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 .
In light of the amendments filed 06/11/2026 wherein claims 1, 10-11, 13, and 19 were amended and claim 8 was cancelled, claims 1-7 and 9-23 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/US22/49418 filed 11/09/2022 which claims priority to U.S. Provisional App. no. 63/278,069 filed 11/10/2021.
Claims 1-7 and 9-23 receive priority to the prior-filed application, filed on 11/10/2021.
Response to Arguments
Rejections of the Claims under 35 U.S.C. 112(b)
The rejections of the claims under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims filed 06/11/2026.
Rejections of the Claims under 35 U.S.C. 102/103
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding cancelled claim 8 (now brought into claim 1; similar limitations to those in claim 8 brought into claims 13 and 19), the applicant asserts that Burnett provides no teaching or suggestion to place a one-way valve between the accumulator and the collection container of Weig as the valves of Burnett are used for a different purpose (preventing outflow from the bag) and are disposed in a different location (at an outlet side of a bag connected to outlet and overflow tubing).
In response to the applicant’s argument, the examiner respectfully disagrees. The applicant asserts that Burnett’s one-way valves prevent fluid from flowing out of the drainage bag through outlet and overflow tubing, that the claimed one-way valve prevents fluid from flowing back from the urine collection container toward an upstream accumulator, and that these are opposite directions of flow prevention. In the previous Office Action filed 03/13/2026, the examiner cited to Burnett (para. 0168) which states, “Urine/fluid drainage bag 1020 includes one way valves 1136 connected to overflow tubing 1138 and outflow tubing 1140 to prevent urine/fluid from exiting the drainage bag once collected…In a preferred embodiment, a single valve is used for both the overflow and outflow tubings.” The applicant seems to understand the overflow tubing and outflow tubing as being connected downstream from the drainage bag of Burnett. Burnett (para. 0158) discloses that the urine drainage lumen (1012) of the catheter is in fluid communication with the urine cassette (1022) and (para. 0159) that when the urine in the cassette gets to a certain volume, the urine is emptied via the pinch valve (1132) on the outflow tubing (1138) into the urine drainage bag (1020). Further, Burnett (para. 0217) discloses that an overflow area (2104) of a cassette allows any excess urine to drain from the cassette. Even further, Burnett (para. 0168) discloses that the urine drainage bag comprises an outflow valve (1146) to empty the bag of fluid/urine. The one-way valves of Burnett are used for the same purpose as those claimed (preventing upstream flow from the urine collection container towards the cassette) and are disposed in a similar location (inlet side of the urine collection container connected to lumens of upstream tubing). Therefore, Burnett discloses a proper motivation to one of ordinary skill in the art to provide a one-way valve in line with a lumen between an upstream container and a urine collection container to avoid backflow of urine (para. 0168).
The amendments to claim 1 have necessitated that the rejection of claim 8 in view of Burnett be brought up into the rejection of claim 1.
The amendments to claims 13 and 19 have necessitated new grounds of rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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Ex. Fig. 1 of Weig Fig. 1
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over US/2011/0060300 A1 to Weig, in view of WO/2018/136306 A1 to Burnett and EP/1872752 A1 to Tanaka.
Regarding claims 1 and 7, Weig discloses (Claim 1) a urinary output monitoring system (Fig. 1-4; para. 0024-0025), comprising:
a urine collection assembly (Fig. 1), comprising:
a drainage tube defining a distal end and a proximal end (Fig. 1, drainage tube 12c);
an accumulator coupled with the drainage tube at the proximal end (Fig. 1, accumulator 3); and a urine collection container fluidly coupled with the accumulator (Fig. 1, urine collection container 7); and
a vacuum pump fluidly coupled with the accumulator, such that air is removed from the accumulator by the vacuum pump (Fig. 1, vacuum pump 2; para. 0024-0025; para. 0030-0032), wherein:
the air removed from the accumulator causes a flow of air combined with a flow of urine along the drainage tube from the distal end to the accumulator (para. 0024-0025; para. 0030-0032), and
the accumulator is configured to separate the flow of air from the flow of urine (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7).
Weig differs from the instantly claimed invention in that Weig fails to disclose
(Claim 1) a one-way valve disposed in line with a lumen extending between the accumulator and the urine collection container, the one-way valve configured to prevent fluid flow from the urine collection container toward the accumulator.
Burnett teaches a urine collection assembly comprising a one-way valve configured to prevent fluid flow from the urine collection container after fluid is collected within the container (para. 0168; Fig. 10A, one-way valves 1136 within urine collection container 1020).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the lumen extending between the accumulator and the urine collection container of the cited prior art to comprise a one-way valve as taught by Burnett, because Burnett teaches that a one-way valve prevents fluid backflow (para. 0168).
Further, Weig differs from the instantly claimed invention in that Weig fails to disclose
(Claim 1) an automated urinary output monitoring device operatively coupled with the urine collection container, the automated urinary output monitoring device including a console in communication with a sensor of the system, the console including a processor and memory having logic stored thereon that, when executed by the processor, performs operations of the system including determining a volume of urine collected within the urine collection container; and
(Claim 7) wherein: the sensor includes a load cell of the automated urinary output monitoring device, the load cell is operatively coupled with the urine collection container, the load cell is configured to determine a gravitational load defined by urine collected within the urine collection container, and determining a volume of urine collected within the urine collection container includes determining the volume of urine based on the gravitational load.
Tanaka teaches (Claim 1) a urine collection assembly comprising an automated urinary output monitoring device operatively coupled with the urine collection container (Fig. 1A-1B, urine monitor 3 operatively coupled with urine collection container 2), the automated urinary output monitoring device including a console in communication with a sensor of the system, the console including a processor and memory having logic stored thereon that, when executed by the processor, performs operations of the system including determining a volume of urine collected within the urine collection container (para. 0055-0060, control board 423 calculates volume based on measurements from sensor; para. 0063, mass sensor 100 may be a load cell; para. 0088-0090; Fig. 1A-1B, console 42 comprising control board 423 comprising CPU, ROM, and a volatile memory in communication with mass sensor 100) to allow for volume to be used as an index for judging of a health condition of a care receiver and timing of disposing of the urine collected in the collection container (para. 0003).
Tanaka further teaches (Claim 7) wherein: the sensor includes a load cell of the automated urinary output monitoring device, the load cell is operatively coupled with the urine collection container, the load cell is configured to determine a gravitational load defined by urine collected within the urine collection container, and determining a volume of urine collected within the urine collection container includes determining the volume of urine based on the gravitational load (para. 0055-0060, control board 423 calculates volume based on measurements from sensor; para. 0063, mass sensor 100 may be a load cell; para. 0088-0090; Fig. 1A-1B, console 42 comprising control board 423 comprising CPU, ROM, and a volatile memory in communication with mass sensor 100).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Weig to further comprise the automated urinary output monitoring device of Tanaka, because Tanaka teaches that providing an automated urine output measurement system allows for volume to be used as an index for judging of a health condition of a care receiver and timing of disposing of the urine collected in the collection container (para. 0003).
Regarding claim 2, the cited prior art suggests the invention of claim 1. Weig further discloses wherein the urine collection assembly further comprises a urinary catheter coupled with the drainage tube at the distal end (Fig. 1, 12b urinary catheter; para. 0024-0025).
Regarding claim 3, the cited prior art suggests the invention of claim 2. Weig further discloses wherein the flow of air passes through the urinary catheter (para. 0024-0025; para. 0030-0035, air inlets 27 allow flow of air to enter drainage tube 12c through urinary catheter 12b).
Regarding claim 4, the cited prior art suggests the invention of claim 2. Weig further discloses wherein the urinary catheter is an external female urinary catheter (para. 0024-0025).
Regarding claim 5, the cited prior art suggests the invention of claim 1. Weig further discloses wherein: the accumulator defines a cavity including an upper cavity portion and a lower cavity portion, the flow of air passes into and out of the upper cavity portion, and only the flow of urine passes into and out of the lower cavity portion (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7; Ex. Fig. 1).
Regarding claim 6, the cited prior art suggests the invention of claim 1. Weig discloses that the liquid in the accumulator drops down via gravity from the suction flow into the urine collection container (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7; Ex. Fig. 1); however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the accumulator is attached to the automated urinary output monitoring device such that the accumulator is disposed in a vertical orientation.
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the combination of the cited prior art of Weig and Tanaka such that the accumulator is attached to the monitoring device such that the accumulator is disposed in a vertical orientation in view of the disclosure of Weig that the liquid of the accumulator flows to the urine collection container by gravity (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7; Ex. Fig. 1).
Claims 1-6 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over US/2011//0060300 A1 to Weig, in view of WO/2018/136306 A1 to Burnett and WO/2020/033752 A1 to Woodard.
Regarding claims 1, 9, and 11, Weig discloses (Claim 1) a urinary output monitoring system (Fig. 1-4; para. 0024-0025), comprising:
a urine collection assembly (Fig. 1), comprising:
a drainage tube defining a distal end and a proximal end (Fig. 1, drainage tube 12c);
an accumulator coupled with the drainage tube at the proximal end (Fig. 1, accumulator 3); and a urine collection container fluidly coupled with the accumulator (Fig. 1, urine collection container 7); and
a vacuum pump fluidly coupled with the accumulator, such that air is removed from the accumulator by the vacuum pump (Fig. 1, vacuum pump 2; para. 0024-0025; para. 0030-0032), wherein:
the air removed from the accumulator causes a flow of air combined with a flow of urine along the drainage tube from the distal end to the accumulator (para. 0024-0025; para. 0030-0032), and
the accumulator is configured to separate the flow of air from the flow of urine (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7); and
(Claim 9) the accumulator is rigidly coupled with the urine collection container (para. 0030; Fig. 1, connector 6 between accumulator 3 and urine collection container 7).
Weig differs from the instantly claimed invention in that Weig fails to disclose
(Claim 1) a one-way valve disposed in line with a lumen extending between the accumulator and the urine collection container, the one-way valve configured to prevent fluid flow from the urine collection container toward the accumulator.
Burnett teaches a urine collection assembly comprising a one-way valve configured to prevent fluid flow from the urine collection container after fluid is collected within the container (para. 0168; Fig. 10A, one-way valves 1136 within urine collection container 1020).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the lumen extending between the accumulator and the urine collection container of the cited prior art to comprise a one-way valve as taught by Burnett, because Burnett teaches that a one-way valve prevents fluid backflow (para. 0168).
Further, Weig differs from the instantly claimed invention in that Weig fails to disclose
(Claim 1) an automated urinary output monitoring device operatively coupled with the urine collection container, the automated urinary output monitoring device including a console in communication with a sensor of the system, the console including a processor and memory having logic stored thereon that, when executed by the processor, performs operations of the system including determining a volume of urine collected within the urine collection container;
(Claim 9) wherein: the urine collection container is a rigid container; and
(Claim 11) wherein: the sensor includes a flow meter disposed in line with the lumen extending between the accumulator and the urine collection container, the flow meter is configured to measure a flow rate of urine passing from the accumulator to urine collection container, determining a volume of urine collected within the urine collection container includes determining the volume of urine based on the flow rate.
Woodard teaches (Claim 1) a urine collection assembly comprising an automated urinary output monitoring device operatively coupled with the urine collection container (Fig. 1-9, urine monitors 110-910 operatively coupled with urine collection system 150 comprising urine collection container 154/756/758), the automated urinary output monitoring device including a console in communication with a sensor of the system, the console including a processor and memory having logic stored thereon that, when executed by the processor, performs operations of the system including determining a volume of urine collected within the urine collection container (Fig. 10, embedded system 1000 comprising microcontroller 1002 having processors 1004 configured to process data from RAM 1006 or ROM 1008 operatively coupled to sensors 1010; para. 0079-0082; para. 0090-0095) to provide more accurate, timely, and consistent volume measurements (para. 0002);
(Claim 9) wherein: the urine collection container is a rigid container (para. 0080, rigid drainage container 756 for volume-based urine-output measurements); and
(Claim 11) wherein: the sensor includes a flow meter disposed in line with the lumen connected to the urine collection container, the flow meter is configured to measure a flow rate of urine passing to the urine collection container, determining a volume of urine collected within the urine collection container includes determining the volume of urine based on the flow rate (para. 0079-0082).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Weig to further comprise the automated urinary output monitoring device of Woodard, because Woodard teaches that providing an automated urine output measurement system provides accurate, timely, and consistent volume measurements for improved treatment decisions (para. 0002).
Regarding claim 2, the cited prior art suggests the invention of claim 1. Weig further discloses wherein the urine collection assembly further comprises a urinary catheter coupled with the drainage tube at the distal end (Fig. 1, urinary catheter 12b; para. 0024-0025).
Regarding claim 3, the cited prior art suggests the invention of claim 2. Weig further discloses wherein the flow of air passes through the urinary catheter (para. 0024-0025; para. 0030-0035, air inlets 27 allow flow of air to enter drainage tube 12c through urinary catheter 12b).
Regarding claim 4, the cited prior art suggests the invention of claim 2. Weig further discloses wherein the urinary catheter is an external female urinary catheter (para. 0024-0025).
Regarding claim 5, the cited prior art suggests the invention of claim 1. Weig further discloses wherein: the accumulator defines a cavity including an upper cavity portion and a lower cavity portion, the flow of air passes into and out of the upper cavity portion, and only the flow of urine passes into and out of the lower cavity portion (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7; Ex. Fig. 1).
Regarding claim 6, the cited prior art suggests the invention of claim 1. Weig discloses that the liquid in the accumulator drops down via gravity from the suction flow into the urine collection container (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7; Ex. Fig. 1); however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the accumulator is attached to the automated urinary output monitoring device such that the accumulator is disposed in a vertical orientation.
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the combination of the cited prior art of Weig and Woodard such that the accumulator is attached to the monitoring device such that the accumulator is disposed in a vertical orientation in view of the disclosure of Weig that the liquid of the accumulator flows to the urine collection container by gravity (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7; Ex. Fig. 1).
Regarding claim 10, the cited prior art suggests the invention of claim 9; however, the prior art differs from the instantly claimed invention in that the combined prior art fails to disclose wherein the urine collection container includes an air vent configured to provide an atmospheric pressure within the urine collection container.
Burnett teaches a urine collection assembly comprising a urine collection container including an air vent configured to provide an atmospheric pressure within the urine collection container to allow for efficient filling of the urine collection container (para. 0168; Fig. 10A, vent 1142).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the urine collection container of the cited prior art to comprise an air vent as taught by Burnett, because Burnett teaches that an air vent prevents excessive air and pressure buildup in the collection container to allow for efficient filling of the collection container (para. 0168).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Weig, Burnett, and Woodard as applied above, and further in view of WO/2019/083104 A1 to Lee.
Regarding claim 12, the cited prior art suggests the invention of claim 9; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the urine collection container includes a detachable lid.
Lee teaches a urine collection assembly comprising a detachable lid connected to an outlet of a urine collection container (Fig. 5-6, urine collection bag 50 comprising detachable lid connected to outlet 72).
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 drain valve (para. 0030; Fig. 1, drain valve 7b on collection container 7) of Weig that may be opened or closed for discharge of urine within the urine collection container, for the detachable lid of Lee since these mechanisms perform the same function of opening and closing a port of a urine collection container for urine discharge. Simply substituting one closure means for another would yield the predicable result of allowing for reusable closure of a urine collection container. See MPEP 2143.
Claims 13-14, 16-19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over US/2011/0060300 A1 to Weig in view of WO/2018/136306 A1 to Burnett.
Regarding claim 13, Weig discloses a urinary output monitoring system method (Fig. 1-4), comprising:
receiving urine from a patient within a drainage tube coupled with and extending proximally away from a urinary catheter (para. 0024-0025; para. 0030-0032; Fig. 1, drainage tube 12c coupled with and extending away from urinary catheter 12b);
establishing a flow of air proximally along the drainage tube between the urinary catheter and an accumulator disposed at a proximal end of the drainage tube (para. 0024-0025; para. 0030-0032; Fig. 1, accumulator 3 disposed at proximal end of drainage tube 12c);
combining the urine with the flow of air such that the flow of air causes the urine to flow proximally along the drainage tube to the accumulator (para. 0024-0025; para. 0030-0032);
separating the flow of air from the urine within the accumulator (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7; Fig. 1); and
collecting the urine within a urine collection container located downstream of the accumulator (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7; Fig. 1).
Weig differs from the instantly claimed method in that Weig fails to disclose wherein a one-way valve disposed in line with a lumen extending between the accumulator and the urine collection container prevents fluid flow from the urine collection container toward the accumulator.
Burnett teaches a urine collection assembly comprising a one-way valve configured to prevent fluid flow upstream from the urine collection container after fluid is collected within the container (para. 0158-0159; para. 0168; Fig. 10A, one-way valves 1136 connected to lumens of overflow and outflow tubing 1138/1140 extending between urine cassette 1022 and urine collection container 1020 and within urine collection container 1020).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the lumen extending between the accumulator and the urine collection container of the cited prior art to comprise a one-way valve as taught by Burnett, because Burnett teaches that a one-way valve prevents fluid backflow (para. 0168).
Regarding claim 14, the cited prior art suggests the method of claim 13. Weig further discloses wherein establishing the flow of air includes activating a vacuum pump fluidly coupled with the accumulator (para. 0025; para. 0031-0035; Fig. 1, vacuum pump 2).
Regarding claim 16, the cited prior art suggests the method of claim 13. Weig further discloses wherein the flow of air enters the drainage tube by way of the urinary catheter (para. 0024; para. 0034-0035, air inlets 27 allow flow of air to enter drainage tube 12c through urinary catheter 12b).
Regarding claim 17, the cited prior art suggests the method of claim 13. Weig further discloses wherein the urinary catheter is an external female urinary catheter (para. 0024; para. 0034-0035, air inlets 27 allow flow of air to enter drainage tube 12c through urinary catheter 12b).
Regarding claim 18, the cited prior art suggests the method of claim 17. Weig further discloses wherein the flow of air enters the urinary catheter via a non-sealing interface between the urinary catheter and the patient (para. 0024; para. 0034-0035, air inlets 27 allow flow of air to enter drainage tube 12c through urinary catheter 12b).
Regarding claim 19, Weig discloses a urine collection assembly (Fig. 1), comprising:
an accumulator defining a closed cavity including an upper cavity portion and a lower cavity portion, the accumulator including an air port in direct fluid communication with the upper cavity portion (Ex. Fig. 1, accumulator 3);
a first drainage tube defining a first distal end and a first proximal end, the first drainage tube coupled with the accumulator at the first proximal end so as to be in direct fluid communication with the upper cavity portion (Ex. Fig. 1, first tube);
a second drainage tube defining a second distal end and a second proximal end, the second drainage tube coupled with the accumulator at the second distal end so as to be in direct fluid communication with the lower cavity portion (Ex. Fig. 1); and
a urine collection container coupled with the second drainage tube at the second proximal end (Ex. Fig. 1, urine collection container 7),
wherein the air port is configured to couple with an air hose of a vacuum pump such that air flow defined by the vacuum pump flows (i) proximally along the first drainage tube and (ii) into and out of the upper cavity portion (Ex. Fig. 1, vacuum pump 2; para. 0024-0025; para. 0030-0032).
Weig differs from the instantly claimed invention in that Weig fails to disclose a one-way valve disposed in line with a lumen extending between the accumulator and the urine collection container, the one-way valve configured to prevent fluid flow from the urine collection container toward the accumulator.
Burnett teaches a urine collection assembly comprising a one-way valve configured to prevent fluid flow upstream from the urine collection container after fluid is collected within the container (para. 0158-0159; para. 0168; Fig. 10A, one-way valves 1136 connected to lumens of overflow and outflow tubing 1138/1140 extending between urine cassette 1022 and urine collection container 1020 and within urine collection container 1020).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the lumen extending between the accumulator and the urine collection container of the cited prior art to comprise a one-way valve as taught by Burnett, because Burnett teaches that a one-way valve prevents fluid backflow (para. 0168).
Regarding claim 21, the cited prior art suggests the invention of claim 19. Weig further discloses a female external catheter coupled with the first drainage tube at the first distal end such that, during use, urine excreted by a patient (i) enters the female external catheter, (ii) flows proximally along the first drainage tube and (iii) enters the accumulator (Ex. Fig. 1, female external catheter fluidly coupled with first tube; para. 0024-0025; para. 0030-0032).
Regarding claim 22, the cited prior art suggests the invention of claim 19. Weig further discloses wherein the air flow defined by the vacuum pump causes the urine to flow proximally along the first drainage tube (para. 0024-0025; para. 0030-0035).
Regarding claim 23, the cited prior art suggests the invention of claim 19. Weig further discloses wherein, during use, the urine excreted by a patient: separates from the air flow within the upper cavity portion, falls from the upper cavity portion to the lower cavity portion, flows proximally along the second drainage tube, and enters the urine collection container (para. 0024-0025; para. 0030-0032, at accumulator 3, liquid drops down via gravity from the suction flow into urine collection container 7).
Claims 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Weig and Burnett as applied above, and further in view of EP/1872752 A1 to Tanaka.
Regarding claim 15, the cited prior art suggests the method of claim 13; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose measuring a gravitational load defined by urine collected within the urine collection container; and determining a volume of the urine collected within the urine collection container based on the gravitational load.
Tanaka teaches a urinary output monitoring method comprising measuring a gravitational load defined by urine collected within a urine collection container; and determining a volume of the urine collected within the urine collection container based on the gravitational load (para. 0055-0060, control board 423 calculates volume in urine collection container 2 based on measurements from sensor; para. 0063, mass sensor 100 may be a load cell; para. 0088-0090; Fig. 1A-1B, console 42 comprising control board 423 comprising CPU, ROM, and a volatile memory in communication with mass sensor 100) to allow for volume to be used as an index for judging of a health condition of a care receiver and timing of disposing of the urine collected in the collection container (para. 0003).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of the cited prior art to further comprise the automated urinary output monitoring device of Tanaka, because Tanaka teaches that providing an automated urine output measurement system allows for volume to be used as an index for judging of a health condition of a care receiver and timing of disposing of the urine collected in the collection container (para. 0003).
Regarding claim 20, the cited prior art suggests the invention of claim 19; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein: the urine collection container is configured to operatively couple with a load cell of an automated urinary output monitoring device such that urine collected within the urine collection container defines a gravitational load applied to the load cell, the automated urinary output monitoring device includes a console in communication with the load cell, and the console includes a processor and memory having logic stored thereon that, when executed by the processor, performs operations of the automated urinary output monitoring device that include determining a volume of the urine collected within the urine collection container based on the gravitational load.
Tanaka teaches a urine collection assembly wherein:
a urine collection container is configured to operatively couple with a load cell of an automated urinary output monitoring device such that urine collected within the urine collection container defines a gravitational load applied to the load cell (Fig. 1A-1B, urine monitor 3 comprising mass sensor as a load cell 100 operatively coupled with urine collection container 2),
the automated urinary output monitoring device includes a console in communication with the load cell, and
the console includes a processor and memory having logic stored thereon that, when executed by the processor, performs operations of the automated urinary output monitoring device that include determining a volume of the urine collected within the urine collection container based on the gravitational load (para. 0055-0060, control board 423 calculates volume based on measurements from sensor; para. 0063, mass sensor 100 may be a load cell; para. 0088-0090; Fig. 1A-1B, console 42 comprising control board 423 comprising CPU, ROM, and a volatile memory in communication with mass sensor 100) to allow for volume to be used as an index for judging of a health condition of a care receiver and timing of disposing of the urine collected in the collection container (para. 0003).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of the cited prior art to further comprise the automated urinary output monitoring device of Tanaka, because Tanaka teaches that providing an automated urine output measurement system allows for volume to be used as an index for judging of a health condition of a care receiver and timing of disposing of the urine collected in the collection container (para. 0003).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights