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 .
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/04/2024 has been entered.
Response to Arguments
2. Applicant's arguments filed 06/04/2026 have been fully considered but they are not persuasive.
Regarding the U.S.C 112a rejections, the Applicants arguments and amendments would not be enough to overcome this rejection. The claims essentially cite using two types of sensor data, merging this data using computations and labeling, and then determining an estimated and expected value of fatigue of a pilot. It is still unclear what is happening between the point or acquiring sensor data and determining a user’s fatigue with this data. For instance, what steps us the Applicant taking to determine fatigue levels from the sensor data? The specification merely discloses using different algorithms or machine taught methods to determine fatigue. There is no real example of how these algorithms are working in terms of how they are taking in sensor data and then from that determining a true level of fatigue. Therefore, the U.S.C. 112a and b rejections still stand. Further, a new U.S.C. 112a new matter rejection has been applied.
Regarding the U.S.C 101 rejection, the Applicant argues that new amendment to the claims would integrate the application into practical application. The Examiner respectfully disagrees. It is not enough to state that real-time computations are being done with sensor data. A person could look at sensor data, in real-time, and continue to update the user on their current fatigue level. If the Applicant is taking these estimated and expected fatigue levels and then using them to provide a service or make adjustments, that would integrate the claims into practical application. For example, this could include, but is not limited to, gathering/analyzing values and then using this to adjust a stimulation parameter or provide a treatment, etc. The U.S.C 101 rejection still stands.
The amendments to the claims have overcome the previously applied U.S.C. 112b rejection.
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.
3. 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 an expected and estimated level of fatigue from the acquired 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 level of fatigue is acquired from the merged sensor data; i.e. what steps are taken from the point of gathering and merging the sensor data to the point of outputting an estimated and expected 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
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.
The claims recite taking in two types of sensor data, one being non-invasive sensor data and one being invasive sensor data. However, there is no support for using invasive sensor data to determine fatigue levels of a pilot. In fact, the Applicant’s specification teaches “However, the measurement of such variables involves sensors which cannot be implemented in a real-life case, because same are too invasive and would then be difficult to accept by the pilot in flight, or not very robust and would not withstand being used in the highly variable conditions of aeronautical operations.”, thus implying it would not be possible to use invasive sensors on a pilot during experimental flights to determine fatigue level. There is also no mention of any invasive sensors being used in general, rather only non-invasive and “minimally or not very invasive” sensors are used. Even if there is support for invasive sensors being used, there is certainly not support for using this type of sensor data in combination with non-invasive sensor data to determine a fatigue level.
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 acquiring two types of sensor data, merging/labeling/storing this data, and then determining an estimated and expected fatigue level of a pilot based on the acquired sensor 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 (including from sensors that are both invasive and non-invasive), merge and label this data, and then determine a level of fatigue from this sensor data, all done in real-time. 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. Pertinent art includes US 20200302825 A1 and US 20170185082 A1, however, neither teach the Applicant’s claims as a whole. These references teach monitoring pilots using either implanted or non-implanted sensors, but they do not teach using both sensor types on a pilot, merging both types of sensor data, and using this merged data to determine an estimated and actual fatigue level of a pilot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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