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 .
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 13 recites “at least one” in line 13, but instead should be --the at least one--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 7-8 and 13-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 7-8 and 13-15 each recite a “fatigue state change predictive model”, but the specification lacks detail regarding the model. The specification fails to provide adequate details regarding the components of the model and the algorithm which governs the model. Further clarification required.
Claim 7 recites “outputting information of an anti-fatigue optical article implementing a prescription adapted to said value representing said level of change od said state of fatigue of said subject” in the last limitation, but lacks proper detail in the specification. It is unclear what component is performing the “outputting” step, is it the processor, a separate device, or something else. Additionally, how is the information being derived.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 6-8, 10, and 13-15 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.
Independent claims 1, 7-8 and 13-15 each recite a “fatigue state change predictive model,” but is found indefinite because subject matter related to the model is absent.
Claim 7 recites “outputting information of an anti-fatigue optical article implementing a prescription adapted to said value representing said level of change od said state of fatigue of said subject” in the last limitation, but is indefinite. It is unclear what element is configured to output the information and how the information is arrived to (see fig. 5). Further clarification required.
Claims not listed are rejected by virtue of claim dependency.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1, 3 ,6, 8, 10 and 13-15 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.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including obtaining a value representing a level of change of said state of fatigue. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of obtaining a value representing a level of change of said state of fatigue sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The obtained value does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the obtained value, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites displaying a question for a subject to answer, measuring pupillary and/or gaze measurements with a camera, and providing input data to a model. Displaying a question, measuring pupils and gaze, and providing input data into a model are well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the displaying, measuring, and providing step are recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and providing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding 8, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited display and camera are generic components configured to perform pre-solutional data gathering activity and the computer system is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
Same rationale applies to claims 13-15.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data processing. The comparing and calculating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
Claims 1, 3, 6, 8, 10, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Samec et al. (US 20170365101), hereinafter Samec, in view of Sunagawa et al. (US 20220287608- Previously cited), hereinafter Sunagawa.
Regarding claims 1, 8, and 14-15, Samec teaches a device and computer-implemented method (abstract and ¶[0863]), comprising:
displaying, on a display screen (¶[0545]), at least one question related to a vision of said subject, the answer to the at least one question being at least one subjective measurement relating to said subject measuring, via a camera, at least one pupillary and/or gaze measurement made on said subject at a same time of displaying the at least one question on the display screen, the measurement of the at least one pupillary and/or gaze measurement being at least one (Samec teaches a display system for performing a user’s level of fatigue, i.e. alertness, based on measuring the user’s reaction to a stimulus (abstract and ¶[0544]). The fatigue level is then used in-part to detect injuries, conditions, or disorders affecting the mental state(¶[0544]). The display system is configured to monitor the user’s objective and subjective reactions to stimuli presented (¶[0488]). Objective responses include, “eye movements, neural signals, and autonomic responses,” and subjective responses include, “psychological or emotional reaction to stimuli” (¶[0488]). The method to detect the user’s reaction to the objective and subjective stimuli are indicative of the user's state of fatigue (¶[0547], “the method may detect a user reaction to the stimulus indicative of the user's state of alertness”). The stimuli can be presented via a display and speaker and detected using cameras and microphones ¶[0473,0542,0545-47,0594], “the microphone is configured to allow the user to provide inputs or commands to the system 60 (e.g., the selection of voice menu commands, natural language questions, etc.)” and “the systems and sensors described above may be used according to method 1700 for detection and/or diagnosis of mental states and/or neurological conditions related to a user's level of alertness” (emphasis added)). Moreover, the data is collected simultaneously to improve the analysis performed on the user to reveal relationships between the condition, treatment, and sensor measurements (¶[0411], “thereby allowing different data to be cross-referenced”),
providing a plurality of input data (¶[0546]), relating to said subject, to a fatigue state change predictive model, wherein said plurality of input data comprises at the least one subjective and objective measurement relating to said subject (¶[0865,0869], “One or more computer vision algorithms may be used” and “individual models may be customized for individual data sets . . . . base model may be used as a starting point to generate additional models specific to a data type”);
obtaining, by a processor implementing said model, a value representing change of said state of fatigue of said subject (¶[0404-09,0550], “provide corrective aids, e.g., perception aids, to help the user address shortcomings in their ability to perceive and/or interact with the world” and “perception aid for the user may include interesting content to increase the user's alertness.” That is, repeated analysis is performed to decrease the user’s fatigue, which requires obtaining a new fatigue value that indicates improvement or worsening). Samec fails to teach wherein the value represents a level of change.
Sunagawa teaches a model to determine a user’s fatigue and a level of change of fatigue (¶[0154,0182], “The degree of fatigue and inattentiveness is represented by, for example, a ten-point scale, and the value increases with an increase in the degree of fatigue and inattentiveness. For example, a degree of fatigue and inattentiveness is 1 when a gaze of a person is frequently shifted, 5 when the gaze is shifted slowly, and 10 when the that gaze is completely fixed” indicating that an objective value is obtained, in addition to user information or user’s environment information, to determine attentive state. “As shown by FIG. 17, when an inattentive state occurs, a curve showing a degree of fatigue and inattentiveness changes suddenly with respect to a curve showing a past degree of fatigue and inattentiveness” and “differential values before and after a change in a degree of fatigue and inattentiveness may be compared in order to determine whether user U is in the inattentive state” indicating that values of the fatigue are tracked and compared resulting in a value that represents a user state.)
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Samec, such that the value represents a level of change of fatigue, as taught by Sunagawa, to aid in determining whether the user is showing a degree of fatigue and therefore inattentive (¶[0182] of Sunagawa).
Regarding claims 3 and 10, Samec teaches wherein the said state of fatigue is a state of visual fatigue (see para. [0546], fatigue is calculated based on at least information from a user’s eyes, therefore it is visual fatigue).
Regarding claim 6, Samec teaches wherein it further comprises storing said model in the cloud and carrying out said obtaining in the cloud (¶[0475]).
Regarding claim 13, Samec teaches a device that comprises at least one device for providing an automated prediction of a change of a state of fatigue of a subject carrying out a visual task involving any kind of visual content (abstract (¶[0404-09,0550,0863], “provide corrective aids, e.g., perception aids, to help the user address shortcomings in their ability to perceive and/or interact with the world” and “perception aid for the user may include interesting content to increase the user's alertness.” That is, repeated analysis is performed to decrease the user’s fatigue, which requires obtaining a new fatigue value that indicates improvement or worsening. As such, a prediction of a change in a worse or improved fatigue state is required.), comprising:
displaying, on a display screen (¶[0545]), at least one question related to a vision of said subject, the answer to the at least one question being at least one subjective measurement relating to said subject measuring, via a camera, at least one pupillary and/or gaze measurement made on said subject at a same time of displaying the at least one question on the display screen, the measurement of the at least one pupillary and/or gaze measurement being at least one (Samec teaches a display system for performing a user’s level of fatigue, i.e. alertness, based on measuring the user’s reaction to a stimulus (abstract and ¶[0544]). The fatigue level is then used in-part to detect injuries, conditions, or disorders affecting the mental state(¶[0544]). The display system is configured to monitor the user’s objective and subjective reactions to stimuli presented (¶[0488]). Objective responses include, “eye movements, neural signals, and autonomic responses,” and subjective responses include, “psychological or emotional reaction to stimuli” (¶[0488]). The method to detect the user’s reaction to the objective and subjective stimuli are indicative of the user's state of fatigue (¶[0547], “the method may detect a user reaction to the stimulus indicative of the user's state of alertness”). The stimuli can be presented via a display and speaker and detected using cameras and microphones ¶[0473,0542,0545-47,0594], “the microphone is configured to allow the user to provide inputs or commands to the system 60 (e.g., the selection of voice menu commands, natural language questions, etc.)” and “the systems and sensors described above may be used according to method 1700 for detection and/or diagnosis of mental states and/or neurological conditions related to a user's level of alertness” (emphasis added)). Moreover, the data is collected simultaneously to improve the analysis performed on the user to reveal relationships between the condition, treatment, and sensor measurements (¶[0411], “thereby allowing different data to be cross-referenced”),
providing measurement input data (¶[0546]) comprising at least one subjective and objective measurement relating to said subject (¶[0865,0869], “One or more computer vision algorithms may be used” and “individual models may be customized for individual data sets . . . . base model may be used as a starting point to generate additional models specific to a data type”), and implementing a fatigue state change model based on the measurement input data and at least one other subject-related datum to obtain a value representing a change of said fatigue of said subject and input into the model (¶[0404-09,0550], “provide corrective aids, e.g., perception aids, to help the user address shortcomings in their ability to perceive and/or interact with the world” and “perception aid for the user may include interesting content to increase the user's alertness.” That is, repeated analysis is performed to decrease the user’s fatigue, which requires obtaining a new fatigue value that indicates improvement or worsening). Samec fails to teach wherein the value represents a level of change and outputting said value representing level of change of said state of fatigue of said subject.
Sunagawa teaches a model to determine a user’s fatigue and a level of change of fatigue (¶[0154,0182], “The degree of fatigue and inattentiveness is represented by, for example, a ten-point scale, and the value increases with an increase in the degree of fatigue and inattentiveness. For example, a degree of fatigue and inattentiveness is 1 when a gaze of a person is frequently shifted, 5 when the gaze is shifted slowly, and 10 when the that gaze is completely fixed” indicating that an objective value is obtained, in addition to user information or user’s environment information, to determine attentive state. “As shown by FIG. 17, when an inattentive state occurs, a curve showing a degree of fatigue and inattentiveness changes suddenly with respect to a curve showing a past degree of fatigue and inattentiveness” and “differential values before and after a change in a degree of fatigue and inattentiveness may be compared in order to determine whether user U is in the inattentive state” indicating that values of the fatigue are tracked and compared resulting in a value that represents a user state.)
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Samec, such that the value represents a level of change of fatigue and is output, as taught by Sunagawa, to aid in bringing the user back to a normal state that may otherwise lead to an accident or the like (¶[0032] of Sunagawa).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Samec in view of Sunagawa and Colbaugh et al. (US 20200094015- Previously cited), hereinafter Colbaugh.
Regarding claim 7, Samec teaches a device and computer-implemented method (abstract and ¶[0863]), comprising:
obtaining an automated prediction of a change of a state of fatigue of said subject carrying out a visual task (¶[0404,0499,0545], “detecting responses to guided imagery and/or audio presented to the user 60 at a display 62 and/or speakers 66. With reference to FIG. 10, the system 2010 may monitor the user through inward facing cameras 24 for eye tracking, such as to detect eye position, movement, or gaze”) involving any king of visual content, by:
displaying, on a display screen (¶[0545]), at least one question related to a vision of said subject, the answer to the at least one question being at least one subjective measurement relating to said subject measuring, via a camera, at least one pupillary and/or gaze measurement made on said subject at a same time of displaying the at least one question on the display screen, the measurement of the at least one pupillary and/or gaze measurement being at least one (Samec teaches a display system for performing a user’s level of fatigue, i.e. alertness, based on measuring the user’s reaction to a stimulus (abstract and ¶[0544]). The fatigue level is then used in-part to detect injuries, conditions, or disorders affecting the mental state(¶[0544]). The display system is configured to monitor the user’s objective and subjective reactions to stimuli presented (¶[0488]). Objective responses include, “eye movements, neural signals, and autonomic responses,” and subjective responses include, “psychological or emotional reaction to stimuli” (¶[0488]). The method to detect the user’s reaction to the objective and subjective stimuli are indicative of the user's state of fatigue (¶[0547], “the method may detect a user reaction to the stimulus indicative of the user's state of alertness”). The stimuli can be presented via a display and speaker and detected using cameras and microphones ¶[0473,0542,0545-47,0594], “the microphone is configured to allow the user to provide inputs or commands to the system 60 (e.g., the selection of voice menu commands, natural language questions, etc.)” and “the systems and sensors described above may be used according to method 1700 for detection and/or diagnosis of mental states and/or neurological conditions related to a user's level of alertness” (emphasis added)). Moreover, the data is collected simultaneously to improve the analysis performed on the user to reveal relationships between the condition, treatment, and sensor measurements (¶[0411], “thereby allowing different data to be cross-referenced”),
providing a plurality of input data (¶[0546]), relating to said subject, to a fatigue state change predictive model, wherein said plurality of input data comprises at the least one subjective and objective measurement relating to said subject (¶[0865,0869], “One or more computer vision algorithms may be used” and “individual models may be customized for individual data sets . . . . base model may be used as a starting point to generate additional models specific to a data type”);
obtaining, by a processor implementing said model, a value representing change of said state of fatigue of said subject (¶[0404-09,0550], “provide corrective aids, e.g., perception aids, to help the user address shortcomings in their ability to perceive and/or interact with the world” and “perception aid for the user may include interesting content to increase the user's alertness.” That is, repeated analysis is performed to decrease the user’s fatigue, which requires obtaining a new fatigue value that indicates improvement or worsening). Samec fails to teach wherein the value represents a level of change.
Sunagawa teaches a model to determine a user’s fatigue and a level of change of fatigue (¶[0154,0182], “The degree of fatigue and inattentiveness is represented by, for example, a ten-point scale, and the value increases with an increase in the degree of fatigue and inattentiveness. For example, a degree of fatigue and inattentiveness is 1 when a gaze of a person is frequently shifted, 5 when the gaze is shifted slowly, and 10 when the that gaze is completely fixed” indicating that an objective value is obtained, in addition to user information or user’s environment information, to determine attentive state. “As shown by FIG. 17, when an inattentive state occurs, a curve showing a degree of fatigue and inattentiveness changes suddenly with respect to a curve showing a past degree of fatigue and inattentiveness” and “differential values before and after a change in a degree of fatigue and inattentiveness may be compared in order to determine whether user U is in the inattentive state” indicating that values of the fatigue are tracked and compared resulting in a value that represents a user state.)
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Samec, such that the value represents a level of change of fatigue, as taught by Sunagawa, to aid in determining whether the user is showing a degree of fatigue and therefore inattentive (¶[0182] of Sunagawa).
Samec-Sunagawa fail to teach outputting an anti-fatigue optical article implementing a prescription adapted to said value representing said level of change of said state of fatigue of said subject.
Colbaugh teaches a system configured to determine user’s fatigue level and based on the determination automatically adjust dynamic optical glasses to meet goals for circadian management and/or photo-biological effect (see para. [0018,0067,0071,0076]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Samec-Sunagawa, such that information of an anti-fatigue optical article implementing a prescription adapted to said physiologically derived values of fatigue and historical values is output, as taught by Colbaugh, to aid in meeting goals for circadian management and/or photo-biological effect. Additionally, the modification is merely applying a known technique (providing user with optical articles) to a known method (fatigue level determination) ready for improvement to yield predictable results.
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not fully persuasive.
Applicant contends that the specification sufficiently discloses the invention and one of ordinary skill in the art recognizes that the inventor possess the claimed invention, on page 9 of the Remarks. Examiner disagrees. The specification broadly states that any number of methods can be used to base the predictive model 14 from, as pointed out by Applicant, but this fails to provide any details beyond merely stating inputting measurement data to the model (¶[0140]). This does not rise to the level of one of ordinary skill in the art to conclude that the inventor possessed the claimed invention. Additionally, the amendments to claim 7 do not overcome the 35 U.S.C. 112(a) rejection because the limitation remains unclear as to what is performing the output and how the output is derived.
Applicant’s arguments with respect to 35 U.S.C. 103 and 101 rejection of amended claims have been considered but are moot because amendments require new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Toth teaches systems and methods for assessment of autonomic neural system (ANS) activity and/or neuroendocrine function of a subject. US 20170231490
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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