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 .
Claims 1-17 were previously cancelled. Claims 18 and 21 are amended. Claims 18-37 are pending.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/07/2026 has been entered.
Claim Rejections - 35 USC § 112(a)
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 18-37 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.
Claim 1 recites “acquiring at least one everyday signal, during one or more monitoring periods outside of any training session and outside any evaluation of an initial impairment of said patient, with the same plurality of wearable sensors, wherein the everyday signal is an indication of patient activity in everyday life.” The instant specification does not provide support for “acquiring at least one everyday signal…outside any evaluation of an initial impairment of said patient….” The specification in [0013] and [0054] discuss evaluating the initial impairment to define a training program, but does not describe a monitoring period “outside any evaluation of an initial impairment.”
Claims 19-37 are rejected as they depend from claim 18.
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.
Claims 18-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 18-37 are drawn to a method for monitoring, which is within the four statutory categories (i.e. process).
Claim 18 (Group I) recites a method for monitoring comprising:
providing to a patient a plurality of wearable sensors, wherein the first wearable sensor of the plurality of wearable sensors comprises a plantar-pressure sensor configured to measure a plantar pressure measurement under the foot of the patient while the patient is walking or standing, and wherein a second wearable sensor of the plurality of wearable sensors comprises a non-pressure sensor (MPEP § 2106.05(f), apply it);
defining for said patient a training program comprising a plurality of training sessions, each training session comprising at least one exercise;
acquiring at least one exercise signal during some or all training sessions with the plurality of wearable sensors (MPEP § 2106.05(g), insignificant extra-solution activity);
acquiring at least one everyday signal during one or more monitoring periods outside of any training session and outside any evaluation of an initial impairment of said patient, with the same plurality of wearable sensors (MPEP § 2106.05(g), insignificant extra-solution activity) wherein the everyday signal is an indication of patient activity in everyday life;
computing a compliance index from exercise signal;
computing an improvement index from successive evaluations of the everyday signal by deriving, from the everyday signal, at least one parameter selected from global walking activity time monitored daily, total distance, maximum distance travelled without stopping, steps number, average speed, and plantar pressure parameters selected from center of pressure trajectories, load, and pressure distribution, aggregating the at least one parameter over a predetermined daily or weekly evaluation interval, and comparing the aggregated at least one parameter across successive predetermined daily or weekly evaluation intervals to compute the improvement index; and
updating the training program when compliance index is lower than a predetermined compliance threshold and/or the improvement index is lower than a predetermined improvement threshold.
The bolded limitations, given the broadest reasonable interpretation, cover mathematical concepts (computing of compliance index and improvement index, comparing compliance index to a threshold) and/or a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people (updating training program in response to data analysis regarding the patient using the collected data). Any limitations not identified above as part of abstract are underlined and deemed “additional elements,” and will be discussed in further detail below.
Dependent Claims 19-37 include other limitations, but these merely further limit the abstract idea or further describe the wearable sensor or its location, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claim 18. Claim 34 recites a digital application (MPEP § 2106.05(h), generally linking).
Furthermore, Claims 18-37 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a plurality of wearable sensors, a plantar pressure sensor, which amounts to merely invoking a computer/machinery as a tool to perform an existing process (e.g., a pressure sensor collecting pressure data), e.g. see paragraphs [0030] of the present Specification, see MPEP 2106.05(f);
add insignificant extra-solution activity to the abstract idea – for example, the recitation of acquiring sensor and/or signal data, which amounts to mere data gathering, see MPEP 2106.05(g); and
generally link the abstract idea to a particular technological environment or field of use – for example, the recitation of digital application, which amounts to limiting the abstract idea to the field of computing, see MPEP 2106.05(h)).
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs [0030] of the Specification discloses that the additional elements (i.e. sensors) comprise a plurality of different types of generic computing systems or sensors that are configured to perform generic computer functions (i.e. acquiring data) that are well-understood, routine, and conventional activities previously known to the pertinent industry;
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives data from the plurality of wearable sensors.
Dependent Claims 19-37 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than further limiting the additional elements found in the independent claim.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 18-37 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 06/08/2026 have been fully considered but they are not persuasive.
Claim Rejections under 35 U.S.C. § 112(b)
The previous rejection is withdrawn in view of the amendment to claim 21.
Claim Rejections under 35 U.S.C. § 101
Applicant asserts that the claims are not abstract as they “now recite[] a specific sensor-based monitoring process in which an everyday signal is acquired during one or more monitoring periods outside training sessions and outside any evaluation of an initial impairment of the patient” and “requires computing an improvement index from successive evaluations of that everyday signal by deriving objective gait and plantar-pressure parameters, aggregating the parameter over a predetermined daily or weekly evaluation interval, and comparing the aggregated parameter across successive
predetermined daily or weekly evaluation intervals,” which “materially narrow the claim to a particular technical manner of measuring and processing physiological movement data from wearable sensors, rather than to the general concept of encouraging or managing patient behavior (Remarks, pages 6-7).”
This is not persuasive as the sensors are recited at an “apply it” level, meaning they are being used for their intended purpose (such as a pressure sensor being used to sense pressure). The receiving of the sensor signal, while an additional element, is considered well-understood, routine and conventional activity according to the MPEP as indicated in the rejection as it is merely gathering data.
Applicant asserts that “the amended ‘improvement index’ is not a subjective evaluation, business rule, or interpersonal management step” and therefore, does not recite a certain method of organizing human activity (Remarks, page 7). Examiner maintains that the claim is managing personal behavior, in this case, by updating the patient’s training program in response to the results of the data analysis using the data collected from the patient’s activities.
Applicant further asserts that the “claim requires a specific arrangement of wearable sensors, including a plantar-pressure sensor configured to measure pressure under the foot while the patient is walking or standing, acquisition of an exercise signal during training sessions, acquisition of an everyday signal during objective monitoring periods outside training sessions and outside initial impairment evaluation, derivation of specific daily-life gait or plantar-pressure parameters, aggregation of those parameters over daily or weekly intervals, comparison across successive intervals, and updating of the training program when the computed compliance or improvement index fails to satisfy a predetermined threshold (Remarks, page 7).” There is no specific arrangement of sensors relative to one another. The claim merely requires “providing to a patient a plurality of wearable sensors.” The instant claims are not similar to those in Thales, where there was a particular configuration/arrangement of inertial sensors and a particular method of using the raw data from the sensors, Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902 (Fed. Cir. 2017). The instant claims do not result in an improved sensor of any kind as they are recited an at an “apply it” level. The location of each sensor relative to one another does not result in improved sensor readings. In other words, the inventive concept is not the sensor itself or the arrangement of sensors. Examiner maintains that mere data gathering is well-understood, routine and conventional per MPEP § 2106.05(g). The “derivation of specific daily-life gait or plantar-pressure parameters, aggregation of those parameters over daily or weekly intervals, comparison across successive intervals, and updating of the training program when the computed compliance or improvement index fails to satisfy a predetermined threshold” is considered part of the abstract idea and not an additional element, and, as such, cannot be used to integrate the abstract idea into a practical application.
Applicant asserts that specification “supports this technical character” and “the specification explains that the wearable sensor may be kept by the patient "all day long" in everyday activities and, when fitted in footwear, may measure pressure under the patient's foot while walking or standing outside training sessions,” and “that the everyday signal is acquired outside training sessions when the patient is not performing a specific exercise but is going about daily tasks, and that the improvement index is computed from successive evaluations of the everyday signal,” as well as “identifies concrete parameters for the improvement index, including global walking activity time monitored daily, total distance, maximum distance travelled without stopping, steps number, average speed, center of pressure trajectories, load, and pressure distribution,” which “confirm that the claims are directed to a concrete sensor-based technique for monitoring gait or balance rehabilitation in everyday conditions, not to a disembodied plan for managing patient behavior.” Putting conditions on when data is collected does not improve the actual sensors. The improvement, if any, resulting from the claims is to the abstract idea itself. The parameter selected for analysis does not improve the sensors. Rather, it is used as part of the abstract idea to determine compute an improvement index.
Applicant asserts that the “ordered combination of amended claim 18 also provides significantly more than any alleged abstract idea” and that the “claim does not simply collect sensor data, display it, or tell a patient to comply with a program (Remarks, page 8).” First, for the ordered combination, the additional elements are considered. The additional elements do not add anything that is not already present when they are considered separately. As indicated above, there is no improvement to any of the sensors themselves as they are merely used to gather data to compute a compliance index and an improvement index. While the independent claim does not explicitly recite displaying data, claim 34 provides “wherein updating the training program is automatic and provided by a digital application,” which is construed as displaying the updating training program to the patient.
Applicant argues that the “time-stamping signals measured by the plurality of wearable sensors and co-registering the signals using the timestamps to align contemporaneous plantar-pressure measurements with inertial-motion, posture, and/or balance measurements for use in computing the compliance index and the improvement index” and is a “multi-sensor signal processing requirement” found in claim 37 integrates the abstract idea into a practical application (Remarks, page 9). Examiner maintains this is part of the data analysis that is part of the abstract idea. Applicant further asserts that “Claim 37 also integrates any alleged abstract idea into a practical application because the claimed co-registration improves the technical quality and usability of the acquired sensor data.” Examiner maintains that this does not result in a practical application as it is considered part of the abstract idea. The sensors themselves are not improved as a result of the steps taken in claim 37. For the same reason, claim 37 does not result in significantly more than the abstract idea itself.
Claim Rejections under 35 U.S.C. § 103
The previous prior art rejection has been withdrawn in view of the amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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