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 .
In light of the amendments to the claims filed 09/10/2025 in which claims 49 and 62-65 were amended and claims 66-68 were added, claims 49-68 are pending in the instant application and are examined on the merits herein.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/10/2025 has been entered.
Priority
The instant application is a continuation of U.S. Application no. 16/326,162 filed 02/15/2019 which is a 371 of PCT/IB2017/001162 filed 08/18/2017 which claims priority to U.S. Provisional Application no. 62/377,418 filed 08/19/2016 and 62/423,441 filed 11/17/2016.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 62/377,418, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application does not provide support in the specification for the limitations of claims 54, 56-57, and 62-65 in the instant application. Regarding claim 54, Application No. '418 provides support for an activity classification comprising one or more of sitting, walking, standing, jumping, traversing stairs, leg extending, leg bending, or performing chair squats, but not breathing or changing positions while lying. Regarding claim 56, Application No. '418 does not provide support for outputting an indication that an individual has changed positions while lying. Regarding claim 57, Application No. '418 does not provide support for outputting an indication that an individual has not changed positions while lying. Regarding claim 62, Application No. '418 does not provide support for determining and providing indication of breathing. Regarding claim 63, Application No. '418 does not provide support for detecting and providing indication of heart or pulse rate. Accordingly, claims 54, 56-57, and 62-63 do not receive priority of the application filed on 08/19/2016.
Priority is given for claims 49-53, 55, 58-61, and 66-68 to the prior-filed application, Application No. 62/377,418, filed on 08/19/2016.
Priority is given for claims 54, 56-57, and 62-65 to the prior-filed application, Application No. 62/423,441, filed on 11/17/2016.
Response to Arguments
Objections to the Claims
The objections to the claims have been withdrawn in view of the amendments to the claims filed 09/10/2025.
Rejections of the Claims under 35 U.S.C. 101/112(a)/112(b)
The previous rejections of the claims under 35 U.S.C. 101/112(a)/112(b) have been withdrawn in view of the amendments to the claims filed 09/10/2025.
Rejections of the Claims under 35 U.S.C. 103
Applicant's arguments filed 09/10/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding independent claims 49 and 64-65, the applicant asserts on pg. 7-9 that the prior art to Weston, Locke, and Bichel fail to disclose determining the activity classification by comparing signals of the data to one or more frequency thresholds.
In response to applicant’s arguments, the examiner respectfully notes that the prior art were not used in the previous Office Action filed 06/12/2025 to read on the limitations at issue. LeBoeuf is newly used as a teaching reference to the prior art to read on the limitations at issue as explained below.
The amendments to the claims have necessitated new grounds of rejection.
Claim Objections
Claim 64 is objected to because of the following informalities: Claim 64 recites the limitation “measured by the sensor” in ln. 10. This should read “measured by the one or more sensors”. Claim 64 further recites the limitation “frequency thresholds;;” in ln. 12. This should read “frequency thresholds;”. Appropriate correction is required.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 49-56, 60, 62-63, and 66-68 are rejected under 35 U.S.C. 103 as being unpatentable over US/2010/0298792 A1 to Weston in view of US/2018/0250452 A1 to Locke, WO/2014/066714 A1 to Bichel, and US/2016/0361020 A1 to LeBoeuf.
Regarding claims 49, 53-56, 60, 62-63, and 66-68, Weston discloses (Claim 49) a system for treating a wound and/or for monitoring the movement of a patient (para. 0003; para. 0011; Fig. 4B, negative pressure apparatus 220), comprising:
a source of negative pressure (Fig. 4B, vacuum pump 230) and a wound dressing (Fig. 4B, wound dressing 224 configured to be applied to the body);
a sensor configured to receive pressure data indicative of a magnitude or frequency of pressure measured in a fluid flow path coupling the negative pressure source to the wound dressing, (para. 0066, conduit 236 communicates negative pressure from vacuum pump 230 to fluid collection system 238 and conduit 246 communicates negative pressure from fluid collection system 238 to wound site 222; para. 0072, pressure sensor 265 monitors approximate pressure within the wound dressing within the fluid flow path); and
a controller (para. 0071; Fig. 4A, control device 132);
wherein the system further includes a user interface (para. 0103-0105); and
(Claims 66-67) wherein the pressure data is indicative of a magnitude of pressure measured in the fluid flow path (para. 0066, conduit 236 communicates negative pressure from vacuum pump 230 to fluid collection system 238 and conduit 246 communicates negative pressure from fluid collection system 238 to wound site 222; para. 0072, pressure sensor 265 monitors approximate pressure within the wound dressing within the fluid flow path).
Weston differs from the instantly claimed invention in that Weston fails to disclose
(Claim 49) the controller configured to determine an activity classification for the patient during a period of time from the pressure data measured by the sensor wherein the controller is configured to determine the activity classification by comparing detected pressure signals to one or more frequency thresholds; wherein the controller is further configured to output an indication denoting the activity classification for the patient; and wherein the user interface is configured to output the indication of the activity classification for presentation;
(Claim 53) wherein the activity classification is indicative of a type of activity engaged in by the patient while wearing the wound dressing;
(Claim 54) wherein the activity classification is one or more of breathing, changing positions while lying, sitting, walking, standing, jumping, traversing stairs, leg extending, leg bending, and performing chair squats;
(Claim 55) wherein the controller is configured to determine that the patient is changing positions while lying down or in another position in response to a change in magnitude of pressure measured by the sensor;
(Claim 56) wherein the controller is further configured to output the indication that the patient is changing positions while lying in response to the change in the magnitude of pressure satisfying a threshold pressure change;
(Claim 60) a memory device configured to store the activity classification;
(Claim 62) wherein the controller is further configured to detect the patient's respiration rate or breathing when the dressing is applied to an area of the body of the patient;
(Claim 63) wherein the controller is further configured to detect the patient's heart rate or pulse when the dressing is applied to an area of the body of the patient;
(Claim 66) wherein the controller is configured to determine the activity classification by comparing the magnitude of pressure and the detected pressure signals over the period of time to one or more pressure magnitude thresholds and the one or more frequency thresholds;
(Claim 67) wherein the controller is further configured to determine the activity classification based on a change of the magnitude of pressure over the period of time; and
(Claim 68) wherein the change of the magnitude of pressure comprises a peak-to-peak change of the detected pressure signals over the period of time.
Locke teaches a system for treating a wound (Fig. 1, negative pressure therapy system 100) comprising a controller configured to determine activity of a user while wearing the system (para. 0026). Locke further teaches that ambulation aids in the healing of a tissue site and that prompting a patient to engage in ambulatory therapy may help a user receive increased therapeutic benefits (para. 0045-0046).
Bichel teaches a wearable medical device (Fig. 1) for determining user activity comprising
(Claim 49) a pressure sensor (pg. 5:30-6:9) and a controller (Fig. 1, evaluation unit 126) configured to determine an activity classification for a patient during a period of time from pressure data measured by a sensor (pg. 5:30-6:9; pg. 6:11-39; pg. 13:37-14:18; pg. 36:17-37:28; Fig. 3-7), wherein the controller is configured to determine the activity classification based on a change in the magnitude of pressure over the period of time (pg. 5:30-6:9; pg. 6:11-39; pg. 13:37-14:18; pg. 36:17-37:28; Fig. 3-7), wherein the controller is further configured to output an indication denoting the activity classification for the patient (pg. 5:30-6:9; pg. 6:11-39; pg. 10:28-12:6; pg. 13:37-14:18; pg. 36:17-37:28; Fig. 3-7); and a user interface configured to output an indication of the activity classification for presentation (pg. 10:28-12:6; pg. 13:18-20; Fig. 1, user interface 130);
(Claim 53) wherein the activity classification is indicative of a type of activity engaged in by an individual (pg. 10:28-12:6; pg. 14:3-18);
(Claim 54) wherein the activity classification comprises one or more of breathing (pg. 41:18-26; Fig. 6, respiratory activity 138), changing positions while lying (pg. 9:4-15), walking (pg. 13:37-14:2), or standing (pg. 6:20-23);
(Claim 55) wherein the controller (Fig. 1, evaluation unit 126) is configured to output an indication that the individual is changing positions while lying in response to the change in the magnitude of pressure measured by the sensor (pg. 6:11-39, pg. 9:2-15; pg. 10:28-12:6; pg. 18:18-20);
(Claim 56) wherein the controller (Fig. 1, evaluation unit 126) is configured to output an indication that the individual is changing positions while lying in response to the change in the magnitude of pressure satisfying a threshold pressure change (pg. 6:11-39, slope of a measurement curve after a position change from resting to standing is compared to an end threshold value to determine the end state of the position change; pg. 9:2-15; pg. 18:18-20);
(Claim 60) wherein the controller (Fig. 1, evaluation unit 126) is further configured to store, in a memory device (Fig. 1, storage device 129), the indication of the activity classification in association with usage data reflecting usage of the system during a corresponding time period (pg. 13:37-14:18);
(Claim 62) wherein the controller (Fig. 1, evaluation unit 126) is further configured to determine and provide indication of breathing (pg. 41:18-26; Fig. 6, respiratory activity 138) based on pressure sensor values (pg. 41:18-26);
(Claim 63) wherein the controller (Fig. 1, evaluation unit 126) is further configured to detect and provide indication of at least one of a heart rate or a pulse (pg. 13:18-20; pg. 14:30-15:3; Fig. 6);
(Claim 66) wherein the controller is configured to determine the activity classification by comparing the magnitude of pressure and the detected pressure signals over the period of time to one or more pressure magnitude thresholds (pg. 5:30-6:9; pg. 6:11-39; pg. 13:37-14:18; Fig. 3-7); and
(Claim 67) wherein the controller is configured to determine the activity classification based on a change of the magnitude of pressure over the period of time (pg. 5:30-6:9; pg. 6:11-39; pg. 13:37-14:18; pg. 36:17-37:28; Fig. 3-7).
Bichel teaches that activity readings as a part of a patient profile allow a clinician to make appropriate medical judgements in a patient’s ongoing treatment and can aid in coaching a user to achieve good physical activity (pg. 43:10-15). Bichel further teaches that the controller configured to detect vital signs can monitor and alert a user that a pulse rate is above/below a threshold value, indicating a possible critical condition (pg. 14:38-15:3).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the controller of Weston to be configured to determine activity classifications as taught by Bichel and Locke, because Bichel teaches that activity readings as a part of a patient profile allow a clinician to make appropriate medical judgements in a patient’s ongoing treatment and can aid in coaching a user to achieve good physical activity (pg. 43:10-15), Bichel further teaches that the controller configured to detect vital signs can monitor and alert a user that a pulse rate is above/below a threshold value, indicating a possible critical condition (pg. 14:38-15:3), and Locke teaches that ambulation aids in the healing of a tissue site and that prompting a patient to engage in ambulatory therapy may help a user receive increased therapeutic benefits (para. 0045-0046).
LeBoeuf teaches a bandage for determining user activity (para. 0040-0041, measurement system 10 may be within a bandage; Fig. 2, measurement system 10) comprising (Claim 49) a sensor (Fig. 2, sensors 14) and a controller configured to determine an activity classification for a user during a period of time from data measured by the sensor (Fig. 2, sensed values from sensors 14 [motion and biometric] are sent to parameter circuit 100; para. 0032, microcontroller may be a signal processing circuit found in a localized system; para. 0033-0035, activity classifications [parameters]; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit), wherein the controller is configured to determine the activity classification by comparing detected signals of the data to one or more frequency thresholds (para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit; Fig. 3, method 200 for determining activity classification; Fig. 5, ramping determination 340; Fig. 6A), wherein the controller is further configured to output an indication denoting the activity classification for the user (para. 0042, parameter circuit 100 determines parameter and outputs parameter to input/output interface 16); and a user interface configured to output an indication of the activity classification for presentation (para. 0042, parameter circuit 100 determines parameter and outputs parameter to input/output interface 16 as a display);
(Claim 53) wherein the activity classification is indicative of a type of activity engaged in by an individual (para. 0033-0035, activity classifications [parameters]; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit);
(Claim 54) wherein the activity classification comprises one or more of breathing, changing positions while lying, walking, standing, jumping, traversing stairs, leg extending, leg bending (Fig. 2, sensed values from sensors 14 [motion and biometric] are sent to parameter circuit 100; para. 0033-0035, activity classifications [parameters]; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit);
(Claims 55-56) wherein the controller is configured to output an indication that the individual is changing positions while lying or in another position (para. 0033-0035, activity classifications [parameters]; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit);
(Claim 60) wherein the controller is further configured to store, in a memory device, the indication of the activity classification in association with usage data reflecting usage of the system during a corresponding time period (para. 0048-0049; Fig. 4, memory 170);
(Claim 62) wherein the controller is further configured to determine and provide indication of breathing (Fig. 2, sensed values from sensors 14 [motion and biometric] are sent to parameter circuit 100; para. 0033-0035, activity classifications [parameters]; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit);
(Claim 63) wherein the controller is further configured to detect and provide indication of at least one of a heart rate or a pulse (Fig. 2, sensed values from sensors 14 [motion and biometric] are sent to parameter circuit 100; para. 0033-0035, activity classifications [parameters]; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit);
(Claim 66) wherein the controller is configured to determine the activity classification by comparing the magnitude and the detected pressure signals over the period of time to one or more magnitude thresholds and the one or more frequency thresholds (para. 0033-0035, activity classifications [parameters]; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit; Fig. 5, ramping determination 340);
(Claim 67) wherein the controller is configured to determine the activity classification based on a change of the magnitude of sensed data over the period of time (para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit; Fig. 3, method 200 for determining activity classification; Fig. 5, ramping determination 340; Fig. 6A); and
(Claim 68) wherein the change of the magnitude of pressure comprises a peak-to-peak change of the detected data over the period of time (para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit; Fig. 3, method 200 for determining activity classification; Fig. 5, ramping determination 340; Fig. 6A).
LeBoeuf further teaches that the frequency threshold comparisons applied in their system can take into account certain factors to more accurately determine the activity classification (para. 0046-0047).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the controller of the cited prior art to alternatively determine the activity classification based on comparing signals of the sensed data to one or more frequency thresholds as taught by LeBoeuf, because LeBoeuf teaches that the frequency threshold comparisons applied in their system can take into account certain factors to more accurately determine the activity classification (para. 0046-0047). Further, this is simply a different known way of determining activity and one of ordinary skill in the art would have had a reasonable expectation of success of determining activity based on either of pressure signal frequency or change of magnitude of pressure over a period of time.
Regarding claim 50, the cited prior art suggests the invention of claim 49. Weston further discloses: wherein the sensor is configured to measure pressure at or near the wound dressing (Fig. 4B, pressure sensor 265 measuring pressure near wound dressing 224; para. 0072).
Regarding claim 51, the cited prior art suggests the invention of claim 49. Weston further discloses: wherein the fluid flow path comprises at least one lumen or a plurality of lumens (para. 0066, conduit 236 communicates negative pressure from vacuum pump 230 to fluid collection system 238 and conduit 246 communicates negative pressure from fluid collection system 238 to wound site 222) and wherein the controller is configured to monitor the pressure in one or lumens of the fluid flow path or at an inlet of the negative pressure source (para. 0071; para. 0072, pressure sensor 265 monitors approximate pressure within the wound dressing within the fluid flow path in conduit 246).
Regarding claim 52, the cited prior art suggests the invention of claim 49. Weston further discloses: wherein the system is a negative pressure wound therapy system (para. 0003; para. 0011; Fig. 4B, negative pressure apparatus 220).
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Weston, Locke, Bichel, and LeBoeuf as applied above, and further in view of U.S. Patent no. 7,378,975 to Smith.
Regarding claim 57, the cited prior art suggests the invention of claim 49.
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the controller is further configured to detect a duration of time during which the patient has not changed positions while lying down or in another position and output another indication in response to the detected duration satisfying a threshold duration.
Smith teaches a system for monitoring movement of a patient utilizing pressure sensor data (Fig. 3) comprising a controller (Fig. 3, microprocessor/CPU 310) configured to detect a duration of time during which an individual has not changed positions while lying (col. 3:57-4:2) and output another indication associated with the development of a pressure ulcer (col. 3:48-52) in response to the detected duration satisfying a threshold duration (col. 4:2-9). Smith further teaches that their system mitigates the risk of bed sores by ensuring a user is moving a frequently as necessary (col. 3:48-52).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the controller of the cited prior art to detect and output an indication that an individual has not changed positions while lying as taught by Smith, because Smith teaches that such a system would help in mitigating the risk that a user would develop bed sores by ensuring that a user is moving as frequently as is medically necessary (col. 3:48-52).
Claims 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Weston, Locke, Bichel, and LeBoeuf as applied above, and further in view of US/2009/0209830 to Nagle.
Regarding claim 58, the cited prior art suggests the invention of claim 49.
The prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the controller is further configured to compare the activity classification to an assigned classification associated with the patient and output an indication of whether the activity classification matches the assigned classification.
Nagle teaches a wearable medical device (Fig. 14 showing patient compliance monitor 50; para. 0195-0196) for determining user activity comprising a controller (Fig. 8, memory 74) configured to: compare the activity (performed by the individual) classification to an assigned classification (treatment regime) associated with the individual (para. 0073:1-10; para. 0154:1-7); and output (Fig. 8, display 76) an indication of whether the activity classification matches the assigned classification (para. 0149:1-5).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application would have been motivated to modify the controller of the cited prior art to be configured to compare the activity classification to an assigned classification as taught by Nagle, because Nagle teaches that an important factor in healing wounds is patient compliance to a treatment regime (para. 0009:1-2; para. 0019).
Regarding claim 59, the cited prior art suggests the invention of claim 58.
The prior art differs from the instantly claimed invention in that the combined prior art fails to disclose wherein the user interface is configured to receive the assigned classification as a user input to the user interface.
LeBoeuf teaches that their user interface is configured to receive the assigned classification as a user input to the user interface (para. 0042-0048; Fig. 4, user input circuit 160 connected to input/output interface which may include a display) to facilitate the determination of the activity being performed (para. 0042-0048; para. 0089).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the cited prior art to comprise the user interface configured to receive the assigned classification as a user input as taught by LeBoeuf, because LeBoeuf teaches that this facilitates the determination of the activity being performed (para. 0042-0048; para. 0089).
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Weston, Locke, Bichel, and LeBoeuf as applied above, and further in view of US/2009/0234262 A1 to Reid.
Regarding claim 61, the cited prior art suggests the invention of claim 49.
The prior art differ from the instantly claimed invention in that the prior art fail to disclose wherein the system is further configured to transmit the indication of the activity classification to a computing device via a communication network.
Reid teaches transmission of heath indicator data, such as respiratory activity (para. 0021), over a wireless network to a computing device at a location remote from the patient (para. 0046-0048).
Reid is considered to be analogous to the instantly claimed invention in that Reid is directed to a health monitoring system. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of the cited prior art to be configured to transmit activity classification information to a computing device as taught by Reid, because Reid teaches that this allows for a healthcare practitioner to receive the transmitted data and modify the therapy provided by the system if desired (para. 0048).
Claims 64-65 are rejected under 35 U.S.C. 103 as being unpatentable over US/2010/0298792 A1 to Weston in view of US/2018/0250452 A1 to Locke and US/2016/0361020 A1 to LeBoeuf.
Regarding claim 64, Weston discloses a system for treating a wound and/or for monitoring the movement of a patient (para. 0003; para. 0011; Fig. 4B, negative pressure apparatus 220), comprising:
a source of negative pressure (Fig. 4B, vacuum pump 230);
a wound dressing placed on a joint of a patient (Fig. 4B, wound dressing 224 placed on wound site 222; any wound site may be considered near a joint);
one or more sensors configured to generate data measured in, at, or near the wound dressing configured to be placed on a joint of the patient (para. 0071, pressure sensors provide signal outputs to control device 232; para. 0072, pressure sensor 265 monitors approximate pressure within the wound dressing within the fluid flow path near wound dressing 224 and may be positioned at various other locations throughout negative pressure apparatus 220);
a controller (para. 0071; Fig. 4A, control device 132); and
wherein the system further includes a user interface (para. 0103-0105).
Weston differs from the instantly claimed invention in that Weston fails to disclose that the sensor data is indicative of movement of the joint, the controller configured to determine the movement of the joint of the patient during a period of time from the data measured by the sensor based on a change of the data over the period of time and by comparing the frequency indicative of the movement of the joint to one or more frequency thresholds; wherein the controller is further configured to output an indication denoting the movement of the joint for the patient; and wherein the user interface is configured to output the indication of the movement of the joint for presentation.
Locke teaches a system for treating a wound (Fig. 1, negative pressure therapy system 100) comprising a controller configured to determine activity of a user while wearing the system (para. 0026). Locke further teaches that ambulation aids in the healing of a tissue site and that prompting a patient to engage in ambulatory therapy may help a user receive increased therapeutic benefits (para. 0045-0046).
LeBoeuf teaches a bandage for determining user activity (para. 0040-0041, measurement system 10 may be within a bandage; Fig. 2, measurement system 10) comprising one or more sensors wherein the sensor data is indicative of movement of the joint, the sensors configured to generate data associated with a frequency indicative of the movement of the joint (Fig. 2, sensors 14; para. 0042), wherein the controller is configured to determine a movement of a joint for a patient during a period of time from data measured by the one or more sensors based on a change of the data over the period of time and by comparing the frequency indicative of the movement of the joint to one or more frequency thresholds (Fig. 2, sensed values from sensors 14 [motion and biometric] are sent to parameter circuit 100; para. 0032, microcontroller may be a signal processing circuit found in a localized system; para. 0033-0035, activity classifications [parameters]; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit; Fig. 3, method 200 for determining activity classification; Fig. 5, ramping determination 340; Fig. 6A), wherein the controller is further configured to output an indication denoting the activity classification for the user (para. 0042, parameter circuit 100 determines parameter and outputs parameter to input/output interface 16; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit); and wherein the user interface is configured to output the indication of the movement of the joint for presentation (para. 0042, parameter circuit 100 determines parameter and outputs parameter to input/output interface 16 as a display).
LeBoeuf further teaches that the frequency threshold comparisons applied in their system can take into account certain factors to more accurately determine the activity classification (para. 0046-0047).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the controller and the sensor array of Weston to determine the activity classification based on comparing signals of the sensed data to one or more frequency thresholds as taught by LeBoeuf and Locke, because LeBoeuf teaches that the frequency threshold comparisons applied in their system can take into account certain factors to more accurately determine an activity classification (para. 0046-0047) and Locke teaches that ambulation aids in the healing of a tissue site and that prompting a patient to engage in ambulatory therapy may help a user receive increased therapeutic benefits (para. 0045-0046).
Regarding claim 65, Weston discloses a system for treating a wound and/or for monitoring the movement of a patient (para. 0003; para. 0011; Fig. 4B, negative pressure apparatus 220), comprising:
a source of negative pressure (Fig. 4B, vacuum pump 230);
a wound dressing placed on a joint of patient (Fig. 4B, wound dressing 224 placed on wound site 222; any wound site may be considered near a joint); one or more sensors configured to generate data measured in, at, or near the wound dressing configured to be placed on the joint of the patient (para. 0071, pressure sensors provide signal outputs to control device 232; para. 0072, pressure sensor 265 monitors approximate pressure within the wound dressing within the fluid flow path near wound dressing 224 and may be positioned at various other locations throughout negative pressure apparatus 220); and
a controller (para. 0071; Fig. 4A, control device 132); and
wherein the system further includes a user interface (para. 0103-0105).
Weston differs from the instantly claimed invention in that Weston fails to disclose that the sensor data is indicative of movement of the joint, the controller configured to determine a movement of a joint for the patient during a period of time from data measured by one or more sensors in, at, or near the wound dressing, the movement of the joint further based on data indicative of a frequency of the movement of the joint measured from at least one of the one or more sensors compared to one or more frequency thresholds; wherein the controller is further configured to calculate and output an indication denoting the movement of the joint for the patient; and wherein the system further includes a user interface configured to present the indication.
Locke teaches a system for treating a wound (Fig. 1, negative pressure therapy system 100) comprising a controller configured to determine activity of a user while wearing the system (para. 0026). Locke further teaches that ambulation aids in the healing of a tissue site and that prompting a patient to engage in ambulatory therapy may help a user receive increased therapeutic benefits (para. 0045-0046).
LeBoeuf teaches a bandage for determining user activity (para. 0040-0041, measurement system 10 may be within a bandage; Fig. 2, measurement system 10) comprising one or more sensors wherein the sensor data is indicative of movement of the joint (Fig. 2, sensors 14; para. 0042), wherein the controller is configured to determine a movement of a joint for a patient during a period of time from data measured by one or more sensors in, at, or near the wound dressing, the movement of the joint further based on data indicative of a frequency of the movement of the joint measured from at least one of the one or more sensors compared one or more frequency thresholds (Fig. 2, sensed values from sensors 14 [motion and biometric] are sent to parameter circuit 100; para. 0032, microcontroller may be a signal processing circuit found in a localized system; para. 0033-0035, activity classifications [parameters]; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit; Fig. 3, method 200 for determining activity classification; Fig. 6A), wherein the controller is further configured to calculate and output an indication denoting the activity classification for the user (para. 0042, parameter circuit 100 determines parameter and outputs parameter to input/output interface 16; para. 0041-0060, methods and structures for determining activity classification comprising parameter circuit 100 as a signal processing circuit); and a user interface configured to present the indication (para. 0042, parameter circuit 100 determines parameter and outputs parameter to input/output interface 16 as a display).
LeBoeuf further teaches that the frequency threshold comparisons applied in their system can take into account certain factors to more accurately determine the activity classification (para. 0046-0047).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the controller and the sensor array of Weston to determine the activity classification based on comparing signals of the sensed data to one or more frequency thresholds as taught by LeBoeuf and Locke, because LeBoeuf teaches that the frequency threshold comparisons applied in their system can take into account certain factors to more accurately determine an activity classification (para. 0046-0047) and Locke teaches that ambulation aids in the healing of a tissue site and that prompting a patient to engage in ambulatory therapy may help a user receive increased therapeutic benefits (para. 0045-0046).
Conclusion
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/Linnae E. Raymond/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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