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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/06/2025 and 03/04/2026 are being considered by the examiner.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 amended claims filed on 01/21/2026 have been entered.
Status of Claims
Claims 1, 4-7, 11-16, and 22-25 are currently pending and under examination. Claims 2-3, 8-10, and 17-21 are canceled. As per the amendments filed on 01/21/2026, claims 1, 12-13, and 22-23 are amended.
Response to Arguments
Applicant’s arguments, see Remarks pages 8-9 (Claim Rejections - 35 U.S.C. § 103), filed 01/21/2026, with respect to the 35 U.S.C. § 103 rejections of claims 1, 4-7, 11-16, and 22-25 have been fully considered. Regarding independent claims 1, 13, and 23, Applicant argues:
Without conceding the propriety of the rejections and merely to expedite prosecution, independent claims 1, 13, and 23 are amended, in part, with subject matter from dependent claims 12 and 22. For example, claim 1 is amended to recite, 'a display screen configured to display [ ... ] one or more physical-attribute plots including at least a plot of respiration rate.' Claims 13 and 23 are similarly amended. While the Examiner asserts Thompson for the one or more physical-attribute plots of dependent claims 12 and 22, Thompson discloses plots related to physical attributes of Thompson's optical-fiber stylet - not physical attributes related to a patient. Indeed, Thompson discloses, for example, 'a plot of curvature vs. arc length 1004, a plot of torsion vs. arc length 1006, a plot of angle vs. arc length 1008, or a plot of position vs. time 1010 for at least the distal-end portion of the optical-fiber stylet.' (Thompson, para. [0065].) Differently, the one or more physical-attribute plots of the claims include at least a plot of respiration rate for the patient. Not one of Mayoral, Ogawa, or Wenzel remedy the foregoing deficiency in Thompson's disclosure." (pages 8-9, 01/21/2026 Remarks)
This argument is not persuasive. The final rejection mailed on 11/21/2025 notes the structural similarities between the claimed apparatus (independent claims 1 and 23) in the instant application and
Thompson (US PG Pub 2021/0045814 A1). Thompson contains a display component for the output of the FBG sensor:
The one or more optical signal converter algorithms are also configured to convert the reflected optical signals from the optical-fiber stylet of the medical device 110 into plottable data for a number of other plots of the plottable data. The display screen 150 or 250 is configured to display the displayable shapes for the medical device 110 over a 3-dimensional grid 1002 or any plot of the number of plots of the other plottable data. ([0063])
Each console of the consoles 140 and 240 can further include an SVC-determiner algorithm of the one or more algorithms 246 configured to automatically determine the distinctive change in the strain of the optical-fiber stylet by way of a distinctive change in plotted curvature of the optical-fiber stylet, or the plottable data therefor, at the moment the tip of the medical device 110 is advanced into the SVC of the patient […] The periodic changes in the plotted curvature result from periodic changes in blood flow within the SVC sensed by the selection of the FBG sensors as a heart of the patient beats. ([0067])
Therefore, Thompson discloses a mechanism to convert reflected optical signals into plottable data which is displayed. The curvature of the optical-fiber stylet is interpreted as the strain signals originating from oscillations in the blood vessel. The FBG catheters in Thompson and the instant application claims are similar, but the FBG catheter in Thompson fails to disclose the processor and processing steps needed to convert a raw FBG strain signal obtained from a blood vessel into a physical attribute such as respiration rate, heart rate, or blood pressure.
Mayoral (NPL, “Fiber Optic Sensors for Vital Signs Monitoring. A Review of Its Practicality in the Health Field”) and Ogawa (NPL, “Simultaneous Measurement of Heart Sound, Pulse Wave and Respiration with Single Fiber Bragg Grating Sensor”) teach algorithms to convert oscillation signals from blood vessels (measured via strain fluctuations in FBG sensors) into physiologic parameters (as discussed in the rejections for independent claims 1, 13, and 23 in the final rejection mailed on 11/21/2025). Mayoral and Ogawa mention these oscillations are recorded by measuring the periodic strain passing through the vessel wall. While using an external position to measure strain, the analysis in the processing portions of Mayoral and Ogawa to determine parameters such as blood pressure, heart rate, and respiration rate is performed on the same signal (i.e. the same oscillatory blood signal). Therefore, it would be obvious for the FBG catheter which measures blood oscillations within the blood vessel in Thompson to incorporate the analysis which converts strain data originating from blood oscillations into physiologic parameters in Mayoral. The display merely shows the outputs of the conversion algorithms in Thompson, which would output physiological parameters after the incorporation of the analysis functions as described in Mayoral (such as the outputs of physiologic parameters displayed in Mayoral Figures 17 and 18). Therefore, the rejections of claims 1, 4-7, 11-16, and 22-25 are maintained.
Summary: The 35 U.S.C. § 103 rejections for claims 1, 4-7, 11-16, and 22-25 are maintained in light of amendments (see “Claim Rejections - 35 USC § 103”).
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 13-16 and 22 are rejected under U.S.C 103 as being unpatentable over Thompson (US PG Pub 2021/0045814 A1, see previously cited) in view of Mayoral et al (NPL, “Fiber Optic Sensors for Vital Signs Monitoring. A Review of Its Practicality in the Health Field”, see previously cited), as evidenced by Ogawa (NPL, “Simultaneous Measurement of Heart Sound, Pulse Wave and Respiration with Single Fiber Bragg Grating Sensor”, see previously cited).
Regarding Claim 13, Thompson discloses a method of a strain-sensing system ([0005]) for determining physical attributes, comprising:
• sending input optical signals from an optical interrogator into an optical-fiber probe integral with or removably disposed in an indwelling medical device ([0004] – optical interrogator sending optical signals to probe) while the indwelling medical device is in place in a superior vena cava ("SVC") of a patient ([0002] – located in superior vena cava) the optical-fiber probe having a number of fiber Bragg grating ("FBG") sensors along at least a distal portion of the optical-fiber probe ([0004] – “comprised of a number of fiber Bragg grating ("FBG") sensors along at least a distal-end portion of the optical-fiber”) that experiences oscillatory motion in the patient for determining the physical attribute ([0006] – periodic changes in strain, interpreted as oscillations, could be used to measure flow: “The periodic changes in the strain result from periodic changes in blood flow within the SVC as a heart of the patient beats”);
• receiving by the optical interrogator FBG sensor-reflected optical signals from the optical-fiber probe ([0011] – “The method also includes enabling FBG sensor-reflected optical signals to be received from the optical-fiber stylet”);
• receiving by a console the FBG sensor-reflected optical signals from the optical interrogator, the console including one or more processors, memory, and executable instructions stored in the memory that cause the console to perform various operations of the method upon execution of the instructions by the one-or-more processors ([0063]);
• converting the FBG sensor-reflected optical signals into converted electrical signals with optical signal-converter logic ([0063]); and
• determining in a real-time determination the physical attribute from at least the converted electrical signals with physical attribute-determination logic ([0067])
• Thompson discloses the detection of oscillations in a blood flow physical attribute via strain measurements using the FBG sensors ([0006]);
• establishing physical attribute-baseline measurements of the physical attributes ([0067]);
• monitoring physical-attribute baselines through the simple oscillations experienced by the distal portion of the optical-fiber probe to determine any deviations from the physical-attribute baselines (Fig. 13, Fig. 15, [0065] – “changes in any one or more of the plots of curvature vs. time 1012a, 1012b, 1012c, ... , 1012n, for the selection of the FBG sensors in the distal-end portion of the optical-fiber stylet can be used to manually identify a distinctive change in strain of the optical-fiber stylet by way of a distinctive change in plotted curvature of the optical fiber stylet at a moment a tip of the medical device 110 is advanced into an SVC of a patient”), and
• displaying the physical attributes on a display screen ([0063]) in one or more physical- attribute plots including at least a plot of a physical attribute ([0067]).
Thompson discloses: “the SVC-determiner algorithm is configured to confirm the tip of the medical device is in the SVC by way of periodic changes in the strain of the optical-fiber stylet sensed by the selection of the FBG sensors. The periodic changes in the strain result from periodic changes in blood flow within the SVC as a heart of the patient beats” ([0006]). Therefore, mechanical oscillations in the circulatory system can be registered and interpreted by the FBG sensor in Thompson. Thompson fails to disclose:
(1) determining in a real-time determination the physical attributes of heart rate and respiration rate from at least the converted electrical signals with physical attribute-determination logic,
(2) correlating measurements of the physical attributes made by one or more measuring devices other than the indwelling medical device with the physical attributes determined in the real-time determination,
(3) establishing physical attribute-baseline measurements through the measurements of the physical attributes by the one-or-more measuring devices other than the indwelling medical device, and
(4) and displaying the physical attributes on a display screen in one or more physical- attribute plots including at least a plot of respiration rate.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors can be used to measure a heart rate (3.3 Pulse or Heart Rate, pages 17-20). Mayoral also teaches FBG sensors can be used to measure respiration rate (3.2. Respiration or Breathing Rate, pages 12-13). Tables 2 or 4 in Mayoral provide reference 7 (Ogawa), which derives respiratory rate and pulse or heart rate from pulsations in the carotid artery or tricuspid area (which would be applicable to the vena cava as a blood vessel) via measurements of strain detected through the skin (Mayoral, Page 23 - “Another FBG sensor for simultaneous measurement of respiration used pulse wave and heart sound with measurements at the tricuspid region of the chest and the carotid artery of the neck”; Ogawa, Abstract – “Heart sound, pulse wave and respiration are simultaneously measured with single fiber Bragg grating (FBG) sensor … sensor is taped near the Tricuspid area and on the carotid artery with the surgical tape. Measured data is denoised through digital Butterworth filter with low pass filter (0.2 Hz), medium frequency band pass filter (0.5 Hz - 5.0 Hz) and higher frequency bandpass filter (35.0 Hz - 55.0 Hz) to extract the information of respiration, pulse wave and heart sound, respectively”). While these devices in Mayoral containing FBG sensors are placed over skin to detect oscillatory strain from the vessel underneath, the principle of processing these strain signals to detect respiration rate and heart rate is established by Mayoral. Thompson discloses an FBG sensor disposed in a blood vessel and able to measure blood oscillations ([0006]). Mayoral provides a mechanism to interpret blood oscillations in terms of heart rate and respiration rate, which are naturally present in blood flow from the beating heart and respiratory artifact. The display in Thompson merely shows the outputs of the conversion algorithms in Thompson, which would output physiological parameters after the incorporation of the analysis functions as described in Mayoral (such as the outputs of physiologic parameters displayed in Mayoral Figures 17 and 18).
Mayoral also teaches FBG sensors need to be filtered and calibrated as the raw light signal in the FBG sensor contains multiple vital signs (4. Discussion, page 24 – “Apart from the fact that the characterization with FBG at that wavelength is a widely tested that has given multiple results using lasers [120], the complexity is to adjust the sensor as a filter fort to measurement of some vital sign [72,114,115]. All the sensors analyzed, are performed for measurements of physical parameters in the medical field (temperature, position, force, torque, stretch) but is necessary its calibration and categorization, as they are able to perform different measurements depending of the configuration and design. Therefore, they are applied for obtained manage and to obtain a response of vital signs [87,121]”). The Examiner interprets Mayoral’s passage as teaching the necessity of calibrating and categorizing strain output from the FBG sensor relative to a known standard for the parameters being measured (temperature, pressure, rate, etc.). A person or ordinary skill in the art would interpret this calibration as comparing an uncalibrated signal to an established measurement of the parameter by another sensor. The 11/21/2025 final office action specifically uses Ogawa (a reference in Mayoral) as evidence for an FBG sensor measuring physiologic parameters from oscillations in a blood vessel (pages 7-11, 11/21/2025 Final Action). As an example, Ogawa compares the FBG sensor measurement to a reference thermocouple to compare the respiration signals (Figure 6, page 2 – “The FBG sensor is taped near the tricuspid area and carotid artery with surgical tape. Thermocouple put on an air cushion mask was used as the reference of respiration”). This example would be characteristic of the Examiner’s interpretation of the calibration process for a dynamic system for measuring parameters within a patient.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor method measuring blood oscillations in the vena cava by incorporating the isolation of heart rate and respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure vital signs (after a filtering and calibration process) such as heart and respiration rates from these signals, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Thompson by incorporating the isolation of heart rate and respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral.
Therefore, Claim 13 is obvious over Thompson in view of Mayoral.
Regarding Claim 14, Thompson, in view of Mayoral, renders obvious the method of a strain-sensing system according to Claim 13, as indicated hereinabove. Thompson further discloses extracting extracted electrical signals from the converted electrical signals with signal-processing logic ([0063]), the converted electrical signals including simple or complex oscillations indicative of those experienced by the distal portion of the optical-fiber probe ([0066]) when placed in the SVC of the patient ([0002]). Thompson states “the SVC-determiner algorithm is configured to confirm the tip of the medical device is in the SVC by way of periodic changes in the strain of the optical-fiber stylet sensed by the selection of the FBG sensors. The periodic changes in the strain result from periodic changes in blood flow within the SVC as a heart of the patient beats” ([0006]). Therefore, mechanical oscillations (whether the oscillations are simple or complex is determined by how different oscillation sources combine into one signal) in the circulatory system can be registered and interpreted by the FBG sensor in Thompson.
Therefore, Claim 14 is obvious over Thompson in view of Mayoral.
Regarding Claim 15, Thompson, in view of Mayoral, renders obvious the method of a strain-sensing system according to Claim 14, as indicated hereinabove. Thompson further discloses the physical attribute- determination logic is configured to determine physical attributes directly from a simple oscillation from an extracted electrical signal of the extracted electrical signals ([0011], [0063]). Thompson fails to disclose the determination of the heart rate directly from a simple oscillation from an extracted electrical signal.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors can be used to measure a heart rate (3.3 Pulse or Heart Rate, pages 17-20). Tables 2 or 4 in Mayoral provide reference 7 (Ogawa), which derives respiratory rate and pulse or heart rate from pulsations in the carotid artery or tricuspid area (which would be applicable to the vena cava as a blood vessel) via measurements of strain detected through the skin (Mayoral, Page 23 - “Another FBG sensor for simultaneous measurement of respiration used pulse wave and heart sound with measurements at the tricuspid region of the chest and the carotid artery of the neck”; Ogawa - Abstract). While these devices in Mayoral containing FBG sensors are placed over skin to detect oscillatory strain from the vessel underneath, the principle of processing these strain signals to detect heart rate is established by Mayoral. Thompson discloses an FBG sensor disposed in a blood vessel and able to measure blood oscillations ([0006]). Mayoral provides a mechanism to interpret blood oscillations in terms of heart rate, which is naturally present in blood flow from the beating heart.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor method measuring blood oscillations in the vena cava by incorporating the isolation of heart rate from blood oscillations measured via an FBG sensor on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure heart rates from these signals, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Thompson by incorporating the isolation of heart rate from blood oscillations measured via an FBG sensor on the skin in Mayoral.
Therefore, Claim 15 is obvious over Thompson in view of Mayoral.
Regarding Claim 16, Thompson, in view of Mayoral, renders obvious the method of a strain-sensing system according to Claim 14, as indicated hereinabove. Thompson further discloses wherein the physical attribute-determination logic is configured to determine physical attributes directly from a simple oscillation from an extracted electrical signal of the extracted electrical signals ([0011], [0063]). Thompson fails to disclose the determination of the respiration rate directly from a simple oscillation from an extracted electrical signal.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors can be used to measure respiration rate (3.2. Respiration or Breathing Rate, pages 12-13). Tables 2 or 4 in Mayoral provide reference 7 (Ogawa), which derives respiratory rate and pulse or heart rate from pulsations in the carotid artery or tricuspid area (which would be applicable to the vena cava as a blood vessel) via measurements of strain detected through the skin (Mayoral, Page 23 - “Another FBG sensor for simultaneous measurement of respiration used pulse wave and heart sound with measurements at the tricuspid region of the chest and the carotid artery of the neck”; Ogawa, Abstract). While these devices in Mayoral containing FBG sensors are placed over skin to detect oscillatory strain from the vessel underneath, the principle of processing these strain signals to detect respiration rate is established by Mayoral. Thompson discloses an FBG sensor disposed in a blood vessel and able to measure blood oscillations ([0006]). Mayoral provides a mechanism to interpret blood oscillations in terms of respiration rate, which is naturally present in blood flow from respiratory artifact.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor method measuring blood oscillations in the vena cava by incorporating the isolation of respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure respiration rates from these signals, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Thompson by incorporating the isolation of respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral.
Therefore, Claim 16 is obvious over Thompson in view of Mayoral.
Regarding Claim 22, Thompson, in view of Mayoral, renders obvious the method of a strain-sensing system according to Claim 16, as indicated hereinabove. Thompson further discloses wherein the one or more physical-attribute plots facilitate historical analysis by an attending clinician (Fig 10, [0065] – display of strain-based physical attributes).
Therefore, Claim 22 is obvious over Thompson in view of Mayoral.
Claims 1, 4-7, 11-12, and 23-25 are rejected under U.S.C 103 as being unpatentable over Thompson (US PG Pub 2021/0045814 A1, see previously cited) in view of Mayoral et al (NPL, “Fiber Optic Sensors for Vital Signs Monitoring. A Review of Its Practicality in the Health Field”, see previously cited), as evidenced by Ogawa (NPL, “Simultaneous Measurement of Heart Sound, Pulse Wave and Respiration with Single Fiber Bragg Grating Sensor”, see previously cited), and Wenzel (US PG Pub 2016/0256224 A1, see previously cited).
Regarding Claim 1, Thompson discloses a strain-sensing system ([0005]) for determining physical attributes, comprising:
• an indwelling medical device for placement in a superior vena cava ("SVC") of a patient, the indwelling medical device ([0002] – located in superior vena cava) including an integrated or removable optical-fiber probe having a number of fiber Bragg grating ("FBG") sensors along at least a distal portion of the optical-fiber probe ([0004] – “comprised of a number of fiber Bragg grating ("FBG") sensors along at least a distal-end portion of the optical-fiber”) that experiences oscillatory motion in the patient for determining the physical attributes ([0006] – periodic changes in strain, interpreted as oscillations, could be used to measure flow: “The periodic changes in the strain result from periodic changes in blood flow within the SVC as a heart of the patient beats”)
• an electrocardiogram (“ECG”) stylet ([0074] – “Optionally, in a same or different longitudinal bead of the catheter tube 312, the PICC 310 can further include an electrocardiogram (‘ECG’) stylet”);
• an optical interrogator configured to send input optical signals into the optical- fiber probe and receive FBG sensor-reflected optical signals from the optical-fiber probe ([0050]);
• a console including one or more processors, memory, and executable instructions stored in the memory that cause the console to perform a set of operations upon execution of the instructions by the one-or-more processors ([0063]), the set of operations including:
-receiving the FBG sensor-reflected optical signals from the optical interrogator ([0063]);
-converting the FBG sensor-reflected optical signals into converted electrical signals with optical signal-converter logic ([0063]); and
-determining in a real-time determination the physical attributes from at least the converted electrical signals with physical attribute-determination logic ([0067]);
• a display screen configured to display the physical attributes ([0063]) associated with a physical attribute ([0067]).
Thompson discloses: “the SVC-determiner algorithm is configured to confirm the tip of the medical device is in the SVC by way of periodic changes in the strain of the optical-fiber stylet sensed by the selection of the FBG sensors. The periodic changes in the strain result from periodic changes in blood flow within the SVC as a heart of the patient beats” ([0006]). Therefore, mechanical oscillations in the circulatory system can be registered and interpreted by the FBG sensor in Thompson. Thompson fails to disclose:
(1) determining in a real-time determination the physical attributes of heart rate and respiration rate from at least the converted electrical signals with physical attribute-determination logic,
(2) a display screen configured to display the physical attributes associated with the heart, the lungs, or both the heart and lungs of the patient in one or more physical-attribute plots including at least a plot of respiration rate, and
(3) receiving ECG data from the ECG stylet, the ECG data complementary to the converted electrical signals and determining one or both of the physical attributes of heart rate and respiration rate from the ECG data.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors can be used to measure a heart rate (3.3 Pulse or Heart Rate, pages 17-20). Mayoral also teaches FBG sensors can be used to measure respiration rate (3.2. Respiration or Breathing Rate, pages 12-13). Tables 2 or 4 in Mayoral provide reference 7 (Ogawa), which derives respiratory rate and pulse or heart rate from pulsations in the carotid artery or tricuspid area (which would be applicable to the vena cava as a blood vessel) via measurements of strain detected through the skin (Mayoral, Page 23 - “Another FBG sensor for simultaneous measurement of respiration used pulse wave and heart sound with measurements at the tricuspid region of the chest and the carotid artery of the neck”; Ogawa, Abstract – “Heart sound, pulse wave and respiration are simultaneously measured with single fiber Bragg grating (FBG) sensor … sensor is taped near the Tricuspid area and on the carotid artery with the surgical tape. Measured data is denoised through digital Butterworth filter with low pass filter (0.2 Hz), medium frequency band pass filter (0.5 Hz - 5.0 Hz) and higher frequency bandpass filter (35.0 Hz - 55.0 Hz) to extract the information of respiration, pulse wave and heart sound, respectively”). While these devices in Mayoral containing FBG sensors are placed over skin to detect oscillatory strain from the vessel underneath, the principle of processing these strain signals to detect respiration rate and heart rate is established by Mayoral. Thompson discloses an FBG sensor disposed in a blood vessel and able to measure blood oscillations ([0006]). Mayoral provides a mechanism to interpret blood oscillations in terms of heart rate and respiration rate, which are naturally present in blood flow from the beating heart and respiratory artifact. The display in Thompson merely shows the outputs of the conversion algorithms in Thompson, which would output physiological parameters after the incorporation of the analysis functions as described in Mayoral (such as the outputs of physiologic parameters displayed in Mayoral Figures 17 and 18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor measuring blood oscillations in the vena cava by incorporating the isolation of heart rate and respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure heart and respiration rates from these signals, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the isolation of heart rate and respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral.
Wenzel, in the same field of endeavor of a sensing catheter assembly ([0072]), teaches a stylet placed to measure an ECG waveform to determine the location of the stylet ([0136]), where locations include the superior vena cava and cavoatrial junction ([0127]). The ECG measurements are used to compute heart rate, which is compared with analyses of blood flow oscillations ([0086] – “An additional embodiment of monitoring turbulent blood flow is to monitor frequency component peaks as the blood flow changes direction. When the turbulent blood flow changes direction, the frequency component will change creating a peak. The peaks and troughs (local maximums and minimums) will indicate the how often the blood flow velocity changes, the magnitude of these changes, and the timing of the changes … The timing of changes in blood flow will help determine if the changes are associated with a heart contraction, respiratory rhythm, or moving of the catheter tip. In some embodiments, the peaks and troughs can be compared with ECG measurements and data to determine whether the changes are associated with the heart rate”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG catheter sensor measuring blood oscillations in the vena cava (containing an ECG stylet) by incorporating the use of a stylet in a vascular catheter which captures ECG and analyzes the ECG to calculate heart rate in Wenzel. This would have been obvious because both Thompson and Wenzel discuss catheter-based measurement of oscillations present in blood vessels and the use of ECG stylets and Wenzel provides a solution/improvement to measure heart rate using the ECG stylet to compare with the detection of heart rate from blood oscillations. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the use of a stylet in a vascular catheter which captures ECG and analyzes the ECG to calculate heart rate in Wenzel.
Therefore, Claim 1 is obvious over Thompson in view of Mayoral and Wenzel.
Regarding Claim 4, Thompson, in view of Mayoral and Wenzel, renders obvious the strain-sensing system according to Claim 1, as indicated hereinabove. Thompson further discloses the set of operations further including extracting extracted electrical signals from the converted electrical signals with signal-processing logic ([0063]), the converted electrical signals including simple or complex oscillations indicative of those experienced by the distal portion of the optical-fiber probe ([0066]) when placed in the SVC of the patient ([0002]). Thompson states “the SVC-determiner algorithm is configured to confirm the tip of the medical device is in the SVC by way of periodic changes in the strain of the optical-fiber stylet sensed by the selection of the FBG sensors. The periodic changes in the strain result from periodic changes in blood flow within the SVC as a heart of the patient beats” ([0006]). Therefore, mechanical oscillations (whether the oscillations are simple or complex is determined by how different oscillation sources combine into one signal) in the circulatory system can be registered and interpreted by the FBG sensor in Thompson.
Therefore, Claim 4 is obvious over Thompson in view of Mayoral and Wenzel.
Regarding Claim 5, Thompson, in view of Mayoral and Wenzel, renders obvious the strain-sensing system according to Claim 4, as indicated hereinabove. Thompson further discloses the physical attribute- determination logic is configured to determine a physical attribute directly from a simple oscillation from an extracted electrical signal of the extracted electrical signals ([0011], [0063]). Thompson fails to disclose the determination of the heart rate directly from a simple oscillation from an extracted electrical signal.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors can be used to measure a heart rate (3.3 Pulse or Heart Rate, pages 17-20). Tables 2 or 4 in Mayoral provide reference 7 (Ogawa), which derives respiratory rate and pulse or heart rate from pulsations in the carotid artery or tricuspid area (which would be applicable to the vena cava as a blood vessel) via measurements of strain detected through the skin (Mayoral, Page 23 - “Another FBG sensor for simultaneous measurement of respiration used pulse wave and heart sound with measurements at the tricuspid region of the chest and the carotid artery of the neck”; Ogawa - Abstract). While these devices in Mayoral containing FBG sensors are placed over skin to detect oscillatory strain from the vessel underneath, the principle of processing these strain signals to detect heart rate is established by Mayoral. Thompson discloses an FBG sensor disposed in a blood vessel and able to measure blood oscillations ([0006]). Mayoral provides a mechanism to interpret blood oscillations in terms of heart rate, which is naturally present in blood flow from the beating heart.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor measuring blood oscillations in the vena cava by incorporating the isolation of heart rate from blood oscillations measured via an FBG sensor on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure heart rates from these signals, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the isolation of heart rate from blood oscillations measured via an FBG sensor on the skin in Mayoral.
Therefore, Claim 5 is obvious over Thompson in view of Mayoral and Wenzel.
Regarding Claim 6, Thompson, in view of Mayoral and Wenzel, renders obvious the strain-sensing system according to Claim 4, as indicated hereinabove. Thompson further discloses wherein the physical attribute-determination logic is configured to determine a physical attribute directly from a simple oscillation from an extracted electrical signal of the extracted electrical signals ([0011], [0063]). Thompson fails to disclose the determination of the respiration rate directly from a simple oscillation from an extracted electrical signal.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors can be used to measure respiration rate (3.2. Respiration or Breathing Rate, pages 12-13). Tables 2 or 4 in Mayoral provide reference 7 (Ogawa), which derives respiratory rate and pulse or heart rate from pulsations in the carotid artery or tricuspid area (which would be applicable to the vena cava as a blood vessel) via measurements of strain detected through the skin (Mayoral, Page 23 - “Another FBG sensor for simultaneous measurement of respiration used pulse wave and heart sound with measurements at the tricuspid region of the chest and the carotid artery of the neck”; Ogawa, Abstract). While these devices in Mayoral containing FBG sensors are placed over skin to detect oscillatory strain from the vessel underneath, the principle of processing these strain signals to detect respiration rate is established by Mayoral. Thompson discloses an FBG sensor disposed in a blood vessel and able to measure blood oscillations ([0006]). Mayoral provides a mechanism to interpret blood oscillations in terms of respiration rate, which is naturally present in blood flow from respiratory artifact.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor measuring blood oscillations in the vena cava by incorporating the isolation of respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure respiration rates from these signals, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the isolation of respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral.
Therefore, Claim 6 is obvious over Thompson in view of Mayoral and Wenzel.
Regarding Claim 7, Thompson, in view of Mayoral and Wenzel, renders obvious the strain-sensing system according to Claim 6, as indicated hereinabove. Thompson discloses the detection of oscillations in a blood flow physical attribute via strain measurements using the FBG sensors ([0006]). However, Thompson does not disclose the set of operations further including correlating measurements of the physical attributes made by the ECG stylet with the physical attributes determined in the real-time determination from the converted electrical signals.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors need to be filtered and calibrated as the raw light signal in the FBG sensor contains multiple vital signs (4. Discussion, page 24 – “Apart from the fact that the characterization with FBG at that wavelength is a widely tested that has given multiple results using lasers [120], the complexity is to adjust the sensor as a filter fort to measurement of some vital sign [72,114,115]. All the sensors analyzed, are performed for measurements of physical parameters in the medical field (temperature, position, force, torque, stretch) but is necessary its calibration and categorization, as they are able to perform different measurements depending of the configuration and design. Therefore, they are applied for obtained manage and to obtain a response of vital signs [87,121]”). The Examiner interprets Mayoral’s passage as teaching the necessity of calibrating and categorizing strain output from the FBG sensor relative to a known standard for the parameters being measured (temperature, pressure, rate, etc.). A person or ordinary skill in the art would interpret this calibration as comparing an uncalibrated signal to an established measurement of the parameter by another sensor. The 11/21/2025 final office action specifically uses Ogawa (a reference in Mayoral) as evidence for an FBG sensor measuring physiologic parameters from oscillations in a blood vessel (pages 7-11, 11/21/2025 Final Action). As an example, Ogawa compares the FBG sensor measurement to a reference thermocouple to compare the respiration signals (Figure 6, page 2 – “The FBG sensor is taped near the tricuspid area and carotid artery with surgical tape. Thermocouple put on an air cushion mask was used as the reference of respiration). This example would be characteristic of the Examiner’s interpretation of the calibration process for a dynamic system for measuring parameters within a patient.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor measuring blood oscillations in the vena cava by incorporating the calculation of vital signs from FBG sensors on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure vital signs (after a filtering and calibration process) from these oscillations, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the calculation of vital signs from FBG sensors on the skin in Mayoral.
Wenzel, in the same field of endeavor of a sensing catheter assembly ([0072]), teaches a stylet placed to measure an ECG waveform to determine the location of the stylet ([0136]), where locations include the superior vena cava and cavoatrial junction ([0127]). The ECG measurements are used to compute heart rate, which is compared with analyses of blood flow oscillations ([0086]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG catheter sensor measuring blood oscillations in the vena cava (containing an ECG stylet) by incorporating the use of a stylet in a vascular catheter which captures ECG and analyzes the ECG to calculate heart rate in Wenzel. This would have been obvious because both Thompson and Wenzel discuss catheter-based measurement of oscillations present in blood vessels and the use of ECG stylets and Wenzel provides a solution/improvement to measure heart rate using the ECG stylet to compare with the detection of heart rate from blood oscillations. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the use of a stylet in a vascular catheter which captures ECG and analyzes the ECG to calculate heart rate in Wenzel.
Therefore, Claim 7 is obvious over Thompson in view of Mayoral and Wenzel.
Regarding Claim 11, Thompson, in view of Mayoral and Wenzel, renders obvious the strain-sensing system according to Claim 7, as indicated hereinabove. Thompson further discloses the set of operations further including: establishing physical attribute-baseline measurements through the measurements of the physical attributes ([0067]) and monitoring physical-attribute baselines through the simple oscillations experienced by the distal portion of the optical-fiber probe to determine any deviations from the physical-attribute baselines (Fig. 13, Fig. 15, [0065] – “changes in any one or more of the plots of curvature vs. time 1012a, 1012b, 1012c, ... , 1012n, for the selection of the FBG sensors in the distal-end portion of the optical-fiber stylet can be used to manually identify a distinctive change in strain of the optical-fiber stylet by way of a distinctive change in plotted curvature of the optical fiber stylet at a moment a tip of the medical device 110 is advanced into an SVC of a patient”). However, Thompson does not disclose measurements of the physical attributes by the ECG stylet.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors need to be filtered and calibrated as the raw light signal in the FBG sensor contains multiple vital signs (4. Discussion, page 24 – “Apart from the fact that the characterization with FBG at that wavelength is a widely tested that has given multiple results using lasers [120], the complexity is to adjust the sensor as a filter fort to measurement of some vital sign [72,114,115]. All the sensors analyzed, are performed for measurements of physical parameters in the medical field (temperature, position, force, torque, stretch) but is necessary its calibration and categorization, as they are able to perform different measurements depending of the configuration and design. Therefore, they are applied for obtained manage and to obtain a response of vital signs [87,121]”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor measuring blood oscillations in the vena cava by incorporating the calculation of vital signs from FBG sensors on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure vital signs (after a filtering and calibration process) from these oscillations, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the calculation of vital signs from FBG sensors on the skin in Mayoral.
Wenzel, in the same field of endeavor of a sensing catheter assembly ([0072]), teaches a stylet placed to measure an ECG waveform to determine the location of the stylet ([0136]), where locations include the superior vena cava and cavoatrial junction ([0127]). The ECG measurements are used to compute heart rate, which is compared with analyses of blood flow oscillations ([0086]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG catheter sensor measuring blood oscillations in the vena cava (containing an ECG stylet) by incorporating the use of a stylet in a vascular catheter which captures ECG and analyzes the ECG to calculate heart rate in Wenzel. This would have been obvious because both Thompson and Wenzel discuss catheter-based measurement of oscillations present in blood vessels and the use of ECG stylets and Wenzel provides a solution/improvement to measure heart rate using the ECG stylet to compare with the detection of heart rate from blood oscillations. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the use of a stylet in a vascular catheter which captures ECG and analyzes the ECG to calculate heart rate in Wenzel.
Therefore, Claim 11 is obvious over Thompson in view of Mayoral and Wenzel.
Regarding Claim 12, Thompson, in view of Mayoral and Wenzel, renders obvious the strain-sensing system according to Claim 1, as indicated hereinabove. Thompson further discloses wherein one or more physical-attribute plots facilitate historical analysis by an attending clinician (Fig 10, [0065] – display of strain-based physical attributes on display screen).
Therefore, Claim 12 is obvious over Thompson in view of Mayoral and Wenzel.
Regarding Claim 23, Thompson discloses a strain-sensing system for determining one or more physical attributes associated with the patient ([0005]), comprising:
•an indwelling medical device for placement in a superior vena cava ("SVC") of a patient ([0002] – located in superior vena cava), the indwelling medical device including an integrated or removable optical-fiber probe having a number of fiber Bragg grating ("FBG") sensors along at least a distal portion of the optical-fiber probe ([0004] – “comprised of a number of fiber Bragg grating ("FBG") sensors along at least a distal-end portion of the optical-fiber”); and
• an electrocardiogram ("ECG") stylet ([0074] – “Optionally, in a same or different longitudinal bead of the catheter tube 312, the PICC 310 can further include an electrocardiogram (‘ECG’) stylet”);
• an optical interrogator configured to send input optical signals into the optical-fiber probe and receive FBG sensor-reflected optical signals from the optical-fiber probe ([0050]);
• a console including one or more processors, memory, and executable instructions stored in the memory that cause the console to perform a set of operations upon execution of the instructions by the one-or-more processors ([0063]), the set of operations including:
-receiving the FBG sensor-reflected optical signals from the optical interrogator ([0063]);
-converting the FBG sensor-reflected optical signals into converted electrical signals with optical signal-converter logic ([0063]), the converted electrical signals including simple or complex oscillations indicative of those experienced by the distal portion of the optical-fiber probe when placed in the SVC of the patient ([0066] – “for the selection of the FBG sensors in the distal-end portion of the optical-fiber stylet can be used to manually confirm the tip of the medical device 110 is in the SVC by way of periodic changes in the strain of the optical-fiber stylet. The periodic changes in the strain of the optical-fiber stylet are evidenced by periodic changes in the plotted curvature of the optical fiber stylet sensed by the selection of the FBG sensors”); and
• determining in a real-time determination the physical attribute of the patient from at least the converted electrical signals with physical attribute-determination logic ([0067]); and
• displaying the physical attributes on a display screen ([0063]) in one or more physical- attribute plots including at least a plot of a physical attribute ([0067]).
Thompson discloses: “the SVC-determiner algorithm is configured to confirm the tip of the medical device is in the SVC by way of periodic changes in the strain of the optical-fiber stylet sensed by the selection of the FBG sensors. The periodic changes in the strain result from periodic changes in blood flow within the SVC as a heart of the patient beats” ([0006]). Therefore, mechanical oscillations in the circulatory system can be registered and interpreted by the FBG sensor in Thompson. Thompson fails to disclose:
(1) the physical attribute is the respiration rate associated with the lungs,
(2) determining a heart rate associated with the heart of the patient from ECG data from the ECG stylet, and
(3) displaying physical attributes on a display screen in one or more physical- attribute plots including at least a plot of respiration rate.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors can be used to measure a heart rate (3.3 Pulse or Heart Rate, pages 17-20). Mayoral also teaches FBG sensors can be used to measure respiration rate (3.2. Respiration or Breathing Rate, pages 12-13). Tables 2 and 4 in Mayoral provide reference 7 (Ogawa), which derives respiratory rate and pulse or heart rate from pulsations in the carotid artery or tricuspid area (which would be applicable to the vena cava as a blood vessel) via measurements of strain detected through the skin (Mayoral, Page 23 - “Another FBG sensor for simultaneous measurement of respiration used pulse wave and heart sound with measurements at the tricuspid region of the chest and the carotid artery of the neck”; Ogawa, Abstract – “Heart sound, pulse wave and respiration are simultaneously measured with single fiber Bragg grating (FBG) sensor … sensor is taped near the Tricuspid area and on the carotid artery with the surgical tape. Measured data is denoised through digital Butterworth filter with low pass filter (0.2 Hz), medium frequency band pass filter (0.5 Hz - 5.0 Hz) and higher frequency bandpass filter (35.0 Hz - 55.0 Hz) to extract the information of respiration, pulse wave and heart sound, respectively”). While these devices in Mayoral containing FBG sensors are placed over skin to detect oscillatory strain from the vessel underneath, the principle of processing these strain signals to detect respiration rate and heart rate is established by Mayoral. Thompson discloses an FBG sensor disposed in a blood vessel and able to measure blood oscillations ([0006]). Mayoral provides a mechanism to interpret blood oscillations in terms of heart rate and respiration rate, which are naturally present in blood flow from the beating heart and respiratory artifact. The display in Thompson merely shows the outputs of the conversion algorithms in Thompson, which would output physiological parameters after the incorporation of the analysis functions as described in Mayoral (such as the outputs of physiologic parameters displayed in Mayoral Figures 17 and 18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor measuring blood oscillations in the vena cava by incorporating the isolation of heart rate and respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure heart and respiration rates from these signals, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the isolation of heart rate and respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral.
Wenzel, in the same field of endeavor of a sensing catheter assembly ([0072]), teaches a stylet placed to measure an ECG waveform to determine the location of the stylet ([0136]), where locations include the superior vena cava and cavoatrial junction ([0127]). The ECG measurements are used to compute heart rate, which is compared with analyses of blood flow oscillations ([0086] – “An additional embodiment of monitoring turbulent blood flow is to monitor frequency component peaks as the blood flow changes direction. When the turbulent blood flow changes direction, the frequency component will change creating a peak. The peaks and troughs (local maximums and minimums) will indicate the how often the blood flow velocity changes, the magnitude of these changes, and the timing of the changes … The timing of changes in blood flow will help determine if the changes are associated with a heart contraction, respiratory rhythm, or moving of the catheter tip. In some embodiments, the peaks and troughs can be compared with ECG measurements and data to determine whether the changes are associated with the heart rate”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG catheter sensor measuring blood oscillations in the vena cava (containing an ECG stylet) by incorporating the use of a stylet in a vascular catheter which captures ECG and analyzes the ECG to calculate heart rate in Wenzel. This would have been obvious because both Thompson and Wenzel discuss catheter-based measurement of oscillations present in blood vessels and the use of ECG stylets and Wenzel provides a solution/improvement to measure heart rate using the ECG stylet to compare with the detection of heart rate from blood oscillations. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the use of a stylet in a vascular catheter which captures ECG and analyzes the ECG to calculate heart rate in Wenzel.
Therefore, Claim 23 is obvious over Thompson in view of Mayoral and Wenzel.
Regarding Claim 24, Thompson, in view of Mayoral and Wenzel, renders obvious the strain-sensing system according to Claim 23, as indicated hereinabove. Thompson further discloses wherein the physical attribute-determination logic is configured to determine the physical attribute directly from a simple oscillation from an extracted electrical signal ([0011], [0063]). Thompson fails to disclose the determination of the respiration rate directly from a simple oscillation from an extracted electrical signal.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors can be used to measure respiration rate (3.2. Respiration or Breathing Rate, pages 12-13). Table 2 in Mayoral provides reference 7 (Ogawa), which derives respiratory rate and pulse or heart rate from pulsations in the carotid artery or tricuspid area (which would be applicable to the vena cava as a blood vessel) via measurements of strain detected through the skin (Mayoral, Page 23 - “Another FBG sensor for simultaneous measurement of respiration used pulse wave and heart sound with measurements at the tricuspid region of the chest and the carotid artery of the neck”; Ogawa, Abstract). While these devices in Mayoral containing FBG sensors are placed over skin to detect oscillatory strain from the vessel underneath, the principle of processing these strain signals to detect respiration rate is established by Mayoral. Thompson discloses an FBG sensor disposed in a blood vessel and able to measure blood oscillations ([0006]). Mayoral provides a mechanism to interpret blood oscillations in terms of respiration rate, which is naturally present in blood flow from respiratory artifact.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor measuring blood oscillations in the vena cava by incorporating the isolation of respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure respiration rates from these signals, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the isolation of respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral.
Therefore, Claim 24 is obvious over Thompson in view of Mayoral and Wenzel.
Regarding Claim 25, Thompson, in view of Mayoral and Wenzel, renders obvious the strain-sensing system according to Claim 23, as indicated hereinabove. Thompson further discloses wherein the physical attribute- determination logic is further configured to determine physical attributes of the patient from a complex oscillation from an extracted electrical signal. Thompson states “the SVC-determiner algorithm is configured to confirm the tip of the medical device is in the SVC by way of periodic changes in the strain of the optical-fiber stylet sensed by the selection of the FBG sensors. The periodic changes in the strain result from periodic changes in blood flow within the SVC as a heart of the patient beats” ([0006]). Therefore, mechanical oscillations (whether the oscillations are simple or complex is determined by how different oscillation sources combine into one signal) in the circulatory system can be registered and interpreted by the FBG sensor in Thompson. However, Thompson fails to disclose physical attributes of heart rate and respiration rate.
Mayoral, in the same field of endeavor of detecting physiologic oscillations with FBG sensors (Abstract), teaches FBG sensors can be used to measure a heart rate (3.3 Pulse or Heart Rate, pages 17-20). Mayoral also teaches FBG sensors can be used to measure respiration rate (3.2. Respiration or Breathing Rate, pages 12-13). Tables 2 and 4 in Mayoral provide reference 7 (Ogawa), which derives respiratory rate and pulse or heart rate from pulsations in the carotid artery or tricuspid area (which would be applicable to the vena cava as a blood vessel) via measurements of strain detected through the skin (Mayoral, Page 23 - “Another FBG sensor for simultaneous measurement of respiration used pulse wave and heart sound with measurements at the tricuspid region of the chest and the carotid artery of the neck”; Ogawa, Abstract). While these devices in Mayoral containing FBG sensors are placed over skin to detect oscillatory strain from the vessel underneath, the principle of processing these strain signals to detect respiration rate and heart rate is established by Mayoral. Thompson discloses an FBG sensor disposed in a blood vessel and able to measure blood oscillations ([0006]). Mayoral provides a mechanism to interpret blood oscillations in terms of heart rate and respiration rate, which are naturally present in blood flow from the beating heart and respiratory artifact.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Thompson’s FBG sensor measuring blood oscillations in the vena cava by incorporating the isolation of heart rate and respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral. This would have been obvious because both Thompson and Mayoral discuss the measurement of oscillations present in blood vessels and Mayoral provides a solution/improvement to measure heart and respiration rates from these signals, thereby enhancing diagnostic information available to a clinician. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the isolation of heart rate and respiration rate from blood oscillations measured via an FBG sensor on the skin in Mayoral.
Therefore, Claim 25 is obvious over Thompson in view of Mayoral and Wenzel.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 8:30 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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