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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). A certified copy of Parent Application 113117523, filed in Taiwan on 13 May 2024 has been received.
Claim Objections
The claims contain minor informalities.
In claim 9, the language “… issuing [[an]] a first alert message from an alert notifier of a monitoring device …” should be changed for clarity.
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 1-3, 5, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Jones; Jill Walthall et al. (US 20230083906 A1) in view of Perkins; James T. (US 20100134303 A1) in view of Conley; Eric et al. (US 20220330867 A1) in view of Benammar; Mohieddine et al. (US 20160271304 A1).
Regarding claim 1, Jones discloses a drainage bottle monitoring system for monitoring the accumulated liquid in a drainage bottle (¶ [0003], an automated urinary output monitoring system; ¶ [0037] FIG. 1 … system 100);
the system comprising: a measuring device having a housing portion for accommodating the drainage bottle (¶ [0037], The system 100 generally includes a urine collection assembly 105, a scale 140, a system module (module) 150, and a vacuum pump (pump) 131); and
the measuring device comprising: a level sensor for detecting the liquid level height of a liquid in the drainage bottle, thereby obtaining liquid level height information (¶ [0057], the container 110 may include one or more sensors 119 configured to detect … a fluid level within the container 110. In some embodiments, the one or more sensors 119 may include pressure sensors that are positioned so as to determine a pressure of the urine at the bottom of the container 110, where the pressure of the urine is related to a depth of the urine within the container 110, and where a volume of the urine may be calculated from the depth … the one or more sensors 119 may include ultrasound emitters, ultrasound sensors, capacitive sensors, or the like to indicate a liquid level of the urine within the container 110);
a weight sensor disposed at the bottom of the housing portion of the measuring device for measuring a weight of the drainage bottle and a weight of the liquid in the drainage bottle, thereby obtaining weight information (¶ [0037] The scale 140 is generally configured to determine a weight urine collected within the container and communicate the weight to the system module 150 which depicts information pertaining to the weight or volume of the urine collected in the container on a display 150A of the module 150; ¶ [0056], The scale 140 may be configured to generate weight data … to transmit the weight data to the module console 152 and the module console 152 may be configured to depict the weight data (one or more weight values or volume values) on the display 150A; ¶ [0065] In some embodiments, the weight value correlation logic 162 may be configured to correlate each weight value with a volume of urine within the container 110); and
a transmission device set within the measuring device and signal-connected to the level sensor and the weight sensor for transmitting the liquid level height information and the weight information (¶ [0056], The scale 140 may be configured to transmit the weight data to the module console 152 and the module console 152 may be configured to depict the weight data (one or more weight values or volume values) on the display 150A);
a monitoring device communication-connected to the transmission device for receiving the liquid level height information and the weight information, and the monitoring device comprising: a computing processor (¶ [0064] FIG. 4 … the module console 152 includes one or more processors 154 … and a number of logic modules);
for calculating the actual liquid volume in the drainage bottle based on the liquid level height information and the weight information (¶ [0057], the one or more sensors 119 may include ultrasound emitters, ultrasound sensors, capacitive sensors, or the like to indicate a liquid level of the urine within the container 110, where a volume of the urine may be calculated from the liquid level; ¶ [0066], the pressure sensor logic 170 calculate the volumes of the urine based on the pressure values. In some embodiments, the fluid level sensor logic 172 may be configured to receive one or more liquid level values from the one or more sensors 119 and in some embodiments, the fluid level sensor logic 172 calculate the volumes of the urine based on the fluid level values; ¶ [0076], For example, the rate of urine output may be determined by dividing the weight of the second amount of urine by the defined deactivation time period to calculate the rate of urine output by weight; ¶ [0077], In some embodiments, depicting the volume may include calculating the volume of the urine within the final collection container based on the weight); and
an alert notifier communication-connected to the computing processor and issuing an alert message when the liquid level height or the actual liquid volume exceeds a preset value (¶ [0066] In some embodiments, the alert logic 174 may be configured to transmit an alert to the display 150A, the external computing device, or the electronic medical record system whenever the pressure within the container 110 falls outside of a pre-determined or user defined threshold. In some embodiments, the alert logic 174 may be configured to transmit an alert to the module 150 whenever the urine volume within the container 110 reaches a pre-determined or user defined level, such as a capacity of the container 110, for example).
Jones lacks an optical sensor comprising light emitting units and multiple light receiving units. Perkins discloses a fluid level sensing assembly comprising: a measuring device having a housing portion for accommodating a bottle (¶ [0001], [0016], [0020], one embodiment of a fluid level sensor device 100, shown in FIGS. 1-4 … The container 102 is a rigid walled container having an interior volume 104; ¶ [0030] In a second embodiment of a fluid level sensor assembly 200, shown in FIGS. 5, 6, and 7); and
the measuring device comprising: an optical sensor disposed on sidewalls within the housing portion of the measuring device, having multiple transmitting-receiving units for detecting the liquid level height of a liquid in the bottle, thereby obtaining liquid level height information; wherein each of the transmitting-receiving units comprises a light emitting unit and multiple light receiving units (¶ [0021], The linear light source 120 may alternatively comprise … a single light source having a plurality of light emitters in a linear arrangement for emitting light from a plurality of different vertical positions, which emitters extend approximately the length of the side wall 106 (as shown in FIG. 7, for example); ¶ [0025] In operation, the linear light source 120 acts as an emitter to emit light while the vertically arranged light sensor array 130 acts as receiver; ¶ [0031], The light source 220 is positioned vertically relative to the side wall 206, and may comprise … a single light source having a plurality of light emitters in a linear arrangement for emitting light from a plurality of different vertical positions, which emitters extend approximately the length of the side wall 106, as shown in FIG. 7; ¶ [0034], the linear light source 220 acts as an emitter to emit light while the vertically arranged light sensor array 230 acts as receiver);
a monitoring device comprising: a computing processor for calculating the actual liquid volume in the bottle based on the liquid level height information (¶ [0029] The circuit 190 may comprise a voltage source "V" and a processor or other component configured to receive an input from the sensor array 130, which provides an output indicative of the level of infusion fluid; ¶ [0037] The linear light source 220 and light sensor array 230 are connected to a circuit 290 that monitors the output of different portions of the light sensor array 230 … The circuit 290 may comprise a voltage source "V" and a processor … which provides an output indicative of the level of infusion fluid).
Perkins explains how to measure fluid with a non-contact sensor. One would be motivated to modify Jones with Perkins’s light emitting units and multiple light receiving units to measure a liquid height with a known sensor since Jones calls for measuring the urine height with one or more known sensors (¶ [0057], the one or more sensors 119 may include ultrasound emitters, ultrasound sensors, capacitive sensors, or the like to indicate a liquid level of the urine within the container 110). Therefore, it would have been obvious to modify Jones with Perkins’s optical sensor in order to measure a liquid height with a known non-contact sensor.
Jones and Perkins do not explicitly calculate a liquid error. Conley discloses systems for urine collection and associated methods and devices (¶ [0002], [0022], [0023], [0029] FIG. 1A … fluid management system 100);
a measuring device comprising: a flow sensor for detecting a liquid level in a container, thereby obtaining liquid level height information (¶ [0023], the second sensor is configured to generate second sensor data based on the urine flow from the patient to the container; ¶ [0063] The sensors can include (i) a first sensor 114a (e.g., a flow sensor, thermal flow sensor (e.g., the Sensirion SLF3x Liquid Flow Sensor), a mechanical paddlewheel type flow sensor, an ultrasonic flow sensor, etc.); ¶ [0121] Referring again to FIG. 4F, the subassembly 424 can further include at least one sensor configured to monitor an amount of fluid in the container 404 and/or a rate of fluid flow into the container 404. … such as weight sensors, flow sensors, fluid level sensors, float sensors, optical sensors, drip counters, or the like; ¶ [0154] FIG. 6D … The second sensor 636 can include a flow sensor and be configured to measure or generate (e.g., on a continuous basis) second sensor data including a flow of the fluid F through the fluid line);
a weight sensor for measuring a weight of the container and a weight of the liquid in the container, thereby obtaining weight information (¶ [0023], The first sensor is configured to generate first sensor data based on a weight of the container; ¶ [0063], (ii) a second sensor 114b (e.g., a weight sensor) coupled to the container 112 and configured to measure weight of the container 112; ¶ [0121] Referring again to FIG. 4F … the upper section 428 includes a weight sensor 470 (e.g., a load cell) configured to measure the weight of the container 404 when the container 404 is coupled to the lower section 430; ¶ [0154], The first sensor 634 can include a load cell and be configured to measure or generate (e.g., on a continuous basis) first sensor data including a weight of the container 612 when coupled to the mounting component 632); and
a monitoring device communication-connected to the transmission device for receiving the liquid level information and the weight information, and the monitoring device comprising: a computing processor for calculating the actual liquid volume in the container and a liquid error based on the liquid level information and the weight information (¶ [0065], For example, in some embodiments the signal from the second sensor 114b can be used as the primary source unless and/or until … (iv) there is a discrepancy between the signals of the first and second sensors 114a-b, indicating the container 112 is being drained and/or one of the signals is not accurate; ¶ [0067] In some embodiments, a determined discrepancy between the first and second sensors 114a-b can identify a potential fault in the system (e.g., faulty sensor) and cause the system 160 to stop all or portions of the fluid therapy, and/or alert the user that such discrepancy exists … if a failure of either of the sensors 114a-b is detected, or if there is a large discrepancy between the readings of the sensors 114a-b, an alert can be generated prior to the initiation of therapy).
Conley improves the accuracy of a volume calculation by comparing measurements from two sensors (¶ [0065], [0067]). One would be motivated to modify Jones and Perkins with Conley’s volume and error calculation to compensate for a faulty sensor or other errors. For example, Jones detects when the bottle tilts off-level and compensates for this effect (¶ [0060], In some embodiments, the scale 140 may apply a correction factor to the weight data when the gyroscope 143 determines that the scale 140 is not level). Therefore, it would have been obvious to modify Jones and Perkins with Conley’s volume and error calculation in order to minimize errors from sensors by comparing their outputs.
Jones further calculates an actual liquid volume by subtracting a weight of the drainage bottle from a weight of the liquid in the drainage bottle (¶ [0064], In some embodiments, the scale 140 may be configured to perform a scale calibration process and the scale receiving logic 160 may be configured to receive confirmation from the scale 140 that the scale 140 has been calibrated)
Jones, Perkins and Conley do not explicitly calculate an actual liquid volume by subtracting a weight of the drainage bottle from a weight of the liquid in the drainage bottle, and then dividing by a density of the liquid. Benammar discloses a system, apparatus and method for monitoring the amount of effluent drained from a body cavity (¶ [0002], [0008], [0022], there is shown in FIG. 1 system 10);
wherein a liquid volume is calculated by obtaining a weight of the liquid and then dividing by a density of the liquid (¶ [0042] At block 100 of FIG. 6, Vout_i is determined by processor device 40; ¶ [0043] Processor device 40 computes Vf_i from Mf_i and ρb. Mf_i is the mass of liquids collected in the vessel 12 during time interval Δti, and ρb is the blood density. Mf_i is determined at block 104 by processor device 40 using signals from weight sensing device 32. The blood density, ρb, of the patient may be assumed constant and equal to 1.050 g/cm.sup.3; ¶ [0044] Alternatively, processor device 40 may use the actual value … processor device 40 can be coupled to an optional input device 48 … to enter a value for the patient's blood density, ρb).
Benammar describes how to convert between mass and volume for a fluid with a known density. One would be motivated to modify Jones, Perkins and Conley with Benammar’s liquid volume calculation since Jones measures the liquid weight and then calculates the liquid volume (¶ [0065], the weight value correlation logic 162 may be configured to correlate each weight value with a volume of urine within the container 110). Therefore, it would have been obvious to modify Jones, Perkins and Conley with Benammar’s liquid volume calculation in order to convert between mass and volume.
Regarding claim 2, Jones discloses that the alert notifier emits a warning when the liquid level height or the actual liquid volume exceeds a preset value (¶ [0066], the alert logic 174 may be configured to transmit an alert to the module 150 whenever the urine volume within the container 110 reaches a pre-determined or user defined level, such as a capacity of the container 110, for example).
Jones and Perkins do not explicitly disclose an indicator light and buzzer. Conley discloses an alert notifier comprising an indicator light and a buzzer, and the indicator light emits a light and the buzzer emits a warning sound (¶ [0051] During the treatment procedure, the controller 140 can output information regarding procedure status to the user via the display 150 … notifications (e.g., alerts, alarms, error messages), and the like; ¶ [0107], the first and second retainers 318a-b can be manually actuated by a user (e.g., in response to a notification or alarm via a light, sound, message, etc.); ¶ [0132], FIG. 4F, the notification device(s) can include a set of indicator lights 492 (e.g., LED lights) … Each indicator light 492 can be turned on, turned off, flash, change color, etc., to indicate the status of the subassembly 424 and/or container 404; ¶ [0145], Stage 550 can include concurrently or subsequently alerting the user (e.g., via a light, a sound, a message, and/or other notification) that the first container should be emptied and/or replaced).
Conley demonstrates more details of how to send an alert message. One would be motivated to modify Jones and Perkins with Conley’s light and buzzer to grab the user’s attention whenever the bottle reaches its capacity or some other error arises. A skilled artisan would have been able to select a red color, or any desired color for the alarm, since Conley’s indicator lights 492 can change color (¶ [0132]). Therefore, it would have been obvious to modify Jones and Perkins with Conley’s light and buzzer in order to deliver an alert message to the user.
Regarding claim 3, Jones does not explicitly disclose that the weight sensor is a load cell. However, Jones calls for a weight sensor that operates electronically, generates data and wirelessly transmits the data (¶ [0011] In some embodiments, the scale includes a scale console that includes a number of processors and a non-transitory computer readable medium having scale logic stored thereon; ¶ [0044], the system module 150 may be coupled with scale 140 via a wired connection. In other embodiments, the scale 140 may be a smart scale capable of wirelessly communicating with the system module 150; ¶ [0056], The scale 140 may be configured to generate weight data composed of one or more weight values. The scale 140 may be configured to transmit the weight data to the module console 152 and the module console 152).
Jones’s electronic interface and transmitter imply that the scale 140 includes a load cell. A load cell directly generates an electronic signal that a processor can receive and transform into human-readable weight information. Jones relies on electronic components for processing and transmitting the scale’s information, which implies that the scale 140 includes a load cell.
Regarding claim 5, Jones and Perkins do not calculate a liquid error. Conley calculates a liquid error by subtracting one liquid volume from another (¶ [0065], For example, in some embodiments the signal from the second sensor 114b can be used as the primary source unless and/or until … (iv) there is a discrepancy between the signals of the first and second sensors 114a-b, indicating the container 112 is being drained and/or one of the signals is not accurate; ¶ [0067] In some embodiments, a determined discrepancy between the first and second sensors 114a-b can identify a potential fault in the system … the first and second sensor can be tested … if there is a large discrepancy between the readings of the sensors 114a-b, an alert can be generated).
A skilled artisan would have been able to modify Jones and Perkins with Conley’s liquid error calculation by comparing Jones’s actual liquid volume versus the liquid level height of the drainage bottle, such as by subtracting. One would be motivated to modify Jones and Perkins with Conley’s liquid error calculation since Jones calls for calculating the liquid volume from both a weight sensor (¶ [0065], the weight value correlation logic 162 may be configured to correlate each weight value with a volume of urine within the container 110); and other sensors (¶ [0057], the one or more sensors 119 may include ultrasound emitters, ultrasound sensors, capacitive sensors, or the like to indicate a liquid level of the urine within the container 110, where a volume of the urine may be calculated from the liquid level). Therefore, it would have been obvious to modify Jones and Perkins with Conley’s liquid error calculation in order to more accurately calculate the liquid volume.
Regarding claim 7, Jones lacks vertically stacked phototransistors. Perkins discloses a transmitting-receiving unit formed by a plurality of vertically stacked phototransistors (¶ [0021], The light sensor array 130 preferably includes vertically arranged light sensors … the light sensor array 130 may comprise a plurality of light sensors located at a plurality of different vertical positions; ¶ [0027], Thus, when fluid is absent at a given level, the light sensor array 130 outputs a signal based on the presence of light at the sensor location corresponding to the absence of fluid; ¶ [0031], The vertically arranged light sensor array 230 can receive light from light source 220 projected at the container 202. The light sensor array 230 preferably includes vertically arranged light sensors, which can be, for example, pixels, separate sensors, or other mechanisms for sensing light).
Perkins implies that the light sensor array 130 / 230 comprises phototransistors, since Perkins operates the sensors electronically (¶ [0027], Thus, when fluid is absent at a given level, the light sensor array 130 outputs a signal; ¶ [0028] The linear light source 120 and light sensor array are connected via electrical wires 162 to a circuit 190 that monitors the output of different portions of the light sensor array 130 to determine which portions of the light sensor array 130 indicate the presence of infusion fluid; ¶ [0029] The circuit 190 may comprise a voltage source "V" and a processor or other component configured to receive an input from the sensor array 130, which provides an output indicative of the level of infusion fluid).
Perkins measures a liquid level noninvasively with a non-contact sensor. Regarding the rationale and motivation to modify Jones with Perkins’s vertically stacked phototransistors, see the discussion of claim 1 above.
Regarding claim 8, Jones discloses a drainage bottle monitoring method (¶ [0003], an automated urinary output monitoring system; ¶ [0037] FIG. 1 … system 100; ¶ [0071] FIG. 6 illustrates a flow chart of an exemplary method 200 of measuring (or otherwise determining) a volume urine output from a patient);
comprising the following steps: housing a drainage bottle in a housing portion of a measuring device (¶ [0037], The system 100 generally includes a urine collection assembly 105, a scale 140, a system module (module) 150, and a vacuum pump (pump) 131);
detecting a liquid level height of the drainage bottle with a sensor of the measuring device to obtain liquid level height information (¶ [0057], the container 110 may include one or more sensors 119 configured to detect … a fluid level within the container 110. In some embodiments, the one or more sensors 119 may include pressure sensors … where the pressure of the urine is related to a depth of the urine within the container 110, and where a volume of the urine may be calculated from the depth … the one or more sensors 119 may include ultrasound emitters, ultrasound sensors, capacitive sensors, or the like to indicate a liquid level of the urine within the container 110);
issuing a first alert message from an alert notifier of a monitoring device when the liquid level height exceeds a preset value (¶ [0066], In some embodiments, the alert logic 174 may be configured to transmit an alert to the display 150A … the alert logic 174 may be configured to transmit an alert to the module 150 whenever the urine volume within the container 110 reaches a pre-determined or user defined level, such as a capacity of the container 110, for example).
Jones lacks an optical sensor. Perkins discloses a method including detecting a liquid level height of a bottle with an optical sensor of a measuring device to obtain liquid level height information (¶ [0021], The linear light source 120 may alternatively comprise … a single light source having a plurality of light emitters … the length of the side wall 106 (as shown in FIG. 7, for example); ¶ [0025] In operation, the linear light source 120 acts as an emitter to emit light while the vertically arranged light sensor array 130 acts as receiver; ¶ [0031], The light source 220 is positioned vertically relative to the side wall 206, and may comprise … a single light source having a plurality of light emitters in a linear arrangement … the length of the side wall 106, as shown in FIG. 7; ¶ [0034], the linear light source 220 acts as an emitter to emit light while the vertically arranged light sensor array 230 acts as receiver); and
issuing an alert message from an alert notifier of a monitoring device (¶ [0029], The circuit 190 may be further configured to activate an audible alarm 192 upon detecting that the amount of infusion fluid within the container has been depleted below a minimum level).
Perkins measures fluid with a known non-contact sensor, which is suitable for measuring the volume of fluid in a container. Regarding the rationale and motivation to modify Jones with Perkins’s optical sensor, see the discussion of claim 1 above.
Jones further discloses measuring a weight of the liquid in the drainage bottle with a weight sensor of the measuring device to obtain weight information; calculating an actual liquid volume of the drainage bottle based on the liquid level height information and the weight information with a computing processor of the measuring device (¶ [0037] The scale 140 is generally configured to determine a weight urine collected within the container and communicate the weight to the system module 150 which depicts information pertaining to the weight or volume of the urine collected in the container on a display 150A of the module 150; ¶ [0056], The scale 140 may be configured to generate weight data … to transmit the weight data to the module console 152 and the module console 152 may be configured to depict the weight data (one or more weight values or volume values) on the display 150A; ¶ [0065] In some embodiments, the weight value correlation logic 162 may be configured to correlate each weight value with a volume of urine within the container 110).
Jones and Perkins do not explicitly calculate a liquid error. Conley discloses systems for urine collection and associated methods and devices (¶ [0002], [0022], [0023], [0029] FIG. 1A … fluid management system 100);
comprising calculating an actual liquid volume and a liquid error of a container based on liquid level information and weight information with a computing processor of a measuring device; and issuing an alert message when the actual liquid volume exceeds a preset value (¶ [0054], The flow control assembly 116 and/or controller 140 can generate an alert to the user to indicate the first container is full and needs to be replaced or emptied; ¶ [0065], For example, in some embodiments the signal from the second sensor 114b can be used as the primary source unless and/or until … (iv) there is a discrepancy between the signals of the first and second sensors 114a-b, indicating the container 112 is being drained and/or one of the signals is not accurate; ¶ [0067] In some embodiments, a determined discrepancy between the first and second sensors 114a-b can identify a potential fault in the system (e.g., faulty sensor) and cause the system 160 to stop all or portions of the fluid therapy, and/or alert the user that such discrepancy exists … if a failure of either of the sensors 114a-b is detected, or if there is a large discrepancy between the readings of the sensors 114a-b, an alert can be generated prior to the initiation of therapy).
Regarding the first and second alert messages, Jones issues at least a first alert (¶ [0066], the alert logic 174 may be configured to transmit an alert … whenever the urine volume within the container 110 reaches a pre-determined or user defined level).
Conley discloses multiple criteria for issuing alerts, including a volume threshold (¶ [0052], Alternatively or in combination, the system 100 can adjust the timing of user alerts related to urine collection capacity; ¶ [0054], The flow control assembly 116 and/or controller 140 can generate an alert to the user to indicate the first container is full and needs to be replaced or emptied); and a discrepancy threshold (¶ [0067] In some embodiments, a determined discrepancy between the first and second sensors 114a-b can identify a potential fault in the system (e.g., faulty sensor) and cause the system 160 to stop all or portions of the fluid therapy, and/or alert the user that such discrepancy exists). Conley further demonstrates how to measure volume with a pair of redundant sensors, namely a flow sensor and weight sensor (¶ [0063] The sensors can include (i) a first sensor 114a (e.g., a flow sensor … an ultrasonic flow sensor, etc.) … and (ii) a second sensor 114b (e.g., a weight sensor) coupled to the container 112).
Conley’s two criteria are analogous to the first and second alerts since the first alert relies on measuring a fluid volume with a first type of sensor (Conley’s flow sensor 114a) and the second alert depends on a weight sensor (Conley’s weight sensor 114b).
Conley compares measurements from the two sensors by computing volume values from multiple sensors and then comparing them. Conley first obtains volume information from a flow sensor, weight sensor and optional additional sensors (¶ [0063], first sensor 114a (e.g., a flow sensor … second sensor 114b (e.g., a weight sensor); ¶ [0141] At stage 520, the method 500 includes measuring an amount of urine in the first container. The urine amount can be quantified based on weight, volume, fluid level, and/or any other suitable parameter).
If one of the measurements exceeds a volume threshold, Conley sends an alert (¶ [0054], The flow control assembly 116 and/or controller 140 can generate an alert to the user to indicate the first container is full and needs to be replaced or emptied; ¶ [0065], For example, in some embodiments the signal from the second sensor 114b can be used as the primary source unless and/or until (i) the weight of the container 112 is above a predetermined threshold, indicating the container 112 is nearly full and needs to be drained). Detecting a full container and sending an alert is analogous to the claimed first alert message.
Conley further compares the values derived from the various sensors, and sends an alert if the sensors disagree (¶ [0065], the signal from the second sensor 114b can be used as the primary source unless and/or until … (iv) there is a discrepancy between the signals of the first and second sensors 114a-b; ¶ [0067], a determined discrepancy between the first and second sensors 114a-b can identify a potential fault in the system (e.g., faulty sensor) and cause the system 160 to … alert the user that such discrepancy exists). Detecting a discrepancy and sending an alert is analogous to the second alert message.
Conley improves the accuracy of a volume calculation by comparing measurements from two sensors (¶ [0065], [0067]). Regarding the rationale and motivation to modify Jones and Perkins with Conley’s volume and error calculation, see the discussion of claim 1 above.
Jones, Perkins and Conley do not explicitly calculate the actual liquid volume by subtracting the weight of the drainage bottle from the weight of the liquid in the drainage bottle, and then dividing by a density of the liquid. Benammar discloses a system, apparatus and method for monitoring the amount of effluent drained from a body cavity (¶ [0002], [0008], [0022], there is shown in FIG. 1 system 10);
wherein a liquid volume is calculated by obtaining a weight of liquid and then dividing by a density of the liquid (¶ [0042] At block 100 of FIG. 6, Vout_i is determined by processor device 40; ¶ [0043] Processor device 40 computes Vf_i from Mf_i and ρb. Mf_i is the mass of liquids collected in the vessel 12 during time interval Δti, and ρb is the blood density. Mf_i is determined at block 104 by processor device 40 using signals from weight sensing device 32. The blood density, ρb, of the patient may be assumed constant and equal to 1.050 g/cm.sup.3; ¶ [0044] Alternatively, processor device 40 may use the actual value … processor device 40 can be coupled to an optional input device 48 … to enter a value for the patient's blood density, ρb).
Benammar describes how to convert between mass and volume for a fluid with a known density. Regarding the rationale and motivation to modify Jones, Perkins and Conley with Benammar’s volume calculation, see the discussion of claim 1 above.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jones, Perkins, Conley and Benammar in view of Woodard; Steven P. et al. (US 20210298653 A1).
Regarding claim 6, Jones further discloses a display device communication-connected to the computing processor for displaying the total liquid capacity of the drainage bottle, the accumulated liquid capacity from the previous hour, time and error (¶ [0045], The display 150A may be configured to project thereon, one or more urine volume measurements or other data pertain to urine output; ¶ [0056], The scale 140 may be configured to transmit the weight data to the module console 152 and the module console 152 may be configured to depict the weight data (one or more weight values or volume values) on the display 150A; ¶ [0064], the energy source 156 may include an external power source or rechargeable battery; ¶ [0065], the display logic 164 may be configured to transmit the weight value, the volume value, and the time of day value to the electronic medical record system or the external computing device; ¶ [0066], the alert logic 174 may be configured to transmit an alert to the display 150A).
Jones, Perkins, Conley and Benammar do not explicitly display battery power. Woodard discloses an automated urine-output-measurement system and method (¶ [0003], [0004], [0022], [0057], [0058] FIG. 1 … system 100);
comprising a display device connected to a computing processor for displaying a total liquid capacity of the container (¶ [0125] As shown, the method 2600 includes a step of a clinician such as a nurse draining the urine-filled drainage receptacle 154, for example, a urine-filled drainage bag when the drainage bag needs to be drained); and
battery power (¶ [0060] The capital equipment can include a urine monitor 110, one or more rechargeable batteries 112, and a medical-grade power cable 114; ¶ [0104] The method 1600 includes a step of displaying a message on the integrated display screen 218 of the urine monitor 110 and providing a visual alert to alert a clinician such as a nurse the battery is a low-charge battery).
Woodard reminds a caregiver to restore the system’s power when the battery runs low. One would be motivated to modify Jones, Perkins, Conley and Benammar with Woodard’s battery power display since Jones calls for a rechargeable battery (¶ [0064], the energy source 156 may include an external power source or rechargeable battery). Therefore, it would have been obvious to modify Jones, Perkins, Conley and Benammar with Woodard’s battery power display in order for a caregiver to recharge the battery when required.
Response to Arguments
The objections to claims 1, 6, 8 and 9 for minor informalities are withdrawn in view of the amendments filed 11 August 2026.
Applicant’s arguments filed 11 August 2026 regarding the rejection of claims 1-3 and 5-8 as amended, under 35 USC § 103 over Jones, Perkins, Conley, Benammar and Woodard, have been fully considered but are not persuasive. Therefore, the rejections are maintained.
Applicant submits that there is no technical motivation for combining Jones and Perkins because the two references rely on fundamentally different structural configurations and measurement principles (remarks p. 7).
In response to applicant's argument that Jones supports a drainage container by an electronic scale (Scale 140) while Perkins grips an exterior surface of a bottle with a clamp, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In this case, Perkins demonstrates how to optically measure a container’s contents with an external device. Jones surrounds a drainage bottle with a frame or platform (¶ [0061] The frame 120 may include one or more walls 130 configured to secure the container 110 within the frame 120). A skilled artisan would have been able to modify Jones with Perkins’s optical sensor by incorporating optical sensors into frame 120 or its walls 130.
Applicant asserts that Conley is directed to an entirely different technical objective. Specifically, Conley compares an in-line conduit flow sensor (114a) with a collection bag scale (114b) to detect whether a urine collection bag has been emptied or replaced by medical personnel, thereby allowing a console to appropriately switch between measurement channels (remarks p. 8). Applicant contends that Conley does not disclose or suggest arranging multiple sensors on the same container housing to evaluate internal fluid conditions.
Examiner notes that Conley explicitly arranges multiple sensors on the same container housing, namely a flow sensor (¶ [0063] The sensors can include (i) a first sensor 114a (e.g., a flow sensor); and a weight sensor (¶ [0063], and (ii) a second sensor 114b (e.g., a weight sensor)). Conley calls for further sensors that measure the container’s volume including an optical sensor (¶ [0080], As described above, the sensor(s) can be configured to measure the urine output rate based on flow rate, weight (e.g., of the container 112 of FIG. 1A), volume, fluid level, and/or any other suitable parameter; ¶ [0121] Referring again to FIG. 4F, the subassembly 424 can further include at least one sensor configured to monitor an amount of fluid in the container 404 and/or a rate of fluid flow into the container 404. The sensor(s) can be or include any of the sensors discussed above with reference to FIG. 3, such as weight sensors, flow sensors, fluid level sensors, float sensors, optical sensors, drip counters, or the like). Conley relates to the problem of measuring urine stored in a container, and verifying the measurement’s accuracy by collecting data from multiple sensors.
Applicant contends that nor does Conley teach deriving a "liquid error" by comparing an optically determined volume with a density-calibrated mass-derived volume (remarks p. 8). Examiner notes that Conley explicitly detects an error or discrepancy between the sensors’ measurements (¶ [0065], and/or (iv) there is a discrepancy between the signals of the first and second sensors 114a-b, indicating the container 112 is being drained and/or one of the signals is not accurate; ¶ [0067], a determined discrepancy between the first and second sensors 114a-b can identify a potential fault in the system … alert the user that such discrepancy exists).
Applicant submits that Benammar neither discloses nor suggests any optical sensing arrangement for determining liquid height (remarks p. 8). Examiner notes Benammar is not necessarily cited as teaching a liquid height sensor, and is instead cited as teaching how convert between mass and volume via density.
Applicant reasons that Benammar provides no teaching regarding the use of density as a calibration bridge between geometrically measured volume and physically measured mass for identifying and compensating for foam-induced measurement errors (remarks p. 8).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., identifying and compensating for foam-induced measurement errors) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Benammar is cited to demonstrate how mass relates to volume through density, which is a ratio of mass to volume. This relationship has been extensively studied. For example, the following references describe how to convert mass to volume by dividing by density:
Westphal; Detlef et al. US 5769087 A
Savagle, Geroge M. et al. US 20020032403 A1
Mitchell; Peter A. et al. US 20080213874 A1
Weil; Roark D. et al. US 20150082877 A1
DiMaria-Ghalili; Rose Ann et al. US 20160166096 A1
Herman; David Michael et al. US 20210140808 A1
Kriscovich; Hannah Rose et al. US 20220192564 A1
Epshteyn; Vitaliy Gennad’yevich et al. US 20240277931 A1
Applicant asserts that Neither Jones, Perkins, Conley, nor Benammar recognizes this clinical problem or provides any mechanism for distinguishing true liquid accumulation from optical artifacts caused by foam or droplets (remarks p. 9). Applicant reasons that the claimed system is not a simple aggregation of known sensors. Instead, it overcomes a longstanding clinical bottleneck ("foam false-alarms") through a density- based mathematical calibration mechanism that neither sensor could accomplish independently (remarks p. 10).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., distinguishing true liquid accumulation from optical artifacts caused by foam or droplets or foam false-alarms) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Instead, amended claims 1 and 8 recite only “…the actual liquid volume is calculated by subtracting the weight of the drainage bottle from the weight of the liquid in the drainage bottle, and then dividing by a density of the liquid.”
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 extension fee 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.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
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