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 .
Response to Amendment
Applicant has amended claims 23-25 including claim 25 which was previously rejected under 35 U.S.C. §112(a) and §112(b); Examiner accordingly withdraws the previous rejection of claims 25 under 35 U.S.C. §112(a) and §112(b).
Claims 1-19 and 21-25 remain pending.
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) 1, 3-4, 6, 8-10, 12-16, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nackaerts et al. (US 20180200431, henceforth Nackaerts) in view of Handler et al. (US 20190183362, henceforth Handler, previously made of record).
Regarding claim 1, Nackaerts discloses a monitoring system for a gravity infusion IV tubing (see system of fig. 2), the system comprising: a drip chamber (interior 204 of drop chamber 202, fig. 2) having an inlet (fluid input 208, fig. 2) configured to receive fluid from a fluid source (fluid reservoir 228, fig. 2) and an outlet (fluid output 210, fig. 2) configured to deliver fluid towards a patient ([0048]); a pressure sensor (pressure sensor 216, fig. 2) pneumatically coupled with the drip chamber ([0065], since the fitting is external and requires coupling which relates to gas, it is a pneumatic coupling; Examiner notes that pneumatic is defined by Merriam-Webster as “of, relating to, or using gas”), the pressure sensor configured to measure the pressure inside the drip chamber ([0052]); a controller (flow rate device 218, fig. 2) configured to receive pressure measurements from the pressure sensor ([0053] and [0054]) and to use the pressure measurements with the counting of a number of drops ([0067]) entering the drip chamber from the fluid source ([0067]). Nackaerts additionally discloses that the number of drops are counted by a drop detector (drop detector 212, see at least [0049] and [0051]) which can have different sensing modalities (see [0049] and [0051] which list drop detector 212 as measuring capacitance in a particular embodiment).
Nackaerts does not explicitly disclose that the pressure sensor is used to count the number of drops. Handler teaches that pressure sensors can be used as IV drop counter sensors ([0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the pressure sensor of Nackaerts for the drop detection functionality of the drop detector 212 in Nackaerts as Handler teaches that pressure sensors are known to be usable as drop detectors and counters and because using a pressure sensor instead of a capacitance sensor would have yielded the same, predictable result of drops being detected within the drip chamber and used for counting.
Regarding claim 3, Nackaerts as modified by Handler (henceforth Nackaerts as modified) discloses the monitoring system wherein the drip chamber has a cover (exterior surface 206 is a cover for interior 204 of drop chamber 202, see [0049] and fig. 2) with a pneumatic tube (the tube which is shown in fig. 2 as connecting pressure sensor 216 and interior 204 of chamber 202 is a pneumatic tube as it connects the gas in the drop chamber between the elements) coupling the drip chamber with the pressure sensor (see fig. 2).
Regarding claim 4, Nackaerts as modified discloses the monitoring system wherein each drop corresponds to a repeating cycle of pressure measurements (see fig. 3 and [0077] – fig. 3 shows a distinct rising and falling sawtooth pattern which could have a processing applied to it by the controller such as to enable drop detection in the modified device).
Regarding claim 6, Nackaerts as modified discloses the monitoring system wherein the controller is configured to determine an occlusion in the IV tubing ([0075]) distal to the drip chamber ([0075], note that the downline tubing as disclosed is distal to drop chamber 202 which comprises interior 204) from the pressure measurements ([0075] and [0067], flow rate is determined by pressure measurements and is used to determine obstructions in downline tubing).
Regarding claim 8, Nackaerts as modified discloses the monitoring system wherein the controller is configured to determine a flow rate into the drip chamber (convert the current number of fluid drops into a flow rate as in [0018] where the drops are entering the chamber and thus flowing into the drip chamber) using the pressure measurements ([0018] and [0067]).
Regarding claim 9, Nackaerts as modified discloses the monitoring system wherein the controller is configured to determine a flow rate out of the drip chamber (flow of fluid exiting the drop chamber, [0070]) using the pressure measurements ([0067]).
Regarding claim 10, Nackaerts as modified discloses the monitoring system wherein the controller is configured to determine a change in relative position of a head height of the fluid in the fluid source relative to the patient ([0060] and [0061]).
Regarding claim 21, Nackaerts as modified discloses the monitoring system wherein the fluid source container is flexible (see [0049], the fluid source container is the fluid source of claim 1 which is mapped to fluid reservoir 228 in the rejection of claim 1 above, and fluid reservoir 228 is a bag as in [0049]; see also the exemplary fluid reservoir of fig. 1 which is a bag as shown which is known to be flexible).
Regarding claim 22, Nackaerts as modified discloses the monitoring system wherein the controller is configured to detect a repeating cycle of a small pressure increase followed by a small pressure decrease (see fig. 3, there is a clear trend shown in the sawtooth pattern of first waveform 302 which is a small increase followed by a small decrease in the measured pressure) corresponding to drop formation (see [0077], the increase in pressure corresponds to a growth in formation of one drop) and to use the detected pressure cycles to count a number of drops entering the drip chamber from the fluid source (since Nackaerts [0077] discloses that the increasing pressures of waveform 302 correspond to formation of a drop and since Handler [0051] teaches that pressure waveforms can be used for counters, it is understood that the modified device would have counted the formations of single drops to have achieved this claimed counting).
Regarding claim 12, Nackaerts discloses a method of monitoring a gravity infusion IV tubing (see fig. 2), the method comprising: providing: a drip chamber (drop chamber 202, fig. 2) having an inlet (fluid input 208, fig. 2) configured to receive fluid from a fluid source (fluid reservoir 228, fig. 2) and an outlet (fluid output 210, fig. 2) configured to deliver fluid towards a patient ([0048]); a pressure sensor (pressure sensor 216, fig. 2) pneumatically coupled with the drip chamber ([0065], since the fitting is external and requires coupling which relates to gas, it is a pneumatic coupling; Examiner notes that pneumatic is defined by Merriam-Webster as “of, relating to, or using gas”), the pressure sensor configured to measure the pressure inside the drip chamber ([0052]); a controller (flow rate device 218, fig. 2) configured to receive pressure measurements from the pressure sensor ([0053] and [0054]); and using the pressure measurements with a counting of a number of drops ([0067]) entering the drip chamber from the fluid source ([0067]). Nackaerts additionally discloses that the number of drops are counted by a drop detector (drop detector 212, see at least [0049] and [0051]) which can have different sensing modalities (see [0049] and [0051] which list drop detector 212 as measuring capacitance in a particular embodiment) and that pressure measurements in the drop chamber include a repeating cycle of a small pressure increase followed by a small pressure decrease (see fig. 3, there is a clear trend shown in the sawtooth pattern of first waveform 302 which is a small increase followed by a small decrease in the measured pressure).
Nackaerts does not explicitly disclose that the pressure sensor is used to count the number of drops. Handler teaches that pressure sensors can be used as IV drop counter sensors ([0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the pressure sensor of Nackaerts for the drop detection functionality of the drop detector 212 in Nackaerts as Handler teaches that pressure sensors are known to be usable as drop detectors and counters and because using a pressure sensor instead of a capacitance sensor would have yielded the same, predictable result of drops being detected within the drip chamber and used for counting. Thus, in the modified method, Nackaerts as modified by Handler would disclose the detecting of a small pressure increase followed by a small pressure decrease (since this is the trend shown for waveform 302 in fig. 3 of Nackaerts and described as a sawtooth pattern in [0077], it is understood that this pattern would be used for the detecting in the modified method).
Regarding claim 13, Nackaerts as modified by Handler (henceforth Nackaerts as modified) discloses the method further comprising determining a flow rate out of the drip chamber (flow of fluid exiting the drop chamber, [0070]) as a function of the pressure measurements ([0067]).
Regarding claim 14, Nackaerts as modified discloses the method further comprising providing an alarm ([0046]) when the determined flow rate deviates by more than a pre-determined amount from a selected flow rate ([0046]).
Regarding claim 15, Nackaerts discloses as modified the method further comprising: determining a head height of the fluid source ([0060]).
Regarding claim 16, Nackaerts as modified discloses the method further comprising: providing a warning (alarm of [0074] is a warning) if an empty fluid source condition is imminent (minimum fluid supply of [0074] is the same as an imminent empty fluid source). {Examiner notes that since the limitation “providing an indication of a time left until the drug container is empty” is listed as optional where the claim says or, it is not required.}
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Nackaerts et al. (US 20180200431, henceforth Nackaerts) in view of Handler et al. (US 20190183362, henceforth Handler) as applied to claim 1 above, and further in view of Davis et al. (US 20130102974, henceforth Davis).
Regarding claim 2, Nackaerts as modified discloses the monitoring system comprising the drip chamber (interior 204 of drop chamber 202, fig. 2) having air in it (see [0063]) which is physically capable of entering the patient line (since the air in interior 204 of drop chamber 202 is not filtered out by a membrane, it could travel through fluid output 210 into a patient).
Nackaerts as modified does not disclose the monitoring system further comprising: an air blocking membrane distal to the drip chamber, the air blocking membrane configured to mitigate air from passing through the air blocking membrane and entering the patient line. Davis teaches a monitoring system comprising an air blocking membrane (membrane 66, fig. 1) distal to a drip chamber (interior of drip chamber 40, fig. 1; see fig. 1, membrane 66 is downstream of drip chamber 40 as it is the distal end of it), the air blocking membrane configured to mitigate air from passing through the air blocking membrane and entering the patient line ([0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the membrane of Davis to the system of Nackaerts for preventing air from leaving the drip chamber and getting into the patient conduit (Davis [0034]), as intravenous infusion of air and hazardous vapors trapped within it can cause dangerous side effects including death (Davis [0003]).
Claims 5, 7, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Nackaerts et al. (US 20180200431, henceforth Nackaerts) in view of Handler et al. (US 20190183362, henceforth Handler) as applied to claim 1 above, and further in view of Carlisle et al. (US 20140350511, henceforth Carlisle).
Regarding claim 5, Nackaerts as modified discloses the monitoring system wherein the controller is configured to determine an occlusion in the IV tubing from the pressure measurements ([0075]).
Nackaerts as modified does not disclose the monitoring system wherein the controller is configured to determine an occlusion in the fluid source proximal to the drip chamber from the pressure measurements. Carlisle teaches a monitoring system (system of fig. 1) comprising a controller (controller 150, fig. 1) configured to determine an occlusion in a fluid source (see [0131], [0139], the occlusion upstream is at fluid source 130 similar to the arrangement of Nackaerts) proximal to a drip chamber (see fig. 1, where proximal means upstream) from pressure measurements (see [0131] and [0139], impedance is found from pressure measurements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used pressure measurements for calculations to determine presence of occlusions in the fluid source as in Carlisle ([0139]) for the benefit of increased usability as the occlusion detection can be used for alarms (Carlisle [0005] and [0130]).
Regarding claim 7, Nackaerts as modified is silent as to the sensitivity of the pressure sensor. Carlisle teaches that highly sensitive pressure sensors can be used to detect presence of air bubbles since air bubbles can prevent proper infusion ([0014]), and that maximizing sensitivity is ideal ([0147] and [0158]).
Although Nackaerts has not specified an exact sensitivity for the pressure sensor that it uses, the fact that it uses a pressure sensor and that Carlisle teaches that maximization of sensitivity as beneficial (Carlisle [0147] and [0158]) demonstrates that one of ordinary skill in the art would be able to determine the optimum value of the pressure sensor sensitivity as it is a result effective variable which contributes to the operation of the device. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a pressure sensor with a sensitivity as claimed to offer increased resolution of measurement and allow for detection of air bubbles since air bubbles can prevent proper infusion (Carlisle [0147], [0159], [0014]), and further since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 23, Nackaerts as modified discloses that pressure inside of the drip chamber causes an effect on the size of the drops (see [0040] and [0067]).
Nackaerts as modified does not discloses the monitoring system wherein the controller is configured to control a pneumatic generator to selectively apply a positive or negative pressure to the drip chamber to regulate fluid flow by modulating internal pressure of the drip chamber. Carlisle teaches the use of controller (controller 150, fig. 1) to control a pneumatic generator (pneumatic drive 101, fig. 1 and [0072]) to selectively apply a positive or negative pressure (see [0016], [0053], [0067]) to a drip chamber (see chambers 171 and 172, fig. 1 and [0053]) to regulate fluid flow by modulating internal pressure of the drip chamber ([0053], the regulation of fluid flow includes removal of bubbles).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the pneumatic drive system of Carlisle to the monitoring system of Nackaerts for management and elimination of air bubbles (see Carlisle [0016], [0020], [0053], and [0067]) and for maintaining a more consistent and reliable droplet size since the pressure could be maintained more consistently (see Nackaerts [0067], droplet size can be set based on pressure in the drop chamber – if the pressure is more consistent because it is maintained with a pneumatic generator, the droplet size would also be more consistent in turn). Such a modified system would include the addition of the flexible membrane 175 of Carlisle to the drip chamber of Nackaerts such as to allow for proper air transfer.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Nackaerts et al. (US 20180200431, henceforth Nackaerts) in view of Handler et al. (US 20190183362, henceforth Handler) as applied to claim 1 above, and further in view of Kamen et al. (WO 2013096909, henceforth Kamen).
Regarding claim 11, Nackaerts as modified discloses the monitoring system of claim 1.
Nackaerts as modified does not disclose the monitoring system wherein the controller is configured to determine a remaining time of the infusion as a function of the fluid from the fluid source to be delivered. Kamen teaches a monitoring system (system of fig. 1) wherein a controller (PCB 3002 which includes control processors, which is understood to be present in the chosen system and is equivalent to the controller of Nackaerts) is configured to determine a remaining time of infusion as a function of remaining liquid to be delivered ([001018], time parameter input field is remaining time of infusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have calculated the amount of time remaining in the infusion such that an alarm can be triggered when the infusion is almost complete but prior to completion to allow the caregiver the time needed to prepare materials needed to continue the infusion if necessary (Kamen [001019]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Nackaerts et al. (US 20180200431, henceforth Nackaerts) in view of Handler et al. (US 20190183362, henceforth Handler) as applied to claim 12 above, and further in view of Davis et al. (US 20130102974, henceforth Davis).
Regarding claims 17, Nackaerts as modified discloses the monitoring system comprising the drip chamber (interior 204 of drop chamber 202, fig. 2) having air in it (see [0063]) which is physically capable of entering the patient line (since the air in interior 204 of drop chamber 202 is not filtered out by a membrane, it could travel through fluid output 210 into a patient). Nackaerts further discloses providing, via program code, providing a positive pressure to the drip chamber (see [0070], positive pressure is formed when flow control device 224 is actuated and is controlled by computing unit 220 as shown in fig. 2) in various events such as when determining that the fluid source is emptying within a pre-defined time period (minimum fluid supply or fluid reservoir empty 228 as in [0074], which would be determined by measuring hydrostatic pressure by fully blocking flow as in [0071]), to prevent further fluid from flowing from the fluid source into the drip chamber and thus block fluid flow from the fluid source ([0071]).
Nackaerts as modified does not disclose the monitoring system further comprising: an air blocking membrane distal to the drip chamber, the air blocking membrane configured to mitigate air from passing through the air blocking membrane and entering the patient line. Davis teaches a monitoring system comprising an air blocking membrane (membrane 66, fig. 1) distal to a drip chamber (interior of drip chamber 40, fig. 1; see fig. 1, membrane 66 is downstream of drip chamber 40 as it is the distal end of it).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the membrane of Davis to the system of Nackaerts for preventing air from leaving the drip chamber and getting into the patient conduit (Davis [0034]), as intravenous infusion of air and hazardous vapors trapped within it can cause dangerous side effects including death (Davis [0003]).
The positive pressure delivered by Nackaerts via the use of flow control device 224 is low enough to not pass through an air blocking membrane because it is simply providing pressure by blocking flow and allowing the forces of fluid flowing from reservoir 228 to create pressure inside of interior 204 of drop chamber 202; this is not enough pressure to force contents through the added membrane of Davis as it is simply a blocking motion to provide positive pressure and does not provide added pressure such as to reverse flow of contents.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Nackaerts et al. (US 20180200431, henceforth Nackaerts) in view of Handler et al. (US 20190183362, henceforth Handler) and Davis et al. (US 20130102974, henceforth Davis).
Regarding claim 18, Nackaerts discloses a computer program product (flow rate device 218, fig. 2) for use on a computer system (first fluid flow device 200 is a computer system since it includes computing unit 220, see fig. 2) for monitoring liquid delivery ([0048]), the computer program product comprising a tangible, non-transitory computer usable medium (microcontroller or microprocessor of [0072]) having computer readable program code thereon (firmware or software of [0072]; note that all arrows shown in fig. 2 denote connections to computing unit 220 and are thus considered to be relationships controlled by said firmware or software), the computer readable program code comprising: program code for causing a pressure sensor pneumatically coupled with a drip chamber to measure pressure within the drip chamber (pressure sensor 216 is pneumatically coupled with a drip chamber which is interior 204 of drop chamber 202 and measures pressure of said drip chamber as in [0052], see also fig. 2 and [0065]); program code for determining that a drop is formed in the chamber ([0054]); program code for calculating a flow rate into the chamber as a function of the measured pressure (convert the current number of fluid drops into a flow rate as in [0018] where the drops are entering the chamber and thus flowing into the drip chamber); and program code for calculating a flow rate out of the chamber as a function of the measured pressure (flow of fluid exiting the drop chamber, [0070]; see also [0053]). Nackaerts additionally discloses the program code using the pressure measurements with the counting of a number of drops ([0067]) entering the drip chamber from the fluid source ([0067]) and further that the number of drops are counted by a drop detector (drop detector 212, see at least [0049] and [0051]) which can have different sensing modalities (see [0049] and [0051] which list drop detector 212 as measuring capacitance in a particular embodiment).
Nackaerts does not explicitly disclose that the program code is meant to determine that a drop is formed in the chamber as a function of the measured pressure or that the pressure sensor is used to count the number of drops. Handler teaches that pressure sensors can be used as IV drop counter sensors ([0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the pressure sensor of Nackaerts for the drop detection functionality of the drop detector 212 in Nackaerts as Handler teaches that pressure sensors are known to be usable as drop detectors and counters and because using a pressure sensor instead of a capacitance sensor would have yielded the same, predictable result of drops being detected within the drip chamber and used for counting. Thus, in the modified apparatus of Nackaerts and Handler, the computer program product would determining that a drop is formed in the chamber as a function of the measured pressure since the pressure measurements are what is used for the drop detector.
Nackaerts as modified by Handler additionally discloses the monitoring system comprising the drip chamber (interior 204 of drop chamber 202, fig. 2) having air in it (see [0063]) which is physically capable of entering the patient line (since the air in interior 204 of drop chamber 202 is not filtered out by a membrane, it could travel through fluid output 210 into a patient). Nackaerts as modified by Handler further discloses providing, via program code, providing a positive pressure to the drip chamber (see [0070], positive pressure is formed when flow control device 224 is actuated and is controlled by computing unit 220 as shown in fig. 2) in various events such as when determining that the drug container is emptying within a pre-defined time period (minimum fluid supply or fluid reservoir empty 228 as in [0074], which would be determined by measuring hydrostatic pressure by fully blocking flow as in [0071]), to prevent further fluid from flowing from the drug container into the drip chamber and thus block fluid flow from the drug container ([0071]).
Nackaerts as modified by Handler does not disclose the monitoring system further comprising: an air blocking membrane distal to the drip chamber, the air blocking membrane configured to mitigate air from passing through the air blocking membrane and entering the patient line. Davis teaches a monitoring system comprising an air blocking membrane (membrane 66, fig. 1) distal to a drip chamber (interior of drip chamber 40, fig. 1; see fig. 1, membrane 66 is downstream of drip chamber 40 as it is the distal end of it).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the membrane of Davis to the system of Nackaerts for preventing air from leaving the drip chamber and getting into the patient conduit (Davis [0034]), as intravenous infusion of air and hazardous vapors trapped within it can cause dangerous side effects including death (Davis [0003]).
The positive pressure delivered by Nackaerts via the use of flow control device 224 is low enough to not pass through an air blocking membrane because it is simply providing pressure by blocking flow and allowing the forces of fluid flowing from reservoir 228 to create pressure inside of interior 204 of drop chamber 202; this is not enough pressure to force contents through the added membrane of Davis as it is simply a blocking motion to provide positive pressure and does not provide added pressure such as to reverse flow of contents.
Regarding claim 19, Nackaerts as modified discloses the computer program product further comprising: program code for determining a downstream occlusion ([0075], note that the downline tubing as disclosed is distal to drop chamber 202 which comprises interior 204). {Examiner notes that since the limitation “determining an upstream occlusion” is listed as optional where the claim says or, it is not required.}
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nackaerts et al. (US 20180200431, henceforth Nackaerts) in view of Handler et al. (US 20190183362, henceforth Handler) as applied to claim 1 above, and further in view of Addiego et al. (US 20200114072, henceforth Addiego).
Regarding claim 24, Nackaerts as modified discloses the monitoring system wherein the controller is configured to detect a downstream occlusion ([0075]).
Nackaerts as modified does not disclose the monitoring system wherein the controller is configured to differentiate between an upstream occlusion and a downstream occlusion based on detecting a pressure decrease or pressure increase trend, respectively, within the drip chamber. Addiego teaches a monitoring system (pump system 100, fig. 1) comprising a drip chamber (drip chamber 130, fig. 1) and using a pressure sensor (pressure sensor 140B, fig. 1) and a controller (controller 105, fig. 1) which is configured to differentiate between an upstream occlusion (upstream occlusion, [0020] and [0025]) and a downstream occlusion (backflow, [0020], [0029]) based on detecting a pressure decrease (see [0025], an upstream occlusion can be detected via the presence of vacuum, which is a pressure decrease from an expected, normal pressure, see also [0032]) or pressure increase (see [0008], a backflow causes an increase in fluid level within the chamber, and see [0032] which teaches that an upstream occlusion which causes a decrease in fluid level is measured as a decrease in measured pressure; thus it is considered to be taught that to maintain the same positive relationship, an increase in fluid level within the chamber as in a backflow would cause an increase in the measured pressure as claimed) trend, respectively (see also [0004], [0022], and [0029] which note more generically that pressure sensors can be used to detect upstream occlusions and backflows).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the controller of Nackaerts to differentiate between an upstream occlusion and a downstream occlusion based on pressure change trends within the drip chamber as claimed for the benefit of being able to provide specific alarms to indicate to the user as to the exact issues that the infusion system is having (see Addiego [0042]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nackaerts et al. (US 20180200431, henceforth Nackaerts) in view of Handler et al. (US 20190183362, henceforth Handler) as applied to claim 1 above, and further in view of Nakayama (Introduction to Fluid Mechanics, Nakayama et al. from 1998, henceforth Nakayama).
Regarding claim 25, Nackaerts as modified discloses the monitoring system wherein the controller is configured to determine a height of the fluid to be delivered from the fluid source (see [0060]-[0063] and see the rejections of claim 25 under 35 U.S.C. 112 above) based on observed changes in hydrostatic pressure over time (see [0061] and [0062], the height is used over time in comparison with empty and full reservoir boundary conditions), and to calculate a remaining volume of fluid based on the dynamically determined height (see [0062]-[0063], an estimated volume of fluid remaining can be determined based on the pressures and height of the fluid). Nackaerts additionally discloses that pressure changes can be nonlinear depending on the type of container that the fluid to be infused is held in (see [0083]-[0084], Nackaerts discloses a pressure decrease profile which displays distinct infusion stages when a bag is used as the fluid container), or that the fluid container can have a more constant shape (see [0049], the fluid container can be a bottle or a bag).
Nackaerts as modified does not explicitly disclose the monitoring system wherein the controller is configured to determine a surface area of the fluid yet to be delivered from the fluid source, or that this surface area is used to determine the remaining volume of fluid to be delivered. However, mathematically, the controller of Nackaerts is capable of determining the surface area of the fluid as it is disclosed to be measuring volumetric flow rate (see at least [0081]), the change in height of the fluid over time ([0060]-[0063]), calculating the volume remaining in the infusion (see [0062]-[0063]), and further dividing volumetric flow rate by head height changes over time to yield the surface area to be infused which can be an indicator of amount of fluid remaining in an alternative determination method (see [0090]-[0094] of Applicant’s specification as provided in US 20220118178). Such a set of calculations and thermodynamic relationships including the use of surface area in said calculations are further described in Nakayama (see pgs. 66-69, including Torricelli’s theorem on pg. 67 and the substitution of a surface area of a circle for area in pg. 68 in the instance where the fluid container is a cylinder, surface area could be calculated using the controller of Nackaerts since all other variables in the equations of 5.26-5.28 are known using the measurements or disclosed calculations of Nackaerts).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the controller of Nackaerts as modified to determine a surface area of the fluid to be delivered from the fluid source to calculate a remaining volume of fluid based on the dynamically determined surface area as claimed and as shown in the mathematical relationships of Nakayama since these are obvious equivalent calculations where they use the same measured variables and can be used to calculate the same resultant outcomes and the relationships between these variables are known as shown in Nakayama and further since substituting the direct method of calculating volume of Nackaerts with the calculations of Nakayama using surface area would yield the same, predictable result of determining the volume remaining in the infusion as a result of calculations made using volumetric flow rate and pressures to indicate fluid height which changes over time.
Additionally, Examiner notes that there does not appear to be any criticality placed on the surface area computation in Applicant’s specification, but rather it is simply used as an intermediate step in the determination of time remaining for the infusion, which further demonstrates that Nackaerts as modified renders the claimed controller configuration obvious.
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive.
Applicant has argued that (1) Nackaerts does not disclose or suggest pressure-based drop counting, (2) Handler does not teach pressure-based drop detection, (3) that a combination of Nackaerts and Handler would not have yielded a predictable result or the claimed result, and (4) that the claimed invention is a distinct and unrecognized use of pressure sensing. Examiner respectfully disagrees.
Regarding argument 1, Examiner notes that the rejection above does not rely on Nackaerts for pressure based sensing. Nackaerts [0077] discloses that pressures in the waveform 302 correspond to drop size and that spikes in the waveform correspond to forming and falling of drops. Nackaerts [0067] also discloses that drop detection and counting is used; while a capacitive sensor is used in Nackaerts for this drop detection, it does not appear that the apparatus of Nackaerts would be rendered nonfunctional by using a different sensor for drop detection.
Regarding argument 2, Handler [0051] explicitly teaches that IV drop counters can be configured from pressure sensors. While the methodology of drop detection in the controller of Handler may be different from that in Applicant’s disclosure, those processing steps are not claimed.
Regarding argument 3, Examiner respectfully disagrees. Nackaerts teaches a pressure sensor which is capable of detecting size variations in drops in an IV chamber and shows a waveform which has a sawtooth pattern resulting from drop formation and falling, and thus Examiner is of the position that the pressure sensor is capable of being used for drop detection since the sensor is used to detect differences in the size of individual drops already. Additionally, since drop detection is already a part of the system of Nackaerts, it is the Examiner’s position that using a different sensor for drop detection would have yielded a predictable result of a system with drop detection. The modification of using the pressure sensor for drop detection would have then yielded the invention as claimed since each of the claim limitations are all met by the modified device as indicated in the rejection above.
Regarding argument 4, Examiner respectfully disagrees as Nackaerts as modified by Handler yields an apparatus meeting each claim limitation as indicated in the body of the rejection above.
Thus, Applicant’s arguments are respectfully found unpersuasive and the claims are rejected as indicated above.
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 SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/ Examiner, Art Unit 3783
/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783