DETAILED ACTION
A complete action on the merits of pending claims 1-18 appears below.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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.
Claims 1-3, 5, 11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voorhees US 20170246374.
Regarding claim 1, Voorhees teaches a fluid outlet (Fig. 1 fluid supply line 91) adapted to fluidly couple to a thermal pad (Fig. 1 pad 90); a fluid inlet (Fig. 1 fluid return 92) adapted to fluidly couple to the thermal pad; a fluid circulation path coupled to the fluid inlet and the fluid outlet; a pump for circulating fluid through the fluid circulation path from the fluid inlet to the fluid outlet; a blood inlet adapted to receive blood from the patient (Fig. 1 line 54); a blood outlet adapted to return blood to the patient (Fig. 1 line 55); a blood circulation path coupled to the blood outlet and the blood inlet (Fig. 1 catheter to 54 to 70 to 42 to 55 and back to catheter); a heat exchange subsystem for adding and removing heat from the fluid and the blood (Fig. 1 thermal exchange module 40), the heat exchange subsystem comprises a first heat exchanger adapted to add or remove heat from the fluid circulating through the fluid circulation path and delivered to the thermal pad, and a second heat exchanger adapted to add or remove heat from the blood circulating through the blood circulation path (par. [0057] first 41 and second 42 volumes of thermal exchange 40); and a controller in communication with the heat exchange subsystem and adapted to control a temperature of the fluid and a temperature of the blood in order to bring the patient to a target patient temperature (par. [0034]), wherein the controller is adapted to independently control the first and second heat exchangers such that the fluid temperature of the circulating fluid delivered to the thermal pad is controlled to a target fluid temperature and the blood temperature is controlled to a target blood temperature, and the controller is further adapted to be able to simultaneously set the target fluid temperature and the target blood temperature to different values (pars. [0025], [0034], [0084] and [0085] different modes based on the blood and pad, exchangers 23 and 43 of 40, pumps 21 and 70 and target temperatures are all independently controllable).
Regarding claim 2, Voorhees teaches a core temperature probe port adapted to receive a core temperature probe for measuring a core temperature of the patient (par. [0061]); and a peripheral temperature probe port adapted to receive a peripheral temperature probe for measuring a peripheral temperature of the patient (par. [0079] temperature sensor downstream of the pad); wherein the controller is adapted to control the temperature of both the fluid and the blood based on temperature readings received from both the core temperature probe port and the peripheral temperature probe port (par. [0079]).
Regarding claim 3, Voorhees teaches wherein the controller is adapted to control the second heat exchanger based upon a temperature of the blood in the blood circulation path and the controller is adapted to control the first heat exchanger based upon a temperature of both the blood and the fluid in the fluid circulating path (pars. [0061] and [0079] the controller can control both based upon any of the readings).
Regarding claim 5, Voorhees teaches wherein the controller is adapted to infer a patient peripheral temperature at a location adjacent a thermal pad based upon a heat transfer rate between the patient and the thermal pad, the thermal pad being fluidly coupled to the fluid outlet and fluid inlet, and the controller being further adapted to control the first and second heat exchangers based on the inferred patient peripheral temperature (par. [0079] temperature sensor downstream of the fluid inlet of the pad).
Regarding claim 11, Voorhees teaches wherein the controller is adapted to infer a patient peripheral temperature at a location adjacent the thermal pad based upon a heat transfer rate between the patient and the thermal pad, and the controller is further adapted to control the heat exchanger based on the inferred patient peripheral temperature (par. [0079] temperature sensor downstream of the fluid inlet of the pad).
Regarding claim 15, Voorhees a fluid outlet adapted to fluidly couple to a fluid supply line (Fig. 1 fluid supply line 91) of a thermal pad (Fig. 1 pad 90), the thermal pad adapted to be wrapped around a portion of the patient's body (par. [0073]); a fluid inlet adapted to fluidly couple to a fluid return line (Fig. 1 fluid return 92) of the thermal pad; a circulation channel coupled to the fluid outlet and the fluid inlet (Fig. 1 90 into 41 and back); a pump for circulating fluid through the circulation channel from the fluid inlet to the fluid outlet (Fig. 1 pump 21); a heat exchanger adapted to add or remove heat from the fluid circulating in the circulation channel (Fig. 1 thermal exchange module 40); a fluid temperature sensor adapted to sense a temperature of the fluid (par. [0079] fluid tank temperature sensor); a patient temperature probe port adapted to receive patient core temperature readings from a patient temperature probe (par. [0061]); a user interface adapted to receive a non-temperature patient parameter (par. [0024] blood pressure sensor), a patient peripheral temperature port adapted to receive patient peripheral temperature readings from a peripheral patient temperature sensors adapted to measure a peripheral temperature of the patient, the controller further adapted to control the heat exchanger based on differences between the patient core temperature readings and the patient peripheral temperature readings (par. [0079] the second temperature sensor downstream from the pad) and a controller in communication with the patient temperature probe port, the pump, the fluid temperature sensor, and the user interface, the controller adapted to control the heat exchanger based on both the patient core temperature readings and the non-temperature patient parameter (par. [0079]).
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.
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees in view of Sites US 6413233.
Regarding claim 4, Voorhees does not explicitly teach wherein the fluid circulation path and blood circulation path are both defined within a cartridge adapted to be inserted into and out of a chamber defined in the thermal control unit, and wherein the first and second heat exchangers are fluidly isolated from the cartridge and remain within the thermal control unit when the cartridge is removed.
Sites, in an analogous device, teaches where each part is separated into disposable subsystems (col 8 lines 27-37). Where one of the systems are fluid cartridges (claim 15)
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Voorhees to have the circulation paths made of removable cartridges, as in Sites. This allows for sterility and quick replacement with every new patient (Sites col 8 lines 27-37).
Regarding claim 9, Voorhees a fluid outlet adapted to fluidly couple to a fluid supply line (Fig. 1 fluid supply line 91) of a thermal pad (Fig. 1 pad 90), the thermal pad adapted to be wrapped around a portion of the patient's body (par. [0073]); a fluid inlet adapted to fluidly couple to a fluid return line (Fig. 1 fluid return 92) of the thermal pad; a circulation channel coupled to the fluid outlet and the fluid inlet (Fig. 1 90 into 41 and back); a pump for circulating fluid through the circulation channel from the fluid inlet to the fluid outlet (Fig. 1 pump 21); a heat exchanger adapted to add or remove heat from the fluid circulating in the circulation channel (Fig. 1 thermal exchange module 40); a fluid temperature sensor adapted to sense a temperature of the fluid (par. [0079] fluid tank temperature sensor); a patient temperature probe port adapted to receive patient core temperature readings from a patient temperature probe (par. [0061]); a user interface adapted to receive a non-temperature patient parameter (par. [0024] blood pressure sensor), a patient peripheral temperature port adapted to receive patient peripheral temperature readings from a peripheral patient temperature sensors adapted to measure a peripheral temperature of the patient, the controller further adapted to control the heat exchanger based on differences between the patient core temperature readings and the patient peripheral temperature readings (par. [0079] the second temperature sensor downstream from the pad) and a controller in communication with the patient temperature probe port, the pump, the fluid temperature sensor, and the user interface, the controller adapted to calculate the differences between the patient core temperature readings and the patient peripheral temperature readings and to control the heat exchanger based on the patient core temperature readings, the non-temperature patient parameter, and the differences between the patient core temperature readings and the patient peripheral temperature readings (pars. [0016, [0017], [0079] changing the output based on the core temperature compared to the other temperature sensors).
Voorhees does not explicitly teach a peripheral temperature port adapted to receive a plug.
Sites, in an analogous device, teaches where connections between two systems can be made with a plug and socket fittings (col 9 lines 8-14).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Voorhees to use plug and socket fittings for any connection. It is a known technique in the art for mechanical and electrical connections. This would yield the predictable result of relaying the temperature signal.
Claims 6, 10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees in view of Briscoe US 20040064169.
Regarding claims 6, 10, and 16, Voorhees does not explicitly teach further including a user interface adapted to receive a non-temperature patient parameter, wherein the controller is further adapted to control the first and second heat exchangers based partially on the non-temperature patient parameter, and wherein the non-temperature patient parameter is one of a body mass index (BMI), a body surface area (BSA), a patient weight, or a patient height.
Briscoe, in an analogous device, teaches where age, weight, sex and height can be input from the user into the controller (par. [0146]). The input parameters from the user affect the medical procedure (par. [0009]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Voorhees to allow for the user to input a patients age, weight, sex and height, as in Briscoe. This presents the advantage of generating the proper outputs to monitor on the user display (Briscoe par. [0148]). Additionally, in the medical field having more sensor data and input is more advantageous to a surgery.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Voorhees in view of Schmidt US 20170106151.
Regarding claim 7, Voorhees does not explicitly teach further comprising a first intravenous needle coupled to the blood inlet and a second intravenous needle coupled to the blood outlet, each of the first and second intravenous needles being adapted to be inserted into a peripheral vein of the patient. However, Voorhees teaches using a catheter to take and reintroduce blood into a patient (Abstract).
Schmidt, in an analogous device, teaches where a catheter or needle can be used to take and reintroduce blood into a person (par. [0046]). There is one needle 108 to take blood from the patient and another 112 to put blood back into the patient (Fig. 1A).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to substitute the catheter of Voorhees for the needles to take and introduce blood into a patient, as in Schmidt. The substitution is seen to perform equally as well and would yield the result of taking and putting blood back into a patient. Additionally, it is well known in the medical field that the use of needles for anything to do with blood is routine and conventional.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Voorhees in view of Brian US 20060177343.
Regarding claim 8, Voorhees does not explicitly teach a sensor positioned within the thermal control unit, the sensor adapted to detect a vital sign of the patient from the blood flowing through the blood circulation path, wherein the vital sign is an oxygenation level of the patient's blood.
Brian, in an analogous device teaches, a sensor that measures gas levels in a patient’s blood (par. [0059]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Voorhees to have a blood oxygenation sensor, as in Brian. This allows for the carbon dioxide to be exchanged with oxygen when cooling/heating blood (Brian par. [0067]).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees in view of Mori US 20050222652 and Norman US 20170000958.
Regarding claims 12 and 14, Voorhees teaches a second fluid outlet adapted to couple to a fluid supply line (Fig. 1 flow line 54) of an auxiliary thermal therapy device (Fig. 1 catheter 60), the auxiliary thermal therapy device being of a type other than a thermal pad (Fig. 1 catheter 60), the auxiliary thermal therapy device being adapted to add or remove heat from the patient (Fig. 1 thermal exchange module 40); and a second fluid inlet adapted to couple to a fluid return line of the auxiliary thermal therapy device (Fig. 1 line 51 to pump 70 to chamber 42 to line 55).
Voorhees does not explicitly teach wherein the auxiliary thermal therapy device includes a fluid passageway positioned in the patient's esophagus and the fluid passageway is adapted to receive circulating fluid from the second fluid outlet and a transceiver adapted to communicate with an auxiliary thermal therapy device, the auxiliary thermal therapy device adapted to supply heat to, and remove heat from, the patient by delivering temperature-controlled air to be breathed in by the patient.
Mori, in an analogous device, teaches where the fluid that is used is thermally treated air (par. [0040]). The device is able to be stuck into the patient’s esophagus to cool or heat the body (par. [0042]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Voorhees to use an air driven esophagus device, as in Mori. The air device allows for thermal transfer without increasing the internal pressure of the patient (Mori par. [0042]).
Mori does not explicitly teach a transceiver.
Norman, in an analogous device, teaches where a transceiver is used for the device (par. [0082]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Voorhees and Mori to use transceivers, as in Norman, so the device can communicate wirelessly (Norman par. [0065]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Voorhees and Sites as applied to claim 9, and further in view of Schmidt.
Regarding claim 13, Voorhees teaches a second fluid outlet adapted to couple to a fluid supply line (Fig. 1 flow line 54) of an auxiliary thermal therapy device (Fig. 1 catheter 60), the auxiliary thermal therapy device being of a type other than a thermal pad (Fig. 1 catheter 60), the auxiliary thermal therapy device being adapted to add or remove heat from the patient (Fig. 1 thermal exchange module 40); and a second fluid inlet adapted to couple to a fluid return line of the auxiliary thermal therapy device (Fig. 1 line 51 to pump 70 to chamber 42 to line 55).
Voorhees does not explicitly teach further comprising a first intravenous needle coupled to the blood inlet and a second intravenous needle coupled to the blood outlet, each of the first and second intravenous needles being adapted to be inserted into a peripheral vein of the patient. However, Voorhees teaches using a catheter to take and reintroduce blood into a patient (Abstract).
Schmidt, in an analogous device, teaches where a catheter or needle can be used to take and reintroduce blood into a person (par. [0046]). There is one needle 108 to take blood from the patient and another 112 to put blood back into the patient (Fig. 1A).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to substitute the catheter of Voorhees for the needles to take and introduce blood into a patient, as in Schmidt. The substitution is seen to perform equally as well and would yield the result of taking and putting blood back into a patient. Additionally, it is well known in the medical field that the use of needles for anything to do with blood is routine and conventional.
Claims 17 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Voorhees and Briscoe as applied to claim 16 above, and further in view of Mori and Norman.
Regarding claims 17 and 18, Voorhees does not explicitly teach a transceiver adapted to communicate with an auxiliary thermal therapy device, the auxiliary thermal therapy device adapted to supply heat to, and remove heat from, the patient and wherein the auxiliary thermal therapy device is adapted to deliver temperature-controlled air to be breathed in by the patient.
Mori, in an analogous device, teaches where the fluid that is used is thermally treated air (par. [0040]). The device is able to be stuck into the patient’s esophagus to cool or heat the body (par. [0042]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Voorhees to use an air driven esophagus device, as in Mori. The air device allows for thermal transfer without increasing the internal pressure of the patient (Mori par. [0042]).
Mori does not explicitly teach a transceiver.
Norman, in an analogous device, teaches where a transceiver is used for the device (par. [0082]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to modify the device of Voorhees and Mori to use transceivers, as in Norman, so the device can communicate wirelessly (Norman par. [0065]).
Conclusion
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/R.T.C./Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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