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
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.
Claims 1-5, 7-9, 18, 29, 32-33, 36, 77 and 79-80 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Paradis et al. (US 2017/0354534).
Regarding claim 1, 29 and 35, Paradis discloses a temperature management system or method for controlling a temperature of a body of a patient and for determining a value indicative of a thermoregulatory activity of the patient, the system comprising: a heat exchange system (fig.1) comprising a heat exchange device (heat-exchange subsystem 13) and an extracorporeal control console (TTM device 2) and a fluid reservoir for storing a cooling fluid (fig.1, refrigeration module 10, the module stores the fluid at least temporarily), the heat exchange system configured to exchange heat with the body of the patient and to record operational data while controlling the temperature of the body of the patient [0056]-[0056]; wherein the operational data comprise a fluid reservoir temperature value associated with the fluid reservoir of the heat exchange system ([0069]” : A component that measures the temperatures and volumes of the fluid utilized by the heat transfer subsystem of the device providing TTM”); a sensor configured to measure temperature data indicative of a temperature of the body of the patient [0112]; a user interface configured to receive user input and emit at least one of a visual alert and audible alert ([0103]-[0104]); and a processor ([0095], [0102], see also fig.2), a memory storing instructions [0120], and associated circuitry communicatively coupled to the sensor (fig.2, see also [0104]) , wherein the processor is configured to: receive the temperature data from the sensor indicative of the temperature of the body of the patient [0104]; control, based on the temperature data, the heat exchange system to maintain the temperature of the body of the patient within a target temperature range [0128]; receive, in response to the controlling, the operational data; determine, based on the temperature data and the operational data comprising the fluid reservoir temperature value ([0073] and [0120]), a value indicative of a thermoregulatory activity of the patient [0102]; and generate, based on the value, an alert through the user interface indicating the thermoregulatory activity of the patient [0104].
Regarding claim 2, Paradis discloses the system of claim 1, wherein the alert comprises a score, the score being indicative of a patient presenting an underlying hyperthermic state or hypothermic state [0029].
Regarding claim 3, Paradis discloses the system of claim 2, wherein the alert comprises a score, the score being indicative of the patient having a damaged or compromised endogenous thermoregulatory mechanism [0029].
Regarding claim 4, Paradis discloses the system of claim 1, wherein the processor is further configured to determine an effectiveness of an endogenous thermoregulatory mechanism of the patient in changing the temperature of the body of the patient [0029].
Regarding claim 5, Paradis discloses the system of claim 1, wherein the value represents cooling power required to change the temperature of the body of the patient a number of degrees over a predefined time interval, the number of degrees being indicative of an effectiveness of an endogenous thermoregulatory mechanism of the patient (fig.5, see also [00148]).
Regarding claim 7, Paradis discloses the system of claim 1, wherein the heat exchange device comprises an intravascular heat exchange catheter or a heat exchange surface pad for exchanging heat with the patient [0022].
Regarding claim 8, Paradis discloses the system of claim 1, wherein the processor is configured, in response to determining the value indicative of the thermoregulatory activity, to cause a therapeutic response by the heat exchange system or another device or system for treating the thermoregulatory activity of the patient [0095].
Regarding claim 9, Paradis discloses the system of claim 1, further comprising a catheter coupled to the sensor, and wherein the sensor is configured to measure a blood temperature of the patient (fig.2-4, see also [0095]).
Regarding claim 18, Paradis discloses the system of claim 1, wherein the processor is further configured to: receive training data comprising a plurality of measurements of a first type of operational data for a plurality of patients (fig.3-4, see also [0098] and [0101]) determine, based on the training data, a relationship between the first type of operational data of the heat exchange system and the thermoregulatory activity of the patient; and adjust one or more thresholds associated with the first type of operational data for generating the alert indicating the thermoregulatory activity of the patient based on the relationship ([0098]-[0111]) .
Regarding claim 32, Paradis discloses the system of claim 29, wherein the therapeutic response by the heat exchange system or another device or system comprises an automatic injection or infusion of a supplemental fluid [0031].
Regarding claim 33, Paradis discloses the system of claim 32, where the automatic injection or infusion is an injection or infusion of an anti-shivering medication [0031].
Regarding claim 36, Paradis discloses the method of claim 35, wherein the alert comprises a score, the score being indicative of a patient presenting an underlying hyperthermic state or hypothermic state ([0121]-[0123]).
Regarding claim 77, Paradis discloses the system of claim 1, wherein determining the value indicative of the thermoregulatory activity of the patient comprises: receiving, at machine learning logic, two or more types of the operational data; and applying the machine learning logic to the two or more types of the operational data [0132].
Regarding claim 79, Paradis discloses the system of claim 29, wherein determining the value indicative of the thermoregulatory activity of the patient comprises: receiving, at machine learning logic, two or more types of the operational data; and applying the machine learning logic to the two or more types of the operational data [0132].
Regarding claim 80, Paradis discloses the method of claim 35, wherein determining the value indicative of the thermoregulatory activity of the patient comprises: receiving, at machine learning logic, two or more types of the operational data; and applying the machine learning logic to the two or more types of the operational data [0132].
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.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Paradis et al. (US 2017/0354534) in view of Dabrowiak et al. (US 2018/0325725).
Regarding claim 11-12, Paradis does not disclose wherein the processor is configured to determine a mass flow rate based on a change in blood temperature over time and wherein the processor is configured to determine a cardiac output value of the patient based on the mass flow rate; and wherein generating the alert indicating the thermoregulatory activity of the patient is based on the cardiac output value of the patient exceeding a threshold cardiac output value.
Dabrowiak teaches devices, systems and methods for controlling the temperature of all or part of the body of a human or animal subject. The system includes wherein the processor is configured to determine a mass flow rate based on a change in blood temperature over time and wherein the processor is configured to determine a cardiac output value of the patient based on the mass flow rate; and wherein generating the alert indicating the thermoregulatory activity of the patient is based on the cardiac output value of the patient exceeding a threshold cardiac output value [0071] and [0170]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed the system of Paradis with a processor that is configured to determine a cardiac output value of the patient based on the mass flow rate as taught by Dabrowiak for the purpose providing a safe treatment to the patient.
Response to Arguments
Applicant's arguments filed 08/22/2025 have been fully considered but they are not persuasive. Paradis describes a "cooler/heater 10" (See Paradis at Fig. 1; See, also, Paradis at para. 0055, referring to a refrigeration module 10). Paradis is entirely silent with respect to a "fluid reservoir" for "storing a cooling fluid" as recited in amended claim
Further, Paradis is entirely silent with respect to "[recording] operational data while controlling the temperature of the body of the patient, wherein the operational data comprise a fluid reservoir temperature value associated with the fluid reservoir of the heat exchange system," as recited in amended claim 1. As Paradis does not describe a fluid reservoir, it is not clear how Paradis could describe a processor configured to "determine, based on the temperature data and the operational data comprising the fluid reservoir temperature value, the value indicative of the thermoregulatory activity of the patient; and generate, based on the value, an alert through the user interface indicating the thermoregulatory activity of the patient," as recited in amended claim 1. This argument is not persuasive.
One of the definitions of store (google) is a quantity or supply of something kept for use as needed. The refrigeration module 10 stores fluid temporarily to cool the fluid for the thermal regulation. The quantity of fluid kept in refrigeration module 10 is used in a thermal temperature regulation. The system uses the temperatures of the fluid (operational data) utilized by the heat transfer system including the fluid in refrigeration module. The temperature value of fluid is used to monitor heat-transfer fluid of the system. The processor configured to "determine, based on the temperature data [0069] and the operational data comprising the fluid reservoir temperature value, the value indicative of the thermoregulatory activity of the patient [0069]; and generate, based on the value, an alert through the user interface indicating the thermoregulatory activity of the patient [0104].
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.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794