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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 filed 12/10/2025 have been fully considered but they are not persuasive.
On pages 6-9 of the Remarks, Applicant argues that the previously presented prior art of Jersey does not teach a pressure sensor positioned adjacent the site of the venous catheter, a temperature sensor positioned adjacent the site of the venous catheter, and a bioimpedance sensor comprising two pairs of bioimpedance electrodes each positioned adjacent the site of the venous catheter. Applicant further states that Jersey only discloses that the sensors 120 are integrated into a film barrier dressing 122 and pictured to be distributed along the perimeter of the dressing in Fig. 1.
Examiner respectfully disagrees and argues that Jersey does teach the electrode configuration of the amended claims. As previously stated, Fig. 1 pictures an array of sensors 120 which are distributed along the perimeter of film barrier dressing 122. In paragraph [0058], Jersey describes the film barrier dressing 122 in detail wherein the dressing 122 includes a transparent window to allow for visualization of the infusion site and forms a structural support for the sensors 120. It can be appreciated that the transparent window would be placed atop the infusion site to allow for a visual, which would result in the sensors 120, which are distributed along the perimeter of the dressing 122 as seen in Fig. 1, to be positioned adjacent the infusion site of the venous catheter. Additionally, in paragraph [0070], Jersey discloses that the sensor dressing may be applied at the perivascular area at the site of the intravascular insertion or may be applied at remote body locations positioned away from the insertion site, which would also result in the sensors being positioned adjacent to the site of the venous catheter.
Applicant also argues that Jersey is silent with respect to the configuration of the computing device 124 relative to the sensor module 118 and does not disclose the distance between their positioning. Examiner agrees with Applicant and presents new grounds of rejection under 35 USC 103 as being unpatentable over Jersey-Willuhn et al (US 20030216663 A1), in view of Hunter et al (US 20160310077 A1), and Close et al (US 20030208154 A1), as necessitated by Applicant’s amendments to the claims.
Applicant further argues that one of ordinary skill in the art would not have been motivated to modify the system as taught by Jersey based on Hunter. Examiner points to paragraph [0068] of Hunter where it is established that the present invention may pertain to catheters or medical devices which are utilized externally on a subject, and paragraphs [0069-0071] which establish that the sensor module may be placed in various locations as is appropriate for the present application including inside a medical device, on the outer surface of a medical device, and/or between the medical device and any device which may carry or deliver it. Therefore, it can be appreciated that there is a prima facie case for obviousness to combine the teachings of Jersey and Hunter as both devices pertain to the monitoring of physiological signals at a site of interest; and motivation to combine the teachings of Jersey and Hunter in order to remotely communicate between a sensor module and a monitoring device.
It should also be noted that Hunter is only relied upon to cure the deficiency of Jersey regarding an interrogation signal and a response signal which communicates between the computing device and the sensor generated data via antenna, which is an effective system for the transfer of data between sensors and a computing device, as elaborated upon in Hunter [0643-0644]).
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, and 12/10/2025 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) 1-4 and 18-19 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, and Close et al (US 20030208154 A1), hereinafter referred to as Close.
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 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 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:
receive the response signal that includes the generated pressure, temperature and bio impedance data (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); and
transmit the generated pressure, temperature and bio impedance data to a user device 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.
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).
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]).
Regarding claim 2, Jersey, Hunter, and Close 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, and Close teach the system according to claim 1. Jersey further teaches wherein the pressure sensor, the 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, and Close 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 18, Jersey, Hunter, and Close 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, and Close teach the system of claim 1. Jersey and Hunter are silent regarding wherein the biocompatible substrate 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]).
Claim(s) 5-9 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.
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);
receiving, a response signal that includes the sensed pressure, temperature and bio impedance values;
transmitting the sensed pressure, temperature and bio impedance values 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.
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.
Regarding claim 6, Jersey and Hunter 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 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.
However, Hunter teaches wherein the transmitter (10) is configured to 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.
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792