DETAILED ACTION
This action is responsive to the application filed 10/26/21.
Claims 56-75 are rejected.
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.
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 .
Election/Restrictions
This application contains claims directed to the following patentably distinct species:
Species I: Fig. 2 and pars. 28
Species II: Fig. 3 and par. 29
Species III: Fig. 4 and par. 30
Species IV: Fig. 5 and pars. 31-32
Species V: Figs. 6a-b and pars. 34-38
Species VI: Fig. 7 and pars. 39-47
The species are independent or distinct because they represent different structures and configurations for implementing combined endovascular and body surface heat exchange and therefore would require different searches. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, none of the claims are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The different species have different structures which would require separate searches in the art, thereby constituting a serious search and/or examination burden.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 67 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 67, the claim recites: “a capture device that captures warm air that exhausts from a heater that warms the heat exchange fluid from the first source”. The examiner does not believe that this limitation has support in the original disclosure. For instance, while it is true that the heat-transfer element of fig. 5 is disclosed as a heater/cooler there is no indication in the specification that the exhaust of heat occurs in the mode in which the heat exchange fluid from the first fluid source is heated rather than cooled. For instance, par. 31 states:
The energy capturing/converting apparatus 45 may comprise a gas-liquid heat exchanger in which warm air exhausted from a condenser of the heater/cooler H/C is used to warm a heat exchange liquid which is then circulated, by way of a second pump (not shown), through the body surface heat exchanger 46. […] In some embodiments the heater/cooler H/C may comprise a radiator style heat exchanger, 6.g., a metal heat exchanger, where air from a condenser can blow over adjacent channels or chambers in cold plates or a cold well holding saline, water or other fluid for a body surface heat exchanger.
Therefore, in the only specified embodiments it is clear that the heat that warms the air is ‘exhausted from a condenser’. By definition, a condenser is designed to transfer heat from a working fluid to a secondary fluid which can be air, and which implies that the heater/cooler is actually operating in a cooling mode which is cooling the first heat exchange fluid by transferring heat from the first heat exchange fluid to the air. Therefore, in the examiner’s opinion applicant does not have support for a heater than simultaneously warms the first heat transfer fluid while also exhausting heat to air.
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.
Claim(s) 56-58, 62-63 and 68-69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins (US 20110137249) in view of Gibbs et al. (US 5871526, “Gibbs”).
Regarding claim 56, Collins teaches a system for controlling a body temperature of a subject (Abstract, ‘An intravenous heat exchange catheter and/or an external cooling pad/bladder can be used to maintain hypothermia in, e.g., a cardiac arrest patient’), the system comprising: a first source of a heat exchange fluid (Fig. 3, saline bag 130); a first heat exchange device configured to heat or cool the body temperature of the subject by transferring heat between the heat exchange fluid and the subject (Fig. 3, catheter 128; par. 47, ‘In the embodiments shown in FIGS. 7 and 8, since two separate working fluid loops are provided, both the catheter and the bladder can be simultaneously, controlled by the controller to heat or cool a patient.’); a first pump configured to circulate the heat exchange fluid through the first heat exchange device from the first source of the heat exchange fluid (Fig. 3 and par. 38, ‘The fluid in the working fluid loop 124 circulates, under the influence of a working fluid pump 126’); a controller configured to control the first fluid working loop (Fig. 3, controller/power supply 133; par. 47, ‘ In the embodiments shown in FIGS. 7 and 8, since two separate working fluid loops are provided, both the catheter and the bladder can be simultaneously, controlled by the controller to heat or cool a patient.’); and a removable secondary heat exchange system (Fig. 7, bladder heat exchange system; par. 47, ‘In both cases, a supply line 316 to the coil 304 and a return line 318 from the bladder 300 (or from the stopcock 312 when one is used as shown in FIG. 7) terminate in quick-disconnect fittings 320, 322 as shown, for operation as described above to alert the system controller to whether the bladder is connected.’) that is configured to interface with the controller (Par. 47, ‘In the embodiments shown in FIGS. 7 and 8, since two separate working fluid loops are provided, both the catheter and the bladder can be simultaneously, controlled by the controller to heat or cool a patient.’), the removable secondary heat exchange system comprising: a second source of a heat exchange fluid (Fig. 7, saline bag 310); a second pump (Fig. 7, pump 308); a second heat exchange device through which the second pump is configured to circulate heat exchange fluid from the second source (Fig. 7, bladder 300; par. 47, ‘In any case, a bladder working fluid loop pump 308 provides the motive force for circulating the working fluid.’; alternatively, the second heat exchange device can comprise coil 304 within coldwell 306); and an electronic storage medium storing instructions (Par. 3, ‘The coolant is warmed or cooled by a computer-controlled heat exchanger that is external to the patient and that is in fluid communication with the catheter.’; a computer implies an electronic storage medium storing instructions) configured to cause the controller to control the second working fluid loop to control the body temperature of the subject (Par. 47, ‘ In the embodiments shown in FIGS. 7 and 8, since two separate working fluid loops are provided, both the catheter and the bladder can be simultaneously, controlled by the controller to heat or cool a patient.’).
While Collins teaches a controller for controlling both the bladder and catheter working fluid loops to control the body temperature of the subject (Par. 47), Collins fails to explicitly teach that the controller controls the first and second pumps to circulate the heat exchange fluid and control the body temperature of the subject.
Philips teaches an analogous system for controlling a body temperature of a subject (Co1, lines 5-10, ‘The present invention relates generally to methods and apparatus for heating and cooling patients for therapeutic purposes, and more particularly to systems for treating brain trauma and brain ischemia by inducing hypothermia in a patient.’) comprising: a first source of a heat exchange fluid (Col. 3, lines 51-57, ‘coolant’, fig. 1, e.g. heat exchanger 18); a first heat exchange device configured to heat or cool the body temperature of the subject by transferring heat between the heat exchange fluid and the subject (Fig. 1, catheter 12; col. 3, lines 51-57, ‘Thus, the catheter 12 is a closed circuit cooling system through which coolant is circulated to remove heat from the patient,’); a first pump configured to circulate the heat exchange fluid through the first heat exchange device from the first source of the heat exchange fluid (Fig. 1, pump 20 which circulates coolant between heat exchanger 18 and catheter 12); a controller (Fig. 1, controller 22) configured to control the first pump to circulate the heat exchange fluid (Col. 4, lines 26-31, ‘The controller 22 can be implemented by a software-executing processor or by discrete logic circuits or other electronic circuitry device to establish a desired patient temperature by appropriately controlling the pump 20 and/or heat exchanger 18.’; col. 2, lines 65-67, ‘As intended by the present invention, the control signal is used to establish at least one of: a speed of the coolant pump, and an energization of the TEC.’).
Therefore, in view of Philips, it would have been obvious to OOSIA at the time that the invention was filed to configure the controller to control the speed of the pumps in order to facilitate feedback control of the subject’s body temperature, as taught by Philips.
Regarding claim 68, Collins teaches a removable secondary heat exchange system (Fig. 7, bladder heat exchange system; par. 47, ‘In both cases, a supply line 316 to the coil 304 and a return line 318 from the bladder 300 (or from the stopcock 312 when one is used as shown in FIG. 7) terminate in quick-disconnect fittings 320, 322 as shown, for operation as described above to alert the system controller to whether the bladder is connected.’) that is configured to interface with a controller of a primary heat exchange system that controls a body temperature of a subject (Par. 47, ‘In the embodiments shown in FIGS. 7 and 8, since two separate working fluid loops are provided, both the catheter and the bladder can be simultaneously, controlled by the controller to heat or cool a patient.’), the removable secondary heat exchange system comprising: a source of a heat exchange fluid (Fig. 7, saline bag 310); a pump (Fig. 7, pump 308); a heat exchange device through which the pump is configured to circulate heat exchange fluid from the source of the heat exchange fluid (Fig. 7, bladder 300; par. 47, ‘In any case, a bladder working fluid loop pump 308 provides the motive force for circulating the working fluid.’); and an electronic storage medium storing instructions (Par. 3, ‘The coolant is warmed or cooled by a computer-controlled heat exchanger that is external to the patient and that is in fluid communication with the catheter.’; a computer implies an electronic storage medium storing instructions) configured to cause the controller to control the pump to control the body temperature of the subject (Collins has previously been modified in view of Philips to configure the controller to control pumps 126/308; see Philips, col. 4, lines 26-31).
Regarding claims 57 and 69, Collins, as modified, further teaches wherein the second heat exchange device /heat exchange device comprises a body surface heat exchange device (Fig. 7, bladder 300; par. 12, ‘an external heat exchange bladder configured for exchanging heat with the skin of a patient’), and wherein the first heat exchange device comprises an endovascular heat exchange device (Fig. 3, catheter 128; par. 12, ‘a closed loop heat exchange catheter configured for placement in the circulatory system of a patient to exchange heat with the blood of the patient’).
Regarding claim 58, Collins, as modified, further teaches an air trap configured to remove air from a first fluid loop in communication with the first pump or a second fluid loop in communication with the second pump (Fig. 3, air trap 132).
Regarding claim 62, Collins, as modified, further teaches a heater or cooler (Fig. 3, coldwell 120; fig. 7, coldwell 306) configured for heating or cooling one or both of the first source of the heat exchange fluid and the second source of the heat exchange fluid (Par. 38, ‘The working fluid exchanges heat with the coolant in the coldwell 120.’).
Regarding claim 63, Collins, as modified, further teaches wherein the heater or cooler comprises a coldwell (Fig. 7, coldwell 306), and wherein the second heat exchange device comprises a circulation coil through which the heat exchange fluid from the second source flows (Fig. 7, heat exchange fluid from saline bag 310 flows through bladder coil 304), the circulation coil configured to be disposed within the coldwell (Fig. 7, bladder coil 304 disposed in coldwell 306).
Claim(s) 59 and 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view Philips, as applied to claims 56-58, 62-63 and 68-69, and further in view of Frey et al. (US 20060212102, “Frey”).
Regarding claims 59 and 71, Collins, as modified, teaches wherein the controller is configured to detect that the (second) pump, the (second) source, or the (second) heat exchange device is connected for heating or cooling the body of the subject (Par. 47, ‘ In both cases, a supply line 316 to the coil 304 and a return line 318 from the bladder 300 (or from the stopcock 312 when one is used as shown in FIG. 7) terminate in quick-disconnect fittings 320, 322 as shown, for operation as described above to alert the system controller to whether the bladder is connected.’),
Collins, as modified, fails to teach wherein the controller automatically controls the (second) pump to circulate the heat exchange fluid from the (second) source in response to the detecting.
Frey teaches an analogous external heat exchange device (Fig. 1, warming blanket 21), comprising: a first source of a heat exchange fluid (Abstract, ‘air’); a first heat exchange device (Fig. 1, warming blanket 21) configured to heat or cool the body temperature of the subject by transferring heat between the heat exchange fluid and the subject (Par. 2, ‘To hypothermically warm a patient, a convective warmer to which a warming blanket is connected is used.’); a first pump configured to circulate the heat exchange fluid through the first heat exchange device from the first source of the heat exchange fluid (Fig. 1, air blower 12; par. 19, ‘Motor controller 6, with power provided from mains board 4, controls the operation of an air blower 12 which, for the purpose of this invention, may be considered a fluid mover that moves, directs or blows a fluid such as air to an outlet hose 14.’); a controller configured to control the first pump to circulate the heat exchange fluid (Fig. 1, motor controller 6; par. 19, ‘Motor controller 6, with power provided from mains board 4, controls the operation of an air blower 12 which, for the purpose of this invention, may be considered a fluid mover that moves, directs or blows a fluid such as air to an outlet hose 14.’); wherein the controller is configured to detect that the pump, the source, or the heat exchange device is connected for heating or cooling the body of the subject (Par. 10, ‘ The blanket for the combination embodiment comprises a flow rate code positioned proximate to its inlet, and the warmer of the combination comprises at least one sensor located proximate to its outlet for detecting the code’); and wherein the controller automatically controls the second pump to circulate the heat exchange fluid from the second source in response to the detecting (Par. 10, ‘such that when the inlet of the blanket is mated to the outlet of the warmer, the heated air is automatically supplied by the warmer at the flow rate indicated by the code to inflate the blanket.’).
Therefore, in view of Frey it would have been obvious to OOSIA at the time that the invention was filed to automatically activate the second pump when the controller identifies a connection of the bladder with the system and to deactivate the pump when the controller identifies a disconnection of the bladder with the system, in order to only supply heat transfer fluid to the bladder when a proper connection is detected, as taught by Frey.
Claim(s) 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view Philips, as applied to claims 56-58, 62-63 and 68-69, and further in view of Rittman (US 20070032835).
Regarding claim 60, Collins, as modified, teaches wherein the controller is configured to perform operations comprising: a first mode wherein heated or cooled heat exchange fluid is circulated through the first heat exchange device comprising an endovascular heat exchange device (Par. 46, ‘FIG. 3 may also be connected to the system using such fittings, so that in any of the embodiments herein, the controller "knows" which device or devices, catheter and/or bladder, is connected’; fig. 3, catheter working fluid loop 124); a second mode wherein heated or cooled heat exchange fluid is circulated through the second heat exchange device comprising a body surface heat exchange device (Par. 46, ‘FIG. 3 may also be connected to the system using such fittings, so that in any of the embodiments herein, the controller "knows" which device or devices, catheter and/or bladder, is connected’; fig. 3, bladder fluid loop 136); and a third mode wherein heated or cooled heat exchange fluid is circulated through both the endovascular heat exchange device and the body surface heat exchange device (Par. 14, ‘and may control both the catheter and bladder simultaneously’); and, controlling the body temperature of the subject in accordance with the selected mode of operation (Par. 12, ‘a system for controlling patient temperature includes a closed loop heat exchange catheter configured for placement in the circulatory system of a patient to exchange heat with the blood of the patient, and an external heat exchange bladder configured for exchanging heat with the skin of a patient.’).
Collins, as modified, fails to teach that controller is configured to perform the operation of: receiving, through a user interface, a selection of the mode of operation.
Rittman teaches an analogous thermotherapeutic device (Abstract, ‘A method and apparatus for diagnosing and treating neural dysfunction is disclosed […] Energy control may achieved by simultaneously comparing the tip temperature of each treatment electrode to a set temperature selected by the operator, and regulating the therapeutic energy output to maintain the set temperature.’), which comprises multiple modes of operation (Par. 36, e.g. EMG, HF or stimulate modes); a controller (Fig. 3, controls 1-3), which is configured to perform the operation of: receiving, through a user interface, a selection of a mode of operation (Fig. 7 and par. 36, ‘FIG. 7 is another exemplary embodiment. Illustrated is a mode select button, 10G, which allows the user to select between EMG, HF, and stimulate modes.’).
Therefore, in view of Rittman, it would have been obvious to OOSIA at the time that the invention was filed to provide Collins with a user-interface having a mode selection element, in order allow the user to select the operation mode of the device, as taught by Rittman.
Claim(s) 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view Philips and Rittman, as applied to claims 60, and further in view of Flint (US 20100087900).
Regarding claim 61, Collins, as modified, further teaches wherein the third mode comprises a first sub-mode wherein the endovascular heat exchange device and the body surface heat exchange device simultaneously cool or warm (Par. 47, ‘both the catheter and the bladder can be simultaneously, controlled by the controller to heat or cool a patient’), but fails to teach at least one other additional sub-mode selected from: a second sub-mode wherein one of the endovascular heat exchange device and the body surface heat exchange device cools while the other of the endovascular heat exchange device and the body surface heat exchange device warms; and a third sub-mode wherein, for an initial period, the endovascular heat exchange device and the body surface heat exchange device simultaneously cool or warm and, for a subsequent period, one of the endovascular heat exchange device and the body surface heat exchange device cools while the other of the endovascular heat exchange device and the body surface heat exchange device warms.
Flint teaches an analogous system for controlling body temperature of a subject (Abstract, ‘Methods and apparatus for the prevention and treatment of shivering encountered during therapeutic temperature regulation are disclosed that utilize an active system of counterwarming’), said system comprising: at least one endovascular heat exchange device (Fig. 2d and par. 24, ‘In some embodiments the cooling apparatus includes […] an endovascular cooling catheter.’); at least one body surface heat exchange device (Fig. 2d and par. 26, ‘In some embodiments the counterwarming elements include heating apparel, including for example heated mittens, heated booties, heated ear muffs, or heated blankets above or below the body’); a user interface (Fig. 2d and par. 65, ‘Attending medical personnel 211 select system settings, such as a target temperature setpoint, using an operator interface 209 associated with the temperature setpoint feedback device’); at least one controller which receives input from the user interface (Fig. 2D and par. 65, ‘Therapeutic cooling of the patient may be controlled by a feedback system, in which the temperature probe 202 is operatively connected (203) to a temperature set point feedback device 208 and the temperature setpoint feedback device 208 is operatively connected (207) to the cooling delivery apparatus 206. Attending medical personnel 211 select system settings, such as a target temperature setpoint, using an operator interface 209 associated with the temperature setpoint feedback device’) and is programmed to control operation of the system in a mode wherein heated or cooled heat exchange fluid is circulated through both the endovascular heat exchange device (Par. 59, ‘Typical cooling devices include a cooling blanket, or cooling pads, or an endovascular cooling catheter; and typical cooling delivery apparatus include a cooling fluid reservoir, and a fluid pump, by which cooling fluid is circulated from the reservoir through the cooling devices and back to the reservoir.’) and the body surface heat exchange device (Par. 26, ‘including in some embodiments circulating warm water (or other liquid)’), wherein during said mode one of the endovascular heat exchange device and the body surface heat exchange device cools while the other of the endovascular heat exchange device and the body surface heat exchange device warms (Par. 17, ‘In another general aspect the invention features a method for applying active counterwarming to a patient during therapeutic temperature regulation of the patient. In some such embodiments the therapeutic temperature regulation includes cooling to reduce the core temperature.’). Flint further teaches that counterwarming helps to reduce shivering during therapeutic temperature regulation (Abstract, ‘Methods and apparatus for the prevention and treatment of shivering encountered during therapeutic temperature regulation are disclosed that utilize an active system of counterwarming […]’).
Therefore, in view of Flint, it would have been obvious to OOSIA at the time that the invention was filed to further modify Collins, as modified, by providing a second sub-mode wherein one of the endovascular heat exchange device and the body surface heat exchange device cools while the other of the endovascular heat exchange device and the body surface heat exchange device warms, in order to configure the device to provide counter-warming so as to reduce shivering during therapeutic temperature regulation, as taught by Flint.
Claim(s) 64 and 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view Philips, as applied to claims 56-58, 62-63 and 68-69, and further in view of Fontenot (US 5174285)
Regarding claim 64, Collins, as modified, teaches a heater or cooler which comprises a coldwell and a second heat exchange device which comprises a coil disposed within the coldwell, but fails to teach wherein the heater or cooler comprises heat exchange plates, and wherein second heat exchange device comprises a cassette through which the heat exchange fluid from the second source flows, the cassette configured to be disposed between the heat exchange plates.
Fontenot, however, teaches an alternative means for imparting heating or cooling to a heat exchange fluid (Abstract, ‘a modular system in which a heating or cooling liquid is circulated in a hermetically sealed flow path between a heating or cooling device and a heating or cooling pad. In a preferred embodiment, the flow path includes a cassette which is reversibly engageable with a pump and a heating or cooling unit located in a housing.’) which comprises a heater or cooler comprising heat exchange plates (Abstract, ‘A thermoelectric heat pump may be configured as a flat plate or plates disposed in heat communicating relation to one or both surfaces of the heat exchange interface element 20.’), and a heat exchange device comprising a cassette (Fig. 1, cassette 7) through which the heat exchange fluid from the fluid source flows (Abstract, ‘In a preferred embodiment, the flow path includes a cassette […]’), the cassette configured to be disposed between the heat exchange plates (Col. 9, lines 12-15, ‘A thermoelectric heat pump may be configured as a flat plate or plates disposed in heat communicating relation to one or both surfaces of the heat exchange interface element 20.’).
Therefore, since both Collins and Fontenot teach alternative means for imparting heating or cooling to a heat exchange fluid flowing through a body surface heat exchange device, it would have been obvious to OOSIA at the time that the invention was filed to substitute one known means for imparting heating or cooling to a heat exchange fluid for the other in order to arrive at the predictable result of a means for imparting heating or cooling to a heat exchange fluid flowing through a body surface heat exchange device. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 75, Collins, as modified, further teaches wherein the heat exchange device a cassette (Collins has previously been modified in view of Fontenot to utilize a cassette heat exchange system; see Fontenot, fig. 1, cassette 7) through which the heat exchange fluid flows (See Fontenot, abstract, ‘In a preferred embodiment, the flow path includes a cassette […]’), the cassette configured to be disposed between heat exchange plates (See Fontenot, col. 9, lines 12-15, ‘A thermoelectric heat pump may be configured as a flat plate or plates disposed in heat communicating relation to one or both surfaces of the heat exchange interface element 20.’) having a temperature that is controlled by the controller (See Fontenot, col. 5, lines 63-68, ‘The system may also include a temperature control circuit that is capable of responding to the temperature of fluid within the conduit, by controlling the polarity and duration of application of an electrical potential to the thermoelectric heat pump.’).
Claim(s) 65-66 and 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view Philips, as applied to claims 56-58, 62-63 and 68-69, and further in view of Gibbs et al. (US 5871526, “Gibbs”).
Regarding claims 65 and 70, Collins, as modified, fails to teach wherein the removable secondary heat exchange system comprises an air separator that prevents air from entering the second pump; or an air trap (in the external bladder working fluid loop) configured to remove air from a fluid loop in communication with the pump.
Gibbs, however, teaches an analogous external heat exchange system (Abstract) comprising: a source of a heat exchange fluid (Col. 4, lines 47-50, ‘temperature control liquid’); a pump (Fig. 1, pump 10); a heat exchange device through which the pump is configured to circulate heat exchange fluid from the source of the heat exchange fluid (Fig. 1, therapy pad 16); and an air trap configured to remove air from a fluid loop in communication with the pump (Fig. 1, air-liquid separator 50).
Therefore, in view of Gibbs, it would have been obvious to OOSIA at the time that the invention was filed to provide an air-trap within the bladder working fluid loop, as taught by Gibbs, in order to increase heat-transfer efficiency between the heat-exchange device and human body by eliminating air bubbles, which can act as thermal insulators.
Regarding claim 66, Collins, as modified, further teaches wherein the removable secondary heat exchange system comprises a dual lumen spike that for connecting tubing to the second source of the heat exchange fluid (Collins has previously been modified in view of Gibbs to comprise an air-separator; see Gibbs, fig. 13, the dual lumen spike can be considered lumens 53/54 which are connected to a source of heat exchange fluid), the dual lumen spike configured to cause air to collect at a top of a reservoir of the second source of the heat exchange fluid as a liquid level lowers in the reservoir (See Gibbs, fig. 13, showing air collecting at the top of reservoir 51).
Claim(s) 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view Philips and Frey, as applied to claims 59 and 71, and further in view Rittman.
Note that the combination over Collins in view of Rittman has already been discussed with regards to claim 60, above and therefore will not be reiterated.
Regarding claim 72, Collins, as modified, further teaches wherein the controller (Fig. 1, control system 14/20) is configured to perform operations comprising, in response to the detecting: receiving, through a user interface, a selection of a mode of operation (Collins has previously been modified in view of Rittman to provide a user-interface for mode selection; see Rittman, fig. 7 and par. 36, ‘FIG. 7 is another exemplary embodiment. Illustrated is a mode select button, 10G, which allows the user to select between EMG, HF, and stimulate modes.’), the mode of operation comprising one of: a first mode wherein heated or cooled heat exchange fluid is circulated through a second heat exchange device comprising an endovascular heat exchange device (Par. 46, ‘FIG. 3 may also be connected to the system using such fittings, so that in any of the embodiments herein, the controller "knows" which device or devices, catheter and/or bladder, is connected’; fig. 3, catheter working fluid loop 124); a second mode wherein heated or cooled heat exchange fluid is circulated through the heat exchange device comprising a body surface heat exchange device (Par. 46, ‘FIG. 3 may also be connected to the system using such fittings, so that in any of the embodiments herein, the controller "knows" which device or devices, catheter and/or bladder, is connected’; fig. 3, bladder fluid loop 136); and a third mode wherein heated or cooled heat exchange fluid is circulated through both the endovascular heat exchange device and the body surface heat exchange device (Par. 14, ‘and may control both the catheter and bladder simultaneously’); and in response to receiving the selection of the mode of operation, controlling the body temperature of the subject in accordance with the selected mode of operation (Par. 12, ‘a system for controlling patient temperature includes a closed loop heat exchange catheter configured for placement in the circulatory system of a patient to exchange heat with the blood of the patient, and an external heat exchange bladder configured for exchanging heat with the skin of a patient.’).
Claim(s) 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view Philips, Frey and Rittiman, as applied to claims 72, and further in view Flint.
Note that the combination over Collins in view of Flint has already been discussed with regards to claim 61, above and therefore will not be reiterated.
Regarding claim 73, Collins, as modified, further teaches wherein the third mode comprises at least two sub- modes (Collins has previously been modified in view of Flint to include a second sub-mode in which the surface heat transfer device provides counter-warming while the endovascular catheter provides cooling) selected from: a first sub-mode wherein the endovascular heat exchange device and the body surface heat exchange device simultaneously cool or warm (Par. 47, ‘both the catheter and the bladder can be simultaneously, controlled by the controller to heat or cool a patient’); a second sub-mode wherein one of the endovascular heat exchange device and the body surface heat exchange device cools while the other of the endovascular heat exchange device and the body surface heat exchange device warms (See Flint, par. 17, ‘In another general aspect the invention features a method for applying active counterwarming to a patient during therapeutic temperature regulation of the patient. In some such embodiments the therapeutic temperature regulation includes cooling to reduce the core temperature.’); and a third sub-mode wherein, for an initial period, the endovascular heat exchange device and the body surface heat exchange device simultaneously cool or warm and, for a subsequent period, one of the endovascular heat exchange device and the body surface heat exchange device cools while the other of the endovascular heat exchange device and the body surface heat exchange device warms (The claim only requires two sub-modes).
Claim(s) 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins in view Philips, as applied to claims 56-58, 62-63 and 68-69, and further in view of Daoud (US 6719779).
Regarding claim 74, Collins, as modified, further teaches wherein the heat exchange device comprises a circulation coil through which the heat exchange fluid flows (Fig. 7, heat exchange fluid from saline bag 310 flows through bladder coil 304), the circulation coil configured to be disposed within a coldwell (Fig. 7, bladder coil 304 disposed in coldwell 306), but fails to teach that the coldwell has a temperature that is controlled by the controller.
Daoud, however, teaches an analogous device heat exchange system (Abstract, ‘The invention provides a single-use, disposable circulation set for a heat transfer catheter. ’) that is configured to interface with a controller (Col. 1, lines 15-17, ‘The present invention relates, in general, to a circulation set for a temperature-controlled catheter and, in particular, to a circulation set for a hypothermia catheter.’), the heat exchange system comprising: a source of a heat exchange fluid (Abstract, ‘disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter’); a pump (Fig. 3, pump 64); a heat exchange device through which the pump is configured to circulate heat exchange fluid from the source of the heat exchange fluid (Fig. 3, coiled heat exchanger 72); wherein the heat exchange device comprises a circulation coil through which the heat exchange fluid flows (Fig. 3, coiled heat exchanger 72); wherein the heat exchange device comprises a circulation coil through which the heat exchange fluid flows (Fig. 3, coiled heat exchanger 72), the circulation coil configured to be disposed within a coldwell (Fig. 1 and col. 9, lines 61-65, ‘n the embodiment of the circulation set illustrated in FIGS. 1 and 3, the heat exchanger 72 is a stainless steel tubing 73 that sits in a bath 102’), having a temperature that is controlled by the controller (Col. 9, line 67- col. 10, line 3, ‘A second heat exchanger (not shown) located in the control unit housing 44 regulates the temperature of the bath 102 for controlling the temperature of the heat transfer fluid in the system 20.’).
Therefore, in view of Daoud, it would have been obvious to OOSIA at the time that the invention was filed to further modify Collins, by configuring the controller to directly control the temperature of the coldwell, as taught by Daoud in order to better control the temperature of the working fluid and thus the body temperature, as taught by Daoud.
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 56-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,123,221 in view of Collins.
For instance, the following is a comparison between application claim 56 and patent claim 1.
Application claim 56
Patent Claim 1 (Note, that the order or the limitations are extensively changed to better correspond to application claim 56)
56. (New) A system for controlling a body temperature of a subject, the system comprising:
a first source of a heat exchange fluid;
a first heat exchange device configured to heat or cool the body temperature of the subject by transferring heat between the heat exchange fluid and the subject;
a first pump configured to circulate the heat exchange fluid through the first heat exchange device from the first source of the heat exchange fluid;
a controller configured to control the first pump to circulate the heat exchange fluid; and
a removable secondary heat exchange system that is configured to interface with the controller, the removable secondary heat exchange system comprising:
a second source of a heat exchange fluid;
a second pump;
a second heat exchange device through which the second pump is configured to circulate heat exchange fluid from the second source; and
an electronic storage medium storing instructions configured to cause the controller to control the second pump to control the body temperature of the subject.
1. A system for controlling body temperature of a subject, said system comprising:
‘at least one source of heat exchange fluid’
‘at least one endovascular heat exchange device’
‘at least one pumping apparatus’
‘at least one controller which receives input from the user interface and is programmed to control operation of the system in alternate modes which comprise: a) a first mode wherein heated or cooled heat exchange fluid is circulated through the at least one endovascular heat exchange device in a first fluid loop; b) a second mode wherein heated or cooled heat exchange fluid is circulated through the at least one body surface heat exchange device in a second fluid loop; and c) a third mode wherein heated or cooled heat exchange fluid is circulated through both the at least one endovascular heat exchange device in the first fluid loop and the at least one body surface heat exchange device in the second fluid loop, the first fluid loop being separate from the second fluid loop’
‘wherein said at least one controller is further programmed, and the user interface is further useable, such that when the third mode is selected the user may further select from a plurality of sub-modes in which the at least one endovascular heat exchange device and the at least one body surface heat exchange device are operable, the plurality of sub-modes comprising: i) a first sub-mode wherein the at least one endovascular heat exchange device and the at least one body surface heat exchange device simultaneously cool or warm; ii) a second sub-mode wherein a first one of the at least one endovascular heat exchange device and the at least one body surface heat exchange device cools while the other of the at least one endovascular heat exchange device and the at least one body surface heat exchange device warms; and iii) a third sub-mode wherein, for an initial period, the at least one endovascular heat exchange device and the at least one body surface heat exchange device simultaneously cool or warm and, for a subsequent period, one of the at least one endovascular heat exchange device and the at least one body surface heat exchange device cools while the other of the at least one endovascular heat exchange device and the at least one body surface heat exchange device warms;’
‘wherein the at least one controller is configured to control a first valve of the first fluid loop to control an amount that the at least one endovascular heat exchange device cools or warms;
’
‘one controller is configured to control a second valve of the second fluid loop to control an amount that the at least one body surface device cools or warms’
‘at least one body surface heat exchange device; at least one heater/cooler’
‘a user interface’
‘wherein the system further comprises a physiological variable or symptom sensor configured to sense a predetermined change in a physiological variable or occurrence of a predetermined symptom; and wherein the initial period ends and the subsequent period begins when the physiological variable or symptom sensor senses the predetermined change in a physiological variable or occurrence of the predetermined symptom.’
As can be seen from the comparison above, the only limitations not explicitly taught by patent claim 1 are related to the second fluid loop comprising a second fluid source and a pump for circulating the fluid, and the electronic storage medium for storing instructions, however these limitations are seen to be obvious over Collins, as discussed above.
Conclusion
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