DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 04/28/2026.
Response to Amendment
Applicant’s Amendments, filed 04/28/2026, has been entered. Claims 1,2, 4-6, 8-12, 17, 109-116 remain pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 4-6, 12, 109-112, 114, 116 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US20160022952), hereafter Brown, in view of H.M. Al-Otaibi, J.G. Hardman, Prediction of arterial oxygen partial pressure after changes in FiO2: validation and clinical application of a novel formula, (British Journal of Anaesthesia, Volume 107, Issue 5, 2011, Pages 806-812, ISSN 0007-0912), hereafter Hardman, further in view of Baker et al. (US20080066752), hereafter Baker.
Regarding Claim 1, Brown discloses a respiratory assistance apparatus (Fig. 1, patient oxygen therapy system 100) comprising: a flow generator configured to provide breathing gases to a patient (Fig. 1 gas delivery system (GDS) 140), the breathing gases comprising supplemental oxygen provided from an oxygen source (Fig. 1, gas blender 120); a controller configured to control an oxygen concentration of the breathing gases (Fig. 1, SDP 102; par. 0021, “…to provide closed loop control of the oxygen concentration”) and at least one sensor (Fig. 1 S.sub.pO.sub.2 sensor 106), the at least one sensor configured to provide a measurement indicative of the patient's blood oxygen concentration to the controller (par. 0020, “Essential inputs include patient S.sub.pO.sub.2 data 104 from S.sub.pO.sub.2 sensor 106”), wherein the controller is configured to determine a target oxygen concentration of the breathing gases (par.0021, “microprocessor and electronics block 102b… compute an F.sub.iO.sub.2 set point”).
Brown then discloses the controller is further configured to calculate an estimated future value of the patient's blood oxygen concentration (par. 0021, “microprocessor and electronics block 102b… to predict the patient S.sub.pO.sub.2 at the next measurement cycle”) is silent on calculate the estimated future value of the patient's blood oxygen concentration based on: a difference between an initial oxygen concentration of the breathing gases and the target oxygen concentration of the breathing gases, the measurement indicative of the patient's blood oxygen concentration, and a time from when the controller controls the oxygen concentration of the breathing gases to the target oxygen concentration of the breathing gases.
However, Hardman teaches a method of calculating a future value of a patient’s blood oxygen (pg. 806, Background, “a novel formula designed to predict PaO2”), the method is to calculate an estimated future value of the patient's blood oxygen concentration (pg. 808, table 2, hemoglobin concentration and oxygen saturation after adjustment are calculated, both represents blood oxygen concentration) based on: a difference between an initial oxygen concentration of the breathing gases and the target oxygen concentration of the breathing gases (See pg. 807, equation 1 oldFIO2 − new FIO2), and the measurement indicative of the patient's blood oxygen concentration (pg. 806, “prediction using a new formula (which utilizes only the pre-adjustment PaO2 and pre- and post-adjustment FIO2 )”; pg. 807 equation 1, oldPaO2). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known apparatus of Brown, with the method of predicting future blood oxygen concentration of Hardman, for improved accuracy and reliability as taught by Hardman (Hardman, pg. 806, Conclusions)
The modified Brown is still silent on the estimated future value of the patient's blood oxygen concentration is based on a time from when the controller controls the oxygen concentration of the breathing gases to the target oxygen concentration of the breathing gases.
However, Baker teaches a respiratory assistance system (Abstract), comprising of a controller configured to calculate an estimated future value of the patient’s blood oxygen concentration (par. 0031, “In one embodiment, adjustments to the controller response time are made based on an estimated amount of circulatory delay. For example, circulatory delay may be estimated by correlating changes in FiO.sub.2 to subsequent changes in the measured SpO.sub.2 value.”; the prior art teaches considering circulatory delay to estimate the change in the blood oxygen value, such change in blood oxygen value includes a present and future value of the blood oxygen level.), based on a time from when the controller controls the oxygen concentration of the breathing gases to the target oxygen concentration of the breathing gases (par. 0039, “an estimation of physiologic delay may be based on historical changes in SpO.sub.2… to estimate a difference in time required for FiO.sub.2 changes to register in blood near a patient's lungs and at a sensor location on the patient”). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known apparatus of Brown, with the system of Baker, to include a time when the concentration of the breathing gas is adjusted when predicting the future value of the blood oxygen concentration, for consistent oxygen supply at the desired level as taught by Baker (Baker, par. 0028).
Regarding Claim 2, the modified Brown discloses the respiratory assistance apparatus of claim 1, wherein the controller is further configured to control the oxygen concentration of the breathing gases based on the target oxygen concentration (Brown, par. 0023, “Oxygen is then blended with the carrier gas to the concentration (F.sub.iO.sub.2) computed by SDP 102”).
Regarding Claim 4, the modified Brown discloses the respiratory assistance apparatus of claim 1, wherein the controller is further configured to receive an input, and based on the input determine the target oxygen concentration of the breathing gases (Brown, par. 0021, “electronics block 102b uses the patient heart rate, current S.sub.pO.sub.2, current F.sub.iO.sub.2… compute an F.sub.iO.sub.2 set point””).
Regarding Claim 5, the modified Brown discloses The respiratory assistance apparatus of claim 4, wherein the input comprises a target oxygen concentration range (Brown, par. 0021, specified S.sub.pO.sub.2 range) comprising an upper target oxygen concentration, and a lower target oxygen concentration (Brown, par. 0024, “for example, may be a target hemoglobin oxygen saturation level (S.sub.pO.sub.2) of 96% with an allowable low of 94% and a maximum of 98%”).
Regarding Claim 6, the modified Brown discloses the controller is further configured to compare said estimated future value of the patient's blood oxygen concentration with a blood oxygen concentration alarm range (Brown, Fig. 4, par. 0029, “The predicted S.sub.pO.sub.2 values are compared to the target and range in Step 216”), and generate an alarm output if the estimated future value of the patient's blood oxygen concentration is not within said blood oxygen concentration alarm range (Brown, par. 0030, “In the event that a persistent S.sub.pO.sub.2 excursion outside of the target range is noted at step 224, an alarm is issued”), and wherein the blood oxygen concentration alarm range comprises an upper blood oxygen concentration alarm threshold and a lower blood oxygen concentration alarm threshold (Brown, par. 0024, “for example, may be a target hemoglobin oxygen saturation level (S.sub.pO.sub.2) of 96% with an allowable low of 94% and a maximum of 98%”).
Regarding Claim 12, the modified Brown discloses the respiratory assistance apparatus of claim 6, wherein the upper blood oxygen concentration alarm threshold and/or the lower blood oxygen concentration alarm threshold is/are based on a target blood oxygen concentration (par. 0024, “for example, may be a target hemoglobin oxygen saturation level (S.sub.pO.sub.2) of 96% with an allowable low of 94% and a maximum of 98%”)
Regarding Claim 8, the modified Brown discloses the respiratory assistance apparatus of claim 6, but is silent on wherein the upper blood oxygen concentration alarm threshold and/or the lower blood oxygen concentration alarm threshold is/are determined based on a time from when the controller controls the oxygen concentration of the breathing gases to the target oxygen concentration.
However, Baker teaches a respiratory assistance system (Abstract), comprising of a controller configured to calculate an estimated future value of the patient’s blood oxygen concentration (par. 0031, “In one embodiment, adjustments to the controller response time are made based on an estimated amount of circulatory delay. For example, circulatory delay may be estimated by correlating changes in FiO.sub.2 to subsequent changes in the measured SpO.sub.2 value.”; the prior art teaches considering circulatory delay to estimate the change in the blood oxygen value, such change in blood oxygen value includes a present and future value of the blood oxygen level.), based on a time from when the controller controls the oxygen concentration of the breathing gases to the target oxygen concentration of the breathing gases (par. 0039, “an estimation of physiologic delay may be based on historical changes in SpO.sub.2… to estimate a difference in time required for FiO.sub.2 changes to register in blood near a patient's lungs and at a sensor location on the patient”). Therefore, it would have been obvious for one of ordinary skilled in the art been to further modify the known apparatus of Brown, and include the time based algorithm of Schulz when calculating the upper/lower blood oxygen alarm threshold, for consistent oxygen supply at the desired level as taught by Baker (Baker, par. 0028).
Regarding Claim 109, the modified Brown discloses the respiratory assistance apparatus of claim 6, wherein the respiratory assistance apparatus, or an associated device, is configured to display the alarm output, or information associated with the alarm output (Brown, par. 0004, “trigger an alarm by the S.sub.pO.sub.2 monitor that alerts care providers”).
Regarding Claim 110, the modified Brown discloses the respiratory assistance apparatus of claim 6, wherein the respiratory assistance apparatus, or the or an associated device, is configured to display the estimated future value of the patient's blood oxygen concentration (Brown, Claim 6, “a visual display enabling an operator to view a plurality of parameters including… predicted S.sub.pO.sub.2”).
Regarding Claim 111, the modified Brown discloses the respiratory assistance apparatus of claim 1, wherein the estimated future value of the patient's blood oxygen concentration is further based on an oxygen efficiency of the patient and/or a haemoglobin saturation function (Hardman, pg. 807, equation 1, old PaO2/old FiO2; in the equation, the ratio between PaO2 and FiO2 is an oxygen efficiency).
Regarding Claim 112, the modified Brown discloses the respiratory assistance apparatus of claim 111, wherein the oxygen efficiency of the patient is based on the measurement indicative of the patient's blood oxygen concentration divided by a measured oxygen concentration of the breathing gases (Hardman, pg. 807, equation 1, old PaO2/old FiO2).
Regarding Claim 114, the modified Brown discloses the respiratory assistance apparatus of claim 1, wherein the controller is further configured to calculate the estimated future value of the patient's blood oxygen concentration based on stored breathing gases oxygen concentration data (Brown, par. 0028, “the predicted next measured S.sub.pO.sub.2 value is based on the patient's history-based ARPs”; par. 0026, “these ARPs… current F.sub.iO.sub.2, current S.sub.pO.sub.2, recent trend of each, current trend of each”).
Regarding Claim 116, the modified Brown discloses the respiratory assistance apparatus of claim 1, wherein the controller is further configured to generate an alarm output based on the estimated future value of the patient's blood oxygen concentration and a comparison with a blood oxygen concentration alarm threshold (Brown, Fig. 4, par. 0029, “The predicted S.sub.pO.sub.2 values are compared to the target and range in Step 216”; Fig. 4 step 224 and 226), and wherein the controller is further configured to generate said alarm output if the estimated future value of the patient's blood oxygen concentration is above an upper blood oxygen concentration alarm threshold or below a lower blood oxygen concentration alarm threshold (Brown, par. 0024, “a typical target and range, for example, may be… an allowable low of 94% and a maximum of 98%”; Fig. 4 step 216, 224, 226).
Claim(s) 9, 10, 11,17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown, in view of Hardman, in view of Baker, further in view of Tehrani (US20050109340), hereafter Tehrani.
Regarding Claim 9, the modified Brown discloses the respiratory assistance apparatus of claim 6, but is silent on wherein the upper blood oxygen concentration alarm threshold and/or the lower blood oxygen concentration alarm threshold is/are determined based on an amount of a change in the target oxygen concentration.
However, Tehrani teaches four upper and lower blood oxygen concentration alarm thresholds (par. 0047, “four threshold values are defined for S.sub.pO2 and they are set at 90%, 93%, 95%, and 97%”; see Fig. 3c step 230, alarm is generated when the data is out of range), wherein the upper blood oxygen concentration alarm threshold and/or the lower blood oxygen concentration alarm threshold is/are determined based on an amount of a change in the target oxygen concentration (Fig 3c-3e, step 224, 232, 254, 260; SpO2 value is compared to different upper/lower blood oxygen concentration threshold; par. 0052, step 228, F.sub.IO2 is increased stepwise) (Examiner Notes: The prior art describe a system comprising of multiple ranges of blood oxygen concentration alarm thresholds, a change in the target oxygen concentration will affect the blood oxygen level, therefore affecting the corresponding upper/lower threshold, see par. 0052-0060). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known apparatus of Brown, with the upper and lower blood oxygen concentration alarm threshold of Tehrani, for adaptive control of the threshold based on FiO2 level and avoid hypoxemia and hyperoxemia as taught by Tehrani (Tehrani, par. 0060).
Regarding Claim 10, the modified Brown discloses the respiratory assistance apparatus of claim 6, but is silent on wherein the upper blood oxygen concentration alarm threshold and/or the lower blood oxygen concentration alarm threshold is/are determined based on the target oxygen concentration.
However, Tehrani teaches four upper and lower blood oxygen concentration alarm thresholds (par. 0047, “four threshold values are defined for S.sub.pO2 and they are set at 90%, 93%, 95%, and 97%”; see Fig. 3c step 230, alarm is generated when the data is out of range), wherein the upper blood oxygen concentration alarm threshold and/or the lower blood oxygen concentration alarm threshold is/are determined based on the target oxygen concentration (Fig 3c-3e, step 224, 232, 254, 260; SpO2 value is compared to different upper/lower blood oxygen concentration threshold; Fig. 3f, step 266, target FiO2 is calculated) (Examiner Notes: The prior art describe a system comprising of multiple ranges of blood oxygen concentration alarm thresholds, a target oxygen concentration will affect the blood oxygen level, therefore affecting the corresponding upper/lower threshold, see par. 0052-0060). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known apparatus of Brown, with the upper and lower blood oxygen concentration alarm threshold of Tehrani, for adaptive control of the threshold based on FiO2 level and avoid hypoxemia and hyperoxemia as taught by Tehrani (Tehrani, par. 0060).
Regarding Claim 11, the modified Brown discloses the respiratory assistance apparatus of claim 6, but is silent on wherein the upper blood oxygen concentration alarm threshold and/or the lower blood oxygen concentration alarm threshold is/are determined based on a current oxygen concentration of gas.
However, Tehrani teaches four upper and lower blood oxygen concentration alarm thresholds (par. 0047, “four threshold values are defined for S.sub.pO2 and they are set at 90%, 93%, 95%, and 97%”; see Fig. 3c step 230, alarm is generated when the data is out of range), wherein the upper blood oxygen concentration alarm threshold and/or the lower blood oxygen concentration alarm threshold is/are determined based on a current oxygen concentration of gas (Fig 3c-3e, step 224, 232, 254, 260; SpO2 value is compared to different upper/lower blood oxygen concentration threshold; Fig. 3a, step 202, initial value of FiO2 is set) (Examiner Notes: The prior art describe a system comprising of multiple ranges of blood oxygen concentration alarm thresholds, an initial oxygen concentration is set as the current oxygen concentration during the initial loop will affect the blood oxygen level, therefore affecting the corresponding upper/lower threshold, see par. 0052-0060). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known apparatus of Brown, with the upper and lower blood oxygen concentration alarm threshold of Tehrani, for adaptive control of the threshold based on FiO2 level and avoid hypoxemia and hyperoxemia as taught by Tehrani (Tehrani, par. 0060).
Regarding Claim 17, the modified Brown discloses the respiratory assistance apparatus of claim 6, but is silent on wherein the upper blood oxygen concentration alarm threshold and/or the lower blood oxygen concentration alarm threshold is/are determined based on a difference between the target oxygen concentration and an upper target oxygen concentration.
However, Tehrani teaches four upper and lower blood oxygen concentration alarm thresholds (par. 0047, “four threshold values are defined for S.sub.pO2 and they are set at 90%, 93%, 95%, and 97%”; see Fig. 3c step 230, alarm is generated when the data is out of range), wherein the upper blood oxygen concentration alarm threshold and/or the lower blood oxygen concentration alarm threshold is/are determined based on a difference between the target oxygen concentration and an upper target oxygen concentration (Fig 3c-3e, step 224, 232, 254, 260; SpO2 value is compared to different upper/lower blood oxygen concentration threshold; Fig. 3f, step 274, 276, a required FiO2 is calculated and compared to an upper FiO2 concentration) (Examiner Notes: The prior art describe a system comprising of multiple ranges of blood oxygen concentration alarm thresholds, a different between the target oxygen concentration and an upper target oxygen concentration will affect the blood oxygen level, therefore affecting the corresponding upper/lower threshold, see par. 0052-0060). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known apparatus of Brown, with the upper and lower blood oxygen concentration alarm threshold of Tehrani, for adaptive control of the threshold based on FiO2 level and avoid hypoxemia and hyperoxemia as taught by Tehrani (Tehrani, par. 0060).
Claim(s) 113 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown, in view of Hardman, in view of Baker, further in view of Kinsky et al. (US10589045), hereafter Kinsky.
Regarding Claim 113, the modified Brown discloses the respiratory assistance apparatus of claim 111, but is silent on wherein the oxygen efficiency of the patient is received as an input for determining the target oxygen concentration of the breathing gases.
However, Kinsky discloses an algorithm for calculating desired oxygen concentration of a breathing gas (Abstract, “the algorithm controls FiO2 using the SpO2”), using an oxygen efficiency of the patient (Abstract, “a ratio of SpO2-to FiO2 (S/.sub.CLCF)”), wherein the oxygen efficiency of the patient is received as an input for determining the target oxygen concentration of the breathing gases (col. 7, line 1-7, “the FiO2 adjustment algorithm 120 in the oxygen delivery system 112… use the S/.sub.CLCF ratio and the rate of change of the S/.sub.CLCF ratio ((Δ(S/.sub.CLCF)/Δt)) to control FiO2 provided to the patient as well”) (Examiner Notes: The prior art uses the oxygen efficiency to adjust the concentration of the breathing gas, a target oxygen concentration inherently exists in the process). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known apparatus of Brown, with the algorithm of Kinsky to determine the target oxygen concentration of the breathing gas, for less hypoxia and hyperoxia as taught by Kinsky (Kinsky, col. 4, line 51-53).
Claim(s) 115 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown, in view of Hardman, in view of Baker, further in view of Amjad et al. (US20110290252), hereafter Amjad.
Regarding Claim 115, the modified Brown discloses the respiratory assistance apparatus of claim 114, wherein stored breathing gases oxygen concentrations of the stored breathing gases oxygen concentration data includes historical data (Brown, par. 0028, “the predicted next measured S.sub.pO.sub.2 value is based on the patient's history-based ARPs”; par. 0026, “these ARPs… current F.sub.iO.sub.2, current S.sub.pO.sub.2, recent trend of each, current trend of each”), but is silent on stored breathing gases oxygen concentrations of the stored breathing gases oxygen concentration data are weighted based on an associated timestamp.
However, Amjad teaches a system for controlling blood oxygen concentration (Abstract), comprising of stored breathing gas oxygen concentration (Fig. 25, FiO2 vs. Time graph), wherein stored breathing gases oxygen concentrations of the stored breathing gases oxygen concentration data are weighted based on an associated timestamp (Fig.4, par. 0099, Kalman filter; par. 0134, “The FiO.sub.2 from the simulated model and the modified control, u.sub.EKF, that was used by the PE-EKF can be seen in FIG. 25”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known apparatus of Brown, and weight the stored breathing gases oxygen concentration with the EFK filter of Amjad, to minimize estimation error as taught by Amjad (Amjad, par. 0099).
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks, filed 04/28/2026, with respect to the rejection of Claims 8-11 and 17 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejection of claims 8-11 and 17 under 35 U.S.C. 112(a) has been withdrawn.
Applicant’s arguments with respect to the amendment made in claim 1 under U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Claim 1 is rejected further in view of Baker, which teaches calculating patient’s blood oxygen value based on a time from when the oxygen gas concentration is controlled.
Applicant further argues that the Hardman equation cannot be utilized to reject claim 1. However, Claim 1 generally recites calculating an estimated blood oxygen concentration based on a difference between an initial oxygen concentration of the breathing gases and the target oxygen concentration of the breathing gases. The Hardman equation shows that such difference has an impact on the blood oxygen level. One of ordinary skilled in the art would be capable of acknowledging the effect of such difference taught by Hardman, and incorporating such difference into the calculation. Since Brown already discloses calculating a future value of the blood oxygen. Therefore, applicant’s arguments regarding the Hardman equation is not persuasive.
Conclusion
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/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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