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 .
Acknowledgments
This office action is in response to the reply filed on 6/3/26. In the reply, the applicant amended claims 1-8, 10-11. Claims 1-11 are pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keith et al. (US 9,480,794) (“Keith”). Keith discloses:
(claim 1) an infusion device (Title; Abstract) comprising: a pump (Col. 4, Lns. 19-21, a pump controller 105 that delivers a pulse of medication fluid to a patient via a fluid path such as tubing 110) comprising a chamber of fluid (Col. 4, Lns. 21-23, the pump controller 105 includes a fluid reservoir 115 containing the medication fluid), and a pump mechanism configured to control dispensing of a volume of fluid from the chamber during a dispense stroke (Col. 5, Lns. 35-37, The pump controller also includes a servo controller 230 for actuating a servo motor 235 for driving the piston 120 to cause fluid to flow from the fluid reservoir 115); a pump measurement device configured to generate pump measurements indicative of pressure (Col. 5, Lns. 39-42, the pump controller 105 may also include a servo sensor 240 to detect pressure applied to the piston during piston 120 movement during medication delivery): and a processing device configured to analyze one or more of the pump measurements obtained during a portion of the dispense
stroke (Col. 4, Lns. 62-66, The fluid detector 125 then communicates the measurement results to the pump controller 105, which uses the fluid measurements to determine if the medication fluid is sufficiently flowing in the fluid path and being delivered to the patient), and pause the pump mechanism during the dispense stroke when one or more of the pump measurements during the portion of the dispense stroke satisfies a designated metric related to a designated pre-occlusion pressure (Col. 13, Lns. 5-11, the fluid feedback device may be configured to stop the medical fluid communication, such as an IV delivery system for example. In the event that the fluid feedback device determines that there is a flow deviation that may affect the patient, the fluid feedback device provides an alarm to indicate that the flow deviation exists; Col. 13, Lns. 37-44, a flow deviation is detected at step 1220, the example process 1200 generates an alarm to indicate that a flow deviation is occurring at step 1225. In other examples, the medical fluid communication may be discontinued at step 1225. After generating the alarm at step 1225 or if the no flow deviation is detected at step 1220, the example process 1200 determines if medication delivery continues at step 1230).
Claim 2: the processing device is configured to control the pump mechanism to resume the dispense stroke (Fig. 5 shows the operation cycle).
Claim 3: the processing device is configured to obtain another pump measurement during the dispense stroke resumed after the pause (Fig. 5 shows the operation cycle), and to pause the pump mechanism again when the pump measurement satisfies a designated metric related to a designated pre-occlusion pressure (Fig. 5 shows the operation cycle; Col. 13, Lns. 41-48, after generating the alarm at step 1225 or if the no flow deviation is detected at step 1220, the example process 1200 determines if medication delivery continues at step 1230. If the medical fluid communication continues, the example process returns to step 1215 to continue measuring and monitoring the flow of the medication fluid. If the medication delivery has ended at step 1230, the example process ends).
Claim 4: the processing device is configured to control the pump mechanism to resume the dispense stroke again (Fig. 5 shows the operation cycle; Col. 13, Lns. 41-48, after generating the alarm at step 1225 or if the no flow deviation is detected at step 1220, the example process 1200 determines if medication delivery continues at step 1230. If the medical fluid communication continues, the example process returns to step 1215 to continue measuring and monitoring the flow of the medication fluid. If the medication delivery has ended at step 1230, the example process ends).
Claim 5: the number of times the processing device pauses the dispense stroke and resumes the dispense stroke can be preconfigured, or dynamically determined, based on criteria chosen from pump motor current, pump motor voltage, encoder count, pump motor drive count, pump motor drive time, dispense stroke energy, volume of the chamber, type of fluid in the chamber, and ambient air pressure (Fig. 5 shows the operation cycle; Col. 13, Lns. 41-48, after
generating the alarm at step 1225 or if the no flow deviation is detected at step 1220, the example process 1200 determines if medication delivery continues at step 1230. If the medical fluid communication continues, the example process returns to step 1215 to continue measuring and monitoring the flow of the medication fluid. If the medication delivery has ended at step 1230, the example process ends).
Claim 6: the frequency with which the processing device pauses and resumes the dispense stroke can be constant or vary throughout the dispense stroke or within designated portions of the dispense stroke (Col. 12, Lns. 7-14, the medication delivery system is sensitive to changes in pressure over a short period of time by relying on recent pressure data to determine if suitable amounts of fluid are being delivered. Thus, the medication delivery system reduces the time to detect occlusions by using recent pressure data in conjunction with higher sensitivity to the actual fluid pressure apart from forces present in the fluid delivery mechanism).
Claim 7: the processing device is configured to perform a feedback loop of obtaining pump measurements and slowing down or speeding up the dispense stroke based on the pump measurements (Col. 13, Lns. 1-5, The fluid feedback device is configured to receive information from the fluid detector 125, process the information to determine if a flow deviation is occurring that could affect the treatment of the patient and provide an indication if a flow deviation is occurring; Col. 13, Lns. 23-26, the fluid feedback device transmits an instruction to the fluid detector 125 to begin measuring the fluid and begins receiving measurements from the fluid detector at step 1215).
Claim 8: the pump measurement is motor current (Col. 10, Lns. 6-12, the pump controller 105 compares current pressure measurements in a medication delivery interval with relevant information to determine if an occlusion is occurring. FIG. 7 illustrates a graph of example pressure measurements in an exemplary medication delivery system 100 during delivery of medication to a patient and illustrates different techniques to determine if an occlusion occurs). and the pump measurement device comprises a current sensing device configured to detect motor current of the pump during the dispense stroke (Col. 10, Lns. 6-30).
Claim 9: the pump is chosen from a positive displacement pump, and a syringe-style pump (Fig. 1 shows the pump 105 as a positive displacement and syringe-style pump).
Claim 10: the designated metric relates to a designated pre-occlusion pressure is chosen from a range of measurements corresponding to pressures above normal pump operating pressures (Col. 9, Lns. 45-51, After calculating the weighted pressure "weight", the example process 600 compares the current minimum pressure to a predetermined threshold pressure "thresh" (e.g., 3 psi) at step 615. In the event that the minimum pressure exceeds the threshold pressure "thresh" the example process 600 determines that an occlusion is occurring at step 620 and exits), and below a minimum leak pressure (Col. 9, Lns. 45-51), and different from transient pressures related to pump start up or pump stroke state change (Col. 10, Lns. 6-12, the pump controller 105 compares current pressure measurements in a medication delivery interval with relevant information to determine if an occlusion is occurring. FIG. 7 illustrates a graph of example pressure measurements in an examplary medication delivery system 100 during delivery of medication to a patient and illustrates different techniques to determine if an occlusion occurs).
Claim 11: the processing device is configured to obtain at least an additional pump measurement during the pause (Fig. 12 shows a secondary measurement of 1220 in between cycles 1225 and 1230), and controls the pump mechanism to resume the dispense stroke when the additional pump measurement corresponds to a normal pump operating pressure and fails to satisfy the designated metric related to a designated pre-occlusion pressure (Col. 10, Lns. 6-12, the pump controller 105 compares current pressure measurements in a medication delivery interval with relevant information to determine if an occlusion is occurring. FIG. 7 illustrates a graph of example pressure measurements in an examplary medication delivery system 100 during delivery of medication to a patient and illustrates different techniques to determine if an occlusion occurs).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues that Keith’s “medication delivery interval” is not a stroke such that in Keith the system does not start a pulse and then resume it during an interval. Applicant admits that Keith at most describes a measurement at beginning of a pulse in an interval and later in interval after the pulse is completed. Applicant argues that Keith does not describe pausing during a pulse in an interval or pausing during a dispense stroke of a pump mechanism. Examiner disagrees. If there are multiple pulses or measurements during the interval then there is a pause as the pause for pressure measurement determines whether the next pulse occurs in interval or the interval ends and the process continues on to occlusion determination 525, see Fig. 5, C7L4-31. As applicant described, Keith does disclose measurement in interval, this is at step 510 (Fig. 5). If the delivery interval has not expired the process of medication delivery continues, therefore the processing device does analyze the pump measurements during a portion of the dispense stroke. Rejections maintained.
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 DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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