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 .
Response to Amendments
The amendment filed May 11, 2026 has been entered.
Examiner acknowledges Applicant’s cancellation of claim 19.
Claims 1-18 are pending.
Applicant’s amendments and arguments are persuasive to obviate the objection to the drawings previously presented.
Response to Arguments
Regarding Applicant’s argument:
“First, Cronin does not teach a "flow meter identifier" as explicitly recited by claim 1. Cronin is directed to tracking usage of a pulse oximeter via a network system and teaches a pulse oximeter that "measures at least one of blood oxygen saturation, pulse rate, perfusion index, and respiration rate." (Cronin, par. [0025]). A pulse oximeter is not a flow meter…The Office Action seemingly conflates a "pulse oximeter identifier" with a "flow meter identifier," but these are identifiers for fundamentally different devices measuring fundamentally different physiological parameters.”
The term “flow meter identifier” has the broadest reasonable interpretation of information which enables a device to be identified by another device or system, as understood in light of Applicant’s Paragraph 0043 (“In some embodiments, the flow meter identifier may include alphanumeric characters, special characters (e.g., punctuation marks, Unicode characters, pictographs, or the like), spaces, and combinations thereof within the flow meter identifier”). Cronin teaches a sensor identifier which is similarly transferrable and identifying for a particular sensor, and discusses that “identification data” is previously applied, generally, to nondescript medical device tracking (Paragraphs 0002, 0019). Thus, the content of the identifier of Cronin itself is agnostic to the function of the device, and serves only to act as a label for information transferred paired along with the identifier.
Regarding Applicant’s argument:
“Further, Cronin does not teach transmitting the identifier "to a monitor" as recited by claim 1. Cronin teaches "transmitting the pulse oximeter data, the pulse oximeter identification data, and the status data from the patient monitoring device to the network server." (Cronin, par. [0022], italics added for emphasis). Thus, in Cronin, the identifier is transmitted to a network server, not to a monitor.”
Examiner utilizes the identifier taught by Cronin, not the particular device to which the identifier is transferred to. Applicant argues against elements of the prior art not incorporated in the rejection. Additionally, the broadest reasonable interpretation of “monitor” also encompasses the network server disclosed by Cronin since the monitor performs an act of “monitoring” (i.e., “observing, checking, or keeping a continuous record of a process or quantity”) received sensor data (Abstract).
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 1-8, 11, 12, and 14 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
Cronin et al. (US 20210202084 A1) (hereinafter – Cronin).
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);
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”); and
wirelessly transmitting
(i) the urine flow rate data (Paragraph 0187: “Output unit 4 includes an interface T for outputting processed flow-related data, as obtained by processing in control unit C. In case of a wireless connection between output unit 4 and an external device 90 such as a computer, e.g., a tablet computer, this may be wireless transmitter or transceiver”).
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 transferring a sensor (e.g., flow meter) identifier.
Cronin teaches analogous art in the technology of sensing physiological parameters (Abstract). Cronin teaches a sensor (pulse oximeter) having a sensor identifier stored in the non-transitory computer-readable medium (Fig. 1’ Paragraph 0024: “The pulse oximeter 100 comprise a memory 106 for storing pulse oximeter identification data”), and further teaches a method wherein such an identifier is transferred to a monitor after association with sensor data and patient information (Abstract).
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 in the method as taught by Cronin, the motivation being that doing so allows for tracking usage of a particular sensor associated with a particular patient (Paragraphs 0001-0004).
Re. Claim 2: Tobescu as modified by Cronin teaches the invention according to claim 1. Tobescu further teaches the invention further including a sample port coupled 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 Cronin teaches the invention according to claim 1. Cronin, 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 (Paragraph 0029: “In an alternative embodiment, the pulse oximeter identification data are acquired by scanning a machine-readable indicia, such as a barcode, a QR code, or an RFID tag, among others”).
Re. Claim 4: Tobescu as modified by Cronin 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 Cronin 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 Cronin 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).
Re. Claim 7: Tobescu as modified by Cronin teaches a urinary output monitoring system, comprising:
the urinary output device according to claim 1the invention according to claim 1 (see rejection of claim 1).
Tobescu further teaches 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”),
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 urine flow rate data and the flow meter identifier from the flow meter (Paragraphs 0187, 0190: wireless transmission of flow data; Examiner notes again that transferring to an external device encompassing a smartphone or computer (see Paragraphs 0019, 0077-0081, 0187, 0190) requires reception of an identifier of a wirelessly connected source of data since such devices typically comprise communication standards such a Bluetooth or Wi-Fi, both of which require transmission of an identifier); and
depicting the urine flow rate data on a display of the monitor (Paragraph 0190: “As has been mentioned already, it can, in general, also be envisaged to dispense with a visual display 5. Then, it is not possible anymore to be readily visually informed about the sensed flow by output unit 4, however, 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. More particularly, it is possible to provide that in output unit 4, more particularly by means of control unit C, files are generated which contain graphics data, such as data representative of a graphic visualization of flow-related data”).
Re. Claim 8: Tobescu as modified by Cronin teaches the invention according to claim 7. Cronin, in teaching further detail regarding the incorporated method, further teaches the invention wherein the monitor operations further include correlating the sensor data (i.e., urine flow rate) with the sensor (i.e., flow meter) identifier (Abstract; similarly recited in Paragraphs 0022, claim 7).
Re. Claim 11: Tobescu as modified by Cronin teaches the invention according to claim 7. Tobescu further teaches the invention wherein the monitor operations further include communicating with an electronic medical record (EMR) system (Abstract: patient information uploaded to a network server).
Re. Claim 2: Tobescu as modified by Cronin teaches the invention according to claim 11. Tobescu teaches output of flow-related data to an external device (Paragraph 0187), whereby Cronin 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 included by Cronin, which then communicates with an EMR system.
Re. Claim 14: Tobescu as modified by Cronin teaches the invention according to claim 11. Tobescu further teaches the invention wherein the monitor operations further include correlating the flow meter identifier with a patient identification from the EMR system (Abstract: patient identification information associated with sensor identification data and status).
Claims 9 and 10 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
Cronin et al. (US 20210202084 A1) (hereinafter – Cronin) in further view of
Crook et al. (US 20210098124 A1) (hereinafter – Crook).
Re. Claims 9 and 10: Tobescu as modified by Cronin 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 Cronin 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).
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
Cronin et al. (US 20210202084 A1) (hereinafter – Cronin) in further view of
Libbus et al. (US 20120108917 A1) (hereinafter – Libbus).
Re. Claim 13: Tobescu as modified by Cronin 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 Cronin 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.
Claim 15 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
Cronin et al. (US 20210202084 A1) (hereinafter – Cronin) in further view of
Nagata et al. (US 20090171169 A1) (hereinafter – Nagata).
Re. Claim 15: Tobescu as modified by Cronin teaches the invention according to claim 14, but does not teach the invention wherein the monitor operations further include depicting the patient identification on the display.
Nagata teaches analogous art in the technology of patient monitoring devices (Abstract). Nagata further teaches the invention wherein the monitor operations further include depicting the patient identification on the display (Fig. 11A-11D: see “Taro Kohden” referring to an exemplary 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 Cronin to have the monitor display a patient name as taught by Nagata, since doing so is further confirmation of an association of a particular patient to a particular sensor.
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
Cronin et al. (US 20210202084 A1) (hereinafter – Cronin) in further view of
Rule et al. (US 20090157430 A1) (disclosed by Applicant) (hereinafter – Rule).
Re. Claims 16 and 17: Tobescu as modified by Cronin 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 Cronin 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 Cronin 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 Cronin 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.
Re. Claims 18: Tobescu as modified by Cronin and Rule teaches the invention according to claim 18. Rule teaches that a patient monitoring device may be attached to a bed using a clamp, which possesses a scope covering all forms of clamps suitable for the same purpose; thus, Rule teaches a structural genus (i.e., clamps). Claim 19 recites a particular type of clamp (i.e., “one or more hinge clamps”).
The skilled artisan, when looking to the disclosure of Rule, would be well-apprised of a variety of types of clamps suitable for the same purpose of attaching a component to a hospital bed, and would be aware of clamps possessing a hinge. The skilled artisan would also be motivated to choose the particular species of hinge clamps since clamps possessing a hinge possess the capability to accommodate a large range of structures within the clamping area itself, allowing for a variety of attachment points along the bed. Thus, in light of the above, the obviousness of the species of hinge clamps is taught when the prior art teaches the genus of clamps. See MPPE 2144.08.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 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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