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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/12/2026 has been entered.
Response to Arguments
2. Applicant’s arguments, filed 06/12/2026, with respect to the U.S.C. 102(a)(2) rejections have been fully considered and are persuasive. The U.S.C. 102(a)(2) rejections of the claims have been withdrawn.
Applicant's arguments, regarding the U.S.C. 101 rejection, filed 06/12/2026 have been fully considered but they are not persuasive. The Applicant argues that the claims as a whole should not be rejected under U.S.C. 101. The Examiner respectfully disagrees. The claims merely encompass data gathering and data analysis, all of which could be done mentally. For instance, looking at claim 1, a user can access the biological data via a screen or a print out, a user can then look at the biological data at particular times to determine an insomnia profile (consisting of mood, resilience, circadian rhythm, energy level, etc.), create a representation of the values, and then observe how particular treatment pathways are working to treat this health conditions/insomnia. This is typically how a doctor’s appointment would work. The use of a processer is well-understood, routine, conventional. The use of processors and machine learning algorithms to train data in this manner are merely used to quickly execute what could be done mentally – Machine learning systems are designed to model human-like learning, problem-solving, and decision-making. Further, there is nothing in the claims that would inhibit a person from doing these steps, if given enough time.
Regarding the new amendment, “providing, by the at least one processor, a notification to the user instructing the user how to implement the second treatment pathway by performing one or more intervention activities configured to improve the set of health indicators”, this would not be enough to integrate the claims into practical application since there is not an actual step about administering the treatment. The Examiner points to the MPEP 2106.04(d)(2):
Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.
Based on the bolded portion of the recited passage, the use of prescribing/recommending treatment is not enough to integrate a judicial exception into practical application. The rejection still stands.
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.
3. Claims 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The independent claim 1 recite a method for generating treatment pathways to help with insomnia via a wearable device, wherein the following steps are taken “characterizing, by the at least one processor, a set of health indicators exhibited by the user during the first time period based on the first timeseries of biosignal data… identify correlations between the first timeseries of biosignal data and the set of health indicators… the set of health indicators, a first insomnia profile representative of an (i) energy level, (ii) sleep quality, (iii) circadian rhythm, (iv) mental resilience, and (v) mood… wherein the trained machine learning process is trained using labeled biosignal data associating biosignal patterns with corresponding health indicator values; and selecting, by the at least one processor, a first treatment pathway for managing the set of health indicators for the user based on the first insomnia profile; and during a second time period succeeding the first time period: accessing, by the at least one processor, and via the communications interface, a second timeseries of biosignal data collected via the set of sensors… characterizing, by the at least one processor, the set of health indicators exhibited by the user during the second time period based on the second timeseries of biosignal data; deriving, by the at least one processor a second insomnia profile representative of the set of health indicators exhibited by the user during the second time period,… a difference between the first insomnia profile and the second insomnia profile characterizing, …effectiveness of the first treatment pathway based on the difference; and [determine] a second treatment pathway for managing the set of health indicators in replacement of the first treatment.” 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, compiling a treatment recommendation for a patient could simply be done by looking at the sensor health data on a printout or screen or could be accomplished 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. Further, the use of sensors in the 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.
For instance, the portion, “providing, by the at least one processor, a notification to the user instructing the user how to implement the second treatment pathway by performing one or more intervention activities configured to improve the set of health indicators”, is not enough to integrate the claims into practical application since there is not an actual step about administering the treatment. The Examiner points to the MPEP 2106.04(d)(2): “Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.”
The additional elements, such as the wearable device with sensors to gather health 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.
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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