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 .
Election/Restrictions
Applicant’s election without traverse of Species A, claims 1-8 in the reply filed on 3/23/2026 is acknowledged.
Claims 9-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/23/2026.
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.
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Claim(s) 1-5 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 2, 3, 4, 5, 14, 15, 17 of U.S. Patent No. 11896376. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application claim(s) is/are broader than the corresponding claim(s) in the reference patent and thus the corresponding claim(s) is/are a species of the more generic instant claim(s). It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Furthermore, they are not patentably distinct from each other because the instant application claim(s) overlap in scope with and are anticipated and/or obvious over the reference claim(s).
Regarding claim 1, U.S. Patent No. 11896376 teaches a system comprising:
a display (claim 1 “display”);
a stimulus on the display (claim 1 “a stimulus on the display”);
a controller, wherein the controller is programmed to move the stimulus about the display (claim 1 “controller…”);
one or more sensors, wherein the one or more sensors track eye movements and pupil size of a user due to movement of the stimulus or light conditions (claim 1 “one or more sensors…”);
a dataset of impaired and sober individuals (claim 1 “a database of impaired and sober individuals…”);
machine learning algorithms that are trained with the dataset of impaired and sober individuals (claim 1 “machine learning algorithms…”); and
a processor programmed to analyze eye movements and pupil size data (claim 1 “a processor…”).
Regarding claim 2, U.S. Patent No. 11896376 teaches wherein the processor programmed to use the machine learning algorithms to analyze eye movements and pupil size data (claim 1 “processor programmed to use the machine learning algorithms…”);
a database of known test subjects (claim 1 “a database of known test subjects”);
wherein the processor is programmed to automatically identify the user based on eye measurement data if the user is contained within the database of known test subjects (claim 1 “wherein the processor is programmed to automatically identify the user…”);
wherein based on the automatic identification of the user the controller is programmed to administer certain tests that are most relevant to the user (claim 1 “wherein based on the automatic identification of the user the controller is programmed to administer certain tests that are most relevant to the user”);
wherein the one or more sensors capture gaze vector data of the user's vision and wherein the processor is programmed to analyze the captured gaze vector data to evaluate impairment (claim 5); and
wherein the controller is programmed to measure lack of convergence, saccades, nystagmus, hippus, eye smoothness, reaction time, pupillary rebound dilation, and pupillary reflex for the purposes of impairment detection (claim 17).
Regarding claim 3, U.S. Patent No. 11896376 teaches wherein the controller is programmed to capture data using skin-contact or non-contact sensors, including one or more of temperature, pulse rate, pulse rate variability, respiratory rate, pulse oxygenation, heart rhythm, blood pressure, and muscle tone (claim 15) and wherein the controller is programmed to move the stimulus to perform an impairment test (claim 2 “the controller is programmed to move the stimulus to perform an impairment test”).
Regarding claim 4, U.S. Patent No. 11896376 teaches wherein the controller is programmed to measure lack of convergence, saccades, nystagmus, hippus, eye smoothness, reaction time, pupillary rebound dilation, eye openness, and pupillary reflex (claim 17) and wherein the controller is program to display specific light levels and measure pupillary reflex response (claim 14).
Regarding claim 5, U.S. Patent No. 11896376 teaches wherein the controller is programmed to stimulate pupil response using varying light conditions to perform an impairment test (claim 3), wherein the one or more sensor capture pupil size data (claim 4), and wherein the one or more sensors capture gaze vector data of the user's vision (claim 5).
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.
Claim(s) 1, 3-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roshan (US 20220386953 A1; Filed 6/4/2020; cited in IDS) in view of Frank (US 20200397306 A1; 12/24/2020; cited in IDS).
Regarding claim 1, Roshan teaches a system comprising:
a display (Fig. 1; Fig. 28; Fig. 31);
a stimulus on the display ([0054]-[0055]; [0072]);
a controller, wherein the controller is programmed to move the stimulus about the display (Fig. 1; Fig. 28; Fig. 31; [0072]; [0077]);
one or more sensors, wherein the one or more sensors track eye movements and pupil size of a user due to movement of the stimulus or light conditions (Fig. 1; Fig. 15 “pupil size”; Fig. 28; Fig. 31; [0081] “eye movement”; [0182]-[0183]).
Roshan does not teach a dataset of impaired and sober individuals;
machine learning algorithms that are trained with the dataset of impaired and sober individuals.
Note that Roshan does teach machine learning ([0167] "analyzed automatically (Al, machine learning, etc.)". However, Frank teaches in the same field of endeavor ([0012]) a dataset of impaired and sober individuals ([0178]);
machine learning algorithms that are trained with the dataset of impaired and sober individuals ([0178]-[0179]).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Roshan to include these features as taught by Frank because this enables using trained machine learning to evaluate impairment/intoxication ([0012]; [0178]-[0179]).
The combination of Roshan and Frank teaches a processor programmed to analyze eye movements and pupil size data (Roshan Fig. 1; Fig. 28; Fig. 31; [0081]; [0182]-[0183]; [0167] "analyzed automatically (Al, machine learning, etc.)"; Frank [0241]; [0392]-[0394] "processor''; [0399] "eye movements and/or pupil diameter").
Regarding claim 3, the combination of Roshan and Frank teaches wherein the controller is programmed to capture data using skin-contact or non-contact sensors (Roshan Fig. 28; [0065]; Frank [0399]), including one or more of temperature (Roshan Fig. 28 "Skin temperature"), pulse rate (Roshan Fig. 28 "Heart rate"), pulse rate variability (Frank [0171] "heart rate variability"), respiratory rate (Frank [0399] “respiration rate”), pulse oxygenation (Frank [0062]), heart rhythm (Roshan Fig. 28 "Heart rate"), blood pressure (Roshan Fig. 28 "Blood pressure"), and muscle tone (Roshan Fig. 28 "Muscle tone"; [0065]) and wherein the controller is programmed to move the stimulus to perform an impairment test (Roshan [0180]-[0183]).
Regarding claim 4, the combination of Roshan and Frank teaches wherein the controller is programmed to measure lack of convergence (Roshan [0122]), saccades (Roshan [0107] "non-smooth movements"; [0112] "sudden and jerky movements"), nystagmus (Roshan [0110]-[0112]), hippus (Roshan claim 15 "Hippus test"), eye smoothness (Roshan claim 15 "lack of smooth pursuit"), reaction time (Roshan [0186]; claim 17), pupillary rebound dilation (interpreted in light of instant specification [0048]; Roshan [0183] "a sudden change in the light intensity will be performed and the movement and size of the pupil will be tracked"), eye openness, and pupillary reflex (Roshan [0183] "amount of constriction or dilation is significantly different than normal eye, or the speed of constriction or dilation is significantly different than normal eye") and wherein the controller is program to display specific light levels and measure pupillary reflex response (Roshan [0183] "sudden change in the light intensity will be performed and the movement and size of the pupil will be tracked").
Regarding claim 5, the combination of Roshan and Frank teaches wherein the controller is programmed to stimulate pupil response using varying light conditions to perform an impairment test (Roshan [0183] “sudden change in the light intensity”), wherein the one or more sensor capture pupil size data (Roshan [0103]; [0183] “size of pupil”), and wherein the one or more sensors capture gaze vector data of the user's vision (Roshan [0091]; [0182]; claim 15).
Regarding claim 6, the combination of Roshan and Frank teaches wherein the controller is programmed to identify impairment due to a central nervous system depressant (Roshan [0091] “alcohol” reads on central nervous system depressant) when the user displays horizontal gaze nystagmus (Roshan [0088]-[0091]; [0110]-[0112]), lack of convergence (Roshan [0122] “not being able to converge”), and slow reaction to light (Roshan [0183] “speed of constriction or dilation is significantly different than normal eye”; [0186] “response time larger than a predetermined threshold”).
Regarding claim 7, the combination of Roshan and Frank teaches wherein the controller is further programmed to identify impairment due to the central nervous system depressant (Roshan [0091] “alcohol” reads on central nervous system depressant).
The combination of Roshan and Frank does not teach when the user's reaction time is below one standard deviation lower than an average reaction time. However, Roshan teaches measuring reaction time (Roshan [0138]-[0139]; [0142]-[0143]; [0186]) and using the measurement below a predetermined threshold to determine impairment due to alcohol, a central nervous depressant (Roshan [0091] “alcohol” reads on central nervous system depressant; [0143] “average reaction time”; [0186] “response time larger than a predetermined threshold”). It would have been obvious to use the threshold of “below one standard deviation lower than an average reaction time” because this is a result-effective variable; MPEP 2144.05; it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
The combination of Roshan and Frank does not teach the user's motion tracking accuracy is below one standard deviation lower than average motion tracking accuracy. However, Roshan teaches measuring motion tracking (Roshan Fig. 10; [0098]; [0107]; [0182] “movement is significantly different than the movement of light…difference should be greater than a predetermined threshold value”). It would have been obvious to use the threshold of “below one standard deviation lower than an average” because this is a result-effective variable; MPEP 2144.05; it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
The combination of Roshan and Frank does not teach the user's saccadic accuracy is below one standard deviation lower than average saccadic accuracy. However, Roshan teaches measuring saccadic accuracy (Roshan [0107] "non-smooth movements"; [0112] "sudden and jerky movements"; [0182] “movement is significantly different than the movement of light…difference should be greater than a predetermined threshold value”; [0183] “eye has jerky movements”). It would have been obvious to use the threshold of “below one standard deviation lower than an average” because this is a result-effective variable; MPEP 2144.05; it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 8, the combination of Roshan and Frank teaches wherein the controller is further programmed to identify impairment due to the central nervous system depressant (Roshan [0091] “alcohol” reads on central nervous system depressant).
The combination of Roshan and Frank does not teach when the user's eye openness is below one standard deviation lower than average eye openness. However, Roshan teaches measuring user's eye openness ([0086]-[0087] “eyelid twitching…movement of the eyelid may be recorded”; [0189] “The significant deviation means a deviation larger than a predetermined threshold value”). It would have been obvious to use “below one standard deviation lower than an average” because this is a result-effective variable; MPEP 2144.05; it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
The combination of Roshan and Frank does not teach the user's pulse rate is below one standard deviation lower than average pulse rate, the user's blood pressure is below one standard deviation lower than average blood pressure, and the user's flaccid muscle tone is below one standard deviation lower than average flaccid muscle tone. However, Roshan teaches measuring user’s pulse rate, blood pressure, and muscle tone (Roshan [0150] “blood pressure, pulse rate…muscle tone; [0189] “blood pressure measurement, heart rate measurement, and muscle tone measurement. “”Failing”” each test means that the measured parameters significantly varies from the ”normal” values. The “normal” values can either be determined with the subject baseline information…measuring the parameter on multiple subjects and averaging the values for a “normal” value. The significant deviation means a deviation larger than a predetermined threshold value”.). It would have been obvious to use the threshold of “below one standard deviation lower than an average” because this is a result-effective variable; MPEP 2144.05; it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter with respect to 35 U.S.C. 102/35 U.S.C.103
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 2 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the processor is programmed to automatically identify the user based on eye measurement data if the user is contained within the database of known test subjects;
wherein based on the automatic identification of the user the controller is programmed to administer certain tests that are most relevant to the user;
wherein the one or more sensors capture gaze vector data of the user's vision and wherein the processor is programmed to analyze the captured gaze vector data to evaluate impairment; and wherein the controller is programmed to measure lack of convergence, saccades, nystagmus, hippus, eye smoothness, reaction time, pupillary rebound dilation, and pupillary reflex for the purposes of impairment detection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/ Primary Examiner, Art Unit 3792
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