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 .
Status of Claims
The amendments and remarks filed on 08MAY2026 have been entered and considered.
Claims 1, 5-6, 8-9, 11, & 14-26 are currently pending.
Claims 1, 15, 18-19, & 24-26 have been amended.
Claims 1, 5-6, 8-9, 11, & 14-26 are under examination.
Response to Arguments
Applicant's arguments and amendments filed 08MAY2026 regarding the rejections under 35 USC 103 have been fully considered and have been found to be not persuasive. Parts deemed not persuasive discussed below:
Applicant states (see Pages 9-15 of the Remarks):
However, Volpe does not teach or suggest that after tightening (i.e., allegedly in the second mode), the sensing electrode 135 or the therapy electrode 140 are repositioned to a different part of the garment 105 (i.e., different from their initial position before tightening). In fact, tightening the garment 105 in Volpe merely adjusts the fit of already-mounted components; it does not remove components from their respective locations, replace them with different components, or alter the functional configuration of the device into a different operational mode. Moreover, Volpe does not disclose repositioning electrodes to entirely different parts of the garment. Instead, any adjustment maintains the electrodes in their original locations. Accordingly, tightening the garment is functionally and structurally distinct from the claimed reconfiguration involving component removal and replacement. Further, Applicant's disclosure states: "[i]n accordance with various embodiments, the scaffold having the integrated medical device may be reconfigured to remove the therapeutic components (e.g., defibrillator related components), while the monitoring components may be retained to facilitate monitoring of the person's heart (e.g., ECG signal monitoring related components). Since the therapeutic components may have been removed from the scaffold, the scaffold may accommodate components for a variety of other types of medical devices and their corresponding components. For example, a blood oxygen saturation level sensor (e.g., 402) may be disposed in the scaffold. The 402 sensor may be configured to be disposed in a part of the scaffold, which was previously occupied by a component related to therapeutic functionality of the medical device (e.g., therapy electrodes)." See at I [0027] of the as-filed specification (emphasis added). Thus, Applicant's disclosure describes that a component is disposed on a part of the scaffold that was previously occupied by another component. Therefore, in light of the specification, a person ordinary skilled in the art would not interpret that "a first part of the scaffold" could be at a part of the garment (to be attached with one component) in one mode and further could be a different part of the garment (to be attached with another component) in another mode. Therefore, the Office Action's interpretation for the first/second part of scaffold being at different locations of the garment in Volpe is improper.
However, the applicant’s arguments are not persuasive because Volpe discloses the repositioning framework through its adaptable garment system. Under the broadest reasonable interpretation Volpe’s tightening satisfies the claim limitation. Even though Volpe modifies it’s layout through garment tightening its modular structure relies on separating specific electrodes or areas of electrodes to change operational modes. A person of ordinary skill in the art would recognize that reconfiguring a wearable garment’s function structure to change component positions encompasses the movement of elements from their original state. Therefore, the examiner maintains that Volpe teaches the claim limitations.
Volpe merely describes the wearable therapeutic device 100 continues monitoring at all times. However, Volpe does not teach or suggest that responsive to the cardiac health of the patient being improved, the wearable therapeutic device 100 returns from the defibrillation mode to the monitoring mode by replacing at least one component (i.e., therapy component like therapy electrode 140) from one part of the garment 105 by another component (i.e., monitoring component like sensing electrode 135). Thus, there is no disclosure of removal, replacement, or physical reconfiguration of components between modes in Volpe. Therefore, Applicant respectfully submits that the cited portions of Volpe fail to teach or suggest the features of, "responsive to the indicated deterioration in the cardiac health of the patient, notify the patient to reconfigure the medical device to operate under a second mode of operation to provide therapy to improve the cardiac health, wherein, when the medical device is configured to operate under the second mode of operation: the monitor was removed from the first part of the scaffold and replaced with a hub attached to the first part of the scaffold, and the sensor was removed from the second part of the scaffold and replaced with a therapy electrode attached to the second part of the scaffold determine whether the cardiac health of the patient has improved after delivery of the therapy, wherein the medical device is further reconfigured, responsive to a determination that the cardiac health of the patient has improved, to operate under the first mode of operation," as recited in amended independent claim 1. Sullivan does not remedy the above noted deficiencies of Volpe.
However, the arguments are not persuasive. When the references are viewed in combination, Volpe and Sullivan satisfy the claim limitations. Sullivan provides an adaptive multi-mode scaffolds and hub assembly that allows treatment hardware to be adjusted when a patient is in better health. Because Sullivan provides responsive operational modes and reconfiguration elements, the references in combination are maintained to teach the claim limitations.
Volpe et al. (US Patent No. 8644925; Cited Previously), in view of Sullivan (US Patent No. 9592403; Previously Cited).
Further, the Office Action, on pages 7 and 8, states "[f]urthermore, neither Volpe nor Sullivan disclose specific locations for the modular garment units to be attached to interchangeably. It would have been obvious to one having ordinary skill in the art at the time the invention was made to change the way modules are connected in configuration, for the purpose of using certain parts for specific applications and removing unneeded items, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have multiple distinct modular connection sites, for the purpose of reconfigurability, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)." (emphasis added). In response, Applicant respectfully submits that the Office Action appears to be misapplying MPEP § 2144.04 (VI)(C), which cites Japiske and is directed to the "Rearrangement of Parts". Japikse involves the relocation of a starting switch within a device. See Japikse, at [1031]. The facts of Japikse indicate that relocation of the starting switch would not otherwise modify the operation or functionality of the device. However, the claimed features are not directed to mere rearrangement of components. Rather, it requires removal and replacement of components, where the purpose of replacement is to change the operational mode of the medical device. Therefore, the Office Action's reliance on Japikse is improper. A further requirement for applying In re Japikse is provided in USPTO Patent Trial and Appeal Board, Appeal 2023-001092 Ex parte M. Steven Ells. "For example, the Examiner does not establish: (1) that the facts in Japikse are sufficiently similar to those here; and (2) that the prior art provides the motivation for the rearrangement without impermissible hindsight." Applicant respectfully submits that the relocation of a switch that does not modify the operation of the device in Japikse is not sufficiently similar to the replacement of components to change the operational mode of a medical device as claimed in the present application. Furthermore, Applicant respectfully submits that the Office Action appears to be misapplying MPEP § 2144.04 (VI)(B), which cites In re Harza and is directed to the "Duplication of Parts." In re Harza addresses duplication of parts performing the same function (preventing passage of water between masses of concrete). However, the claimed features are not directed to duplication of identical or equivalent components. Instead, they require replacement of components with different components that perform different functions, thereby enabling a change in the mode of operation of the device. Because the claimed features involve functional substitution and mode-based reconfiguration, rather than mere duplication, the Office Action's reliance on Harza is likewise improper.
However, the argument is not persuasive. The office action does not rely on a mere nonfunctional rearrangement or duplication of parts to establish obviousness. While Japikse addresses the relocation of a component that does not alter device function or operation and Harza discusses the duplication of parts, Sullivan can be found to teach the reconfiguration of components (Sullivan Figure 1-3 & ¶0031). The cited references further show components in a condensed system rather than having the distinct components as found in the instant application. Since Sullivan provides a functional motivation for the combination of references the examiner maintains that the references in combination teach the claim limitations without the need to solely rely on any rearranging of parts motivation. The cited references provide a structural and functional basis for the reconfiguration and represents a predictable application of the known elements.
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.
Claims 1, 5-6, 8, 11, 15, 17-18, & 26 are rejected under 103 as being unpatentable over Volpe et al. (US Patent No. 8644925; Cited Previously), in view of Sullivan (US Patent No. 9592403; Previously Cited).
Regarding claim 1, Volpe discloses “A wearable healthcare system comprising: a scaffold that is integrated into a garment that is configured to be worn by a patient (Volpe Abstract “A wearable therapeutic device to facilitate care of a subject is provided. The wearable therapeutic device can include a garment having a sensing electrode. The garment includes at least one of an inductive element and a capacitive element, and a controller identifies an inductance of the inductive element or a capacitance of the capacitive element, and determines a confidence level of information received from the sensing electrode based on the inductance or the capacitance. The wearable therapeutic device also includes an alarm module coupled with the controller and configured to provide a notification to a subject based on the confidence level.”; Column 5 Lines 34-44); and a medical device integrated within the scaffold (Volpe Column 5 Lines 30-37 “For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145. These elements may also be integrated into belt 110 or strap 145, and these elements may be a permanent part of belt 110 or strap 145, or releasable from belt 110 or strap 145.”), wherein the medical device includes at least one processor (Volpe Column 6 Lines 34-35 “controller 130 includes at least one processor”; Figure 5), wherein, when the medical device is configured to operate under the first mode of operation a monitor is attached to a first part of the scaffold (Volpe Figures 1-2 & Figure 5; (Volpe Figures 1-2 & Figure 5; Showing the connection of parts for the general system and how they interact as seen in figures 1 and 5, including sensing electrodes 124, therapeutics 140, alarming systems 120, and hub (i.e controller) 30 in a modular design attached to the garment of figure 2); and a sensor is attached to a second part of the scaffold wherein a sensor is communicatively coupled to the monitor and is configured to measure physiological characteristics of the patient (Volpe Column 14 Lines 10-15 “For example, where the confidence level is low or decreasing with respect to a previous confidence level, controller 130 (and sensing electrodes 135) can sense ECG signals more frequently, or controller 130 can lengthen a response time during which the subject can respond to an alarm indicating a detected arrhythmia, or both."), and responsive to the indicated deterioration in the cardiac health of the patient, notify the patient to reconfigure the medical device to operate under a second mode of operation to provide therapy to improve the cardiac health (Volpe Column 15 Lines 10-16 “Providing the wearable therapeutic device (ACT 705) may also include providing a device with an alarm module coupled with a controller to notify the subject of events, conditions, or information about the subject's condition or about the condition of the wearable therapeutic device,”; Column 8 Lines 52-54 “instruct the subject to reposition sensing electrode 135 or therapy electrode 140, for example by tightening garment 105.”) wherein, when the medical device is configured to operate under the second mode of operation: the monitor was removed from the first part of the scaffold and replaced with a hub attached to the first part of the scaffold(Volpe Figures 1-2 & Figure 5; Showing the connection of parts for the general system and how they interact as seen in figures 1 and 5, including sensing electrodes 124, therapeutics 140, alarming systems 120, and hub (i.e controller) 30 in a modular design attached to the garment of figure 2; Column 5 Lines 26-37 “In one embodiment, at least one of defibrillator 115, alarm module 120, monitor 125, controller 130, sensing electrode 135, therapy electrode 140, inductive element 150, and capacitive element 155 are included in or attached to belt 110 or strap 145. For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145. These elements may also be integrated into belt 110 or strap 145, and these elements may be a permanent part of belt 110 or strap 145, or releasable from belt 110 or strap 145.”; Column 6, Lines 42-49, Column 12, Lines 40-50 & 62-67; Column 5 Lines 30-36; where the listed plurality of fasteners create the modularity sites as claimed.; Column 7 Lines 15-30 showing how the monitoring system preps a defibrillation shock but is waiting to determine the subject response before switching to applying the treatment. Showing the Monitoring, Therapeutics, and determination of modes 1 & 2)(Volpe Column 2 Lines 28-32 “A defibrillator is coupled to the therapy electrode and together with the therapy electrode can apply treatment to the subject, based on the confidence level of the information received from the sensing electrode.”; Defibrillator 115; Column 5 Lines 26-37 “In one embodiment, at least one of defibrillator 115, alarm module 120, monitor 125, controller 130, sensing electrode 135, therapy electrode 140, inductive element 150, and capacitive element 155 are included in or attached to belt 110 or strap 145. For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145. These elements may also be integrated into belt 110 or strap 145, and these elements may be a permanent part of belt 110 or strap 145, or releasable from belt 110 or strap 145.”); causing a change in the cardiac health of the patient (Volpe Column 18 Lines 44-47 “Because the wearable therapeutic device can operate essentially at all times, this data can be used to generate a comprehensive real time record of the subject's health over an extended period of time.” Showing that the device will be in a monitoring mode continuously unless therapy intervention is determined to be needed, which causes the device to switch to a defibrillation mode as shown previously. The use of the real time analysis shows an iterative process of detection, intervention, and reset back to detection for future episodes). determine whether the cardiac health of the patient has improved after delivery of the therapy, wherein the medical device is further reconfigured, responsive to a determination that the cardiac health of the patient has improved, to operate under the first mode of operation. (Volpe Column 18 Lines 44-47 “Because the wearable therapeutic device can operate essentially at all times, this data can be used to generate a comprehensive real time record of the subject's health over an extended period of time.” Showing that the device will be in a monitoring mode continuously unless therapy intervention is determined to be needed, which causes the device to switch to a defibrillation mode as shown previously. The use of the real time analysis shows an iterative process of detection, intervention, and reset back to detection for future episodes).
Volpe does not disclose instructions for the wearable medical device to determine a first health status of the patient at a first time instance and a second health status at a second time instance based on measurements received for health of the patient, compare the first health status and the second health status to assess changes that indicate a deterioration in cardiac health of the patient , wherein the indication is based on a negative change in the first health status to the second health status. Sullivan in a similar field of endeavor of wearable defibrillators teaches to determine a first health status of the patient at a first time instance and a second health status at a second time instance based on measurements received for health of the patient (Sullivan Column 5 Lines 13-15 “In some embodiments, the local parameter is a trend that can be detected in a monitored physiological parameter of patient 82. A trend can be detected by comparing values of parameters at different times.”), compare the first health status and the second health status to assess changes that indicate a deterioration in cardiac health of the patient , wherein the indication is based on a negative change in the first health status to the second health status (Sullivan Column 5 Lines 25-30 “Once a trend is detected, it can be stored and/or reported via a communication link, along perhaps with a warning. From the report, a physician monitoring the progress of patient 82 will know about a condition that is either not improving or deteriorating.”). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure an apparatus comprising instructions for the wearable medical device to determine a first health status of the patient at a first time instance and a second health status at a second time instance based on measurements received for health of the patient, compare the first health status and the second health status to assess changes that indicate a deterioration in cardiac health of the patient , wherein the indication is based on a negative change in the first health status to the second health status, as taught in Sullivan, with a wearable healthcare system as disclosed by Volpe for the purpose of reducing the number of active devices on the wearable system to create a more user friendly mobile system. Furthermore, neither Volpe nor Sullivan disclose specific locations for the modular garment units to be attached to interchangeably. It would have been obvious to one having ordinary skill in the art at the time the invention was made to change the way modules are connected in configuration, for the purpose of using certain parts for specific applications and removing unneeded items, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have multiple distinct modular connection sites, for the purpose of reconfigurability, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 5, claim 1 is obvious over Volpe in view of Sullivan. Volpe further discloses the wearable healthcare system wherein the hub comprises a medical modular junction hub. (Volpe Figures 1 & 5; Showing the connection of parts for the general system and how they interact.).
Regarding claim 6, claim 1 is obvious over Volpe in view of Sullivan. Volpe further discloses the wearable healthcare system wherein the monitor comprises electrocardiogram (ECG) electrodes. (Volpe Column 6 Lines 7-10 “When positioned against the subject, sensing electrodes 135 can sense electrocardiogram signals used by controller 130 to monitor the subject's cardiac activity.”). Volpe discloses the claimed invention except for the monitor having a plurality of ECG electrodes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have multiple ECG electrodes, for the purpose of site targeting, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 8, claim 1 is obvious over Volpe in view of Sullivan. Volpe further discloses the wearable healthcare system wherein the sensor comprises a strain sensor (Volpe Column 11 Lines 6-19 “Stretch detector 515 determines if at least a portion of garment 105 has stretched based upon the measured inductance or capacitance value. For example, controller 130 can determine the inductance or capacitance with garment 105 in an unstretched position at a baseline first time when wearable therapeutic device 100 is not being worn; and in a stretched position at a second time when wearable therapeutic device 100 is being worn. In one embodiment, comparator circuit 520 compares the unstretched baseline inductance or capacitance value with the stretched inductance or capacitance value to determine whether or not garment 105 has expanded or stretched, or to determine relative stretching between the baseline and stretched values.” Where the strain sensor is related to the stretch sensor and strain can be determined based on the data provided by the sensor).
Regarding claim 11, claim 1 is obvious over Volpe in view of Sullivan. Volpe further discloses the wearable healthcare system wherein the therapy electrode is configured to provide a defibrillating electrical shock to the patient. (Volpe Column 2 Lines 28-32 “A defibrillator is coupled to the therapy electrode and together with the therapy electrode can apply treatment to the subject, based on the confidence level of the information received from the sensing electrode.”; Defibrillator 115).
Regarding claim 15, Volpe discloses a wearable modular cardiac therapy and monitoring system (Volpe Column 1 Lines 47-53 “Based at least in part on changes in the inductance or the capacitance as the wearable therapeutic device changes shape, the wearable therapeutic device can provide notifications to the subject regarding 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”), comprising: a scaffold that is integrated into a garment that is configured to be worn by a patient (Volpe Abstract “A wearable therapeutic device to facilitate care of a subject is provided. The wearable therapeutic device can include a garment having a sensing electrode. The garment includes at least one of an inductive element and a capacitive element, and a controller identifies an inductance of the inductive element or a capacitance of the capacitive element, and determines a confidence level of information received from the sensing electrode based on the inductance or the capacitance. The wearable therapeutic device also includes an alarm module coupled with the controller and configured to provide a notification to a subject based on the confidence level.”; Column 5 Lines 34-44); a medical device integrated within the scaffold (Volpe Column 5 Lines 30-37 “For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145. These elements may also be integrated into belt 110 or strap 145, and these elements may be a permanent part of belt 110 or strap 145, or releasable from belt 110 or strap 145.”), wherein the medical device includes at least one processor (Volpe Column 6 Lines 34-35 “controller 130 includes at least one processor”; Figure 5), wherein, when the medical device is configured to operate under a first mode of operation: a monitor is attached to a first part of the scaffold (Volpe Figures 1-2 & Figure 5; (Volpe Figures 1-2 & Figure 5; Showing the connection of parts for the general system and how they interact as seen in figures 1 and 5, including sensing electrodes 124, therapeutics 140, alarming systems 120, and hub (i.e controller) 30 in a modular design attached to the garment of figure 2), and a sensor is attached to a second part of the scaffold wherein the sensor is communicatively coupled to the monitor and is configured to measure physiological characteristics of the patient (Volpe Column 14 Lines 10-15 “For example, where the confidence level is low or decreasing with respect to a previous confidence level, controller 130 (and sensing electrodes 135) can sense ECG signals more frequently, or controller 130 can lengthen a response time during which the subject can respond to an alarm indicating a detected arrhythmia, or both."), and responsive to the indicated deterioration in the cardiac health of the patient, notify the patient to reconfigure the medical device to operate under a second mode of operation to provide therapy to improve the cardiac health (Volpe Column 15 Lines 10-16 “Providing the wearable therapeutic device (ACT 705) may also include providing a device with an alarm module coupled with a controller to notify the subject of events, conditions, or information about the subject's condition or about the condition of the wearable therapeutic device,”; Column 8 Lines 52-54 “instruct the subject to reposition sensing electrode 135 or therapy electrode 140, for example by tightening garment 105.”); wherein, when the medical device is configured to operate under the second mode of operation: the monitor was removed from the first part of the scaffold and replaced with a hub attached to the first part of the scaffold (Volpe Figures 1-2 & Figure 5; Showing the connection of parts for the general system and how they interact as seen in figures 1 and 5, including sensing electrodes 124, therapeutics 140, alarming systems 120, and hub (i.e controller) 30 in a modular design attached to the garment of figure 2; Column 5 Lines 26-37 “In one embodiment, at least one of defibrillator 115, alarm module 120, monitor 125, controller 130, sensing electrode 135, therapy electrode 140, inductive element 150, and capacitive element 155 are included in or attached to belt 110 or strap 145. For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145. These elements may also be integrated into belt 110 or strap 145, and these elements may be a permanent part of belt 110 or strap 145, or releasable from belt 110 or strap 145.”; Column 6, Lines 42-49, Column 12, Lines 40-50 & 62-67; Column 5 Lines 30-36; where the listed plurality of fasteners create the modularity sites as claimed.; Column 7 Lines 15-30 showing how the monitoring system preps a defibrillation shock but is waiting to determine the subject response before switching to applying the treatment. Showing the Monitoring, Therapeutics, and determination of modes 1 & 2); the sensor was removed from the second part of the scaffold and replaced with a therapy electrode(Volpe Column 2 Lines 28-32 “A defibrillator is coupled to the therapy electrode and together with the therapy electrode can apply treatment to the subject, based on the confidence level of the information received from the sensing electrode.”; Defibrillator 115; Column 5 Lines 26-37 “In one embodiment, at least one of defibrillator 115, alarm module 120, monitor 125, controller 130, sensing electrode 135, therapy electrode 140, inductive element 150, and capacitive element 155 are included in or attached to belt 110 or strap 145. For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145. These elements may also be integrated into belt 110 or strap 145, and these elements may be a permanent part of belt 110 or strap 145, or releasable from belt 110 or strap 145.”); causing a change in the cardiac health of the patient, (Volpe Column 18 Lines 44-47 “Because the wearable therapeutic device can operate essentially at all times, this data can be used to generate a comprehensive real time record of the subject's health over an extended period of time.” Showing that the device will be in a monitoring mode continuously unless therapy intervention is determined to be needed, which causes the device to switch to a defibrillation mode as shown previously. The use of the real time analysis shows an iterative process of detection, intervention, and reset back to detection for future episodes) determine whether the cardiac health of the patient has improved after delivery of the therapy, wherein the medical device is further reconfigured, responsive to a determination that the cardiac health of the patient has improved, to operate under the first mode of operation. (Volpe Column 18 Lines 44-47 “Because the wearable therapeutic device can operate essentially at all times, this data can be used to generate a comprehensive real time record of the subject's health over an extended period of time.” Showing that the device will be in a monitoring mode continuously unless therapy intervention is determined to be needed, which causes the device to switch to a defibrillation mode as shown previously. The use of the real time analysis shows an iterative process of detection, intervention, and reset back to detection for future episodes)
Volpe does not disclose instructions for the wearable medical device to determine a first health status of the patient at a first time instance and a second health status at a second time instance based on measurements received for health of the patient, compare the first health status and the second health status to assess changes that indicate a deterioration in cardiac health of the patient , wherein the indication is based on a negative change in the first health status to the second health status. Sullivan in a similar field of endeavor of wearable defibrillators teaches to determine a first health status of the patient at a first time instance and a second health status at a second time instance based on measurements received for health of the patient (Sullivan Column 5 Lines 13-15 “In some embodiments, the local parameter is a trend that can be detected in a monitored physiological parameter of patient 82. A trend can be detected by comparing values of parameters at different times.”), compare the first health status and the second health status to assess changes that indicate a deterioration in cardiac health of the patient , wherein the indication is based on a negative change in the first health status to the second health status (Sullivan Column 5 Lines 25-30 “Once a trend is detected, it can be stored and/or reported via a communication link, along perhaps with a warning. From the report, a physician monitoring the progress of patient 82 will know about a condition that is either not improving or deteriorating.”). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure an apparatus comprising instructions for the wearable medical device to determine a first health status of the patient at a first time instance and a second health status at a second time instance based on measurements received for health of the patient, compare the first health status and the second health status to assess changes that indicate a deterioration in cardiac health of the patient , wherein the indication is based on a negative change in the first health status to the second health status, as taught in Sullivan, with a wearable healthcare system as disclosed by Volpe for the purpose of reducing the number of active devices on the wearable system to create a more user friendly mobile system. Furthermore, neither Volpe nor Sullivan disclose specific locations for the modular garment units to be attached to interchangeably. It would have been obvious to one having ordinary skill in the art at the time the invention was made to change the way modules are connected in configuration, for the purpose of using certain parts for specific applications and removing unneeded items, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have multiple distinct modular connection sites, for the purpose of reconfigurability, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 17, claim 15 is obvious over Volpe in view of Sullivan. Volpe further discloses the wearable modular cardiac therapy and monitoring system wherein the sensor comprises a strain sensor (Volpe Column 11 Lines 6-19 “Stretch detector 515 determines if at least a portion of garment 105 has stretched based upon the measured inductance or capacitance value. For example, controller 130 can determine the inductance or capacitance with garment 105 in an unstretched position at a baseline first time when wearable therapeutic device 100 is not being worn; and in a stretched position at a second time when wearable therapeutic device 100 is being worn. In one embodiment, comparator circuit 520 compares the unstretched baseline inductance or capacitance value with the stretched inductance or capacitance value to determine whether or not garment 105 has expanded or stretched, or to determine relative stretching between the baseline and stretched values.”; Where the strain sensor is related to the stretch sensor and strain can be determined based on the data provided by the sensor).
Regarding claim 18, claim 15 is obvious over Volpe in view of Sullivan. Volpe further discloses the wearable modular cardiac therapy and monitoring system wherein at least one of the first part of the scaffold, the second part of the scaffold, or the third part of the scaffold comprises a snap. (Volpe Column 5 Lines 30-34 “For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145.”).
Regarding claim 26, claim 15 is obvious over Volpe in view of Sullivan. Volpe further discloses wherein at least one of the first part of the scaffold, the second part of the scaffold or the third part of the scaffold comprises a latch. (Volpe Column 5 Lines 30-34 “For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145.”).
Claims 9, 19, 22, & 24-25 are rejected under 103 as being unpatentable over Volpe et al. (US Patent No. 8644925; Cited Previously) in view of Sullivan (US Patent No. 9592403; Previously Cited), and O’Connor et al (US Publication 20170173261; Cited Previously; Previously Cited).
Regarding claim 9, claim 1 is obvious over Volpe in view of Sullivan. Volpe in view of Sullivan discloses the elements of claim 1 as described above. However, Volpe nor Sullivan specifically disclose wherein the sensor comprises a continuous glucose monitoring (CGM) module. O’Connor teaches the wearable healthcare system wherein the sensor comprises a continuous glucose monitoring (CGM) module (O’Connor ¶ 0023 “The sensor 108 can be a glucose sensor. For example, the sensor 108 can be a continuous glucose monitor (CGM).”). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure an apparatus comprising a continuous glucose monitoring module as taught in O’Connor with a wearable healthcare system comprising a support structure, medical defibrillator device, a monitoring system with physical sensors, and a therapy device, as disclosed by Volpe in view of Sullivan. The motivation to integrate the technology of Volpe, Sullivan, and O’Connor was configuring an apparatus capable of monitoring a user’s physiological data while being able to walk around freely, as described by Volpe, with the added property of having a glucose monitoring module. This is useful as it empowers the device to have multiple functions and reduce the number of devices needed to monitor a patient medical status, as they are already deemed needing the wearable defibrillator and now perhaps a glucose monitor.
Regarding claim 19, Volpe discloses a wearable healthcare system comprising: a scaffold that is integrated into a garment that is configured to be worn by a patient (Volpe Abstract “A wearable therapeutic device to facilitate care of a subject is provided. The wearable therapeutic device can include a garment having a sensing electrode. The garment includes at least one of an inductive element and a capacitive element, and a controller identifies an inductance of the inductive element or a capacitance of the capacitive element, and determines a confidence level of information received from the sensing electrode based on the inductance or the capacitance. The wearable therapeutic device also includes an alarm module coupled with the controller and configured to provide a notification to a subject based on the confidence level.”; Column 5 Lines 34-44): a medical device integrated within the scaffold (Volpe Column 5 Lines 30-37 “For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145. These elements may also be integrated into belt 110 or strap 145, and these elements may be a permanent part of belt 110 or strap 145, or releasable from belt 110 or strap 145.”), wherein the medical device includes at least one processor (Volpe Column 6 Lines 34-35 “controller 130 includes at least one processor”; Figure 5), wherein, when the medical device is configured to operate under a first mode of operation: a monitor is(Volpe Figures 1-2 & Figure 5; (Volpe Figures 1-2 & Figure 5; Showing the connection of parts for the general system and how they interact as seen in figures 1 and 5, including sensing electrodes 124, therapeutics 140, alarming systems 120, and hub (i.e controller) 30 in a modular design attached to the garment of figure 2)and a sensor is attached to a second part of the scaffold(Volpe Column 5 Lines 26-30 “In one embodiment, at least one of defibrillator 115, alarm module 120, monitor 125, controller 130, sensing electrode 135, therapy electrode 140, inductive element 150, and capacitive element 155 are included in or attached to belt 110 or strap 145.” Showing the multiple items that may be attached, indicating that there is a place for the items to be mounted on the garment; Figures 1-2 & Figure 5; Showing the connection of parts for the general system and how they interact as seen in figures 1 and 5, including sensing electrodes 124, therapeutics 140, alarming systems 120, and hub (i.e controller) 30 in a modular design attached to the garment of figure 2) wherein the sensor is communicatively coupled to the monitor and measures physiological characteristics of the patient, (Volpe Column 14 Lines 10-15 “For example, where the confidence level is low or decreasing with respect to a previous confidence level, controller 130 (and sensing electrodes 135) can sense ECG signals more frequently, or controller 130 can lengthen a response time during which the subject can respond to an alarm indicating a detected arrhythmia, or both."); and responsive to the indicated deterioration in the cardiac health of the patient, notify the patient to reconfigure the medical device to operate under a second mode of operation to provide therapy to improve the cardiac health (Volpe Column 15 Lines 10-16 “Providing the wearable therapeutic device (ACT 705) may also include providing a device with an alarm module coupled with a controller to notify the subject of events, conditions, or information about the subject's condition or about the condition of the wearable therapeutic device,”; Column 8 Lines 52-54 “instruct the subject to reposition sensing electrode 135 or therapy electrode 140, for example by tightening garment 105.”); wherein, when the medical device is configured to operate under the second mode of operation: the monitor was removed from the first part of the scaffold and replaced with a hub attached to a first part of the scaffold (Volpe Figures 1-2 & Figure 5; Showing the connection of parts for the general system and how they interact as seen in figures 1 and 5, including sensing electrodes 124, therapeutics 140, alarming systems 120, and hub (i.e controller) 30 in a modular design attached to the garment of figure 2; Column 5 Lines 26-37 “In one embodiment, at least one of defibrillator 115, alarm module 120, monitor 125, controller 130, sensing electrode 135, therapy electrode 140, inductive element 150, and capacitive element 155 are included in or attached to belt 110 or strap 145. For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145. These elements may also be integrated into belt 110 or strap 145, and these elements may be a permanent part of belt 110 or strap 145, or releasable from belt 110 or strap 145.”; Column 6, Lines 42-49, Column 12, Lines 40-50 & 62-67; Column 5 Lines 30-36; where the listed plurality of fasteners create the modularity sites as claimed.; Column 7 Lines 15-30 showing how the monitoring system preps a defibrillation shock but is waiting to determine the subject response before switching to applying the treatment. Showing the Monitoring, Therapeutics, and determination of modes 1 & 2); the sensor was removed from the second part of the scaffold and replaced with another device (Volpe Column 2 Lines 28-32 “A defibrillator is coupled to the therapy electrode and together with the therapy electrode can apply treatment to the subject, based on the confidence level of the information received from the sensing electrode.”; Defibrillator 115; Column 5 Lines 26-37 “In one embodiment, at least one of defibrillator 115, alarm module 120, monitor 125, controller 130, sensing electrode 135, therapy electrode 140, inductive element 150, and capacitive element 155 are included in or attached to belt 110 or strap 145. For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145. These elements may also be integrated into belt 110 or strap 145, and these elements may be a permanent part of belt 110 or strap 145, or releasable from belt 110 or strap 145.”); wherein the medical device is further reconfigured to operate, responsive to the improved health of the patient, under the first mode of operation (Volpe Column 18 Lines 44-47 “Because the wearable therapeutic device can operate essentially at all times, this data can be used to generate a comprehensive real time record of the subject's health over an extended period of time.” Showing that the device will be in a monitoring mode continuously unless therapy intervention is determined to be needed, which causes the device to switch to a defibrillation mode as shown previously. The use of the real time analysis shows an iterative process of detection, intervention, and reset back to detection for future episodes).
Volpe does not disclose instructions for the wearable medical device to determine a first health status of the patient at a first time instance and a second health status at a second time instance based on measurements received for health of the patient, compare the first health status and the second health status to assess changes that indicate a deterioration in cardiac health of the patient , wherein the indication is based on a negative change in the first health status to the second health status. Sullivan in a similar field of endeavor of wearable defibrillators teaches to determine a first health status of the patient at a first time instance and a second health status at a second time instance based on measurements received for health of the patient (Sullivan Column 5 Lines 13-15 “In some embodiments, the local parameter is a trend that can be detected in a monitored physiological parameter of patient 82. A trend can be detected by comparing values of parameters at different times.”), compare the first health status and the second health status to assess changes that indicate a deterioration in cardiac health of the patient , wherein the indication is based on a negative change in the first health status to the second health status (Sullivan Column 5 Lines 25-30 “Once a trend is detected, it can be stored and/or reported via a communication link, along perhaps with a warning. From the report, a physician monitoring the progress of patient 82 will know about a condition that is either not improving or deteriorating.”). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure an apparatus comprising instructions for the wearable medical device to determine a first health status of the patient at a first time instance and a second health status at a second time instance based on measurements received for health of the patient, compare the first health status and the second health status to assess changes that indicate a deterioration in cardiac health of the patient , wherein the indication is based on a negative change in the first health status to the second health status, as taught in Sullivan, with a wearable healthcare system as disclosed by Volpe for the purpose of reducing the number of active devices on the wearable system to create a more user friendly mobile system. Furthermore, neither Volpe nor Sullivan disclose specific locations for the modular garment units to be attached to interchangeably. It would have been obvious to one having ordinary skill in the art at the time the invention was made to change the way modules are connected in configuration, for the purpose of using certain parts for specific applications and removing unneeded items, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have multiple distinct modular connection sites, for the purpose of reconfigurability, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Volpe in view of Sullivan does not specifically disclose wherein the therapy module comprises an insulin pump is installed in the mounting location wherein the insulin pump is configured to improve the health of the patient. O’Connor teaches an insulin pump is attached to the second part of the scaffold wherein the insulin pump is configured to improve the health of the patient (O’Connor ¶ 0033 “In various embodiments, a glucose sensor (e.g., the sensor 108) is provided as part of a wearable insulin pump”.). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure an apparatus comprising a continuous glucose monitoring module with a insulin pump as taught in O’Connor with a wearable healthcare system as disclosed by Volpe combined with Sullivan. The motivation to integrate the technology of Volpe, Sullivan, and O’Connor was configuring an apparatus capable of monitoring a user’s physiological data while being able to walk around freely, with the added property of having a insulin pump to empower the device to have multiple functions and reduce the number of devices needed to monitor a patient medical status, as provide therapy based on their glucose levels in the form of having the insulin pump.
Regarding claim 22, claim 19 is obvious over Volpe in view of Sullivan. Volpe further discloses wherein the sensor comprises a strain sensor. (Volpe Column 11 Lines 6-19 “Stretch detector 515 determines if at least a portion of garment 105 has stretched based upon the measured inductance or capacitance value. For example, controller 130 can determine the inductance or capacitance with garment 105 in an unstretched position at a baseline first time when wearable therapeutic device 100 is not being worn; and in a stretched position at a second time when wearable therapeutic device 100 is being worn. In one embodiment, comparator circuit 520 compares the unstretched baseline inductance or capacitance value with the stretched inductance or capacitance value to determine whether or not garment 105 has expanded or stretched, or to determine relative stretching between the baseline and stretched values.” Where the strain sensor is related to the stretch sensor and strain can be determined based on the data provided by the sensor).
Regarding claim 24, Volpe in view of Sullivan and O’Connor further discloses the elements of claim 19 as described above. Volpe further discloses wherein at least one of the first part of the scaffold or the second part of the scaffold comprises a snap. (Volpe Column 5 Lines 30-34 “For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145.”).
Regarding claim 25, Volpe in view of Sullivan and O’Connor further discloses the elements of claim 19 as described above. Volpe further discloses wherein at least one of the first part of the scaffold or the second part of the scaffold comprises a latch. (Volpe Column 5 Lines 30-34 “For example, wearable therapeutic device 100 components can be fitted into open or closed pockets of belt 110 or strap 145, or otherwise attached to these elements via buckles, hook and loop fasteners, holsters, loops, or sleeves that form part of belt 110 or strap 145.”).
Claims 14 & 16 are rejected under 103 as being unpatentable over Volpe et al. (US Patent No. 8644925; Cited Previously) in view of Sullivan (US Patent No. 9592403; Previously Cited), and Whiting et al (US Publication 20130325078; Cited Previously).
Regarding claim 14, claim 1 is obvious over Volpe in view of Sullivan. However, Volpe nor Sullivan specifically disclose wherein at least one of the hub or the monitor are configured to communicate wirelessly with a server. Whiting in a similar field of wearable therapeutics teaches wherein at least one of the hub or the monitor are configured to communicate wirelessly with a server. (Whiting ¶0037 “The medical monitoring and treatment device 100 includes a plurality of electrocardiographic (ECG) sensing electrodes 112 that are disposed by the harness 110 at various positions about the patient's body and electrically coupled (wirelessly or by a wired connection) to a portable treatment controller 120 via a connection pod 130.”; ¶0050-¶0051).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure an apparatus comprising wireless communication abilities as taught in Whiting with a wearable healthcare system as disclosed by Volpe in view of Sullivan. The motivation to integrate the technology of Volpe, Sullivan, and Whiting was configuring an apparatus capable of monitoring a user’s cardiac data while being able to walk around freely, as described by Volpe, with the added property of having wireless connections and communications to allow the patient freedom of movement even beyond a hospital setting.
Regarding claim 16, claim 15 is obvious over Volpe in view of Sullivan. However, Volpe nor Sullivan specifically disclose wherein the therapy is a cardiac pacing treatment. Whiting in a similar field of wearable therapeutics teaches wherein the therapy is a cardiac pacing treatment. (Whiting ¶0054 “Applicants have further appreciated that, in other embodiments, a medical monitoring and treatment device can be configured to perform pacing to treat pulseless electrical activity. In accordance with an aspect of the present invention, the device can be configured to pace the heart of the patient at a fixed energy level and pulse rate, to pace the heart of the patient on demand with a fixed energy level and an adjustable rate responsive to the detected intrinsic activity level of the patient's heart, or to pace the heart of the patient using capture management with an adjustable energy level and rate responsive to the detected intrinsic activity level of the patient's heart and the detected response of the patient's heart.”; ¶0055-¶0060).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure an apparatus comprising a pacing module as taught in Whiting with a wearable healthcare system as disclosed by Volpe in view of Sullivan. The motivation to integrate the technology of Volpe, Sullivan, and Whiting was configuring an apparatus capable of monitoring a user’s cardiac data while being able to walk around freely, as described by Volpe, with the added property of having a pacer for detected irregular heartbeats as it empowers the device to have multiple functions and reduce the number of devices needed to monitor a patient medical status, as they are already deemed needing the wearable defibrillator and in turn the pacing module, and can get therapy based on their ECG data as it is being monitored and controlled.
Claims 20-21 are rejected under 103 as being unpatentable over Volpe et al. (US Patent No. 8644925; Cited Previously) in view of Sullivan (US Patent No. 9592403; Previously Cited), and Toth et al (US Publication 20150335288; Cited Previously).
Regarding claim 20, Volpe in view of Sullivan further discloses the elements of claim 1 as described above. However, Volpe nor Sullivan specifically disclose wherein the sensor comprises a moisture/perspiration sensor. Toth in a similar field of wearable therapeutics teaches wherein the sensor comprises a moisture/perspiration sensor. (Toth ¶0078 “In aspects, the patch interface may include a sensor coupled with the substrate, and electrically coupled with the microcircuit, the sensor configured to monitor one or more physiologic parameters of the subject when coupled thereto. Some non-limiting sensor components include an electrophysiologic sensor, a temperature sensor, a thermal gradient sensor, a barometer, an altimeter, an accelerometer, a gyroscope, a humidity sensor, a magnetometer, an inclinometer, an oximeter, a colorimetric monitor, a sweat analyte sensor, a perfusion sensor, a galvanic skin response sensor, a hydration sensor, an interfacial pressure sensor, a flow sensor, a stretch sensor, a microphone, a combination thereof, and the like.”; ¶0088; ¶0156; ¶0364). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure an apparatus comprising a moisture sensor as taught in Toth with a wearable healthcare system as disclosed by Volpe in view of Sullivan to empower the device to have multiple functions and reduce the number of devices needed to monitor a patient medical status, the moisture sensing allows for the device to mediate possible ill affects a poor connection could lead to while the device is in use, as sweat may indicate lack of direct contact, device shifting due, or even that the patient is doing physical activity that creates false positives regarding the need to apply therapy.
Regarding claim 21, Volpe in view of Sullivan further discloses the elements of claim 15 as described above. However, Volpe nor Sullivan specifically disclose wherein the sensor comprises a moisture/perspiration sensor. Toth in a similar field of wearable therapeutics teaches wherein the sensor comprises a moisture/perspiration sensor. (Toth ¶0078 “In aspects, the patch interface may include a sensor coupled with the substrate, and electrically coupled with the microcircuit, the sensor configured to monitor one or more physiologic parameters of the subject when coupled thereto. Some non-limiting sensor components include an electrophysiologic sensor, a temperature sensor, a thermal gradient sensor, a barometer, an altimeter, an accelerometer, a gyroscope, a humidity sensor, a magnetometer, an inclinometer, an oximeter, a colorimetric monitor, a sweat analyte sensor, a perfusion sensor, a galvanic skin response sensor, a hydration sensor, an interfacial pressure sensor, a flow sensor, a stretch sensor, a microphone, a combination thereof, and the like.”; ¶0088; ¶0156; ¶0364). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure an apparatus comprising a moisture sensor as taught in Toth with a wearable healthcare system as disclosed by Volpe in view of Sullivan to empower the device to have multiple functions and reduce the number of devices needed to monitor a patient medical status, the moisture sensing allows for the device to mediate possible ill affects a poor connection could lead to while the device is in use, as sweat may indicate lack of direct contact, device shifting due, or even that the patient is doing physical activity that creates false positives regarding the need to apply therapy.
Claim 23 is rejected under 103 as being unpatentable over Volpe et al. (US Patent No. 8644925; Cited Previously) in view of Sullivan (US Patent No. 9592403; Previously Cited), O’Connor et al (US Publication 20170173261; Cited Previously), and Toth et al (US Publication 20150335288; Cited Previously).
Regarding claim 23, Volpe in view of Sullivan and O’Connor further discloses the elements of claim 19 as described above. However, Volpe nor Sullivan or O’Connor specifically disclose wherein the sensor comprises a moisture/perspiration sensor. Toth in a similar field of wearable therapeutics wherein the sensor comprises a moisture/perspiration sensor. (Toth ¶0078 “In aspects, the patch interface may include a sensor coupled with the substrate, and electrically coupled with the microcircuit, the sensor configured to monitor one or more physiologic parameters of the subject when coupled thereto. Some non-limiting sensor components include an electrophysiologic sensor, a temperature sensor, a thermal gradient sensor, a barometer, an altimeter, an accelerometer, a gyroscope, a humidity sensor, a magnetometer, an inclinometer, an oximeter, a colorimetric monitor, a sweat analyte sensor, a perfusion sensor, a galvanic skin response sensor, a hydration sensor, an interfacial pressure sensor, a flow sensor, a stretch sensor, a microphone, a combination thereof, and the like.”; ¶0088; ¶0156; ¶0364). Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to configure an apparatus comprising a moisture sensor as taught in Toth with a wearable healthcare system as disclosed by Volpe in view of Sullivan and O’Connor to empower the device to have multiple functions and reduce the number of devices needed to monitor a patient medical status, the moisture sensing allows for the device to mediate possible ill affects a poor connection could lead to while the device is in use, as sweat may indicate lack of direct contact, device shifting due, or even that the patient is doing physical activity that creates false positives regarding the need to apply therapy.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/MEGAN T FEDORKY/
Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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