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 amendment filed October 10, 2025 has been entered. Claims 1-2, 8-9, 11-13, 16, 19-22, and 25 remain pending in the application. Claims 3-7, 10, 14-15, 17-18, and 23-24 have been cancelled. Applicant’s amendments to the claims have overcome the objections and rejections under 35 USC 112 previously set forth in the Non-Final Office Action mailed 07/01/25.
Claim Objections
Claim 11 is objected to because of the following informalities: there is typo regarding the punctuation of “…longer than the second extension tube,;” as opposed to “…longer than the second extension tube;” in line 10. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: there is typo regarding “a first port” and “a second port” in line 1, as opposed to “the first port” and “the second port”. The limitations “first port” and “second port” are introduced in claim 11, line3 Appropriate correction is required.
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.
Claims 1-2, 8-9, 11-13, 16, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Corbett (US 2013/0053622) in view of Goldoni et al. (WO 2009/147510) in further view of Reichert et al. (US 20150045772) and further in view of Jones et al. (US 2017/0043126).
Regarding claim 1, Corbett discloses a device (fluid delivery apparatus 20 and fluid source 24) to flush a catheter assembly (device 22; “The fluid provided to the first fluid input port 26 via the second tube 40 flushes the pump motor of the ventricular assist device to keep it clear of blood.” [0045]), the device comprising:
a first extension tube (second tube 40), comprising a distal end (distal end 44), a proximal end (proximal end 42), and a first fluid pathway (through second tube 40) extending through the first extension tube (“the y-shaped connector 60 divides the incoming fluid stream through the first tube 30 into two outgoing fluid streams through the second tube 40 and the third tube 50.” [0041]);
a first connector (where output connector 46 is connected; “the output connectors 46 and 56 may be removably coupled to the distal end 44 of the second tube 40 and the distal end 54 of the third tube 50 (e.g., via a screw-type or pressure fitting, etc.).” [0043]) coupled to the distal end of the first extension tube (“a distal end 44 coupled to an output connector 46” [0041]; Figure 3);
a second extension tube (third tube 50), comprising a distal end (distal end 54), a proximal end (proximal end 52), and a second fluid pathway (through third tube 50) extending through the second extension tube (“the y-shaped connector 60 divides the incoming fluid stream through the first tube 30 into two outgoing fluid streams through the second tube 40 and the third tube 50.” [0041]);
a second connector (where output connector 56 is connected; “the output connectors 46 and 56 may be removably coupled to the distal end 44 of the second tube 40 and the distal end 54 of the third tube 50 (e.g., via a screw-type or pressure fitting, etc.).” [0043]) coupled to the distal end of the second extension tube (“a distal end 54 coupled to an output connector 56” [0041]; Figure 3); and
a housing (y-shaped connector 60), wherein the proximal end of the first extension tube and the proximal end of the second extension tube are fixed within the housing (“The second tube 40 extends from a proximal end 42 coupled to the y-shaped connector 60 to a distal end 44 coupled to an output connector 46 (e.g., fitting, coupling, etc.). The third tube 50 likewise extends from a proximal end 52 coupled to the y-shaped connector 60 to a distal end 54 coupled to an output connector 56 (e.g., fitting, coupling, etc.)” [0041]; Figure 3);
a third connector (input connector 36);
a fluid source (fluid source 24 and tube 25) in fluid communication with the first extension tube and the second extension tube (“The input connector 36 is configured to provide a sterile attachment to the fluid source 24 to provide fluid communication between the fluid source 24 and the first tube 30.” [0038]), wherein the fluid source is coupled to the third connector (“the female Luer connector 20 [36] at the end of the first tube 30 may either be bonded or removably coupled to an end of the tube 25 extending from the fluid source 24, e.g., via a male Luer connector located at the end of the tube 25.” [0038]; Figure 2);
a third extension tube (first tube 30; Figure 3) having a distal end (proximal end 32, noted that “proximal end 32” is located at the distal/downstream end of tube 30) fixed within the housing (Figure 3; “the first tube 30 extends from a proximal end 32 coupled to the y-shaped connector 60” [0038]) and a proximal end (distal end 34, noted that “distal end 34” is located at the proximal/upstream end of tube 30) fixed within the third connector (Figure 3; “The input connector 36 may be, for example, a female Luer connector that is permanently coupled to the distal end 34 of the first tube 30 (e.g., fused via heat, solvents or adhesive) and configured to be coupled to a corresponding male Luer connector. In other embodiments, the input connector 36 may be removably coupled to the proximal end 34 of the first tube 30 (e.g., via a screw-type or pressure fitting, etc.).” [0038]);
a first needleless connector (output connector 46) coupled to the first connector; and
a second needleless connector (output connector 56) coupled to the second connector (Figure 3; “the output connectors 46 and 56 may be removably coupled to the distal end 44 of the second tube 40 and the distal end 54 of the third tube 50 (e.g., via a screw-type or pressure fitting, etc.).” [0043]).
Corbett, in the embodiment of Figures 2 and 3, fails to explicitly teach the fluid source is a syringe; wherein the first extension tube is longer than the second extension tube, and in response to crossing the first extension tube and the second extension tube and depressing the syringe a single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid for an equal time.
Corbett teaches an embodiment of a device to flush a catheter assembly, wherein a first extension tube (second tube 40) is longer than a second extension tube (third tube 50; “In various embodiments, the first, second, and third tubes 30, 40, and 50 may be of any suitable length. For example, in some embodiments, the second and third tubes 40, and 50 may be of differing length” [0042]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Corbett in the embodiment of Figures 2 and 3 to include that the first extension tube is longer than the second extension tube based on the teachings of Corbett to facilitate easy connection to the catheter assembly (Corbett [0042]).
Modified Corbett fails to explicitly teach the fluid source is a syringe; and in response to crossing the first extension tube and the second extension tube and depressing the syringe a single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid for an equal time.
Goldoni teaches a device (catheter flush and fill unit 1) to flush a catheter assembly (“a catheter flush and fill unit designed to eliminate open preliminary flushing of the catheter tube.” [Col 3, line 12-14]), the device comprising: a first extension tube (from connection assembly 2 to first port 6) comprising a first fluid pathway (Figure 1); a second extension tube (from connection assembly 2 to second port 7) comprising a second fluid pathway (Figure 1); and a syringe (syringe 4) in fluid communication with the first extension tube and the second extension tube (Figure 1), wherein the syringe is coupled to a third connector (Figure 1), wherein in response to depressing the syringe the single time, the first fluid pathway, the second fluid pathway, a first connector (first port 6), and a second connector (second port 7) are each flushed with a volume of fluid for an equal time (“the operator pushes plunger 17, the fluid flows through haemocompatible filter 15… fluid from reservoir 11 flows through nonreturn valve 9 and, non-return valve 8 being closed, flows back, filtered, into the vascular system.” [Page 7, line 10-18]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the fluid source of the device of Corbett to be a syringe based on the teachings of Goldoni to ensure complete elimination of air from and flushing of the device and catheter assembly (Goldoni [Page 6, lines 15-20]); and it would have been obvious to modify the device of Corbett to include in response to depression of the syringe the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with a volume of fluid for an equal time based on the teachings of Goldoni to allow for the flow through the device to fully manually controlled by the operator (Goldoni [Col 7, lines 10-15]).
Modified Corbett fails to explicitly teach in response to crossing the first extension tube and the second extension tube and depressing the syringe a single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid.
Reichert teaches a device to flush a catheter (Figure 2b) comprising a first extension tube (secondary IV set 118’) comprising a first fluid pathway (Figure 2b), a second extension tube (secondary IV set 120’) comprising a second fluid pathway (Figure 2b), and first and second needleless connectors (access ports 110’); and in response to crossing the first extension and the second extension tube (see annotated Figure 2B below), the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with a volume of fluid (Figure 1 and 2b showing the fluid pathways are crossed and capable of being flushed with a volume of fluid).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of the catheter system of Corbett to include that the first extension tube and the second extension tube are crossed to form a crossing and in response to crossing the first extension and the second extension tube, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with a volume of fluid based on the teachings of Reichert to provide smooth flow transitions from the extension tubes to the catheter assembly and improve organization when multiple IV lines are required (Reichert [0055], [0071]).
Modified Corbett fails to explicitly teach in response to depressing the syringe a single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid.
Jones teaches a device (adapter 298) to flush a catheter assembly (“FIG. 30 illustrates a partially sectional view of a syringe adapter for flushing all lumens of a double lumen catheter” [0111]), wherein in response to depression of a syringe the single time, a first fluid pathway, a second fluid pathway, a first connector and a second connector are each flushed with an approximately equal volume of fluid for an equal time (“adapter 298 for a standard luer syringe having a luer fitting 300 for connecting with a double lumen distal catheter connector 302. The adapter bifurcation 304 from the single channel into a multi-lumen channel to allow a provider to flush all lumens of the catheter with a single action from a standard syringe…the adapter may be configured with a valve system or be used with a single syringe having three separate channels, e.g., to ensure a higher flow resistance in one lumen of the multi-lumen catheter (such as from a catheter occlusion) does not redirect flow to the other lumens, but instead ensures all lumens are flushed with an equal volume of fluid.” [0111-0112], wherein the equal time is the time it takes for a provided to perform the single action from the syringe).
Before the effective filing date of the same invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Corbett to include wherein in response to depressing the syringe the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid for an equal time based on the teachings of Jones to allow the entirety of the catheter assembly to flushed in a simple manner with a single action by the provider (Jones [0111]).
Regarding claim 2, modified Corbett teaches the device of claim 1, further comprising: a third fluid pathway (through first tube 30) extending through the third extension tube (first tube 30), wherein the third fluid pathway branches into the first fluid pathway and the second fluid pathway (“the y-shaped connector 60 divides the incoming fluid stream through the first tube 30 into two outgoing fluid streams through the second tube 40 and the third tube 50.” [0041]).
Regarding claim 8, modified Corbett teaches the device of claim 1, wherein the proximal end of the first extension tube (second tube 40) is disposed at a fixed angled with respect to the proximal second extension tube (third tube 50; the proximal ends of the first and second extension tubes are shown in a fixed 0° angle relative to each other at the location they are secured in the Y-shaped connector 60: “The fluid delivery apparatus 20 includes a first tube 30 (e.g., input tube), a second tube 40 (e.g., first output tube), and a third tube 50 (e.g., second output tube) coupled together by a y-shaped connector 60.” [0037]; Figures 2-3).
Regarding claim 9, modified Corbett teaches the device of claim 8.
Modified Corbett fails to explicitly teach wherein an angle between the first extension tube and the second extension tube is between about 30° and 60° or between 15° and 45°.
Reichert teaches a catheter device (Figure 2b) comprising a first extension tube (primary flow line 108’) and a second extension tube (secondary IV set 120’), wherein an angle between the first extension tube and the second extension tube is between about 30° and 60° or between 15° and 45° (“As one skilled in the art will recognize, other angular orientations may be used where merited by the circumstances, such as angular orientations between 30 and 150 degrees (as measured from the longitudinal axis of the primary line 500), or even others. For example, FIG. 2B illustrates that the IV set system of FIGS. 1 and 2A can comprise an alternative configuration of a merging fluid pathway. In this example, the merging fluid pathway 154' comprises access ports 110' oriented on about a 30 degree orientation relative to the primary flow line 108' of the primary IV set 100'.” [0055]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Corbett to include that an angle between the first extension tube and the second extension tube is between about 30° and 60° or between 15° and 45° based on the teachings of Reichert to provide smooth flow transitions from the extension tubes to the catheter assembly (Reichert [0055], [0071]).
Regarding claim 11, Corbett discloses a method of flushing a catheter assembly (device 22; “The fluid provided to the first fluid input port 26 via the second tube 40 flushes the pump motor of the ventricular assist device to keep it clear of blood.” [0045]), the method comprising:
coupling a device (fluid delivery apparatus 20 and fluid source 24) to an adapter (fluid input ports 26 and 27) of a catheter assembly (device 22; “the device 22 is a percutaneous ventricle assist device catheter based device with multiple lumens” [0045]), wherein the adapter comprises a first port (connector 28) and a second port (connector 29), wherein the device comprises:
a first extension tube (second tube 40), comprising a distal end (distal end 44), a proximal end (proximal end 42); and a first fluid pathway (through second tube 40) extending through the first extension tube (“the y-shaped connector 60 divides the incoming fluid stream through the first tube 30 into two outgoing fluid streams through the second tube 40 and the third tube 50.” [0041]);
a first connector (where output connector 46 is connected; “the output connectors 46 and 56 may be removably coupled to the distal end 44 of the second tube 40 and the distal end 54 of the third tube 50 (e.g., via a screw-type or pressure fitting, etc.).” [0043]) coupled to the distal end of the first extension tube (“a distal end 44 coupled to an output connector 46” [0041]; Figure 3);
a second extension tube (third tube 50), comprising a distal end (distal end 54), a proximal end (proximal end 52), and a second fluid pathway (through third tube 50) extending through the second extension tube (“the y-shaped connector 60 divides the incoming fluid stream through the first tube 30 into two outgoing fluid streams through the second tube 40 and the third tube 50.” [0041]);
a second connector (where output connector 56 is connected; “the output connectors 46 and 56 may be removably coupled to the distal end 44 of the second tube 40 and the distal end 54 of the third tube 50 (e.g., via a screw-type or pressure fitting, etc.).” [0043]) coupled to the distal end of the second extension tube (“distal end 54 coupled to an output connector 56” [0041]);
a housing (y-shaped connector 60), wherein the proximal end of the first extension tube and the proximal end of the second extension tube are fixed within the housing (“The second tube 40 extends from a proximal end 42 coupled to the y-shaped connector 60 to a distal end 44 coupled to an output connector 46 (e.g., fitting, coupling, etc.). The third tube 50 likewise extends from a proximal end 52 coupled to the y-shaped connector 60 to a distal end 54 coupled to an output connector 56 (e.g., fitting, coupling, etc.)” [0041]; Figure 3);
a third connector (input connector 36);
a fluid source (fluid source 24 and tube 25) in fluid communication with the first extension tube and the second extension tube (“The input connector 36 is configured to provide a sterile attachment to the fluid source 24 to provide fluid communication between the fluid source 24 and the first tube 30.” [0038]), wherein the fluid source is directly coupled to the third connector (“the female Luer connector 20 [36] at the end of the first tube 30 may either be bonded or removably coupled to an end of the tube 25 extending from the fluid source 24, e.g., via a male Luer connector located at the end of the tube 25.” [0038]; Figure 2), wherein coupling the device to the adapter comprises coupling the first extension tube (second tube 40) to the first port (connector 28) of the adapter and coupling the second extension tube (third tube 50) to the second port (connector 29) of the adapter (“The output connectors 46 and 56 are coupled to connectors 28 and 29 of the device 22, respectively. The output connectors 46 and 56 are configured to provide a sterile attachment to the fluid input ports 26 and 27 of the device 22 via connectors 28 and 29.” [0041]; Figure 2); and
a third extension tube (first tube 30; Figure 3) having a distal end (proximal end 32, noted that “proximal end 32” is located at the distal/downstream end of tube 30) fixed within the housing (Figure 3; “the first tube 30 extends from a proximal end 32 coupled to the y-shaped connector 60” [0038]) and a proximal end (distal end 34, noted that “distal end 34” is located at the proximal/upstream end of tube 30) fixed within the third connector (Figure 3; “The input connector 36 may be, for example, a female Luer connector that is permanently coupled to the distal end 34 of the first tube 30 (e.g., fused via heat, solvents or adhesive) and configured to be coupled to a corresponding male Luer connector. In other embodiments, the input connector 36 may be removably coupled to the proximal end 34 of the first tube 30 (e.g., via a screw-type or pressure fitting, etc.).” [0038]);
wherein fluid within the fluid source flows through the first extension tube, the second extension tube, and the catheter assembly (“fluid from a single fluid source 24 to be delivered to two inputs 26 and 27 of the medical device 22.” [0037]; “the y-shaped connector 60 divides the incoming fluid stream through the first tube 30 into two outgoing fluid streams through the second tube 40 and the third tube 50.” [0041]; “the fluid provided to the first fluid input port 26 via the second tube 40 flushes the pump motor of the ventricular assist device to keep it clear of blood…The fluid provided to the second input port 27 via the third tube 50 provides a pressure reading from an additional pressure transducer located in the device 22 (or other suitable location).” [0045]).
Corbett, in the embodiment of Figures 2 and 3, fails to explicitly teach the first extension tube and the second extension tube are configured to cross over each other, wherein the first extension tube is longer than the second extension tube; wherein the fluid source is a syringe, wherein the syringe comprises a plunger; and crossing the first extension tube and the second extension tube prior to depressing the plunger of the syringe to form a crossing, wherein an entirety of the first extension tube proximal to the crossing is on a first side of an axis of the second extension tube and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube; after crossing the first extension tube and the second extension tube, depressing the plunger of the syringe a single time, wherein in response to depressing the plunger the single time, fluid within the syringe flows through the first extension tube, the second extension tube, and the catheter assembly, wherein in response to depressing the plunger the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of a fluid for an equal time.
Corbett teaches an embodiment of a device to flush a catheter assembly, wherein a first extension tube (second tube 40) is longer than a second extension tube (third tube 50; “In various embodiments, the first, second, and third tubes 30, 40, and 50 may be of any suitable length. For example, in some embodiments, the second and third tubes 40, and 50 may be of differing length” [0042]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Corbett in the embodiment of Figures 2 and 3 to include that the first extension tube is longer than the second extension tube based on the teachings of Corbett to facilitate easy connection to the catheter assembly (Corbett [0042]).
Modified Corbett fails to explicitly teach the first extension tube and the second extension tube are configured to cross over each other; wherein the fluid source is a syringe, wherein the syringe comprises a plunger; and crossing the first extension tube and the second extension tube prior to depressing the plunger of the syringe to form a crossing, wherein an entirety of the first extension tube proximal to the crossing is on a first side of an axis of the second extension tube and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube; after crossing the first extension tube and the second extension tube, depressing the plunger of the syringe a single time, wherein in response to depressing the plunger the single time, fluid within the syringe flows through the first extension tube, the second extension tube, and the catheter assembly, wherein in response to depressing the plunger the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of a fluid for an equal time.
Goldoni teaches a method of flushing a catheter assembly (“a catheter flush and fill unit designed to eliminate open preliminary flushing of the catheter tube.” [Col 3, line 12-14]), the method comprising: coupling a device (catheter flush and fill unit 1) to a catheter assembly (“a catheter flush and fill unit comprising a connection assembly 2 for connection to a catheter (not shown)” [Page 4, line 1-2]), wherein the device comprises: a first extension tube (from connection assembly 2 to first port 6) comprising a first fluid pathway (Figure 1); a second extension tube (from connection assembly 2 to second port 7) comprising a second fluid pathway (Figure 1); a third connector (end portion 12 of reservoir 11); and a syringe (syringe 4) in fluid communication with the first extension tube and the second extension tube and directly connected to third connector (Figure 1), wherein the syringe comprises a plunger (plunger 17); and depressing the plunger of the syringe a single time, wherein in response to depressing the plunger the single time, fluid within the syringe flows through the first extension tube, the second extension tube, and the catheter assembly (“the operator pushes plunger 17, the fluid flows through haemocompatible filter 15…The fluid from reservoir 11 flows through nonreturn valve 9 and, non-return valve 8 being closed, flows back, filtered, into the vascular system.” [Page 7, line 10-18]), wherein in response to depressing the syringe the single time, the first fluid pathway, the second fluid pathway, a first connector (first port 6), and a second connector (second port 7) are each flushed with a volume of fluid for an equal time (“the operator pushes plunger 17, the fluid flows through haemocompatible filter 15… fluid from reservoir 11 flows through nonreturn valve 9 and, non-return valve 8 being closed, flows back, filtered, into the vascular system.” [Page 7, line 10-18]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the fluid source of the device of Corbett to be a syringe comprising a plunger based on the teachings of Goldoni to ensure complete elimination of air from and flushing of the device and catheter assembly (Goldoni [Page 6, lines 15-20]); and it would have been obvious to modify the method of Corbett to include depressing the plunger of the syringe a single time, wherein in response to depressing the plunger the single time, fluid within the syringe flows through the first extension tube, the second extension tube, and the catheter assembly and the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with a volume of fluid for an equal time based on the teachings of Goldoni to allow for the flow through the device to fully manually controlled by the operator (Goldoni [Col 7, lines 10-15]).
Modified Corbett fails to explicitly teach the first extension tube and the second extension tube are configured to cross over each other; and crossing the first extension tube and the second extension tube prior to depressing the plunger of the syringe to form a crossing, wherein an entirety of the first extension tube proximal to the crossing is on a first side of an axis of the second extension tube and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube; after crossing the first extension tube and the second extension tube, depressing the plunger of the syringe a single time.
Modified Corbett fails to explicitly teach the first extension tube and the second extension tube are configured to cross over each other; and crossing the first extension tube and the second extension tube prior to depressing the plunger of the syringe to form a crossing, wherein an entirety of the first extension tube proximal to the crossing is on a first side of an axis of the second extension tube and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube; after crossing the first extension tube and the second extension tube, depressing the plunger of the syringe a single time, wherein in response to depressing the plunger the single time, fluid within the syringe flows through the first extension tube, the second extension tube, and the catheter assembly, wherein in response to depressing the plunger the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of a fluid for an equal time.
Reichert teaches a method of using a catheter assembly (Figure 2b), the method comprising a first extension tube (secondary IV set 118’) comprising a first fluid pathway (Figure 2b), a second extension tube (secondary IV set 120’) comprising a second fluid pathway (Figure 2b), and crossing the first extension and the second extension tube to form a crossing (see annotated Figure 2B above), wherein an entirety of the first extension tube (secondary IV set 118’) proximal to the crossing is on a first side of an axis of the second extension tube (secondary IV set 120’; Figure 2B) and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube (Figure 2B); the method further comprising crossing the first extension tube and the second extension tube prior to delivering fluid through the device and only delivering fluid after the first and second extension tubes are crossed (Figures 1 and 2b showing that the IV sets are crossed prior to connection to any fluid source. Therefore, the first and second extension tubes are crossed prior to any fluid being delivered through the lines).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Corbett to include crossing the first extension tube and the second extension tube prior to depressing the plunger of the syringe to form a crossing, wherein an entirety of the first extension tube proximal to the crossing is on a first side of an axis of the second extension tube and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube; and after crossing the first extension tube and the second extension tube, depressing the plunger of the syringe a single time based on the teachings of Reichert to provide smooth flow transitions from the extension tubes to the catheter assembly and improve organization when multiple IV lines are required (Reichert [0055], [0071]).
Modified Corbett fails to explicitly teach wherein in response to depressing the plunger the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of a fluid for an equal time.
Jones teaches a method of flushing a catheter assembly (“FIG. 30 illustrates a partially sectional view of a syringe adapter for flushing all lumens of a double lumen catheter” [0111]), the method comprising coupling a device (adapter 298) to an adapter of a catheter assembly (“adapter 298 for a standard luer syringe having a luer fitting 300 for connecting with a double lumen distal catheter connector 302.” [0111]), wherein in response to depressing the plunger the single time, a first fluid pathway, a second fluid pathway, a first connector, and a second connector are flushed with an approximately equal volume of a fluid for an equal time (“adapter 298 for a standard luer syringe having a luer fitting 300 for connecting with a double lumen distal catheter connector 302. The adapter bifurcation 304 from the single channel into a multi-lumen channel to allow a provider to flush all lumens of the catheter with a single action from a standard syringe…the adapter may be configured with a valve system or be used with a single syringe having three separate channels, e.g., to ensure a higher flow resistance in one lumen of the multi-lumen catheter (such as from a catheter occlusion) does not redirect flow to the other lumens, but instead ensures all lumens are flushed with an equal volume of fluid.” [0111-0112], wherein the equal time is the time it takes for a provided to perform the single action from the syringe).
Before the effective filing date of the same invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Corbett to include wherein i wherein in response to depressing the plunger the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of a fluid for an equal time based on the teachings of Jones to allow the entirety of the catheter assembly to flushed in a simple manner with a single action by the provider (Jones [0111]).
Regarding claim 12, modified Corbett teaches the method of claim 11, wherein the device further comprises: a third fluid pathway (through first tube 30) extending through the extension (first tube 30), wherein the third fluid pathway branches into the first fluid pathway and the second fluid pathway (“the y-shaped connector 60 divides the incoming fluid stream through the first tube 30 into two outgoing fluid streams through the second tube 40 and the third tube 50.” [0041]), wherein in response to depressing the plunger (Goldoni: plunger 17) a single time (Goldoni [Page 7, line 10-18]), fluid within the syringe (Goldoni: syringe 4) flows in a distal direction from the syringe to third fluid pathway and then to the first fluid pathway and the second fluid pathway (“fluid from a single fluid source 24 to be delivered to two inputs 26 and 27 of the medical device 22.” [0037]; “the y-shaped connector 60 divides the incoming fluid stream through the first tube 30 into two outgoing fluid streams through the second tube 40 and the third tube 50.” [0041]).
Regarding claim 13, modified Corbett teaches the method of claim 11, wherein the adapter includes a Y-adapter (at inputs 26 and 27 of medical device 27; Figure 2).
Regarding claim 16, modified Corbett teaches the method of claim 11, further comprising: filling the fluid source (fluid source 24 and tube 25) with fluid (“fluid source 24 may be a commonly used device such as a pressure bag containing a useful fluid such as a saline solution (NaCL)” [0039]); and directly coupling the third connector to the fluid source (“the female Luer connector 20 [36] at the end of the first tube 30 may either be bonded or removably coupled to an end of the tube 25 extending from the fluid source 24, e.g., via a male Luer connector located at the end of the tube 25.” [0038]; Figure 2).
Modified Corbett fails to explicitly teach the method further comprising filling the syringe with a fluid.
Goldoni teaches a method of flushing a catheter assembly (“a catheter flush and fill unit designed to eliminate open preliminary flushing of the catheter tube.” [Col 3, line 12-14]), the method further comprising: filling the syringe with fluid (“the operator pulls plunger 17, and the blood from the catheter mixes with the physiological solution in unit 1 to form a liquid that flows through non-return valve 8 and along conduit 10 into reservoir 11.” [Page 6, line 27]; wherein the mixture would also fill the syringe 5 because no air remains in unit 1 “At this start or priming stage, the content of the syringe completely fills every cavity of unit 1, and the operator makes sure no air is left inside” [Page 6, lines 17-23]); and directly coupling the third connector to the syringe (Figure 1; “Syringe 4 may be connected removably…between the suction and delivery branches.” [Page 9, line 10]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Corbett to include filling the syringe with a fluid based on the teachings of Goldoni to allow for the flow through the device to fully manually controlled by the operator (Goldoni [Col 7, lines 10-15]).
Regarding claim 19, modified Corbett teaches the method of claim 11, wherein coupling the first extension tube (second tube 40) to the first port of the adapter (connector 28) and coupling the second extension tube (third tube 50) to the second port of the adapter (connector 29) comprises coupling the first connector to the first port and coupling the second connector to the second port (“The output connectors 46 and 56 are coupled to connectors 28 and 29 of the device 22, respectively. The output connectors 46 and 56 are configured to provide a sterile attachment to the fluid input ports 26 and 27 of the device 22 via connectors 28 and 29.” [0041]).
Regarding claim 20, modified Corbett teaches the method of claim 11, further coupling a first needleless connector (output connector 46) to the first connector and a second needleless connector (output connector 56) to the second connector (Figure 3; “the output connectors 46 and 56 may be removably coupled to the distal end 44 of the second tube 40 and the distal end 54 of the third tube 50 (e.g., via a screw-type or pressure fitting, etc.).” [0043]), wherein coupling the first extension tube (second tube 40) to the first port of the adapter (connector 28) and coupling the second extension tube (third tube 50) to the second port of the adapter (connector 29) comprises coupling the first needleless connector to the first port and coupling the second needleless connector to the second port (“The output connectors 46 and 56 are coupled to connectors 28 and 29 of the device 22, respectively. The output connectors 46 and 56 are configured to provide a sterile attachment to the fluid input ports 26 and 27 of the device 22 via connectors 28 and 29.” [0041]).
Regarding claim 21, modified Corbett teaches the method of claim 20, further comprising an adapter (fluid input ports 26 and 27) having a first port (tube 28) coupled to the first needleless connector (output connector 46) and a second port (tube 29) coupled to the second needleless connector (output connector 56; “The output connectors 46 and 56 are coupled to connectors 28 and 29 of the device 22, respectively.” [0041]).
Modified Corbett fails to explicitly teach wherein in response to depression of the plunger of the syringe the single time, the first port and the second port are flushed with an equal volume from the syringe for an equal time.
Goldoni teaches a device (catheter flush and fill unit 1) to flush a catheter assembly (“a catheter flush and fill unit designed to eliminate open preliminary flushing of the catheter tube.” [Col 3, line 12-14]), the device comprising: a first extension tube (from connection assembly 2 to first port 6); a second extension tube (from connection assembly 2 to second port 7); and a syringe (syringe 4) in fluid communication with the first extension tube and the second extension tube (Figure 1), the device further comprising a first port and second port coupled to the first and second extension tubes (“Ports 6 and 7 are then connected respectively to the vein and artery lines” [Page 6, lines 24-25]), wherein in response to depression of the plunger (plunger 17) of the syringe the single time, the first port and the second port are flushed with a volume from the syringe for an equal time (“the operator pushes plunger 17, the fluid flows through haemocompatible filter 15… fluid from reservoir 11 flows through nonreturn valve 9 and, non-return valve 8 being closed, flows back, filtered, into the vascular system.” [Page 7, line 10-18]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Corbett to include wherein in response to depression of the plunger of the syringe the single time, the first port and the second port are flushed with a volume from the syringe for an equal time based on the teachings of Goldoni to allow for the flow through the device to fully manually controlled by the operator (Goldoni [Col 7, lines 10-15]).
Modified Corbett fails to explicitly teach wherein in response to depression of the plunger of the syringe the single time, the first port and the second port are flushed with an equal volume from the syringe.
Jones teaches a device (adapter 298) to flush a catheter assembly (“FIG. 30 illustrates a partially sectional view of a syringe adapter for flushing all lumens of a double lumen catheter” [0111]), wherein in response to depression of the plunger of the syringe the single time, the first port and the second port are flushed with an equal volume from the syringe for an equal time (“adapter 298 for a standard luer syringe having a luer fitting 300 for connecting with a double lumen distal catheter connector 302. The adapter bifurcation 304 from the single channel into a multi-lumen channel to allow a provider to flush all lumens of the catheter with a single action from a standard syringe…the adapter may be configured with a valve system or be used with a single syringe having three separate channels, e.g., to ensure a higher flow resistance in one lumen of the multi-lumen catheter (such as from a catheter occlusion) does not redirect flow to the other lumens, but instead ensures all lumens are flushed with an equal volume of fluid.” [0111-0112], wherein the equal time is the time it takes for a provided to perform the single action from the syringe).
Before the effective filing date of the same invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Corbett in view of Goldoni to include wherein in response to depression of the plunger of the syringe the single time, the first port and the second port are flushed with an equal volume from the syringe for an equal time based on the teachings of Jones to allow the entirety of the catheter assembly to flushed in a simple manner with a single action by the provider (Jones [0111]).
Regarding claim 22, modified Corbett teaches the method of claim 11.
Modified Corbett fails to explicitly teach wherein in response to depression of the plunger of the syringe the single time, the first port and the second port are flushed with an equal volume from the syringe for an equal time.
Jones teaches a method of flushing a catheter assembly (“FIG. 30 illustrates a partially sectional view of a syringe adapter for flushing all lumens of a double lumen catheter” [0111]), the method comprising coupling a device (adapter 298) to an adapter of a catheter assembly (“adapter 298 for a standard luer syringe having a luer fitting 300 for connecting with a double lumen distal catheter connector 302.” [0111]), wherein in response to depression of the plunger of the syringe the single time, the first port and the second port are flushed with an equal volume from the syringe for an equal time (“adapter 298 for a standard luer syringe having a luer fitting 300 for connecting with a double lumen distal catheter connector 302. The adapter bifurcation 304 from the single channel into a multi-lumen channel to allow a provider to flush all lumens of the catheter with a single action from a standard syringe…the adapter may be configured with a valve system or be used with a single syringe having three separate channels, e.g., to ensure a higher flow resistance in one lumen of the multi-lumen catheter (such as from a catheter occlusion) does not redirect flow to the other lumens, but instead ensures all lumens are flushed with an equal volume of fluid.” [0111-0112], wherein the equal time is the time it takes for a provided to perform the single action from the syringe).
Before the effective filing date of the same invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Corbett in view of Goldoni to include wherein in response to depression of the plunger of the syringe the single time, the first port and the second port are flushed with an equal volume from the syringe for an equal time based on the teachings of Jones to allow the entirety of the catheter assembly to flushed in a simple manner with a single action by the provider (Jones [0111]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Corbett (US 20130053622) in view of Goldoni et al. (WO 2009147510) in further view of Reichert (US 20150045772) in further view of Jones et al. (US 2017/0043126) and in further view of Ang (US 20170319822).
Regarding claim 25, Corbett discloses a catheter system (Figure 2), comprising:
a device (fluid delivery apparatus 20 and fluid source 20) to flush the catheter system (“The fluid provided to the first fluid input port 26 via the second tube 40 flushes the pump motor of the ventricular assist device to keep it clear of blood.” [0045]), the device comprising:
a first extension tube (second tube 40), comprising a distal end (distal end 44) a proximal end (proximal end 42), and a first fluid pathway (through second tube 40) extending through the first extension tube (“the y-shaped connector 60 divides the incoming fluid stream through the first tube 30 into two outgoing fluid streams through the second tube 40 and the third tube 50.” [0041]);
a first connector (where output connector 46 is connected; “the output connectors 46 and 56 may be removably coupled to the distal end 44 of the second tube 40 and the distal end 54 of the third tube 50 (e.g., via a screw-type or pressure fitting, etc.).” [0043]) coupled to the distal end of the first extension tube (“a distal end 44 coupled to an output connector 46” [0041]; Figure 3);
a second extension tube (third tube 50), comprising a distal end (distal end 54), a proximal end (proximal end 52), and a second fluid pathway (through third tube 50) extending through the second extension tube (“the y-shaped connector 60 divides the incoming fluid stream through the first tube 30 into two outgoing fluid streams through the second tube 40 and the third tube 50.” [0041]);
a second connector (where output connector 56 is connected; “the output connectors 46 and 56 may be removably coupled to the distal end 44 of the second tube 40 and the distal end 54 of the third tube 50 (e.g., via a screw-type or pressure fitting, etc.).” [0043]) coupled to the distal end of the second extension tube (“a distal end 54 coupled to an output connector 56” [0041]; Figure 3); and
a housing (y-shaped connector 60), wherein the proximal end of the first extension tube and the proximal end of the second extension tube are fixed within the housing (“The second tube 40 extends from a proximal end 42 coupled to the y-shaped connector 60 to a distal end 44 coupled to an output connector 46 (e.g., fitting, coupling, etc.). The third tube 50 likewise extends from a proximal end 52 coupled to the y-shaped connector 60 to a distal end 54 coupled to an output connector 56 (e.g., fitting, coupling, etc.)” [0041]; Figure 3);
a third connector (input connector 36);
a fluid source (fluid source 24 and tube 25) in fluid communication with the first extension tube and the second extension tube (“The input connector 36 is configured to provide a sterile attachment to the fluid source 24 to provide fluid communication between the fluid source 24 and the first tube 30.” [0038]), wherein the fluid source is directly coupled to the third connector (“the female Luer connector 20 [36] at the end of the first tube 30 may either be bonded or removably coupled to an end of the tube 25 extending from the fluid source 24, e.g., via a male Luer connector located at the end of the tube 25.” [0038]; Figure 2);
a third extension tube (first tube 30; Figure 3) having a distal end (proximal end 32, noted that “proximal end 32” is located at the distal/downstream end of tube 30) fixed within the housing (Figure 3; “the first tube 30 extends from a proximal end 32 coupled to the y-shaped connector 60” [0038]) and a proximal end (distal end 34, noted that “distal end 34” is located at the proximal/upstream end of tube 30) fixed within the third connector (Figure 3; “The input connector 36 may be, for example, a female Luer connector that is permanently coupled to the distal end 34 of the first tube 30 (e.g., fused via heat, solvents or adhesive) and configured to be coupled to a corresponding male Luer connector. In other embodiments, the input connector 36 may be removably coupled to the proximal end 34 of the first tube 30 (e.g., via a screw-type or pressure fitting, etc.).” [0038]);
a first needleless connector (output connector 46) coupled to the first connector; and
a second needleless connector (output connector 56) coupled to the second connector (Figure 3; “the output connectors 46 and 56 may be removably coupled to the distal end 44 of the second tube 40 and the distal end 54 of the third tube 50 (e.g., via a screw-type or pressure fitting, etc.).” [0043]).
a catheter assembly (catheter device 22), comprising:
a Y-adapter having a first port (fluid input port 28 with connector 28) directly coupled to the first needleless connector (output connector 46; “The output connectors 46 and 56 are coupled to connectors 28 and 29 of the device 22, respectively. The output connectors 46 and 56 are configured to provide a sterile attachment to the fluid input ports 26 and 27 of the device 22 via connectors 28 and 29.” [0041]) and a second port (fluid input port 27 with connector 29) directly coupled to the second needleless connector (output connector 56; “The output connectors 46 and 56 are coupled to connectors 28 and 29 of the device 22, respectively. The output connectors 46 and 56 are configured to provide a sterile attachment to the fluid input ports 26 and 27 of the device 22 via connectors 28 and 29.” [0041]); and
a fourth extension tube (tube at distal end of device 22) having a proximal end fixed within the Y-adapter (Figure 2).
Corbett, in the embodiment of Figures 2 and 3, fails to explicitly teach the fluid source is a syringe, and wherein the first extension tube and the second extension tube are crossed between the housing and the first needleless connector and the second needleless connector to form a crossing, wherein an entirety of the first extension tube proximal to the crossing is on a first side of an axis of the second extension tube and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube, wherein the first extension tube is longer than the second extension tube, and in response to crossing the first extension tube and the second extension tube and depressing the syringe a single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid for an equal time; and the catheter assembly comprising: a catheter adapter, comprising a distal end, a proximal end, a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending distally from the distal end of the catheter adapter; and the fourth extension tube having a distal end extending from the side port.
Corbett teaches an embodiment of a device to flush a catheter assembly, wherein a first extension tube (second tube 40) is longer than a second extension tube (third tube 50; “In various embodiments, the first, second, and third tubes 30, 40, and 50 may be of any suitable length. For example, in some embodiments, the second and third tubes 40, and 50 may be of differing length” [0042]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Corbett in the embodiment of Figures 2 and 3 to include that the first extension tube is longer than the second extension tube based on the teachings of Corbett to facilitate easy connection to the catheter assembly (Corbett [0042]).
Modified Corbett fails to explicitly teach the fluid source is a syringe, and wherein the first extension tube and the second extension tube are crossed between the housing and the first needleless connector and the second needleless connector to form a crossing, wherein an entirety of the first extension tube proximal to the crossing is on a first side of an axis of the second extension tube and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube, and in response to crossing the first extension tube and the second extension tube and depressing the syringe a single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid for an equal time; and the catheter assembly comprising: a catheter adapter, comprising a distal end, a proximal end, a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending distally from the distal end of the catheter adapter; and the fourth extension tube having a distal end extending from the side port.
Goldoni teaches a device (catheter flush and fill unit 1) to flush a catheter assembly, the device comprising: a first extension tube (from connection assembly 2 to first port 6) comprising a first fluid pathway (Figure 1); a second extension tube (from connection assembly 2 to second port 7) comprising a second fluid pathway (Figure 1); a third connector (port 14); and a syringe (“port 14 is connected to a syringe (not shown)” [Page 6, line 15]) in fluid communication with the first extension tube and the second extension tube and directly coupled to the third connector (Figure 1; “port 14 is connected to a syringe (not shown) of physiological solution, possibly containing an anticoagulant additive. At this start or priming stage, the content of the syringe completely fills every cavity of unit 1” [Page 6, lines 15-19]); wherein in response to depressing the syringe the single time, the first fluid pathway, the second fluid pathway, a first connector (first port 6), and a second connector (second port 7) are each flushed with a volume of fluid for an equal time (“the operator pushes plunger 17, the fluid flows through haemocompatible filter 15… fluid from reservoir 11 flows through nonreturn valve 9 and, non-return valve 8 being closed, flows back, filtered, into the vascular system.” [Page 7, line 10-18]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the fluid source of the catheter system of Corbett to be a syringe based on the teachings of Goldoni to ensure complete elimination of air from and flushing of the device and catheter assembly (Goldoni [Page 6, lines 15-20]); and it would have been obvious to modify the device of Corbett to include in response to depression of the syringe the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with a volume of fluid for an equal time based on the teachings of Goldoni to allow for the flow through the device to fully manually controlled by the operator (Goldoni [Col 7, lines 10-15])..
Modified Corbett fails to explicitly teach wherein the first extension tube and the second extension tube are crossed between the housing and the first needleless connector and the second needleless connector to form a crossing, wherein an entirety of the first extension tube proximal to the crossing is on a first side of an axis of the second extension tube and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube, and in response to crossing the first extension tube and the second extension tube and depressing the syringe a single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid for an equal time; and the catheter assembly comprising: a catheter adapter, comprising a distal end, a proximal end, a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending distally from the distal end of the catheter adapter; and the fourth extension tube having a distal end extending from the side port.
Reichert teaches a catheter device (Figure 2b) comprising a first extension tube (secondary IV set 118’), a second extension tube (secondary IV set 120’), a housing (attachment member 160, unlabeled in Figure 2B), and first and second needleless connectors (access ports 110’); wherein the first extension and the second extension tube are crossed between the housing and the first needleless connector and the second needleless connector to form a crossing (see annotated Figure 2B above), wherein an entirety of the first extension tube (secondary IV set 118’) proximal to the crossing is on a first side of an axis of the second extension tube (secondary IV set 120’; Figure 2B) and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube (Figure 2B).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of the catheter system of Corbett to include that the first extension tube and the second extension tube are crossed to form a crossing, wherein an entirety of the first extension tube proximal to the crossing is on a first side of an axis of the second extension tube and an entirety of the first extension tube distal to the crossing is on a second side of the axis of the second extension tube based on the teachings of Reichert to provide smooth flow transitions from the extension tubes to the catheter assembly and improve organization when multiple IV lines are required (Reichert [0055], [0071]).
Modified Corbett in view of Goldoni and Reichert fails to explicitly teach the catheter assembly comprising: a catheter adapter, comprising a distal end, a proximal end, a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending distally from the distal end of the catheter adapter; and the fourth extension tube having a distal end extending from the side port.
Modified Corbett fails to explicitly teach in response to crossing the first extension tube and the second extension tube and depressing the syringe a single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid for an equal time; and the catheter assembly comprising: a catheter adapter, comprising a distal end, a proximal end, a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending distally from the distal end of the catheter adapter; and the fourth extension tube having a distal end extending from the side port.
Jones teaches a device (adapter 298) to flush a catheter assembly (“FIG. 30 illustrates a partially sectional view of a syringe adapter for flushing all lumens of a double lumen catheter” [0111]), wherein in response to depression of a syringe the single time, a first fluid pathway, a second fluid pathway, a first connector and a second connector are each flushed with an approximately equal volume of fluid for an equal time (“adapter 298 for a standard luer syringe having a luer fitting 300 for connecting with a double lumen distal catheter connector 302. The adapter bifurcation 304 from the single channel into a multi-lumen channel to allow a provider to flush all lumens of the catheter with a single action from a standard syringe…the adapter may be configured with a valve system or be used with a single syringe having three separate channels, e.g., to ensure a higher flow resistance in one lumen of the multi-lumen catheter (such as from a catheter occlusion) does not redirect flow to the other lumens, but instead ensures all lumens are flushed with an equal volume of fluid.” [0111-0112], wherein the equal time is the time it takes for a provided to perform the single action from the syringe).
Before the effective filing date of the same invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Corbett to include wherein in response to depressing the syringe the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid for an equal time based on the teachings of Jones to allow the entirety of the catheter assembly to flushed in a simple manner with a single action by the provider (Jones [0111]).
Modified Corbett fails to explicitly teach the catheter assembly comprising: a catheter adapter, comprising a distal end, a proximal end, a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending distally from the distal end of the catheter adapter; and the fourth extension tube having a distal end extending from the side port.
Ang teaches a catheter assembly (IV catheter assembly 100) comprising: a catheter adapter (catheter hub 102), comprising a distal end (at connection to canula 101), a proximal end (at connection to needle housing 110), a side port (port 114) between the distal end of the catheter adapter and the proximal end of the catheter adapter (Figure 2), and a lumen (lumen 122) extending through the distal end of the catheter adapter and the proximal end of the catheter adapter (“The catheter hub 102 comprises a main body portion 130 having a lumen 122.” [0069]); a catheter (cannula 101) extending distally from the distal end of the catheter adapter (Figure 1); a Y-adapter (Y-connector 104) having a first port and a second port (Figure 4); and a fourth extension tube (extension tube 103) having a distal end extending from the side port and a proximal end fixed within the Y-adapter (Figure 4; “The fluid may be injected along an extension tube 103 which is coupled to the port 114, and the extension tube 103 may be coupled at the other end to a Y-connector 104” [0069]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter assembly of the catheter system of Corbett to include a catheter adapter comprising a side port between distal and proximal ends of the catheter adapter and a lumen extending through catheter adapter; a catheter extending distally from the catheter adapter; and the fourth extension tube having a distal end extending from the side port based on the teachings of Ang to provide a means of inserting a catheter into a patient to provide intravenous access and allow for an injection of fluid into a catheter and therefore into the patient (Ang [0068-0069]).
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 8-9, 11-13, 16, 19-22, and 25 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.
Regarding the argument that the prior art of record fails to explicitly disclose or suggest “wherein the first extension tube is longer than the second extension tube” and “wherein the first extension tube is longer than the second extension tube, and in response to crossing the first extension tube and the second extension tube and depressing the syringe a single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid for an equal time” as required by amended claims 1, 11, and 25 (Remarks, page 3-4), the examiner respectfully disagrees and maintains that these features are disclosed by the combination of Corbett (US 20130053622), Goldoni et al. (WO 2009147510), Reichert (US 20150045772), and Jones et al. (US 2017/0043126) as detailed in the rejections of independent claims 1, 11, and 25 above and summarized below:
Corbett discloses a device (20, 24) to flush a catheter assembly comprising: a first extension tube (40) comprising a first fluid pathway ([0041]); a second extension tube (50) comprising a second fluid pathway ([0041]); first and second connectors ([0043]); and a third connector (input connector 36); a fluid source (24, 25; [0038]; Figure 2); a third extension tube (30; Figure 3); a first needleless connector (46) and a second needleless connector (56). Corbett additionally teaches an embodiment of a device to flush a catheter assembly wherein a first extension tube is longer than a second extension tube ([0042]); and it would have been obvious to one having ordinary skill in the art to modify the device of Corbett in the embodiment of Figures 2 and 3 to include that the first extension tube is longer than the second extension tube based on the teachings of Corbett to facilitate easy connection to the catheter assembly (Corbett [0042]).
Goldoni teaches a device (1) to flush a catheter assembly comprising: a first extension tube (from connection assembly 2 to first port 6) comprising a first fluid pathway (Figure 1); a second extension tube (from connection assembly 2 to second port 7) comprising a second fluid pathway (Figure 1); wherein in response to depressing the syringe (4) a single time, the first fluid pathway, the second fluid pathway, a first connector (6), and a second connector (7) are each flushed with a volume of fluid for an equal time ([Page 7, line 10-18]). It would have been obvious to modify the device of Corbett to include in response to depression of the syringe the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with a volume of fluid for an equal time based on the teachings of Goldoni to allow for the flow through the device to fully manually controlled by the operator (Goldoni [Col 7, lines 10-15]).
Reichert teaches a device to flush a catheter (Figure 2b) comprising a first extension tube (118’) comprising a first fluid pathway, a second extension tube (120’) comprising a second fluid pathway, and first and second needleless connectors (110’); and in response to crossing the first extension and the second extension tube (see annotated Figure 2B above), the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with a volume of fluid (Figure 1 and 2b showing the fluid pathways are crossed and capable of being flushed with a volume of fluid). It would have been obvious to one having ordinary skill in the art to further modify the device of the catheter system of Corbett to include that the first extension tube and the second extension tube are crossed to form a crossing and in response to crossing the first extension and the second extension tube, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with a volume of fluid based on the teachings of Reichert to provide smooth flow transitions from the extension tubes to the catheter assembly and improve organization when multiple IV lines are required (Reichert [0055], [0071]).
Jones teaches a device (298) to flush a catheter assembly ([0111]), wherein in response to depression of a syringe the single time, a first fluid pathway, a second fluid pathway, a first connector and a second connector are each flushed with an approximately equal volume of fluid for an equal time (“adapter 298 for a standard luer syringe having a luer fitting 300 for connecting with a double lumen distal catheter connector 302. The adapter bifurcation 304 from the single channel into a multi-lumen channel to allow a provider to flush all lumens of the catheter with a single action from a standard syringe…the adapter may be configured with a valve system or be used with a single syringe having three separate channels, e.g., to ensure a higher flow resistance in one lumen of the multi-lumen catheter (such as from a catheter occlusion) does not redirect flow to the other lumens, but instead ensures all lumens are flushed with an equal volume of fluid.” [0111-0112], wherein the equal time is the time it takes for a provided to perform the single action from the syringe). It would have been obvious to one having ordinary skill in the art to further modify the device of Corbett to include wherein in response to depressing the syringe the single time, the first fluid pathway, the second fluid pathway, the first connector, and the second connector are each flushed with an approximately equal volume of fluid for an equal time based on the teachings of Jones to allow the entirety of the catheter assembly to flushed in a simple manner with a single action by the provider (Jones [0111]).
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783