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 141-145, and 148-159 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Paradis et al. (US 2017/0354534).
Regarding claim 141, Paradis discloses a temperature management system for controlling a temperature of a body of a patient, the system comprising: a heat exchange system (fig.1) comprising a heat exchange device (fig.1; heat-exchange subsystem 13) and an extracorporeal control console (fig.1; TTM device 2), the heat exchange system configured to exchange heat with the body of the patient and to record operational data representing operation of the heat exchange system while controlling the temperature of the body of the patient ; a user interface configured to receive user input and generate an alert ([103]-[0111]); and a processor (fig.4), a memory storing instructions (fog.3, see also [0013]), and circuitry communicatively coupled to the heat exchange system [0024], wherein the processor is configured to: receive the operational data (fig.4); determine a value indicative of a level of thermoregulatory activity of the patient corresponding to the operational data; and in response to determining the value [0095], generate an alert for display on the user interface to indicate the level of thermoregulatory activity of the patient [0104].
Regarding claim 142 and 152, Paradis discloses the system of claim 141, wherein determining the value indicative of the level of the thermoregulatory activity of the patient comprises: determining a change of a temperature (ΔT) of heat exchange fluid, the ΔT of the heat exchange fluid comprising a difference between an input temperature for fluid to the heat exchange device and an output temperature for fluid from the heat exchange device; and determining a heating or cooling power of the heat exchange device based on the ΔT of the heat exchange fluid; and determining, based on the heating or cooling power, the value indicative of the level of thermoregulatory activity of the patient ([0098]-[0099]).
Regarding claim 143 and 153, Paradis discloses wherein the processor is further configured to: determine a rate of change of the temperature of the body of the patient; and determine, based on the rate of change of the temperature of the patient and the operational data, the value indicative of the level of thermoregulatory activity of the patient [0103].
Regarding claim 144 and 154, Paradis discloses wherein the heat exchange device comprises a pad configured to be placed on the patient and receive heat exchange fluid for heating or cooling the pad [0022].
Regarding claim 145, Paradis discloses wherein determining the value indicative of the level of the thermoregulatory activity of the patient comprises: comparing a flow rate of heat exchange fluid circulating through the heat exchange system to an expected operating range of the flow rate of heat exchange fluid circulating through the heat exchange system; and determining, based on the comparing, the value indicative of the level of thermoregulatory activity of the patient [0124].
Regarding claim 148, Paradis discloses wherein determining the value indicative of the level of the thermoregulatory activity of the patient comprises: receiving values for two or more types of the operational data (the temperature of the TTM system coolant flowing into the patient and the temperature of the TTM system coolant flowing out of the patient); comparing the values for the two or more types of the operational data [0098]-[0099]; and determining, based on a relationship between the values for the two or more types of the operational data, a state of a thermoregulatory activity of the patient ([0098]-[0099] and [0121]).
Regarding claim 149 and 156, Paradis discloses wherein the processor is further configured to cause a therapeutic response by the heat exchange system or an additional device or system for treating the patient ([0031], administer drugs).
Regarding claim 150 and 157, Paradis discloses wherein the therapeutic response by the heat exchange system comprises raising or lowering a body temperature of the patient [0053].
Regarding claim 151, Paradis discloses a temperature management system for controlling a temperature of a body of a patient (fig.1), the system comprising: a heat exchange system (fig.1) comprising a heat exchange device (fig.1; heat-exchange subsystem 13) and an extracorporeal control console (fig.1; TTM 2), the heat exchange system configured to exchange heat with the body of the patient and to record operational data representing operation of the heat exchange system while controlling the temperature of the body of the patient; a user interface configured to receive user input and present an alert ([103]-[0111]); and a processor (fig.4), a memory storing instructions (fig.3), and circuitry communicatively coupled to the heat exchange system [0024], wherein the processor is configured to perform operations comprising: receiving a value of a first type of operational data of a plurality of types of operational data associated with a heat exchange system configured for exchanging heat with the body of the patient (plurality of the temperature of the TTM system coolant flowing into the patient); receiving a value of a second type of the operational data of the plurality of types of the operational data (plurality of the temperature of the TTM system coolant flowing out of the patient); determining that a relationship between the value of the first type of the operational data and the value of the second type of the operational data is satisfied [0098]: “P.sub.cool=c.sub.pρw(T.sub.outflow−T.sub.inflow)”); determining a state of a thermoregulatory activity of the patient based on determining that the relationship is satisfied ([0102]: “In one embodiment, a separate line displayed upon the graph of values of P.sub.cool may be positioned at a constant value known to be associated with a typical fever”, see also [0102] ); and generating, though the user interface, an data indicating the state of the thermoregulatory activity of the patient ([0098]-[0099] and [0104]).
Regarding claim 155, Paradis discloses the system of claim 151, wherein types of operational data comprise two or more of a flow rate of heat exchange fluid circulating through the heat exchange system [0098], a pressure of heat exchange fluid circulating through the heat exchange system, a temperature of heat exchange fluid circulating through the heat exchange system [0098], a temperature of heat exchange bath in the heat exchange system, and a pump speed of a pump of the heat exchange system [0098].
Regarding claim 158, Paradis discloses wherein determining that the relationship between the value of the first type of the operational data and the value of the second type of the operational data is satisfied comprises: determining that the value of the first type of the operational data exceeds a first threshold; and determining that the value of the second type of the operational data exceeds a second threshold. The signals from the sensors (first type and second type) remain in analog form, then are manipulated in the Processor by known analog electronic devices [0100]. Paradis also teaches that the system uses a negative feedback mechanism that is configured to adjusts the temperature of the coolant flowing through heat exchange catheter placed within a major vein of the patient so as to reduce the difference between the patient core temperature and the Set Point Temperature [0095].
Regarding claim 159, Paradis discloses wherein determining that the relationship between the value of the first type of the operational data and the value of the second type of the operational data is satisfied comprises: determining that the value of the first type of the operational data is within a first predetermined value range; and determining that the value of the second type of the operational data is within a second predetermined value range. The signals from the sensors (first type and second type) remain in analog form, then are manipulated in the Processor by known analog electronic devices [0100]. Paradis also teaches that the system uses a negative feedback mechanism that is configured to adjusts the temperature of the coolant flowing through heat exchange catheter placed within a major vein of the patient so as to reduce the difference between the patient core temperature and the Set Point Temperature [0095].
Claims 141-143, 145-153 and 155-157 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Dabrowiak (US 2018/0325725).
Regarding claim 141 and 151, Dabrowiak discloses a temperature management system for controlling a temperature of a body of a patient (fig.1), the system (system 10) comprising: a heat exchange system (fig.1) comprising a heat exchange device (fig.1; heat exchanger 18) and an extracorporeal control console (fig.1; control console 14), the heat exchange system configured to exchange heat with the body of the patient and to record operational data representing operation of the heat exchange system while controlling the temperature of the body of the patient [0004]; a user interface (fig.1; user interfaces 38) configured to receive user input and present an alert [0053]; and a processor [0004], a memory storing instructions ([0197]-[0203]), and circuitry communicatively coupled to the heat exchange system [0053], wherein the processor is configured to perform operations comprising: receiving a value of a first type of operational data of a plurality of types of operational data associated with a heat exchange system configured for exchanging heat with the body of the patient (the plurality of data repressing temperature of heat exchange fluid flowing to the heat exchanger 18); receiving a value of a second type of the operational data of the plurality of types of the operational data (the plurality of data representing the temperature of heat exchange fluid flowing from the heat exchanger 18); determining that a relationship between the value of the first type of the operational data and the value of the second type of the operational data is satisfied [0077]; determining a state of a thermoregulatory activity of the patient based on determining that the relationship is satisfied (the heating or cooling power maybe used to estimate the temperature of the target, see [0066]-[0070]); and generating, though the user interface, an data indicating the state of the thermoregulatory activity of the patient [0219].
Regarding claim 142 and 152, Dabrowiak discloses the system of claim 141, wherein determining the value indicative of the level of the thermoregulatory activity of the patient comprises: determining a change of a temperature (ΔT) of heat exchange fluid, the ΔT of the heat exchange fluid comprising a difference between an input temperature for fluid to the heat exchange device and an output temperature for fluid from the heat exchange device; and determining a heating or cooling power of the heat exchange device based on the ΔT of the heat exchange fluid; and determining, based on the heating or cooling power, the value indicative of the level of thermoregulatory activity of the patient ([0077]-[0082]).
Regarding claim 143 and 153, Dabrowiak discloses wherein the processor is further configured to: determine a rate of change of the temperature of the body of the patient; and determine, based on the rate of change of the temperature of the patient and the operational data, the value indicative of the level of thermoregulatory activity of the patient [0103].
Regarding claim 145, Dabrowiak discloses wherein determining the value indicative of the level of the thermoregulatory activity of the patient comprises: comparing a flow rate of heat exchange fluid circulating through the heat exchange system to an expected operating range of the flow rate of heat exchange fluid circulating through the heat exchange system; and determining, based on the comparing, the value indicative of the level of thermoregulatory activity of the patient ([0077] and [0102]: “The power calculation is in turn dependent on the accuracy of the catheter inlet and outlet temperature measurements, and the accuracy of the catheter flow rate measurement.”).
Regarding claim 146, Dabrowiak discloses wherein determining the value indicative of the level of the thermoregulatory activity of the patient comprises: comparing a pump speed value to an expected range of values for the pump speed; and determining, based on the comparing, the value indicative of the level of thermoregulatory activity of the patient ([0087]-[0101]: when pump stops, speed is zero).
Regarding claim 147, Dabrowiak discloses wherein determining the value indicative of the level of the thermoregulatory activity of the patient comprises: comparing a pressure value of heat exchange fluid circulating through the heat exchange system to an expected operating range of the pressure of heat exchange fluid circulating through the heat exchange system; and determining, based on the comparing, the value indicative of the level of thermoregulatory activity of the patient ([0182]-[0184]: “ the system shall regulate and limit working fluid or saline pressure for catheters as follows: <20 C: 60 psi nominal, 90 psi limit; >=20 C: 40 psi nominal, 70 psi limit; or 40 psi nominal, 70 psi limit. The console working fluid pump and cassette shall be capable of an output up to 600 mL/min at 70 psi. Saline or working fluid pressure at the outlet of the saline pump may be measured, e.g., over a range of 0-100 psi with an accuracy of ±5 psi over the range 10-70 psi.”).
Regarding claim 148, Dabrowiak discloses wherein determining the value indicative of the level of the thermoregulatory activity of the patient comprises: receiving values for two or more types of the operational data ([0077]: “Power (Watts)=(HE Fluid Temp OUT−HE Fluid Temp IN)”); comparing the values for the two or more types of the operational data ([0077]: “Power (Watts)=(HE Fluid Temp OUT−HE Fluid Temp IN)”); and determining, based on a relationship between the values for the two or more types of the operational data, a state of a thermoregulatory activity of the patient ([0077]-[0083]).
Regarding claim 149 and 156, Dabrowiak discloses wherein the processor is further configured to cause a therapeutic response by the heat exchange system or an additional device or system for treating the patient ([0034], administration of a reperfusion agent (e.g., thrombolytic drug)).
Regarding claim 150 and 157, Dabrowiak discloses wherein the therapeutic response by the heat exchange system comprises raising or lowering a body temperature of the patient [0004].
Regarding claim 155, Dabrowiak discloses the system of claim 151, wherein types of operational data comprise two or more of a flow rate of heat exchange fluid circulating through the heat exchange system [0077], a pressure of heat exchange fluid circulating through the heat exchange system [0181], a temperature of heat exchange fluid circulating through the heat exchange system [0077], a temperature of heat exchange bath in the heat exchange system, and a pump speed of a pump of the heat exchange system [0073].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 141-159 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5, 7-9, 11-12, 18, 29 and 32-33 of copending Application No. 17796379. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 17/796,379 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794