JDETAILED 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 .
Claim Objections
Claims 1 4 are objected to because of the following informalities:
Regarding claim 1, “…Im(Zaw); f) modeling at least the real component…” in lines 25-26, should read “…Im(Zaw); and f) modeling at least the real component…”
Regarding claim 4, “Im(Zaw) = j x (k x ω x Iaw + (–H)/ωα” in line 5, should read “Im(Zaw) = j x (k x ω x Iaw + (–H)/ωα)”.
Regarding claim 15, “…Im(Zaw); f) modeling at least the real component…” in lines 27-28, should read “…Im(Zaw); and f) modeling at least the real component…”
Appropriate correction is required.
Specification
The amendment filed 01/11/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the incorporation by reference of the international patent application PCT/EP2021/064749 and of the foreign patent application DE10/20201185294 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 06/02/2021, see MPEP 1893.03(b). Therefore, the specification amendment of 01/11/2023 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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: “gas supply device” in claims 1 and 15 and “gas discharge device” in claims 1, 12, 15, and 17.
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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 6-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kaczka (Kaczka DW, Dellacá RL. Oscillation mechanics of the respiratory system: applications to lung disease; DOI: 10.1615/CritRevBiomedEng.v39.i4.60) in view of Trivikram (US 20190298947 A1).
Regarding claim 1, Kaczka discloses a pressure sensor for sensing a pressure Ptrach in the airway (The airway opening pressure (Pao) is measured as set forth for Figure 1 on page 22, page 3 paragraph 5, and utilized in equation (1) on page 2), and a control device for operating the ventilator (Microprocessors for used in devices for implementing a forced oscillation technique as set forth on page 4 paragraph 4); wherein the control device is configured to carry out a method comprising at least the following steps:
a) defining a pressure interval in which the patient is to be ventilated for a defined time interval (The impedance used in FOT, forced oscillation technique, given in equation (1) as Z(ω) is defined as the ratio of pressure (P) to flow (V) as a function of oscillation frequency as set forth on page 2 paragraph 4; oscillation frequency inherently involving a time interval to determine its value; Additionally, the use of a Fourier Transform for the sensed value is performed as set forth on page 3 paragraph 6 and page 7 paragraph 2, meaning the time dependent signals of pressure and flow are converted into a frequency);
b) repeatedly and alternately carrying out one inspiration process at a time with the first fluid flow Q1 and one expiration process at a time with the second fluid flow Q2 within the pressure interval (The impedance used in FOT, forced oscillation technique, given in equation (1) as Z(ω) is defined as the ration of pressure (P) to flow (V) as a function of oscillation frequency as set forth on page 2 paragraph 4; specific pressures and flows measured repeatedly during oscillatory motion would include a first fluid flow during the inspiration process and a second fluid flow during the expiration process),
c) sensing the fluid flows and the pressure which changes during step b) (The concept of mechanical impedance embodies a precise quantitative relationship between specific pressures and flows measured during oscillatory motion as set forth on page 4 paragraph, the measured values being the sensed fluid flows and pressures);
d) carrying out a Fourier transform for the sensed values of the pressure and forming a first frequency spectrum for the pressure and carrying out a Fourier transform for the sensed values of the fluid flows and forming a second frequency spectrum for the fluid flows (After high pass filtering the measured flow and pressures signals, impedance could be computed using various Fourier Transform methods as set forth on page 3 paragraph 6; To calculate impedance spectra from oscillatory flow and pressure waveforms, several signal processing techniques can be used. The simplest and most direct is to excite the respiratory system at one discrete frequency while the subject remains apneic, and then determine the value of impedance from the corresponding pressure and flow using Equation 1 at this frequency. By continually forcing the respiratory system with different discrete frequencies, values of the impedance can be obtained over a particular frequency range, the input flow and output pressure signals can then be spectrally decomposed into their individual frequency components using standard Fourier analysis, from which the value of the impedance can be determined at each particular frequency as set forth on page 5 paragraph 4 – page 6 paragraph 1);
e) calculating an impedance Zaw of the airway by dividing the first frequency spectrum by the second frequency spectrum (Set forth for equation 1 on page 2 and equation 6 on page 6) wherein the impedance comprises a real component Real(Zaw) and an imaginary component Im(Zaw) (Set forth for equation 2 on page 3, equations 8 and 9 on page 7, and equation 12 on page 8, where j is the unit imaginary number; Additionally, page 4 paragraph 1 sets forth that the real part of impedance is generally constant with frequency, while the imaginary part increases monotonically with frequency, behaviors consistent with simple, constant resistive-inertial-compliant properties of the respiratory system);
f) modeling at least the real component by a first mathematical model (The distribution of parallel airway resistances can be approximated with a predefined probability density function, P(Raw), with lower and upper bounds Raw,min and Raw,max, respectively, the impedance predicted by such a model is given by equation 12 on page 8 as set forth in paragraph 3) and ascertaining an alveolar pressure Palv or a plot of an alveolar pressure Palv (A fundamental part of oscillatory mechanics of the respiratory system is the measurement of pressure, which may be obtained within the alveoli, these pressures may be transduced relative to atmosphere by differential sensors, where traditionally, variable reluctance transducers have been used for FOT measurements as set forth on page 5 paragraph 2).
Kaczka fails to explicitly disclose the use of the system as set forth above with the use of a ventilator. However, Kazka does teach that many of these forced oscillation systems can easily be incorporated into existing ventilator platforms in the operating room or intensive care unit, to allow for bedside assessment of respiratory mechanics with minimal disruption of ventilatory support (As set forth Page 4 paragraph 3 and shown in Figure 1 page 22) and that oscillatory V̇ao is applied at the mouth or trachea (As set forth for Figure 1 on page 22 and page 3 paragraph 5).
Kaczka as modified fails to explicitly disclose that the ventilator comprises a gas supply device and a gas discharge device, for supplying a first fluid flow to an airway of a patient and for discharging a second fluid flow from the airway back into the ventilator or to an environment and that the first fluid flow Q1 by means of the gas supply device and one expiration process at a time with the second fluid flow Q2 by means of the gas discharge device.
However, Trivikram teaches a ventilator (Trivikram: FIG. 13 Respiratory apparatus 200 as set forth in [0097]) comprising a gas supply device (Trivikram: FIG. 13 Pressure generating source 206 and the pressure restricting valve as set forth in [0096]) and a gas discharge device (Trivikram: FIG. 13 Pressure generating source 208 and the pressure restricting valve as set forth in [0096]) capable of supplying a first fluid flow Q1 by means of the gas supply device and discharging a second fluid flow Q2 by means of the gas discharge device (FIG. 13 The position of the first pressure restricting valve 214 and the position of the second pressure restricting valve 216 can be changed alternately to block/unblock the at least one first pressure generating source 206 and the at least one second pressure generating source 208 respectively to generate aggressive oscillation by forming alternate positive and negative waveforms as set forth in [0096]).
Kaczka and Trivikram are both considered to be analogous to the claimed invention because they are in the same field of utilizing the forced oscillation technique/spirometry in combination with a ventilator. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system/control method as disclosed by Kaczka to incorporate the teaching of Trivikram and include a ventilator (Trivikram: FIG. 13 Respiratory apparatus 200 as set forth in [0097]) comprising a gas supply device (Trivikram: FIG. 13 Pressure generating source 206 as set forth in [0096]) and a gas discharge device (Trivikram: FIG. 13 Pressure generating source 208 as set forth in [0096]) capable of supplying a first fluid flow Q1 by means of the gas supply device and discharging a second fluid flow Q2 by means of the gas discharge device (FIG. 13 The position of the first pressure restricting valve 214 and the position of the second pressure restricting valve 216 can be changed alternately to block/unblock the at least one first pressure generating source 206 and the at least one second pressure generating source 208 respectively to generate aggressive oscillation by forming alternate positive and negative waveforms as set forth in [0096]). Doing so would enable the use of the forced oscillation technique to determine patient parameters to be used in combination with a ventilator (Trivikram: As set forth in [0097])and would enable greater control over the oscillation waveform (Trivikram: By changing the speed of the pressure generating sources and position of the pressure restricting valves, additional control over pressure and flow of oscillatory waveform can be achieved. Further, in aggressive oscillation generation switching between the positive pressure generator and negative pressure generator helps to generate oscillatory waveform. Such an approach of oscillation generation is more aggressive and hence, more variation in flow/pressure can be achieved in lesser time using this approach. Extent to which the pressure restricting valves open decides the amount of pressure generated and the flow delivered to the patient. Additionally, by changing speed of the pressure generating sources, additional control over pressure and flow of the oscillatory waveform can be achieved in this process. As set forth in [0101]). It would be obvious to one of ordinary skill in the art that the patient’s inhaled/exhaled fluid would have an effect on the parameters utilized in determining lung impedance (for example, the inhalation and exhalation flow rates), and therefore would be more easily determined given a system capable of providing set positive and negative pressure to the patient airway, given the ability to control the waveform as set forth above.
Regarding claim 6, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kaczka further discloses, wherein at least steps a) to c) are carried out in different pressure intervals (In one instance, measurements were made at PEEPs of 0 and 6 cm H2O as set forth on page 12 paragraph 2)
Regarding claim 7, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kaczka further discloses, wherein the pressure interval encompasses at most 10 mbar (PEEPs of 0 and 6 cm H2O are under 10 mbar).
Regarding claim 8, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kaczka fails to explicitly disclose wherein the fluid volume supplied or discharged within the pressure interval is at most 10% of a maximum volume of the airway.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the fluid volume supplied or discharged within the pressure interval is at most 10% of a maximum volume of the airway in the device of Kaczka because Applicant has not disclosed that the specific percentage provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states on page 11 paragraph 3 that “the fluid volume supplied and/or discharged within the pressure interval (and within one ventilation process) is at most 10%, preferably at most 5%, particularly preferably 2%, of a maximum volume of the airway. In particular, the fluid volume is at least 1%, preferably at least 2%, of the maximum volume of the airway”. One of ordinary skill in the art, furthermore, would have expected the fluid volume supplied or discharged in Kaczka, and Applicant's fluid volume, to perform equally well because both ventilators perform the same function of providing respiratory support while monitoring and acquiring pressure and flow data in reference to the respiratory parameters of the patient.
Therefore, it would have been prima facie obvious to modify Kaczka to obtain the invention as specified in claim 8, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired fluid volume supplied to and discharged from the patient for providing ventilation as well as creating a condition allowing for the acquisition of patient respiratory parameters and thus fails to patentably distinguish over the prior art of Kaczka.
Regarding claim 9, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kaczka fails to explicitly disclose wherein at least five inspiration processes and expiration processes are carried out in step b).
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the number of inspiration processes and expiration processes carried out in step b) at least five in the device of Kaczka because Applicant has not disclosed that the specific number provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states on page 11 paragraph 5 that “In particular, at least five, preferably at least seven, particularly preferably at least 10, inspiration processes and expiration processes are carried out in step b)”. One of ordinary skill in the art, furthermore, would have expected amount of times step b) is carried out in Kaczka, and Applicant's amount of times step b) is carried out, to perform equally well because both ventilators perform the same function of providing respiratory support while monitoring and acquiring pressure and flow data in reference to the respiratory parameters of the patient.
Therefore, it would have been prima facie obvious to modify Kaczka to obtain the invention as specified in claim 9, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired amount of times step b) is carried out in order to maintain the provision of ventilation supplied to the patient as well as maintaining a condition allowing for the acquisition of patient respiratory parameters and thus fails to patentably distinguish over the prior art of Kaczka.
Regarding claim 10, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kaczka fails to explicitly disclose, wherein values for the pressure and the fluid flow are sensed at the same time points in each case in step c).
However, Kaczka does teach that Impedance (Z) is defined as the complex ratio of pressure (P) to flow (V̇) as a function of oscillation frequency (ω). It would be obvious to one of ordinary skill in the art that the measurement of pressure and flow would need to be taken simultaneously at the same time points. Doing so would ensure that the correct ratio between parameters and frequency are determined for use in determining the impedance in the forced oscillation technique.
Kaczka as modified fails to explicitly disclose, wherein the time points have time intervals of at most 0.1 seconds.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the time intervals at most 0.1 seconds in the device of Kaczka because Applicant has not disclosed that the specific time interval provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, the specification states on page 11 paragraph 6 that “In particular, values for the pressure and the fluid flow are sensed at the same time points in each case in step c) and the time points have time intervals of at most 0.1 seconds, preferably at most 0.05 seconds, particularly preferably at most 0.01 seconds. In particular, the time points have time intervals of at least 0.005 seconds, preferably at least 0.01 seconds”. One of ordinary skill in the art, furthermore, would have expected time intervals as carried out in Kaczka, and Applicant's time intervals, to perform equally well because both ventilators perform the same function of providing respiratory support while monitoring and acquiring pressure and flow data in reference to the respiratory parameters of the patient.
Therefore, it would have been prima facie obvious to modify Kaczka to obtain the invention as specified in claim 10, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired time interval is used in order to maintain the provision of ventilation supplied to the patient as well as maintaining a condition allowing for the acquisition of patient respiratory parameters and thus fails to patentably distinguish over the prior art of Kaczka.
Regarding claim 11, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kaczka as modified further discloses, wherein the ventilator is suitably designed for sole ventilation of the patient; wherein normoventilation of the patient is performable via the control device at least before step a) or after step c) (Many of these forced oscillation systems can easily be incorporated into existing ventilator platforms (such as the one taught by Trivikram) in the operating room or intensive care unit, to allow for bedside assessment of respiratory mechanics with minimal disruption of ventilatory support as set forth on page 4 paragraph 3; indicating that normoventilation is provided at least before step a) or after step c)).
Regarding claim 12, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kaczka as modified by Trivikram further teaches, wherein the gas discharge device comprises a suction device, so that in step b) the second fluid flow is at least partially generated by suction in at least an expiration process (Trivikram: FIG. 13 Pressure generating source 208 as set forth in [0096]; which would provide the second fluid flow in the system of Kackza as modified by Trivikram).
Regarding claim 13, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kaczka as modified by Trivikram further discloses, wherein the fluid flow is adjustable to a constant value at least during an inspiration process and an expiration process (The complex ratio of the resulting pressure to the delivered flow is defined as the mechanical input impedance as set forth on page 1 paragraph 2, meaning the fluid flow is being delivered at a determined value); wherein the first fluid flow Q1 and the second fluid flow Q2 are both constant during step b) (An inherent aspect of forced oscillation is that the inspiratory and expiratory flow are constant; Trivikram: In aggressive oscillation generation, which is delivered by the ventilator of Trivikram while forced oscillation spirometry can be performed, switching between the positive pressure generator and negative pressure generator helps to generate oscillatory waveform as set forth in [0101]).
Regarding claim 14, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Kaczka as modified by Trivikram further discloses, wherein the fluid flows are of equal size (An inherent aspect of forced oscillation is that the inspiratory and expiratory flow are of equal size; Trivikram: In aggressive oscillation generation, which is delivered by the ventilator of Trivikram while forced oscillation spirometry can be performed, switching between the positive pressure generator and negative pressure generator helps to generate oscillatory waveform as set forth in [0101]).
Regarding claim 15, Kaczka discloses a method for determining at least an alveolar pressure Palv of a patient (The airway opening pressure (Pao) is measured as set forth for Figure 1 on page 22, page 3 paragraph 5, and utilized in equation (1) on page 2), a pressure sensor for sensing a pressure Ptrach in the airway (The airway opening pressure (Pao) is measured as set forth for Figure 1 on page 22, page 3 paragraph 5, and utilized in equation (1) on page 2), and a control device for operating the ventilator (Microprocessors for used in devices for implementing a forced oscillation technique as set forth on page 4 paragraph 4); wherein the control device is configured to carry out a method comprising at least the following steps:
a) defining a pressure interval in which the patient is to be ventilated for a defined time interval (The impedance used in FOT, forced oscillation technique, given in equation (1) as Z(ω) is defined as the ratio of pressure (P) to flow (V) as a function of oscillation frequency as set forth on page 2 paragraph 4; oscillation frequency inherently involving a time interval to determine its value; Additionally, the use of a Fourier Transform for the sensed value is performed as set forth on page 3 paragraph 6 and page 7 paragraph 2, meaning the time dependent signals of pressure and flow are converted into a frequency);
b) repeatedly and alternately carrying out one inspiration process at a time with the first fluid flow Q1 by means of the gas supply device and one expiration process at a time with the second fluid flow Q2 by means of the gas discharge device within the pressure interval (The impedance used in FOT, forced oscillation technique, given in equation (1) as Z(ω) is defined as the ration of pressure (P) to flow (V) as a function of oscillation frequency as set forth on page 2 paragraph 4; specific pressures and flows measured repeatedly during oscillatory motion would include a first fluid flow during the inspiration process as dictated by the ventilator and a second fluid flow during the expiration process as dictated by the ventilator),
c) sensing the fluid flows and the pressure which changes during step b) (The concept of mechanical impedance embodies a precise quantitative relationship between specific pressures and flows measured during oscillatory motion as set forth on page 4 paragraph, the measured values being the sensed fluid flows and pressures);
d) carrying out a Fourier transform for the sensed values of the pressure and forming a first frequency spectrum for the pressure and carrying out a Fourier transform for the sensed values of the fluid flows and forming a second frequency spectrum for the fluid flows (After high pass filtering the measured flow and pressures signals, impedance could be computed using various Fourier Transform methods as set forth on page 3 paragraph 6; To calculate impedance spectra from oscillatory flow and pressure waveforms, several signal processing techniques can be used. The simplest and most direct is to excite the respiratory system at one discrete frequency while the subject remains apneic, and then determine the value of impedance from the corresponding pressure and flow using Equation 1 at this frequency. By continually forcing the respiratory system with different discrete frequencies, values of the impedance can be obtained over a particular frequency range, the input flow and output pressure signals can then be spectrally decomposed into their individual frequency components using standard Fourier analysis, from which the value of the impedance can be determined at each particular frequency as set forth on page 5 paragraph 4 – page 6 paragraph 1);
e) calculating an impedance Zaw of the airway by dividing the first frequency spectrum by the second frequency spectrum (Set forth for equation 1 on page 2 and equation 6 on page 6) wherein the impedance comprises a real component Real(Zaw) and an imaginary component Im(Zaw) (Set forth for equation 2 on page 3, equations 8 and 9 on page 7, and equation 12 on page 8, where j is the unit imaginary number; Additionally, page 4 paragraph 1 sets forth that the real part of impedance is generally constant with frequency, while the imaginary part increases monotonically with frequency, behaviors consistent with simple, constant resistive-inertial-compliant properties of the respiratory system);
f) modeling at least the real component by a first mathematical model (The distribution of parallel airway resistances can be approximated with a predefined probability density function, P(Raw), with lower and upper bounds Raw,min and Raw,max, respectively, the impedance predicted by such a model is given by equation 12 on page 8 as set forth in paragraph 3) and ascertaining an alveolar pressure Palv or a plot of an alveolar pressure Palv (A fundamental part of oscillatory mechanics of the respiratory system is the measurement of pressure, which may be obtained within the alveoli, these pressures may be transduced relative to atmosphere by differential sensors, where traditionally, variable reluctance transducers have been used for FOT measurements as set forth on page 5 paragraph 2).
Kaczka fails to explicitly disclose wherein the method is conducted by means of a ventilator. However, Kazka does teach that many of these forced oscillation systems can easily be incorporated into existing ventilator platforms in the operating room or intensive care unit, to allow for bedside assessment of respiratory mechanics with minimal disruption of ventilatory support (As set forth Page 4 paragraph 3 and shown in Figure 1 page 22) and that oscillatory V̇ao is applied at the mouth or trachea (As set forth for Figure 1 on page 22 and page 3 paragraph 5).
Kaczka as modified fails to explicitly disclose that the ventilator comprises a gas supply device and a gas discharge device, for supplying a first fluid flow to an airway of a patient and for discharging a second fluid flow from the airway back into the ventilator or to an environment.
However, Trivikram teaches a ventilator (Trivikram: FIG. 13 Respiratory apparatus 200 as set forth in [0097]) comprising a gas supply device (Trivikram: FIG. 13 Pressure generating source 206 and the pressure restricting valve as set forth in [0096]) and a gas discharge device (Trivikram: FIG. 13 Pressure generating source 208 and the pressure restricting valve as set forth in [0096]) capable of supplying a first fluid flow by means of the gas supply device and discharging a second fluid flow by means of the gas discharge device (FIG. 13 The position of the first pressure restricting valve 214 and the position of the second pressure restricting valve 216 can be changed alternately to block/unblock the at least one first pressure generating source 206 and the at least one second pressure generating source 208 respectively to generate aggressive oscillation by forming alternate positive and negative waveforms as set forth in [0096]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system/control method as disclosed by Kaczka to incorporate the teaching of Trivikram and include a ventilator (Trivikram: FIG. 13 Respiratory apparatus 200 as set forth in [0097]) comprising a gas supply device (Trivikram: FIG. 13 Pressure generating source 206 as set forth in [0096]) and a gas discharge device (Trivikram: FIG. 13 Pressure generating source 208 as set forth in [0096]) capable of supplying a first fluid flow by means of the gas supply device and discharging a second fluid flow by means of the gas discharge device (FIG. 13 The position of the first pressure restricting valve 214 and the position of the second pressure restricting valve 216 can be changed alternately to block/unblock the at least one first pressure generating source 206 and the at least one second pressure generating source 208 respectively to generate aggressive oscillation by forming alternate positive and negative waveforms as set forth in [0096]). Doing so would enable the use of the forced oscillation technique to determine patient parameters to be used in combination with a ventilator (Trivikram: As set forth in [0097])and would enable greater control over the oscillation waveform (Trivikram: By changing the speed of the pressure generating sources and position of the pressure restricting valves, additional control over pressure and flow of oscillatory waveform can be achieved. Further, in aggressive oscillation generation switching between the positive pressure generator and negative pressure generator helps to generate oscillatory waveform. Such an approach of oscillation generation is more aggressive and hence, more variation in flow/pressure can be achieved in lesser time using this approach. Extent to which the pressure restricting valves open decides the amount of pressure generated and the flow delivered to the patient. Additionally, by changing speed of the pressure generating sources, additional control over pressure and flow of the oscillatory waveform can be achieved in this process. As set forth in [0101]). It would be obvious to one of ordinary skill in the art that the patient’s inhaled/exhaled fluid would have an effect on the parameters utilized in determining lung impedance (for example, the inhalation and exhalation flow rates), and therefore would be more easily determined given a system capable of providing set positive and negative pressure to the patient airway, given the ability to control the waveform as set forth above.
Regarding claim 16, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Kaczka as modified further discloses, wherein the ventilator is suitably designed for sole ventilation of the patient; wherein normoventilation of the patient is carried out via the control device at least before step a) (Many of these forced oscillation systems can easily be incorporated into existing ventilator platforms (such as the one taught by Trivikram) in the operating room or intensive care unit, to allow for bedside assessment of respiratory mechanics with minimal disruption of ventilatory support as set forth on page 4 paragraph 3; indicating that normoventilation is provided at least before step a) or after step c)).
Regarding claim 17, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Kaczka as modified by Trivikram further teaches, wherein the gas discharge device comprises a suction device, so that in step b) the second fluid flow is at least partially generated by suction in at least an expiration process (Trivikram: FIG. 13 Pressure generating source 208 as set forth in [0096]; which would provide the second fluid flow in the system of Kackza as modified by Trivikram).
Regarding claim 18, Kaczka as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Kaczka as modified by Trivikram further discloses, wherein the fluid flow has been adjusted to a constant value at least during an inspiration process and an expiration process (The complex ratio of the resulting pressure to the delivered flow is defined as the mechanical input impedance as set forth on page 1 paragraph 2, meaning the fluid flow is being delivered at a determined value); wherein the first fluid flow Qi and the second fluid flow Q2 are both constant during step b) (An inherent aspect of forced oscillation is that the inspiratory and expiratory flow are constant; Trivikram: In aggressive oscillation generation, which is delivered by the ventilator of Trivikram while forced oscillation spirometry can be performed, switching between the positive pressure generator and negative pressure generator helps to generate oscillatory waveform as set forth in [0101]).
Regarding claim 19, Kaczka discloses a control device that is equipped, configured or programmed to carry out the method as claimed in claim 15 (Microprocessors for used in devices for implementing a forced oscillation technique as set forth on page 4 paragraph 4; see rejection for claim 15 above).
While Kaczka fails to explicitly disclose the use of the system as set forth above with the use of a ventilator. Kaczka does teach that many of these forced oscillation systems can easily be incorporated into existing ventilator platforms in the operating room or intensive care unit, to allow for bedside assessment of respiratory mechanics with minimal disruption of ventilatory support (As set forth Page 4 paragraph 3 and shown in Figure 1 page 22).
Allowable Subject Matter
Claims 2-5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, Kaczka teaches, wherein the first model comprises the equation Real(Zaw) = Raw +𝑗𝜔𝐼𝑎𝑤 + G/ωα, with Raw: airway-related resistance; G/ωα: tissue-related resistance; with G as a constant, ω as the angular frequency and α as a constant; wherein the real component describes the resistance, i.e., the resistances to be overcome during inspiration or expiration (The predicted lung impedance (ẐL) as a function of angular frequency (ω) is given by equation 9 on page 7 which accounts for airway resistance, tissue damping and tissue elastance, and angular frequency with α as a constant as set forth on page 7 paragraph 5; the lung impedance encompassing the resistances to be overcome during inspiration or expiration), but fails to teach the equation Real(Zaw) = Raw + G/ωα, the difference being the presence of variable: 𝑗𝜔𝐼𝑎𝑤. It would not have been obvious to eliminate the necessary variables in Kaczka, and is therefore novel.
Regarding claim 4, Kaczka teaches, wherein the imaginary component is also modellable in step f) by a second mathematical model, wherein the second model comprises the equation Zaw= Raw+ k x j x ω x Iaw + (G – j x H)/ωα (Equation 9 on page 7); but fails to teach the equation Zaw= Raw+ k x j x ω x Iaw + (G – j x H)/ωα and a second model explicitly comprising where Im(Zaw) = j x (k x ω x Iaw + (–H)/ωα; with k: a constant; Iaw: inertia of the airway; (–H)/ωα: resilience of the airway with H as a constant; wherein the imaginary component describes the airway reactance Xa, wherein a compliance of the airway is described by C = - 1/(ω x Xa). It would not have been obvious to add or eliminate the necessary variables in Kaczka, and is therefore novel.
Regarding claim 3, Kaczka is silent as to the specific determination of alveolar pressure, wherein the alveolar pressure Palv is ascertained from the equation Palv = Ptrach – Qi x Raw; with Qi: the current fluid flow.
However, Diehl (Jean-Luc Diehl, Daniel Isabey, Gilbert Desmarais, Laurent Brochard, Alain Harf, and Frédéric Lofaso; Journal of Applied Physiology 1999 87:1, 428-437 DOI:10.1152/jappl.1999.87.1.428) teaches PA = Paw – (V · Raw) (Diehl: As set forth on page 429 paragraph 1), which derives the alveolar pressure from the airway pressure, flow rate, and airway resistance, the same of which could be applied given the tracheal pressure.
Kaczka and Diehl are both considered to be analogous to the claimed invention because they are in the same field of ventilator support and the determination of respiratory parameters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kackza to incorporate the teaching of Diehl and include wherein the determination of alveolar pressure can be derived from the equation PA = Paw – (V · Raw) (Diehl: As set forth on page 429 paragraph 1), which derives the alveolar pressure from the airway pressure, flow rate, and airway resistance, the same of which could be applied given the tracheal pressure. Doing so would provide a more accurate depiction of the pressure within the patients respiratory system given the determination of pressure at the alveolar level, given that since the inspiratory line of the breathing circuit and the respiratory system generate substantial resistance to flow, a pressure gradient exists between the ventilator, the airway opening, and the alveoli, therefore, when a pressure signal is generated inside the ventilator, the pressure signal in the airways is far from being constant throughout inspiration and is even highly flow dependent at the alveolar level (Diehl: As set forth on page 428 paragraph 2).
Claim 3, however, is dependent on claim 2, and is therefore novel.
Regarding claim 5, Kaczka as modified is silent as to the exact configuration of the ventilator and fails to explicitly disclose, wherein the pressure sensor is arranged endotracheally.
Trivikram, however, does teach wherein the ventilator can deliver gas endotracheally (Trivikram: As set forth in [0045] and [0085]) and Enk (US 20190022342 A1) teaches, wherein the pressure sensor is arranged endotracheally (Enk: A pressure sensor is thus preferably arranged in the airway, such that a continuous pressure measurement can in particular also take place in the airway even during the ventilation),
Kaczka as modified by Trivikram and Enk are both considered to be analogous to the claimed invention because they are in the same field of ventilator support and the determination of respiratory parameters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kackza as modified by Trivikram to incorporate the teaching of Enk and include wherein the pressure sensor is arranged endotracheally (Enk: A pressure sensor is thus preferably arranged in the airway, such that a continuous pressure measurement can in particular also take place in the airway even during the ventilation as set forth in [0022])). Doing so would allow for a continuous pressure measurement can in particular also take place in the airway even during the ventilation (Enk: As set forth in [0022]).
Claim 5, however, is dependent on claim 2, and is therefore novel.
Conclusion
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/KEIRA EILEEN CALLISON/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785