DETAILED ACTION
This Office Action is in response to the filing of amendments to the claims on 10/24/2025. As per the amendments, claims 1-16, 19-32, and 34 have been amended, claims 17-18, 33, and 35 have been cancelled, and no claims have been added. Thus, claims 1-16, 19-32, and 34 are pending in the application.
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 .
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.
Claims 1-5, 7, 11-12, 15-16, 19, 21-22, 26-27, and 31 rejected under 35 U.S.C. 103 as being unpatentable over Farrow et al. (US Pub. 2013/0331753) in view of Roth et al. (US Pat. 7,771,376).
Regarding claim 1, Farrow discloses a multifunction knee brace (see knee orthosis 10 in Figs. 1A-2A), comprising: a flexible sleeve (see Fig. 2A the structure of bladder 12), the flexible sleeve comprising: a first section comprising a first inflatable chamber (see Figs. 2A lower chamber 38); and a third section proximal of the first section comprising at least one additional inflatable chamber (see Fig. 2A upper chambers 36 and 40); a rigid frame portion extending at least in the third section and comprising an upper portion and a lower portion (see Figs. 1A and 4A-4B where hinge bars 90/106 extend along the knee joint, with upper portions 92/108 and lower portions 94/110); and a hinge portion movably connecting the upper portion and the lower portion which allows for bending of the rigid frame portion about a knee of a patient when fitted to the patient (see Figs. 4A-4B where the hinge bars 90/106 have hinges 96/112 for a pivotal motion between the upper and lower sections of the hinge bars, allowing for bending of the hinge bars about the knee); wherein a device is provided for controlling inflation of the inflatable chambers (see Fig. 2A fluid inlet line 64).
Farrow lacks a detailed description of the first section being a set of inflatable chambers, a second section proximal of the first section comprising a second set of inflatable chambers, the third section being proximal the second section, and a control device is provided for controlling inflation and deflation of the inflatable chambers.
However, Roth teaches a worn garment with inflatable bladders, having a first section being a set of inflatable chambers (see Figs. 2A-2B a first section having inflatable bladders 250a-250d), a second section proximal of the first section comprising a second set of inflatable chambers (see figs. 2A-2B a second section having inflatable bladders 250e-250h), the third section being proximal the second section comprising at least one additional inflatable chamber (see Figs. 2A-2B a third section having inflatable bladders 250i-250l), and a control device is provided for controlling inflation and deflation of the inflatable chambers (see microcontroller 328 in Fig. 3B and Col. 9 line 58 to Col. 10 line 2 where the signals from the microcontroller are used to drive the compressor and solenoid valves for the selective inflation/ deflation of the bladders).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inflatable bladders, inflation system, and control thereof of Farrow to include a plurality of inflatable chambers both above and below the joint, and having their inflation/ deflation controlled as taught by Roth, as it would provide a massage effect to the worn brace as an additional form of therapy (Farrow; see [0009] where Farrow contemplates the inclusion of therapeutic interactions for improving patient health while wearing the brace), with the control device allowing for uniform inflation characteristics for a more satisfying massage (Roth; see Col. 1 lines 3-14).
Regarding claim 2, the modified Farrow device has wherein the first set of inflatable chambers, the second set of inflatable chambers, and the at least one additional inflatable chamber (Roth; see Figs. 2A-2B the sections of bladders 250a-250l as modified onto the Farrow device) are inflated in sequence from the most distal to the most proximal to reduce swelling in at least one of a joint and limb of a patient (Roth; see Fig. 4C and Col. 10 lines 28-46 where the bladders are inflated first from distal bladder 250a, then 250b, and in sequence to 250l).
Regarding claim 3, the modified Farrow device has wherein the first set of inflatable chambers, the second set of inflatable chambers and the at least one additional inflatable chamber are deflated in sequence from the most distal to the most proximal (Roth; see Fig. 4C and Col. 10 lines 28-46 where the bladders are deflated first from distal bladder 250a, then 250b, and in sequence to 250l).
Regarding claim 4, the modified Farrow device has wherein the control device cycles the inflation and the deflation of the first set of inflatable chambers, the second set of inflatable chambers, and the at least one additional inflatable chamber such that after inflation in the sequence the chambers are deflated in the same sequence from the most distal to the most proximal (Roth; see Fig. 4C and Col. 10 lines 28-46 where the bladders are inflated first from distal bladder 250a, which then deflates, then bladder 250b inflates and deflates, and continues in this sequence to 250l).
Regarding claim 5, the modified Farrow device has wherein the control device repeatedly cycles the inflation and the deflation of the chambers for a programmable period of time (Roth; see Col. 11 lines 18-29).
Regarding claim 7, the modified Farrow device has wherein the control device is adapted to control the inflation and the deflation of the first set of inflatable chambers, the second set of inflatable chambers, and the at least one additional inflatable chamber independently of one another (Roth; see Fig. 2B and Col. 5 lines 20-30 and Col. 10 lines 15-20 where 310A-L are each independent inflation tubes that connect to a respective inflation bladder).
Regarding claim 11, the modified Farrow device has one or more thermal elements for the application of heat or cold to at least one of the first section, the second section, and the third section (Farrow; see [0009] where the bladders can have a cold gel pack placed on them).
Regarding claim 12, the modified Farrow device has wherein the one or more thermal elements each comprise one of a gel pack (Farrow; see [0009]).
Regarding claim 15, the modified Farrow device has wherein the first set of inflatable chambers comprises three inflatable chambers (Roth; see Figs. 2A-2B where bladders 250a-250c are three bladders, as modified onto the brace of Farrow).
Regarding claim 16, the modified Farrow device has wherein the second set of inflatable chambers comprises three inflatable chambers (Roth; see Figs. 2A-2B where bladders 250e-250g are three bladders as modified onto the brace of Farrow).
Regarding claim 19, the modified Farrow device has wherein the frame portion is removably fixed to at least the third section (Farrow; see [0005] and [0010] where the hinge bars are removably connected to the bladders, including the third section).
Regarding claim 21, the modified Farrow device has wherein the first set of inflatable chambers, the second set of inflatable chambers, and the at least one additional inflatable chamber are each inflated and maintained at a constant pressure to provide a rigid sleeve (Roth; see Fig. 4C where the applied pressure to each inflation bladder is a constant pressure value once inflated, and further see Col. 11 lines 46-53 where the pressure can be maintained via a hold input to a selection of bladders to continue to press against the body with some amount of rigidity).
Regarding claim 22, the modified Farrow device has wherein at least one of the first set of inflatable chambers, the second set of inflatable chambers, and the at least one additional inflatable chamber is inflated and maintained at a constant pressure to provide rigid portions of the sleeve (Roth; see Fig. 4C where the applied pressure to each inflation bladder is a constant pressure value once inflated, and further see Col. 11 lines 46-53 where the pressure can be maintained via a hold input to a selection of bladders to continue to press against the body with some amount of rigidity).
Regarding claim 26, the modified Farrow device has wherein an air pump is connected to the sleeve and in communication with the control device for inflating of the first set of inflatable chambers, the second set of inflatable chambers, and the at least one additional inflatable chamber (Roth; see Figs. 3A-3B where compressor 320 is within the inflation assembly 300 to act as a pump, and provide the inflation to the bladders when told by the microcontroller; see Col. 9 lines 20-44).
Regarding claim 27, the modified Farrow device has wherein a user device is in communication with the control device (Roth; see Fig. 3E where display panel 360 contains inputs for a user to control the device, such as hold button 380 and selectors 362/ 364/ 366 which communicate a user’s choices to the microcontroller for modifying the therapy).
Regarding claim 31, the modified Farrow device has wherein the control device is integral to the user device (Roth; see Fig. 3E where display panel 360 is formed with and integrally connect to inflation assembly 300).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Farrow in view of Roth as applied to claim 4 above, and further in view of Raley et al. (US Pat. 7,976,486).
Regarding claim 6, the modified Farrow device has cycles of compression and decompression.
The modified Farrow device lacks a detailed description of a programmable wait period is provided between the cycles.
However, Raley teaches a similar compression garment, where the controller can have a wait cycle between subsequent pressurization events, which can be modified as necessary (see Col. 6 lines 58-64).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compression cycles of the modified Farrow device to be programmable to have a wait period as taught by Raley, as it would allow for better control over the use of the compression sleeve, especially during prolonged use where the limb will have time to rest and maintain regular blood flow between cycles.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Farrow in view of Roth as applied to claim 1 above, and further in view of Santa Maria et al. (US Pat. 9,956,113).
Regarding claim 8, the modified Farrow device discloses the second section, as well as thermal therapy (Farrow; see [0009]).
The modified Farrow device lacks a detailed description of wherein the second section further comprises one or more temperature sensors.
However, Santa Maria teaches a similar limb compression device, which is used to deliver heat to the limbs (see Figs. 4A-4B and Col. 13 lines 40-55 where thermal energy is transferred through the body interface member 111, thermal energy transfer members 113, and blood flow regulation members 112), and includes temperature sensors (see Col. 8 lines 10-30 where temperature sensors can be included on the interface 111 for sensing the temperature and sending signals back to the control unit).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bladder inflation system of the modified Farrow device to include thermal energy transfer and temperature sensors as taught by Santa Maria, as it would provide means for monitoring and controlling the temperature of the patient’s limb, to promote blood flow and prevent hypothermia. It is understood that in the modified Farrow device, the temperature sensors can be placed anywhere along the device that interfaces with the patient, including the second section.
Regarding claim 9, the modified Farrow device has wherein the control device receives temperature readings from the one or more temperature sensors (Santa Maria; see Col. 8 lines 10-30 where temperature sensors send signals back to the control unit).
Regarding claim 10, the modified Farrow device has wherein: the third section further comprises a thermal element for application of heat therapy (Santa Maria; see Figs. 4A-4B and Col. 13 lines 40-55 where thermal energy is transferred through the body interface member 111, thermal energy transfer members 113, and blood flow regulation members 112, and thus through the sections of the modified Farrow device including the third section); and the control device receives temperature data from the thermal element (Santa Maria; see Col. 8 lines 10-30 where temperature sensors send signals back to the control unit).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Farrow in view of Roth as applied to claim 1 above, and further in view of Parish et al. (US Pat. 9,119,705).
Regarding claim 13, the modified Farrow device has the multifunction sleeve and control device, and thermal elements (Farrow; see [0009]).
The modified Farrow device lacks a detailed description of one or more thermal elements comprising at least one conduit section; wherein a thermal unit in communication with the control device provides heated or cooled fluid to the at least one conduit section.
However, Parish teaches a similar sleeve for a limb that delivers heat therapy, where the thermal elements can be a conduit for thermal fluid integrated into the sleeve (see Figs. 14-15 where a blanket 8 has an inlet hose 500 and outlet hose 502 for the thermal fluid, which is then sent through the blanket for transferring thermal energy) which is controlled by and connected to a control unit (see control unit 4 in Fig. 5).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bladders and control system of the modified Farrow device to include tubes for carrying heat transfer fluid into the bladder and the control thereof as taught by Parish, as it would add the thermal transfer of either hot or cold to the patient, for providing either hot or cold therapy to patients to benefit them during healing or deliver therapy (Parish; see Col. 1 lines 55-65).
Regarding claim 14, the modified Farrow device has wherein the thermal unit is one of wired or wirelessly connected to the control device (Parish; see Fig. 2 where the control unit 4 (as modified to be included into the inflation assembly 300 of Roth, as modified into the system of Farrow) includes a heat transfer assembly 202, thermal transfer plate 95, and other elements for the thermal unit which are part of the modified control system, and are connected either wired or wirelessly to the controller (where it is understood that the thermal unit is connected to and controlled by the modified control device, and must be at least one of wired or wirelessly connected as those are the only possible options for a connection and include all possibilities)).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Farrow in view of Roth as applied to claim 1 above, and further in view of McBean et al. (US Pat. 8,585,620).
Regarding claim 20, the modified Farrow device has the frame portion.
The modified Farrow device lacks a detailed description of one or more range of motion sensors fixed to the rigid frame portion.
However, McBean teaches a similar worn bracing device for the limb of a user, where range of motion sensors are fixed to the rigid frame (see Fig. 3 where padding 6 on brace 7 shows a rigid frame to be placed around a limb, and see Col. 27 lines 2-17 where a range of motion sensor can be included on the device).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sleeve and control system of the modified Farrow device to have range of motion sensors on the sleeve and communicating with the control system as taught by McBean, as it would allow for monitoring of the user’s range of motion to determine and track progress made with exercise/ therapy/ rehabilitation (McBean; see Col. 13 lines 24-39).
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Farrow in view of Roth as applied to claim 1 above, and further in view of Santa Maria and McBean.
Regarding claim 23, the modified Farrow device has the multifunction sleeve, and a thermal element for cold therapy (Farrow; see [0009]).
The modified Farrow device lacks a detailed description one or more temperature sensors.
However, Santa Maria teaches a similar limb compression device, which is used to deliver heat to the limbs (see Figs. 4A-4B and Col. 13 lines 40-55 where thermal energy is transferred through the body interface member 111, thermal energy transfer members 113, and blood flow regulation members 112), and includes temperature sensors (see Col. 8 lines 10-30 where temperature sensors can be included on the interface 111 for sensing the temperature and sending signals back to the control unit).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bladder inflation system of the modified Farrow device to include thermal energy transfer and temperature sensors as taught by Santa Maria, as it would provide means for monitoring and controlling the temperature of the patient’s limb, to promote blood flow and prevent hypothermia.
The modified Farrow device lacks a detailed description of one or more range of motion sensors.
However, McBean teaches a similar worn bracing device for the limb of a user, where range of motion sensors are fixed to the rigid frame (see Fig. 3 where padding 6 on brace 7 shows a rigid frame to be placed around a limb, and see Col. 27 lines 2-17 where a range of motion sensor can be included on the device).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sleeve and control system of the modified Farrow device to have range of motion sensors on the sleeve and communicating with the control system as taught by McBean, as it would allow for monitoring of the user’s range of motion to determine and track progress made with exercise/ therapy/ rehabilitation (McBean; see Col. 13 lines 24-39).
Regarding claim 24, the modified Farrow device has wherein the control device at least one of: receives temperature data from the one or more temperature sensors (Santa Maria; see Col. 8 lines 10-30 where temperature sensors send signals back to the control unit of the modified Farrow device).
Regarding claim 25, the modified Farrow device has a communication module enabling communication between the sleeve and the control device (Roth; see Fig. 3E where display 360 has selectors 362/ 364/ 366 which communicate with the microcontroller within the device to then control and communicate the inputs to the sleeve of the user); a microprocessor in communication with the communication module and with the one or more temperature sensors (Roth; see Fig. 3B where the microcontroller 328 receives the data and inputs of the entire system, including the temperature sensors as taught by Santa Maria), the one or more range of motion sensors (Roth; see Fig. 3B where the microcontroller 328 receives the data and inputs of the entire system, including the range of motion sensors as taught by McBean), the one or more thermal elements (Roth; see Fig. 3B where the microcontroller 328 receives the data and inputs of the entire system, including the thermal elements as taught by Santa Maria/ disclosed by Farrow), and the inflatable chambers for processing commands from the control device and providing data to the control device via the communication module (Roth; see Col. 9 line 58 to Col. 10 line 2).
Claims 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Farrow in view of Roth as applied to claim 27 above, and further in view of Rapp et al. (US Pub. 2017/0100300).
Regarding claim 28, the modified Farrow device has wherein: the user device is one of wired or wirelessly connected to the at least one of the control device (Roth; see Fig. 3E where display 360 has selectors 362/ 364/ 366 which communicate with the microcontroller and must be one of wired or wirelessly connected to the microcontroller).
The modified Farrow device lacks a detailed description of wherein: the user device is one of wired or wirelessly connected to the at least one of the control device and the sleeve; the user device receives, stores and analyzes data received from the at least one of the control device and the sleeve.
However, Rapp teaches a similar compression garment device, wherein: the user device is one of wired or wirelessly connected to the at least one of the control device and the sleeve (see [0036] where outputted data from the device can communicate with a phone); the user device receives, stores and analyzes data received from the at least one of the control device and the sleeve (see [0036] where the phone can have an application for receiving and interpreting the data, and at least temporarily storing the data to display).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the user device of the modified Farrow device to be a remote phone device as taught by Rapp, as it would allow for the system to connect to the ubiquitous smartphones for easy and remote access to the data from the device.
Regarding claim 29, the modified Farrow device has wherein the user device comprises at least one of a software application and a web-based software interface (Rapp; see [0036] where the phone can run an application).
Regarding claim 30, the modified Farrow device has wherein the at least one of the software application and the web-based software interface are adapted to predict an onset of an adverse patient health event based on the data received at the user device (Rapp; see [0037], [0040], and [0084]-[0085] where the phone can alert the user when the pressure is excessive and causing damage, or that the thermal application is not ideal and potentially harmful).
Claims 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Roth in view of Santa Maria in view of McBean in view of Rapp.
Regarding claim 32, Roth discloses a system for applying multiple modalities to a jointed limb (system of Fig. 1), comprising: a flexible sleeve (see inflatable garment 200 in Fig. 2A) comprising: a first section comprising a first set of inflatable chambers (see Figs. 2A-2B a first section having inflatable bladders 250a-250d), a second section proximal of the first section comprising a second set of inflatable chambers (see Figs. 2A-2B a second section having inflatable bladders 250e-250h), and a third section proximal of the second section comprising at least one additional inflatable chamber (see Figs. 2A-2B a third section having inflatable bladders 250i-250l); a control device (see microcontroller 328 in Fig. 3B), adapted to: control timing, order and duration of inflation and deflation of the first set of inflatable chambers, the second set of inflatable chambers, and the at least one additional inflatable chamber (see microcontroller 328 in Fig. 3B and Col. 9 line 58 to Col. 10 line 2 where the signals from the microcontroller are used to drive the compressor and solenoid valves for the selective inflation/ deflation of the bladders; see Col. 10 lines 47-64 where the order of compression can be adjusted, and see Col. 11 lines 17-28 where the timing and duration can be adjusted); and a user device in communication with at least one of the control device and the sleeve (see Fig. 3E where display panel 360 contains inputs for a user to control the device, such as hold button 380 and selectors 362/ 364/ 366 which communicate a user’s choices to the microcontroller for modifying the therapy).
Roth lacks a detailed description of one or more temperature sensors, one or more thermal elements for application of heat or cold therapy, a control device, adapted to: receive temperature data from the one or more temperature sensors; receive temperature data from the one or more thermal elements; and control application, timing, temperature, and duration of the heat or cold therapy.
However, Santa Maria teaches a similar limb compression device, which is used to deliver heat to the limbs (see Figs. 4A-4B and Col. 13 lines 40-55 where thermal energy is transferred through the body interface member 111, thermal energy transfer members 113, and blood flow regulation members 112), and includes temperature sensors (see Col. 8 lines 10-30 where temperature sensors can be included on the interface 111 for sensing the temperature and sending signals back to the control unit), where the temperature sensors are communicated to a control device to receive the temperature data (see Col. 5 lines 5-15), and the control devices controls the application, and temperature of the heat or cold therapy (see Col. 5 lines 5-15).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bladder inflation system and controller of Roth to include thermal energy transfer and temperature sensors being communicated with and controlled by the controller as taught by Santa Maria, as it would provide means for monitoring and controlling the temperature of the patient’s limb, to promote blood flow and prevent hypothermia. It is understood that in the modified Roth device, the modified Roth microcontroller is able to adjust the timing, duration, and intensity of both the applied pressure and the applied temperature.
The modified Roth device lacks a detailed description of one or more range of motion sensors, and a control device, adapted to: receive range of motion data from the one or more range of motion sensors.
However, McBean teaches a similar worn bracing device for the limb of a user, where range of motion sensors are attached to the device (see Col. 27 lines 2-17 where a range of motion sensor can be included on the device) and the control device receives the range of motion data (see Col. 26 line 64 to Col. 27 line 17 and lines 34-41 where the range of motion data is communicated to a controller).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sleeve and control system of the modified Roth device to have range of motion sensors on the sleeve and communicating with the control system as taught by McBean, as it would allow for monitoring of the user’s range of motion to determine and track progress made with exercise/ therapy/ rehabilitation (McBean; see Col. 13 lines 24-39).
The modified Roth device lacks a detailed description of the user device adapted to receive, store and analyze data received from the at least one of the control device and the sleeve, wherein an onset of an adverse patient health event based on the data received at the user device is predicted.
However, Rapp teaches a similar compression garment device, wherein: the user device is one of wired or wirelessly connected to the at least one of the control device and the sleeve (see [0036] where outputted data from the device can communicate with a phone); the user device receives, stores and analyzes data received from the at least one of the control device and the sleeve (see [0036] where the phone can have an application for receiving and interpreting the data, and at least temporarily storing the data to display), wherein an onset of an adverse patient health event based on the data received at the user device is predicted (see [0037], [0040], and [0084]-[0085] where the phone can alert the user based on sensed data to predict when the pressure is excessive and causing damage, or predict that the thermal application is not ideal and potentially harmful).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the user device of the modified Roth device to be a remote phone device that can predict adverse health events as taught by Rapp, as it would allow for the system to connect to the ubiquitous smartphones for easy and remote access to the data from the device, while ensuring that the device does not damage the user.
Regarding claim 34, Roth discloses a method for applying multiple modalities to a jointed limb (system of Fig. 1), comprising: providing a flexible sleeve (see inflatable garment 200 in Fig. 2A) comprising: a first section comprising a first set of inflatable chambers (see Figs. 2A-2B a first section having inflatable bladders 250a-250d), a second section proximal of the first section comprising a second set of inflatable chambers (see Figs. 2A-2B a second section having inflatable bladders 250e-250h), and a third section proximal of the second section comprising at least one additional inflatable chamber (see Figs. 2A-2B a third section having inflatable bladders 250i-250l) controlling timing, order and duration of inflation and deflation of the first set of inflatable chambers, the second set of inflatable chambers, and the at least one additional inflatable chamber (see microcontroller 328 in Fig. 3B and Col. 9 line 58 to Col. 10 line 2 where the signals from the microcontroller are used to drive the compressor and solenoid valves for the selective inflation/ deflation of the bladders; see Col. 10 lines 47-64 where the order of compression can be adjusted, and see Col. 11 lines 17-28 where the timing and duration can be adjusted).
Roth lacks a detailed description of one or more temperature sensors, one or more thermal elements for application of heat or cold therapy, receiving temperature data from the one or more temperature sensors; receiving temperature data from the one or more thermal elements; and controlling application, timing, temperature, and duration of the heat or cold therapy.
However, Santa Maria teaches a similar limb compression device, which is used to deliver heat to the limbs (see Figs. 4A-4B and Col. 13 lines 40-55 where thermal energy is transferred through the body interface member 111, thermal energy transfer members 113, and blood flow regulation members 112), and includes temperature sensors (see Col. 8 lines 10-30 where temperature sensors can be included on the interface 111 for sensing the temperature and sending signals back to the control unit), where the temperature sensors are communicated to a control device to receive the temperature data (see Col. 5 lines 5-15), and the control devices controls the application, and temperature of the heat or cold therapy (see Col. 5 lines 5-15).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bladder inflation system and controller of Roth to include thermal energy transfer and temperature sensors being communicated with and controlled by the controller as taught by Santa Maria, as it would provide means for monitoring and controlling the temperature of the patient’s limb, to promote blood flow and prevent hypothermia. It is understood that in the modified Roth device, the modified Roth microcontroller is able to adjust the timing, duration, and intensity of both the applied pressure and the applied temperature.
The modified Roth device lacks a detailed description of one or more range of motion sensors, and receiving range of motion data from the one or more range of motion sensors.
However, McBean teaches a similar worn bracing device for the limb of a user, where range of motion sensors are attached to the device (see Col. 27 lines 2-17 where a range of motion sensor can be included on the device) and the control device receives the range of motion data (see Col. 26 line 64 to Col. 27 line 17 and lines 34-41 where the range of motion data is communicated to a controller).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sleeve and control system of the modified Roth device to have range of motion sensors on the sleeve and communicating with the control system as taught by McBean, as it would allow for monitoring of the user’s range of motion to determine and track progress made with exercise/ therapy/ rehabilitation (McBean; see Col. 13 lines 24-39).
The modified Roth device lacks a detailed description of the device predicting an onset of an adverse patient health event based on the received data.
However, Rapp teaches a similar compression garment device, wherein: the user device is one of wired or wirelessly connected to the at least one of the control device and the sleeve (see [0036] where outputted data from the device can communicate with a phone); the user device receives, stores and analyzes data received from the at least one of the control device and the sleeve (see [0036] where the phone can have an application for receiving and interpreting the data, and at least temporarily storing the data to display), wherein an onset of an adverse patient health event based on the data received at the user device is predicted (see [0037], [0040], and [0084]-[0085] where the phone can alert the user based on sensed data to predict when the pressure is excessive and causing damage, or predict that the thermal application is not ideal and potentially harmful).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the user device of the modified Roth device to be a remote phone device that can predict adverse health events as taught by Rapp, as it would allow for the system to connect to the ubiquitous smartphones for easy and remote access to the data from the device, while ensuring that the device does not damage the user.
Response to Arguments
Applicant’s arguments with respect to claims 1-5, 7, 11-12, 15-16, 19, 21-22, 26-27, and 31 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record. Specifically, the newly applied primary reference of Farrow is now used to teach the limitations of these claims, as modified by Roth.
With respect to claims 30, 32, and 34, it is understood that the teachings of Rapp do include an alert based on an adverse health event, as seen by the amended rejections above, specifically pointing to the additional paragraphs of [0040] and [0084]-[0085] that show the alerts can be used to stop situations that cause pain or discomfort.
For the reasons above, the rejections hold.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Fri 10:00-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785