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 09/23/2025. Per the amendment, claims 1-16 are as currently amended. Claims 1-16 are pending in the instant application. The amendments specification have been considered by the Examiner and hereby are entered.
All specification objections made in the Office Action mailed 08/21/2025 are withdrawn in light of the amendments.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided (see “by means of a ventilator” in the last sentence of the abstract).
Claim Objections
Claims 1 and 15 are objected to because of the following informalities:
Claim 1, line 12, and all other recitations: “and at the same time” should read “simultaneously” for clarity and to avoid potential antecedent basis issues.
Claim 15, line 2: “the end-expiratory state” should read “an end-expiratory state” to establish antecedent basis.
Claim 15, lines 3: “the end-inspiratory state” should read “an end-inspiratory state” to establish antecedent basis.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “mathematically determinable” in claim 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 (line 9) and claim 12 (line 10) recite the limitation “a constant first fluid flow”. It is unclear if the applicant is disclosing the first fluid flow, supplied from the gas supply device, at a constant flow, or if the applicant is disclosing a new limitation. For the purpose of examination, the above limitation will be interpreted as – the first fluid flow, supplied from the gas supply device, at a constant flow.
Claim 1 (line 17) and claim 12 (line 17) recite the limitation “a constant second fluid flow”. It is unclear if the applicant is disclosing the second fluid flow, discharged from the gas discharge device, at a constant flow, or if the applicant is disclosing a new limitation. For the purpose of examination, the above limitation will be interpreted as – the second fluid flow, discharged from the gas discharge device, at a constant flow.
Claim 7 limitation “wherein at least the second pressure or the fourth pressure is mathematically determinable” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification discloses at least the second pressure or the fourth pressure is mathematically determinable by a control device (Pg. 13, lines 19-20); however, the specification does not disclose how the mathematical determination is performed, or what the mathematical determination is (i.e., algorithm, processor). Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-6, 8-11, and 13-16 are rejected due to 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:
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 at the same time as step c), wherein the first fluid flow remains stopped during the time interval; 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 at the same time as step e);
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 a control unit (105) configured to carry out a method comprising:
stopping the first fluid flow (end-inspiratory pause; Col. 10, line 15) by means of the 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 a first time point (inspiratory phase), and at the same time
determining a first pressure present at the first time point (measuring airway pressure, Paw, during end-inspiratory pause; col. 10, lines 13-16) and a second pressure occurring after a time interval (end-inspiratory esophageal pressure, PESEIP, where PESEIP is measured; col. 15., lines 34-37) by means of a pressure sensor (inspiratory pressure transducer 113), wherein 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 a time interval; col. 13, lines 9-13),
stopping the second fluid flow (end-expiratory pause; Col. 10, line 15) by means of the gas discharge device (evacuation system 141, expiratory valve 140, expiratory valve 130, and expiratory branch 126; Fig. 1) at a second time point (expiratory phase), and at the same time
determining a third pressure present at the second time point (measuring airway pressure, PEEP, during end-expiratory pause; col. 10, lines 13-16) and a fourth pressure (end-expiratory esophageal pressure, PESEE, where PESEE is measured; col. 15, lines 34-37) 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 (pressure transducer 131).
Stenqvist does not explicitly teach
determining a first pressure difference between the first pressure and the second pressure,
determining a second pressure difference between the third pressure and the fourth pressure, and
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 does teach 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
)
Stenqvist further teaches lung compliance (CL) to be the ratio of the tidal volume (VT) to the transpulmonary pressure difference (
∆
PTP; see col. 10, lines 34-37), where the tidal volume is measure by a flow transducer (112, 132). Additionally, it is well-known 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 modify Enk with Stenqvist such that the control device (6; Fig. 1) is configured to carry out a method comprising the following steps:
stopping the first fluid flow (Stenqvist: end-inspiratory pause; Col. 10, line 15) by means of the gas supply device (Stenqvist: 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 a first time point (inspiratory phase), and at the same time,
determining a first pressure difference (Stenqvist: difference between Paw and PESEIP, see equation above) between a first pressure present at the first time point (Stenqvist: measuring airway pressure, Paw, during end-inspiratory pause; col. 10, lines 13-16) and a second pressure occurring after a time interval (Stenqvist: end-inspiratory esophageal pressure, PESEIP, where PESEIP is measured; col. 15., lines 34-37) by means of a pressure sensor (Stenqvist: inspiratory pressure transducer 113), wherein the first fluid flow remains stopped during the time interval (Stenqvist: PESEIP is measured after an end-inspiration pause, hence the end-inspiratory pause will occur for the a time interval; col. 13, lines 9-13),
stopping the second fluid flow (Stenqvist: end-expiratory pause; Col. 10, line 15) by means of the gas discharge device (Stenqvist: evacuation system 141, expiratory valve 140, expiratory valve 130, and expiratory branch 126; Fig. 1) at a second time point (expiratory phase), and at the same time,
determining a second pressure difference (Stenqvist: difference between PEEP and PESEE, see equation above) between a third pressure present at the second time point (Stenqvist: measuring airway pressure, PEEP, during end-expiratory pause; col. 10, lines 13-16) and a fourth pressure (Stenqvist: end-expiratory esophageal pressure, PESEE, where PESEE is measured; col. 15, lines 34-37) occurring after a time interval (Stenqvist: 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 (Stenqvist: pressure transducer 131), and
defining and providing a difference (Stenqvist:
∆
PTP, see equation above) between the first pressure difference (Stenqvist: difference between Paw and PESEIP, see equation above) and the second pressure difference (Stenqvist: difference between PEEP and PESEE, see equation above) as a first index which is usable for determination of at least a tissue-related resistance of the patient (Stenqvist:
∆
PTP can be used to calculate lung resistance of the patient, see equation and explanation above) 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 (Stenqvist: PEEP, see equation above) 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) is defined and provided (see claim 1 above) and an airway-related resistance of the patient is thus determinable (Stenqvist: PEEP used to determine
∆
P
A
W
, where
∆
P
A
W
is the total respiratory system driving pressure; col. 7, line 13).
Regarding claim 5, Enk as modified teaches the invention as set forth in claim 1, wherein the pressure sensor (pressure sensor 24; [0126]; [0021) is arranged endotracheally ([0031], lines 3-4).
Regarding claim 6, Enk as modified teaches the invention as set forth in claim 1, wherein a second index (Stenqvist: second pressure difference, see claim 1 above, the difference is between PEEP and PESEE) is also defined and provided by means of the control device in step g) (see claim 1), 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) 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), and an alveolar pressure (control device 6 is capable of determining airway-related pressure, Paw, 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 at least the second pressure (Stenqvist: end-inspiratory esophageal pressure, PESEIP, where PESEIP is measured; col. 15., lines 34-37; Equation 1) or the fourth pressure (Stenqvist: end-expiratory esophageal pressure, PESEE, where PESEE is measured; col. 15, lines 34-37; Equation 1) is mathematically determinable (mathematically determinable by control device 6, see claim 1 above).
Regarding 8, Enk as modified teaches the invention as set forth in claim 1, wherein at least the first time point (inspiratory phase) 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) 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 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 (pressure sensor 24; [0126]; [0021]) for measuring a pressure in the airway ([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 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 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),
stopping the first fluid flow (Stenqvist: end-inspiratory pause; Col. 10, line 15) by means of the gas supply device (Stenqvist: 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 a first time point (inspiratory phase), and at the same time,
determining a first pressure difference (Stenqvist: difference between Paw and PESEIP, see equation above) between a first pressure present at the first time point (Stenqvist: measuring airway pressure, Paw, during end-inspiratory pause; col. 10, lines 13-16) and a second pressure occurring after a time interval (Stenqvist: end-inspiratory esophageal pressure, PESEIP, where PESEIP is measured; col. 15., lines 34-37) by means of a pressure sensor (Stenqvist: inspiratory pressure transducer 113),
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),
stopping the second fluid flow (Stenqvist: end-expiratory pause; Col. 10, line 15) by means of the gas discharge device (Stenqvist: evacuation system 141, expiratory valve 140, expiratory valve 130, and expiratory branch 126; Fig. 1) at a second time point (expiratory phase), and at the same time,
determining a second pressure difference (Stenqvist: difference between PEEP and PESEE, see equation above) between a third pressure present at the second time point (Stenqvist: measuring airway pressure, PEEP, during end-expiratory pause; col. 10, lines 13-16) and a fourth pressure (Stenqvist: end-expiratory esophageal pressure, PESEE, where PESEE is measured; col. 15, lines 34-37) occurring after a time interval (Stenqvist: 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 (Stenqvist: pressure transducer 131), and
defining and providing a difference (Stenqvist:
∆
PTP, see equation above) between the first pressure difference (Stenqvist: difference between Paw and PESEIP, see equation above) and the second pressure difference (Stenqvist: difference between PEEP and PESEE, see equation above) as a first index and determining at least a tissue-related resistance of the patient (Stenqvist:
∆
PTP can be used to calculate lung resistance of the patient, see equation and explanation 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) to f) (see claim 12), and when the third pressure (Stenqvist: measuring airway pressure, PEEP, during end-expiratory pause; col. 10, lines 13-16; see Equation 1 in claim 1 above) 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) is defined and provided (see claim 12 above) and an airway-related resistance of the patient is thus determined (Stenqvist: PEEP used to determine
∆
P
A
W
, where
∆
P
A
W
is the total respiratory system driving pressure; 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 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 (6; Fig. 1) for a ventilator (1; Fig. 1) 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 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 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
610
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).
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 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 (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 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 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 (see claim 3).
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 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; Annotated Fig. 1 in claim 3) to more accurately calculate the total resistance during an inspiratory phase.
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; Annotated Fig. 1 in claim 3).
Response to Arguments
Applicant's arguments filed 09/23/2025 have been fully considered but they are not persuasive.
Applicant argues neither “PEEP” nor “Paw” would have been reasonably regarded as being a “pressure difference between a third pressure present at the second time point of stopping and a fourth pressure occurring after a time interval”, but fails to provide reasoning for how “PEEP” and “Paw” would not be reasonably regarded as reading on the third pressure and the fourth pressure as required by the claim’s step “I(f)”. As best understood by the Examiner, the requirements of the claim’s step “(f)” include:
Determining a third pressure present at the second time point,
Determining a fourth pressure, where the fourth pressure occurs after a time interval,
Determining the third pressure and the fourth pressure by means of a pressure sensor, and
Determining a second pressure difference between the third pressure and fourth pressure.
Enk in combination with Stenqvist teaches the above requirements of the claim’s step “(f)”, as explained in claim 1 above.
Applicant further argues the prior art, viewed as a whole, fails to teach or suggest the possibility of using a pair of pressure differences obtained by measuring pressure drops following cessation of fluid flow during inspiration and expiration to derive a characteristic value from the resulting pressure difference. However, the prior art does teach using a pair of pressure differences (the difference between an airway pressure during an end-inspiratory pause and an end-inspiratory esophageal pressure; the difference between an airway pressure during and end-expiratory pause and an end-expiratory esophageal pressure, see claims 1 and 12 above) obtained by measuring changes in pressure following a cessation of fluid flow during inspiration (the difference between Paw and PESEIP, see claims 1 and 12) and expiration (the difference between PEEP and PESEE, see claims 1 and 12), where the difference in transpulmonary pressure is derived from the resulting pressure differences (see claims 1 and 12 above).
Applicant states “[t]o prove that steps “(d),” “(f),” and “(g)” were known to be an obvious way to accurately determine PTP, the examiner relies on D2’s col. 5, lines 25-26.” However, col. 5, lines 25-26 of Stenqvist were not used to explain the claim’s steps “(d),” “(f),” and “(g)” are an accurate way to determine PTP, but was cited as motivation to combine Stenqvist and Enk. Meanwhile, Col. 10, line 15; Col. 6, lines 35-38; col. 10, lines 13-16; col. 15, lines 34-37; col. 13, lines 9-13; Col. 15, lines 37-40; Col. 10, lines 13-19 of Stenqvist (see claims 1 and 12 above) were used to explain how the claim’s steps “(d),” “(f),” and “(g)” are a known way to determine PTP.
Applicant further argues “articulated reasoning with some rational underpinning” has not been provided to explain why one of ordinary skill in the art would have understood claim 1’s steps “(d),” “(f),” and “(g)” to be another way to refer to using small PEEP steps. The Examiner agrees as the Examiner did not present the use of small PEEP steps to perform the claim’s steps “(d),” “(f),” and “(g)”, nor the use of small PEEP steps in general, in the Office Action mailed 08/21/2025, hence no explanation is required. In addition, the Examiner clarifies carrying out an expiration process with a constant second fluid flow by means off a gas discharge device, a second pressure difference (difference between PEEP and PESEE as explained in claims 1 and 12 above), and a difference between a first pressure difference (difference between Paw and PESEIP as explained in claims 1 and 12 above) and the second pressure difference (difference between PEEP and PESEE as explained in claims 1 and 12 above) results in the transpulmonary pressure difference which is used to calculate lung resistance of a patient (see claims 1 and 12 above).
Applicant further states it is not clear if resistance is equal to (∆pressure)/(∆flow), as allegedly taught by Stenqvist, is correct. The Examiner agrees this is not correct. However, resistance is equal to (∆pressure)/(flow). This is a well-known concept within the art, as explained above in claims 1 and 12. In addition to the provided explanation in claims 1 and 12, “Pressure-Flow-Resistance” by Reed & Clark provides further support (see Equ. 1 on pg. 1 of provided pdf).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jafari et al. (US 6626175 B2): Regarding measuring and calculating a pressure difference with a medical ventilation system.
Kremeier (US 20190231202 A1): Regarding a breathing system capable of measuring and calculating pressure differences and optimizing the respiration of patients.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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