DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 11, 2026 has been entered.
Response to Amendments
The amendment filed August 27, 2026 has been entered.
Claims 1-13 and 15-18 are pending.
Response to Arguments
Applicant’s arguments with respect to the rejection of the claims under 35 U.S.C. 103 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.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over:
Tobescu et al. (US 20170113000 A1) (disclosed by Applicant) (hereinafter – Tobescu) in view of
Stoddard et al. (US 20180146266 A1) (hereinafter – Stoddard).
Re. Claim 1: Tobescu teaches a urinary output collection device (Figs. 9, 12),
comprising:
a urinary catheter coupled with a urine collection bag via a drainage tube extending between the urinary catheter and the urine collection bag (Fig. 9: catheter 2 coupled to container 8 (which may be a bag, per Paragraph 0173) via at least tubing 15); and
a flow meter in line with the drainage tube configured to determine a flow rate of urine flowing from the urinary catheter to the urine collection bag (Fig. 9: system 6 comprising sensing unit 3 for sensing flow per Paragraph 0140),
the flow meter including a flow meter console (Figs. 9, 11: system 6 comprising output unit 4)
including one or more processors and a non-transitory computer-readable medium (Fig. 11: control unit C, memory M)
having stored thereon flow meter logic that, when executed by the one or more processors, causes flow meter operations that include:
determining urine flow rate data (Paragraph 0198: “Sensed signals from sensing unit 3 received in the output unit 4 may be merely processed for enabling the transmission or may be processed in excess thereto, e.g., for obtaining gauged flow rate values from the sensed signals, or even for producing data representative of a graphic representation”).
Tobescu teaches wireless transmission of sensor data to an external device 90, which includes patient monitoring devices (Paragraphs 0187, 0190), but does not explicitly teach:
transmitting a sensor (e.g., flow meter) identifier stored in the non-transitory computer-readable medium to a monitor; and
wirelessly transmitting the urine flow rate data to the monitor, wherein the monitor receives the urine flow rate data from the flow meter only when the flow meter identifier transmitted by the flow meter is a correct flow meter identifier for the monitor.
Stoddard teaches analogous art in the technology of authentication of physiological monitoring devices connected to a patient monitor (Abstract). Stoddard teaches a sensor which may be any device available in the art for acquiring or detecting physiological information from a patient (Fig. 1: data acquisition device and sensor 8; Paragraph 0026). Such a sensor is configured to provide a device identification code (i.e., a sensor identifier) to the patient monitor via wireless connection (Paragraph 0014). An authentication process occurs, whereby a received identification code is compared to a list of acceptable identification codes (Paragraph 0015; Fig. 3: steps 60-70). After the device is authenticated, physiological data is transmitted to the patient monitor (Fig. 3: step 74). In cases where the device is not authenticated, physiological data transmission is prevented (Paragraph 0014).
It would have been obvious to one having skill in the art before the effective filing date to have modified Tobescu to have included transmitting a sensor identifier in association with transmitted data and only transmitting stored sensor data after the device is authenticated in the method as taught by Stoddard, the motivation being that doing so ensures patient safety by confirming that an unidentified device is an approved physiological data acquisition device (Paragraphs 0013-0014).
Re. Claim 2: Tobescu as modified by Stoddard teaches the invention according to claim 1. Tobescu further teaches the invention further including a sample port coupled to the drainage tube, the sample port configured to enable a clinician to draw a sample of the urine from the drainage tube via a volumetric device (Figs. 12, 13: syringe 14 connected to port of tubing 15 for taking urine samples, per Paragraph 0195).
Re. Claim 3: Tobescu as modified by Stoddard teaches the invention according to claim 1. Stoddard, in teaching further detail regarding the incorporated sensor identifier, further teaches wherein the flow meter identifier includes characters selected from the group consisting of alphanumeric characters, special characters, spaces, and combinations thereof (Paragraphs 0031-0032: hashing algorithm and hash keys; Paragraphs 0039-0040: comparison to a list of identification codes, i.e., characters).
Re. Claim 4: Tobescu as modified by Stoddard teaches the invention according to claim 1. Tobescu further teaches the invention wherein the flow meter console includes a battery (Paragraph 0188: “Output unit 4 includes its own power supply, usually in form of an energy storage unit 7 such as a battery, e.g., a button cell”).
Re. Claim 5: Tobescu as modified by Stoddard teaches the invention according to claim 1. Tobescu further teaches the invention wherein urinary catheter, the drainage tube, and the urine collection bag define a pre-connected closed fluid system (Fig. 9).
Re. Claim 6: Tobescu as modified by Stoddard teaches the invention according to claim 1. Tobescu further teaches the invention wherein the flow meter is disposable (Fig. 9 any component of the system may be disposed of – Applicant’s claim fails to structurally distinguish a disposable flow meter from a non-disposable flow meter).
Claims 7, 8, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over:
Tobescu et al. (US 20170113000 A1) (disclosed by Applicant) (hereinafter – Tobescu) in view of
Stoddard et al. (US 20180146266 A1) (hereinafter – Stoddard) in further view of
Mazar et al. (US 20150302539 A1) (hereinafter – Mazar).
Re. Claim 7: Tobescu teaches a urinary output monitoring system, comprising:
the urinary output collection device according to claim 1 (see rejection of claim 1), and
the monitor of claim 1 in wireless communication with the flow meter (Paragraph 0187: wireless connection to external device 90; Paragraph 0190: “…corresponding information may be displayed using a unit connectable (via interface T) to output unit 4, e.g., to a smart phone or to a tablet computer or to an intensive care monitoring device wirelessly connected to output unit 4”).
Tobescu does not teach the monitor including a monitor console including one or more processors and a non-transitory computer-readable medium having stored thereon monitor logic that, when executed by the one or more processors, causes monitor operations that include:
receiving the flow meter identifier from the flow meter;
responsive to the flow meter identifier being the correct flow meter identifier, receiving the urine flow rate from the flow meter.
Stoddard teaches such limitations. See rejection of claim 1; motivation to modify Tobescu with the teachings of Stoddard are identical.
Tobescu as modified by Stoddard do not teach the invention further comprising:
correlating the flow meter identifier with a patient identification;
aggregating the urine flow rate data with previous urine flow rate data correlated with the patient identification resulting in aggregate urine flow rate data; and
depicting the aggregate urine flow rate data on a display of the monitor.
Mazar teaches analogous art in the technology of health information management systems (Abstract). Mazar further teaches the invention comprising:
correlating the sensor identifier with a patient identification (Paragraphs 0087-0088, 0204);
aggregating the urine flow rate data with previous urine flow rate data correlated with the patient identification resulting in aggregate urine flow rate data (Paragraphs 0134-0135, 0140: historic readings and patient information); and
depicting the aggregate sensor data on a display of the monitor (Fig. 3E: historic sensor data; see citations above).
It would have been obvious to one having skill in the art before the effective filing date to have modified Tobescu as modified by Stoddard to further include association of a sensor with a patient and tracking and displaying aggregated historical information as taught by Mazar, the motivation being that doing so assists caregivers to review historic information to identify trends or patterns that can be indicative of issues related to the patient's health (Paragraph 0140).
Re. Claim 8: Tobescu as modified by Stoddard and Mazar teaches the invention according to claim 7, including wherein the monitor operations further include correlating the urine flow rate data with the flow meter identifier (see citations of rejection of claim 7: a particular sensor’s data is correlated with a sensor identifier; see also modification in light of Stoddard).
Re. Claim 15: Tobescu as modified by Stoddard and Mazar teaches the invention according to claim 7, but does not teach the invention wherein the monitor operations further include depicting the patient identification on the display.
Mazar further teaches the invention wherein the monitor operations further include depicting the patient identification on the display (Fig. 3E: see patient name).
It would have been obvious to one having skill in the art before the effective filing date to have modified Tobescu as modified by Stoddard and Mazar to include display of patient identification information on the display, the motivation being that such an operation further assists caregivers to review historic information to identify trends or patterns relative to a particular patient (Paragraph 0140).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over:
Tobescu et al. (US 20170113000 A1) (disclosed by Applicant) (hereinafter – Tobescu) in view of
Stoddard et al. (US 20180146266 A1) (hereinafter – Stoddard) in further view of
Mazar et al. (US 20150302539 A1) (hereinafter – Mazar) in further view of
Crook et al. (US 20210098124 A1) (hereinafter – Crook).
Re. Claims 9 and 10: Tobescu as modified by Stoddard and Mazar teaches the invention according to claim 7. Tobescu teaches that system 6 of the device (i.e., encompassing a flowmeter) performs a variety of operations, including,
as required by claim 9, correlating the urine flow rate data with a time of day to define correlated urine flow rate data (Paragraph 0085: “Output unit 4 also includes a clock 44, in particular wherein clock 44 provides real-time information, such as at least the hour of the day, usually also, in addition, the day of the week and/or the full date. This way, sensed flow-related data can be linked to the time of sensing. Thus, it is possible to obtain (and store) information such as ‘today, between 11 a.m. and 12 a.m., 89 ml urine were collected’ or ‘yesterday, between 11 a.m. and 12 a.m., 48 ml urine were collected’”) and,
as required by claim 10, integrating the urine flow rate data with respect to time to calculate a urine output volume, and depicting the urine output volume on the display (“Paragraph 0105: “…determining a quantity related to a flow of a fluid flowing through a catheter or cannula applied to a body. That quantity may be, e.g., a flow rate or an amount, e.g., a volume, of the fluid emitted from the body within a preset time interval…;” Paragraph 0151: “…the processing may also include integrating sensed signals and performing various calculations and the like;” Paragraph 0154: “User interface U is provided, e.g., for selecting which data shall be outputted by output unit 4, or for selecting the length of a time interval during which sensed fluid amounts shall be integrated;” Paragraph 0141: “… output unit 4 optionally includes a display unit 5 such as a visual display 5, which may, e.g., as illustrated in FIG. 1, be an alphanumerical display, e.g., indicating a flow rate or an amount (such as a volume) of fluid which has flowed through sensing unit 3 within a selected time span such as 5 minutes”).
Tobescu only differs in the claimed subject matter in reciting that the processing is performed by the system 6 rather than an external device 90, such as a patient monitoring device.
Crook teaches analogous art in the technology of physiological monitoring devices (Abstract). Crook further teaches that operations of a sensor device may be implemented by a local external device (Paragraph 0048: particularly, “it is understood that at least a portion of the operations may be divided between multiple devices. For example, certain operations may be implemented by the medical device, while other operations may be implemented by a local external device and/or remote server. When the operations are split between a medical device and a local external device and/or remote server, information may be conveyed in real time between the various devices. Additionally or alternatively, when the operations are split between a medical device and a local external device and/or remote server, the operations by the local external device and/or remote server may be performed at a separate point in time than (e.g., before) the operations by the medical device”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Tobescu as modified by Stoddard and Mazar to include having one or more operations of the system 6 (including those recited in claims 9 and 10) to be carried out by a local external device (e.g., a patient monitor as contemplated by Tobescu), the motivation being that doing so reduces energy consumption of the sensor device, allowing for better energy management and minimization of the battery required by the sensor (Paragraphs 0002-0004, 0048).
Re. Claim 11: Tobescu as modified by Stoddard, Mazar, and Crook teaches the invention according to claim 10, but does not teach the invention wherein the monitor operations further include communicating with an electronic medical record (EMR) system.
Mazar further teaches the invention wherein the monitor operations further include communicating with an electronic medical record (EMR) system (Fig. 1: see monitor communicating with network communicating with central server 113 which communicates with electronic medical records; Paragraph 0075: “For example, the central server 113 can access electronic medical records (EMRs)”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Tobescu as modified by Stoddard and Mazar to further include communicating with an electronic medical record (EMR) system as taught by Mazar, the motivation being that doing so enables storage of medical data which may not be associated with a singular healthcare facility (Paragraph 0075), thus allowing caregivers at remote locations to monitor patient data (Paragraph 0104).
For completeness, Examiner also notes that such an aspect is also taught by Stoddard (Paragraph 0033).
Re. Claim 12: Tobescu as modified by Stoddard, Mazar, and Crook teaches the invention according to claim 11. Tobescu teaches output of flow-related data to an external device (Paragraph 0187), whereby Mazar in the combination teaches a monitor which transfers correlated sensor data to a server containing patient related information (i.e., an electronic medical record system). While Tobescu contemplates that flow rate data may be “e.g., a flow rate or an amount, e.g., a volume, of the fluid emitted from the body within a preset time interval, or a quantity related thereto,” it is not explicit that Tobescu contemplates transmitting both a rate and volume are transmitted. However, the data that Tobescu contemplates are recited within an “or clause,” and may be viewed as adjacent embodiments (e.g., an embodiment which measures a flow rate and anther embodiment which measures a volume). As per Boston Scientific Scimed, Inc. v. Cordis Corp., "[c]ombining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness." Thus, it would have been obvious for Tobescu to also include transferring flow rate data comprising both a rate and a volume to the patient monitor, which then communicates with an EMR system as disclosed in Mazar.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over:
Tobescu et al. (US 20170113000 A1) (disclosed by Applicant) (hereinafter – Tobescu) in view of
Stoddard et al. (US 20180146266 A1) (hereinafter – Stoddard) in further view of
Mazar et al. (US 20150302539 A1) (hereinafter – Mazar) in further view of
Crook et al. (US 20210098124 A1) (hereinafter – Crook) in further view of
Libbus et al. (US 20120108917 A1) (hereinafter – Libbus).
Re. Claim 13: Tobescu as modified by Stoddard, Mazar, and Crook teaches the invention according to claim 11, but does not teach the invention wherein the monitor operations further include:
receiving a flow meter battery level from the flow meter; and
at least one of
depicting the battery level on the display or
transmitting the battery level to the EMR system.
Libbus teaches analogous art in the technology of patient monitoring systems (Abstract). Libbus further teaches the invention wherein the monitor operations further include:
receiving a flow meter battery level from the flow meter (see citation below - implicit); and
at least one of
depicting the battery level on the display (Paragraph 0101: “The plurality of central displays may also be configured to display the status of the patient devices adhered to patients, for example configured to display at least one of a battery power level or a status of a connection of the device to the patient”) or
transmitting the battery level to the EMR system.
It would have been obvious to one having skill in the art before the effective filing date to have modified the monitor of Tobescu as modified by Stoddard, Mazar, and Crook to also display a battery level of a sensor device in operative connection with the monitor as taught by Libbus, the motivation being that doing so allows a user of the monitoring system to warn a user of the sensor (i.e., flow meter) of a potential low energy status of the device connected to the monitor.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over:
Tobescu et al. (US 20170113000 A1) (disclosed by Applicant) (hereinafter – Tobescu) in view of
Stoddard et al. (US 20180146266 A1) (hereinafter – Stoddard) in further view of
Mazar et al. (US 20150302539 A1) (hereinafter – Mazar) in further view of
Rule et al. (US 20090157430 A1) (disclosed by Applicant) (hereinafter – Rule).
Re. Claims 16 and 17: Tobescu as modified by Stoddard and Mazar teaches the invention according to claim 7, but does not teach the invention wherein the monitor receives electrical power from a facility power source.
Rule teaches analogous art in the technology of patient monitoring devices (Abstract; Title). Rule further teaches a configuration for powering a patient monitor which is capable of
receiving electrical power powered by a wall socket (i.e., “facility power source”) as required by claim 16, and
being powered by a backup battery(Paragraph 0045: “The battery 134 may be used as a main or backup power supply for the monitoring device 102 (which may additionally or alternatively accept electrical power from a wall socket)”) as required by claim 17.
It would have been obvious to one having skill in the art before the effective filing date to have modified the non-descript method of powering a patient monitor of Tobescu as modified by Stoddard and Mazar to instead utilize the method of powering a patient monitor as taught by Rule, the motivation being that the powering configuration of Rule enables the patient monitor to utilize consistent facility power without the need to replace or charge a battery (in the case that a battery is used alone), while also providing resilience against power outages in the case of facility power loss since Rule contemplates a backup battery as capable of continuously providing power to the patient monitoring system.
Re. Claims 18: Tobescu as modified by Stoddard and Mazar teaches the invention according to claim 7, but does not teach the invention wherein the monitor includes a coupling device configured to detachably secure the monitor to a patient bed.
Rule teaches the invention wherein the monitor includes a coupling device configured to detachably secure the monitor to a patient bed (Paragraph 0233: “As shown in FIG. 26, the monitoring apparatus 2632 is connected to a support apparatus 2636… The support apparatus 2636 can also include a clamp adapted to secure the apparatus to a hospital bed, an ICU bed, or another variety of patient conveyance device”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Tobescu as modified by Stoddard and Mazar to include a coupling device configured to detachably secure the monitor to a patient bed as taught by Rule, the motivation being that doing so enables the patient monitor to be moved with the patient while in a conveyance device (Paragraph 0233), allowing the same monitor and attached sensor systems to be utilized.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Islam (US 7294105 B1) – Col. 3, line 63 – Col. 4, line 3: “In one embodiment, sensor 18 may attach a patient and/or sensor identification code to the monitored physiological data that enables CIF 30 to associate the data with patient 20 upon receipt. Attaching an identification code to the monitored physical data can advantageously prevent system 10 from associating the data with the wrong sensor, which may result from inputting the data into the wrong port on transmitter 22;”
Matsumura et al. (US 20200113436 A1) – Paragraph 0110: “According to the operation example, as described above, it is possible to easily know who performed reading of the sensor identification information and the patient identification information (so called, the three-point recognition). This is because the physiological information detection sensor 20 transmits, as the fourth association information, the nurse identification information F in addition to the sensor identification information and the patient identification information, and the received fourth association information (the sensor identification information, the patient identification information, the physiological information of the patient 50, and the nurse identification information) is stored as a history in the storage section provided in the physiological information display device 40 or the like;” Figs. 3-6, 10-15;
Avery et al. (US 20200020428 A1) – Paragraph 0072: “At process block 118, a particular patient monitoring device 12 is identified, for example, by selecting from a list of local wireless devices or by connecting a cable. The particular patient monitoring device must be positively identified by a near field technique to prevent possible wireless connections to devices in adjacent rooms or the like. For example, a serial number affixed to the housing of the patient monitoring device 12 may be matched to a list of devices forming potential Bluetooth pairing partners automatically presented by the CDI device 20. The caregiver 22 may simply select among those devices per process block 118 or use other entry methods to confirm the particular patient monitoring device 12, for example, using scanning of barcodes or the reading of an RFID tag and the like affixed to the patient monitoring device 12. Generally these near field techniques will be limited to operation at less than 3 m and ideally less than 1 m;” Figs. 3-7;
Rondini et al (US 20190371478 A1) – Abstract: “Methods and systems provide for interrogating a medical device associated with a patient to obtain device data using a first processor… The aggregated patient data is accessed at the remote server by at least one of the first, second, and third processors or a separate processor. The aggregated patient data is displayed on a display coupled to at least one of the first, second, and third processors or the separate processor;”
Russo (US 12527497 B2) – Claim 18: “A continuous glucose monitoring (CGM) system, comprising: a CGM device comprising a wireless transmitter, a disposable CGM sensor, and a sensor barcode attached to the disposable CGM sensor… wherein a sensor identifier identifying the disposable CGM sensor of the CGM device and a security code are encoded in the sensor barcode; and an external device comprising a memory configured to store a plurality of sensor identifiers, a wireless receiver, and one or more non-transitory computer-readable media comprising computer-executable instructions that, when executed by at least one processor, perform a method, comprising: requesting a user to scan the sensor barcode via the external device when the disposable CGM sensor is inserted into the user's skin and prior to sensing the user's glucose levels; in response to the user scanning the sensor barcode via the external device, receiving the sensor identifier and the security code encoded in the sensor barcode; detecting reinsertion of the disposable CGM sensor into the user's skin by determining whether the sensor identifier matches one or more of the plurality of sensor identifiers stored in the memory by comparing the sensor identifier to one or more of the plurality of sensor identifiers, wherein, when the sensor identifier of the disposable CGM sensor inserted into the user's skin does not match any of the plurality of sensor identifiers stored in the memory, causing the sensor identifier to be stored in the memory and set a usage count corresponding to the sensor identifier to zero, wherein, when the sensor identifier of the disposable CGM sensor inserted into the user's skin matches at least one of the plurality of sensor identifiers stored in the memory, determining whether the usage count corresponding to the sensor identifier is less than a predetermined usage limit corresponding to the sensor identifier prior to sensing the user's glucose levels; requesting the user to input the security code into the external device, wherein, when a code input by the user does not match the security code, preventing communication between the disposable CGM sensor and the wireless transmitter; responsive to receiving, via the wireless receiver, a glucose level from the CGM device, increasing the usage count corresponding to the sensor identifier by one increment; determining whether the usage count has reached the predetermined usage limit; responsive to a determination that the usage count has reached the predetermined usage limit, causing the CGM device to cease generating the electrical signals; and notifying the user that glucose monitoring is halted and the disposable CGM sensor requires replacement.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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