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 .
Response to Arguments
1. Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
Regarding the U.S.C 112a and 112b rejections, the Applicant argues that the specification does provide working examples, guidance, and steps as to how a true level of fatigue is determined, specifically citing page 8 of the specification. The Examiner respectfully disagrees. The cited page merely just discloses using different algorithms or machine taught methods to determine a true level of fatigue. There is no real example of how these algorithms are actually working in terms of how they are taking in sensor data and then from that determining a true level of fatigue. It is also still unclear what makes the data useful vs what makes it true. Further, the Applicant states in their arguments that the true level of fatigue is when the training algorithm uses solely useful data; however, the claims state merging useful data and labeling data to determine the true value of the level of fatigue. Therefore, the U.S.C. 112a and b rejections still stand.
Regarding the U.S.C 101 rejection, the Applicant argues that the claims would not invoke a 101 rejection. The Examiner respectfully disagrees. At its core, the claims are merely directed to data gathering and labeling performed by an algorithm. A user could gather data, label this data, and then compare/analyze this data to determine the level of fatigue a user is experiencing. Using an algorithm does not take the claims out of a U.S.C. 101 mental process rejection since machine taught algorithms are based upon what a user can do mentally. The U.S.C 101 rejection still stands. There are still no art rejections based upon the lack of clarity of the claims.
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.
2. Claims 1-17 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.
With respect to claims 1-17, the claims recite the step of computing a true level of fatigue from the acquired labeling data. However, the specification does not provide any working examples, guidance, or steps as to how this function is achieved. Rather, there are only mentions the using filtering/merging/supervised/unsupervised leaning algorithms. It is unclear how exactly the true level of fatigue is acquired from the acquired labeling data; i.e. what steps are taken from the point of gathering the labeling data via sensors to the point of outputting a true fatigue level.
As noted in the MPEP, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient).
It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement
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.
3. Claims 1-17 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.
In further regards to claim 1, it is unclear what is meant by “true fatigue level”. Is this different from a normal fatigue level, and if so, how is it different? the Applicant states in their arguments that the true level of fatigue is when the training algorithm uses solely useful data; however, the claims state merging useful data and labeling data to determine the true value of the level of fatigue.
Claims 2-17 are rejected by virtue of their 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.
4. Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claims 1 and 9 recite a method for labeling useful data, wherein useful data and labeling data are acquired, a level of true fatigue is determined, and then and then storing new labeled useful data. The limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, a person can acquire these different types of data (there is not step about how to acquire this, so this data could simply be shown on a screen/on paper to a person), determine a level of fatigue from the user, and then label data based on this mentally. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. This judicial exception is not integrated into a practical application.
The components are recited at a high-level of generality such that it amounts no more than any structure that can look a patient data/data in general, determine fatigue, and label the data. Further, the use of sensors in the dependent claims, are merely insignificant extra-solution activity of data gathering. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The additional elements, such as the sensor to gather patient data, while being mere structures for data gathering are also well-understood, routine, conventional activity that is widely prevalent or common use in the relevant industry. The use of sensors to gather patient information are well known in the art as disclosed by the following references: US 20040122790 A1 and US 20210343384 A1. Well-understood, routine and conventional activity cannot be significantly more than the abstract idea itself. The claims are not patent eligible.
Prior Art Rejection
5. There are currently no art rejections applied. Per the MPEP, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. Some pertinent art includes CogBeacon: A Multi-Modal Dataset and Data-Collection Platform for Modeling Cognitive Fatigue (NPL) as well as Identification and classification of construction equipment operators' mental fatigue using wearable eye-tracking technology (NPL).
Conclusion
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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/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792