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 .
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).
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Claims 1-3 and 5-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 8-10 of U.S. Patent No. 11918719 B2 (referred to as “Tommasi”) in view of Silvestri et al. (WO 2015104725 A1, hereafter “Silvestri”).
Regarding claim 1 of the instant application, claim 1 of Tommasi discloses a blood processing apparatus comprising:
a housing having a first end and a second end, with a blood inlet at the first end (column 8 lines 24-25);
a heat exchanger fluid inlet and a heat exchanger fluid outlet at the second end (column 8 lines 26-27);
a heat exchanger core situated in the housing (column 8 line 28);
a cylindrical shell extending coaxially about the heat exchanger core (column 8 lines 29-30);
a blood flow distributor in fluid communication with the blood inlet near the first end and configured to direct blood from the blood inlet at the first end through the blood flow distributor to the heat exchanger chamber (column 8 lines 31-34);
a plurality of heat exchanger hollow fibers disposed in the heat exchanger chamber, the heat exchanger hollow fibers configured to direct heat exchanger fluid from the heat exchanger fluid inlet at the second end through the heat exchanger hollow fibers to a fluid flow distributor near the first end (column 8 lines 38-43); and
a central chamber disposed in the heat exchanger core and in fluid communication with a plurality of fluid distributing apertures in the fluid flow distributor, the central chamber configured to direct the heat exchanger fluid from the plurality of fluid distributing apertures in the fluid flow distributor near the first end through the central chamber to the heat exchanger fluid outlet at the second end (column 8 lines 47-54).
However, claim 1 of Tommasi fails to disclose a cylindrical shell defining a heat exchanger chamber defined between an exterior of the heat exchanger core and an interior of the cylindrical shell, and wherein at least for some portion of the heat exchanger chamber, the blood and heat exchanger fluid flow in generally opposing directions
Silvestri teaches a similar device in the same field of endeavor with a cylindrical shell (62) defining a heat exchanger chamber (void inside the shell, fig. 5A and 6) defined between an exterior of the heat exchanger core (40) and an interior of the cylindrical shell (62), and wherein at least for some portion of the heat exchanger chamber, the blood and heat exchanger fluid flow in generally opposing directions (fluid outlet 28 may be disposed at the opposite end of the fluid inlet 29, see fig. 8 where blood inlet would be where fluid outlet is).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Tommasi and incorporate the heat exchanger chamber and directional flow of Silvestri because having both radial and longitudinal directional flow can improve heat transfer (page 11 paragraph 3).
Regarding claim 2, the combination of Tommasi and Silvestri discloses the apparatus of claim 1. Claim 1 of Tommasi further discloses wherein the blood flow distributor defines a plurality of radially distributed blood distributing apertures spaced around a circumference of the blood flow distributor (column 8 lines 35-37).
Regarding claim 3, the combination of Tommasi and Silvestri discloses the apparatus of claim 2. Claim 1 of Tommasi further discloses wherein the fluid flow distributor defines a plurality of radially distributed fluid distributing apertures equally spaced around a circumference of the fluid flow distributor (column 8 lines 43-46).
Regarding claim 5, the combination of Tommasi and Silvestri discloses the apparatus of claim 1. Claim 3 of Tommasi discloses wherein the cylindrical shell further includes an annular shell aperture near the second end and configured to direct blood from the heat exchanger chamber to an exterior of the cylindrical shell (column 8 lines 58-62).
Regarding claim 6, the combination of Tommasi and Silvestri discloses the apparatus of claim 1. Claim 4 of Tommasi discloses an inlet chamber in fluid communication with the heat exchanger fluid inlet and an entirety of the heat exchanger hollow fibers near the second end (column 8 lines 63-67).
Regarding claim 7, the combination of Tommasi and Silvestri discloses the apparatus of claim 1. Claim 5 of Tommasi discloses a post chamber in fluid communication with an entirety of the heat exchanger hollow fibers and the fluid flow distributor near the first end (column 9 lines 1-5).
Regarding claim 8, the combination of Tommasi and Silvestri discloses the apparatus of claim 1. Claim 6 of Tommasi discloses wherein the blood flow distributor and the fluid flow distributor are portions of a multi-flow distributor (column 9 lines 6-8).
Regarding claim 9, the combination of Tommasi and Silvestri discloses the apparatus of claim 1. Claim 8 of Tommasi discloses wherein the blood flow distributor is disposed 5 percent to 35 percent of a length of the housing from the first end (column 9 lines 13-15).
Regarding claim 10, the combination of Tommasi and Silvestri discloses the apparatus of claim 1. Claim 9 of Tommasi discloses wherein the fluid flow distributor is disposed 5 percent to 35 percent of a length of the housing from the first end (column 9 lines 16-18).
Regarding claim 11, the combination of Tommasi and Silvestri discloses the apparatus of claim 5. Claim 10 of Tommasi discloses wherein the annular shell aperture is disposed 5 percent to 25 percent of a length of the housing apart from the second end (column 19-21).
Regarding claim 12 of the instant application, claim 11 of Tommasi discloses a blood processing apparatus comprising:
a housing having a first end and a second end, with a blood inlet at the first end (column 9 lines 22-24);
a heat exchanger fluid inlet and a heat exchanger fluid outlet at the second end (column 9 lines 25-26);
a heat exchanger core situated in the housing (column 9 line 27);
a cylindrical shell extending coaxially about the heat exchanger core with an annular shell aperture near the second end (column 9 lines 28-30),
a blood flow distributor in fluid communication with the blood inlet near the first end and configured to direct blood from the blood inlet through the blood flow distributor to the heat exchanger chamber, and through the annular shell aperture to an exterior of the cylindrical shell near the second end (column 9 lines 31-36);
a plurality of heat exchanger hollow fibers disposed in the heat exchanger chamber such that heat exchanger fluid flows from the heat exchanger fluid inlet through an inlet chamber to an entirety of the heat exchanger hollow fibers near the second end, and to a post chamber in fluid communication with the entirety of the heat exchanger hollow fibers near the first end (column 9 lines 40-46); and
a fluid flow distributor disposed near the first end and in fluid communication with the post chamber, wherein the fluid flow distributor defines a plurality of radially distributed fluid distributing apertures equally spaced around a circumference of the fluid flow distributor (column 9 lines 47-51).
However, Tommasi fails to disclose the cylindrical shell defining a heat exchanger chamber defined between an exterior of the heat exchanger core and an interior of the cylindrical shell and wherein at least for some portion of the heat exchanger chamber, the blood and heat exchanger fluid flow in generally opposing directions.
Silvestri teaches a similar device in the same field of endeavor with a cylindrical shell (62) defining a heat exchanger chamber (void inside the shell, fig. 5A and 6) defined between an exterior of the heat exchanger core (40) and an interior of the cylindrical shell (62), and wherein at least for some portion of the heat exchanger chamber, the blood and heat exchanger fluid flow in generally opposing directions (fluid outlet 28 may be disposed at the opposite end of the fluid inlet 29, see fig. 8 where blood inlet would be where fluid outlet is).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Tommasi and incorporate the heat exchanger chamber and directional flow of Silvestri because having both radial and longitudinal directional flow can improve heat transfer (page 11 paragraph 3).
Regarding claims 13 and 14, the combination of Tommasi and Silvestri discloses the apparatus of claim 12, and are found in claim 11 of Tommasi: wherein the plurality of radially distributed fluid distributing apertures extend radially through the fluid flow distributor (the apertures need to extend through the distributor in order to be an aperture/opening/area void of material) and are spaced apart around a circumference of the fluid flow distributor (column 9 lines 47-51), and wherein the blood flow distributor defines a plurality of radially distributed blood distributing apertures spaced around a circumference of the blood flow distributor (column 9 lines 36-39).
Regarding claim 16, the combination of Tommasi and Silvestri discloses the apparatus of claim 12. Claim 12 of Tommasi discloses wherein the heat exchanger chamber is defined by an exterior of the heat exchanger core and an interior of the cylindrical shell (column 9 lines 52-54).
Regarding claim 17, the combination of Tommasi and Silvestri discloses the apparatus of claim 12. Claim 13 of Tommasi discloses a central chamber disposed in the heat exchanger core in fluid communication with the fluid flow distributor, the central chamber configured to direct the heat exchanger fluid from the post chamber near the first end through the central chamber to the heat exchanger fluid outlet at the second end (column 10 lines 1-6).
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.
Claim(s) 1-2, 5-11 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ikeda et al. (US 20020039543 A1, hereafter “Ikeda”) in view of Silvestri (WO 2015104725 A1).
Regarding claim 1, Ikeda teaches a blood processing apparatus (i.e. oxygenator of hollow membrane type, [Abstract]) comprising:
a housing (21/22/23) having a first end (formed by (23)) and a second end (formed by (22)) (Fig. 1), with a blood inlet (24) at the first end (23) (Fig. 1);
a heat exchanger fluid inlet (28) and a heat exchanger fluid outlet (29) at the second end (22) (Fig. 1);
a heat exchanger core (32) situated in the housing (21) (Fig. 12);
a cylindrical shell (5) extending coaxially about the heat exchanger core (32) (Fig. 12) and defining a heat exchanger chamber defined between an exterior of the heat exchanger core (32) and an interior of the cylindrical shell (5, Fig. 12);
a blood flow distributor (at least grooves (51) and openings (55)) in fluid communication with the blood inlet near the first end and configured to direct blood from the blood inlet at the first end through the blood flow distributor to a heat exchanger chamber ([0038], Figs. 11-12, 17);
a plurality of heat exchanger elements (i.e. a bellows type heat exchanger having a plurality of hollow annular projections, [0075]) disposed in the heat exchanger chamber (space between (32) and (5)) (See Fig. 12), the heat exchanger elements configured to direct heat exchanger fluid from the heat exchanger fluid inlet at the second end through the heat exchanger hollow fibers to a fluid flow distributor (formed by (32a)) near the first end (See Fig. 10); and
a central chamber disposed in the heat exchanger core and in fluid communication with a plurality of fluid distributing apertures (annotated Figure below) in the fluid flow distributor, the central chamber (42) configured to direct heat exchanger fluid from the fluid flow distributor near the first end through the central chamber to the heat exchanger fluid outlet (29) at the second end (See Fig. 11).
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Ikeda fails to teach that the heat exchange elements are formed from hollow fibers, and that the heat exchange medium flows through the fibers, and wherein at least for some portion of the heat exchanger chamber, the blood and heat exchanger fluid flow in generally opposing directions.
Silvestri teaches a heat exchange oxygenator (1) (See Fig. 1) wherein the heat exchanger comprises a plurality of hollow fibers, through which the heat exchange medium flow, and which are positioned between a heat exchanger core (140), and a cylindrical shell (62), and wherein at least for some portion of the heat exchanger chamber, the blood and heat exchanger fluid flow in generally opposing directions (fluid outlet 28 may be disposed at the opposite end of the fluid inlet 29, see fig. 8 where blood inlet would be where fluid outlet is).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to replace the bellow heat exchanger of Ikeda with the hollow fiber heat exchanger of Silvestri for the predictable of heating the blood. The simple substitution of one known element for another to obtain a predictable result is obvious to one of ordinary skill. See KSR, 550 U.S. at 416, 82 USPQ2d at 1395; See MPEP 2143(I)(A), 2143(I)B).
Regarding claim 2, the combination of Ikeda and Silvestri discloses the apparatus of claim 1. Ikeda fails to teach that the blood flow distributor defines a plurality of radially distributed blood distributing apertures spaced around a circumference of the blood flow distributor. Silvestri teaches a blood flow distributor (upstream section of heat exchanger core (140)) which defines a plurality of radially distributed blood distributing apertures (core apertures (154)) spaced around a circumference of the blood flow distributor (Fig. 4A). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Ikeda based on the teachings of Silvestri and to provide a plurality of radially distributed blood distributing apertures spaced around a circumference of the blood flow distributor, in order to cause a radial flow of blood and in order to ensure equal and uniform flow over the heat exchanger fibers [0030-0032]. One of ordinary skill would have found it obvious to modify the device of Ikeda by replacing the blood flow distributing apertures with those of Silvestri for the purpose of providing flow to the entire fiber bundle and with the reasonable expectation that the device would operate as desired and with a high degree of gas exchange.
Regarding claim 5, the combination of Ikeda and Silvestri discloses the apparatus of claim 1. Ikeda teaches wherein the cylindrical shell further includes an annular shell aperture (55), but is silent as to its axial position. Silvestri teaches the cylindrical shell (62) having an annular shell aperture (70) near the second end (i.e. the end opposite the blood inlet) and configured to direct blood from the heat exchanger chamber to an exterior of the cylindrical shell (See Fig. 8). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Ikeda with the teachings of Silvestri and to provide the shell aperture as claimed in order to create an axial flow as desired by Silvestri. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Regarding claim 6, the combination of Ikeda and Silvestri discloses the apparatus of claim 1. Ikeda in view of Silvestri further teaches an inlet chamber in fluid communication with the heat exchanger fluid inlet and the entirety of the heat exchanger hollow fibers near the second end, at least because the heat exchanger fiber arrangement of Silvestri as incorporated into Ikeda necessarily provides an inlet chamber (portion of housing receiving both fiber and the incoming flow of heat exchange medium), and further because all elements and portions of a fluid flow path are in fluid communication.
Regarding claim 7, the combination of Ikeda and Silvestri discloses the apparatus of claim 1. Ikeda in view of Silvestri further teaches a post chamber (Ikeda, formed by (23a)) in fluid communication with the entirety of the heat exchanger hollow fibers (because all elements and portions of a fluid flow path are in fluid communication), and the fluid flow distributor near the first end (See Fig. 11).
Regarding claim 8, the combination of Ikeda and Silvestri discloses the apparatus of claim 1. Ikeda further teaches that the blood flow distributor and the fluid flow distributor are portions of a multi-flow distributor (including at least portions (23, 24, or 32)).
Regarding claims 9-11, Ikeda in view of Silvestri teaches the device of claim 1, but fails to specifically recite the relative positioning and size of the elements as claimed. In particular, wherein the blood flow distributor is disposed 5 percent to 35 percent of a length of the housing from the first end, wherein the fluid flow distributor is disposed 5 percent to 35 percent of a length of the housing from the first end, and wherein the annular shell aperture is disposed 5 percent to 25 percent of a length of the housing apart from the second end.
However, since in the proposed combination of Ikeda and Silvestri, the blood flow distributor is disposed substantially at or near the first end, the fluid flow apertures are disposed substantially at or near the second end, and the annular shell apertures are disposed substantially at or near the second end, the device having the relative dimensions as claimed would not perform any differently than the device of the prior art. Therefore, the device of the claims is not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), 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.
Regarding claim 18, Ikeda teaches a method of directing blood and heat exchanger fluid through a blood processing apparatus comprising:
providing a blood processing apparatus having:
a housing (21/22/23) having a first end (formed by (23)) and a second end (formed by (22)) (Fig. 1);
a blood inlet (24) at the first end (23) (Fig. 1);
a heat exchanger fluid inlet (28) and a heat exchanger fluid outlet (29) at the second end (22) (Fig. 1);
a heat exchanger core (32) situated in the housing (21) (Fig. 12);
a cylindrical shell (5) extending coaxially about the heat exchanger core (32) (Fig. 12) and defining a heat exchanger chamber defined between an exterior of the heat exchanger core (32) (Fig. 12) and an interior of the cylindrical shell (5);
a blood flow distributor (at least grooves (51) and openings (55)) in fluid communication with the blood inlet near the first end and configured to direct blood from the blood inlet at the first end through the blood flow distributor to a heat exchanger chamber ([0038], Figs. 11-12, 17) in a first direction, and through an annular shell aperture (55) to an exterior of the cylindrical shell; and
a plurality of heat exchanger elements (i.e. a bellows type heat exchanger having a plurality of hollow annular projections, [0075]) disposed in the heat exchanger chamber (space between (32) and (5)) (See Fig. 12), the heat exchanger elements configured to direct heat exchanger fluid from the heat exchanger fluid inlet at the second end, along the heat exchanger element (i.e. along the inner surface) through the heat exchanger hollow fibers to a fluid flow distributor (formed by (32a)) near the first end (See Fig. 10) in a second direction; and
Ikeda fails to teach that the heat exchange elements are formed from hollow fibers, and that the heat exchange medium flows through the fibers, and that the entirety of the heat exchanger hollow fibers near the second end, and to a post chamber in fluid communication with the entirety of the heat exchanger hollow fibers near the first end and wherein at least over some portion of the heat exchanger chamber, blood and the heat exchanger fluid flow in generally opposing directions.
Silvestri teaches a heat exchange oxygenator (1) (See Fig. 1) wherein the heat exchanger comprises a plurality of hollow fibers, through which the heat exchange medium flow, and which are positioned between a heat exchanger core (140), and a cylindrical shell (62), and that the entirety of the heat exchanger hollow fibers near the second end, and to a post chamber in fluid communication with the entirety of the heat exchanger hollow fibers near the first end and wherein at least for some portion of the heat exchanger chamber, the blood and heat exchanger fluid flow in generally opposing directions (fluid outlet 28 may be disposed at the opposite end of the fluid inlet 29, see fig. 8 where blood inlet would be where fluid outlet is). Silvestri is interpreted to meet the limitations regarding the flow through the entirety of the hollow fibers, at least because the plurality of hollow fibers may be arbitrarily defined as any portion of the totality of hollow fibers.
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to replace the bellow heat exchanger of Ikeda with the hollow fiber heat exchanger of Silvestri for the predictable of heating the blood. Th simple substitution of one known element for another to obtain a predictable result is obvious to one of ordinary skill. See KSR, 550 U.S. at 416, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976). See MPEP 2143(I)(A), 2143(I)B).
Ikeda teaches wherein the cylindrical shell further includes an annular shell aperture (55), but is silent as to its axial position. Silvestri teaches the cylindrical shell (62) having an annular shell aperture (70) near the second end (i.e. the end opposite the blood inlet) and configured to direct blood from the heat exchanger chamber to an exterior of the cylindrical shell (See Fig. 8). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Ikeda with the teachings of Silvestri and to provide the shell aperture as claimed in order to create an axial flow as desired by Silvestri. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395
Regarding the steps of directing blood from the blood inlet at the first end in a first direction through the blood flow distributor to the exterior of the heat exchanger core in the heat exchange chamber, and through the annular shell aperture near the second end; and
directing heat exchanger fluid in a second direction from the heat exchanger fluid inlet at the second end through the heat exchanger hollow fibers to a fluid flow distributor near the first end and to the central chamber and to the heat exchanger fluid outlet at the second end;
the steps as claimed are interpreted to be at least implicit or obvious over the combination of Ikeda in view of Silvestri because the steps are in essence a statement to use the device in the manner intended. The combination of Ikeda in view of Silvestri is therefore interpreted to perform the steps during the normal operation.
Regarding claim 19, the combination of Ikeda and Silvestri is interpreted to perform the step of directing heat exchanger fluid from the heat exchanger inlet through an inlet chamber to the entirety of the heat exchanger hollow fibers. Ikeda in view of Silvestri is interpreted to meet the limitations regarding the flow through the entirety of the hollow fibers, at least because the plurality of hollow fibers may be arbitrarily defined as any portion of the totality of hollow fibers.
Regarding claim 20, the combination of Ikeda and Silvestri is interpreted to perform the step of directing heat exchanger fluid from the entirety of the heat exchanger hollow fibers through a post chamber to the fluid flow distributor. Ikeda in view of Silvestri is interpreted to meet the limitations regarding the flow through the entirety of the hollow fibers, at least because the plurality of hollow fibers may be arbitrarily defined as any portion of the totality of hollow fibers.
Allowable Subject Matter
Claim 3 is 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. Claim 4 is allowable by virtue of its dependency on claim 3.
Claims 12-17 are indicated as allowable because the independent claim 12 has allowable subject matter. Claim 12 was rejected under non-statutory double patenting with no outstanding 35 U.S.C. 101 or 112 rejections. Claims 3 and 12 are indicated as allowable for the following reasons:
No prior art alone or in combination discloses a blood processing apparatus with a housing, a heat exchanger core situated in the housing, a blood flow distributor and a fluid flow distributor. Further, the fluid flow distributor disposed near the first end and in fluid communication with the post chamber, wherein the fluid flow distributor defines a plurality of radially distributed fluid distributing apertures equally spaced around a circumference of the fluid flow distributor.
Ikeda teaches a similar hollow fiber membrane-type oxygenator with heat exchanging parts, but the fluid flow distributor does not define a plurality of radially distributed fluid apertures equally spaced around a circumference of the fluid flow distributor. Ikeda teaches apertures/openings in the chambers of the heat exchanger, but the required radial spread is not contemplated by Ikeda. It would not have been obvious to change the apertures of Ikeda and duplicate them or equally space them around the circumference with a teaching to reasonably rely on. In a similar fashion, Silvestri does not cure such deficiencies because Silvestri teaches a similar device but lacks radially spread apertures equally spaced around the circumference of the fluid flow distributor. Claims 13-17 are allowable by virtue of their dependency on claim 12.
Conclusion
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 20 February 2026