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 § 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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen et al. (US Patent No. 11,244,745 B2, herein Kamen (A)) in view of Jacobson et al. (US Patent No. 11,135,360 B1, herein Jacobson) and Kamen et al. (US Patent No. 11,227,687 B2, herein Kamen (B)).
Regarding claim 1, Kamen (A) in view of Jacobson and Kamen (B) discloses a system (Kamen (A), 1, Fig. 1) comprising:
a syringe pump (Kamen (A), “The medical device 26 may be … syringe pumps… “– Col. 35 Line 37, Fig. 1) comprising a receptable for receiving a syringe (Kamen (A), “… install a syringe on a medical device…”, “syringe barrel clamp” – Para [963);
one or more sensors configured to generate sensor data pertaining to the syringe within the receptable of the syringe pump (Kamen (A), “The device may make the determination that a syringe is not present in any number of suitable ways. This determination may be based data generated by one or more sensor on the device.” – Col. 174 Line 24); and
one or more processors configured to execute instructions and perform operations (Kamen (A), “FIG. 7 illustrates a software program that is executable on a processor…” – Col. 20 Line 8), comprising:
receiving, based on the sensor data, an indication of a new syringe being loaded into the syringe pump (Kamen (A), Device determines if a syringe has been installed 2500, Fig. 182);
determining, after receiving the indication based on electronically stored information associated with the syringe pump, that the syringe pump is currently associated with a first fluid delivery order (Kamen (A), User Programs and Begins An Infusion 2840, Fig. 193) for a predetermined amount of a first fluid, and that at least a first portion of the first fluid was previously delivered by the syringe pump according to the first fluid delivery order (Kamen (A), Device Delivers Infusion 2842, Fig. 193) before the new syringe was loaded into the syringe pump (Kamen (A), User Replaces Syringe 2876, Fig. 193);
the second portion of the first fluid being in a downstream IV line (Kamen (A), Device flushed the line 2874, Fig. 193).
electronically indicating the first fluid delivery order as being complete (Kamen (A), User discontinues parent infusion 2736, Fig. 189),
de-associating the first fluid delivery order from the syringe pump (Kamen (A), Parent infusion is canceled 2742, Fig. 189);
associating the syringe pump with the second fluid delivery order Kamen (A), Device Starts Secondary 2762, Fig. 190);
generating a start condition for the second delivery order (Kamen (A), Device notifies user and progresses to next programmed step 2826, Fig. 191), wherein the start condition for the second fluid delivery order is not generated until only after the first fluid delivery order is determined to be complete by way of the second remaining portion having been purged from the downstream IV line (Kamen (A), Device checks for defined step complete behavior 2824, Fig. 191);
Kamen does not expressly disclose determining a second portion of the first fluid remaining to be delivered to complete the predetermined amount of the first fluid for the first fluid delivery order, initiating delivery of a second fluid from the new syringe by the syringe pump according to a second fluid delivery order; wherein the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump, when an amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered, wherein the start condition for the second fluid delivery order is not generated until only after the first fluid delivery order is determined to be complete by way of the second remaining portion having been purged from the downstream IV line and continuing delivery of the second fluid from the new syringe, and wherein the indicating of the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor.
Jacobson teaches determining a second portion of the first fluid remaining to be delivered to complete the predetermined amount of the first fluid for the first fluid delivery order (“At block 591, the method 581 monitors the volume of second fluid driven at the first infusion rate and determines when the monitored volume equals or exceeds the common line flush volume.” – Col. 20, Line 66) initiating delivery of a second fluid (second fluid 122, Fig. 1A) from the new syringe (second reservoir 120, Fig. 1A) by the syringe pump according to a second fluid delivery order (589, Fig. 5C) (Pause primary infusion and drive a second fluid at the first infusion rate 589, “At block 589, the method 581 stops drawing fluid from the first reservoir (pauses the primary infusion), and instead only draws fluid from the second reservoir” – Col. 20 Line 53 when an amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered (Volume of the driven second fluid equal to the common line flush volume 591, Fig. 5C) continuing delivery of the second fluid from the new syringe (“The method 581 drives the second fluid to the common line at the first infusion rate in order to auto flush.” – Col. Line 54 wherein the indicating of the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor (“At block 589, the method 581 stops drawing fluid from the first reservoir (pauses the primary infusion), and instead only draws fluid from the second reservoir.” – Col. 20 Line 53).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen to include that determining a second portion of the first fluid remaining to be delivered to complete the predetermined amount of the first fluid for the first fluid delivery order, initiating delivery of a second fluid from the new syringe by the syringe pump according to a second fluid delivery order; when an amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered, wherein the start condition for the second fluid delivery order is not generated until only after the first fluid delivery order is determined to be complete by way of the second remaining portion having been purged from the downstream IV line and continuing delivery of the second fluid from the new syringe, and wherein the indicating of the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor as taught by Jacobson for “safely performing a sequential infusion…” (Jacobson, Para [61]).
Examiner interprets the first fluid that is being flushed to be in a downstream IV line in order to be flushed.
Examiner interprets the pausing/de-associating of the first fluid delivery order and the delivery/association of the second fluid delivery order occurring within the same step (block 589) as occurring without stopping the motor as taught by Kamen.
Kamen (A) in view of Jacobson does not expressly disclose that the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump.
Kamen (B) teaches that the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump (Kamen (B), “The syringe infusion pump 6 may be any pump driven by a motor…” – Para [29]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) in view of Jacobson to include that the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump as taught by Kamen (B) to “treat an acute or chronic ailment.” (Kamen (B), Para [2]).
Claim(s) 2-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen et al. (US Patent No. 11,244,745 B2, herein Kamen (A)) in view of Jacobson et al. (US Patent No. 11,135,360 B1, herein Jacobson) and Kamen et al. (US Patent No. 11,227,687 B2, herein Kamen (B)) and in further view of Biasi et al. (EP 3965112 A1, herein Biasi).
Regarding claim 2, Kamen (A) in view of Jacobson, Kamen (B) and Biasi discloses a system (Kamen (A), 1, Fig. 1) as recited above, the operations further comprising:
Kamen (A) in view of Jacobson and Kamen (B) does not expressly disclose receiving, before the new syringe is loaded into the syringe pump, an indication of a first syringe loaded in the syringe pump being emptied; generate, based on receiving the indication of the first syringe being emptied, an empty condition for the first fluid delivery order; generating a restart condition for the first fluid delivery order contemporaneously with initiating the delivery of the second fluid according to the second fluid delivery order; and generating a start condition for the second fluid delivery order contemporaneously with associating the syringe pump with the second fluid delivery order to continue delivery of the second fluid from the new syringe.
Biasi teaches receiving, before the new syringe is loaded into the syringe pump (“The medical devices 26 may be… syringe pumps…” – Para [0060], User replaces syringe 2876, Fig. 193), an indication of a first syringe loaded in the syringe pump being emptied (Device alerts to indicate infusion near end 2844, Fig, 193);
generate, based on receiving the indication of the first syringe (the syringe from block 2840) being emptied, an empty condition for the first fluid delivery order (2842, Fig. 193) (“… the device may alert to indicate that the infusion is near end.”, “In some embodiments, the infusion near end alert may be triggered when a defined volume remains for the infusion”, Fig. 193);
generating a restart condition (Device populates infusion parameters from previous infusion 3228, Fig. 202) for the first fluid delivery order (previous infusion from block 3228, Fig. 202) contemporaneously with initiating the delivery of the second fluid (fluid in the replacement syringe from block 3226, Fig. 202) according to the second fluid delivery order (User confirms parameters and commands restart of infusion 3230, Fig. 202);
and generating a start condition (Device checks syringe against DAL file 3230, Fig. 202) for the second fluid delivery order (3230, Fig. 202) contemporaneously with associating the syringe pump with the second fluid delivery order to continue delivery of the second fluid from the new syringe (replacement syringe from block 3226, Fig. 202) (Deliver at infusion rate 3244, Fig. 202).
Examiner interprets the start condition for the second fluid delivery order to be the event that triggers the second fluid delivery order. In Biasi, the device checking the syringe against the DAL file is the event that then triggers the delivery of the second fluid according to the second fluid delivery order. Examiner interprets the initiation of the second delivery order to deliver the second fluid from the replacement syringe as necessitating the association of the syringe pump with the second fluid delivery order.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) in view of Jacobson and Kamen (B) to include the operations further comprising: receiving, before the new syringe is loaded into the syringe pump, an indication of a first syringe loaded in the syringe pump being emptied; generate, based on receiving the indication of the first syringe being emptied, an empty condition for the first fluid delivery order; generating a restart condition for the first fluid delivery order contemporaneously with initiating the delivery of the second fluid according to the second fluid delivery order; and generating a start condition for the second fluid delivery order contemporaneously with associating the syringe pump with the second fluid delivery order to continue delivery of the second fluid from the new syringe as taught by Biasi to “install a replacement syringe on a medical device during the course of an infusion…” (Biasi, Para [0058]).
Regarding claim 3, Kamen (A) in view of Jacobson, Kamen (B) and Biasi discloses a system (Kamen (A), 1, Fig. 1) as recited above.
Kamen (A) does not expressly disclose delivery of the first fluid and the second fluid is measured in volumetric units, the operations further comprising: continuously measuring, for the first fluid delivery order, a total volume of the first fluid over a delivery of a portion of the first fluid from the first syringe before the empty condition is generated and through the delivery of the second fluid from the new syringe until the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered; confirming that the measured total volume of the first fluid was delivered according to the first fluid delivery order; and providing the total volume for display on a display device.
Jacobson teaches that delivery of the first fluid (first fluid 112, Fig. 1A) and the second fluid (second fluid 122, Fig. 1A) is measured in volumetric units (mL/hr, Fig. 3), the operations further comprising:
continuously measuring, for the first fluid delivery order (585, Fig. 5C), a total volume of the first fluid over a delivery of a portion of the first fluid from the first syringe (first reservoir 110, Fig. 1A) before the empty condition is generated (“At block 590, the method 580 is configured to monitor volume of the first fluid driven at the combined rate and determine when the monitored volume equals or exceeds the common line flush volume” – Col. 19, Line 56) and through the delivery of the second fluid from the new syringe (second reservoir 120, Fig. 1A) until the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered (“At block 591, the method 581 monitors the volume of second fluid driven at the first infusion rate and determines when the monitored volume equals or exceeds the common line flush volume. If the monitored volume is equal to or exceeds the common line flush volume, the method 581 proceeds to block 593.” – Col. 20 Line 66)
confirming that the measured total volume of the first fluid was delivered according to the first fluid delivery order (“… the method 581 may determine that … a desired volume of fluid has been infused…”, “The method 581 can thus accurately track the rate, time, and an amount of each fluid delivered to the patient.” – Col. 21 Line 15); and providing the total volume for display on a display device (“The first fluid displayed volume and/or the second fluid displayed volume can be displayed on a user interface 236.” – Col. 14 Line 1)
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) to delivery of the first fluid and the second fluid is measured in volumetric units, the operations further comprising: continuously measuring, for the first fluid delivery order, a total volume of the first fluid over a delivery of a portion of the first fluid from the first syringe before the empty condition is generated and through the delivery of the second fluid from the new syringe until the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered; confirming that the measured total volume of the first fluid was delivered according to the first fluid delivery order; and providing the total volume for display on a display device as taught by Jacobson to “accurately track the rate, time, and an amount of each fluid delivered to the patient.” (Jacobson, Para [66]).
Regarding claim 4, Kamen (A) in view of Jacobson, Kamen (B), and Biasi discloses a system (Kamen (A), 1, Fig. 1) as recited above.
Kamen (A) does not expressly disclose the first fluid is a medication and the second fluid is a non-medicinal flush infusate, the operations further comprising: causing the syringe pump to deliver a portion of the first fluid from the first syringe until the indication of the first syringe being emptied is received; pausing the first fluid delivery order before the delivery of the second fluid is initiated, wherein, when the first syringe is emptied and the delivery of the second fluid is initiated, the second portion of the first fluid remaining to be delivered is residing in an infusion line connected to the syringe pump but not delivered to a patient; and causing, responsive to initiating delivery of the second fluid, the syringe pump to deliver the portion of first fluid from the infusion line by way of pushing the portion of the first fluid through the infusion line with the second fluid.
Jacobson teaches that the first fluid is a medication (“… the first fluid is a medicinal fluid…” – Col. Line 34) and the second fluid (second fluid 122, Fig. 1A) is a non-medicinal flush infusate (“Fluid as used herein can be any fluid suitable to be administered to a patient by infusion, including saline fluid…” – Col. 8 Line 43), the operations further comprising:
causing the syringe pump to deliver a portion of the first fluid from the first syringe (first reservoir 110, Drive a first fluid from a first reservoir at a first infusion rate 585, Fig. 1A and 5C) until the indication of the first syringe being emptied is received (“At block 587, the method 581 determines whether to pause the first infusion and initiate a “piggyback’ infusion…” – Col. 20 Line 46);
pausing the first fluid delivery order (585, Fig. 5C) before the delivery of the second fluid is initiated (Pause primary infusion and drive a second fluid 589, Fig. 5C), wherein, when the first syringe is emptied (“… the method 581 may determine… that a desired volume of fluid has been infused…” – Col. 21 Line 33) and the delivery of the second fluid is initiated, the second portion of the first fluid remaining to be delivered is residing in an infusion line (common line 140, Fig. 1A) connected to the syringe pump (infusion pump 130, Fig. 1A) but not delivered to a patient (“…the volume of the common line of the first fluid remaining in the common line.” – Col. 20 Line 55);
and causing, responsive to initiating delivery of the second fluid (589, fig. 5C), the syringe pump to deliver the portion of first fluid from the infusion line by way of pushing the portion of the first fluid through the infusion line with the second fluid (“The method 581 drives the second fluid to the common line at the first infusion rate in order to auto flush or clear the volume of the common line of the first fluid remaining in the common line” – Col. 20 Line 54).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) to include that the first fluid is a medication and the second fluid is a non-medicinal flush infusate, the operations further comprising: causing the syringe pump to deliver a portion of the first fluid from the first syringe until the indication of the first syringe being emptied is received; pausing the first fluid delivery order before the delivery of the second fluid is initiated, wherein, when the first syringe is emptied and the delivery of the second fluid is initiated, the second portion of the first fluid remaining to be delivered is residing in an infusion line connected to the syringe pump but not delivered to a patient; and causing, responsive to initiating delivery of the second fluid, the syringe pump to deliver the portion of first fluid from the infusion line by way of pushing the portion of the first fluid through the infusion line with the second fluid as taught by Jacobson to provide “concurrent infusion with common line auto flush.” (Jacobson, Abstract).
Regarding claim 5, Kamen (A) in view of Jacobson, Kamen (B), and Biasi discloses a system (Kamen (A), 1, Fig. 1) as recited above.
Kamen (A) does not expressly disclose receiving, from a remote computing system, an automated programming command to configure the syringe pump to deliver the non-medicinal flush infusate according to the second fluid delivery order; and responsive to receiving the automated programming command, without user intervention: disabling a syringe empty alarm currently set to be provided when the first syringe loaded in the syringe pump is emptied; and automatically programming the syringe pump to initiate the delivery of the second fluid from the new syringe by the syringe pump according to the second fluid delivery order.
Jacobson teaches receiving, from a remote computing system, an automated programming command (Jacobson, “The infusion pump 130 can be operable to receive the common line flush volume value for the common line 140 automatically from the drug library stored in a memory locally in the infusion pump system 100 or remotely on a server.” – Col. 11 Line 27, “A drug library may include an indication (e.g. flag, value, etc.) to enable or disable infusion until reservoir depletion functionality, as described with respect to Fig. 5B.” – Col. 16 Line 50) to configure the syringe pump (Jacobson, infusion pump 130, Fig. 1A) to deliver the non-medicinal flush infusate (Jacobson, second fluid 122, Fig. 1A) according to the second fluid delivery order (Jacobson, 589, Fig. 5C);
and automatically programming the syringe pump to initiate the delivery of the second fluid (Jacobson, “The method 581 determines whether to pause the first infusion and initiate a “piggyback” infusion, or infusion of a second fluid…” – Col. 20 Line 46) from the new syringe (Jacobson, second reservoir 120, Fig. 1A) by the syringe pump (Jacobson, infusion pump 130, Fig. 1A) according to the second fluid delivery order (Jacobson, 589, Fig. 5C) (Jacobson, “If the monitored volume is equal to or exceeds the common line flush volume, the method 581 proceeds to block 593.” – Col. 21 Line 6; Drive the second fluid at the second infusion rate 593, Fig. 5C).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) to include receiving, from a remote computing system, an automated programming command to configure the syringe pump to deliver the non-medicinal flush infusate according to the second fluid delivery order; and responsive to receiving the automated programming command, without user intervention: disabling a syringe empty alarm currently set to be provided when the first syringe loaded in the syringe pump is emptied; and automatically programming the syringe pump to initiate the delivery of the second fluid from the new syringe by the syringe pump according to the second fluid delivery order as taught by Jacobson to provide “common line auto flush” (Jacobson, Abstract).
Jacobson does not expressly disclose that responsive to receiving the automated programming command, without user intervention: disabling a syringe empty alarm currently set to be provided when the first syringe loaded in the syringe pump is emptied.
Biasi teaches that responsive to receiving the automated programming command, without user intervention: disabling a syringe empty alarm (“The device may resolve the alert or alarm…” – Para [0801], Fig. 193) currently set to be provided when the first syringe loaded in the syringe pump is emptied (Device alarms and stops the infusion 2858, Fig. 193) (“In some embodiments, the infusion near end alert may be triggered when a defined volume remains for the infusion.” – Para [0796]);
Examiner interprets the device resolving the alarm as an automated action completed by the device according to its programmed command without user intervention.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen in view of Jacobson to include that responsive to receiving the automated programming command, without user intervention: disabling a syringe empty alarm currently set to be provided when the first syringe loaded in the syringe pump is emptied as taught by Biasi to “…flush an IV line from a medical device which is a syringe pump.” (Biasi, Para [0838]).
Regarding claim 6, Kamen (A) in view of Jacobson, Kamen (B), and Biasi discloses a system (Kamen (A), 1, Fig. 1) as recited above.
Kamen (A) in view of Kamen (B) does not expressly disclose automatically programming the syringe pump to initiate the delivery of the first fluid from the first syringe by the syringe pump according to the first fluid delivery order; prompt, when the first syringe is emptied, a user to unload the first syringe and to load the new syringe; and automatically stop delivery of the second fluid when the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered
Jacobson teaches automatically programming the syringe pump (“The flow controller 235 is operable to execute the programming code…” – Col. 13 Line 19, “The method 581 can be programed by a flow controller (e.g., flow controller 235)…” – Col. 20 Line 28) to initiate the delivery of the first fluid (first fluid 112, Fig. 1A) from the first syringe (first reservoir 110, Fig. 1A) by the syringe pump (infusion pump 130, Fig. 1A) according to the first fluid delivery order (Drive a first fluid from a first reservoir at a first infusion rate 585, Fig. 5C);
and automatically stop delivery of the second fluid (second fluid 122, Fig. 1A) when the amount of the second fluid delivered from the new syringe (second reservoir 120, Fig. 1A) satisfies the second portion of the first fluid remaining to be delivered (Volume of the driven second fluid equal to the common line flush volume 591, “At block 595, the method 581 determines whether the piggyback infusion is complete. For example, the method 581 may determine that the second reservoir is depleted of fluid that a desired volume has been infused…” – Col. 21 Line 31, Fig. 5C).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) to include disclose automatically programming the syringe pump to initiate the delivery of the first fluid from the first syringe by the syringe pump according to the first fluid delivery order; prompt, when the first syringe is emptied, a user to unload the first syringe and to load the new syringe; and automatically stop delivery of the second fluid when the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered as taught by Jacobson for “safe and accurate administration of fluids and medications.” (Jacobson, Para [3]).
Jacobson does not expressly disclose to prompt, when the first syringe is emptied, a user to unload the first syringe and to load the new syringe
Biasi teaches to prompt, when the first syringe is emptied (Device alerts to indicate infusion near end 2844, Fig. 193), a user to unload the first syringe and to load the new syringe (“The device displays instructions for installing the replacement syringe in step 3222.” – Para [0838]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) in view of Jacobson to prompt, when the first syringe is emptied, a user to unload the first syringe and to load the new syringe as taught by Biasi “for flushing the IV line associated with a medical device.” (Biasi, Para [0838]).
Regarding claim 7, Kamen (A) in view of Jacobson, Kamen (B), and Biasi discloses a system (Kamen (A), 1, Fig. 1) as recited above, the operations further comprising;
Kamen (A) does not expressly disclose causing the syringe pump to deliver the second fluid by driving a motor of the syringe pump responsive to initiating delivery of the second fluid from the syringe; and causing the syringe pump to continue delivery of the second fluid from the new syringe, wherein indicating the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor
Jacobson teaches causing the syringe pump (infusion pump 130, Fig. 1A) to deliver the second fluid (second fluid 122, Fig. 1A) responsive to initiating delivery of the second fluid from the syringe (“If the method 581 determines that the second fluid program should be initiated, the method 581 proceeds to block 589.” – Col. 20, Line 48);
and causing the syringe pump to continue delivery of the second fluid from the new syringe (Pause primary infusion and drive a second fluid at the first infusion rate (589), Fig. 5C), wherein indicating the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order (“At block 589, the method 581 stops drawing fluid from the first reservoir (pauses the primary infusion), and instead only draws fluid from the second reservoir.” – Col. 20 Line 52), and continuing delivery of the second fluid is performed (“The method 581 drives the second fluid to the common line at the first infusion rate in order to auto flush.” – Col. 20 Line 54).
Examiner interprets the pausing/de-associating of the first fluid delivery order and the delivery/association of the second fluid delivery order occurring within the same step (block 589) as occurring without stopping the motor as taught by Kamen.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) to include causing the syringe pump to deliver the second fluid responsive to initiating delivery of the second fluid from the syringe; and causing the syringe pump to continue delivery of the second fluid from the new syringe, wherein indicating the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor as taught by Jacobson to “flush the common line” (Jacobson, Para [47]).
Jacobson does not expressly disclose driving a motor of the syringe pump.
Kamen (B) teaches driving a motor of the syringe pump (‘The syringe infusion pump 6 may be any pump driven by a motor…” – Para [29]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) in view of Jacobson to include driving a motor of the syringe pump as taught by Kamen (B) to “treat an acute or chronic ailment.” (Kamen (B), Para [2]).
Regarding claim 8, Kamen (A) in view of Jacobson, Kamen (B), and Biasi discloses a system (Kamen (A), 1, Fig. 1) as recited above
Kamen (A) does not disclose indicating the first fluid delivery order as being complete comprises: associating a type of the second fluid and a flush complete event with the first fluid delivery order.
Jacobson teaches that indicating the first fluid delivery order (585, Fig. 5C) as being complete comprises:
associating a type of the second fluid (“If the method 581 determines that the second fluid program should be initiated, the method 581 proceeds to block 589.” – Col. 20 Line 48) and a flush complete event (“At block 587, the method 581 determines whether to pause the first infusion and initiate a “piggyback” infusion…” – Col. 20 Line 46) with the first fluid delivery order (585, Fig. 5C).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) to include that indicating the first fluid delivery order as being complete comprises: associating a type of the second fluid and a flush complete event with the first fluid delivery order as taught by Jacobson to “auto flush or clear the volume of the common line of the first fluid remaining in the common line.” (Jacobson, Para [63]).
Regarding claim 9, Kamen (A) in view of Jacobson, Kamen (B), and Biasi discloses a system (Kamen (A), 1, Fig. 1) as recited above
Kamen (A) does not expressly disclose receiving, based on the generated sensor data, an indication of the new syringe being emptied; and providing an indication that the second fluid delivery order is complete when the indication of the new syringe being emptied is received.
Jacobson teaches receiving, based on the generated sensor data, an indication of the new syringe (second reservoir 122, Fig. 1A) being emptied (“… the method 581 may determine that the second reservoir is depleted of fluid…” – Para [66], “Determining that the second reservoir is depleted may include receiving a sensor signal…” – Col. 21 Line 34);
and providing an indication that the second fluid delivery order is complete when the indication of the new syringe being emptied is received (“At block 595, the method 581 determines whether the piggyback infusion is complete. For example, the method 581 may determine that the second reservoir is depleted of fluid.” – Col. 21 Line 31).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) to include that receiving, based on the generated sensor data, an indication of the new syringe being emptied; and providing an indication that the second fluid delivery order is complete when the indication of the new syringe being emptied is received as taught by Jacobson to “determine that an infusion of the second fluid has been completed…” (Jacobson, Para [11]).
Regarding claim 10, Kamen (A) in view of Jacobson, Kamen (B), and Biasi discloses a system (Kamen (A), 1, Fig. 1) as recited above
Kamen (A) does not expressly disclose that when the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered, automatically, without user intervention: prompting a user for a confirmation to continue delivery of the second fluid from the new syringe; and continuing delivery of the second fluid from the new syringe responsive to receiving the confirmation
Jacobson teaches that when the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered (Volume of the driven second fluid equal to the common line flush volume (591, Fig. 5C)),
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen to include that when the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered as taught by Jacobson to ““auto flush or clear the volume of the common line of the first fluid remaining in the common line.” (Jacobson, Para [63]).
Jacobson does not expressly disclose automatically, without user intervention: prompting a user for a confirmation to continue delivery of the second fluid from the new syringe; and continuing delivery of the second fluid from the new syringe responsive to receiving the confirmation.
Biasi teaches automatically, without user intervention: prompting a user for confirmation to continue delivery of the second fluid from the new syringe (Device displays setup help and prompts user to start secondary 2756, Fig. 190)
and continuing delivery of the second fluid from the new syringe responsive to receiving the confirmation (User indicates they would like to begin administration of the secondary infusion 2760, Device starts secondary 2762, Fig. 190).
Examiner interprets the new syringe claimed above as the same new syringe disclosed by Biasi in Figure 202.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen to include automatically, without user intervention: prompting a user for a confirmation to continue delivery of the second fluid from the new syringe; and continuing delivery of the second fluid from the new syringe responsive to receiving the confirmation as taught by Biasi to “deliver a secondary infusion.” (Biasi, Para [0779]).
Regarding claim 11, Kamen (A) in view of Jacobson, Kamen (B), and Biasi disclose a method (Kamen (A), Fig. 191) performed by a machine, comprising:
receiving, from one or more sensors associated with a syringe pump, an indication of a new syringe being loaded into the syringe pump (Kamen (A),“The device may make the determination that a syringe is not present in any number of suitable ways. This determination may be based data generated by one or more sensor on the device.” – Col. 174 Line 24);
determining, after receiving the indication based on electronically stored information associated with the syringe pump, that the syringe pump is currently associated with a first fluid delivery order (Kamen (A), User Programs and Begins An Infusion 2840, Fig. 193) for a predetermined amount of a first fluid, and that at least a first portion of the first fluid was previously delivered by the syringe pump according to the first fluid delivery order (Kamen (A), Device Delivers Infusion 2842, Fig. 193) before the new syringe was loaded into the syringe pump (Kamen (A), User Replaces Syringe 2876, Fig. 193);
the second portion of the first fluid being in a downstream IV line (Kamen (A), Device flushed the line 2874, Fig. 193).
electronically indicating the first fluid delivery order as being complete (Kamen (A), User discontinues parent infusion 2736, Fig. 189),
de-associating the first fluid delivery order from the syringe pump (Kamen (A), Parent infusion is canceled 2742, Fig. 189);
associating the syringe pump with the second fluid delivery order Kamen (A), Device Starts Secondary 2762, Fig. 190);
generating a start condition for the second delivery order (Kamen (A), Device notifies user and progresses to next programmed step 2826, Fig. 191), wherein the start condition for the second fluid delivery order is not generated until only after the first fluid delivery order is determined to be complete by way of the second remaining portion having been purged from the downstream IV line (Kamen (A), Device checks for defined step complete behavior 2824, Fig. 191);
Kamen (A) does not expressly disclose determining a second portion of the first fluid remaining to be delivered to complete the predetermined amount of the first fluid for the first fluid delivery order, initiating delivery of a second fluid from the new syringe by the syringe pump according to a second fluid delivery order; wherein the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump, when an amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered, wherein the start condition for the second fluid delivery order is not generated until only after the first fluid delivery order is determined to be complete by way of the second remaining portion having been purged from the downstream IV line and continuing delivery of the second fluid from the new syringe, and wherein the indicating of the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor.
Jacobson teaches determining a second portion of the first fluid remaining to be delivered to complete the predetermined amount of the first fluid for the first fluid delivery order (“At block 591, the method 581 monitors the volume of second fluid driven at the first infusion rate and determines when the monitored volume equals or exceeds the common line flush volume.” – Col. 20 Line 66), initiating delivery of a second fluid (second fluid 122, Fig. 1A) from the new syringe (second reservoir 120, Fig. 1A) by the syringe pump according to a second fluid delivery order (589, Fig. 5C) (Pause primary infusion and drive a second fluid at the first infusion rate 589, “At block 589, the method 581 stops drawing fluid from the first reservoir (pauses the primary infusion), and instead only draws fluid from the second reservoir” – Col. 20 Line 52) when an amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered (Volume of the driven second fluid equal to the common line flush volume 591, Fig. 5C) continuing delivery of the second fluid from the new syringe (“The method 581 drives the second fluid to the common line at the first infusion rate in order to auto flush.” – Col. 20 Line 54), wherein the indicating of the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor (“At block 589, the method 581 stops drawing fluid from the first reservoir (pauses the primary infusion), and instead only draws fluid from the second reservoir.” – Col. 20 Line 52).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) to include that determining a second portion of the first fluid remaining to be delivered to complete the predetermined amount of the first fluid for the first fluid delivery order, initiating delivery of a second fluid from the new syringe by the syringe pump according to a second fluid delivery order; when an amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered, wherein the start condition for the second fluid delivery order is not generated until only after the first fluid delivery order is determined to be complete by way of the second remaining portion having been purged from the downstream IV line and continuing delivery of the second fluid from the new syringe, and wherein the indicating of the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor as taught by Jacobson for “safely performing a sequential infusion…” (Jacobson, Para [61]).
Examiner interprets the first fluid that is being flushed to be in a downstream IV line in order to be flushed.
Examiner interprets the pausing/de-associating of the first fluid delivery order and the delivery/association of the second fluid delivery order occurring within the same step (block 589) as occurring without stopping the motor as taught by Kamen.
Kamen (A) in view of Jacobson does not expressly disclose that the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump.
Kamen (B) teaches that the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump (Kamen (B), “The syringe infusion pump 6 may be any pump driven by a motor…” – Para [29]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) in view of Jacobson to include that the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump as taught by Kamen (B) to “treat an acute or chronic ailment.” (Kamen (B), Para [2]).
Regarding claim 12, Kamen (A) in view of Jacobson, Kamen (B), and Biasi disclose the method (Kamen (A), Fig. 191) recited above, further comprising:
Kamen (A) in view of Jacobson and Kamen (B) does not expressly disclose receiving, before the new syringe is loaded into the syringe pump, an indication of a first syringe loaded in the syringe pump being emptied; generate, based on receiving the indication of the first syringe being emptied, an empty condition for the first fluid delivery order; generating a restart condition for the first fluid delivery order contemporaneously with initiating the delivery of the second fluid according to the second fluid delivery order; and generating a start condition for the second fluid delivery order contemporaneously with associating the syringe pump with the second fluid delivery order to continue delivery of the second fluid from the new syringe.
Biasi teaches receiving, before the new syringe is loaded into the syringe pump (“The medical devices 26 may be… syringe pumps…” – Para [0060], User replaces syringe 2876, Fig. 193), an indication of a first syringe loaded in the syringe pump being emptied (Device alerts to indicate infusion near end 2844, Fig, 193);
generate, based on receiving the indication of the first syringe (the syringe from block 2840) being emptied, an empty condition for the first fluid delivery order (2842, Fig. 193) (“… the device may alert to indicate that the infusion is near end.”, “In some embodiments, the infusion near end alert may be triggered when a defined volume remains for the infusion”, Fig. 193);
generating a restart condition (Device populates infusion parameters from previous infusion 3228, Fig. 202) for the first fluid delivery order (previous infusion from block 3228, Fig. 202) contemporaneously with initiating the delivery of the second fluid (fluid in the replacement syringe from block 3226, Fig. 202) according to the second fluid delivery order (User confirms parameters and commands restart of infusion 3230, Fig. 202); and
generating a start condition (Device checks syringe against DAL file 3230, Fig. 202) for the second fluid delivery order (3230, Fig. 202) contemporaneously with associating the syringe pump with the second fluid delivery order to continue delivery of the second fluid from the new syringe (replacement syringe from block 3226, Fig. 202) (Deliver at infusion rate 3244, Fig. 202).
Examiner interprets the start condition for the second fluid delivery order to be the event that triggers the second fluid delivery order. In Biasi, the device checking the syringe against the DAL file is the event that then triggers the delivery of the second fluid according to the second fluid delivery order. Examiner interprets the initiation of the second delivery order to deliver the second fluid from the replacement syringe as necessitating the association of the syringe pump with the second fluid delivery order.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) to include the operations further comprising: receiving, before the new syringe is loaded into the syringe pump, an indication of a first syringe loaded in the syringe pump being emptied; generate, based on receiving the indication of the first syringe being emptied, an empty condition for the first fluid delivery order; generating a restart condition for the first fluid delivery order contemporaneously with initiating the delivery of the second fluid according to the second fluid delivery order; and generating a start condition for the second fluid delivery order contemporaneously with associating the syringe pump with the second fluid delivery order to continue delivery of the second fluid from the new syringe as taught by Biasi to “install a replacement syringe on a medical device during the course of an infusion…” (Biasi, Para [0058]).
Regarding claim 13, Kamen (A) in view of Jacobson, Kamen (B), and Biasi disclose the method (Kamen (A), Fig. 191) as recited above, wherein
Kamen (A) does not expressly disclose that delivery of the first fluid and the second fluid is measured in volumetric units, the method further comprising: continuously measuring, for the first fluid delivery order, a total volume of the first fluid over a delivery of the first fluid from the first syringe before the empty condition is generated and through the delivery of the second fluid from the new syringe until the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered; confirming that the measured total volume of the first fluid was delivered according to the first fluid delivery order; and providing the total volume for display on a display device.
Jacobson teaches that delivery of the first fluid (first fluid 112, Fig. 1A) and the second fluid (second fluid 122, Fig. 1A) is measured in volumetric units (mL/hr, Fig. 3), the method further comprising:
continuously measuring, for the first fluid delivery order (585, Fig. 5C), a total volume of the first fluid over a delivery of a portion of the first fluid from the first syringe (first reservoir 110, Fig. 1A) before the empty condition is generated ( “At block 590, the method 580 is configured to monitor volume of the first fluid driven at the combined rate and determine when the monitored volume equals or exceeds the common line flush volume” – Col 19 Line 56) and through the delivery of the second fluid from the new syringe (second reservoir 120, Fig. 1A) until the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered ( “At block 591, the method 581 monitors the volume of second fluid driven at the first infusion rate and determines when the monitored volume equals or exceeds the common line flush volume. If the monitored volume is equal to or exceeds the common line flush volume, the method 581 proceeds to block 593.” – Col. 20 Line 66);
confirming that the measured total volume of the first fluid was delivered according to the first fluid delivery order ( “… the method 581 may determine that … a desired volume of fluid has been infused…”, “The method 581 can thus accurately track the rate, time, and an amount of each fluid delivered to the patient.” – Col. 20 Line 15); and providing the total volume for display on a display device ( “The first fluid displayed volume and/or the second fluid displayed volume can be displayed on a user interface 236.” – Col. 14 Line 1).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) to include that delivery of the first fluid and the second fluid is measured in volumetric units, the method further comprising: continuously measuring, for the first fluid delivery order, a total volume of the first fluid over a delivery of the first fluid from the first syringe before the empty condition is generated and through the delivery of the second fluid from the new syringe until the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered; confirming that the measured total volume of the first fluid was delivered according to the first fluid delivery order; and providing the total volume for display on a display device as taught by Jacobson for “safely performing a sequential infusion…” (Jacobson, Para [61]).
Regarding claim 14, Kamen (A) in view of Jacobson, Kamen (B), and Biasi disclose the method (Kamen (A), Fig. 191) as recited above, wherein
Kamen (A) does not expressly disclose that the first fluid is a medication and the second fluid is a non-medicinal flush infusate, the method further comprising: causing the syringe pump to deliver a portion of the first fluid from the first syringe until the indication of the first syringe being emptied is received; pausing the first fluid delivery order before the delivery of the second fluid is initiated, wherein, when the first syringe is emptied and the delivery of the second fluid is initiated, the second portion of the first fluid remaining to be delivered is residing in an infusion line connected to the syringe pump but not delivered to a patient; and causing, responsive to initiating delivery of the second fluid, the syringe pump to deliver the portion of first fluid from the infusion line by way of pushing the portion of the first fluid through the infusion line with the second fluid
Jacobson teaches that the first fluid is a medication (“… the first fluid is a medicinal fluid…” – Col. 15 Line 34) and the second fluid (second fluid 122, Fig. 1A) is a non-medicinal flush infusate (“Fluid as used herein can be any fluid suitable to be administered to a patient by infusion, including saline fluid…” – Col. 8 Line 43), the operations further comprising:
causing the syringe pump to deliver a portion of the first fluid from the first syringe (first reservoir 110, Drive a first fluid from a first reservoir at a first infusion rate 585, Fig. 1A and 5C) until the indication of the first syringe being emptied is received (“At block 587, the method 581 determines whether to pause the first infusion and initiate a “piggyback’ infusion…” – Col. 20 Line 46);
pausing the first fluid delivery order (585, Fig. 5C) before the delivery of the second fluid is initiated (Pause primary infusion and drive a second fluid 589, Fig. 5C), wherein, when the first syringe is emptied (“… the method 581 may determine… that a desired volume of fluid has been infused…” – Col. 21 Linen 33) and the delivery of the second fluid is initiated, the second portion of the first fluid remaining to be delivered is residing in an infusion line (common line 140, Fig. 1A) connected to the syringe pump (infusion pump 130, Fig. 1A) but not delivered to a patient (“…the volume of the common line of the first fluid remaining in the common line.” – Col. 20 Line 55); and
causing, responsive to initiating delivery of the second fluid (589, fig. 5C), the syringe pump to deliver the portion of first fluid from the infusion line by way of pushing the portion of the first fluid through the infusion line with the second fluid (“The method 581 drives the second fluid to the common line at the first infusion rate in order to auto flush or clear the volume of the common line of the first fluid remaining in the common line” – Col. 20 Line 54).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) to include that the first fluid is a medication and the second fluid is a non-medicinal flush infusate, the method further comprising: causing the syringe pump to deliver a portion of the first fluid from the first syringe until the indication of the first syringe being emptied is received; pausing the first fluid delivery order before the delivery of the second fluid is initiated, wherein, when the first syringe is emptied and the delivery of the second fluid is initiated, the second portion of the first fluid remaining to be delivered is residing in an infusion line connected to the syringe pump but not delivered to a patient; and causing, responsive to initiating delivery of the second fluid, the syringe pump to deliver the portion of first fluid from the infusion line by way of pushing the portion of the first fluid through the infusion line with the second fluid as taught by Jacobson for “safely performing a sequential infusion…” (Jacobson, Para [61]).
Regarding claim 15, Kamen (A) in view of Jacobson, Kamen (B), and Biasi disclose the method (Kamen (A), Fig. 191) recited above, further comprising:
Kamen (A) does not expressly disclose receiving, from a remote computing system, an automated programming command to configure the syringe pump to deliver the non-medicinal flush infusate according to the second fluid delivery order; and responsive to receiving the automated programming command, without user intervention: disabling a syringe empty alarm currently set to be provided when the first syringe loaded in the syringe pump is emptied; and automatically programming the syringe pump to initiate the delivery of the second fluid from the new syringe by the syringe pump according to the second fluid delivery order.
Jacobson teaches receiving, from a remote computing system, an automated programming command (“The infusion pump 130 can be operable to receive the common line flush volume value for the common line 140 automatically from the drug library stored in a memory locally in the infusion pump system 100 or remotely on a server.” – Col. 11 Line 24, “A drug library may include an indication (e.g. flag, value, etc.) to enable or disable infusion until reservoir depletion functionality, as described with respect to Fig. 5A.” – Col. 16 Line 50) to configure the syringe pump (infusion pump 130, Fig. 1A) to deliver the non-medicinal flush infusate (second fluid 122, Fig. 1A) according to the second fluid delivery order (589, Fig. 5C);and
automatically programming the syringe pump to initiate the delivery of the second fluid (“The method 581 determines whether to pause the first infusion and initiate a “piggyback” infusion, or infusion of a second fluid…” – Col. 20 Line 46) from the new syringe (second reservoir 120, Fig. 1A) by the syringe pump (infusion pump 130, Fig. 1A) according to the second fluid delivery order (589, Fig. 5C) ( “If the monitored volume is equal to or exceeds the common line flush volume, the method 581 proceeds to block 593.” – Col. 21 Line 4; Drive the second fluid at the second infusion rate 593, Fig. 5C).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) to include receiving, from a remote computing system, an automated programming command to deliver the non-medicinal flush infusate according to the second fluid delivery order; and automatically programming the syringe pump to initiate the delivery of the second fluid and automatically programming the syringe pump to initiate the delivery of the second fluid from the new syringe by the syringe pump according to the second fluid delivery order as taught by Jacobson for “safely performing a sequential infusion…” (Jacobson, Para [61]).
Jacobson does not expressly disclose that responsive to receiving the automated programming command, without user intervention: disabling a syringe empty alarm currently set to be provided when the first syringe loaded in the syringe pump is emptied.
Biasi teaches that responsive to receiving the automated programming command, without user intervention: disabling a syringe empty alarm (“The device may resolve the alert or alarm…” – Para [0801], Fig. 193) currently set to be provided when the first syringe loaded in the syringe pump is emptied (Device alarms and stops the infusion 2858, Fig. 193) (“In some embodiments, the infusion near end alert may be triggered when a defined volume remains for the infusion.” – Para [0796]);
Examiner interprets the device resolving the alarm as an automated action completed by the device according to its programmed command without user intervention.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) in view of Jacobson to include that responsive to receiving the automated programming command, without user intervention: disabling a syringe empty alarm currently set to be provided when the first syringe loaded in the syringe pump is emptied as taught by Biasi to “…flush an IV line from a medical device which is a syringe pump.” (Biasi, Para [0838]).
Regarding claim 16, Kamen (A) in view of Jacobson, Kamen (B), and Biasi disclose the method (Kamen (A), Fig. 191) recited above, wherein
Kamen (A) does not expressly disclose that the automated programming command causes the syringe pump to: automatically programming the syringe pump to initiate the delivery of the first fluid from the first syringe by the syringe pump according to the first fluid delivery order; prompt, when the first syringe is emptied, a user to unload the first syringe and to load the new syringe; and automatically stop delivery of the second fluid when the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered.
Jacboson teaches that the automated programming command causes the syringe pump (Jacobson, “The flow controller 235 is operable to execute the programming code…” – Col. 13 Line 19, “The method 581 can be programed by a flow controller (e.g., flow controller 235) …” – Col. 20 Line 28) to:
automatically programming the syringe pump (“The flow controller 235 is operable to execute the programming code…” – Col. 13 Line 19, “The method 581 can be programed by a flow controller (e.g., flower controller 235)…” – Col. 20 Line 28) to initiate the delivery of the first fluid (first fluid 112, Fig. 1A) from the first syringe (first reservoir 110, Fig. 1A) by the syringe pump (infusion pump 130, Fig. 1A) according to the first fluid delivery order (Drive a first fluid from a first reservoir at a first infusion rate 585, Fig. 5C); and
automatically stop delivery of the second fluid (second fluid 122, Fig. 1A) when the amount of the second fluid delivered from the new syringe (second reservoir 120, Fig. 1A) satisfies the second portion of the first fluid remaining to be delivered (Volume of the driven second fluid equal to the common line flush volume 591, “At block 595, the method 581 determines whether the piggyback infusion is complete. For example, the method 581 may determine that the second reservoir is depleted of fluid that a desired volume has been infused…” – Col. 21 Line 31, Fig. 5C).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) to include that that the automated programming command causes the syringe pump to: automatically programming the syringe pump to initiate the delivery of the first fluid from the first syringe by the syringe pump according to the first fluid delivery order; and automatically stop delivery of the second fluid when the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered as taught by Jacobson for “safely performing a sequential infusion…” (Jacobson, Para [61]).
Jacobson does not expressly disclose to prompt, when the first syringe is emptied, a user to unload the first syringe and to load the new syringe
Biasi teaches to prompt, when the first syringe is emptied (Device alerts to indicate infusion near end 2844, Fig. 193), a user to unload the first syringe and to load the new syringe (“The device displays instructions for installing the replacement syringe in step 3222.” – Para [0838]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) in view of Jacobson to prompt, when the first syringe is emptied, a user to unload the first syringe and to load the new syringe as taught by Biasi “for flushing the IV line associated with a medical device.” (Biasi, Para [0838]).
Regarding claim 18, Kamen (A) in view of Jacobson, Kamen (B), and Biasi disclose the method (Kamen (A), Fig. 191) as recited above, wherein
Kamen (A) does not expressly disclose that indicating the first fluid delivery order as being complete comprises: associating a type of the second fluid and a flush complete event with the first fluid delivery order.
Jacobson teaches that indicating the first fluid delivery order (Jacobson, 585, Fig. 5C) as being complete comprises:
associating a type of the second fluid (Jacobson, “If the method 581 determines that the second fluid program should be initiated, the method 581 proceeds to block 589.” – Col. 20 Line 48) and a flush complete event (Jacobson, “At block 587, the method 581 determines whether to pause the first infusion and initiate a “piggyback” infusion…” – Col. 20, Line 46) with the first fluid delivery order (Jacobson, 585, Fig. 5C).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) to include that indicating the first fluid delivery order as being complete comprises: associating a type of the second fluid and a flush complete event with the first fluid delivery order as taught by Jacobson for “safely performing a sequential infusion…” (Jacobson, Para [61]).
Regarding claim 19, Kamen (A) in view of Jacobson, Kamen (B), and Biasi disclose the method (Kamen (A), Fig. 191) as recited above, further comprising:
Kamen (A) does not expressly disclose receiving an indication of the new syringe being emptied; and providing an indication that the second fluid delivery order is complete when the indication of the new syringe being emptied is received.
Jacobson teaches that receiving, based on the generated sensor data, an indication of the new syringe (Jacobson, second reservoir 122, Fig. 1A) being emptied (Jacobson, “… the method 581 may determine that the second reservoir is depleted of fluid…” –Col. 21 Line 32, “Determining that the second reservoir is depleted may include receiving a sensor signal…” – Col. 4 Line 14); and
providing an indication that the second fluid delivery order is complete when the indication of the new syringe being emptied is received (Jacobson, “At block 595, the method 581 determines whether the piggyback infusion is complete. For example, the method 581 may determine that the second reservoir is depleted of fluid.” – Col. 21 Line 31).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) to include receiving an indication of the new syringe being emptied; and providing an indication that the second fluid delivery order is complete when the indication of the new syringe being emptied is received as taught by Jacobson for “safely performing a sequential infusion…” (Jacobson, Para [61]).
Regarding claim 20, Kamen (A) in view of Jacobson, Kamen (B), and Biasi disclose the method (Kamen (A), Fig. 191) as recited above, further comprising,
Kamen (A) does not expressly disclose that when the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered, automatically, without user intervention: prompting a user for a confirmation to continue delivery of the second fluid from the new syringe; and continuing delivery of the second fluid from the new syringe responsive to receiving the confirmation
Jacobson teaches that when the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered (Jacobson, Volume of the driven second fluid equal to the common line flush volume (591, Fig. 5C)),
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) to include that when the amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered as taught by Jacobson for “safely performing a sequential infusion…” (Jacobson, Para [61]).
Jacobson does not expressly disclose automatically, without user intervention: prompting a user for a confirmation to continue delivery of the second fluid from the new syringe; and continuing delivery of the second fluid from the new syringe responsive to receiving the confirmation.
Biasi teaches automatically, without user intervention: prompting a user for confirmation to continue delivery of the second fluid from the new syringe (Device displays setup help and prompts user to start secondary 2756, Fig. 190)
and continuing delivery of the second fluid from the new syringe (User sets up the secondary infusion 2758, Fig. 190) responsive to receiving the confirmation (User indicates they would like to begin administration of the secondary infusion 2760, Device starts secondary 2762, Fig. 190).
Examiner interprets the new syringe claimed above as the same new syringe disclosed by Biasi in Figure 202.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Kamen (A) in view of Jacobson to include automatically, without user intervention: prompting a user for a confirmation to continue delivery of the second fluid from the new syringe; and continuing delivery of the second fluid from the new syringe responsive to receiving the confirmation as taught by Biasi to “deliver a secondary infusion.” (Biasi, Para [0779]).
Regarding claim 21, Kamen (A) in view of Jacobson, Kamen (B), and Biasi disclose a non-transitory machine-readable storage medium embodying instructions that when executed by a machine (Kamen (A)“The local storage device may be a USB memory stick …” – Col. 8 Line 52), facilitate the machine to perform a method (Kamen (A), Fig. 191), comprising:
receiving, from one or more sensors associated with a syringe pump, an indication of a new syringe being loaded into the syringe pump (Kamen (A),“The device may make the determination that a syringe is not present in any number of suitable ways. This determination may be based data generated by one or more sensor on the device.” – Col. 174 Line 24);
determining, after receiving the indication based on electronically stored information associated with the syringe pump, that the syringe pump is currently associated with a first fluid delivery order (Kamen (A), User Programs and Begins An Infusion 2840, Fig. 193) for a predetermined amount of a first fluid, and that at least a first portion of the first fluid was previously delivered by the syringe pump according to the first fluid delivery order (Kamen (A), Device Delivers Infusion 2842, Fig. 193) before the new syringe was loaded into the syringe pump (Kamen (A), User Replaces Syringe 2876, Fig. 193);
the second portion of the first fluid being in a downstream IV line (Kamen (A), Device flushed the line 2874, Fig. 193).
electronically indicating the first fluid delivery order as being complete (Kamen (A), User discontinues parent infusion 2736, Fig. 189),
de-associating the first fluid delivery order from the syringe pump (Kamen (A), Parent infusion is canceled 2742, Fig. 189);
associating the syringe pump with the second fluid delivery order Kamen (A), Device Starts Secondary 2762, Fig. 190);
generating a start condition for the second delivery order (Kamen (A), Device notifies user and progresses to next programmed step 2826, Fig. 191), wherein the start condition for the second fluid delivery order is not generated until only after the first fluid delivery order is determined to be complete by way of the second remaining portion having been purged from the downstream IV line (Kamen (A), Device checks for defined step complete behavior 2824, Fig. 191);
Kamen (A) does not expressly disclose determining a second portion of the first fluid remaining to be delivered to complete the predetermined amount of the first fluid for the first fluid delivery order, initiating delivery of a second fluid from the new syringe by the syringe pump according to a second fluid delivery order; wherein the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump, when an amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered, wherein the start condition for the second fluid delivery order is not generated until only after the first fluid delivery order is determined to be complete by way of the second remaining portion having been purged from the downstream IV line and continuing delivery of the second fluid from the new syringe, and wherein the indicating of the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor.
Jacobson teaches determining a second portion of the first fluid remaining to be delivered to complete the predetermined amount of the first fluid for the first fluid delivery order (“At block 591, the method 581 monitors the volume of second fluid driven at the first infusion rate and determines when the monitored volume equals or exceeds the common line flush volume.” – Col. 20 Line 66), initiating delivery of a second fluid (second fluid 122, Fig. 1A) from the new syringe (second reservoir 120, Fig. 1A) by the syringe pump according to a second fluid delivery order (589, Fig. 5C) (Pause primary infusion and drive a second fluid at the first infusion rate 589, “At block 589, the method 581 stops drawing fluid from the first reservoir (pauses the primary infusion), and instead only draws fluid from the second reservoir” – Col. 20 Line 52) when an amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered (Volume of the driven second fluid equal to the common line flush volume 591, Fig. 5C) continuing delivery of the second fluid from the new syringe (“The method 581 drives the second fluid to the common line at the first infusion rate in order to auto flush.” – Col. 20 Line 54), wherein the indicating of the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor (“At block 589, the method 581 stops drawing fluid from the first reservoir (pauses the primary infusion), and instead only draws fluid from the second reservoir.” – Col. 20 Line 52).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) to include that determining a second portion of the first fluid remaining to be delivered to complete the predetermined amount of the first fluid for the first fluid delivery order, initiating delivery of a second fluid from the new syringe by the syringe pump according to a second fluid delivery order; when an amount of the second fluid delivered from the new syringe satisfies the second portion of the first fluid remaining to be delivered, wherein the start condition for the second fluid delivery order is not generated until only after the first fluid delivery order is determined to be complete by way of the second remaining portion having been purged from the downstream IV line and continuing delivery of the second fluid from the new syringe, and wherein the indicating of the first fluid delivery order as being complete, de-associating the first fluid delivery order from the syringe pump, associating the syringe pump with the second fluid delivery order, and continuing delivery of the second fluid is performed without stopping the motor as taught by Jacobson for “safely performing a sequential infusion…” (Jacobson, Para [61]).
Examiner interprets the first fluid that is being flushed to be in a downstream IV line in order to be flushed.
Examiner interprets the pausing/de-associating of the first fluid delivery order and the delivery/association of the second fluid delivery order occurring within the same step (block 589) as occurring without stopping the motor as taught by Kamen.
Kamen (A) in view of Jacobson does not expressly disclose that the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump.
Kamen (B) teaches that the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump (Kamen (B), “The syringe infusion pump 6 may be any pump driven by a motor…” – Para [29]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Kamen (A) in view of Jacobson to include that the syringe pump is configured to deliver the second fluid by driving a motor of the syringe pump as taught by Kamen (B) to “treat an acute or chronic ailment.” (Kamen (B), Para [2]).
Response to Arguments
Applicant’s arguments, see pages 1-3, filed 4/17/2026, with respect to the rejection(s) of claim(s) 1-21 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of different interpretation of the previously applied references.
Applicant argues that Biasi, however, is not seen to disclose or even suggest, the features of “determining a second portion of the first fluid remaining to be delivered… the second portion … being in a downstream IV line,” “initiating delivery of a second fluid… according to a second fluid delivery order,” and “when an amount of the second fluid delivered from the new syringe satisfies the second portion … indicating the first fluid delivery order as being complete, associating the syringe pump with the second fluid delivery order and generating a start condition for the second delivery order … wherein the start condition for the second fluid delivery order is not generated until only after the first fluid delivery order is determined to be complete by way of the second remaining portion having been purged from the downstream IV line.
Biasi does not teach of even suggest automatically performing the foregoing steps of de-associating the first delivery order, associating the second fluid delivery order and continuing delivery of the second fluid, all without stopping the motor, as claimed.
Examiner interprets Jacobson and Kamen (A) to teach the limitation cited in the applicant’s arguments above as cited in the rejection above.
The rejection above is maintained and all dependent claims are addressed in the claims they depend from.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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