DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on September 2, 2025. As directed by the amendment: claims 2 and 12 have been amended, claims 1, 4, 5, 7-10, 13-14, and 20 have been canceled, and new claims 38-40 have been added. Thus, claims 2, 3, 6, 11, 12, 15-19, and 21-40 are presently pending in the application.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 2, 3, 18, 19, 23, 24, 26, 27, 32, 33, 38 and 39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), and further in view of Levy et al. (US 4,340,044) and Hradek et al. (US 5,071,453).
As to claim 2, Wallace discloses a ventilator and monitoring apparatus (Fig. 1 and Fig. 2) for providing mechanical ventilation to a patient, comprising:
at least one sensor 27 (Fig. 2) for sensing at least one physiological parameter of the patient (signals from sensors 27 indicative of patient condition and status of the respirator 22, col. 6, ln. 25-34);
a user interface 20 (graphical user interface 20, col. 5, ln. 66-col. 6, ln. 3); and
a controller 30 (processor 30, Fig. 2) configured to: control the ventilator to provide a plurality of breaths of at least one of: a controlled volume and a controlled pressure breathing gas to the patient (col. 6, ln. 9-11, 25-27; col. 12, ln. 42-56; col. 19, ln. 54-60),
determine that at least one alarm condition has occurred (col. 18, ln. 17-32), wherein the at least one alarm condition relates to at least one of: (1) at least one physiological parameter value that is above or below an acceptable limit (when monitored parameter value received from sensors 27 violates a limit or limits for a particular alarm setting, col. 18, ln. 17-32); or (2) at least one fault of the ventilator and monitoring apparatus comprising a fault relating to one or more sensors coupled to the patient’s airway (note that the second option (2) is not required under the broadest reasonable interpretation of the claim since only “at least one of: (1)… or (2)” is recited), and
upon determining that the at least one alarm condition has occurred:
display, on the user interface 20, an alarm message 120, 602 providing a description of the at least one alarm condition that has occurred (text prompt identifies the monitored parameter and cause of the alarm in the alarm messages area 120, Fig. 3, col. 18, ln. 26-32; message 602 includes base message 604 identifying the alarm and analysis message 606 gives the root cause of the alarm, Fig. 12, col. 18, ln. 63-65), and
display, on the user interface 20, a visual indicator of an alarm condition priority (urgency alarm indicators 110, 112, 114, Fig. 3, col. 8, ln. 59-67), wherein the alarm condition priority comprises: a high priority alarm condition 110 (see Wallace, col. 9, ln. 15-20 describing high priority alarms as requiring immediate attention to ensure patient safety), a medium priority alarm condition 112 when the at least one alarm condition requires immediate intervention by an operator (see Wallace, col. 9, ln. 7-14 describing that medium urgency alarms typically require prompt attention), and a low priority alarm condition 114 when the at least one alarm condition requires that the operator be aware of the alarm condition (see Wallace, col. 9, ln. 1-7 describing that low urgency alarms are used to inform the user that there has been some change in the status of the system).
Wallace lacks detailed description as to the limitation that the apparatus comprises at least one patient airway sensor for use in detection of mechanical ventilations delivered to the patient and that the high priority alarm condition occurs when the at least one alarm condition relates to loss of communication between the at least one patient airway sensor and the controller.
However, Truschel teaches a ventilator having a patient airway sensor 25 (flow sensor 25, Fig. 2, paragraph [0031]) and that an alarm condition occurs when there is a loss of communication between the at least one patient airway sensor 25 and the ventilator 5 (see Table 1 and Table 2 on pgs. 4-5 for of the disclosure, “Active Circuit Proximal Flow Sensor Failure” and/or “Monitor/Proximal Flow Sensor Detection Problem”). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the apparatus of Wallace to include an patient airway sensor, as taught by Truschel, in order to alert the operator that flow sensor readings are not being obtained so that the ventilator can be restored and/or another source of pressure support can be obtained quickly.
As to the limitation that the alarm condition is a high priority alarm condition, Wallace describes high urgency alarms as those requiring immediate attention to ensure patient safety (see Wallace, col. 9, ln. 1-20) and Truschel describes the alarm condition as on in which the ventilator is inoperative (see Table 1, “Active Circuit Proximal Flow Sensor Failure – Vent Inop”. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the flow sensor failure as taught by Truschel is classified as a high urgency alarm condition since one of ordinary skill in the art would recognize the situation of not being able to operate the ventilator as a condition requiring immediate attention to ensure patient safety.
Wallace does not expressly disclose that the high priority alarm condition occurs when the at least one alarm condition relates to a ventilator self-check.
However, Levy teaches an alarm condition related to a ventilator self-check (col. 20, ln. 30-44; a power failure or ventilator inoperative condition is considered a ventilator self-check since the system is essentially checking itself for adequate power to the ventilator and detecting that none exists, see also Applicant’s TABLE at alarm code 1172: 5 Volt Self Check Failure). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace to include a ventilator self-check alarm condition (when a power failure of the ventilator is detected and/or when the ventilator is inoperative), as taught by Levy, in order to alert the operator about the ventilator malfunction or power failure so that the ventilator can be restored or another source of pressure support can be obtained quickly.
As to the limitation that the alarm condition is a high priority alarm condition, Wallace describes high urgency alarms as those requiring immediate attention to ensure patient safety (see Wallace, col. 9, ln. 1-20). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the ventilator inoperative or power failure alarm condition taught by Levy is classified as a high urgency alarm condition since one of ordinary skill in the art would recognize the situation of not being able to operate the ventilator as a condition requiring immediate attention to ensure patient safety.
Wallace also does not disclose a high priority alarm condition when the at least one alarm condition relates to a failure in calibration of the at least one sensor. However, Hradek teaches activating an alarm (warning light 93) when a sensor 66 has failed a calibration check (Fig. 1A-1B, col. 11, ln. 22-27). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace to include a sensor calibration failure alarm condition, as taught by Hradek, in order to alert the operator about the inability to properly sense important parameters.
As to the limitation that the alarm condition is a high priority alarm condition, Wallace describes high urgency alarms as those requiring immediate attention to ensure patient safety (see Wallace, col. 9, ln. 1-20). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the sensor calibration failure condition taught by Hradek is classified as a high urgency alarm condition since one of ordinary skill in the art would recognize the situation of not being able to monitor important parameters as a condition requiring immediate attention to ensure patient safety.
As to claim 3, the modified apparatus of Wallace discloses that a high priority alarm conditions require immediate attention by an operator of the ventilator and monitoring apparatus (see Wallace, col. 9, ln. 15-20 describing high priority alarms as requiring immediate attention to ensure patient safety).
As to claim 18, the modified apparatus of Wallace discloses that the alarm condition priority further comprises another high priority alarm condition comprising a loss of external power alarm condition, and wherein the controller is configured to, upon determining that the loss of external power alarm condition has occurred, display an icon that provides an indication of loss of external power (see Levy col. 20, ln. 30-44; the ventilator self-check alarm condition being the ventilator inoperative condition, the “another high priority alarm condition” being the power failure alarm; see also explanation of claim 2 above).
As to the limitation that the controller is configured to, upon determining that the loss of external power alarm condition has occurred, display an icon that provides an indication of loss of external power, Wallace discloses displaying an icon (alarm symbol) for each alarm condition (see Fig. 12, col. 18, ln. 63-col. 19, ln. 5). Thus, the modified apparatus of Wallace would have an alarm symbol/icon associated with the loss of power alarm, as modified by Levy.
As to claim 19, the modified apparatus of Wallace discloses an alarm condition comprising a high pressure alarm condition relating to a determined pressure that is above a highest acceptable pressure limit (see Wallace, Fig. 12, where a high circuit pressure is indicated in alarm message area 604 and 606, “↑Pcirc 3 or more breaths ≥ set limit.”).
As to the limitation that the alarm condition is a medium priority alarm condition, Wallace describes medium urgency alarms as those requiring prompt attention by the operator to correct the cause of the alarm, but don’t require immediate attention to ensure patient safety as in the case of high urgency alarms (see Wallace, col. 9, ln. 1-20). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the high pressure alarm condition taught by Baker is classified as a medium urgency alarm condition since one of ordinary skill in the art would have recognized a high circuit pressure condition as one requiring prompt correction by the operator to restore optimal pressure levels, but that does not place the patient in immediate danger.
As to claim 23, the modified apparatus of Wallace discloses that the controller is configured to control the ventilator and monitoring apparatus in delivering the breathing gas to the patient based at least in part on a sensed one or more physiological parameters of the patient (see Wallace, col. 6, ln. 25-30: controller/processor 30 provides control signals to the respirator processor 60 and receives signals indicative of patient condition from sensors 27; col. 18, ln. 17-35: the processor can control the ventilator to abort delivery of the current breath if a value of a monitored parameter (sensed by sensors 27) exceeds the limits set for an alarm condition).
As to claim 24, the modified apparatus of Wallace discloses that the alarm message 602 describes a nature of the at least one alarm condition that has occurred (see Wallace, col. 18, ln. 63-col. 19, ln. 5: base message 604 identifies the alarm, analysis message 606 gives the root cause of the alarm).
As to claim 26, the modified apparatus of Wallace discloses that the at least one alarm condition comprises at least a first alarm condition and a second alarm condition, wherein the first alarm condition relates to the at least one physiological parameter value that is above or below an acceptable limit (see Wallace, col. 18, ln. 17-32) and the second alarm condition relates to at least one fault of the ventilator and monitoring apparatus (power failure or ventilator inoperative, see Levy at col. 20, ln. 30-44).
As to claim 27, the modified apparatus of Wallace discloses that the controller is configured to display, on the user interface, a visual indication of the at least one physiological parameter that is above or below an acceptable limit (see Wallace, col. 18, ln. 63 – col. 19, ln. 5: alarm base message 604 identifies the alarm and analysis message 606 gives the root cause of the alarm, see Fig. 12 showing the messages 604, 606 as “↑Pcirc 3 or more breaths ≥ set limit.” In Fig. 12).
As to claim 32, the modified apparatus of Wallace discloses that the alarm condition priority further comprises another high priority alarm condition that occurs when the ventilator cannot provide the mechanical ventilations to the patient comprising the plurality of breaths of the at least one of: the controlled volume or the controlled pressure (ventilator inoperative, see Levy at col. 20, ln. 30-44; the ventilator self-check alarm condition being the power failure alarm, the “another high priority alarm condition” being the ventilator inoperative alarm; see also explanation of claim 2 above).
As to claim 33, the modified apparatus of Wallace discloses that the at least one fault of the ventilator comprises a fault that prevents the ventilator from providing the mechanical ventilations comprising the plurality of breaths to the patient at the at least one of: the controlled volume or the controlled pressure (power failure or ventilator inoperative, see Levy at col. 20, ln. 30-44).
As to claim 38, the modified apparatus of Wallace discloses that the at least one patient airway sensor comprises a sensor configured to detect flow in the patient airway (Truschel, paragraph [0025]).
As to claim 39, the modified apparatus of Wallace discloses that the at least one patient airway sensor comprises a patient airway pressure transducer 25, 50, 85 (see Truschel, paragraph [0025]-[0027]).
Claims 6, 12, and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Chekal et al. (US 2009/0212962).
As to claim 6, the modified apparatus of Wallace discloses that, for the high priority alarm conditions, the visual indicator is illuminated in a red color (see Wallace, col. 9, ln. 15-20), but lacks detailed description as to the limitation that, for the low priority alarm condition, the visual indicator is illuminated in a yellow color (Wallace does not specify the color of the low urgency alarm light 114, col. 9, ln. 1-7). However, Chekal teaches a low priority alarm being indicated by a yellow colored light (see Chekal, paragraph [0074]) in contrast to the critically high priority alarms, which are indicated by a red flashing light (paragraph [0077]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the apparatus of Wallace so that the low priority indicator light 114 is yellow, as taught by Chekal, in order to provide an additional indication to the operator of the relative urgency required for the particular alarm condition which is simple and easy to quickly interpret.
As to claim 12, the modified apparatus of Wallace lacks detailed description as to the limitation that the medium priority alarm condition comprises one or more of a high breath rate alarm condition, a ventilator battery related alarm condition, or a PEEP related alarm condition. However, Chekal teaches detecting a high breath rate (rapid breath) and categorizing it as a medium priority alarm condition (paragraphs [0053], [0071]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that a high breathing rate is detected and indicated as a medium priority alarm, as taught by Chekal, in order to give adequate warning to the operator that the situation needs to be addressed soon, without causing excessive panic.
As to claim 17, the modified apparatus of Wallace discloses the claimed invention except that the medium priority alarm condition comprises a patient disconnect alarm condition.
However, Chekal teaches detecting a patient disconnect alarm condition and classifying it as a medium priority alarm condition (the check cannula method detects when inhalation of the user has not occurred for a predetermined time, paragraph [0052] and “check cannula” alarm condition is set to medium priority, paragraph [0071]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that a patient disconnect condition is detected (by detecting a lack of inhalation by the user) and indicated as a medium priority alarm condition, as taught by Chekal, in order to provide adequate warning to the operator that the connections to the patient need to be checked for proper oxygen support.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Baker, Jr. (US 2009/0241957).
As to claim 11, the modified apparatus of Wallace discloses the claimed invention except that the medium priority alarm condition comprises a low tidal volume alarm condition. However, Baker teaches displaying an alarm/alert when any ventilation parameter exceeds a threshold (paragraph [0019]) and lists tidal volume as one of the monitored parameters (paragraph [0020]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the monitored parameters include a tidal volume and an alarm condition is recognized when the tidal volume is above or below a threshold, as taught by Baker, in order to provide useful information to the operator about the patient and ventilator condition.
As to the limitation that the low tidal volume condition is a medium priority alarm condition, Wallace describes medium urgency alarms as those requiring prompt attention by the operator to correct the cause of the alarm, but don’t require immediate attention to ensure patient safety as in the case of high urgency alarms (see Wallace, col. 9, ln. 1-20). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the low tidal volume alarm condition taught by Baker is classified as a medium urgency alarm condition since one of ordinary skill in the art would have recognized a low tidal volume condition as one requiring prompt correction by the operator, but that does not place the patient in immediate danger.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Halperin (US 5,687,717).
As to claim 15, the modified apparatus of Wallace discloses the claimed invention except that the medium priority alarm condition comprises a high heart rate alarm condition, wherein the high heart rate alarm condition relates to a determined heart rate that is above a highest acceptable heart rate limit.
However, Halperin teaches an alarm condition including a heart rate exceeding a high limit (col. 12, ln. 47-49). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the monitored parameters include a heart rate and an alarm condition is recognized when the heart rate is above a threshold, as taught by Halperin, in order to provide useful information to the operator about the patient condition.
As to the limitation that the high heart rate alarm condition is a medium priority alarm condition, Wallace describes medium urgency alarms as those requiring prompt attention by the operator to correct the cause of the alarm, but not requiring immediate attention and ventilator shutdown to ensure patient safety as in the case of high urgency alarms (see Wallace, col. 9, ln. 1-20). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the high heart rate related alarm condition taught by Halperin is classified as a medium urgency alarm condition since one of ordinary skill in the art would recognize a high heart rate as a condition requiring prompt correction by the operator, but which continued use of the ventilator would not cause harm to the patient.
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Schmidt et al. (US 6,186,142).
As to claim 16, the modified apparatus of Wallace discloses the claimed invention except that the medium priority alarm condition comprises a low SpO2 alarm condition. However, Schmidt teaches an alarm condition for when a low SpO2 is detected (a blood oxygen saturation level below a healthy level for a period of time, col. 19, ln. 55-61). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the monitored parameters include an SpO2 level of the patient and an alarm condition is recognized when the SpO2 below a threshold, as taught by Schmidt, in order to provide useful information to the operator about the patient condition falling outside of a desired range.
As to the limitation that the low SpO2 alarm condition is a medium priority alarm condition, Wallace describes medium urgency alarms as those requiring prompt attention by the operator to correct the cause of the alarm, but not requiring immediate attention and ventilator shutdown to ensure patient safety as in the case of high urgency alarms (see Wallace, col. 9, ln. 1-20). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the low SpO2 alarm condition taught by Schmidt is classified as a medium urgency alarm condition since one of ordinary skill in the art would recognize low SpO2 as a condition requiring prompt correction by the operator to restore optimal therapy levels, but which continued use of the ventilator would not cause harm to the patient.
Claim 21 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Loescher et al. (US 4,990,894).
As to claim 21, the modified apparatus of Wallace discloses the claimed invention except that the medium priority alarm condition comprises a low pressure alarm condition relating to a determined pressure that is below a lowest acceptable pressure limit.
However, Loescher teaches an alarm condition comprising a low pressure alarm condition relating to a determined pressure being below a lowest acceptable limit (see Fig. 1, low pressure LED, col. 2, ln. 22-26 and col. 3, ln. 34-40). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify the apparatus of Wallace so that the alarm conditions include a low pressure alarm condition, as taught by Loescher, in order to provide useful information to the operator about the condition of the patient and ventilator.
As to the limitation that the alarm condition is a medium priority alarm condition, Wallace describes medium urgency alarms as those requiring prompt attention by the operator to correct the cause of the alarm, but don’t require immediate attention to ensure patient safety as in the case of high urgency alarms (see Wallace, col. 9, ln. 1-20). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the low pressure alarm condition taught by Loescher is classified as a medium urgency alarm condition since one of ordinary skill in the art would have recognized a low pressure condition as one requiring prompt correction by the operator to restore optimal therapy levels, but that does not place the patient in immediate danger.
Claim 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further, in view of Harvie (US 2003/0189492).
As to claim 22, the modified apparatus of Wallace discloses the claimed invention except that the medium priority alarm condition comprises an oxygen supply related alarm condition.
However, Harvie teaches an alarm condition for when a compressed oxygen supply is low (paragraph [0002]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify the apparatus of Wallace so that the alarm conditions include an oxygen supply related alarm condition, as taught by Harvie, in order to provide useful information to the operator about the low condition of the oxygen source so that prompt attention can be given to secure a new supply.
As to the limitation that the alarm condition is a medium priority alarm condition, Wallace describes medium urgency alarms as those requiring prompt attention by the operator to correct the cause of the alarm, but don’t require immediate attention to ensure patient safety as in the case of high urgency alarms (see Wallace, col. 9, ln. 1-20). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the low oxygen supply alarm condition taught by Harvie is classified as a medium urgency alarm condition since one of ordinary skill in the art would have recognized a low oxygen supply condition as one requiring prompt correction by the operator to replace the oxygen supply, but that does not place the patient in immediate danger.
Claim 25 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Jones (US 2005/0061321).
As to claim 25, the modified apparatus of Wallace discloses the claimed invention except that the alarm message identifies and provides a verbal description of the at least one alarm condition that has occurred.
However, Jones teaches an alarm which includes informative verbal instructions (paragraph [0037]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify the apparatus of Wallace so that the alarm message provides a verbal description of the alarm condition, as taught by Jones, in order to provide a suitable means for assisting the operator in understanding and correcting the alarm condition efficiently and accurately.
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Baker, Jr. (US 2009/0241957) and Chekal et al. (US 2009/0212962).
As to claim 28, the modified apparatus of Walker lacks detailed description as to the limitation that the ventilator comprises a compressor.
However, Baker teaches that a source 20 (gas delivery apparatus) of pressurized air for a breathing assistance system can be a compressor (paragraph [0025]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the ventilator of Wallace so that the source of pressurized air is a compressor, as taught by Baker, in order to provide a suitable known type of pressurized air source capable of delivering breathing gas to the patient with adequate pressure.
The modified apparatus of Walker now discloses the claimed invention except that a high priority alarm condition occurs when the compressor fails to provide flow required to deliver a breath of the plurality of breaths to the patient at the at least one of: the controlled volume or the controlled pressure.
However, Chekal teaches a controller for an oxygen generating and monitoring apparatus (an oxygen delivery system is considered analogous to a ventilator since both deliver pressurized breathing gas to a patient), which determines that a high priority alarm condition occurs upon detection of a compressor failure (see Chekal, paragraph [0040]: detects compressor failure & paragraph [0070]: compressor failure alarm is critically high priority). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace and Baker so that a compressor failure is detected and indicated as a high priority, as taught by Chekal, in order to ensure immediate attention can be given, to ensure safety and adequate patient support.
Claim 29 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Elsworth et al. (US 4,708,831).
As to claim 29, the modified apparatus of Wallace discloses that the controller comprises at least one processor 30, 60 (see Fig. 2of Wallace), but lacks detailed description as to the limitation that the at least one fault of the ventilator comprises a system fault related to operation of the at least one processor comprising partial or total failure of the at least one processor, and wherein the display of the alarm message and the visual indicator is provided by a backup processor of the controller.
However, Elsworth teaches a backup processor 60 in addition to a main microcontroller 56, the backup processor 60 being configured to detect a failure of the main processor 60 and generate an alarm in response (see Fig. 8, col. 6, ln. 48-63: each processor checks that the other is operating correctly; col. 7, ln. 24-37: back-up processor 60 checks if main/logical processor 56 is running and if not, after three failed attempts to restart, an alarm is generated).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify the apparatus of Wallace to include a backup processor that detects when the controller processor is inoperative and generates an alarm, as taught by Elsworth, in order to provide a safety backup and protect against maloperation (see Elsworth, col. 6, ln. 48-54).
Claim 30 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Schmidt et al. (US 6,186,142).
As to claim 30, the modified apparatus of Wallace discloses that the controller is configured to determine that multiple alarm conditions have occurred, and wherein, when multiple alarm conditions have occurred, the controller is configured to cause the user interface to display the alarm message and the visual indicator of the alarm condition priority for a selected alarm condition of the multiple alarm conditions (see Wallace, col. 18, ln. 47-col. 19, ln. 5; col. 8, ln. 59-67).
Modified Wallace lacks detailed description as to the limitation that the user interface displays an indication of a number of alarm conditions that have occurred.
However, Schmidt teaches a user interface 32 of an oxygen delivery system which presents an indication of the number of alarm conditions that have occurred (total number of times each alarm condition has occurred, col. 21, ln. 63 - col. 22, ln. 5). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the user interface displays an indication of the number of alarm conditions that have occurred, as taught by Schmidt, in order to track the patient’s condition and performance of the ventilator over time.
Claim 34 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Robbins (US 4,466,433).
As to claim 34, the modified apparatus of Wallace discloses the claimed invention except that the at least one alarm condition related to the ventilator self-check (power failure or ventilator inoperative, taught by Levy) occurs at start-up of the apparatus.
However, Robbins teaches a power failure alarm condition 183, 187 (Fig. 1) that occurs during start-up of the ventilator (col. 9, ln. 15-26, alarm 183, 187 activates upon electrical power failure to the ventilator when it is turned on). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify the apparatus of Wallace so that the ventilator self-check related alarm condition (when a power failure of the ventilator is detected and/or when the ventilator is inoperative) occurs during start-up of the device, as taught by Robbins, in order to alert the operator about the ventilator malfunction or power failure as soon as possible so that the ventilator power can be restored or another source of pressure support can be obtained quickly.
Claims 35 and 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of Levy et al. (US 4,256,100).
As to claim 35, the modified apparatus of Wallace lacks detailed description as to the limitation that upon occurrence of the high priority alarm condition related to the ventilator self-check, the controller is configured to display on the user interface a mitigation instruction comprising an instruction to manually ventilate the patient. However, Levy (‘100) teaches a ventilator which displays a mitigation instruction to “manually ventilate” in the event the ventilator is inoperative (Fig. 1 at visual indicator 15, col. 4, ln. 34-40). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify the apparatus of Wallace to display a mitigation instruction to manually ventilate the patient in the event of a power failure or ventilator inoperative condition, as taught by Levy (‘100), in order to provide information to the operator of what to do when the patient is unable to receive adequate support from the ventilator.
As to claim 40, the modified apparatus of Wallace lacks detailed description as to the limitation that the alarm message for the high priority alarm condition that relates to loss of communication between the at least one patient airway sensor and the comprises a mitigation instruction to manually ventilate the patient. However, Truschel does teach that in the event of flow sensor failure, the ventilator is considered inoperative (see Table 1: Vent Inop). Furthermore, Levy (‘100) teaches a ventilator which displays a mitigation instruction to “manually ventilate” in the event the ventilator is inoperative (Fig. 1 at visual indicator 15, col. 4, ln. 34-40). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to further modify the apparatus of Wallace to display a mitigation instruction to manually ventilate the patient in the event of a ventilator inoperative condition, as taught by Levy (‘100), in order to provide information to the operator of what to do when the patient is unable to receive adequate support from the ventilator.
Claim 37 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wallace et al. (US 5,881,723), in view of Truschel et al. (US 2011/0209706), Levy et al. (US 4,340,044), and Hradek et al. (US 5,071,453), as applied to claim 2 above, and further in view of DeNando et al. (US 2009/0121592).
As to claim 37, the modified apparatus of Wallace discloses the claimed invention except that the at least one alarm condition related to the ventilator self-check further comprises an alarm condition that occurs when software configured to be executed by the controller fails.
However, DeNando teaches a medical device which includes an alarm condition when a software error occurs (software error code and error code is indicated to the user, paragraph [0109]-[0111]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the apparatus of Wallace so that the ventilator self-check alarm condition further comprises a software failure/error alarm condition, as taught by DeNando, in order to provide more information to the user about the operation of the device so that prompt attention can be given to address the error.
Allowable Subject Matter
Claims 31 and 36 are allowed.
Response to Arguments
Applicant’s arguments with respect to claims 2, 3, 6, 11, 12, 15-19, and 21-40 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
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.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785