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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/01/2026 has been entered.
Status of the Claims
Claims 1-3, 5, 11, and 15 are currently amended. Claims 1-17 are currently pending. Claims 1-17 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/01/2026, with respect to the rejection(s) of claim(s) 1 and 11 as currently amended under 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 Therefore, the rejection has been withdrawn.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 Wang et al (US 20090113996 A1).
The amendments to the claims overcome the previous 112 rejections and objections.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 11-12, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 20120283630 A1; hereafter Lee630) in view of Wang et al (US 20090113996 A1; hereafter Wang).
Regarding claim 1, Lee630 discloses an administration set (shown in fig. 1) for delivering an infusion fluid into a patient's anatomic space, the administration set comprising: an infusion fluid path (12, 14. 22, 24 and 26 collectively; fig. 1; [0044] describes fluid line portions) having a first portion (IV lines 12 and 14, [0044], fig. 1) to connect with a source (primary IV bag 16 and secondary IV bag 18, [0044], fig. 1) of the infusion fluid and a second portion (outlet line 22 leading to needle 26 which may be inserted into a patient; [0045], fig. 1) to deliver the infusion fluid into the patient's anatomic space ([0045] infusion fluid delivered to patient);
and a first flow rate sensor (flow rate sensor 42, [0055], fig. 2 shown between first portion 12/14 and second portion 22) disposed in the infusion fluid path between the first and second portion to determine a flow rate measurement of the infusion fluid ([0064] flow rate sensor 42 may consist of a thermal time-of-flight based flow meter using thermal data to calculate the flow rate) and to generate a signal indicative of the flow rate measurement to control the flow rate of the infusion fluid through the fluid path ([0055] controller 60 receives a signal from flow rate sensor 42 and controller 60 ensures desired dose and delivery rate to patient).
Lee630 is silent to wherein the first flow rate sensor determines a flow rate measurement of the infusion fluid using viscosity of the infusion fluid.
Wang, in the art of medical fluid delivery sets, teaches wherein a first flow rate sensor (flow sensor 16, fig. 1, [0102]) disposed in the infusion fluid path between the first and second portion (see fig. 1, first portion of fluid flow path 4 located between the fluid source 6 and flow restrictor 14; second portion of fluid flow path 4 located between the flow restrictor 14 and the patient) to determine a flow rate measurement of the infusion fluid using viscosity of the infusion fluid ([0107] Thus, such viscosity or viscosity dependent constants may be determined by sensing the pressure at the selected locations between the upstream and downstream of the flow restriction before and after valve closure for a known time interval, assuming that temperature during such time interval is constant. Such viscosity may then be used to determine a more accurate measurement of the actual flow rate to the patient and for comparison to the desired flow rate as previously described above).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the infusion system of Lee630 to use the viscosity of the infusion fluid to determine the flow rate measurement, as taught by Wang, since both references deal with flow rate of infusion fluid delivered to a patient. One would have been motivated to make the modification because, as noted by Wang [0107], using the actual sensed viscosity of a fluid to determine the flow rate can “determine a more accurate measurement of the actual flow rate to the patient”. An accurate flow rate measurement is of course desirable to ensure that the patient is receiving the correct amount of infusion fluid as prescribed.
Regarding claim 11, Lee630 discloses an infusion system for delivering an infusion fluid into a patient's anatomic space, the system comprising: a pump (pump 24, fig. 1) to drive infusion fluid from a source of the infusion fluid (primary IV bag 16 and secondary IV bag 18, [0044], fig. 1) into the patient's anatomic space;
an administration set (shown in fig. 1) including: an infusion fluid path (12, 14. 22, 24 and 26 collectively; fig. 1; [0044] describes fluid line portions) having a first portion (portion of line 22 connected to exit of pump 24, [0044], fig. 1) fluidically connected to the pump (pump 24, [0044], fig. 1) and a second portion (portion of outlet line 22 connected to needle 26 which may be inserted into a patient; [0045], fig. 1) to deliver the infusion fluid into the patient's anatomic space ([0045] infusion fluid delivered to patient);
and a first flow rate sensor (flow rate sensor 42, [0055], fig. 2 shown in the infusion fluid path) disposed in the infusion fluid path to determine a flow rate measurement of the infusion fluid ([0064] flow rate sensor 42 may consist of a thermal time-of-flight based flow meter using thermal data to calculate the flow rate) and to generate a signal indicative of the flow rate measurement to control the flow rate of the infusion fluid through the fluid path ([0055] controller 60 receives a signal from flow rate sensor 42 and controller 60 ensures desired dose and delivery rate to patient).
Lee630 is silent to wherein the first flow rate sensor determines a flow rate measurement of the infusion fluid using viscosity of the infusion fluid.
Wang, in the art of medical fluid delivery sets, teaches wherein a first flow rate sensor (flow sensor 16, fig. 1, [0102]) disposed in the infusion fluid path between the first and second portion (see fig. 1, first portion of fluid flow path 4 located between the fluid source 6 and flow restrictor 14; second portion of fluid flow path 4 located between the flow restrictor 14 and the patient) to determine a flow rate measurement of the infusion fluid using viscosity of the infusion fluid ([0107] Thus, such viscosity or viscosity dependent constants may be determined by sensing the pressure at the selected locations between the upstream and downstream of the flow restriction before and after valve closure for a known time interval, assuming that temperature during such time interval is constant. Such viscosity may then be used to determine a more accurate measurement of the actual flow rate to the patient and for comparison to the desired flow rate as previously described above).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the infusion system of Lee630 to use the viscosity of the infusion fluid to determine the flow rate measurement, as taught by Wang, since both references deal with flow rate of infusion fluid delivered to a patient. One would have been motivated to make the modification because, as noted by Wang [0107], using the actual sensed viscosity of a fluid to determine the flow rate can “determine a more accurate measurement of the actual flow rate to the patient”. An accurate flow rate measurement is of course desirable to ensure that the patient is receiving the correct amount of infusion fluid as prescribed.
Regarding claim 12, Lee630 modified by Wang discloses the infusion system of claim 11, as described above. Lee630 further discloses comprising: a fluid flow gate (metering clamps 36, fig. 2) to control the flow rate of the infusion fluid through the infusion fluid path ([0055] controller 60 controls metering clamps 36 to ensure desired dose and flow rate); and a controller (controller 60) to control at least one of the group of the pump and the fluid flow gate ([0055] controller 60 controls metering clamps 36) based upon the signal from the first flow rate sensor ([0055] controller 60 receives a signal from flow rate sensor 42), and wherein the controller is configured to modulate the flow rate of the infusion fluid including to reduce an instantaneous flow rate to zero ([0069] processor 61, part of controller 60, may close metering clamp 36 if flow exceeds a set limit) or to maintain an actual pressure of the infusion fluid within a predetermined acceptable range ([0055] controller 60 ensures desired dose and delivery rate to patient based on signal from flow rate sensor 42).
Regarding claim 17, Lee630 modified by Wang discloses the infusion system of claim 11, as described above. Lee630further discloses wherein the pump comprises an infusion driver selected from one of the group of a constant pressure system, elastomeric pump, gravity system, coil spring pump, variable pressure pump, and electrically powered pump ([0045] pump 24 is a peristaltic pump, implicitly electrically powered; [0006] system may also be used as a gravity flow infusion system).
Claim(s) 2-4, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee630 modified by Wang and further in view of Lee et al (US 20140114238 A1; hereafter Lee238).
Regarding claim 2, Lee630 modified by Wang discloses the administration set of claim 1 and further discloses wherein the first flow rate sensor (flow rate sensor 42) is located within the infusion fluid path ([0055], fig. 2 shown between first portion 12/14 and second portion 22).
Lee630 modified by Wang is silent to a second flow rate sensor.
Lee238, which discloses an infusion set, teaches wherein a first flow rate sensor and a second flow rate sensor ([0041] patient-end of IV tubing 24 may additionally contain a sensor 86 positioned close the patient, sensor 86 similar to sensor 30, shown in fig. 1) are spaced apart a predefined distance within the infusion fluid path (fig. 1 sensor 30 located within the syringe pump, fig. 10 sensor 86 located at the patient end 34 by the hypodermic needle 36, distance is defined by the length of the tubing between the syringe pump and the patient end).
It would have been obvious prior to one of ordinary skill in the art prior to the filing date of the claimed invention to duplicate the flow rate sensor of Lee630 modified by Wang as taught by Lee238 to arrive at a system having two flow sensors spaced apart, since both references deal with monitoring flow of fluid delivered to a patient. One would have been motivated to make the modification because, by having a second flow rate sensor location at the patient insertion site, it is possible to monitor the flow rate at both the controller portion (Lee630 fig. 1 shows metering clamps 36 near flow rate sensor 42) where the flow may be immediately altered if found not to match the target flow rate, but also at the patient insertion site to better monitor the flow rate at which the fluid enters the patient (the point at which the flow rate must match the desired rate in order to ensure the proper fluid volume is being delivered to the patient).
Regarding claim 3, Lee630 modified by Wang and Lee238 discloses the administration set of claim 2, as described above. Lee630 further discloses comprising: an extension set (portion of outlet line 22 between Y-connector 20 and infusion pump 24; [0044], fig. 1-2); and a needle tube (portion of outlet line 22 from infusion pump 24 to needle 26; [0044], fig. 1-2), and wherein one of the first and second flow rate sensors is disposed in the extension set (flow rate sensor 42 located between Y-connector 20 and infusion pump 24, fig. 1-2).
Lee630 modified by Wang and Lee238 as applied to claim 2 above discloses wherein the other one of the first and second flow rate sensors is disposed in the needle tube (Lee238 shows second sensor 86 in the portion of the fluid line between the needle 36 and the pump 10), with the first and second flow rate sensors being spaced apart a predefined distance (predefined distance is the length of tubing between the two sensors).
It would have been obvious prior to one of ordinary skill in the art prior to the filing date of the claimed invention to locate the second sensor at the needle tube, close to the patient as taught by Lee238, since as noted above all references deal with monitoring flow in fluid delivered to a patient. One would have been motivated to make this modification because this would allow a user to better monitor the flow rate at which the fluid enters the patient which would ensure that there was no interruption of flow between the first flow rate sensor in the extension set and the second flow rate sensor in the needle tube, thus better ensuring successful fluid delivery to the patient.
Regarding claim 4, Lee630 modified by Wang discloses the administration set of claim 1, as described above. Lee630 further discloses a flow rate sensor (flow rate sensor 42) within the infusion fluid path ([0055], fig. 2 shown between first portion 12/14 and second portion 22).
Lee630 modified by Wang is silent to a second flow rate sensor.
Lee238, directed to an infusion set, teaches first and second sensors ([0041] patient-end of IV tubing 24 may additionally contain a sensor 86 positioned close the patient, sensor 86 similar to sensor 30, shown in fig. 1) and wherein the sensors are spaced apart a predefined distance within the infusion fluid path (fig. 1 sensor 30 located within the syringe pump, fig. 10 sensor 86 located at the patient end 34 by the hypodermic needle 36, distance is defined by the length of the tubing between the syringe pump and the patient end).
It would have been obvious prior to one of ordinary skill in the art prior to the filing date of the claimed invention to duplicate the flow rate sensor of Lee630 modified by Wang as taught by Lee238 to arrive at a system having two flow sensors spaced apart, since both references deal with monitoring flow of fluid delivered to a patient. One would have been motivated to make the modification because, by having a second flow rate sensor location at the patient insertion site, it is possible to monitor the flow rate at both the controller portion (Lee630 fig. 1 shows metering clamps 36 near flow rate sensor 42) where the flow may be immediately altered if found not to match the target flow rate, but also at the patient insertion site to better monitor the flow rate at which the fluid enters the patient (the point at which the flow rate must match the desired rate in order to ensure the proper fluid volume is being delivered to the patient).
Regarding claim 15, Lee630 modified by Wang discloses the infusion system of claim 11 as described above. Lee630 further discloses comprising: an extension set (portion of outlet line 22 between Y-connector 20 and infusion pump 24; [0044], fig. 1-2); a needle tube (portion of outlet line 22 from infusion pump 24 to needle 26; [0044], fig. 1-2), one or more flow switches (metering clamps 36, fig. 2; [0055] controller 60 controls metering clamps 36 to ensure desired dose and flow rate), and one of the first and second flow rate sensors disposed in the extension set (flow rate sensor 42 located between Y-connector 20 and infusion pump 24, fig. 1-2).
Lee630 modified by Wang is silent to another flow rate sensor in the needle tube.
Lee238, directed to an infusion set, teaches first (30) and second (86) sensors ([0041] patient-end of IV tubing 24 may additionally contain a sensor 86 positioned close the patient, sensor 86 similar to sensor 30, shown in fig. 1), and wherein the other of the first and second flow rate sensors (86, fig. 10) is disposed in the needle tube (Lee238 shows second sensor 86 in the portion of the fluid line nearest the needle 36), with the first and second flow rate sensors being spaced apart a predefined distance (fig. 1 sensor 30 located within the syringe pump, fig. 10 sensor 86 located at the patient end 34 by the hypodermic needle 36, distance is defined by the length of the tubing between the syringe pump and the patient end).
It would have been obvious prior to one of ordinary skill in the art prior to the filing date of the claimed invention to duplicate the flow rate sensor of Lee630 modified by Wang as taught by Lee238 to arrive at the system comprising two flow rate sensors, since all references deal with monitoring flow of fluid delivered to a patient. One would have been motivated to make the modification because, by having a second flow rate sensor location at the patient insertion site, it is possible to monitor the flow rate at both the controller/pump portion (Lee630 fig. 1 shows metering clamps 36 near flow rate sensor 42) where the flow may be immediately altered if found not to match the target flow rate, but also at the patient insertion site to better monitor the flow rate at which the fluid enters the patient. Furthermore, it would make sense to know the distance between the sensors so that the effect of tubing resistance can be monitored and potentially compensated for as necessary to arrive at the appropriate flow rate at the patient insertion site (note Lee630 [0062] notes that the length of the tubing may influence flow rate).
Regarding claim 16, Lee630 modified by Wang discloses the infusion system of claim 11 as described above. Lee630 further discloses a first flow rate sensor (flow rate sensor 42) within the infusion fluid path ([0055], fig. 2 shown between first portion 12/14 and second portion 22).
Lee630 modified by Wang is silent to a second flow rate sensor.
Lee238 teaches a second sensor ([0041] patient-end of IV tubing 24 may additionally contain a sensor 86 positioned close the patient, sensor 86 similar to sensor 30, shown in fig. 1) and wherein the first and second flow rate sensors are disposed in the infusion path and are spaced apart a predefined distance (fig. 1 sensor 30 located within the syringe pump, fig. 10 sensor 86 located at the patient end 34 by the hypodermic needle 36, distance is defined by the length of the tubing between the syringe pump and the patient end).
It would have been obvious prior to one of ordinary skill in the art prior to the filing date of the claimed invention to duplicate the flow rate sensor of Lee630 modified by Wang as taught by Lee238 to arrive at the system comprising two flow rate sensors, since all references deal with monitoring flow of fluid delivered to a patient. One would have been motivated to make the modification because, by having a second flow rate sensor location at the patient insertion site, it is possible to monitor the flow rate at both the controller portion (Lee630 fig. 1 shows metering clamps 36 near flow rate sensor 42) where the flow may be immediately altered if found not to match the target flow rate, but also at the patient insertion site to better monitor the flow rate at which the fluid enters the patient. Furthermore, it would make sense to know the distance between the sensors so that the effect of tubing resistance can be monitored and potentially compensated for as necessary to arrive at the appropriate flow rate at the patient insertion site (note Lee630 [0062] notes that the length of the tubing may influence flow rate).
Claim(s) 5 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee630, in view of Wang et al (US 20090113996 A1; hereafter Wang), in further view of Janna et al (US 20100145337 A1; hereafter Janna).
Regarding claim 5, Lee630 modified by Wang as applied above discloses the administration set of claim 1.
Lee630 modified by Wang is silent to the first flow rate sensor being of the specific types listed.
Janna, also in a medical application involving flow measurements, in this case an orthopedic implant with sensors, teaches wherein a sensor is selected from one of the group of a nano wire of platinum coated with a thin layer of parylene, a spinning wheel sensor, and a platinum wire strain sensor ([0078] platinum strain gauge may be used; [0087] strain gauge may indicate any kind of condition including, but not limited to, strain, pH, temperature, pressure, displacement, flow, acceleration).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the platinum strain gauge taught by Janna in the flow rate sensor of Lee630 modified by Wang because the platinum strain gauge is an equivalent structure, as noted by Janna [0087] which notes that the sensor 12 may be a strain gauge and may indicate temperature, pressure, or flow. Janna [0078] motivates the modification by noting that using a platinum strain gauge may enhance durability and resistance to sterilization and attach by biological fluids.
Regarding claim 14, Lee630 modified by Wang discloses the infusion system of claim 11 as described above.
Lee630 modified by Wang is silent to the first flow rate sensor being of the specific types listed.
Janna, also in a medical application involving flow measurements, in this case an orthopedic implant with sensors, teaches wherein a sensor comprises at least one of the group of a nano wire of platinum coated with a thin layer of parylene, a spinning wheel sensor, and a platinum wire strain sensor ([0078] platinum strain gauge may be used; [0087] strain gauge may indicate any kind of condition including, but not limited to, strain, pH, temperature, pressure, displacement, flow, acceleration), and the flow rate measurement comprises a resistance measurement ([0065]-[0066] strain gauges measure strain based on changes in resistance).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the platinum strain gauge taught by Janna in the flow rate sensor of Lee630 modified by Wang because the platinum strain gauge is an equivalent structure to the flow sensor of Lee630 modified by Wang, as noted by Janna [0087] which notes that the sensor 12 may be a strain gauge and may indicate temperature, pressure, or flow. Janna [0078] motivates the modification by noting that using a platinum strain gauge may enhance durability and resistance to sterilization and attack by biological fluids.
Claim(s) 6-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee630, in view of Wang et al (US 20090113996 A1; hereafter Wang), in further view of Barak (US 20020127114 A1; hereafter Barak).
Regarding claim 6, Lee630 modified by Wang discloses the administration set of claim 1, as described above. Lee630 further discloses comprising: a controller (60) to receive the signal indicative of the flow rate measurement from the first flow rate sensor ([0055] controller 60 receives a signal from flow rate sensor 42 and controller 60 ensures desired dose and delivery rate to patient), and parameters input by a user ([0056] switches 38 used for inputting data to the controller 60, for example selecting solution delivery line);
and a fluid flow gate (metering clamps 36) to control the flow rate of the infusion fluid through the fluid path ([0055] controller 60 controls metering clamps 36 to ensure desired dose and flow rate).
Lee630 modified by Wang is silent to the user-input parameter including a flow rate. Examiner notes that Wang [0050] does describe a patient interface 24 “to allow user programming or setting of a fluid therapy profile”.
Barak, directed to fluid pumping, teaches wherein the parameters include at least one of the group of a pre-set maximum pressure, a pre-set resumption pressure, and a pre-set flow rate ([0038] user interface 14 allows user to input parameters such as a flow rate).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the user inputs of Lee630 modified by Wang to include the user-input flow rate as taught by Barak, since Barak also deals with fluid infusion to a patient. One would have been motivated to make the modification because allowing the user to alter the target flow rate allows for the administration set to be used at a variety of flow rates. The versatility provided by modulating the flow rate is desirable.
Regarding claim 7, Lee630 modified by Wang and Barak discloses the administration set of claim 6, as described above. Lee630 further discloses wherein the controller (controller 60, fig. 3) is a programmable logic controller ([0007] controller executes stored programs, receives signals, and provides electrical signals to the metering clamps) configured to operate the fluid flow gate (metering clamp 36, fig. 2) to control the flow rate of the infusion fluid through the fluid path in a pulsatile manner ([0055] controller 60 controls metering clamps 36 to ensure desired dose and flow rate).
Claim language of “configured to” implies a functional language and the prior art must only be capable of performing the recited function. The controller 60 can open and close the metering clamps 36, and thus is capable of delivering fluid through the flow path in a pulsatile manner.
Regarding claim 8, Lee630 modified by Wang and Barak discloses the administration set of claim 6, as described above. Lee630 further discloses wherein the fluid flow gate (36) comprises at least two gates (two metering clamps 36 shown in fig. 2) configured to turn on and off, and the first flow rate sensor (42) disposed in the infusion path (fig. 2 shows flow rate sensor 42 in the fluid path) is configured to generate a signal indicative of the flow rate measurement to enable the controller to determine at least one of the group of a viscosity, a presence of air inside the fluid path, and a flow rate and error correction ([0055] controller 60 receives a signal from flow rate sensor 42 and controller 60 ensures desired dose and delivery rate to patient).
Claim language of “configured to” implies a functional language and the prior art must only be capable of performing the recited function. Controller 60 receives and signal from the flow rate sensor 42 and manages the flow rate to ensure that it remains on target, thus controller 60 must at least determine the flow rate from the sensor reading and an error correction to maintain the flow rate.
Regarding claim 10, Lee630 modified by Wang and Barak discloses the administration set of claim 6, as described above. Lee630 further discloses wherein the controller (60) is further configured to generate an alarm signal when the flow rate exceeds a maximum flow rate, or when the flow rate fails to meet a minimum flow rate, or when the controller acts upon the fluid flow gate to stop or slow flow of the infusion fluid for patient safety ([0052] speaker 44 can be used to generate an alarm when preset condition is met, such as flow rate out of range; [0055] controller 60 monitors and maintains flow rate).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee630 modified by Wang and Barak and further of view of Lee238.
Regarding claim 9, Lee630 modified by Wang and Barak discloses the administration set of claim 6.
Lee modified by Wang and Barak is silent to the sensor signal being used to determine internal pressures.
Lee238, directed to an infusion system, further teaches wherein the signal received from the sensor is used to determine internal pressures inside the patient's anatomic space to limit adverse site reactions (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) ([0041] sensor 86 measures not only pressure of the fluid medicament but also the pressure fluctuations of the patient’s vascular system carried through liquid 75 to sensor 86, fluid pressure near to patient insertion site is synonymous with internal pressure because the vasculature and the fluid tube are coupled at the insertion site point).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to use the sensor signal of Lee630 modified by Wang and Barak to determine internal pressures inside the patient’s anatomic space to limit adverse site reactions as taught by Lee238 since Lee238 also involves fluid delivery and pressure measurements. One would have been motivated to make the modification because monitoring the flow and pressure at the patient insertion site allows a clinician to better monitor the flow rate at which the fluid enters the patient and understand the actual delivery conditions.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as obvious over Lee630 modified by Wang or, in the alternative, under 35 U.S.C. 103 as obvious over Lee630 modified by Wang and further in view of Sundar et al (US 20100211003 A1; hereafter Sundar).
Regarding claim 13, Lee630 modified by Wang discloses the infusion system of claim 11 as described above. Lee630 further discloses wherein the controller (60) is configured to modulate a flow rate of the infusion fluid based on the signal ([0055] controller 60 receives a signal from flow rate sensor 42) using a pulse width modulation to create an off/on cycle ([0019] controller executes stored program and can pinch off the IV tubes) to control the flow rate of the infusion fluid, and wherein the pulse width includes a time in which the infusion fluid is flowing at a non-zero flow rate to maintain an actual pressure of the infusion fluid within a predetermined acceptable range ([0055] controller 60 ensures desired dose and delivery rate to patient by controlling metering clamps 36; [0052] flow rate has a range).
Claim language of “configured to” implies a functional language and the prior art must only be capable of performing the recited function. The controller 60 controls the metering clamps 36 and can pinch off the tubes, which creates an on/off cycle of flow through each metering clamp with a non-zero flow rate when the clamp is open.
Alternatively, regarding claim 13, Lee630 modified by Wang discloses the infusion system of claim 11 as described above. Lee630 further discloses wherein the controller (60) is configured to modulate a flow rate of the infusion fluid based on the signal ([0055] controller 60 receives a signal from flow rate sensor 42 and manages the flow rate using the metering clamps 36) to control the flow rate of the infusion fluid.
Lee630 modified by Wang is silent to using pulse width modulation.
Sundar, disclosing a precision infusion pump, teaches using a pulse width modulation ([0045]the frequency of drops, measured by measuring the frequency of the pulses, corresponds to the volume flow rate; [0045] the system compensates for variations in drop volumes using the pulse width) to create an off/on cycle and wherein the pulse width includes a time in which the infusion fluid is flowing at a non-zero flow rate ([0045] each time a fluid drop enters the reservoir, the flow rate is non-zero) to maintain an actual pressure of the infusion fluid within a predetermined acceptable range ([0040] controller ensures that pressure reaches and maintains a target value).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the system of Lee630 modified by Wang to use pulse width modulation as taught by Sundar, since Sundar also discloses an infusion pump. One would have been motivated to make the modification because this would allow the system of Lee630 to correct for flow rate differences that may arise from different bag heights. If the IV bag is higher, the fluid pressure prior to the metering clamp 36 may be higher, and so a smaller period of time with the clamp open could allow for the same flow rate to be reached.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 06/23/2026
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