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 .
Status of Claims
The amendments filed September 22, 2026 have been entered.
Claim 13 is canceled.
Claims 1, 3, 5-6, 12, 14 and 16 are amended.
Claims 17-20 are new.
Claims 1-12 and 14-20 are pending.
Response to Arguments
Applicant’s arguments filed September 22, 2026, with respect to the rejections of claims 1, 4-6, 10-12, and 14-16 under 35 U.S.C. 103, have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Alaris, Stewart and Graseby. MedFusion is reapplied only for the near-empty trigger, the monitoring, the residual volume, and the Syringe Empty alarm. It is not reapplied for the KVO switch or the bolus.
Applicant argues on line 30 of page 1 to line 29 of page 2 of the remarks filed September 22, 2026, regarding claim 1, that MedFusion does not disclose, responsive to the trigger condition, automatically causing the infusion device to enter a syringe empty mode and to adjust an operational parameter by increasing a speed at which a plunger of the syringe moves to purge fluid from the syringe. Applicant argues that pages 101-102 disclose only that infusion continues after the Volume Empty position because of syringe variation and residual medication and does not disclose an increase in plunger speed. Applicant argues that page 60 is a separate bolus that pauses the main infusion, is prompted or included in the programming steps, and is not initiated by the empty trigger to purge residual fluid. Applicant argues that page 75 selects the KVO rate or the current rate, whichever is less, and does not increase plunger speed.
The argument is persuasive as to the mapping in the non-final action. Pages 60 and 75 are not relied on for the speed increase. The new ground does not combine those features with each other.
The new ground meets the limitation. MedFusion pages 101-102 determine a Syringe Near Empty alarm and a Syringe Volume Near Empty alarm from remaining volume, flow rate, and time to empty, and state that infusion continues after the Volume Empty position because syringe variation leaves a residual volume of medication. Page 102 raises a Syringe Empty alarm and stops delivery when the plunger reaches the end of the syringe. Alaris, Purge, pages 15 and 25, delivers a limited volume of fluid to purge the extension set, including after replacement of a near-empty syringe, at 100-500 mL/h. That purge is user-initiated in Alaris. It would have been obvious to automatically invoke that purge when the MedFusion near-empty trigger is satisfied, in order to complete delivery of the residual MedFusion already identifies, rather than leave the residual or run it out at the programmed rate. Automating that manual purge does not change what either step does. See MPEP 2144.04(III). Therefore, the new rejection of claim 1 stands.
Claims 14 and 16 now recite the claim 1 steps and are rejected on the same MedFusion and Alaris ground.
Applicant argues on lines 12-17 of page 3 of the remarks filed September 22, 2026, regarding claims 2-12 and 15, that the claims depending from claim 1, 14 and 16 are allowable for same reasons.
Examiner, however, respectfully disagrees. The new ground applied to the independent claims applies to each dependent claim, and the additional limitations are addressed in the rejection. The new rejections of claims 2-12 and 15 stand. Claims 17-20 are new claims rejected under 35 U.S.C. 103 as detailed in the rejection below.
Claim Objections
Claims 5 and 12 are objected to because of the following informalities:
Claim 5 recites “wherein the syringe comprises a plunger.” Claim 1 recites “a plunger of the syringe.” A suggested amendment is “wherein the syringe comprises the plunger.”
Claim 12 recites “the threshold.” Claim 1 recites “a flow rate or a threshold,” so “the threshold” has no antecedent when the adjusted parameter is the flow rate. A suggested amendment is “a threshold, wherein the threshold is a pressure limit associated with the fluid delivery being complete.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-5, 10, 14-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over MedFusion (Smiths Medical (2013), MedFusion® Syringe Pump Model 3500 [Operator’s Manual Software Version 6]) in view of Alaris (CareFusion (2018), Alaris® CC Syringe Pump [Directions for Use]).
Regarding claim 1, MedFusion discloses a method for detection and control of a syringe pump empty condition, comprising, by a control unit associated with an infusion device (Medfusion 3500 Manual: pp. 126-127, “Safety Features”: describes the pump electronics- a microcontroller supplies the microprocessor and the associated electronics, including program memory and RAM; pp. 5 describes the delivery modes and configurations as programmable):
determining a trigger condition for entering a syringe empty mode (Medfusion 3500 Manual: pp. 101-102, “Syringe Empty Alarm Process”: Medfusion Model 3500 pump determines a “Syringe Near Empty” alarm and “Syringe Volume Near Empty” alarm, both calculated in real time from remaining syringe volume, flow rate, and time to empty) to complete a fluid delivery performed by a syringe associated with the infusion device (Medfusion 3500 Manual: pp. 101-102, “Syringe Empty Alarm Process”: Medfusion Model 3500 pump determines a “Syringe Near Empty” alarm and “Syringe Volume Near Empty” alarm, both calculated in real time from remaining syringe volume, flow rate, and time to empty; after the Volume Empty position, infusion continues because syringe variation leaves a residual volume of medication);
monitoring the fluid delivery for the trigger condition (Medfusion 3500 Manual, pp. 96-97, “Total volume, program volume / dose delivered”: trigger condition “Program Volume Delivered” or “Program Dose Delivered” is continuously performed throughout infusion);
detecting that the adjusted operational parameter has been satisfied (Medfusion 3500 Manual, pp. 102, “Syringe Volume Near Empty”: “Syringe Volume Near Empty” alarm indicates that syringe has reached “Volume Empty” position); and
providing an alert responsive to detecting the adjusted operational parameter is satisfied (Medfusion 3500 Manual, pp. 102, “Syringe Empty” alarm: high priority alarm advising the syringe is empty and stops delivery once plunger reaches the end of the syringe);
MedFusion fails, however, to disclose a syringe empty mode in which an operational parameter of the infusion device is adjusted to complete a fluid delivery; and
responsive to the fluid delivery satisfying the trigger condition, automatically causing the infusion device to enter the syringe empty mode and to adjust the operational parameter to complete the fluid delivery by increasing a speed at which a plunger of the syringe moves to purge fluid from the syringe, wherein the adjusted operational parameter comprises a flow rate or a threshold associated with completing the fluid delivery.
Alaris teaches adjusting the operational parameter to complete the fluid delivery by increasing a speed at which a plunger of the syringe moves to purge fluid from the syringe (Alaris CC Syringe Pump: pp. 15, “Purge”: the purge button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient or after changing a syringe; pp. 25, “Purge Specification”: purge rate is configurable from 100 mL/h to 500 mL/h), wherein the adjusted operational parameter comprises a flow rate (Alaris CC Syringe Pump: pp. 25, “Purge Specification”: purge rate is configurable from 100 mL/h to 500 mL/h flow rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the near-empty trigger of MedFusion to automatically invoke the high-speed purge when the trigger is satisfied, as taught by Alaris, in order to complete delivery of the residual volume remaining after the Volume Empty position rather than leave that residual volume or run it out at the programmed rate.
Regarding claim 4, modified MedFusion discloses the method of claim 1, further comprising: determining an amount of fluid emptied from the syringe; and wherein the trigger condition is satisfied based on a predetermined amount of fluid emptied from the syringe (Medfusion 3500 Manual, pp. 101-102, “Syringe Empty Alarm Process”: Medfusion Model 3500 pump determines a “Syringe Near Empty” alarm and “Syringe Volume Near Empty” alarm, both calculated in real time from remaining syringe volume).
Regarding claim 5, modified MedFusion discloses the method of claim 1, wherein the syringe comprises a plunger, the method further comprising: monitoring a motion of the plunger, wherein the trigger condition is satisfied based on the motion reaching a predetermined distance (Medfusion 3500 Manual, pp. 101-102, “Syringe Empty Alarm Process”: trigger condition is satisfied based on the motion reaching a predetermined distance. The “Syringe Volume Empty” alarm occurs at a syringe position near the end of the syringe travel).
Regarding claim 10, modified MedFusion discloses the method of claim 1, wherein the trigger condition is determined based on a characteristic of a syringe coupled to an infusion device (Medfusion 3500 Manual, pp. 44-48, “Dose / kg / time”: user selects syringe model and size using PharmGuard® Toolbox 2; once selected from library, pump calculates correct flow rate to achieve required dose).
Regarding claim 14, modified MedFusion discloses a non-transitory, machine-readable storage medium embodying instructions that when executed by a machine, facilitate the machine to perform operations comprising: (Medfusion 3500 Manual, pp. 5; pump configurations and firmware can be updated, and infusion settings and events history downloaded in combination with the PharmGuard® Toolbox 2 software application).
determining a trigger condition for entering a syringe empty mode (Medfusion 3500 Manual: pp. 101-102, “Syringe Empty Alarm Process”: Medfusion Model 3500 pump determines a “Syringe Near Empty” alarm and “Syringe Volume Near Empty” alarm, both calculated in real time from remaining syringe volume, flow rate, and time to empty) to complete a fluid delivery performed by a syringe associated with the infusion device (Medfusion 3500 Manual: pp. 101-102, “Syringe Empty Alarm Process”: Medfusion Model 3500 pump determines a “Syringe Near Empty” alarm and “Syringe Volume Near Empty” alarm, both calculated in real time from remaining syringe volume, flow rate, and time to empty; after the Volume Empty position, infusion continues because syringe variation leaves a residual volume of medication);
monitoring the fluid delivery for the trigger condition (Medfusion 3500 Manual, pp. 96-97, “Total volume, program volume / dose delivered”: trigger condition “Program Volume Delivered” or “Program Dose Delivered” is continuously performed throughout infusion);
detecting that the adjusted operational parameter has been satisfied (Medfusion 3500 Manual, pp. 102, “Syringe Volume Near Empty”: “Syringe Volume Near Empty” alarm indicates that syringe has reached “Volume Empty” position); and
providing an alert responsive to detecting the adjusted operational parameter is satisfied (Medfusion 3500 Manual, pp. 102, “Syringe Empty” alarm: high priority alarm advising the syringe is empty and stops delivery once plunger reaches the end of the syringe);
MedFusion fails, however, to disclose a syringe empty mode in which an operational parameter of the infusion device is adjusted to complete a fluid delivery; and
responsive to the fluid delivery satisfying the trigger condition, automatically causing the infusion device to enter the syringe empty mode and to adjust the operational parameter to complete the fluid delivery by increasing a speed at which a plunger of the syringe moves to purge fluid from the syringe, wherein the adjusted operational parameter comprises a flow rate or a threshold associated with completing the fluid delivery.
Alaris teaches adjusting the operational parameter to complete the fluid delivery by increasing a speed at which a plunger of the syringe moves to purge fluid from the syringe (Alaris CC Syringe Pump: pp. 15, “Purge”: the purge button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient or after changing a syringe; pp. 25, “Purge Specification”: purge rate is configurable from 100 mL/h to 500 mL/h), wherein the adjusted operational parameter comprises a flow rate (Alaris CC Syringe Pump: pp. 25, “Purge Specification”: purge rate is configurable from 100 mL/h to 500 mL/h flow rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the instructions of modified MedFusion, which calculate the near-empty trigger, to automatically invoke the high-speed purge when the trigger is satisfied, as taught by Alaris, in order to complete delivery of the residual volume remaining after the Volume Empty position rather than leave that residual volume or run it out at the programmed rate.
Regarding claim 15, modified MedFusion discloses a system, comprising: one or more processors; and memory including instructions that, when executed by the one or more processors, cause the one or more processors to perform the method of claim 1 (Medfusion 3500 Manual, pp. 126-127, contains microcontroller to power and supply the microprocessor and associated electronics including program memory and RAM; pp. 5, pump offers a variety of delivery modes programmable to meet specific patient care needs)
Regarding claim 16, modified MedFusion discloses an infusion device, comprising: one or more processors (Medfusion 3500 Manual, pp. 126-127, infusion device includes microprocessor, microcontroller, and power supply that monitors the associated electronics); and memory including instructions that, when executed by the one or more processors, cause the one or more processors to perform operations comprising:
determine a trigger condition for entering a syringe empty mode (Medfusion 3500 Manual: pp. 101-102, “Syringe Empty Alarm Process”: Medfusion Model 3500 pump determines a “Syringe Near Empty” alarm and “Syringe Volume Near Empty” alarm, both calculated in real time from remaining syringe volume, flow rate, and time to empty) to complete a fluid delivery performed by a syringe associated with the infusion device (Medfusion 3500 Manual: pp. 101-102, “Syringe Empty Alarm Process”: Medfusion Model 3500 pump determines a “Syringe Near Empty” alarm and “Syringe Volume Near Empty” alarm, both calculated in real time from remaining syringe volume, flow rate, and time to empty; after the Volume Empty position, infusion continues because syringe variation leaves a residual volume of medication);
monitor the fluid delivery for the trigger condition (Medfusion 3500 Manual, pp. 96-97, “Total volume, program volume / dose delivered”: trigger condition “Program Volume Delivered” or “Program Dose Delivered” is continuously performed throughout infusion);
detect that the adjusted operational parameter has been satisfied (Medfusion 3500 Manual, pp. 102, “Syringe Volume Near Empty”: “Syringe Volume Near Empty” alarm indicates that syringe has reached “Volume Empty” position); and
provide an alert responsive to detecting the adjusted operational parameter is satisfied (Medfusion 3500 Manual, pp. 102, “Syringe Empty” alarm: high priority alarm advising the syringe is empty and stops delivery once plunger reaches the end of the syringe);
MedFusion fails, however, to disclose a syringe empty mode in which an operational parameter of an infusion device is adjusted to complete a fluid delivery; and
responsive to the fluid delivery satisfying the trigger condition, automatically causing the infusion device to enter the syringe empty mode and to adjust the operational parameter to complete the fluid delivery by increasing a speed at which a plunger of the syringe moves to purge fluid from the syringe, wherein the adjusted operational parameter comprises a flow rate or a threshold associated with completing the fluid delivery.
Alaris teaches adjusting the operational parameter to complete the fluid delivery by increasing a speed at which a plunger of the syringe moves to purge fluid from the syringe (Alaris CC Syringe Pump: pp. 15, “Purge”: the purge button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient or after changing a syringe; pp. 25, “Purge Specification”: purge rate is configurable from 100 mL/h to 500 mL/h), wherein the adjusted operational parameter comprises a flow rate (Alaris CC Syringe Pump: pp. 25, “Purge Specification”: purge rate is configurable from 100 mL/h to 500 mL/h flow rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of modified MedFusion, which determines the near-empty trigger, to automatically invoke the high-speed purge when the trigger is satisfied, as taught by Alaris, in order to complete delivery of the residual volume remaining after the Volume Empty position rather than leave that residual volume or run it out at the programmed rate.
Regarding claim 19, modified MedFusion discloses the infusion device of Claim 16, wherein the one or more processors are further caused to: determine an amount of fluid emptied from the syringe, wherein the trigger condition is satisfied based on a predetermined amount of fluid being emptied from the syringe (Medfusion 3500 Manual, pp. 101-102, “Syringe Empty Alarm Process”: Medfusion Model 3500 pump determines a “Syringe Near Empty” alarm and “Syringe Volume Near Empty” alarm, both calculated in real time from remaining syringe volume).
Claims 2, 7-9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over MedFusion in view of Alaris, as applied to claim 1 above, and further in view of Pippin (US 2019/0351132).
Regarding claim 2, modified MedFusion discloses the method of Claim 1 but fails to disclose the method of claim 1 further comprising: monitoring a real-time delivery pressure associated with the fluid delivery; and
wherein the trigger condition is satisfied based on the real-time delivery pressure satisfying a predetermined pressure.
Pippin teaches monitoring a real-time delivery pressure associated with the fluid delivery (Pippin: para [0022], [0034-0035], downstream force/pressure sensor continuously calculates real-time pressure on the plunger head); and
wherein the trigger condition is satisfied based on the real-time delivery pressure satisfying a predetermined pressure (Pippin: para [0022], pressure is compared to configurable baseline pressure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the near-empty trigger of modified MedFusion to be satisfied by the real-time downstream pressure comparison, as taught by Pippin, in order to detect the end-of-delivery pressure rise from a measured plunger pressure rather than from calculated remaining volume alone.
Regarding claim 7, modified MedFusion discloses the method of claim 1, but fails to disclose wherein the trigger condition is triggered based on a pressure measured downstream of the syringe satisfying a pressure curve, the pressure curve being representative of how the pressure measured downstream of the syringe changes during a predetermined period at an end of the fluid delivery.
Pippin teaches a trigger condition is triggered based on a pressure measured downstream of the syringe satisfying a pressure curve, the pressure curve being representative of how the pressure measured downstream of the syringe changes during a predetermined period at an end of the fluid delivery (Pippin: para [0022], detection uses the slope of the pressure curve, area under the pressure, or comparison to baseline pressure during infusion to determine if barrel is blocked).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure trigger of modified MedFusion to use the slope, area, or baseline comparison of the downstream pressure curve, as taught by Pippin, in order to detect the end-of-delivery pressure change over a predetermined period rather than from a single pressure value.
Regarding claim 8, modified MedFusion discloses the method of Claim 7, but fails to disclose the method of claim 1 further comprising: receiving an identifier associated with a type of the syringe; and performing a parameter lookup based on the identifier to obtain the trigger condition, wherein the trigger condition is determined as a result of the parameter lookup.
Pippin teaches receiving an identifier associated with a type of the syringe; and performing a parameter lookup based on the identifier to obtain the trigger condition, wherein the trigger condition is determined as a result of the parameter lookup (Pippin: para [0125], trigger condition “down-stream occlusion” or DSO pressure calculated based on syringe size value stored in a database having different values for different syringe sizes; used in calibration factor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure trigger of modified MedFusion to obtain the trigger condition from the syringe-size lookup, as taught by Pippin, in order to set the pressure threshold for the syringe actually loaded rather than use one threshold for every syringe.
Regarding claim 9, modified MedFusion discloses the method of Claim 7, wherein the trigger condition is determined based on a rate of the fluid delivery or historical data for one or more other fluid deliveries (Medfusion 3500 Manual, pp. 92, “Time to occlusion” and “FlowSentryTM pressure monitoring”: internal program that monitors and analyzes delivery pressure and is configured to respond to pressure changes that are affected by flow rate of fluid delivery; characteristic pressure rise at the end of fluid delivery occurs faster at higher flow rates, so the point at which the pressure curve with, its historical data, are satisfied is determined using the rate of flow; pp. 5, imports and exports data to assist in history data management).
Regarding claim 17, modified MedFusion discloses the infusion device of Claim 16, wherein the one or more processors are further caused to: monitor a real-time delivery pressure associated with the fluid delivery (Pippin: para [0022], [0034-0035], downstream force/pressure sensor continuously calculates real-time pressure on the plunger head), wherein the trigger condition is satisfied based on the real-time delivery pressure satisfying a predetermined pressure (Pippin: para [0022], pressure is compared to configurable baseline pressure).
The processor is modified for the same reasons as claim 2.
Claims 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over MedFusion in view of Alaris and Pippin, as applied to claims 2 and 17 above, and further in view of Stewart (US 2024/0017006).
Regarding claim 3, modified MedFusion discloses the method of Claim 2, but fails to disclose the method of claim 2 further comprising: monitoring the real-time delivery pressure according to a first frequency before the trigger condition is satisfied and at a second frequency, greater than the first frequency, after the infusion device enters the syringe empty mode.
Stewart teaches monitoring the real-time delivery pressure according to a first frequency before the trigger condition is satisfied and at a second frequency, greater than the first frequency, after the infusion device enters the syringe empty mode (Stewart: first frequency and then at a second frequency greater than the first frequency in fig. 7; para [0045]; raises frequency because of a pre-occlusion pressure and the amount of stroke remaining).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure monitoring of modified MedFusion to use the increased measurement frequency, as taught by Stewart, in order to sample the rising end-of-delivery pressure more often while the residual volume is being purged and completion is being detected.
Regarding claim 18, modified MedFusion discloses the infusion device of Claim 17, wherein the one or more processors are further caused to: monitor the real-time delivery pressure according to a first frequency before the trigger condition is satisfied and at a second frequency, greater than the first frequency, after the infusion device enters the syringe empty mode (Stewart: first frequency and then at a second frequency greater than the first frequency in fig. 7; para [0045] ; raises frequency because of a pre-occlusion pressure and the amount of stroke remaining).
The processor is modified for the same reasons as claim 3.
Claims 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over MedFusion in view of Alaris, as applied to claim 1 above, and further in view of McDaniel (US 5,236,416).
Regarding claim 6, modified MedFusion discloses the method of Claim 5, but fails to disclose the method of Claim 5 further comprising: monitoring the motion using a camera or an optical detector; determining that the trigger condition is satisfied based on the motion of the plunger reaching a predetermined distance; and detecting that the motion reached the predetermined distance based on the camera or the optical detector detecting a distance marker associated with the plunger at a predetermined location.
McDaniel teaches monitoring the motion using a camera or an optical detector; determining that the trigger condition is satisfied based on the motion of the plunger reaching a predetermined distance; and detecting that the motion reached the predetermined distance based on the camera or the optical detector detecting a distance marker (McDaniel: col 2 lines 3-6, optical markers at fixed positions along the travel of the plunger driver are read by an optical detector on the plunger driver) associated with the plunger at a predetermined location (McDaniel: col 6 lines 55-61, the processor may be used to determine a fixed or selectable near end of travel (NEOT) position of the syringe plunger and alarm to indicate NEOT; trigger is satisfied because the plunger motion reached that predetermined NEOT distance).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger-position trigger of modified MedFusion to use the optical markers and detector, as taught by McDaniel, in order to satisfy the near-empty trigger by reading a distance marker at the near-end-of-travel position rather than from calculated syringe position alone.
Regarding claim 20, modified MedFusion discloses the infusion device of Claim 16, wherein the one or more processors are further caused to: monitor a motion of the plunger using a camera or an optical detector (McDaniel: col 2 lines 3-6, optical markers at fixed positions along the travel of the plunger driver are read by an optical detector on the plunger driver); determine that the trigger condition is satisfied based on the camera or the optical detector detecting a distance marker associated with the plunger at a predetermined location (McDaniel: col 6 lines 55-61, the processor may be used to determine a fixed or selectable near end of travel (NEOT) position of the syringe plunger and alarm to indicate NEOT; trigger is satisfied because the plunger motion reached that predetermined NEOT distance).
The processor is modified for the same reasons as claim 6.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over MedFusion in view of Alaris, as applied to claim 1 above, and further in view of New Era (New Era Pump Systems, Inc (2016), Model NE-1000 Multi-PhaserTM [Quick Start Instructions] and [Dual Pumps Communications Cable, Part # CBL-DUAL-3 Documentation]).
Regarding claim 11, modified MedFusion discloses the method of claim 1, but fails to disclose the method of claim 1 further comprising: responsive to the infusion device entering the syringe empty mode, causing a second infusion device to initiate a flush of a fluid line providing the fluid delivery from the syringe.
New Era teaches a method responsive to the infusion device entering the syringe empty mode, causing a second infusion device to initiate a flush of a fluid line providing the fluid delivery from the syringe (New Era pump NE-1000, Dual Pumps Special Applications User Manual, “Dual Pumps Communications Cable” instructions: pp. 4, creation of overlap between the infusing pump and alternate pump allow the alternate pump to prime (or flush) the syringe before the infusing pump stops).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe empty mode of modified MedFusion to cause the second pump to prime the line before the infusing pump stops, as taught by New Era, in order to flush the fluid line when the syringe is empty rather than stop delivery with fluid left in the line.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over MedFusion in view of Alaris and Pippin, as applied to claim 1 above, and further in view of Graseby (Sims Graseby (2000), Graseby 3400 Anaesthesia Syringe Pump [Technical Service Manual]).
Regarding claim 12, modified MedFusion discloses the method of claim 1, wherein adjusting the operational parameter comprises the threshold, and wherein adjusting the operational parameter comprises: lowering the threshold (Pippin: para [0039], the threshold may be lower for the rapid occlusion detection mode than the non-rapid occlusion detection mode) and an alert that indicates that the syringe is empty and the fluid delivery is complete (Medfusion 3500 Manual, pp. 101-102, “Syringe Empty Alarm Process”: pump determines when the fluid delivery is complete and triggers the high-priority “Syringe Empty” alarm).
Modified MedFusion fails, however, to disclose wherein the threshold is a pressure limit associated with the fluid delivery being complete.
Graseby teaches wherein the threshold is a pressure limit associated with the fluid delivery being complete (Graseby 3400 Anesthesia Syringe Pump Technical Service Manual, pp. 32 (3-3) and pp. 80 (6-3): the OCCLUSION alarm is also raised when the syringe reaches the end of travel at the end of a normal infusion, the display is EMPTY/OCCLUSION, and the pump stops; pp. 27 (2-7): the plunger-force threshold is factory set at 5.7 to 6.2 kg and is adjustable).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lowered pressure threshold of modified MedFusion, as taught by Graseby, in order to declare the syringe empty and the delivery complete when the plunger-force threshold is met, rather than declaring only an occlusion.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
