DETAILED ACTION
Primary Examiner acknowledges Claims 1-14 are pending in this application, as originally filed February 17, 2023.
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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in European Patent Office on May 3, 2022. It is noted, however, that Applicant has not filed a certified copy of the EP 22171395 application as required by 37 CFR 1.55.
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 2, 3, and 5-7 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.
Specifically, Claim 2, Line 1; and Claim 3, Line 1 recite the limitation “the measured parameter”; however, the breath and scope of this limitation is unclear as it appears the term “measured parameter” lacks antecedent basis in the claims. Primary Examiner is unsure if the limitation “measured parameter” is meant to encompass the former “the determined parameter” seen initially stated in Claim 1, Line 17, OR alternatively, if this term “measured parameter” is a separate and distinct limitation. Appropriate correction and clarification is required.
Specifically, terms “SpO2” (Claims 5-7) and “FiO2” (Claim 5) are recited within the claim listing; however, the original specification as filed provides no definitions for these terms; hence, the breadth and scope of these limitations is unclear. Primary Examiner is unsure if these terms can be met with a generic oxygen concentration sensor or if there is a special oxygen concentration sensor required. By traditional convention, the term “SpO2” relates to the peripheral oxygen saturation or blood oxygen saturation – measured by a non-invasive pulse oximeter; while the term “FiO2” relates to the Fraction of Inspired Oxygen – ventilation setting manually set by health care professional. Primary Examiner requests clarification that Applicant is reciting these terms in the claims under traditional convention. Still further, it should be noted the term “SaO2” is also conventionally known in the field of endeavor, whereby the term “SaO2” relates to arterial oxygen saturation – measured by invasive arterial blood gas testing. Consequently, Primary Examiner is unsure if Applicant is attempting to narrow the concept of oxygen saturation to only non-invasive or invasive testing, or if these testing modules are seen by Applicant to be functionally equivalent so long as there is a detected oxygen saturation value. Appropriate correction and clarification is required.
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, 4-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Choncholas et al. (2007/0062529) in view of Kuck et al. (6,200,271) and Packer et al. (5,402,796).
As to Claims 1, 11, and 14, Choncholas discloses a therapy system (best seen Figure 1), comprising: a patient interface (via 36, “patient limb 36. During inspiration, patient limb 36 provides breathing gases to lungs 38 of patient 12. Patient limb 36 receives breathing gases from the lungs of the patient during expiration. … Patient limb 36 includes gas flow and pressure sensor 57” Paras 0035 and 0036) adapted to deliver gas to a patient; a delivery system (10, “FIG. 1 shows mechanical ventilator 10 for providing breathing gases to patient 12. Ventilator 10 receives air in conduit 14 from an appropriate source, not shown, such as a cylinder of pressurized air or a hospital air supply manifold. Ventilator 10 also receives pressurized oxygen in conduit 16 also from an appropriate source, not shown, such as a cylinder or manifold. The flow of air in ventilator 10 is measured by flow sensor 18 and controlled by valve 20. The flow of oxygen is measured by flow sensor 22 and controlled by valve 24. The operation of valves 20 and 24 is established by a control device such as central processing unit 26 in the ventilator.” Para 0034) for delivering oxygen-enriched breathing gas (via 30, “The air and oxygen are mixed in conduit 28 of ventilator 10 and provided to inspiratory limb 30 of breathing circuit 32.” Para 0035) to the patient interface (via 36), wherein the delivery system (10) is adapted to deliver a total flow rate of breathing gas (via 28, “The air and oxygen are mixed in conduit 28” Para 0035) comprising an oxygen flow rate (22, “The flow of oxygen is measured by flow sensor 22 and controlled by valve 24.” Para 0034) and an air flow rate (18, “The flow of air in ventilator 10 is measured by flow sensor 18 and controlled by valve 20.” Para 0034), wherein the delivery system (10) is controllable to adjust one or more of the total flow rate (operation of both 20 and 24, wherein 20 – “The flow of air in ventilator 10 is measured by flow sensor 18 and controlled by valve 20.” Para 0034) and wherein 24 – “The flow of oxygen is measured by flow sensor 22 and controlled by valve 24.” Para 0034), the oxygen flow rate (via 24, “The flow of oxygen is measured by flow sensor 22 and controlled by valve 24.” Para 0034) and the air flow rate (via 20, “The flow of air in ventilator 10 is measured by flow sensor 18 and controlled by valve 20.” Para 0034); a controller (defined by the cooperative interaction of 26/74, wherein 26 - “The operation of valves 20 and 24 is established by a control device such as central processing unit 26 in the ventilator.” Para 0034, and wherein 74 - “The output of gas module 64 is provided in data bus 72 to central processing unit 74 in ventilator display unit 76. Central processing unit 26 in ventilator 10 is also connected to central processing unit 74 via data bus 78.” Para 0036; also see: “central processing unit 74 in display unit 76 carries out the determination of functional residual capacity, recruited/de-recruited volumes, and other quantities employed in the present invention.” Para 0040) for controlling the delivery system (10); a sensor arrangement (70 via 64, “Gas analyzer 70 may measure the amount of oxygen and carbon dioxide in the breathing gases.” Para 0036, wherein 64 – “Respiratory and metabolic gas module 64 …. The output of gas module 64 is provided in data bus 72 to central processing unit 74 in ventilator display unit 76. Central processing unit 26 in ventilator 10 is also connected to central processing unit 74 via data bus 78.” Para 0036) adapted to enable measurement or estimation of carbon dioxide of the patient over time and thereby generator capnograph data (via 102f, “Display portion 102f of display 62 shows additional data as selected by the clinician. In the example of FIG. 3 end tidal CO.sub.2(E.sub.tCO.sub.2), lung compliance, expiratory alveolar minute volume (MVe (alv)), respiratory rate, total positive end expiratory pressure, and inspiratory alveolar minute volume (MVi (alv)) are being shown.” Para 0045); and wherein the controller (26) is adapted to iteratively (feedback operation represented by the double headed arrows within Figure 1, nominally the interaction between 26 and 74, such that the data from 70 is directed to 74 and then sent to 26 to operate the control of the valves 20/24 as desired); determine a parameter from the capnograph (“end tidal CO.sub.2(E.sub.tCO.sub.2” Para 0045), which is representatively of CO2 washout; adjust one or more of the total flow rate (operation of both 20 and 24), the oxygen flow rate (via 24) or the air flow rate (via 20) of the breathing gas (via 28) delivered by the delivery system (10); and determine the impact of the adjusting upon the determined parameter (“end tidal CO.sub.2(E.sub.tCO.sub.2” Para 0045), in order to determine a value of the total flow rate (operation of both 20 and 24), the oxygen flow rate (via 24) or the air flow rate (via 20) which maximizes CO2 washout or achieves a desired level of CO2 washout and set the total flow rate (operation of both 20 and 24), the oxygen flow rate (via 24) or the air flow rate (via 20) at the determined value (through “central processing unit 74 in display unit 76 carries out the determination of functional residual capacity, recruited/de-recruited volumes, and other quantities employed in the present invention.” Para 0040).
Yet, Choncholas does not expressly disclose the construction of the patient interface to “deliver gas to a nasal cavity of the patient” nor the sensor arrangement for “the arterial partial pressure of arterial carbon dioxide, PaCO2”.
Regarding the patient interface, Kuck teaches a therapy system (Figures 1 and 2) having a patient interface (52, “FIG. 1 schematically illustrates an exemplary re-breathing circuit 50 that includes a tubular airway 52 that communicates air flow to and from the lungs of a patient. Tubular airway 52 may be placed in communication with the trachea of the patient by known intubation processes, or by connection to a breathing mask positioned over the nose and/or mouth of the patient.” Column 3, Lines 20-30), a delivery system (“ventilator (not shown)” via 50, wherein 50 – “re-breathing circuit 50 … A Y-piece 58, disposed on hose 60 opposite flow meter 72 and carbon dioxide sensor 74, facilitates the connection of an inspiratory hose 54 and an expiratory hose 56 to re-breathing circuit 50 and the flow communication of the inspiratory hose 54 and expiratory hose 56 with hose 60. During inhalation, gas flows into inspiratory hose 54 from the atmosphere or a ventilator (not shown). During normal breathing, valve 68 is positioned to prevent inhaled and exhaled air from flowing through deadspace 70. During re-breathing, valve 68 is positioned to direct the flow of exhaled and inhaled gases through deadspace 70.” Column 3, Lines 20-50), a controller (20, “Flow sensor 12 and CO.sub.2 sensor 14 are connected to a flow monitor 16 and a CO.sub.2 monitor 18, respectively, each of which may be operatively associated with a computer 20 so that data from the flow and CO.sub.2 monitors 16 and 18, representative of the signals from each of flow sensor 12 and CO.sub.2 sensor 14, may be detected by computer 20 and processed according to programming (e.g., by software) thereof. Preferably, raw flow and CO.sub.2 signals from the flow monitor and CO.sub.2 sensor are filtered to remove any significant artifacts. As several respiratory flow and CO.sub.2 pressure measurements are made, the respiratory flow and CO.sub.2 pressure data may be stored by computer 20. Thus, cardiac output may be calculated, in accordance with the carbon dioxide Fick equation or by any other suitable equation known in the art, by computer 20.” Column 9, Lines 1-25), and a sensor arrangement (14, “Flow sensor 12 and CO.sub.2 sensor 14 are connected to a flow monitor 16 and a CO.sub.2 monitor 18, respectively, each of which may be operatively associated with a computer 20 so that data from the flow and CO.sub.2 monitors 16 and 18, representative of the signals from each of flow sensor 12 and CO.sub.2 sensor 14, may be detected by computer 20 and processed according to programming (e.g., by software) thereof.” Column 9, Lines 1-25) to generate capnograph data (via “Printer/Display” of Figure 2).
With respect to the specific patient interface being able to “deliver gas to a nasal cavity of the patient”, Kuck expressly states the use of an endotracheal tube and “a breathing mask positioned over the nose and/or mouth of the patient” (Column 3, Lines 20-30) are functional equivalents suitable for imparting breathing gas to and from the patient within the therapy system. Thus, the resultant effect of the teachings of Kuck as modifying Choncholas is a simple substitution of known patient interfaces suitable for conveying gases to/from a patient in a therapy system.
Regarding the sensor arrangement, Packer discloses a therapy system (best seen Figures 1, 6A, 6B) having a patient interface (“Airway Circuit” of Figure 6A), a delivery system (16 of Figure 1 or 7200 of Figure 6A – “A mechanical ventilator 16 such as a Puritan-Bennett 7200 is typically connected both to the A/D converter 12 and the computer 15 as shown.” Column 3, Lines 1-10), a controller (15, “computer 15” Column 3, Lines 1-10), and a sensor arrangement (10 of Figure 1 or “Capnograph” of Figure 6A, “ In FIG. 1 the outlet port of capnograph 10 is connected, via connection 11, to analogue to digital (A/D) converter 12.” Column 2, Lines 60-70) to generate capnograph data (“Display” of Figure 6A).
With respect to the specific sensor arrangement including “the arterial partial pressure of arterial carbon dioxide, PaCO2”, Packer teaches an “arterial CO.sub.2 monitor and closed loop controller for use with a ventilator monitors a patient's breath and determines PaCO.sub.2 based upon a determination of a deadspace ratio, which is the ratio of the alveolar deadspace to alveolar tidal volume.” (Abstract), wherein the “method and apparatus for continuously and non-invasively monitoring arterial blood CO.sub.2 partial pressure (PaCO.sub.2) of artificially ventilated patients.” (Column 1, Lines 1-15; also see: “method and apparatus for continuously and non-invasively monitoring arterial blood CO.sub.2 partial pressure (PaCO.sub.2) of artificially ventilated patients, by monitoring a patient's breath and determining PaCO.sub.2 based upon a determination of a deadspace ratio, which is the ratio of the alveolar deadspace to alveolar tidal volume.” Column 1, Lines 40-60). Thus, the resultant effect of the teachings of Packer as modifying Choncholas yields an alternative capnograph suitable for monitoring the carbon dioxide of the patient to modulate the operation and functionality of the delivery system in response to the detected carbon dioxide concentration values – capnograph data.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface of Choncholas to be a breathing mask suitable for imparting breathing gas to the nasal cavity of the patient, as taught by Kuck to be a functionally equivalent patient interface suitable for conveying gases to/from the patient in a therapy system, and to modify the sensor arrangement of Choncholas to include the specific detection of carbon dioxide concentration values – capnograph data – utilizing the arterial partial pressure of arterial carbon dioxide, as taught by Packer to be a known alternative capnograph detection monitoring system suitable for modulating the operation and functionality of the delivery system in response to the detected carbon dioxide concentration values – capnograph data.
As to Claims 2 and 12, the modified Choncholas, specifically Choncholas discloses the determined parameter from the capnograph data is the end-tidal CO2 concentration (“end tidal CO.sub.2(E.sub.tCO.sub.2” Para 0045); and the controller (defined by the cooperative interaction of 26/74) is adapted to determine the value of the total flow rate (operation of both 20 and 24), the oxygen flow rate (via 24) or the air flow rate (via 20) for maximizing CO2 washout by maximizing the end tidal CO2. Although the modified Choncholas, specifically Choncholas does not expressly state the concept of “maximizing CO2 washout”, Choncholas is expressly concerned with the concept of “functional residual capacity”, whereby a “technique for determining functional residual capacity is the inert gas wash-out technique. This technique is based on a determination of the amount of gas exhaled from the patient's lungs and corresponding changes in gas concentrations in the exhaled gas.” (Para 0005), wherein “in order to determine the functional residual capacity of patient 12 by a gas wash-out/wash-in technique, it is necessary to alter the composition of the breathing gases supplied to patient 12.” (Para 0057). In operation, “When the amount of oxygen in the expired breathing gases remains unchanged for a predetermined number of breaths, it is an indication that the wash out/wash in the inert gas is complete and that the functional residual capacity determination can be terminated.” (Para 0075). As well-known, routine, and conventional practice, the amount of oxygen is inversely proportional to the amount of carbon dioxide retained within the expired gas. Hence, the monitoring of the “functional residual capacity” includes the adaptation of gas flows and concentrations to maximize washing out of the gases.
Additionally, it is noted the modified Choncholas, specifically Packer is also concerned with the end-tidal CO2 concentration – “The various parameters may be obtained from the plot of airwave CO.sub.2 partial pressure versus expired volume for each breath a shown in the single breath test graph of FIG. 3 On the graph PE.sup.1 CO.sub.2 is end tidal CO.sub.2, and V.sub.T.sup.alv is tidal volume involved in gas exchange.” Column 3, Lines 35-50; also see: “(iii) If Alveolar minute volume increases and arterial or end-tidal CO.sub.2 increases, deadspace may have changed. (iv) If Alveolar minute volume decreases and arterial or end-tidal CO.sub.2 decreases, deadspace may have changed.” Column 4, Lines 50-60; “Various measurable parameters are recorded during the experiments for correlation with deadspace changes. These include airway compliance and resistance, peak airway pressure, peak air flow, inspiratory time, positive end-expiratory pressure (PEEP), inspiratory to expiratory ratio (I:E), slope of the CO.sub.2 versus expired-volume waveform, end-tidal CO.sub.2 and SaO.sub.2.” Column 6, Lines 5-25; “Test results also showed that deadspace ratio change can be expected when alveolar tidal volume and frequency changes are not: followed by expected changes in end-tidal CO.sub.2, estimated PaCO.sub.2 or CO.sub.2 production. Results from a trial are presented in FIG. 5. At point A, the increase in alveolar tidal volume and ventilation rate product (alveolar minute-volume) is not followed by a drop in both end-tidal CO.sub.2 and estimated PaCO.sub.2, indicating a blood test is needed. At point B, alveolar minute-volume decrease is not followed by an increase in end-tidal CO.sub.2. In each case, the new estimation system correctly identifies the deadspace ratio change and estimates PaCO.sub.2 reliably, compared to using the traditional method based on a constant arterial--end tidal difference.” Column 6, Lines 25-45; “Determine end-tidal CO.sub.2, the maximum airway CO.sub.2. … Parameters calculated for this breath are summed with parameters from previous breaths within a minute. The parameters are: the number of breaths, areaX, VD.sub.airway, tidal volume (V.sub.T) , end-tidal CO.sub.2 (ETCO.sub.2), plateau phase slope, Tinsp and number of rejected waveforms.” Column 9, Lines 10-30).
Hence, clearly, the modified Choncholas is concerned with the claimed subject matter to ensure proper ventilation of the patient to wash out the gases retained in the expired gas through monitoring and maximizing the end tidal CO2 values.
As to Claim 4, the modified Choncholas, specifically Packer teaches the controller (15) is adapted to derive (“The following are the decision rules derived: (i) If Alveolar minute volume increases and CO.sub.2 production decreases, deadspace ratio may have changed. (ii) If Alveolar minute decreases and CO.sub.2 production increases, deadspace ratio may have changed. (iii) If Alveolar minute volume increases and arterial or end-tidal CO.sub.2 increases, deadspace may have changed. (iv) If Alveolar minute volume decreases and arterial or end-tidal CO.sub.2 decreases, deadspace may have changed. It is possible to derive further rules to indicate a change in deadspace ratio. For example, changes to airway resistance, peak airway pressure (PAP), peak flow, SaO.sub.2, inspiratory to expiratory ratio, and positive end-expiratory pressure (PEEP) should indicate a change in the deadspace ratio. By automatically recording these parameters during a clinical trial, including blood test results, correlation between the change in parameters and change in deadspace ratio can be performed.” Column 4, Lines 45-70; also see: “For large deadspace changes, the experimentally derived rules can be relied upon to signal for a blood gas test.” Column 6, Lines 45-60), from the measurement or estimation of the arterial partial pressure ( “arterial or end-tidal CO.sub.2”), a patient parameter or index (“deadspace ratio” or change in deadspace); monitor the patient parameter or index (“deadspace ratio” or change in deadspace) over time to detect or monitor a patient condition (“changes to airway resistance, peak airway pressure (PAP), peak flow, SaO.sub.2, inspiratory to expiratory ratio, and positive end-expiratory pressure (PEEP)” Column 4, Lines 45-70); and adjust one or more of the total flow rate, the oxygen flow rate, or the air flow rate of the breathing gas delivered by the delivery system in dependence on the detected or monitored patient condition (“changes to airway resistance, peak airway pressure (PAP), peak flow, SaO.sub.2, inspiratory to expiratory ratio, and positive end-expiratory pressure (PEEP)” Column 4, Lines 45-70).
Regarding the concept of adjusting the breathing gas, recall the modified Choncholas, specifically Choncholas discloses the determined parameter from the capnograph data is the end-tidal CO2 concentration (“end tidal CO.sub.2(E.sub.tCO.sub.2” Para 0045); and the controller (defined by the cooperative interaction of 26/74) is adapted to determine the value of the total flow rate (operation of both 20 and 24), the oxygen flow rate (via 24) or the air flow rate (via 20).
As to Claim 5, please see the rejection of Claim 4, whereby modified Choncholas, specifically Packer teaches the monitoring of the patient parameter or index (“deadspace ratio” or change in deadspace) over time comprises monitoring the “arterial or end-tidal CO.sub.2” (Column 4, Lines 45-70).
As to Claim 6, the modified Choncholas, specifically Choncholas discloses the sensor arrangement (70 via 64) is adapted to measure or estimate oxygen saturation (“Gas analyzer 70 may measure the amount of oxygen and carbon dioxide in the breathing gases.” Para 0036) over time, and the controller (defined by the cooperative interaction of 26/74) is adapted to receive or determine a target oxygen saturation level (via 70) and adjust one or more of the total flow rate (operation of both 20 and 24), the oxygen flow rate (via 24) or the air flow rate (via 20) of the breathing gas (via 28) in dependence on the measured or estimated oxygen saturation level (“amount of oxygen”) to achieve the target or desired oxygen saturation level.
Additionally, it is noted the modified Choncholas, specifically Packer is also concerned with the oxygen saturation (“It is possible to derive further rules to indicate a change in deadspace ratio. For example, changes to airway resistance, peak airway pressure (PAP), peak flow, SaO.sub.2, inspiratory to expiratory ratio, and positive end-expiratory pressure (PEEP) should indicate a change in the deadspace ratio. By automatically recording these parameters during a clinical trial, including blood test results, correlation between the change in parameters and change in deadspace ratio can be performed.” Column 4, Lines 45-70; also see: “Various measurable parameters are recorded during the experiments for correlation with deadspace changes. These include airway compliance and resistance, peak airway pressure, peak air flow, inspiratory time, positive end-expiratory pressure (PEEP), inspiratory to expiratory ratio (I:E), slope of the CO.sub.2 versus expired-volume waveform, end-tidal CO.sub.2 and SaO.sub.2.” Column 6, Lines 5-25; “Changes to compliance and resistance, peak airway pressure, peak flow, SaO.sub.2 and I:E should indicate a change in the deadspace ratio but more results are needed before these relationships can be quantified.” Column 6, Lines 40-50).
Hence, clearly, the modified Choncholas is concerned with the claimed subject matter to ensure proper ventilation of the patient through monitoring and maximizing the oxygen saturation values.
As to Claim 7, the modified Choncholas, specifically Choncholas discloses the controller (defined by the cooperative interaction of 26/74) is adapted to adjust the air flow (via 24) for maximum CO2 washout; and then adjust the oxygen flow (via 20) to achieve the target oxygen saturation; as a function of the feedback control operations.
As to Claim 8, the modified Choncholas, specifically Packer teaches the controller (15) is adapted to compensate for dilution of the flow by constructing adjusted capnograph data and estimating a calibration factor, wherein the estimating a calibration factor comprises generating a first set of capnograph data (estimated PaCO2 – “determines PaCO.sub.2 based upon a determination of a deadspace ratio, which is the ratio of the alveolar deadspace to alveolar tidal volume.” Abstract) and a second set of capnograph data (actual PaCO2 from blood test - “obtaining an input value of PaCO.sub.2 from a blood sample of the patient and using the patients breath parameters and the input value to calculate the deadspace ratio” Abstract); the controller (15) is adapted to control the sensor arrangement (10) and the total flow rate of the delivery system (16) to generate the first set of capnograph data (estimated PaCO2 – “determines PaCO.sub.2 based upon a determination of a deadspace ratio, which is the ratio of the alveolar deadspace to alveolar tidal volume.” Abstract) and a second set of capnograph data (actual PaCO2 from blood test - “obtaining an input value of PaCO.sub.2 from a blood sample of the patient and using the patients breath parameters and the input value to calculate the deadspace ratio” Abstract) at different flows; and the calibration factor (via programming code – “a new deadspace ratio is then determined from the patient's breath parameters and further input value of PaCO.sub.2 from the patient's blood sample.” Abstract; also see: “means are also preferably provided for further receiving decision rules enabling identification of the onset of changes in the deadspace ratio to thereby signal the need for a further blood sample to re-calculate the deadspace ratio.” Column 2, Lines 15-40, “(e) Correction of capnograph signal for vapor pressure and airway pressure is done by Equation (7). As mentioned above the decision rules are obtained by experimentations to determine rules which indicate a change in the deadspace ratio whereby the system may signal that a new blood test is required.” Column 4, Lines 40-50; “At point A, the increase in alveolar tidal volume and ventilation rate product (alveolar minute-volume) is not followed by a drop in both end-tidal CO.sub.2 and estimated PaCO.sub.2, indicating a blood test is needed.” Column 6, Lines 25-40; “ For large deadspace changes, the experimentally derived rules can be relied upon to signal for a blood gas test.” Column 6, Lines 45-55; “Whenever the rules below are triggered three times consecutively, a warning is generated (Note that the parameters are compared with the values obtained from the most recent blood gas results):” Column 9, Lines 55-60; “Entered from blood gas results: pH, HCO.sub.3, settings limits (I:E ratio minimum, rate limits, volume limits, peak pressure limit). From ventilator requests: RR, MV, MAP, IE, VT, SMV, PAP, SRR, SVT, PIF, PEEP, DMC, DMR. From Calculations: Vdphy, EPaCO.sub.2.) If new blood test result is available, calculate new CO.sub.2 setpoint:” Column 10, Lines 15-25). In this aforementioned analysis, the resultant effect is a recalibration of the values of PaCO2 to modulate the operation and functionality of the ventilation assistance provided to the patient to ensure the deadspace ratio remains suitable to effectively assess the ventilation needs of the patient.
As to Claim 9, please see the rejection of Claim 8. The modified Choncholas, specifically Packer teaches the feeding of the newly calibrated capnograph signal provided to the patient to ascertain the total flow rate of the delivery system (16) based on the calibrated PaCO to achieve a constant or zero change in dead space ratio, until the certain changes within the “rules” (Column 9, Lines 55-60) necessitate recalibration through a “signal for a blood gas test” (Column 6, Lines 45-55) as it appears the deadspace ratio has undergone a significant change.
As to Claim 10, the modified Choncholas, specifically Choncholas discloses the sensor arrangement (70 via 64) is adapted to measure intrinsic PEEP level, and wherein the controller (defined by the cooperative interaction of 26/74) is adapted to determine a target PEEP taking in account the intrinsic PEEP level. Explicitly, Choncholas discloses “The final value(s) for the functional residual capacity are preferably displayed in tabular portion 112 of screen 102g2 along with additional associated data such as the time and date at which functional residual capacity was determined, or the values of PEEPe and PEEPi existing when the functional residual capacity determination was made. PEEPe is the end expiratory pressure established by ventilator 10. PEEPi, also known as auto PEEP, is the intrinsic end expiratory pressure and is a measurement in pressure of the volume of gas trapped in the lungs at the end of expiration to the PEEPe level.” (Para 0074). In operation, “it is common practice to alter, usually increase, the PEEP to improve ventilation of lungs 38 of patient 12 by opening areas of the lung that are not being properly ventilated. Tabulating the actual measured values for PEEPe and PEEPi, along with the corresponding functional residual capacity determination, as shown in FIG. 5, allows the clinician to see the effect, if any of applied PEEPe therapy on the volume of the functional residual capacity of the patient's lungs, as well as on the intrinsic PEEP. As also shown in FIG. 5, a history of a certain number of functional residual capacity determinations and PEEP pressures are shown in display region 70 to present trends and the history of these quantities. In the example shown there, an increase in PEEPe has resulted in an increase in functional residual capacity of patient 12.” (Para 0078). Consequently, the known values of PEEPi as detected by the pressure measurement (66 via 64, “ One of the pressure lines is connected to pressure measurement unit 66 to measure the pressure in patient limb 36.” Para 0036) are utilized to control the operation and functionality of the PEEPe to open and close the valve (54, “The expired breathing gases in expiratory limb 46 are provided through valve 54 and flow sensor 56 for discharge from ventilator 10. Valve 54 may be used to establish the PEEP for patient 12.” Para 0035) as directed by the controller (defined by the cooperative interaction of 26/74).
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Choncholas et al. (2007/0062529) in view of Kuck et al. (6,200,271) and Packer et al. (5,402,796), as applied to Claims 1 and 11, and further in view of Heinonen et al. (8,479,731).
As to Claims 3 and 13, the modified Choncholas, specifically Choncholas discloses the controller (defined by the cooperative interaction of 26/74) is adapted to determine to determine the value of total flow rate, oxygen flow rate or air flow rate to optimize a positive end-expiratory pressure, PEEP in order to achieve the maximum CO2 washout.
Explicitly, Choncholas discloses “The final value(s) for the functional residual capacity are preferably displayed in tabular portion 112 of screen 102g2 along with additional associated data such as the time and date at which functional residual capacity was determined, or the values of PEEPe and PEEPi existing when the functional residual capacity determination was made. PEEPe is the end expiratory pressure established by ventilator 10. PEEPi, also known as auto PEEP, is the intrinsic end expiratory pressure and is a measurement in pressure of the volume of gas trapped in the lungs at the end of expiration to the PEEPe level.” (Para 0074). In operation, “it is common practice to alter, usually increase, the PEEP to improve ventilation of lungs 38 of patient 12 by opening areas of the lung that are not being properly ventilated. Tabulating the actual measured values for PEEPe and PEEPi, along with the corresponding functional residual capacity determination, as shown in FIG. 5, allows the clinician to see the effect, if any of applied PEEPe therapy on the volume of the functional residual capacity of the patient's lungs, as well as on the intrinsic PEEP. As also shown in FIG. 5, a history of a certain number of functional residual capacity determinations and PEEP pressures are shown in display region 70 to present trends and the history of these quantities. In the example shown there, an increase in PEEPe has resulted in an increase in functional residual capacity of patient 12.” (Para 0078). Consequently, the known values of PEEPi as detected by the pressure measurement (66 via 64, “ One of the pressure lines is connected to pressure measurement unit 66 to measure the pressure in patient limb 36.” Para 0036) are utilized to control the operation and functionality of the PEEPe to open and close the valve (54, “The expired breathing gases in expiratory limb 46 are provided through valve 54 and flow sensor 56 for discharge from ventilator 10. Valve 54 may be used to establish the PEEP for patient 12.” Para 0035) as directed by the controller (defined by the cooperative interaction of 26/74).
Further, it is noted within the modified Choncholas, specifically Packer teaches a graphical representation of the capnograph data over a series of phases (Figure 3).
Yet, does not expressly disclose the claimed configuration by which “the capnograph data is a phase two angle, said phase two angle defined as an angle between respective slopes of phases II and III of a capnograph generated from the capnograph data … to provide the maximum phase two angle”
Heinonen teaches an alternative graphical representation of the capnograph data over each of the recited phases, including phase II and phase III, whereby there is an angle (12 of Figure 2, “The beginning of the alveolar expiration phase and of sector III in the graph of FIG. 2 may be nominated as the point 12 at which the slope of the VCap curve portion 14 is reduced to a predetermined percentage of the maximum slope determined during the transition phase of sector II. 15% has been observed as a good value for the denomination, although the method is not limited to this limit. It could be as well 10% or 20% without a major effect on the outcome of the technique.” Column 5, Lines 15-30) between the respective slopes of phases II and III of the capnograph generated from the capnograph data. In operation, the detection of the angle (12 of Figure 2) is compared to the angular relationship within phases III (at 14 of Figure 2) to determine the efficacy of the charted data to determine a measurement of a pulmonary embolism in the patient. (Column 5, Lines 30-40). The resultant effect of the capnograph of Heinonen provides a determination of the efficacy of the treatment protocol to assure proper ventilatory care provided to the patient and detect hazards of a pulmonary embolism or diseased characteristics of the patient’s lungs. Consequently, when the slope is reducing at phase III the data provided is correct to ascertain a pulmonary embolism or diseased state of the patient’s lungs, while when the slope of is increasing at phase III the data provided is determined to be inaccurate to be utilized to accurately ascertain a pulmonary embolism or diseased state of the lungs.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the capnograph of the modified Choncholas to include a discussion of the slopes at phases II and III in order to properly ascertain the efficacy of the charted data to determine a measurement of a pulmonary embolism or diseased lung in the patient, as taught by Heinonen, in order to assure proper ventilatory support provided to the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Freeman et al. (2007/0169779 and 2015/0157816); Rayburn (5,800,361); Scherer et al. (5,971,934); and Alysworth (2022/0265164) each disclose a graphical representation of the capnograph data having a three phase analysis over time.
Delpy (5,251,632); Schnitzer et al. (5,692,497); Schulz et al. (4,326,513); and Acker et al. (2007/0144518) each disclose additional therapy systems including a multi-gas delivery to the patient whereby capnograph data in the form of oxygen concentration/saturation undergoes feedback to modulate the delivery systems.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785