DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over (Smiths Medical (2013), MedFusion® Syringe Pump Model 3500 [Operator’s Manual Software Version 6]), hereinafter, MedFusion.
Regarding Claim 1, MedFusion discloses a method for detection and control of a syringe pump empty condition, comprising:
determining a trigger condition (MedFusion, pp. 101-102, under the heading “Syringe Empty Alarm Process”: MedFusion pump determines a “Syringe Near Empty” alarm and a “Syringe Volume Near Empty” alarm, which are both calculated in real time from remaining syringe volume, flow rate, and time to empty; the “Syringe Volume Near Empty” alarm can serve as a “trigger condition” for entering into an “empty mode”; MedFusion, pp. 96-97, “Total volume, program volume / dose delivered”: additional trigger conditions “Program Volume Delivered” or “Program Dose Delivered” are continuously performed throughout infusion) for entering a syringe empty mode in which an operational parameter of an infusion device is adjusted (MedFusion, pp. 75; pump automatically changes operational behavior when the programmed volume limit is reached and adjusts the flow rate parameter which shows that the MedFusion device is capable of adjusting the flow rate parameter; MedFusion, pp. 60, shows that a bolus dose can be delivered at a higher rate than main infusion and is configurable to be automatically prompted or included in the programming steps of a drug program) to complete a fluid delivery performed by a syringe associated with the infusion device (MedFusion, pp. 101-102, under heading “Syringe Volume Near Empty” and step “3”: after the remaining syringe volume trigger condition has started the end-of-infusion part of the treatment, the infusion continues until the no fluid remains (i.e., no volume – trigger condition satisfied); due to syringe variation there may still be a residual volume of medication in the syringe; therefor the infusion continues)
monitoring the fluid delivery for the trigger condition (MedFusion, pp. 101-102, “Syringe Empty Alarm Process”: MedFusion 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; the “Syringe Volume Near Empty” alarm can serve as a “trigger condition” for entering into an “empty mode”; MedFusion, pp. 96-97, “Total volume, program volume / dose delivered”: additional trigger conditions “Program Volume Delivered” or “Program Dose Delivered” are continuously performed throughout infusion);
responsive to the fluid delivery satisfying the trigger condition, causing the infusion device to enter the syringe empty mode and adjusting the operational parameter to complete the fluid delivery, wherein the adjusted operational parameter comprises a flow rate or a threshold associated with completing the fluid delivery (MedFusion, pp. 101-102, under heading “Syringe Volume Near Empty” and step “3”: after the remaining syringe volume trigger condition has started the end-of-infusion part of the treatment, the infusion continues until the no fluid remains (i.e., no volume – trigger condition satisfied); due to syringe variation there may still be a residual volume of medication in the syringe; therefor the infusion continues; MedFusion, pp. 75; step “7” and “8”: the device adjusts to a KVO flow rate after the “syringe empty” alarm or continues at a current programmed rate);
detecting that the adjusted operational parameter has been satisfied (MedFusion, pp. 101-102, “Syringe Volume Near Empty”: “Syringe Volume Near Empty” alarm indicates that syringe has reached “Volume Empty” position, but infusion continues due to syringe variation and residual volume of medication); and
providing an alert responsive to detecting the threshold is satisfied (MedFusion, 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 does not explicitly disclose that satisfying the trigger condition itself causes the infusion device to enter the syringe-empty mode.
As stated above, however, MedFusion does disclose on page 75 that the pump automatically changes operations behavior when the programmed volume limit is reached. MedFusion discloses on page 60 that a bolus dose is delivered at a higher rate than main infusion and is configurable to be automatically prompted or included in the programming steps of a drug program and also discloses on pages 101-102 that infusion continues after a volume-empty status but continues the infusion due to syringe variation and residual volume of medication.
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 and end-of-infusion behavior of MedFusion to automatically apply the high-speed bolus adjustment as a result of reaching a trigger condition in order to complete the remaining fluid delivery faster and provide an accurate “Syringe Empty” alert.
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, pp. 101-102, “Syringe Empty Alarm Process”: MedFusion 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 the plunger, wherein the trigger condition is satisfied based on the motion reaching a predetermined distance (MedFusion, 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, 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 13, modified MedFusion discloses the method of claim 1, wherein adjusting the flow rate or the threshold associated with the fluid delivery comprises: increasing a speed at which a plunger of the syringe moves to purge fluid from the syringe (MedFusion, pp. 60, bolus dose is delivered at a higher rate than main infusion and is configurable to be automatically prompted or included in the programming steps of a drug program).
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 the method of Claim 1 (MedFusion, 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).
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, 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; 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, pp. 126-127, infusion device includes microprocessor, microcontroller, and power supply that monitors the associated electronics).
Claims 2-3, 7-9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over MedFusion, as applied to Claim 1 above, and further in view of Pippin (US Publication No. 2019/0351132), hereinafter, Pippin.
Regarding Claim 2, modified MedFusion discloses the method of Claim 1, but fails to disclose the method 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 a method further comprising: 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 trigger condition of MedFusion to incorporate the real-time downstream pressure monitoring and predetermined pressure threshold, as taught by Pippin, in order to achieve faster and more reliable detection of the physical end-of-delivery.
Regarding Claim 3, modified MedFusion discloses the method of Claim 2, but fails to disclose the method wherein the real-time delivery pressure is monitored according to a first frequency before the fluid delivery satisfying the trigger condition and increased to a second frequency responsive to the infusion device entering the syringe empty mode.
Pippin teaches a method wherein the real-time delivery pressure is monitored according to a first frequency before the fluid delivery satisfying the trigger condition and increased to a second frequency responsive to the infusion device entering the syringe empty mode (Pippin: para [0039] and Claim 20, selected occlusion detection mode includes either a rapid occlusion detection mode or a no-rapid occlusion detection mode).
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 MedFusion to incorporate the rapid detection mode, as taught by Pippin, in order to more quickly detect the rising pressure at the of delivery.
Regarding Claim 7, modified MedFusion discloses the method of Claim 1, but fails to disclose the method 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: para [0022], detection uses the slope of the pressure curve, area under the pressure, or comparison to baseline pressure during infusion).
Pippin teaches 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).
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 end-of-infusion detection of MedFusion to incorporate the downstream pressure curve, as taught by Pippin, in order to more accurately detect the physical end of delivery.
Regarding Claim 8, modified MedFusion discloses the method of Claim 7, but fails to disclose the method 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: para [0125], trigger condition or DSO pressure calculated based on syringe size value stored in a database having different values for different syringe sizes; used in calibration factor).
Pippin teaches a 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 syringe configuration of MedFusion to incorporate the syringe-size-based parameter database look-up, as taught by Pippin, in order to tailor the pressure-curve trigger to the specific syringe being used.
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, 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; the pressure curve / slope detection at the end of the fluid delivery is directly affected by the current infusion rate; a higher flow rate causes a faster pressure rise, so the point at which the pressure curve is satisfied is determined using the rate of the fluid delivery; pp. 5, imports and exports data to assist in history data management).
Regarding Claim 12, modified MedFusion discloses the method of Claim 1, wherein adjusting the flow rate or the threshold associated with the fluid delivery comprises a pressure limit associated with the fluid delivery being complete, wherein the alert indicates that the syringe is empty and the fluid delivery is complete (MedFusion, pp. 101-102, “Syringe Empty Alarm Process”: pump determines when the fluid delivery is complete and triggers the high-priority “Syringe Empty” alarm; the manual also discloses configurable pressure limits used in conjunction with end-of-delivery detection and alarms on pp. 92; “FlowSentryTM pressure monitoring”: internal program that monitors and analyzes delivery pressure).
MedFusion fails, however, to explicitly disclose that adjusting the flow rate or the threshold associated with the fluid delivery comprises: lowering the threshold.
Pippin teaches adjusting the flow rate or the threshold associated with the fluid delivery comprises: lowering the threshold associated with the fluid delivery being complete (Pippin: para [0039], the threshold may be lower for the rapid occlusion detection mode than the non-rapid occlusion detection mode).
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 threshold of MedFusion to incorporate the lowered threshold in rapid detection mode, as taught by Pippin, in order to more promptly detect completion of the fluid delivery.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over MedFusion, as applied to Claim 1 above, and further in view of McDaniel (US Patent No. 5,236,416), hereinafter, McDaniel.
Regarding Claim 6, MedFusion discloses the method of Claim 5, but fails to disclose the method further comprising: monitoring the motion using a camera or an optical detector; 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 a method further comprising: monitoring the motion using a camera or an optical detector; 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 of selectable near end of travel (NEOT) position of the syringe plunger and alarm to indicate NEOT).
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 motion monitoring of MedFusion to incorporate the optical detector and distance markers, as taught by McDaniel, in order to provide accurate, non-contact detection of the plunger position during delivery.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over MedFusion, as applied to Claim 1 above, and further in view of (New Era Pump Systems, Inc (2016), Model NE-1000 Multi-PhaserTM [Quick Start Instructions] and [Dual Pumps Communications Cable, Part # CBL-DUAL-3 Documentation]), hereinafter, New Era.
Regarding Claim 11, MedFusion discloses the method of Claim 1, but fails to disclose the method 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 causing a second infusion device to initiate a flush of a fluid line providing the fluid delivery from the syringe (New Era, , “Dual Pumps Communications Cable” documentation: pp. 4, “Overlap start of alternate pump”: 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 MedFusion to incorporate the automatic second-pump priming, as taught by New Era, in order to ensure continuous delivery and clear the fluid line without interruption.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights