DETAILED ACTION
This action is responsive to the RESPONSE TO NON-FINAL OFFICE ACTION dated 15 December 2025. The Examiner acknowledges the amendments to claims 1, 4, and 19-20. Claims 1-16 and 18-20 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 101
Examiner’s Note Regarding § 101 Analysis: The Examiner’s analysis as recited in the Non-Final Rejection dated 17 September 2025, p. 3-4, is maintained.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5-8, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick (US-20080172013-A1, previously presented) in view of Inan (US-20190328330-A1, previously presented) and Ono (US-7546776-B2).
Regarding claim 1, Kucklick teaches
A system for determining an arterial blood pressure value from a patient, comprising:
a disposable catheter configured to insert into the patient's venous system [anti-extravasation catheter (Kucklick ¶0032, Figure 7), wherein the Examiner notes that being “disposable” is not considered to be structurally of functionally limiting, such that any catheter may be disposed of];
a pressure sensor positioned along the disposable catheter and configured to measure physiological signals indicating a pressure in the patient's venous system [Pressure transducer 36 is operably connected to control system 20 and the central lumen of the tube 4. The transducer 36 is able to measure pressure in the vein of the patient...Extravasation can result from a thrombosed or collapsed vein 44. A collapsed vein will cause a pressure increase within the vein of the patient due to the backflow of an infusate. When a pressure increase exceeding an acceptable threshold is detected by pressure transducer 36, the control system 20 may operate a pump operably coupled to the dilution source to flush the surrounding tissue (Kucklick ¶0032), wherein the position of pressure transducer 36 as depicted in Kucklick Figure 6 is considered to read on being disposed “along the disposable catheter”];
a plurality of electrodes, the plurality of electrodes configured to measure physiological signals indicating bioimpedance [Other sensors that may detect extravasation may be provided with the anti-extravasation catheter and operably coupled to the catheter including electrical impedance sensors, Ph sensors, optical sensors or tissue temperature sensors. (The infiltration of an infusate into interstitial tissue may result in one or more changes in impedance, Ph or temperature.) (Kucklick ¶0032)]; and
a processing system disposed within a reusable electronics module [control system 20 (Kucklick ¶0032), wherein “reusable” fails to impart any specific structural or functional limitations of the electronics module, such that the control system 20 of Kucklick is considered to read on the claimed processing system disposed within a reusable electronics module], the reusable electronics module electrically coupled to the disposable catheter via a second cable [a pressure transducer 36 operably connected to the control system (Kucklick ¶0028); see Kucklick Figure 6, which is considered to depict a wired connection between the anti-extravasation catheter the control system 20 (processing system comprising a processor) in an electronic module (reusable electronics module) comprising at least a display 21] and physically adjacent to the disposable catheter [A control system 20 may be operably connected to the fluid source to deliver fluid and to the vacuum source to remove interstitial fluid by activating the vacuum source (Kucklick ¶0022), and as depicted in Kucklick Fig. 6, the control system (reusable electronics module) being operable to deliver fluid through the catheter and being depicted physically relative to the catheter is considered to read as being “physically adjacent” to the catheter], wherein the processing system is configured to: i) receive the physiological signals from the pressure sensor and the physiological signals from the plurality of electrodes; and ii) process the physiological signals, via a processor, to determine IV infiltration [Pressure transducer 36 is operably connected to control system 20…Other sensors that may detect extravasation may be provided with the anti-extravasation catheter and operably coupled to the catheter including electrical impedance sensors (Kucklick ¶0032)].
However, while Kucklick does disclose electrical connections between the electrodes configured to measure physiological signals indicating bioimpedance and the catheter [Kucklick ¶0032], Kucklick fails to explicitly disclose that the plurality of electrodes comprises four electrodes, positioned in four corners of an arm-worn polymeric base, wherein the arm-worn housing is electrically coupled to the disposable catheter via a first cable, wherein the reusable electronics module is configured to be affixed to the patient’s arm via adhesive, wherein the processing includes identification of a decrease in an impedance waveform associated with IV infiltration, and wherein the processor is physically disposed within the reusable electronics module.
Inan discloses systems directed towards detecting IV infiltration, wherein Inan discloses four electrodes, positioned in four corners of an arm-worn polymeric base [The location of four EBI electrodes for detecting IV infiltration have been determined through experimentation. The location provides good positioning both in terms of comfort for the patient and in properly detecting the infiltration. Similar techniques have been used by the inventors for experimentally determining optimal electrode positioning for the knee, as shown in FIG. 5(c) (Inan ¶0052, Figure 5C); The sensors described herein can be placed into contact with the patient via a sleeve formed of neoprene or any other material. A sleeve or wrap can, in some embodiments can be closed using hook and loop fasteners (such as Velcro®), hook and eye fasteners, zippers, or any other closure mechanisms that can be used in the medical setting. In some embodiments, the sensors can be applied to the patient using adhesive patches or bandages (Inan ¶0045); Three modalities of sensors were placed at the limb: four Ag/AgCl gel adhesive electrodes 602 for electrical bioimpedance (EBI) measurement (two proximal to the catheter insertion site 604, and two distal to the catheter insertion site 604) (Inan ¶0068), wherein based on the cited portions of Inan, the electrodes are considered to be positioned in 4 corners of an arm-worn housing], the four electrodes configured to measure physiological signals indicating bioimpedance [The location of four EBI electrodes for detecting IV infiltration have been determined through experimentation. The location provides good positioning both in terms of comfort for the patient and in properly detecting the infiltration…a four electrode Kelvin sensing scheme may be used with a small, safe, AC current excitation to two electrodes (I=1 mA.sub.pp, f.sub.c=50 kHz); and the resultant AC differential voltage measured across the other two electrodes…The ratio of the measured voltage to the injection current will provide the impedance soft the tissue, with the skin-electrode impedance being removed. These techniques have been shown to provide substantially accurate, substantially linear and substantially consistent measurements of EBI], and wherein processing the measured physiological signals indicating bioimpedance includes identification of a decrease in an impedance waveform associated with IV infiltration [a measurement of EBI across the wrist, which would be reduced by the increased presence of fluid (a highly conductive medium) due to infiltration (Inan ¶0052)]. Inan further discloses positioning a processing system comprising a processor in a housing affixed to a patient’s arm [By combining non-invasive sensing with a low power embedded processing system, this device could be mechanically designed to sit around the catheter site for long periods of time without impeding the patient's mobility (Inan ¶0043); In an exemplary embodiment, hardware may include sensors, e.g., a strain gauge, temperature sensors, a light emitting diode (LED)/photodiode pair and a plurality of electrodes. The electrodes may be interfaced with analog “Front end” circuitry to a microcontroller for wireless transfer, e.g., via Bluetooth or other wireless technology to a computer or storage device. The system may be applied to the top of the subject's hand, for example, if an IV is inserted in to the hand, as is common (Inan ¶0070); It is contemplated that a device according to the present disclosure may be designed to be in a mechanical structure to include all components and be placed near an IV catheter site regardless of position on the body (Inan ¶0076)], and discloses known methods of data transfer including a wired connection [Inan ¶0044].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick to employ four electrodes, positioned in four corners of an arm-worn polymeric base, wherein the processing includes identification of a decrease in an impedance waveform associated with IV infiltration, as this modification amounts to mere simple substitution of one known element [electrode system of Kucklick ¶0032] for another [Inan ¶0052] with similar expected results of using electrodes to determine IV infiltration [MPEP § 2143(I)(B)], and as Inan discloses that the change in the impedance waveform associated with IV infiltration is a decrease in an impedance waveform [Inan ¶0052].
It would also have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan to employ wherein the arm-worn polymeric base is electrically coupled to the disposable catheter via a first cable, as this modification would amount to mere simple substitution of one known element [electronic coupling between electrodes and catheter (Kucklick ¶0032)] for another [wired connection (Inan ¶0044)] with similar expected results [MPEP § 2143(I)(B)].
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan to employ wherein the processor is disposed within the reusable electronics module and wherein the reusable electronics module comprising the processing system is affixed to the patient’s arm and is physically adjacent to the disposable catheter, so as to not limit patient mobility while allowing for processing to determine IV infiltration.
However, Kucklick in view of Inan fails to explicitly disclose that the reusable electronics module is configured to be affixed to the patient’s arm via adhesive.
Inan discloses the use of adhesives to affix sensors to a patient’s arm [the sensors can be applied to the patient using adhesive patches or bandages (Inan ¶0045)], and further suggests structures that comprise the aforementioned sensors and a processor [Inan ¶¶0043, 0070, 0076].
Ono discloses systems for detecting leak of a liquid injected into a blood vessel, wherein Ono discloses the use of an adhesive to affix an electronics module to a patient’s arm to be physically adjacent to a catheter configured to inject the liquid into the blood vessel, wherein the electronics module comprises a processing system disposed therein to process physiological signals [leak detection unit 401 has a flat box-shaped unit housing 402, as shown in FIG. 7 (Ono Col 4:19-20); central processing circuit 408, which comprises logic circuits in a predetermined structure, has a variety of hardware components which function as interval measuring circuit 411, interval storing circuit 412, difference calculating circuit 413, and difference comparing circuit 414 (Ono Col 4:47-51); leak detection unit 401 is mounted on adhesive pad 213 (Ono Col 6:26-27, Fig. 13)], wherein Ono further suggests wired data communication between the electronics module and the catheter [while the foregoing embodiment has illustrated that leak detection unit 401 makes radio communications with injector body 101 through radiowave signals, liquid injector 100 can employ any communication scheme, including an ultrasonic signal based wireless communication, an optical signal based wireless communication, an electric signal based wired communication, an optical signal based wired communication, and so on (Ono Col 9:56-63)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan to employ wherein the reusable electronics module is configured to be affixed to the patient’s arm via adhesive, as this modification amounts to mere simple substitution of one known element [non-specific method to affix the reusable electronics module to the patient’s arm of Inan] for another [adhesive] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 5, Kucklick in view of Inan and Ono teaches
The system of claim 1, wherein the processing system is enclosed by an enclosure that is configured to attach directly to the patient [Inan ¶¶0044, 0070, 0076].
Regarding claim 6, Kucklick in view of Inan and Ono teaches
The system of claim 1.
However, Kucklick in view of Inan and Ono fails to explicitly disclose wherein the processing system further comprises a motion-detecting sensor.
Inan discloses the use of a motion-detecting sensor in the system for detecting IV infiltration [The impedance signal starts varying as a subject moves the limb being measured, due to local impedance changes caused by limb motion. Therefore, it is useful to include sensors that measure limb motion, position, and inertia along with EBI signals. Accelerometers, gyroscopes, and magnetometers are a few exemplary sensors that can be used for position and motion tracking. These or other types of position or motion sensors can be used alone, or in combination with each other (Inan ¶0059); Sensing modalities other than EBI, such as strain sensors, optical sensing, and temperature sensing, are also prone to changes due to limb position and motion. Therefore, these sensing modalities can also benefit from use in combination with one or more motion, position, or inertial sensors, such as accelerometers, gyroscopes, and/or magnetometers, to indicate that a questionable reading may be a result of or influenced by movement. Information indicating limb movement may be used to adjust other measurements that might be influenced by movement, and thus reduce falsely positive indications of IV infiltration (Inan ¶0060)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan and Ono to employ the processing system to further comprise a motion-detecting sensor, as taught by Kucklick, so as to account for measurement changes caused by limb motion and reduce the chance of false positive identification of IV infiltration [Inan ¶¶0059-0060].
Regarding claim 7, Kucklick in view of Inan and Ono teaches
The system of claim 6, wherein the motion-detecting sensor is one of an accelerometer and a gyroscope [Inan ¶¶0059-0060].
Regarding claim 8, Kucklick in view of Inan and Ono teaches
The system of claim 6, wherein the processing system is further configured to receive signals from the motion-detecting sensor and process them to determine the patient's degree of motion [Inan ¶¶0059-0060].
Regarding claim 19, Kucklick teaches
A system for determining an arterial blood pressure value from a patient, comprising:
a disposable catheter configured to insert into the patient's venous system [anti-extravasation catheter (Kucklick ¶0032, Figure 7), wherein the Examiner notes that being “disposable” is not considered to be structurally of functionally limiting, such that any catheter may be disposed of];
a pressure sensor positioned along the disposable catheter and configured to measure physiological signals indicating a pressure in the patient's venous system [Pressure transducer 36 is operably connected to control system 20 and the central lumen of the tube 4. The transducer 36 is able to measure pressure in the vein of the patient...Extravasation can result from a thrombosed or collapsed vein 44. A collapsed vein will cause a pressure increase within the vein of the patient due to the backflow of an infusate. When a pressure increase exceeding an acceptable threshold is detected by pressure transducer 36, the control system 20 may operate a pump operably coupled to the dilution source to flush the surrounding tissue (Kucklick ¶0032), wherein the position of pressure transducer 36 as depicted in Kucklick Figure 6 is considered to read on being disposed “along the disposable catheter”];
a plurality of electrodes, the plurality of electrodes configured to measure physiological signals indicating bioimpedance [Other sensors that may detect extravasation may be provided with the anti-extravasation catheter and operably coupled to the catheter including electrical impedance sensors, Ph sensors, optical sensors or tissue temperature sensors. (The infiltration of an infusate into interstitial tissue may result in one or more changes in impedance, Ph or temperature.) (Kucklick ¶0032)];
a processing system disposed within a reusable electronics module [control system 20 (Kucklick ¶0032), wherein “reusable” fails to impart any specific structural or functional limitations of the electronics module, such that the control system 20 of Kucklick is considered to read on the claimed processing system disposed within a reusable electronics module], the reusable electronics module electrically coupled to the disposable catheter via a second cable [a pressure transducer 36 operably connected to the control system (Kucklick ¶0028); see Kucklick Figure 6, which is considered to depict a wired connection between the anti-extravasation catheter the control system 20 (processing system comprising a processor) in an electronic module (reusable electronics module) comprising at least a display 21] and physically adjacent to the disposable catheter [A control system 20 may be operably connected to the fluid source to deliver fluid and to the vacuum source to remove interstitial fluid by activating the vacuum source (Kucklick ¶0022), and as depicted in Kucklick Fig. 6, the control system (reusable electronics module) being operable to deliver fluid through the catheter and being depicted physically relative to the catheter is considered to read as being “physically adjacent” to the catheter], the processing system configured to: i) receive the physiological signals from the pressure sensor and the physiological signals from the plurality of electrodes; and iv) process the physiological signals, via a processor of the processing system, to determine IV infiltration [Pressure transducer 36 is operably connected to control system 20…Other sensors that may detect extravasation may be provided with the anti-extravasation catheter and operably coupled to the catheter including electrical impedance sensors (Kucklick ¶0032)].
However, while Kucklick does disclose electrical connections between the electrodes configured to measure physiological signals indicating bioimpedance and the catheter [Kucklick ¶0032], Kucklick fails to explicitly disclose that the plurality of electrodes comprises four electrodes, positioned in four corners of an arm-worn polymeric base, wherein the arm-worn housing is electrically coupled to the disposable catheter via a first cable, wherein the reusable electronics module is configured to be affixed to the patient’s arm via adhesive, wherein the processing includes identification of a decrease in an impedance waveform associated with IV infiltration, and wherein the processor is physically disposed within the reusable electronics module at the arm-worn housing. Kucklick further fails to explicitly disclose a motion sensor configured to measure motion signals; and wherein the processing system is configured to: ii) receive the motion signals from the motion sensor; iii) process the motion signals, via a processor physically disposed within the reusable electronics module at the arm-worn housing, by comparing them to a pre-determined threshold value to determine when the patient has a relatively low degree of motion.
Inan discloses systems directed towards detecting IV infiltration, wherein Inan discloses four electrodes, positioned in four corners of an arm-worn polymeric base [The location of four EBI electrodes for detecting IV infiltration have been determined through experimentation. The location provides good positioning both in terms of comfort for the patient and in properly detecting the infiltration. Similar techniques have been used by the inventors for experimentally determining optimal electrode positioning for the knee, as shown in FIG. 5(c) (Inan ¶0052, Figure 5C); The sensors described herein can be placed into contact with the patient via a sleeve formed of neoprene or any other material. A sleeve or wrap can, in some embodiments can be closed using hook and loop fasteners (such as Velcro®), hook and eye fasteners, zippers, or any other closure mechanisms that can be used in the medical setting. In some embodiments, the sensors can be applied to the patient using adhesive patches or bandages (Inan ¶0045); Three modalities of sensors were placed at the limb: four Ag/AgCl gel adhesive electrodes 602 for electrical bioimpedance (EBI) measurement (two proximal to the catheter insertion site 604, and two distal to the catheter insertion site 604) (Inan ¶0068), wherein based on the cited portions of Inan, the electrodes are considered to be positioned in 4 corners of an arm-worn housing], the four electrodes configured to measure physiological signals indicating bioimpedance [The location of four EBI electrodes for detecting IV infiltration have been determined through experimentation. The location provides good positioning both in terms of comfort for the patient and in properly detecting the infiltration…a four electrode Kelvin sensing scheme may be used with a small, safe, AC current excitation to two electrodes (I=1 mA.sub.pp, f.sub.c=50 kHz); and the resultant AC differential voltage measured across the other two electrodes…The ratio of the measured voltage to the injection current will provide the impedance soft the tissue, with the skin-electrode impedance being removed. These techniques have been shown to provide substantially accurate, substantially linear and substantially consistent measurements of EBI], and wherein processing the measured physiological signals indicating bioimpedance includes identification of a decrease in an impedance waveform associated with IV infiltration [a measurement of EBI across the wrist, which would be reduced by the increased presence of fluid (a highly conductive medium) due to infiltration (Inan ¶0052)]. Inan further discloses positioning a processing system comprising a processor in a housing affixed to a patient’s arm [By combining non-invasive sensing with a low power embedded processing system, this device could be mechanically designed to sit around the catheter site for long periods of time without impeding the patient's mobility (Inan ¶0043); In an exemplary embodiment, hardware may include sensors, e.g., a strain gauge, temperature sensors, a light emitting diode (LED)/photodiode pair and a plurality of electrodes. The electrodes may be interfaced with analog “Front end” circuitry to a microcontroller for wireless transfer, e.g., via Bluetooth or other wireless technology to a computer or storage device. The system may be applied to the top of the subject's hand, for example, if an IV is inserted in to the hand, as is common (Inan ¶0070); It is contemplated that a device according to the present disclosure may be designed to be in a mechanical structure to include all components and be placed near an IV catheter site regardless of position on the body (Inan ¶0076)], and discloses known methods of data transfer including a wired connection [Inan ¶0044]. Inan also discloses the use of a motion-detecting sensor in the system for detecting IV infiltration [The impedance signal starts varying as a subject moves the limb being measured, due to local impedance changes caused by limb motion. Therefore, it is useful to include sensors that measure limb motion, position, and inertia along with EBI signals. Accelerometers, gyroscopes, and magnetometers are a few exemplary sensors that can be used for position and motion tracking. These or other types of position or motion sensors can be used alone, or in combination with each other (Inan ¶0059); Sensing modalities other than EBI, such as strain sensors, optical sensing, and temperature sensing, are also prone to changes due to limb position and motion. Therefore, these sensing modalities can also benefit from use in combination with one or more motion, position, or inertial sensors, such as accelerometers, gyroscopes, and/or magnetometers, to indicate that a questionable reading may be a result of or influenced by movement. Information indicating limb movement may be used to adjust other measurements that might be influenced by movement, and thus reduce falsely positive indications of IV infiltration (Inan ¶0060)], wherein the processing system is configured to ii) receive the motion signals from the motion sensor [Inan ¶¶0059-0060], iii) process the motion signals at the arm-worn housing by comparing them to a pre-determined threshold value to determine when the patient has a relatively low degree of motion [One exemplary way of using the information from motion, position, or inertial sensors is to design a method of detecting when the measured limb is in motion and exclude those time instances from the analysis. The position of the limb devised using the information from motion, position, or inertial sensors can also be combined with other types of measurements to compensate for changes due to limb position. An exemplary way of doing this would be to detect when the subject's limb is in a certain position via a position sensor, and monitor the other sensor measurements taken in those time instances for detection. The position information may help the user understand otherwise questionable readings from the other sensors (Inan ¶0060), wherein detecting when the subject’s limb is in motion from when the subject’s limb is not in motion is considered to read on comparison between motion signals to a pre-determined threshold value to determine when the patient has a relatively low degree of motion].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick to employ four electrodes, positioned in four corners of an arm-worn polymeric base, wherein the processing includes identification of a decrease in an impedance waveform associated with IV infiltration, as this modification amounts to mere simple substitution of one known element [electrode system of Kucklick ¶0032] for another [Inan ¶0052] with similar expected results of using electrodes to determine IV infiltration [MPEP § 2143(I)(B)], and as Inan discloses that the change in the impedance waveform associated with IV infiltration is a decrease in an impedance waveform [Inan ¶0052].
It would also have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan to employ wherein the arm-worn polymeric base is electrically coupled to the disposable catheter via a first cable, as this modification would amount to mere simple substitution of one known element [electronic coupling between electrodes and catheter (Kucklick ¶0032)] for another [wired connection (Inan ¶0044)] with similar expected results [MPEP § 2143(I)(B)].
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan to employ wherein the processor is disposed within the reusable electronics module and wherein the reusable electronics module comprising the processing system is affixed to the patient’s arm and is physically adjacent to the disposable catheter, so as to not limit patient mobility while allowing for processing to determine IV infiltration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick to employ a motion sensor configured to measure motion signals and wherein the processing system is configured to ii) receive the motion signals from the motion sensor, iii) process the motion signals at the arm-worn housing by comparing them to a pre-determined threshold value to determine when the patient has a relatively low degree of motion, so as to account for measurement changes caused by limb motion and reduce the chance of false positive identification of IV infiltration.
However, Kucklick in view of Inan fails to explicitly disclose that the reusable electronics module is configured to be affixed to the patient’s arm via adhesive.
Inan discloses the use of adhesives to affix sensors to a patient’s arm [the sensors can be applied to the patient using adhesive patches or bandages (Inan ¶0045)], and further suggests structures that comprise the aforementioned sensors and a processor [Inan ¶¶0043, 0070, 0076].
Ono discloses systems for detecting leak of a liquid injected into a blood vessel, wherein Ono discloses the use of an adhesive to affix an electronics module to a patient’s arm to be physically adjacent to a catheter configured to inject the liquid into the blood vessel, wherein the electronics module comprises a processing system disposed therein to process physiological signals [leak detection unit 401 has a flat box-shaped unit housing 402, as shown in FIG. 7 (Ono Col 4:19-20); central processing circuit 408, which comprises logic circuits in a predetermined structure, has a variety of hardware components which function as interval measuring circuit 411, interval storing circuit 412, difference calculating circuit 413, and difference comparing circuit 414 (Ono Col 4:47-51); leak detection unit 401 is mounted on adhesive pad 213 (Ono Col 6:26-27, Fig. 13)], wherein Ono further suggests wired data communication between the electronics module and the catheter [while the foregoing embodiment has illustrated that leak detection unit 401 makes radio communications with injector body 101 through radiowave signals, liquid injector 100 can employ any communication scheme, including an ultrasonic signal based wireless communication, an optical signal based wireless communication, an electric signal based wired communication, an optical signal based wired communication, and so on (Ono Col 9:56-63)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan to employ wherein the reusable electronics module is configured to be affixed to the patient’s arm via adhesive, as this modification amounts to mere simple substitution of one known element [non-specific method to affix the reusable electronics module to the patient’s arm of Inan] for another [adhesive] with similar expected results [MPEP § 2143(I)(B)].
Claim(s) 2-4, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick in view of Inan and Ono, as applied to claims 1 and 8 above, in further view of Handler (US-20190000326-A1, previously presented).
Regarding claim 2, Kucklick in view of Inan and Ono teaches
The system of claim 1.
However, Kucklick in view of Inan and Ono fails to explicitly disclose wherein the processing system is further configured to filter out respiratory components from the physiological signals to determine the arterial blood pressure value.
Handler discloses systems for determining an arterial blood pressure value from a patient, wherein Handler discloses isolating a peripheral venous pressure component within a measured physiological signal indicating a pressure in the patient’s venous system [in addition to other Fourier transforms, the evaluation may include wavelet transforms or time-frequency representations of the measured PVP data signal (Handler ¶0070); As an example, a band-pass filter centered around a frequency twice the heart rate frequency (F.sub.1) and having a band width of twenty percent of the heart rate frequency (F.sub.1) may be used to define a range of the frequency-domain representation of the PVP signal that contains the first harmonic peak (P.sub.2)… the peaks (P.sub.N) of the frequency-domain representation of the PVP signal may be distinguished from other local maxima arising from noise or other minor phenomena in the circulatory system (Handler ¶0079), wherein isolating the peripheral venous pressure is considered to read on filtering out respiratory components].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan and Ono to employ the processing system being further configured to filter out respiratory components from the physiological signals to determine the arterial blood pressure value, so as to remove noise or other irrelevant minor phenomena.
Regarding claim 3, Kucklick in view of Inan, Ono, and Handler teaches
The system of claim 2, wherein the processing system is further configured to operate a bandpass filter to filter out respiratory components from the physiological signals [Handler ¶0079].
Regarding claim 4, Kucklick in view of Inan, Ono, and Handler teaches
The system of claim 2, wherein processing the physiological signals includes operating a filter based on wavelets to filter out respiratory components from the physiological signals [Handler ¶0070].
Regarding claim 9, Kucklick in view of Inan and Ono teaches
The system of claim 8.
However, Kucklick in view of Inan and Ono fails to explicitly disclose wherein the processing system is further configured to collectively process the patient's degree of motion and the physiological signals to determine the arterial blood pressure value.
Handler discloses correlating gyroscopic data to intravenous pressure measurements [the additional sensors 150 may further include any of the following to measure orientation or motion of the patient: a real-time three-dimensional gyroscope, one or more cameras monitoring the local physical environment around the patient, or a microphone configured to monitor sounds in the local physical environment. Sensor data from the additional sensors 150 may be correlated with IV pressure measurements or other pressure-related measurements associated with the PVP of the patient (Handler ¶0058)], wherein Handler identifies patient movement as affecting measurements of peripheral venous pressure [Other factors influence PVP, such as blood volume and patient movement (Handler ¶0066)].
It would have been obvious to one of ordinary skill in the art to have modified the system of Kucklick in view of Inan and Ono to employ the processing system being further configured to collectively process the patient’s degree of motion and the physiological signals to determine the arterial blood pressure value, as patient movement may influence measurements of peripheral venous pressure.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick in view of Inan and Ono, as applied to claim 6 above, and further in view of McCombie (US-20100298661-A1, previously presented).
Regarding claim 10, Kucklick in view of Inan and Ono teaches
The system of claim 6.
However, Kucklick in view of Inan and Ono fails to explicitly disclose wherein the processing system is further configured to receive signals from the motion-detecting sensor and process them to determine a relative height associated with a body part associated with the patient.
McCombie discloses systems for monitoring a patient’s arterial blood pressure [see McCombie abstract], wherein McCombie discloses using motion-detecting sensors to determine a relative height associated with a body part associated with the patient [To calculate a patient's arm height it is necessary to build a mathematical model representing the geometric orientation of the patient's arm, as detected with signals from the three accelerometers (McCombie ¶0099); the algorithm can use digitized signals from the accelerometers mounted on the patient's bicep and wrist, along with equations (8) and (16), to accurately determine the patient's arm height and position. As described below, these parameters can then be used to correct the PTT and provide a blood pressure calibration, similar to the cuff-based indexing measurement described above, that can further improve the accuracy of this measurement (McCombie ¶0103)], wherein McCombie identifies arm height as being correlated to an accuracy of a blood pressure measurement [A patient's blood pressure, as measured near the brachial artery, will vary with their arm height due to hydrostatic forces and gravity. This relationship between arm height and blood pressure enables two measurements: 1) a blood pressure `correction factor`, determined from slight changes in the patient's arm height, can be calculated and used to improve accuracy of the base blood pressure measurement; and 2) the relationship between PTT and blood pressure can be determined (like it is currently done using the indexing measurement) by measuring PTT at different arm heights, and calculating the change in PTT corresponding to the resultant change in height-dependent blood pressure (McCombie ¶0104)].
It would have been obvious to one of ordinary skill in the art to have modified the system of Kucklick in view of Inan and Ono to employ the processing system being configured to receive signals from the motion-detecting sensor and process them to determine a relative height associated with a body part associated with the patient, as arm height can be correlated to arterial blood pressure and determining arm height can allow for the determination of a corrected blood pressure.
Regarding claim 11, Kucklick in view of Inan, Ono, and McCombie teaches
The system of claim 10, wherein the body part is the patient's arm [McCombie ¶0104].
Regarding claim 12, Kucklick in view of Inan, Ono, and McCombie teaches
The system of claim 10.
However, Kucklick in view of Inan, Ono, and McCombie as presently modified fails to explicitly disclose wherein the processing system is further configured to collectively process the relative height associated with the body part associated with the patient and the physiological signals to determine the arterial blood pressure value.
McCombie discloses wherein the processing system is further configured to collectively process the relative height associated with the body part associated with the patient and the physiological signals to determine the arterial blood pressure value [McCombie ¶0103].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan, Ono, and McCombie to employ the processing system being further configured to collectively process the relative height associated with the body part associated with the patient and the physiological signals to determine the arterial blood pressure value, as arm height can be correlated to arterial blood pressure and determining arm height can allow for the determination of a corrected blood pressure.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick in view of Inan and Ono, as applied to claim 1 above, and further in view of Watson (US-20150208965-A1, previously presented).
Regarding claim 13, Kucklick in view of Inan and Ono teaches
The system of claim 1.
However, Kucklick in view of Inan and Ono fails to explicitly disclose wherein the processing system is further configured to receive a calibration blood pressure value from an external source.
Watson discloses systems for monitoring venous blood pressure, wherein Watson discloses receiving a calibration blood pressure value from an external source [In some embodiments, the venous signal may track and/or be proportional to changes in the blood pressure, but may not provide an absolute measurement. The venous signal may be combined with additional signals in order to accurately determine blood pressure values. In an example, information from a venous signal may be used in combination with another blood pressure measurement such as a manual or automatic auscultatory measurement, such as with a blood pressure cuff. For example, an auscultatory measurement may be used to determine a value of blood pressure, and changes from that value may be based on changes in a venous signal. In another example, changes in a venous signal may be used to trigger a measurement event such as a calibration event. Calibration may include taking an auscultatory measurement and using that information to calibrate a continuous monitoring system such as one based on a venous signal, a Doppler signal, any other suitable information, or any combination thereof (Watson ¶0081)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan and Ono to employ the processing system being further configured to receive a calibration blood pressure value from an external source, so as to provide a more accurate blood pressure reading.
Regarding claim 14, Kucklick in view of Inan, Ono, and Watson teaches
The system of claim 13.
However, Kucklick in view of Inan, Ono, and Watson as presently modified fails to explicitly disclose wherein the processing system is further configured to process the calibration blood pressure value with the physiological signals to determine the arterial blood pressure value.
Watson discloses wherein the processing system is further configured to process the calibration blood pressure value with the physiological signals to determine the arterial blood pressure value [Watson ¶0081].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan, Ono, and Watson to employ the processing system being further configured to process the calibration blood pressure value with the physiological signals to determine the arterial blood pressure value, so as to provide a more accurate blood pressure reading.
Regarding claim 15, Kucklick in view of Inan, Ono, and Watson teaches
The system of claim 14, wherein the external source is one of a blood pressure cuff and an arterial catheter [wherein in light of the § 103 rejection of claim 13 above, the external source is one of a blood pressure cuff and an arterial catheter (Watson ¶0081)].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick in view of Inan, Ono, and Watson as applied to claim 14 above, and further in view of Blume-Jensen (US-20180360978-A1, previously presented), hereinafter Blume.
Regarding claim 16, Kucklick in view of Inan, Ono, and Watson teaches
The system of claim 14.
However, while the combination of Kucklick in view of Inan, Ono, and Watson discloses that there is a relationship between venous pressure and a calibration blood pressure value comprising an arterial pressure value taken using a blood pressure cuff [Watson ¶0081], Kucklick in view of Inan and Watson fails to explicitly disclose wherein the processing system is further configured to process a patient-specific relationship between venous blood pressure and arterial blood pressure, along with the calibration blood pressure value and the physiological signals, to determine the arterial blood pressure value.
Blume discloses systems for drug therapy based on a patient’s blood pressure, wherein Blume discloses a patient-specific relationship between venous blood pressure and arterial blood pressure [As used herein, the term “mean arterial pressure” (MAP) is art recognized and refers to the average over a cardiac cycle and is determined by the cardiac output (CO), systemic vascular resistance (SVR), and central venous pressure (CVP), MAP=(CO×SVR)+CVP (Blume ¶1556)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan, Ono, and Watson to employ the processing system being further configured to process a patient-specific relationship between venous blood pressure and arterial blood pressure, along with the calibration blood pressure value and the physiological signals, to determine the arterial blood pressure value, so as to account for patient specific cardiac output and systemic vascular resistance.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick in view of Inan, Ono, and Watson, as applied to claim 14 above, and further in view of Marshall (US-5606976-A, previously presented).
Regarding claim 18, Kucklick in view of Inan, Ono, and Watson teaches
The system of claim 14.
However, Kucklick in view of Inan, Ono, and Watson fails to explicitly disclose wherein the processing system is further configured to additionally process biometric information corresponding to the patient to determine the arterial blood pressure.
Marshall discloses systems and methods for monitoring a patient’s pulmonary pressure, wherein Marshall discloses processing biometric information corresponding to the patient to determine the patient-specific relationship between venous blood pressure and arterial blood pressure [Initially, based upon the patient's size, weight and lung capacity, a model of a normal patient's cardiac output and actual blood flow is determined using data stored in memory such as RAM (Marshall, Col 5, lines 46-49), wherein determining cardiac output based on patient-specific size, weight and lung capacity, is considered to read on processing biometric information corresponding to the patient to determine the arterial blood pressure, as cardiac output is a known parameter of the relationship between venous blood pressure and arterial blood pressure, such that arterial pressure may be known].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan, Ono, and Watson to employ the processing system being further configured to process biometric information corresponding to the patient to determine the patient-specific relationship between venous blood pressure and arterial blood pressure, as patient-specific biometric information is indicative of parameters incorporated in the relationship between venous blood pressure and arterial blood pressure.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick in view of Inan, Ono, and McCombie.
Regarding claim 20, Kucklick teaches
A system for determining an arterial blood pressure value from a patient, comprising:
a disposable catheter configured to insert into the patient's venous system [anti-extravasation catheter (Kucklick ¶0032, Figure 7), wherein the Examiner notes that being “disposable” is not considered to be structurally of functionally limiting, such that any catheter may be disposed of];
a pressure sensor positioned along the disposable catheter and configured to measure physiological signals indicating a pressure in the patient's venous system [Pressure transducer 36 is operably connected to control system 20 and the central lumen of the tube 4. The transducer 36 is able to measure pressure in the vein of the patient...Extravasation can result from a thrombosed or collapsed vein 44. A collapsed vein will cause a pressure increase within the vein of the patient due to the backflow of an infusate. When a pressure increase exceeding an acceptable threshold is detected by pressure transducer 36, the control system 20 may operate a pump operably coupled to the dilution source to flush the surrounding tissue (Kucklick ¶0032), wherein the position of pressure transducer 36 as depicted in Kucklick Figure 6 is considered to read on being disposed “along the disposable catheter”];
a plurality of electrodes, the plurality of electrodes configured to measure physiological signals indicating bioimpedance [Other sensors that may detect extravasation may be provided with the anti-extravasation catheter and operably coupled to the catheter including electrical impedance sensors, Ph sensors, optical sensors or tissue temperature sensors. (The infiltration of an infusate into interstitial tissue may result in one or more changes in impedance, Ph or temperature.) (Kucklick ¶0032)];
a processing system disposed within a reusable electronics module [control system 20 (Kucklick ¶0032), wherein “reusable” fails to impart any specific structural or functional limitations of the electronics module, such that the control system 20 of Kucklick is considered to read on the claimed processing system disposed within a reusable electronics module], the reusable electronics module electrically coupled to the disposable catheter via a second cable [a pressure transducer 36 operably connected to the control system (Kucklick ¶0028); see Kucklick Figure 6, which is considered to depict a wired connection between the anti-extravasation catheter the control system 20 (processing system comprising a processor) in an electronic module (reusable electronics module) comprising at least a display 21] and physically adjacent to the disposable catheter [A control system 20 may be operably connected to the fluid source to deliver fluid and to the vacuum source to remove interstitial fluid by activating the vacuum source (Kucklick ¶0022), and as depicted in Kucklick Fig. 6, the control system (reusable electronics module) being operable to deliver fluid through the catheter and being depicted physically relative to the catheter is considered to read as being “physically adjacent” to the catheter], the processing system configured to: i) receive the physiological signals from the pressure sensor and the physiological signals from the plurality of electrodes; and iv) process the physiological signals, via a processor of the processing system, to determine IV infiltration [Pressure transducer 36 is operably connected to control system 20…Other sensors that may detect extravasation may be provided with the anti-extravasation catheter and operably coupled to the catheter including electrical impedance sensors (Kucklick ¶0032)].
However, while Kucklick does disclose electrical connections between the electrodes configured to measure physiological signals indicating bioimpedance and the catheter [Kucklick ¶0032], Kucklick fails to explicitly disclose that the plurality of electrodes comprises four electrodes, positioned in four corners of an arm-worn polymeric base, wherein the arm-worn housing is electrically coupled to the disposable catheter via a first cable, wherein the reusable electronics module is configured to be affixed to the patient’s arm via adhesive, wherein the processing includes identification of a decrease in an impedance waveform associated with IV infiltration, and wherein the processor is physically disposed within the reusable electronics module. Kucklick further fails to explicitly disclose a motion sensor configured to measure motion signals; and wherein the processing system is configured to: ii) receive the motion signals from the motion sensor; iii) process the motion signals, via a processor physically disposed within the reusable electronics module at the arm-worn housing, by comparing them to a pre-determined threshold value to determine when the patient has a relatively low degree of motion.
Inan discloses systems directed towards detecting IV infiltration, wherein Inan discloses four electrodes, positioned in four corners of an arm-worn polymeric base [The location of four EBI electrodes for detecting IV infiltration have been determined through experimentation. The location provides good positioning both in terms of comfort for the patient and in properly detecting the infiltration. Similar techniques have been used by the inventors for experimentally determining optimal electrode positioning for the knee, as shown in FIG. 5(c) (Inan ¶0052, Figure 5C); The sensors described herein can be placed into contact with the patient via a sleeve formed of neoprene or any other material. A sleeve or wrap can, in some embodiments can be closed using hook and loop fasteners (such as Velcro®), hook and eye fasteners, zippers, or any other closure mechanisms that can be used in the medical setting. In some embodiments, the sensors can be applied to the patient using adhesive patches or bandages (Inan ¶0045); Three modalities of sensors were placed at the limb: four Ag/AgCl gel adhesive electrodes 602 for electrical bioimpedance (EBI) measurement (two proximal to the catheter insertion site 604, and two distal to the catheter insertion site 604) (Inan ¶0068), wherein based on the cited portions of Inan, the electrodes are considered to be positioned in 4 corners of an arm-worn housing], the four electrodes configured to measure physiological signals indicating bioimpedance [The location of four EBI electrodes for detecting IV infiltration have been determined through experimentation. The location provides good positioning both in terms of comfort for the patient and in properly detecting the infiltration…a four electrode Kelvin sensing scheme may be used with a small, safe, AC current excitation to two electrodes (I=1 mA.sub.pp, f.sub.c=50 kHz); and the resultant AC differential voltage measured across the other two electrodes…The ratio of the measured voltage to the injection current will provide the impedance soft the tissue, with the skin-electrode impedance being removed. These techniques have been shown to provide substantially accurate, substantially linear and substantially consistent measurements of EBI], and wherein processing the measured physiological signals indicating bioimpedance includes identification of a decrease in an impedance waveform associated with IV infiltration [a measurement of EBI across the wrist, which would be reduced by the increased presence of fluid (a highly conductive medium) due to infiltration (Inan ¶0052)]. Inan further discloses positioning a processing system comprising a processor in a housing affixed to a patient’s arm [By combining non-invasive sensing with a low power embedded processing system, this device could be mechanically designed to sit around the catheter site for long periods of time without impeding the patient's mobility (Inan ¶0043); In an exemplary embodiment, hardware may include sensors, e.g., a strain gauge, temperature sensors, a light emitting diode (LED)/photodiode pair and a plurality of electrodes. The electrodes may be interfaced with analog “Front end” circuitry to a microcontroller for wireless transfer, e.g., via Bluetooth or other wireless technology to a computer or storage device. The system may be applied to the top of the subject's hand, for example, if an IV is inserted in to the hand, as is common (Inan ¶0070); It is contemplated that a device according to the present disclosure may be designed to be in a mechanical structure to include all components and be placed near an IV catheter site regardless of position on the body (Inan ¶0076)], and discloses known methods of data transfer including a wired connection [Inan ¶0044]. Inan also discloses the use of a motion-detecting sensor in the system for detecting IV infiltration [The impedance signal starts varying as a subject moves the limb being measured, due to local impedance changes caused by limb motion. Therefore, it is useful to include sensors that measure limb motion, position, and inertia along with EBI signals. Accelerometers, gyroscopes, and magnetometers are a few exemplary sensors that can be used for position and motion tracking. These or other types of position or motion sensors can be used alone, or in combination with each other (Inan ¶0059); Sensing modalities other than EBI, such as strain sensors, optical sensing, and temperature sensing, are also prone to changes due to limb position and motion. Therefore, these sensing modalities can also benefit from use in combination with one or more motion, position, or inertial sensors, such as accelerometers, gyroscopes, and/or magnetometers, to indicate that a questionable reading may be a result of or influenced by movement. Information indicating limb movement may be used to adjust other measurements that might be influenced by movement, and thus reduce falsely positive indications of IV infiltration (Inan ¶0060)], wherein the processing system is configured to ii) receive the motion signals from the motion sensor [Inan ¶¶0059-0060], iii) process the motion signals at the arm-worn housing by comparing them to a pre-determined threshold value to determine when the patient has a relatively low degree of motion [One exemplary way of using the information from motion, position, or inertial sensors is to design a method of detecting when the measured limb is in motion and exclude those time instances from the analysis. The position of the limb devised using the information from motion, position, or inertial sensors can also be combined with other types of measurements to compensate for changes due to limb position. An exemplary way of doing this would be to detect when the subject's limb is in a certain position via a position sensor, and monitor the other sensor measurements taken in those time instances for detection. The position information may help the user understand otherwise questionable readings from the other sensors (Inan ¶0060), wherein detecting when the subject’s limb is in motion from when the subject’s limb is not in motion is considered to read on comparison between motion signals to a pre-determined threshold value to determine when the patient has a relatively low degree of motion].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick to employ four electrodes, positioned in four corners of an arm-worn polymeric base, wherein the processing includes identification of a decrease in an impedance waveform associated with IV infiltration, as this modification amounts to mere simple substitution of one known element [electrode system of Kucklick ¶0032] for another [Inan ¶0052] with similar expected results of using electrodes to determine IV infiltration [MPEP § 2143(I)(B)], and as Inan discloses that the change in the impedance waveform associated with IV infiltration is a decrease in an impedance waveform [Inan ¶0052].
It would also have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan to employ wherein the arm-worn housing is electrically coupled to the disposable catheter via a first cable, as this modification would amount to mere simple substitution of one known element [electronic coupling between electrodes and catheter (Kucklick ¶0032)] for another [wired connection (Inan ¶0044)] with similar expected results [MPEP § 2143(I)(B)].
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan to employ wherein the processor is disposed within the reusable electronics module and wherein the reusable electronics module comprising the processing system is affixed to the patient’s arm and is physically adjacent to the disposable catheter, so as to not limit patient mobility while allowing for processing to determine IV infiltration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick to employ a motion sensor configured to measure motion signals and wherein the processing system is configured to ii) receive the motion signals from the motion sensor, so as to account for measurement changes caused by limb motion and reduce the chance of false positive identification of IV infiltration.
However, Kucklick in view of Inan fails to explicitly disclose that the reusable electronics module is configured to be affixed to the patient’s arm via adhesive.
Inan discloses the use of adhesives to affix sensors to a patient’s arm [the sensors can be applied to the patient using adhesive patches or bandages (Inan ¶0045)], and further suggests structures that comprise the aforementioned sensors and a processor [Inan ¶¶0043, 0070, 0076].
Ono discloses systems for detecting leak of a liquid injected into a blood vessel, wherein Ono discloses the use of an adhesive to affix an electronics module to a patient’s arm to be physically adjacent to a catheter configured to inject the liquid into the blood vessel, wherein the electronics module comprises a processing system disposed therein to process physiological signals [leak detection unit 401 has a flat box-shaped unit housing 402, as shown in FIG. 7 (Ono Col 4:19-20); central processing circuit 408, which comprises logic circuits in a predetermined structure, has a variety of hardware components which function as interval measuring circuit 411, interval storing circuit 412, difference calculating circuit 413, and difference comparing circuit 414 (Ono Col 4:47-51); leak detection unit 401 is mounted on adhesive pad 213 (Ono Col 6:26-27, Fig. 13)], wherein Ono further suggests wired data communication between the electronics module and the catheter [while the foregoing embodiment has illustrated that leak detection unit 401 makes radio communications with injector body 101 through radiowave signals, liquid injector 100 can employ any communication scheme, including an ultrasonic signal based wireless communication, an optical signal based wireless communication, an electric signal based wired communication, an optical signal based wired communication, and so on (Ono Col 9:56-63)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan to employ wherein the reusable electronics module is configured to be affixed to the patient’s arm via adhesive, as this modification amounts to mere simple substitution of one known element [non-specific method to affix the reusable electronics module to the patient’s arm of Inan] for another [adhesive] with similar expected results [MPEP § 2143(I)(B)].
However, Kucklick in view of Inan and Ono fails to explicitly disclose wherein the processing of the motion signals is to determine a relative height between a body part associated with the patient and an infusion system; and wherein step iv) includes processing the physiological signals and the relative height.
McCombie discloses processing the motion signals to determine a relative height between a body part associated with the patient and an infusion system [To calculate a patient's arm height it is necessary to build a mathematical model representing the geometric orientation of the patient's arm, as detected with signals from the three accelerometers (McCombie ¶0099); the algorithm can use digitized signals from the accelerometers mounted on the patient's bicep and wrist, along with equations (8) and (16), to accurately determine the patient's arm height and position. As described below, these parameters can then be used to correct the PTT and provide a blood pressure calibration, similar to the cuff-based indexing measurement described above, that can further improve the accuracy of this measurement (McCombie ¶0103)]; and processing the physiological signals and the relative height to determine the arterial blood pressure value [To calculate a patient's arm height it is necessary to build a mathematical model representing the geometric orientation of the patient's arm, as detected with signals from the three accelerometers (McCombie ¶0099); the algorithm can use digitized signals from the accelerometers mounted on the patient's bicep and wrist, along with equations (8) and (16), to accurately determine the patient's arm height and position. As described below, these parameters can then be used to correct the PTT and provide a blood pressure calibration, similar to the cuff-based indexing measurement described above, that can further improve the accuracy of this measurement (McCombie ¶0103)], wherein McCombie identifies arm height as being correlated to arterial blood pressure [A patient's blood pressure, as measured near the brachial artery, will vary with their arm height due to hydrostatic forces and gravity. This relationship between arm height and blood pressure enables two measurements: 1) a blood pressure `correction factor`, determined from slight changes in the patient's arm height, can be calculated and used to improve accuracy of the base blood pressure measurement; and 2) the relationship between PTT and blood pressure can be determined (like it is currently done using the indexing measurement) by measuring PTT at different arm heights, and calculating the change in PTT corresponding to the resultant change in height-dependent blood pressure (McCombie ¶0104)].
It would have also been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kucklick in view of Inan and Ono to employ the processing system being configured to: iii) process the motion signals to determine a relative height between a body part associated with the patient and an infusion system; and iv) process the physiological signals and the relative height to determine the arterial blood pressure value, as arm height can be correlated to arterial blood pressure and determining arm height can allow for the determination of a corrected blood pressure.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8, filed 15 December 2025, with respect to the previously presented claim objections have been fully considered and are persuasive. The claim objection of claims 1 and 19-20 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejection of claim 4 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8-11, with respect to the rejection(s) of claim(s) 1, 19-20, and those dependent therefrom under § 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 Kucklick (US-20080172013-A1, previously presented) in view of Inan (US-20190328330-A1, previously presented) and Ono (US-7546776-B2) with respect to claims 1 and 19; and in view of Kucklick (US-20080172013-A1, previously presented) in view of Inan (US-20190328330-A1, previously presented), Ono (US-7546776-B2), and McCombie (US-20100298661-A1, previously presented) with respect to claim 20.
The Applicant asserts that the amended limitations wherein “the arm-worn polymeric base is electrically coupled to the disposable catheter via a first cable” and that “the reusable electronics module electrically coupled to the disposable catheter via a second cable, wherein the reusable electronics module is configured to be affixed to the patient’s arm via adhesive and is physically adjacent to the disposable catheter” fails to be disclosed, taught, or suggested by the cited portions of Kucklick and Inan, wherein the Applicant directs attention to the control system 20 of Kucklick, which was previously applied to read on the reusable electronics module, as being an IV pump and related control means not being analogous to the arm-worn housing as presently claimed. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Kucklick discloses electrical connections between the electrodes configured to measure physiological signals indicating bioimpedance and the catheter [Kucklick ¶0032] and Inan discloses known methods of data transfer including a wired connection [Inan ¶0044], Inan additionally discloses the use of an arm-worn polymeric base [The sensors described herein can be placed into contact with the patient via a sleeve formed of neoprene or any other material. A sleeve or wrap can, in some embodiments can be closed using hook and loop fasteners (such as Velcro®), hook and eye fasteners, zippers, or any other closure mechanisms that can be used in the medical setting. In some embodiments, the sensors can be applied to the patient using adhesive patches or bandages (Inan ¶0045)], such that the combination of Kucklick in view of Inan teaches the amended limitation “the arm-worn polymeric base is electrically coupled to the disposable catheter via a first cable”. The Examiner notes that Inan further suggests positioning a reusable electronics module such that the module is affixed to a patient’s arm physically adjacent a catheter, and wherein the module contains a processor for processing signals [By combining non-invasive sensing with a low power embedded processing system, this device could be mechanically designed to sit around the catheter site for long periods of time without impeding the patient's mobility (Inan ¶0043); In an exemplary embodiment, hardware may include sensors, e.g., a strain gauge, temperature sensors, a light emitting diode (LED)/photodiode pair and a plurality of electrodes. The electrodes may be interfaced with analog “Front end” circuitry to a microcontroller for wireless transfer, e.g., via Bluetooth or other wireless technology to a computer or storage device. The system may be applied to the top of the subject's hand, for example, if an IV is inserted in to the hand, as is common (Inan ¶0070); It is contemplated that a device according to the present disclosure may be designed to be in a mechanical structure to include all components and be placed near an IV catheter site regardless of position on the body (Inan ¶0076)]. The Examiner does note that the Applicant’s arguments with respect to the reusable electronics module being affixed to the patient’s arm via adhesive has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Kucklick in view of Inan is further modified by Ono to employ the use of an adhesive to configure the reusable electronics module to be affixed onto the patient’s arm [leak detection unit 401 is mounted on adhesive pad 213 (Ono Col 6:26-27, Fig. 13)].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791