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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation "a radiopharmaceutical drug delivery system" in lines 3-4. It is not clear whether:
The radiopharmaceutical drug delivery system is the same as the one introduced on line 1 of claim 17.
Or it is a different radiopharmaceutical drug delivery system.
For examination purposes examiner is interpreting the claim limitation according the first interpretation: the radiopharmaceutical drug delivery system is the same as the one introduced on line 1 of claim 17.
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 1-12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over
Griffth et al. (US20150335821A1) in view of Morcos et al. (US 20150279490 A1) in further view of Rivas et al. (US 20090036764 A1).
Regarding claim 1, Griffth embodiment of Fig 48, hereinafter Griffth-48 discloses a drug delivery system (Fig 48) comprising: an assembly (Assembly (A): pharmaceutical source (not shown)+ Cartridge (C): syringe 380’+ T-connector 393+ single-patient fluid path set 700+ vented cannula 208, Fig 48) containing the dose of the pharmaceutical drug (pharmaceutical source (not shown); a disposable sealed fluid cartridge (Cartridge (C): syringe 380’+ T-connector 393+ single-patient fluid path set 700+ vented cannula 208, Fig 48) connectable with the syringe or the vial (pharmaceutical source (not shown); please note that this embodiment also supports radiopharmaceuticals; [0153]: shielding) via a sealable fitting (vented cannula 208), the disposable sealed fluid cartridge (Cartridge (C): syringe 380’+ T-connector 393+ single-patient fluid path set 700+ vented cannula 208, Fig 48) comprising an integrated infusion pump (syringe 380’, Fig 48), wherein the disposable sealed fluid cartridge (C) is configured for withdrawing customizable volumes from the vessel (pharmaceutical source (not shown) wherein the assembly (A) is formed separately from the movable cart (Assembly (A) is formed separated from a cart); and a fluid path extending between the syringe or the vial (pharmaceutical source (not shown) and a patient port (patient end 704, Fig 48)
Griffth-48 is silent regarding a radiopharmaceutical drug delivery system comprising: (i) a movable cart having an administration system for administering a dose of the radiopharmaceutical drug to a patient; (ii) an informatics system with a computer screen configured as a user interface; the assembly comprising:(1) a configurable dose transporter, wherein the configurable dose transporter comprises: a) a separable radioactive dose transportation and containment module; a shielding for use with one or more of different radionuclide types, quantities, and volumes; and c) a radioactive dose within a vessel selected from a syringe or a vial; the fluid cartridge connectable with the syringe or the vial via a sealable fitting for installation in the administration system; an enclosure enclosing at least a portion of the integrated infusion pump, wherein the assembly is installable to the administration system, and wherein the configurable dose transporter and the enclosure of the disposable sealed fluid cartridge comprise respective mating alignment features configured to position the configurable dose transporter and the disposable sealed fluid cartridge in a predetermined orientation relative to one another.
Morcos teaches (iii) an assembly (Assembly (A’), comprised of housing 500 including shielding + vial 510 + concentrator device 20 + injection device 45 +body 30+ injection port 40 + fluid path ; Fig 3) containing the dose of the radiopharmaceutical drug, the assembly comprising: (1) a configurable dose transporter (housing 500 including shielding, Fig 3 + vial 510, Fig 3; radiopharmaceutical inside vial 510; [0260]), wherein the configurable dose transporter comprises: a) a separable radioactive dose transportation and containment module (housing 500, Fig 3); b) a shielding for use with one or more of different radionuclide types, quantities, and volumes ([0230]); and c) a radioactive dose in a vessel selected from a syringe or a vial (vial 510, Fig 3; radiopharmaceutical inside vial 510; [0260]); and (2) a disposable sealed fluid cartridge (concentrator device 20, Fig 3) connectable with the syringe or the vial (510) via a sealable fitting (sealing connection between syringe needle 220 and vial 510 throughout septum 515, Fig 3) ([0227]-[0228]), the disposable sealed fluid cartridge (20) comprising an integrated infusion pump (injection device 45, [0220]), an enclosure (body 30+ injection port 40, Fig 1) enclosing at least a portion of the integrated infusion pump (45), and a fluid path (Fig 3 shows a fluid path) extending from the syringe or the vial (510), wherein the assembly (A’) is formed separately from the movable cart (assembly is form separately from any other device or component), and wherein the configurable dose transporter (500+510) and the enclosure (30) of the disposable sealed fluid cartridge (20) comprise respective mating alignment features (500+10 is inserted in port 32e of body 30; [0173]) configured to position the configurable dose transporter (500+510) and the disposable sealed fluid cartridge (20) in a predetermined orientation relative to one another (orientation seen in Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48 with similar configurable dose transporter for radiopharmaceutical and enclosure as taught by Morcos for the purpose of protecting the internals of the cartridge and provide a secured connection between the cartridge and the dose transporter containing the radiopharmaceutical ([0173]; [0227]-[0228]; [0260]).
Griffth-48/Morcos are silent regarding a radiopharmaceutical drug delivery system comprising: (i) a movable cart having an administration system for administering a dose of the radiopharmaceutical drug to a patient; (ii) an informatics system with a computer screen configured as a user interface; the connection of disposable sealed fluid cartridge with the syringe or the vial for installation in the administration system and the assembly is installable to the administration system.
Griffth embodiment of Fig 1, hereinafter Griffth-1 teaches 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])
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos to incorporate a movable cart and informatics system as taught by Griffth-1 for the purpose of transporting the components of the system and facilitating documentation ([0071]; [0084])
Griffth-48/Morcos/Griffth-1 are silent the connection of disposable sealed fluid cartridge with the syringe or the vial for installation in the administration system and the assembly is installable to the administration system.
Rivas teaches a disposable sealed fluid cartridge (1000) connectable with the syringe or the vial via a sealable fitting for installation ([0152]) in the administration system (Fig 48 shows the connection and fig 49 the insertion into the system).
Griffth-48/Morcos/Griffth-1/Rivas as modified discloses the assembly (assembly A, modified with teachings of Morcos to include a dose transporter oriented in a predetermined position in the enclosure, and teaching of Rivas to be inserted into the infusion system of a cart) is installable to the administration system (administration system of a cart as taught by Griffth-1 in further teaching of Rivas).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1 to insert the assembly into the cart as taught by Rivas to improve user experience and reduce the time for set up ([0329]).
Regarding claim 2, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 is silent wherein the vessel can be selected from different standard sizes.
Griffth-1 teaches wherein the vessel (902) can be selected from different standard sizes ([0137]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with possible selection of various sizes of vial as taught by Griffth-1 for the purpose to facilitate the user to use adequate size vials upon needed ([0137])
Regarding claim 3, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 is silent wherein the shielding system is configured to be used with a variety of sizes of the syringe or the vial being inserted or connected therein.
Griffth-1 teaches 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]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with possible selection of various sizes of shielding for different vial sizes as taught by Griffth-1 for the purpose to facilitate the user to use adequate size vials and shielding upon needed ([0137]).
Regarding claim 4, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 is silent wherein the computer screen is a touch screen.
Griffth-1 teaches 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”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with a touchscreen as taught by Griffth-1 for ease of use ([0071]).
Regarding claim 5, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 discloses wherein the disposable sealed fluid cartridge (C) is configured to permit withdrawal of custom volumes from the vial or syringe ([0156]).
Griffth-48 is silent wherein the withdrawal is based on one or more of patient weight, sex, age, other physical parameters, and health history data.
Griffth-1 discloses wherein the disposable sealed fluid cartridge (200+700+180) is configured to permit withdrawal of custom volumes from the vial or syringe ([0091]) based on one or more of patient weight, sex, age, other physical parameters, and health history data (200+700+180 permits withdrawal of costume volumes from the vial 902, ([0091]) 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).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with withdrawals based on weight of the patient as taught by Griffth-1 for the purpose of avoiding human error since withdrawal will be selected based on stablished parameters ([0210]-[0211]).
Regarding claim 6, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 is silent wherein the drug delivery system is configured to support a drug specific infusion parameter.
Griffth-1 teaches 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).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with withdrawals based on weight of the patient as taught by Griffth-1 for the purpose of avoiding human error since withdrawal will be selected based on stablished parameters ([0210]-[0211]).
Regarding claim 7, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 is silent wherein the separable radioactive dose transportation and containment module is shielded.
Morcos teaches wherein the separable radioactive dose transportation and containment module (500) is shielded ([0230]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with shielding of dose transportation and containment module as taught by Morcos for the purpose of protecting the user against radiation ([0230]).
Regarding claim 8, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 is discloses wherein the disposable sealed fluid cartridge comprises a port for eliminating errors in connecting a patient line or a saline line to the cartridge ([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).
Regarding claim 9, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 is silent regarding wherein the system 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.
Griffth-1 teaches 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").
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with a similar tracking function as taught by Griffth-1 for the purpose of document and display total volume of injected fluid ([0243]).
Regarding claim 10, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 silent wherein the system further comprises a control system to control the process of infusion of a medical fluid into the patient.
Griffth-1 teaches 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)).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with similar control system as taught by Griffth-1 for the purpose of control the injection and warn the user if there is an interruption to allow discarding the dose ([0235]).
Regarding claim 11, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 10. Griffth-48 is silent wherein the control system is configured to halt the infusion process due to system error.
Griffth-1 teaches 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).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with similar control system as taught by Griffth-1 for the purpose of control the injection and warn the user if there is an interruption to allow discarding the dose ([0235]).
Regarding claim 12, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 is silent 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.
Griffth-1 teaches 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 results from unexpected sequence of events)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with similar alert resulting from unexpected sequence of events as taught by Griffth-1 for the purpose of control the injection and warn the user if there is an interruption to allow discarding the dose ([0235]).
Regarding claim 14, Griffth embodiment of Fig 48, hereinafter Griffth-48 discloses a drug delivery system (Fig 48) comprising: an assembly containing the dose of the pharmaceutical drug (pharmaceutical source (not shown); a disposable sealed fluid cartridge (Fig 48) connectable with the syringe or the vial (pharmaceutical source (not shown); please note that this embodiment also supports radiopharmaceuticals; [0153]: shielding) via a sealable fitting (vented cannula 208), the disposable sealed fluid cartridge (Cartridge (C): syringe 380’+ T-connector 393+ single-patient fluid path set 700+ vented cannula 208, Fig 48) comprising an integrated infusion pump (syringe 380’, Fig 48), wherein the assembly (A) is formed separately from the movable cart (Assembly is formed separated from a cart); and a fluid path extending between the syringe or the vial (pharmaceutical source (not shown) and a patient port (patient end 704, Fig 48); wherein the disposable sealed fluid cartridge (C) is configured for withdrawing customizable volumes from the vessel (pharmaceutical source (not shown).
Griffth-48 is silent regarding a radiopharmaceutical drug delivery system comprising: (i) a movable cart having an administration system for administering a dose of a radiopharmaceutical drug to a patient; (ii) an informatics system with a computer screen as a graphical user interface (GUI); (iii) a status light system that illuminates a working area for monitoring a status of an infusion component; and (iv) an assembly containing the dose of the radiopharmaceutical drug, the assembly comprising:(1) a configurable dose transporter, wherein the configurable dose transporter comprises: a) a separable radioactive dose transportation and containment module; b) a shielding for use with one or more of different radionuclide types, quantities, and volumes; and c) a radioactive dose within a vessel selected from a syringe or a vial; an enclosure enclosing at least a portion of the integrated infusion pump, wherein the assembly is installable to the administration system, and wherein the configurable dose transporter and the enclosure of the disposable sealed fluid cartridge comprise respective mating alignment features configured to position the configurable dose transporter and the disposable sealed fluid cartridge in a predetermined orientation relative to one another.
Morcos teaches and (iv) an assembly (Assembly (A’), comprised of housing 500 including shielding + vial 510 + concentrator device 20 + injection device 45 +body 30+ injection port 40 + fluid path ; Fig 3) containing the dose of the radiopharmaceutical drug (dose of radiopharmaceutical inside vial 510), the assembly comprising:(1) a configurable dose transporter (housing 500 including shielding, Fig 3 + vial 510, Fig 3; radiopharmaceutical inside vial 510; [0260]), wherein the configurable dose transporter comprises: a) a separable radioactive dose transportation and containment module (housing 500, Fig 3); b) a shielding for use with one or more of different radionuclide types, quantities, and volumes ([0230]); and c) a radioactive dose within a vessel selected from a syringe or a vial (vial 510, Fig 3; radiopharmaceutical inside vial 510; [0260]); and (2) a disposable sealed fluid cartridge (concentrator device 20, Fig 3) connectable with the syringe or the vial (510) via a sealable fitting (sealing connection between syringe needle 220 and vial 510 throughout septum 515, Fig 3) ([0227]-[0228]), the disposable sealed fluid cartridge (20) comprising an integrated infusion pump (injection device 45, [0220]), an enclosure enclosing at least a portion of the integrated infusion pump (45), and a fluid path (Fig 3 shows a fluid path) extending from the syringe or the vial (510), wherein the disposable sealed fluid cartridge (20) is configured for withdrawing customizable volumes from the vessel (510) (fluid cartridge is structurally capable of drawing custom volumes from the vial 510 using pump 45), wherein the assembly is formed separately from the movable cart (assembly is form separately from any other device or component) and wherein the configurable dose transporter (500+510) and the enclosure (30) of the disposable sealed fluid cartridge (20) comprise respective mating alignment features (500+10 is inserted in port 32e of body 30; [0173]) configured to position the configurable dose transporter (500+510) and the disposable sealed fluid cartridge (20) in a predetermined orientation relative to one another (orientation seen in Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48 with similar configurable dose transporter for radiopharmaceutical and enclosure as taught by Morcos for the purpose of protecting the internals of the cartridge and provide a secured connection between the cartridge and the dose transporter containing the radiopharmaceutical ([0173]; [0227]-[0228]; [0260]).
Griffth-48/Morcos are silent regarding a radiopharmaceutical drug delivery system comprising: (i) a movable cart having an administration system for administering a dose of the radiopharmaceutical drug to a patient; (ii) an informatics system with a computer screen configured as a user interface; (iii) a status light system that illuminates a working area for monitoring a status of an infusion component the connection of disposable sealed fluid cartridge with the syringe or the vial for installation in the administration system and the assembly is installable to the administration system.
Griffth embodiment of Fig 1, hereinafter Griffth-1 teaches 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) 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")
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos to incorporate a movable cart and informatics system and status light system as taught by Griffth-1 for the purpose of transporting the components of the system and facilitating documentation and provide status information ([0071]; [0084]; [0179]).
Morcos/Griffth-48/Griffth-1 are silent regarding the connection of disposable sealed fluid cartridge with the syringe or the vial for installation in the administration system and the assembly is installable to the administration system and the assembly is installable to the administration system.
Rivas teaches a disposable sealed fluid cartridge (1000) connectable with the syringe or the vial via a sealable fitting for installation ([0152]) in the administration system (Fig 48 shows the connection and fig 49 the insertion into the system)
Griffth-48/Morcos/Griffth-1/Rivas as modified discloses the assembly (assembly A, modified with teachings of Morcos to include a dose transporter oriented in a predetermined position in the enclosure, and teaching of Rivas to be inserted into the infusion system of a cart) is installable to the administration system (administration system of a cart as taught by Griffth-1 in further teaching of Rivas).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1 to insert the assembly into the cart as taught by Rivas to improve user experience and reduce the time for set up ([0329]).
Regarding claim 16, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 14. Griffth-48 is silent wherein the status light system is controlled by a control system.
Griffth-1 teaches wherein the status light system ([0179]: light status generated by display see Fig 7) is controlled by a control system (controller 5, [0084]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with similar light status generated by the display as taught by Griffth-1 for the purpose of providing status information to the user ([0179]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US20150335821A1) in view of Morcos et al. (US 20150279490 A1) in further view of Rivas et al. (US 20090036764 A1) in further view of Juretich et al. (US 20150202384 A1).
Regarding claim 13, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 1. Griffth-48 is silent wherein the infusion pump is configured to protect the patient from an air infusion and comprises an alarm signal for air detection in real-time.
Griffth-1 teaches wherein the infusion pump (22+180) 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).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas to expel a small amount through the patient end before it is connected to the patient; and an air detector as taught by Griffth-1 for to detect air and prevent an air embolism ([0158]).
Griffth-48/Morcos/Griffth-1/Rivas are 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-48/Morcos/Griffth-1/Rivas with similar air-in-line sensor coupled to pump as taught by Juretich to trigger safety alarms ([0004]).
Claim 15 are rejected under 35 U.S.C. 103 as being unpatentable over Griffth et al. (US20150335821A1) in view of Morcos et al. (US 20150279490 A1) in further view of Rivas et al. (US 20090036764 A1) in further view of Barron et al. (US 20090149743 A1).
Regarding claim 15, Griffth-48/Morcos/Griffth-1/Rivas discloses the delivery system according to claim 14. Griffth-48 is silent wherein the status light system indicates the different state 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-48/Morcos/Griffth-1/Rivas 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]).
Claim 17 and 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) in further view of Morcos et al. (US 20150279490 A1).
Regarding claim 17, Griffth embodiment of Fig 48, hereinafter Griffth-48 discloses a drug delivery system (Fig 48) comprising: an assembly (Assembly 399 comprised of pharmaceutical source (not shown)+ Cartridge (C): syringe 380’+ T-connector 393+ single-patient fluid path set 700+ vented cannula 208, Fig 48) formed separately from a movable cart (Assembly 399 is formed separated from a cart), the assembly comprising: a disposable sealed fluid cartridge (Cartridge (C): syringe 380’+ T-connector 393+ single-patient fluid path set 700+ vented cannula 208, Fig 48+ tubing segments 390, 391, 392, Fig 48); wherein the disposable sealed fluid cartridge (C) comprises: (i) one or more selectable integrated flow channels (first, second and third tubing segments 390, 391, 392, Fig 48); (ii) an adapter (vented cannula 208, Fig 48) to access the syringe or the vial (vented cannula 208 is structurally capable of access a radiopharmaceutical vial); (iii) a patient port (patient end 704, Fig 48); an integrated precision pump (380’) configured to control a flow of the radiopharmaceutical drug from the syringe or the vial (380’ control a flow of pharmaceutical source, and is structurally capable of control a flow of a radiopharmaceutical vial); wherein the disposable sealed fluid cartridge (C) is configured for withdrawing a customizable volume from the syringe or the vial (syringe 380’ of cartridge (C) withdraws a customizable volume pharmaceutical source, and is structurally capable of control a flow of a radiopharmaceutical vial).
Griffth-48 is silent regarding a radiopharmaceutical drug delivery system; the assembly comprising a configurable dose transporter, a separable radioactive dose transportation and containment module; a shielding; and a syringe or a vial; the cartridge comprising a saline port and one or more pressure sensors, and wherein all components of the disposable sealed fluid cartridge are at least partially enclosed in an enclosure, and wherein the configurable dose transporter and the enclosure of the disposable sealed fluid cartridge comprise respective mating alignment features configured to position the configurable dose transporter and the disposable sealed fluid cartridge in a predetermined orientation relative to one another.
Griffth embodiment of Fig 1, hereinafter Griffth-1 discloses a radiopharmaceutical drug delivery system comprising: a configurable dose transporter (vial shield 544 Fig 4A+ vial 902; [0119]), a separable radioactive dose transportation and containment module (vial 902, Fig 4A); a shielding (vial shield 544 Fig 4A; [0119]); a disposable sealed fluid cartridge (MPDS 200+ SPDS 700+ pump 180, Fig 2A); and a syringe or a vial (vial 902; [0073]); wherein the disposable sealed fluid cartridge comprises:(i) one or more selectable integrated flow channels (tubing section 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 the radiopharmaceutical 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-48/Griffth-1 as modified disclose a radiopharmaceutical drug delivery system (399 from Griffth-48 , modified with teaching of Griffth-1 to deliver a radiopharmaceutical); the assembly (399 of Griffth-48 modified to include vial shield 544 + vial 902 + spike 202 and associate tubing from Griffth-1) comprising a configurable dose transporter (vial shield 544 + vial 902, from Griffth-1), a separable radioactive dose transportation and containment module (Vial 902 from Griffth-1); a shielding (vial shield 544 from Griffth-1); the cartridge comprising a saline port (Cartridge (C) from Griffth-1 modified with teaching of a saline port and associated tubing connected to the connector), the integrated precision pump being configured to control a flow of the radiopharmaceutical drug from the syringe or the vial (syringe 380’ from Griffth-48 control a flow of pharmaceutical source, modified with teaching of Griffth-1 to be in the form of radiopharmaceutical vial 902); wherein the disposable sealed fluid cartridge is configured for withdrawing a customizable volume from the syringe or the vial (syringe 380’ from Griffth-48 is configured for withdrawing a customizable volume from pharmaceutical source, modified with teaching of Griffth-1 to be in the form of radiopharmaceutical vial 902).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48 with similar configurable dose transporter, a separable radioactive dose transportation and containment module, a shielding and a saline port as taught by Griffth-1 for the purpose of priming the system and protect the user from radiation and perform delivery of contrast agent for medical procedures ([0096]; [0128]; [0273]).
Griffth-48/Griffth-1 are silent wherein the disposable sealed fluid cartridge comprises one or more pressure sensors; wherein all components of the disposable sealed fluid cartridge are at least partially enclosed in an enclosure, and wherein the configurable dose transporter and the enclosure of the disposable sealed fluid cartridge comprise respective mating alignment features configured to position the configurable dose transporter and the disposable sealed fluid cartridge in a predetermined orientation relative to one another.
Burbank teaches a disposable sealed fluid cartridge (sealed disposable fluid circuit,[0179]) comprises 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-48/Griffth-1 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]).
Griffth-48/Griffth-1/Burbank are silent wherein all components of the disposable sealed fluid cartridge are at least partially enclosed in an enclosure, and wherein the configurable dose transporter and the enclosure of the disposable sealed fluid cartridge comprise respective mating alignment features configured to position the configurable dose transporter and the disposable sealed fluid cartridge in a predetermined orientation relative to one another.
Morcos teaches an assembly (Assembly (A’), comprised of housing 500 including shielding + vial 510 + concentrator device 20 + injection device 45 +body 30+ injection port 40 + fluid path ; Fig 3) formed separately from a movable cart of a radiopharmaceutical drug delivery system (assembly is form separately from any other device or component), the assembly comprising: a configurable dose transporter (housing 500 including shielding, Fig 3 + vial 510, Fig 3; radiopharmaceutical inside vial 510; [0260]), a separable radioactive dose transportation and containment module (housing 500, Fig 3); a shielding ([0230]); a disposable sealed fluid cartridge (concentrator device 20, Fig 3); and a syringe or a vial (vial 510, Fig 3; radiopharmaceutical inside vial 510; [0260]); wherein the disposable sealed fluid cartridge comprises: (i) one or more selectable integrated flow channels (channels connecting the disposable components of concentrator 20, Fig 3);(ii) an adapter (needle 220, Fig 3) to access the syringe or the vial (510);(iii) a patient port and a saline port (injection port 40 is a saline port ; [0220]); an integrated precision pump (syringe 45, Fig 3), and wherein all components of the disposable sealed fluid cartridge (20) are at least partially enclosed in an enclosure (body 30+ injection port 40, Fig 1), and wherein the configurable dose transporter (housing 500 including shielding, Fig 3 + vial 510, Fig 3; radiopharmaceutical inside vial 510; [0260]) and the enclosure (30+40) of the disposable sealed fluid cartridge (20) comprise respective mating alignment features (500+10 is inserted in port 32e of body 30; [0173]) configured to position the configurable dose transporter(500+510) and the disposable sealed fluid cartridge (20)in a predetermined orientation relative to one another(orientation seen in Fig 3).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48 with similar configurable dose transporter for radiopharmaceutical and enclosure as taught by Morcos for the purpose of protecting the internals of the cartridge and provide a secured connection between the cartridge and the dose transporter containing the radiopharmaceutical ([0173]; [0227]-[0228]; [0260]).
Regarding claim 19, Griffth-48/Griffth-1/Burbank/Morcos discloses the delivery system according to claim 17. Griffth-48 discloses wherein the disposable sealed fluid cartridge (C) is configured to permit withdrawal of custom volumes from the vial or syringe ([0156]).
Griffth-48 is silent wherein the withdrawal is based on one or more of patient weight, sex, age, other physical parameters, and health history data.
Griffth-1 discloses wherein the disposable sealed fluid cartridge (200+700+180) is configured to permit withdrawal of custom volumes from the vial or syringe ([0091]) based on one or more of patient weight, sex, age, other physical parameters, and health history data (200+700+180 permits withdrawal of costume volumes from the vial 902, ([0091]) 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).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Griffth-48/Morcos/Griffth-1/Rivas with withdrawals based on weight of the patient as taught by Griffth-1 for the purpose of avoiding human error since withdrawal will be selected based on stablished parameters ([0210]-[0211]).
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 Morcos et al. (US 20150279490 A1) in further view of Kaintz et al. (US 20130331634 A1).
Regarding claim 18, Griffth-48/Griffth-1/Burbank/Morcos discloses the delivery system according to claim 17. Griffth-48 is 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-48/Griffth-1/Burbank/Morcos with similar RFID encoding as taught by Kaintz for the purpose of to ensure that the correct part 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 Morcos et al. (US 20150279490 A1) in further view of Cork et al.( US 20020128585 A1).
Regarding claim 20, Griffth-48/Griffth-1/Burbank/Morcos discloses the delivery system according to claim 17. Griffth-48 is 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-48/Griffth-1/Burbank/Morcos 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 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
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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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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