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 .
Response to Amendment
Applicant's submission filed on 02 February 2026 has been entered. Claims 1-5, 7-13, 16-19, and 22 are pending. Claims 6, 14-15, and 20-21 are canceled.
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.
Claim(s) 1-5, 7, 13-14, 16-17, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arne (US 20140051946 A1) in view of Kumar (US 20200282225 A1).
Regarding claim 1, Arne teaches a sensor module (Wearable wireless device 102) for attachment to a wearer’s back (Paragraph 0078-0079— removably attached to the torso), the sensor module comprising
a first submodule (reusable module 204) comprising
an electronic unit (Paragraph 0039-- The reusable component 204 comprises an electronics module…) for capturing and transmitting movement data (Paragraph 0029—monitored parameters include…position of wearer…global positioning system…among other…; Paragraph 0043, 0048—reusable electronic module 204 also comprises…an accelerometer 222), and
a first structure (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…), and
a second submodule (disposable component 202) comprising
a fastening means for fastening the second submodule to a wearer (0008, 0063—adhesive for adhering the disposable component to the skin of a living subject; Paragraph 0102—adhesive base 502 of disposable component; paragraph 0107—disposable component 900 secured to a user via an adhesive overlay 902) and
a second structure (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…),
characterized in that the first structure can form a reversible mechanical connection with the second structure, with the result that the first submodule and the second submodule can be reversibly connected to one another (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…)
wherein the sensor module is configured for attachment to the wearer’s back (Paragraph 0078-0079— removably attached to the torso). It is noted that by teaching an arrangement on the torso of the wearer, Arne demonstrates that the sensor module is capable of attachment to the wearer’s back, which is part of the torso.
Arne additionally teaches the power source and electronic unit are configured to be housed in a housing (see Fig. 6, 12A, 14, 16A-E) such that the first submodule comprises a sheath, wherein the housing comprises closed-cell foam (Paragraph 0106) such that it is made of a flexible material.
However, Arne fails to explicitly teach wherein the first submodule comprises a sheath comprising one flexible, linear, region which forms a bending axis, about which the first submodule can be bent and wherein the first submodule comprises a flexible conductor connection which connects the electronic unit to a power source which supplies the electronic unit with energy.
Kumar, in the same field of endeavor of a wearable medical device with disposable and reusable components (Abstract), teaches a reusable component of the system analogous to a first submodule wherein this first submodule comprises a sheath made of a flexible material (Paragraph 0006, 0113), where the sheath comprises one flexible, linear, region which forms a single bending axis, about which the first submodule can be bent (Paragraph 0005-0006--the reusable component having a plurality of sealed housings mechanically coupled to each other and movable with respect to each other...the reusable component further includes a flexible circuit configured to provide electrical communication among electrical components within the housings. The flexible circuit may optionally be affixed to back surfaces of the plurality of housings; Paragraph 0078--the reusable component of the wearable device of this invention have multiple housings or modules each containing one or more electrical components; paragraph 0116--the disposable component is a patient engagement substrate adhesively attached to a patient and the reusable component is a plurality of housings mechanically attached to the patient engagement substrate), and wherein the first submodule comprises a flexible conductor connection which connects the electronic unit to a power source which supplies the electronic unit with energy (Paragraph 0022-0023, 0078-0079, 0082--a flexible electrical circuit extends between the housings or modules to provide connections among the electronic components...housings 14 each contain one or more of a battery, a capacitor or a controller).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the flexible region about which the first submodule can be bent of Kumar in order to predictably improve the durability and comfort of the device by permitting it to bend or flex with movement of the wearer (see Kumar paragraph 0078-- the flexible circuit can withstand the flexing twisting, stretching, bending, compression, tension, etc., that may come from patient movement while wearing the wearable device) and to include a flexible conductor connection which connects the electronic unit to a power source in order to predictably ensure that the device remains powered even as the user causes bending and flexing of the sensor module through normal movements and activities which would improve the module over a similar system with a more rigid power construction which may be dislodged by movement.
Regarding claim 2, the combination of Arne and Kumar teaches the sensor module of claim 1. Arne additionally teaches wherein the first structure comprises one from the group of hook structure or loop structure and the second structure comprises the other from the group of hook structure or loop structure, wherein the first structure and the second structure form a reversible mechanical connection when the first structure is pressed together with the second structure (Paragraph 0112).
Regarding claim 3, the combination of Arne and Kumar teaches the sensor module of claim 1. Arne additionally teaches wherein the reversible mechanical connection comprises a hook-and-loop fastening (Paragraph 0112).
Regarding claim 4, the combination of Arne and Kumar teaches the sensor module of claim 1. Arne additionally teaches wherein the fastening means comprises an adhesive layer which can adhere to the human skin (0008, 0063—adhesive for adhering the disposable component to the skin of a living subject; Paragraph 0102—adhesive base 502 of disposable component; paragraph 0107—disposable component 900 secured to a user via an adhesive overlay 902).
Regarding claim 5, the combination of Arne and Kumar teaches the sensor module of claim 1. Arne additionally teaches wherein the second submodule is in the form of a stretchy adhesive strip (0008, 0063—adhesive for adhering the disposable component to the skin of a living subject; Paragraph 0102—adhesive base 502 of disposable component; paragraph 0107—disposable component 900 secured to a user via an adhesive overlay 902…may comprise a 3-piece composite with a center section 904 configured to hold the reusable component 800 comprising the electronics module in place, but not create a sticky build up on the module, an hydrocolloid for primary skin adhesion and an acrylic with function as described above). It is noted that the disclosure of the disposable submodule as being an adhesive base such as a hydrocolloid effectively discloses that the second submodule may be not just an adhesive strip but a stretchy adhesive strip, as hydrocolloid dressings are stretchy and conformable to the user’s skin.
Regarding claim 7, the combination of Arne and Kumar teaches the sensor module of claim 1. Arne additionally teaches wherein the electronic unit comprises at least one acceleration sensor for measuring acceleration data and/or a GPS module for capturing and transmitting spatial coordinates of the first submodule or of the sensor module (Paragraph 0029—monitored parameters include…position of wearer…global positioning system…among other…; Paragraph 0043, 0048—reusable electronic module 204 also comprises…an accelerometer 222).
Regarding claim 13, the combination of Arne and Kumar teaches the sensor module of claim 1. Arne additionally teaches wherein the electronic unit comprises a communication module which is used to transmit the captured data to an evaluation unit outside the sensor module (Paragraph 0029-0030—make and receive data over a radio link; Paragraph 0039-- The electronics module of the reusable component 204 comprises a wireless communication circuit 206, such as a mobile chipset RF wireless circuit or simply cellular radio; Paragraph 0041-0044-- the reusable electronic module 204 comprises an RF wireless communication circuit 206. The RF wireless communication circuit 206 comprises an antenna for receive and transmit wireless signals, a transmitter circuit, a receiver circuit, and a link master controller that includes a mechanism to connect (establish a link) to another, external, wireless device and transfer data).
Regarding claim 16, the combination of Arne and Kumar teaches the sensor module of claim 1. Kumar additionally discloses the first submodule can be bent about the bending axis, wherein the flexible region runs transversely with respect to the flexible conductor connection, with the result that the flexible conductor connection is orthogonal to the bending axis and is likewise bent when bending the first submodule around the linear region (Paragraph 006, 0113-- Extending across the bottom surfaces of the housings 310 is a flexible circuit…; paragraph 0078--The flexible electrical circuit may be waterproof or covered with waterproof material. In addition, in embodiments of the invention the flexible circuit can withstand the flexing twisting, stretching, bending, compression, tension, etc., that may come from patient movement while wearing the wearable device; alternatively: paragraph 0029--the trigger prevention mechanism is configured to be disengaged by bending a portion of at least one of the disposable component mechanical connector and the reusable component mechanical connector; Figs. 23A-23B). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the flexible region about which the first submodule can be bent of Kumar in order to predictably improve the durability and comfort of the device by permitting it to bend or flex with movement of the wearer.
Regarding claim 17, the combination of Arne and Kumar teaches a care set comprising the sensor module of claim 1. Arne additionally teaches wherein an electronic evaluation unit which is arranged separately from the sensor module and has software which is used to receive, evaluate and display the measured data, or
a computer program product which, when installed and executed on an electronic evaluation unit, forms software which is used to receive, evaluate and display the measured data (Paragraph 000039-0045-- The wireless communication circuit 206 may be a low power mobile chipset and is configured to connect to the cellular network 108 as well as other wireless devices (cell-phones, smart phones, tablet computers, laptop computers, gateway devices, among others)…the reusable electronic module 204 comprises an RF wireless communication circuit 206. The RF wireless communication circuit 206 comprises an antenna for receive and transmit wireless signals, a transmitter circuit, a receiver circuit, and a link master controller that includes a mechanism to connect (establish a link) to another, external, wireless device and transfer data…In one aspect, the link master controller establishes connection to an external device; paragraph 0075-0077--Some embodiments may be implemented, for example, using a machine-readable medium or article which may store an instruction or a set of instructions that, if executed by a machine, may cause the machine to perform a method and/or operations in accordance with the embodiments. Such a machine may include, for example, any suitable processing platform, computing platform, computing device, processing device, computing system, processing system, computer, processor, or the like, and may be implemented using any suitable combination of hardware and/or software…).
Regarding claim 22, Arne teaches a sensor module (Wearable wireless device 102) for attachment to a wearer’s back (Paragraph 0078-0079— removably attached to the torso), the sensor module comprising
a first submodule (reusable module 204) comprising
an electronic unit (Paragraph 0039-- The reusable component 204 comprises an electronics module…) for capturing and transmitting movement data (Paragraph 0029—monitored parameters include…position of wearer…global positioning system…among other…; Paragraph 0043, 0048—reusable electronic module 204 also comprises…an accelerometer 222), and
a first structure (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…), and
a second submodule (disposable component 202) comprising
a fastening means for fastening the second submodule to a wearer (0008, 0063—adhesive for adhering the disposable component to the skin of a living subject; Paragraph 0102—adhesive base 502 of disposable component; paragraph 0107—disposable component 900 secured to a user via an adhesive overlay 902) and
a second structure (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…),
characterized in that the first structure can form a reversible mechanical connection with the second structure, with the result that the first submodule and the second submodule can be reversibly connected to one another (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…)
Arne additionally teaches the power source and electronic unit are configured to be housed in a housing (see Fig. 6, 12A, 14, 16A-E) such that the first submodule comprises a sheath, wherein the housing comprises closed-cell foam (Paragraph 0106) such that it is made of a flexible material.
However, Arne fails to explicitly teach wherein the first submodule comprises a sheath comprising one flexible, linear, region which forms a bending axis, about which the first submodule can be bent.
Kumar, in the same field of endeavor of a wearable medical device with disposable and reusable components (Abstract), teaches a reusable component of the system analogous to a first submodule wherein this first submodule comprises a sheath made of a flexible material (Paragraph 0006, 0113), where the sheath comprises one flexible, linear, region which forms a single bending axis, about which the first submodule can be bent (Paragraph 0005-0006--the reusable component having a plurality of sealed housings mechanically coupled to each other and movable with respect to each other...the reusable component further includes a flexible circuit configured to provide electrical communication among electrical components within the housings. The flexible circuit may optionally be affixed to back surfaces of the plurality of housings; Paragraph 0078--the reusable component of the wearable device of this invention have multiple housings or modules each containing one or more electrical components; paragraph 0116--the disposable component is a patient engagement substrate adhesively attached to a patient and the reusable component is a plurality of housings mechanically attached to the patient engagement substrate).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the flexible region about which the first submodule can be bent of Kumar in order to predictably improve the durability and comfort of the device by permitting it to bend or flex with movement of the wearer (see Kumar paragraph 0078-- the flexible circuit can withstand the flexing twisting, stretching, bending, compression, tension, etc., that may come from patient movement while wearing the wearable device).
However, Arne fails to explicitly teach wherein the sheath encloses the power source and the electronic unit by means of a molding method, with the result that the power source and the electronic unit form a non-releasable form fit with the sheath. Arne provides for a receiver of the system which includes electrical components which may be molded into a sheath with the result that the power source and the electronic unit form a non-releasable form fit with the sheath (Paragraph 0120-- seal the battery and integrated circuit components, 1101 and 1120, in a fluid tight housing…In some instances, the electrical components may be molded into the top and/or bottom housing plates).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the sensor module system of Arne to utilize a molded sheath as described by Arne in relation to a receiver component to enclose the power source and the electronic unit in order to predictably improve the ability of the device to shield the electronic components from water ingress and thus improve the durability of the device.
Claim(s) 1-5, 7, 13-14, 16-18, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arne (US 20140051946 A1) in view of Kumar (US 20200282225 A1), further in view of Obma (US 20160242646 A1).
Regarding claim 1, Arne teaches a sensor module (Wearable wireless device 102) for attachment to a wearer’s back (Paragraph 0078-0079— removably attached to the torso), the sensor module comprising
a first submodule (reusable module 204) comprising
an electronic unit (Paragraph 0039-- The reusable component 204 comprises an electronics module…) for capturing and transmitting movement data (Paragraph 0029—monitored parameters include…position of wearer…global positioning system…among other…; Paragraph 0043, 0048—reusable electronic module 204 also comprises…an accelerometer 222), and
a first structure (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…), and
a second submodule (disposable component 202) comprising
a fastening means for fastening the second submodule to a wearer (0008, 0063—adhesive for adhering the disposable component to the skin of a living subject; Paragraph 0102—adhesive base 502 of disposable component; paragraph 0107—disposable component 900 secured to a user via an adhesive overlay 902) and
a second structure (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…),
characterized in that the first structure can form a reversible mechanical connection with the second structure, with the result that the first submodule and the second submodule can be reversibly connected to one another (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…).
Arne demonstrates that the sensor module is capable of attachment to the wearer’s torso (Paragraph 0078-0079— removably attached to the torso).
Arne additionally teaches the power source and electronic unit are configured to be housed in a housing (see Fig. 6, 12A, 14, 16A-E) such that the first submodule comprises a sheath, wherein the housing comprises closed-cell foam (Paragraph 0106) such that it is made of a flexible material.
However, Arne fails to explicitly teach wherein the first submodule comprises a sheath comprising one flexible, linear, region which forms a bending axis, about which the first submodule can be bent and wherein the first submodule comprises a flexible conductor connection which connects the electronic unit to a power source which supplies the electronic unit with energy.
Kumar, in the same field of endeavor of a wearable medical device with disposable and reusable components (Abstract), teaches a reusable component of the system analogous to a first submodule wherein this first submodule comprises a sheath made of a flexible material (Paragraph 0006, 0113), where the sheath comprises one flexible, linear, region which forms a single bending axis, about which the first submodule can be bent (Paragraph 0005-0006--the reusable component having a plurality of sealed housings mechanically coupled to each other and movable with respect to each other...the reusable component further includes a flexible circuit configured to provide electrical communication among electrical components within the housings. The flexible circuit may optionally be affixed to back surfaces of the plurality of housings; Paragraph 0078--the reusable component of the wearable device of this invention have multiple housings or modules each containing one or more electrical components; paragraph 0116--the disposable component is a patient engagement substrate adhesively attached to a patient and the reusable component is a plurality of housings mechanically attached to the patient engagement substrate), and wherein the first submodule comprises a flexible conductor connection which connects the electronic unit to a power source which supplies the electronic unit with energy (Paragraph 0022-0023, 0078-0079, 0082--a flexible electrical circuit extends between the housings or modules to provide connections among the electronic components...housings 14 each contain one or more of a battery, a capacitor or a controller).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the flexible region about which the first submodule can be bent of Kumar in order to predictably improve the durability and comfort of the device by permitting it to bend or flex with movement of the wearer (see Kumar paragraph 0078-- the flexible circuit can withstand the flexing twisting, stretching, bending, compression, tension, etc., that may come from patient movement while wearing the wearable device) and to include a flexible conductor connection which connects the electronic unit to a power source in order to predictably ensure that the device remains powered even as the user causes bending and flexing of the sensor module through normal movements and activities which would improve the module over a similar system with a more rigid power construction which may be dislodged by movement.
However, Arne fails to explicitly disclose the sensor module is configured for attachment to the wearer’s back. Obma, in the same field of endeavor of a wearable modular sensor system (Abstract), discloses a sensor module including a first submodule (Paragraph 0055-0068— Each sensor of the type mentioned above is incorporated into the wearable sensing device) and a second submodule (Paragraph 0068-- “wearable” is intended to mean clothing, clothing portions, such as arm sleeves and leg sleeves, joint sleeves, joint wraps, torso coverings, other wraps, any type of removable patches, including both reusable and disposable patches that are attachable using medical grade adhesives, arm slings, knee braces, protective walking boots and other recuperative medical supports and braces), wherein the sensor module is fastened to the wearer’s back (Paragraph 0028, 0068, 0093--cervical spine motion could be monitored via a sensor placed on the upper-most portion of the neck and another at the upper-most portion of the thoracic spine. Likewise, lower back, or lumbar spine, range of movement could be monitored using multiple sensors placed in strategic locations as well).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of Arne, which discloses that a sensor module may generally be placed on a torso, with the teachings of Obma of placing a sensor module on the back of a wearer, as a matter of simple substitution of the placement site, wherein the placement may allow the sensors of the sensor module to monitor different areas of interest or for different measurement applications (See Obma, paragraph 0028).
Regarding claim 2, the combination of Arne, Kumar, and Obma teaches the sensor module of claim 1. Arne additionally teaches wherein the first structure comprises one from the group of hook structure or loop structure and the second structure comprises the other from the group of hook structure or loop structure, wherein the first structure and the second structure form a reversible mechanical connection when the first structure is pressed together with the second structure (Paragraph 0112).
Regarding claim 3, the combination of Arne, Kumar, and Obma teaches the sensor module of claim 1. Arne additionally teaches wherein the reversible mechanical connection comprises a hook-and-loop fastening (Paragraph 0112).
Regarding claim 4, the combination of Arne, Kumar, and Obma teaches the sensor module of claim 1. Arne additionally teaches wherein the fastening means comprises an adhesive layer which can adhere to the human skin (0008, 0063—adhesive for adhering the disposable component to the skin of a living subject; Paragraph 0102—adhesive base 502 of disposable component; paragraph 0107—disposable component 900 secured to a user via an adhesive overlay 902).
Regarding claim 5, the combination of Arne and Kumar teaches the sensor module of claim 1. Arne additionally teaches wherein the second submodule is in the form of a stretchy adhesive strip (0008, 0063—adhesive for adhering the disposable component to the skin of a living subject; Paragraph 0102—adhesive base 502 of disposable component; paragraph 0107—disposable component 900 secured to a user via an adhesive overlay 902…may comprise a 3-piece composite with a center section 904 configured to hold the reusable component 800 comprising the electronics module in place, but not create a sticky build up on the module, an hydrocolloid for primary skin adhesion and an acrylic with function as described above). It is noted that the disclosure of the disposable submodule as being an adhesive base such as a hydrocolloid effectively discloses that the second submodule may be not just an adhesive strip but a stretchy adhesive strip, as hydrocolloid dressings are stretchy and conformable to the user’s skin.
Regarding claim 7, the combination of Arne, Kumar, and Obma teaches the sensor module of claim 1. Arne additionally teaches wherein the electronic unit comprises at least one acceleration sensor for measuring acceleration data and/or a GPS module for capturing and transmitting spatial coordinates of the first submodule or of the sensor module (Paragraph 0029—monitored parameters include…position of wearer…global positioning system…among other…; Paragraph 0043, 0048—reusable electronic module 204 also comprises…an accelerometer 222).
Regarding claim 13, the combination of Arne, Kumar, and Obma teaches the sensor module of claim 1. Arne additionally teaches wherein the electronic unit comprises a communication module which is used to transmit the captured data to an evaluation unit outside the sensor module (Paragraph 0029-0030—make and receive data over a radio link; Paragraph 0039-- The electronics module of the reusable component 204 comprises a wireless communication circuit 206, such as a mobile chipset RF wireless circuit or simply cellular radio; Paragraph 0041-0044-- the reusable electronic module 204 comprises an RF wireless communication circuit 206. The RF wireless communication circuit 206 comprises an antenna for receive and transmit wireless signals, a transmitter circuit, a receiver circuit, and a link master controller that includes a mechanism to connect (establish a link) to another, external, wireless device and transfer data).
Regarding claim 16, the combination of Arne, Kumar, and Obma teaches the sensor module of claim 1. Kumar additionally discloses the first submodule can be bent about the bending axis, wherein the flexible region runs transversely with respect to the flexible conductor connection, with the result that the flexible conductor connection is orthogonal to the bending axis and is likewise bent when bending the first submodule around the linear region (Paragraph 006, 0113-- Extending across the bottom surfaces of the housings 310 is a flexible circuit…; paragraph 0078--The flexible electrical circuit may be waterproof or covered with waterproof material. In addition, in embodiments of the invention the flexible circuit can withstand the flexing twisting, stretching, bending, compression, tension, etc., that may come from patient movement while wearing the wearable device; alternatively: paragraph 0029--the trigger prevention mechanism is configured to be disengaged by bending a portion of at least one of the disposable component mechanical connector and the reusable component mechanical connector; Figs. 23A-23B). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the flexible region about which the first submodule can be bent of Kumar in order to predictably improve the durability and comfort of the device by permitting it to bend or flex with movement of the wearer.
Regarding claim 17, the combination of Arne, Kumar, and Obma teaches a care set comprising the sensor module of claim 1. Arne additionally teaches wherein an electronic evaluation unit which is arranged separately from the sensor module and has software which is used to receive, evaluate and display the measured data, or
a computer program product which, when installed and executed on an electronic evaluation unit, forms software which is used to receive, evaluate and display the measured data (Paragraph 000039-0045-- The wireless communication circuit 206 may be a low power mobile chipset and is configured to connect to the cellular network 108 as well as other wireless devices (cell-phones, smart phones, tablet computers, laptop computers, gateway devices, among others)…the reusable electronic module 204 comprises an RF wireless communication circuit 206. The RF wireless communication circuit 206 comprises an antenna for receive and transmit wireless signals, a transmitter circuit, a receiver circuit, and a link master controller that includes a mechanism to connect (establish a link) to another, external, wireless device and transfer data…In one aspect, the link master controller establishes connection to an external device; paragraph 0075-0077--Some embodiments may be implemented, for example, using a machine-readable medium or article which may store an instruction or a set of instructions that, if executed by a machine, may cause the machine to perform a method and/or operations in accordance with the embodiments. Such a machine may include, for example, any suitable processing platform, computing platform, computing device, processing device, computing system, processing system, computer, processor, or the like, and may be implemented using any suitable combination of hardware and/or software…).
Regarding claim 18, Arne teaches a connecting method comprising the steps of: connecting a second submodule (disposable component 202) to a first submodule (reusable module 204) in a sensor module (102), wherein the first submodule can capture and transmit movement data by means of an electronic unit (Paragraph 0039-- The reusable component 204 comprises an electronics module…; Paragraph 0029—monitored parameters include…position of wearer…global positioning system…among other…; Paragraph 0043, 0048—reusable electronic module 204 also comprises…an accelerometer 222) and comprises a first structure (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…), wherein the second submodule comprises a fastening means for fastening the second submodule to a wearer (0008, 0063—adhesive for adhering the disposable component to the skin of a living subject; Paragraph 0102—adhesive base 502 of disposable component; paragraph 0107—disposable component 900 secured to a user via an adhesive overlay 902) and comprises a second structure (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…), which forms a reversible mechanical connection with the first structure when being pressed together (Paragraph 0112), with the result that the first submodule and the second submodule can be reversibly connected to one another (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…)
Arne additionally discloses that the sensor module may be fastened to a torso of the user (Paragraph 0078-0079).
Arne additionally teaches the power source and electronic unit are configured to be housed in some housing (see Fig. 6, 12A, 14, 16A-E) such that the first submodule comprises a sheath, wherein the housing comprises closed-cell foam (Paragraph 0106) such that it is made of a flexible material.
However, Arne fails to explicitly teach wherein the first submodule comprises a sheath comprising one flexible, linear, region which forms a bending axis, about which the first submodule can be bent.
Kumar, in the same field of endeavor of a wearable medical device with disposable and reusable components (Abstract), teaches a reusable component of the system analogous to a first submodule wherein this first submodule comprises a sheath made of a flexible material (Paragraph 0006, 0113), where the sheath comprises one flexible, preferably linear, region which forms a bending axis, about which the first submodule can be bent, wherein the flexible region runs transversely with respect to the flexible conductor connection, with the result that the flexible conductor connection is preferably likewise bent when bending the first submodule around the linear region (Paragraph 006, 0113; paragraph 0078--The flexible electrical circuit may be waterproof or covered with waterproof material. In addition, in embodiments of the invention the flexible circuit can withstand the flexing twisting, stretching, bending, compression, tension, etc., that may come from patient movement while wearing the wearable device; alternatively: paragraph 0029--the trigger prevention mechanism is configured to be disengaged by bending a portion of at least one of the disposable component mechanical connector and the reusable component mechanical connector).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the flexible region about which the first submodule can be bent of Kumar in order to predictably improve the durability and comfort of the device by permitting it to bend or flex with movement of the wearer (see Kumar paragraph 0078-- the flexible circuit can withstand the flexing twisting, stretching, bending, compression, tension, etc., that may come from patient movement while wearing the wearable device).
However, Arne fails to explicitly disclose fastening the sensor module to the wearer’s back. Obma, in the same field of endeavor of a wearable modular sensor system (Abstract), discloses a sensor module including a first submodule (Paragraph 0055-0068— Each sensor of the type mentioned above is incorporated into the wearable sensing device) and a second submodule (Paragraph 0068-- “wearable” is intended to mean clothing, clothing portions, such as arm sleeves and leg sleeves, joint sleeves, joint wraps, torso coverings, other wraps, any type of removable patches, including both reusable and disposable patches that are attachable using medical grade adhesives, arm slings, knee braces, protective walking boots and other recuperative medical supports and braces), wherein the sensor module is fastened to the wearer’s back (Paragraph 0028, 0068, 0093--cervical spine motion could be monitored via a sensor placed on the upper-most portion of the neck and another at the upper-most portion of the thoracic spine. Likewise, lower back, or lumbar spine, range of movement could be monitored using multiple sensors placed in strategic locations as well).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of Arne, which discloses that a sensor module may generally be placed on a torso, with the teachings of Obma of placing a sensor module on the back of a wearer, as a matter of simple substitution of the placement site, wherein the placement may allow the sensors of the sensor module to monitor different areas of interest or for different measurement applications (See Obma, paragraph 0028).
Regarding claim 22, Arne teaches a sensor module (Wearable wireless device 102) for attachment to a wearer (Paragraph 0078-0079— removably attached to the torso), the sensor module comprising
a first submodule (reusable module 204) comprising
an electronic unit (Paragraph 0039-- The reusable component 204 comprises an electronics module…) for capturing and transmitting movement data (Paragraph 0029—monitored parameters include…position of wearer…global positioning system…among other…; Paragraph 0043, 0048—reusable electronic module 204 also comprises…an accelerometer 222), and
a first structure (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…), and
a second submodule (disposable component 202) comprising
a fastening means for fastening the second submodule to a wearer (0008, 0063—adhesive for adhering the disposable component to the skin of a living subject; Paragraph 0102—adhesive base 502 of disposable component; paragraph 0107—disposable component 900 secured to a user via an adhesive overlay 902) and
a second structure (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…),
characterized in that the first structure can form a reversible mechanical connection with the second structure, with the result that the first submodule and the second submodule can be reversibly connected to one another (paragraph 0112—disposable component and reusable component may be interconnected by way of…hook-and-loop connectors…)
Arne additionally teaches the power source and electronic unit are configured to be housed in a housing (see Fig. 6, 12A, 14, 16A-E) such that the first submodule comprises a sheath, wherein the housing comprises closed-cell foam (Paragraph 0106) such that it is made of a flexible material.
However, Arne fails to explicitly teach wherein the first submodule comprises a sheath comprising one flexible, linear, region which forms a bending axis, about which the first submodule can be bent.
Kumar, in the same field of endeavor of a wearable medical device with disposable and reusable components (Abstract), teaches a reusable component of the system analogous to a first submodule wherein this first submodule comprises a sheath made of a flexible material (Paragraph 0006, 0113), where the sheath comprises one flexible, linear, region which forms a single bending axis, about which the first submodule can be bent (Paragraph 0005-0006--the reusable component having a plurality of sealed housings mechanically coupled to each other and movable with respect to each other...the reusable component further includes a flexible circuit configured to provide electrical communication among electrical components within the housings. The flexible circuit may optionally be affixed to back surfaces of the plurality of housings; Paragraph 0078--the reusable component of the wearable device of this invention have multiple housings or modules each containing one or more electrical components; paragraph 0116--the disposable component is a patient engagement substrate adhesively attached to a patient and the reusable component is a plurality of housings mechanically attached to the patient engagement substrate).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the flexible region about which the first submodule can be bent of Kumar in order to predictably improve the durability and comfort of the device by permitting it to bend or flex with movement of the wearer (see Kumar paragraph 0078-- the flexible circuit can withstand the flexing twisting, stretching, bending, compression, tension, etc., that may come from patient movement while wearing the wearable device).
However, Arne fails to explicitly teach wherein the sheath encloses the power source and the electronic unit by means of a molding method, with the result that the power source and the electronic unit form a non-releasable form fit with the sheath. Arne provides for a receiver of the system which includes electrical components which may be molded into a sheath with the result that the power source and the electronic unit form a non-releasable form fit with the sheath (Paragraph 0120-- seal the battery and integrated circuit components, 1101 and 1120, in a fluid tight housing…In some instances, the electrical components may be molded into the top and/or bottom housing plates).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the sensor module system of Arne to utilize a molded sheath as described by Arne in relation to a receiver component in order to predictably improve the ability of the device to shield the electronic components from water ingress and thus improve the durability of the device.
However, Arne fails to explicitly disclose the sensor module is configured for attachment to the wearer’s back. Obma, in the same field of endeavor of a wearable modular sensor system (Abstract), discloses a sensor module including a first submodule (Paragraph 0055-0068— Each sensor of the type mentioned above is incorporated into the wearable sensing device) and a second submodule (Paragraph 0068-- “wearable” is intended to mean clothing, clothing portions, such as arm sleeves and leg sleeves, joint sleeves, joint wraps, torso coverings, other wraps, any type of removable patches, including both reusable and disposable patches that are attachable using medical grade adhesives, arm slings, knee braces, protective walking boots and other recuperative medical supports and braces), wherein the sensor module is fastened to the wearer’s back (Paragraph 0028, 0068, 0093--cervical spine motion could be monitored via a sensor placed on the upper-most portion of the neck and another at the upper-most portion of the thoracic spine. Likewise, lower back, or lumbar spine, range of movement could be monitored using multiple sensors placed in strategic locations as well).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of Arne, which discloses that a sensor module may generally be placed on a torso, with the teachings of Obma of placing a sensor module on the back of a wearer, as a matter of simple substitution of the placement site, wherein the placement may allow the sensors of the sensor module to monitor different areas of interest or for different measurement applications (See Obma, paragraph 0028).
Claim(s) 8 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arne in view of Kumar, further in view of Sick AG (DE 202016103635 U1).
Regarding claim 8 and 19, the combination of Arne and Kumar teaches a care set comprising the sensor module of claim 1 and 18. However, Arne fails to disclose wherein the second submodule comprises a near-field communication transmitter for transmitting data, and the first submodule comprises a near-field communication receiver for receiving the data, wherein the data are used to verify the functionality of the pairing of the first submodule with the second submodule, and/or the correct attachment of the first submodule, and/or the use of a proprietary second submodule.
Sick AG, in the same field of endeavor of a modular sensor system (Abstract), discloses a sensor system (10) including a first submodule (12) and a second submodule (14; “The holder is used for mechanical fixation and is also the communication partner of the sensor”) wherein the second submodule comprises a near-field communication transmitter for transmitting data (NFC interface 22), and the first submodule comprises a near-field communication receiver for receiving the data (NFC interface 18), wherein the data are used to verify the functionality of the pairing of the first submodule with the second submodule, and/or the correct attachment of the first submodule, and/or the use of a proprietary second submodule (“The invention has the advantage that access to the sensor is provided in a very simple and comfortable manner via NFC. Commissioning, maintenance, diagnosis and replacement of the sensors are thus possible in a short time”; “In another embodiment, NFC may be used for product authentication or counterfeit detection and part tracking”). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne with the particular NFC usage of Sick AG in order to predictably improve the ability of the device to determine that the device is properly applied to the skin of the wearer (e.g. that a connection is proper) thus increasing the accuracy of any measurements performed by the device.
Claim(s) 8 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arne in view of Kumar, further in view of Obma, further in view of Sick AG (DE 202016103635 U1).
Regarding claim 8 and 19, the combination of Arne, Kumar, and Obma teaches a care set comprising the sensor module of claim 1 and 18. However, Arne fails to disclose wherein the second submodule comprises a near-field communication transmitter for transmitting data, and the first submodule comprises a near-field communication receiver for receiving the data, wherein the data are used to verify the functionality of the pairing of the first submodule with the second submodule, and/or the correct attachment of the first submodule, and/or the use of a proprietary second submodule.
Sick AG, in the same field of endeavor of a modular sensor system (Abstract), discloses a sensor system (10) including a first submodule (12) and a second submodule (14; “The holder is used for mechanical fixation and is also the communication partner of the sensor”) wherein the second submodule comprises a near-field communication transmitter for transmitting data (NFC interface 22), and the first submodule comprises a near-field communication receiver for receiving the data (NFC interface 18), wherein the data are used to verify the functionality of the pairing of the first submodule with the second submodule, and/or the correct attachment of the first submodule, and/or the use of a proprietary second submodule (“The invention has the advantage that access to the sensor is provided in a very simple and comfortable manner via NFC. Commissioning, maintenance, diagnosis and replacement of the sensors are thus possible in a short time”; “In another embodiment, NFC may be used for product authentication or counterfeit detection and part tracking”). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne with the particular NFC usage of Sick AG in order to predictably improve the ability of the device to determine that the device is properly applied to the skin of the wearer (e.g. that a connection is proper) thus increasing the accuracy of any measurements performed by the device.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arne in view of Kumar, further in view of Larson (US 20180214051 A1).
Regarding claim 9, the combination of Arne and Kumar teaches a care set comprising the sensor module of claim 1. However, Arne fails to disclose wherein the first submodule comprises a capacitive sensor for measuring capacitance values between a capacitor electrode belonging to the capacitive sensor and the wearer's skin surface. Larson, in analogous art of a wearable sensor system (Abstract) discloses that a submodule comprises a capacitive sensor for measuring capacitance values between a capacitor electrode belonging to the capacitive sensor and the wearer’s skin surface (Paragraph 0099-0100—capacitive sensor 315; Paragraph 0106--the orientation sensor is considered properly attached to the patient only when detected biometric parameters fall within predefined values based on known physiological behavior. If the detected biometric parameters fall outside of predefined limits, then the patient orientation sensor is considered to be improperly secured to the patient, or not attached to the patient, and caregivers can be alerted. The detected biometric parameters can include, but are not limited to, skin capacitance). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the capacitance sensor of Larson in order to predictably improve the ability of the device to determine that the device is properly applied to the skin of the wearer (e.g. that a connection is proper) thus increasing the accuracy of any measurements performed by the device.
Regarding claim 10, the combination of Arne and Kumar teaches a care set comprising the sensor module of claim 1. However, Arne fails to disclose wherein the electronic unit comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt data to be measured, captured and/or transmitted only when the present capacitance value is greater than or equal to or less than or equal to the reference value. Larson, in analogous art of a wearable sensor system (Abstract) discloses that the system includes an electronic unit which comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt data to be measured, captured and/or transmitted only when the present capacitance value is greater than or equal to or less than or equal to the reference value (Paragraph 0106--the orientation sensor is considered properly attached to the patient only when detected biometric parameters fall within predefined values based on known physiological behavior. If the detected biometric parameters fall outside of predefined limits, then the patient orientation sensor is considered to be improperly secured to the patient, or not attached to the patient, and caregivers can be alerted. The detected biometric parameters can include, but are not limited to, skin capacitance; paragraph 0149, 0224-0225--Among other things the capacitive sensor can be used to detect if the patient sensor is attached to the patient. The capacitive threshold is the capacitance reading at which the sensor is becomes attached or unattached. The capacitive threshold can be set by the system, by the user, or by the facility. The unattached-to-attached capacitive reading threshold can be different from the attached-to-unattached reading threshold. This reduces the rapid switching between unattached an attached near the threshold. In one embodiment, the unattached-to-attached capacitive reading threshold is greater than the attached-to-unattached capacitive reading threshold…; paragraph 0275-- In one embodiment, the system triggers the unattached alert if the attachment sensor, which can be but is not limited to a capacitance sensor, reports a reading beyond the threshold for human attachment). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the capacitance comparisons of Larson in order to predictably improve the ability of the device to determine that the device is properly applied to the skin of the wearer (e.g. that a connection is proper) thus increasing the accuracy of any measurements performed by the device.
Regarding claim 11, the combination of Arne and Kumar teaches a care set comprising the sensor module of claim 1. However, Arne fails to disclose wherein the electronic unit comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt the data relating to the acceleration, the spatial coordinates and the verification to be measured, captured and/or transmitted only when the present capacitance value is less than or equal to the reference value. Larson, in analogous art of a wearable sensor system (Abstract) discloses that the system includes an electronic unit which comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt data to be measured, captured and/or transmitted only when the present capacitance value is greater than or equal to or less than or equal to the reference value (Paragraph 0106--the orientation sensor is considered properly attached to the patient only when detected biometric parameters fall within predefined values based on known physiological behavior. If the detected biometric parameters fall outside of predefined limits, then the patient orientation sensor is considered to be improperly secured to the patient, or not attached to the patient, and caregivers can be alerted. The detected biometric parameters can include, but are not limited to, skin capacitance; paragraph 0149, 0224-0225--Among other things the capacitive sensor can be used to detect if the patient sensor is attached to the patient. The capacitive threshold is the capacitance reading at which the sensor is becomes attached or unattached. The capacitive threshold can be set by the system, by the user, or by the facility. The unattached-to-attached capacitive reading threshold can be different from the attached-to-unattached reading threshold. This reduces the rapid switching between unattached an attached near the threshold. In one embodiment, the unattached-to-attached capacitive reading threshold is greater than the attached-to-unattached capacitive reading threshold…; paragraph 0275-- In one embodiment, the system triggers the unattached alert if the attachment sensor, which can be but is not limited to a capacitance sensor, reports a reading beyond the threshold for human attachment). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the capacitance comparisons of Larson in order to predictably improve the ability of the device to determine that the device is properly applied to the skin of the wearer (e.g. that a connection is proper) thus increasing the accuracy of any measurements performed by the device.
Regarding claim 12, the combination of Arne and Kumar teaches a care set comprising the sensor module of claim 1. However, Arne fails to disclose wherein the electronic unit comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt the data relating to the acceleration, the spatial coordinates and the verification to be measured, captured and/or transmitted only when the present capacitance value is greater than or equal to the reference value. Larson, in analogous art of a wearable sensor system (Abstract) discloses that the system includes an electronic unit which comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt data to be measured, captured and/or transmitted only when the present capacitance value is greater than or equal to or less than or equal to the reference value (Paragraph 0106--the orientation sensor is considered properly attached to the patient only when detected biometric parameters fall within predefined values based on known physiological behavior. If the detected biometric parameters fall outside of predefined limits, then the patient orientation sensor is considered to be improperly secured to the patient, or not attached to the patient, and caregivers can be alerted. The detected biometric parameters can include, but are not limited to, skin capacitance; paragraph 0149, 0224-0225--Among other things the capacitive sensor can be used to detect if the patient sensor is attached to the patient. The capacitive threshold is the capacitance reading at which the sensor is becomes attached or unattached. The capacitive threshold can be set by the system, by the user, or by the facility. The unattached-to-attached capacitive reading threshold can be different from the attached-to-unattached reading threshold. This reduces the rapid switching between unattached an attached near the threshold. In one embodiment, the unattached-to-attached capacitive reading threshold is greater than the attached-to-unattached capacitive reading threshold…; paragraph 0275-- In one embodiment, the system triggers the unattached alert if the attachment sensor, which can be but is not limited to a capacitance sensor, reports a reading beyond the threshold for human attachment). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the capacitance comparisons of Larson in order to predictably improve the ability of the device to determine that the device is properly applied to the skin of the wearer (e.g. that a connection is proper) thus increasing the accuracy of any measurements performed by the device.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arne in view of Kumar, further in view of Obma, further in view of Larson (US 20180214051 A1).
Regarding claim 9, the combination of Arne, Kumar, and Obma teaches a care set comprising the sensor module of claim 1. However, Arne fails to disclose wherein the first submodule comprises a capacitive sensor for measuring capacitance values between a capacitor electrode belonging to the capacitive sensor and the wearer's skin surface. Larson, in analogous art of a wearable sensor system (Abstract) discloses that a submodule comprises a capacitive sensor for measuring capacitance values between a capacitor electrode belonging to the capacitive sensor and the wearer’s skin surface (Paragraph 0099-0100—capacitive sensor 315; Paragraph 0106--the orientation sensor is considered properly attached to the patient only when detected biometric parameters fall within predefined values based on known physiological behavior. If the detected biometric parameters fall outside of predefined limits, then the patient orientation sensor is considered to be improperly secured to the patient, or not attached to the patient, and caregivers can be alerted. The detected biometric parameters can include, but are not limited to, skin capacitance). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the capacitance sensor of Larson in order to predictably improve the ability of the device to determine that the device is properly applied to the skin of the wearer (e.g. that a connection is proper) thus increasing the accuracy of any measurements performed by the device.
Regarding claim 10, the combination of Arne, Kumar, and Obma teaches a care set comprising the sensor module of claim 1. However, Arne fails to disclose wherein the electronic unit comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt data to be measured, captured and/or transmitted only when the present capacitance value is greater than or equal to or less than or equal to the reference value. Larson, in analogous art of a wearable sensor system (Abstract) discloses that the system includes an electronic unit which comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt data to be measured, captured and/or transmitted only when the present capacitance value is greater than or equal to or less than or equal to the reference value (Paragraph 0106--the orientation sensor is considered properly attached to the patient only when detected biometric parameters fall within predefined values based on known physiological behavior. If the detected biometric parameters fall outside of predefined limits, then the patient orientation sensor is considered to be improperly secured to the patient, or not attached to the patient, and caregivers can be alerted. The detected biometric parameters can include, but are not limited to, skin capacitance; paragraph 0149, 0224-0225--Among other things the capacitive sensor can be used to detect if the patient sensor is attached to the patient. The capacitive threshold is the capacitance reading at which the sensor is becomes attached or unattached. The capacitive threshold can be set by the system, by the user, or by the facility. The unattached-to-attached capacitive reading threshold can be different from the attached-to-unattached reading threshold. This reduces the rapid switching between unattached an attached near the threshold. In one embodiment, the unattached-to-attached capacitive reading threshold is greater than the attached-to-unattached capacitive reading threshold…; paragraph 0275-- In one embodiment, the system triggers the unattached alert if the attachment sensor, which can be but is not limited to a capacitance sensor, reports a reading beyond the threshold for human attachment). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the capacitance comparisons of Larson in order to predictably improve the ability of the device to determine that the device is properly applied to the skin of the wearer (e.g. that a connection is proper) thus increasing the accuracy of any measurements performed by the device.
Regarding claim 11, the combination of Arne, Kumar, and Obma teaches a care set comprising the sensor module of claim 1. However, Arne fails to disclose wherein the electronic unit comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt the data relating to the acceleration, the spatial coordinates and the verification to be measured, captured and/or transmitted only when the present capacitance value is less than or equal to the reference value. Larson, in analogous art of a wearable sensor system (Abstract) discloses that the system includes an electronic unit which comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt data to be measured, captured and/or transmitted only when the present capacitance value is greater than or equal to or less than or equal to the reference value (Paragraph 0106--the orientation sensor is considered properly attached to the patient only when detected biometric parameters fall within predefined values based on known physiological behavior. If the detected biometric parameters fall outside of predefined limits, then the patient orientation sensor is considered to be improperly secured to the patient, or not attached to the patient, and caregivers can be alerted. The detected biometric parameters can include, but are not limited to, skin capacitance; paragraph 0149, 0224-0225--Among other things the capacitive sensor can be used to detect if the patient sensor is attached to the patient. The capacitive threshold is the capacitance reading at which the sensor is becomes attached or unattached. The capacitive threshold can be set by the system, by the user, or by the facility. The unattached-to-attached capacitive reading threshold can be different from the attached-to-unattached reading threshold. This reduces the rapid switching between unattached an attached near the threshold. In one embodiment, the unattached-to-attached capacitive reading threshold is greater than the attached-to-unattached capacitive reading threshold…; paragraph 0275-- In one embodiment, the system triggers the unattached alert if the attachment sensor, which can be but is not limited to a capacitance sensor, reports a reading beyond the threshold for human attachment). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the capacitance comparisons of Larson in order to predictably improve the ability of the device to determine that the device is properly applied to the skin of the wearer (e.g. that a connection is proper) thus increasing the accuracy of any measurements performed by the device.
Regarding claim 12, the combination of Arne, Kumar, and Obma teaches a care set comprising the sensor module of claim 1. However, Arne fails to disclose wherein the electronic unit comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt the data relating to the acceleration, the spatial coordinates and the verification to be measured, captured and/or transmitted only when the present capacitance value is greater than or equal to the reference value. Larson, in analogous art of a wearable sensor system (Abstract) discloses that the system includes an electronic unit which comprises a comparison unit which is designed to compare a capacitance reference value with a present capacitance value and to prompt data to be measured, captured and/or transmitted only when the present capacitance value is greater than or equal to or less than or equal to the reference value (Paragraph 0106--the orientation sensor is considered properly attached to the patient only when detected biometric parameters fall within predefined values based on known physiological behavior. If the detected biometric parameters fall outside of predefined limits, then the patient orientation sensor is considered to be improperly secured to the patient, or not attached to the patient, and caregivers can be alerted. The detected biometric parameters can include, but are not limited to, skin capacitance; paragraph 0149, 0224-0225--Among other things the capacitive sensor can be used to detect if the patient sensor is attached to the patient. The capacitive threshold is the capacitance reading at which the sensor is becomes attached or unattached. The capacitive threshold can be set by the system, by the user, or by the facility. The unattached-to-attached capacitive reading threshold can be different from the attached-to-unattached reading threshold. This reduces the rapid switching between unattached an attached near the threshold. In one embodiment, the unattached-to-attached capacitive reading threshold is greater than the attached-to-unattached capacitive reading threshold…; paragraph 0275-- In one embodiment, the system triggers the unattached alert if the attachment sensor, which can be but is not limited to a capacitance sensor, reports a reading beyond the threshold for human attachment). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Arne to include the capacitance comparisons of Larson in order to predictably improve the ability of the device to determine that the device is properly applied to the skin of the wearer (e.g. that a connection is proper) thus increasing the accuracy of any measurements performed by the device.
Response to Arguments
Applicant's arguments filed 02 February 2026 with regards to the combination of Arne and Kumar in the rejection of claims 1-5, 7-17, 19 have been fully considered but they are not persuasive.
Applicant’s arguments as to the “interconnection” of Arne as previously relied upon in the office action of 01 October 2025 are moot as Kumar has been newly relied upon to disclose the relevant limitation.
Furthermore, the applicant’s arguments that “the overall context of Kumar…consistently shows for all illustrated embodiments that there are four housings, which are connected to each other, resulting in three bending axes to be formed” is not convincing.
Kumar refers to the number of housings simply as “multiple” or “a plurality” (see Paragraphs 0005-0006, 0078, 0116) and which may thus include two ‘housings’, which would require only a single bending axis. While the drawings of Kumar demonstrate only an example having four housings, Kumar never states in the disclosure that the invention has or must have a certain number of housings beyond “multiple” or “a plurality”. Furthermore, Kumar discusses that the embodiments of the reusable component are similar to those shown in WO2017/035502 (see paragraph 0078 of Kumar) which itself discloses a device having one or more housings. As Kumar also defines a housing or module as containing one or more electrical components (Paragraph 0078), it additionally may be seen that the possible number of housings of the first submodule of Arne, wherein the first submodule 204 comprises electronics unit 222, a power source 214, and other electrical components (see Fig. 2), can be as low as one (including all electrical components) or some plurality (each housing including one or some electrical components), such that the combination of references is clearly compatible in an embodiment having two housings with a single bending axis between them.
Regarding claim 5, the applicant argues that “Arne is silent regarding the “stretchy” characteristic” of the claim. As noted above, Arne discloses that the second submodule may comprise an adhesive hydrocolloid, which are known to be stretchy.
Regarding claim 16, the applicant argues that “Kumar is silent regarding the exact angle formed between the flexible circuit and the bending axes which are formed between the housings”. Should the applicant argue against the disclosure of the drawings which demonstrate an orthogonal relationship between the flexible circuit and the bending axes, paragraph 0113 of Arne additionally discloses an orthogonal relationship via the disclosure of the flexible circuit as extending across the bottom surfaces of the housings which include the bending axes.
Applicant’s arguments as to the new claim 22 including a molding method of Kumar as previously relied upon in the office action of 01 October 2025 are moot as Arne has been newly relied upon to disclose the relevant limitation.
The applicant’s argument is thus not convincing and the claims remain rejected under 35 U.S.C. 103.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791
