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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 November 2025 has been entered.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 3, 5, 8-11, 13-18, 20, 24, 26-29 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett; Daniel R. et al. (US 20130030262 A1) in view of Nishtala; Vasu et al. (US 20080312550 A1) in view of Biondi; James W. (US 20120095304 A1).
Regarding claim 3, Burnett discloses a system for controlling infusion into a patient body (¶ [0007], a Foley type catheter for sensing physiologic data; ¶ [0026], the data processing apparatus includes a stand-alone console; ¶ [0041], the system may include a fluid infusion apparatus), comprising:
an elongate catheter having one or more openings at or near a distal end of the catheter and further defining a drainage lumen in fluid communication with the one or more openings (¶ [0082], FIGS. 5A-6D … sensing Foley catheter 10; ¶ [0083], A urine drainage lumen 23 has a distal opening 41 that resides in the bladder portion 12 of the catheter);
a controller in communication with the drainage lumen (¶ [0075] In some embodiments, the bedside console or controller is portable and able to travel with the patient; ¶ [0104] Embodiments of the disclosed system and method include automatic pressure tuning by a controller); and
a urine reservoir in fluid communication with the drainage lumen and which is in communication with the controller which is further programmed to monitor a urine output received in the urine reservoir from the patient body (¶ [0073], Embodiments of the urine collecting receptacle 60 may include level or volume sensors 62, as well as other analyte sensors);
a fluid reservoir in fluid communication with an infusion lumen and which is in communication with the controller (¶ [0077], FIG. 3 … A bedside console 80 may integrate patient data, such as fluids received or urine output recorded, and then automate therapeutic infusion in response to these data … The console may also integrate a hydrating or medicinal fluid infusion capability, such as an IV infusion pump, and may adjust infusion rates based on these data or based on data acquired from other sensors automatically);
wherein the controller is further programmed to adjust a flow of fluid from the fluid reservoir into the patient body (¶ [0077], The console may also integrate a hydrating or medicinal fluid infusion capability, such as an IV infusion pump, and may adjust infusion rates based on these data or based on data acquired from other sensors automatically);
based upon the monitored urine output or the physiological pressure (¶ [0077], The console may also integrate a hydrating or medicinal fluid infusion capability, such as an IV infusion pump, and may adjust infusion rates based on these data or based on data acquired from other sensors automatically; ¶ [0086], all methods associated with processing and responding to pressure-based physiologic data, as described for embodiments with a pressure-sensing balloon, are enabled).
Burnett teaches the invention substantially as claimed by Applicant except for a controller that adjusts a pressure level in the drainage lumen, a venting mechanism and a controller programmed to predict acute kidney injury. Nishtala discloses urine collection devices, systems and methods (¶ [0006], [0010], [0013], [0051] FIG. 1 shows an example of a urine collection device 100; ¶ [0073], FIG. 4, the urine collection device 400; ¶ [0079], urine collection system 600);
comprising an elongate catheter having one or more openings at or near a distal end of the catheter and further defining a drainage lumen in fluid communication with the one or more openings (¶ [0052], Foley catheter 120);
a controller in communication with the drainage lumen and which is programmed to periodically adjust a pressure level within the drainage lumen to clear obstructions at predefined intervals of time (¶ [0074], The urinary collection device shown in FIG. 4 also includes a pump 425 that can draw urine from the tubing and into the meter and receptacle; ¶ [0079], FIG. 6 … A pump 615 is also included in order to draw urine from the tubing 625 into the meter 601 and receptacle 640; ¶ [0085] Any appropriate pump may be used. For example, the pump may operate by applying positive pressure (blowing) or negative pressure (suction); ¶ [0086], the pump may be activated (turned on and/or off) either manually or automatically … the pump may include a timer so that it runs for some predetermined time period; ¶ [0089], FIG. 8 shows an impeller-type pump 800 … rotation of the impeller blade draws a vacuum that pulls urine down the tubing 805 in the direction shown 807; ¶ [0090], The pump may draw (e.g., by negative pressure or vacuum) or push (by positive pressure) fluid through the tubing. The pump may be activated when urine is present in the tubing and inactivated when urine is no longer in the tubing);
wherein the pressure level is automatically increased and maintained until the obstruction is cleared after which the pressure level is then reduced automatically (¶ [0013], a pump configured to move urine through the tubing … The pump may be controlled either automatically, manually or both. In some variations, the pump may be controlled by a sensor that detects urine within the tubing; ¶ [0086], In some variations, the pump is connected to a sensor that can control the operation of the pump. For example, the sensor may detect fluid within the tubing (or a region of the tubing, e.g., near the catheter), and may activate the pump. In some variations, the pump is controlled by a controller. The controller can include hardware, software, or any combination thereof, for controlling the operation of any portion of the urine collection system, such as the pump, meters, and other sensors, air inlet/outlet valves, etc);
a venting mechanism coupled to the drainage lumen, the venting mechanism configured to pass air from an environment and directly into the venting mechanism when a negative pressure is applied to the venting mechanism by the controller to clear any obstructions (¶ [0085], The pump may be associated with one or more air inlet valve to prevent suction from entering a subject's catheter. For example, an appropriate air inlet (or outlet) valve may include a one-way valve or air inlet port located near the catheter/tubing interface (e.g., near one end of the tubing). In some variations, the urine collection system includes multiple air inlet/outlet valves to help regulate the pressure within the urine collection system);
a urine reservoir in fluid communication with the drainage lumen (¶ [0052], an outlet or drain 105 that connects to a flushable pouch 107 or other removal system; ¶ [0058], In some variations, the urine collection system includes an outlet having a check valve interface for coupling to a receiving device (e.g., a flushable pouch or other transfer container); ¶ [0074], FIG. 4 … The receptacle is shown as a collapsible bag 475; ¶ [0079], FIG. 6 … receptacle 650, or drainage bag; ¶ [0080] FIG. 7 … Either the transfer container 710 or the flushable bag 715 may be attached to the outlet valve 635 to empty urine from the receptacle for disposal); and
which is in communication with the controller which is further programmed to monitor a urine output received in the urine reservoir from the patient body (¶ [0051], For example, the expandable container can include a sensor that detects the level of urine within the receptacle, so that it may be indicated; ¶ [0069] The meter can also determine the flow rate of urine from the catheter. Thus, the meter can include a sensor for detecting the flow rate of urine. The meter can determine the amount of urine entering the urine collection device over a known time by including a timer with a calibrated measurement region).
Nishtala prevents urine from pooling or stagnating in a catheter or tube by actively propelling it through the system (¶ [0007], The urine collection devices described herein are adapted to prevent retention of urine within the tubing … a pump for moving urine through the tubing and into a receptacle; ¶ [0082] In general, the flow of urine from the subject (e.g., a catheter in a subject) into the urine collection system may be facilitated by actively moving urine through the system. In some variations, a pump may be used to move urine within at least a portion of the collection system). One would be motivated to modify Burnett with Nishtala’s controller and venting mechanism in order to reduce the risk of pooling in the catheter. For example, Burnett describes a customized lumen shape that discourages fluid droplets from obstructing the lumen (¶ [0111], a custom extrusion and lumen shape may also be used to prevent obstruction in the case of liquid and/or air-filled lumens … a lumen that is stellate in cross sectional profile … hydrophobic walls). Therefore, it would have been obvious to modify Burnett with Nishtala’s controller and venting mechanism in order to prevent urine from pooling or stagnating.
Burnett and Nishtala do not explicitly program the controller to predict acute kidney injury. Biondi discloses a system for displaying a patient clinical status (¶ [0004], [0007], [0018], FIG. 1, a patient 10 is monitored by a number of physiologic patient monitors, generally 20);
comprising a controller programmed to analyze patient data obtained from the patient (¶ [0018], Each of these monitors 20 produces one or more signals which are input signals to a processor 40);
and from other patients (¶ [0028], Thus, the setting of an alarm based on rate of change of a parameter may vary according to the baseline of the individual patient, the patient population or the experience of the clinician);
including the urine output and one or more additional parameters (¶ [0005]-[0007], the plurality of patient parameters comprise temperature, blood pressure, pulse rate, respiration rate, blood oxygen level, respiration tidal volume, expired respiratory gas, urine output, clinical blood chemistries, or other clinical signs or clinical parameters);
to compile aggregated patient data (¶ [0028], Thus, the setting of an alarm based on rate of change of a parameter may vary according to the baseline of the individual patient, the patient population or the experience of the clinician);
such that the controller determines one or more trends or relationships based on a combination of the urine output and the one or more additional parameters as a predictor of acute kidney injury of the patient (¶ [0040] Referring to FIG. 9, renal failure can be monitored in real-time by analyzing a renal failure profile which can include, for example, urinary output (UO), blood urea nitrogen (BUN), creatinine (Creat), and blood pressure (BP)).
Biondi warns a caregiver when the patient’s risk for renal failure crosses a threshold (¶ [0040], A renal failure alarm triggers when a predetermined threshold is crossed). A skilled artisan would have been able to modify Burnett and Nishtala with Biondi’s AKI prediction model by installing Biondi’s AKI prediction model on Burnett’s controller. One would be motivated to modify Burnett and Nishtala with Biondi’s AKI prediction model since Burnett calls for monitoring a patient’s kidney function (¶ [0036], For example, embodiments of the system may be used to monitor clinical parameters relevant to kidney function or diabetes). Therefore, it would have been obvious to modify Burnett and Nishtala with Biondi’s AKI prediction model in order to more closely monitor the patient’s kidney function.
Regarding claim 24, Burnett discloses a method of controlling infusion into a patient body (¶ [0042], a method for monitoring physiologic data from the urinary tract of a patient; ¶ [0076], Some embodiments of the system may also have an intravenous infusion capability (see FIG. 3)), comprising:
receiving urine into one or more openings defined at or near a distal end of an elongate catheter and through a drainage lumen defined through the elongate catheter (¶ [0082], FIGS. 5A-6D … sensing Foley catheter 10; ¶ [0083], A urine drainage lumen 23 has a distal opening 41 that resides in the bladder portion 12 of the catheter);
collecting the urine within a urine reservoir which is in fluid communication with the drainage lumen and monitoring a urine output received within the urine reservoir via the controller (¶ [0073], Embodiments of the urine collecting receptacle 60 may include level or volume sensors 62, as well as other analyte sensors);
infusing a flow of fluid from a fluid reservoir and into the patient body through an infusion lumen (¶ [0077], The console may also integrate a hydrating or medicinal fluid infusion capability, such as an IV infusion pump, and may adjust infusion rates based on these data or based on data acquired from other sensors automatically); and
adjusting the flow of fluid from the fluid reservoir based upon the monitored urine output (¶ [0077], The console may also integrate a hydrating or medicinal fluid infusion capability, such as an IV infusion pump, and may adjust infusion rates based on these data or based on data acquired from other sensors automatically; ¶ [0086], all methods associated with processing and responding to pressure-based physiologic data, as described for embodiments with a pressure-sensing balloon, are enabled).
Burnett teaches the invention substantially as claimed by Applicant except for an accelerometer and a venting mechanism that clears obstructions. Nishtala discloses urine collection devices, systems and methods (¶ [0006], [0010], [0013], [0051] FIG. 1 shows an example of a urine collection device 100; ¶ [0073], FIG. 4, the urine collection device 400; ¶ [0079], urine collection system 600);
comprising: receiving urine into one or more openings defined at or near a distal end of an elongate catheter and through a drainage lumen defined through the elongate catheter (¶ [0010], methods of collecting urine from a subject having a urinary catheter (e.g., a Foley catheter); ¶ [0052], Foley catheter 120; ¶ [0081], The urinary collection devices described herein may be attached to a urinary catheter (e.g., a Foley catheter) so that urine may flow into the urinary collection device);
collecting the urine within a urine reservoir which is in fluid communication with the drainage lumen (¶ [0052], an outlet or drain 105 that connects to a flushable pouch 107 or other removal system; ¶ [0058], In some variations, the urine collection system includes an outlet having a check valve interface for coupling to a receiving device (e.g., a flushable pouch or other transfer container); ¶ [0074], FIG. 4 … The receptacle is shown as a collapsible bag 475; ¶ [0079], FIG. 6 … receptacle 650, or drainage bag; ¶ [0080] FIG. 7 … Either the transfer container 710 or the flushable bag 715 may be attached to the outlet valve 635 to empty urine from the receptacle for disposal);
monitoring a urine output received within the urine reservoir via a controller (¶ [0051], For example, the expandable container can include a sensor that detects the level of urine within the receptacle, so that it may be indicated; ¶ [0069] The meter can also determine the flow rate of urine from the catheter. Thus, the meter can include a sensor for detecting the flow rate of urine. The meter can determine the amount of urine entering the urine collection device over a known time by including a timer with a calibrated measurement region); and
periodically adjusting a pressure level within the drainage lumen via the controller by venting air from an environment and directly into a venting mechanism (¶ [0085], The pump may be associated with one or more air inlet valve to prevent suction from entering a subject's catheter. For example, an appropriate air inlet (or outlet) valve may include a one-way valve or air inlet port located near the catheter/tubing interface (e.g., near one end of the tubing). In some variations, the urine collection system includes multiple air inlet/outlet valves to help regulate the pressure within the urine collection system);
when a negative pressure is applied to the venting mechanism which is in communication with the drainage lumen to clear obstructions within the drainage lumen ¶ [0074], The urinary collection device shown in FIG. 4 also includes a pump 425 that can draw urine from the tubing and into the meter and receptacle; ¶ [0079], FIG. 6 … A pump 615 is also included in order to draw urine from the tubing 625 into the meter 601 and receptacle 640; ¶ [0085] Any appropriate pump may be used. For example, the pump may operate by applying positive pressure (blowing) or negative pressure (suction); ¶ [0089], FIG. 8 shows an impeller-type pump 800 … rotation of the impeller blade draws a vacuum that pulls urine down the tubing 805 in the direction shown 807; ¶ [0090], The pump may draw (e.g., by negative pressure or vacuum) or push (by positive pressure) fluid through the tubing. The pump may be activated when urine is present in the tubing and inactivated when urine is no longer in the tubing);
at predefined intervals of time (¶ [0086], the pump may be activated (turned on and/or off) either manually or automatically … the pump may include a timer so that it runs for some predetermined time period).
wherein the pressure level is automatically increased and maintained until the obstruction is cleared after which the pressure level is then reduced automatically (¶ [0013], a pump configured to move urine through the tubing … The pump may be controlled either automatically, manually or both. In some variations, the pump may be controlled by a sensor that detects urine within the tubing; ¶ [0086], In some variations, the pump is connected to a sensor that can control the operation of the pump. For example, the sensor may detect fluid within the tubing (or a region of the tubing, e.g., near the catheter), and may activate the pump. In some variations, the pump is controlled by a controller. The controller can include hardware, software, or any combination thereof, for controlling the operation of any portion of the urine collection system, such as the pump, meters, and other sensors, air inlet/outlet valves, etc).
Nishtala actively propels urine through a collection system in order to prevents pooling or stagnating (¶ [0007], [0082]). Regarding the rationale and motivation to modify Burnett with Nishtala’s venting mechanism and controller, see the discussion of claim 3 above.
Burnett and Nishtala do not program the controller to predict acute kidney injury. Biondi discloses a system for displaying a patient clinical status (¶ [0004], [0007], [0018], FIG. 1, a patient 10 is monitored by a number of physiologic patient monitors, generally 20);
comprising a controller programmed to analyze patient data obtained from the patient (¶ [0018], processor 40);
and from other patients (¶ [0028], Thus, the setting of an alarm based on rate of change of a parameter may vary according to the baseline of the individual patient, the patient population or the experience of the clinician);
including the urine output and one or more additional parameters (¶ [0005]-[0007], the plurality of patient parameters comprise temperature, blood pressure, pulse rate, respiration rate, blood oxygen level, respiration tidal volume, expired respiratory gas, urine output, clinical blood chemistries, or other clinical signs or clinical parameters);
to compile aggregated patient data (¶ [0028], Thus, the setting of an alarm based on rate of change of a parameter may vary according to the baseline of the individual patient, the patient population or the experience of the clinician);
such that the controller determines one or more trends or relationships based on a combination of the urine output and the one or more additional parameters as a predictor of acute kidney injury of the patient (¶ [0040] Referring to FIG. 9, renal failure can be monitored in real-time by analyzing a renal failure profile which can include, for example, urinary output (UO), blood urea nitrogen (BUN), creatinine (Creat), and blood pressure (BP)).
Biondi warns a caregiver when the patient’s risk for renal failure crosses a threshold (¶ [0040]). Regarding the rationale and motivation to modify Burnett and Nishtala with Biondi’s AKI prediction model, see the discussion of claim 3 above.
Regarding claims 5, 8 and 26, Burnett does not explicitly disclose a one-way valve or a controller programmed to apply negative pressure at predefined intervals of time. Nishtala discloses a system and method wherein the venting mechanism comprises a one-way valve which is configured to prevent fluid from exiting the drainage lumen (¶ [0085], The pump may be associated with one or more air inlet valve to prevent suction from entering a subject's catheter. For example, an appropriate air inlet (or outlet) valve may include a one-way valve or air inlet port located near the catheter/tubing interface (e.g., near one end of the tubing));
wherein the controller is further programmed to apply a negative pressure to the drainage lumen at the predefined intervals of time (¶ [0086], the pump may be activated (turned on and/or off) either manually or automatically … the pump may include a timer so that it runs for some predetermined time period).
Nishtala actively propels urine through a collection system in order to prevents pooling or stagnating (¶ [0007], [0082]). Regarding the rationale and motivation to modify Burnett with Nishtala’s venting mechanism and controller, see the discussion of claim 3 above.
Regarding claims 9-11, 13-18, 20, 27-29 and 31-33, Burnett discloses a system and method wherein the fluid from the fluid reservoir comprises a hydrating fluid or medication, wherein the controller is programmed to automatically adjust the flow of fluid based on the monitored urine output (¶ [0076], Some embodiments of the system may also have an intravenous infusion capability (see FIG. 3) to provide use sensed data to regulate delivery of fluids or medicinal agents such as a diuretic drug, by way of an automated system based on the urine output feedback);
the controller is programmed to adjust the flow of fluid based on a semi-closed loop feedback of the monitored urine output (¶ [0077], The console may also integrate a hydrating or medicinal fluid infusion capability, such as an IV infusion pump, and may adjust infusion rates based on these data or based on data acquired from other sensors automatically);
the controller is further configured to store patient data in a memory component or wherein the system is configured to transfer the patient data to a remote database (¶ [0076], Embodiments of the system may include a docking station for the urine collecting receptacle, the docking station being configured for data transmission to a data receiving and processing apparatus such as a bedside console or a networked central computer);
the urine reservoir comprises a cassette component having a rigid housing; wherein the controller is configured to receive and interface with the cassette component (¶ [0073] FIGS. 1-4 … a urine receptacle 60 (holding a urine output 61), a docking station 65 to hold the receptacle; ¶ [0079], Embodiments of the receptacle may connect to a docking station through electrical contacts);
the controller is further programmed to sense one or more physiological parameters of the patient comprising a respiratory rate or a heart rate (¶ [0085], Embodiments thus further equipped are capable of delivering other forms of physiologic data, as for example, blood pressure, oxygen saturation, pulse oximetry, EKG).
Regarding the limitation of a cassette component having a rigid housing, Burnett calls for a urine receptacle and a docking station (¶ [0073], urine receptacle 60 … docking station 65; ¶ [0076], a docking station for the urine collecting receptacle; ¶ [0079], Embodiments of the receptacle may connect to a docking station through electrical contacts). This implies a need for a rigid housing. In contrast, a non-rigid housing would not be capable of reliably connecting to the docking station or its electrical contacts.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett, Nishtala and Biondi in view of Lampotang; Samsun et al. (US 20130172840 A1).
Regarding claims 6 and 7, Burnett, Nishtala and Biondi are silent whether the venting mechanism comprises a hydrophobic membrane including PTFE or ePTFE. Lampotang discloses a venting or bypass system (¶ [0037], [0039], [0063], [0121], FIGS. 13A and 13B, a venting collar 130 can be used to vent a drainage tube 100 to atmosphere);
wherein the venting system comprises a vent having a hydrophobic membrane which is configured to transmit gas but not liquid therethrough, comprising a hydrophobic membrane comprises a PTFE or ePTFE membrane (¶ [0117], An example of a hydrophobic gas-permeable membrane is PTFE membrane with 0.2 micron pores such as that used in the Millipore syringe filter (SLFG025NS); ¶ [0121], vent port 133 (covered with a gas-permeable membrane)).
Lampotang constructs a filter membrane from a well-known and easily obtained material. One would be motivated to modify Burnett, Nishtala and Biondi with Lampotang’s PTFE membrane to select a commercially available filter material.
Claims 12 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett, Nishtala and Biondi in view of Gelfand; Mark et al. (US 20060235353 A1).
Regarding claims 12 and 30, Burnett, Nishtala and Biondi do not explicitly disclose an open-loop control system. Gelfand discloses a patient hydration system and method (¶ [0002], [0035], [0036], [0059] Patient hydration system 10), comprising:
an elongate catheter (¶ [0060], catheter 14 (e.g., a Foley catheter);
a controller (¶ [0062] Electronic controller 22);
a urine reservoir (¶ [0061], urine collection chamber 52 on scale 50 is connected to catheter 14 via tubing 16);
a fluid reservoir (¶ [0059], source 24 of infusion fluid 26 (e.g., saline));
wherein the fluid from the fluid reservoir comprises a medication (¶ [0061], diuretic administration system 60 including a source 62 of a diuretic such as furosemide … tubing 66 can be connected to the patient P via hydration I.V. 30 using standard clinical techniques);
wherein the controller is programmed to adjust the flow of fluid based as an open loop (¶ [0082], the urine output measurement is sharply varying and the controller can be programmed to control the infusion pump to hydrate the patient at a preset minimum infusion rate, for example, 1 milliliter per hour per kilogram of patient body weight).
Gelfand demonstrates how to dispense fluids at a predetermined rate. One would be motivated to modify Burnett, Nishtala and Biondi with Gelfand’s open-loop control protocol to dispense a predictable volume of fluid to a patient, independently of measurements. Therefore, it would have been obvious to modify Burnett, Nishtala and Biondi with Gelfand’s open-loop control in order to deliver a fixed volume of fluid according to a preset schedule.
Claims 21-23 and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Burnett, Nishtala and Biondi in view of Lichtenstein; Eric S. (US 4370983 A), with incorporation of Lichtenstein ‘762; Eric S. (US 3774762 A).
Regarding claims 21-23 and 35-38, Burnett, Nishtala and Biondi lack a light transmitter and receiver and a controller further programmed to analyze one or more wavelengths. Lichtenstein discloses an apparatus for monitoring and control of medical, diagnostic and therapeutic procedures (col. 2, lines 40-55; col. 5, lines 50-65, medical drainage and irrigation procedures including monitoring or urinary output), comprising:
a urine reservoir (col. 17, lines 35-50, Right side 94 of interface 62 (FIG. 4) can accept a module (not shown) designed either for taking a fluid from a patient say through a tube in groove 107 or infusing a fluid into a patient, say through a tube in groove 108 … production of urine by a patient can be determined);
a controller (col. 9, lines 30-40, FIG. 1 illustrates an arrangement of the apparatus in which signals are received from various sensors by microcomputer, hereinafter termed MC);
programmed to monitor a urine output received in the urine reservoir from a patient body (col. 22, lines 45-55, The results of the reaction with the reagent or reagents can be noted in a variety of ways, the combination of light source 141 and photoelectric cell 142 exemplifying a spectrophotometric method which can be controlled by the microcomputer 101);
the controller is further programmed to sense one or more physiological parameters of the patient comprising a respiratory rate or a heart rate (col. 11, lines 35-40, Depending on the condition of the patient, it may also be essential to monitor his pulse rate, breathing rate);
further comprising a light transmitter and receiver in proximity to the reservoir, wherein the reservoir defines an optically clear section; wherein the receiver is in communication with the controller which is further programmed to detect one or more wavelengths transmitted through the urine reservoir and through a volume of the urine contained within (col. 22, lines 50-55, the combination of light source 141 and photoelectric cell 142 exemplifying a spectrophotometric method which can be controlled by the microcomputer 101);
wherein the controller is further programmed to analyze the one or more wavelengths for a presence of bacteria, red blood cells, plasma, or white blood cells as indicative of an infection (col. 22, lines 30-40, the patient's physiological status being monitored by microcomputer 101 through sensor 136 which may be noting any or a number of variables indicative of the condition of the patient).
Lichtenstein automatically detects problems based on analyzing a patient’s urine, and also reduces the risk of infection by constructing the system as a disposable module (col. 30, lines 1-15). One would be motivated to modify Burnett, Nishtala and Biondi with Lichtenstein’s cassette component, light transmitter and receiver to avoid introducing contaminants or to detect an existing infection, since Burnett calls for an embodiment including an optical volume sensor (¶ [0037], Embodiments of the fluid volume measuring systems may include any of a weight-sensitive system, a fluid height sensing system, a mechanical mechanism, or an optically-sensitive system). Burnett also calls for a sensor that detects bacteria or blood (¶ [0038], analyte sensors may be sensitive to any one or more analytes selected from a group consisting of bacteria, blood, hemoglobin). Therefore, it would have been obvious to modify Burnett, Nishtala and Biondi with Lichtenstein’s light transmitter and receiver in order to reduce the risk of causing a UTI, and to respond quickly if the patient develops a UTI or other abnormal condition.
Response to Arguments
Applicant’s arguments filed 13 November 2025 regarding the rejection of claims 3, 5-18, 20-24, 26-33 and 35-38 as amended, under 35 USC § 103 over Burnett, Nishtala, Mendels, Lampotang, Gelfand, Lichtenstein and Lichtenstein ‘762, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Burnett, Nishtala, Biondi, Lampotang, Gelfand, Lichtenstein and Lichtenstein ‘762 (see above).
Applicant’s arguments regarding Mendels have been considered but are moot because the reference is no longer cited in the current rejection.
Applicant submits that independent claim 3 has been amended to recite "wherein the controller is further programmed to analyze patient data … as a predictor of acute kidney injury of the patient" (remarks p. 8). Applicant notes that independent claim 24 has been similarly amended (remarks p. 8). Examiner responds that Burnett, Nishtala and Biondi are cited in the new grounds of rejection as teaching all features of amended claims 3 and 24. Biondi discloses a system that collects a patient’s data via multiple sensors, and then predicts a risk of kidney injury (¶ [0040], FIG. 9, renal failure can be monitored in real-time … A renal failure alarm triggers when a predetermined threshold is crossed).
Applicant asserts that on the other hand, none of the cited references teach or disclose where the controller is programmed to analyze patient data … to compile aggregated patient data … as a predictor of acute kidney injury of the patient, as presently claimed (remarks p. 8). Examiner notes that Biondi’s system predicts kidney disease based on data from the individual patient in addition to the patient population or the experience of the clinician (¶ [0028]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rosen; Richard et al. US 20060025931 A1
Goodson; Harry B. et al. US 20080221551 A1
Pereira-Kamath; Nikhil L. et al. US 20090306625 A1
Wang; Exing et al. US 20130116518 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781