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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/16/2026 has been entered.
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, 4-6, 12-13, 23, 31-32, 36, 39, 47-48, 64, 73-77, 83 and 131-132 are rejected under 35 U.S.C. 103 as being unpatentable over Biondi (US 2002/0026941 A1) in view of Hickle (US 2006/0093785 A1).
Regarding claim 1, Biondi discloses an apparatus for treating a patient experiencing respiratory distress (abstract discloses a medical ventilator thus disclosing an apparatus for respiratory distress), the apparatus comprising: a respiratory distress management ventilator (#17/14 fig 1), comprising: a mechanical ventilation apparatus (#45/41 fig 1), for providing mechanical ventilation to the patient, comprising: a gas flow generator (#45/41 fig 1); and a gas delivery apparatus (#21 fig 1), coupled with the gas flow generator, comprising a patient circuit extending from the housing and configured to interface with the patient at least in part for delivery of gas to the patient (par 0033 "the ventilator 17 is in pneumatic communication with a flexible tubing 21 capable of attachment to a patient 20"); and a ventilator controller (#14 fig 1), the ventilator controller comprising a processor (#30, 31, 32 fig 1) and a memory (#15 fig 1), the ventilator controller being configured such that: the ventilator controller determines whether a fault mode condition exists at a particular time (par 0043 discloses controller 14 re-validating the settings of a breath control structure, par 0083 discloses the controller determining if the structure is in-valid, the presence of an invalid structure is seen as a fault mode condition); if the fault mode condition is determined not to exist, the ventilator controller enables control of the mechanical ventilation apparatus of the ventilator by at least one controlling source separate from the ventilator in delivering mechanical ventilation to the patient, via signals received by the ventilator controller from the at least one controlling source (par 0043 discloses the controller determining the structure received from at least one source, #12 fig 1, is valid and thus controlling the ventilator according to the received structure); and if the fault mode condition is determined to exist, the ventilator controller controls the mechanical ventilation apparatus of the ventilator in delivering the mechanical ventilation to the patient (par 0083 discloses the controller determining the structure received from at least one source to be invalid and instead controlling the ventilator based on previous valid structures or a predefined structure).
Biondi does not expressively disclose a ventilator housing that the ventilator and controller are disposed within. Biondi does not expressly disclose that the display controller/controlling source is physically separate from the ventilator. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a housing onto the apparatus of Biondi in order to protect the components of the ventilator and embedded controller.
Hickle teaches a care system providing ventilation (#10 fig 1, par 0065) that receives physician input through at least one controlling source physically separate from the care system (#45 fig 1, par 0074 “User interface system 16 includes devices that permit the nonanesthetist to interact with the care system via … remote control unit 45”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ensure that the display controller of Biondi is physically separate from the ventilator as taught by Hickle as doing so enable the physician to control the system remotely (Hickle: par 0156).
Regarding claim 2, modified Biondi discloses the apparatus of claim 1. Biondi further discloses if the fault mode condition is determined to exist at the particular time, the ventilator controller controls the mechanical ventilation apparatus of the ventilator in delivering the mechanical ventilation to the patient according to at least one of: previously stored ventilation control parameter values and previously stored last received valid ventilation control parameter values (par 0083 discloses last known valid and predefined/previously stored valid).
Regarding claim 4, modified Biondi discloses the apparatus of claim 1. Biondi further discloses the ventilator controller is configured to: determine whether the fault mode condition exists, wherein the fault mode condition is associated with the ventilator (the fault mode condition is considered to be associated with the respiratory distress management device as it is associated with the breath control structure to be implemented), and wherein the at least one controlling source is separate from the ventilator (see modifications taught by Hickle, and further Biondi: see fig 1 showing the display controller/at least one source #12 being separate from the embedded controller #14, further par 0031 disclosing 14 as an embedded controller interfacing the ventilator and 12 as a display controller for interfacing the clinician).
Regarding claim 5, modified Biondi discloses the apparatus of claim 1. Biondi further discloses the ventilator controller is configured to: determine whether a fault mode condition exists at a particular time (par 0043 the particular time being upon receiving the breath control structure from the at least one source), wherein the particular time is a first predetermined time (the predetermined time being upon receiving the breath control structure); if the fault mode condition is determined not to exist at the first predetermined time, enable control of the mechanical ventilation apparatus of the ventilator by at least one controlling source in delivering mechanical ventilation to the patient, via signals received by the ventilator controller from the at least one controlling source (par 0043 discloses the controller 14 determining the structure received from at least one source, #12 fig 1, is valid and thus controlling the ventilator according to the received structure); and if the fault mode condition is determined to exist at the first predetermined time, control the mechanical ventilation apparatus of the ventilator in delivering the mechanical ventilation to the patient (par 0083 discloses the controller determining the structure received from at least one source to be invalid and instead controlling the ventilator based on previous valid structures or a predefined structure).
Regarding claim 6, modified Biondi discloses the apparatus of claim 5. Biondi further discloses the ventilator controller is configured to: determine whether a fault mode condition exists at a second predetermined time (par 0043 it is seen that the controller would perform validation a second time upon receiving a new breath control structure), wherein the second predetermined time follows the first predetermined time by a predetermined period of time (the predetermined period of time being the time between breath control structures being input/sent to the controller); if the fault mode condition is determined not to exist at the second predetermined time, enable control of the mechanical ventilation apparatus of the ventilator by at least one controlling source in delivering mechanical ventilation to the patient, via signals received by the ventilation controller from the at least one controlling source (par 0043 discloses the controller determining the structure received from at least one source, #12 fig 1, is valid and thus controlling the ventilator according to the received structure); and if the fault mode condition is determined to exist at the second predetermined time, control the mechanical ventilation apparatus of the ventilator in delivering the mechanical ventilation to the patient (par 0083 discloses the controller determining the structure received from at least one source to be invalid and instead controlling the ventilator based on previous valid structures or a predefined structure).
Alternatively, Biondi further discloses the ventilator controller is configured to: determine whether a fault mode condition exists at a second predetermined time, wherein the second predetermined time follows the first predetermined time by a predetermined period of time (par 0036 discloses the embedded controller performing redundancy checks on the source continually, thus disclosing determining whether the fault mode conditions occurs at a second predetermined time occurring a predetermined period of time after the first predetermined time).
Regarding claim 8, modified Biondi discloses the apparatus of claim 6. Biondi does not expressly disclose that the predetermined period of time is set to one of: one second, between 0.1 second and 1 second, and between 1 second and 10 seconds, only disclosing checks being performed continuously (par 0036).
The period of time effects the frequency of the redundancy checks of Biondi thus affecting the effectiveness of the checks in preventing implementation of invalid inputs. It therefore would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a period of time set to one second, between 0.1 second and 1 second, and between 1 second and 10 seconds as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."
Regarding claim 12, modified Biondi discloses the apparatus of claim 1. Biondi further discloses at least one pressure sensor (#7 fig 1), disposed within the mechanical ventilation apparatus, configured to sense signals representative of gas flow within the gas delivery apparatus (par 0032); and wherein the ventilator controller is configured to: receive the signals representative of the gas flow; based at least in part on the received signals representative of the gas flow, generate respiratory parameter data corresponding with at least one respiratory parameter of the patient (par 0041); and transmit the respiratory parameter data to a second device coupled with the ventilator (par 0032), the respiratory parameter data being for use in determining a respiratory status of the patient (par 0037 discloses displaying patient history to highlight “patient status”).
Regarding claim 13, modified Biondi discloses the apparatus of claim 12. Biondi further discloses the ventilator controller is configured to transmit the respiratory parameter data to the second device for use by the second device in displaying at least one of data related to the respiratory status of the patient (par 0032) on a graphical user interface of a display (par 0037) of the second device and user-interactive context sensitive guidance relating to treatment of the patient (par 0037, 0039).
Regarding claim 23, modified Biondi discloses the apparatus of claim 1. Biondi further discloses the ventilator controller determines whether the fault mode condition exists using one or more algorithms stored in the memory of the ventilator controller and executed by the processor of the ventilator controller (par 0068 discloses the controller running the algorithms required for measurement and control).
Regarding claim 31, modified Biondi discloses the apparatus of claim 1. Biondi further discloses the ventilator controller is configured to, in an event that the fault mode condition is determined to exist, switch from enabling the control of the mechanical ventilation by the at least one controlling source to the ventilator controller controlling the mechanical ventilation (par 0083).
Regarding claim 32, modified Biondi discloses the apparatus of claim 1. Biondi does not expressly disclose the fault mode condition indicates that the control by the at least one controlling source would be at least one of: insufficiently safe, insufficiently reliable with respect to receipt of mechanical ventilation control data by the ventilator controller from the at least one controlling source, and suboptimal with respect to the treatment of the patient relative to the control by the ventilator controller. Biondi only indicates the fault mode condition relates to validity/invalidity.
Hickle teaches a ventilator controller halting the flow of drugs in response to insufficiently safe conditions (par 0103 “electronic controller 14, halt or reduce the flow of drugs to the patient in the event of an occurrence of unsafe patient or system conditions”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the controller of modified Biondi recognize a breath control structure provided by the at least one source as invalid when insufficiently safe as taught by Hickle as doing so prevents the controller from implementing a structure that could cause harm to the patient.
Regarding claim 36, modified Biondi discloses the apparatus of claim 1. Biondi further discloses the fault mode condition indicates that ventilation control data received by the ventilator controller from the at least one controlling source is at least one of: invalid (par 0083 “invalid”), corrupt, and inconsistent.
Regarding claim 39, modified Biondi discloses the apparatus of claim 1. Biondi does not expressly disclose the fault mode condition indicates that enabling the control by the at least one controlling source would cause operation of the mechanical ventilation apparatus according to at least one ventilation parameter value that exceeds at least one range comprising at least one of: a range associated with patient safety, a flow rate range, and a pressure range. Biondi only indicates the fault mode condition relates to validity/invalidity.
Hickle teaches a ventilator controller halting the flow of drugs in response to values exceeding patient safety range conditions (par 0103 “electronic controller 14, halt or reduce the flow of drugs to the patient in the event of an occurrence of unsafe patient or system conditions”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the controller of modified Biondi recognize a breath control structure provided by the at least one source as invalid when patient safety conditions are exceeded as taught by Hickle as doing so prevents the controller from implementing a structure that could cause harm to the patient.
Regarding claim 47, modified Biondi discloses the apparatus of claim 1. Biondi further discloses that upon a reset of the ventilator controller following a controller processing freeze that occurred during the control by the at least one controlling source, if communication ability does not exist between the ventilator and the at least one controlling source, the ventilator controller controls the mechanical ventilation in accordance with at least one of: one or more backup ventilation control parameter values stored in the memory of the controller, and current ventilation control data from the at least one controlling source (par 0036 discloses that when communication is lost between the source and the controller that the controller operates with the last known valid setting maintained in a non-volatile record of the controls).
Regarding claim 48, modified Biondi discloses the apparatus of claim 1. Biondi further discloses the ventilator controller is configured to perform cyclic redundancy checks on mechanical ventilation control data received from the at least one controlling source (par 0036 discloses the embedded controller performing redundancy checks on the source continually).
Regarding claim 64, modified Biondi discloses the apparatus of claim 1. Biondi further discloses the ventilator controller is configured to generate user alarms relating to particular detected conditions (par 0036 “the systems provide alarms”, par 0064 discloses a variety of alarm settings), the alarms comprising at least one of: alarms to provide alerts regarding potentially unsafe ventilation conditions, alarms to provide alerts regarding potentially unsafe respiratory parameter values of the patient, alarm indications that are for display to a user of the ventilator on a graphical user interface that is separate from the ventilator, alarms relating to ventilation parameter values relating to control by the at least one controlling source, alarms relating to patient physiological parameters, one or more alarms relating to a high breath rate of the patient (par 0064 table listed below Alarms and indicators “high/low respiratory rate alarm”), and one or more alarms relating to an incomplete exhalation condition of the patient (par 0064 table listed below Alarms and indicators “high/low exhaled tidal volume alarm”).
Regarding claim 73, Biondi discloses a system for treating a patient experiencing respiratory distress (abstract discloses a medical ventilator thus disclosing treating respiratory distress), the system comprising: a respiratory distress management ventilator, comprising: a mechanical ventilation system (#17 fig 1) for providing mechanical ventilation to the patient, comprising at least one pressure sensor (#7 fig 1) configured to sense signals representative of gas flow within the mechanical ventilation system (par 0032); and a ventilator controller (“embedded controller” #14 fig 1), comprising a processor (#30, 31, 32 fig 1) and a memory (#15 fig 1), the ventilator controller being configured such that: the ventilator controller determines whether a fault mode condition exists at a particular time (par 0043 discloses controller 14 re-validating the settings of a breath control structure, par 0083 discloses the controller determining if the structure is in-valid, the presence of an invalid structure is seen as a fault mode condition); if the fault mode condition is determined not to exist, the ventilator controller enables control of the mechanical ventilation system by at least one controlling source separate from the ventilator in delivering mechanical ventilation to the patient, via signals received by the controller from the at least one controlling source (par 0043 discloses the controller 14 determining the structure received from at least one source, #12 fig 1 controller associated with the display/clinician, is valid and thus controlling the ventilator according to the received structure); and if the fault mode condition is determined to exist, the ventilator controller controls the mechanical ventilation system in delivering the mechanical ventilation to the patient (par 0083 discloses the controller determining the structure received from at least one source to be invalid and instead controlling the ventilator based on previous valid structures or a predefined structure).
Biondi does not expressively disclose that the display controller/controlling source is physically separate from the ventilator.
Hickle teaches a care system providing ventilation (#10 fig 1, par 0065) that receives physician input through at least one controlling source physically separate from the care system (#45 fig 1, par 0074 “User interface system 16 includes devices that permit the nonanesthetist to interact with the care system via … remote control unit 45”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ensure that the display controller of Biondi is physically separate from the ventilator as taught by Hickle as doing so enable the physician to control the system remotely (Hickle: par 0156).
Regarding claim 74, modified Biondi discloses the system of claim 73. Biondi further discloses the ventilator controller is configured to: determine whether the fault mode condition exists, wherein the fault mode condition is associated with ventilator (the fault mode condition is considered to be associated with the ventilator as it is associated with the breath control structure to be implemented), and wherein the at least one controlling source is separate from the ventilator (see fig 1 showing the display controller/at least one source #12 being separate from the embedded controller #14, also par 0031 disclosing the display controller being associated with the display for the clinician and the embedded controller being associated with the ventilator).
Regarding claim 75, Biondi discloses the system of claim 73. Biondi further discloses the ventilator controller is configured to: receive the signals representative of the gas flow; based at least in part on the received signals representative of the gas flow, generate respiratory parameter data corresponding with at least one respiratory parameter of the patient (par 0041); and transmit the respiratory parameter data to a device coupled with the ventilator (par 0032), the respiratory parameter data being for use in determining a respiratory status of the patient (par 0037 discloses displaying patient history to highlight “patient status”).
Regarding claim 76, Biondi discloses the system of claim 75. Biondi further discloses the ventilator controller is configured to transmit the respiratory parameter data to the device for use by the device in displaying data related to the respiratory status of the patient (par 0032) on a graphical user interface of a display (par 0037) of the device.
Regarding claim 77, Biondi discloses the system of claim 76. Biondi further discloses the ventilator controller is configured to transmit the respiratory parameter data to the device for use by the device in displaying user-interactive context sensitive guidance relating to treatment of the patient (par 0032, 0037, 0039).
Regarding claim 83, Biondi discloses the system of claim 73. Biondi further discloses the ventilator controller determines whether the fault mode condition exists using one or more algorithms stored in the memory of the ventilator controller and executed by the processor of the ventilator controller (par 0068 discloses the controller running the algorithms required for measurement and control)
Regarding claim 131, Biondi discloses a computer-implemented method for treating a patient experiencing respiratory distress (abstract discloses a medical ventilator thus disclosing treating respiratory distress), the method comprising: a ventilator controller (#14 fig 1), disposed within a respiratory distress management ventilator (#10 fig 1, see also #17 fig 1 shown as a ventilator), the controller comprising a processor (#30, 31, 32 fig 1) and a memory (#15 fig 1), determining whether, at a particular time, a fault mode condition exists (par 0043 discloses controller 14 re-validating the settings of a breath control structure, par 0083 discloses the controller determining if the structure is in-valid, the presence of an invalid structure is seen as a fault mode condition), the fault mode condition being associated with the ventilator and at least one controlling source (#12 fig 1) that is separate from the ventilator (par 0043, 0083 the fault mode condition is considered to be associated with the respiratory distress management device and the at least one source, as it is associated with the breath control structure to be implemented by the respiratory distress management device and provided by the source); if the fault mode condition is determined not to exist, the ventilator controller enabling control of a mechanical ventilation system (#45/41 fig 1)) of the ventilator (#17 fig 1) by the at least one controlling source (#12 fig 1) in delivering mechanical ventilation to the patient, via signals received by the ventilator controller from the at least one source (par 0043 discloses the controller 14 determining the structure received from at least one source, #12 fig 1, is valid and thus controlling the ventilator according to the received structure); and if the fault mode condition is determined to exist, the ventilator controller controlling the mechanical ventilation system of the ventilator in delivering the mechanical ventilation to the patient (par 0083 discloses the controller determining the structure received from at least one source to be invalid and instead controlling the ventilator based on previous valid structures or a predefined structure).
Biondi does not expressively disclose that the display controller/controlling source is physically separate from the ventilator.
Hickle teaches a care system providing ventilation (#10 fig 1, par 0065) that receives physician input through at least one controlling source physically separate from the care system (#45 fig 1, par 0074 “User interface system 16 includes devices that permit the nonanesthetist to interact with the care system via … remote control unit 45”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ensure that the display controller of Biondi is physically separate from the ventilator as taught by Hickle as doing so enable the physician to control the system remotely (Hickle: par 0156).
Regarding claim 132, Biondi discloses the method of claim 131. Biondi further discloses the mechanical ventilation system comprises: at least one pressure sensor (#7 fig 1), disposed within a gas delivery system (#21 fig 1) of the mechanical ventilation system, configured to sense signals representative of gas flow within the gas delivery system (par 0032); and wherein the ventilator controller: receives the signals representative of the gas flow; based at least in part on the received signals representative of the gas flow, generates respiratory parameter data corresponding with at least one respiratory parameter of the patient (par 0041); and transmits the respiratory parameter data to a second device coupled with the ventilator (par 0032), the respiratory parameter data being for use in determining a respiratory status of the patient (par 0037 discloses displaying patient history to highlight “patient status”).
Claims 14 and 78 are rejected under 35 U.S.C. 103 as being unpatentable over modified Biondi and Biondi as applied to claims 13 and 77 above respectively, and further in view of Milne (US 8,595,639 B2).
Regarding claim 14, modified Biondi discloses the apparatus of claim 13. Biondi further discloses the ventilator controller is configured to transmit the respiratory parameter data to the second device for use by the second device in displaying user-interactive context sensitive guidance relating to treatment of the patient (par 0032, 0037, 0039).
Biondi does not expressly disclose the context sensitive guidance comprising a therapy recommendation provided to a user of the second device and relating to a therapy to be delivered to the patient at least in part by the ventilator upon selection by the user of the therapy recommendation. Biondi instead discloses interpreting the respiratory parameter data and providing “decision support information on the display”, it is seen that decision support information suggests a therapy recommendation.
Milne teaches a ventilatory apparatus (abstract) that uses respiratory parameter data to provide guidance comprising a therapy recommendation provided to a user of the device and relating to a therapy to be delivered to the patient at least in part by the ventilator upon selection by the user of the therapy recommendation (col 1 ln 47- col 2 ln 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate recommendations as taught by Milne on the apparatus of modified Biondi as doing so allows for a clinician or an untrained user to better understand the data provided by the apparatus (Milne col 1 ln 16-19).
Regarding claim 78, Biondi discloses the system of claim 77. Biondi further discloses the ventilator controller is configured to transmit the respiratory parameter data to the device for use by the device in displaying user-interactive context sensitive guidance relating to treatment of the patient (par 0032, 0037, 0039).
Biondi does not expressly disclose the context sensitive guidance comprising a therapy recommendation provided to a user of the second device and relating to a therapy to be delivered to the patient at least in part by the ventilator upon selection by the user of the therapy recommendation. Biondi instead discloses interpreting the respiratory parameter data and providing “decision support information on the display”, it is seen that decision support information suggests a therapy recommendation.
Milne teaches a ventilatory apparatus (abstract) that uses respiratory parameter data to provide guidance comprising a therapy recommendation provided to a user of the device and relating to a therapy to be delivered to the patient at least in part by the ventilator upon selection by the user of the therapy recommendation (col 1 ln 47- col 2 ln 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate recommendations as taught by Milne on the system of Biondi as doing so allows for a clinician or an untrained user to better understand the data provided by the apparatus (Milne col 1 ln 16-19).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over modified Biondi as applied to claim 12 above and further in view of Chen (US 4,121,583).
Regarding claim 17, modified Biondi discloses the apparatus of claim 12. Biondi discloses the ventilator controller is configured to generate respiratory parameter data corresponding with at least one respiratory parameter of the patient (par 0041).
Biondi is silent to the at least one respiratory parameter comprises forced vital capacity (FVC) and forced expiratory volume (FEV).
Chen teaches a respiratory apparatus (abstract) that monitors forced vital capacity (FVC) and forced expiratory volume (FEV) (col 6 ln 12-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize FVC and FEV as taught by Chen for the respiratory parameters of modified Biondi as they are known indictors of pulmonary functions (Chen col 6 ln 12-38).
Claims 20, 24 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over modified Biondi as applied to claims 1 and 12 above and further in view of Freeman (US 2018/0280646 A1).
Regarding claim 20, modified Biondi discloses the apparatus of claim 12. Biondi is silent to the mechanical ventilation apparatus comprises at least one spirometer, and wherein the at least one pressure sensor is coupled with or part of at least one pneumotachometer disposed within the mechanical ventilation apparatus.
Freeman teaches a ventilator (abstract) comprising at least one spirometer and at least one pneumotachometer (par 0192).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the spirometer and pneumotachometer as taught by Freeman on the mechanical ventilation apparatus of modified Biondi as doing so allows for volume and flow calibration (Freeman par 0192).
Regarding claim 24, modified Biondi discloses the apparatus of claim 1. Biondi does not expressly disclose the at least one controlling source comprises at least one of: a portable computing device, a tablet, a critical care monitor, a defibrillator, and one or more aspects of a cloud-based computing system.
Freeman teaches the use of a critical care monitor with a ventilator (par 0249).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a critical care monitor as taught by Freeman for the at least one source of Biondi as doing so allows for effects related to heart failure to be monitored (Freeman par 0249).
Regarding claim 43, modified Biondi discloses the apparatus of claim 1. Biondi is silent to the fault mode condition indicates that enabling the control by the at least one controlling source would cause operation of the mechanical ventilation apparatus according to values for at least two parameters, wherein a combination of the values would exceed a range of allowed value combinations for the at least two parameters.
Freeman teaches a ventilatory apparatus that recognizes when a combination of the values would exceed a range of allowed value combinations for the at least two parameters (par 0203 “utilizes the range of acceptable values of the following measurements individually and in combination to provide a single number related to respiratory sufficiency or insufficiency”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the controller of modified Biondi recognize a breath control structure provided by the at least one source as invalid when a combination of values would exceed an allowed range as taught by Freeman as doing so prevents the controller from implementing a structure that could cause harm to the patient due to values outside acceptable values.
Claims 29, 88 and 144 are rejected under 35 U.S.C. 103 as being unpatentable over modified Biondi as applied to claims 1, 73 and 131 above and further in view of Schmidt (US 6,186,142 B1).
Regarding claim 29, modified Biondi discloses the apparatus of claim 1. Biondi is silent to the ventilator controller is configured to enable the control by the at least one controlling source, wherein the control by the at least one controlling source comprises utilizing closed loop ventilation control based on oxygen concentration measurements of the patient's blood, wherein the closed loop ventilation control comprises utilizing at least one oxygen saturation sensor to monitor an oxygen concentration of the patient's blood and adjusting oxygen delivery during the delivery of the mechanical ventilation to the patient to maintain the oxygen concentration of the patient's blood at a desired level or range.
Schmidt teaches a ventilatory apparatus (abstract) involving a closed loop ventilation control based on oxygen concentration measurements of the patient's blood, wherein the closed loop ventilation control comprises utilizing at least one oxygen saturation sensor to monitor an oxygen concentration of the patient's blood and adjusting oxygen delivery during the delivery of the mechanical ventilation to the patient to maintain the oxygen concentration of the patient's blood at a desired level or range (see fig 3a-4, col 15 ln 18-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the control by the at least one source of modified Biondi involve a closed loop ventilation control for adjusting oxygen delivery based on the oxygen saturation of the patient’s blood sensed as taught by Schmidt, as doing so allows for the system to not only utilize inputs by a clinician as taught by Biondi but also utilize oxygen saturation sensor values as input to maintain oxygen levels in a patient.
Regarding claim 88, modified Biondi discloses the apparatus of claim 73. Biondi is silent to the ventilator controller is configured to enable the control by the at least one controlling source, wherein the control by the at least one controlling source comprises utilizing closed loop ventilation control based on oxygen concentration measurements of the patient's blood, wherein the closed loop ventilation control comprises utilizing at least one oxygen saturation sensor to monitor an oxygen concentration of the patient's blood and adjusting oxygen delivery during the delivery of the mechanical ventilation to the patient to maintain the oxygen concentration of the patient's blood at a desired level or range.
Schmidt teaches a ventilatory apparatus (abstract) involving a closed loop ventilation control based on oxygen concentration measurements of the patient's blood, wherein the closed loop ventilation control comprises utilizing at least one oxygen saturation sensor to monitor an oxygen concentration of the patient's blood and adjusting oxygen delivery during the delivery of the mechanical ventilation to the patient to maintain the oxygen concentration of the patient's blood at a desired level or range (see fig 3a-4, col 15 ln 18-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the control by the at least one source of Biondi involve a closed loop ventilation control for adjusting oxygen delivery based on the oxygen saturation of the patient’s blood sensed as taught by Schmidt, as doing so allows for the system to not only utilize inputs by a clinician as taught by Biondi but also utilize oxygen saturation sensor values as input to maintain oxygen levels in a patient.
Regarding claim 144, modified Biondi discloses the apparatus of claim 131. Biondi is silent to the ventilator controller is configured to enable the control by the at least one controlling source, wherein the control by the at least one controlling source comprises utilizing closed loop ventilation control based on oxygen concentration measurements of the patient's blood, wherein the closed loop ventilation control comprises utilizing at least one oxygen saturation sensor to monitor an oxygen concentration of the patient's blood and adjusting oxygen delivery during the delivery of the mechanical ventilation to the patient to maintain the oxygen concentration of the patient's blood at a desired level or range.
Schmidt teaches a ventilatory apparatus (abstract) involving a closed loop ventilation control based on oxygen concentration measurements of the patient's blood, wherein the closed loop ventilation control comprises utilizing at least one oxygen saturation sensor to monitor an oxygen concentration of the patient's blood and adjusting oxygen delivery during the delivery of the mechanical ventilation to the patient to maintain the oxygen concentration of the patient's blood at a desired level or range (see fig 3a-4, col 15 ln 18-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the control by the at least one source of Biondi involve a closed loop ventilation control for adjusting oxygen delivery based on the oxygen saturation of the patient’s blood sensed as taught by Schmidt, as doing so allows for the system to not only utilize inputs by a clinician as taught by Biondi but also utilize oxygen saturation sensor values as input to maintain oxygen levels in a patient.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over modified as applied to claims 29 above and further in view of Freeman.
Regarding claim 30, modified Biondi discloses the apparatus of claim 29. Schmidt further discloses the at least one oxygen saturation sensor is part of a pulse oximeter (col 8 ln 14-15).
Freeman teaches the use of a critical care monitor with a ventilator (par 0249).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a critical care monitor as taught by Freeman for the at least one source of Biondi as doing so allows for effects related to heart failure to be monitored (Freeman par 0249).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over modified as applied to claim 1 above and further in view of Poltorak (US 9,942,051 B1).
Regarding claim 50, modified Biondi discloses the apparatus of claim 1. Biondi is silent to the ventilator controller is configured to perform processing utilizing at least one of: task prioritization, data sampling protection, one or more histograms in data handling in order to minimize data noise, a single thread configuration, thread-safe operating system objects, a round robin software processing design in order to minimize processing delay, performance of token count checks on ventilation control data received from the at least one controlling source, disabling of software processing interrupts under one or more conditions, prioritization with respect to one or more aspects of communication with the at least one controlling source, one or more checks relating to a ventilation control data receipt rate from the at least one controlling source, maintenance of a minimum portion of unused memory in order to protect against potential data storage overload, an acknowledgement (ACK) and non-acknowledgement (NACK) scheme in ensuring receipt of ventilation control data from the at least one controlling source, an automatic reset in the event of a software processing freeze or deadlock condition, continuous communication between the ventilator and the at least one controlling source in correcting any data receipt errors continuously, and one or more checks to ensure that the at least one controlling source is properly configured for communication with the respiratory distress management device.
Poltorak teaches the use of round robin software processing (col 23 ln 13-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the processing of modified Biondi utilizing round robin processing as taught by Poltorak as round robin is a known software processing method.
Response to Arguments
Applicant’s arguments with respect to claims 1, 73 and 131 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pawlikowski US 2002/0077856 A1 discloses a wireless communication connection between an internal controller of a medical device and an external controller/device (see #36 fig 1)
Kwok US 7,958,892 B2 discloses physically separate controllers 14 and 16 for communicating with flow generator 12
Chen US 4,121,583 discloses assessing pulmonary function with FEV and FVC
GB-2053512-A discloses recognizing an invalid input by the input falling outside a range
GB 2176313 A discloses a system not adjusting when an oxygen sensor reading is potentially hazardous, and requiring an operator to respond to an alarm
Rubsamen US 5,450,336 discloses well known pulmonary functions such as FEV and FVC
Richey US 7,204,249 B1 discloses a ventilator that resets when a fault is detected
Vij US 8,788,236 B2 discloses a medical device that determines pass or fail of data depending on whether the data is in an acceptable range
Steinhauer US 9,058,741 B2 discloses a ventilator that rules an implementer to prevent patient harm
Schranz US 2020/0282163 A1 discloses using older operating parameters when a faulty flow sensor is determined
Taube US 2021/0128032 A1 discloses activating a software switch when invalid data is received from an oximeter
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/KIRA B DAHER/Examiner, Art Unit 3785 /BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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