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 statement (IDS) submitted on 07/21/2026 is being considered by the Examiner.
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 07/21/2026, claims 1, 13, and 23 are amended.
Priority
No domestic or foreign priority is claimed. Therefore, the effective filing date is the filing date of the instant non-provisional application 17/728,802 and all prior art will be evaluated with respect to that date (04/25/2022).
Response to Arguments
Applicant’s arguments, see Remarks pages 8-9 (Claim Rejections - 35 U.S.C. § 103), filed 07/21/2026, 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 claim 1 is amended to recite " ... the indwelling medical device including: a removable optical-fiber probe .... " In rejecting independent claim 1, the Examiner relies on Thompson to teach the indwelling medical device citing paragraph [0004]. Thompson explicitly teaches in paragraph [0004] inter alia that the medical device includes an integrated optical fiber stylet. At no point does Thompson teach that the stylet is removable from the medical device. Therefore, Thompson fails to teach " ... the indwelling medical device including: a removable optical-fiber probe .... " as required by independent claim 1. Mayoral, Ogawa, and Wenzel fail to remedy the deficiencies of Thompson.
Accordingly, Thompson, Mayoral, Ogawa, and Wenzel fail to teach each and every element of independent claim 1. Applicant has similarly amended independent claims 13 and 23. For at least the foregoing reasons, Applicant respectfully requests favorable reconsideration and withdrawal of the rejections under 35 U.S.C. § 103 for independent claims 1, 13, and 23 as well as dependent claims depending therefrom by virtue of their inherited subject matter. (07/21/2026 Remarks, pages 8-9)
This argument is persuasive. The previous version of the independent claims included some form of limitation “indwelling medical device including: an integrated or removable optical-fiber probe having a number of fiber Bragg grating sensors” (claim 1) where an integrated or removable option could be selected. Thompson only discusses an integrated optical fiber stylet ([0004], [0011]). Therefore, the rejections of independent claims 1, 13, and 23 and dependent claims 4-7, 11-12, 14-16, 22, and 24-25 are withdrawn. However, upon further consideration, a new grounds of rejection is made newly in view of Messerly (US 2018/0289927 A1).
Summary: The 35 U.S.C. § 103 rejections of claims 1, 4-7, 11-16, and 22-25 are withdrawn. New 35 U.S.C. § 103 rejections for claims 1, 4-7, 11-16, and 22-25, newly in view of Messerly, are added.
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 2021/0045814 A1) in view of Mayoral et al (NPL, “Fiber Optic Sensors for Vital Signs Monitoring. A Review of Its Practicality in the Health Field”) and Messerly (US 2018/0289927 A1), as evidenced by Ogawa (NPL, “Simultaneous Measurement of Heart Sound, Pulse Wave and Respiration with Single Fiber Bragg Grating Sensor”).
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 an indwelling medical device ([0004] – optical interrogator sending optical signals to integrated stylet) 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);
• 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 the 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 discusses 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 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.
Thompson also fails to disclose (5) an optical-fiber probe removably disposed in an indwelling medical device.
Messerly, in the same field of endeavor of detecting strain in a catheter system with FBG sensors (Abstract), teaches a catheter 72 containing stylet 130 in its lumen 216 which include a fiber-bearing portion 138, which further contains optical fiber 140 with strain sensors 204 (which are specifically FBG sensors) to measure strain to determine the catheter’s position (Fig. 1, [0048]). The tip of the catheter is placed through the superior vena cava ([0026]). The stylet 130, which contains optical fiber 140, is noted to have embodiments where the stylet is removably received within a general catheter already providing access ([0036], claim 21) or the optical fiber is directly integrated into a more specialized catheter structure to eliminate the need for a stylet ([0051]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson’s method of using a catheter-based stylet with FBG sensors by incorporating the removable stylet with FBG sensors placed into a catheter in Messerly. This would have been obvious because both Thompson and Messerly discuss stylets containing FBG sensors placed within catheters. Messerly presents two embodiments (two options possible: attached or not attached) defining an optical fiber stylet’s attachment to a catheter within the strain sensing system: (1) an integrally-attached optical fiber and (2) a removable optical fiber stylet. Given both embodiments have advantages and Messerly does not explicitly favor one solution over another, it would have been obvious to try a removable optical fiber stylet within the catheter of Thompson. A person of ordinary skill in the art would have a reasonable expectation of successfully using the removable optical fiber stylet within the method of Thompson.
Regarding Claim 14, the method of a strain-sensing system according to Claim 13 is obvious over Thompson in view of Mayoral and Messerly, 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.
Regarding Claim 15, the method of a strain-sensing system according to Claim 14 is obvious over Thompson in view of Mayoral and Messerly, 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.
As stated in claim 13, the proposed combination with Mayoral yields FBG sensors measuring 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; 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.
Regarding Claim 16, the method of a strain-sensing system according to Claim 14 is obvious over Thompson in view of Mayoral and Messerly, 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.
As stated in claim 13, the proposed combination with Mayoral yields FBG sensors measuring 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; 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.
Regarding Claim 22, the method of a strain-sensing system according to Claim 16 is obvious over Thompson in view of Mayoral and Messerly, 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).
Claims 1, 4-7, 11-12, and 23-25 are rejected under U.S.C 103 as being unpatentable over Thompson (US 2021/0045814 A1) in view of Mayoral et al (NPL, “Fiber Optic Sensors for Vital Signs Monitoring. A Review of Its Practicality in the Health Field”), Wenzel (US 2016/0256224 A1), and Messerly (US 2018/0289927 A1), as evidenced by Ogawa (NPL, “Simultaneous Measurement of Heart Sound, Pulse Wave and Respiration with Single Fiber Bragg Grating Sensor”).
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 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);
• 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.
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.
Thompson also fails to disclose (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.
The medical device locator within the venous return to the heart in Wenzel would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the optical fiber catheter system positioned within the vena cava in the instant application because Wenzel 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]). ECG measurements are used to compute heart rate, which is compared with analyses of blood flow oscillations caused by heart contraction, respiratory artifact, or a moving catheter ([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 to determine heart rate 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. Wenzel provides a solution/improvement to measure heart rate using the ECG stylet to compare and determine the effect of heart rate on blood oscillation measurements. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the use of the stylet in a vascular catheter, which captures ECG to determine the effect of heart rate on blood oscillations, in Wenzel.
Thompson also fails to disclose (4) the indwelling medical device including a removable optical-fiber probe.
Messerly, in the same field of endeavor of detecting strain in a catheter system with FBG sensors (Abstract), teaches a catheter 72 containing stylet 130 in its lumen 216 which include a fiber-bearing portion 138, which further contains optical fiber 140 with strain sensors 204 (which are specifically FBG sensors) to measure strain to determine the catheter’s position (Fig. 1, [0048]). The tip of the catheter is placed through the superior vena cava ([0026]). The stylet 130, which contains optical fiber 140, is noted to have embodiments where the stylet is removably received within a general catheter already providing access ([0036], claim 21) or the optical fiber is directly integrated into a more specialized catheter structure to eliminate the need for a stylet ([0051]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson’s system using a catheter-based stylet with FBG sensors by incorporating the removable stylet with FBG sensors placed into a catheter in Messerly. This would have been obvious because both Thompson and Messerly discuss stylets containing FBG sensors placed within catheters. Messerly presents two embodiments (two options possible: attached or not attached) defining an optical fiber stylet’s attachment to a catheter within the strain sensing system: (1) an integrally-attached optical fiber and (2) a removable optical fiber stylet. Given both embodiments have advantages and Messerly does not explicitly favor one solution over another, it would have been obvious to try a removable optical fiber stylet within the catheter of Thompson. A person of ordinary skill in the art would have a reasonable expectation of successfully using the removable optical fiber stylet within the system of Thompson.
Regarding Claim 4, the strain-sensing system according to Claim 1 is obvious over Thompson in view of Mayoral, Wenzel, and Messerly, 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.
Regarding Claim 5, the strain-sensing system according to Claim 4 is obvious over Thompson in view of Mayoral, Wenzel, and Messerly, 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.
As stated in claim 1, the proposed combination with Mayoral yields FBG sensors measuring 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; 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.
Regarding Claim 6, the strain-sensing system according to Claim 4 is obvious over Thompson in view of Mayoral, Wenzel, and Messerly, 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.
As stated in claim 1, the proposed combination with Mayoral yields FBG sensors measuring 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; 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.
Regarding Claim 7, the strain-sensing system according to Claim 6 is obvious over Thompson in view of Mayoral, Wenzel, and Messerly, 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.
As stated in claim 1, the proposed combination with Mayoral further yields FBG sensors needing 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 discusses 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.
As stated in claim 1, the proposed combination with Wenzel yields 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]). ECG measurements are used to compute heart rate, which is compared with analyses of blood flow oscillations caused by heart contraction, respiratory artifact, or a moving catheter ([0086]). Wenzel provides a solution/improvement to measure heart rate using the ECG stylet to compare and determine the effect of heart rate on blood oscillation measurements.
Regarding Claim 11, the strain-sensing system according to Claim 7 is obvious over Thompson in view of Mayoral, Wenzel, and Messerly, 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.
As stated in claim 1, the proposed combination with Mayoral further yields 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).
As stated in claim 1, the proposed combination with Wenzel yields 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]). ECG measurements are used to compute heart rate, which is compared with analyses of blood flow oscillations caused by heart contraction, respiratory artifact, or a moving catheter ([0086]). Wenzel provides a solution/improvement to measure heart rate using the ECG stylet to compare and determine the effect of heart rate on blood oscillation measurements.
Regarding Claim 12, the strain-sensing system according to Claim 1 is obvious over Thompson in view of Mayoral, Wenzel, and Messerly, 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).
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 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) 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.
Thompson also fails to disclose (3) determining a heart rate associated with the heart of the patient from ECG data from the ECG stylet.
The medical device locator within the venous return to the heart in Wenzel would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the optical fiber catheter system positioned within the vena cava in the instant application because Wenzel 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]). ECG measurements are used to compute heart rate, which is compared with analyses of blood flow oscillations caused by heart contraction, respiratory artifact, or a moving catheter ([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 to determine heart rate 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. Wenzel provides a solution/improvement to measure heart rate using the ECG stylet to compare and determine the effect of heart rate on blood oscillation measurements. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Thompson by incorporating the use of the stylet in a vascular catheter, which captures ECG to determine the effect of heart rate on blood oscillations, in Wenzel.
Thompson also fails to disclose (4) the indwelling medical device including a removable optical-fiber probe.
Messerly, in the same field of endeavor of detecting strain in a catheter system with FBG sensors (Abstract), teaches a catheter 72 containing stylet 130 in its lumen 216 which include a fiber-bearing portion 138, which further contains optical fiber 140 with strain sensors 204 (which are specifically FBG sensors) to measure strain to determine the catheter’s position (Fig. 1, [0048]). The tip of the catheter is placed through the superior vena cava ([0026]). The stylet 130, which contains optical fiber 140, is noted to have embodiments where the stylet is removably received within a general catheter already providing access ([0036], claim 21) or the optical fiber is directly integrated into a more specialized catheter structure to eliminate the need for a stylet ([0051]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thompson’s system using a catheter-based stylet with FBG sensors by incorporating the removable stylet with FBG sensors placed into a catheter in Messerly. This would have been obvious because both Thompson and Messerly discuss stylets containing FBG sensors placed within catheters. Messerly presents two embodiments (two options possible: attached or not attached) defining an optical fiber stylet’s attachment to a catheter within the strain sensing system: (1) an integrally-attached optical fiber and (2) a removable optical fiber stylet. Given both embodiments have advantages and Messerly does not explicitly favor one solution over another, it would have been obvious to try a removable optical fiber stylet within the catheter of Thompson. A person of ordinary skill in the art would have a reasonable expectation of successfully using the removable optical fiber stylet within the system of Thompson.
Regarding Claim 24, the strain-sensing system according to Claim 23 is obvious over Thompson in view of Mayoral, Wenzel, and Messerly, 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.
As stated in claim 23, the proposed combination with Mayoral yields FBG sensors measuring 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; 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.
Regarding Claim 25, the strain-sensing system according to Claim 23 is obvious over Thompson in view of Mayoral, Wenzel, and Messerly, 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.
As stated in claim 23, the proposed combination with Mayoral yields FBG sensors measuring 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; 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.
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.
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 9:00 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
