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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 12/8/25, amended claim(s) 1 and 18 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-13, 18, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2016/0073874 to Tsai et al. (hereinafter “Tsai”) in view of U.S. Patent Application Publication No. 2004/0233061 to Johns.
For claim 1, Tsai discloses a method for detecting changes associated with an eye generated in response to impaired neurological function (para [0022]), the method comprising:
stimulating at least one facial region of a subject using at least one stimulator so as to cause an involuntary blink response in the subject (para [0005], [0006], and/or [0007]) (see “Apply Stimulus” in Fig. 6C);
detecting a start of eyelid movement resulting from the stimulating step (see Figs. 6B and 6C including TBR) (also see Figs. 8A-D) (para [0081]);
determining at least one parameter of the response by calculating a lid velocity value (670 in Fig. 6C, 840 in Fig. 8B) based on measuring one or both eyes (para [0080]) over a time period following the detected start of eyelid movement (TBR in Fig. 6C);
comparing the calculated lid velocity value (840) (Fig. 8B) (para [0095]) over the time period following the detected start of eyelid movement to a baseline lid velocity value (830) (Fig. 8B) (para [0095]) over the time period following the detected start of eyelid movement (para [0095], see “baseline blink reflex” and “blink reflex of the eye … at a current time”);
determining at least one additional parameter of the response from one or both eyes based on measuring one or both eyes beyond the time period and resulting from the stimulating step (“blink period associated with the phases of the blink,” para [0082]) (Examiner’s Note: Fig. 6C shows that the stimulus is provided before TBR since the “Apply Stimulus” vertical line is to the left of TBR in the graph depicted in Fig. 6C); and
displaying information related to the at least one parameter and the at least one additional parameter (para [0030], [0032], and [0059]) (also see claims 15-16, 18, and 24).
Tsai does not expressly disclose that the time period is preset and that the comparing is over a preset time period.
However, Johns teaches a preset time period (“predetermined duration,” para [0028]) and making a comparison over that preset time period (para [0028]), the comparison can be based on lid velocity (para [0017]).
It would have been obvious to a skilled artisan to modify Tsai such that the time period is preset and that the comparing is over a preset time period, in view of the teachings of Johns, for the obvious advantage of continuously updating the baseline so that it is dynamic and personalized to the individual (see para [0028] of Johns).
For claim 2, Tsai further discloses wherein the at least one additional parameter comprises individual latency of one or both eyes of the subject (“blink period,” para [0022]) (also see para [0037]).
For claim 3, Tsai further discloses wherein the at least one additional parameter comprises a differential latency between both eyes of the subject (para [0038]).
For claim 5, Tsai further discloses wherein the at least one additional parameter comprises measuring the tonic lid position of one or both eyes of the subject (para [0036]-[0037] and [0043]).
For claim 6, Tsai further discloses wherein the at least one additional parameter comprises changes in at least one of individual latency, differential latency, oscillations, and tonic lid position (para [0025], [0035]-[0036], and/or [0038]-[0039]).
For claim 7, Tsai further discloses comparing the at least one additional parameter to the at least one parameter measured at baseline (para [0004] and/or [0006]); and displaying information related to at least one difference between the at least one additional parameter and the at least one parameter measured at baseline (para [0006] and [0032]).
For claim 8, Tsai further discloses wherein the suspected impaired neurological function is the result of a traumatic event, a head impact, or a mild traumatic brain injury (para [0004]).
For claim 9, Tsai further discloses determining if the subject has a mild traumatic brain injury (para [0004] and [0006]).
For claim 10, Tsai further discloses wherein the at least one facial region comprises the temple (see Figs. 1A-B) (also see para [0028]).
For claim 11, Tsai further discloses wherein the at least one facial region comprises the outer canthus (see Figs. 1A-B) (also see para [0028]).
For claim 12, Tsai further discloses wherein the at least one facial region comprises the eye (see Figs. 1A-B) (also see para [0028]).
For claim 13, Tsai further discloses comparing the at least one additional parameter to at least one parameter measured at baseline (para [0004] and/or [0006]); displaying information related to a difference between the at least one additional parameter and the at least one parameter measured at baseline (para [0006] and [0032]); determining based on the at least one additional parameter whether the subject has suffered a mild traumatic brain injury (para [0004] and [0006]); and indicating whether the subject has suffered a mild traumatic brain injury (para [0004] and [0006]); wherein the at least one parameter comprises measuring in one or both eyes of the subject changes in at least one of individual latency, differential latency, oscillations, and tonic lid position (para [0025], [0035]-[0036], and/or [0038]-[0039]).
For claim 18, Tsai discloses a method for detecting changes associated with an eye generated in response to impaired neurological function (para [0022]), the method comprising:
stimulating a subject using at least one stimulator so as to cause an involuntary blink response in the subject (para [0005], [0006], and/or [0007]) (see “Apply Stimulus” in Fig. 6C);
detecting a start of eyelid movement resulting from the stimulating step (see Figs. 6B and 6C including TBR) (also see Figs. 8A-D) (para [0081]);
determining at least one parameter of the response by calculating a lid velocity value (670 in Fig. 6C, 840 in Fig. 8B) based on measuring one or both eyes (para [0080]) over a time period following the start of eyelid movement (TBR in Fig. 6C);
comparing the calculated lid velocity value (840) (Fig. 8B) (para [0095]) over the time period following the detected start of eyelid movement to a baseline lid velocity value (830) (Fig. 8B) (para [0095]) over the time period following the detected start of eyelid movement (para [0095], see “baseline blink reflex” and “blink reflex of the eye … at a current time”);
determining at least one additional parameter of the response from one or both eyes based on measuring one or both eyes beyond the time period and resulting from the stimulating step (“blink period associated with the phases of the blink,” para [0082]) (Examiner’s Note: Fig. 6C shows that the stimulus is provided before TBR since the “Apply Stimulus” vertical line is to the left of TBR in the graph depicted in Fig. 6C); and
generating a signal (“signal,” para [0060]-[0061]) indicative of an impairment when the calculated lid velocity is less than the baseline calculated lid velocity value (para [0095]).
Tsai does not expressly disclose that the time period is preset and that the comparing is over a preset time period.
However, Johns teaches a preset time period (“predetermined duration,” para [0028]) and making a comparison over that preset time period (para [0028]), the comparison can be based on lid velocity (para [0017]).
It would have been obvious to a skilled artisan to modify Tsai such that the time period is preset and that the comparing is over a preset time period, in view of the teachings of Johns, for the obvious advantage of continuously updating the baseline so that it is dynamic and personalized to the individual (see para [0028] of Johns).
For claim 21, Tsai futher discloses comparing the measured lid velocity (840) (Fig. 8B) to a baseline lid velocity (830) (Fig. 8B) (para [0095]); and generating a signal (“signal,” para [0060]-[0061]) indicative of an impairment when the measured lid velocity is less than the baseline lid velocity (para [0095]).
Claim(s) 4 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai in view Johns, and further in view of U.S. Patent Application Publication No. 2016/0317056 to Moon et al. (hereinafter “Moon”).
For claim 4, Tsai further discloses wherein the at least one additional parameter comprises oscillations of one or both eyes of the subject (“when the eyelid, in an open state, begins to close … and the eye of the subject returns to the open state,” para [0035]).
Tsai and Johns do not expressly disclose counting oscillations/eyeblinks.
However, Moon teaches counting oscillations/eyeblinks (para [0337]).
It would have been obvious to a skilled artisan to modify Tsai wherein the at least one parameter comprises counting oscillations/eyeblinks, in view of the teachings of Moon, for the obvious advantage of taking into account a condition of the user such as fatigue when performing the diagnosis of Tsai.
For claim 19, Tsai further discloses measuring the involuntary blink response (para [0005], [0006], and/or [0007]).
Tsai and Johns do not expressly disclose counting oscillations of one or both eyes of the subject.
However, Moon teaches counting oscillations of one or both eyes of the subject (para [0337]).
It would have been obvious to a skilled artisan to modify Tsai to include counting oscillations of one or both eyes of the subject, in view of the teachings of Moon, for the obvious advantage of taking into account a condition of the user such as fatigue when performing the diagnosis of Tsai.
For claim 20, Tsai, as modified, further discloses comparing the counted oscillations to a threshold (see para [0337] of Moon).
Response to Arguments
Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 12/8/25.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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