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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/24/2026 has been entered.
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 1,3-10, 13-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Abulhaj (US 7232420 B1) in view of Hsu et al. (US 20190001054 A1) in further view of O'Boyle (US 4822344 A).
Regarding claim 1, Abulhaj discloses a system (flow rate selection valve 10 + spike structure 100 + drip chamber 200+ IV line (L); Col 1, lines 7-13; Fig 1-5) for controlled delivery of a medical fluid (medical solution inside intravenous bag; Col 1, lines 7-13), the system comprising: a valve member (flow rate selection valve 10, Fig 3-5) having an inlet aperture (1003, Annotated Fig 2) and an outlet aperture (1004, Annotated Fig 2) for directing direct the medical fluid (medical solution ) out of the valve member (10) wherein the valve member (gate cylinder 20, Fig 4) is movable between an initial closed position (position where none of the predetermined bores 22, 24, 26 align with flow ports 82,84, 86, Fig 4-5) such that movement of the medical fluid (medical solution) out of the valve member (10) is resisted (position where none of the predetermined bores 22, 24, 26 align with flow ports 82,84, 86 the fluid across valve 10 is resisted), a fully open position (bore of largest diameter either 22,24,26, Fig 4) where the medical fluid (medical solution) is permitted to move out of the valve member (10) at a predetermined fluid flow rate (Col 4, line 67 – Col 5, line 1: “The gate cylinder 20 preferably includes the three flow rate determining passageways 22, 24 and 26, although providing other numbers of such passageways is contemplated.”), and at least one intermediate open flow position (bore of intermediate diameter either 22,24,26, Fig 4) where the medical fluid (medical solution) is permitted to move out of the valve member (10) at a flow rate below the predetermined fluid flow rate (intermediate fluid position deliver medical solution at a flow rate below predetermined flow rate of fully open position; Col 2, lines 23-31); and a tubing (spike structure 100).
Abulhaj is silent regarding an elastomeric pump comprising an elastomeric membrane and a shell surrounding the elastomeric membrane, the elastomeric membrane defining a chamber containing the medical fluid within the chamber such that the chamber exerts a pressure on the medical fluid contained therein and is configured to force the medical fluid from the elastomeric membrane; the valve inlet aperture fluidly coupled to the elastomeric pump; and a tubing interposed between and fluidly coupling an outlet of the elastomeric membrane with the inlet aperture of the valve member.
Hsu teaches a system (infusion assembly 100, Fig 1) comprising an elastomeric pump (elastomeric pump 102, Fig 1) comprising an elastomeric membrane (elastic sleeve 118, Fig 1) and a shell (housing 120, Fig 1) surrounding the elastomeric membrane (Shell 120 surrounds elastomeric membrane 118; [0039]), the elastomeric membrane (elastomeric bladder 118, Fig 1) defining a chamber (chamber 134, Fig 1) containing the medical fluid (fluid; [0045]) within the chamber (134) such that the chamber exerts a pressure on the medical fluid (liquid drug) contained therein ([0039]; chamber 134 is defined by elastomeric bladder 118, which expands and contract exerting pressure on the liquid drug, Fig 1) and is configured to force the medical fluid (liquid drug) from the elastomeric membrane (118) ([0039]); a valve member (flow regulator 130, Fig 1; [0043]) having an inlet aperture (inlet aperture positioned in flow path 110; [0043]) fluidly coupled to the elastomeric pump (102) and an outlet aperture (outlet aperture positioned in flow path 110; [0043]) for directing the medical fluid out (fluid) of the valve member (130); and a tubing (tubing 108, Fig 1) interposed between and fluidly coupling an outlet (outlet port 124, Fig 1) of the elastomeric membrane (118) with the inlet aperture (inlet aperture positioned in flow path 110; [0043]) of the valve member (130)(Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abulhaj with similar elastomeric pump fluidly coupled to the valve as taught by Hsu for the purpose of for making the system portable, and provide a source of fluid under pressure at a controlled and predictable rate ([0037]; [0039]).
Abulhaj/Hsu are silent regarding wherein a pressure of the medical fluid is greater than a pressure of the vein by a predetermined value to keep the vein open.
O'Boyle teaches a system (Fig 29) for controlled delivery of a medical fluid (IV solution inside bag 8, Fig 29), the system comprising a valve (device 1, Fig 1) wherein a pressure of the medical fluid (IV solution) is greater than a pressure of the vein by a predetermined value to keep the vein open (Col 5, lines 6-13: pressure at KVO position is greater than vein pressure)
Therefore, it would be prima facie obvious before the effective filing date of the present invention to modify the device of Abulhaj/Hsu with a similar KVO position and respective aperture based on predetermined pressure for KVO as taught by O'Boyle for the purpose of having an additional valve position that keeps the vein of the patient open while administering only a minimum of IV solution to the patient (Col 5, lines 6-13).
Regarding claim 3, Abulhaj/Hsu/O’Boyle discloses discloses the system of Claim 1. Abulhaj discloses wherein the valve member comprises a stopcock valve (valve 10, Fig 4-8 is a stopcock).
Regarding claim 4, Abulhaj/Hsu/O’Boyle discloses the system of Claim 3. Abulhaj discloses wherein the valve member comprises: a base portion (valve housing 60, Fig 5) comprising a longitudinally extending body (body comprising lumen 90, Fig 5) having a lumen (receiving bore 90, Fig 5) extending longitudinally through at least a portion of the base portion (60); and a body portion (gate cylinder 20, Fig 4) comprising a handle (rotation engagement structure 40, Fig 4) and a stem (1000, Annotated Fig 1) extending longitudinally from the handle (40) and being disposed at least partially in the lumen (90) (Fig 3).
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Regarding claim 5, Abulhaj/Hsu/O’Boyle discloses the system of Claim 4. Abulhaj discloses wherein the base portion (60) comprises a cylindrically extending longitudinal body (cylindrical extending longitudinal body of 60 that comprises lumen 90, gray area seen in Annotated Fig 2) having an outer surface (1001, Annotated Fig 2), an inner surface (1002, Annotated Fig 2) defining the lumen (90), and a sidewall (barrier 80, Fig 4) defined between the inner surface (1002) and the outer surface (1001).
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Regarding claim 6, Abulhaj/Hsu/O’Boyle discloses the system of Claim 5. Abulhaj discloses wherein the inlet aperture (1003, Annotated Fig 2) extends through the sidewall (80) and the outlet aperture (1004, Annotated Fig 2) extends through another side of the sidewall (80) of the base portion (60), the inlet aperture (1003, Annotated Fig 2) and outlet aperture (1004, Annotated Fig 2) fluidly coupling the base portion (60) to a lumen of the tubing (lumen of IV line, Col 1, lines 7-13).
Regarding claim 7, Abulhaj/Hsu/O’Boyle discloses the system of Claim 6. Abulhaj discloses wherein the stem (1000, Annotated Fig 1) comprises a body (body of stem 1000, Annotated Fig 1) including a plurality of flow channels (passageways 22, 24, 26, Fig 3) extending laterally though the body (Fig 4).
Regarding claim 8, Abulhaj/Hsu/O’Boyle discloses the system of Claim 7. Abulhaj discloses wherein the plurality of flow channels (22, 24, 26) are longitudinally spaced apart from each other along a circumference of the body (body of stem 1000, Annotated Fig 1) (Fig 4 shows the channels spaced apart longitudinally).
Regarding claim 9, Abulhaj/Hsu/O’Boyle discloses the system of Claim 7. Abulhaj discloses wherein the plurality of flow channels (22, 24, 26) comprise different sizes (Col 4, lines 32-35).
Regarding claim 10, Abulhaj/Hsu/O’Boyle discloses the system of Claim 7. Abulhaj discloses wherein the plurality of flow channels (22, 24, 26) comprise a first flow (fist passageway 22, Fig 4) channel having a first diameter, a second flow (second passageway 24, Fig 4) channel having a second diameter, and a third flow channel (fist passageway 26, Fig 4) having a third diameter (Col 4, lines 32-35: flow passageway 22, 24 and 26 have each different diameters).
Regarding claim 13, Abulhaj discloses a system (flow rate selection valve 10 + spike structure 100 + drip chamber 200+ IV line (L), Col 1, lines 7-13; Fig 1-5) for controlled delivery of a medical fluid (medical solution inside intravenous bag; Col 1, lines 7-13), the system comprising: a valve member (flow rate selection valve 10, Fig 3-5) comprising (i) a base portion (valve housing 60, Fig 5) including an inner lumen (receiving bore 90, Fig 5), an inlet aperture (1003, Annotated Fig 2), and an outlet aperture (1004, Annotated Fig 2), and (ii) a body portion (gate cylinder 20, Fig 4) including a stem (1000, Annotated Fig 1) disposed at least partially within the inner lumen (90) (Fig 3) and including a handle (rotation engagement structure 40, Fig 4), the stem (1000, Annotated Fig 1) comprising a plurality of flow channels (passageways 22, 24, 26, Fig 3) extending therethrough and defining fluid pathways of different sizes (Col 4, lines 32-35).
Abulhaj is silent regarding an elastomeric pump comprising an elastomeric membrane and a shell surrounding the elastomeric membrane, the elastomeric membrane defining a chamber containing the medical fluid therein such that the chamber exerts a pressure on the medical fluid contained therein and is configured to force the medical fluid out of the elastomeric membrane; wherein the valve member fluidly couples the elastomeric pump and a catheter via each of the flow channels for selectively delivering the medical fluid to a patient's vein having a second pressure less than the first pressure by a predetermined value to keep the patient's vein open; and a tubing interposed between and fluidly coupling an outlet of the elastomeric membrane with the inlet aperture of the valve member, and the catheter.
Hsu teaches a system (infusion assembly 100, Fig 1) an elastomeric pump (elastomeric pump 102, Fig 1) comprising an elastomeric membrane (elastomeric bladder 118, Fig 1) and a shell (housing 120, Fig 1) surrounding the elastomeric membrane (118), the elastomeric membrane (118) defining a chamber (chamber 134, Fig 1) containing the medical fluid (fluid; [0045]) therein such that the chamber exerts a pressure on the medical fluid (fluid; [0045]) contained therein and is configured to force the medical fluid out of the elastomeric membrane (118) ([0049] housing 120 is position radially outwards from bladder 118 and expands and contracts exerting pressure on the bladder 118); wherein the valve (flow regulator 130, Fig 1; [0043]) member fluidly couples the elastomeric pump (102) and a catheter (catheter 114, Fig 1) for selectively delivering the medical fluid (fluid ; [0045]) having a second pressure; and a tubing (tubing 108) interposed between (Fig 1) and fluidly coupling an outlet (outlet port 124, Fig 1) of the elastomeric membrane (118) with the inlet aperture (inlet aperture positioned in flow path 110; [0043]) of the valve member (130), and the catheter (114).
Note: Abulhaj/Hsu discloses the valve member (10, from Abulhaj) fluidly couples the elastomeric pump (102 from Hsu) and a catheter (IV line, from Abulhaj) via each of the flow channels (passageways 22, 24, 26; from Abulhaj) for selectively delivering the medical fluid (medical solution; from Abulhaj) to a patient's vein (Col 1, lines 7-13; from Abulhaj).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abulhaj with similar elastomeric pump fluidly coupled to the valve as taught by Hsu for the purpose of for making the system portable, and provide a source of fluid under pressure at a controlled and predictable rate ([0037]; [0039])
Abulhaj/Hsu are silent regarding having a second pressure less than the first pressure by a predetermined value to keep the patient's vein open.
O'Boyle teaches a system (Fig 29) for controlled delivery of a medical fluid (IV solution inside bag 8, Fig 29), the system comprising a valve (device 1, Fig 1) wherein a pressure of the medical fluid (IV solution) is greater than a pressure of the vein by a predetermined value to keep the vein open (Col 5, lines 6-13: pressure at KVO position is greater than vein pressure) (abstract).
Therefore, it would be prima facie obvious before the effective filing date of the present invention to modify the device of Abulhaj/Hsu with a similar KVO position and respective aperture based on a second pressure for KVO as taught by O'Boyle for the purpose of having an additional valve position that keeps the vein of the patient open while administering only a minimum of IV solution to the patient (Col 5, lines 6-13).
Regarding claim 14, Abulhaj/Hsu/O'Boyle discloses the system of Claim 13. Abulhaj discloses wherein the valve member (10) is movable between (i) an initial closed position (position where none of the predetermined bores 22, 24, 26 align with flow ports 82,84, 86, Fig 4-5) where the stem (1000, Annotated Fig 1) occludes the inner lumen (90) of the base portion (60) and blocks fluid communication between an intravenous bag and the catheter (IV line; Col 1, lines 7-13), and (ii) a plurality of open positions (Positions where bores 22, 24, 26 are aligned to the path flow by rotation of selection knob 42; Fig 3 shows alignment of bore 24) where each of the flow channels (22, 24, 26) selectively fluidly couples the intravenous bag and the catheter (IV line; Col 1, lines 7-13) such that the medical fluid (medical solution) is delivered to the patient's vein (Col 1, lines 7-13) at a predetermined fluid flow rate (predetermined flow rate depending on the position of knob 42 and the bore being aligned) to keep the patient's vein open (Bores 22, 24, 26 from Abulhaj has a high pressure and flow rate; therefore will also maintain vein open when used).
Abulhaj is silent regarding an elastomeric pump and where the stem blocks fluid communication between the elastomeric pump and the catheter; where each of the flow channels selectively fluidly couples the elastomeric pump and the catheter.
Hsu teaches a system (infusion assembly 100, Fig 1) comprising an elastomeric pump (elastomeric pump 102, Fig 1) a valve member (flow regulator 130, Fig 1; [0043]) and a catheter (catheter 114, Fig 1).
Note: Abulhaj/Hsu discloses where the stem (1000, Annotated Fig 1, from Abulhaj) occludes the inner lumen (90, from Abulhaj) of the base portion (60, from Abulhaj) and blocks fluid communication between the elastomeric pump (102, from Hsu; as modified in claim 13) and the catheter (IV line; Col 1, lines 7-13, from Abulhaj), and (ii) a plurality of open positions (Positions where bores 22, 24, 26 are aligned to the path flow by rotation of selection knob 42; Fig 3 shows alignment of bore 24, from Abulhaj) where each of the flow channels (22, 24, 26, from Abulhaj) selectively fluidly couples the elastomeric pump (102, from Hsu; as modified in claim 13) and the catheter (IV line; Col 1, lines 7-13, from Abulhaj)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abulhaj with similar elastomeric pump fluidly coupled to the valve as taught by Hsu for the purpose of for making the system portable, and provide a source of fluid under pressure at a controlled and predictable rate ([0037]; [0039]).
Regarding claim 15, Abulhaj/Hsu/O’Boyle discloses the system of Claim 14. Abulhaj discloses wherein the plurality of flow channels (22, 24, 26) are longitudinally spaced apart from each other along a circumference of the stem (body of stem 1000, Annotated Fig 1) (Fig 4 shows the channels spaced apart longitudinally).
Regarding claim 16, Abulhaj/Hsu/O’Boyle discloses the system of Claim 14. Abulhaj discloses wherein the plurality of flow channels (22, 24, 26) have different sizes (Col 4, lines 32-35).
Regarding claim 18, Abulhaj/Hsu/O’Boyle discloses the system of Claim 14. Abulhaj discloses wherein the plurality of flow channels (22, 24, 26) comprise a first flow channel (bore 22, Fig 3) having a first diameter (diameter of bore 22, Fig 3), a second flow channel (bore 24, Fig 3) having a second diameter (diameter of bore 22, Fig 3), and a third flow channel (bore 26, Fig 3) having a third diameter (diameter of bore 26, Fig 3) (Col 4, lines 32-35).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Abulhaj (US 7232420 B1) in view of Hsu et al. (US 20190001054 A1) in further view of O'Boyle (US 4822344 A) in view of Walborn (US 20080262441 A1).
Regarding claim 2, Abulhaj/Hsu/O'Boyle discloses the system of Claim 1. Abulhaj is silent wherein the valve member comprises a check valve.
Walborn teaches a system (Fig 1) for controlled delivery of a medical fluid (medical fluid, abstract) wherein the valve member comprises a check valve (check valve 50, Fig 4).
Therefore, it would be prima facie obvious before the effective filing date of the present invention to modify the valve of device of Abulhaj/Walborn/O'Boyle to incorporate similar structure as check valve taught by Walborn for the purpose of allowing flow only towards the patient direction while maintaining the pressure regulation functions ([0033]).
Claims 11 and 17 is rejected under 35 U.S.C. 103 as being unpatentable over Abulhaj (US 7232420 B1) in view of Hsu et al. (US 20190001054 A1) in further view of O'Boyle (US 4822344 A) in view of Beebe (US 20140190408 A1).
Regarding claim 11, Abulhaj/Hsu/O’Boyle discloses the system of Claim 7. Abulhaj/Hsu/O’Boyle are silent wherein the inner surface of the base portion comprises a plurality of threads and the stem comprises a plurality of complimentary threads on an outer surface thereof; and wherein, in an engaged configuration of the complimentary threads, the body portion is rotatable about a central axis of the base portion to translate the body portion proximally and distally within the lumen.
Beebe teaches a system (system, Fig 8 and 10A-C) comprising a valve (stopcock assembly 210, Fig 10C) further comprising an inner surface (2000, Annotated Fig 3) of a base portion (211) comprises a plurality of threads (2001, Annotated Fig 3) and a stem (2002, Annotated Fig 3) comprises a plurality of complimentary threads (2003, Annotated Fig 3) on an outer surface thereof (2004, Annotated Fig 3); and wherein, in an engaged configuration of the complimentary threads (Fig 10C), a body portion (2004, Annotated Fig 3) is rotatable about a central axis (2006, Annotated Fig 3)of the base portion (211) to translate the body portion (2005, Annotated Fig 3) proximally and distally within the lumen (lumen where body portion 2005 is inserted, Fig 10C; threaded connection shown in Fig 10C allows upper and lower displacement of the stem).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abulhaj/Hsu/O’Boyle with a similar threading engagement between the stem and base portion as taught by Beebe for the purpose of having a strong and reliable joint between the valve components of the pressurized system while the valve moves from one position to another ([0057]).
Regarding claim 17, Abulhaj/Hsu/O’Boyle discloses the system of Claim 13. Abulhaj/Hsu/O’Boyle are silent wherein an inner surface of the base portion comprises a plurality of threads and the stem comprises a plurality of complimentary threads on an outer surface thereof; and wherein, in an engaged configuration of the complimentary threads, the body portion is rotatable about a central axis of the base portion to translate the body portion proximally and distally within the inner lumen.
Beebe teaches a system (system, Fig 8 and 10A-C) comprising a valve (stopcock assembly 210, Fig 10C) further comprising an inner surface (2000, Annotated Fig 3) of a base portion (211) comprises a plurality of threads (2001, Annotated Fig 3) and a stem (2002, Annotated Fig 3) comprises a plurality of complimentary threads (2003, Annotated Fig 3) on an outer surface thereof (2004, Annotated Fig 3); and wherein, in an engaged configuration of the complimentary threads (Fig 10C), a body portion (2004, Annotated Fig 3) is rotatable about a central axis (2006, Annotated Fig 3)of the base portion (211) to translate the body portion (2005, Annotated Fig 3) proximally and distally within the inner lumen (lumen where body portion 2005 is inserted, Fig 10C; threaded connection shown in Fig 10C allows upper and lower displacement of the stem).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abulhaj/Hsu/O’Boyle with a similar threading engagement between the stem and base portion as taught by Beebe for the purpose of having a strong and reliable joint between the valve components of the pressurized system while the valve moves from one position to another ([0057]).
Claims 12, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Abulhaj (US 7232420 B1) in view of Hsu et al. (US 20190001054 A1) in further view of O'Boyle (US 4822344 A) in view of Stim (US 4187849 A).
Regarding claim 12, Abulhaj/Hsu/O’Boyle discloses the system of Claim 7. Abulhaj discloses wherein, the second flow channel (24) is co-axially aligned with the inlet (1004, Annotated Fig 2) and outlet (1004, Annotated Fig 2) apertures and the lumen of the tubing (lumen of tube 100, Fig 3)in a second flow condition (condition seen in Fig 3).
Abulhaj/Hsu/O’Boyle are silent regarding the first flow channel is co-axially aligned with the inlet and outlet apertures and the lumen of the tubing in a first flow condition; and the third flow channel is co-axially aligned with the inlet and outlet apertures and the lumen of the tubing in a third flow condition.
Stim teaches a system (Fig 1-2) comprising a valve (rotary tube support member 32 + housing 24, Fig 2) comprising a first flow channel (bore 40, Fig 2) co-axially aligned with an inlet (adjacent port 44, Fig 2) and outlet (opening 42,Fig 2) apertures and the lumen of the tubing (lumen of suction tube 35, Fig 2) in a first flow condition (First position of the rotary tube support member seen in Fig 3; Col 4, lines 22-34), the second flow channel (bore 38, Fig2) is co-axially aligned with the inlet (44) and outlet (42) apertures and the lumen of the tubing (lumen of suction tube 35, Fig 2) in a second flow condition (second position of the rotary tube support member seen in Fig 4b; Col 4, lines 22-34) and the third flow channel (bore 36, Fig 2) is co-axially aligned with the inlet (44) and outlet (42) apertures and the lumen of the tubing (lumen of suction tube 35, Fig 2) in a third flow condition (third position of the rotary tube support member seen in Fig 4c; Col 4, lines 22-34).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abulhaj/Hsu/O’Boyle with coaxial alignment of each flow channel with the inlet and outlet apertures and the tube lumen at each position of the valve as taught by Stim for the purpose of communicating each bore with the inlet and outlet and modifying the desired flow rate (Col 4, lines 22-34).
Regarding claim 19, Abulhaj/Hsu/O’Boyle discloses the system of Claim 18, Abulhaj discloses wherein, the second flow channel (24) is co-axially aligned with the inlet (1004, Annotated Fig 2) and outlet (1004, Annotated Fig 2) apertures and a lumen of the tubing (lumen of tube 100, Fig 3)in a second flow condition (condition seen in Fig 3).
Abulhaj/Hsu/O’Boyle are silent regarding the first flow channel is co-axially aligned with the inlet and outlet apertures and a lumen of the tubing in a first flow condition; and the third flow channel is co-axially aligned with the inlet and outlet apertures and the lumen of the tubing in a third flow condition.
Stim teaches a system (Fig 1-2) comprising a valve (rotary tube support member 32 + housing 24, Fig 2) comprising a first flow channel (bore 40, Fig 2) co-axially aligned with an inlet (adjacent port 44, Fig 2) and outlet (opening 42,Fig 2) apertures and the lumen of the tubing (lumen of suction tube 35, Fig 2) in a first flow condition (First position of the rotary tube support member seen in Fig 3; Col 4, lines 22-34), the second flow channel (bore 38, Fig2) is co-axially aligned with the inlet (44) and outlet (42) apertures and the lumen of the tubing (lumen of suction tube 35, Fig 2) in a second flow condition (second position of the rotary tube support member seen in Fig 4b; Col 4, lines 22-34) and the third flow channel (bore 36, Fig 2) is co-axially aligned with the inlet (44) and outlet (42) apertures and the lumen of the tubing (lumen of suction tube 35, Fig 2) in a third flow condition (third position of the rotary tube support member seen in Fig 4c; Col 4, lines 22-34).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abulhaj/Hsu/O’Boyle with coaxial alignment of each flow channel with the inlet and outlet apertures and the tube lumen at each position of the valve as taught by Stim for the purpose of communicating each bore with the inlet and outlet and modifying the desired flow rate (Col 4, lines 22-34).
Regarding claim 20, Abulhaj/Hsu/O’Boyle/Stim discloses the system of Claim 19, Abulhaj discloses wherein the first flow condition (bore 22 aligned position) comprises a first predetermined fluid flow rate (flow rate predetermined by diameter of bore 22), the second flow condition (bore 24 aligned position, Fig 3) comprises a second predetermined fluid flow rate (flow rate predetermined by diameter of bore 24), and the third flow condition (bore 24 aligned position, Fig 3) comprises a third predetermined fluid flow rate (flow rate predetermined by diameter of bore 26).
Abulhaj is silent regarding and the second predetermined fluid flow rate is greater than the first fluid predetermined flow rate, and the third predetermined fluid flow rate is greater than the second predetermined fluid flow rate.
O'Boyle teaches a system (Fig 29) for controlled delivery of a medical fluid (IV solution inside bag 8, Fig 29), the system comprising a valve (device 1, Fig 1) wherein a pressure of the medical fluid (IV solution) is greater than a pressure of the vein by a predetermined value to keep the vein open (Col 5, lines 6-13: pressure at KVO position is greater than vein pressure).O'Boyle further teaches a second predetermined fluid flow rate (91 ml/hr position; Fig 1) is greater than the first fluid predetermined flow rate (83ml/hr position, Fig 1), and the third predetermined fluid flow rate (100ml/hr position, Fig 1) is greater than the second predetermined fluid flow rate (91ml/hr position, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Abulhaj/Hsu/O’Boyle/Stim with of a sequentially increase predetermined flow rate positions as taught by O'Boyle for the purpose of having individually selected positions to incrementally vary the flow rate through the device (Col 4, line 60- Col 5, line 1).
Response to Arguments
Applicant's arguments filed 03/27/2026 have been fully considered but they are not persuasive. Applicant submits that amended limitations are not taught by the cited prior art. Examiner respectfully disagrees. Please see relevant portion below:
Hsu teaches a system (infusion assembly 100, Fig 1) comprising an elastomeric pump (elastomeric pump 102, Fig 1) comprising an elastomeric membrane (elastic sleeve 118, Fig 1) and a shell (housing 120, Fig 1) surrounding the elastomeric membrane (shell 120 surrounds elastomeric membrane 118; [0039]), the elastomeric membrane (118) defining a chamber (chamber 134, Fig 1) containing the medical fluid (fluid; [0045]) within the chamber (134) such that the chamber exerts a pressure on the medical fluid (liquid drug) contained therein ([0039]; chamber 134 is defined by elastomeric bladder 118, which expands and contract exerting pressure on the liquid drug, Fig 1) and is configured to force the medical fluid (liquid drug) from the elastomeric membrane (118) ([0039]); a valve member (flow regulator 130, Fig 1; [0043]) having an inlet aperture (inlet aperture positioned in flow path 110; [0043]) fluidly coupled to the elastomeric pump (102) and an outlet aperture (outlet aperture positioned in flow path 110; [0043]) for directing the medical fluid out (fluid) of the valve member (130); and a tubing (tubing 108, Fig 1) interposed between and fluidly coupling an outlet (outlet port 124, Fig 1) of the elastomeric membrane (118) with the inlet aperture (inlet aperture positioned in flow path 110; [0043]) of the valve member (130)(Fig 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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