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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2, 3, 5, and 9, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 5, and 9, recite the limitation "the sensor" in ln 1. Claim 3 recites the limitation “the sensors” in ln 5. Claim 15 recites the limitation "the sensors" in 6. Claim 20 recites the limitation “the sensor” in line 2. There is insufficient antecedent basis for this limitation in the claims. Examiner interprets “the sensor” to refer to the same element as “a flow rate sensor” of claim 1 and 11 or “an in-line flow rate sensor” of 18 for the respective dependent claims. If this interpretation is correct, please replace “the sensor(s)” with “the flow rate sensor(s)” or “the in-line flow rate sensor(s)” as appropriate.
Claim 2 recites the limitation “the sensor comprises two flow rate sensors”. Conventionally, “the sensor” means “one sensor” note “two sensors”. Examiner interprets this limitation to mean that there is an additional flow rate sensor.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 11, 12, and 17-19 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Lee et al (US 20120283630 A1; hereafter Lee630).
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 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 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).
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 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 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).
Regarding claim 12, 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 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 discloses the infusion system of claim 11 as described above and further 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).
Regarding claim 18, Lee630 further discloses a method for administering an infusion fluid into a patient's anatomic space via an infusion fluid path, the method comprising: receiving an in-line flow rate measurement from an in-line flow rate sensor in the infusion fluid path ([0055] controller 60 receives a signal from flow rate sensor 42, an in-line flow sensor); modulating a flow rate of the infusion fluid into the patient's anatomic space to maintain the in- line flow rate measurement within a predefined acceptable range ([0055] controller 60 controls metering clamps 36 to ensure desired dose and flow rate, [0052] flow rate has a range).
Regarding claim 19, Lee630 further discloses the method of claim 18, further comprising: determining at least one of the group of a viscosity, a presence of air inside the fluid path, and a flow rate ([0055] flow rate sensor 42 signals flow rate to controller 60); and error correcting to maintain the flow rate ([0055] controller 60 controls metering clamps 36 to ensure desired dose and flow rate, [0052] flow rate has a range, [0069] processor 61, part of controller 60, may close metering clamp 36 if flow exceeds a set limit).
Claim Rejections - 35 USC § 103
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) 2-4, 15, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee630 in view of Lee et al (US 20140114238 A1; hereafter Lee238).
Regarding claim 2, Lee360 discloses the administration set of claim 1 and further discloses wherein the sensor (flow rate sensor 42) comprises a flow rate sensor within the infusion fluid path ([0055], fig. 2 shown between first portion 12/14 and second portion 22).
Lee630 is silent to a second flow rate sensor.
Lee238, which discloses an infusion set, teaches a sensor comprising two 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) 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 sensor of Lee360 as taught by Lee238 to arrive at the sensor comprising two flow sensors. By having a second flow 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.
Regarding claim 3, Lee630 discloses the administration set of claim 2 and 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 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 Lee238 as applied to claim 2 above discloses wherein another flow rate sensor 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 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 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 sensor in the extension set and the second flow sensor in the needle tube, thus better ensuring successful fluid delivery to the patient.
Regarding claim 4, Lee630 discloses the administration set of claim 1 and 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 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) 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 sensor of Lee360 as taught by Lee238 to arrive at the sensor comprising two flow sensors. By having a second flow 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.
Regarding claim 15, Lee630 discloses the infusion system of claim 11 as described above and 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), with one of the 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 is silent to another flow sensor in the needle tube. Lee238 teaches a sensor comprising two 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 another flow rate sensor (86, fig. 10) disposed in the needle tube (Lee238 shows second sensor 86 in the portion of the fluid line nearest the needle 36), with the 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 sensor of Lee360 as taught by Lee238 to arrive at the sensor comprising two flow sensors. By having a second flow 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.
Regarding claim 16, Lee630 discloses the infusion system of claim 11 as described above and 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 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 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 sensor of Lee360 as taught by Lee238 to arrive at the sensor comprising two flow sensors. By having a second flow 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.
Regarding claim 20, Lee630 further discloses the method of claim 18, further comprising: adjusting the flow rate of the infusion fluid to limit adverse site reactions ([0068] flow rate monitoring increases safety in case of pump 24 failing in an open state; [0055] controller 60 controls metering clamps 36 to ensure desired dose and delivery rate to patient, controller 60 receives signals from flow rate sensor 42; Examiner notes that since an open flow is considered unsafe for the patient, it is understood that open flow could cause adverse site reactions.).
Lee630 is silent to determining internal pressures of a patient’s anatomic space.
Lee238 teaches determining, based on a signal from the sensor, internal pressures of the patient's anatomic space ([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 infusion site).
Claim(s) 5, 14, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee630 in view of Janna et al (US 20100145337 A1; hereafter Janna).
Regarding claim 5, Lee630 discloses the administration set of claim 1 and further discloses wherein the flow rate measurement comprises a resistance measurement ([0066] flow rate sensor 42 may be a differential pressure sensor, deformation of sensing element results in a resistance change which can be used to calculate differential pressure).
Lee630 is silent to the sensor being of the specific types listed.
Janna, also in a medical application involving pressure measurements, in this case an orthopedic implant with sensors, teaches wherein the 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).
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 sensor of Lee630 because the platinum strain gauge is an equivalent structure and Janna motivates the modification by noting that the platinum strain gauge has high durability.
Regarding claim 14, Lee630 discloses the infusion system of claim 11 as described above and further discloses wherein the flow rate measurement comprises a resistance measurement ([0066] flow rate sensor 42 may be a differential pressure sensor, deformation of sensing element results in a resistance change which can be used to calculate differential pressure).
Lee630 is silent to the sensor being of the specific types listed.
Janna, also in a medical application involving pressure measurements, in this case an orthopedic implant with sensors, teaches wherein the in-line flow 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).
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 sensor of Lee630 because the platinum strain gauge is an equivalent structure and Janna motivates the modification by noting that the platinum strain gauge has high durability.
Regarding claim 21, Lee630 further discloses the method of claim 18, wherein the step of receiving the in-line flow rate measurement comprises receiving a resistance measurement ([0066] flow rate sensor 42 may be a differential pressure sensor, deformation of sensing element results in a resistance change which can be used to calculate differential pressure).
Lee630 is silent to the sensor being of the specific types listed.
Janna, also in a medical application involving pressure measurements, in this case an orthopedic implant with sensors, teaches wherein the measurement is received from 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).
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 sensor of Lee630 because the platinum strain gauge is an equivalent structure and Janna motivates the modification by noting that the platinum strain gauge has high durability.
Claim(s) 6-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee630 in view of Barak (US 20020127114 A1; hereafter Barak).
Regarding claim 6, Lee630 discloses the administration set of claim 1 and further discloses comprising: a controller (60) to receive the signal indicative of the flow rate measurement from the flow 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 is silent to the user-input parameter including a flow rate.
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 to include the user-input flow rate as taught by Barak. 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 Barak discloses the administration set of claim 6 and 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 Barak discloses the administration set of claim 6 and 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 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 Barak discloses the administration set of claim 6 and 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 Barak and further of view of Lee238.
Regarding claim 9, Lee630 modified by Barak discloses the administration set of claim 6 but is silent to the sensor signal being used to determine internal pressures. Lee238 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 ([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).
Claim(s) 13 and 22 is/are rejected under 35 U.S.C. 102((a)(1)/(a)(2)) as anticipated by Lee630 or, in the alternative, under 35 U.S.C. 103 as obvious over Lee630 in view of Sundar et al (US 20100211003 A1; hereafter Sundar).
Regarding claim 13, Lee630 discloses the infusion system of claim 11 as described above and 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 discloses the infusion system of claim 11 as described above and 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 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 to use pulse width modulation as taught by Sundar 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.
Regarding claim 22, Lee630 discloses the method of claim 18, and further discloses wherein modulating the flow rate of the infusion fluid into the patient's anatomic space comprises: changing at least one of the group of a pulse repetition frequency of the infusion fluid, a duration of a pulse of the infusion fluid, a pulse width of the infusion fluid, and a period of a pulse of the infusion fluid ([0045] pump 24 is peristaltic, Examiner notes that peristaltic pumps provide pulses of fluid flow as they alternately compress and release a line containing fluid; [0045] pump 24 accurately meters liquid and may provide for a time control of flow through the outlet line; [0003] peristaltic pump element pumps solution controllably to patient)).
Alternatively, regarding claim 22, Lee630 discloses the method of claim 18 but is silent to using pulses to modulate the flow rate.
Sundar teaches wherein modulating the flow rate of the infusion fluid into the patient's anatomic space comprises: changing at least one of the group of a pulse repetition frequency of the infusion fluid, a duration of a pulse of the infusion fluid, a pulse width of the infusion fluid, and a period of a pulse of the infusion fluid ([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).
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 to use pulse width modulation as taught by Sundar 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.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee630 in view of Sundar.
Regarding claim 23, Lee630 discloses the method of claim 18, but is silent to the infusion fluid comprising an antibiotic. Sundar teaches wherein the infusion fluid comprises a chemotherapeutic, antibiotic, or an immunoglobulin ([0006] infusion of antibiotics via an infusion pump).
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 infusion system of Lee630 to administer an antibiotic as taught by Sundar because antibiotics would allow the system to treat bacterial infections, which is a desirable ability for the system to have.
Conclusion
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/11/2025