DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 3,430,688 to Crocker (Crocker).
Regarding claim 17, Crocker teaches a wearable heat exchange device (title “Liquid Cooled Garment”) comprising a plurality of tubes (20 and Col. 1, lines 44-50 which state in part “The liquid cooled heat exchanging garment of this invention uses a series of flexible polyvinyl or polyethylene tubes which are joined together in such a way to form a network of heat exchanging tubes from which the garment is constructed.”), at least one tube of the plurality of tubes having a lumen configured to receive fluid (Col. 2, lines 33-36 which state in part “The heat exchanging fluid passes from this manifold upwardly across the arm of the wearer through flexible tubes 20…”), the at least one tube configured to allow for fluid flow through the lumen (Col. 2, lines 33-36), the plurality of tubes interconnected into a pattern such that the plurality of interconnected tubes is configured to conform into a wearable three-dimensional shape (Figs. 1 and 2), the pattern being stretchable at least along a first axis and at least along a second axis that is different from the first axis (Col. 3, lines 4-25).
Regarding claim 18, Crocker teaches the device of claim 17 as well as wherein the plurality of interconnected tubes form a conformable fabric or material that is conformable to a three dimensional surface (Figs. 1 and 2).
Regarding claim 19, Crocker teaches the device of claim 17 as well as wherein fluid flow in at least one tube of the plurality of tubes is configured to heat or cool the at least one tube, and wherein the at least one tube is configured to perform heat transfer with an object in contact with the at least one tube, the heat transfer being based on the fluid flow through the at least one tube (Col. 2, line 30-Col. 3, line 4).
Regarding claim 20, Crocker teaches the device of claim 18 as well as wherein the conformable fabric or material is comprised solely of the plurality of tubes (Col. 1, lines 37-43).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4-7, 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crocker in view of US 2013/0138185 A1 to Paxman et al. (Paxman).
Regarding claim 1, Crocker teaches a system (see for example Figs. 1 and 2) for providing external heat exchange to a patient, the system comprising a wearable heat exchange device (title “Liquid Cooled Garment”) for placement on the patient, the heat exchanging device comprising a plurality of tubes (20 and Col. 1, lines 44-50 which state in part “The liquid cooled heat exchanging garment of this invention uses a series of flexible polyvinyl or polyethylene tubes which are joined together in such a way to form a network of heat exchanging tubes from which the garment is constructed.”), at least one tube of the plurality of tubes having a lumen configured to receive fluid (Col. 2, lines 33-36 which state in part “The heat exchanging fluid passes from this manifold upwardly across the arm of the wearer through flexible tubes 20…”), the at least one tube configured to allow for fluid flow through the lumen (Col. 2, lines 33-36), the plurality of tubes interconnected into a pattern such that the plurality of interconnected tubes is configured to conform into a wearable three-dimensional shape (Figs. 1 and 2), the pattern being stretchable at least along a first axis and at least along a second axis that is different from the first axis (Col. 3, lines 4-25), a pump (23) configured to pump fluid through the at least one tube of the plurality of tubes and a heat exchanger (24) in thermal communication with the fluid for flowing through the lumen of the at least one tube of the plurality of tubes to heat or cool the at least one tube.
Crocker does not teach a control console comprising the pump, the heat exchanger, a controller configured to control operation of the pump, or a user interface configured to receive inputs for controlling the pump and to display operational data for operation of the pump.
Paxman teaches an analogous system (body part temperature regulating apparatus 10) for providing external heat exchange to a patient, the system comprising a heat exchange device (cap 210) for placement on the patient ([0179] which states “The scalp cooling attachment 200 comprises a cap 210 for placing over the scalp of a patient”), comprising a plurality of tubes (tubing 212 and flexible hosing 220) with at least one of the tubes having a lumen configured to receive fluid for flowing through the lumen ([0180] which states “The scalp cooling attachment 200 also comprise two lengths of flexible hosing 220 which connect the scalp 210 to the outlet connection 184 and the return connection 182, respectively. The flexible hosing 220 terminates at the cap 210 in such a way as to promote good fluid movement of the coolant 190 around the cap 210, and thereby promote efficient heat transfer from the patient's scalp.”), a control console (refrigeration and control unit 100) comprising a pump (pump 120) configured to pump liquid through the at least one tube of the plurality of tubes, a heat exchanger (heat exchanger 110) in thermal communication with the fluid for flowing through the lumen of the at least one tube of the plurality of tubes to heat or cool the at least one tube, a controller (controller 130) configured to control operation of the pump ([0170] which states in part “…a controller 130 arranged to output control signals via outputs 131 and 132 to control operation of the heat exchanger 110 and pump 120, respectively.”), and a user interface (user I/O 139) configured to receive inputs for controlling the pump and to display operation data for operation of the pump ([0189-0191]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Crocker to include the control console of Paxman to allow for precise control of the temperature of the device as taught by Paxman (Fig. 7).
Regarding claim 4, Crocker the combination teaches the system of claim 1 as well as Crocker teaching wherein the plurality of interconnected tubes form a conformable fabric or material that is conformable to a three dimensional surface (Figs. 1 and 2).
Regarding claim 5, the combination teaches the system of claim 1 as well as Crocker teaching wherein fluid flow in at least one tube of the plurality of tubes is configured to heat or cool the at least one tube, and wherein the at least one tube is configured to perform heat transfer with an object in contact with the at least one tube, the heat transfer being based on the fluid flow through the at least one tube (Col. 2, line 30-Col. 3, line 4).
Regarding claim 6, the combination teaching the system of claim 4 as well as Crocker teaching wherein the conformable fabric or material is comprised solely of the plurality of tubes (Col. 1, lines 37-43).
Regarding claim 7, the combination teaches the system of claim 1 as well as wherein the plurality of tubes are interconnected in a conformable knit pattern (Fig. 9), the conformable knit pattern being stretchable at least along the fist axis in a first dimension and at least along the second axis in a second dimension (Col. 4, lines 4-31).
Regarding claim 14, the combination teaches the system of claim 1 as well as Croker teaching a pump tube (Fig. 1) that is configured to interface with the pump, the pump tube being connected to the at least one tube of the plurality of tubes in a closed loop (Fig. 1).
Regarding claim 16, the combination teaches the system of claim 1 as well as Crocker teaching wherein the plurality of interconnected tubes form a conformable fabric or material (Figs. 1 and 2), wherein the fabric or material comprises edge pieces (see for example 16, 21, 22) or the tubing of the plurality of interconnected tubes forms edging of the fabric or material.
Claim(s) 2, 3 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crocker and Paxman as applied to claim 1 above, and further in view of US 2018/0207024 A1 to Dabrowiak et al. (Dabrowiak).
Regarding claim 2, Crocker in view of Paxman teaches the system of claim 1, as well as Paxman teaching a connector (230) that allows fluid communication with another device in series ([0199]) but not an intravenous catheter connected in series or in parallel with the heat exchange device. Dabrowiak teaches an analogous system (body temperature management system 10) to that of Crocker and Paxman including a control console (10a) which is useable to control both an endovascular heat exchange catheter (44) and a body surface heat exchange apparatus (for example 46v/46t). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Crocker in view of Paxman to include the intravenous catheter of Dabrowiak to allow for a combination of intravenous and body surface heat exchange to control a patient’s body temperature (abstract).
Regarding claim 3, Croker in view of Paxman teaches the system of claim 1, but not a cartridge configured to interface with the heat exchanger of the control console to exchange heat with the heat exchanger, the cartridge configured for fluid communication with the heat exchange device. Dabrowiak teaches an analogous system (body temperature management system 10) to that of Crocker and Paxman including a control console (10a) which is useable to control both an endovascular heat exchange catheter (44) and a body surface heat exchange apparatus (for example 46v/46t). The control console (10a) includes heating/cooling apparatus (32), at least one pump (34), programmable controller (36), and a user interface (38) that displays system information and also receives a user input and displays information ([0022]). The heater/cooler (32) may include a refrigerant circuit including heat exchange plates having chambers through which refrigerant and/or other fluids flow. The heat exchange plates may be configured to receive a heat exchange cassette through which heat exchange fluid flows, such that the refrigerant, other fluid, e.g. water, and/or the heat exchange fluid are in thermal contact with each other to facilitate heat exchange between the fluids or the heat/cooler may include a refrigerant circuit, cold well, and/or heat exchange coil, which may be positionable within the cold well. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Croker in view of Paxman to utilize the heater/cooler configuration of Dabrowiak as an obvious substitution of one known heater/cooler for another. This is especially true as Dabrowiak teaches both a cassette and cold well configuration as alternative embodiments for the heater/cooler.
Regarding claim 15, Crocker in view of Paxman teaches the system of claim 14, but not wherein the pump is a peristaltic pump configured to drive fluid through the pump tube and the at least one tube of the plurality of tubes. Dabrowiak teaches an analogous system (body temperature management system 10) to that of Crocker in view of Paxman including a control console (10a) which is useable to control both an endovascular heat exchange catheter (44) and a body surface heat exchange apparatus (for example 46v/46t). The control console (10a) includes heating/cooling apparatus (32), at least one pump (34), programmable controller (36), and a user interface (38) that displays system information and also receives user input and displays information ([0022]). The pump is a peristaltic pump (Figs. 8A-9B). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Crocker in view of Paxman to have utilized peristaltic pump of Dabrowiak as an obvious matter of engineering design choice.
Allowable Subject Matter
Claims 8-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794