DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 06/08/2026 has been entered. Claims 1 and 12 have been amended. No claims have been newly added nor cancelled. Claims 1, 4-5, 8-12, 14-19, and 21-23 remain pending in the instant application.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 5, 8, 9, 10, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over US20210244902A1 to Andersson et al. (hereinafter “Andersson”) in view of US6718975B2 to Blomberg (hereinafter “Blomberg”), US20190125277A1 to Radke (hereinafter “Radke”), and DE69636501T2 to Magdy (hereinafter “Magdy”).
Regarding claim 1, Andersson discloses a ventilator for ventilating the lungs of a patient with breathing air (Fig. 1 mechanical ventilation system 1), the ventilator comprising:
a ventilation module configured to generate a breathing air flow (Fig. 1 breathing apparatus 2); a determination module (Fig. 1 flow sensors 23 and pressure sensors 25 are taken together to be the determination module) configured to determine a first ventilation parameter (Fig. 1 pressure sensors 25) as well as a second ventilation parameter of the ventilator (Fig. 1 flow sensors 23), said second ventilation parameter being ventilation volume, the first ventilation parameter being ventilation pressure (as set forth above);
a control module configured to control the ventilator as a function of the determined first ventilation parameter and/or the determined second ventilation parameter (Fig. 1 control computer 15; Paragraph 0061 discloses the control computer controls ventilation for the patient based on measurements obtained by the sensors of the breathing apparatus),
wherein the control module is configured automatically to reduce the ventilation pressure over an analysis period comprising at least one breathing cycle (Paragraph 0063 discloses flow (23, 23’, 23’’) and pressure (25, 25’, 25’’) sensors send signals to the control computer 15 which then adjusts the inspiratory and expiratory flows to the patient; Paragraph 0098 discloses the breathing apparatus reduces PEEP over a range of 6-15 breaths; Paragraph 0102-0104 discloses the breathing apparatus 2 may be configured to automatically reduce PEEP over a period of multiple breaths (breathing cycles); Paragraph 0109 discloses the breathing apparatus (and therein the control module) monitors and analyzes each patient breath), the control module being configured to automatically reduce the first ventilation parameter by a reduction factor in a stepwise manner (Fig. 2 during “PEEP titration” shows a stepwise decrease in airway pressure for the patient; See also Fig. 5 which shows a stepwise decrease (Line A`) in airway pressure during auto recruitment; Paragraph 0063 discloses the measurement signals from the flow sensors 23, 23`, 23`` and pressure sensors 25, 25`, 25`` are transmitted to the control computer 15. The control computer then adjusts the airway pressure and flow based on the signals from the sensors; Examiner notes that the reduction factor is the amount the airway pressure drops per increment as seen in the graphs of Figs. 2 and 5); and
a ventilator configured to classify the pulmonary status of the lungs of the patient on the basis of a change in the second ventilation parameter, which change was brought about by the automatic reduction of the first ventilation parameter (Paragraph 0124 discloses the breathing apparatus 2 is configured to monitor a stress index which relies upon the sensed pressure and volume relationship. The stress index indicates a pulmonary status of the lungs (i.e. distension) based on the measured parameters; Paragraph 0125 discloses the breathing apparatus 2 may adjust the therapy on a breath-by-breath basis to make the stress curve approach a value of 1 (when no stress on the user is present)); an inhalation port (Fig. 1 the point where inhalation line 5 meets the structure of breathing apparatus 2 is considered to be the port);
an exhalation port (Fig. 1 the point where the exhalation line 7 meets the structure of breathing apparatus 2 is considered to be the port),
the first ventilation parameter being detected in an area of the inhalation port (Fig. 1 pressure sensor 25’ is directly adjacent to the designated inhalation port),
the second ventilation parameter being detected in an area of the exhalation port (Fig. 1 flow sensor 23’’ is directly adjacent to the designated exhalation port),
wherein the control module is configured to carry out a recruitment maneuver to improve the pulmonary status (Paragraph 0064 discloses the control computer 15 carries out lung recruitment; Paragraph 0066 discloses the aim of recruitment maneuvers is re-open collapsed alveoli), wherein the control module is configured to reduce the first ventilation parameter stepwise over an analysis period comprising a plurality of breathing cycles (Paragraph 0063 discloses pressure sensors 25, 25’, 25’’, send signals to the control computer 15 which then adjusts inspiratory and expiratory flows to the patient; Paragraph 0098 discloses the breathing apparatus reduces PEEP over a range of 6-15 breaths; Fig. 5 during “PEEP titration” shows a stepwise decrease (Line A’) in airway pressure for the patient), wherein the first ventilation parameter is only reduced stepwise during the plurality of breathing cycles (Fig. 5 during “PEEP titration” shows a stepwise decrease (Line A’) in airway pressure for the patient; Paragraph 0098 discloses the breathing apparatus reduces PEEP over a range of 6-15 breaths; Examiner notes each breath (inhale and exhale) is counted as a breathing cycle, thus 6-15 breaths is considered to be a plurality of breathing cycles).
Andersson does disclose the breathing apparatus classifies the stress index to determine pulmonary status (Paragraph 0124). Andersson does not explicitly disclose a classification module. However, Blomberg teaches a method for assessing pulmonary stress of a patient comprising several microprocessors to determine stress index (Col. 5 lines 11-20 disclose control unit 30 may be made of several processors and memories, and determines pulmonary stress index based upon measurements from flow and pressure sensors.).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the control computer of Andersson to have multiple processors, as taught by Blomberg, to provide a more efficient processing system. Examiner notes that more processors will result in reduced load compared to a singular processor, thus reducing calculation times, and mitigating the chances of system failure due to technical difficulties.
Examiner notes that Andersson modified by Blom discloses carrying out a recruitment maneuver corresponding to a classification of the pulmonary status of the lungs of the patient, which classification was carried out by the classification module (Blomberg Col. 5 lines 11-20 disclose control unit 30 may be made of several processors and memories, and determines pulmonary stress index based upon measurements from flow and pressure sensors; Examiner notes that Andersson as modified by Blom would use the classification module to make the recruitment maneuvers, similar to the function of Andersson (Paragraph 0124 discloses the breathing apparatus classifies the stress index to determine pulmonary status)).
Andersson does not disclose wherein the classification module is configured to classify the pulmonary status of the lungs of the patient qualitatively as collapsed, overdistended or normal. However, Radke teaches a medical diagnosis system which identifies pulmonary status qualitatively (Fig. 2 computer 16, tidal image 22, distribution image 23; Paragraph 0054 discloses the images are used to tell whether there is overdistension, atelectasis (collapse), or normal functioning state of the lung).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the computer and display unit of Andersson to output images regarding pulmonary status, as taught by Radke, to allow the user to quickly identify problems in the ventilation and counteract these problems by modifying the adjustment parameters of the ventilation system (Paragraph 0008).
Examiner notes Andersson classifying a pulmonary status of the lungs of the patient based upon a stress index which is based upon a relationship between pressure and volume detected within the patient (Paragraphs 0124-0125).
Modified Andersson does not explicitly disclose classifying a pulmonary status of the lungs of the patient based on a ratio of the ventilation volume to the ventilation pressure and a change in the ratio resulting from the reduction of the first ventilation parameter. However, Magdy teaches a method for determining pulmonary status of a patient based on a ratio of ventilation volume to the ventilation pressure and a change in the ratio resulting from the reduction of ventilation pressure (Paragraph 0017 discloses the adjust of ventilation support relies upon calculating pressure minus PEEP divided by average volume to provide an elastance value; Paragraph 0017 then discloses this ratio us used to measure the presence of dynamic distension or airway closure; Paragraphs 0012-0017 discloses the preferred method for determining the pressure-volume ratio).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Andersson’s processor logic to also classify patient pulmonary status based on based on a ratio of the ventilation volume to the ventilation pressure and a change in the ratio resulting from the reduction of the first ventilation parameter, as taught by Magdy, in order to provide an additional means of determining pulmonary status of a patient (Paragraphs 0012-0017). Examiner notes that providing an additional means of classifying pulmonary status would ensure accuracy of the patient’s pulmonary status.
Regarding claim 4, Andersson in view of Blomberg, Magdy, and Radke discloses the ventilator in accordance with claim 1, and Andersson further discloses wherein the classification module is configured to classify the pulmonary status of the lungs of the patient quantitatively (Andersson Paragraph 0124 discloses the breathing apparatus 2 uses a stress index based off of Pressure-Volume relationship for each breath of the patient to indicate whether there is normal functioning or distension).
Regarding claim 5, Andersson in view of Blomberg, Magdy, and Radke discloses the ventilator in accordance with claim 4, and Andersson further discloses an alarm device configured to output an alarm (Paragraphs 0153 & 0154 disclose an alarm based on recruitment maneuvers). Andersson does not disclose an alarm output when the quantitative classified pulmonary status falls below a collapse limit value or exceeds an overdistention limit value. However, Blomberg teaches a method for assessing pulmonary stress of a patient using an alarm based on pulmonary status (Col. 2 lines 49-55 disclose an alarm is present in the apparatus if the stress index is too high or too low; Andersson Paragraph 0124 discloses the stress index parameter and the use of the stress index is found in Blomberg; Examiner notes the alarm of Blomberg would be incorporated to the apparatus of Andersson).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the alarm of Andersson to activate based on pulmonary status, as taught by Blomberg, in order to indicate that a possibly injurious therapy is being delivered to a subject (Col. 2 lines 54-55).
Regarding claim 8, Andersson in view of Blomberg, Magdy, and Radke discloses the ventilator in accordance with claim 1, and Andersson further discloses a display device, wherein the display device is configured to display the pulmonary status of the lungs of the patient and/or to display a recruitment maneuver recommended on the basis of the pulmonary status (Figs. 5 & 8 display many characteristics regarding the pulmonary status of the patient’s lungs including pressures and volumes which are used to further assess pulmonary status).
Regarding claim 9, Andersson in view of Blomberg, Magdy, and Radke discloses the ventilator in accordance with claim 1, and Andersson further discloses wherein the classification module is configured to estimate a linear lung model of the lungs of the patient on the basis of the first ventilation parameter and second ventilation parameter (Paragraph 0124 discloses the breathing apparatus 2 uses a stress index based off of Pressure-Volume relationship for each breath of the patient to indicate whether there is normal functioning or distension), which were determined prior to the automatic reduction of the first ventilation parameter (Paragraph 0102-0104 discloses the breathing apparatus 2 may be configured to automatically reduce PEEP over a period of multiple breaths (breathing cycles); Examiner notes that the flow and pressure sensors function when the breathing apparatus is on, and thus ventilation parameters would be determined before, during, and after changes in the ventilation parameters), wherein the classification module is further configured to classify the pulmonary status of the lungs on the basis of the estimated lung model and on the basis of the second ventilation parameter determined after the automatic reduction of the first ventilation parameter (Paragraph 0124 discloses pulmonary status may be determined on the basis of the pressure-volume relationship [read by the flow and pressure sensors, i.e. the determination module]; Paragraphs 0121-0122 discloses the stress index may be used to predict whether or not the optimal PEEP can be reliably determined during the PEEP titration phase (reduction of the first ventilation parameter)).
Regarding claim 10, Andersson in view of Blomberg, Magdy, and Radke discloses the ventilator in accordance with claim 1, and Andersson as modified by Blomberg further discloses wherein the classification module is configured to take into account a change in the distension and/or compliance of the lungs, which was brought about after the automatic reduction of the first ventilation parameter (Paragraph 0063 discloses flow (23, 23’, 23’’) and pressure (25, 25’, 25’’) sensors send signals to the control computer 15 which then adjusts the inspiratory and expiratory flows to the patient; Paragraph 0098 discloses the breathing apparatus reduces PEEP over a range of 6-15 breaths; Paragraph 0102-0104 discloses the breathing apparatus 2 may be configured to automatically reduce PEEP over a period of multiple breaths (breathing cycles); Examiner notes that the classification module [processor] of Blomberg is integrated into Andersson’s computer).
Andersson in view of Blomberg does not disclose an EIT module for determining a pulmonary status of the lungs or at least a part of the lungs of the patient and a change in the distention and/or compliance of the lungs during the classification of the pulmonary status. However, Radke teaches a medical diagnosis system which identifies pulmonary status via an EIT module (Fig. 1 EIT device 1; Paragraph 0008 discloses the EIT system and ventilation system work together to identify distended and collapsed regions of a user’s lungs; Paragraph 0008 discloses the EIT system and ventilation system work together to identify distended and collapsed regions of a user’s lungs).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ventilator of Andersson to further include and EIT module, as taught by Radke, in order to immediately identify overdistended and atelectacic regions (Paragraph 0008).
Regarding claim 22, Andersson in view of Blomberg, Magdy, and Radke discloses a ventilator in accordance with claim 1, and Andersson further discloses wherein the classification module is configured to classify the pulmonary status of the lungs of the patient based on a ratio of the ventilation volume to the ventilation pressure (Paragraph 0124 discloses the breathing apparatus 2 is configured to monitor a stress index which relies upon the sensed pressure and volume relationship. The stress index indicates a pulmonary status of the lungs (i.e. distension) based on the measured parameters of volume to pressure; Paragraph 0125 discloses the breathing apparatus 2 may adjust the therapy on a breath-by-breath basis to make the stress curve approach a value of 1 (when no stress on the user is present)).
Claims 12, 14-15, 17-19, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Andersson in view of Blomberg and Magdy.
Regarding claim 12, Andersson discloses a process for ventilating lungs of a patient with breathing air by means of a ventilator, the process comprising the steps of (Fig. 1 mechanical ventilation system 1; Paragraph 0013 discloses ventilating a patient’s lungs):
generating a breathing air flow by means of a ventilation module of the ventilator (Fig. 1 breathing apparatus 2, pneumatic unit 17; Paragraph 0061 discloses the pneumatic unit of the breathing apparatus generates airflow to the patient);
determining a first ventilation parameter (Fig. 1 pressure sensors 25; Paragraph 0062 discloses pressure is measured by the pressure sensors) and a second ventilation parameter (Fig. 1 flow sensors 23; Paragraph 0062 discloses the flow is measured by the flow sensors) by means of a determination module of the ventilator after generating the breathing air flow (Paragraph 0061 discloses the control computer may control ventilation based on measurements obtained by the sensors 23, 25), the second ventilation parameter being different from the first ventilation parameter (Fig. 1 flow sensors 23 (second parameter) are different from pressure sensors 25 (first parameter)), the first ventilation parameter being a ventilation pressure, the second ventilation parameter being a ventilation volume (See parameters set forth above);
automatically reducing the ventilation pressure over an analysis period comprising at least one breathing cycle by means of a control device of the ventilator after determining the first ventilation parameter and the second ventilation parameter (Fig. 1 control computer 15; Paragraph 0061 discloses the control computer controls ventilation for the patient based on measurements obtained by the sensors of the breathing apparatus; Paragraph 0063 discloses flow (23, 23’, 23’’) and pressure (25, 25’, 25’’) sensors send signals to the control computer 15 which then adjusts the inspiratory and expiratory flows [and therein pressures] to the patient; Paragraph 0098 discloses the breathing apparatus reduces PEEP over a range of 6-15 breaths; Paragraph 0102-0104 discloses the breathing apparatus 2 may be configured to automatically reduce PEEP over a period of multiple breaths (breathing cycles); Paragraph 0109 discloses the breathing apparatus (and therein the control module) monitors and analyzes each patient breath; Examiner notes that the machine adjusts ventilation controls automatically based upon sensor information about the flow and pressure);
wherein the first ventilation parameter is reduced by a reduction factor stepwise over an analysis period comprising a plurality of breathing cycles (Paragraph 0063 discloses pressure sensors 25, 25’, 25’’, send signals to the control computer 15 which then adjusts inspiratory and expiratory flows to the patient; Paragraph 0098 discloses the breathing apparatus reduces PEEP over a range of 6-15 breaths; Fig. 5 during “PEEP titration” shows a stepwise decrease (Line A’) in airway pressure for the patient; Examiner notes that the reduction factor is the amount the airway pressure drops per increment as seen in the graphs of Figs. 2 and 5), the first ventilation parameter only being reduced stepwise during the plurality of breathing cycles (Fig. 5 during “PEEP titration” shows a stepwise decrease (Line A’) in airway pressure for the patient);
determining a change in the second ventilation parameter, which change was brought about by the automatic reduction of the first ventilation parameter, by means of the determination module after reducing the ventilation pressure (Fig. 1 flow sensors 23 determine changes in the flow; Examiner notes that when pressure [first ventilation parameter] is reduced in the breathing apparatus circuit, flow [second ventilation parameter] will also naturally be reduced, and this change will be sensed by the flow sensors); See Paragraph 0063 where the control computer 15 reduces airway pressure via sensor readings; Examiner notes that reducing pressure (first parameter) would naturally result in a decrease of flow as well; Examiner further notes the flow sensor would detect the change once the pressure has dropped in the airway); and
classifying a pulmonary status of the lungs of the patient by means of a module of the ventilator after determining the change in the second ventilation parameter (Paragraph 0124 discloses the breathing apparatus 2 is configured to monitor a stress index which relies upon the sensed pressure and volume relationship. The stress index indicates a pulmonary status of the lungs (i.e. distension) based on the measured parameters; Paragraph 0125 discloses the breathing apparatus 2 may adjust the therapy on a breath-by-breath basis to make the stress curve approach a value of 1 (when no stress on the user is present); Paragraph 0063 discloses the control computer 15 adjusts ventilation parameters automatically based on the flow and pressure sensors; Examiner notes that when the pressure is changed, it naturally follows the flow would be changed as well, which the flow sensor would detect).
Andersson does disclose the breathing apparatus classifies the stress index to determine pulmonary status (Paragraph 0124). Andersson does not explicitly disclose a classification module. However, Blomberg teaches a method for assessing pulmonary stress of a patient comprising several microprocessors to determine stress index (Col. 5 lines 11-20 disclose control unit 30 may be made of several processors and memories, and determines pulmonary stress index based upon measurements from flow and pressure sensors.).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the control computer of Andersson to have multiple processors, as taught by Blomberg, to provide a more efficient processing system. Examiner notes that more processors will result in reduced load compared to a singular processor, thus reducing calculation times, and mitigating the chances of system failure due to technical difficulties.
Examiner notes Andersson classifying a pulmonary status of the lungs of the patient based upon a stress index which is based upon a relationship between pressure and volume detected within the patient (Paragraphs 0124-0125).
Modified Andersson does not explicitly disclose classifying a pulmonary status of the lungs of the patient based on a ratio of the ventilation volume to the ventilation pressure and a change in the ratio resulting from the reduction of the first ventilation parameter. However, Magdy teaches a method for determining pulmonary status of a patient based on a ratio of ventilation volume to the ventilation pressure and a change in the ratio resulting from the reduction of ventilation pressure (Paragraph 0017 discloses the adjust of ventilation support relies upon calculating pressure minus PEEP divided by average volume to provide an elastance value; Paragraph 0017 then discloses this ratio us used to measure the presence of dynamic distension or airway closure; Paragraphs 0012-0017 discloses the preferred method for determining the pressure-volume ratio).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Andersson’s processor logic to also classify patient pulmonary status based on based on a ratio of the ventilation volume to the ventilation pressure and a change in the ratio resulting from the reduction of the first ventilation parameter, as taught by Magdy, in order to provide an additional means of determining pulmonary status of a patient (Paragraphs 0012-0017). Examiner notes that providing an additional means of classifying pulmonary status would ensure accuracy of the patient’s pulmonary status.
Regarding claim 14, Andersson in view of Blomberg and Magdy discloses the process in accordance with claim 12, and Andersson further discloses wherein the classified pulmonary status of the lungs of the patient (Figs. 5 & 8 display many characteristics regarding the pulmonary status of the patient’s lungs including pressures and volumes which are used to further assess pulmonary status) and/or a recruitment maneuver suitable for improving the pulmonary status of the lungs are displayed by means of a display device of the ventilator (Figs. 1 and 4-8 show display 32 which has recruitment status and many other statistics regarding the patient’s pulmonary status), and/or a recruitment maneuver suitable for improving the pulmonary status of the lungs is carried out by means of the control device, the first ventilation parameter being detected in an area of an inhalation port (Fig. 1 the point where inhalation line 5 meets the structure of breathing apparatus 2 is considered to be the port; Fig. 1 pressure sensor 25' is directly adjacent to the designated inhalation port) of the ventilator and the second ventilation parameter being detected in an area of an exhalation port of the ventilator (Fig. 1 the point where the exhalation line 7 meets the structure of breathing apparatus 2 is considered to be the port; Fig. 1 flow sensor 23" is directly adjacent to the designated exhalation port), the second ventilation parameter being different from the first ventilation parameter (Parameters are different as set forth above).
Regarding claim 15, Andersson in view of Blomberg and Magdy discloses the process in accordance with claim 12, and Andersson as modified by Blomberg further discloses wherein the control device is configured to carry out a recruitment maneuver to improve the pulmonary status corresponding to a classification of the pulmonary status of the lungs of the patient, which classification was carried out by the classification module (Paragraph 0064 discloses the control computer 15 includes a program for lung recruitment stored in memory 31, and the program comprises functionality for configuring, initiating, monitoring, and evaluating the automated lung recruitment maneuver; Examiner notes classification module is part of breathing apparatus’ 2 control computer as modified by Blomberg).
Regarding claim 17, Andersson in view of Blomberg and Magdy discloses the process in accordance with claim 15, and Andersson wherein the classification module is configured to classify the pulmonary status of the lungs of the patient quantitatively (Paragraph 0124 discloses the breathing apparatus 2 uses a stress index based off of Pressure-Volume relationship for each breath of the patient to indicate whether there is normal functioning or distension).
Regarding claim 18, Andersson in view of Blomberg and Magdy discloses the process in accordance with claim 17, and Andersson discloses an alarm device configured to output an alarm (Paragraphs 0153 & 0154 disclose an alarm based on recruitment maneuvers). Andersson does not disclose an alarm output when the quantitative classified pulmonary status falls below a collapse limit value or exceeds an overdistention limit value. However, Blomberg teaches a method for assessing pulmonary stress of a patient using an alarm based on pulmonary status (Col. 2 lines 49-55 disclose an alarm is present in the apparatus if the stress index is too high or too low; Andersson Paragraph 0124 discloses the stress index parameter and the use of the stress index is found in Blomberg; Examiner notes the alarm of Blomberg would be incorporated to the apparatus of Andersson).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the alarm of Andersson to activate based on pulmonary status, as taught by Blomberg, in order to indicate that a possibly injurious therapy is being delivered to a subject (Col. 2 lines 54-55).
Regarding claim 19, Andersson in view of Blomberg and Magdy discloses the process in accordance with claim 15, and Andersson further discloses wherein the control module is configured to reduce a ventilation volume and/or a ventilation pressure automatically as a first ventilation parameter (Andersson Paragraph 0063 discloses flow (23, 23’, 23’’) and pressure (25, 25’, 25’’) sensors send signals to the control computer 15 which then adjusts the inspiratory and expiratory flows to the patient; Paragraph 0098 discloses the breathing apparatus reduces PEEP over a range of 6-15 breaths; Paragraph 0102-0104 discloses the breathing apparatus 2 may be configured to automatically reduce PEEP over a period of multiple breaths (breathing cycles)) wherein the first ventilation parameter is only reduced by the reduction factor in the stepwise during the analysis period (Examiner notes Fig. 5 shows stepwise reduction of the pressure (Line A’); Examiner notes that the reduction factor is the amount the airway pressure drops per increment as seen in the graphs of Figs. 2 and 5).
Regarding claim 21, Andersson in view of Blomberg and Magdy discloses the process in accordance with claim 15, and Andersson further discloses wherein the pulmonary status of the lungs of the patient is classified based on a ratio of the ventilation volume to the ventilation pressure (Paragraph 0124 discloses the breathing apparatus 2 is configured to monitor a stress index which relies upon the sensed pressure and volume relationship. The stress index indicates a pulmonary status of the lungs (i.e. distension) based on the measured parameters of volume to pressure; Paragraph 0125 discloses the breathing apparatus 2 may adjust the therapy on a breath-by-breath basis to make the stress curve approach a value of 1 (when no stress on the user is present)).
Regarding claim 23, Andersson in view of Blomberg and Magdy discloses a process in accordance with claim 15, and Andersson further discloses wherein the ventilator comprises an inhalation port (Fig. 1 the point where inhalation line 5 meets the structure of breathing apparatus 2 is considered to be the port); an exhalation port (Fig. 1 the point where the exhalation line 7 meets the structure of breathing apparatus 2 is considered to be the port), the first ventilation parameter being detected in an area of the inhalation port (Fig. 1 pressure sensor 25’ is directly adjacent to the designated inhalation port), the second ventilation parameter being detected in an area of the exhalation port (Fig. 1 flow sensor 23’’ is directly adjacent to the designated exhalation port).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Andersson in view of Blomberg, Magdy, and Radke as applied to claim 2 above, and further in view of US20070068528A1 to Bohm et al. (hereinafter “Bohm”).
Regarding claim 11, Andersson in view of Blomberg, Magdy, and Radke discloses the ventilator in accordance with claim 1, and Andersson further discloses wherein the control device is configured to reduce the first ventilation parameter automatically (Paragraph 0063 discloses flow (23, 23’, 23’’) and pressure (25, 25’, 25’’) sensors send signals to the control computer 15 which then adjusts the inspiratory and expiratory flows to the patient; Paragraph 0098 discloses the breathing apparatus reduces PEEP over a range of 6-15 breaths; Paragraph 0102-0104 discloses the breathing apparatus 2 may be configured to automatically reduce PEEP over a period of multiple breaths (breathing cycles)), wherein the first ventilation parameter is only reduced by the reduction factor in the stepwise manner during the analysis period (Examiner notes Fig. 5 shows stepwise reduction of the pressure (Line A’); Examiner notes that the reduction factor is the amount the airway pressure drops per increment as seen in the graphs of Figs. 2 and 5).
Andersson does not disclose reducing pressure by between 20% and 60%. However, Bohm discloses a method and apparatus for determining the status of a ventilated lung that reduces pressure parameters during treatment (Paragraph 0146-0149 disclose gradual decreasing of airway pressures from 20 cmH.sub.2O to 8cmH.sub.2O (a 0-60% decrease)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ventilator of Andersson to allow for specific ranges of pressure reduction, as taught by Bohm, to ensure patients remain comfortable during operation of the ventilator. Examiner notes that being comfortable will naturally result in higher patient compliance and effectiveness of the treatment.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Andersson in view of Blomberg and Magdy as applied to claim 15 above, and further in view of Radke.
Regarding claim 16, Andersson in view of Blomberg and Magdy discloses the process in accordance with claim 15, but Andersson does not disclose wherein the classification module is configured to classify the pulmonary status of the lungs of the patient qualitatively as collapsed, overdistended or normal. However, Radke teaches a medical diagnosis system which identifies pulmonary status qualitatively (Fig. 2 computer 16, tidal image 22, distribution image 23; Paragraph 0054 discloses the images are used to tell whether there is overdistension, atelectasis (collapse), or normal functioning state of the lung).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the computer and display unit of Andersson to output images regarding pulmonary status, as taught by Radke, to allow the user to quickly identify problems in the ventilation and counteract these problems by modifying the adjustment parameters of the ventilation system (Paragraph 0008).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20230263973-A1 to Bell; and US-20190275276-A1 to Kremeier.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30.
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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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