing speed and cognitive capabilities associated with MS, in order to measure cognitive impairment and identify cognitive losses that have arisen due to multiple sclerosis.
U.S. Patent No. 11,694,803 B2 does not recite presenting to the subject the chart without including the stimulus image presented in step c, where the subject is requested to fixate in a zone that is where the stimulus image of step c appeared.
Berme (US 11033453 B1) directed to a neurocognitive training system 800 having a data processing device 814 programmed to generate and display a plurality of visual objects discloses presenting targets 838 in a predetermined pattern for a predetermined period of time (col. 57 line 55-col. 58 line 34); and presenting to the subject the chart without including the stimulus image presented in step c, where the subject is requested to indicate a zone that is where the stimulus image of step c appeared (“period of time … remove the plurality of targets 838 … input signals from the user input device … user's perceived replication of the location and sequence of the plurality of targets”, col. 57 line 55-col. 58 line 34). Berme further discloses that the second training mode continues for a predetermined duration of time with targets being arranged in different patterns during each trial of the training mode and that the neurocognitive training system 800 may be used to diagnose and/or treat the effects of a concussion or traumatic brain injury (TBI) for either preventative maintenance or as part of a return to play protocol (col. 72 lines 60-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 11 of U.S. Patent No. 11,694,803 B2 such that the method further comprises presenting to the subject the chart without including the stimulus image presented in step c, where the subject is requested to fixate in a zone that is where the stimulus image of step c appeared, as such a modification would have been merely a substitution of the step of presenting a cue to the subject of U.S. Patent No. 11,694,803 B2 for the step of removing the plurality of targets and receiving input signals/requesting the user to look at the user's perceived replication of the location and sequence of the plurality of targets in order to diagnose effects of a neurological disorder.
Claim 4 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent No. US 11,694,803 B2 in view of Publicover (US 20150338915 A1). Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are obvious over claim 1 of U.S. Patent No. 11,694,803 B2 in view of Publicover (US 20150338915 A1).
Claim 4 of the instant application corresponds to the patented claim as follows:
Instant application 18/227,577
Regarding claim 4. A system for detecting one or more neurological disorders and/or measuring, fine- motor skills, processing speed, decision making, and cognitive processes in a subject by measuring eye movements, oculomotor features or pupil behaviour, comprising:
a. an eye tracker, configured to monitor eye movements of a subject while the subject is visualizing, recognizing, maintaining, controlling, fixating and analyzing targets;
b. a processor configured to receive data from the eye tracker while the subject is visualizing, recognizing, maintaining, controlling, fixating and analyzing the targets; and
c. a display configured to display a test report received from the processor,
wherein the processor is further configured to analyze the eye-tracking data for evidence of one or more neurological disorders or general cognitive performance and to report, in the test report, a detection of the one or more neurological disorders or a measure of cognitive performance of the subject.
U.S. Patent No. 11,694,803 B2
Regarding claim 1. A system for detecting one or more cognitive disorders that include frontal, temporal, and or parietal lobes alterations in a subject by measuring eye movements; said measuring of eye movements performed while said subject is reading; said system comprising
a. an eye tracker, configured to monitor eye movements of a subject while the subject is reading a text;
b. a processor, configured to receive data from said eye tracker while said subject is reading said text; and
c. a display means configured to display a test report received from said processor;
wherein said processor is further configured to analyze the eye-tracking data for evidence of one or more cognitive compromises and to report, in said test report, a detection of a measure of cognitive compromises in specific cognitive domains that include at least one of working memory, retrieval memory, executive and attentional processes of said subject.
U.S. Patent No. 11,694,803 B2 does not recite a subject visualizing, recognizing, maintaining, controlling, fixating and analyzing.
Publicover (US 20150338915 A1) directed to systems and methods provided for discerning the intent of a device wearer primarily based on movements of the eyes using eye tracking cameras and using measurements of eye movements to determine a wide range of pathological conditions (in particular, neuro-muscular disorders) and the effects of drugs and other compounds (para. [0128, 0236]) discloses a subject visualizing, recognizing, maintaining, controlling, fixating and analyzing (“recognize”; “fixation … maintain”; “control”; “visualizing virtual objects”, para. [0091, 0122, 0163, 0220-0221, 0302-0303, 0478]) targets (real or virtual object 130, star icon 134, parallelogram icon 136, figs. 1A-1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 1 of U.S. Patent No. 11,694,803 B2 such that the subject is visualizing, recognizing, maintaining, controlling, fixating and analyzing targets, in view of the teachings of Publicover, as such a modification would have yielded predictable results, namely tracking and measuring eye movements of the subject visualizing virtual objects to detect or monitor pathological conditions/neurological disorders.
Claim Objections
Claims 1-2, 5 and 7 are objected to because of the following informalities:
“the zone in which was presented the stimulus image presented in step c” in claim 1 line 16 should recite “the zone in which the stimulus image was presented in step c”.
“iv.” in claim 1 line 25 should recite “j.”
“v.” in line claim 1 line 26 should recite “k.”
“the step of presenting a stimulus image” in claim 1 line 30 should recite “the step of presenting the stimulus image”.
Claim 1 line 44 “ii) Area ” should recite “iii) Area” and be moved into line 43. iii-ix used in lines 46-56 should use iv-x.
The punctuation “.” in claim 1 lines 44 & 52 should be “;”.
The space between lines 57 & 58 in claim 1 should be removed.
“preventing them from” in claim 2 line 5 and claim 6 line 5 should recite “preventing the lymphocytes from”.
“ofvisualizing” in claim 5 line 18 should be “of visualizing”.
“testreport” in claim 5 line 27 should be “test report”.
The punctuation “.” in claim 5 lines 32, 37 & 54 should be “;”.
The space between lines 39 & 41 in claim 5 should be removed.
The space between lines 56 & 57 in claim 5 should be removed.
Claim 5 line 65 “cartesian coordinates. They give” should recite “cartesian coordinates to give.”
Claim 5 recites step “x.” in lines 56 & 72. Since claim 5 has more than 26 steps (more steps than the number of possible letters) it is suggested to remove the letters a-z that designate each step or re-write claim 5 with numbers designating each step.
The punctuation “.” should be added after “Ofatumumab” in claim 7.
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.
Claim 1-3 and 5-7 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.
Regarding claim 1 (claims 2-3 by virtue of dependency), the phrase “e.g.” renders the claim indefinite because it is unclear whether the limitation(s) (“rectangles”) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2 (claim 3 by virtue of dependency) recites the limitations “test the Sphingosine-l-phosphate receptor modulator”, “the lymphocytes nodes”, and “analyze the effect … the activation”. There is insufficient antecedent basis for these limitation in the claim. The limitations are suggested to recite “test a Sphingosine-l-phosphate receptor modulator”, “sequesters lymphocytes in lymphocytes nodes”, and “analyze an effect … an activation”.
Claim 5 recites the limitation “the pupil diameter” in line 33. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a pupil diameter”.
Claim 5 recites the limitations “the length of gaze duration” in line 44. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a length of gaze”.
Claim 6 (claim 7 by virtue of dependency) recites the limitations “the lymphocytes nodes” and “analyze the effect … the activation”. There is insufficient antecedent basis for these limitation in the claim. The limitations are suggested to recite “sequesters lymphocytes in lymphocytes nodes”, and “analyze an effect … an activation”.
Claims 1-3 and 5 are rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim 1 (claims 2-3 by virtue of dependency) (see claim 1 lines 42-57) and claim 5 (see lines 56-78) are narrative in form and replete with indefinite language with respect to the limitations defining the Microsaccades’ Factors of Form. The structure/steps which goes to make up the device/method must be clearly and positively specified. The structure/steps must be organized and correlated in such a manner as to present a complete operative device/method. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited.
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 4-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 4-7 are all within at least one of the four categories.
Independent claim 4 recites:
A system for detecting one or more neurological disorders and/or measuring, fine- motor skills, processing speed, decision making, and cognitive processes in a subject by measuring eye movements, oculomotor features or pupil behaviour, comprising: a. an eye tracker, configured to monitor eye movements of a subject while the subject is visualizing, recognizing, maintaining, controlling, fixating and analyzing targets; b. a processor configured to receive data from the eye tracker while the subject is visualizing, recognizing, maintaining, controlling, fixating and analyzing the targets; and c. a display configured to display a test report received from the processor, wherein the processor is further configured to analyze the eye-tracking data for evidence of one or more neurological disorders or general cognitive performance and to report, in the test report, a detection of the one or more neurological disorders or a measure of cognitive performance of the subject.
The above claim limitations (detecting, measuring, monitoring, analyzing) constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
The claimed steps of detecting, measuring, monitoring, analyzing can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps detecting one or more neurological disorders and/or measuring, fine-motor skills, processing speed, decision making, and cognitive processes that includes detecting, measuring, monitoring, analyzing.
Examples of ineligible claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract (claims 5-7) or 2) additional data gathering/output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
This judicial exception (abstract idea) in Claims 4-7 is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for detecting, measuring, monitoring, analyzing merely invoke a computer as a tool.
The data-gathering step (receiving) and the data-output step (display[ing]) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for detecting, measuring, monitoring, analyzing.
The claims do not apply the abstract idea to affect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine detect one or more neurological disorders and/or measure, fine-motor skills, processing speed, decision making, and cognitive processes.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for detecting, measuring, monitoring, analyzing. The claims do not apply the obtained calculation to a particular machine. Rather, the data is merely output in a post-solution step.
The additional elements are identified as follows: eye tracker; processor; display.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s specification (e.g., pages 21-22) which discloses the processor comprises generic computer components that are configured to perform the generic computer functions (e.g., calculat[ing], identify[ing], exclud[ing]) that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Applicant’s Background in the specification;
Whitlow (US 20120259803 A1) disclose, in para. [0030], a conventional processor.
Hein (US 20140003658 A1) discloses, in para. [0037], a conventional eye-tracker;
Ettenhofer (US 20160022136 A1) discloses, in para. [0077], conventional eye-tracking technologies to assess the fixation of the subject’s gaze.
Kwon (US 20140337740 A1) discloses, in para. [0047], a conventional display apparatus.
The non-patent literature of record in the application.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e., the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Fernandez (US 20210174959 A1) in view of Martucci (US 20160262680 A1), and further in view of Berme (US 11033453 B1).
Regarding claim 1, Fernandez discloses a method for evaluating compromises in neurological disorders, associated with Multiple Sclerosis (MS) (Abstract, fig. 3A, para. [0258-0280), the method comprising a. providing a system for evaluating compromises in neurological disorders, associated with MS (305, fig. 3A, para. [0259]); b. requesting a subject to fixate on a reference target of a chart (“reference target … central position … chart”, para. [0080, 0260]), where the chart includes multiple regions (e.g., rectangles) placed in different zones (“zones”, para. [0080, 0261], as seen in fig. 1); c. for a number of repetitions, presenting a stimulus image in one of the zones to the subject, the subject being requested to remember which zone each stimulus image appeared and in what order (“repetitions, presenting … remember which zone”, para. [0261]).
Fernandez does not disclose the method/system for evaluating compromises in fine-motor skills, executive processes, decision making, processing speed and cognitive capabilities associated with MS.
However, Martucci directed to computer-implemented cognitive assessment tool discloses method/system (Abstract, para. [0002]) for evaluating compromises in fine-motor skills, executive processes, decision making, processing speed and cognitive capabilities (“motor”, “executive function”, “decision-making”, “processing speed”; “cognitive abilities”, para. [0094-0095, 0173]) associated with MS (“cognitive losses … multiple sclerosis”, para. [0094-0095, 0147, 0173]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fernandez such that the method/system evaluates compromises in fine-motor skills, executive processes, decision making, processing speed and cognitive capabilities associated with MS, in order to measure cognitive impairment and identify cognitive losses that have arisen due to multiple sclerosis.
Fernandez further discloses presenting to the subject a cue corresponding to one of the presented stimulus images and that the subject is requested to look at the zone in which was the presented stimulus image corresponding to the cue (para. [0263]).
Fernandez, as modified by Martucci hereinabove, does not disclose d. presenting to the subject the chart without including the stimulus image presented in step c, where the subject is requested to fixate in a zone that is where the stimulus image of step c appeared.
However, Berme directed to a neurocognitive training system 800 having a data processing device 814 programmed to generate and display a plurality of visual objects discloses presenting targets 838 in a predetermined pattern for a predetermined period of time (col. 57 line 55-col. 58 line 34); and presenting to the subject the chart without including the stimulus image presented in step c, where the subject is requested to indicate a zone that is where the stimulus image of step c appeared (“period of time … remove the plurality of targets 838 … input signals from the user input device … user's perceived replication of the location and sequence of the plurality of targets”, col. 57 line 55-col. 58 line 34). Berme further discloses that the second training mode continues for a predetermined duration of time with targets being arranged in different patterns during each trial of the training mode and that the neurocognitive training system 800 may be used to diagnose and/or treat the effects of a concussion or traumatic brain injury (TBI) for either preventative maintenance or as part of a return to play protocol (col. 72 lines 60-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fernandez such that the method further comprises presenting to the subject the chart without including the stimulus image presented in step c, where the subject is requested to fixate in a zone that is where the stimulus image of step c appeared, as such a modification would have been merely a substitution of the step of presenting a cue to the subject of Fernandez for the step of removing the plurality of targets and receiving input signals/requesting the user to look at the user's perceived replication of the location and sequence of the plurality of targets in order to diagnose effects of a neurological disorder.
Fernandez, as modified by Martucci and Berme hereinabove, discloses e. measuring a saccade of the subject in response to the presenting of step d who is requested to look at the zone in which was presented the stimulus image presented in step c (“measuring a saccade”, para. [0263]); f. repeating steps d and e of presenting a chart and measuring a saccade (“repeating”, para. [0264]); g. repeating steps b-f for a number of trials modifying a time in which the stimulus images are shown (Fernandez, “repeating … trials”, para. [0265] & Berme col 57 line 55 – col. 58 line 34); h. calculating one or more of: i. a WM effect, wherein the WM effect is a measure that increases when WM demand increases. For each stimulus image fixated, the WM effect is represented by the ratio between the number of errors reported by the subject through all the trials, and a number of trials) (“WM effect”, para. [0267]); and iv. an average saccadic latency, saccadic latency defined as an amount of time for the subject to initiate a saccade to the zone (“average saccadic latency”, para. [0268]); and reporting one or more of v. a degree of compromise in working memory, with increased the WM effect (para. [0270]); and l. a degree of compromise in executive processes, with increased saccadic latency (para. [0271]); m. wherein the method further comprises additional steps comprising measurements performed during the step of presenting a stimulus image, during which the subject is further requested to look at the stimulus image (para. [0272-0273]); the measurements comprising measuring one or more of a. an amplitude of pupillary dilatation of the subject (para. [0274]); b. a number of fixations made by the subject on the stimulus image (para. [0275]); c. a gaze duration by the subject on the stimulus image (para. [00276]); d. binocular disparity by the while visual exploring and target visualization; e. target hit by the subject fixate where the visual stimulus was present previously; f. number of consecutive target hits by the subject when considering a trial; g. Number of blinks coming from the left eye, the right eye or from both eyes (para. [0178, 0287]); h. an intelligent algorithm with ocolumotor behaviour as income for classifying person's performance (para. [0034, 0281); i. Microsaccades' Factors of Form (FF) (para. [0288]): i) HEWI: shows the microsacade's height / width relationship (para. [0290]). ii) AREA: shows the area of the rectangle in which the microsaccade is inscribed (para. [0290]); ii) LONG: is the longitude of the horizontal-vertical plane trajectory of the microsaccade (para. [0291]). iii) ANG: is the sum of all the angles in the plane horizontal - vertical plane of the microsaccade (para. [0292]); iv) AANG: is the sum of all the absolute values of angles in radians in the plane horizontal - vertical plane of the microsacaccade (para. [0293]); v) MOD and THETA: are the modulus and the angle of the polar coordinates of the sum of the cartesian coordinates (para. [0294]); i) TIME: is the time duration in milliseconds of the microsaccade (para. [0296]). vii) VMIN and VMAX: are the minimum and maximum velocities of the microsaccades in degrees per second (para. [0297]); viii) Microsaccade rate: is the instantaneous rate in each time bin (para. [0298]); ix) Directional congruency: is the congruency between the microsaccade direction and the location of the stimulus (para. [0299]); j. Obtaining eye position information coming from the left eye, the right eye or from both eyes while performing visual exploration (para. [0300]).
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wetzel (US 20160022137 A1) in view of Publicover (US 20150338915 A1) in view of Martucci (US 20160262680 A1).
Regarding claim 4 Wetzel discloses a system (figs. 1-2) for detecting one or more neurological disorders (“assessing Parkinson’s Disease”; “eye movements … oculomotor function”, Abstract, para. [0027, 0039, 0094-0098]) and/or measuring, fine- motor skills, processing speed, decision making, and cognitive processes in a subject by measuring eye movements, oculomotor features or pupil behaviour (“eye movements … oculomotor function”, Abstract, para. [0027, 0039, 0094-0098]), comprising: a. an eye tracker (eye tracker 10, fig. 1), configured to (Examiner’s Note: functional language, i.e., capable of) monitor eye movements of a subject while the subject is following targets (“reading analysis … eye movement”; “stimuli were presented … data were then collected while subjects followed”, para. [0027-0028, 0034-0035, 0052], (see also para. [0039, 0056, 0106])); b. a processor (“processor”, para. [0027, 0041-0042]) configured to receive data from the eye tracker while the following the targets (“reading analysis”; “stimuli were presented … data were then collected while … target”, para. [0027-0028, 0034-0035, 0052], (see also para. [0039, 0056, 0106]), fig. 1); and c. a display (“output device … display”, para. [0045]) configured to (Examiner’s Note: functional language, i.e., capable of) display a test report received from the processor (“output”, para. [0045], diagnosis 30, fig. 1), wherein the processor (“processor”, para. [0027, 0041-0042]) is further configured to analyze the eye-tracking data for evidence of one or more neurological disorders or general cognitive performance (“algorithmic stages … detection … likely neurological diagnosis”, para. [0027-0028, 0039], fig. 1) and to report, in the test report, a detection of the one or more neurological disorders (diagnosis 30, fig. 1 & suggestive of PD 184, fig. 7B) or a measure of cognitive performance of the subject.
Wetzel does not expressly disclose a subject visualizing, recognizing, maintaining, controlling, fixating and analyzing targets.
However, Publicover directed to systems and methods provided for discerning the intent of a device wearer primarily based on movements of the eyes using eye tracking cameras and using measurements of eye movements to determine a wide range of pathological conditions (in particular, neuro-muscular disorders) and the effects of drugs and other compounds (para. [0128, 0236]) discloses a subject visualizing, recognizing, maintaining, controlling, fixating and analyzing (“recognize”; “fixation … maintain”; “control”; “visualizing virtual objects”, para. [0091, 0122, 0163, 0220-0221, 0302-0303, 0478]) targets (real or virtual object 130, star icon 134, parallelogram icon 136, figs. 1A-1B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wetzel such that the subject is visualizing, recognizing, maintaining, controlling, fixating and analyzing targets, in view of the teachings of Publicover, as such a modification would have yielded predictable results, namely tracking and measuring eye movements of the subject visualizing virtual objects to assess Parkinson’s disease.
Wetzel, as modified by Publicover does not disclose measuring, fine-motor skills, processing speed, decision making, and cognitive processes in a subject, general cognitive performance and to report, in the test report, a measure of cognitive performance of the subject.
However, Martucci directed to computer-implemented cognitive assessment tool discloses measuring, fine-motor skills, processing speed, decision making, and cognitive processes in a subject (para. [0094-0095, 0173]) by measuring eye movements, oculomotor features or pupil behaviour (“measurements … eye movements, pupil dilation”, para. [0095, 0099]), general cognitive performance (“cognitive performance”, para. [0113-0114]) and to report, in a test report, a measure of cognitive performance of the subject (“output a cognitive measure”, para. [0113-0114]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wetzel, as modified by Publicover hereinabove, such that the system measures, fine- motor skills, processing speed, decision making, and cognitive processes in a subject, analyzes the eye-tracking data for evidence of one or more of general cognitive performance and to report, in the test report, a measure of cognitive performance of the subject, in view of the teachings of Publicover, in order to assess cognitive ability of an individual while multi-tasking by providing a computer-implemented methods for measuring cognitive function of an individual.
Allowable Subject Matter
Claims 2-3 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.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record either taken singularly or in a combination fails to anticipate or fairly suggest the limitations:
“calculating, modelling and reporting one or more effects of drugs or treatments that (a) decrease inflammation and prevent nerve damage that can cause symptoms of multiple sclerosis); (b) test Sphingosine-l-phosphate receptor modulator, which sequesters lymphocytes in the lymphocytes nodes, preventing them from contributing to an autoimmune reaction); (c) check an immune suppressor agent that works on the lymphocyte's pathway); and/or (d) analyze the effect of Monoclonal Antibodies for inhibiting the activation of lymphocyte B”;
“the drugs are selected from the group consisting of Dimethyl fumarate, Fingolimod, Cladribine, Interferon-Beta and Ofatumumab”;
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Alster (US 7275830 B2) directed to methods systems for performing an eye test and for detecting eye disease and screen diagrams 300, 320, 330, 340, 350, 360 including exemplary test patterns comprising segments 229 and a fixation target 228 adjacent to one of the segments which may be presented to a tested subject; Gazzaley (US 20140370479 A1) directed to methods and tools for enhancing cognition and improving well being in an individual whose cognitive losses have arisen as a consequence of multiple sclerosis (Abstract, para. [0196]); Londesbrough (US 20220169668 A1) directed to methods of treating neurocognitive disorders, chronic pain and reducing inflammation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/A.E.H./Examiner, Art Unit 3791