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 .
Response to Amendment
The amendments filed on 12/10/2025 has been entered. Claims 1-6, and 9 have been amended; claims 11-20 have been added. Accordingly, claims 1-20 are pending and under consideration.
Response to Arguments
Applicant’s arguments filed on 12/10/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Vickers 9,284,841 B1 (previously cited) in view of Ajiri et al. US 2008/0087271 A1 (newly cited).
Claim Rejections - 35 USC § 103
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.
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 1, 4, 5, 6, 7, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Vickers 9,284,841 B1 (previously cited, hereinafter Vickers) in view of Ajiri et al. US 2008/0087271 A1 (newly cited, hereinafter Ajiri).
Regarding claim 1, Vickers discloses a heat exchange system (Fig. 3F – “heat exchanger assembly”) configured to control a temperature (Claim 10 – “controlling the temperature of fluid flowing through the assembly”) of blood of a patient (Abstract discusses the assembly work with cell culture or protein containing fluid, thus, the assembly is highly capable of controlling the temperature of blood), the heat exchange system (Fig. 3F) comprising:
a disposable component 5 (Fig. 3C – disposable bag manifold assembly 5) comprising:
a blood inlet 106 (Fig. 2 – inlet tube 106) configured to receive blood from the patient (Col. 4, line 53-55 – “The disposable bag manifold assembly 5 is filled in place where the cell culture or protein purification process fluid enters from the bottom process inlet port”; thus the inlet port 8A is also capable of receive blood from a patient) and a blood outlet 8B (Fig. 3C – outlet port 8B) configured to return blood to the patient (Col. 4, line 64-65 – “The process fluid then exits out the top process outlet port 8B”, thus the outlet port 8B is capable of delivering blood back to patient);
a first surface of the disposable component 5 (see annotated Fig. 3F below);
a second surface of the disposable component 5 (see annotated Fig. 3F below), opposite to that of the first surface (see annotated Fig. 3F below);
and a permanent component 2 (Fig. 3D – heat exchanger shell manifold assembly 2) including:
a first housing 1.1 (Fig. 3B – stainless steel plate member 1, and see annotated Fig. 3F below – plate member 1.1 which is the left-most plate member; Examiner notes that the plate member of Vickers is block-shaped, which is consistent with Applicant’s description of the housing in Par. 26 of PG-Pub) comprising:
an inlet (see annotated Fig. 3F below for the inlet of the left-most plate member 1.1) and an outlet 3B (Fig. 3B and Fig. 3F – outlet port 3B of the left-most plate member 1.1) configured to exchange thermal fluid with an external device (Col. 5, line 12-14 – “The heating/cooling fluid enters the top stainless steel heat transfer fluid inlet port 3A on the last plate in the heat exchanger shell manifold assembly 2”, and Col. 5, line 18-20 – “The flow continues through the entire series of stainless steel plate members 1 and exits out the bottom stainless steel heat transfer outlet port 3B”); and
a second housing 1.2 (see annotated Fig. 3F below – the plate member 1.2 that succeeds the left-most plate member 1.1; similarly as discussed above, Examiner notes that the plate member of Vickers is block-shaped, which is consistent with Applicant’s description of the housing in Par. 26 of PG-Pub) comprising an inlet (see annotated Fig. 3F below – inlet of the second housing 1.2) and an outlet (see annotated Fig. 3F below – outlet of the second housing 1.2) configured to exchange thermal fluid with the external device (Col. 5, line 12-14 – “The heating/cooling fluid enters the top stainless steel heat transfer fluid inlet port 3A on the last plate in the heat exchanger shell manifold assembly 2”, and Col. 5, line 18-20 – “The flow continues through the entire series of stainless steel plate members 1 and exits out the bottom stainless steel heat transfer outlet port 3B”),
wherein the disposable component 5 (Fig. 3F) is configured to be inserted between the first housing 1.1 and the second housing 1.2 (see annotated Fig. 3F below demonstrates the inserted configuration of the bag assembly 5 into the shell assembly 2; bag assembly 5, including individual bag 4, is sandwiched between the annotated first housing 1.1 and the annotated second housing 1.2) such that the first surface of the disposable component 5 (see annotated Fig. 3F below) is pressed into contact with a surface of the first housing 1.1 (see annotated Fig. 3F below – the left surface of bag 5 is in contact with the right surface of the annotated first housing 1.1) the second surface (see annotated Fig. 3F below) of the disposable component 5 (see annotated Fig. 3F below) is pressed into contact with a surface of the second housing 1.2 (see annotated Fig. 3F below – the right surface of bag 5 is in contact with the left surface of the annotated second housing 1.2).
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Annotated Fig. 3F of Vickers
However, Vickers does not disclose a first surface of the disposable component that includes a first thermal adhesive, a second surface of the disposable component that includes a second thermal adhesive, such that the first thermal adhesive of the first surface of the disposable component is pressed into contact with a surface of the first housing and the second thermal adhesive of the second surface of the disposable component is pressed into contact with a surface of the second housing.
Ajiri, in the same field of endeavor of heating body for medical purposes (Title and Par. 25), teaches first surface 2 (Fig. 1 – packaging material 2, top layer) of the disposable component 1 (Fig. 1 – heating composition 1, and Par. 25 – “disposable body warmer”) that includes a first thermal adhesive (Par. 31, and Par. 50 – “packaging material made of (a mixture film of thermal adhesive plastic component…”), a second surface 2 (Fig. 1 – packaging material 2, bottom layer) of the disposable component 1 (Fig. 1) that includes a second thermal adhesive (Par. 31, and Par. 50 – “packaging material made of (a mixture film of thermal adhesive plastic component…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disposable component of Vickers to further have its two surfaces include thermal adhesives as taught by Ajiri, in order to provide uniformity in controlling heating temperature (Par. 11 of Ajiri). Once the modification is made as discussed, each surface of the disposable component 5 of Vickers will include thermal adhesives as taught by Ajiri, thus each surface will be pressed into contact with a surface of the first/second housing. Thus, the limitation is suggested by the combination of Vickers in view of Ajiri.
Regarding claim 4, Vickers in view of Ajiri suggests the invention of claim 1. The combination further discloses wherein the disposable component 5 (Fig. 3C of Vickers) further comprises: multiple posts X (Fig. 3C of Vickers – weld lines X) that extend between the first surface and the second surface (see annotated Fig. 3F of Vickers above).
Regarding claim 5, Vickers in view of Ajiri suggests the invention of claim 1. The combination further discloses wherein the first and second surfaces of the disposable component 5 (see annotated Fig. 3F of Vickers above) are separated (Fig. 3C and Fig. 3F of Vickers – each bag 4 of disposable bag assembly 5 has a predetermined thickness)
However, the combination does not disclose the first and second surfaces of the disposable component are separated by less than a quarter inch.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the spacing between the first and second surface of Vickers’ disposable component to be less than a quarter inch, in order to fit the particular procedure being done since this claimed dimension of the disposable component does not change the bag ability to be filled with fluid. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 29 of Applicant’s PG-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 6, Vickers in view of Ajiri suggests the invention of claim 1. Vickers combination further discloses wherein the first and second surfaces of the disposable component 5 (see annotated Fig. 3F of Vickers above) are substantially flat (Fig. 3C of Vickers, and see annotated Fig. 3F of Vickers – both surfaces the disposable assembly 5 are substantially flat).
Regarding claim 7, Vickers in view of Ajiri suggests the invention of claim 1. The combination further discloses wherein the permanent component 2 (Fig. 3D of Vickers) comprises an attachment device S (Fig. 3D of Vickers – support S) for coupling the first housing 1.1 and the second housing 1.2 (see annotated Fig. 3F of Vickers above, Fig. 3D of Vickers, and Col. 4, line 42-46 of Vickers – “Also, as depicted in FIG. 3D supports S may be provided for holding the plate members in place”).
Regarding claim 12, Vickers in view of Ajiri suggests the invention of claim 1. However, the combination further discloses wherein the disposable component is a substantially hexagonal chamber through which the blood flows.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disposable component of the combination to have a substantially hexagonal chamber, since the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). In this instant case, the disposable component that is substantially rectangular will still be able to deliver blood throughout the channels with a hexagonal chamber without new and unexpected results.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Vickers in view of Ajiri as applied to claim 1 above, and further in view of Yun KR 101636340 B1 (previously cited, hereinafter Yun).
Regarding claim 2, Vickers in view of Ajiri suggests the invention of claim 1. The combination further discloses wherein the surface of the first housing 1.1 (see annotated Fig. 3F of Vickers above) is thermally conductive (Col. 4, line 32 of Vickers – “stainless steel plate members 1”).
However, Vickers does not disclose wherein the surface of the first housing comprises a first thermally conductive membrane.
Yun, in the same field of endeavor of heat exchange system (Par. 1 in the provided translation – thawing device), teaches wherein the surface of the first housing (Fig. 1 – first water pack 130) comprises a first thermally conductive membrane (Par. 24 in the provided translation – “the plasma pack (50) can be stored between the first hot water pack (130) and the second hot water pack (140) and be thawed by the temperatures of the first hot water pack (130) and the second hot water pack (140)”, and “At this time, the plasma pack (50)… rapidly lowers the surface temperature of the first hot water pack (130) and the second hot water pack (140) after coming into contact with the first hot water pack (130) and the second hot water pack (140)”; thus demonstrating the thermal exchanging capability of the pack 130).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the first housing of the combination that is a plate member allowing fluid/water to enter and making contact with the targeted component for heat exchange, for water pack of Yun since these mechanisms perform the same function of holding an amount of fluid for heat exchange via surface contact. Simply substituting one heat exchanging means for another would yield the predicable result of allowing thermal convection between the components. See MPEP 2143.
Regarding claim 3, Vickers in view of Ajiri suggests the invention of claim 1. The combination further discloses wherein the surface of the second housing 1.2 (see annotated Fig. 3F of Vickers above) is a thermally conductive (Col. 4, line 32 of Vickers – “stainless steel plate members 1”).
However, the combination does not disclose wherein the surface of the second housing comprises a second thermally conductive membrane.
Yun, in the same field of endeavor of heat exchange system (Par. 1 in the provided translation – thawing device), teaches wherein the surface of the second housing (Fig. 1 – second water pack 140, top water pack) comprises a second thermally conductive membrane (Par. 24 in the provided translation – “the plasma pack (50) can be stored between the first hot water pack (130) and the second hot water pack (140) and be thawed by the temperatures of the first hot water pack (130) and the second hot water pack (140)”, and “At this time, the plasma pack (50)… rapidly lowers the surface temperature of the first hot water pack (130) and the second hot water pack (140) after coming into contact with the first hot water pack (130) and the second hot water pack (140)”; thus demonstrating the thermal exchanging capability of the pack 140).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second housing of the combination that is a plate member allowing fluid/water to enter and making contact with the targeted component for heat exchange, for water pack of Yun since these mechanisms perform the same function of holding an amount of fluid for heat exchange via surface contact. Simply substituting one heat exchanging means for another would yield the predicable result of allowing thermal convection between the components. See MPEP 2143.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Vickers in view of Ajiri as applied to claim 1 above, and further in view of Bakke US 2004/0265168 A1 (previously cited, hereinafter Bakke).
Regarding claim 8, Vickers in view of Ajiri suggests the invention of claim 7. However, the combination does not currently disclose wherein the attachment device comprises a hinge that rotatably couples the first and second housing.
Bakke, in the same field of endeavor of heat transfer of biological fluids (Abstract), teaches wherein the attachment device 18 (Fig. 1-2 – hinge supports 18) comprises a hinge 18 (Fig. 1-2) that rotatably couples (Par. 48 – “Hinge supports 18 are attached to top case 12… allowing top case 12 to be opened for insertion or removal of bags 16”) the first 12 (Fig. 1-2 – top case 12) and second housing 14 (Fig. 1-2 – bottom case 14).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the attachment mechanism of the combination that allows the device to connect the first and second housing, for the hinge mechanism of Bakke since these mechanisms perform the same function of attaching one housing to another. Simply substituting one attaching means for another would yield the predicable result of connecting components to each other. See MPEP 2143.
Regarding claim 9, Vickers in view of Ajiri in view of Bakke suggests the invention of claim 7. The combination further discloses wherein the hinge 18 (Fig. 1-2 of Bakke) is configured to rotate the first housing 1.1 (see annotated Fig. 3F of Vickers above) and the second housing 1.2 (see annotated Fig. 3F of Vickers above) between the closed position and an open position (Par. 48 of Bakke – “Hinge supports 18 are attached to top case 12… allowing top case 12 to be opened for insertion or removal of bags 16”), wherein the closed position (Fig. 2 of Bakke shows a closed position) is a position where the surface of the first housing is pressed into contact with the first thermal adhesive and where the surface of the second housing is pressed into contact with the second thermal adhesive (Fig. 2 of Bakke; Examiner notes that once the modification is made as discussed in claim 8, the hinge 18 of Bakke is incorporated into the permanent component of Vickers, thereby connecting the plate members 1, including the first housing 1.1 and second housing 1.2, of Vickers via a hinge in the same manner of Bakke), and wherein the open position is a position where at least the surface of the first housing or the surface of the second housing is not pressed into contact with the first or second thermal adhesive (Par. 48 of Bakke – “Hinge supports 18 are attached to top case 12… allowing top case 12 to be opened for insertion or removal of bags 16”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Vickers in view of Ajiri as applied to claim 1 above, and further in view of Sites et al. US 5,730,720 A (previously cited, hereinafter Sites).
Regarding claim 10, Vickers in view of Ajiri suggests the invention of claim 1. However, the combination does not disclose wherein the first housing and the second housing are configured to form a hollow cylinder and the disposable component comprises a cylinder.
Sites, in the same field of endeavor of heat exchanger (Col. 25, line 60-61), teaches wherein the first housing 1610 (Fig. 17C-17D – clam-shell half 1610) and the second housing 1620 (Fig. 17C-17D – clam-shell half 1620) are configured to form a hollow cylinder (Fig. 17C-17F) and the disposable component 1700” (Fig. 17G – disposable blood-tube assembly 1700”) comprises a cylinder (Fig. 17G).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heat exchange system of the combination to have hollow cylindrical housings and cylindrical disposable component as taught by Sites, in order to utilize a usable clam-shell heat exchanger with a disposable blood tube (Col. 26, line 48-50 of Sites, and Col. 27, line 32-33 of Sites). Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the first, second housings, and the disposable component of Vickers in the manner of cylindrical configuration as taught by Sites, as this is a known and suitable arrangement for heat exchanger in the art, and since it is a matter of engineering design to configure the heat exchanger components in different ways, where the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Vickers in view of Ajiri as applied to claim 1 above, and further in view of Ford US 5,245,693 A (newly cited, hereinafter Ford).
Regarding claim 11, Vickers in view of Ajiri suggests the invention of claim 1. However, the combination does not disclose wherein the disposable component is comprised of stainless steel, iron, or aluminum.
Ford, in the same field of endeavor of fluid warmer apparatus (Title), teaches wherein the disposable component (Abstract – “a disposable cassette which in one presently preferred embodiment is made up of a unitary member”) is comprised of aluminum (Abstract – “Thin, flexible metallic foil membranes are sealingly joined to the unitary member”, and claim 17 – “wherein the metallic foil is aluminum”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disposable component of the combination to be comprised of aluminum as taught by Ford, in order to provide thin and flexible heat conductive membrane (Abstract of Ford).
Claims 13, 14, 15, 18, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sites.
Regarding claim 13, Sites discloses a heat exchange system 1600 (Fig. 16A – modular clam-shell heat exchanger 1600) configured to control temperature of blood of a patient (Abstract), the heat exchange system 1600 (Fig. 16A) comprising:
a disposable component 1700 (Fig. 17A – disposable blood-tube assembly 1700) comprising a blood inlet 1710 (Fig. 17A – end connector 1710, one of the two ends) configured to receive blood from the patient (Col. 26, line 30-31 – “One or more end connectors 1710 each provide a connection means to blood tubing 302”) and a blood outlet 1710 (Fig. 17A - end connector 1710, the other end) configured to blood to the patient (Col. 26, line 30-31); and
a permanent component 1601 (Fig. 17C – reusable clam-shell assembly 1601) including:
a first housing 1610 (Fig. 17C – clam-shell half 1610) that is configured to exchange thermal fluid with an external device (Col. 26, line 65-67 – “Cavity 1650 provides a path for the heat-exchange water to flow around and/or through blood-tube assembly 1700. Water nozzles 1616 provide water inlet and outlet points”) using a first fluid path 1650 (Fig. 17C – cavity 1650 of half 1610) that is defined by a first inlet 1616 (Fig. 17C – nozzle 1616, on one of the two nozzles), a first channel 1650 (Fig. 17C) of the first housing 1610 (Fig. 17C), and a first outlet 1616 (Fig. 17C – nozzle 1616, the other nozzle); and
a second housing 1620 (Fig. 17C – clam-shell half 1620) that is configured to exchange thermal fluid with the external device (Col. 26, line 65-67 – “Cavity 1650 provides a path for the heat-exchange water to flow around and/or through blood-tube assembly 1700. Water nozzles 1616 provide water inlet and outlet points”) using a second fluid path 1650 (Fig. 17C – cavity 1650 of half 1620);
a first hinge 1630 (Fig. 17C – hinge 1630, one of the two hinges) a second hinge 1630 (Fig. 17C – hinge 1630, the other hinge) that are disposed on differing ends of a side of the permanent component 1601 (Fig. 17C) and that are configured to connect the first housing 1610 and the second housing 1620 (Fig. 17C), and
wherein the disposable component 1700 (Fig. 17A) is configured to be inserted between the first housing 1610 (Fig. 16A) and the second housing 1620 (Fig. 16A) such that a first surface 1740 (Fig. 17A – O-rings 1740, one of the two ends) of the disposable component 1700 (Fig. 17A) is pressed into contact with a surface 1613+1614 (Fig. 17C – inner and outer cylindrical grooves 1613, 1614 of shell 1610) of the first housing 1610 (Fig. 16A, and Fig. 17C) and a second surface 1740 (Fig. 17A – O-rings 1740, the other end) of the disposable component 1700 (Fig. 17A) is pressed into contact with a surface 1613+1614 (Fig. 17C – inner and outer cylindrical grooves 1613, 1614 of shell 1620) of the second housing 1620 (Fig. 16A, and Fig. 17C).
However, Sites does not currently disclose a second inlet, a second channel, and a second outlet , wherein the first inlet and the first outlet are positioned such that the first inlet is nearer the first hinge than the second inlet and that the first outlet is nearer the second hinge than the second outlet.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated inlet and outlet of the first housing for the second housing since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the first inlet and first outlet, to so it was nearer the first hinge and second hinge, respectively, since applicant has not given any criticality to why the position of the inlet/outlet disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 14, Sites suggests the invention of claim 13. Sites further discloses wherein the first hinge 1630 (Fig. 17C – one of the two hinges) and the second hinge 1630 (Fig. 17C – the other hinge) rotatably couple the first housing 1610 and the second housing 1620 (Fig. 17D, Fig. 17F).
Regarding claim 15, Sites suggests the invention of claim 14. Sites further discloses wherein the first hinge 1630 (Fig. 17C – one of the two hinges) and the second hinge 1630 (Fig. 17C – the other hinge) are configured to rotate the first housing 1610 (Fig. 17C) and the second housing 1620 (Fig. 17C) between a closed position (Fig. 17D) and an open position (Fig. 17F), wherein the closed position (Fig. 17D) is a position where the first surface 1740 (Fig. 17A – O-rings 1740, one of the two ends) of the disposable component 1700 (Fig. 17A) is pressed into contact with the surface 1613+1614 (Fig. 17C – inner and outer cylindrical grooves 1613, 1614 of shell 1610) of the first housing 1610 (Fig. 16A, and Fig. 17C) and the second surface 1740 (Fig. 17A – O-rings 1740, the other end) of the disposable component 1700 (Fig. 17A) is pressed into contact with the surface 1613+1614 (Fig. 17C – inner and outer cylindrical grooves 1613, 1614 of shell 1620) of the second housing 1620 (Fig. 16A, and Fig. 17C), and wherein the open position (Fig. 16A, Fig. 17F) is a position where at least the surface 1613+1614 (Fig. 17C – inner and outer cylindrical grooves 1613, 1614 of shell 1620) of the second housing 1620 (Fig. 16A) is not pressed into contact with the first surface 1740 (Fig. 17A – O-rings 1740, one of the two ends) of the disposable component 1700 (Fig. 17A) or the second surface 1740 (Fig. 17A – O-rings 1740, the other end) of the disposable component 1700 (Fig. 17A).
Regarding claim 18, Sites suggests the invention of claim 13. Sites further discloses wherein the disposable component 1700 (Fig. 17A) further comprises:
multiple posts 1730 (Fig. 17A – heat-exchange tubes 1730) that extend between the first surface 1740 (Fig. 17A – one of the two ends) and the second surface 1740 (Fig. 17A – one of the two ends).
Regarding claim 19, Sites suggests the invention of claim 13. However, Sites does not currently disclose wherein the first and second surfaces of the disposable component are substantially flat and form a substantially hexagonal chamber through which the blood flows.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disposable component of the Sites to have be substantially flat with hexagonal chamber, since the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). In this instant case, the disposable component that is substantially rectangular will still be able to deliver blood throughout the channels with a hexagonal chamber without new and unexpected results.
Regarding claim 20, Sites suggests the invention of claim 13. Sites further discloses wherein the first housing 1610 and the second housing 1620 (Fig. 17C) are configured to form a hollow cylinder (Fig. 17D, Fig. 17F) and the disposable component 1700 comprises a cylinder (Fig. 17A).
14. Claim(s) 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sites as applied to claim 13 above, and further in view of Yun.
Regarding claim 16, Sites suggests the invention of claim 13. However, Sites does not disclose wherein the surface of the first housing comprises a first thermally conductive membrane.
Yun, in the same field of endeavor of heat exchange system (Par. 1 in the provided translation – thawing device), teaches wherein the surface of the first housing (Fig. 1 – first water pack 130) comprises a first thermally conductive membrane (Par. 24 in the provided translation – “the plasma pack (50) can be stored between the first hot water pack (130) and the second hot water pack (140) and be thawed by the temperatures of the first hot water pack (130) and the second hot water pack (140)”, and “At this time, the plasma pack (50)… rapidly lowers the surface temperature of the first hot water pack (130) and the second hot water pack (140) after coming into contact with the first hot water pack (130) and the second hot water pack (140)”; thus demonstrating the thermal exchanging capability of the pack 130).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the first housing of the combination that is a shell member allowing fluid/water to enter and making contact with the targeted component for heat exchange, for a thermally conductive membrane of Yun since these mechanisms perform the same function of holding an amount of fluid for heat exchange via surface contact. Simply substituting one heat exchanging means for another would yield the predicable result of allowing thermal convection between the components. See MPEP 2143.
Regarding claim 17, Sites suggests the invention of claim 13. However, the combination does not disclose wherein the surface of the second housing comprises a second thermally conductive membrane.
Yun, in the same field of endeavor of heat exchange system (Par. 1 in the provided translation – thawing device), teaches wherein the surface of the second housing (Fig. 1 – second water pack 140, top water pack) comprises a second thermally conductive membrane (Par. 24 in the provided translation – “the plasma pack (50) can be stored between the first hot water pack (130) and the second hot water pack (140) and be thawed by the temperatures of the first hot water pack (130) and the second hot water pack (140)”, and “At this time, the plasma pack (50)… rapidly lowers the surface temperature of the first hot water pack (130) and the second hot water pack (140) after coming into contact with the first hot water pack (130) and the second hot water pack (140)”; thus demonstrating the thermal exchanging capability of the pack 140).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the second housing of the combination that is a plate member allowing fluid/water to enter and making contact with the targeted component for heat exchange, for a thermally conductive membrane of Yun since these mechanisms perform the same function of holding an amount of fluid for heat exchange via surface contact. Simply substituting one heat exchanging means for another would yield the predicable result of allowing thermal convection between the components. See MPEP 2143.
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781