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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griffth et al. (US20150335821A1).
Regarding claim 1, Griffth discloses a radiopharmaceutical drug delivery system (Fig 1) comprising: (i) a movable cart (cart 9, Fig 1) having an administration system (Fig 32B) for administering a dose of the radiopharmaceutical drug (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C) to a patient ([0234]); (ii) an informatics system with a computer screen configured as a user interface (graphical user interface (GUI) 15, Fig 1; [0071]; [0084]); (iii) an infusion pump (peristaltic pump 22, Fig 2A); and (iv) an assembly containing the dose of the radiopharmaceutical drug (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C), the assembly formed separately from the movable cart 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.”; therefore the assembly (200+700+902+1554) is structurally capable of being formed separately from the movable cart 9; sub-assemblies 200+700 and 902+1554 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: 1) a configurable dose transporter (vial shield 1554+ septum cap 1562, Fig 5A-D), wherein the configurable dose transporter comprises: a) a separable radioactive dose transportation and containment module (vial 902; Fig 4C); b) a shielding (vial shield 1554, Fig 5A-D) for use with one or more of different radionuclide types, quantities, and volumes ([0136]); and c) a radioactive dose (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C) in a vessel selected from a syringe or a vial (vial 902, Fig 4C ); and (2) a disposable sealed fluid cartridge (MPDS 200+ SPDS 700; fluid path are sealed by means of connectors and/or adapters) connectable with the syringe or the vial (902) via a sealable fitting 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; [0100];[0107]-[0108]; assembly is installed in the cart 9 wells in connection to catheter [0108]).
Regarding claim 2, Griffth discloses the delivery system according to claim 1, wherein the vessel (902) can be selected from different standard sizes ([0137]).
Regarding claim 3, Griffth discloses the delivery system according to claim 1, wherein the shielding system (1554) is configured to be used with a variety of sizes of the syringe or the vial (902) being inserted or connected therein ([0137]).
Regarding claim 4, Griffth discloses the delivery system according to claim 1, wherein the computer screen is a touch screen (graphical user interface (GUI) 15, Fig 1; [0071]: “The display 15 may be a color display and incorporate touch-screen capability, as known in the art, for ease of use”).
Regarding claim 5, Griffth discloses the delivery system according to claim 1, wherein the disposable sealed fluid cartridge (200+700) is configured to permit withdrawal of custom volumes from the vial or syringe based on one or more of patient weight, sex, age, other physical parameters, [[or]]and health history data ([0082]: 200+ 700 permits withdrawal of costume volumes from the vial 902 to the patient trough vented cannula 208 and patient end 704; [0210]-[0211] desired activity level can be set based on the weight of the patient).
Regarding claim 6, Griffth discloses the delivery system according to claim 1, wherein the drug delivery system is configured to support a drug specific infusion parameter (activity level [0089]; [0210]- [0211] desired activity level can be set based on the weight of the patient).
Regarding claim 7, Griffth discloses the delivery system according to claim 1, wherein the separable radioactive dose transportation and containment module (902) is shielded ([0117]-[0118]).
Regarding claim 8, Griffth discloses the delivery system according to claim 1, wherein the disposable sealed fluid cartridge (200+700)comprises a port (704) for eliminating errors in connecting a patient line or a saline line ([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 is secure and structurally capable of reduce or eliminate human error at the time of connection) to the cartridge.
Regarding claim 9, Griffth discloses the delivery system according to claim 1, wherein the system (Fig 1A) is configured to monitor and track one or more of the total volume in syringes, total volume administered in real-time, total volume from an IV bag, and total volume infused into the patient ([0243]: "the display 1360 indicates the total volume (35.0 ml) of injected fluid").
Regarding claim 10, Griffth discloses the delivery system according to claim 1, wherein the system further comprises a control system (system controller 5, Fig 1D-E) to control the process of infusion of a medical fluid into the patient ([0084]; controller 5 controls system 10 functionalities, including infusion of medical fluid (saline+ radioactive liquid)).
Regarding claim 11, Griffth discloses the delivery system according to claim 10, wherein the control system (5; [0084]) is configured to halt the infusion process due to system error ([0076]; [0235]: system interruption without user intention; error displayed as alert indicating to discard dose and present button for the purpose).
Regarding claim 12, Griffth discloses the delivery system according to claim 1, wherein the system has a feature to alert a user to occurrence of one or more of fluid occlusion, a pump failure, a deviation from a programmed volume, and an unexpected sequence of events in real-time ([0076]; [0220]; alert is generated as screen notification display Fig 27B (visual alarm) as result of activation of pause button 1212d in real time; the alert is expected from the sequence of events).
Regarding claim 12, Griffth discloses a radiopharmaceutical drug delivery system (Fig 1) comprising: (i) a movable cart (cart 9, Fig 1A) having an administration system (Fig 32B) for administering a dose of a radiopharmaceutical drug (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C) to a patient ([0234]); (ii) an informatics system with a computer screen as a graphical user interface (GUI) (graphical user interface (GUI) 15, Fig 1; [0071]; [0084]); (iii) an infusion pump (peristaltic pump 22, Fig 2A); (iv) a status light system that illuminates a working area (touchscreen surface area of graphical user interface 15, Fig 1A) for monitoring a status of an infusion component ([0179]: "provide status information on the system 10" (... ) "activity present 1012, fluid motion/injection status 1014, check for air/priming status 1016, and system battery status 1018"); and (v) an assembly containing the dose of the radiopharmaceutical drug (drug inside radiopharmaceutical vial 902, Fig 4) , the assembly formed separately from the movable cart and installable to the administration system (administration system of cart 9) ([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.”; therefore the assembly (200+700+902+1554) is structurally capable of being formed separately from the movable cart 9; sub-assemblies 200+700 and 902+1554 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: 1) a configurable dose transporter (vial shield 1554+ septum cap 1562, Fig 5A-D), wherein the configurable dose transporter comprises: a) a separable radioactive dose transportation and containment module (vial 902; Fig 4C); b) a shielding (vial shield 1554, Fig 5A-D) for use with one or more of different radionuclide types, quantities, and volumes ([0136]); and c) a radioactive dose (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C) within a vessel selected from a syringe or a vial (vial 902, Fig 4C); and 2) a disposable sealed fluid cartridge (200+700) connectable with the syringe or the vial (902) via a sealable fitting 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; [0100];[0107]-[0108]; assembly is installed in the cart 9 wells in fluid connection with catheter for delivery under control of controller 5 [0108]) wherein the disposable sealed fluid cartridge (200+700) is configured for withdrawing customizable volumes from the vessel (200+700 permits withdrawal of costume volumes from the vial 902 to the patient trough patient end 704 ([0082],Fig 1C); [0210)-(0211] desired activity level can be set based on the weight of the patient).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. ( US 20150335821 A1) in view of Juretich et al. (US 20150202384 A1).
Regarding claim 13, Griffth discloses the delivery system according to claim 1, wherein the infusion pump is configured to protect the patient from an air infusion ([0158]: “air is purged from the fluid path by pumping an amount of the pharmaceutical and/or a diluent, such as saline, through the fluid path to the end of a tubing set (e.g., MPDS 200 or SPDS 700) before connecting the tubing set to a catheter in the patient. 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.”); System (10) comprises an air detector (176); However Griffth embodiment of Fig 1 is silent regarding a pump comprising an alarm signal for air detection in real-time.
Juretich teaches an alarm signal for air detection in real-time ([0004]; cassette is loaded into a pump and contains air-in-line sensor used to trigger alarm 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 with similar air-in-line sensor coupled to pump as taught by Juretich to trigger safety alarms ([0004]).
Claim 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. ( US 20150335821 A1) in view of Barron et al. (US 20090149743 A1).
Regarding claim 15, Griffth discloses the delivery system according to claim 14. Griffth discloses wherein the status light system ([0179]: light status generated by display see Fig 7) indicates the different state (state indicated by highlighted symbols ). 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 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])
Regarding claim 16, Griffth/Barron discloses the delivery system according to claim 14. Griffth discloses wherein the status light system ([0179]: light status generated by display see Fig 7) is controlled by a control system (controller 5, [0084]).
Claim 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. ( US 20150335821 A1) in view of Burbank et al. (US 20140018727 A1).
Regarding claim 17, Griffth discloses a radiopharmaceutical drug delivery system comprising: a configurable dose transporter (carrying system 500, Fig 4A including vial shield 544 Fig 4A+ vial 902 + MPDS 200+ SPDS 700, Fig 1C); [0119]), a separable radioactive dose transportation and containment module (carrying system 500, Fig 4A); a shielding (vial shield 544 Fig 4A; [0119]); a disposable sealed fluid cartridge (MPDS 200+ SPDS 700, Fig 1C); and a syringe or a vial (vial 902; [0073]); wherein the disposable sealed fluid cartridge (200+700+180) comprises:(i) one or more selectable integrated flow channels (Tubing sections 204, 210, 216, 220, 226, 230 and tubing section of 700, Fig 1C and 2A);(ii) an adapter (connector end 228, Fig 2A) to access the syringe or the vial (902) ([0107]);(iii) a patient port (patient end 704, Fig 1C) and a saline port (spike 202, Fig 2A); and (v) an integrated precision pump (pump 180 is structurally and functionally connected; [0091]) configured to control a flow of a radioactive drug (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C) from the syringe or the vial (902); wherein the disposable sealed fluid cartridge (200+700+180) is configured for withdrawing a customizable volume from the syringe or the vial (200+700+180 permits withdrawal of costume volumes from the vial 902 to the patient trough 704 ([0082],Fig 1C); [0210]-[0211] desired activity level can be set based on the weight of the patient).
Griffth is silent regarding the disposable sealed fluid cartridge comprises and (iv) one or more pressure sensors
Burbank teaches a disposable sealed fluid cartridge (sealed disposable fluid circuit,[0179]) comprises and (iv) one or more pressure sensors (pressure transducer; [0179]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the disposable sealed fluid cartridge device of Griffth with similar pressure sensor at the distal end as taught by Burbank for the purpose of detecting pressure of fluid medication being delivered to the patient ([0179]).
Regarding claim 19 Griffth/Burbank discloses the delivery system according to claim 17. Griffth discloses wherein the disposable sealed fluid cartridge (200+700+180) is configured for withdrawing a customizable volume based on one or more of patient weight, sex, age, health history data, and other physical parameter (200+700+180 permits withdrawal of costume volumes from the vial 902 to the patient trough 704 ([0082],Fig 1C); [0210]-[0211] desired activity level can be set based on the weight of the patient; [0210]: “(…)the system 10 can include more than pre-set or predefined weight-based formulas. For example, the system 10 can also include formulas based on other patient parameters, such as glucose-level or cardiac output, or scanner parameters, such as acquisition time or crystal type.”).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. ( US 20150335821 A1) in view of Burbank et al. (US 20140018727 A1) in further view of Kaintz et al. (US 20130331634 A1).
Regarding claim 18, Griffth/Burbank discloses the delivery system according to claim 17. Griffth/Burbank are silent regarding wherein the adapter is tagged with one or more of an RFID, barcode, or 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/Burbank with similar RFID encoding as taught by Kaintz for the purpose of to ensure that the correct SPDS is connected ([0097])
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. ( US 20150335821 A1) in view of Burbank et al. (US 20140018727 A1) in further view of Cork et al.( US 20020128585 A1).
Regarding claim 20, Griffth/Burbank discloses the delivery system according to claim 17. Griffth/Burbank are silent wherein the disposable sealed fluid cartridge comprises preconnected ports to eliminate errors in selection of the patient and the saline lines.
Cork teaches a delivery system (Fig 3) comprising disposable sealed fluid cartridge (disposable fluid circuit 104, Fig 5; ([0075])) comprises preconnected ports to eliminate errors in selection of the patient and the saline lines ([0079]: “the fluid circuit 104 pre-connects the processing chamber 106, the containers 110, the fluid control cassettes 112 and the MEMS carrier/cassette 96. The assembly thereby preferably forms an integral pre-assembled sterile unit”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the disposable sealed fluid cartridge of device of Griffth/Burbank with similar pre-connections of its ports forming an integral unit as taught by Cork for the purpose of reducing human error at the time of connections and reducing assembly time by having a preassembled unit ([0079])
Response to Arguments
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
Applicant submits that Griffith fails to disclose the claimed assembly as amended in claims 1 and 14 and a disposable fluid cartridge having an integrated precision pump as amended in claim 17. Examiner respectfully disagrees.
Griffith discloses the assembly as amended please see relevant portion of Claim 1
(…)the assembly comprising: 1) a configurable dose transporter (vial shield 1554+ septum cap 1562, Fig 5A-D), wherein the configurable dose transporter comprises: a) a separable radioactive dose transportation and containment module (vial 902; Fig 4C); b) a shielding (vial shield 1554, Fig 5A-D) for use with one or more of different radionuclide types, quantities, and volumes ([0136]); and c) a radioactive dose (drug inside radiopharmaceutical vial 902; [0073]; Fig 4C) in a vessel selected from a syringe or a vial (vial 902, Fig 4C ); and (2) a disposable sealed fluid cartridge (MPDS 200+ SPDS 700; fluid path are sealed by means of connectors and/or adapters) connectable with the syringe or the vial (902) via a sealable fitting 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; [0100];[0107]-[0108]; assembly is installed in the cart 9 wells in connection to catheter [0108]).
Griffith discloses the assembly (200+700+902+1554) is structurally capable of being formed separately from the movable cart 9. The sub-assemblies 200+700 and 902+1554 can be connected through cannula 208 and access system 600 and then inserted in the wells and cavities of the cart 9 for installation in the administration system. Please see relevant portion of the specification: [0118]: “The vial access system 600 is removably disposed within well 111” ;[0137]: “(…) an operator of the fluid delivery system 10 can select the appropriate vial shield and vial access system and place it in the well 111 of the fluid delivery system to enable a fluid injection procedure.”; [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.” Therefore, vial access system 600 is removably disposed within well 111 and structurally capable of stablish the connection of assembly (200+700+902+1554) through cannula 208 separately from the movable cart 9.
Griffith discloses a disposable fluid cartridge (200+700+180) having an integrated precision pump (peristaltic pump 180) as amended in claim 17 (pump 180 is structurally and functionally connected; [0091]) Note: pump 180 is disposable but at a slower rate (upon damage or malfunction) compared to the remainder components of the cartridge.
Further, Griffith discloses [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.”; an in-line pump or piston-driven syringe pump would be formed in direct physical connection with the fluid cartridge).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Akerele et al. (WO 2019222713 A1) teaches a delivery system (delivery device 500, Fig 13) comprising a separably formed assembly (sled assembly 540+ vial assembly 580) further comprising: 1) a configurable dose transporter (vial shield 557+ vial body 589, Fig 16-18), wherein the configurable dose transporter comprises: a) a separable radioactive dose transportation and containment module (vial assembly 580, Fig 16); b) a shielding (vial shield 557, Fig 16) for use with one or more of different radionuclide types, quantities, and volumes ([00240]); and c) a radioactive dose (radioactive dose inside vial assembly 580; Fig 16) in a vessel selected from a syringe or a vial and (2) a disposable ([00242]) sealed fluid cartridge (sled assembly 540, Fig 30)connectable with the syringe or the vial via (580) a sealable fitting (needle 559, Fig 15) for installation in the administration system ([00237]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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