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 18-35 are amended. Claims 36-37 are new. Claims 18-37 are pending.
Claim Rejections - 35 USC § 112(b)
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.
Claim 21 is 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.
Claim 21 recites “wherein the wearable non-pressure sensor comprises at least one sensor selected from a pressure sensor, a motion sensor, a posture sensor or a balance sensor.” It is unclear how a “non-pressure sensor” can be a “pressure sensor” as currently claimed or if the “non-pressure sensor” should be “pressure sensor,” rendering the claim indefinite. For purposes of examination, the limitation will be interpreted as “wherein the wearable pressure sensor comprises at least one sensor selected from a pressure sensor, a motion sensor, a posture sensor or a balance sensor.”
Appropriate correction is required.
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 1 (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 outside training sessions 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; 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 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. 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 1. Claim 34 recites a digital application.
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 and non-pressure sensor, which amounts to merely invoking a computer/machinery as a tool to perform an existing process, 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 data, which amounts to mere data gathering, see MPEP 2106.05(g)
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.
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.
Claims 18-37 are rejected under 35 U.S.C. 103 as being unpatentable over Avni (U.S. Pub. No. 2013/0236867 A1) in view of Zanotto (U.S. Pub. No. 2025/0344966 A1)
Regarding claim 18, Avni discloses a method for monitoring a progress during a rehabilitation comprising:
providing to a patient a plurality of wearable sensors, wherein a 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 (Paragraphs [0035-0036], [0150] and [0153] discuss the patient wearing an insole containing pressure sensors to sense the patient’s movement.);
defining for said patient a training program comprising a plurality of training sessions, each training session comprising at least one exercise (Paragraph [0248] discusses a training program flow for each user containing various exercises.) ;
acquiring at least one exercise signal during some or all training sessions with the wearable sensor (Paragraph [0150] discusses obtaining data from user during the patient’s therapy regimen in second mode.);
acquiring at least one everyday signal outside training sessions with the same wearable sensor (Paragraph [0150] discusses obtaining data from a first mode from the insole sensor, construed as being outside of the training sessions.);
wherein the everyday signal is an indication of patient activity in everyday life (Paragraphs [0150] and [0155] discuss obtaining data from a first mode from the insole sensor including for the patient’s activities of daily living, construed as being outside of the training sessions.);
computing a compliance index from exercise signal (Paragraph [0247] discusses analyzing the results to obtain a patient compliance score.);
computing an improvement index from successive evaluations of the everyday signal (Paragraph [0024] discusses quantifying patient improvements and paragraph [0247-0248] discuss analyzing the results to update the program.); 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 (Paragraphs [0359-0361] and [0378] discuss updating the training programs based on compliance and progress.);
but Avni does not appear to explicitly disclose wherein a second wearable sensor of the plurality of wearable sensors comprises a non-pressure sensor.
Zanotto teaches wherein a second wearable sensor of the plurality of wearable sensors comprises a non-pressure sensor (Paragraph [0011] discusses the sensors including inertial sensors, construed as a non-pressure sensor.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the wearable sensor to include a non-pressure sensor, as taught by Zanotto, in order to “capture raw gait data (time-series) from the wearer in real-life or controlled environments (Zanotto, Paragraph [0038]).”
Regarding claim 19, Avni discloses wherein an initial impairment of said patient is evaluated with the wearable sensor and wherein the training program is defined according to said initial impairment (Paragraph [0032] discusses providing rehabilitation for a patient based on their injury.).
Regarding claim 20, Avni discloses further comprising acquiring feedback from the patient and wherein the improvement index is further computed from the feedback given by the patient (Paragraph [0362] discusses presenting exercise options for the patient to select, construed as acquiring feedback from the patient, and then adjusting the training to increase compliance with regimen.).
Regarding claim 21, Avni discloses wherein the pressure sensor comprises at least one sensor selected from a pressure sensor, a motion sensor, a posture sensor or a balance sensor (Paragraph [0036] discusses the insole sensors being pressure sensitive, construed as a pressure sensor.).
Regarding claim 22, Avni discloses wherein the first wearable sensor is fitted in a footwear (Paragraph [0153] discusses the pneumatic insole being placed in the patient’s shoe.).
Regarding claim 23, Avni discloses wherein the first wearable sensor is a pressure sensitive insole (Paragraph [0036] discusses the insole sensors being pressure sensitive.).
Regarding claim 24, Avni discloses wherein the first wearable sensor measures the plantar pressure measurement under the foot of the patient while walking or standing during and outside of training sessions (Paragraphs [0042] and [0380] discusses measuring the weight distribution, construed as measuring the plantar pressure measurement under the foot while walking or standing. Paragraphs [0150], [0155] and [0220] discuss obtaining data from a first mode from the insole sensor including for the patient’s activities of daily living, construed as being outside of the training sessions and during the sessions.).
Regarding claim 25, Avni discloses wherein the first wearable sensor measures the plantar pressure measurement under the foot of the patient while walking or standing outside training sessions (Paragraphs [0042] and [0380] discusses measuring the weight distribution, construed as measuring the pressure field under the foot while walking or standing while at home, construed as outside the training sessions.).
Regarding claim 26, Avni discloses wherein updating the training program comprises at least one of updating the number of sessions, updating the characteristics of one session, adding new sessions, deleting sessions, updating the settings of one exercise (Paragraphs [0397] discusses updating the training program, including specific exercises, time/repetition and time in the target.).
Regarding claim 27, Avni discloses wherein the training program is updated during a training session (Paragraph [0220] discusses the training program thresholds being updated during the training sessions.).
Regarding claim 28, Avni discloses wherein the training program is updated after completion of a predetermined number of training sessions (Paragraph [0361] discusses updating the training program when the patient completes the training program successful, construed as after completion of a predetermined number of training sessions.).
Regarding claim 29, Avni discloses wherein the plurality of wearable sensors provide the patient with a real-time sensor feedback during a training session or with a sensor feedback outside the training sessions in relationship with everyday activities (Paragraph [0152] discusses the patient receiving real-time feedback.).
Regarding claim 30, Avni discloses wherein the method targets gait rehabilitation and/or balance rehabilitation (Paragraph [0003] discusses the focus being to provide rehabilitation for gait training and improving balance.).
Regarding claim 31, Avni discloses wherein the compliance index is a function of at least one of: the number of training sessions completed, the characteristics of training sessions completed, the settings of exercises completed, the level of completion of training sessions, the performance scores of the exercises of the session (Paragraph [0384] discusses the compliance score being calculated as a percentage of success at the required repetitions for each exercise, including the patient reaching and/or staying at the limit range.).
Regarding claim 32, Avni discloses wherein the improvement index is a function of at least one of: global walking activity time monitored daily; and spatio-temporal parameters of the walking activities such as total distance, maximum distance travelled without stopping, steps number, average speed, average stride length, number of stairs climbed or descended, phases of the step and plantar pressure parameters such as center of pressure trajectories, load, pressure distribution (Paragraphs [0018] discusses the rehabilitation focusing on improving the gait speed, stride length, or steps taken.).
Regarding claim 33, Avni discloses wherein the training program is updated when the compliance index is lower than a predetermined compliance threshold and the improvement index is decreasing (Paragraph [0247] discusses the training program being updated to adjust to patient trends, including noncompliance or deterioration.).
Regarding claim 34, Avni discloses wherein updating the training program is automatic and provided by a digital application (Paragraphs [0155] and [0361] discuss the program being automatic and provided to the patient via an application.).
Regarding claim 35, Avni discloses wherein updating the training program is remote (Paragraph [0041] discusses the therapy being done remotely.).
Regarding claim 36, Avni discloses wherein computing the improvement index comprises deriving, from the second wearable sensor during acquisition outside the training sessions (Paragraphs [0042] and [0380] discusses measuring the weight distribution, construed as measuring the pressure field under the foot while walking or standing while at home, construed as outside the training sessions.);
but Avni does not appear to explicitly disclose:
at least one parameter selected from maximum uninterrupted walking distance, global daily walking activity time, steps number, and average walking speed.
Zanotto teaches at least one parameter selected from maximum uninterrupted walking distance, global daily walking activity time, steps number, and average walking speed (Paragraph [0012] discusses measuring walking speed of the user.).
Zanotto teaches wherein a second wearable sensor of the plurality of wearable sensors comprises a non-pressure sensor (Paragraph [0011] discusses the sensors including inertial sensors, construed as a non-pressure sensor.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the wearable sensor to collect walking speed, as taught by Zanotto, in order to “capture raw gait data (time-series) from the wearer in real-life or controlled environments (Zanotto, Paragraph [0038]).”
Regarding claim 37, Avni does not appear to explicitly disclose wherein acquiring the exercise signal and the everyday signal comprises 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.
Zanotto teaches wherein acquiring the exercise signal and the everyday signal comprises 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 (Paragraph [0014] discusses synchronizing the various measurements for analysis.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the wearable sensor to synchronize the data, as taught by Zanotto, in order to “capture raw gait data (time-series) from the wearer in real-life or controlled environments (Zanotto, Paragraph [0038]).”
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Claim Rejections under 35 U.S.C. § 101
Applicant asserts that the claims are not abstract as they contain sensors and recite “a specific, technology-centric method implemented with a plurality of concrete wearable sensors and specific signal acquisitions that cannot be performed in the human mind (Remarks, page 6).” This is not persuasive as the sensors are recited at an “apply it” level, meaning they are doing what they are designed to do (such as a pressure sensor sensing pressure) and the claims are not categorized as being a mental process so it is irrelevant whether the steps can be performed in the human mind. The claims are classified as reciting “organizing human activity.” The receiving of the sensor signal, while an additional element, is considered well-understood, routine and conventional activity as indicated in the rejection.
The sensors themselves are not characterized as well-understood, routine and conventional, rather, the collection of data from the sensors is well-understood, routine and conventional as stated in the MPEP. The additional elements recited in the claims do not result in a practical application as they are either recited at an apply level, recite well-understood, routine and conventional activity, or are merely generally linking. The claims do not result in solving a technical problem. The problem is “[c]ompliance and behavioral improvement of the patient are evaluated and allow for updating of training” as indicated in the instant specification [0001].
Claim Rejections under 35 U.S.C. § 102
Applicant’s arguments are directed towards the amendments, which have been addressed in the above updated rejection, which includes new prior art.
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.
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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