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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/15/2026 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 1-2, 4, 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kazuhiro (US 20100228121 A1) in view of John (US 0984037 A) in further view of Mahurkar (US 6156013 A).
Regarding claim 1, Kazuhiro discloses a syringe (dual chamber syringe 10, Fig 1A) comprising: a substantially cylindrically shaped barrel (cylindrical body 11, Fig 1A), which defines an inner side wall (inner side or wall 14, Fig 1A), the barrel (11) having an open proximal end (proximal open of barrel 11, Fig 1A), and a distal end (cone shaped forward end 25, Fig 1A), the distal end (25)of the barrel including a connector (nozzle 20 with external threads 24, Fig 1A) defining an outlet lumen therethrough (lumen of nozzle 20, Fig 1A), the outlet lumen (lumen of nozzle 20, Fig 1A) in fluid communication with an interior of the barrel (11), the interior defined by the open proximal end (proximal open of barrel 11, Fig 1A), the distal end (25), and the inner side wall (14); concentrically nested primary (pushrod 76, Fig 5) and secondary plungers (inner chamber pushrod 81, Fig 5), disposed within the barrel (11) interior (both plunger 76 and 81 are disposed inside barrel 11 when assembled. Being directly connected to the pistons 75 and 91; Fig 5), respectively having primary (extending cylindrical body of pushrod 76, Fig 5) and secondary plunger rods (extending distal portion of cylindrical body of pushrod 81, Fig 5) capable of selective translation within the barrel (11) interior along a common axis (Axis seen in Fig 5; movement of rod is independent form each other; Fig 1A, 5); a primary stopper (rubber piston 75, Fig 1A) coupled to a distal end (distal end of pushrod 76 containing locking projections 79a, b, Fig 3) of the primary plunger (76), the primary stopper (75) having a proximal end (rear end comprising wall 80, Fig 3) surface facing the proximal end of the barrel (proximal open of barrel 11, Fig 1A) and a distal end surface (distal surface of rubber piston 75, Fig 3) facing the distal end (25) of the barrel (11), the primary stopper (75) defining a through aperture (through hole of rubber piston 75, Fig 3) between its proximal (80) and distal end (distal surface of rubber piston 75, Fig 3) surfaces, in fluid communication with the outlet lumen (lumen of nozzle 20, Fig 3); a secondary stopper (rubber piston 91, Fig 3) coupled to a distal end (distal end containing projections 90, Fig 3; [0039]) of the secondary plunger (81), the secondary stopper (91) having a distal end (distal end of piston 91, Fig 3) surface facing the distal end (25) of the barrel (11); a manually actuated, selective isolation valve (valve assembly 46, Fig 1A comprises a duckbill valve which is actuated (opening of distal end) by manual force exerted on the rod 81, attached piston 91, which displaces fluid under pressure through the valve assembly 46; fluid is isolated when valve 46 is closed) disposed within the barrel (11) interior, axially offset, along the common axis (axially offset towards the distal portion of common axis seen in Fig 1A), toward the distal end (25) of the barrel (11) away from the distal end surface of the secondary stopper (distal end of rubber piston 91, Fig 1A), the valve (46) having an inlet (inlet of valve 46, Fig 1A) in fluid communication with the distal end surface of the secondary stopper (distal end of rubber piston 91, Fig 1A) and an outlet (outlet of valve 46, Fig 1A) in fluid communication with the through aperture of the primary stopper (through hole of piston 75, Fig 1A) and the outlet lumen (lumen of nozzle 20, Fig 3) ( outlet of valve 46, and through hole of piston 75 are in fluid communication inside opening 57, Fig 1E); an annular-shaped, primary fluid chamber (outer chamber 15, Fig 1A) within the barrel (11) interior, defined between the distal end surface of the primary stopper (distal end of rubber piston 75, Fig 1A) and the distal end (25) of the barrel (11), volume of the primary fluid chamber (15) being selectively variable by translation of the primary plunger rod (extending distal portion of cylindrical body of pushrod 76, Fig 5); and a secondary fluid chamber (inner chamber 32, Fig 1A), nested within the primary fluid chamber (15) and within the barrel interior (11), defined between the distal end surface of the secondary stopper (distal end of rubber piston 91, Fig 1A) and the valve inlet (inlet of vale 46, Fig 1), in fluid communication with the valve inlet (inlet of vale 46, Fig 1), volume of the secondary fluid chamber (32) being selectively variable by translation of the secondary plunger rod (extending distal portion of cylindrical body of pushrod 81, Fig 5); wherein, when the valve (one way duck bill 46, [0042]) is closed the secondary fluid chamber (32) is isolated from the outlet lumen (lumen of nozzle 20, Fig 3), so that translation of the primary plunger rod (extending distal portion of cylindrical body of pushrod 76, Fig 5) only aspirates fluid into or dispenses fluid out of the primary chamber (15), via the outlet lumen (lumen of nozzle 20, Fig 3) (One way valve 46 only allows fluid flow in the distal direction, which isolates chamber 32, preventing inflow; the reciprocating movement of rubber piston 75 caused by pushrod 76 aspirates in the proximal direction and dispense in the distal direction; [0042], Fig 1A); and wherein, when the valve (46) is open the secondary fluid chamber (32) is fluid communication with the outlet lumen (lumen of nozzle 20, Fig 3), so that translation of the secondary plunger rod (extending distal portion of cylindrical body of pushrod 81, Fig 5) dispenses fluid out of the secondary chamber (32), via the outlet lumen (lumen of nozzle 20, Fig 3).
Kazuhiro is silent wherein the selective isolation valve comprises a fluted knob wherein the fluted knob is configured to open and close the valve.
John teaches a syringe (Fig 1) comprising an isolation valve (valve F+ stem F1+ handle F2, Fig 1) comprises a knob (handle F2, Fig 1-3) is configured to open and close the valve (movement of handle F2 causes axial displacement of valve F; page 1, Col 2, lines 90-110).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Kazuhiro with similar valve assembly as taught by John for the purpose of transfer a specific quantity of fluid to the front end of the chamber, reducing preparation steps when different medications or mixing is required for the final medicament, lowering contamination risk (Page 2; lines 56-63).
Kazuhiro/John are silent wherein the knob is fluted.
Mahurkar teaches wherein the knob is fluted (serrated knob 20, Fig 2) (Col 5, lines 9-11).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Kazuhiro/John with similar serrated pattern on the knob as taught by Mahurkar for the purpose of facilitating gripping of the knob (Col 5, lines 9-11).
Regarding claim 2, Kazuhiro/John/Mahurkar discloses the syringe of claim 1. Kazuhiro discloses the manually actuated, selective isolation valve comprising a one-way valve (46) that prevents aspiration of fluid into the secondary chamber (32) ([0042]).
Regarding claim 4, Kazuhiro/John/Mahurkar discloses the syringe of claim 1. Kazuhiro discloses the secondary plunger rod (extending distal portion of cylindrical body of pushrod 81, Fig 5) selectively coupled to the secondary plunger (81) when dispensing fluid out of the secondary chamber (32)(pushrod 81 is selectively coupled to the its rod distal end as an integral structure by design choice, Fig 3).
Regarding claim 6, Kazuhiro/John/Mahurkar discloses the syringe of claim 1. Kazuhiro the secondary chamber (32) prefilled with fluid ([0049]: “Factory pre-filling may fill the syringe inner and outer chambers to various volumes”).
Regarding claim 7, Kazuhiro/John/Mahurkar discloses the syringe of claim 1. Kazuhiro discloses further comprising an inner surface (inner surface 16) of the distal end (25) of the barrel (11) defining a seating surface for abutting engagement with the distal end surface of the primary stopper (distal surface of rubber piston 75, Fig 3) when the primary stopper (75) is completely advanced within the barrel (11), thereby isolating the primary chamber (15) from the outlet lumen (lumen of nozzle 20, Fig 3) and the outlet of the valve (outlet of valve 46, Fig 1A) (Chamber 16 is physically separated from lumen of nozzle 20, and outlet of valve 46, Fig 1A ).
Regarding claim 8, Kazuhiro/John/Mahurkar discloses the syringe of claim 7. Kazuhiro discloses further comprising an inner surface (conical section 27, Fig 1A) of the distal end of the secondary chamber (distal end of inner chamber 32, Fig 1A) defines a seating surface for abutting engagement with the distal end surface of the secondary stopper (distal end of plunger 91, Fig 1A) when the secondary stopper (91) is completely advanced within the barrel (11), thereby isolating the secondary chamber (32) from the outlet lumen and the outlet of the valve(outlet of valve 46, Fig 1A) (Chamber 16 is physically separated from lumen of nozzle 20, and outlet of valve 46, Fig 1A ).
Regarding claim 9, Kazuhiro/John/Mahurkar discloses the syringe of claim 1. Kazuhiro discloses further comprising an inner surface (conical section 27, Fig 1A) of the distal end of the secondary chamber (distal end of inner chamber 32, Fig 1A) defines a seating surface for abutting engagement with the distal end surface of the secondary stopper (distal end of plunger 91, Fig 1A) when the secondary stopper (91) is completely advanced within the barrel (11), thereby isolating the secondary chamber (32) from the outlet lumen and the outlet of the valve(outlet of valve 46, Fig 1A) (Chamber 16 is physically separated from lumen of nozzle 20, and outlet of valve 46, Fig 1A ).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kazuhiro (US 20100228121 A1) in view of John (US 0984037 A) in further view of Mahurkar (US 6156013 A) in view of Haber et al. (US 4931040 A).
Regarding claim 5, Kazuhiro/John/Mahurkar discloses the syringe of claim 4. Kazuhiro discloses further comprising the secondary plunger rod (extending distal portion of cylindrical body of pushrod 81, Fig 5) selectively coupled to the secondary plunger (81) (pushrod 81 is selectively coupled to the rod distal end as an integral structure by design choice, Fig 3).
Kazuhiro is silent with mating male and female threads.
Haber teaches a syringe (Fig 1) comprising a plunger (piston stem 14, Fig 1) and a plunger rod (connector 56, Fig 6) selectively coupled to the secondary plunger with mating male and female threads. (Col 6, line 51- Col 7, line 5)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the plunger and plunger rod coupling of device of Kazuhiro/John/Mahurkar with similar threading connection as taught by Haber for the purpose of being adapted to be detachably connected to the plunger (Col 6, lines 62-66)
Claims 10-11, 13-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kazuhiro (US 20100228121 A1) in view of John (US 0984037 A) in further view of Johansen (US 20170043094 A1).
Regarding claim 10, Kazuhiro discloses a syringe (dual chamber syringe 10, Fig 1A) comprising: a substantially cylindrically shaped barrel (cylindrical body 11, Fig 1A), which defines an inner side wall (inner side or wall 14, Fig 1A), the barrel (11) having an open proximal end (proximal open of barrel 11, Fig 1A), and a distal end (cone shaped forward end 25, Fig 1A), the distal end (25)of the barrel including a connector (nozzle 20 with external threads 24, Fig 1A) defining an outlet lumen therethrough (lumen of nozzle 20, Fig 1A), the outlet lumen (lumen of nozzle 20, Fig 1A) in fluid communication with an interior of the barrel (11), the interior defined by the open proximal end (proximal open of barrel 11, Fig 1A), the distal end (25), and the inner side wall (14); an inner barrel (inner body 30, Fig 1A) having a distal tip (forward end 40, Fig 1A) proximate the distal tip (forward end 25, Fig 1A) of the barrel (11) and nested within the barrel (11) in radially spaced relationship (Fig 1A); concentrically nested primary (pushrod 76, Fig 5) and secondary plungers (inner chamber pushrod 81, Fig 5), disposed within the barrel (11) interior (both plunger 76 and 81 are disposed inside barrel 11 when assembled. Being directly connected to the pistons 75 and 91; Fig 5), respectively having a primary plunger rod (extending cylindrical body of pushrod 76, Fig 5) and a secondary plunger rod (extending distal portion of cylindrical body of pushrod 81, Fig 5) capable of selective translation within the barrel (11) interior along a common axis (Axis seen in Fig 5; movement of rod is independent form each other; Fig 1A, 5), with the primary plunger (76) circumscribing the inner barrel (30) and the secondary plunger (81) nested within the inner barrel (30) (Fig 3); a primary stopper (rubber piston 75, Fig 1A) coupled to a distal end (distal end of pushrod 76 containing locking projections 79a, b, Fig 3) of the primary plunger (76), the primary stopper (75) having an annular cross-section (stopper 75 has annular cross-section, Fig 1A), a proximal end surface (rear end comprising wall 80, Fig 3) facing the proximal end of the barrel (proximal open of barrel 11, Fig 1A) and a distal end surface (distal surface of rubber piston 75, Fig 3) facing the distal end (25) of the barrel (11), the primary stopper (75) defining a through aperture (through hole of rubber piston 75, Fig 3) between its proximal (80) and distal end (distal surface of rubber piston 75, Fig 3) surfaces for receipt of the inner barrel (30) therein, the primary stopper (75) in fluid communication with the outlet lumen (lumen of nozzle 20, Fig 3); a secondary stopper (rubber piston 91, Fig 3) coupled to a distal end (distal end containing projections 90, Fig 3; [0039]) of the secondary plunger (81), the secondary stopper (91) having a distal end surface (distal end of piston 91, Fig 3) facing the distal end (25) of the barrel (11); an isolation valve (valve assembly 46, Fig 1A), the isolation valve disposed within the barrel (11) interior, axially offset, along the common axis (axially offset towards the distal portion of common axis seen in Fig 1A), toward the distal end (25) of the barrel (11) away from the distal end surface of the secondary stopper (distal end of rubber piston 91, Fig 1A), the valve (46) having a valve inlet (inlet of valve 46, Fig 1A) coupled to the distal tip of the inner barrel, the valve inlet in fluid communication with the distal end surface of the secondary stopper (distal end of rubber piston 91, Fig 1A), and an outlet (outlet of valve 46, Fig 1A) in fluid communication with the through aperture of the primary stopper (through hole of piston 75, Fig 1A) and the outlet lumen (lumen of nozzle 20, Fig 3) (outlet of valve 46, and through hole of piston 75 are in fluid communication inside opening 57, Fig 1E), the valve (46) selectively isolating the secondary chamber (32) from the outlet lumen (lumen of nozzle 20, Fig 3) and the primary chamber (15); (Fig 1A; [0042]); an annular-shaped, primary fluid chamber (15) defined within the distal end surface of the primary stopper (distal surface of rubber piston 75, Fig 3), the distal end (25) of the barrel (11), inner side wall (14) of the barrel (11), and an outer side wall (outer wall 31, Fig 1A) of the inner barrel (30), volume of the primary fluid chamber (15) being selectively variable by translation of the primary plunger rod (extending distal portion of cylindrical body of pushrod 76, Fig 5); and a secondary fluid chamber (inner chamber 32, Fig 1A), defined within the distal end surface of the secondary stopper (distal end of rubber piston 91, Fig 1A), the distal tip (40) of the inner barrel (30), including the valve inlet (inlet of valve 46, Fig 1A), and an inner side wall (conical section 27, Fig 1A) of the inner barrel (30), the secondary fluid chamber (32) in fluid communication with the valve inlet (inlet of valve 46, Fig 1A), volume of the secondary fluid chamber (32) being selectively variable by translation of the secondary plunger rod (extending distal portion of cylindrical body of pushrod 81, Fig 5); wherein, when the valve (one way duck bill 46, [0042]) is closed the secondary fluid chamber (32) is isolated from the outlet lumen (lumen of nozzle 20, Fig 3), so that translation of the primary plunger rod (extending distal portion of cylindrical body of pushrod 76, Fig 5) only aspirates fluid into or dispenses fluid out of the primary chamber (15), via the outlet lumen (lumen of nozzle 20, Fig 3) (One way valve 46 only allows fluid flow in the distal direction, which isolates chamber 32, preventing inflow; the reciprocating movement of rubber piston 75 caused by pushrod 76 aspirates in the proximal direction and dispense in the distal direction; [0042], Fig 1A); and wherein, when the valve (46) is open the secondary fluid chamber (32) is fluid communication with the outlet lumen (lumen of nozzle 20, Fig 3), so that translation of the secondary plunger rod (extending distal portion of cylindrical body of pushrod 81, Fig 5) dispenses fluid out of the secondary chamber (32), via the outlet lumen (lumen of nozzle 20, Fig 3).
Kazuhiro is silent wherein the isolation valve comprises a spring loaded, shaft-mounted needle valve disposed in the primary plunger and a mating seat formed in the through aperture of the primary stopper, the primary plunger defines at least one cam slot with open engagement surface portions and closed engagement surface portions, within which constrains a radially projecting cross pin of the shaft of the needle valve; the selective isolation valve comprises a fluted knob wherein, when the valve is closed by twisting and depressing the fluted knob on the shaft of the needle valve.
John teaches a syringe (Fig 1) comprising an isolation valve (valve F+ stem F1, Fig 1) comprises a shaft-mounted needle valve (stem F1, Fig 1) disposed in the primary plunger (hollow piston rod D1, Fig 1) and a mating seat (mating seat portion of piston D and distal portion of follow piston rod, where the valve F+F1 is secured, Fig 1) formed in the through aperture of the primary stopper (through aperture of stopper D), the primary plunger (D’) defines at least one cam slot (bayonet slot E1, Fig ) with open engagement surface portions and closed engagement surface portions (Fig 1 show the surface portion labeled), within which constrains a radially projecting cross pin (pin of valve stem F1, Fig 1) of the shaft (F’) of the needle valve (F+F1); the isolation valve comprises a knob (handle F2, Fig 1-3), when valve is closed by twisting and depressing the fluted knob on the shaft of the needle valve (Col 2, Lines 90-110, retracting of the knob (toward the outer (i.e. upper) end of slot E’) opens the valve and depressing of the knob (towards the inner (i.e. lower) end of slot E’ such that it ends approximately midway between the ends of the slot E’) closes the valve – this would be “depressing”.)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Kazuhiro with similar valve assembly as taught by John for the purpose of transfer a specific quantity of fluid to the front end of the chamber, reducing preparation steps when different medications or mixing is required for the final medicament, lowering contamination risk (Page 2; lines 56-63).
Kazuhiro/John are silent regarding the valve being spring loaded; wherein the knob is fluted.
Johansen teaches a syringe ([0089]; Fig. 5a-5b) comprising an isolation valve (one way valve 3 + movable valve member 33 + compressible spring 31, Fig 5a-b) comprises a spring loaded, shaft-mounted needle valve (movable valve member 33, is spring loaded and mounted to needle valve 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the shaft of device of Kazuhiro/John with similar spring as taught by Johansen to bias the shaft towards the closed position, improving user experience by automatically closing the valve reducing user effort ([0092]).
Kazuhiro/John/Johansen are silent wherein the knob is fluted.
Mahurkar teaches wherein the knob is fluted (serrated knob 20, Fig 2) (Col 5, lines 9-11).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Kazuhiro/John with similar serrated pattern on the knob as taught by Mahurkar for the purpose of facilitating gripping of the knob (Col 5, lines 9-11).
Regarding claim 11, Kazuhiro/John/Johansen/Mahurkar discloses the syringe of claim 10. Kazuhiro discloses the valve (46) comprising a one-way valve ([0042]).
Regarding claim 13, Kazuhiro/John/Johansen/Mahurkar discloses the syringe of claim 10. Kazuhiro discloses the primary plunger (76) comprising a tubular profile (tubular profile of pushrod 76; Fig 3).
Regarding claim 14, Kazuhiro/John/Johansen/Mahurkar discloses the syringe of claim 10. Kazuhiro discloses further comprising an inner surface (inner surface 16) of the distal end (25) of the barrel (11) defining a seating surface for abutting engagement with the distal end surface of the primary stopper (distal surface of rubber piston 75, Fig 3) when the primary stopper (75) is completely advanced within the barrel (11), thereby isolating the primary chamber (15) from the outlet lumen (lumen of nozzle 20, Fig 3) and the outlet of the valve (outlet of valve 46, Fig 1A) (Chamber 16 is physically separated from lumen of nozzle 20, and outlet of valve 46, Fig 1A ).
Regarding claim 15, Kazuhiro/John/Johansen/Mahurkar discloses the syringe of claim 14. Kazuhiro discloses further comprising an inner surface (conical section 27, Fig 1A) of the distal end of the secondary chamber (distal end of inner chamber 32, Fig 1A) defines a seating surface for abutting engagement with the distal end surface of the secondary stopper (distal end of plunger 91, Fig 1A) when the secondary stopper (91) is completely advanced within the barrel (11), thereby isolating the secondary chamber (32) from the outlet lumen and the outlet of the valve(outlet of valve 46, Fig 1A) (Chamber 16 is physically separated from lumen of nozzle 20, and outlet of valve 46, Fig 1A ).
Regarding claim 16, Kazuhiro/John/Johansen/Mahurkar discloses the syringe of claim 10. Kazuhiro discloses further comprising an inner surface (conical section 27, Fig 1A) of the distal end of the secondary chamber (distal end of inner chamber 32, Fig 1A) defines a seating surface for abutting engagement with the distal end surface of the secondary stopper (distal end of plunger 91, Fig 1A) when the secondary stopper (91) is completely advanced within the barrel (11), thereby isolating the secondary chamber (32) from the outlet lumen and the outlet of the valve(outlet of valve 46, Fig 1A) (Chamber 16 is physically separated from lumen of nozzle 20, and outlet of valve 46, Fig 1A ).
Regarding claim 17, Kazuhiro/John/Johansen/Mahurkar discloses the syringe of claim 1. Kazuhiro discloses the secondary plunger rod (extending distal portion of cylindrical body of pushrod 81, Fig 5) selectively coupled to the secondary plunger (81) when dispensing fluid out of the secondary chamber (32) (pushrod 81 is selectively coupled to the its rod distal end as an integral structure by design choice, Fig 3).
Regarding claim 19, Kazuhiro/John/Johansen/Mahurkar discloses the syringe of claim 10. Kazuhiro is silent regarding further comprising an annular shaft seal disposed between the elongated stem of the isolation valve and the primary plunger.
John teaches an annular shaft seal (lower portion annular rubber valve F, Fig 4) disposed between the elongated stem (F1) of the isolation valve (F+F1) and the primary plunger (D).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Kazuhiro with similar valve assembly as taught by John for the purpose of transfer a specific quantity of medication to the front end of the chamber (Page 2; lines 56-63).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kazuhiro (US 20100228121 A1) in view of John (US 0984037 A) in further view of Johansen (US 20170043094 A1) in view of Haber et al. (US 4931040 A).
Regarding claim 18, Kazuhiro/John/Johansen/Mahurkar discloses the syringe of claim 17. Kazuhiro discloses further comprising the secondary plunger rod (extending distal portion of cylindrical body of pushrod 81, Fig 5) selectively coupled to the secondary plunger (81) (pushrod 81 is selectively coupled to the rod distal end as an integral structure by design choice, Fig 3). Kazuhiro is silent with mating male and female threads.
Haber teaches a syringe (Fig 1) comprising a plunger (piston stem 14, Fig 1) and a plunger rod (connector 56, Fig 6) selectively coupled to the secondary plunger with mating male and female threads. (Col 6, line 51- Col 7, line 5)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the plunger and plunger rod coupling of device of Kazuhiro/John/Johansen/Mahurkar with similar threading connection as taught by Haber for the purpose of being adapted to be detachably connected to the plunger (Col 6, lines 62-66).
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4-11 and 13-19 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.
In regards to claim 10-11, 13-17, and 19 rejection over Kazuhiro (US 20100228121 A1) in view of John (US 0984037 A) in further view of Johansen (US 20170043094 A1), applicant submits that proposed
modification would change the principle of operation of the prior art.
Examiner respectfully disagrees.
The fundamental operation of Kazuhiro (US 20100228121 A1) comprises a selective injection of fluid from the injector chambers. Modification presented in claim 10 does not alter the fundamental principle of operation of device of Kazuhiro (US 20100228121 A1), the changes relate to implementation details of secondary features of the valve and plunger, the modified system would still allow the user to selectively inject fluid from the multiple chambers.
Aplicant submits that the rejection over Kazuhiro (US 20100228121 A1) in view of John (US 0984037 A) in further view of Johansen (US 20170043094 A1) does not provide reasoning for the combination.
Examiner respectfully disagrees. The modification of the device of Kazuhiro with similar valve assembly as taught by John for the purpose of transfer a specific quantity of fluid to the front end of the chamber (Page 2; lines 56-63). This modification will reduce preparation steps in case different medications or mixing is required for the medicament lowering contamination risk. Also modify the shaft of device of Kazuhiro/John with similar spring as taught by Johansen to bias the shaft towards the closed position ([0092]), modification will improve user experience by automatically closing the valve reducing user effort.
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
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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