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 .
Response to Amendment
The amendment filed 3/9/2026 has been entered. Claims 1-9 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lagerborg et al. (US 8646448 B2), hereafter Lagerborg, in view of Euliano (US 20210016035 A1).
Regarding claim 1, Lagerborg discloses a computer-implemented method for detecting onset of a spontaneous breath by a patient coupled to a ventilation system, comprising: receiving, at a processor (control unit 9; Fig. 1), a pressure signal from a pressure sensor and/or a flow signal from a flow sensor, respectively, coupled to a portion of a breathing circuit coupled to an airway of the patient (ventilator triggering uses airway inspiratory flow or pressure; col. 3 ln 50-51); receiving, at the processor, signals from one or more sensors coupled to the patient that measure different physiological parameters from the pressure sensor and the flow sensor (ventilator triggering also uses EMG signals; col. 3 ln 50-51); detecting, via the processor, the onset of the spontaneous breath by the patient based on the pressure signal and/or the flow signal (step S61, ventilate in a support mode, such as pressure support or volume support mode, which uses pressure/flow signals for pneumatic triggering; Fig. 6, col. 1 ln 10-16, col. 3 ln 4-29, col. 5 ln 29-39, col. 5 ln 58-col. 6 ln 4); synchronizing, via the processor, providing breathing support to the patient via the ventilation system with the onset of the spontaneous breath detected utilizing the pressure signal and/or the flow signal (step S61, ventilate in a support mode, such as pressure support or volume support mode, which uses pressure/flow signals for pneumatic triggering; Fig. 6, col. 1 ln 10-16, col. 3 ln 50-51, col. 5 ln 29-39, col. 5 ln 58-col. 6 ln 4); while utilizing the pressure signal and/or the flow signal to synchronize providing breathing support, determining whether EMG signal is synchronized with the patient’s breathing activity (while ventilating in a pneumatic support mode, EMG signal is monitored for synchrony; Fig. 6, col. 5 ln 29-col. 6 ln 4); after determining synchrony, switching to: detecting, via the processor, the onset of the spontaneous breath by the patient based on the signals from the one or more sensors (if synchrony is determined, switch to EMG controlled mode for ventilation; Fig. 6, col. 5 ln 62-67); and synchronizing, via the processor, providing breathing support to the patient via the ventilation system with the onset of the spontaneous breath detected utilizing the signals from the one or more sensors (if synchrony is determined, switch to EMG controlled mode for ventilation; Fig. 6, col. 5 ln 62-67).
Lagerborg does not disclose calibrating, via the processor, parameters and thresholds to be utilized in detecting the onset of the spontaneous breath based on the signals from the one or more sensors and switching to detecting and synchronizing based on the signals from the one or more sensors after calibration.
Euliano teaches calibrating a sensor before using the sensor to determine triggering (a short duration of Pes sensor measurement can be used to calibrate a non-invasive measurement to be used in determining asynchrony and triggering; par. 0105) for the purpose of improving the performance and accuracy of the sensor (“Using a Pes sensor as a spot check or to calibrate the non-invasive measurement can dramatically improve the performance of the estimate and the clinician's trust of its accuracy”, par. 0105).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Lagerborg to comprise calibrating a sensor prior to using the sensor as taught by Euliano for the purpose of improving the performance and accuracy of the sensor (Euliano par. 0105).
Regarding claim 2, the modified Lagerborg discloses the method of claim 1 (shown above), comprising: in response to a change in a patient's physiological parameter exceeding a specific threshold, switching from synchronizing providing breathing support to the patient via the ventilation system with the onset of the spontaneous breath detected utilizing the signals from the one or more sensors to (if asynchrony is detected based on relationships between inspiratory and expiratory phases or respiratory rate difference exceeding a threshold, switch from EMG controlled mode to pressure support; Lagerborg Fig. 4, col. 4 ln 16-col. 5 ln 21): detecting, via the processor, the onset of the spontaneous breath by the patient based on the pressure signal and/or the flow signal (switch to pressure support; Lagerborg Fig. 4); synchronizing, via the processor, providing breathing support to the patient via the ventilation system with the onset of the spontaneous breath detected utilizing the pressure signal and/or the flow signal (switch to pressure support; Lagerborg Fig. 4); and while utilizing pressure signal and/or the flow signal to synchronize providing breathing support, recalibrating, via the processor, the parameters and the thresholds (significant changes in sensor data leads to calibration check; Euliano par. 0105).
Regarding claim 4, the modified Lagerborg discloses the method of claim 1 (shown above), wherein the one or more sensors comprises a plurality of electromyography (EMG) sensors (catheter 5 carries multiple electrodes to record EMG signal; Lagerborg Fig. 1, col. 2 ln 59-col. 3 ln 3).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lagerborg in view of Euliano as applied to claim 1 above, and further in view of Strom (US 5937853 A).
Regarding claim 3, the modified Lagerborg discloses the method of claim 1 (shown above), comprising: switching from synchronizing providing breathing support to the patient via the ventilation system with the onset of the spontaneous breath detected utilizing the signals from the one or more sensors (switch from EMG controlled mode to pressure support; Lagerborg Fig. 4, col. 4 ln 16-col. 5 ln 21) to: detecting, via the processor, the onset of the spontaneous breath by the patient based on the pressure signal and/or the flow signal (step S61, ventilate in a support mode, such as pressure support or volume support mode, which uses pressure/flow signals for pneumatic triggering; Lagerborg Fig. 6, col. 1 ln 10-16, col. 3 ln 50-51, col. 5 ln 29-39, col. 5 ln 58-col. 6 ln 4); synchronizing, via the processor, providing breathing support to the patient via the ventilation system with the onset of the spontaneous breath detected utilizing the pressure signal and/or the flow signal (step S61, ventilate in a support mode, such as pressure support or volume support mode, which uses pressure/flow signals for pneumatic triggering; Lagerborg Fig. 6, col. 1 ln 10-16, col. 3 ln 50-51, col. 5 ln 29-39, col. 5 ln 58-col. 6 ln 4); and while utilizing pressure signal and/or the flow signal to synchronize providing breathing support, recalibrating, via the processor, the parameters and the thresholds (significant changes in sensor data leads to calibration check; Euliano par. 0105).
The modified Lagerborg does not disclose after a set period of time, switching to detecting and synchronizing based on the pressure and/or flow signal.
Strom teaches a ventilator that switches to a different mode after a set period of time (ventilator switches operating modes after apnea of a predetermined length of time; col. 2 ln 48-57) for the purpose of obtaining sufficient ventilation of the patient (col. 2 ln 52-57).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify Lagerborg to switch modes after a set period of time as taught by Strom for the purpose of obtaining sufficient ventilation of the patient (Strom col. 2 ln 52-57).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lagerborg in view of Euliano as applied to claim 4 above, and further in view of Sinderby et al. (US 10517528 B2), hereafter Sinderby.
Regarding claim 5, the modified Lagerborg discloses the method of claim 4 (shown above).
The modified Lagerborg does not disclose wherein the plurality of EMG sensors comprises a first surface EMG sensor disposed on the patient adjacent upper airway muscles and a second surface EMG sensor disposed on the patient adjacent intercostal space.
Sinderby teaches non-invasive sensors for detecting inspiratory muscle activity can be placed adjacent upper airway muscles (sensors for detecting muscle activity synchronized with inspiratory effort can be applied to neck muscles such as the scalenes and sternocleidomastoids; col. 5 ln 15-45) and adjacent intercostal space (sensors can be placed on the thorax at the costal portions of the diaphragm, the external intercostals, and the serratus anterior muscles; col. 5 ln 31-45) for the purpose of avoiding the use of invasive sensors (col. 3 ln 18-28).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Lagerborg to use surface EMG sensors disposed on the patient adjacent upper airway muscles and intercostal space as taught by Sinderby for the purpose of avoiding the use of invasive sensors (Sinderby col. 3 ln 18-28).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lagerborg in view of Euliano as applied to claim 1 above, and further in view of Eger (US 20230001117 A1).
Regarding claim 6, the modified Lagerborg discloses the method of claim 1 (shown above).
The modified Lagerborg does not disclose wherein the one or more sensors comprises one or more of a piezoelectric sensor, an electrocardiogram sensor, and an ultrasound sensor.
Eger teaches an ultrasound sensor can be used as an alternative to an EMG sensor in detecting activation of the muscle caused by spontaneous breathing effort (par. 0137).
The substitution of one known element for another would have been obvious to one having ordinary skill in the art before the effective filing date of the invention since the substitution of one known sensor (the ultrasound sensor of Eger) for another (the EMG sensor of Lagerborg) would have yielded predictable results, namely, detecting activation of the muscle caused by spontaneous breathing effort. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Lagerborg as taught by Eger since the courts have held that simple substitution of one known element for another to obtain predictable results supports a conclusion of obviousness. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lagerborg in view of Euliano as applied to claim 1 above, and further in view of McWilliams (US 5513631 A).
Regarding claim 7, the modified Lagerborg discloses the method of claim 1 (shown above), wherein the one or more sensors comprises a plurality of sensors (catheter 5 carries multiple electrodes to record EMG signal; Lagerborg Fig. 1, col. 2 ln 59-col. 3 ln 3).
The modified Lagerborg does not disclose wherein detecting the onset of the spontaneous breath by the patient based on the signals from the one or more sensors comprises separately detecting the onset of the spontaneous breath in respective signals from the plurality of sensors.
McWilliams teaches triggering a ventilator based on separately detecting the onset of the spontaneous breath in respective signals from the plurality of sensors (a nasal sensor to detect movement of the nostrils indicative of spontaneous breath, col. 2 ln 22-47; a second sensor can be an electrical sensor used to measure muscle contraction in a muscle associated with breathing to measure initiation of spontaneous breath, col. 4 ln 46-64) for the purpose of providing the most reliable triggering and synchronization of the ventilator and spontaneous breathing (abstract ln 3-13).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify Lagerborg to separately detect the onset of the spontaneous breath in respective signals from the plurality of sensors as taught by McWilliams for the purpose of providing the most reliable triggering and synchronization of the ventilator and spontaneous breathing (McWilliams abstract ln 3-13).
Regarding claim 8, the modified Lagerborg discloses the method of claim 7 (shown above), wherein detecting the onset of the spontaneous breath separately in respective signals comprises utilizing a different onset detection algorithm for each respective signal to determine the onset of the spontaneous breath (onset of spontaneous breath is detected using a nasal movement sensor and a secondary sensor such as an electrical sensor measuring muscle contraction; McWilliams col. 2 ln 22-33, col. 4 ln 46-64, examiner notes: one of ordinary skill in the art would understand that two different algorithms would be used for the two different sensors providing two different signals).
Regarding claim 9, the modified Lagerborg discloses the method of claim 7 (shown above), wherein providing breathing support occurs upon separately detecting the onset of the spontaneous breath in at least two signals from the plurality of sensors (when a nasal flare is detected by the nasal sensor and a breathing initiation is detected by the second sensor, the ventilator is triggered, McWilliams col. 7 ln 15-26).
Response to Arguments
Applicant's arguments filed 3/9/2026 have been fully considered but they are not persuasive.
Regarding claims 1 and 2, Applicant argues that Euliano does not teach using a pressure/flow signal to synchronize breathing support. However, Euliano was not relied upon to teach this limitation. As shown in the rejection above, Lagerborg discloses switching from an EMG-controlled mode to a support mode when asynchrony is detected (Lagerborg Fig. 4, col. 4 ln 16-col. 5 ln 21). Further, Lagerborg teaches the desire to switch back to the EMG-controlled mode (Lagerborg Fig. 6, col. 5 ln 62-67). Euliano teaches calibrating an EMG sensor before using the EMG sensor for triggering (Euliano par. 0105). This would have educated Lagerborg to include the claimed limitations because it would have been obvious to ensure that the EMG-controlled mode will be properly synchronized before switching back to the EMG-controlled mode for the purpose of avoiding asynchrony.
Applicant further argues that the esophageal pressure measurement of Euliano does not occur on a portion of a breathing circuit coupled to an airway of the patient. However, Euliano is not relied upon to teach this limitation. Lagerborg teaches ventilating in a pressure support mode using airway inspiratory flow or pressure (Lagerborg col. 3 ln 50-51, as cited in the rejection above).
Regarding claim 3, Applicant argues that Lagerborg, in view of Euliano, in view of Strom, does not disclose recalibrating after a set period of time. However, Strom teaches that after a set period of time (of apnea), it is desirable for the ventilator to switch modes to maintain sufficient ventilation. Lagerborg, in view of this, would have recognized that switching modes after a set period of time (of apnea) would be advantageous to maintain sufficient ventilation of the patient. Applicant argues that a set period of time of apnea is not a general set period of time. However, the claim recites “a set period of time” which does not require a general set period of time.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/K.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785