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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/27/2026 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, 7-8 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US 20150335821 A1) in view of by Nakamura (JP 2014061155 A).
Regarding claim 1, Griffth discloses a radiopharmaceutical drug delivery system (Fig 1) comprising: a movable cart (cart 9, Fig 1A) having an administration system (administration system for drug delivery; Fig 32B) for administering a dose of a radiopharmaceutical drug (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C) to a patient ([0234]) and a theranostic informatics management system (informatic system controlled by controller 5, Fig 1D and 1E) for controlling operation of the administration system (Fig 32B)([0069]: “a medical procedure and includes, but is not limited to, substances used in imaging procedures (for example, contrast media) and therapeutic substances”) an assembly (200+700+22+180, Fig 2A and 902+1554+ 600, Fig 4C, 5C) containing the dose of the radiopharmaceutical drug (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C), the assembly formed separately from the movable cart (9) and installable to the administration system ([0118];[0137]; [0149]: “While the preferred method of operating the vial access system 600 and the vented cannula 208 is provided above, the method and steps can be conducted in any suitable order or arrangement to achieve the desired results.”; the assembly (200+700+22+180+902+1554+600) is structurally capable of being partially formed separately from the movable cart 9; sub-assemblies 200+700 and 902+1554+600 can be connected through cannula 208 and access system 600 and then inserted in the wells and cavities of the cart 9 including the necessary connections for fluid delivery administration to the patient using control system 10), the assembly comprising: a configurable dose transporter (vial access system 600, Fig 6); a separable radioactive dose transportation and containment module (vial 902; Fig 4C); a shielding (vial shield 1554, Fig 5A-D) positioned around at least a portion of the radioactive dose transportation and containment module (902) (Fig 5B); a disposable sealed fluid cartridge (MPDS 200+ SPDS 700+22+180; fluid path are sealed by means of connectors and/or adapters) connectable with the configurable dose transporter (600) for installation in the administration system (sealed connection is formed when first end 702 is connected to connector end 228 which couples to vial 902 by means of vented cannula 208 of MPDS 200 connected to vial shield 1554 and septum cap 1562, Fig 5A-D); [0100];[0107]-[0108]; assembly is installed in the cart 9 wells in connection to catheter [0108]); wherein the disposable sealed fluid cartridge (200+700+22+180) comprises: a) an adapter (cannula 208, Fig 2A) to secure a drug vial (vial 902, Fig 4C) or syringe to the fluid cartridge (200+700+22+180); b) one or more integrated fluid channels to allow bi-directional flow of fluids (all lumens of 200+700 are structurally capable of bidirectional fluid flow; [0074]: discloses that pump could be piston-driven syringe pump); c) an integrated precision pump (pump system 22 and 180, Fig 2A; pumps are structurally and functionally connected; [0074]: “any suitable type of pumping mechanism, such as a piston-driven syringe pump, gear pump, rotary pump or in-line pump, may be used.”;[0091]) configured to control the flow of a customizable amount of a radioactive drug ([0101]); d) a patient port (patient end 704, Fig 1C) and a saline port (spike 202, Fig 2B), wherein the patient port (704) and the saline port (202) are configured to present differently a patient line (line of SPDS 700, Fig 1C) and a saline line (first tubing section 204, Fig 2A) to a user (patient); e) an integrated valve system (T-connector 205 (preferably including check valves 214, 215)) to control flow of fluids (saline and radioactive fluid) through the integrated fluid channels (Channel comprised of lumen of tube sections 204, 210, 216, 220, 226, 230 and tubing section of 700, Fig 1C and 2A); and f) one or more guide features (channels of fluid draw needle 340 and vent needle 342, Fig 6C) and mechanical interlocks (needle 340 and vent needle 342; [0150]) that interact with one or more guide features (cap of vial 902, Fig 4C) and mechanical interlocks (septum of vial 902, Fig 4C) of the dose transportation and containment module (902) when the fluid cartridge (200+700+22+180) is mounted to the configurable dose transporter (600).
Griffth does not explicitly discloses the one or more fluid channels to allow bi-directional flow of fluids and wherein all components of the disposable sealed fluid cartridge are disposable.
Nakamura teaches a radiopharmaceutical drug delivery system (radioactive drug administration device 1, Fig 1) comprising: an assembly (A) comprising: (1) a configurable dose transporter (radioactive drug 30+ vial 32+ shielding container 33), wherein the configurable dose transporter (30+32+33) comprises: a) a separable radioactive dose transportation and containment module (vial 32, Fig 1); b) a shielding (shielding material of container 33, Fig 1) for use with one or more of different radionuclide types, quantities, and volumes; and c) a radioactive dose (dose of radiopharmaceutical 30) in a vessel selected from a syringe or a vial (vial 30, Fig 1); and (2) a disposable sealed fluid cartridge (disposable cartridge comprise at least from tubing 34, 38, 45, 42 + three-way stopcock 35, 40, 43 + syringes 25+36, Fig 1) connectable with the syringe or the vial (32) via a sealable fitting (sealable fitting between vial 32 seal and catalan needle 34a, Fig 1) for installation in the administration system (administration unit 13, Fig 1), the disposable sealed fluid cartridge (34+38+45+42, 35+40+43, and 25+36) comprising an integrated infusion pump (syringes 25+36, Fig 1), one or more fluid channels (channel of stopckock 35 allows flow towards and away of syringe 36, Fig 1) to allow bi-directional flow of fluids and wherein all components of the disposable sealed fluid cartridge are disposable ([0049]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the cartridge device of Griffth with to include disposable pumps, the cartridge being structurally capable of bi-directional fluid flow as taught by Nakamura for the purpose of reducing risk of contamination and radiation exposure, improving safety ([0049]).
Regarding claim 2, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Griffth discloses further comprising a transfer chamber (dose calibrator or ionization chamber 160, [0089, Fig 3F]), wherein the disposable fluid cartridge (200+700+22+180) is insertable into the configurable dose transporter (600) to allow charging of the fluid cartridge (Fig 3F, shows portion of the cartridge (coil assembly 400 and associated tubing 220+216) with a radioisotope using the integrated precision pump (22+180) to draw a fluid from a saline source (23) and a radioisotope from the drug vial (Pump system uses pump 22 to draw fluid from saline source 23 and pump 180 for radiopharmaceutical fluid inside vial 902, Fig 4C, is draw by pump 180) or syringe into the transfer chamber (160) of the fluid cartridge (200+700+22+180) ([0160] : “The pump 23 is then activated again to draw additional saline from saline source 23 to thereby move the volume of pharmaceutical present in third tubing section 216 into the tube coil 444 of coil assembly 400 located in the dose calibrator 160.”).
Regarding claim 4, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Griffth discloses wherein the disposable fluid cartridge (200+700+22+180) is configured for withdrawing the customizable amount of the radioactive drug based on one or more of patient weight, sex, age, health history data and/or other physical parameter (200+700 permits withdrawal of costume amounts from the vial 902 to the patient using pumps 180 and cannula 208 and dispensing through patient end 704 ([0082],Fig 1C); [0210]-[0211] desired activity level can be set based on the weight of the patient).
Regarding claim 7, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Griffth discloses wherein the disposable fluid cartridge (200+700+22+180) comprises a connected port (port of patient 704, Fig 2A) for eliminating errors in connecting a patient line (catheter (not shown ), Fig 1C) or a saline line to the cartridge.
Regarding claim 8, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Griffth discloses wherein the disposable fluid cartridge (200+700+22+180) is configured to be placed in the dose transporter (600) to permit delivery of the radioactive drug (drug inside vial 902, Fig 4C) via the delivery system (10, Fig 1A-E; [0096]).
Regarding claim 10, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Griffth discloses wherein the delivery system (10) further comprises a controller (system controller 5, Fig 1D, 1E) to control an operation of the fluid cartridge (200+700+22+180)([0084] system controller 5 control operations of system 10 including fluid cartridge 200+700+22+180).
Regarding claim 11, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Griffth discloses wherein the configurable dose transporter (600) is configured to be connected in line with the disposable sealed fluid cartridge (Vial access system 600 is structurally connected in line with vented cannula 208 by means of cap member 684, Fig 6C).
Regarding claim 12, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Griffth discloses wherein the infusion of the radioactive drugs (radiopharmaceutical fluid inside container 902, Fig 4C) to a patient comprises four major modes consisting of priming ([0096]: “priming (i.e., purging air from) the MPDS 200”, charging ([0089]: “FDG (or other radiopharmaceutical) to be drawn from a bulk radiopharmaceutical vial 902 and placed into a coil assembly 400 that allows an ionization chamber 160 to measure the amount of activity in the coil assembly 400”), infusing ([0089]: “Once the system prepares a dose having the desired activity level, the fluid delivery system 10 will deliver the FDG dose to the patient (through the SPDS 700).”), and backflushing ([0096]: “providing a saline flush, while minimizing or eliminating exposure of administering or operating personnel to the detrimental effects of the pharmaceutical and minimizing or eliminating creation of contaminated waste.”).
Regarding claim 13, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 12. Griffth discloses wherein a priming mode (priming (i.e., purging air from) the MPDS 200) comprises a process of checking for air bubbles or any occlusion (air detector 174, Fig 1C; structurally capably of air detection [0107];[0096]; [0158] “Such an air purging or “priming” procedure is standard practice to prevent the occurrence of an air embolism in a patient, which can cause serious injury or death”.) in an infusion line (tube 216, Fig 2A)that is connected with the pump (pump system 22 and 180, Fig 2A), a dose vessel (vial 902, Fig 4A), and a saline vessel (vessel containing saline source 23, Fig 1D)
Regarding claim 14, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 12. Griffth discloses wherein a charging mode comprises a process of using the disposable fluid cartridge (200+700+22+180) to draw a required volumes of saline (saline volume extracted from saline source 23, Fig 2B) and radiopharmaceutical drug (radiopharmaceutical fluid from vial 902, Fig 4C) to the transfer chamber (160)([0089]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US 20150335821 A1) in view of by Nakamura (JP 2014061155 A) in further view of Nystrom (US 8915399 B1) in further view of D.J. Dochon (US 7169135 B2).
Regarding claim 3, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Griffth is silent regarding further comprising one or more pressure sensors to detect a pressure of the patient port and a pressure of the saline port.
Nystrom teaches a drug delivery system (Fig 1) comprising one or more pressure sensors to detect a pressure of the patient port (Col 6, lines 54-57: “When used, the pressure sensor may be in fluid communication with outlet port 80 and/or catheter 30 and configured to measure the pressure of the contrast medium during high pressure injection.”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth/Nakamura with similar pressure sensor located at the outlet port as taught by Nystrom to measure the pressure of the injection (Col 6, lines 54-57).
Griffth/Nakamura/Nystrom as modified are silent regarding the one or more pressure sensors detect a pressure the saline port.
D.J. Dochon teaches a drug delivery system (Fig 1) comprising one or more pressure sensors (pressure sensor 36, Fig 1) detect a pressure of a saline port (saline check valve 38; Col 6, lines 19-31)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth/Nakamura/Nystrom with similar pressure sensor as taught by D.J. Dochon for the purpose of measuring pressure of saline fluid near saline port (Col 6, lines 19-31).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US 20150335821 A1) in view of by Nakamura (JP 2014061155 A) in further view of Thor et al. (US 20130310845 A1).
Regarding claim 5, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Griffth is silent wherein the patient port and the saline port are preconnected to eliminate errors in selection of the patient and saline lines for connection to the patient port and the saline port, respectively.
Thor teaches drug delivery system (Fig 1) wherein the patient port (outlet port, claim 19) and the saline port ([0053]) are preconnected to eliminate errors in selection of the patient and saline lines for connection to the patient port and the saline port, respectively ([0053] pre-connection prevents user error at time of connection of saline and patient port (implicit)).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth/Nakamura with similar pre-connections of its components for the purpose of reducing human error at the time of connections and reducing assembly time ([0053]; claim 19)
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US 20150335821 A1) in view of by Nakamura (JP 2014061155 A) in further view of Kaintz et al. (US 20130331634 A1).
Regarding claim 6 Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Griffth is silent wherein the adapter is tagged with one or more of an RFID, a barcode, and a QR code.
Kaintz teaches a delivery system (Fig 1) comprising an adapter (SPDS connector 317a, Fig 2B) is tagged with one or more of an RFID, barcode, or QR code ([0097]: “the SPDS connector 317a can be encoded through RFID”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the adapter of device of Griffth/Nakamura with similar RFID encoding as taught by Kaintz to ensure that the correct fluid path set is connected ([0097]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US 20150335821 A1) in view of by Nakamura (JP 2014061155 A) in further view of Barron et al. (US 20090149743 A1).
Regarding claim 9, Griffth/Nakamura discloses the radiopharmaceutical drug delivery system of claim 1. Grifft discloses wherein the theranostic informatics system comprises a control system (system controller 5, Fig 1D, 1E) for controlling an infusion process ([0084]) with a light (light emited by GUI 15 ;[0179, light status generated by display 15 see Fig 7) used to show different states of the system (state indicated by highlighted symbols,[0179]).
However, Griffth is silent wherein the system indicates of different states of the device with various colors.
Barron teaches a delivery system (Fig 1) comprising a graphical user interface (GUI) and status light system indicating the different state of the device with various colors ([0233]: “the graphical icons can also be displayed in different colors to indicate the status, or state, or the device”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify GUI of the device of Griffth/Nakamura with similar color indication associated with symbols as taught by Barron for the purpose of helping the user to recognize status of device helping speed the workflow and prevent mistakes ([0233])
Claims 15, and 17-18 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US 20150335821 A1) in view of by Nakamura (JP 2014061155 A) in further view of Gillespie et al. (US 20030233069 A1).
Regarding claim 15, Griffth discloses a disposable fluid cartridge system (MPDS 200+ SPDS 700, pumps 22 and 180 Fig 1C) for delivering radiopharmaceutical drugs (radiopharmaceutical drug inside of vial 902, Fig 4C), the disposable fluid cartridge system (700+200+22+180) comprising an enclosure (enclosure of system comprised by external walls of MPDS 200, and SPDS 700 and pumps 22 and 180, Fig 1C and 2A) having external walls (external walls of system comprising MPDS 200, and SPDS 700 and pumps 22 and 180, Fig 1C and 2A) and an internal volume (internal volume defined by the external walls of system comprising 200+700+22+180, Fig 1C and 2A): a) an adapter (cannula 208, Fig 2A) to secure a vial (vial 902, Fig 4C) or syringe containing a radiopharmaceutical drug (radiopharmaceutical drug inside of vial 902, Fig 4C) to the disposable fluid cartridge system (200+ 700+22+180); b) one or more integrated fluid channels (channels of 200 +700) within the enclosure (enclosure of system comprised by external walls of MPDS 200, and SPDS 700 and pumps 22 and 180, Fig 1C and 2A) to allow bi-directional flow of fluids (all lumens of 200+700 are structurally capable of bidirectional fluid flow; [0074]: discloses that pump could be piston-driven syringe pump); c) an integrated precision pump (pump system 22+180, Fig 2A; [0074]: disclose that pump can be in-line pump or syringe pump) within the enclosure (enclosure of system comprised by external walls of MPDS 200, and SPDS 700 and pumps 22+180, Fig 1C and 2A) and configured for withdrawing custom amounts ([0209]) of a radiopharmaceutical drug (withdrawal of costume volumes from the vial 902 to the patient using pumps 22+180 and cannula 208 and dispensing through patient end 704 ([0082],Fig 1C; custom volumes are withdrawn based on the desired activity level [0209]) ;d) a patient port (patient end 704, Fig 1C) and a saline port (spike 202, Fig 2B) extending from the enclosure (enclosure of system comprised by external walls of MPDS 200, and SPDS 700 and pump 22+180, Fig 1C and 2A) (spike 202 extends from a portion of enclosure to connect to saline source 23, Fig 1D); e) a valve system (T-connectors 205 and 222, Fig 2A) within the enclosure (enclosure of system comprised by external walls of MPDS 200, and SPDS 700 and pumps 22+180, Fig 1C and 2A) and configured to control flow of fluids (saline and radiopharmaceutical fluid; [0095]) in the fluid channels (lumens of 200+700, Fig 1C and 2A); and f) a first sensor (controller 5+ air detector 174, Fig 1C; [0084]; [0107]) wherein, the disposable fluid cartridge system (enclosed system 200+700+22+180 , disposable to prevent cross contamination; [0082]; [0106]) is configured to be mounted into the configurable dose transporter (vial access system 600; [0149]) to allow an infusion system (fluid delivery system 10, Fig 1) to withdrawn custom amounts of the radiopharmaceutical drug (radiopharmaceutical fluid inside vial 902, Fig 4C) for infusion to a patient ([0149]; canula 208 draws radiopharmaceutical fluid inside vial 902, which is infused through patient end 704).
Griffth does not explicitly discloses the one or more fluid channels to allow bi-directional flow of fluids and; a second sensor; wherein all components of the disposable fluid cartridge system are disposable.
Nakamura teaches a radiopharmaceutical drug delivery system (radioactive drug administration device 1, Fig 1) comprising: an assembly (A) comprising: (1) a configurable dose transporter (radioactive drug 30+ vial 32+ shielding container 33), wherein the configurable dose transporter (30+32+33) comprises: a) a separable radioactive dose transportation and containment module (vial 32, Fig 1); b) a shielding (shielding material of container 33, Fig 1) for use with one or more of different radionuclide types, quantities, and volumes; and c) a radioactive dose (dose of radiopharmaceutical 30) in a vessel selected from a syringe or a vial (vial 30, Fig 1); and (2) a disposable sealed fluid cartridge (disposable cartridge comprise at least from tubing 34, 38, 45, 42 + three-way stopcock 35, 40, 43 + syringes 25+36, Fig 1) connectable with the syringe or the vial (32) via a sealable fitting (sealable fitting between vial 32 seal and catalan needle 34a, Fig 1) for installation in the administration system (administration unit 13, Fig 1), the disposable sealed fluid cartridge (34+38+45+42, 35+40+43, and 25+36) comprising an integrated infusion pump (syringes 25+36, Fig 1), one or more fluid channels (channel of stopckock 35 allows flow towards and away of syringe 36, Fig 1) to allow bi-directional flow of fluids and wherein all components of the disposable sealed fluid cartridge are disposable ([0049]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the cartridge device of Griffth with to include disposable pumps, the cartridge being structurally capable of bi-directional fluid flow as taught by Nakamura for the purpose of reducing risk of contamination and radiation exposure, improving safety ([0049]).
Griffth/Nakamura are silent regarding a second sensor.
Gillespie teaches a disposable fluid cartridge system (Fig 1) comprising an occlusion sensor (occlusion sensor 22, Fig. 14)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth/Nakamura with similar occlusion sensor as taught by Gillespie for the purpose of detecting blockage in an infusion line ([0087]).
Regarding claim 17, Griffth/Nakamura/Gillespie discloses the disposable fluid cartridge system according to claim 15. Griffth discloses wherein the patient port (704) and the saline port (202) are configured to prevent errors in selection of patient and saline lines for connection to the patient port and the saline port, respectively. ([0082]: “a patient end 704 having a luer connector that is attachable to, for example, a catheter (not shown) placed in a venous structure of a patient”; patient end 704 is a port connecting to a catheter; luer connection between end 704 and catheter; [0095]: saline port 202 is connected to saline 23 by a piercing connection with port 7 of saline source 23; therefore both port use structurally different connections which prevent human error of mistakenly selected the incorrect connection).
Regarding claim 18, Griffth/Nakamura/Gillespie discloses the disposable fluid cartridge system according to claim 15. Griffth discloses wherein the fluid cartridge (200+700+22+180 including their system enclosure) includes an interlock (spring arms 350, Fig 6C) component for interlocking with the dose transporter (600) when the fluid cartridge (200+700+22+180 including their system enclosure) is mounted in the dose transporter (600) (cannula 208 of fluid cartridge comprises spring arms 350 which interlock with engage the rear edges 692 of the tab members 690 of dose transporter 600; [0146]).
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US 20150335821 A1) in view of Rule (US 20100121170 A1) in further view of Nakamura (JP 2014061155 A).
(Note: This is an alternate rejection for Claim 15 if Applicant does not find the original rejection persusavie)
Regarding claim 15, Griffth discloses a disposable fluid cartridge system (MPDS 200+ SPDS 700, pumps 22 and 180 Fig 1C) for delivering radiopharmaceutical drugs (radiopharmaceutical drug inside of vial 902, Fig 4C), the disposable fluid cartridge system (700+200+22+180) comprising: a) an adapter (cannula 208, Fig 2A) to secure a vial (vial 902, Fig 4C) or syringe containing a radiopharmaceutical drug (radiopharmaceutical drug inside of vial 902, Fig 4C) to the disposable fluid cartridge system (200+ 700+22+180); b) one or more integrated fluid channels (channels of 200 +700) to allow bi-directional flow of fluids (all lumens of 200+700 are structurally capable of bidirectional fluid flow; [0074]: discloses that pump could be piston-driven syringe pump); c) an integrated precision pump (pump system 22+180, Fig 2A; [0074]: disclose that pump can be in-line pump or syringe pump) and configured for withdrawing custom amounts ([0209]) of a radiopharmaceutical drug (withdrawal of costume volumes from the vial 902 to the patient using pumps 22+180 and cannula 208 and dispensing through patient end 704 ([0082],Fig 1C; custom volumes are withdrawn based on the desired activity level [0209]) ;d) a patient port (patient end 704, Fig 1C) and a saline port (spike 202, Fig 2B); e) a valve system (T-connectors 205 and 222, Fig 2A) and configured to control flow of fluids (saline and radiopharmaceutical fluid; [0095]) in the fluid channels (lumens of 200+700, Fig 1C and 2A); and f) a first sensor (controller 5+ air detector 174, Fig 1C; [0084]; [0107]) wherein, the disposable fluid cartridge system (enclosed system 200+700+22+180 , disposable to prevent cross contamination; [0082]; [0106]) is configured to be mounted into the configurable dose transporter (vial access system 600; [0149]) to allow an infusion system (fluid delivery system 10, Fig 1) to withdrawn custom amounts of the radiopharmaceutical drug (radiopharmaceutical fluid inside vial 902, Fig 4C) for infusion to a patient ([0149]; canula 208 draws radiopharmaceutical fluid inside vial 902, which is infused through patient end 704).
Griffth does not explicitly discloses the disposable fluid cartridge system comprising an enclosure having external walls and an internal volume; the one or more integrated fluid channels, the integrated precision pump and the valve system are within the enclosure and a saline port extending from the enclosure; the one or more fluid channels to allow bi-directional flow of fluids and; a second sensor; wherein all components of the disposable fluid cartridge system are disposable; a second sensor.
Rule teaches the disposable fluid cartridge system (Fig 10) comprising an enclosure (body of the cartridge 1000, Fig 10) having external walls (external walls of 1000, Fig 10) and an internal volume (internal volume of 1000, Annotated Fig 10); the one or more integrated fluid channels (tubing portion 1008, Fig 10), the integrated precision pump (pumps 1016, Fig 10) and the valve system (valves inserted in apertures 1009, [0156]) are within the enclosure (1000) and a saline port extending from the enclosure ([0154]; [0277] discloses that spikes could be used to connect with saline bags); a second sensor ([0156]; [0090]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth with similar disposable cartridge enclosure and additional sensors such as a fluid sensors to detect fluid along the path as taught by Rule for the purpose of facilitating insertion and disposal of the cartridge ([0153]; [0156];[0090]).
Griffth/Rule are silent regarding the one or more fluid channels to allow bi-directional flow of fluids and; wherein all components of the disposable fluid cartridge system are disposable.
Nakamura teaches a radiopharmaceutical drug delivery system (radioactive drug administration device 1, Fig 1) comprising: an assembly (A) comprising: (1) a configurable dose transporter (radioactive drug 30+ vial 32+ shielding container 33), wherein the configurable dose transporter (30+32+33) comprises: a) a separable radioactive dose transportation and containment module (vial 32, Fig 1); b) a shielding (shielding material of container 33, Fig 1) for use with one or more of different radionuclide types, quantities, and volumes; and c) a radioactive dose (dose of radiopharmaceutical 30) in a vessel selected from a syringe or a vial (vial 30, Fig 1); and (2) a disposable sealed fluid cartridge (disposable cartridge comprise at least from tubing 34, 38, 45, 42 + three-way stopcock 35, 40, 43 + syringes 25+36, Fig 1) connectable with the syringe or the vial (32) via a sealable fitting (sealable fitting between vial 32 seal and catalan needle 34a, Fig 1) for installation in the administration system (administration unit 13, Fig 1), the disposable sealed fluid cartridge (34+38+45+42, 35+40+43, and 25+36) comprising an integrated infusion pump (syringes 25+36, Fig 1), one or more fluid channels (channel of stopckock 35 allows flow towards and away of syringe 36, Fig 1) to allow bi-directional flow of fluids and wherein all components of the disposable sealed fluid cartridge are disposable ([0049]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the cartridge device of Griffth with to include disposable pumps, the cartridge being structurally capable of bi-directional fluid flow as taught by Nakamura for the purpose of reducing risk of contamination and radiation exposure, improving safety ([0049]).
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US 20150335821 A1) in view Nakamura (JP 2014061155 A) in further view of Gillespie et al. (US 20030233069 A1) in further view of Cole et al. (US 6142008 A)
Regarding claim 16, Griffth/Nakamura/Gillespie discloses the disposable fluid cartridge system according to claim 15. Griffth discloses wherein the integrated precision pump (22+180) is shielded ([0073]; upper surface 103 portion of cart 9 is shielding pump 180 located beneath) to prevent radiation exposure ([0073]) and is configured to protect the patient from an air infusion (pump system to flush the lines to purge air [0158])
Griffth is silent wherein the pump comprises a signal to the controller for air detection in real-time.
Cole teaches a system (Fig 7) comprising a pump (pump assembly 100, Fig 1) comprises a signal to the controller (controller 162, Fig 7) for air detection in real-time. (Col 8 lines 41-49: controller actuates air sensor 176 when the pump is being actuated; therefore a signal from pump actuation is used by controller to detect air in real time)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth/Nakamura/Gillespie with similar communication between pump controller and air sensor as taught by Cole for the purpose of reduce power consumption of the system (Col 7 line 67- Col 8 line 3)
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US 20150335821 A1) in view Nakamura (JP 2014061155 A) in further view of Gillespie et al. (US 20030233069 A1) in further view of Epstein et al. (US 5108367 A).
Regarding claim 19, Griffth/Nakamura/Gillespie discloses the disposable fluid cartridge system according to claim 15. wherein the patient port (104) is configured to receive a first fluid flow line (line of single-patient fluid path set 700, Fig 1C) to deliver a fluid (radiopharmaceutical fluid inside container 902, Fig 4C) to a patient and the saline port (202) is configured to receive a second fluid flow line (tubing section 204, Fig 2A) to receive fluid from the vial (medical fluid source 23, Fig 2B) or syringe and
Griffth is silent wherein the first sensor (5) is configured to measure a fluid pressure in proximity to the patient port.
Epstein teaches a disposable fluid cartridge system (Fig 3A) comprising the first sensor (system controller, Fig 9; Col 20 lines 58-64) is configured to measure a fluid pressure in proximity to the patient port (Col 13, lines 38-51; port not shown of patient line is in proximity to the fluid pressure being measured in the patient line by system controller).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth/Nakamura/Gillespie with similar configuration of controller and associated hardware as taught by Epstein for the purpose of measuring patient line pressure and alarm the user in case it falls above or below normal range (Col 20 lines 58-64; Col 13, lines 38-51).
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US 20150335821 A1) in view Nakamura (JP 2014061155 A) in further view of Gillespie et al. (US 20030233069 A1) in further view of Truitt (US 5910252 A).
Regarding claim 20, Griffth/Nakamura/Gillespie discloses a radiopharmaceutical drug delivery system (Fig 1) comprising: a movable cart (cart 9, Fig 1A) having an administration system (administration system for drug delivery; Fig 32B) for administering a dose of a radiopharmaceutical drug (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C) to a patient and a controller (controller 5, Fig 1D) for controlling operation of the administration system (administration system for drug delivery; Fig 32B); an assembly (200+700+22+180+902+1554+600) containing the dose of the radiopharmaceutical drug (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C), the assembly formed separately from the movable cart (9) and installable to the administration system (administration system for drug delivery; Fig 32B: installation of assembly is necessary for injection to take place), the assembly (200+700+22+180+902+1554+600) comprising: a configurable dose transporter (vial access system 600, Fig 4A-B); a separable radioactive dose transportation and containment module (vial 902, Fig 4C); a shielding (vial shield 544 Fig 4A; [0119]) positioned around at least a portion of the radioactive dose transportation and containment module (902); the disposable fluid cartridge system of claim 15 (200+700); see rejection of claim 15), wherein the disposable fluid cartridge system (200+700) is connectable with the configurable dose transporter (600) for installation to the administration system (sealed connection is formed when first end 702 is connected to connector end 228 which couples to vial 902 by means of vented cannula 208 of MPDS 200 connected to vial access system 600; [0100];[0107]-[0108]; assembly is installed in the cart 9 wells in connection to catheter [0108]), and wherein the controller (5) is configure to prevent unauthorized use ([0072]: system comprises a software-implemented lock that prevents unauthorized use).
Griffth/Nakamura/Gillespie are silent regarding the controller configured to halt the operation of the drug delivery system in case of any threat of an unauthorized use being detected and maintain that any operation of the drug delivery system is stopped.
Truitt teaches a delivery system (Fig 1) comprising a controller (control processor 122, Fig 1) configured to halt the operation of the drug delivery system in case of any threat of an unauthorized use being detected and maintain that any operation of the drug delivery system is stopped (Col 19, lines 8-29)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth/Gillespie with similar configuration of the controller and related components to the al as taught by Truitt for the purpose of indicate and alert the user of device use beyond parameters and halt the process until addressed (Col 19, lines 8-29).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 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.
Conclusion
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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