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 .
Election/Restrictions
Applicant’s election without traverse of species II, i.e. claims 5-13 & 17-20 in the reply filed on August 27, 2025 is acknowledged.
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 1, 5, 13 & 17, specifically independent claims 1 & 13, are directed to an abstract idea without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 1 is directed to a system, i.e. a product, a statutory category of invention.
Claim 13 is directed to a method, a statutory category of invention.
Step 2A, Prong 1:
Claim 1 recites the method steps of (via a control circuit):
“…receive physical activity information…”
“…receive a prescribed treatment…”
“…determine an indication of patient…”
“…determine an indication of patient condition…”
“…provide the determined indication of patient compliance…”
Claim 13 recites the method comprises:
“…detecting physical activity of a patient…”
“…receiving physical activity information…”
“…receiving a prescribed treatment…”
“…determining an indication of patient…”
“…determining an indication of patient condition…”
“…providing the determined indication of patient compliance…”
These limitations, under the broadest interpretation, fall within the mental processes (i.e. detecting, receiving, determining and providing) grouping of an abstract idea. It would be practical, but for the recitation “a control circuit” to perform the steps in a human’s mind, or with a pen and paper, to utilize the claimed signals.
Step 2A, Prong 2:
The claims as a whole fails to integrate the abstract idea into a practical application. Claims 1 & 13 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application.
“…a motion sensor…” which is directed to data gathering, see MPEP 2106.05(g).
“…a control circuit…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
Therefore, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claims 1 & 13 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The claims are also silent to providing any treatment at all to a patient.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. body surface/unipolar electrodes) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
Therefore, the claims fail to recite significantly more than the abstract idea and claims 1, 8 & 15 are rejected under 35 U.S.C 101.
The examiner also notes that limitations of the dependent claims 5 & 17 further define the steps of determining indication of patient compliance, which further limits the claim limitations already indicated above as being directed to an abstract idea. Therefore, claims 5 & 17 are also directed to patient-ineligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5-7, 11-13, 17-19 & 21-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Treacy et al. (US 2018/0261066).
1.
A system for monitoring patient condition and patient compliance with prescribed treatment comprising: a motion sensor configured to detect physical activity of a patient;
and a control circuit configured to: receive physical activity information from the motion sensor;
E.G. via the disclosed patient monitoring system 1 that may include a hub device 15 and computing system 135 having a processor 139 that serves to control an activity sensor, such as an accelerometer and/or a gyroscope in the form of wireless sensing device 3a-3c, in order to provide a patient’s position and motion {[0016], [0021], [0043] & (Fig 1)}.
receive a prescribed treatment including an activity threshold;
E.G. via the disclosed hub 15 that directly communicates with the wireless sensing devices in order to coordinate with the patient’s activity levels that may fall below a ‘prescribed’ care regime in which an alert is sent in order to encourage the patient to engage in therapeutic activity ([0015] & [0019]), wherein said activity levels may include motion indicators based on thresholds that are used for a given time frame {[0067] & (Fig 7)}.
determine an indication of patient compliance using a comparison of the received physical activity information occurring over a first period to the prescribed treatment;
determine an indication of patient condition using the received physical activity information occurring over a second period or with respect to a previously determined indication of patient condition;
E.G. via the disclosed patient activity indicator determination that accounts for the patient’s interactions, such as from an analysis module 26 that is directly associated with a patient activity indicator that is determined based on an activity indicator value 70 that is ‘executed’ and/or compared to activity requirements/thresholds that are met for a given time frame (i.e. step 110) and re-generated based on the results {[0015], [0017], [0066]-[0067] & (Figs. 6 & 7)}.
and provide the determined indication of patient compliance and the determined indication of patient condition to a user or process.
E.G. via the disclosed one or more total activity indicators 71 calculated/determined based on the record over time that is compared to the activity threshold that may be generated by a display 16 of the hub and/or display 52 of the central monitoring station 50 ([0015] & [0066]).
5.
The system of claim 1, wherein the control circuit is configured to generate a first control signal to activate a first indicator to provide the determined indication of patient compliance and to generate a second control signal to activate a second indicator to provide the determined indication of patient condition, wherein the second indicator is different from the first indicator.
E.G. via the disclosed patient location being received via the tracking module in the tracking system 40 at step 103 and the position and/or motion indicators being received at step 104 via the activity analysis module 26 associated with the activity sensors {[0067] & (Fig 7)}.
Note: The examiner is interpreting the patient location received as being the first control signal to activate a first indicator and the position and/motion indicators received as being the second control signal.
6.
The system of claim 5, wherein the first indicator includes at least one of a visual indicator, an audible indicator, or a haptic indicator.
E.G. via the disclosed use of the user interface display [0067].
7.
The system of claim 6, comprising: a self-contained monitoring device including the motion sensor, the control circuit, the temperature sensor, and the first indicator.
E.G. via the disclosed wireless sensing devices 3a-3C contains one or more sensors for measuring parameter data such as temperature sensors- {[0021] & (Fig 1)}.
11.
The system of claim 1, wherein the prescribed treatment includes an activity threshold, wherein to determine the indication of patient compliance includes to determine that the received physical activity information does not exceed the activity threshold.
E.G. via the disclosed patient activity indicator value 70 ([0066]-[0067]).
12.
The system of claim 1, wherein the determined indication of patient condition includes one of a worsening patient condition, a stable patient condition, or an improving patient condition over the second period.
E.G. via the disclosed method step of determining if an activity threshold is met, in which the determined indication provides a ‘precise’ measurement of the physical activity that the patient is engaged in ([0016] & [0066]).
13.
A method comprising: detecting physical activity of a patient using a motion sensor; and using a control circuit: receiving physical activity information from the motion sensor;
E.G. via the disclosed patient monitoring method 80 that utilizes a hub device 15 and computing system 135 having a processor 139 that serves to control an activity sensor, such as an accelerometer and/or a gyroscope in the form of wireless sensing device 3a-3c {[0016], [0021], [0043], [0066] & (Figs. 1 & 7)}.
receiving a prescribed treatment including an activity threshold;
E.G. via the disclosed hub 15 that directly communicates with the wireless sensing devices in order to coordinate with the patient’s activity levels that may fall below a ‘prescribed’ care regime in which an alert is sent in order to encourage the patient to engage in therapeutic activity ([0015] & [0019]), wherein said activity levels may include motion indicators based on thresholds that are used for a given time frame {[0067] & (Fig 7)}.
determining an indication of patient compliance using a comparison of the received physical activity information occurring over a first period to the prescribed treatment; determining an indication of patient condition using the received physical activity information occurring over a second period or with respect to a previously determined indication of patient condition;
E.G. via the disclosed patient activity indicator determination that accounts for the patient’s interactions, such as from an analysis module 26 that is directly associated with a patient activity indicator that is determined based on an activity indicator value 70 that is ‘executed’ and/or compared to activity requirements/thresholds that are met for a given time frame (i.e. step 110) and re-generated based on the results {[0017], [0066]-[0067] & (Figs. 6 & 7)}.
and providing the determined indication of patient compliance and the determined indication of patient condition to a user or process.
E.G. via the disclosed one or more total activity indicators 71 calculated/determined based on the record over time that is compared to the activity threshold that may be generated by a display 16 of the hub and/or display 52 of the central monitoring station 50 [0066].
and provide the determined indication of patient compliance and the determined indication of patient condition to a user or process.
E.G. via the disclosed one or more total activity indicators 71 calculated/determined based on the record over time that is compared to the activity threshold that may be generated by a display 16 of the hub and/or display 52 of the central monitoring station 50 [0066].
17.
The method of claim 13, comprising, using the control circuit: generating a first control signal to activate a first indicator to provide the determined indication of patient compliance; and generating a second control signal to activate a second indicator to provide the determined indication of patient condition, wherein the second indicator is different from the first indicator.
E.G. via the disclosed patient location being received via the tracking module in the tracking system 40 at step 103 and the position and/or motion indicators being received at step 104 via the activity analysis module 26 associated with the activity sensors {[0067] & (Fig 7)}.
Note: The examiner is interpreting the patient location received as being the first control signal to activate a first indicator and the position and/motion indicators received as being the second control signal.
18.
The method of claim 17, wherein the first indicator includes at least one of a visual indicator, an audible indicator, or a haptic indicator.
E.G. via the disclosed use of the user interface display [0067].
19.
The method of claim 18, wherein the motion sensor, the control circuit, the temperature sensor, and the first indicator are components of a self-contained monitoring device.
E.G. via the disclosed wireless sensing devices 3a-3C contains one or more sensors for measuring parameter data such as temperature sensors- {[0021] & (Fig 1)}.
21.
The system of claim 1, wherein prescribed treatment includes prescribed treatment with a treatment device, wherein the treatment device includes a brace or a wrap,
wherein the motion sensor comprises an accelerometer and is configured to be coupled to the treatment device or placed against the patient during use.
E.G. via the disclosed activity sensors 8a-8c that are strapped to the chest on the patient, wherein the activity sensor monitors a position and/or motion ([0048]-[0049]).
22.
The system of claim 1, comprising: a self-contained monitoring device including the motion sensor, wherein the self-contained monitoring device is configured to be placed against the patient during use.
E.G. via the disclosed patient monitoring system 1 that may include a hub device 15 and computing system 135 having a processor 139 that serves to control an activity sensor, such as an accelerometer and/or a gyroscope in the form of wireless sensing device 3a-3c {[0016], [0021], [0043] & (Fig 1)}.
Note: The examiner is interpreting the accelerometer as being the claimed motion sensor.
23.
The system of claim 1, wherein the indication of patient condition includes one of a worsening patient condition, a stable patient condition, or an improving patient condition.
E.G. via the disclosed patient activity indicator based on the medical condition, wherein the activity alert can then be generated based on the patient’s activity meeting a prescribed ‘minimum’ activity level [0015].
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 8-10 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Treacy et al. (US 2018/0261066) in view of Amro et al. (WO 2005/041131).
Treacy et al. discloses the claimed invention having a system and method comprising a monitor sensor and control circuit configured to receive physical activity information and determine indications of patient condition based on a determined indication of patient compliance and patient condition except wherein said system and method further comprises a treatment device positionable at a treatment location on a body comprising a therapy component of at least electrical or thermal therapy configured to apply a treatment at the treatment location.
Amro et al. teaches that it is known to use system and methods including a remote localization and sensing device 100 having a sensor(s) 240 for determining or measuring a desired parameter [007], such as muscular activity, temperature, motion, etc. wherein the sensor output is monitored to generate alert messages if the sensor data exceeds a threshold based on the device communicating the position and sensor data to a processing unit, ASP 200 ([020]-[021]). The device 100 further controls an output unit which provides thermal or electrical stimuli based the information received by the ASP 200 {[0048] & (Fig 2B)}.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system and method as taught by Treacy et al. with the use of the remote device having an output unit to provide electrical or thermal stimulation based on the response of coupled sensors as taught by Amro et al. since such a modification would provide the predictable results pertaining to efficiently providing feedback or stimuli to a person via an output unit in order to provide stimulation adapted to be controlled by motion-sensor data (Amro, [0020]-[0021] & [0048]).
Allowable Subject Matter
Claims 25-26 are objected to as being dependent upon a rejected base claim, but would be considered allowable subject matter if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The examiner, however, notes that the base claim, independent claim 1 is currently rejected as being considered non-statutory subject matter, i.e. directed to abstract subject matter. The claims will not be allowed unless the above 101 rejection is rectified accordingly. Please the above action.
Response to Arguments
Applicant's arguments filed January 15, 2026 have been fully considered but they are not persuasive. The applicant argues the following points in which the examiner provides a reason(s) as to why the arguments are not persuasive:
Based on the applicant’s claim amendments, the applicant argues that claims 1, 5, 13 and 17 are not directed to an abstract idea without significantly more since the motion sensor and control circuit perform specific steps over specific periods to provide dual compliance and condition indications and providing those determinations to enable treatment monitoring, which is not an abstract idea dressed in generic computer components. The applicant also argues that claim limitations address the technical problem of providing dual-metric patient assessment from motion sensor data through particular defined operational parameters.
Based on Step 2A-Prong One the claims are directed to the abstract idea of collecting motion data, analyzing the data and determining patient condition and compliance. This constitutes a mental process, which can be performed in the human mind or with pen and paper.
The recitation of “monitoring patient condition and patient compliance” is merely intended use language and does not impose a meaningful limitation on the claimed invention.
Based on Step 2A-Prong Two, the examiner disagrees and further points out that that the additional elements, including the motion sensor and control circuit, are recited at a high level of generality and perform their well-understood, routine and conventional functions of data acquisition and processing.
The claims do not recite an improvement to sensor technology, signal processing, or computer functionality. Instead, the additional elements merely implement the abstract idea using generic components. The alleged “technical problem” of assessing patient condition from motion data is not a technological problem, but rather an informational or analytical one. The claims therefore do not integrate the abstract idea into a practical application.
Therefore, the claims are directed towards an abstract idea and are directed to an abstract idea without significantly more.
The applicant argues that the primary reference, Treacy et al, fails to disclose the claimed invention since the reference fails to mention that the patient compliance and patient condition are two, separate and distinct elements, i.e. Treacy et al. fails to teach or disclose separate determinations of patient condition and patient compliance as required.
Based on the broadest reasonable interpretation of the claims the examiner disagrees and further points out that Treacy et al. discloses a patient activity indicator determination that accounts for the patient’s interactions, i.e. one or more total activity indicators 71 [0066]. Treacy et al. also discloses, which is previously cited by the examiner, that the patient monitoring system includes one or more sensing devices which measure different physiological parameter data, such as patient condition, wherein is further utilized by the disclosed method 80, wherein the patient activity indicator determination is based on analysis module 26 versus said physiological parameter data that is used to obtain the patient condition data ([0019] & [0066]-[0067]). In addition, Treacy et al. discloses that the patient activity indicator is assessed based on one or more activity thresholds, such as the medical condition, therefore providing a separate determination of patient condition and patient compliance, i.e. patient activity [0015].
Conclusion
THIS ACTION IS MADE FINAL. 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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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