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
This office action is responsive to the amendment filed on 10/24/2025. As directed by the
amendment: claims 1, 5, 6, 7, 12, 13, 14, 15, 18, and 19 have been amended, no claims have been canceled, and no new claims have been added. Thus, claims 1-20 are presently pending in the application.
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.
Claims 1-10 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Blanch (US 20140171817 A1) in view of Euliano (US 20210016035 A1) and Novotni (US 20150217069 A1).
Regarding claim 1, Blanch discloses a device (Shown by the embodiment depicted in FIG. 1 as set forth in [0058]) for determining an indicator of an intrinsic end-expiratory pressure in lungs of a patient (FIG. 1 is an apparatus for detecting and quantifying intrinsic positive end-expiratory pressure of a respiratory patient breathing with the assistance of a ventilator set forth in the abstract, [0032] and [0058]), the device comprising: an interface configuration (FIG. 1 Controller 26 set forth in [0058]) comprising one or more interfaces configured for an exchange of information with a ventilation device; and a control unit (FIG. 1 Central processing unit CPU set forth in [0104]) configured: to determine first information on a first breathing pressure (Lung pressure Pl set forth in [0090]-[0091]) generated by muscles of the patient, at a first time (tonset set forth in [0091] at inhalation onset), at which an inhalation attempt (Inhalation onset set forth in [0067]-[0068] and [0091]) of the patient is present; to determine second information on a second breathing pressure (Lung pressure Pl set forth in [0090] at zero flow) generated by the muscles of the patient, at a second time (tend set forth in [0091]) at which breathing gas flow towards the patient starts (Location at zero flow set forth in [0090] and when flow towards the patient starts as shown in FIG. 3 below); and to determine the indicator of the intrinsic end-expiratory pressure based on the first information and based on the second information (Set forth in [0090] and shown by the formula below).
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Blanch fails to explicitly disclose, wherein the device is configured to receive an electromyographic signal representing patient muscle activity, and wherein at least the first information at the first time, at which an inhalation attempt of the patient is present, is determined from the electromyographic signal.
However, Euliano teaches wherein the device is configured to receive an electromyographic signal representing patient muscle activity and wherein alternative means for determining the pressure representing patient muscle activity outside of a direct pressure sensor can be utilized, including an EMG of the inspiratory muscles and/or diaphragm (Euliano: As set forth in [0105]).
Blanch and Euliano are both considered to be analogous to the claimed invention because they are in the same field of ventilation devices provided with means for patient monitoring. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified data acquisition for determining “the first and second information” of Blanch to incorporate the teaching of Euliano and include wherein the device is configured to receive an electromyographic signal representing patient muscle activity and wherein alternative means for determining the pressure representing patient muscle activity outside of a direct pressure sensor can be utilized, including an EMG of the inspiratory muscles and/or diaphragm (Euliano: As set forth in [0105]). Doing so would provide the device with an alternative non-invasive means for estimating pressure generated by the muscles of the patient in a circumstance where maintaining the accuracy of a pressure sensor may be difficult (Euliano: As set forth in [0105]).
Blanch as modified fails to explicitly disclose, wherein the control unit is configured to calibrate the determination of the iPEEP based on a measurement of the ventilation device during an occlusion during a ventilation of the patient.
However, Novotni teaches wherein the determination of the indicator of the intrinsic end-expiratory pressure in lungs of the patient based on a measurement of the ventilation device during an occlusion (Novotni: On the basis of an occlusion effected at the end of the expiration phase or at the end of the inspiration phase, and the new PEEP can then be determined as set forth in [0022]).
Blanch and Novotni are both considered to be analogous to the claimed invention because they are in the same field of breath analyzers for users being ventilated. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blanch to incorporate the teaching of Novotni and include wherein the determination of the indicator of the of indicator of the intrinsic end-expiratory pressure in lungs of the patient based on a measurement of the ventilation device during an occlusion (Novotni: On the basis of an occlusion effected at the end of the expiration phase or at the end of the inspiration phase, and the new PEEP can then be determined). Doing so would result in a more precise intrinsic end-expiratory pressure (Novotni: Set forth in [0022]).
Regarding claim 2, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch further discloses a device, further comprising a sensor arrangement comprising one or more sensors (FIG. 1 Flow, pressure, CO2 sensors 14) for detecting measured values during a ventilation of a patient.
Regarding claim 3, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch further discloses a device, wherein the control unit is configured to detect measured pressure values (FIG. 1 Sensors 14 measure the flow, pressure, and partial pressure of carbon dioxide in the gases that pass to and from the patient, creating signals 18 that are preprocessed in signal processor 20, processed in a parameter extraction module 22 and modeled by a neural network 24, all part of the CPU as set forth in [0058]) during a ventilation of the patient.
Regarding claim 4, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch further discloses a device, wherein the determination of the indicator comprises determining one or more of: a difference or a weighted difference between breathing pressure caused by muscle activity of the patient at the first time and breathing pressure caused by muscle activity of the patient at the second time (Difference of a breathing pressure at a first and second time is shown by the formula below as set forth in [0091]).
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Regarding claim 5, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch further discloses a device, wherein the determination of the indicator further comprises a sorting of measured pressure values from a plurality of breathing phases (A value for PEEPi is predicted by using the measured airway parameters and in a linear multiple regression model or nonlinear multiple regression modeling set forth in [0059]).
Regarding claim 6, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch as modified by Euliano further teaches a device, wherein the determination of the first information and of the second information is based on the electromyographic signal and comprises an estimation of the breathing pressure generated by muscle activity of the patient based on based on the electromyographic signals (FIG. 1 Sensors 14 measure airway pressure Paw set forth in [0087], which is used to determine lung pressures Pl set forth in [0090]-[0091] at tonset and tend times; As modified for claim 1 above, the device is configured to receive an electromyographic signal representing patient muscle activity and wherein alternative means for determining the pressure representing patient muscle activity outside of a direct pressure sensor can be utilized, including an EMG of the inspiratory muscles and/or diaphragm (Euliano: As set forth in [0105]).
Regarding claim 7, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch further discloses a device, wherein the control unit is configured to receive one or more of: information on an airway pressure generated at the patient from a ventilation device currently ventilating the patient (FIG. 1 Sensors 14 are provided such as an airway flow and pressure sensor attached to the circuit such as at the y-piece of the standard ventilator circuit); information on a tidal volume from a ventilation device currently ventilating the patient: and information on a tidal volume flow from a ventilation device currently ventilating the patient.
Regarding claim 8, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch further discloses a device, wherein the determination of the first information comprises an estimation of the first time (tonset set forth in [0091] at inhalation onset) based on a starting of a breathing gas flow, in a direction of the patient, generated by the muscles of the patient (Inhalation onset can be detected by a flow onset marker as set forth in [0091]).
Regarding claim 9, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch further discloses a device, wherein the determination of the first information comprises one or more of: an estimation of the first time based on a patient breathing effort signal passing through a threshold value; and an estimation of the first time based on a starting of a spontaneous breathing of the patient (Input data used by the invention includes the “flow onset” as set forth in [0035], flow onset indicates the start of a spontaneous breath, where the patient is making an inhalation effort set forth in [004]).
Regarding claim 10, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch further discloses a device, wherein the determination of the second information comprises an estimation of the second time (tend set forth in [0091]) based on a starting of a breathing gas flow in the direction of the patient (Location at zero flow set forth in [0090] and when flow towards the patient starts as shown in FIG. 3 below).
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Regarding claim 12, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch as modified by Novotni further teaches wherein the control unit is configured to calibrate the determination of the indicator of the intrinsic end-expiratory pressure in lungs of the patient based on a measurement of the ventilation device during occlusions (Novotni: On the basis of an occlusion effected at the end of the expiration phase or at the end of the inspiration phase, and the new PEEP can then be determined as set forth in [0022]) with the occlusions and associated measurements of the ventilation device taking place at regular intervals during the ventilation of the patient and with the occlusions being interspersed between successive determinations of the iPEEP based on the first information and based on the second information (Novotni: The device proceeds such that, at the end of each breathing cycle, a preliminary value for the PEEP and/or the maximum airway pressure is determined in the subsequent breathing cycle by way of the gas flow in the airway at the end of the expiration phase and/or at the end of the inspiration phase, and if the preliminary value for the PEEP and/or the maximum airway pressure in the subsequent breathing cycle differs from the set value for the PEEP and/or the maximum airway pressure by a predetermined threshold value or more, a brief occlusion is performed in the subsequent breathing cycle, and a new value for the PEEP and/or the maximum airway pressure will be determined as set forth in [0026]).
Regarding claim 13, Blanch discloses a ventilation device comprising: a ventilator (Set forth in the abstract) configured to ventilate a patient during a ventilation; and a device (Shown by the embodiment depicted in FIG. 1 as set forth in [0058]) for determining an indicator of an intrinsic end-expiratory pressure in lungs of a patient (FIG. 1 is an apparatus for detecting and quantifying intrinsic positive end-expiratory pressure of a respiratory patient breathing with the assistance of a ventilator set forth in the abstract, [0032] and [0058]), the device comprising: an interface configuration (FIG. 1 Controller 26 set forth in [0058]) comprising one or more interfaces configured for an exchange of information with the ventilator; and a control unit (FIG. 1 Central processing unit CPU set forth in [0104]) configured: to determine first information on a first breathing pressure (Lung pressure Pl set forth in [0090]-[0091]) generated by muscles of the patient, at a first time (tonset set forth in [0091] at inhalation onset), at which an inhalation attempt (Inhalation onset set forth in [0067]-[0068] and [0091]) of the patient is present; to determine second information on a second breathing pressure (Lung pressure Pl set forth in [0090] at zero flow) generated by the muscles of the patient, at a second time (tend set forth in [0091]) at which breathing gas flow towards the patient starts during the ventilation (Location at zero flow set forth in [0090] and when flow towards the patient starts as shown in FIG. 3 below); and to determine, during the ventilation, the indicator of the intrinsic end-expiratory pressure based on the first information and based on the second information (Set forth in [0090] and shown by the formula below).
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Blanch fails to explicitly disclose, wherein the ventilator is configured to receive an electromyographic signal representing patient muscle activity during the ventilation and wherein the first and second information are from the electromyographic signal
However, Euliano teaches wherein the device is configured to receive an electromyographic signal representing patient muscle activity and wherein alternative means for determining the pressure representing patient muscle activity outside of a direct pressure sensor can be utilized, including an EMG of the inspiratory muscles and/or diaphragm (Euliano: As set forth in [0105]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified data acquisition for determining “the first and second information” of Blanch to incorporate the teaching of Euliano and include wherein the device is configured to receive an electromyographic signal representing patient muscle activity and wherein alternative means for determining the pressure representing patient muscle activity outside of a direct pressure sensor can be utilized, including an EMG of the inspiratory muscles and/or diaphragm (Euliano: As set forth in [0105]). Doing so would provide the device with an alternative non-invasive means for estimating pressure generated by the muscles of the patient in a circumstance where maintaining the accuracy of a pressure sensor may be difficult (Euliano: As set forth in [0105]).
Blanch as modified fails to explicitly disclose, wherein the control unit is configured to calibrate the determination of the iPEEP based on a measurement of the ventilation device during an occlusion during a ventilation of the patient.
However, Novotni teaches wherein the determination of the indicator of the intrinsic end-expiratory pressure in lungs of the patient based on a measurement of the ventilation device during an occlusion (Novotni: On the basis of an occlusion effected at the end of the expiration phase or at the end of the inspiration phase, and the new PEEP can then be determined as set forth in [0022]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blanch to incorporate the teaching of Novotni and include wherein the determination of the indicator of the of indicator of the intrinsic end-expiratory pressure in lungs of the patient based on a measurement of the ventilation device during an occlusion (Novotni: On the basis of an occlusion effected at the end of the expiration phase or at the end of the inspiration phase, and the new PEEP can then be determined). Doing so would result in a more precise intrinsic end-expiratory pressure (Novotni: Set forth in [0022]).
Regarding claim 14, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Blanch further discloses a ventilation device, further comprising a sensor arrangement comprising one or more sensors (FIG. 1 Flow, pressure, CO2 sensors 14) for detecting measured values during a ventilation of a patient.
Regarding claim 15, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Blanch further discloses a ventilation device, wherein the control unit is configured to detect measured pressure values (FIG. 1 Sensors 14 measure the flow, pressure, and partial pressure of carbon dioxide in the gases that pass to and from the patient, creating signals 18 that are preprocessed in signal processor 20, processed in a parameter extraction module 22 and modeled by a neural network 24, all part of the CPU as set forth in [0058]) or measured pressure signals during a ventilation of the patient.
Regarding claim 16, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Blanch further discloses a ventilation device, wherein the determination of the indicator comprises determining one or more of: a difference or a weighted difference between breathing pressure caused by muscle activity of the patient at the first time and breathing pressure caused by muscle activity of the patient at the second time (Difference of a breathing pressure at a first and second time is shown by the formula below as set forth in [0091]); and a quotient or a weighted quotient of breathing pressure generated by muscle activity of the patient at the first time and breathing pressure caused by muscle activity of the patient at the second time.
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Regarding claim 17, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Blanch further discloses a ventilation device, wherein the determination of the indicator comprises a sorting of measured pressure values from a plurality of breathing phases (A value for PEEPi is predicted by using the measured airway parameters and in a linear multiple regression model or nonlinear multiple regression modeling set forth in [0059]).
Regarding claim 18, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Blanch as modified by Euliano further teaches a ventilation device, wherein the determination of the first information and of the second information from the electromyographic signal comprises an estimation of the breathing pressure generated by muscle activity of the patient based on an airway pressure generated at the patient (FIG. 1 Sensors 14 measure airway pressure Paw set forth in [0087]), which is used to determine lung pressures Pl set forth in [0090]-[0091] at tonset and tend times; As modified for claim 1 above, the device is configured to receive an electromyographic signal representing patient muscle activity and wherein alternative means for determining the pressure representing patient muscle activity outside of a direct pressure sensor can be utilized, including an EMG of the inspiratory muscles and/or diaphragm (Euliano: As set forth in [0105])).
Regarding claim 19, Blanch discloses a process for determining an indicator of an intrinsic end-expiratory pressure in the lungs of a patient, the process comprising the steps of: ventilating a patient with a ventilator device (Abstract); determining first information on a first breathing pressure generated by muscle activity of the patient (FIG. 1 is an apparatus for detecting and quantifying intrinsic positive end-expiratory pressure of a respiratory patient breathing with the assistance of a ventilator set forth in the abstract, [0032] and [0058]) at a first time (tonset set forth in [0091] at inhalation onset), at which an inhalation attempt (Inhalation onset set forth in [0067]-[0068] and [0091]) of the patient is present; determining second information on a second breathing pressure (Lung pressure Pl set forth in [0090] at zero flow) generated by muscle activity of the patient at a second time (tend set forth in [0091]), at which a breathing gas flow towards the patient starts during the ventilation of the patient (Location at zero flow set forth in [0090] and when flow towards the patient starts as shown in FIG. 3 below); determining the indicator of the an intrinsic end-expiratory pressure based on the first information and based on the second information (Set forth in [0090] and shown by the formula below).
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Blanch fails to explicitly disclose, wherein the ventilator is configured to receive an electromyographic signal representing patient muscle activity during the ventilation and wherein the first and second information are from the electromyographic signal
However, Euliano teaches wherein the device is configured to receive an electromyographic signal representing patient muscle activity and wherein alternative means for determining the pressure representing patient muscle activity outside of a direct pressure sensor can be utilized, including an EMG of the inspiratory muscles and/or diaphragm (Euliano: As set forth in [0105]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified data acquisition for determining “the first and second information” of Blanch to incorporate the teaching of Euliano and include wherein the device is configured to receive an electromyographic signal representing patient muscle activity and wherein alternative means for determining the pressure representing patient muscle activity outside of a direct pressure sensor can be utilized, including an EMG of the inspiratory muscles and/or diaphragm (Euliano: As set forth in [0105]). Doing so would provide the device with an alternative non-invasive means for estimating pressure generated by the muscles of the patient in a circumstance where maintaining the accuracy of a pressure sensor may be difficult (Euliano: As set forth in [0105]).
Blanch as modified fails to explicitly disclose, wherein the control unit is configured to calibrate the determination of the iPEEP based on a measurement of the ventilation device during an occlusion during a ventilation of the patient.
However, Novotni teaches wherein the determination of the indicator of the of indicator of the intrinsic end-expiratory pressure in lungs of the patient based on a measurement of the ventilation device during an occlusion (Novotni: On the basis of an occlusion effected at the end of the expiration phase or at the end of the inspiration phase, and the new PEEP can then be determined as set forth in [0022]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blanch to incorporate the teaching of Novotni and include wherein the determination of the indicator of the intrinsic end-expiratory pressure in lungs of the patient based on a measurement of the ventilation device during an occlusion (Novotni: On the basis of an occlusion effected at the end of the expiration phase or at the end of the inspiration phase, and the new PEEP can then be determined). Doing so would result in a more precise intrinsic end-expiratory pressure (Novotni: Set forth in [0022]).
Regarding claim 20, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 19 above.
Blanch further discloses a process, wherein a computer program with a program code performs at least some of the process steps when the program code is executed on a computer, on a processor or on a programmable hardware component (Steps are implemented as a computer program product with a computer-readable medium having code thereon. The program product includes a program and a signal bearing media bearing the program as set forth in [0042]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Blanch (US 20140171817 A1) in view of Euliano (US 20210016035 A1) and Novotni (US 20150217069 A1) as applied to claim 1, in further view of Verhoeven (US 20210022642 A1).
Regarding claim 11, Blanch as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Blanch does not explicitly disclose a device, wherein the control unit is configured to obtain an improved indicator of the indicator of the intrinsic end-expiratory pressure in lungs of the patient by one or more of: averaging a plurality of indicators of the intrinsic end-expiratory pressure in lungs of the patient determined sequentially in time: smoothing a plurality of indicators of the intrinsic end-expiratory pressure in lungs of the patient determined sequentially in time: and suppressing outliers of a plurality of indicators of the intrinsic end-expiratory pressure in lungs of the patient determined sequentially in time: and determining a median from a plurality of indicators of the intrinsic end-expiratory pressure in lungs of the patient determined sequentially in time.
However, Verhoeven teaches wherein the control unit (Verhoeven: Set forth in [0009]) is configured to obtain an improved indicator of the indicator of the intrinsic end-expiratory pressure in lungs of the patient averaging a plurality of indicators of the intrinsic end-expiratory pressure in lungs of the patient determined sequentially in time (Verhoeven: Set forth in [0095]-[0096]).
Blanch and Verhoeven are both considered to be analogous to the claimed invention because they are in the same field of breath analyzers for users being ventilated. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Blanch to incorporate the teaching of Verhoeven and include wherein the control unit (Verhoeven: Set forth in [0009]) is configured to obtain an improved indicator of the indicator of the intrinsic end-expiratory pressure in lungs of the patient by averaging a plurality of indicators of the intrinsic end-expiratory pressure in lungs of the patient determined sequentially in time (Verhoeven: Set forth in [0095]-[0096]). Doing so would result in a more accurate indicator of the intrinsic end-expiratory pressure since an average value represents the entire set of data, not just during one time increment.
Response to Arguments
In response to Applicant’s amendments, the 35 U.S.C. 102(a)(1) rejections drawn to claims 1-10 and 13-20 for failing to comply with the written description requirement have been withdrawn.
In response to Applicant’s amendment to claim 12, the objection drawn to an informality has been withdrawn.
New grounds of rejection are made above to address the amendments to claims 1, 5, 6, 7, 12, 13, 14, 15, 18, and 19 above.
Applicant's arguments filed 09/15/2025 have been fully considered but they are not persuasive.
Applicant argues for claims 1, 13, and 19 that Blanch does not disclose determining muscle-generated breathing pressure or inhalation attempt of the patient based on electromyographic signal and that the values used are not derived from the patient’s muscular effort, meaning that Blanch provides no indication that Blanch estimates pressure generated by respiratory muscles.
In response to applicant's argument that the references fail to show specifically, determining muscle-generated breathing pressure or inhalation attempt of the patient based on electromyographic signal, it is noted that the features upon which applicant relies (i.e., determining muscle-generated breathing pressure based on EMG) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). New grounds of rejection are made above to address the amendments to claims 1, 13, and 19 above. In response to the argument that that Blanch provides no indication that Blanch estimates pressure generated by respiratory muscles and that the values used are not derived from the patient’s muscular effort, Examiner points to [0015] of Blanch that discloses wherein the invention addresses a need in the art for accurately detecting and quantifying PEEP non-invasively, especially in spontaneously breathing patients. The consideration of, at the very least, the muscular pressure resulting from a spontaneous breath, would indicate that the estimated lung pressure as disclosed in the rejection above, would be representative of pressure generated by respiratory muscles derived from the patient’s muscular effort.
Applicant further argues in reference to the independent claims that Blanch fails to disclose ventilator-occlusion calibration.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., ventilator-occlusion calibration) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). New grounds of rejection are made above to address the amendments to claims 1, 13, and 19 above.
Applicant argues for claim 6 that Blanch does not disclose determining muscle-generated breathing pressure or inhalation attempt of the patient based on electromyographic signal and that it only analyses ventilator-derived signals, and that claim 6 adds both a required EMG foundation and explicit alternative estimation modalities that are absent from Blanch.
In response to applicant's argument that the references fail to show specifically, determining muscle-generated breathing pressure or inhalation attempt of the patient based on electromyographic signal, it is noted that the features upon which applicant relies (i.e., determining muscle-generated breathing pressure based on EMG) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). New grounds of rejection are made above to address the amendments to claims 1, 13, and 19 above. In response to the argument that that Blanch only analyses ventilator-derived signals, Examiner points to [0015] of Blanch that discloses wherein the invention addresses a need in the art for accurately detecting and quantifying PEEP non-invasively, especially in spontaneously breathing patients. The consideration of, at the very least, the muscular pressure resulting from a spontaneous breath, would indicate that the estimated lung pressure as disclosed in the rejection above, would be representative of pressure generated by respiratory muscles derived from the patient’s muscular effort.
Applicant further argues that the claimed invention provides a non-invasive approach.
In response to applicant's argument that the references fail to show that the invention provides a non-invasive approach, it is noted that the features upon which applicant relies (i.e., non-invasive approach) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). New grounds of rejection are made above to address the amendments to the claims above. Additionally, Blanch does utilize a non-invasive approach (Abstract).
Applicant argues for claim 11 that neither Blanch or Verhoeven determine Pmus for iPEEP computation, and that the enhancements recited in claim 11 of averaging, smoothing, and outlier removal-are not generic improvements but are specifically directed at time-resolved iPEEP indicators based on Pmus.
However, Verhoeven is relied upon solely for its disclosure of obtaining an improved indicator of the indicator of the intrinsic end-expiratory pressure in lungs of the patient averaging a plurality of indicators of the intrinsic end-expiratory pressure in lungs of the patient determined sequentially in time (Verhoeven: Set forth in [0095]-[0096]). The determination of Pmus for iPEEP computation in Verhoeven is not material to the teaching for which the reference is applied. Verhoeven clearly demonstrates obtaining an improved indicator of the indicator of the intrinsic end-expiratory pressure in lungs of the patient averaging a plurality of indicators of the intrinsic end-expiratory pressure. That functionality is exactly what is relied upon in the rejection above given that Blanch as modified is disclosing the determination of Pmus for iPEEP computation. Verhoeven simply provides a method for obtaining an improved indicator, which would be considered a generic improvement to one of ordinary skill in the art of the claimed invention.
Applicant argues for claim 12 that neither Blanch or Novotni teach the claimed subject matter given that the determinations are based on Pmus and that Novotoni does not use occlusion measurements to calibrate a muscle-pressure-based iPEEP estimator or use interspersed occlusion.
However, Examiner points to [0015] of Blanch that discloses wherein the invention addresses a need in the art for accurately detecting and quantifying PEEP non-invasively, especially in spontaneously breathing patients. The consideration of, at the very least, the muscular pressure resulting from a spontaneous breath, would indicate that the estimated lung pressure as disclosed in the rejection above, would be representative of pressure generated by respiratory muscles derived from the patient’s muscular effort. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., calibrate a muscle-pressure-based iPEEP estimator or use interspersed occlusion) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). New grounds of rejection are made above to address the amendments to the claims above.
Applicant further argues that the combination would still not yield claim 12’s features. Implementing Claim 12 demands (i) the physiological framework of Claim 1 detecting the first information, at the first time from electromyographic signal and determining Pmus-based “first” and “second” breathing pressures and a calibration cadence that periodically inserts occlusions between successive Pmus-based iPEEP computations to align and maintain the estimation.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., detecting the first information, at the first time from electromyographic signal and a calibration cadence that periodically inserts occlusions between successive Pmus-based iPEEP computations) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). New grounds of rejection are made above to address the amendments to claims 1 and 12 above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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