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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/10/2025 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks dates 04/10/2026, with respect to the rejection(s) of claims 1-9 and 18-19 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of previously presented prior art Jersey, Hunter, and Close, and newly presented prior art Pollack (US 20130131506 A1).
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 07/19/2022, 08/11/2022, 01/16/2025, 04/07/2025, 06/16/2025, 12/10/2025, 01/22/2026, and 03/23/2026 have been considered by the examiner.
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.
Claim(s) 1-6 and 18-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jersey-Willuhn et al (US 20030216663 A1), hereinafter referred to as Jersey, in view of Hunter et al (US 20160310077 A1), hereinafter referred to as Hunter, Close et al (US 20030208154 A1), hereinafter referred to as Close, and Pollack (US 20130131506 A1).
Regarding claim 1, Jersey teaches a sensing system for sensing a potential complication at a site of a venous catheter inserted within a vein of a patient (see Jersey [0025]; an infusion system capable of monitoring infusion complications), the sensing system comprising:
(i) a sensor module (118) configured for attachment at the site of the venous catheter (see Jersey [0026]; a flexible membrane that incorporates a plurality of sensors capable of detecting tissue condition), the sensor module including:
(a) a pressure sensor (one of sensors 120; also identified as 910, 912, and/or 914) positioned adjacent the site of the venous catheter (see Jersey Fig. 1, [0058]; sensor module 118 having sensors 120 is integrated into film barrier dressing 122, which may have a transparent window for visualization of the infusion site, and as pictured in Fig. 1 has sensors 120 surrounding its perimeter, which means that when the dressing 122 is applied to the infusion site, the sensors which may comprise at least one pressure sensor, are positioned adjacent to the venous catheter infusion site) and configured to generate pressure data representing measured pressure at the site of the venous catheter (see Jersey Fig. 9, [0146-0147]; sensors 910, 912, and 914 may include a pressure sensor, the sensors may be incorporated into layers of the flexible dressing material);
(b) a first temperature sensor (one of sensors 120; also identified as 910, 912, and/or 914) positioned adjacent to the site of the venous catheter (see Jersey Fig. 1, [0058]; sensor module 118 having sensors 120 is integrated into film barrier dressing 122, which may have a transparent window for visualization of the infusion site, and as pictured in Fig. 1 has sensors 120 surrounding its perimeter, which means that when the dressing 122 is applied to the infusion site, the sensors which may comprise at least one pressure sensor, are positioned adjacent to the venous catheter infusion site) and configured to generate temperature data representing measured temperature at the site of the venous catheter (see Jersey Fig. 9, [0146]; sensors 910, 912, and 914 could include a thermistor, thermometer, or other temperature sensing device, the sensors may be incorporated into layers of the flexible dressing material);
(c) a bio impedance sensor (400, also identified as one of sensors 120 and 910, 912, and/or 914 in an embodiment) comprising two pairs of bio impedance electrodes (410) each positioned adjacent the pressure sensor (see Jersey [0146-0147]; biosensors can be incorporated into layers of a flexible dressing material wherein those biosensors may be bio-impedance sensors or pressure sensors, therefore, the bio-impedance electrodes/sensors are positioned adjacent the pressure sensor as they are all disposed in the layers of the flexible dressing applied to the patient) that are together configured to generate bio impedance data comprising bio-electrical signals representing bioelectrical activity at the site of the venous catheter (see Jersey Fig. 4, [0101]; electrical impedance sensor 400 has six electrodes 410);
(d) a transmitter (934 as a part of processor 928) coupled to the sensors and the bio impedance electrodes, the transmitter configured to produce a response signal, the response signal including the generated pressure, temperature and bio impedance data (see Jersey [0160]; signals from the sensors 910, 912, and/or 914 can be supplied directly to a processor 928 or may be communicated to a remote receiving device 930 via a transmitter/receiver 934); and
(e) a biocompatible substrate (122, also identified as 300 in an embodiment) configured to support the pressure sensor, the first temperature sensor, the bio impedance sensor and the transmitter (see Jersey [0057]; film barrier dressing 122 supports the array of sensors 120 and connects to the sensor signal pathway 126 which communicates with the control unit) and
(ii) a computing device including a non-transitory computer readable medium having stored thereon a program (see Jersey [0068]; control unit 124 may include various processors wherein the processor can be programmed to perform a variety of analysis, storage, and control functions), wherein execution of the program of the non-transitory computer readable medium configures the computing device to:
wirelessly receive the response signal that includes the pressure, temperature and bio impedance data generated by the sensor module (see Jersey [0061]; the sensors 120 comprise one or more sensor arrays adapted for transmitting signals into tissue and receiving signals from the tissue using one or more sensing technologies, [0057]; film barrier dressing 122 which has integrated sensors 120 uses sensor signal pathway 126 to connect with the control unit 124 to carry data and control signals, the pathway 126 may be a wireless channel); and
transmit to a user device the pressure, temperature and bio impedance data generated by the sensor module for comparing the generated pressure, temperature and bio impedance data to threshold values indicative of intravenous complications (see Jersey [0027]; sense, detect, quantify, monitor, and generate an alert notification of tissue parameters, [0068]; communication program for communicating information to a remote location, enabling remote surveillance of tissue measurements and characteristics).
Jersey is silent regarding wherein the transmitter is configured to receive an interrogation signal and produce a response signal in response to the interrogation signal, and
wherein the computing device emits, with an antenna system of the computing device, an interrogation signal; and receives, with the antenna system of the computing device, a response signal in response to the interrogation signal; and
regarding the computing device being positioned adjacent the sensor module such that the distance between the computing device and the sensor module is less than 20 cm, and including
a second temperature sensor being configured to generate temperature data representing measured temperature at a site on the patient that is spaced apart from the site of the venous catheter; and
the computing device being configured to wirelessly transmit to a user device the pressure, temperature, and bio impedance data generated by the sensor module as well as the temperature data generated by the second temperature sensor of the computing device for
comparing the pressure, temperature, and bio impedance data generated by the sensor module to threshold values indicative of intravenous complications and
comparing the temperature data generated by the sensor module with the temperature data generated by the computing device to identify fluctuations of the temperature data generated by the sensor module.
Hunter teaches a system for monitoring medical devices using a sensing system, wherein the transmitter is configured to receive an interrogation signal and produce a response signal in response to the interrogation signal (see Hunter Fig. 6; sensor-module network), and wherein the computing device (see Hunter Fig. 2; sensor modules 10i) emits, with an antenna system of the computing device (see Hunter Fig. 6; antennas 22i), an interrogation signal (see Hunter [0153]; the initiating and responding sensor modules establish communications using a handshake technique); and receives, with the antenna system of the computing device, a response signal in response to the interrogation signal (see Hunter [0154]; if the initiating sensor is requesting data, then the responding sensor module transmits a signal to the initiating sensor module); and
wherein the computing device (10) may wirelessly transmit to a user device (82) the sensor data (see Hunter Fig. 4, [0131]; remote data-receiving device 82).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensing system as taught by Jersey with the interrogation and response signals as taught by Hunter. One of ordinary skill in the art would have been motivated to make this modification in order to establish communication between a computing device and sensor module in order to request the measuring and transmission of patient data while monitoring the patient condition.
Close teaches a system for monitoring the site of an intravenous catheter wherein a mounting assembly (140) is fastened to the user at the infusion site for a needle (10) where the mounting assembly supports a sensor module (130) via sensor connecting assemblies (123 and 124). The mounting assembly is operatively connected to a computing device (control unit 160) that is connected adjacent to the sensor module (see Fig. 9 where mounting assembly 140 for sensor module 130 and computing device 160 are positioned adjacent to one another on a patient’s arm).
Close is silent regarding the distance between the computing device and the sensor module being less than 20 cm. However, it can be appreciated that with consideration of Fig. 9 and paragraphs [0073] and [0085] in which the mounting assembly 140 is described as formed on an armband and the control unit 160 is also connected to the patient via band 161 and the two bands are connected via link 150, that the computing device and the sensor module are positioned adjacent one another such that they are on the same limb, in this case an arm. The device of the prior art discloses the claimed invention except for the distance between the computing device and the sensor module being less than 20 cm. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the relative spacing between the computing device and the sensor module, since such a modification would have involved a mere change in the size of a component, in this case, the length of link 150. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04(IV)(A), In re Rose, 105 USPQ 237.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensing system as taught by Jersey utilizing the communication protocol of Hunter with the computing device positioned adjacent to the sensor module as taught by Close. One of ordinary skill in the art would have been motivated to make this modification in order to operatively link the sensor module with the computing device in a fashion where the computing device may be portable rather so the patient does not have to be tethered to stationary monitoring device (Close [0083-0086]).
Pollack teaches a system for intravenous infiltration detection using an array of sensors (60A-D) which are positioned directed over and surrounding the injection site, or in the proximity of the injection site and sense information including temperature (Pollack Fig. 4, [0042]). The sensor arrays (60A, 60C, and 60D) which are not located directly over the injection site, may be regarded as computing devices because they are configured to transmit information to a user device (74) via an electrical connector (66, 68, 70, 72) so that the user device (74) may compare the measured signals from the sensor module located at the injection site to threshold values indicative of intravenous complications (see Pollack [0042]; signal analyzer 74 processes received information from the sensor modules for determining whether an infiltration or extravasation has occurred based on a comparison to a threshold value); and compare the temperature data generated by the sensor module at the injection site with the temperature data generated by the computing device located adjacent to the injection site to identify fluctuations of the temperature data generated by the sensor module (see Pollack [0042]; signal analyzer 74 processes received information including temperature from the sensor modules for determining whether an infiltration or extravasation has occurred using threshold values).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the computing device and sensor module as taught by Jersey and Close with an additional sensor module located adjacent to the injection site as taught by Pollack. One of ordinary skill in the art would have been motivated to make this modification in order to monitor the tissue surrounding an injection site as a means for determining infiltration or extravasation (Pollack [0010]).
Regarding claim 2, Jersey, Hunter, Close, and Pollack teach the system of claim 1. Jersey further teaches wherein the computing device comprises a microcontroller (928; see Jersey [0163]; processor 928 may be any suitable processing device including microcontroller) where the microcontroller receives pressure, temperature, and bio impedance data and modulating the pressure, temperature, and bio impedance data onto a response signal, and transmits the response signal to the user device (see Jersey [0068]; The processor also includes a control program for controlling signals acquisition by the sensors 120. The processor may include a communication program for communicating information to a remote location, enabling remote surveillance of tissue measurements and characteristics; and [0061]; The sensors 120 comprise one or more sensor arrays adapted for transmitting signals into tissue and receiving signals from the tissue using one or more sensing technologies.)
Jersey is silent regarding a near field communication (NFC) reader coupled to the microcontroller, and wherein the antenna system of the computing device is a wireless transmitter coupled to the microcontroller for transmitting the response signal to the user device.
However, Hunter teaches a near field communication (NFC) reader coupled to the microcontroller (see Hunter Fig. 4, [0137]; the sensor module 10 transmits a signal using the sensor data according to a communications protocol such as NFC), and wherein the antenna system (22) of the computing device is a wireless transmitter coupled to the microcontroller for transmitting the response signal to the user device (see Hunter Fig. 4, [0132]; the remote data-receiving device 82 receives, demodulates, and recovers sensor data from the wireless signal that the sensor module 10 transmits via the antenna 22).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify sensing system as taught by Jersey with near field communication coupled to the microcontroller for receiving and modulating the collected data, and the antenna system coupled to the microcontroller for transmitting the response signal to the user device. One of ordinary skill in the art would have been motivated to make this modification in order to establish a reliable, wireless connection between the sensing system that interfaces with the patient and the remote user device that monitors the patient’s condition.
Regarding claim 3, Jersey, Hunter, Close, and Pollack teach the system according to claim 1. Jersey further teaches wherein the pressure sensor, the first temperature sensor, and the bio impedance sensor are positioned on the same layer of the biocompatible substrate (122; see Jersey [0026]; flexible film barrier dressing in a flexible membrane that incorporates a plurality of sensors capable of detecting tissue condition and a control unit capable of coupling to the film barrier dressing that monitors signals from the sensors).
Regarding claim 4, Jersey, Hunter, Close, and Pollack teach the sensing system of claim 1. Jersey is silent regarding wherein the antenna system is a wireless transmitter that is configured to emit signals via short-range wireless communication or Wi-Fi.
However, Hunter teaches wherein the antenna system (22) is a wireless transmitter that is configured to emit signals via Bluetooth or Wi-Fi (see Hunter [0132]; the sensor module 10 transmits via the antenna 22, [0136]; the sensor module 10 transmits a signal including the sensor data according to a communications protocol such as Bluetooth® or NFC).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensing system of Jersey with wireless transmission via Bluetooth or NFC and taught by Hunter. One of ordinary skill in the art would have been motivated to make this modification in order to establish a reliable wireless connection between the sensing system that interfaces with the patient and the remote user device that monitors the patient’s condition using well-understood technologies.
Regarding claim 5, Jersey teaches a method for sensing a potential complication at a site of a venous catheter inserted within a vein of a patient, the method comprising:
positioning an intravenous complication sensing module over the site of the venous catheter, the intravenous complication sensing module configured to sense pressure, temperature and bio impedance values at the site of the venous catheter (see Jersey [0058]; film barrier dressing 122 has one or more adhesive layers capable of contacting and affixing to patient tissue and also capable of securing a needle or intravenous catheter against the skin and sealing the top of an intravascular insertion);
positioning a computing device (124) on the patient at a location beside the sensing module (see Jersey [0068]; control unit 124 may include various processors wherein the processor can be programmed to perform a variety of analysis, storage, and control functions),
wirelessly receiving, a response signal that includes the sensed pressure, temperature and bio impedance values from the sensing module (see Jersey [0061]; the sensors 120 comprise one or more sensor arrays adapted for transmitting signals into tissue and receiving signals from the tissue using one or more sensing technologies, [0057]; film barrier dressing 122 which has integrated sensors 120 uses sensor signal pathway 126 to connect with the control unit 124 to carry data and control signals, the pathway 126 may be a wireless channel);
wirelessly transmitting the sensed pressure, temperature and bio impedance values at the site of the venous catheter to a user device (see Jersey [0068]; processor may include a communication program for communicating information to a remote location, enabling remote surveillance of tissue measurements and characteristics);
comparing, at the user device, the sensed pressure, temperature and bio impedance values to threshold pressure, temperature and bio impedance values indicative of intravenous complications (see Jersey [0080]; processor 220 stores data, compares the data with preset information including threshold and patterns to determine the presence of absence of conditions that may indicate infiltration or extravasation); and
alerting the user of the user device of the potential intravenous complication, with an output interface of the user device (222, 224, 226), when one or more of the sensed pressure, temperature and bio impedance values exceeds one or more of the threshold values (see Jersey [0074]; processor 220 can be connected to an alert tone generator 222 to inform a caretaker or the patient of an alert condition).
Jersey is silent regarding emitting, with an antenna system of a computing device, an interrogation signal; and
receiving, with the antenna system of the computing device, a response signal to the interrogation signal; and
the computing device configured to sense temperature values of the patient at the site of the computing device,
wirelessly transmit to a user device the sensed pressure, temperature and bio impedance values at the site of the venous catheter and the sensed temperature values of the patient at the site of the computing device, comparing, at the user device, the temperature value of the patient at the site of the venous catheter with the temperature value of the patient at the site of the computing device; and
alerting the user of the user device when the temperature value at the site of the venous catheter fluctuates as compared with the temperature value of the patient at the site of the computing device.
However, Hunter teaches emitting, with an antenna system (22) of a computing device (10), an interrogation signal (see Hunter [0153]; the initiating and responding sensor modules establish communications using a handshake technique); and receiving, with the antenna system (22) of the computing device (10), a response signal (see Hunter [0154]; if the initiating sensor is requesting data, then the responding sensor module transmits a signal to the initiating sensor module).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify sensing system as taught by Jersey with the interrogation and response signals as taught by Hunter. One of ordinary skill in the art would have been motivated to make this modification in order to establish communication between a computing device and sensor module in order to request the measuring and transmission of patient data while monitoring the patient condition.
Close teaches a system for monitoring the site of an intravenous catheter wherein a mounting assembly (140) is fastened to the user at the infusion site for a needle (10) where the mounting assembly supports a sensor module (130) via sensor connecting assemblies (123 and 124). The mounting assembly is operatively connected to a computing device (control unit 160) that is connected adjacent to the sensor module (see Fig. 9 where mounting assembly 140 for sensor module 130 and computing device 160 are positioned adjacent to one another on a patient’s arm).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensing system as taught by Jersey utilizing the communication protocol of Hunter with the computing device positioned adjacent to the sensor module as taught by Close. One of ordinary skill in the art would have been motivated to make this modification in order to operatively link the sensor module with the computing device in a fashion where the computing device may be portable rather so the patient does not have to be tethered to stationary monitoring device (Close [0083-0086]).
Pollack teaches a system for intravenous infiltration detection using an array of sensors (60A-D) which are positioned directed over and surrounding the injection site, or in the proximity of the injection site and sense information including temperature (Pollack Fig. 4, [0042]). The sensor arrays (60A, 60C, and 60D) which are not located directly over the injection site, may be regarded as computing devices because they are configured to transmit information to a user device (74) via an electrical connector (66, 68, 70, 72) so that the user device (74) may compare the measured signals from the sensor module located at the injection site to threshold values indicative of intravenous complications (see Pollack [0042]; signal analyzer 74 processes received information from the sensor modules for determining whether an infiltration or extravasation has occurred based on a comparison to a threshold value); and compare the temperature data generated by the sensor module at the injection site with the temperature data generated by the computing device located adjacent to the injection site to identify fluctuations of the temperature data generated by the sensor module (see Pollack [0042]; signal analyzer 74 processes received information including temperature from the sensor modules for determining whether an infiltration or extravasation has occurred using threshold values).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the computing device and sensor module as taught by Jersey and Close with an additional sensor module located adjacent to the injection site as taught by Pollack. One of ordinary skill in the art would have been motivated to make this modification in order to monitor the tissue surrounding an injection site as a means for determining infiltration or extravasation (Pollack [0010]).
Regarding claim 6, Jersey, Hunter, Close, and Pollack teach the method of claim 5. Jersey further teaches wherein the positioning step comprises:
positioning the intravenous complication sensing module along the vein where a capillary of the catheter was inserted; and
adhering the positioned intravenous complication sensing module to skin of the patient (see Jersey [0058]; film barrier dressing 122 has one or more adhesive layers capable of contacting and affixing to patient tissue and also capable of securing a needle or intravenous catheter against the skin and sealing the top of an intravascular insertion).
Regarding claim 18, Jersey, Hunter Close, and Pollack teach the system of claim 1. Jersey and Hunter are silent regarding wherein the biocompatible substrate comprises a reusable wearable patch configured for attachment at the site of the venous catheter.
Close teaches wherein the biocompatible substrate (120) comprises a reusable wearable patch (140) configured for attachment at the site of the venous catheter (see Close Fig. 9, [0073]; the connector assembly 120 includes sensor connector assemblies 123 and 124 which link the sensor assemblies to the circuitry within the mounting assembly 140 which comprises an armband, and it can be appreciated that the armband is reusable while the intravenous needle/connector assembly is disposed of).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Jersey with the reusable patch configured for attachment to the patient as taught by Close. One of ordinary skill in the art would have been motivated to make this modification in order to ensure the sensor module may remain in its desired position on the patient and safely house any necessary control circuitry (Close [0073]), maintaining the function of the control circuitry while disposing of the intravenous assembly to reduce the risk of infection.
Regarding claim 19, Jersey, Hunter, Close, and Pollack teach the system of claim 18. Jersey and Hunter are silent regarding wherein the computing device comprises a wearable and removable device having a band configured for attachment to the patient.
Close teaches wherein the biocompatible substrate (120) comprises a wearable and removable device having a band configured for attachment to the patient (see Close Fig. 9, [0073]; the connector assembly 120 includes sensor connector assemblies 123 and 124 which link the sensor assemblies to the circuitry within the mounting assembly 140 which comprises an armband).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Jersey with the removable band configured for attachment to the patient as taught by Close. One of ordinary skill in the art would have been motivated to make this modification in order to ensure the sensor module may remain in its desired position on the patient and safely house any necessary control circuitry (Close [0073]).
Regarding claim 20, Jersey, Hunter, Close, and Pollack teach the system of claim 1. They are silent regarding wherein the first temperature sensor is electrically couped in series with the bio-impedance sensor. However, it can be appreciated that within the context of the claimed invention, the means of coupling the first temperature sensor and the bio-impedance sensor in series or parallel would not have an effect on the operation of the device and the particular placement/means of coupling the sensors would be a matter of design choice. See MPEP 2144.04(VI), In re Japikse, 181 F.2d 1019.
Regarding claims 21, 24, 27, and 28 Jersey, Hunter, Close, and Pollack teach the system of claim 1. With respect to the location of the pressure sensor, first temperature sensor, and bio impedance electrodes on the biocompatible substrate, it can be appreciated that a device having the claimed relative sensor dimensions/positions would not perform differently than the prior art device disclosed by Jersey, Hunter, Close, and Pollack, at least because both devices comprise a sensor module positioned to cover a surface area of the skin near the venous catheter insertion site in order to measure physiological signals. It can be appreciated that therefore, the claimed invention is obvious over and not patentably distinct from the prior art device.
See MPEP 2144.04(IV)(A) which states: In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See also MPEP 2144.04(VI), In re Japikse, 181 F.2d 1019.
Regarding claim 22, Jersey, Hunter, Close, and Pollack teach the system of claim 1. Jersey further teaches wherein the first temperature sensor is aligned with the venous catheter (see Jersey Fig. 1 wherein sensors 120 may be aligned with the venous catheter).
Regarding claim 23, Jersey, Hunter, Close, and Pollack teach the system of claim 1. Jersey further teaches wherein the sensor module is passive and does not include a power source (see Jersey Fig. 1, [0057-0061]; sensor dressing 118 with sensors 120 integrated into the film barrier dressing 122, wherein there is not power source associated with the sensor module).
Regarding claim 25, Jersey, Hunter, Close, and Pollack teach the system of claim 1. Jersey further teaches wherein the sensor module (118) and the computing device (124) are physically disconnected (see Jersey [0057]; a sensor signal pathway 126 connects the film barrier dressing 122 and the control unit 124 to carry data and control signals and may be of any suitable technology including wireless channels; which would result in a physical disconnection between the sensor module and the computing device).
Regarding claim 26, Jersey, Hunter, Close, and Pollack teach the system of claim 1. Jersey further teaches wherein the computing device further comprises an artificial intelligence unit that is configured to recognize patterns, filter out irrelevant data, and reduce the possibility of false alarms (see Jersey [0063]; control unit 124 can utilize information obtained using the multiple sensing technologies, store and analyze a time history of the information using various techniques such as thresholding and pattern recognition).
7. Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Jersey-Willuhn et al (US 20030216663 A1), hereinafter referred to as Jersey, in view of Hunter et al (US 20160310077 A1), hereinafter referred to as Hunter.
Regarding claim 7, Jersey teaches a sensing module (see Jersey [0025]; an infusion system capable of monitoring infusion complications) configured for attachment at a site of a venous catheter inserted within a vein of a patient (see Jersey [0058]; capable of securing a needle or intravenous catheter against the skin and sealing the top of an intravascular insertion), the sensing module comprising:
a pressure sensor (910, 912, and/or 914) configured to generate pressure data representing measured pressure at the site of the venous catheter (see Jersey Fig. 9, [0146]; sensors 910, 912, and 914 could include a pressure sensor);
a temperature sensor (910, 912, and/or 914) configured to generate temperature data representing measured temperature at the site of the venous catheter (see Jersey Fig. 9, [0146]; sensors 910, 912, and 914 could include a thermistor, thermometer, or other temperature sensing device);
a bio impedance sensor (400, also identified as 910, 912, and/or 914 in an embodiment) comprising two pairs of bio impedance electrodes (410) that are together configured to generate bio impedance data comprising bio-electrical signals representing bioelectrical activity at the site of the venous catheter (see Jersey Fig. 4, [0101]; electrical impedance sensor 400 has six electrodes 410);
a transmitter coupled to the pressure sensor, the bio impedance sensor and the temperature sensor, the transmitter configured to produce a response signal, the response signal including the generated pressure, bio impedance and temperature data (see Jersey [0160]; signals from the A/D converter 922 and/or the sensors 910, 912, and 914 may be communicated to a remote receiving device 930 via a transmitter/receiver 934 for storage or analysis); and
a biocompatible substrate (122, also identified as 300 in an embodiment) configured to support the pressure sensor, the temperature sensor, the bio impedance sensor and the transmitter (see Jersey [0084]; film barrier dressing 300 is a flexible membrane can be temporarily attached to a patient's skin and later removed).
Jersey is silent regarding the transmitter is configured to receive an interrogation signal and produce a response signal in response to the interrogation signal, and
wherein the pressure sensor covers a larger surface area of skin near the venous catheter insertion site as compared with the temperature sensor.
However, Hunter teaches wherein the transmitter (10) is configured to wirelessly receive an interrogation signal (see Hunter [0153]; the initiating and responding sensor modules establish communications using a handshake technique) and produce a response signal in response to the interrogation signal (see Hunter [0154]; if the initiating sensor is requesting data, then the responding sensor module transmits a signal to the initiating sensor module).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify sensing system as taught by Jersey with the interrogation and response signals as taught by Hunter. One of ordinary skill in the art would have been motivated to make this modification in order to establish communication between a computing device and sensor module in order to request the measuring and transmission of patient data while monitoring the patient condition.
In this instance, a device having the claimed relative dimensions of the pressure and temperature sensors would not perform differently than the prior art device disclosed by Jersey and Hunter at least because both devices comprise a pressure sensor and temperature sensor located near the venous catheter insertion site. Therefore, the claimed invention is obvious over and not patentably distinct from the prior art device. See MPEP 2144.04(IV)(A) which states: In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding claim 8, Jersey and Hunter teach the sensing module of claim 7. Jersey further teaches wherein the biocompatible substrate (122) includes an adhesive configured to adhere the sensing module to the site of the venous catheter (see Jersey [0058]; film barrier dressing 122 has one or more adhesive layers capable of contacting and affixing to patient tissue and also capable of securing a needle or intravenous catheter against the skin and sealing the top of an intravascular insertion).
Regarding claim 9, Jersey and Hunter teach the sensing module of claim 7. Jersey further teaches wherein pressure sensor, the temperature sensor, and the bio impedance sensor are positioned on a same layer of the biocompatible substrate (see Jersey [0057]; sensors 120 integrated into a film barrier dressing 122).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Merz et al (US 20100010327 A1) which teaches a sensor module for a catheter.
Duesterhoft et al (US 20130274630 A1) which teaches dormant to active appurtenances for reporting information regarding wound dressings.
Willybiro et al (US 20200230320 A1) which teaches an intravenous device with integrated sensors.
Roger et al (US 20080195021 A1) which teaches acoustic access disconnection systems and methods.
Meisal (US 20190343397 A1) which teaches a sensor system and method for continuous and wireless monitoring and analysis of temperature in organisms.
Brockway et al (US 20050197585 A1) teaches a vascular blood pressure monitoring system with transdermal catheter and telemetry capabilities.
Hann (US 20130338480 A1) teaches a system for inserting and monitoring an intravenous apparatus including monitoring physiological conditions at the site.
Carr (US 4647281 A) which teaches an infiltration detection apparatus that detects sub-cutaneous temperature at an infusion site.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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