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 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-10, 12, 53-57, 61, and 68-70 are rejected under 35 U.S.C. 103 as being unpatentable over Perry et al., (US 2014/0207036; hereinafter Perry) in view of Coza et al., (US 2013/0274587; hereinafter Coza), Volpe et al., (US 2014/0206974; hereinafter Volpe), Cudak et al., (US 20170061774; hereinafter Cudak), and Robertson et al., (US 20170249602; hereinafter Robertson).
Regarding claims 1 and 3-5, Perry discloses (Figures 1-8) a wearable medical device apparatus for pairing with a first garment or a second garment of associable garments (sleeves) comprising: a medical device controller (14); a first garment identification component (the respective connection connecting the respective sleeve to the system) disposed as a part of the first garment, the first garment identification component configured to operably couple with a medical device controller (14), wherein the medical device controller (14) is configured to: disassociate the first garment (a first sleeve) from the medical device controller (data communication between the garment and the controller are dissociated when the first sleeve is removed from the system), the first garment comprising a first garment identification component (the respective connection connecting the respective sleeve to the system), initiate data communication between the medical device controller (14) and the first garment (a second sleeve) of the associable garments (initiate pressure measurement of the second garment), the second garment comprising a second garment identification component (the respective connection connecting the respective sleeve to the system), receive, from the second garment identification component (the respective connection connecting the respective sleeve to the system) of the second garment, an identifier (pressure) of the second garment, wherein the second garment identification component is disposed as a part of the second garment and is configured to operably couple with the medical device controller (14), compare one or more stored identifiers (stored pressures associated with different sleeves i.e. using a look-up table) of the associable garments to the identifier (pressure) received from the second garment identification component, and based on the comparison, cause the second garment to be paired with the medical device controller ([0062]-[0066]: a predetermined interval is when one treatment regimen ends and the system is restarted to repeat the garment detection cycle; the system will then identify whether one sleeve has been replaced with another sleeve based on the pressure values).
Perry fails to disclose that the first and second garments are configured to be worn about a torso of a patient, the first garment identification component comprises at least one of a near field communication (NFC) element and a machine-readable data element, the NFC element comprises a radio-frequency identification (RFID) element and the machine-readable data element comprises a barcode. However, Coza teaches (Figure 1) an apparatus comprising a wearable medical device, wherein a garment (500) is configured to be worn about a torso of a patient ([0060], [0062]) and identifiable by the system using a garment identification component comprising at least one of a near field communication (NFC) element and a machine-readable data element, the NFC element comprising a radio-frequency identification (RFID) element and the machine-readable data element comprises a barcode ([0136]-[0138]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry such that the apparatus comprises a wearable medical device, the garment is configured to be worn about a torso of a patient, the first garment identification component comprises at least one of a near field communication (NFC) element and a machine-readable data element, the NFC element comprises a radio-frequency identification (RFID) element and the machine-readable data element comprises a barcode, as taught by Coza, because the modification would provide a simple, low-power wireless communication protocol for garment monitoring (Coza, [00138]). Furthermore, since the modified device would include first and second garments, the first and second garments would be configured to be worn about a torso of a patient. Furthermore, since the modified device would include first or second garments, the modifications would apply to both the first and second garments.
Perry/Coza fails to teach a plurality of ECG electrodes configured to be disposed in the first garment or the second garment and monitor an ECG signal of the patient; and therapy electrodes configured to be disposed in the garment and deliver one or more therapy shocks, the one or more therapy shocks being delivered responsive to a determination by the medical device controller of a cardiac arrhythmia event occurring in the patient based on the monitored ECG signal of the patient; further wherein the apparatus comprises a wearable cardiac monitoring and treatment device, and wherein the one or more therapy shocks comprises at least one of one or more pacing shocks or one or more defibrillation shocks; wherein the medical device controller is configured to: determine when the first garment has been associated with the medical device controller for a threshold variable based on a first garment identification component of the first garment; responsive to the determination that the first garment has been associated with the medical device controller for the threshold variable, provide, via a user interface of the medical device controller, a prompt to the patient to at least one of launder the first garment or replace the first garment with the second garment of the associable garments; on determining that the first garment has been laundered, provide via the user interface of the medical device controller a prompt to the patient confirming whether the first garment has been laundered; and the medical device controller is configured to, on determining that the first garment is to be replaced with the second garment, disassociate the first garment when the first garment is replaced with the second garment of the associable garments.
However, Volpe discloses (Figure 2) a wearable medical device including a medical device controller (130), ([0033]); a plurality of ECG electrodes configured to be disposed in a garment being configured to be worn about a torso of a patient, and monitor an ECG signal of the patient ([0034]: at least one sensing electrode 135, which is used for ECG); and therapy electrodes (140) configured to be disposed in the garment and deliver one or more therapy shocks ([0034]), the one or more therapy shocks being delivered responsive to a determination by the medical device controller of a cardiac arrhythmia event occurring in the patient based on the monitored ECG signal of the patient; further wherein the apparatus comprises a wearable cardiac monitoring and treatment device, and wherein the one or more therapy shocks comprises at least one of one or more pacing shocks or one or more defibrillation shocks ([0037]), wherein the medical device controller (130) is configured to: determine when the first garment has been associated with the medical device controller for a threshold variable based on a first garment identification component of the first garment; responsive to the determination that the first garment has been associated with the medical device controller for the threshold variable, provide, via a user interface (120) of the medical device controller, a prompt to the patient to at least one of launder the first garment or replace the first garment with the second garment of the associable garments when the first garment is replaced with the second garment of the associable garments ([0061], [0063]-[0064]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry to include a plurality of ECG electrodes configured to be disposed in the first garment and monitor an ECG signal of the patient; and therapy electrodes configured to be disposed in the first garment and deliver one or more therapy shocks, the one or more therapy shocks being delivered responsive to a determination by the medical device controller of a cardiac arrhythmia event occurring in the patient based on the monitored ECG signal of the patient; further wherein the apparatus comprises a wearable cardiac monitoring and treatment device, and wherein the one or more therapy shocks comprises at least one of one more pacing shocks or one or more defibrillation shocks, wherein the medical device controller is configured to provide, via a user interface of the medical device controller, a prompt to the patient to at least one of launder the first garment or replace garments for washing, as taught by Volpe, because the modification would provide notifications to the subject regarding and treat the subject based on arrhythmias, cardiac events, the condition of the wearable therapeutic device, and the positioning of electrodes or other wearable therapeutic device components relative to the subject (Volpe; [0006]). Furthermore, since the modified device would include first or second garments, the plurality of ECG electrodes would be configured to be disposed in a first garment or a second garment of the associable garments. Finally, Perry teaches that programming of the system controller can either be performed manually by the user through a display interface ([0008], [0036]). Since the modified device would include the prompt to the patient based on a determination of various conditions which are affected by washing and extended wear, the medical device controller would be configured to disassociate the first garment at least based on a response to the prompt from the patient, on determining that that the first garment is to be replaced with the second garment, for manual programming of the system controller as explained above. Furthermore, on determining that the first garment has been laundered in the modified device, the user interface of the medical device controller would provide a prompt to the patient confirming whether the first garment has been laundered since the modified device would be continually monitoring the laundering condition of the device. Therefore, a laundering prompt would be provided until it is confirmed by the device that the laundering condition has been met.
Perry/Coza/Volpe fails to teach that the threshold variable is a threshold amount of time. However, Cudak (Figures 1-3) teaches a healthcare garment comprising a controller configured to use washing history as an indicator of time between wash cycles. This difference between the time of the last wash and the current wear of the garment is compared to a threshold amount of time to alert the user whether the garment may be worn or must be replaced ([0013]-[0015], [0026]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry/Coza/Volpe such that the threshold variable is a threshold amount of time since using the threshold amount of time in relation to washing history for the prevention/control of pathogens during use (Cudak; [0013]-[0015], [0026]).
Perry/Coza/Volpe/Cudak fails to teach that the garment monitoring system used to determine that the first garment has been laundered is also based on data received from at least one sensor disposed in the first garment configured to sense at least one of a measured temperature, humidity, or pH associated with the first garment; wherein the medical device controller is configured to determine when the first garment is insufficient to maintain electrode to skin contact between the therapy electrodes and the patient based on data received from at least one sensor disposed in the first garment configured to sense at least one of a measured temperature, humidity, pH or fabric stretch associated with the first garment responsive to the determination that the first garment is insufficient to maintain electrode to skin contact. However, Robertson teaches an apparatus comprising a sensor configured to sense temperature or humidity values to monitor the presence of a fluid in the apparatus to determine if a garment is soiled ([0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry/Coza/Volpe/Cudak to include at least one of the temperature or humidity sensors taught by Robertson into the garment monitoring system because the modification would aid in determining whether the garment is soiled (Robertson; [0045]). Furthermore, when the temperature or humidity values indicate the presence of a fluid in a soiled garment, electrode to skin contact may be insufficient between the therapy electrodes in the modified device since there would be a fluid separation between the two. Therefore, in the modified device, the medical device controller would be configured to wherein the medical device controller is configured to determine when the first garment is insufficient to maintain electrode to skin contact between the therapy electrodes and the patient based on data received from at least one sensor disposed in the first garment configured to sense at least one of a measured temperature, humidity, pH or fabric stretch associated with the first garment responsive to the determination that the first garment is insufficient to maintain electrode to skin contact.
Regarding claim 2, Perry further discloses that the medical device controller (14) is configured to associate with the first garment after identifying the first garment ([0062]-[0066]).
Regarding claims 6-9, Perry/Coza/Volpe/Cudak/Robertson teaches the apparatus of claim 2, but Perry/Coza/Cudak/Robertson fails to teach that the medical device controller is configured to determine an amount of time that the first garment has been worn by the patient, wherein the medical device controller is configured to determine an amount of time that the first garment has been worn by the patient by determining an amount of time that the first garment has been associated with the medical device controller without the medical device controller being associated with another garment, wherein the medical device controller is configured to determine that the first garment is to be removed or replaced based on the amount of time that the first garment has been associated with the medical device controller without the medical device controller being associated with another garment, wherein the medical device controller is configured to determine that the first garment is to be removed or replaced if the amount of time meets a predetermined threshold variable.
However, Volpe teaches (Figures 1-7) an apparatus comprising a medical device controller (130) configured to determine an amount of time that a first garment (105) has been worn by a patient (the system measures stretch over time), wherein the medical device controller (130) is configured to determine an amount of time that the first garment (105) has been worn by the patient by determining an amount of time that the first garment (105) has been associated with the medical device controller (130) without the medical device controller (130) being associated with another garment (the time that stretching is monitored before indication of replacement is alerted is the amount of time that the garment has been worn by the patient), wherein the medical device controller (130) is configured to determine that the first garment (105) is to be removed or replaced based on the amount of time that the first garment (105) has been associated with the medical device controller (130) without the medical device controller (130) being associated with another garment (105), wherein the medical device controller (130) is configured to determine that the first garment (105) is to be removed or replaced if the amount of time meets a predetermined threshold variable ([0061], [0063]: the system provides an alert that the garment should be replaced due to its age). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry/Coza/Cudak/Robertson such that the medical device controller is configured to determine an amount of time that the first garment has been worn by the patient, wherein the medical device controller is configured to determine an amount of time that the first garment has been worn by the patient by determining an amount of time that the first garment has been associated with the medical device controller without the medical device controller being associated with another garment, wherein the medical device controller is configured to determine that the first garment is to be removed or replaced based on the amount of time that the first garment has been associated with the medical device controller without the medical device controller being associated with another garment, wherein the medical device controller is configured to determine that the first garment is to be removed or replaced if the amount of time meets a predetermined threshold variable, as taught by Volpe, because the modification would enable the user to be alerted that the garment may be nearing end of life and be in need of replacement (Volpe, [0063]) to ensure proper elasticity and use of the system.
Regarding claim 10, Perry further discloses that the medical device controller (14) is configured to operably couple with a third garment identification component (the respective port connecting the respective sleeve to the system) disposed as a part of a third garment (a third sleeve), wherein the medical device controller (14) is configured to identify the third garment based on one or more values provided by the third garment identification component ([0062]-[0066]). Furthermore, since the modified device includes the garment being configured to be worn about the torso of the patient, the second garment would also be configured to be worn about the torso of the patient.
Regarding claim 12, Perry further discloses that the medical device controller (14) is configured to, upon identifying the third garment, provide a prompt to a user to enable the user to cause the medical device controller (14) to disassociate the medical device controller (14) from the second garment and associate the medical device controller (14) with the third garment ([0062]-[0066]).
Regarding claim 53, Perry further discloses that the one or more identifiers of the associable garments comprise a numerical identifier (a particular pressure value associated with a particular garment type, as explained in the rejection of claim 1).
Regarding claim 54, Perry/Coza/Volpe/Cudak/Robertson teaches that the first garment is disassociated from the medical device controller in response to determining that the first garment was removed from the torso of the patient. Specifically, Perry discloses that when one treatment regimen ends and the system is restarted to repeat the garment detection cycle; the system will then identify whether one sleeve has been replaced with another sleeve based on the pressure values ([0062]-[0066]). Therefore, the first garment will be dissociated from the controller in response to determining that the first garment was removed in the modified device.
Regarding claim 55, Perry/Coza/Volpe/Cudak/Robertson teaches that the medical device controller (Volpe; 130) is further configured disassociate the first garment based on a determination whether the first garment has been laundered according to a predetermined schedule based at least in part on two or more measured values, the two or more measured values being measured by one or more sensors embedded in the first garment and communicatively coupled to the medical device controller, the two or more measured values indicating whether the first garment has not been in a laundering environment (Volpe; [0061]-[0063]: component 515 measures stretch deterioration from a baseline value over time and determines whether laundering is required according to this schedule).
Regarding claim 56, Perry/Coza/Volpe/Cudak/Robertson teaches that the two or more measured values including at least one of the following: a temperature value, a humidity value, a pH value, a fabric stretch value, and any combination thereof (Volpe; [0061]).
Regarding claim 57, Perry/Coza/Volpe/Cudak/Robertson teaches that the indicating whether the first garment has not been in the laundering environment is based on a determination whether the two or more measured values meeting corresponding predetermined threshold values (Volpe; [0061]).
Regarding claim 61, Perry/Coza/Volpe/Cudak/Robertson teaches that the garment association time threshold comprises one day or two days. Specifically, the example disclosed in paragraph [0015] of Cudak uses one day as the threshold for the garment association time.
Regarding claim 68, Perry/Coza/Volpe/Cudak/Robertson teaches that determining that the first garment is insufficient to maintain electrode to skin contact between the therapy electrodes and the patient is responsive to a plurality of the at least one sensor concurrently satisfying a respective threshold. Specifically, the plurality of sensors taught by the Perry/Coza/Volpe/Cudak/Robertson combination would be used to determine that the first garment is insufficient to maintain electrode to skin contact. Therefore, the determination would be obtained with the plurality of sensors concurrently satisfying a respective threshold.
Regarding claim 69, Perry/Coza/Volpe/Cudak/Robertson that the at least one sensor includes a strain sensor embedded in the first garment and the medical device controller determines that the first garment is insufficient to maintain electrode to skin contact between therapy electrodes and the patient when a measured stretch value or a change between first and second stretch values exceeds a stored threshold value indicative of a loss of electrode-to-skin contact. Specifically, Volpe teaches a strain sensor (150/155) embedded in the first garment (105) and the medical device controller determines that the first garment (105) is insufficient to maintain electrode to skin contact between therapy electrodes (140) and the patient when a measured stretch value or a change between first and second stretch values exceeds a stored threshold value indicative of a loss of electrode-to-skin contact ([0038]-[0042], [0054]).
Regarding claim 70, Perry/Coza/Volpe/Cudak/Robertson that the medical device controller inhibits delivery of one or more therapy shocks when it is determined that the first garment is insufficient to maintain electrode to skin contact. Specifically, Volpe pauses treatment and provides a prompt to the patient based on a determination of insufficient electrode to skin contact between therapy electrodes. Therefore, the modified medical device controller would be configured to disassociate the first garment at least based on a response to the prompt from the patient, on determining that that the first garment is to be replaced with the second garment. Furthermore, on determining that the first garment has been laundered in the device, the user interface of the medical device controller would provide a prompt to the patient confirming whether the first garment has been laundered since the modified device would be continually monitoring the laundering condition of the device. Therefore, the modified medical device controller would inhibit delivery of one or more therapy shocks when it is determined that the first garment is insufficient to maintain electrode to skin contact.
Claims 13-18 and 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Perry in view of Volpe, Cudak, and Robertson.
Regarding claim 13, Perry discloses (Figures 1-8) a wearable medical device comprising: a controller (14), ([0062]); a memory (system uses a look-up table) storing a first identifier (a pressure value associated with a particular type of sleeve) identifying a first garment (a first sleeve) and a second identifier (a pressure value associated with a another particular type of sleeve) identifying a second garment ( a second sleeve), the first garment being configured to couple with the controller (14) to initiate data communication between the controller (14) and the first garment ([0062]: pressure measurement is initiated) at a first time and to disassociate the first garment from the medical device controller at a second time, and the second garment being configured to initiate data communication between the controller and the second garment at the second time ([0062]-[0066]: a predetermined interval is when one treatment regimen ends and the system is restarted to repeat the garment detection cycle; the system will then identify whether one sleeve has been replaced with another sleeve based on the pressure values); a communication interface (the system transmits the measured values to the controller/processor and information on the identified sleeves is communicated to the operator via a display); and one or more processors ([0069]) configured for receiving, from the communication interface, a second identifier (pressure) identifying a second garment (a second sleeve, such as the thigh leg sleeve, which is different from the first sleeve), the second garment being configured to couple with the controller, comparing the first identifier and the second identifier, and based on the comparison of the first identifier and the second identifier, storing data indicative of whether the first garment has been removed on at least a predetermined interval ([0062]-[0066]: the pressure values are being continuously monitored by the system (predetermined interval), wherein the pressure values of different sleeves are monitored (comparing first and second values), so when a sleeve is removed, this is detected by the system and a low pressure alarm is triggered).
Perry fails to disclose a plurality of ECG electrodes configured to be disposed in the first garment or the second garment and monitor an ECG signal of the patient; and therapy electrodes configured to be disposed in the first garment or the second garment and deliver one or more therapy shocks, the one or more therapy shocks being delivered responsive to a determination by the medical device controller of a cardiac arrhythmia event occurring in the patient based on the monitored ECG signal of the patient; wherein the medical device controller is configured to provide, via a user interface of the medical device controller, a prompt to the patient to at least one of launder the first garment or replace the first garment with the second garment of the associable garments; on determining that the first garment has been laundered, providing via the user interface of the medical device controller a prompt to the patient confirming whether the first garment has been laundered; and the medical device controller is configured to, on determining that that the first garment is to be replaced with the second garment, disassociate the first garment when the first garment is replaced with the second garment of the associable garments.
However, Volpe discloses (Figure 2) a wearable medical device including a medical device controller; a plurality of ECG electrodes configured to be disposed in the first garment and monitor an ECG signal of the patient ([0034]: at least one sensing electrode 135, which is used for ECG); and therapy electrodes (140) configured to be disposed in the first garment and deliver one or more therapy shocks ([0034]), the one or more therapy shocks being delivered responsive to a determination by the medical device controller of a cardiac arrhythmia event occurring in the patient based on the monitored ECG signal of the patient ([0037]), wherein the medical device controller (130) is configured to provide, via a user interface (120) of the medical device controller, a prompt to the patient to at least one of launder the first garment or replace the first garment with the second garment of the associable garments when the first garment is replaced with the second garment of the associable garments ([0061], [0063]-[0064]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry to include a plurality of ECG electrodes configured to be disposed in the first garment or the second garment and monitor an ECG signal of the patient; and therapy electrodes configured to be disposed in the first garment or the second garment and deliver one or more therapy shocks, the one or more therapy shocks being delivered responsive to a determination by the medical device controller of a cardiac arrhythmia event occurring in the patient based on the monitored ECG signal of the patient, wherein the medical device controller is configured to provide, via a user interface of the medical device controller, a prompt to the patient to replace the first garment with the second garment of the associable garments when the first garment is replaced with the second garment of the associable garments, as taught by Volpe, because the modification would provide notifications to the subject regarding and treat the subject based on arrhythmias, cardiac events, the condition of the wearable therapeutic device, and the positioning of electrodes or other wearable therapeutic device components relative to the subject (Volpe; [0006]). Furthermore, Perry teaches that programming of the system controller can either be performed manually by the user through a display interface ([0008], [0036]). Since the modified device would include the prompt to the patient based on a determination of various conditions which are affected by washing and extended wear, the medical device controller would be configured to disassociate the first garment at least based on a response to the prompt from the patient, on determining that that the first garment is to be replaced with the second garment, for manual programming of the system controller as explained above. Furthermore, on determining that the first garment has been laundered in the modified device, the user interface of the medical device controller would provide a prompt to the patient confirming whether the first garment has been laundered since the modified device would be continually monitoring the laundering condition of the device. Therefore, a laundering prompt would be provided until it is confirmed by the device that the laundering condition has been met.
Perry/Volpe fails to teach that the threshold variable is a threshold amount of time. However, Cudak (Figures 1-3) teaches a healthcare garment comprising a controller configured to use washing history as an indicator of time between wash cycles. This difference between the time of the last wash and the current wear of the garment is compared to a threshold amount of time to alert the user whether the garment may be worn or must be replaced ([0013]-[0015], [0026]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry/Volpe such that the threshold variable is a threshold amount of time since using the threshold amount of time in relation to washing history for the prevention/control of pathogens during use (Cudak; [0013]-[0015], [0026]).
Perry/Volpe/Cudak fails to teach that the garment monitoring system used to determine that the first garment has been laundered is also based on data received from at least one sensor disposed in the first garment configured to sense at least one of a measured temperature, humidity, or pH associated with the first garment; wherein the medical device controller is configured to determine when the first garment is insufficient to maintain electrode to skin contact between the therapy electrodes and the patient based on data received from at least one sensor disposed in the first garment configured to sense at least one of a measured temperature, humidity, pH or fabric stretch associated with the first garment responsive to the determination that the first garment is insufficient to maintain electrode to skin contact. However, Robertson teaches an apparatus comprising a sensor configured to sense temperature or humidity values to monitor the presence of a fluid in the apparatus to determine if a garment is soiled ([0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry/Volpe/Cudak to include at least one of the temperature or humidity sensors taught by Robertson into the garment monitoring system because the modification would aid in determining whether the garment is soiled (Robertson; [0045]). Furthermore, when the temperature or humidity values indicate the presence of a fluid in a soiled garment, electrode to skin contact may be insufficient between the therapy electrodes in the modified device since there would be a fluid separation between the two. Therefore, in the modified device, the medical device controller would be configured to wherein the medical device controller is configured to determine when the first garment is insufficient to maintain electrode to skin contact between the therapy electrodes and the patient based on data received from at least one sensor disposed in the first garment configured to sense at least one of a measured temperature, humidity, pH or fabric stretch associated with the first garment responsive to the determination that the first garment is insufficient to maintain electrode to skin contact.
Regarding claim 14, Perry further discloses that one or both of the first identifier (pressure) identifying the first garment and the second identifier (pressure) identifying the second garment is unique to the respective garment and comprises data that corresponds to an identity of the respective garment, the data corresponding to one or more of a serial number of the respective garment, a model number of the respective garment, and a size of the respective garment ([0062]: each sleeve, which has a respective size, is identified based on the pressure values that the system monitors; therefore, the different, unique pressure values identifying each sleeve correspond to the sizes of the respective sleeves).
Regarding claim 15, Perry further discloses that the data indicative of whether the first garment has been removed on at least a predetermined interval comprises data indicative of whether the first garment has been replaced with the second garment on at least a predetermined interval ([0062]-[0066]: the predetermined interval is when one treatment regimen ends and the system is restarted to repeat the garment detection cycle; the system will then identify whether the first sleeve has been replaced with the second sleeve based on the pressure values).
Regarding claim 16, Perry further discloses a user interface (32) configured to provide one or more messages based at least in part on the data indicative of whether the first garment has been removed on at least a predetermined interval ([0036], [0065]).
Regarding claim 17, Perry further discloses that the one or more processors are configured for calculating the data indicative of whether the first garment has been removed on at least a predetermined interval, based at least on the second identifier ([0062]-[0066]: the predetermined interval is when one treatment regimen ends and the system is restarted to repeat the garment detection cycle; the treatment regimen is then decided based on the second value (to establish the predetermined interval based on the treatment regimen).
Regarding claim 18, Perry further discloses a network communication interface configured to transmit, to a server in communication with a network, the data indicative of whether the first garment has been removed on at least a predetermined interval ([0015], [0036]: processor in communication with the control panel to show indicators for number and types of sleeves connected).
Regarding claim 58, Perry/Volpe/Cudak/Robertson teaches that the medical device controller (Volpe; 130) is further configured disassociate the first garment based on a determination whether the first garment has been laundered according to a predetermined schedule based at least in part on two or more measured values, the two or more measured values being measured by one or more sensors embedded in the first garment and communicatively coupled to the medical device controller, the two or more measured values indicating whether the first garment has not been in a laundering environment (Volpe; [0061]-[0063]: component 515 measures stretch deterioration from a baseline value over time and determines whether laundering is required according to this schedule).
Regarding claim 59, Perry/Volpe/Cudak/Robertson teaches that the two or more measured values including at least one of the following: a temperature value, a humidity value, a pH value, a fabric stretch value, and any combination thereof (Volpe; [0061]).
Regarding claim 60, Perry/Volpe/Cudak/Robertson teaches that the indicating whether the first garment has not been in the laundering environment is based on a determination whether the two or more measured values meeting corresponding predetermined threshold values (Volpe; [0061]).
Claims 19-25 and 28-35 are rejected under 35 U.S.C. 103 as being unpatentable over Volpe in view of Robertson and Cudak.
Regarding claim 19, Volpe discloses (Figures 1-7) an apparatus comprising: a garment (105) configured to be worn about a torso of a patient ([0035]); a garment monitoring component (515) disposed as a part of the garment (105), ([0061]) and configured to determine whether the garment (105) has been laundered according to a predetermined schedule ([0061]-[0063]), wherein the garment monitoring component (515) comprises a fabric stretch sensor (150/155) configured to measure stretch of the garment ([0048]-[0052]); and a communication device operably connected to the garment monitoring component (515) and configured to initiate data communication between the garment and a medical device controller (initiate stretch measurement), and exchange information related to the association of the garment (105) with the medical device controller ([0061]-[0063], [0082]: notifications of elasticity loss are transmitted over a network, via a communication device, to a doctor at a remote location by an alarm module), provide, via a user interface (120) of the medical device controller (130), based on the exchanged information, a prompt to the patient to at least one of launder the first garment or replace the first garment with the second garment of the associable garments when the first garment is replaced with the second garment of the associable garments, wherein the prompt instructs replacement of the garment (105) to preserve therapy efficacy ([0061], [0063]-[0064]: controller prevents application of treatment based on data thresholds, thereby dissociating from the garment). Specifically, the controller of Volpe inherently determines that it has not been in a laundering environment during the duration of the wear using soil level, elasticity, and wear/tear as indirect measures which determine whether or not the garment has been in a laundered environment. The claim only requires that the controller needs to determine whether the garment has been or has not been in a laundering environment. It is silent as to the parameters used to determine whether or not the garment has been washed. Therefore, the controller (garment monitoring system) of Volpe is capable of alerting the user that it is time for washing inherently using soil level, elasticity, and wear/tear as indirect measures which determine whether or not the garment has been in a laundered environment. Since the Volpe device includes the prompt to the patient based on a determination of various conditions which are affected by washing and extended wear, the medical device controller would be configured to disassociate the first garment at least based on a response to the prompt from the patient, on determining that that the first garment is to be replaced with the second garment. Furthermore, on determining that the first garment has been laundered in the device, the user interface of the medical device controller would provide a prompt to the patient confirming whether the first garment has been laundered since the modified device would be continually monitoring the laundering condition of the device. Therefore, a laundering prompt would be provided until it is confirmed by the device that the laundering condition has been met ([0061]-[0063]).
Volpe fails to disclose that the garment monitoring system used to determine that the first garment has been laundered is also based on data received from at least one sensor disposed in the first garment configured to sense at least one of a measured temperature, humidity, or pH associated with the first garment. However, Robertson teaches an apparatus comprising a sensor configured to sense temperature or humidity values to monitor the presence of a fluid in the apparatus to determine if a garment is soiled ([0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Volpe to include at least one of the temperature or humidity sensors taught by Robertson into the garment monitoring system because the modification would aid in determining whether the garment is soiled (Robertson; [0045]).
Volpe/Robertson fails to teach that the communication device is configured to detect the second garment in proximity of the medical device controller and determine whether the detected second garment is the same as the first garment or whether the second garment is distinct from the first garment; wherein whether the first garment has been laundered is determined on determining that the second garment is the same as the first garment. However, Cudak (Figures 1-3) teaches a garment monitoring system in which each garment (104) has a unique identification device (105) in order to distinguish the garments and whether they have been laundered ([0013]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Volpe/Robertson to include unique identification devices for the garments such that the communication device is configured to detect the second garment in proximity of the medical device controller and determine whether the detected second garment is the same as the first garment or whether the second garment is distinct from the first garment, as taught by Cudak, because the modification would enforce proper sanitation and washing rules for garments (Cudak; [0013]). Furthermore, since the modified device would be continually monitoring the laundering condition of the device, as taught by Volpe, whether the first garment has been laundered would also be determined on determining that the second garment is the same as the first garment.
Volpe/Robertson also fails to teach that the threshold variable is a threshold amount of time. However, Cudak (Figures 1-3) teaches a healthcare garment comprising a controller configured to use washing history as an indicator of time between wash cycles. This difference between the time of the last wash and the current wear of the garment is compared to a threshold amount of time to alert the user whether the garment may be worn or must be replaced ([0013]-[0015], [0026]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Volpe/Robertson such that the threshold variable is a threshold amount of time since using the threshold amount of time in relation to washing history for the prevention/control of pathogens during use (Cudak; [0013]-[0015], [0026]).
Regarding claim 20, Volpe further discloses that the garment monitoring component (515) comprises at least one sensor (105/155) that measures fabric stretch ([0048]-[0052], [0061]).
Regarding claim 21, Volpe further discloses that the garment monitoring component (515) is configured to determine whether the garment (105) has been laundered according to a predetermined schedule based at least in part on two or more measured values ([0061]-[0063]: component 515 measures stretch deterioration from a baseline value over time and determines whether laundering is required according to this schedule).
Regarding claims 22 and 23, Volpe/Robertson/Cudak further teaches that the two or more measured values are temperature values measured by a temperature sensor, and the determination of whether the garment has been laundered according to the predetermined schedule is based on whether any of the temperature values meets a predetermined threshold, wherein a temperature value that meets the predetermined threshold is indicative of the garment having been in a laundering environment. Specifically, the modified device includes the teachings of Robertson, which teaches an apparatus comprising a garment monitoring component (knit sensor system) which uses temperature values for monitoring ([0091], [0093], [0095]). Since the modified device would include the knit temperature sensor, the two or more measured values would include temperature values measured by a temperature sensor, and the determination of whether the garment has been laundered according to the predetermined schedule would be based on whether any of the temperature values meets a predetermined threshold, wherein a temperature value that meets the predetermined threshold is indicative of the garment having been in a laundering environment.
Regarding claims 24 and 25, Volpe/Robertson/Cudak further teaches that the two or more measured values are humidity values measured by a humidity sensor, and the determination of whether the garment has been laundered according to the predetermined schedule is based on whether any of the humidity values meets a predetermined threshold, wherein a humidity value that meets the predetermined threshold is indicative of the garment having been in a laundering environment. Specifically, the modified device includes the teachings of Robertson, which teaches an apparatus comprising a garment monitoring component (sensor) which uses humidity values for monitoring ([0016]-[0017], [0021], [0088]). Since the modified device would include the humidity sensor, the two or more measured values would include humidity values measured by a humidity sensor, and the determination of whether the garment has been laundered according to the predetermined schedule would be based on whether any of the humidity values meets a predetermined threshold, wherein a humidity value that meets the predetermined threshold is indicative of the garment having been in a laundering environment.
Regarding claim 28, Volpe further discloses that the two or more measured values are stretch values measured by a strain sensor, and the determination of whether the garment (105) has been laundered according to the predetermined schedule is based on whether any of the stretch values meets a predetermined threshold ([0061]-[0063]).
Regarding claim 29, Volpe further discloses that a stretch value that meets the predetermined threshold is indicative of the garment (105) having not been in a laundering environment ([0061]-[0063]).
Regarding claim 30, Volpe further discloses that a difference between a first stretch value and a second stretch value that meets the predetermined threshold is indicative of the garment (105) having been in a laundering environment ([0061]-[0063]).
Regarding claim 31, Volpe further discloses that the strain sensor (515) comprises a coil embedded in fabric of the garment ([0048]).
Regarding claim 32, Volpe further discloses that the two or more measured values include one or both of an inductance value and a capacitance value indicative of stretch experienced by the garment (105), ([0061]-[0063]).
Regarding claim 33, Volpe further discloses that the medical device controller (130) comprises a user interface configured to provide one or more messages based at least in part on the information related to the laundering of the garment (105), ([0061]-[0063]).
Regarding claim 34, Volpe further discloses that the communication device is configured to transmit, to a server in communication with a network, the information related to the laundering of the garment (105), ([0061]-[0063]).
Regarding claim 35, Volpe further discloses that the information related to the laundering of the garment (105) includes one or more of a measured temperature value, humidity value, pH value, and stretch value, and one or more laundering events experienced by the garment (105) are identified based on the information related to the laundering of the garment (105), ([0061]-[0063]).
Claims 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Volpe in view of Robertson and Cudak, as applied to claim 21 above, and further in view of Springer et al., (US 2008/0255528; hereinafter Springer).
Regarding claims 26 and 27, Volpe/Robertson/Cudak teaches the apparatus of claim 21, but fails to disclose that the two or more measured values are pH values measured by a pH sensor, and the determination of whether the garment has been laundered according to the predetermined schedule is based on whether any of the pH values meets a predetermined threshold, wherein a pH value that meets the predetermined threshold is indicative of the garment having been in a laundering environment. However, However, Springer teaches an apparatus comprising a garment monitoring component (pH sensor) which uses pH values for monitoring ([0015], [0058]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Volpe/Robertson/Cudak to include the pH sensor taught by Springer because the modification would warn the user the pH concentration within the article approaches a degree of toxicity that can cause or exacerbate damage to the wearer's skin and other membranes (Springer; [0015]). Furthermore, since the modified device would include the pH sensor, the two or more measured values would include pH values measured by a pH sensor, and the determination of whether the garment has been laundered according to the predetermined schedule would be based on whether any of the pH values meets a predetermined threshold, wherein a pH value that meets the predetermined threshold is indicative of the garment having been in a laundering environment.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Volpe in view of Robertson and Cudak, as applied to claim 19 above, and further in view of Coza.
Regarding claim 36, Volpe/Robertson/Cudak teaches the apparatus of claim 19, but fails to disclose that the communication device operates according to an NFC protocol. However, Coza teaches (Figure 1) an apparatus comprising a wearable medical device ([0060], [0062]) with a garment identification system comprising a communication device operating according to an NFC protocol ([0136]-[0138]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Volpe/Robertson/Cudak such that the communication device operates according to an NFC protocol, as taught by Coza, because the modification would provide a simple, low-power wireless communication protocol for garment monitoring (Coza, [00138]).
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Perry/Coza/Volpe/Cudak/Robertson, as applied to claim 1 above, and further in view of Alampallam et al., (US 20170092098; hereinafter Alampallam).
Regarding claim 62, Perry/Coza/Volpe/Cudak/Robertson teaches the apparatus of claim 1, but fails to teach wherein the at least one sensor further comprises a conductive mesh configured to sense a tear and the apparatus is further configured to determine that the first garment has been laundered based on data received from the at least one sensor configured to sense the tear. However, Alampallam teaches an apparatus (102) comprising at least one sensor (104) comprising a conductive mesh configured to sense a tear ([0033], [0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry/Coza/Volpe/Cudak/Robertson to include at least one sensor further comprising a conductive mesh configured to sense a tear, as taught by Alampallam, because the modification would determine whether there is a tear, torsion, or strain on the apparatus (Alampallam; [0042]) to provide information on any damage to the apparatus. Furthermore, since the garment monitoring system of the modified device would include inputs from all the sensors of the apparatus for garment monitoring, the modified apparatus would be further configured to determine that the first garment has been laundered based on data received from the at least one sensor configured to sense the tear.
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over Perry/Coza/Volpe/Cudak/Robertson, as applied to claim 1 above, and further in view of Manzke et al., (US 20140088377; hereinafter Manzke).
Regarding claim 63, Perry/Coza/Volpe/Cudak/Robertson teaches apparatus of claim 1, but fails to teach wherein the at least one sensor further comprises an optical sensor configured to sense stretch of the garment and the apparatus is further configured to determine that the first garment has been laundered based on data received from the at least one sensor indicative of a stretch of the first garment. However, Manzke teaches an apparatus (106) comprising at least one sensor (104) comprising an optical sensor configured to sense stretch of the garment ([0025], [0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry/Coza/Volpe/Cudak/Robertson to include at least one sensor further comprising an optical sensor configured to sense stretch of the garment, as taught by Manzke, because the modification would provide information on the geometry of the apparatus, including any stretch or strain (Manzke; [0025], [0033]). Furthermore, since the garment monitoring system of the modified device would include inputs from all the sensors of the apparatus for garment monitoring, the modified apparatus would be further configured to determine that the first garment has been laundered based on data received from the at least one sensor indicative of a stretch of the first garment.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Perry/Volpe/Cudak/Robertson, as applied to claim 13 above, and further in view of Alampallam.
Regarding claim 64, Perry/Volpe/Cudak/Robertson teaches the apparatus of claim 13, but fails to teach wherein the at least one sensor further comprises a conductive mesh configured to sense a tear and the apparatus is further configured to determine that the first garment has been laundered based on data received from the at least one sensor configured to sense the tear. However, Alampallam teaches an apparatus (102) comprising at least one sensor (104) comprising a conductive mesh configured to sense a tear ([0033], [0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry/Volpe/Cudak/Robertson to include at least one sensor further comprising a conductive mesh configured to sense a tear, as taught by Alampallam, because the modification would determine whether there is a tear, torsion, or strain on the apparatus (Alampallam; [0042]) to provide information on any damage to the apparatus. Furthermore, since the garment monitoring system of the modified device would include inputs from all the sensors of the apparatus for garment monitoring, the modified apparatus would be further configured to determine that the first garment has been laundered based on data received from the at least one sensor configured to sense the tear.
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Perry/Volpe/Cudak/Robertson, as applied to claim 13 above, and further in view of Manzke.
Regarding claim 65, Perry/Volpe/Cudak/Robertson teaches the apparatus of claim 13, but fails to teach wherein the at least one sensor further comprises an optical sensor configured to sense stretch of the garment and the apparatus is further configured to determine that the first garment has been laundered based on data received from the at least one sensor indicative of a stretch of the first garment. However, Manzke teaches an apparatus (106) comprising at least one sensor (104) comprising an optical sensor configured to sense stretch of the garment ([0025], [0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Perry/Volpe/Cudak/Robertson to include at least one sensor further comprising an optical sensor configured to sense stretch of the garment, as taught by Manzke, because the modification would provide information on the geometry of the apparatus, including any stretch or strain (Manzke; [0025], [0033]). Furthermore, since the garment monitoring system of the modified device would include inputs from all the sensors of the apparatus for garment monitoring, the modified apparatus would be further configured to determine that the first garment has been laundered based on data received from the at least one sensor indicative of a stretch of the first garment.
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Volpe/Robertson/Cudak, as applied to claim 21 above, and further in view of Alampallam.
Regarding claim 66, Volpe/Robertson/Cudak teaches the apparatus of claim 19, but fails to teach wherein the at least one sensor further comprises a conductive mesh configured to sense a tear and the apparatus is further configured to determine that the first garment has been laundered based on data received from the at least one sensor configured to sense the tear. However, Alampallam teaches an apparatus (102) comprising at least one sensor (104) comprising a conductive mesh configured to sense a tear ([0033], [0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Volpe/Robertson/Cudak to include at least one sensor further comprising a conductive mesh configured to sense a tear, as taught by Alampallam, because the modification would determine whether there is a tear, torsion, or strain on the apparatus (Alampallam; [0042]) to provide information on any damage to the apparatus. Furthermore, since the garment monitoring system of the modified device would include inputs from all the sensors of the apparatus for garment monitoring, the modified apparatus would be further configured to determine that the first garment has been laundered based on data received from the at least one sensor configured to sense the tear.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Volpe/Robertson/Cudak, as applied to claim 21 above, and further in view of Manzke.
Regarding claim 67, Volpe/Robertson/Cudak teaches the apparatus of claim 19, but fails to teach wherein the at least one sensor further comprises an optical sensor configured to sense stretch of the garment and the apparatus is further configured to determine that the first garment has been laundered based on data received from the at least one sensor indicative of a stretch of the first garment. However, Manzke teaches an apparatus (106) comprising at least one sensor (104) comprising an optical sensor configured to sense stretch of the garment ([0025], [0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Volpe/Robertson/Cudak to include at least one sensor further comprising an optical sensor configured to sense stretch of the garment, as taught by Manzke, because the modification would provide information on the geometry of the apparatus, including any stretch or strain (Manzke; [0025], [0033]). Furthermore, since the garment monitoring system of the modified device would include inputs from all the sensors of the apparatus for garment monitoring, the modified apparatus would be further configured to determine that the first garment has been laundered based on data received from the at least one sensor indicative of a stretch of the first garment.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive. In response to Applicant’s argument that the combination of references fails to teach the amended claim limitations, Examiner respectfully disagrees.
With regard to limitation “wherein the medical device controller is configured to determine when the first garment is insufficient to maintain electrode to skin contact between the therapy electrodes and the patient based on data received from at least one sensor disposed in the first garment configured to sense at least one of a measured temperature, humidity, pH or fabric stretch associated with the first garment responsive to the determination that the first garment is insufficient to maintain electrode to skin contact” in claims 1, 13, ad 19, Examiner notes that Robertson teaches an apparatus comprising a sensor configured to sense temperature or humidity values to monitor the presence of a fluid in the apparatus to determine if a garment is soiled ([0045]). Therefore, when the temperature or humidity values indicate the presence of a fluid in a soiled garment, electrode to skin contact may be insufficient between the therapy electrodes in the modified device since there would be a fluid separation between the two. Therefore, in the modified device, the medical device controller would be configured to wherein the medical device controller is configured to determine when the first garment is insufficient to maintain electrode to skin contact between the therapy electrodes and the patient based on data received from at least one sensor disposed in the first garment configured to sense at least one of a measured temperature, humidity, pH or fabric stretch associated with the first garment responsive to the determination that the first garment is insufficient to maintain electrode to skin contact.
With regard to limitation “a fabric stretch sensor configured to measure stretch of the garment” in claim 19, Examiner notes that Volpe teaches a fabric strain sensor (150/155) configured to measure stretch of the garment ([0038]-[0042]). Therefore, Examiner maintains that the cited combination of references teach the invention as recited at least in the amended set of claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794