DETAILED ACTION
Applicant’s arguments, filed on 02/23/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 02/23/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 7-9, 11, 13-15, 17-19, and 21 are the current claims hereby under examination, with claims 17-19 withdrawn.
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 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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claims 7-9, 11, 13-15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Duval (US 20170241978) in view of Tanaka (US 7722584), Lark (US 20210000361), Tran (US 20210113130), and Valer (NL 2013740).
Regarding independent claim 7, Duval teaches a urine collection system (Abstract: “A collector-analyzer apparatus for urine has a urine collecting tube joined with a urine receiving canister”), comprising:
an external urinary catheter (Interconnection tube 20);
a urine collection bag fluidly coupled with the external urinary catheter via a drainage tube of the external urinary catheter (Canister 210; Urine tube 10);
a pump coupled in line with the drainage tube, the pump configured to displace urine along the drainage tube to the urine collection bag, wherein the drainage tube includes a drainage tube sensor operatively coupled with the drainage tube, wherein the first drainage tube sensor is disposed upstream adjacent the pump (Abstract: “When urine flows into the urine collecting tube a sensor triggers a vacuum pump to produce a higher level of suction to flush the urine into the canister where a level sensor determines the quantity of urine received or resident within the canister.”; urine sensor 62 is the first drainage tube sensor on the urine tube 10, which is the drainage tube).
However, Duval does not teach that the sensor is a moisture sensor.
Tanaka discloses a urine collection apparatus. Specifically, Tanaka teaches the urine sensor being a moisture sensor (Column 2, lines 48-50: “both the urine sensor S1 and the human waste sensor S2 are sensors for detecting moisture”). Duval and Tanaka are analogous art as they are both related to devices used to collect and measure urine.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the urine sensor being a moisture sensor from Tanaka into the system from Duval as Duval is silent on the type of sensor that the urine sensor is, and Tanaka discloses a suitable type of sensor in an analogous device.
However, the Duval/Tanaka combination does not teach wherein the drainage tube includes a plurality of drainage tube sensors, the plurality of drainage tube sensors including a second drainage tube moisture sensor disposed downstream adjacent the pump.
Lark disclose an apparatus and method for monitoring urine output. Specifically, Lark teaches wherein the drainage tube includes a plurality of drainage tube sensors, the plurality of drainage tube sensors including a second drainage tube sensor disposed downstream adjacent the pump (Fig. 2, pressure transducer 104 is positioned before the pump (the first drainage tube sensor) and pressure transducer 114 is positioned after the pump (the second drainage tube sensor). Although Lark uses pressure transducers as the sensors, it would have been obvious that the second sensor teaching is applicable to the moisture sensors as shown in the Duval/Tanaka combination above, since the second sensor of Lark is used to detect the filling of the urine collection bag (Lark, [0180]: “A second pressure transducer 114, or other mean to measure pump output port pressure, may be added to the hardware setup at the outlet port of the pump 105, with its input port in fluid communication with the lumen of the device tube 103, in order to detect blockage of the urine drain tube 108 or filling of the urine collection bag 109”), which is analogous to the function of the moisture sensor, as demonstrated in the citation from Tanaka above.). Duval, Tanaka, and Lark are analogous art as they are all related to devices used to collect and measure urine.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the second moisture sensor, as a second sensor is suggested by Lark, into the Duval/Tanaka combination as it allows the system to better gauge the movement of the urine through the tube, such as monitoring the filling of the collection bag and controlling the pump based off of the urine in the tube, which can allow for better control of the system.
The Duval/Tanaka/Lark combination teaches a urine detection system (Duval, [0033]: “When urine enters urine tube 10 urine sensor 62 detects this substance”), comprising:
a liquid absorption device coupled to the external urinary catheter (Duval, [0058]: “FIG. 4 shows an enablement wherein urine tube 10 is engaged with an undergarment 80 such as an underwear, under-pant, panty, diaper or similar item worn by an individual when using apparatus 100.”), the liquid absorption device configured to be worn around a pelvic or groin region to secure a position of the external urinary catheter (Duval, [0028]: “urine tube 10 may be inserted through an opening or a slit, fold, etc. 82 in undergarment 80, wherein opening 82 may have a strong elastic edge or closure capable of helping to hold urine tube 10 in place so that axial movement between urine tube 10 and undergarment 80 is minimized”).
Duval teaches the liquid absorption device coupled to the external urinary catheter, however Duval does not teach the devices being fluidly connected.
Tran teaches a device for collecting urine. Specifically, Tran teaches the liquid absorption device being fluidly connected to the external urinary catheter (Fig. 1C). Duval and Tran are analogous arts as they are both related to devices used to collect urine from a patient.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the fluid connection from Tran into the system from the Duval/Tanaka/Lark combination as it allows for a more comfortable connection, as well as allows female patients to use a more effective device.
The Duval/Tanaka/Lark/Tran combination discloses a liquid absorption device, however the combination does not disclose including sensors in the liquid absorption device.
Valer discloses a system for monitoring incontinence. Specifically, Valer teaches wherein the liquid absorption device includes a number of sensors disposed on or integrated into the liquid absorption device (Page 2, lines 3-6: “a urine sensitive circuit arranged to present a changed electrical characteristic when exposed to urine; measurement circuit arranged to perform a measurement on a urine bladder of a wearer”), the number of sensors including at least a first set of sensors configured to detect urine excreted by a patient (Page 2, line 9: “determine whether the urine sensitive circuit has been exposed to urine”; Page 11, lines 9-10: “The urine sensitive circuit 210 includes a first and a second electrode 214, 215.”). Duval, Tran, and Valer are analogous arts as they are all related to devices that measure parameters related to urine.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sensors from Valer into the system from the Duval/Tanaka/Lark/Tran combination as it allows the system to record information about the presence of urine as soon as it comes in contact with the device, which can provide faster information and allow for a quicker analysis.
The Duval/Tanaka/Lark/Tran/Valer combination teaches a console in communication with the number of sensors, the pump, and the plurality of drainage tube sensors (Duval, [0033]: “Computer 208 controls operations.”), the console comprising an energy source (Duval, [0030]: “Vacuum pump 220 may be powered by AC current via power cord 270 as shown, or alternately may be powered by a DC battery pack with inverter (not shown).”), a number of processors (Duval, [0013]: “Such detections produce signals which are directed to the digital processor for data logging and analysis”; [0029]: “System 208 may be a Seetec model W759 digital processor with seven-inch LCD monitor resistive touch panel and WIFI, Bluetooth, and GPS communication capability or any equivalent as will be known to those of skill in the art.”).
However, the Duval/Tanaka/Lark/Tran/Valer combination is silent on where the data is stored.
Valer teaches a memory including a non-transitory computer readable medium having logic stored thereon that, when executed by the processors, performs operations of the system, including: detecting the urine excreted by the patient (Page 22, lines 11-15: “The logic governing the operations of the processing circuit 430 may for example be stored as software instructions in a storage medium (typically non-transitory form), for example the memory 434, which instructions are arranged to perform the operations of the processing circuit 430 described herein when executed by the processing circuit 430.”; Page 2, line 9: “determine whether the urine sensitive circuit has been exposed to urine”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the memory from Valer into the system from the Duval/Tanaka/Lark/Tran/Valer combination as the combination is silent on where the data is stored, and Valer discloses a suitable memory in an analogous device.
The Duval/Tanaka/Lark/Tran/Valer combination teaches activating the pump in response to the detecting the urine (Duval, Abstract: “When urine flows into the urine collecting tube a sensor triggers a vacuum pump to produce a higher level of suction to flush the urine into the canister where a level sensor determines the quantity of urine received or resident within the canister.”).
However, the Duval/Tanaka/Lark/Tran/Valer combination does not teach determining a count of pump cycles when both the first and second drainage tube sensors detect the urine within the drainage tube.
Lark discloses determining a count of pump cycles when both the first and second drainage tube sensors detect the urine within the drainage tube, and calculating a volume of the urine delivered by the pump to the urine collection bag based the count of pump cycles (Page 17: “UO values are calculated by logging pump cycles and time”. “UO” is urine output, which can include the volume of urine. The pump only pumps when urine is detected in the urine tube as stated in Duval ([0033]: “When urine enters urine tube 10 urine sensor 62 detects this substance and signals computer 208 which, in turn, signals vacuum gage 240. Gage 240 opens vacuum valve 230 and turns on vacuum pump 220”)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include determining pump cycles from Lark into the system from the Duval/Tanaka/Lark/Tran/Valer combination as it allows the time cycles of the pump’s activity to be monitored and determine the volume of urine, which can provide more information to the system about the user’s urine output and health conditions relative to urine output.
Regarding claim 8, the Duval/Tanaka/Lark/Tran/Valer combination teaches the system according to claim 7, wherein the drainage tube is detachably coupled with at least one of the external urinary catheter or the collection bag (Duval, [0026]: “Connector 70 is used to allow separation of interconnection tube 20”).
Regarding claim 9, the Duval/Tanaka/Lark/Tran/Valer combination teaches the system according to claim 7.
However, the Duval/Tanaka/Lark/Tran/Valer combination is silent on the structure of the liquid absorption device.
Valer teaches wherein the liquid absorption device includes: a liquid absorbent layer (Page 8, lines 3-6: “the urine sensitive circuit 110 may typically be positioned in a crotch region of the wearer, for example at an absorbent article (e.g. a diaper/nappy, a sanitary napkin/pad, or some other article for absorbing urine) or in connection to the underwear or undergarment.”) and a liquid impermeable layer disposed external to the liquid absorbent layer, and one or more sensors of the first set of sensors are coupled with the liquid absorbent layer (Page 15, lines 12-15: “To avoid or reduce possibly undesired shifting of the resonance frequency of the urine sensitive circuit 210, a fluid impermeable layer or encapsulation (e.g. plastic) may be arranged to cover the urine sensitive circuit 210 but exposing the portion 212 with the electrodes 214, 215.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the structure of the liquid absorption device from Valer into the Duval/Tanaka/Lark/Tran/Valer combination as the combination is silent on the structure of the liquid absorption device, and Valer discloses a suitable structure in an analogous device.
Regarding claim 11, the Duval/Tanaka/Lark/Tran/Valer combination teaches the system according to claim 7.
However, the Duval/Tanaka/Lark/Tran/Valer combination does not teach further comprising: a collection bag holder configured for containing the collection bag, the collection bag holder having a strap configured to secure the collection bag holder to a user.
Valer teaches further comprising: a holder configured for containing the device, the holder having a strap configured to secure the device to a user (Page 22, lines 8-10: “The carrier may preferably be a relatively light-weight and unobtrusive unit which may be secured to the skin at the bladder region (e.g. by means of an adhesive) of the wearer, secured to the wearer by means of a strap or secured to an edge of the diaper or underwear.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the strap securement from Valer into the Duval/Tanaka/Lark/Tran/Valer combination as it allows the device to be attached to the user and held without the need for the user to carry around the collection bag in their hands.
Regarding claim 13, the Duval/Tanaka/Lark/Tran/Valer combination teaches the system according to claim 7, wherein the operations further include transmitting the detecting the urine to a computing device (Duval, Claim 1: “a computer in signal communication with said fluid sensor wherein said vacuum pump is activated when urine enters said urine tube; a fluid level sensor in said canister in communication with said computer for limiting a fluid level in said canister; and a fluid characteristics sensor in said canister in communication with said computer for logging fluid characteristics”).
Regarding claim 14, the Duval/Tanaka/Lark/Tran/Valer combination teaches the system according to claim 13, wherein the number of sensors include: a second set of sensors configured to measure a number of analytes in the urine, wherein the second set of sensors includes one or more of a pH sensor, a blood sensor, or a bacteria sensor, and the operations further include: obtaining the analyte measurements in response to the detecting the urine (Duval, [0031]: “Sensors 280a, 280b, and 280c are representative of a wide variety of sensors that may be utilized in characterizing collected samples of urine. Such sensors may be mounted, as shown, in strips on the interior side surface of canister 210 as shown or may have another form and may be mounted in other ways. Such sensors may be able to detect liquid level, trace chemicals, biological agents, occult blood, and other features of urine”); and transmitting the analyte measurements to the computing device (Duval, Claim 1: “a computer in signal communication with said fluid sensor wherein said vacuum pump is activated when urine enters said urine tube; a fluid level sensor in said canister in communication with said computer for limiting a fluid level in said canister; and a fluid characteristics sensor in said canister in communication with said computer for logging fluid characteristics”).
Regarding claim 15, the Duval/Tanaka/Lark/Tran/Valer combination teaches the system according to claim 14.
However, the Duval/Tanaka/Lark/Tran/Valer combination does not teach wherein the operations further include: comparing the analyte measurements with one or more analyte limits stored in the memory; as a result of the comparison, generating one or more alerts when any of the analyte measurements are outside of the one or more analyte limits; and transmitting the one or more alerts to the computing device.
Valer teaches wherein the operations further include: comparing the measurements with one or more limits stored in the memory; as a result of the comparison, generating one or more alerts when any of the measurements are outside of the one or more limits; and transmitting the one or more alerts to the computing device (Page 19, lines 19-28: “The processing circuit 130 may also be arranged to continuously, or repeatedly compare the data representing the parameter(s) as determined by the measurement circuit 120 to a respective threshold … The threshold may be stored in a memory accessible to the processing circuit 130. If the processing circuit 130 determines that the threshold is met or exceeded an alert signal (i.e. warning signal) may be provided to the wearer to indicate that the risk of an involuntary urination event is increased.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the comparison and the alert from Valer into the Duval/Tanaka/Lark/Tran/Valer combination as it allows the system to monitor the analyte levels and ensure that if the levels reach a certain amount, a user is notified and can take action if necessary.
Regarding claim 21, the Duval/Tanaka/Lark/Tran/Valer combination teaches the system according to claim 7, wherein: the console includes a wireless module (Duval, [0013]: “Wireless operation is also possible.”), and the operations further include: defining a correlated time of day with the detecting the urine (Duval, [0013]: “Such detections produce signals which are directed to the digital processor for data logging and analysis including plotting values against time”); and wirelessly transmitting the detecting the urine and the correlated time of day to a computing device (Duval, Claim 1: “a computer in signal communication with said fluid sensor wherein said vacuum pump is activated when urine enters said urine tube; a fluid level sensor in said canister in communication with said computer for limiting a fluid level in said canister; and a fluid characteristics sensor in said canister in communication with said computer for logging fluid characteristics”).
Response to Arguments
Applicant’s arguments with respect to claims 7-9, 11, 13-15, and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 5712727540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights