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
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 01/15/2026.
Response to Amendment
The examiner acknowledges the new claims 21-23 added to the prosecution. Claims 1-23 are currently pending in the present application.
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.
Claim(s) 1-4, 7-10, 12-17, 20-21 is/are rejected under 35 U.S.C. 103 as being anticipated by Kavounas (US Patent No 20150297904) in view of Treacy (US Patent No 20180261066).
Regarding claim 1, Kavounas teaches a system comprising: a treatment device positionable at a treatment location on a body of a patient (wearable system configured to be worn by a person 82, [0042]), the treatment device comprising a therapy component including at least one of an electrical therapy component or a thermal therapy component configured to apply a treatment at the treatment location (the system may include a capacitor configured to deliver an electrical charge to the body of the patient, [0051]); a temperature sensor configured to detect temperature information associated with the treatment device (sensor 1862 may include a temperature sensor, [0156]); and a control circuit (processor 330 containing the controller, [0068]) configured to: receive temperature information from the temperature sensor; determine an indication of patient compliance using the received temperature information occurring over a first period (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy); and provide the determined indication of patient compliance to a user or process (interface 370 may include a screen or display to provide visuals on how the processor 330 containing the controller which communicates the data, [0068]).
Kavounas does not explicitly teach in which the controller determines and provides the indication of patient compliance with the addition of a prescribed treatment method to a user.
However, the analogous patient monitoring and activity tracking device disclosed by Treacy does teach the controller (see the hub device 15 in conjunction with a computing system 135 and processor 139 which serve as an equivalent controller, [0043]) which determines and provides the indication of patient compliance with the addition of a prescribed treatment method to a user (see from Treacy, [0015], in which the system is capable of assessing the patient activity indicator against one or more predetermined thresholds based on their medical care or compliance, and an activity alert may be generated and sent to the patient and/or the care professional indicating the prescribed treatment level needed to obtain compliance again).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the thermal therapy system of Kavounas to include the therapy compliance control and communication methods taught by Treacy in order to instruct and indicate better treatment methods to the user as to avoid insufficient or incorrect treatment during device use as taught by Treacy, [0015].
Regarding claim 2, Kavounas teaches the system of claim 1, wherein the control circuit is configured to determine the indication of patient compliance using the received temperature information occurring over the first period with respect to a first temperature compliance threshold (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy, this can be used in communication with the temperature sensor for determining temperature values, [0156]).
Regarding claim 3, Kavounas teaches the system of claim 1, wherein the control circuit is configured to provide a control signal to control at least one of the electrical or thermal therapy component based on the determined indication of patient compliance (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy).
Regarding claim 4, Kavounas teaches the system of claim 1, wherein the control circuit is configured to determine the indication of patient compliance if the received temperature information comprises one of an increase in temperature that exceeds a first temperature compliance threshold or a temperature gradient at different locations of the treatment device that exceeds a second temperature compliance threshold (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy, this can be used in communication with the temperature sensor for determining if temperature values exceed the threshold, [0156]).
Regarding claim 7, Kavounas teaches the system of claim 1, comprising: a motion sensor configured to detect physical activity of the patient (wherein one of the sensor modules 121,122 can be motion sensors, [0043]), wherein the control circuit is configured to: receive physical activity information from the motion sensor (wherein control signals are received indicative of the motion of the patient, [0048]); and determine the indication of patient compliance using the received physical activity information and the received temperature information occurring over the first period (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy).
Regarding claim 8, Kavounas teaches the system of claim 7, wherein the control circuit is configured to receive a prescribed treatment, wherein the control circuit is configured to determine the indication of patient compliance based on a comparison of the received physical activity information occurring over the first period to the prescribed treatment (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy, this can be used in communication with the motion sensors to determine physical activity, [0048]).
Regarding claim 9, Kavounas teaches the system of claim 7, wherein the control circuit is configured to 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 (see [0043] which discloses that multiple sensor modules 121, 122 can be used at different time frames for determining different motion data at different time periods), wherein the control circuit is configured to provide the determined indication of patient compliance and the determined indication of patient condition to the user or process (interface 370 may include a screen or display to provide visuals on how the processor 330 containing the controller which communicates the data, [0068]).
Regarding claim 10, Kavounas teaches the system of claim 7, comprising a wrap positionable at the treatment location, wherein the treatment device, the motion sensor, and the temperature sensor are integrated into or onto the wrap (wherein the entire wearable system including the sensors and treatment device can be integrated on a wrap, [0127]).
Regarding claim 12, Kavounas teaches the system of claim 7, comprising: a wrap positionable at the treatment location on the body of the patient, the wrap comprising the treatment device, the electrical therapy component, and the thermal therapy component (wherein the wearable system including the treatment device can be integrated on a wrap, [0127]); and a separate self-contained monitoring device configured to monitor treatment of the treatment device and use of the treatment device by the patient, the monitoring device comprising a housing, the housing including the motion sensor and the control circuit (see [0160] as well as figure 18B which shows that there is a space 1898 between the patient and the module containing all of the sensors and circuitry).
Regarding claim 13, Kavounas teaches the system of claim 1, comprising a patient indicator including at least one of a visual indicator, an audible indicator, or a haptic indicator, wherein the control circuit is configured to provide a patient indicator control signal to transition a state of the patient indicator based on the determined indication of patient compliance (interface 370 may include a screen or display to provide visuals on how the processor 330 containing the controller which communicates the data, [0068]).
Regarding claim 14, Kavounas teaches a method comprising: detecting, using a temperature sensor (sensor 1862 may include a temperature sensor, [0156]), temperature information associated with a treatment device positionable at a treatment location on a body of a patient (wearable system configured to be worn by a person 82, [0042]), the treatment device comprising a therapy component including at least one of an electrical therapy component or a thermal therapy component configured to apply a treatment at the treatment location (the system may include a capacitor configured to deliver an electrical charge to the body of the patient, [0051]); and using a control circuit: receiving temperature information from the temperature sensor; determining an indication of patient compliance using the received temperature information occurring over a first period (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy, this can be used in communication with the temperature sensor for determining temperature values, [0156]); and providing the determined indication of patient compliance to a user or process (interface 370 may include a screen or display to provide visuals on how the processor 330 containing the controller which communicates the data, [0068]).
Kavounas does not explicitly teach in which the controller determines and provides the indication of patient compliance with the addition of a prescribed treatment method to a user.
However, the analogous patient monitoring and activity tracking device disclosed by Treacy does teach the controller (see the hub device 15 in conjunction with a computing system 135 and processor 139 which serve as an equivalent controller, [0043]) which determines and provides the indication of patient compliance with the addition of a prescribed treatment method to a user (see from Treacy, [0015], in which the system is capable of assessing the patient activity indicator against one or more predetermined thresholds based on their medical care or compliance, and an activity alert may be generated and sent to the patient and/or the care professional indicating the prescribed treatment level needed to obtain compliance again).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the thermal therapy system of Kavounas to include the therapy compliance control and communication methods taught by Treacy in order to instruct and indicate better treatment methods to the user as to avoid insufficient or incorrect treatment during device use as taught by Treacy, [0015].
Regarding claim 15, Kavounas teaches the method of claim 14, wherein determining the indication of patient compliance comprises comparing the received temperature information occurring over the first period with respect to a first temperature compliance threshold (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy, this can be used in communication with the temperature sensor for determining temperature values, [0156]).
Regarding claim 16, Kavounas teaches the method of claim 14, comprising: providing, using the control circuit, a control signal to control at least one of the electrical or thermal therapy component based on the determined indication of patient compliance (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy).
Regarding claim 17, Kavounas teaches the method of claim 14, wherein determining the indication of patient compliance comprises if the received temperature information includes one of an increase in temperature that exceeds a first temperature compliance threshold or a temperature gradient at different locations of the treatment device that exceeds a second temperature compliance threshold (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy, this can be used in communication with the temperature sensor for determining if temperature values exceed the threshold, [0156]).
Regarding claim 20, Kavounas teaches the method of claim 14, comprising: detecting physical activity of the patient using a motion sensor (wherein one of the sensor modules 121,122 can be motion sensors, [0043]); and using the control circuit: receiving physical activity information from the motion sensor (wherein control signals are received indicative of the motion of the patient, [0048]); and determining the indication of patient compliance using the received physical activity information and the received temperature information occurring over the first period (see for example [0047] which depicts how the system with the controller has certain threshold values in which the system determines if the patient is in compliance or not to receive electrical therapy).
Regarding claim 21, Kavounas teaches the system of claim 1, wherein the first period comprises a plurality of discrete treatment periods, wherein the control circuit is configured to determine the indication of patient compliance across the plurality of discrete treatment periods (see [0177], in which the device is measuring whether the wearer is in compliance during a multiplicity of time period deadlines, thereby teaching multiple discrete time periods).
Claim(s) 5-6, 11, 18-19, 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kavounas (US Patent No 20150297904) in view of Treacy (US Patent No 20180261066) further in view of Coleman (US Patent No 20160213924).
Regarding claim 5, Kavounas and Treacy teach the system of claim 1.
The previous combination does not teach wherein the temperature sensor includes three separate temperature sensors configured to be located at different locations of the treatment device, including: first and second temperature sensors configured to be located on opposing sides of the treatment device when the treatment device is in operation; and a third temperature sensor located proximate the thermal therapy component on the treatment device.
However, the analogous therapy delivery and measurement brace of Coleman does teach wherein the temperature sensor includes three separate temperature sensors configured to be located at different locations of the treatment device (from Coleman, the feedback sensor can comprise multiple temperature sensors, one in the brace system, at least one proximate to the body, and at least one proximate to the stimulation electrodes, [0165], resulting in at least three temperature sensors), including: first and second temperature sensors configured to be located on opposing sides of the treatment device when the treatment device is in operation (from Coleman, at least one sensor in the brace system, at least one proximate to the body, and thereby having temperature sensors on opposite sides of the treatment device, [0165]); and a third temperature sensor located proximate the thermal therapy component on the treatment device (from Coleman, at least one sensor proximate to the stimulation electrodes, [0165]).
Therefore, it would have been obvious for one skilled in the art to combine the teachings of the device system of Kavounas and Treacy to contain the multiple temperature sensors and respective positions taught by Coleman in order to effectively sense the temperature values at all the critical points on the patient and the device as disclosed by Coleman, [0165].
Regarding claim 6, the combination teaches the system of claim 5, wherein the control circuit is configured to determine the indication of patient compliance using temperature information from the first and second temperature sensors (from Coleman, wherein human response feedback is measured from the sensors proximate to the body and within the brace, [0165]), wherein the control circuit is configured to determine an indication of desired thermal therapy function of the thermal therapy component using temperature information from the third temperature sensor (from Coleman, wherein the third sensor is used to receive temperature measurements indicative of if the feedback should change the power, voltage, current being applied to the thermal therapy electrode, [0165]).
Regarding claim 11, the combination teaches the system of claim 10, wherein the motion sensor is positioned on the wrap at a location having a substantially large moment arm of movement associated with the treatment location of the body (Kavounas, see [0127]-[0128] indicating that the motion sensor may be on a wrist or ankle for detecting large movement capabilities), wherein the temperature sensor comprises first and second temperature sensors, the first temperature sensor located on a first side of the wrap and the second temperature sensor located on a second side of the wrap, the first and second temperature sensors configured to sense a temperature variance across the wrap (from Coleman, at least one sensor in the brace system, at least one proximate to the body, and thereby having temperature sensors on opposite sides of the treatment device, [0165]), wherein the control circuit is configured to determine the indication of patient compliance using temperature information from the first and second temperature sensors (from Coleman, wherein human response feedback is measured from the sensors proximate to the body and within the brace, [0165]).
Regarding claim 18, the combination teaches the method of claim 14, wherein the temperature sensor includes three separate temperature sensors located at different locations of the treatment device (from Coleman, the feedback sensor can comprise multiple temperature sensors, one in the brace system, at least one proximate to the body, and at least one proximate to the stimulation electrodes, [0165], resulting in at least three temperature sensors), wherein detecting the temperature information comprises: detecting a first temperature difference between first and second temperature sensors located on opposing sides of the treatment device when the treatment device is in operation (from Coleman, at least one sensor in the brace system, at least one proximate to the body, and thereby having temperature sensors on opposite sides of the treatment device, [0165]); and detecting a temperature of the thermal therapy component using a third temperature sensor located proximate the thermal therapy component on the treatment device (from Coleman, wherein the third sensor is used to receive temperature measurements indicative of if the feedback should change the power, voltage, current being applied to the thermal therapy electrode, [0165]).
Regarding claim 19, the combination teaches the method of claim 18, wherein determining the indication of patient compliance includes using temperature information from the first and second temperature sensors (from Coleman, wherein human response feedback is measured from the sensors proximate to the body and within the brace, [0165]), the method comprising: determining, using the control circuit, an indication of desired thermal therapy function of the thermal therapy component using temperature information from the third temperature sensor (from Coleman, wherein the third sensor is used to receive temperature measurements indicative of if the feedback should change the power, voltage, current being applied to the thermal therapy electrode, [0165]).
Regarding claim 22, the combination teaches the system of claim 1, wherein the temperature sensor is configured to detect temperature information within a housing of the temperature sensor and outside of the housing between the temperature sensor and the patient during use (see in which Coleman, [0165], teaches that temperature sensors may be used to monitor the temperature of the muscle stimulation electrodes, which are found within the housing, and they are also capable of measuring the temperature between the electrodes and the skin of the patient during use).
Regarding claim 23, the combination teaches the system of claim 1, wherein the treatment device includes a patient side configured to be placed against the patient during use and an external side opposite the patient side, wherein the temperature sensor is configured to detect temperature information from the patient side of the treatment device and from the external side of the treatment device (see in which Coleman, [0165], teaches that temperature sensors may be used to monitor the temperature of the muscle stimulation electrodes, which are found within the housing, and they are also capable of measuring the temperature between the electrodes and the skin of the patient during use), wherein the treatment device comprises a brace or a wrap (from Coleman, in which the sensors and electrodes are found within a brace assembly, [0007], see for example also fig 1A which shows the brace with a patient side and external side).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
With regards to the arguments presented with respect to claims 1 and 14, the examiner agrees with the applicant that the previous prior art of record Sham does not explicitly teach the claim limitations of determining and providing the indication of patient compliance along with a prescribed treatment method as it is described within the specification of the present application. However, as the request for continued examination in view of the presented arguments and remarks has necessitated the grounds for further search and consideration, the new prior art of record of Treacy has been found to fully disclose the claim limitations as presented in view of the patient compliance as defined in the specification of the present application. Specifically, the analogous patient monitoring and activity tracking device disclosed by Treacy does teach the controller (see the hub device 15 in conjunction with a computing system 135 and processor 139 which serve as an equivalent controller, [0043]) which determines and provides the indication of patient compliance with the addition of a prescribed treatment method to a user (see from Treacy, [0015], in which the system is capable of assessing the patient activity indicator against one or more predetermined thresholds based on their medical care or compliance, and an activity alert may be generated and sent to the patient and/or the care professional indicating the prescribed treatment level needed to obtain compliance again) as claimed and taught in the present specification. Therefore, as the newly amended claim limitations of claims 1 and 14 are taught by the prior art of record, the independent claims 1 and 14 remain rejected under the new prior art of record rejection of Kavounas in view of Treacy set forth in the present office action.
Furthermore, as the new prior art of record rejection also teaches all of the limitations presented in the new claims 21-23, they too remain rejected under the new prior art of record rejection of Kavounas in view of Treacy as well as Kavanous in view of Treacy further in view of Coleman set forth in the present office action.
All other claims remain rejected under the new prior art of record rejection as per their dependency on independent claims 1 and 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794