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 .
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 19 and 40 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Taylor (US 20200405529 A1).
Regarding claim 19, Taylor teaches a thermal control unit for controlling a patient's temperature during a thermal therapy session (FIG. 2, thermal control unit 22), the thermal control unit comprising:(a) a circulation channel (Fig 3; circulation channel 36) coupled to a fluid inlet (Fig 2; inlet ports 62) and a fluid outlet (Fig 2; outlet ports 58); (b) a pump for circulating fluid through the circulation channel from the fluid inlet to the fluid outlet (Fig 2; pump 34); (c) a heat exchanger adapted to add or remove heat from the fluid circulating in the circulation channel ([0051] heat exchanger 40 that adjusts, as necessary, the temperature of the circulating fluid); (d) a fluid temperature sensor adapted to detect a temperature of the fluid (Fig 3; temperature sensor 56); (e) a patient temperature probe port adapted to receive patient temperature readings from a patient temperature probe ([0061] Patient sensor module 74 includes one or more patient temperature sensor ports 84 (FIGS. 2 & 3) that are adapted to receive one or more conventional patient temperature sensors or probes 86); (f) a control panel comprising a display adapted to display data and a control thereon ([0057] User interface 76, which may be implemented as a control panel or in other manners, allows a user to operate thermal control unit 22. User interface 76 communicates with controller 60 and includes a display 88); and (g) a controller adapted to control the heat exchanger in response to readings from the fluid temperature sensor ([0062] Controller 60, in some embodiments, controls the temperature of the circulating fluid using closed-loop feedback from temperature sensor 56. That is, controller 60 determines (or receives) a target temperature of the fluid, compares it to the measured temperature from sensor 56, and issues a command to heat exchanger 40 that seeks to decrease the difference between the desired fluid temperature and the measured fluid temperature) and the patient temperature probe in order to control the patient's temperature ([0063] controller 60 may use a second closed-loop control loop that determines the difference between a patient target temperature and a measured patient temperature. The patient target temperature is input by a user of thermal control unit 22 using user interface 76. The measured patient temperature comes from a patient temperature sensor 86 coupled to one of patient temperature sensor ports 84 (FIG. 3)), to display data on the display ([0114] controller 60 is configured to display the readings from the auxiliary sensor 144 on display 88 along with patient temperature readings and other data gathered during the thermal therapy session), and to implement a function in response to a user activating the control ([0057] User interface 76, which may be implemented as a control panel or in other manners, allows a user to operate thermal control unit 22. User interface 76 communicates with controller 60 and includes a display 88 and a plurality of dedicated controls 82a, 82b, 82c, etc).
Regarding claim 40, Taylor teaches the thermal control unit of claim 19 wherein the controller is further adapted to display a graph of thermal data over a period of time (Fig 14), and wherein the controller is further adapted to allow the user to select a characteristic of the graph ([0147] Controller 60 is further adapted, in at least some embodiments, to allow the user to customize what data is displayed on graph 160, including the manner in which the data is displayed (e.g. in what units, whether overlaid on top of the patient temperature readings or spaced from these readings, etc.)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 20 and 41 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Geller (US 10467782 B2).
Regarding claim 20, Taylor teaches the thermal control unit of claim 19 wherein the controller is adapted to display a graph of thermal data over a period of time ([0144] In some embodiments, controller 60 is configured to display the readings from the auxiliary sensor 144 on display 88 along with patient temperature readings and other data gathered during the thermal therapy session. FIG. 14 illustrates one example of a graph 160 that may be displayed on display 88 by controller 60 when at least one of the auxiliary sensor ports 94 is coupled to an auxiliary sensor 144), but fails to teach a movable cursor adapted to be moved to a user- selectable moment in time, and a set of information corresponding to the user-selected moment in time, wherein the controller is further configured to update the set of information as the user moves the movable cursor.
However, Geller teaches a movable cursor adapted to be moved to a user- selectable moment in time ([22] time selectors 211 and 212 which are referred to herein as grippers) ([22] an interactive time range selector 210 can be used to select a range of time which is used to populate the other components of the user interface 200), and a set of information corresponding to the user-selected moment in time ([22]), wherein the controller is further configured to update the set of information as the user moves the movable cursor ([22] The time range selector 210 also includes a pair of time selectors 211 and 212 which are referred to herein as grippers. The pair of time selectors 211 and 212 can traverse a time bar via commands entered through the user interface and can be used to specify a start of a desired time range and an end of a desired time range. The interactive time range selector 210 also includes a time range indicator 213 which visually indicates the units of time that are selected on the time bar through some sort of visually identifier). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include a movable cursor adapted to be moved to a user- selectable moment in time, and a set of information corresponding to the user-selected moment in time, wherein the controller is further configured to update the set of information as the user moves the movable cursor. Doing so allows the user to view a specific range of data by selecting with the grippers for a specific reason.
Regarding claim 41, Taylor teaches the thermal control unit of claim 40, but fails to teach wherein the characteristic is a unit of time the controller is adapted to display the graph with a horizontal time axis in whichever unit of time the user selects, and the controller is adapted to allow the user to select one of the following units of time: days, hours, or minutes.
However, Geller teaches wherein the characteristic is a unit of time the controller is adapted to display the graph with a horizontal time axis in whichever unit of time the user selects, and the controller is adapted to allow the user to select one of the following units of time: days, hours, or minutes [30] The granularity may be changed by selecting one of the modification units 403 and 404 which can be used to convert the time unit from hours, days, weeks, months, or the like, and which can be used to move the time shown within the time units back in time or ahead in time) ([35] FIG. 4E, time range selector 400E includes a number of units indicator label 441 which indicates a number of time units (in this case days) which have been selected. The time units may changes based on settings (e.g., hours, days, weeks, months, etc.) The number of units indicator label 441 allows the viewer to quickly understand the current selection range). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the characteristic is a unit of time the controller is adapted to display the graph with a horizontal time axis in whichever unit of time the user selects, and the controller is adapted to allow the user to select one of the following units of time: days, hours, or minutes. Doing so allows for the user to select a preferred unit of time to display the data in a preferred way.
Claims 21 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Geller (US 10467782 B2), further in view of Fletcher (US 20160105338 A1).
Regarding claim 21, Taylor teaches the thermal control unit of claim 20 wherein the controller is further configured to display a horizontal time axis ([0144] Graph 160 includes an X-axis 162 that corresponds to time), but fails to teach a vertical bar attached to the movable cursor, and wherein the moment in time corresponds to a time defined by an intersection of the vertical bar with the horizontal time axis.
However, Fletcher teaches thermal control unit of claim 20 wherein a vertical bar attached to the movable cursor ([1025] FIG. 55A illustrates an example of a visual interface 5300 with a user manipulable visual indicator 5514 spanning across the time-based graph lanes, in accordance with one or more implementations of the present disclosure. Visual indicator 5514, also referred to herein as a “lane inspector,” may include, for example, a line or other indicator that spans vertically across the graph lanes 5302, 5304, 5306 at a given point in time along time axis 5410. The visual indicator 5514 may be user manipulable such that it may be moved along time axis 5410 to different points. For example, visual indicator 5514 may slide back and forth along the lengths of graph lanes 5302, 5304, 5306 and time axis 5410 in response to user input received with a mouse, touchpad, touchscreen, etc.), and wherein the moment in time corresponds to a time defined by an intersection of the vertical bar with the horizontal time axis (Fig 55A). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include a vertical bar attached to the movable cursor, and wherein the moment in time corresponds to a time defined by an intersection of the vertical bar with the horizontal time axis. Doing so allows for a way to find a specific point on the graph.
Claims 22 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Geller (US 10467782 B2), further in view of Blair (US 20110304466 A1).
Regarding claim 22, Taylor teaches the thermal control unit of claim 20 wherein the set of information is displayed inside of an oval shape and the set of information includes a patient temperature ([0144] Graph 160 further includes a plot of the patient's temperature readings 164, a plot of the target temperature 146 for the patient), a patient target temperature ([0144] Graph 160 further includes a plot of the patient's temperature readings 164, a plot of the target temperature 146 for the patient).
Taylor fails to teach a fluid temperature, and a machine effort.
However, Blair teaches a fluid temperature ([0009] The refrigeration system and method monitor at least one temperature associated with the refrigeration system utilizing a plurality of temperature sensors located within the refrigeration system and display a graphical representation of at least a portion of the refrigeration system. The refrigeration system and method further display a graphical representation of at least one temperature sensor in the graphical representation of the at least a portion of the refrigeration system) ([0081] The freezer settings screen 300 allows the user to view and/or adjust temperature and time settings associated with the ULT 10. The freezer settings screen 300 includes a primary setpoint temperature control 302 the user selects to adjust the operating temperature for the ULT 10, a warm alarm setpoint temperature control 304 the user selects to adjust the alarm temperature for the ULT 10), and a machine effort ([0077] In response to the user selecting the power settings icon 210, the power mode screen 250 illustrated in FIG. 11 is displayed. The power mode screen 250 allows a user to select a power mode for the ULT 10. These power modes may include a performance mode (in which the ULT 10 reacts to temperature changes quickly at the expense of greater power consumption), a normal mode (in which the ULT 10 reacts to temperature changes at a normal rate with respect to normal power consumption), and an energy save mode (in which the ULT 10 reacts to temperature changes at a slightly slower rate with respect to less power consumption than in either the performance mode or the energy saver mode)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include a fluid temperature, and a machine effort. Doing so allows for the fluid temperature and machine effort to be monitored while in use.
Claims 24, 25, 27, 29 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Taylor (2) (US 20190192339 A1).
Regarding claim 24, Taylor teaches the thermal control unit of claim 19 wherein the controller is further adapted to display a time axis ([0144] Graph 160 includes an X-axis 162 that corresponds to time), but fails to teach and a plurality of event icons associated with events, wherein the event icons are displayed along the time axis at locations corresponding to respective times at which the events occurred.
However, Taylor (2) teaches a plurality of event icons associated with events, wherein the event icons are displayed along the time axis at locations corresponding to respective times at which the events occurred ([0062] Thermal therapy graph 102 also includes a plurality of event icons 108 that are positioned at locations along the X-axis 104 corresponding to the times at which the events associated with event icons 108 occurred). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include a plurality of event icons associated with events, wherein the event icons are displayed along the time axis at locations corresponding to respective times at which the events occurred. Doing so allows for events to be identified when they occur and to view them on the display.
Regarding claim 25, Taylor teaches the thermal control unit of claim 24 but fails to teach wherein the controller is further adapted to display a skip forward control and, in response to a user activating the skip forward control, to display data corresponding to a next most recent event associated with one of the plurality of event icons.
However, Taylor (2) teaches wherein the controller is further adapted to display a skip forward control and, in response to a user activating the skip forward control, to display data corresponding to a next most recent event associated with one of the plurality of event icons ([0008] the user interface is adapted to provide further information about the event when the event icon is touched by a user. The event may be one or more of the following: a medication delivered to the patient; a detection of patient shivering; a sedation of the patient; a changing of a thermal pad coupled to the fluid supply line and fluid return line; an adjustment of a thermal pad coupled to the fluid supply line and fluid return line; a change in location of the patient temperature sensor; a flushing of the patient's body adjacent the patient temperature sensor; a performance of maintenance on the thermal control unit; an error detected by the controller; an alert issued by the controller; and/or another type of event). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is further adapted to display a skip forward control and, in response to a user activating the skip forward control, to display data corresponding to a next most recent event associated with one of the plurality of event icons. Doing so allows for the user to be informed of the next steps when an event occurs for ease of operation.
Regarding claim 27, Taylor teaches the thermal control unit of claim 24, but fails to teach wherein the controller is further adapted to automatically add display an event icon in response to detecting an event, wherein the event is at least one of the following: (a) a patient temperature reading deviating from a target patient temperature by more than a threshold: (b) a malfunction associated with the patient temperature probe port; (c) a change in a phase of the thermal therapy session; (d) a pause in the thermal therapy session; or (e) an alarm.
However, Taylor (2) teaches wherein the controller is further adapted to automatically add display an event icon in response to detecting an event ([0063] controller 60 records the data internally within a memory inside of thermal control unit 22 and displays shivering event icon 108a on graph 102 whenever graph 102 is displayed on display 80), wherein the event is at least one of the following: (a) a patient temperature reading deviating from a target patient temperature by more than a threshold: (b) a malfunction associated with the patient temperature probe port; (c) a change in a phase of the thermal therapy session; (d) a pause in the thermal therapy session; or (e) an alarm ([0066] Still other events include, but are not limited to, the following: adjustment, relocation, cleaning, and/or replacement of one or more thermal pads 24 on the patient; adjustment, relocation, cleaning, and/or replacement of a temperature sensor 86; changing of a setting on thermal control unit 22 (e.g. a rate of heating or cooling, a range of acceptable fluid temperature, etc.); performance of a maintenance task associated with the thermal control unit; detection of an error and/or a patient alert event (e.g. a low potassium level, an elevated blood pressure, a low blood pressure, a low oxygen level, etc.); and/or flushing a patient's body adjacent a temperature sensor). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is further adapted to automatically add display an event icon in response to detecting an event, wherein the event is at least one of the following: (a) a patient temperature reading deviating from a target patient temperature by more than a threshold: (b) a malfunction associated with the patient temperature probe port; (c) a change in a phase of the thermal therapy session; (d) a pause in the thermal therapy session; or (e) an alarm. Doing so allows for events to be identified when they occur and to view them on the display.
Regarding claim 29, Taylor teaches the thermal control unit of claim 19 wherein the controller is further adapted to display a graph of a desired patient temperature over a period of time ([0144] Graph 160 includes an X-axis 162 that corresponds to time, a first Y-axis 164a that correspond to temperature) and a range in which the patient's temperature is desirably maintained (Fig 14; a plot of the target temperature 146 for the patient), but fails to teach wherein the range is displayed on the graph as an upper line positioned above the desired patient temperature and a lower line positioned below the desired patient temperature, wherein both the upper line and the lower line are graphed over the period of time, and wherein the upper line and lower line are spaced apart from each other by an amount corresponding to the range in which the patient's temperature is desirably maintained.
However, Taylor (2) teaches wherein the range is displayed on the graph as an upper line positioned above the desired patient temperature and a lower line positioned below the desired patient temperature, wherein both the upper line and the lower line are graphed over the period of time, and wherein the upper line and lower line are spaced apart from each other by an amount corresponding to the range in which the patient's temperature is desirably maintained (Fig 8; [0080] Thermal therapy graph 102″ includes a maximum permissible fluid temperature setting 130 and a minimum permissible fluid temperature setting 132. Maximum permissible fluid temperature setting 130 refers the maximum permissible temperature of the circulating fluid delivered to thermal pads 24. Minimum permissible fluid temperature setting 132 refers to the minimum permissible temperature of the circulating fluid delivered to thermal pads 24). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the range is displayed on the graph as an upper line positioned above the desired patient temperature and a lower line positioned below the desired patient temperature, wherein both the upper line and the lower line are graphed over the period of time, and wherein the upper line and lower line are spaced apart from each other by an amount corresponding to the range in which the patient's temperature is desirably maintained. Doing so allows for a visual display of the threshold values on the graph during operation for real time monitoring.
Claims 46 and 60 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Blair (US 20110304466 A1).
Regarding claim 46, Taylor teaches the thermal control unit of claim 19, but fails to teach wherein the controller is adapted to display a power control on the display, and wherein the controller is further adapted and to change a characteristic characteristics of the power control when the thermal control unit is implementing the thermal therapy session when compared to when the thermal control unit is not implementing the thermal therapy session, wherein the characteristic is one of a size of the power control or a color of the power control.
However, Blair teaches wherein the controller is adapted to display a power control on the display ([0072] the controller 130 is configured to determine a power on event, a power off event, a power failure event, a power restored event), and wherein the controller is further adapted and to change a characteristic characteristics of the power control when the thermal control unit is implementing the thermal therapy session when compared to when the thermal control unit is not implementing the thermal therapy session ([0072] the controller 130 is configured to determine a power on event, a power off event) ([0077] In response to the user selecting the power settings icon 210, the power mode screen 250 illustrated in FIG. 11 is displayed. The power mode screen 250 allows a user to select a power mode for the ULT 10. These power modes may include a performance mode (in which the ULT 10 reacts to temperature changes quickly at the expense of greater power consumption), a normal mode (in which the ULT 10 reacts to temperature changes at a normal rate with respect to normal power consumption), and an energy save mode (in which the ULT 10 reacts to temperature changes at a slightly slower rate with respect to less power consumption than in either the performance mode or the energy saver mode)), wherein the characteristic is one of a size of the power control ([0077]) or a color of the power control. It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is adapted to display a power control on the display, and wherein the controller is further adapted and to change a characteristic characteristics of the power control when the thermal control unit is implementing the thermal therapy session when compared to when the thermal control unit is not implementing the thermal therapy session, wherein the characteristic is one of a size of the power control or a color of the power control. Doing so allows for a visual indicator for the battery and power control.
Regarding claim 60, Taylor teaches the thermal control unit of claim 19 further comprising a transceiver adapted to communicate with a server ([0094] thermal control unit 22 includes a WiFi transceiver that communicates with the healthcare facility's local area network via the network's wireless access points), but fails to teach and wherein the controller is further adapted to display a first icon on the display indicating connectivity of the transceiver to a local area network of a facility in which the thermal control unit is located.
However, Blair teaches wherein the controller is further adapted to display a first icon on the display indicating connectivity of the transceiver to a local area network of a facility in which the thermal control unit is located (Fig 15 and 16). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is further adapted to display a first icon on the display indicating connectivity of the transceiver to a local area network of a facility in which the thermal control unit is located. Doing so allows for a visual indication of the connectivity of the transceiver.
Claims 32 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Carson (US 20090099629 A1).
Regarding claim 32, Taylor teaches the thermal control unit of claim 19 wherein the controller is further adapted display a preset therapy selector that allows a user to select a preset therapy ([0129] FIG. 10, first therapy screen 150 lists four therapy profiles 156a-d. It will be appreciated that this number of profiles 156 varied. Further, although FIG. 10 identifies the four different therapy profiles 156 generically (therapy A, therapy B, etc.), in actual use, controller 60 displays a more descriptive term for the various therapies, such as, but not limited to, “cardiac arrest, “neurosurgery,” “fever,” etc. Indeed, in many embodiments, controller 60 is configured to allow the user to assign names of their choosing to the various therapy profiles 156) ([0132] Therapy profile setting 158d allows the user to specify a target temperature for the patient for the corresponding therapy profile 156); and wherein the preset therapy includes definitions for a plurality of phases of the thermal therapy session ([0130] Once a user selects one of the therapy profiles 156a-d displayed on first therapy editing screen 150, controller 60 displays a second editing screen 152 that corresponds to the particular therapy profile selected on screen 150. Thus, in the example shown in FIGS. 10 and 11, the user has selected “Therapy A” on first screen 150, and controller 60 is displaying details regarding the profile for “Therapy A” on second screen 152); and wherein the controller is configured to follow the definitions for the plurality of phases when following the preset therapy ([0132] Therapy profile setting 158e allows the user to specify how long the patient is to be maintained at the target temperature specified by setting 158d. Therapy profile setting 158f allows the user to specify whether the warming rate of the patient after the time period specified by setting 158e expires will be one of the standard warming rates of thermal control unit 22, or a customized warming rate. In the example shown in FIG. 11, the user has selected a custom warming rate. Thermal profile setting 158g allows the user to numerically specify the actual warming rate the thermal control unit 22 will attempt to achieve during the warming phase of the thermal therapy session); the plurality of phases include a cooling phase ([0131] Therapy profile setting 158b allows the user to enable usage of, or disable usage of, the corresponding therapy profile 156. Therapy profile setting 158c allows the user to specify what cooling rate to utilize when cooling the patient, such as, but not limited to, a low cooling rate, a medium cooling rate, and/or a maximum cooling rate), a maintenance phase ([0132] Therapy profile setting 158e allows the user to specify how long the patient is to be maintained at the target temperature specified by setting 158d), and a warming phase ([0132] Thermal profile setting 158g allows the user to numerically specify the actual warming rate the thermal control unit 22 will attempt to achieve during the warming phase of the thermal therapy session. Finally, thermal profile settings 158h allows the user to specify the temperature that the patient is to be warmed to during the warming phase of the thermal therapy session); and wherein the controller is further adapted to display a preset summary indicating information about each of the plurality of phases of the preset therapy ([0135] Controller 60 stores such groupings of alarm, user, auxiliary sensor, location, and therapy profile customizations as records within memory 80. Several illustrative examples of such records are shown in FIGS. 12 and 13 and discussed further below) ([0136] FIG. 12 illustrates three therapy customization records 170a-c that may be stored in memory 80. Therapy customization records 170a-c are identified according to the therapy they correspond to) (Fig 10 and 11; indicating the therapy type and the parameters).
Taylor fails to teach the preset summary including a phase indicator for each of the plurality of phases of the preset therapy, and wherein each phase indicator includes an icon identifying a type of phase and text describing the phase of each phase indicator.
However, Carson teaches the preset summary including a phase indicator for each of the plurality of phases of the preset therapy ([0058] the graphic display region 214 may be provided to visually indicate which of a plurality of therapy phases is currently in process), and wherein each phase indicator includes an icon identifying a type of phase ([0058] For example, in FIG. 3B a portion of the graphic display region 214 may be presented in a different manner (e.g. a different color) than the rest of the display (e.g. as indicated by angled lines in FIG. 3B) to indicate that "Phase 1" has been or is about to be initiated. Similarly, in FIG. 3C a portion of graphic display region 214 visually indicates that "Phase 2" is currently-in-process (e.g. via a different color than the rest of the display as reflected by the diagonal lines of FIG. 3C), and in FIG. 3D graphic display region 214 visually indicates that "Phase 3" is underway) and text describing the phase of each phase indicator ([0058] Additionally, the graphic display region 214 may be provided to visually indicate which of a plurality of therapy phases is currently in process. For example, in FIG. 3B a portion of the graphic display region 214 may be presented in a different manner (e.g. a different color) than the rest of the display (e.g. as indicated by angled lines in FIG. 3B) to indicate that "Phase 1" has been or is about to be initiated. Similarly, in FIG. 3C a portion of graphic display region 214 visually indicates that "Phase 2" is currently-in-process (e.g. via a different color than the rest of the display as reflected by the diagonal lines of FIG. 3C), and in FIG. 3D graphic display region 214 visually indicates that "Phase 3" is underway). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include the preset summary including a phase indicator for each of the plurality of phases of the preset therapy, and wherein each phase indicator includes an icon identifying a type of phase and text describing the phase of each phase indicator. Doing so allows for a visual indication of the current phase for a real time update of the operation.
Claims 36 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Carson (US 20090099629 A1), further in view of Blair (US 20110304466 A1) and Hunter (US 20130262527 A1).
Regarding claim 36, Taylor teaches the thermal control unit of claim 32, but fails to teach wherein both the icon and the text are positioned inside of an oval displayed on the display, each phase indicator is arranged vertically above another phase indicator in chronological order starting with a first phase indicator on a top of the preset summary and a second phase indicator below the first phase indicator, and wherein the controller is configured to fill in more and more of the oval as the thermal therapy session progresses through the phase corresponding to the oval.
However, Blair teaches wherein both the icon and the text are positioned inside of an oval displayed on the display ([0108] FIG. 34 is an illustration of a help screen 590 in which a user may view context relevant data, such as textual help, associated with the screen from which the help icon 212 was selected) ([0103] Returning to FIG. 27, the expanded line graph 522 includes events that occurred over the predetermined period of time, each of which is associated with an icon 530-534. In specific embodiments, each of the icons 530-534 is a user selectable icon that indicate additional information associated with that event when selected by the user). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein both the icon and the text are positioned inside of an oval displayed on the display. Doing so allows for a visual indication on a specific spot on the screen for the icon and text to be displayed. Further, it would have been an obvious matter of design choice to make the location wherein both the icon and the text are positioned of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Further, Carson teaches each phase indicator is arranged vertically above another phase indicator in chronological order starting with a first phase indicator on a top of the preset summary and a second phase indicator below the first phase indicator (Fig 3C; Phases in chronological order left to right). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include each phase indicator is arranged vertically above another phase indicator in chronological order starting with a first phase indicator on a top of the preset summary and a second phase indicator below the first phase indicator. Doing so allows for a visual indication of what phase it is currently in and which is coming next. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to rearrange the phase indicators on top of one another in chronological order, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Further, Hunter teaches wherein the controller is configured to fill in more and more of the oval as the thermal therapy session progresses through the phase corresponding to the oval ([0033] FIG. 3B illustrates exemplary smart progress pie chart 308. Smart progress pie chart 308 can start from empty at the beginning of a task. A filled portion of smart progress pie chart 308 can include one or more wedges the angles of which can grow as the task progresses. The wedges can expand clockwise or counter-clockwise. When a tasks starts from zero and progresses, the filled portion of smart progress pie chart can have a first color and a first pattern, as illustrated by wedge 310. When conditions specified in a trigger are satisfied, the first color and a first pattern can change to a second color and a second pattern as illustrated by wedge 312, and then to a third color and a third pattern as illustrated by wedge 314). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is configured to fill in more and more of the oval as the thermal therapy session progresses through the phase corresponding to the oval. Doing so allows for a visual indication of the session progress for the user to monitor. Further, it would have been an obvious matter of design choice to make the different portions of the location wherein both the icon and the text are positioned of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claims 43 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Su (US 20130072998 A1).
Regarding claim 43, Taylor teaches the thermal control unit of claim 40 wherein the characteristic is a first direction in which time measurements are displayed and a second direction in which time measurements are displayed ([0147] Controller 60 is further adapted, in at least some embodiments, to allow the user to customize what data is displayed on graph 160, including the manner in which the data is displayed (e.g. in what units, whether overlaid on top of the patient temperature readings or spaced from these readings, etc.)).
Taylor fails to teach wherein the first direction includes increasing numerical measurements from a left side of the display to a right side of the display such that the numerical measurements are measurements of a total amount of time elapsed since the thermal therapy session began, and wherein the second direction includes increasing numerical measurements from the right side of the display to the left side of the display such that the numerical measurements are measurements of a total amount of time prior to the present time.
However, Su teaches wherein the first direction includes increasing numerical measurements from a left side of the display to a right side of the display such that the numerical measurements are measurements of a total amount of time elapsed since the thermal therapy session began (Fig 12; time from 0-20 after a stimulation), and wherein the second direction includes increasing numerical measurements from the right side of the display to the left side of the display such that the numerical measurements are measurements of a total amount of time prior to the present time (Fig 12; time from 0 to -15 prior to a stimulation). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include the first direction includes increasing numerical measurements from a left side of the display to a right side of the display such that the numerical measurements are measurements of a total amount of time elapsed since the thermal therapy session began, and wherein the second direction includes increasing numerical measurements from the right side of the display to the left side of the display such that the numerical measurements are measurements of a total amount of time prior to the present time. Doing so allows for the recordings to start prior to application to compare the before and after results.
Claims 50 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Blair (US 20110304466 A1), further in view of Pracar (US 20150073309 A1).
Regarding claim 50, Taylor teaches the thermal control unit of claim 19 but fails to teach wherein the controller is adapted to display a power control on the display, and wherein the controller is further adapted to change a color of the power control when the thermal control unit is in different states, wherein the different states include a first state in which the power control has not been activated to turn on power to the thermal control unit, a second state in which the power control has been activated to turn on power to the thermal control unit, and a third state in which electrical power is no longer supplied from a mains electrical outlet to the thermal control unit.
However, Blair teaches wherein the controller is adapted to display a power control on the display ([0098] FIG. 25 is an illustration of a power systems screen 470 that is provided in response to the user selecting the power systems icon 422 of the system health screen 410. The power systems screen 470 provides an indication of the power mode of the ULT 10 as well as the status of the primary power source 192 and the backup power source 194). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is adapted to display a power control on the display. Doing so allows for a visual indication of power so that the user can identify the controls.
Further, Pracar teaches wherein the controller is further adapted to change a color of the power control when the thermal control unit is in different states ([0033] notification light can be used to display system conditions such as battery life, etc. This notification light may be a single color or multiple colors. In particular, the light could display a different color for different types of notifications, such as battery status, sleep mode, awake mode, etc. In other embodiments, the light could take the form of different shapes displayed for different types of notifications. For instance, awake mode could display a light in the shape of an open eye, sleep mode could display a light in the shape of a closed eye, and battery life can display a light in the shape of a battery, etc. The color of the shaped light might indicate whether the battery is fully charged (e.g. green), partially charged (e.g. yellow), or needs charge (e.g. red)), wherein the different states include a first state in which the power control has not been activated to turn on power to the thermal control unit (sleep mode), a second state in which the power control has been activated to turn on power to the thermal control unit (awake mode), and a third state in which electrical power is no longer supplied from a mains electrical outlet to the thermal control unit (battery life). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is further adapted to change a color of the power control when the thermal control unit is in different states wherein the different states include a first state in which the power control has not been activated to turn on power to the thermal control unit, a second state in which the power control has been activated to turn on power to the thermal control unit, and a third state in which electrical power is no longer supplied from a mains electrical outlet to the thermal control unit. Doing so allows for a visual indication of the power control when the unit is in different sates so the user can identify what state it is in.
Claims 53 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Blair (US 20110304466 A1), further in view of Pracar (US 20150073309 A1), further in view of Dabrowiak (US 20190151143 A1) and Scott (US 20060293734 A1).
Regarding claim 53, Taylor teaches the thermal control unit of claim 50, but fails to teach wherein the controller is configured to display a plot of an amount of effort exerted by the thermal control unit over time, and to display the plot in a first color for moments in time when the thermal control unit is heating the circulating fluid and in a second color for moments in time when the thermal control unit is cooling the circulating fluid.
However, Dabrowiak teaches wherein the controller is configured to display a plot of an amount of effort exerted by the thermal control unit over time (Fig 18-20; [0194] Warming Effort and Cooling Effort shows the percentage of the system's maximum warming or cooling capability currently being expended). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is configured to display a plot of an amount of effort exerted by the thermal control unit over time. Doing so allows for a visual indication of the effort applied during operation.
Further, Scott teaches to display the plot in a first color for moments in time when the thermal control unit is heating the circulating fluid and in a second color for moments in time when the thermal control unit is cooling the circulating fluid ([0108] Several graphic icons are positioned adjacent the left of the upper three LCD displays 174,176, and 178, to indicate their respective display functions. Specifically, a patient temperature icon 182a, a target temperature LED 182b, and a cooling/warming rate LED 182c are provided. Just below the cooling/warming rate LED 182c, an operational mode LED 182d and associated vertical series of three mode indicators 184 are provided. Only one of the indicators 184 lights up at any one time, depending on whether the system is in the COOLING, WARMING, or MAINTAINING mode. In lieu of the mode indicators 184, the display 180 may carry the message COOLING PATIENT, WARMING PATIENT, or MAINTAINING so that the operator can easily identify the mode of functioning of the controller). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include to display the plot in a first color for moments in time when the thermal control unit is heating the circulating fluid and in a second color for moments in time when the thermal control unit is cooling the circulating fluid. Doing so allows for a visual indication of what phase it is in at the moment.
Claims 57 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Kim (US 20190294287 A1).
Regarding claim 57, Taylor teaches the thermal control unit of claim 19, wherein the control is one of a power control, a pause control, or a lock control ([0085] Controller 60 is also configured to allow the user to change whether any of the alarms issued for any of the alarm conditions 102 can be paused by a user. In one embodiment, when an alarm is issued, controller 60 displays a pause icon (not shown) on display 88 that, when touched by a user, temporarily pauses the emitted alarm sound), but fails to teach wherein the controller is adapted to implement the function in response to the user activating the control if a user presses and holds the control for longer than a predetermined amount of time, but to not implement the function if the user presses the power control for less than the predetermined amount of time, wherein the predetermined amount of time falls within a range of a half a second to three seconds.
However, Kim teaches wherein the controller is adapted to implement the function in response to the user activating the control if a user presses and holds the control for longer than a predetermined amount of time, but to not implement the function if the user presses the power control for less than the predetermined amount of time, wherein the predetermined amount of time falls within a range of a half a second to three seconds ([0107] the touch input which is released after touching the display (for example, the display 430) (for example, the touch input inputted in operation 605) is a touch input of less than 1 second, and may be referred to as a tap touch. The long touch refers to an input which touches the display and then holds the touch for longer than a reference time (for example, 1 second). That is, when an additional force input is not detected while the touch input is being held, the processor 120 may recognize the touch input detected in operation 601 as a long touch. In this case, the processor 120 may perform a function corresponding to the long touch). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is adapted to implement the function in response to the user activating the control if a user presses and holds the control for longer than a predetermined amount of time, but to not implement the function if the user presses the power control for less than the predetermined amount of time, wherein the predetermined amount of time falls within a range of a half a second to three seconds. Doing so allows for a tough to hold button to distinguish between separate button functions.
Claims 61 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Blair (US 20110304466 A1), further in view of Zaman (US 9015606 B2).
Regarding claim 61, Taylor teaches the thermal control unit of claim 60, but fails to teach wherein the controller is further adapted to display a second icon on the display indicating connectivity of the transceiver to the server a third icon on the display indicating a software update is available for the thermal control unit, and a fourth icon on the display indicating information shown on the display may be displayed in different languages.
However, Blair teaches wherein the controller is further adapted to display a second icon on the display indicating connectivity of the transceiver to the server (Fig 15-17), and a fourth icon on the display indicating information shown on the display may be displayed in different languages ([0075] These include the user language icon 214 the user selects to activate a drop-down control 216 (for the user to select a language)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is further adapted to display a second icon on the display indicating connectivity of the transceiver to the server, and a fourth icon on the display indicating information shown on the display may be displayed in different languages. Doing so allows for a visual sign feature for the connectivity and selecting different languages on the display for ease of the user.
Further, Zaman teaches a third icon on the display indicating a software update is available for the thermal control unit ([88] Tile 1600 includes indicators presenting various types of information about an associated application. Examples include an installation indicator 1602, an expiration indicator 1604, a software update indicator 1606, and an execution status indicator 1608…Software update indicator 1606 indicates that an update is available). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include a third icon on the display indicating a software update is available for the thermal control unit. Doing so allows for the user to be notified of a software update in order to have the most recent software downloaded.
Claims 67 is/are rejected under 35 U.S.C. 103 as being obvious over Taylor (US 20200405529 A1) in view of Taylor (2) (US 20190192339 A1) and Taylor (3) (US 20170348144 A1).
Regarding claim 67, Taylor teaches the thermal control unit of claim 19, but fails to teach wherein the controller is further adapted to display an alarm history screen and an alarm filter the alarm history screen including a listing of alarms that were active during the thermal therapy session, the alarm filter adapted to filter the alarm listing according to a type of alarm selected by the user, and wherein, in response to a user activating the alarm filter, the controller is configured to only include in the alarm listing those alarms matching the type of alarm selected by the user, wherein the type of alarm selected by the user includes at least one of the following: a patient temperature alarm, a patient temperature sensor alarm, a fluid alarm, or a device alarm.
However, Taylor (2) teaches an alarm filter ([0014] The thermal control unit, in some embodiments, includes a user interface having a filter control that, when selected, filters one or more selected event icons such that the user interface does not display any filtered event icons) ([0008] the user interface is adapted to provide further information about the event when the event icon is touched by a user. The event may be one or more of the following: an alert issued by the controller), the alarm history screen including a listing of alarms that were active during the thermal therapy session, the alarm filter adapted to filter the alarm listing according to a type of alarm selected by the user ([0071] FIG. 6 illustrates a display control window 112 that is displayed on display 80 along with graph 102′. Display control window 112 identifies a plurality of display parameters 114. The display parameters 114 illustrated in FIG. 6 include patient temperature, water (fluid) temperature, shivering, sedation administration, and a patient's low potassium level. Other display parameters may, of course, be added to control window 112. Next to each display parameter 114 is a check box 116 that, when selected by a user, causes controller 60 to display on thermal therapy graph 102′ the corresponding display parameter. When the check box 116 is not selected by a user, then the corresponding display parameter 114 is not shown by controller 60 on thermal therapy graph 102′. Display control window 112 and check boxes 116 therefore act together to provide a filtering function for the information displayable on display 80). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include an alarm filter, the alarm history screen including a listing of alarms that were active during the thermal therapy session, the alarm filter adapted to filter the alarm listing according to a type of alarm selected by the user. Doing so allows for the event history to be selectively viewed for a user to look at the patient’s history for context during an operation.
Further, Taylor (3) teaches wherein the controller is further adapted to display an alarm history screen ([0073] At least one of the user interfaces 38 of control units 20 or 20′ includes a control that enables the caregiver to search through and selectively display the flagged data so that the caregiver doesn't have to review the entire thermal history data for events of potential significance), in response to a user activating the alarm filter, the controller is configured to only include in the alarm listing those alarms matching the type of alarm selected by the user ([0071]), wherein the type of alarm selected by the user includes at least one of the following: a patient temperature alarm, a patient temperature sensor alarm, a fluid alarm, or a device alarm ([0074] one type of event that is flagged is any movement of the patient's temperature in a direction opposite to the temperature direction desired for the patient (e.g. if the patient's temperature increases while water colder than the patient's temperature is being applied to the patient's thermal pads 30, or vice versa). Another type of event is a power level that exceeds a predetermined threshold. Still other events of interest that are flagged include any errors (within control units 20 or 20′ themselves, from patient temperature sensor 46, or from other sources), any patient temperature variations that exceeds one or more predetermined speeds). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Taylor to include wherein the controller is further adapted to display an alarm history screen, in response to a user activating the alarm filter, the controller is configured to only include in the alarm listing those alarms matching the type of alarm selected by the user, wherein the type of alarm selected by the user includes at least one of the following: a patient temperature alarm, a patient temperature sensor alarm, a fluid alarm, or a device alarm. Doing so allows for the user to select which events would be displayed for a customizable graph.
The applied references have a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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