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 in response to the Amendments filed on 04/27/2026. Claims 1, 7, 12, and 15 are as amended. Claims 2-6, 8-11, 13-14, and 16 are as previously presented. As such, claims 1-16 are pending in the instant application.
The amendments to the drawings and abstract are accepted and entered in the instant application.
All objections and claim objections pursuant of 35 U.S.C. 112(b) are withdrawn in light of the amendments.
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 1-16 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.
Claim 1 recites the limitations “determining a first pressure difference between a first pressure present at the first time point and a second pressure occurring after a time interval” in lines 11-12 and “determining a second pressure difference between a third pressure present at the second time point and a fourth pressure occurring after a time interval” in lines 18-19. It is unclear if the time interval recited in line 19 references the time interval recited in line 12, or if Applicant is attempting to disclose a new limitation with the time interval recited in line 19. For the purpose of examination, the recitation of the time interval in line 19 of claim 1 will be interpreted as – a second time interval.
Similarly, claim 12 recites the limitations “determining a first pressure difference between a first pressure present at the first time point and a second pressure occurring after a time interval” in lines 12-13 and “determining a second pressure difference between a third pressure present at the second time point and a fourth pressure occurring after a time interval” in lines 19-20. For at least the same reasons as set forth above for claim 1, the scope of the time interval recited in line 20 of claim 12 is unclear. For the purpose of examination, the recitation of the time interval in line 20 of claim 12 will be interpreted as – a second time interval.
Claim 16 recites the limitation “…that is equipped, configured, or programmed to carry out the method as claimed in claim 12.” As such, claim 16 includes the limitations of “determining a first pressure difference between a first pressure present at the first time point and a second pressure occurring after a time interval” (claim 12, lines 12-13) and “determining a second pressure difference between a third pressure present at the second time point and a fourth pressure occurring after a time interval” (claim 12, lines 19-20), as recited in claim 12. For at least the same reasons as above (see claim 12 above), the scope of the cited claim limitations are unclear, and will be interpreted as set forth above for claim 12, for the purpose of examination.
As such, claims 2-11 and 13-15 are rejected due to their dependency on a rejected claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 5-8, 12-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Enk (US 20190022342 A1) in view of Stenqvist (US 9655544 B2).
Regarding claim 1, Enk discloses a ventilator (1; Fig. 1) comprising at least a gas supply device and a gas supply device (fluid supply unit 2; Fig. 1) and a gas discharge device (fluid discharge unit 3; Fig. 1), for supplying a first fluid flow (a flow of fluid from fluid supply unit 2) to an airway of a patient (supply of a flow of fluid from fluid supply unit 2 to an airway 5 of a patient; [0093], lines 3-5) and for discharging a second fluid flow (flow of fluid from fluid discharge unit 3) from the airway back into the ventilator (flow of fluid from fluid discharge unit 3 is discharged from airway 5 to ventilator 1; Fig. 1; [0073]) or to an environment, a pressure sensor (pressure sensor 24; [0126]; [0021]) for measuring a pressure in the airway of the patient ([0022], lines 3-4), and a control device (6; Fig. 1) for operating the ventilator ([0084], lines 3-4); wherein the control device (6; Fig. 1) is configured to carry out a method comprising the following steps:
carrying out an inspiration process (intended duration of inhalation 20; Fig. 5) with a constant first fluid flow (constant fluid supply rate 30; Fig. 5) by means of the gas supply device (fluid supplied to airway 5 is supplied by fluid supply unit 2), and
carrying out an expiration process (intended duration of exhalation 21; Fig. 5) with a constant second fluid flow (constant fluid discharge rate 31; Fig. 5) by means of the gas discharge device (fluid discharged from airway is discharged by fluid discharge unit 3).
Enk fails to explicitly disclose the control device (6; Fig. 1) is configured to carry out a method comprising the following steps:
stopping the first fluid flow by means of the gas supply device at a first time point, and simultaneously
determining a first pressure difference between a first pressure present at the first time point and a second pressure occurring after a time interval by means of the pressure sensor, wherein the first fluid flow remains stopped during the time interval; and
stopping the second fluid flow by means of the gas discharge device at a second time point, and simultaneously
determining a second pressure difference between a third pressure present at the second time point and a fourth pressure occurring after a time interval by means of the pressure sensor;
defining and providing a difference between the first pressure difference and the second pressure difference as a first index which is usable for determination of at least a tissue-related resistance of the patient.
However, Stenqvist teaches an analogous breathing apparatus (1; Fig. 1) with a control unit (105; Fig. 1; col. 6, lines 62-67) capable of performing steps to determine transpulmonary pressure (col. 7, lines 1-3; col. 13, lines 48-60), including:
stopping a first fluid flow (end-inspiratory pause, see col. 10, line 15) by means of a gas supply device (first source of pressurized gas 101, further source of pressurized gas 102, inspiratory gas valves 110, and inspiratory branch 116; col. 6, lines 35-38) at an inspiratory phase, and simultaneously
determining a first airway pressure at the inspiratory phase (Paw, see col. 10, lines 13-16) and an end-inspiratory esophageal pressure (PESEIP) occurring after a time interval (PESEIP, see col. 15, lines 34-37) by means of a pressure sensor (113, 133, catheter-mounted balloon cuff; 113 to measure airway pressure during inspiratory phase, see col. 11, lines 22-25 and col. 10, lines 13-16; catheter-mounted balloon cuff functioning as an esophageal pressure transducer to measure PESEIP, see col. 2, lines 13-15 and col. 14, lines 58-59; col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube), where the first fluid flow remains stopped during the time interval (PESEIP is measured after an end-inspiration pause, hence the end-inspiratory pause will occur for the time interval; col. 13, lines 9-13); and
stopping a second fluid flow (end-expiratory pause; col. 10, line 15) by means of a gas discharge device (evacuation system 141, expiratory valve 140, expiratory valve 130, and expiratory branch 126; Fig. 1) at an expiratory phase, and simultaneously
determining an expiratory airway pressure (PEEP, see col. 10, lines 13-16) and an end-expiratory esophageal pressure (PESEE) occurring after a time interval (PESEE is measured after an end-expiratory pause, hence the time interval is the duration of the end-expiratory pause; col. 13, lines 9-13) by means of the pressure sensor (113, 133, catheter-mounted balloon cuff; 133 to measure PEEP, see col. 11, lines 16-18; catheter-mounted balloon cuff to measure PESEE, see col. 2, lines 13-15 and col. 14, lines 58-59; col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube).
Stenqvist further teaches determining a difference in tidal transpulmonary pressure (
∆
P
T
P
) as the difference between the change in total respiratory system driving pressure (
∆
P
A
W
) and the change in tidal variation in esophageal pressure (
∆
P
E
S
; Col. 15, lines 37-40), where the change in total respiratory system driving pressure (
∆
P
A
W
) is the difference between the airway pressure during an end-inspiratory pause (Paw) and the airway pressure during an end-expiratory pause (PEEP; Equation 1; Col. 10, lines 13-19), and the change in tidal variation in esophageal pressure (
∆
P
E
S
; Col. 15, lines 37-40) is the difference between an end-inspiratory esophageal plateau pressure (PESEIP) and an end-expiratory esophageal plateau pressure (PESEE; Col. 15, lines 34-37). Therefore, the difference in tidal transpulmonary pressure (
∆
P
T
P
) can be depicted with the following equation:
∆
P
T
P
=
∆
P
A
W
-
(
∆
P
E
S
)
Hence,
∆
P
T
P
=
P
a
w
-
P
E
E
P
-
(
P
E
S
E
I
P
-
P
E
S
E
E
)
The above equation can be rewritten as,
∆
P
T
P
=
P
a
w
-
P
E
S
E
I
P
-
(
P
E
E
P
-
P
E
S
E
E
)
,
Hence, Stenqvist teaches a first pressure difference between the first airway pressure at the inspiratory phase (Paw, see col. 10, lines 13-16) and the end-inspiratory esophageal pressure (PESEIP) occurring after the time interval (PESEIP, see col. 15, lines 34-37) by means of the pressure sensor (113, 133, catheter-mounted balloon cuff; 113 to measure airway pressure during inspiratory phase, see col. 11, lines 22-25 and col. 10, lines 13-16; catheter-mounted balloon cuff functioning as an esophageal pressure transducer to measure PESEIP, see col. 2, lines 13-15 and col. 14, lines 58-59; col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube), where the first fluid flow remains stopped during the time interval (PESEIP is measured after an end-inspiration pause, hence the end-inspiratory pause will occur for the time interval; col. 13, lines 9-13); and a second pressure difference between the expiratory airway pressure (PEEP, see col. 10, lines 13-16) and the end-expiratory esophageal pressure (PESEE) occurring after the time interval (PESEE is measured after an end-expiratory pause, hence the time interval is the duration of the end-expiratory pause; col. 13, lines 9-13) by means of the pressure sensor (113, 133, catheter-mounted balloon cuff; 133 to measure PEEP, see col. 11, lines 16-18; catheter-mounted balloon cuff to measure PESEE, see col. 2, lines 13-15 and col. 14, lines 58-59; col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube), where a difference between the first pressure difference (difference between Paw and PESEIP) and the second pressure difference (difference between PEEP and PESEE) determines a transpulmonary pressure difference (see Equation provided above).
Additionally, Stenqvist teaches determining lung compliance (CL) based on the ratio of tidal volume (VT) to the determined transpulmonary pressure difference (
∆
PTP; see col. 10, lines 34-37), where the tidal volume is measure by a flow transducer (112, 132). It is well-known by one of ordinary skill in the art that resistance is the change in pressure divided by flow, hence the calculated transpulmonary pressure difference (
∆
PTP) and the flow rate measured by the flow transducer (112, 132) can be used to calculate lung resistance, where lung resistance is a tissue-related resistance.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the pressure sensor taught by Enk with the pressure sensor taught by Stenqvist (Stenqvist 113, 133, catheter-mounted balloon cuff, see above) to obtain the predictable result of measuring a pressure such that a pressure in the airway can be measured (Stenqvist col. 11, lines 22-25; col. 10, lines 13-16; col. 11, lines 16-18), and to replace the control device taught by Enk with the control unit taught by Stenqvist (Stenqvist 105; Stenqvist Fig. 1; Stenqvist col. 6, lines 62-67) to yield the predictable result of operating the ventilator, where the ventilator taught by Enk in combination with Stenqvist, carries out the method of at least the following steps:
Stopping the first fluid flow (constant fluid supply rate 30 paused during end-inspiratory pause, as taught by Stenqvist; Stenqvist col. 10, line 15) by means of the gas supply device (fluid supplied to airway 5 is supplied by fluid supply unit 2) at a first time point (inspiratory phase, as taught by Stenqvist, see above), and simultaneously
determining a first pressure difference (Stenqvist: difference between Paw and PESEIP, see equation above) between a first pressure (Paw, as taught by Stenqvist, see Stenqvist col. 10, lines 13-16) present at the first time point (inspiratory phase, as taught by Stenqvist, see above) and a second pressure (PESEIP, as taught by Stenqvist, see above) occurring after a time interval (PESEIP, see col. 15, lines 34-37) by means of the pressure sensor (Stenqvist 113, 133, catheter-mounted balloon cuff; Stenqvist 113 to measure airway pressure during inspiratory phase, see Stenqvist col. 11, lines 22-25 and col. 10, lines 13-16; catheter-mounted balloon cuff, as taught by Stenqvist, functioning as an esophageal pressure transducer to measure PESEIP, see Stenqvist col. 2, lines 13-15 and col. 14, lines 58-59; Stenqvist col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube), wherein the first fluid flow remains stopped during the time interval (Stenqvist: PESEIP is measured after an end-inspiration pause, as taught by Stenqvist above, hence the end-inspiratory pause will occur for the time interval; Stenqvist col. 13, lines 9-13); and
stopping the second fluid flow (constant fluid discharge rate 31 paused during end-expiratory pause, as taught by Stenqvist; Fig. 5; Stenqvist col. 10, line 15) by means of the gas discharge device (fluid discharged from airway is discharged by fluid discharge unit 3) at a second time point (expiratory phase), and simultaneously
determining a second pressure difference (difference between PEEP and PESEE, as taught by Stenqvist, see equation above) between a third pressure (PEEP, as taught by Stenqvist, see Stenqvist col. 10, lines 13-16) present at the second time point (expiratory phase, as taught by Stenqvist, see above) and a fourth pressure (PESEE, as taught by Stenqvist, see above) occurring after a time interval (PESEE is measured after an end-expiratory pause, as taught by Stenqvist above, hence the time interval is the duration of the end-expiratory pause; Stenqvist col. 13, lines 9-13) by means of the pressure sensor (Stenqvist 113, 133, catheter-mounted balloon cuff; Stenqvist 133 to measure PEEP, see Stenqvist col. 11, lines 16-18; catheter-mounted balloon cuff, as taught by Stenqvist above, to measure PESEE, see Stenqvist col. 2, lines 13-15 and col. 14, lines 58-59; Stenqvist col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube);
defining and providing a difference between the first pressure difference and the second pressure difference as a first index (see Equation to calculate
∆
P
T
P
above, as taught by Stenqvist) which is usable for determination of at least a tissue-related resistance of the patient (
∆
PTP can be used to calculate lung resistance of the patient, as taught by Stenqvist, see above for equation and explanation taught by Stenqvist) to calculate measured and recorded patient data to personalize the ventilation treatment received by the patient (Stenqvist col. 7, lines 12-13).
Regarding claim 2, Enk as modified teaches the invention as set forth in claim 1, wherein, by carrying out steps d) (see claim 1 above) to f) (see claim 1 above), and when the third pressure (PEEP, as taught by Stenqvist) corresponds to an end-expiratory pressure (Stenqvist col. 10, lines 13-16), a second index (second pressure difference, see claim 1 above, the difference is between PEEP and PESEE as taught by Stenqvist) is defined and provided (see claim 1 above) and an airway-related resistance of the patient is thus determinable (PEEP used to determine
∆
P
A
W
, where
∆
P
A
W
is the total respiratory system driving pressure, as taught by Stenqvist; Stenqvist col. 7, line 13).
Regarding claim 5, Enk as modified teaches the invention as set forth in claim 1, wherein the pressure sensor is arranged endotracheally (Stenqvist 113, 133, catheter-mounted balloon cuff; Stenqvist col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube).
Regarding claim 6, Enk as modified teaches the invention as set forth in claim 1, wherein a second index (second pressure difference is the difference is between PEEP and PESEE as taught by Stenqvist, see claim 1 above) is also defined and provided by means of the control device in step g) (Stenqvist 105, see claim 1 above), whereby the following quantities are thus determinable: an airway-related resistance (Stenqvist: second pressure difference is used to determine transpulmonary pressure difference, see claim 1 above, from which the total respiratory system driving pressure,
∆
P
a
w
, and difference in airway pressure, Paw, can be determined, where the difference in airway pressure; Stenqvist flow transducers 112 and 132 measure change in flow; hence, an airway-related resistance is determinable), by conversion to the constant fluid flow (constant supplied flow of fluid from fluid supply unit 2 and/or constant discharged flow of fluid from fluid discharge unit 3; [0080]), the pressure drop in the airway during the inspiration process (inherent to one of ordinary skill in the art that pressure in the airway would drop, relative to atmospheric pressure, during inspiration to draw air into the lungs; control device 6 determines pressure difference during inspiration process, see claim 1 above) and the expiration process (inherent to one of ordinary skill in the art that during expiration, alveolar pressure increases and esophagus pressure becomes more negative during expiration to create a pressure gradient to cause air to flow out of the alveoli and lungs; control device 6 determines pressure difference during expiration process, see claim 1 above), and an alveolar pressure (Stenqvist 105 is capable of determining Paw, see claim 1 above, where the airway-related pressure is the sum of the airway opening, or endotracheal, pressure and the alveolar pressure) or a plot thereof.
Regarding claim 7, Enk as modified teaches the invention as set forth in claim 1, wherein the control device (Stenqvist 105) is configured to mathematically determine at least the second pressure (PESEIP, as taught by Stenqvist; Stenqvist col. 15., lines 34-37; Equation 1 above; mathematically determinable by Stenqvist 105, see claim 1 above) or the fourth pressure (PESEE, as taught by Stenqvist; Stenqvist col. 15, lines 34-37; Equation 1 above; mathematically determinable by Stenqvist 105, see claim 1 above).
Regarding claim 8, Enk as modified teaches the invention as set forth in claim 1, wherein at least the first time point (inspiratory phase, as taught by Stenqvist) is defined in a temporal second half of the inspiration process (where end-inspiratory pause occurs right before expiration begins and the end-inspiratory pause occurs at the first time point, see claim 1 above, hence the first time point is within a temporal second half of the inspiration process) or the second time point (expiratory phase, as taught by Stenqvist) is defined in a temporal second half of the expiration process (where end-expiratory pause occurs right before inspiration begins, and the end-expiratory pause occurs at the second time point, see claim 1 above, hence the second time point is within a temporal second half of the expiration process).
Regarding claim 12, Enk as modified by Stenqvist above teaches a method for determining at least a tissue-related resistance of a patient ([0012], where compliance is a measurement of elastic resistance) by means of a ventilator (1; Fig. 1), wherein the ventilator (1; Fig. 1) at least a gas supply device (fluid supply unit 2; Fig. 1) and a gas discharge device (fluid discharge unit 3; Fig. 1), for supplying a first fluid flow to an airway of a patient (supply of a flow of fluid from fluid supply unit 2 to an airway 5 of a patient; [0093], lines 3-5) and for discharging a second fluid flow (flow of fluid from fluid discharge unit 3) from the airway back into the ventilator (flow of fluid from fluid discharge unit 3 is discharged from airway 5 to ventilator 1; Fig. 1; [0073]) or to an environment, a pressure sensor (Stenqvist 113, 133, catheter-mounted balloon cuff) for measuring a pressure in the airway (Stenqvist 113 to measure airway pressure during inspiratory phase, see Stenqvist col. 11, lines 22-25 and col. 10, lines 13-16; Stenqvist 133 to measure PEEP, see Stenqvist col. 11, lines 16-18), and a control device (Stenqvist 105; Stenqvist Fig. 1) for operating the ventilator (Stenqvist col. 6, lines 62-67); wherein the control device (Stenqvist 105) is suitably designed to carry out a method comprising at least the following steps:
carrying out an inspiration process (intended duration of inhalation 20; Fig. 5) with the first fluid flow at a constant flow rate (constant fluid supply rate 30; Fig. 5) by means of the gas supply device (fluid supplied to airway 5 is supplied by fluid supply unit 2),
stopping the first fluid flow (constant fluid supply rate 30 paused during end-inspiratory pause, as taught by Stenqvist; Stenqvist col. 10, line 15) by means of the gas supply device (fluid supplied to airway 5 is supplied by fluid supply unit 2) at a first time point (inspiratory phase, as taught by Stenqvist, see above), and simultaneously
determining a first pressure difference (Stenqvist: difference between Paw and PESEIP, see equation above) between a first pressure (Paw, as taught by Stenqvist, see Stenqvist col. 10, lines 13-16) present at the first time point (inspiratory phase, as taught by Stenqvist, see above) and a second pressure (PESEIP, as taught by Stenqvist, see above) occurring after a time interval (PESEIP, see col. 15, lines 34-37) by means of the pressure sensor (Stenqvist 113, 133, catheter-mounted balloon cuff; Stenqvist 113 to measure airway pressure during inspiratory phase, see Stenqvist col. 11, lines 22-25 and col. 10, lines 13-16; catheter-mounted balloon cuff, as taught by Stenqvist, functioning as an esophageal pressure transducer to measure PESEIP, see Stenqvist col. 2, lines 13-15 and col. 14, lines 58-59; Stenqvist col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube); and
carrying out an expiration process (intended duration of exhalation 21; Fig. 5) with the second fluid flow at a constant flow rate (constant fluid discharge rate 31; Fig. 5) by means of the gas discharge device (fluid discharged from airway is discharged by fluid discharge unit 3),
stopping the second fluid flow (constant fluid discharge rate 31 paused during end-expiratory pause, as taught by Stenqvist; Fig. 5; Stenqvist col. 10, line 15) by means of the gas discharge device (fluid discharged from airway is discharged by fluid discharge unit 3) at a second time point (expiratory phase), and simultaneously
determining a second pressure difference (difference between PEEP and PESEE, as taught by Stenqvist, see equation above) between a third pressure (PEEP, as taught by Stenqvist, see Stenqvist col. 10, lines 13-16) present at the second time point (expiratory phase, as taught by Stenqvist, see above) and a fourth pressure (PESEE, as taught by Stenqvist, see above) occurring after a time interval (PESEE is measured after an end-expiratory pause, as taught by Stenqvist above, hence the time interval is the duration of the end-expiratory pause; Stenqvist col. 13, lines 9-13) by means of the pressure sensor (Stenqvist 113, 133, catheter-mounted balloon cuff; Stenqvist 133 to measure PEEP, see Stenqvist col. 11, lines 16-18; catheter-mounted balloon cuff, as taught by Stenqvist above, to measure PESEE, see Stenqvist col. 2, lines 13-15 and col. 14, lines 58-59; Stenqvist col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube);
defining and providing a difference between the first pressure difference and the second pressure difference as a first index (see Equation to calculate
∆
P
T
P
above, as taught by Stenqvist) and determining at least a tissue-related resistance of the patient (lung resistance of the patient is determined using
∆
PTP, as taught by Stenqvist above; Stenqvist col. 10, lines 34-37 and further explanation in claim 1 above).
Regarding claim 13, Enk as modified teaches the invention as set forth in claim 12, wherein, by carrying out steps d) (see claim 12 above) to f) (see claim 12 above), and when the third pressure (PEEP, as taught by Stenqvist) corresponds to an end-expiratory pressure (Stenqvist col. 10, lines 13-16), a second index (second pressure difference, see claim 12 above, the difference is between PEEP and PESEE as taught by Stenqvist) is defined and provided (see claim 12 above) and an airway-related resistance of the patient is thus determined (PEEP used to determine
∆
P
A
W
, where
∆
P
A
W
is the total respiratory system driving pressure, as taught by Stenqvist; Stenqvist col. 7, line 13).
Regarding claim 14, Enk as modified teaches the invention as set forth in claim 12, and further teaches determining a profile of a compliance curve by the supply and/or discharge of a fluid to and/or from a patient ([0038]), determining a position of a pressure interval wither pressures (P1 and P2) along the profile of the at least one subregion of the compliance curve ([0039]), and supplying and/or discharging the fluid to and/or from the patient within the pressure interval determined ([0040]), but fails to explicitly teach wherein at least steps a) to c) during an inspiration process or steps d) to f) during an expiration process are in each case carried out multiple times together with step g).
However, Stenqvist further teaches a desired transpulmonary pressure is continually adapted and adjusted accordingly with a PEEP step maneuver (Col. 13, lines 48-50), where the PEEP step maneuver is taught in steps a) to c) with g) in claim 12 (see claim 12 above) for an inspiration process and steps d) to f) with g) in claim 12 (see claim 12 above) for an expiration process.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Enk with Stenqvist, such that at least steps a) to c) during an inspiration process (see claim 12 above) or steps d) to f) during an expiration process (see claim 12 above) are in each case carried out multiple times together with step g) (Stenqvist: Col. 13, lines 48-50; claim 12 above) to improve patient-specific therapy and treatment by continually updating and adapting the ventilation strategy of a patient (Stenqvist: Col. 7, lines 12-13).
Regarding claim 16, Enk as modified teaches a control device (Stenqvist 105; Stenqvist Fig. 1) for a ventilator (1; Fig. 1; Stenqvist col. 6, lines 62-67) that is equipped, configured or programmed to carry out the method as claimed in claim 12 (see claim 12 above).
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Enk (US 20190022342 A1) in view of Stenqvist (US 9655544 B2) as applied to claims 1 and 12 above, and further in view of Al-Rawas et al. (Article: Expiratory time constant for determinations of plateau pressure, respiratory system compliance, and total resistance; hereinafter “Al-Rawas et al.”).
Regarding claim 3, Enk as modified teaches the invention as set forth in claim 1, but fails to explicitly teach wherein it is defined for step g) (see claim 1 above) that the tissue-related resistance is negligible in an end-expiratory state and maximal in an end-inspiratory state and wherein, between the end-expiratory state and the end-inspiratory state, the tissue-related resistance, increases linearly during the inspiration process and decreases linearly during the expiration process.
However, it is well-known to a person of ordinary skill in the art that tissue resistance is negligible at end of expiration as the flow is constant and the pressure is low due to the expulsion of air from the lungs and tissue resistance will be the highest at the end of inspiration as the lungs are full of air, the flow is constant, and the pressure is high. Further, Al-Rawas et al. teaches a negligible tissue-related resistance in an end-expiratory state, a maximal tissue-related resistance in an end-inspiratory state, a linear increase in tissue-related resistance in between an end-expiratory state and an end-inspiratory state, and a linear decrease in tissue-related resistance in between an end-inspiratory state and an end-expiratory state (see Annotated Fig. 1 below).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Enk with Al-Rawas et al., such that the tissue-related resistance is negligible in the end-expiratory state and maximal in the end-inspiratory state and wherein, between the end-expiratory state and the end-inspiratory state, the tissue-related resistance, increases linearly during the inspiration process and decreases linearly during the expiration process (Al-Rawas et al.: see Annotated Fig. 1 below) as these are well-known physiological processes to one of ordinary skill in the art.
PNG
media_image1.png
597
717
media_image1.png
Greyscale
Annotated Fig. 1
Regarding claim 15, Enk as modified teaches the invention as set forth in claim 12, wherein it is defined for step g) (see claim 12 above) that the tissue-related resistance is negligible in the end-expiratory state and maximal in the end-inspiratory state and wherein, in between the end-expiratory state and the end-inspiratory state, the tissue-related resistance increases linearly during the inspiration process and decreases linearly during the expiration process (Al-Rawas et al.: see Annotated Fig. 1 above, where these are well-known physiological processes in the art).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Enk (US 20190022342 A1) in view of Stenqvist (US 9655544 B2) in further view of Al-Rawas et al. (Article: Expiratory time constant for determinations of plateau pressure, respiratory system compliance, and total resistance) as applied to claim 3 above, and further in view of Tham et al. (US 6068602 A).
Regarding claim 4, Enk as modified teaches the invention as set forth in claim 3, but fails to teach wherein a regression analysis is performable by means of the control device at least to determine the tissue-related resistance.
However, Tham et al. teaches a CPU (28) receives pressure measurements from a pressure sensor (22), and is programmed to calculate an airway resistance and lung compliance (Col. 3, lines 37-41), where the airway resistance and lung compliance are calculated using regression analysis (Col. 5, lines 56-59). The controller (28) is capable of calculating a resistance within the airway using regression analysis based on measurements from the pressure sensor (22) and is capable of taking measurements of lung-related pressures to calculate lung compliance using regression analysis, hence the controller (28) would be capable of calculating a lung resistance using regression analysis based on pressure measurements from the pressure sensor (22).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Enk with Tham et al., such that a regression analysis is performable by means of the control device (Tham et al.: regression analysis performed by controller 28; Col. 5, lines 56-59) at least to determine the tissue-related resistance (Tham et al.: Col. 3, lines 37-41; Col. 5, lines 56-59, where controller 28 is capable of calculating lung resistance, see explanation above) to decrease the impact of measurement noise on tissue-related resistance calculations (Tham et al.: Col. 5, lines 59-61).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Enk (US 20190022342 A1) in view of Stenqvist (US 9655544 B2) as applied to claim 1 above, and further in view of Banner & Blanch (US 20030010339 A1).
Regarding claim 9, Enk as modified teaches the invention as set forth in claim 1, but fails to explicitly teach wherein, at least in step b) (see claim 1 above), the first fluid flow (a flow of fluid from fluid supply unit 2) is stopped when a defined peak inspiratory pressure has been reached.
However, Banner & Blanch teaches a ventilator (20) with a pressure sensor (100) that detects the peak inflation pressure, PIP, prior to the initiation of an inhalation hold ([0099], lines 14-20).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Enk with Banner, such that at least in step b) (see claim 1 above), the first fluid flow (a flow of fluid from fluid supply unit 2) is stopped when a defined peak inspiratory pressure (Banner & Blanch: peak inflation pressure, PIP, occurs immediately prior to the initiation of an inhalation hold; [0099], lines 14-20) has been reached to have accurate, real-time analysis of a patient’s respiratory system resistances (Banner & Blanch: [0128], lines 7-12).
Claims 10 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Enk (US 20190022342 A1) in view of Stenqvist (US 9655544 B2) further in view of Banner & Blanch (US 20030010339 A1) as applied to claim 9 above, and further in view of Al-Rawas et al. (Article: Expiratory time constant for determinations of plateau pressure, respiratory system compliance, and total resistance).
Regarding claim 10, Enk as modified teaches the invention as set forth in claim 9, but fails to explicitly state wherein, in the case of the first pressure difference (Stenqvist: difference between Paw and PESEIP, see equation in claim 1 above), a (total) resistance arises from a sum total of an airway-related resistance and a maximum of a tissue-related resistance.
However, Al-Rawas et al. teaches during inhalation, total resistance includes the series of resistance of the endotracheal tube plus physiologic airways resistance (Pg. 1, last sentence; Pg. 2, first sentence), where physiological airways resistance is a tissue-related resistance, and where a maximal tissue-related resistance occurs in an end-inspiratory state (as taught by Al-Rawas et al. in claim 3 above).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Enk with Al-Rawas et al., such that in the case of the first pressure difference (Stenqvist: difference between Paw and PESEIP, see equation in claim 1 above), a (total) resistance arises from a sum total of an airway-related resistance and a maximum of a tissue-related resistance (Al-Rawas et al.: Pg. 1, last sentence; Pg. 2, first sentence; claim 3 above; see Al-Rawas et al. Annotated Fig. 1 below) to more accurately calculate the total resistance during an inspiratory phase.
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Al-Rawas et al. Annotated Fig. 1
Regarding claim 11, Enk as modified teaches the invention as set forth in claim 9, wherein, in the case of the second pressure difference (Stenqvist: difference between PEEP and PESEE, see equation in claim 1), the (total) resistance arises from the airway-related resistance (Al-Rawas et al.: Pg. 1, last sentence; Pg. 2, first sentence, where physiological airways resistance is a tissue-related resistance, and where tissue-related resistance is negligible in an end-expiratory state, hence the total resistance in the end-expiratory state would be the series of resistance of the endotracheal tube; see claim 3 above; Al-Rawas et al. Annotated Fig. 1 above).
Response to Arguments
On page 10 of the Remarks (filed 04/27/2026), Applicant argues neither Enk nor Stenqvist, taken alone or in any proper combination, describes or suggests “determining a first pressure difference between a first pressure present at the first time point and a second pressure occurring after a time interval by means of the pressure sensor” and “determining a second pressure difference between a third pressure present at the second time point and a fourth pressure occurring after a time interval by means of the pressure sensor” as recited in claim 1.
Applicant specifically states independent claim 1 requires both the first pressure difference and the second pressure difference are determined “by means of the pressure sensor” which is a single pressure sensor located in the airway (see pg. 10 of Remarks). However, claim 1 simply recites “a pressure sensor for measuring a pressure in the airway of the patient” (see claim 1, lines 3-4). Applicant’s specification states “[t]he use of indefinite articles (“a”, “an”), especially in the claims and in the description reproducing said claims, should be understood as such and not as a numeral. Terms or components correspondingly introduced thereby are therefore to be understood in such a way that they are present at least once and can in particular, however, also be present multiple times” (see [0129] of PGPub US 20230201502 A1). Hence, the pressure sensor disclosed in claim 1 is not a single pressure sensor and is to be understood as – at least one pressure sensor – where there may be one or more pressure sensors. Furthermore, the pressure sensor recited in claim 1 is not explicitly located in the airway, it is “for measuring a pressure in the airway” (see claim 1, line 4). Hence, the pressure sensor must be capable of measuring a pressure in the airway, but is not required to be located in the airway (MPEP §2114). Enk in combination with Stenqvist, as presented above (see 103 rejection of claim 1 above) teaches at least one pressure sensor capable of determining a pressure in the airway of the patient and determines a first pressure at the first time point, a second pressure occurring after a time interval, a third pressure present at the second time point , and a fourth pressure occurring after a time interval.
Similarly, independent claims 12 and 16 recite the same pressure sensor and pressure difference limitations. As such, the above response applies with equal force to claims 12 and 16.
On page 11 (see Remarks filed 04/27/2026), Applicant argues the mapping of Stenqvist’s airway pressure transducers 113 and 131 to measure PESEIP and PESEE, which are respectively mapped to the claimed “second pressure” and “fourth pressure”, is unsupported by the reference. Stenqvist’s pressure transducers are not explicitly airway pressure sensors; however, the reference only discloses the use of pressure transducers 113 and 131 for the purpose of Paw and PEEP, which are generally understood as airway pressures. As such, Applicant’s argument (see pg. 11 of Remarks), with respect to independent claims 1, 12, and 16 have been fully considered and are persuasive. The rejection of claims 1, 12, and 16 have been withdrawn.
However, upon further consideration, a new ground of rejection is made in view of a different interpretation of the previously applied references. Enk in combination with Stenqvist teaches a pressure sensor (Stenqvist 113, 133, catheter-mounted balloon cuff) to measure PESEIP (Stenqvist 113, 133, catheter-mounted balloon cuff; catheter-mounted balloon cuff, as taught by Stenqvist, functioning as an esophageal pressure transducer to measure PESEIP, see Stenqvist col. 2, lines 13-15 and col. 14, lines 58-59; Stenqvist col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube) and PESEE (Stenqvist 113, 133, catheter-mounted balloon cuff; catheter-mounted balloon cuff, as taught by Stenqvist above, to measure PESEE, see Stenqvist col. 2, lines 13-15 and col. 14, lines 58-59; Stenqvist col. 14, lines 54-54-59, where airway pressure transducer and catheter-mounted balloon cuff may be positioned on a pressure line together to be inserted into and endotracheal tube) as presented above in the rejection of claims 1, 12, and 16 under 35 U.S.C. 103.
On page 12 of the Remarks, Applicant argues the passage of Stenqvist provided during the interview on 04/15/2026 reciting “Tracheal airway and esophageal pressure was measured via a pressure line introduced through the ETT” (see Stenqvist col. 14, lines 54-55) was not read in context as the following sentence recites “[e]sophageal pressure was measured with a balloon catheter positioned at the lower part of the esophagus” (see Stenqvist col. 14, lines 57-59). Applicant further states, as such, the provided Stenqvist passage does not state a single sensor measures both [airway and esophageal] pressures (see pg. 12 of Remarks). However, the Examiner interprets the provided Stenqvist passage as – a pressure line comprising a balloon catheter, such that the pressure line, when introduced through the ETT, measures both tracheal airway and esophageal pressure. As such, the pressure line taught by Stenqvist does measure both airway and esophageal pressure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Andrieux & Jourdain (US 9649458 B2): Regarding a breathing assistance system to analyze at least one or more pressure sensor signals and control the breathing assistance system accordingly.
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/ABIGAYLE DALE/Examiner, Art Unit 3785 /BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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