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 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.
Claim Rejections - 35 USC § 102
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.
Claim(s) 9 and 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hopper et al., (US 20140343639; hereinafter Hopper).
Regarding claim 9, Hopper (Figures 1-2 and 5) discloses a thermal control unit (20) for controlling a patient's temperature during a thermal therapy session, the thermal control unit comprising: a fluid outlet (24) adapted to fluidly couple to a fluid supply line; a fluid inlet (26) adapted to fluidly couple to a fluid return line; a circulation channel (54) coupled to the fluid inlet and the fluid outlet; a pump (52) for circulating fluid through the circulation channel from the fluid inlet to the fluid outlet; a heat exchanger (58) adapted to add or remove heat from the fluid circulating in the circulation channel; a fluid temperature sensor (74a) adapted to sense a temperature of the fluid; a patient temperature sensor port (50) adapted to receive patient temperature readings from a patient temperature sensor; a memory containing a set of alarm (alert) conditions; an audio pause control ([0100]: a confirmation from the user may pause the alarm); a display (46); and a controller (72) adapted to control the heat exchanger in order to control the patient's temperature, the controller further adapted to issue an alarm (alert) in response to detecting any one of the alarm conditions in the set of alarm (alert) conditions ([0011], [0024], [0049], [0059]-[0060], [0065]-[0067], [0084], [0092], [0098]-[0100], [0105]), to not issue the alarm in response to detecting any one of the alarm conditions that are not in the set of alarm condition ([0011], [0024], [0049], [0059]-[0060], [0065]-[0067], [0084], [0092], [0098]-[0100], [0105]: the alert is only issued when one of the alarm conditions is detected and not when one of them is not detected), and to allow a user to use an alarm customization control to customize what alarm conditions are in the set of alarm conditions ([0100]: user designates which ports are active and inactive to set the alarm conditions) and what alarm conditions are not in the set of alarm conditions ([0089]: icon 160e may be used by the user to silence any audible alarms for a predetermined period of time; therefore, the user may choose which audible alarms are active and which audible alarms are not); the controller still further adapted to pause an audio portion of the alarm in response to a user activating the audio pause control ([0100]: user designates which ports are active and inactive to set the alarm conditions, and a confirmation from the user may pause the alarm after the alarm is triggered); and wherein the set of alarm conditions includes at least one of the following alarms: a patient temperature sensor disconnection, a high fluid temperature, a low fluid temperature, a pause in therapy, an overall low fluid level within thermal control unit, a patient temperature deviation, or a patient temperature sensor malfunction ([0100]: user designates which ports are active and inactive to set the alarm conditions, which corresponds to a patient temperature sensor disconnection).
Regarding claim 11, Hopper further discloses that the memory further includes a therapy profile and a plurality of alarm characteristics for each alarm condition in the set of alarm conditions, the therapy profile defining at least two of the following: a target temperature for cooling the patient, a cooling rate for the patient, an amount of time the patient is maintained at a temperature, a warming rate for the patient, or a target temperature for warming the patient; the plurality of alarm characteristics including at least two of the following settings: an on/off setting, a tone setting, a priority setting, a repeat/non-repeat setting, a delay between repeats setting, an audio pause setting, or a pause duration setting; and wherein the controller is further adapted to perform the following: (i) allow the user to customize the plurality of alarm characteristics for each of the alarm conditions in the set of alarms conditions, (ii) follow the therapy profile during the thermal therapy session; and (iii) allow a user to customize the therapy profile and to store the customized therapy profile in the memory ([0011], [0024], [0049], [0059]-[0060], [0065]-[0067], [0084], [0092], [0098]-[0100], [0105]).
Regarding claim 12, Hopper further discloses an auxiliary input adapted to receive sensor readings from an auxiliary sensor (76b/c/d), the auxiliary sensor being adapted to detect at least one of the following characteristics of the patient: an end tidal carbon dioxide (ETCO2) level, an oxygen saturation (SpO2) level, a respiration rate, a blood pressure, a heart rate, an electrolyte level, a pulse wave velocity, a bioimpedance, an electrocardiogram, or a rate of temperature change; and wherein the controller is further configured to display an indication on the display identifying a type of auxiliary sensor the user should couple to the auxiliary input in order to carry out the thermal therapy session ([0011], [0024], [0049], [0059]-[0060], [0065]-[0067], [0084], [0092], [0098]-[0100], [0105]: if any supply or return lines 30a or 30b are disconnected from a set of active ports 24, 26, or if any supply or return lines 30a or 30b are connected to a set of inactive ports 24, 26, controller 72 will sense these changes, via pressure sensors 76, b, c, and/or d, and will present information on control panel 72 alerting a user of these changes; therefore, the controller alerts the user that the correct sensor 76 should be connected with the right lines in order to maintain active lines; second, third, and/or fourth temperature sensors may be used as the auxiliary sensor).
Regarding claim 13, Hopper further discloses a therapy-type input adapted to receive an input from the user indicating a therapy type for the thermal therapy session, wherein the therapy-type input is a control on a user interface of the thermal control unit, the therapy type is at least one of a cardiac arrest therapy, a neuro-trauma therapy, a neurosurgery therapy, a fever therapy, or a pediatric therapy, and the controller is adapted to automatically select the type of auxiliary sensor based on the therapy-type input ([0011], [0024], [0049], [0059]-[0060], [0065]-[0067], [0084], [0092], [0098]-[0100], [0105]).
Regarding claim 14, Hopper further discloses a user input adapted to receive user data identifying a user of the thermal control unit, wherein the controller is adapted to automatically select the type of auxiliary sensor based on the user data and to use the output from the auxiliary sensor to control the temperature of the circulating fluid, and wherein the auxiliary sensor is a potassium sensor adapted to detect a level of potassium in the patient and the controller is adapted to display the potassium level on the display ([0011], [0024], [0049], [0059]-[0060], [0065]-[0067], [0084], [0092], [0098]-[0100], [0105]).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al., (US 20180140459; hereinafter Taylor) in view of Goldberg et al., (US 20010049465; hereinafter Goldberg).
Regarding claim 1, Taylor (Figures 1-3) discloses a thermal control unit (22) for controlling a patient's temperature during a thermal therapy session, the thermal control unit comprising: a main body; a fluid outlet (46) adapted to fluidly couple to a fluid supply line (28a), ([0027]); a fluid inlet (56) adapted to fluidly couple to a fluid return line (28b), ([0031]); a circulation channel (34) coupled to the fluid inlet (56) and the fluid outlet (46), ([0026]); a pump (32) positioned in the main body for circulating fluid through the circulation channel (34) from the fluid inlet (56) to the fluid outlet (46), ([0026]); a heat exchanger (38) positioned in the main body and adapted to add or remove heat from the fluid circulating in the circulation channel (34), ([0026], [0040]); a fluid temperature sensor (42) adapted to sense a temperature of the fluid ([0027]); a patient temperature sensor port (84) adapted to receive patient temperature readings from a patient temperature sensor (patient temperature sensor 80), ([0044], [0046]); an auxiliary input (auxiliary input 28c for tissue oxygenation readings) adapted to receive sensor readings from an auxiliary sensor (auxiliary sensor 80 for tissue oxygenation readings) external to the main body ([0042], [0046]); a memory in which is stored an identification of a first type of auxiliary sensor to be used with a first type of therapy and a second type of auxiliary sensor to be used with a second type of therapy ([0024], [0037]: each of the auxiliary lines 28c is associated with a different auxiliary sensor 80 in combination with a respective thermal pad 24 applying a respective type of therapy associated with that thermal pad 24); a display (64), ([0030]); and a controller (48) positioned in the main body adapted to control the heat exchanger (38) in order to control the patient's temperature ([0027], [0030]).
Taylor fails to disclose that the controller is further adapted to determine if the thermal control unit is going to be used to perform the first type of therapy or the second type of therapy and to display a first indication on the display of the first type of auxiliary sensor if the thermal control unit is going to be used to perform the first type of therapy, and to display a second indication on the display of the second type of auxiliary sensor if the thermal control unit is going to be used to perform the second type of therapy. However, Goldberg (Figure 23) teaches a thermal control unit (10) comprising a controller (200) adapted to determine if an auxiliary sensor (202) is to be used during a session and, if so, to display an indication (240/242) on the display identifying a type of auxiliary sensor (202) a user should couple to the auxiliary input in order to carry out the session ([0187]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Taylor such that the controller is further adapted to determine which auxiliary sensor is to be used during a thermal therapy session and, if so, to display an indication on the display identifying a type of auxiliary sensor associated with that thermal therapy session, as taught by Goldberg, because the modification would ensure that any/all auxiliary sensors are properly connected to carry out the thermal therapy session (Goldberg; [0187]). Furthermore, since the types of auxiliary sensors in the modified device would be the two types stored in the memory of Taylor, the controller of the modified device would be further adapted to determine if the thermal control unit is going to be used to perform the first type of therapy or the second type of therapy and to display a first indication on the display of the first type of auxiliary sensor if the thermal control unit is going to be used to perform the first type of therapy, and to display a second indication on the display of the second type of auxiliary sensor if the thermal control unit is going to be used to perform the second type of therapy.
Regarding claim 2, Taylor (Figures 1-3) further discloses that the first type of auxiliary sensor is adapted to detect at least one of the following characteristics of the patient: an end tidal carbon dioxide (ETCO2) level, an oxygen saturation (SpO2) level, a respiration rate, a blood pressure, a heart rate, an electrolyte level, a pulse wave velocity, a bioimpedance, an electrocardiogram, a rate of temperature change, or a level of potassium in the patient ([0042]).
Regarding claim 3, Taylor/Goldberg teaches a therapy-type input adapted to receive an input from the user indicating whether the thermal control unit is going to be used to perform the first type of therapy or the second type of therapy, as explained in the rejection of claim 1 above.
Regarding claim 4, Taylor (Figures 1-3) further discloses that the therapy-type input is a control on a user interface (of control panel 64) of the thermal control unit (22), and wherein the first type of therapy is at least one of a cardiac arrest therapy, a neuro-trauma therapy, a neurosurgery therapy, a fever therapy, or a pediatric therapy ([0013], [0032]-[0033], [0075], [0078]: fever therapy by way of shivering detection).
Regarding claim 8, Taylor (Figures 1-3) further discloses a memory ([0037]) containing a therapy profile, and wherein the controller (48) is configured to follow the therapy profile during the thermal therapy session, to allow a user to customize the therapy profile, and to store the customized therapy profile in the memory; wherein the therapy profile defines at least two of the following: a target temperature for cooling the patient, a cooling rate for the patient, an amount of time the patient is maintained at a temperature, a warming rate for the patient, or a target temperature for warming the patient ([0032]-[0034]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor/Goldberg, as applied to claim 1, and further in view of Hopper.
Regarding claim 5, Taylor/Goldberg teaches the thermal control unit of claim 1, but fails to teach a location input adapted to receive an input indicating a location of the thermal control unit within a healthcare facility, the location input including a screen on the display in which the user enters the location of the thermal control unit, and wherein the controller is adapted to automatically select the type of auxiliary sensor based on the location input. However, Hopper further teaches a location input adapted to receive an input indicating a location of the thermal control unit within a healthcare facility on the patient, the location input including a screen on the display in which the user enters the location of the thermal control unit, and wherein the controller is adapted to automatically select the type of auxiliary sensor based on the location input ([0049], [0056]-[0060], [0066]-[0067], [0098]-[0100], [0105]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Taylor/Goldberg to include a location input, as taught by Hopper, because the modification would enable user-controllable treatment according to desired patient temperature control (Hopper; [0056]).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor/ Goldberg, as applied to claim 1, and further in view of Hopper and Taylor et al., (US 20170348144; hereinafter T2).
Regarding claim 6, Taylor/Goldberg teaches the thermal control unit of claim 1, but fails to teach a user input adapted to receive user data identifying a user of the thermal control unit, and a memory containing a default set of alarm conditions; wherein the controller is further adapted to perform the following: (i) automatically select the type of auxiliary sensor based on the user data; (ii) allow a user to customize the default set of alarm conditions; and (iv) use the sensor readings from the auxiliary sensor to control the temperature of the circulating fluid. However, Hopper further teaches a user input adapted to receive user data identifying a user of the thermal control unit, and a memory containing a default set of alarm (alert) conditions; wherein the controller is further adapted to perform the following: (i) automatically select the type of auxiliary sensor based on the user data; (ii) allow a user to customize the default set of alarm conditions; and (iv) use the output from the auxiliary sensor to control the temperature of the circulating fluid ([0011], [0024], [0049], [0059]-[0060], [0065]-[0067], [0084], [0092], [0098]-[0100], [0105]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Taylor/Goldberg to include the user input as taught by Hopper, because the modification would enable user-controllable treatment according to desired patient temperature control (Hopper; [0056]).
Taylor/Goldberg/Hopper fails to teach the controller is further adapted to display a graph on the display, the graph including both a plot of patient temperature readings from the patient temperature sensor port plotted with respect to time and a plot of auxiliary readings from the auxiliary input plotted with respect to time. However, T2 (Figure 6) teaches a thermal control unit comprising a controller adapted to display a graph (48) on a display (40), the graph (48) including multiple plots of readings from different sensors/auxiliary inputs with respect to time ([0068]-[0069], [0072]-[0073]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Taylor/Goldberg/Hopper to include a graph displayed on the display, the graph including multiple plots of readings from different sensors/auxiliary inputs with respect to time, as taught by T2 because the modification would provide readings of multiple sensors/auxiliary inputs on one screen for the user (T2; [0068]-[0069]) so that the user has easy access to the readings on the display without having to shift between different graphs or other means for viewing the readings for different sensors/auxiliary sensors. Furthermore, the sensor/auxiliary input readings in the modified device would be patient temperature readings from the patient temperature sensor port and auxiliary readings from the auxiliary input, as disclosed by Taylor. Therefore, in the modified device, the graph would include both a plot of patient temperature readings from the patient temperature sensor port plotted with respect to time and a plot of auxiliary readings from the auxiliary input plotted with respect to time
Regarding claim 7, Hopper further teaches that the set of default alarm (alert) conditions includes at least two of the following alarm conditions: a patient temperature sensor disconnection, a high fluid temperature, a low fluid temperature, a low fluid flow rate, a pause in therapy, a low fluid level, a patient temperature deviation, or a patient temperature sensor malfunction; the memory further includes a plurality of alarm characteristics for each of the at least two alarm conditions, the controller is further adapted to allow the user to customize the plurality of alarm characteristics for each of the at least two alarm conditions; and the alarm characteristics include at least two of the following characteristics: an on/off setting, a tone setting, a priority setting, a repeat/non-repeat setting, a delay between repeats setting, an audio pause setting, or a pause duration setting (Hopper; [0011], [0024], [0049], [0059]-[0060], [0065]-[0067], [0084], [0092], [0098]-[0100], [0105]).
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of T2.
Regarding claim 15, Taylor (Figures 1-3) discloses a thermal control unit (22) for controlling a patient's temperature during a thermal therapy session, the thermal control unit (22) comprising: a main body; a fluid outlet (46) adapted to fluidly couple to a fluid supply line (28a), ([0027]); a fluid inlet (56) adapted to fluidly couple to a fluid return line (28b), ([0031]); a circulation channel (34) coupled to the fluid inlet (56) and the fluid outlet (46), ([0026]); a pump (32) for circulating fluid through the circulation channel (34) from the fluid inlet (56) to the fluid outlet (46), ([0026]); a heat exchanger (38) adapted to add or remove heat from the fluid circulating in the circulation channel (34), ([0026], [0040]); a fluid temperature sensor (42) adapted to sense a temperature of the fluid ([0027]); a patient temperature sensor port (84) adapted to receive patient temperature readings from a patient temperature sensor (patient temperature sensor 80), ([0044], [0046]); an auxiliary input (auxiliary input 28c for tissue oxygenation readings) adapted to receive sensor readings from an auxiliary sensor (auxiliary sensor 80 for tissue oxygenation readings) selectable by a user (the user selects which sensor 80 is activated based on which pad/pads 24, carrying sensors 80, is applied to the user in a desired location), the auxiliary sensor located external to the main body ([0042], [0046]); a display (64), ([0030]); a memory containing a plurality of therapy profiles (cooling modes with shivering protocols), each therapy profile (cooling mode with shivering protocol) defining a sequence of cooling, maintaining, and warming a patient ([0012]-[0013], [0023], [0070]: the cooling mode may include a sequence of cooling, maintaining the cooling, and warming the patient in response to the detection of shivering during cooling/maintaining), and each sequence (cooling mode with shivering protocol) including at least three of the following: a target temperature for cooling the patient (target temperature), a cooling rate for the patient (cooling rate), an amount of time the patient is maintained at a temperature, a warming rate for the patient (heating rate), or a target temperature for warming the patient ([0012]-[0013], [0032]-[0034], [0037], [0070]); and a controller (48) adapted to control the heat exchanger (38) in order to control the patient's temperature ([0027], [0030]); wherein the controller (48) is further adapted to allow a user to select one of the therapy profiles (cooling mode) from the plurality of therapy profiles (cooling modes), to automatically follow the selected therapy profile (cooling mode) during the thermal therapy session, to allow a user to customize the selected therapy profile (cooling mode), and to store the customized therapy profile (cooling mode) in the memory for future selection by the user ([0013], [0032]-[0037]: the selected therapy profile may be performed automatically).
Taylor fails to disclose that the controller is further adapted to display a graph on the display, the graph including both a plot of patient temperature readings from the patient temperature sensor port plotted with respect to time and a plot of auxiliary readings from the auxiliary input plotted with respect to time. However, T2 (Figure 6) teaches a thermal control unit comprising a controller adapted to display a graph (48) on a display (40), the graph (48) including multiple plots of readings from different sensors/auxiliary inputs with respect to time ([0068]-[0069], [0072]-[0073]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Taylor to include a graph displayed on the display, the graph including multiple plots of readings from different sensors/auxiliary inputs with respect to time, as taught by T2 because the modification would provide readings of multiple sensors/auxiliary inputs on one screen for the user (T2; [0068]-[0069]) so that the user has easy access to the readings on the display without having to shift between different graphs or other means for viewing the readings for different sensors/auxiliary sensors. Furthermore, the sensor/auxiliary input readings in the modified device would be patient temperature readings from the patient temperature sensor port and auxiliary readings from the auxiliary input, as disclosed by Taylor. Therefore, in the modified device, the graph would include both a plot of patient temperature readings from the patient temperature sensor port plotted with respect to time and a plot of auxiliary readings from the auxiliary input plotted with respect to time
Regarding claim 16, Taylor (Figures 1-3) further discloses a second auxiliary input (auxiliary input 28c for vibration/movement readings) adapted to receive sensor readings from a second auxiliary sensor (auxiliary sensor 80 for vibration/movement readings), ([0043], [0046]). The modified device includes the controller adapted to include plots of sensor readings from multiple sensors/auxiliary inputs, as taught by T2 ([0068]-[0069], [0072]-[0073]). Therefore, in the modified device, the controller would be further adapted to include a plot of the sensor readings from the second auxiliary sensor on the graph plotted with respect to time.
Regarding claim 17, Taylor (Figures 1-3) further discloses that the auxiliary sensor is adapted to detect at least one of the following characteristics of the patient: an end tidal carbon dioxide (ETCO2) level, an oxygen saturation (SpO2) level, a respiration rate, a blood pressure, a heart rate, an electrolyte level, a pulse wave velocity, a bioimpedance, an electrocardiogram, or a rate of temperature change ([0042]).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor/T2, as applied to claim 15, and further in view of Hopper.
Regarding claim 18, Taylor (Figures 1-3) further discloses a therapy-type input adapted to receive an input from the user indicating a therapy type for the thermal therapy session ([0013], [0032]-[0033], [0075], [0078]), but Taylor/T2 fails to teach the therapy-type input being a control on a user interface of the thermal control unit, and the therapy type including at least one of a cardiac arrest therapy, a neuro-trauma therapy, a neurosurgery therapy, a fever therapy, or a pediatric therapy; and a user input adapted to receive user data identifying a user of the thermal control unit; wherein the controller is further configured to perform the following: (i) automatically select, based on the therapy type and the user data, a type of auxiliary sensor the user should couple to the auxiliary input in order to carry out the thermal therapy session; and (ii) display an indication on the display identifying the selected type of auxiliary sensor. However, Hopper discloses a thermal control unit in which a therapy-type input is a control on a user interface of the thermal control unit, and the therapy type including at least one of a cardiac arrest therapy, a neuro-trauma therapy, a neurosurgery therapy, a fever therapy, or a pediatric therapy; and a user input adapted to receive user data identifying a user of the thermal control unit; wherein the controller is further configured to perform the following: (i) automatically select, based on the therapy type and the user data, a type of auxiliary sensor the user should couple to the auxiliary input in order to carry out the thermal therapy session; and (ii) display an indication on the display identifying the selected type of auxiliary sensor ([0011], [0024], [0049], [0059]-[0060], [0065]-[0067], [0084], [0092], [0098]-[0100], [0105]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Taylor/T2 such that the therapy-type input is a control on a user interface of the thermal control unit, and the therapy type including at least one of a cardiac arrest therapy, a neuro-trauma therapy, a neurosurgery therapy, a fever therapy, or a pediatric therapy; and a user input adapted to receive user data identifying a user of the thermal control unit; wherein the controller is further configured to perform the following: (i) automatically select, based on the therapy type and the user data, a type of auxiliary sensor the user should couple to the auxiliary input in order to carry out the thermal therapy session; and (ii) display an indication on the display identifying the selected type of auxiliary sensor, as taught by Hopper, because the modification would ensure that any/all auxiliary units are properly connected to carry out the thermal therapy session (Hooper; [0075]). Furthermore, in the modified thermal control unit, the auxiliary unit would be the auxiliary sensor.
Regarding claim 19, Taylor/T2 fails to teach a default set of alarm conditions stored in the memory and a plurality of alarm characteristics for each alarm condition in the default set of alarm conditions stored in the memory, the default set of alarm conditions including at least two of the following alarm conditions: a patient temperature sensor disconnection, a high fluid temperature, a low fluid temperature, a low fluid flow rate, a pause in therapy, a low fluid level, a patient temperature deviation, or a patient temperature sensor malfunction; and the plurality of alarm characteristics including at least two of the following characteristics: an on/off setting, a tone setting, a priority setting, a repeat/non-repeat setting, a delay between repeats setting, an audio pause setting, and a pause duration setting; and wherein the controller is further configured to allow a user to customize the default set of alarm conditions and the plurality of alarm characteristics. However, Hopper teaches a thermal control unit comprising a memory containing a default set of alarm (alert) conditions and a plurality of alarm conditions for each alarm condition in the default set of alarm conditions; the default set of alarm (alert) conditions includes at least two of the following alarm conditions: a patient temperature sensor disconnection, a high fluid temperature, a low fluid temperature, a low fluid flow rate, a pause in therapy, a low fluid level, a patient temperature deviation, or a patient temperature sensor malfunction; and the plurality of alarm characteristics including at least two of the following characteristics: an on/off setting, a tone setting, a priority setting, a repeat/non-repeat setting, a delay between repeats setting, an audio pause setting, and a pause duration setting, wherein the controller is further configured to allow a user to customize the default set of alarm conditions and the plurality of alarm characteristics ([0011], [0024], [0049], [0059]-[0060], [0065]-[0067], [0084], [0092], [0098]-[0100], [0105]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Taylor/T2 to include the default set of alarm conditions and plurality of alarm characteristics customizable by a user stored in the memory, as taught by Hopper, because the modification would ensure that any/all auxiliary units are properly connected to carry out the thermal therapy session (Hooper; [0075]) and enable user-controllable treatment according to desired patient temperature control (Hopper; [0056]).
Response to Arguments
Applicant's arguments filed 12/31/2025 have been fully considered, but they are not persuasive.
With regard to Applicant's first argument that Taylor/Goldberg combination fails to teach the newly amended limitations in claim 1 directed to a first type of auxiliary sensor to be used with a first type of therapy and a second type of auxiliary sensor to be used with a second type of therapy, Examiner respectfully disagrees. The Taylor reference already discloses that each of the auxiliary lines 28c is associated with a different auxiliary sensor 80 in combination with a respective thermal pad 24 applying a respective type of therapy associated with that thermal pad 24 ([0024], [0037]). Therefore, the memory would contain an identification of a first type of auxiliary sensor to be used with a first type of therapy (associated with a first port 28c, its respective sensor 80, and its respective thermal pad and therapy 24) and a second type of auxiliary sensor to be used with a second type of therapy (associated with a second port 28c, its respective sensor 80, and its respective thermal pad and therapy 24). The secondary Goldberg reference is used to teach that an auxiliary sensor (which may be any sensor connected to the controller; therefore, the sensor 202 of Goldberg is just an example of an auxiliary sensor) may be connected to the controller such that the controller determines which auxiliary sensor is to be used during a thermal therapy session and, if so, to display an indication on the display identifying a type of auxiliary sensor associated with that thermal therapy session. therefore, since the types of auxiliary sensors in the modified device would be the two types stored in the memory of Taylor, the controller of the modified device would be further adapted to determine if the thermal control unit is going to be used to perform the first type of therapy or the second type of therapy and to display a first indication on the display of the first type of auxiliary sensor if the thermal control unit is going to be used to perform the first type of therapy, and to display a second indication on the display of the second type of auxiliary sensor if the thermal control unit is going to be used to perform the second type of therapy.
With regard to Applicant’s second argument that the Hopper reference fails to disclose the newly amended limitation “the controller further adapted…to not issue the alarm in response to detecting any one of the alarm conditions that are not in the set of alarm condition” in claim 9, Examiner respectfully disagrees. Paragraphs [0089] and [0100] of Hopper discloses that the user designates which ports are active and inactive to set the alarm conditions, and the alert is only triggered when one of the alarm conditions is detected, and not when one of the arm conditioned is not detected. Therefore, Hopper discloses the newly amended limitation of claim 9.
With regard to Applicant’s third argument that the Taylor/T2 combination fails to teach the newly amended limitations directed to the automatic implementation of the therapy profiles in claim 15, Examiner respectfully disagrees. Paragraphs [0012]-[0013], [0023], [0032]-[0037], and [0070] of Taylor discloses that the memory of the device contains therapy profiles (cooling modes with shivering protocols) defining a sequence of cooling, maintaining, and warming a patient (the cooling mode may include a sequence of cooling, maintaining the cooling, and warming the patient in response to the detection of shivering during cooling/maintaining), and each sequence including at least three two of the following: a target temperature for cooling the patient (target temperature), a cooling rate for the patient (cooling rate), an amount of time the patient is maintained at a temperature, a warming rate for the patient (heating rate), or a target temperature for warming the patient. Furthermore, paragraph [0013] specifically details how the therapy profiles (cooling modes with shivering protocols) may be implemented automatically. Therefore, Examiner maintains that the Taylor/T2 combination teaches the invention as recited at least in amended claim 15.
Conclusion
THIS ACTION IS MADE FINAL. 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 CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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