DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection necessitated by Applicant’s amendments does not rely on any matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-8, 10-13 and 15-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/172837 A1 to Paradis et al. (Paradis) in view of US 2004/0170409 A1 to Faries, JR et al. (Faries) and US 2016/0242957 A1 to Schaefer et al. (Schaefer).
Regarding claim 1, Paradis teaches a patient temperature control system (Figs. 1 and 2), comprising a heat exchange system (cooler heater 10) configured to heat or cool a fluid, a circulating pump (inherent in view of Figs. 1 and 2 and [0039, 0057, 0075] which discuss circulating coolant fluid and fluid flow rates and adjustments to fluid flow rates) configured to circulate the fluid through the heat exchanger and at least one interconnectable pad (heat-exchange subsystem 13 and [0012] which states in part “The body heat exchange device may [be] any type of body heat exchange device, including but not limited to body surface heat exchange systems (e.g., blankets, pads, garments, etc.)…), a patient temperature sensor (S1, Fig. 2 and [0054] which states in part “sensor S1 measures the core temperature of the patient”), and a control module (2 Fig. 1) including one or more fluid temperature sensor (S2 and s4, Fig. 2 and [0057] which states in part “sensor S2 (Figure 2) measures the temperature of the TTM system coolant flowing into the patient and sensor S4 measures the temperature of the TTM system coolant flowing out of the patient”), a volumetric flow rate sensor (S3 and S5, Fig. 2 and [0057] which states in part “Sensors S3 and S5 measure the volume flow rate of the TTM coolant flowing into and out of the patient…”), one or more processors (Figs. 3 and 4) and a non-transitory computer-readable medium (inherent in that a processor has an internal storage that stores algorithms that are to be executed by the processor, see [0024 and 0048]) having stored thereon logic ([0011] which states “a algorithmic combination of the thermal input or output, temperature of the cooling/heating transfer subsystem, along with environment temperature, and patient specifics, may be utilized.” [0023] which states “To avoid oscillation, the control system may include feedforward and dampening algorithms.” [0044] which states in part “The different requirements to provide cooler or warmer fluid 3 or the difference in the energy required by the TTM 2 device may, with or without combination with other data, be utilized in an algorithm 11 to predict impending shivering and deploying counter-shivering therapies.” [0046] which states “To improve the accuracy of the system in detecting changes in patient endogenous set-point temperature, the environment temperature 14, or changes in the environment temperature 14, may be incorporated into the algorithm utilized.”), that when executed by the one or more processors, causes operations including initiating a targeted temperature management (TTM) therapy (inherent), obtaining fluid temperature measurements from the one or more fluid sensors (Figs. 3-4), the fluid temperature measurements comprising a first temperature when the fluid is flowing to the at least one interconnectable pad and a second temperature when the fluid is returning from the at least one interconnectable pad ([0057] which states in part “sensor S2 (Figure 2) measures the temperature of the TTM system coolant flowing into the patient and sensor S4 measures the temperature of the TTM system coolant flowing out of the patient”), obtaining a measurement of volumetric flow rate (Figs. 3-4) of the fluid during circulation from the volumetric flow rate sensor ([0057] which states in part “Sensors S3 and S5 measure the volume flow rate of the TTM coolant flowing into and out of the patient…”), obtaining one or more measurements of patient temperature (Figs. 3-4) from the patient temperature sensor ([0054] which states in part “sensor S1 measures the core temperature of the patient”), determining a level of patient heat generation ([0044] which states in part ““The different requirements to provide cooler or warmer fluid 3 or the difference in the energy required by the TTM 2 device may, with or without combination with other data, be utilized in an algorithm 11 to predict impending shivering and deploying counter-shivering therapies.”) based on the fluid temperature measurements and the measurement of volumetric flow rate ([0050] which states in part “Methods for the derivation of a multivariable algorithm for detection of changes in endogenous set-point temperature based on measurements of fluid transfer temperatures, fluid transfer volumes, heating or cooling energy requirements, or a combination of these parameters, would be devisable by skilled practitioner in the art of heat transfer and mathematical modeling.” And [0057), and transmitting via one or more wireless signals ([0062] which states in part “Alternatively or additionally, such alarm or alert may be transmitted by wired or wireless connection to, and emitted by, one or more alarm emitting devices perceivable within the patient's room and/or at remote locations.”), data indicating the level of patient heat generation to a network device ([0062] which states in part “change in the patient’s endogenous temperature set-point and/or febrile status”) to a network device ([0062] which states in part “nonlimiting examples of the types of alarm or alert emitting devices may include but are not limited to one or more of: a display or emitter that is included in the TTM system; a portable alarm module that is a component of the TTM system; a separate electronic monitor; a patient bedside monitor; a monitor located remotely from the patient's bedside. a central unit monitoring station; and a remotely located computer, tablet computing device, pager, or smartphone.”), and adjusting operation of the heat exchange system to modify the TTM therapy based on the level of patient ([0054] which states in part “The TTM system compares the value of patient core temperature to the value of the TTM Set Point Temperature specified by the physician treating the patient, then adjusts the temperature of the coolant flowing through heat exchange catheter placed within a major vein of the patient so as to reduce the difference between the patient core temperature and the Set Point Temperature.”).
However, Paradis does not specifically teach transmitting data thereby causing display of a graphical user interface display including a first region illustrating the level of patient heat generation as a function of time or initiating a targeted temperature management therapy in accordance with a result from a query to a treatment database.
Faries teaches a method and apparatus for controlling temperature of infusion liquids (title) including reports that may be arranged in any fashion and including any desired information ([0073]). The report information may be arranged and/or presented (e.g., printed, displayed, etc.) in any desired formats (e.g., text, charts, graphs, columns, rows, tables, etc.) and in any order or arrangement. The graph may include any quantity of axes each associated with any desired information (e.g., time, temperature, etc.) in any desired scales or units (e.g., Celsius, Fahrenheit, etc.). The reports may provide information (e.g., temperature, etc.) measured or collected continuously or at any desired preset or user specified time intervals (e.g., hours, minutes, seconds, etc.). The temperature display may be of any quantity, shape or size, may be disposed at any location on or remote from the system, may be implemented by any conventional or other displays (e.g., LED, LCD, etc.) and may display any desired information. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paradis to include the graphical display of Faries to allow the information to be conveyed to the user or monitor of the device as taught by Faries.
Schaefer teaches a thermal contrast therapy devices, method, and systems (title) including a customized treatment sequence may correspond to a treatment program having been prescribed to a user, or selected by a user. The customized treatment system may be uploaded or stored in a database accessible by a thermal contrast therapy system or device and a treatment or user may select a treatment from a menu of one or more treatment options in a database associated with a thermal contrast therapy system configured to provide customized thermal contrast therapy treatment programs ([0078, 0139]) which allows for automatic adjustment of one or more sequence parameters so as to perform a selected treatment sequence ([0078]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a treatment protocol database to allow for the storing of multiple treatment sequences as taught by Schaefer ([0078, 0139]).
Regarding claim 3, the combination teaches the system of claim 1 as well as Paradis teaching wherein determining the level of patient heat generation includes calculating an amount of heat transfer between the fluid and the patient based on a different between the first temperature and the second temperature, the volumetric flow rate, and a heat capacity of the fluid ([0057-0075]).
Regarding claim 4, the combination teaches the system of claim 1 as well as Paradis teaching wherein the logic, when executed by the one or more processors, determines the level of patient heat generation based on the obtained one or more measurements of patient temperature in accordance with a predetermined set rule ([0079-0083]).
Regarding claims 5 and 6, the combination teaches the system of claim 1, as well as Schaefer teaching adjusting one or more parameters of a treatment sequence based, at least in part, on one or more characteristics of a particular treatment pad to enable a desired treatment across multiple different treatment pads having varying dimensions and/or configurations. This is done by automatically adjusting one or more of fluid temperature, flow rate, and/or duration of time, based at least in part, on the identification a particular pad is operably connected to the device and/or one or more characteristics of such a pad ([0080]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paradis to include the pad characteristic as input and in the determination of patient heat generation in order to enable a desired treatment as taught by Schaefer.
Regarding claim 7, the combination teaches the system of claim 1 as well as Paradis teaching wherein the logic, when executed by the one or more processors, causes further operations including generating a user interface display configured to visually indicate the level of patient heat generation (Fig. 4).
Regarding claim 8, the combination teaches the system of claim 7 as well as Paradis wherein the user interface is rendered on a display screen of the control module and includes a time-based graphic providing an indication of patient heat generation ([0079 and 0083]).
Regarding claim 10, the combination teaches the system of claim 7 as well as Paradis teaching wherein the user interface is rendered on a display screen of the network device ([0062]).
Regarding claim 11, the combination teaches the system of claim 1 as well as Paradis teaching wherein the level of patient heat generation is utilized as feedback to the logic control module and employable to generate one or more instructions to modify operation of the heat exchange system ([0044]).
Regarding claim 12, Paradis teaches a method (title), comprising initiating a targeted temperature management (TTM) therapy (inherent) with a patient temperature control system (2, Fig. 1) including a heat exchange system (cooler heater 10) configured to heat or cool a fluid, a circulating pump (inherent in view of Figs. 1 and 2 and [0039, 0057, 0075] which discuss circulating coolant fluid and fluid flow rates and adjustments to fluid flow rates) configured to circulate the fluid through the heat exchanger and at least one interconnectable pad (heat-exchange subsystem 13 and [0012] which states in part “The body heat exchange device may [be] any type of body heat exchange device, including but not limited to body surface heat exchange systems (e.g., blankets, pads, garments, etc.)…), obtaining fluid temperature measurements (Figs. 3-4) from one or more fluid temperature sensors (S2 and S4), the fluid temperature measurements comprising a first temperature when the fluid is flowing to the at least one interconnectable pad and a second temperature when the fluid is returning from the at least one interconnectable pad (0057] which states in part “sensor S2 (Figure 2) measures the temperature of the TTM system coolant flowing into the patient and sensor S4 measures the temperature of the TTM system coolant flowing out of the patient”), obtaining a measurement of volumetric flow rate (Figs. 3-4) of the fluid during circulation from a volumetric flow rate sensor ([0057] which states in part “Sensors S3 and S5 measure the volume flow rate of the TTM coolant flowing into and out of the patient…”), obtaining one or more measurements of patient temperature (Figs. 3-4) from a patient temperature sensor ([0054] which states in part “sensor S1 measures the core temperature of the patient”), determining a level of patient heat generation ([0044] which states in part ““The different requirements to provide cooler or warmer fluid 3 or the difference in the energy required by the TTM 2 device may, with or without combination with other data, be utilized in an algorithm 11 to predict impending shivering and deploying counter-shivering therapies.”) based on the fluid temperature measurements and the measurement of volumetric flow rate ([0050] which states in part “Methods for the derivation of a multivariable algorithm for detection of changes in endogenous set-point temperature based on measurements of fluid transfer temperatures, fluid transfer volumes, heating or cooling energy requirements, or a combination of these parameters, would be devisable by skilled practitioner in the art of heat transfer and mathematical modeling.” And [0057), and transmitting via one or more wireless signals ([0062] which states in part “Alternatively or additionally, such alarm or alert may be transmitted by wired or wireless connection to, and emitted by, one or more alarm emitting devices perceivable within the patient's room and/or at remote locations.”), data indicating the level of patient heat generation to a network device ([0062] which states in part “change in the patient’s endogenous temperature set-point and/or febrile status”) to a network device ([0062] which states in part “nonlimiting examples of the types of alarm or alert emitting devices may include but are not limited to one or more of: a display or emitter that is included in the TTM system; a portable alarm module that is a component of the TTM system; a separate electronic monitor; a patient bedside monitor; a monitor located remotely from the patient's bedside. a central unit monitoring station; and a remotely located computer, tablet computing device, pager, or smartphone.”), and adjusting operation of the heat exchange system to modify the TTM therapy based on the level of patient ([0054] which states in part “The TTM system compares the value of patient core temperature to the value of the TTM Set Point Temperature specified by the physician treating the patient, then adjusts the temperature of the coolant flowing through heat exchange catheter placed within a major vein of the patient so as to reduce the difference between the patient core temperature and the Set Point Temperature.”).
However, Paradis does not specifically teach transmitting data thereby causing display of a graphical user interface display including a first region illustrating the level of patient heat generation as a function of time or initiating a targeted temperature management therapy in accordance with a result from a query to a treatment database.
Faries teaches a method and apparatus for controlling temperature of infusion liquids (title) including reports that may be arranged in any fashion and including any desired information ([0073]). The report information may be arranged and/or presented (e.g., printed, displayed, etc.) in any desired formats (e.g., text, charts, graphs, columns, rows, tables, etc.) and in any order or arrangement. The graph may include any quantity of axes each associated with any desired information (e.g., time, temperature, etc.) in any desired scales or units (e.g., Celsius, Fahrenheit, etc.). The reports may provide information (e.g., temperature, etc.) measured or collected continuously or at any desired preset or user specified time intervals (e.g., hours, minutes, seconds, etc.). The temperature display may be of any quantity, shape or size, may be disposed at any location on or remote from the system, may be implemented by any conventional or other displays (e.g., LED, LCD, etc.) and may display any desired information. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paradis to include the graphical display of Faries to allow the information to be conveyed to the user or monitor of the device as taught by Faries.
Schaefer teaches a thermal contrast therapy devices, method, and systems (title) including a customized treatment sequence may correspond to a treatment program having been prescribed to a user, or selected by a user. The customized treatment system may be uploaded or stored in a database accessible by a thermal contrast therapy system or device and a treatment or user may select a treatment from a menu of one or more treatment options in a database associated with a thermal contrast therapy system configured to provide customized thermal contrast therapy treatment programs ([0078, 0139]) which allows for automatic adjustment of one or more sequence parameters so as to perform a selected treatment sequence ([0078]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a treatment protocol database to allow for the storing of multiple treatment sequences as taught by Schaefer ([0078, 0139]).
Regarding claim 13, the combination teaches the method of claim 12 as well as Paradis teaching wherein the patient temperature control system includes a control module (2 Fig. 1) including the one or more fluid temperature sensor (S2 and s4, Fig. 2 and [0057] which states in part “sensor S2 (Figure 2) measures the temperature of the TTM system coolant flowing into the patient and sensor S4 measures the temperature of the TTM system coolant flowing out of the patient”),the volumetric flow rate sensor (S3 and S5, Fig. 2 and [0057] which states in part “Sensors S3 and S5 measure the volume flow rate of the TTM coolant flowing into and out of the patient…”), one or more processors (Figs. 3 and 4) and a non-transitory computer-readable medium (inherent in that a processor has an internal storage that stores algorithms that are to be executed by the processor, see [0024 and 0048]) having stored thereon logic ([0011] which states “a algorithmic combination of the thermal input or output, temperature of the cooling/heating transfer subsystem, along with environment temperature, and patient specifics, may be utilized.” [0023] which states “To avoid oscillation, the control system may include feedforward and dampening algorithms.” [0044] which states in part “The different requirements to provide cooler or warmer fluid 3 or the difference in the energy required by the TTM 2 device may, with or without combination with other data, be utilized in an algorithm 11 to predict impending shivering and deploying counter-shivering therapies.” [0046] which states “To improve the accuracy of the system in detecting changes in patient endogenous set-point temperature, the environment temperature 14, or changes in the environment temperature 14, may be incorporated into the algorithm utilized.”) that is executable by the one or more processors.
Regarding claim 15, the combination teaches the method of claim 12 as well as Paradis teaching wherein determining the level of patient heat generation is based at least in part on the obtained measurements of fluid temperature and volumetric flow rate ([0057-0075]).
Regarding claim 16, the combination teaches the method of claim 15 as well as Paradis teaching wherein determining the level of patient heat generation includes calculating an amount of heat transferred between the fluid and the patient based on the difference between the first temperature and the second temperature, the volumetric flow rate of the fluid, and a heat capacity of the fluid ([0057-0075]).
Regarding claim 17, the combination teaches the method of claim 12 as well as Paradis teaching wherein determining the level of patient heat generation is based on the obtained one or more measurements of patient temperature in accordance with one or more predetermined rule sets ([0079-0083]).
Regarding claim 18, the combination teaches the method of claim 18, as well as Schaefer teaching adjusting one or more parameters of a treatment sequence based, at least in part, on one or more characteristics of a particular treatment pad to enable a desired treatment across multiple different treatment pads having varying dimensions and/or configurations. This is done by automatically adjusting one or more of fluid temperature, flow rate, and/or duration of time, based at least in part, on the identification a particular pad is operably connected to the device and/or one or more characteristics of such a pad ([0080]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paradis to include the pad characteristic as input and in the determination of patient heat generation in order to enable a desired treatment as taught by Schaefer.
Regarding claim 19, the combination teaches the method of claim 12 as well as generating a user interface display configured to visually indicate the level of patient heat generation via a time-based graphic ([0079 and 0083]).
Regarding claim 20, the combination teaches the method of claim 19 as well as Faries teaching causing rendering of the graphical user interface on a display screen of the network device ([0073]).
Regarding claim 21, the combination teaches the system of claim 1 as well as Schaefer teaches wherein the treatment database stores one or more preset procedures for the TTM therapy (([0078, 0139]).
Regarding claim 22, the combination teaches the system of claim 1 as well as wherein the level of patient heat generation is based on patient temperature trend data ([0038] which states in part “a change in the patient's endogenous temperature set-point may be detected as a change in: 1 ) the energy of warming or cooling 10 required to maintain the therapeutically targeted temperature, 2) the volume and/or temperature of the heat-transfer fluid 3, 3) the energy expenditure of the heat-cooling subsystem 9 and 10, or a combination of these.”).
Claim(s) 2 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paradis, Faries and Schaefer as applied to claims 1 and 12, and further in view of US 12,109,146 B1 to Stefanoff (Stefanoff).
Regarding claim 2, Paradis in view of Faries teaches the system of claim 1, but not wherein the control module is configured to receive return signals from the network device, the return signals employable by the control module to modify the TTM therapy. Stefanoff teaches an analogous system (title) to that of Paradis including a communication interface that allows a controller to transmit and/or receive data over a network connections that can include cable networks, the Internet, wireless networks, and other private and/or public networks to allow for remote temperature monitoring, control, and data logging of apparatus temperatures (Col. 8, lines 5-19). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paradis to include the two way communication of Stefanoff to allow for remote temperature monitoring, control , and data logging of apparatus temperature as taught by Stefanoff (Col. 8, lines 5-19).
Regarding claim 14, Paradis in view of Faries teaches the method of claim 12, but not wherein the patient temperature control system is configured to receive return signals from the network device, the return signals employable by the patient temperature control system to modify the TTM therapy. Stefanoff teaches an analogous method (title) to that of Paradis including a communication interface that allows a controller to transmit and/or receive data over a network connections that can include cable networks, the Internet, wireless networks, and other private and/or public networks to allow for remote temperature monitoring, control, and data logging of apparatus temperatures (Col. 8, lines 5-19). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paradis to include the two way communication of Stefanoff to allow for remote temperature monitoring, control , and data logging of apparatus temperature as taught by Stefanoff (Col. 8, lines 5-19).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paradis, Faries and Schaefer as applied to claim 8, and further in view of US 2008/0255637 A1 to Oishi (Oishi).
Regarding claim 9, Paradis in view of Faries teaches the system of claim 8, but not wherein the time-based graphic provides the indication of patient heat generation through the duration of the TTM therapy following a wait-period following initiation of the TTM therapy. Oishi teaches an analogous system (title) to that of Paradis including providing an indication of patient temperature following a wait-period (Fig. 8). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paradis to provide indication of patient heat generation after an initial waiting period as taught by Oishi to give time for the patient to respond to the treatment.
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 KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
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