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 .
Response to Amendment
The amendment filed July 07, 2026 has been entered. Claims 1-2, 6, 9-18, 20-21, 24, 26-27, 33, and 43 remain pending in the application. Claims 3-5, 7-8, 19, 22-23, 25, 28-32, 34-42, and 44-46 have been cancelled. Applicant’s amendments to the claims have overcome the rejections under 35 USC 101 and 112 previously set forth in the Non-Final Office Action mailed April 24, 2026.
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.
Claims 1-2, 6, and 9-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piehl et al. (US 20170319783).
Regarding claim 1, Piehl discloses a fluid drug delivery system (system 10, having pressuring monitoring system 815), comprising:
an actuator (plunger 41, trigger 37, shuttle mechanism 56) and connected to a valve (dual check valve 31) for releasing a pressurized treatment fluid (“The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157], noted that “a pressurized treatment fluid” is not positively recited or claimed);
a fluid chamber (syringe 48) configured to comprise the pressurized treatment fluid (“infuse fluid from a syringe 48” [0155]) and comprising a volume that changes in response to the release of the pressurized treatment fluid (“The inlet 34 of the dual check value 31 can allow fluid from the fluid reservoir to enter the syringe 48 when the plunger 41 is retracted. The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figures 4-5);
an external pressure interface (pressuring monitoring system 815) in fluid communication with the fluid chamber (“This pressure monitoring system 815 may allow a user to know the pressure being applied to the pressure monitoring system 815 at various points during infusion” [0215]); and
a pressure sensor (load cell 802) operatively connected to the fluid chamber and the external pressure interface, configured to monitor fluid pressure of the fluid chamber and direct an operator of the system to a correct pressure application (“This pressure monitoring system 815 may allow a user to know the pressure being applied to the pressure monitoring system 815 at various points during infusion, and may be used to alert the user if a pressure limit is exceeded…A load cell 800 may detect the force applied between the syringe flange 40 and the housing 62, when a trigger…is being actuated and fluid is being forced into or out of the syringe 48.” [0215]; “, a display 802 on the outside of the housing 62 may show the current pressure being applied to the fluid in the syringe 48” [0217]).
Regarding claim 2, Piehl discloses the system of claim 1, the actuator comprising a reinforced flange (flange 40).
Regarding claim 6, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid comprises gemcitabine, paclitaxel, or combinations thereof (“infuse fluid from a syringe 48” [0155], noted that “the pressurized treatment fluid” is not positively recited or claimed).
Regarding claim 9, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid is configured to be delivered through into a target cystic tumor (Noted that the “pressurized treatment fluid” is not positively recited or claimed and the claim has been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed as detailed in the rejection under 35 USC 112 above) through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure of approximately 4 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 4 ATM is within the disclosed range) for approximately 90 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003] wherein 90 seconds is within the disclosed range of 5 minutes), the pressurized treatment fluid comprising at least one or a combination of approximately 10 cm3 of gemcitabine and paclitaxel (“A 10 ml syringe 48 (or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169], noted that the pressurized treatment fluid is not positively recited or claimed).
Regarding claim 10, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid is configured to be delivered through into a target cystic tumor (Noted that the “pressurized treatment fluid” is not positively recited or claimed and the claim has been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed as detailed in the rejection under 35 USC 112 above) through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure of approximately 5 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 5 ATM is within the disclosed range) for approximately 76 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003] wherein 76 seconds is within the disclosed range of 5 minutes), the pressurized treatment fluid comprising at least one or a combination of approximately 10 cm3 of gemcitabine and paclitaxel (“A 10 ml syringe 48 (or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169], noted that the pressurized treatment fluid is not positively recited or claimed).
Regarding claim 11, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid is configured to be delivered through into a target cystic tumor (Noted that the “pressurized treatment fluid” is not positively recited or claimed and the claim has been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed as detailed in the rejection under 35 USC 112 above) through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure of approximately 6 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 6 ATM is within the disclosed range) for approximately 59 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003] wherein 59 seconds is within the disclosed range of 5 minutes), the pressurized treatment fluid comprising at least one or a combination of approximately 10 cm3 of gemcitabine and paclitaxel (“A 10 ml syringe 48 (or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169], noted that the pressurized treatment fluid is not positively recited or claimed).
Regarding claim 12, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid (Noted that the “pressurized treatment fluid” is not positively recited or claimed and the claim has been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed as detailed in the rejection under 35 USC 112 above) is configured to be delivered through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure of approximately 8 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 8 ATM is within the disclosed range) for approximately 42 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003] wherein 42 seconds is within the disclosed range of 5 minutes), the pressurized treatment fluid comprising at least one or a combination of approximately 10 cm3 of gemcitabine and paclitaxel (“A 10 ml syringe 48 (or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169], noted that the pressurized treatment fluid is not positively recited or claimed).
Regarding claim 13, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid (Noted that the “pressurized treatment fluid” is not positively recited or claimed and the claim has been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed as detailed in the rejection under 35 USC 112 above) is configured to be delivered through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure of approximately 10 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 10 ATM is within the disclosed range) for approximately 32 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003], wherein 32 seconds is within the disclosed range of 5 minutes), the pressurized treatment fluid comprising at least one or a combination of approximately 10 cm3 of gemcitabine and paclitaxel (“A 10 ml syringe 48 (or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169], noted that the pressurized treatment fluid is not positively recited or claimed).
Regarding claim 14, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid (Noted that the “pressurized treatment fluid” is not positively recited or claimed and the claim has been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed as detailed in the rejection under 35 USC 112 above) is configured to be delivered through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure of approximately 6 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 6 ATM is within the disclosed range) for approximately 625 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003], wherein 32 seconds is within the disclosed range of 5-15 minutes), the pressurized treatment fluid comprising at least one or a combination of approximately 10 cm3 of gemcitabine and paclitaxel (“A 10 ml syringe 48 (or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169], noted that the pressurized treatment fluid is not positively recited or claimed).
Regarding claim 15, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid (Noted that the “pressurized treatment fluid” is not positively recited or claimed and the claim has been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed as detailed in the rejection under 35 USC 112 above) is configured to be delivered through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure of approximately 12 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 12 ATM is within the disclosed range) for approximately 26 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003], wherein 26 seconds is within the disclosed range of 5 minutes), the pressurized treatment fluid consisting of approximately 10 cm3 of paclitaxel (“A 10 ml syringe 48 (or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169], noted that the pressurized treatment fluid is not positively recited or claimed).
Regarding claim 16, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid (Noted that the “pressurized treatment fluid” is not positively recited or claimed and the claim has been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed as detailed in the rejection under 35 USC 112 above) is configured to be delivered through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure of approximately 12 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 12 ATM is within the disclosed range) for approximately 196 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003], wherein 196 seconds is within the disclosed range of 5 minutes), the pressurized treatment fluid consisting of approximately 10 cm3 of paclitaxel (“A 10 ml syringe 48 (or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169], noted that the pressurized treatment fluid is not positively recited or claimed).
Regarding claim 17, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid (Noted that the “pressurized treatment fluid” is not positively recited or claimed and the claim has been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed as detailed in the rejection under 35 USC 112 above) is configured to be delivered through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure of approximately 14 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 14 ATM is within the disclosed range) for approximately 21 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003], wherein 22 seconds is within the disclosed range of 5 minutes), the pressurized treatment fluid consisting of approximately 10 cm3 of paclitaxel (“A 10 ml syringe 48 (or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169], noted that the pressurized treatment fluid is not positively recited or claimed).
Regarding claim 18, Piehl discloses the system of claim 1, wherein the pressurized treatment fluid (Noted that the “pressurized treatment fluid” is not positively recited or claimed and the claim has been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed as detailed in the rejection under 35 USC 112 above) is configured to be delivered through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure of approximately 14 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 14 ATM is within the disclosed range) for approximately 156 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003], wherein 156 seconds is within the disclosed range of 5 minutes), the pressurized treatment fluid consisting of approximately 10 cm3 of paclitaxel (“A 10 ml syringe 48 (or other sizes, such as 5 ml, 20 ml, or 30 ml, not shown) can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169], noted that the pressurized treatment fluid is not positively recited or claimed).
Regarding claim 20, Piehl discloses a fluid delivery system (system 10 having pressure transducer 93 and display 90 of Figure 9; “FIG. 9 is a view of a delivery mechanism of FIGS. 1-3, having an added pressure transducer and display according to embodiments of the invention.” [0074]), comprising:
a pneumatic assembly (syringe 48) comprising a pressurized treatment fluid (“infuse fluid from a syringe 48” [0155]);
an actuator (plunger 41, trigger 37, shuttle mechanism 56) comprising a flange button surface (flange 40) on a plunger rod and piston (plunger 41) for pressurizing and releasing the pressurized treatment fluid from the pneumatic assembly (“The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]);
a hydraulic assembly (inlet tubing set 100 connected to container; Figure 17 for example) distally connected to and in fluid communication with the pneumatic assembly (Figure 17), the hydraulic assembly configured to input and output the pressurized treatment fluid through an external interface in response to pressure from the pressurized treatment fluid (“The syringe 48 can be connected to a dual check valve 31. The inlet 34 of the dual check value 31 can allow fluid from the fluid reservoir to enter the syringe 48 when the plunger 41 is retracted.” [0157], see also [0168-0170]);
a pressure sensor (pressure transducer 93) in fluid communication with the pressurized treatment fluid operably connected to the hydraulic assembly to monitor pressure from the pneumatic assembly (“a pressure transducer 93 is shown in communication with the patient side of the tubing” [0162]); and
a pressure interface (display 90) connected to the sensor to display pressure measurements monitored by the sensor and setting a predetermined pressure for infusion (“The display 90 may show…infusion pressure or other information to the user on a LCD screen, electronic ink, or other screen 91….a pressure transducer 93…connected to the display 90. Buttons 92 may allow the user to choose set points, change units, and or reset the values displayed on the screen.” [0162]; see also [0217] for details regarding setting a predetermined pressure).
Regarding claim 24, Piehl discloses the system of claim 20, wherein the hydraulic assembly comprises a coupling (dual check valve 31) separating a fluid chamber within the pneumatic assembly from released pressurized treatment fluid, and configured to move within the hydraulic assembly while simultaneously maintaining a seal between the fluid chamber and the released pressurized treatment fluid (“The syringe 48 can be connected to a dual check valve 31. The inlet 34 of the dual check value 31 can allow fluid from the fluid reservoir to enter the syringe 48 when the plunger 41 is retracted. The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]).
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.
Claims 21, 26, 33, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Piehl et al. (US 20170319783) in view of Weadock et al. (US 20160074626).
Regarding claim 21, Piehl discloses the system of claim 20.
Piehl fails to explicitly disclose the pressurized treatment fluid comprises gemcitabine, paclitaxel, or combinations thereof.
Weadock discloses a fluid delivery system (cannula 500) comprising a pressurized treatment fluid comprising gemcitabine, paclitaxel, or combinations thereof (“The proximal end of a cannula having a lumen for a guidewire and at least one other lumen for a therapeutic agent is then coupled, via a luer-lock fitting, to a source of conventional chemotherapeutic agent, e.g., selected from the group consisting of Gemcitabine (Gemzar®)…Paclitaxel (Taxol®)…The chemotherapeutic agent is allowed, by way of the valve or luer-lock fitting between the cannula and source of chemotherapeutic agent, to be delivered to the tumor and surrounding tissues at a pre-determined rate. This rate may vary from 0.01 ml-10 ml per hour” [0077]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of Piehl to include the pressurized treatment fluid comprises gemcitabine, paclitaxel, or combinations thereof based on the teachings of Weadock to treat tumors by delivering chemotherapy directly to the tumor site without necessitating systemic delivery of the chemotherapy drugs (Weadock [0008]).
Regarding claim 26, Piehl discloses a method of infusing an agent, comprising:
actuating, by an actuator (plunger 41, trigger 37, shuttle mechanism 56) of a fluid delivery system (system 10 having pressure transducer 93 and display 90 of Figure 9; “FIG. 9 is a view of a delivery mechanism of FIGS. 1-3, having an added pressure transducer and display according to embodiments of the invention.” [0074]), to pressurize a treatment fluid (“The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]);
measuring, by a pressure sensor (pressure transducer 93) in fluid communication with a pneumatic assembly (syringe 48) of the fluid delivery system, a pressure of a pressurized treatment fluid (“FIG. 9 shows a display 90 integrated into the housing. The display 90 may show volume infused, number of a strokes completed, infusion pressure or other information to the user on a LCD screen, electronic ink, or other screen 91. Buttons 92 may allow the user to choose set points, change units, and or reset the values displayed on the screen. In this configuration a pressure transducer 93 is shown in communication with the patient side of the tubing and connected to the display 90.” [0162]); and
releasing the pressurized treatment fluid from the fluid delivery system to a hydraulic assembly (tubing set 10S; Figure 17) in response to the pressurized treatment fluid achieving a predetermined pressure (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The inlet 34 of the dual check value 31 can allow fluid from the fluid reservoir to enter the syringe 48 when the plunger 41 is retracted. The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient. [0157]; Figure 17).
Piehl fails to explicitly teach the method for infusion a chemoablation agent, the treatment fluid associated with a chemotherapeutic agent.
Weadock discloses a method of infusing a chemoablation agent comprising pressurizing a treatment fluid associated with a chemotherapeutic agent (“The proximal end of a cannula having a lumen for a guidewire and at least one other lumen for a therapeutic agent is then coupled, via a luer-lock fitting, to a source of conventional chemotherapeutic agent…The chemotherapeutic agent is allowed, by way of the valve or luer-lock fitting between the cannula and source of chemotherapeutic agent, to be delivered to the tumor and surrounding tissues at a pre-determined rate. This rate may vary from 0.01 ml-10 ml per hour” [0077]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Piehl to include infusing a chemoablation agent, the treatment fluid associated with a chemotherapeutic agent based on the teachings of Weadock to treat tumors by delivering chemotherapy directly to the tumor site without necessitating systemic delivery of the chemotherapy drugs (Weadock [0008]).
Regarding claim 33, modified Piehl discloses the method according to Claim 26, further comprising: delivering the pressurized treatment fluid through a 22-gauge needle (“The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; Table 1 disclosing IV/IO access size of 22 G and 22 G Central Line [0217]) on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure ranging from approximately 6 ATMs to approximately 14 ATMs (Table 1 [0217] disclosing pressures of 21.1-110.6 PSI for a 22 G needle, equivalent to 1.4-7.5 ATM, overlapping the claimed range of 6-14 ATM) for a time period ranging from approximately 260 seconds to approximately 625 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003] wherein 260-625 seconds is within the disclosed range of 0-15 minutes), the pressurized treatment fluid comprising at least one or a combination of approximately 10 cm3 of treatment fluid (“A 10 ml syringe 48…can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169]).
Modified Piehl fails to explicitly teach the pressurized treatment fluid comprising at least one or a combination of gemcitabine and paclitaxel.
Weadock discloses a fluid delivery system (cannula 500) comprising a pressurized treatment fluid comprising at least one or a combination of gemcitabine and paclitaxel (“The proximal end of a cannula having a lumen for a guidewire and at least one other lumen for a therapeutic agent is then coupled, via a luer-lock fitting, to a source of conventional chemotherapeutic agent, e.g., selected from the group consisting of Gemcitabine (Gemzar®)…Paclitaxel (Taxol®)…The chemotherapeutic agent is allowed, by way of the valve or luer-lock fitting between the cannula and source of chemotherapeutic agent, to be delivered to the tumor and surrounding tissues at a pre-determined rate. This rate may vary from 0.01 ml-10 ml per hour” [0077]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Piehl to include the pressurized treatment fluid comprising at least one or a combination of gemcitabine and paclitaxel based on the teachings of Weadock to treat tumors by delivering chemotherapy directly to the tumor site without necessitating systemic delivery of the chemotherapy drugs (Weadock [0008]).
Regarding claim 43, modified Piehl discloses the method according to Claim 26.
Modified Piehl fails to explicitly disclose the pressurized treatment fluid is delivered to treat a renal neoplastic lesion, neoplastic hepatic cysts, tumors, or combinations thereof
Weadock teaches a method of infusing a chemoablation agent, wherein the pressurized treatment fluid is delivered to treat a renal neoplastic lesion, neoplastic hepatic cysts, tumors, or combinations thereof (“a novel method and system for delivering therapeutic agents to target tissue sites such as a tumor” [0009]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Piehl to include the pressurized treatment fluid is delivered to treat a tumors based on the teachings of Weadock to treat tumors by delivering chemotherapy directly to the tumor site without necessitating systemic delivery of the chemotherapy drugs (Weadock [0008]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Piehl et al. (US 20170319783) in view of Weadock et al. (US 20160074626) as applied in claim 26 above, and further in view of Dizerega et al. (US 20200261367).
Regarding claim 27, modified Piehl discloses the method according to Claim 26, further comprising: delivering the pressurized treatment fluid into a target through a needle on a distal end of one or more tubular members distally connected to the fluid delivery system (“To facilitate easier connections to the IV or IO needle, a set of adaptor tubing 109 may be used...The small bore tubing 109 may connect directly to a male luer 112, via another tubing pocket connection capable of withstanding high pressures. This male luer connection 112 can connect directly to an IV or IO placed into a patient.” [0171]; “The outlet 32 of the dual check valve 31 can allow high pressure fluid to exit the syringe 48 when the plunger 41 is forcibly depressed, and travel to the patient.” [0157]; Figure 17) at a predetermined fluid pressure ranging from approximately 4 ATMs to approximately 10 ATMs (“to limit the pressure at which fluid is delivered by the infusion device to below a defined pressure from 5.8 PSI to 325 PSI” [0206], wherein 5.8-325 PSI is 0.4-22.1 ATM and 4-10 ATM is within the disclosed range) for a time period ranging from approximately 32 seconds to approximately 93 seconds (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003] wherein 32-93 seconds is within the disclosed range of 0-15 minutes), the pressurized treatment fluid comprising at least one or a combination of approximately 10 cm3 of treatment fluid (“A 10 ml syringe 48…can be directly connected (e.g. pre-attached) to a dual check valve 31” [0169]).
Modified Piehl fails to explicitly teach delivering the pressurized treatment fluid into a center of a target pancreatic cystic tumor through a 19-gauge needle, and the pressurized treatment fluid comprising at least one or a combination of gemcitabine and paclitaxel.
Weadock discloses a fluid delivery system (needle 105 and cannula 500) comprising delivering a pressurized treatment fluid into a center of a target pancreatic tumor (“a target tissue 120 such as a tumor that may be present in an organ 125 such as a pancreas.” [0047]) through a 19-gauge needle (“The proximal end 140 of the needle 105 is seen to have a hub 155 for connecting to a source of therapeutic agent…The needle 105 is preferably 18-22 gauge” [0046]), the pressurized treatment fluid comprising at least one or a combination of gemcitabine and paclitaxel (“The proximal end of a cannula having a lumen for a guidewire and at least one other lumen for a therapeutic agent is then coupled, via a luer-lock fitting, to a source of conventional chemotherapeutic agent, e.g., selected from the group consisting of Gemcitabine (Gemzar®)…Paclitaxel (Taxol®)…The chemotherapeutic agent is allowed, by way of the valve or luer-lock fitting between the cannula and source of chemotherapeutic agent, to be delivered to the tumor and surrounding tissues at a pre-determined rate. This rate may vary from 0.01 ml-10 ml per hour” [0077]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Piehl to include delivering the pressurized treatment fluid into a center of a target pancreatic tumor through a 19-gauge needle, and the pressurized treatment fluid comprising at least one or a combination of gemcitabine and paclitaxel based on the teachings of Weadock to treat tumors by delivering chemotherapy directly to the tumor site without necessitating systemic delivery of the chemotherapy drugs (Weadock [0008]).
Modified Piehl fails to explicitly teach delivering the pressurized treatment fluid into a center of a target pancreatic cystic tumor.
Dizerega discloses a method of infusing a chemoablation agent comprising delivering a pressurized treatment fluid into a center of a target pancreatic cystic tumor (“a method of treating cancer in a subject, the method comprising: (a) administering a first composition comprising antineoplastic particles directly into a cyst of the subject by intracystic injection…the cyst is a malignant cyst...the cyst is a pancreatic cyst.” [0010], see also [0228-0231]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Piehl to include delivering the pressurized treatment fluid into a center of a target pancreatic cystic tumor based on the teachings of Dizerega to treat cancer by stopping tumor growth and metastasis (Dizerega [0010]).
Response to Arguments
Applicant's arguments filed July 07, 2026 have been fully considered but they are not persuasive.
Regarding the argument that Piehl does not disclose “an external pressure interface in fluid communication with the fluid chamber” (Remarks, page 8-9), the examiner respectfully disagrees. As detailed in the rejection of claim 1 above, Piehl discloses an external pressure interface (pressuring monitoring system 815) in fluid communication with the fluid chamber (syringe 48; “This pressure monitoring system 815 may allow a user to know the pressure being applied to the pressure monitoring system 815 at various points during infusion” [0215]). The claimed “external pressure interface” is considered to be the entirety of the pressure monitoring system 815, not only the load cell 800. The pressure monitoring system 815 as a whole is in fluid communication with syringe 48 due to the pressure monitoring system 815 direct engagement with the plunger 41, which is in direct engagement with the syringe 48 and any fluid inside of it. It is noted that the language of claim 1 does not require that the pressure sensor is direct fluid communication with the pressurized treatment fluid. It is also noted claim 1 requires that the external pressure interface is in fluid communication with the fluid chamber, which differs from amended claims 20 and 26 which require that a pressure sensor is in fluid communication with a pressurized treatment fluid (Claim 20) or a pneumatic assembly (Claim 26). Claims 20 and 26 are rejected in view of Piehl, the embodiment of Claim 9.
Regarding the argument that Piehl “does not disclose or suggest the durations recited in each of claims 9-18” (Remarks, page 9-10) or the durations recited in claims 27 and 33 (Remarks, page 12), the examiner respectfully disagrees. Piehl discloses that “PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” ([0003]), and then discloses a system 10 (with various embodiments) that is designed to at least meet these guidelines. Claims 9-18 each require that a pressurized treatment fluid is configured to be delivered at a predetermined pressure for a specific period of time (90, 76, 59, 42, 32, 625, 26, 196, 21, 156, 32-93, 260-625 seconds, respectively). Each of claims 9-18 has been interpreted the pressurized treatment fluid is configured to be delivered at a predetermined pressure for at least the specific period of time. The claim language as currently presented does not limit the pressurized treatment fluid to be configured to be delivered for only the specified period of time. Piehl discloses pressurized treatment fluid is configured to be delivered for at least 5 minutes, including 15 minutes. (“PALS calls for 20 ml per kilogram of body weight to be infused over 5 minutes, and up to 60 ml/kg in the first 15 minutes.” [0003]). If a pressurized treatment fluid is delivered for at least 5-15 minutes, the pressurized treatment fluid is delivered for the each of the claimed specific period of time (90, 76, 59, 42, 32, 625, 26, 196, 21, 156, 32-93, 260-625 seconds, respectively), continuing to be delivered after the claimed specific period of time.
Regarding the argument that “neither Piehl not Weadock disclose or suggest pressurizing gemcitabine and paclitaxel” as required by claim 21 (Remarks, page 12), the examiner respectfully disagrees. As detailed above, Piehl discloses a fluid delivery system (10) comprising a pressurized treatment fluid (at least [0155]), but does not explicitly disclose the pressurized treatment fluid comprises gemcitabine, paclitaxel, or combinations thereof. Weadock discloses a fluid delivery system (500) comprising a pressurized treatment fluid comprising gemcitabine, paclitaxel, or combinations thereof ([0077]). Weadock discloses that gemcitabine and/or paclitaxel are delivered from a source through a fluid delivery system at a specific rate, which requires a force or pressurization. Both Piehl and Weadock disclose delivery of a pressurized treatment fluid, and one having ordinary skill in the art would have found it obvious to modify the system of Piehl to include the pressurized treatment fluid comprises gemcitabine, paclitaxel, or combinations thereof based on the teachings of Weadock to treat tumors by delivering chemotherapy directly to the tumor site without necessitating systemic delivery of the chemotherapy drugs (Weadock [0008]).
Applicant’s arguments with respect to amended independent claims 20 and 26 (Remarks, page 11-12) 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. Independent Claims 20 and 26 are rejected in view of Piehl, the embodiment of Claim 9 as detailed above.
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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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