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 1/6/2026 has been entered. Applicant's amendments overcome the previous specification objection and 35 U.S.C. 101 rejections. Claims 16-21 have been added. Claims 1-21 remain pending.
Claim Objections
Claim 21 is objected to because of the following informalities:
Claim 21 line 30-31 reads “for calcuating the overall lung complicance”. This should read --for calculating the overall lung compliance--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 13, and claims 2-6 and 14-19 by dependency, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 13 recite the limitation "the regional lung compliances" in line 20. There is insufficient antecedent basis for this limitation in the claim. For the purposes of this Office Action, this limitation is interpreted as referring to the regional lung compliance of each lung region.
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) 1-5, 13-15, 16-19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication US 2019/0246949 A1 (hereafter "Holzhacker"), in view of Euliano (U.S. Patent Publication US 2021/0016035 A1), in view of Kremeier (US 20210244901 A1).
Regarding claim 1, Holzhacker discloses a device (parts of system #400; Fig. A below) for determining for each lung region of a plurality of different given lung regions of the lungs of a patient (the system evaluates several regions of the lung; Holzhacker ¶ 37) a respective value indicative of a regional lung compliance of the lung region (the system evaluates the compliance for each region of the lung evaluated; Holzhacker Abstract, ¶ 37), the device comprising:
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Figure A: adapted from Holzhacker Fig. 4.
an EIT measuring device (EIT system #404; Holzhacker ¶ 43, Fig. A above) configured to measure for each lung region of the plurality of different lung regions a value indicative of a respective change in volume of the lung region by applying electrical impedance tomography (the EIT system #404 measures changes in lung volume for each region evaluated; Holzhacker ¶ 37, 66, 113);
a pneumatic airway pressure sensor (gas monitoring sensors #426, including a pressure sensor proximate to an entrance of the endotracheal tube of the patient, a gas sensor being inherently pneumatic; Holzhacker ¶ 48, 56, 59, Fig. A above) configured to measure a value indicative of a pressure, which is variable over time, at an airway of the patient (the pressure measured by the pressure sensor varies over time; Holzhacker Fig. 6A, ¶ 6, 36, 49, 56, 59, 69); and
a data processing control device (the system has a controller #406, including data processing system #320, the controller #406 being the data processing control device; Holzhacker ¶ 8, 40, 50) configured:
to determine for each lung region of the plurality of different lung regions a respective value indicative of a difference between an end-inspiratory volume and an end-expiratory volume using signals of the EIT measuring device (the system is configured to use the EIT to determine both the end-inspiratory and end-expiratory volumes for each region of the lung evaluated; Holzhacker ¶ 74, 113); and
to calculate for each lung region of the plurality of different lung regions a quotient of the volume difference of the lung region and the pressure difference present at the lungs as the value indicative of a regional lung compliance of the lung region (lung compliance for at least one region of the lung is calculated using a quotient (ΔV/ΔP) of the change in lung volume (ΔV) and the change in lung pressure (ΔP), which is a value representing the lung compliance for the region(s) evaluated; Holzhacker ¶ 74, 97).
Holzhacker does not explicitly disclose to determine a value indicative of a transpulmonary pressure difference between an end-inspiratory transpulmonary pressure present at the lungs and an end-expiratory transpulmonary pressure present at the lungs using signals of the airway pressure sensor; and to calculate lung compliance using the transpulmonary pressure difference.
Euliano teaches determining a value indicative of a transpulmonary pressure difference between an end-inspiratory transpulmonary pressure present at the lungs and an end-expiratory transpulmonary pressure present at the lungs using signals of an airway pressure sensor [the difference between airway pressure (Paw), which can be measured by an airway pressure sensor as seen in Fig. 16, and esophageal pressure (Pes), which can be measured by an esophageal pressure sensor also seen in Fig. 16, can be used to estimate transpulmonary pressure (transpulmonary pressure = Paw-Pes), par. 0004; the difference between a transpulmonary pressure (Paw- Pes) end inhalation and transpulmonary pressure (Paw- Pes) end exhalation can be used to calculate lung compliance, par. 0008] and calculating lung compliance using the transpulmonary pressure difference [lung compliance is calculated as a quotient of a change in volume (VT) and the transpulmonary pressure difference ((Paw−Pes) end inhalation−(Paw−Pes)end−exhalation), par. 0008; esophageal pressure and airway pressure data enable accurate estimates of compliance; par. 0121, 0141] for the purpose of improving ventilator function since a ventilator strategy using esophageal pressures to estimate the transpulmonary pressure significantly improves oxygenation and compliance (par. 0009).
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 device of Holzhacker to calculate lung compliance using a transpulmonary pressure difference, which is calculated as a difference between an airway pressure and an esophageal pressure, as taught by Euliano for the purpose of improving ventilator function (Euliano par. 0009).
The modified Holzhacker does not explicitly disclose a patient monitor configured to display the regional lung compliances.
Kremeier teaches a patient monitor configured to display the regional lung compliances (par. 0013, 0037) for the purpose of allowing an observer to easily understand a distribution of regional compliances in the lung (par. 0037).
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 Holzhacker to comprise a patient monitor configured to display the regional lung compliances as taught by Kermeier for the purpose of allowing an observer to easily understand a distribution of regional compliances in the lung (Kremeier par. 0037).
Regarding claim 2, the modified Holzhacker discloses a device in accordance with claim 1 (shown above), further comprising a pneumatic esophageal pressure sensor configured to measure a value indicative of an esophageal pressure, which is variable over time, in the esophagus of the patient (esophageal pressure sensor 1602 measures esophageal pressure data of a patient being ventilated; Euliano Fig. 16, par. 0018, 0077) , wherein the control device is configured: to determine the end-inspiratory transpulmonary pressure as a difference between the end-inspiratory airway pressure and the end-inspiratory esophageal pressure (the difference between airway pressure (Paw) and esophageal pressure (Pes) can be used to estimate transpulmonary pressure (transpulmonary pressure = Paw-Pes), Euliano par. 0004; a transpulmonary pressure (Paw- Pes) end inhalation is used in lung compliance calculation, Euliano par. 0008; esophageal pressure and airway pressure data are used to determine accurate estimates of compliance; Euliano par. 0121, 0141); and to determine the end-expiratory transpulmonary pressure as a difference between the end-expiratory airway pressure and the end-expiratory esophageal pressure (a transpulmonary pressure (Paw- Pes) end exhalation is used in lung compliance calculation, par. 0008; esophageal pressure and airway pressure data are used to determine accurate estimates of compliance; Euliano par. 0121, 0141).
Regarding claim 3, the modified Holzhacker discloses a device in accordance with claim 1 (above), wherein:
the device is configured to be in a data connection with a ventilator (the ventilator and EIT are in operable connection to the controller; Holzhacker ¶ 43, 48), which is configured to mechanically ventilate the patient (the ventilator is by definition configured to ventilate a patient, and is disclosed as such; Holzhacker ¶ 48, 51);
the ventilator is configured to mechanically ventilate the patient such that an end-expiratory pressure at the airway of the patient assumes a predefined value (the ventilator applies a series of disparate, predefined PEEPs, equivalent to end-expiratory pressure at the airway of the patient, according to predefined values; Holzhacker ¶ 5, 36, 51, 63);
the control device is configured to actuate the ventilator such that the actuated ventilator carries out a mechanical ventilation (the controller controls the operation of the ventilator to ventilate; Holzhacker ¶ 48) such that the end-expiratory pressure first assumes a predefined first value and subsequently assumes at least one predefined second value, which is different from the first value (the ventilator applies a series of disparate, predefined PEEPs, equivalent to end-expiratory pressure at the airway of the patient, according to predefined values; Holzhacker ¶ 5, 36, 51, 63).
Regarding claim 4, the modified Holzhacker discloses a device in accordance with claim 3 (above), wherein the control device is configured to determine for each lung region a respective end-expiratory pressure value indicative of the regional lung compliance resulting from the first and second values of the end-expiratory pressure (the disparate, predefined PEEPs, equivalent to end-expiratory pressure, are used to determine lung compliance for each region evaluated; Holzhacker ¶ 5, 36, 51, 57, 63).
Regarding claim 5, the modified Holzhacker discloses a device in accordance with claim 3 (above), wherein:
the control device is configured to calculate a required operating parameter of the end-expiratory pressure at the airway (the control device calculates the applied PEEP levels, which is a required operating parameter according to Specification ¶ 18 of the present Application; Holzhacker ¶ 57);
the control device is configured to calculate the required operating parameter depending on a value indicative of the overall lung compliance (the PEEP levels are used to calculate lung compliance, which is in turn used to subsequently re-calculate the next PEEP level; Holzhacker ¶ 57, 62-64, 67-70); and
the control device is configured to cumulate over the regional lung compliance values of the lung regions for calculating the overall lung compliance (Holzhacker ¶ 68).
Regarding claim 13, Holzhacker discloses a process for determining for each lung region of a plurality of different lung regions of a patient a respective value indicative of a regional lung compliance of the lung region (Holzhacker Abstract, ¶ 37), wherein the process is carried out with a device (parts of system #400; Fig. A above), which comprises an EIT measuring device (EIT system #404; Holzhacker ¶ 43, Fig. A above) configured to measure a value indicative of a change in volume of a lung region (the EIT system #404 measures changes in lung volume for each region evaluated; Holzhacker ¶ 37, 66, 113); a pneumatic airway pressure sensor (gas monitoring sensors #426, including a pressure sensor proximate to an entrance of the endotracheal tube of the patient, a gas sensor being inherently pneumatic; Holzhacker ¶ 48, 56, 59, Fig. A above) configured to measure a value indicative of a pressure, which is variable over time, at the airway of the patient (the pressure measured by the pressure sensor varies over time; Holzhacker Fig. 6A, ¶ 6, 36, 49, 56, 59, 69), the process comprising the steps of:
measuring, with the EIT measuring device for each lung region of the plurality of different lung regions, a change in volume of the lung region by electrical impedance tomography (the system is configured to use the EIT to determine both the end-inspiratory and end-expiratory volumes for each region of the lung evaluated; Holzhacker ¶ 74, 113);
for each lung region of the plurality of different lung regions determining a value indicative of a difference between an end-inspiratory volume and an end-expiratory volume of the lung region using signals of the EIT measuring device (the system is configured to use the EIT to determine both the end-inspiratory and end-expiratory volumes for each region of the lung evaluated; Holzhacker ¶ 74, 113);
for each lung region of the plurality of different lung regions calculating a quotient of the volume difference for the lung region and the pressure difference present at the lungs as the value indicative of the regional lung compliance of the lung region (lung compliance for at least one region of the lung is calculated using a quotient (ΔV/ΔP) of the change in lung volume (ΔV) and the change in lung pressure (ΔP), which is a value representing the lung compliance for the region(s) evaluated; Holzhacker ¶ 74, 97).
Holzhacker does not explicitly disclose determining a value indicative of the transpulmonary pressure difference between an end-inspiratory transpulmonary pressure present at the lungs and an end-expiratory transpulmonary pressure present at the lungs and calculating lung compliance using the transpulmonary pressure difference.
Euliano teaches determining a value indicative of a transpulmonary pressure difference between an end-inspiratory transpulmonary pressure present at the lungs and an end-expiratory transpulmonary pressure present at the lungs using signals of an airway pressure sensor [the difference between airway pressure (Paw), which can be measured by an airway pressure sensor as seen in Fig. 16, and esophageal pressure (Pes), which can be measured by an esophageal pressure sensor also seen in Fig. 16, can be used to estimate transpulmonary pressure (transpulmonary pressure = Paw-Pes), par. 0004; the difference between a transpulmonary pressure (Paw- Pes) end inhalation and transpulmonary pressure (Paw- Pes) end exhalation can be used to calculate lung compliance, par. 0008] and calculating lung compliance using the transpulmonary pressure difference [lung compliance is calculated as a quotient of a change in volume (VT) and the transpulmonary pressure difference ((Paw−Pes) end inhalation−(Paw−Pes)end−exhalation), par. 0008; esophageal pressure and airway pressure data enable accurate estimates of compliance; par. 0121, 0141] for the purpose of improving ventilator function since a ventilator strategy using esophageal pressures to estimate the transpulmonary pressure significantly improves oxygenation and compliance (par. 0009).
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 process of Holzhacker to calculate lung compliance using a transpulmonary pressure difference, which is calculated as a difference between an airway pressure and an esophageal pressure, as taught by Euliano for the purpose of improving ventilator function (Euliano par. 0009).
The modified Holzhacker does not explicitly disclose displaying the regional lung compliances on a patient monitor.
Kremeier teaches a patient monitor configured to display the regional lung compliances (par. 0013, 0037) for the purpose of allowing an observer to easily understand a distribution of regional compliances in the lung (par. 0037).
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 Holzhacker to display the regional lung compliances on a patient monitor as taught by Kermeier for the purpose of allowing an observer to easily understand a distribution of regional compliances in the lung (Kremeier par. 0037).
Regarding claim 14, the modified Holzhacker discloses a process according to claim 13 (above), wherein:
the device comprises a data processing control device (the system has a controller #406, including data processing system #320, the controller #406 being the data processing control device; Holzhacker ¶ 8, 40, 50) configured to execute a computer program (Holzhacker ¶ 27-28);
the control device is arranged to receive signals from the EIT measuring device for measuring a value indicative of the change in the volume of the lung region (the system is configured to use the EIT to determine both the end-inspiratory and end-expiratory volumes for each region of the lung evaluated; Holzhacker ¶ 74, 113);
the control device is arranged to receive signals from the pneumatic airway pressure sensor for measuring the value indicative of the pressure (controller 406 utilizes signal from gas monitoring sensors 426 which includes pressure sensor; Holzhacker par. 0048); and
the control device is arranged to perform the process steps when receiving signals from the EIT measuring device and the airway pressure sensor (the programming is executed when signals are received from the EIT and sensor; Holzhacker ¶ 8, 37).
Regarding claim 15, the modified Holzhacker discloses a process according to claim 13 (above), wherein the control device is activated by a signal sequence that causes the control device to carry out at least some of the process steps (the control device is activated by sensing with the pressure sensor a manual change in PEEP, causing the control device to carry out the steps of the process; Holzhacker ¶ 37).
Regarding claim 16, the modified Holzhacker discloses a process in accordance with claim 13 (shown above), further comprising: controlling a ventilator using the regional lung compliances of the lungs such that neither is a region of the lungs hyperdistended, nor does a region collapse (a potential recruitment value of a region of the lungs is calculated using regional lung compliances to determine patient responsiveness to an alveolar recruitment maneuver performed by the ventilator, Holzhacker par. 0043, 0105; alveolar recruitment maneuver aims to open collapsed regions of the lungs while limiting distension of the lungs, Holzhacker par. 0034, 0036, 0053).
Regarding claim 17, the modified Holzhacker discloses a device in accordance with claim 1 (shown above), wherein: the device is configured to be in a data connection with a ventilator (the ventilator and EIT are in operable connection to the controller; Holzhacker ¶ 43, 48), which is configured to mechanically ventilate the patient (the ventilator is by definition configured to ventilate a patient, and is disclosed as such; Holzhacker ¶ 48, 51) using the regional lung compliances of the lungs of the patient (ventilator system #402 is operated by the controller #406, which uses the values determined by the data processing system #320, including lung compliances, to adjust the PEEP values of the applied ventilation; Holzhacker ¶ 36, 57, 77).
Regarding claim 18, the modified Holzhacker discloses a device in accordance with claim 17 (shown above), wherein: the ventilator has at least one operating parameter from the group of: tidal volume, maximum volume flow per minute, maximum ventilation pressure during a ventilation stroke, plateau pressure, end-expiratory pressure (PEEP), ramp time, a duration of an inhalation phase, a duration of an exhalation phase, and a frequency at which ventilation strokes are carried out; wherein a predefined calculation rule is used to calculate a value of said operating parameter as a function of the regional lung compliances (ventilator system #402 is operated by the controller #406, which uses the values determined by the data processing system #320, including lung compliances, to adjust the PEEP values of the applied ventilation in an alveolar recruitment maneuver; Holzhacker ¶ 36, 57, 77).
Regarding claim 19, the modified Holzhacker discloses a device in accordance with claim 17 (shown above), wherein: the ventilator uses the regional lung compliances of the lungs such that neither is a region of the lungs hyperdistended, nor does a region collapse (a potential recruitment value of a region of the lungs is calculated using regional lung compliances to determine patient responsiveness to an alveolar recruitment maneuver performed by the ventilator, Holzhacker par. 0043, 0105; alveolar recruitment maneuver aims to open collapsed regions of the lungs while limiting distension of the lungs, Holzhacker par. 0034, 0036, 0053).
Regarding claim 21, Holzhacker discloses a process for determining for each lung region of a plurality of different given lung regions of a patient, a respective value indicative of a regional lung compliance of the lung region (Holzhacker Abstract, ¶ 37), the process comprising the steps of: providing an EIT measuring device (EIT system #404; Holzhacker ¶ 43, Fig. A above); measuring with the EIT measuring device by applying electrical impedance tomography, for each lung region of a plurality of different given lung regions of the lungs of a patient, a value indicative of a respective change in volume of the lung region (the EIT system #404 measures changes in lung volume for each region evaluated; Holzhacker ¶ 37, 66, 113); providing a pneumatic airway pressure sensor (gas monitoring sensors #426, including a pressure sensor proximate to an entrance of the endotracheal tube of the patient, a gas sensor being inherently pneumatic; Holzhacker ¶ 48, 56, 59, Fig. A above); measuring with the pneumatic airway pressure sensor, a value indicative of a pressure, which is variable over time, at an airway of the patient (the pressure measured by the pressure sensor varies over time; Holzhacker Fig. 6A, ¶ 6, 36, 49, 56, 59, 69); determining for each lung region of the plurality of different lung regions, a respective value indicative of a difference between an end-inspiratory volume and an end-expiratory volume of the lung region using signals of the EIT measuring device (the system is configured to use the EIT to determine both the end-inspiratory and end-expiratory volumes for each region of the lung evaluated; Holzhacker ¶ 74, 113); calculating for each lung region of the plurality of different lung regions a quotient of the volume difference of the lung region and the pressure difference present at the lungs as the value indicative of a regional lung compliance of the lung region (lung compliance for at least one region of the lung is calculated using a quotient (ΔV/ΔP) of the change in lung volume (ΔV) and the change in lung pressure (ΔP), which is a value representing the lung compliance for the region(s) evaluated; Holzhacker ¶ 74, 97); providing a ventilator (a ventilator is in operable connection to the controller; Holzhacker ¶ 43, 48); mechanically ventilating the patient as a function of determined regional lung compliance values of the lung regions of the plurality of different lung regions (ventilator system #402 is operated by the controller #406, which uses the values determined by the data processing system #320, including lung compliances, to adjust the PEEP values of the applied ventilation; Holzhacker ¶ 36, 57, 77); further mechanically ventilating the patient such that an end-expiratory pressure first is provided at a predefined first value and, subsequent to providing at the predefined first value, mechanically ventilating at least one predefined second value, which is different from the first value (the ventilator applies a series of disparate, predefined PEEPs, equivalent to end-expiratory pressure at the airway of the patient, according to predefined values; Holzhacker ¶ 5, 36, 51, 63), calculating a required operating parameter of the end-expiratory pressure at the airway (the control device calculates the applied PEEP levels, which is a required operating parameter according to Specification ¶ 18 of the present Application; Holzhacker ¶ 57); calculating the required operating parameter depending on a value indicative of an overall lung compliance (the PEEP levels are used to calculate lung compliance, which is in turn used to subsequently re-calculate the next PEEP level; Holzhacker ¶ 57, 62-64, 67-70); and cumulating over the regional lung compliance values of the lung regions for calcluating the overall lung compliance (Holzhacker ¶ 68).
Holzhacker does not explicitly disclose determining a value indicative of a transpulmonary pressure difference between an end-inspiratory transpulmonary pressure present at the lungs and an end-expiratory transpulmonary pressure present at the lungs using signals of the airway pressure sensor; calculating lung compliance using the transpulmonary pressure difference.
Euliano teaches determining a value indicative of a transpulmonary pressure difference between an end-inspiratory transpulmonary pressure present at the lungs and an end-expiratory transpulmonary pressure present at the lungs using signals of an airway pressure sensor [the difference between airway pressure (Paw), which can be measured by an airway pressure sensor as seen in Fig. 16, and esophageal pressure (Pes), which can be measured by an esophageal pressure sensor also seen in Fig. 16, can be used to estimate transpulmonary pressure (transpulmonary pressure = Paw-Pes), par. 0004; the difference between a transpulmonary pressure (Paw- Pes) end inhalation and transpulmonary pressure (Paw- Pes) end exhalation can be used to calculate lung compliance, par. 0008] and calculating lung compliance using the transpulmonary pressure difference [lung compliance is calculated as a quotient of a change in volume (VT) and the transpulmonary pressure difference ((Paw−Pes) end inhalation−(Paw−Pes)end−exhalation), par. 0008; esophageal pressure and airway pressure data enable accurate estimates of compliance; par. 0121, 0141] for the purpose of improving ventilator function since a ventilator strategy using esophageal pressures to estimate the transpulmonary pressure significantly improves oxygenation and compliance (par. 0009).
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 process of Holzhacker to calculate lung compliance using a transpulmonary pressure difference, which is calculated as a difference between an airway pressure and an esophageal pressure, as taught by Euliano for the purpose of improving ventilator function (Euliano par. 0009).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holzhacker in view of Euliano, in view of Kremeier as applied to claim 3 above, and further in view of Stenqvist (US 8701663 B2).
Regarding claim 6, the modified Holzhacker discloses a device in accordance with claim 3 (above), wherein:
the device is configured to determine a value indicative of the respective end-expiratory lung volume at the first value and at the second value of the end-expiratory pressure (the device determines an end expiratory lung volume (EELV) for each PEEP level; Holzhacker ¶ 5, 37).
The modified Holzhacker does not explicitly disclose the device is configured to calculate, the value indicative of the difference between the end-inspiratory transpulmonary pressure and the end-expiratory transpulmonary pressure, depending on the quotient of the difference between the two measured end-expiratory lung volumes and the difference between the two set values for the end-expiratory pressure.
Stenqvist teaches a device for determining transpulmonary pressure of a patient (abstract ln 1-3) configured to calculate, as the value indicative of the difference between the end-inspiratory transpulmonary pressure and the end-expiratory transpulmonary pressure, the quotient of the difference between the two measured end-expiratory lung volumes and the difference between the two set values for the end-expiratory pressure (a control unit (105) is operable to determine the transpulmonary pressure based on a change in end-expiratory lung volume and a difference between a first PEEP level and second PEEP level; abstract, col. 3 ln 51-col. 4 ln 2) for the purpose of determining a transpulmonary pressure difference even when an esophageal pressure measurement is unobtainable or unreliable (col. 2 ln 8-col. 3 ln 6).
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 device of Holzhacker to calculate, as the value indicative of the difference between the end-inspiratory transpulmonary pressure and the end-expiratory transpulmonary pressure, the quotient of the difference between the two measured end-expiratory lung volumes and the difference between the two set values for the end-expiratory pressure as taught by Stenqvist for the purpose of determining a transpulmonary pressure difference even when an esophageal pressure measurement is unobtainable or unreliable (Stenqvist col. 2 ln 8-col. 3 ln 6).
Claim(s) 7-11 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holzhacker, in view of Euliano.
Regarding claim 7, Holzhacker discloses a mechanical ventilation system (system #400; Fig. A above) comprising:
a device (parts of system #400; Fig. A above) comprising:
an EIT measuring device (EIT system #404; Holzhacker ¶ 43, Fig. A above) configured to measure for each lung region of a plurality of different given lung regions of the lungs of a patient a value indicative of a respective change in volume of the lung region by applying electrical impedance tomography (the EIT system #404 measures changes in lung volume for each region evaluated; Holzhacker ¶ 37, 66, 113);
a pneumatic airway pressure sensor (gas monitoring sensors #426, including a pressure sensor proximate to an entrance of the endotracheal tube of the patient, a gas sensor being inherently pneumatic; Holzhacker ¶ 48, 56, 59, Fig. A above) configured to measure a value indicative of a pressure, which is variable over time, at an airway of the patient (the pressure measured by the pressure sensor varies over time; Holzhacker Fig. 6A, ¶ 6, 36, 49, 56, 59, 69); and
a data processing control device (the system has a controller #406, including data processing system #320, the controller #406 being the data processing control device; Holzhacker ¶ 8, 40, 50) configured:
to determine for each lung region of the plurality of different lung regions a respective value indicative of a difference between an end-inspiratory volume and an end-expiratory volume of the lung region using signals of the EIT measuring device (the system is configured to use the EIT to determine both the end-inspiratory and end-expiratory volumes for each region of the lung evaluated; Holzhacker ¶ 74, 113); and
to calculate for each lung region of the plurality of different lung regions a quotient of the volume difference of the lung region and the pressure difference present at the lungs as the value indicative of a regional lung compliance of the lung region (lung compliance for at least one region of the lung is calculated using a quotient (ΔV/ΔP) of the change in lung volume (ΔV) and the change in lung pressure (ΔP), which is a value representing the lung compliance for the region(s) evaluated; Holzhacker ¶ 74, 97); and
a ventilator (ventilator system #402; Holzhacker ¶ 43, Fig. A above) configured to carry out a mechanical ventilation of the patient as a function of determined regional lung compliance values of the lung regions of the plurality of different lung regions (ventilator system #402 is operated by the controller #406, which uses the values determined by the data processing system #320, including lung compliances, to adjust the PEEP values of the applied ventilation; Holzhacker ¶ 36, 57, 77).
Holzhacker does not explicitly disclose to determine a value indicative of a transpulmonary pressure difference between an end-inspiratory transpulmonary pressure present at the lungs and an end-expiratory transpulmonary pressure present at the lungs using signals of the airway pressure sensor; and to calculate lung compliance using the transpulmonary pressure difference.
Euliano teaches determining a value indicative of a transpulmonary pressure difference between an end-inspiratory transpulmonary pressure present at the lungs and an end-expiratory transpulmonary pressure present at the lungs using signals of an airway pressure sensor [the difference between airway pressure (Paw), which can be measured by an airway pressure sensor as seen in Fig. 16, and esophageal pressure (Pes), which can be measured by an esophageal pressure sensor also seen in Fig. 16, can be used to estimate transpulmonary pressure (transpulmonary pressure = Paw-Pes), par. 0004; the difference between a transpulmonary pressure (Paw- Pes) end inhalation and transpulmonary pressure (Paw- Pes) end exhalation can be used to calculate lung compliance, par. 0008] and calculating lung compliance using the transpulmonary pressure difference [lung compliance is calculated as a quotient of a change in volume (VT) and the transpulmonary pressure difference ((Paw−Pes) end inhalation−(Paw−Pes)end−exhalation), par. 0008; esophageal pressure and airway pressure data enable accurate estimates of compliance; par. 0121, 0141] for the purpose of improving ventilator function since a ventilator strategy using esophageal pressures to estimate the transpulmonary pressure significantly improves oxygenation and compliance (par. 0009).
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 mechanical ventilation system of Holzhacker to calculate lung compliance using a transpulmonary pressure difference, which is calculated as a difference between an airway pressure and an esophageal pressure, as taught by Euliano for the purpose of improving ventilator function (Euliano par. 0009).
Regarding claim 8, the modified Holzhacker discloses a mechanical ventilation system in accordance with claim 7 (shown above), wherein the device further comprises a pneumatic esophageal pressure sensor configured to measure a value indicative of an esophageal pressure, which is variable over time, in the esophagus of the patient (esophageal pressure sensor 1602 measures esophageal pressure data of a patient being ventilated; Euliano Fig. 16, par. 0018, 0077) , wherein the control device is configured: to determine the end-inspiratory transpulmonary pressure as a difference between the end-inspiratory airway pressure and the end-inspiratory esophageal pressure (the difference between airway pressure (Paw) and esophageal pressure (Pes) can be used to estimate transpulmonary pressure (transpulmonary pressure = Paw-Pes), Euliano par. 0004; a transpulmonary pressure (Paw- Pes) end inhalation is used in lung compliance calculation, Euliano par. 0008; esophageal pressure and airway pressure data are used to determine accurate estimates of compliance; Euliano par. 0121, 0141); and to determine the end-expiratory transpulmonary pressure as a difference between the end-expiratory airway pressure and the end-expiratory esophageal pressure (a transpulmonary pressure (Paw- Pes) end exhalation is used in lung compliance calculation, par. 0008; esophageal pressure and airway pressure data are used to determine accurate estimates of compliance; Euliano par. 0121, 0141).
Regarding claim 9, the modified Holzhacker discloses a mechanical ventilation system in accordance with claim 7 (above), wherein the control device is configured to actuate the ventilator such that the actuated ventilator carries out a mechanical ventilation (the controller controls the operation of the ventilator to ventilate; Holzhacker ¶ 48) such that an end-expiratory pressure first is provided at a predefined first value and, subsequent to assuming the predefined first value, at least one predefined second value, which is different from the first value (the ventilator applies a series of disparate, predefined PEEPs, equivalent to end-expiratory pressure at the airway of the patient, according to predefined values; Holzhacker ¶ 5, 36, 51, 63).
Regarding claim 10, the modified Holzhacker discloses a mechanical ventilation system in accordance with claim 9 (above), wherein the control device is configured to determine for each lung region a respective end-expiratory pressure value indicative of the regional lung compliance resulting from the first and second values of the end-expiratory pressure (the disparate, predefined PEEPs, equivalent to end-expiratory pressure, are used to determine lung compliance for each region evaluated; Holzhacker ¶ 5, 36, 51, 57, 63).
Regarding claim 11, the modified Holzhacker discloses a mechanical ventilation system in accordance with claim 9 (above), wherein:
the control device is configured to calculate a required operating parameter of the end-expiratory pressure at the airway (the control device calculates the applied PEEP levels, which is a required operating parameter according to Specification ¶ 18 of the present Application; Holzhacker ¶ 57);
the control device is configured to calculate the required operating parameter depending on a value indicative of the overall lung compliance (the PEEP levels are used to calculate lung compliance, which is in turn used to subsequently re-calculate the next PEEP level; Holzhacker ¶ 57, 62-64, 67-70); and
the control device is configured to cumulate over the regional compliance values of the lung regions for calculating the overall lung compliance (Holzhacker ¶ 68).
Regarding claim 20, the modified Holzhacker discloses a mechanical ventilation system in accordance with claim 7 (shown above), wherein: the ventilator uses the regional lung compliances of the lungs such that neither is a region of the lungs hyperdistended, nor does a region collapse (a potential recruitment value of a region of the lungs is calculated using regional lung compliances to determine patient responsiveness to an alveolar recruitment maneuver performed by the ventilator, Holzhacker par. 0043, 0105; alveolar recruitment maneuver aims to open collapsed regions of the lungs while limiting distension of the lungs, Holzhacker par. 0034, 0036, 0053).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holzhacker in view of Euliano as applied to claim 9 above, and further in view of Stenqvist.
Regarding claim 12, the modified Holzhacker discloses a mechanical ventilation system in accordance with claim 9 (above), wherein:
the device is configured to determine a value indicative of the respective end-expiratory lung volume at the first value and at the second value of the end-expiratory pressure (the device determines an end expiratory lung volume (EELV) for each PEEP level; Holzhacker ¶ 5, 37).
The modified Holzhacker does not explicitly disclose the device is configured to calculate, as the value indicative of the difference between the end-inspiratory transpulmonary pressure and the end-expiratory transpulmonary pressure, the quotient of the difference between the two measured end-expiratory lung volumes and the difference between the two set values for the end-expiratory pressure.
Stenqvist teaches a device for determining transpulmonary pressure of a patient (abstract ln 1-3) configured to calculate, as the value indicative of the difference between the end-inspiratory transpulmonary pressure and the end-expiratory transpulmonary pressure, the quotient of the difference between the two measured end-expiratory lung volumes and the difference between the two set values for the end-expiratory pressure (a control unit (105) is operable to determine the transpulmonary pressure based on a change in end-expiratory lung volume and a difference between a first PEEP level and second PEEP level; abstract, col. 3 ln 51-col. 4 ln 2) for the purpose of determining a transpulmonary pressure difference even when an esophageal pressure measurement is unobtainable or unreliable (col. 2 ln 8-col. 3 ln 6).
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 device of Holzhacker to calculate, as the value indicative of the difference between the end-inspiratory transpulmonary pressure and the end-expiratory transpulmonary pressure, the quotient of the difference between the two measured end-expiratory lung volumes and the difference between the two set values for the end-expiratory pressure as taught by Stenqvist for the purpose of determining a transpulmonary pressure difference even when an esophageal pressure measurement is unobtainable or unreliable (Stenqvist col. 2 ln 8-col. 3 ln 6).
Response to Arguments
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to a display of the regional lung compliances 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.
Applicant argues Holzhacker does not disclose carrying out a mechanical ventilation as a function of the determined regional lung compliances. However, the use of regional lung compliances as an intermediate step to determine a patient’s responsiveness to an alveolar recruitment maneuver (ARM) would still be carrying out ventilation as a function of regional lung compliances since regional lung compliances are used in the calculations and an ARM is a mechanical ventilation maneuver carried out by a ventilator by applying different PEEP values. Therefore, Holzhacker carries out ventilation as a function of regional lung compliances by controlling the ventilator to apply different PEEP levels in an ARM depending on a patient’s responsiveness to an ARM which is calculated using regional lung compliances.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In particular, Applicant argues that Holzhacker does not disclose calculating a transpulmonary pressure difference. However, Euliano is relied upon to teach this limitation.
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.
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/K.R./Examiner, Art Unit 3785
/BRANDY S LEE/