DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-20 are currently pending and under consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the fluid inlet line" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes this is being interpreted as “a fluid inlet line”.
Claim 11 recites the limitation “configured to restrict at least a portion of fluid travel being the associated drain inlet and the drain outlet”. The terminology of “being” in the sentence makes it unclear as to what is being claimed by this limitation. For the purpose of examination this is being interpreted to mean between rather than the stated “being”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
Claim(s) 1-2, 6, and 13-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elbadry et al. (U.S. Publication 2019/0358387) herein further referred to as Elbadry.
Regarding claim 1, Elbadry discloses a medical drain device (Fig. 13), comprising: a drain inlet 12 for receiving fluid flow from a patient (¶0121 fluid communication with fresh dialysate and waste dialysis draining out of a patient); a drain outlet (see illustrative diagram of Fig. 13 below) for releasing fluid flow to a reservoir 57; a sensor system 00 interposed fluidically between the drain inlet and the drain outlet (¶0214 port 58 connects to catheter, port 60 connects to infusion/drainage fluid tubing port), the sensor system producing a sensed flow pressure signal responsive to fluid travel between the drain inlet and the drain outlet (¶0121 flow sensor and pressure sensor); a flow regulator (Fig. 26 element 61a) interposed fluidically between the drain inlet and the drain outlet and being configured to selectively restrict at least a portion of fluid travel between the drain inlet and the drain outlet (¶0193 one way valve prevents the fluid from entering the sensor fluid conduit); and a controller (¶0116 microcontroller) configured to receive the sensed flow pressure signal (¶0116 receive the signal output from the sensors; ¶0295 flow sensor mechanism including…pressure-based meters) and responsively produce at least one of a flow rate indication signal (¶0017 flow rate measured using flow sensor) and a flow volume indication signal (¶0017 total flow volume measured using flow sensor).
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Illustrative diagram of Fig. 13 of Elbadry.
Regarding claim 2, Elbadry discloses the medical drain device of claim 1. Elbadry further discloses the sensor system 00 including a sensor housing (26, 60, and 58) having a housing input port 58 in fluid communication with the drain inlet (¶0214 port 58 connects to catheter, port 60 connects to infusion/drainage fluid tubing port), a housing output port 60 in fluid communication with the drain outlet (¶0214 port 58 connects to catheter, port 60 connects to infusion/drainage fluid tubing port), and a housing body (26, Fig. 16A shows fluid conduit 34 forming portion) interposed between the housing input and output ports (Fig. 18 shows element 26 in-between 60 and 58), the housing input port, the housing output port, and the housing body defining an inner housing chamber for fluid travel between the drain inlet and the drain outlet (fluid conduit 34); and at least one sensor (11 pressure sensors; ¶0295 pressure-based meter) connected to the sensor housing (¶0183 network of sensors combined with the rest of the hardware system and embedded with the PCB which contains the…enclosure); and producing the sensed flow pressure signal responsive to fluid travel through the inner housing chamber (¶0291 flow sensor track flow rate and direction of fluid along channel).
Regarding claim 6, Elbadry discloses the medical drain device of claim 1. Elbadry further discloses a fluid inlet line 12 having a first inlet line end (end placed in patient as seen in Fig. 13) at which the drain inlet is provided and a second inlet line end (end at connector 14) connected to the sensor system (connected through connector 14), wherein the flow regulator (61a) is selectively connected to the fluid inlet line (selectively connected by connector 53 of patient monitoring device 00) and is configured to selectively restrict at least a portion of fluid travel through the fluid inlet line (selectively restricts fluid travel back into the fluid inlet line during drainage).
Regarding claim 13, Elbadry discloses the medical drain device of claim 1. Elbadry further discloses a power source 32 in electrical communication with the sensor system and the controller (¶0182 connected to pcb, via PCB, the control device may be connected to each sensor for power supply to the sensor and data output from each sensor to the control device).
Regarding claim 14, Elbadry discloses the medical drain device of claim 13. Elbadry further discloses the power source including a rechargeable power source (¶0182 charged by USB) in selective electrical communication with the sensors and the controller (¶0321 powers on and off).
Regarding claim 15, Elbadry discloses the medical drain device of claim 1. Elbadry further discloses a communications system comprising a computing device in electronic communication with the controller (¶0006 patient parameters wirelessly transmitted to database which stores and processes data with user interface displaying monitored data), the controller outputting the flow rate indication signal and the flow volume indication signal to the computing device (¶0116 transmit data via a wireless network to a database server), and the computing device displaying information from the flow volume indication signal in a user-perceptible format (Fig. 60 shows display of volume differential which is a ratio of flow volumes of drained fluid to infused fluid ¶0034).
Regarding claim 16, Elbadry discloses the medical drain device of claim 15. Elbadry further discloses the controller being in electronic communication with a remote server via the computing device (¶0006 database includes user interface, user interface for the provider allows remote monitoring).
Regarding claim 17, Elbadry discloses the medical drain device of claim 1. Elbadry further discloses a memory (¶0116 memory chip) for selectively retaining the flow rate indication signal and the flow volume indication signal (¶0116 store the data locally on a memory chip).
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.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elbadry et al. (U.S. Publication 2019/0358387) in view of Boillat et al. (U.S. Publication 2021/0262840) herein further referred to as Boillat.
Regarding claims 3-5, Elbadry discloses the medical drain device of claim 1. Elbadry further discloses the medical drain device comprising a multitude of sensors (Fig. 16A-C, element 44) wherein the housing body (26, Fig. 16A) has a first connector port (element 70 closes to arrow 34) adjacent the housing input port, and a second connector port (element 70 directly adjacent to first connector port) adjacent the housing output port wherein the sensors are in fluid communication with the inner housing chamber when connected to the first connector port and the second connector port (¶0187 fluid contacting sensors disposed within corresponding set of holes) and the controller being configured to receive sensed flow pressure signals (¶0116 receive the signal output from the sensors, analyze data; ¶0326) to estimate a flow volume that has been drained from the patient (¶0292 flow meter would operate through the duration of infusing and draining cycle. The overall flow volume of drainage solution can be quantified) responsive to the determined flow rate (flow volume based on flow rate and duration of draining cycle).
Elbadry does not expressly disclose the first and second sensors having first and second sensor ports respectively that connect to the first and second connector ports respectively.
However, Boillat, in the same field of endeavor of measuring fluid flow rates of a conduit (Title), teaches a flow sensor 1 comprising two pressure sensors (¶0024 pressure sensor assembly 7; sensors 17 and 23) wherein a first of the pressure sensors 17 has a first sensor port (see below illustrative diagram of Fig. 3 of Boillat) and a second of the pressure sensors 23 has a second sensor port (see below illustrative diagram of Fig. 3 of Boillat) that connect to first and second connector ports (9b and 11b respectively) that are adjacent to respective housing (1) input/output ports (ends of elements 9 and 11 input/output depends upon direction of fluid flow) wherein the first and second sensor ports are fluidically connected to the first and second connector ports as to be in fluid communication with an inner housing chamber (9 through to 5 through to 11) when connected (¶0031 cavity 17a, 23a in fluidic communication with respective ports 9b, 11b, ¶0027 first ports 9a and third port 11a are fluidically connected with each other), wherein the first and second sensors are configured to sense respective first and second flow pressures (each sensor senses respective pressure ¶0034 pressures sensed by strain gauges 18,25) in the inner housing chamber adjacent the first connector port and second connector port respectively (first sensor port adjacent 9b adjacent to 9; second sensor port adjacent to 11b adjacent to 11) to responsively produce first and second sensed flow pressure signals (¶0034 signals), determine a differential pressure between the first and second flow pressures (¶0004 difference in strain measured by subtracting the pressure sensor outputs can be used to calculate the flow rate) and estimate a flow volume responsive to a determined differential pressure (¶0004 by integrating the flow rate with respect to time, the volume of fluid which has flowed can be calculated).
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Illustrative diagram of Fig. 3 of Boillat.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the flow sensor arrangement of Elbadry that performs the function of sensing sensor signals to calculate fluid flow rate and flow volume for the fluid flow rate sensor arrangement of Boillat since these elements perform the same function of sensing through sensors parameters to calculate fluid flow rate and flow volume. Simply substituting one fluid flow rate/volume sensing means for another would yield the predictable result of allowing a(n) the fluid flow rate and volume of a fluid flow pathway to be calculated. See MPEP 2143.
Furthermore, Elbadry discloses the controller being configured to receive sensed signals from the flow meter to calculate the fluid flow rate and flow volume drained from the patient and thus it would have been obvious to have modified the controller to have received the first and second sensed flow pressure signals from the pressure based flow sensor arrangement to determine the differential pressure between the first and second flow pressures from the first and second sensed flow pressure signals in order to calculate the flow rate and flow volume as taught by Boillat for the purpose of calculating the fluid flow rate and flow volume from signals produced by the differential pressure flow sensor.
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elbadry et al. (U.S. Publication 2019/0358387) in view of Browd et al. (U.S. Publication 2018/0028794).
Regarding claims 7-10, Elbadry discloses the medical drain device of claim 1. Elbadry does not expressly disclose the flow regulator being configured to selectively elastically deform the fluid inlet line, deformation of the fluid inlet line restricting at least a portion of fluid travel through the fluid inlet line (Claim 7), an amount to which the flow regulator deforms the fluid inlet line and restricts fluid travel through the fluid inlet line being predetermined at least partially in response to at least one of a user command and one or more variables that are responsive to the sensed flow pressure signal (Claim 8); the flow regulator including a regulator arm and a motor selectively actuatable to rotate the regulator arm about an axis of rotation, the regulator arm being selectively connected to a portion of the fluid inlet line between the first and second inlet line ends, selective rotation of the regulator arm at least partially elastically bending the fluid inlet line to restrict at least a portion of fluid travel through the fluid inlet line (Claim 9); or the motor being selectively actuatable to rotate the regulator arm into a position in which a kink formed in the fluid inlet line prevents fluid from traveling through the fluid inlet line (Claim 10).
However, Browd, in the same field of endeavor of body fluid drainage systems (Title), teaches providing a flow regulator 104 configured to selectively elastically deform a fluid drainage line 102 to restrict at least a portion of fluid travel through the fluid inlet line (¶0033 incrementally open or close the valve device and by what percentage, thus can restrict at least a portion) (Claim 7), an amount to which the flow regulator deforms the fluid inlet line and restricts fluid travel through the fluid inlet line being predetermined at least partially in response to a user command (¶0082 user controls allow a user to select and adjust the desired condition for pressure or flow rate, as well as the tolerances of drainage system; user controls can change the desired ICP and/or flow rate…such that the controller can adjust the valve device to output the selected ICP or flow rate) and one or more variables that are responsive to the sensed flow pressure signal (¶0033 compares sensed flow rate with desired flow rate to adjust valve device accordingly) (Claim 8); the flow regulator (104) including a regulator arm (Fig. 3D element 367) and a motor (¶0040 valve device utilized power to change position of actuator and thus serves as motor) selectively actuatable to rotate the regulator arm about an axis of rotation (Fig. 3D arrow shows axis of rotation of regulator arm about fulcrum point), selective rotation of the regulator arm at least partially elastically bending the fluid inlet line to restrict at least a portion of fluid travel through the fluid inlet line (Fig. 3D shows elastic bending of the fluid inlet line; ¶0033 incrementally close the valve device) (Claim 9); and the motor being selectively actuatable to rotate the regulator arm into a position in which a kink formed in the fluid inlet line prevents fluid from traveling through the fluid inlet line (¶0050 controller can close the actuator to obstruct all flow through the valve device)(Claim 10) for the purpose of allowing a medical professional to select and adjust the desired condition for pressure or flow rate of drainage from the device (¶0082 can allow a user (e.g. a medical professional) to select and adjust the desired condition for pressure or flow rate, as well as the tolerance of the drainage system).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device and controller of Elbadry to have included the flow regulator that would be controllable by the controller based on measured flow rate signals, as taught by Browd, for the purpose of allowing a medical professional to select and adjust the desired condition for pressure or flow rate of drainage from the device (¶0082 can allow a user (e.g. a medical professional) to select and adjust the desired condition for pressure or flow rate, as well as the tolerance of the drainage system).
Elbadry in view of Browd do not expressly disclose the regulator arm being selectively connected to a portion of the fluid inlet line between the first and second inlet line ends, however, it would have been obvious to one of ordinary skill in the art to have arranged the device such that the regulator arm selectively connects to a portion of the fluid inlet line between the first and second inlet ends since this position would still allow for the device to selectively control the fluid flow through the drainage tubing and this position does not change the ability of the device to perform the selective control of fluid flow through a flow pathway of the device such that drainage flow rates can be controlled. Since applicant has not given any criticality to why the position of the flow regulator disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bengtson (U.S. Publication 2012/0071841 in view of Morse et al. (U.S. Publication 2022/0062601).
Regarding claims 1, 11, and 12, Bengston discloses a medical drain device, (Fig. 5 with Fig. 25 drain inlet configuration) comprising: a drain inlet 12 for receiving fluid flow from a patient (Abstract convey fluid from an internal wound site or body cavity by applying negative pressure from a source outside the internal wound site or body cavity through a wound drain assembly that is placed directly inside the internal wound site or body cavity); a drain outlet (end of element 22 connected to element 30) for releasing fluid flow to a reservoir 30 (Claim 1 components);
a plurality of drain inlets (Fig. 25 elements 12);
and a splitter (see Fig. 25A showing splitter between drainage tubing 52 coming from drainage inlets 12 and singular drainage tube 14) interposed between the drain outlet and drain inlet for combining the drainage flow of the plurality of drain inlets into one drainage line 14.
Bengston does not expressly disclose a sensor system or plurality of sensor system (as claimed in claim 12) interposed fluidically between the drain inlet and the drain outlet, the sensor system producing a sensed flow pressure signal responsive to fluid travel between the drain inlet and the drain outlet; a plurality of flow regulator interposed fluidically between the drain inlet and the drain outlet and being configured to selectively restrict at least a portion of fluid travel between the drain inlet and the drain outlet; or a controller configured to receive the sensed flow pressure signal and responsively produce at least one of a flow rate indication signal and a flow volume indication signal.
However, Morse, in the same field of endeavor of patient drainage fluid management (Title, Abstract), discloses a sensor system (pressure and flow sensors; 80 and 28; ¶0082 drainage flow rate measurements may be accomplished with an ultrasonic sensor, a mass flowrate sensor, or any similar sensor, ¶0083 pressure measurement may be accomplished by two or more disposable pressure sensors) interposed fluidically between (Fig. 11 shows in-between position of 50, 50 placed internally to element 10) the drain inlet (66) and the drain outlet (62), the sensor system producing a sensed flow pressure signal (measures pressure and therefore would measure flow pressure) responsive to fluid travel between the drain inlet and the drain outlet; a flow regulator 22 interposed fluidically between the drain inlet and the drain outlet (interposed with element 10) and being configured to selectively restrict at least a portion of fluid travel between the drain inlet and the drain outlet (¶0080 soft flexible tube in patient interface assembly is variably or intermittently compressed by a flowrate control actuator); and a controller (20 control subassembly) configured to receive the sensed flow pressure signal and responsively produce a flow rate indication signal and a flow pressure indication signal (¶0088 in operable combination with user interface subassembly, which includes user interface for displaying system settings and outputs (current or historical pressure or flowrate data), display of outputs necessitates receiving of sensed flow pressure signals from sensors) for the purpose of being able to monitor and control pressure or flow rate of a bodily fluid based on sensor derived parameters (¶0084).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bengston to have included the flow regulator and sensor system taught by Morse for the purpose of being able to monitor and control pressure and/or flow rate of a bodily fluid based on sensor derived parameters (¶0084 of Morse) which provides the benefit of allowing a clinician to control based on patient condition (¶0022 of Morse).
Regarding the placement of a plurality of flow regulators between the drain outlet and an associated one of the drain inlets and the placement of either one sensor system with a splitter interposed between the sensor system and the plurality of drain inlets as claimed in Claim 11, or a plurality sensor systems placed such as to produce a sensed flow pressure signal for each of the associated drain inlets, Bengston discloses each of the drain inlets being placed in a separate cavities of the body (¶0102 drainage both inside and outside the abdomen), and Morse further teaches being able to configure the system to monitor or control two body fluids independently such as monitoring two fluid lines (¶0130 system may be configured to monitor or control two body fluids independently (for example, to monitor intra-abdominal pressure via connection to an indwelling urinary catheter on a first fluid line and..CSF on a second fluid line) as well as being able to provide the associated components either as a single integrated assembly or separate components (¶0130 patient interface assembly may be comprise of a single integrated assembly, whereas in other embodiments…components may be separate patient interface assemblies).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bengston to have separate flow regulators for each drain inlet for the purpose of controlling the drainage out of each of the separate bodily compartments in which the corresponding drainage inputs are placed individually based on the individual drainage needs of the compartments. Furthermore with regards to the sensor system arrangement of Claim 11 with the flow sensor system placed after the splitter, or having separate sensor systems for each of the associated drain inlets (claim 11), it would have been obvious to one of ordinary skill in the art to have arranged the sensor system in either arrangement depending on whether the user would rather simply have controlled the system based on measurement of the combined drainage flow/volume of the spaces or measurement of each drainage input individually.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Browd et al. (U.S. Publication 2018/0028794) in view of Boillat et al. (U.S. Publication 2021/0262840) herein further referred to as Boillat.
Regarding claim 18, Browd discloses a method for managing patient fluid drain (Abstract), the method comprising: providing a medical drain device (Fig. 1B) comprising: a drain inlet 116 for receiving fluid flow from a patient (¶0026 in fluid communication with a site of excess body fluid such that the body fluid can flow into the catheter);
A drainage outlet 118 for releasing fluid flow to a reservoir 114;
A sensor system (106a,106b) interposed fluidically between the drain inlet and the drain outlet (Fig. 1B shows elements 106a and 106b interposed between 116 and 118), the sensor system producing a sensed flow pressure signal (¶0029 measure the flow rate and/or pressure) responsive to fluid travel between the drain inlet and the drain outlet; and
A controller 110 configured to receive the sensed flow pressure signal (¶0033 controller can read the measurements taken from the sensors, operatively connected to sensors) and responsively produce a flow rate indication signal (¶0082 displays drainage rate);
The sensor system comprising first and second pressure sensors (106a and 106b);
Sensing a first flow pressure in the medical drain device with the first pressure sensor (¶0029 first sensor measures the flow rate and/or the pressure within the proximal catheter);
Producing and transmitting a first flow pressure signal responsive to the first flow pressure within the first pressure sensor (¶0033 controller reads measurements taken from sensors and thus signal from first sensor is produced and transmitted to controller);
Sensing a second flow pressure in the medical drain device with the second pressure sensor (¶0029 second sensor measure a pressure substantially equal to the pressure at the outlet region 18);
Producing and transmitting a second flow pressure signal responsive to the second flow pressure with the second pressure sensor (¶0033 controller reads measurements taken from sensors and thus signal from second sensor is produced and transmitted to controller);
Receiving the first and second sensed flow pressure signals at the processor (¶0033 controller reads measurements taken from sensors and thus signal from first and second sensor is produced and transmitted to controller and received by the controller);
Determining a differential pressure between the first and second flow pressures from the received first and second sensed flow pressure signals with the processor (¶0031 desired pressure measurement is simply the difference between the two measured pressures as taken from two independent sensors; ¶0033 controller compare pressure measurements from sensors with a desired ICP to determine whether to incrementally open or close the valve device).
Browd does not expressly disclose or suggest determining a flow rate responsive to the determined differential pressure with the processor; or estimating a flow volume that has been drained from the patient as a function of the determined flow rate with the processor.
However, Boillat, in the same field of endeavor of measuring fluid flow rates of a conduit (Title), teaches a flow sensor 1 comprising two pressure sensors (¶0024 pressure sensor assembly 7; sensors 17 and 23) wherein a first of the pressure sensors 17 has a first sensor port (see above illustrative diagram of Fig. 3 of Boillat) and a second of the pressure sensors 23 has a second sensor port (see above illustrative diagram of Fig. 3 of Boillat) that connect to first and second connector ports (9b and 11b respectively) that are adjacent to respective housing (1) input/output ports (ends of elements 9 and 11 input/output depends upon direction of fluid flow) wherein the first and second sensor ports are fluidically connected to the first and second connector ports as to be in fluid communication with an inner housing chamber (9 through to 5 through to 11) when connected (¶0031 cavity 17a, 23a in fluidic communication with respective ports 9b, 11b, ¶0027 first ports 9a and third port 11a are fluidically connected with each other), wherein the first and second sensors are configured to sense respective first and second flow pressures (each sensor senses respective pressure ¶0034 pressures sensed by strain gauges 18,25) in the inner housing chamber adjacent the first connector port and second connector port respectively (first sensor port adjacent 9b adjacent to 9; second sensor port adjacent to 11b adjacent to 11) to responsively produce first and second sensed flow pressure signals (¶0034 signals), determine a differential pressure between the first and second flow pressures (¶0004 difference in strain measured by subtracting the pressure sensor outputs can be used to calculate the flow rate) and estimate a flow volume responsive to a determined differential pressure (¶0004 by integrating the flow rate with respect to time, the volume of fluid which has flowed can be calculated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Browd, to have determined the flow rate and a subsequent flow volume through differential pressure measurement as taught by Boillat since it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. This known technique of measuring flow rate and subsequently estimating flow volume through sensing a differential pressure between two pressure sensors would have yielded predictable results of allowing quantification of flow rate and flow volume of drainage in the system. This would result allowing the pressure sensors of Browd being capable of not only the pressure measurements but also capable of providing the function of a flow sensor allowing both measurements to be accomplished using the same set of sensors rather than a separate flow and pressure sensor as disclosed by Browd. See MPEP 2143.
Allowable Subject Matter
Claims 19 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Browd et al. (U.S. Publication 2018/0028794) in view of Boillat et al. (U.S. Publication 2021/0262840) is seen to suggest the method of claim 18 upon which claim 19 depends upon. Claim 19 stipulates the method comprising estimating a future flow volume accumulation as a function of the estimated flow volume and determined flow rate with the processor; comparing the estimated future flow volume accumulation with a predetermined future flow volume accumulation with the processor; and restricting at least a portion of fluid travel between the drain inlet and the drain outlet with the flow regulator if the estimated future flow volume accumulation is greater than the predetermined future flow volume accumulation.
While Browd discloses restricting at least a portion of fluid travel between the drain inlet and the drain outlet with the flow regulator if a calculated flow rate is outside a predetermined value (¶0082 controller can adjust the valve device to output the selected ICP or flow rate), neither Browd nor Boillat suggest estimating a future flow volume accumulation as a function of the estimated flow volume and determined flow rate with the processor, or comparing the estimated future flow volume accumulation with a predetermined future flow volume accumulation with the processor, and thus also does not restrict the fluid travel based on if the estimated future flow volume accumulation is greater than the predetermined future flow volume accumulation.
The prior of Elbadry et al (U.S. Publication 2019/0358387) discloses estimating drainage flow volume (DV) based on flow sensor data in order to calculate the relationship between fill volume (FV) and drainage volume, wherein the drainage volume is estimated based on the flow rate measurement ¶0017, however there is no mention of restriction a portion of fluid travel based on the estimated drainage volume being greater than a predetermined value and as such this would not render the claim limitation of claim 19 obvious to one of ordinary skill in the art.
Furthermore, some prior art references such as Krystek et al. (U.S. Patent No. 8,740,865) and Angelides (U.S. Patent No. 9,928,341) teach determining a likely fill level and predicting if a fluid collection reservoir should be replaced to avoid the container reaching a maximum fill (Krystek), and predicting a rate of fill of a drainage container based on flow rates (Angelides), neither of these references would suggest to one of ordinary skill in the art a restriction of the fluid flow between the drain inlet and the drain outlet based on whether the predicted fill level compared to a predetermined fill amount and as such would not have rendered the limitation of restricting at least a portion of fluid travel between the drain inlet and the drain outlet with the flow regulator if the estimated future flow volume accumulation is greater than the predetermined future flow volume accumulation.
Claim 20 is dependent upon claim 19 and as such includes the allowable subject matter.
Conclusion
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781