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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 29, 2026 has been entered.
Response to Amendment
The amendment filed April 29, 2026 has been entered. Claims 1, 9, and 26-28 remain pending in the application. Claims 2-8 and 10-25 have been cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Final Office Action mailed January 29, 2026.
Claim Objections
Claim 26 is objected to because there is a lack of antecedent basis for “the fluid in the syringe” in line 6. 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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Corbett (US 2013/0053622) in view of Jones et al. (US 2017/0043126).
Regarding claim 1, Corbett discloses a device (fluid delivery apparatus 20 and fluid source 24) for 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]) after the catheter assembly has been used to perform a blood draw, the catheter assembly comprising a catheter adapter from which a catheter extends distally, a side port that extends from the catheter adapter, an extension tube that extends from the side port, and a Y-adapter having a distal port that is coupled to the extension tube that extends from the side port, a first port that is inline with the distal port and a second port that is offset from the first port at a first angle, the first and second ports being in fluid communication with the catheter via the extension tube that extends from the side port, the catheter assembly being configured to perform the blood draw when the catheter is inserted intravenously, the device being configured to simultaneously flush blood from the first and second ports of the Y-adapter when the catheter assembly is flushed after the blood draw (noted that a “catheter assembly” and its associated structures are not positively recited or claimed. The examiner is considering the italicized text as a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Corbett discloses in paragraph [0046] that apparatus 20 can be used with “any medical instrument that includes multiple functions or sub-components requiring a sterile fluid”. Additionally, when reading the preamble in the context of the entire claim, the recitation italicized above is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.), 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]), the third extension tube forming a third fluid pathway (through 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]);
a first needleless connector (output connector 46) coupled to the first connector, the first needleless connector being configured to couple to the first port of the Y-adapter (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], noted that “the first port of the Y-adapter” is not positively recited or claimed, and the output connector 46 is capable of coupling to a first port of a Y-adapter); and
a second needleless connector (output connector 56) coupled to the second connector, the second needleless connector being configured to couple to the second port of the Y-adapter while the first needleless connector is coupled to the first port of the Y-adapter (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]; noted that “the second port of the Y-adapter” is not positively recited or claimed, and the output connectors 46, 56 are capable of being simultaneously connected to two different ports of a single connector as shown in Figure 3);
wherein the first extension tube has a first length that is longer than a second length of the second extension tube (“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 to facilitate easy connection and fit to the medical device 22.” [0042]), wherein the first and second lengths are configured to correspond with the first angle at which the second port is offset from the first port (Figure 2; wherein the different lengths correspond to how the medical device 22 is designed such as the angles of the port; noted that “the first angle”, “the second port”, and “the first port” are not positively recited or claimed) so that, while the fluid source is fluidically connected to the third fluid pathway, the combination of the first length, the second length, and the first angle causes the fluid to be distributed through the first fluid pathway and the second fluid pathway such that volumes of the fluid flow through the first connector and the second connector and through the first and second ports of the Y-adapter (Figure 2; “Fluid from the fluid source is caused to flow from the second tube into the first fluid input port and through the pump purge line to a pump of the percutaneous ventricular assist device located in a cardiac structure, or blood vessel of a patient to maintain the pump substantially free of blood (step 92). Fluid from the fluid source is caused to flow from the third tube into the second fluid input port to a placement signal line; and is used in the placement signal line to measure a pressure signal indicative of the placement of the percutaneous ventricle assist device in a cardiac structure, or blood vessel of a patient (step 94).” [0051], noted that “the first and second ports of the Y-adapter” are not positively recited or claimed).
Corbett fails to explicitly teach the fluid source is a syringe; while the syringe is continuously depressed to inject fluid into the third fluid pathway, approximately equal volumes of the fluid flow through the first connector and the second connector and through the first and second ports of the Y-adapter.
Jones teaches a device (adapter 298 and associated syringe) 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]), the device comprising a fluid source that is a syringe (“a standard syringe” [0111]) in fluid communication with a first fluid pathway and a second fluid pathway (at adapter bifurcation 304 of connector 302; Figure 30), wherein the syringe is coupled to a third connector (luer fitting 300; “an adapter 298 for a standard luer syringe having a luer fitting 300” [0111]; Figure 30); wherein while the syringe is continuously depressed to inject fluid into a third fluid pathway at the third connector, approximately equal volumes of the fluid flow through the first connector and the second connector and their connected ports (“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…ensures all lumens are flushed with an equal volume of fluid.” [0111-0112]).
Before the effective filing date of the same invention, it would have been obvious to one having ordinary skill in the art to modify the device of Corbett to include the fluid source is a syringe; and while the syringe is continuously depressed to inject fluid into the third fluid pathway, approximately equal volumes of the fluid flow through the first connector and the second connector and through the first and second ports of the Y-adapter 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Corbett (US 2013/0053622) in view of Jones et al. (US 2017/0043126) as applied in claim 1 above, and further in view of Reichert et al. (US 20150045772).
Regarding claim 9, modified Corbett teaches the device of claim 1.
Modified Corbett fails to explicitly teach wherein the proximal ends of the first and second extension tubes cross over one another at an angle as they extend from the housing, wherein the angle 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 the proximal ends of the first and second extension tubes cross over one another at an angle (Figure 2b) as they extend from a housing (at attachment members 160; Figure 1 for example), wherein the angel 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 the proximal ends of the first and second extension tubes cross over one another at an angle as they extend from the housing, wherein the angle 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 and improve organization when multiple IV lines are required (Reichert [0055], [0071]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Corbett (US 2013/0053622) in view of Jones et al. (US 2017/0043126) as applied in claim 1 above, and further in view of Cluff et al. (US 20080200904).
Regarding claim 26, modified Corbett discloses a method for 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 device may be any medical instrument that includes multiple functions or sub-components requiring a sterile fluid.” [0046]), the catheter assembly comprising a catheter adapter (body of device 22) from which a catheter extends distally (Figure 2), a first port (connector 28) and a second port (connector 29) that is offset from the first port at a first angle (Figure 2), the method comprising:
coupling the device of claim 1 (fluid delivery apparatus 20 and fluid source 24) to the catheter assembly (device 22) by connecting the first needleless connector (output connector 46) to the first port (connector 28) and connecting the second needleless connector (output connector 56) 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]; “The input connector of the first tube is connected to the fluid source (step 84). The output connector of the second tube is connected to a first fluid input port of the catheter based device (step 86). The output connector of the third tube is connected to a second fluid input port of the catheter based device (step 88).” [0048]); and
continuously deliver fluid from the fluid source into the third fluid pathway to thereby cause fluid to flow through the first and second ports (Figure 2; “Fluid from the fluid source is caused to flow from the second tube into the first fluid input port and through the pump purge line to a pump of the percutaneous ventricular assist device located in a cardiac structure, or blood vessel of a patient to maintain the pump substantially free of blood (step 92). Fluid from the fluid source is caused to flow from the third tube into the second fluid input port to a placement signal line; and is used in the placement signal line to measure a pressure signal indicative of the placement of the percutaneous ventricle assist device in a cardiac structure, or blood vessel of a patient (step 94).” [0051]).
Modified Corbett fails to explicitly disclose the method is for flushing the catheter assembly recited in claim 1, comprising a catheter adapter from which a catheter extends distally, a side port that extends from the catheter adapter, an extension tube that extends from the side port, and a Y-adapter having a distal port that is coupled to the extension tube that extends from the side port, a first port that is inline with the distal port and a second port that is offset from the first port at a first angle, the first and second ports being in fluid communication with the catheter via the extension tube that extends from the side port, the catheter assembly being configured to perform the blood draw when the catheter is inserted intravenously; and the method comprising: after the catheter assembly has been used to draw blood, coupling the device to the catheter assembly; and depressing the syringe to continuously inject the fluid in the syringe into the third fluid pathway to thereby cause an approximately equal volume of the fluid to flow through the first and second ports of the Y-adapter.
Cluff teaches a method for flushing a catheter assembly (extravascular system 10; “replaces the vent plug 22 with another vascular access device such as an infusion set connection or a Luer access device similar or identical to Luer access device or port 24, unclamps the catheter 16, flushes the blood from the catheters 14 and 16 back into the vasculature of the patient, and re-clamps the catheter 16.” [0054]) comprising a catheter adapter (Figure 1) from which a catheter (catheter 14) extends distally, a side port (from which extension tube/catheter 16 extends; Figure 1 below) that extends from the catheter adapter, an extension tube (catheter 16) that extends from the side port, and a Y-adapter (Y adapter 18) having a distal port that is coupled to the extension tube that extends from the side port (“an integrated extension tubing 16…with a Y adapter 18” [0052]), a first port (at vent plug 22) that is inline with the distal port (Figure 1) and a second port (port 24) that is offset from the first port at a first angle (Figure 1), the first and second ports being in fluid communication with the catheter via the extension tube that extends from the side port (“The slide clamp 20 on the integrated extension tubing 16 is provided to eliminate blood exposure when the vent plug 22 is replaced with another vascular access device such as an infusion set connection or another Luer access device or port 24.” [0053]), the catheter assembly being configured to perform the blood draw when the catheter is inserted intravenously (“A device operator will insert the needle 12 into the vasculature of a patient and wait for flashback of blood to travel into the system 10 to confirm that the needle 12 is properly located within the vasculature of the patient. The blood travels into and along the catheters 14 and 16 because a vent plug 22 permits air to escape the system 10 as blood enters the system 10.” [0054]), the method comprising: after the catheter assembly has been used to draw blood, coupling a device for flushing to the catheter assembly and delivering fluid through the first and second ports of the Y-adapter (“A device operator will insert the needle 12 into the vasculature of a patient and wait for flashback of blood to travel into the system 10 to confirm that the needle 12 is properly located within the vasculature of the patient. The blood travels into and along the catheters 14 and 16 because a vent plug 22 permits air to escape the system 10 as blood enters the system 10. After an operator confirms proper placement, and after adequate venting of the system 10 has occurred, the operator clamps the catheter 16 to halt the progression of blood through the catheters 14 and 16, removes the vent plug 22, replaces the vent plug 22 with another vascular access device such as an infusion set connection or a Luer access device similar or identical to Luer access device or port 24, unclamps the catheter 16, flushes the blood from the catheters 14 and 16 back into the vasculature of the patient, and re-clamps the catheter 16.” [0054]).
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 for flushing a catheter assembly of Corbett to include that the method is for flushing the catheter assembly recited in claim 1, the method comprising: after the catheter assembly has been used to draw blood, coupling the device of claim 1 to the catheter assembly; and delivering fluid through the third fluid pathway to thereby cause a volume of the fluid to flow through the first and second ports of the Y-adapter based on the teachings of Cluff to ensure that the catheter assembly is able to utilized for vascular access to allow for both infusion and withdrawal of blood (Cluff [0054, [0080]]).
Modified Corbett fails to explicitly disclose the method comprising: depressing the syringe to continuously inject the fluid in the syringe into the third fluid pathway to thereby cause an approximately equal volume of the fluid to flow through the first and second ports of the Y-adapter.
Jones teaches method for 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 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]); and depressing a syringe (“a standard syringe” [0111]) to continuously inject the fluid in the syringe into a third fluid pathway to thereby cause an approximately equal volume of the fluid to flow through first and second ports (“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…ensures all lumens are flushed with an equal volume of fluid.” [0111-0112]).
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 depressing the syringe to continuously inject the fluid in the syringe into the third fluid pathway to thereby cause an approximately equal volume of the fluid to flow through the first and second ports of the Y-adapter 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 27 is rejected under 35 U.S.C. 103 as being unpatentable over Cluff (US 20080200904) in view of Corbett (US 2013/0053622) in view of Jones et al. (US 2017/0043126).
Regarding claim 27, Cluff discloses a flushing solution (“flushes the blood from the catheters 14 and 16 back into the vasculature of the patient” [0054]) comprising:
a catheter assembly (extravascular system 10) comprising:
a catheter adapter (Figure 1) from which a catheter (catheter 14) extends distally (Figure 1) and a side port (from with extension tubing/catheter 16 extends) that extends from the catheter adapter (Figure 1);
an extension tube (catheter 16) that extends from the side port (Figure 1); and
a Y-adapter (Y adapter 18) having a distal port that is coupled to the extension tube that extends from the side port (“an integrated extension tubing 16…with a Y adapter 18” [0052]), a first port (at vent plug 22) that is inline with the distal port (Figure 1) and a second port (port 24) that is offset from the first port at a first angle (Figure 1), the first and second ports being in fluid communication with the catheter via the extension tube that extends from the side port (“The slide clamp 20 on the integrated extension tubing 16 is provided to eliminate blood exposure when the vent plug 22 is replaced with another vascular access device such as an infusion set connection or another Luer access device or port 24.” [0053]), the catheter assembly being configured to perform a blood draw when the catheter is inserted intravenously (“A device operator will insert the needle 12 into the vasculature of a patient and wait for flashback of blood to travel into the system 10 to confirm that the needle 12 is properly located within the vasculature of the patient. The blood travels into and along the catheters 14 and 16 because a vent plug 22 permits air to escape the system 10 as blood enters the system 10.” [0054]); and
a device for flushing the catheter assembly after the catheter assembly has been used to perform the blood draw (“A device operator will insert the needle 12 into the vasculature of a patient and wait for flashback of blood to travel into the system 10 to confirm that the needle 12 is properly located within the vasculature of the patient. The blood travels into and along the catheters 14 and 16 because a vent plug 22 permits air to escape the system 10 as blood enters the system 10. After an operator confirms proper placement, and after adequate venting of the system 10 has occurred, the operator clamps the catheter 16 to halt the progression of blood through the catheters 14 and 16, removes the vent plug 22, replaces the vent plug 22 with another vascular access device such as an infusion set connection or a Luer access device similar or identical to Luer access device or port 24, unclamps the catheter 16, flushes the blood from the catheters 14 and 16 back into the vasculature of the patient, and re-clamps the catheter 16.” [0054]),
wherein fluid is delivered to cause a volume of fluid to flow through the first and second ports of the Y-adapter (“replaces the vent plug 22 with another vascular access device such as an infusion set connection or a Luer access device similar or identical to Luer access device or port 24, unclamps the catheter 16, flushes the blood from the catheters 14 and 16 back into the vasculature of the patient, and re-clamps the catheter 16.” [0054]),
Cluff fails to explicitly disclose the device comprising: a first extension tube, comprising a distal end, a proximal end, and a first fluid pathway extending through the first extension tube; a first connector coupled to the distal end of the first extension tube; a second extension tube, comprising a distal end, a proximal end, and a second fluid pathway extending through the second extension tube; a second connector coupled to the distal end of the second extension tube; and a housing, wherein the proximal end of the first extension tube and the proximal end of the second extension tube are fixed within the housing; a third connector; a syringe in fluid communication with the first extension tube and the second extension tube, wherein the syringe is coupled to the third connector; a third extension tube having a distal end fixed within the housing and a proximal end fixed within the third connector, the third extension tube forming a third fluid pathway, wherein the third fluid pathway branches into the first fluid pathway and the second fluid pathway; a first needleless connector coupled to the first connector, the first needleless connector being configured to couple to the first port of the Y-adapter; and a second needleless connector coupled to the second connector, the second needleless connector being configured to couple to the second port of the Y-adapter while the first needleless connector is coupled to the first port of the Y-adapter; wherein the first extension tube has a first length that is longer than a second length of the second extension tube, wherein the first and second lengths are configured to correspond with the first angle at which the second port is offset from the first port so that, while the syringe is continuously depressed to continuously inject fluid from the syringe into the third fluid pathway, the combination of the first and second lengths and the first angle are configured to cause an approximately equal volume of the fluid injected from the syringe to flow through the first and second ports of the Y-adapter.
Corbett discloses a device (fluid delivery apparatus 20 and fluid source 24) for 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 device may be any medical instrument that includes multiple functions or sub-components requiring a sterile fluid.” [0046]), 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]), the third extension tube forming a third fluid pathway (through 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]); a first needleless connector (output connector 46) coupled to the first connector, the first needleless connector being configured to couple to a first port (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]); and a second needleless connector (output connector 56) coupled to the second connector, the second needleless connector being configured to couple to a second port while the first needleless connector is coupled to the first port (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 the first extension tube has a first length that is longer than a second length of the second extension tube (“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 to facilitate easy connection and fit to the medical device 22.” [0042]), wherein the first and second lengths are configured to correspond with the first angle at which the second port is offset from the first port (Figure 2; “the second and third tubes 40, and 50 may be of differing length to facilitate easy connection and fit to the medical device 22.” [0042], wherein the different lengths correspond to how the medical device 22 is designed such as the angles of the port) so that, while the fluid source is fluidically connected to the third fluid pathway, the combination of the first length, the second length, and the first angle are configured to cause a volume of the fluid to flow through the first and second ports (Figure 2; “Fluid from the fluid source is caused to flow from the second tube into the first fluid input port and through the pump purge line to a pump of the percutaneous ventricular assist device located in a cardiac structure, or blood vessel of a patient to maintain the pump substantially free of blood (step 92). Fluid from the fluid source is caused to flow from the third tube into the second fluid input port to a placement signal line; and is used in the placement signal line to measure a pressure signal indicative of the placement of the percutaneous ventricle assist device in a cardiac structure, or blood vessel of a patient (step 94).” [0051]).
Before the effective filing date of the claimed invention, it would have been obvious one having ordinary skill in the art to modify the flushing solution of Cluff to include a device for flushing the catheter assembly, the device comprising a first, second, and third extension tubes and connectors, a housing, a fluid source, first and second needleless connectors configured to couple to the first and second ports of the Y-adapter, wherein the first extension tube has a first length that is longer than a second length of the second extension tube, wherein the first and second lengths are configured to correspond with the first angle at which the second port is offset from the first port so that, while the fluid is continuously delivered from the fluid source into the third fluid pathway, the combination of the first and second lengths and the first angle are configured to cause a volume of the fluid injected from the syringe to flow through the first and second ports of the Y-adapter based on the teachings Corbett to efficiently clear the catheter assembly of blood in a sterile manner that provides flushing fluid to two ports simultaneously (Corbett [0050-0052]; Figures 2 and 4).
Modified Cluff fails to explicitly disclose the fluid source is a syringe; and while the syringe is continuously depressed to continuously inject fluid from the syringe into the third fluid pathway, approximately equal volume of the fluid injected from the syringe to flow through the first and second ports of the Y-adapter.
Jones teaches a flushing solution 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]) comprising a device (adapter 298 and associated syringe) comprising a fluid source that is a syringe (“a standard syringe” [0111]) in fluid communication with a first fluid pathway and a second fluid pathway (at adapter bifurcation 304 of connector 302; Figure 30), wherein the syringe is coupled to a third connector (luer fitting 300; “an adapter 298 for a standard luer syringe having a luer fitting 300” [0111]; Figure 30); wherein while the syringe is continuously depressed to inject fluid into a third fluid pathway at the third connector, approximately equal volumes of the fluid injected from the syringe flow through the first connector and the second connector and their connected ports (“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…ensures all lumens are flushed with an equal volume of fluid.” [0111-0112]).
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 flushing solution of Cluff in view of Corbett to include the fluid source is a syringe; and while the syringe is continuously depressed to continuously inject fluid from the syringe into the third fluid pathway, approximately equal volume of the fluid injected from the syringe to flow through the first and second ports of the Y-adapter 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 28 is rejected under 35 U.S.C. 103 as being unpatentable over Cluff (US 20080200904) in view of Corbett (US 2013/0053622) in view of Jones et al. (US 2017/0043126) as applied in claim 27 above, and further in view of Reichert et al. (US 20150045772).
Regarding claim 28, modified Cluff teaches the device of claim 27.
Modified Cluff fails to explicitly teach wherein the proximal ends of the first and second extension tubes cross over one another at an angle as they extend from the housing, wherein the angle is between about 30° and 60° or between 15° and 45°.
Reichert teaches a device (Figure 2b) comprising a first extension tube (primary flow line 108’) and a second extension tube (secondary IV set 120’), wherein the proximal ends of the first and second extension tubes cross over one another at an angle (Figure 2b) as they extend from a housing (at attachment members 160; Figure 1 for example), wherein the angel 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 the flushing solution of Cluff in view Corbett to include the proximal ends of the first and second extension tubes cross over one another at an angle as they extend from the housing, wherein the angle 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 and improve organization when multiple IV lines are required (Reichert [0055], [0071]).
Response to Arguments
Applicant’s arguments with respect to claims 1, 9, and 26-28 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 “Corbett does not disclose a device for flushing a catheter assembly” and the argument that “Corbett’s design renders post-use flush unnecessary and therefore teaches away from the claimed embodiments” (Remarks, page 2), the examiner respectfully disagrees. As detailed in the rejections above, Corbett discloses that the device 20 can be used to purge or flush blood from the medical 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]; see also [0051]). Corbett additionally discloses that the medical device 22 “may be any medical instrument that includes multiple functions or sub-components requiring a sterile fluid.” [0046]. Based on this disclosure, it is maintained that Corbett discloses a flushing device that is capable of being used to flush a catheter assembly after a blood draw, such as disclosed by Cluff et al. (US 20080200904) as detailed above. It is noted that independent claim 1 does not positively recite or claim the catheter assembly and its related structures.
Regarding the argument that “Corbett does not appear to teach or suggest the claimed length-angle relationship for accomplishing the equal volume flushing as required in combination with the other claims” (Remarks, page 3), it is noted that the disclosure of Corbett was modified with the disclosure of Jones et al. (US 2017/0043126) for teaching this limitation. As detailed above, Corbett discloses the first extension tube has a first length that is longer than a second length of the second extension tube ([0042]), wherein the first and second lengths are configured to correspond with the first angle at which the second port is offset from the first port (Figure 2; [0042], wherein the different lengths correspond to how the medical device 22 is designed such as the angles of the ports) so that, while the fluid source is fluidically connected to the third fluid pathway, the combination of the first length, the second length, and the first angle are configured to cause a volume of the fluid to flow through the first and second ports (Figure 2; [0051]). Jones teaches a device (298) to flush a catheter assembly ([0111]), wherein while the syringe is continuously depressed to inject fluid into a third fluid pathway at the third connector, approximately equal volumes of the fluid flow through the first connector and the second connector and their connected ports ([0111-0112]). It is maintained that it would have been obvious to modify the device of Corbett to include that while the syringe is continuously depressed to inject fluid into the third fluid pathway, approximately equal volumes of the fluid flow through the first connector and the second connector and through the first and second ports of the Y-adapter 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
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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