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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-3, 6, 8-9, 15, 19-21, 23-24, 49-50, 56-61 in the reply filed on 09/08/2025 is acknowledged. Group 2 containing claims 29-30, 32 and 33 are withdrawn. Claims 69-71 are new and depend from elected group 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 8-9, 19-21, 23, 49-50, 56-58, 60, 70 are rejected under 35 U.S.C. 103 as being unpatentable over Farrugia (U.S 2008/0053440 A1) in view of Bertinetti (U.S 2016/0158478 A1).
Regarding claim 1, Farrugia discloses a method comprising:
generating, by a sensor, data including current data that is associated with a current sleep session of a plurality of sleep sessions and historical data that is associated with one or more prior sleep sessions of the plurality of sleep sessions (Paragraph 0020-0021, 0027, 0031, 0044; Flow sensors provide an index associated with sleep disordered breathing for current or historic/past sessions, which dictate the adjustment of flow to limit the occurrence of apneas or other SDB);
analyzing the historical data to determine a behavior pattern associated with a user (Paragraph 0012, 0020, 0047; A pattern may be established over several prior sessions to adjust the provided pressure to the user on subsequent sessions), and a user interface in relation to the user (mask 18, see Fig. 1 and Paragraph 0029), wherein the user interface is coupled to a respiratory therapy device configured to supply pressurized air to an airway of the user during the plurality of sleep sessions (Paragraph 0029 and Fig. 1, the mask is connected to a blower 8 to produce the pressurized air to be delivered to the user during the sleep sessions).
Farrugia is silent regarding analyzing the current data to determine a condition of a user interface in relation to the user and generating an alarm based at least in part on the behavior pattern associated with the user and the condition of the user interface in relation to the user.
Bertinetti teaches analyzing the current data to determine a condition of a user interface in relation to the and generating an alarm based at least in part on the behavior pattern associated with the user and the condition of the user interface in relation to the user (Paragraph 0071-0073, 0080-0081, 0085, 0091-0092; The respiratory/flow signals can be monitored to determine condition of the user interface and an alarm can be generated according to a sensed apnea pattern condition, a threshold of which is based on historic sleep data in Farrugia, and according to mask disconnection/leak).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Farrugia to have included monitoring the patient interface attachment and generating an alarm based on sensed apnea or disconnection of the mask, such as that taught by Bertinetti, in order to notify a user or operator of system fault (Paragraph 0072) or cessation of delivery of gases to the patient (Paragraph 0085).
Regarding claim 2, the modified method of Farrugia discloses the method of claim 1.
Bertinetti further teaches wherein the condition of the user interface in relation to the user includes an indication of whether the user interface is securely engaged to the user, or an indication that the user interface has been disengaged from the user for a predetermined amount of time (0071-0073, 0080-0081, 0091-0092, the user condition is a mask leak or mask disconnection condition, which is an indication of both secure engagement/disengagement).
Regarding claim 3, the modified method of Farrugia discloses the method of claim 2.
Bertinetti further teaches determining the predetermined amount of time based at least in part on (i) the current data, (ii) the behavior pattern associated with the user, or (iii) both (i) and (ii) (Paragraph 0071-0085, the alarm can be based on different predetermined thresholds of time such as 6 second for mask leak, no breaths within 4-45 seconds for apnea, etc.).
Regarding claim 8, the modified method of Farrugia discloses the method of claim 1.
Bertinetti further teaches setting a parameter of the alarm, the parameter of the alarm including: (a) a nature of the alarm, the nature of the alarm including a type of sound, a type of notification, a type of light, or any combination thereof, (b) a magnitude of the alarm, the magnitude including a volume of the type of sound, (c) a duration of the alarm, (e) a frequency of the alarm, or (h) any combination thereof (Paragraph 0063, 0065, 0091-0101, the alarm can be a sound, notification on a display and light indicator and thus the claimed nature of the alarm; The frequency and volume of the sound signal can be adjusted)
Regarding claim 9, the modified method of Farrugia discloses the method of claim 1.
Bertinetti further teaches adjusting the alarm, according to the set parameters, wherein the adjusting includes starting the alarm, varying the alarm, stopping the alarm, or any combination thereof (Paragraphs 0092-0102, the alarm frequency can be varied; also see Paragraph 0065 regarding automatic setting of alarm volume; see Paragraph 0071 regarding stopping of alarms via latching alarms and pressing a reset button; also see Paragraph 0080).
Regarding claim 19, the modified method of Farrugia discloses the method of claim 1.
Farrugia further discloses wherein the behavior pattern associated with the user includes one or more events associated with the user, the one or more events including: (v) the user experiencing an apnea event during the one or more prior sleep sessions (Paragraph 0020, 0046-0048, previous experiences of SDB can set an index used for future determination of SDB and adjustments to pressure delivery).
Regarding claim 20, the modified method of Farrugia discloses the method of claim 19.
Bertinetti further discloses wherein generating the alarm is based at least in part on a type of the at least one of the one or more events (Paragraph 0072-0091, the type of failure condition will dictate the signal received by the alarm module, which in turn generates an appropriate alarm based on the type of alarm message received), a frequency of at least one of the one or more events, a time of day of occurrence of the at least one of the one or more events, or any combination thereof (the generation of the alarm is also contingent upon the frequency of the failure condition and the time of the occurrence; For example, the occurrence happening at a frequency of every hour will cause the alarm to signal every hour, the occurrence happening at night will cause the alarm to signal at night; Applicant may wish to clarify how the generation of the alarm is impacted by the frequency or time of occurrence).
Regarding claim 21, the modified method of Farrugia discloses the method of claim 1.
Farrugia is silent regarding specifically wherein the generating the alarm is further based at least in part on (i) a predicted remaining duration of the current sleep session.
However, Farrugia also teaches that the index is based on the number of apneas and hypopneas during a particular measured time, such as the duration of the sleep study (Paragraph 0015, 0034-0042; The AHI index can be based on the average across the sleep duration or on an average hourly AHI) and that the prescriptive therapeutic pressure increase is based on the AHI exceeding a previous AHI index (Paragraph 0015, 0034-0042).
Bertinetti also teaches generation of the alarm in response to the measure of apnea above a threshold (0071-0085).
Furthermore, it would be obvious to have excessive apneas/hypopneas exceeding a previous night’s AHI index after only a few hours trigger the threshold for the AHI index and to generate an alert. A patient can have variability between nights in the amount of apneas/hypopneas and if a patient has a particularly bad duration of sleep the AHI index will be surpassed despite a predicted remaining duration in sleep, or with a number of remaining number of expected hours of sleep based on the total duration of the first sleep session. In other words, the generation of the alert/alarm is obvious to generate if the current AHI has already surpassed the AHI index for a previous night after only a few hours, since the patient is experiencing a drastic increase in SDB that should be disrupted to reattempt regular sleep.
Regarding claim 23, the modified method of Farrugia discloses the method of claim 21.
Farrugia further discloses determining a likelihood that the user will experience an apnea event during the predicted remaining duration of the current sleep session (see rejection of claim 21 above and Paragraphs 0015, 0034-0042 of Farrugia; An increased frequency of apneas/hypopneas over a relatively small duration of time can be indicative to be in gross excess of previous AHI index to generate the alert; Thus, the generation of the alert is according to a high likelihood since the patient is experiencing SDB at a higher rate than the normal previous night).
Additionally, Bertinetti teaches wherein generating the alarm is based at least in part on the condition of the user interface indicating that the user interface is not securely engaged to the user (Paragraphs 0071-0085). Additionally, high apnea count can result from leaky mask seals since the pressure at the patient interface will be depressed or irregular and thereby can be considered cessation of breathing/SDB.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Farrugia to include generating the alarm based on the likelihood that the user will experience an apnea event during the predicted remaining duration and based on the user interface being not securely engaged, such as that taught by Farrugia and Bertinetti, in order to prompt the user to reseat the mask and re-attempt normal sleep after predicted excessive SDB (Paragraph 0015, 0034-0042 of Farrugia, 0071-0085 of Bertinetti).
Regarding claim 49, Farrugia discloses a system comprising:
a respiratory therapy device configured to supply, by way of a user interface coupled to the respiratory therapy device via a conduit, pressurized air to an airway of a user during a plurality of sleep sessions (Paragraph 0029 and Fig. 1, a mask is connected to a blower 8 via a conduit to deliver pressurized air to the user during a plurality of sleep sessions; also see Paragraph 0020-0021);
a sensor configured to generate data (Paragraph 0020-0021, 0027, 0031, 0044; Flow sensors provide an index of SDB for current or historic/past sessions);
one or more memory devices storing machine-readable instructions and at least a portion of the data generated by the sensor, the stored data including current data that is associated with a current sleep session of the plurality of sleep sessions and historical data that is associated with one or more prior sleep sessions of the plurality of sleep sessions (Paragraph 0020-0021, 0027, 0031, 0044; Flow sensors provide an index associated with sleep disordered breathing for current or historic/past sessions, which dictate the adjustment of flow to limit the occurrence of apneas or other SDB; also see Paragraph 0028 regarding the controller storing data in memory); and
a control system including one or more processors configured to execute the machine- readable instructions (controller 6, see Paragraph 0028) to:
analyze the historical data to determine a behavior pattern associated with the user (Paragraph 0012, 0020, 0047; A pattern may be established over several prior sessions to adjust the provided pressure to the user on subsequent sessions).
Farrugia is silent regarding analyzing the current data to determine a condition of a user interface in relation to the user and generating an alarm based at least in part on the behavior pattern associated with the user and the condition of the user interface in relation to the user.
Bertinetti teaches analyzing the current data to determine a condition of a user interface in relation to the and generating an alarm based at least in part on the behavior pattern associated with the user and the condition of the user interface in relation to the user (Paragraph 0071-0073, 0080-0081, 0085, 0091-0092; The respiratory/flow signals can be monitored to determine condition of the user interface and an alarm can be generated according to a sensed apnea pattern condition and according to mask disconnection/leak).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Farrugia to have included monitoring the patient interface attachment and generating an alarm based on sensed apnea or disconnection of the mask, such as that taught by Bertinetti, in order to notify a user or operator of system fault (Paragraph 0072) or cessation of delivery of gases to the patient (Paragraph 0085).
Regarding claim 50, the modified device of Farrugia discloses the device of claim 49.
Bertinetti further teaches wherein the condition of the user interface in relation to the user includes an indication of whether the user interface is securely engaged to the user, or an indication that the user interface has been disengaged from the user for a predetermined amount of time (0071-0073, 0080-0081, 0091-0092, the user condition is a mask leak or mask disconnection condition, which is an indication of both secure engagement/disengagement).
Regarding claim 56, the modified device of Farrugia discloses the device of claim 49.
Farrugia further discloses wherein the behavior pattern associated with the user includes one or more events associated with the user, the one or more events including: the user experiencing an apnea event during the one or more prior sleep sessions (Paragraph 0020, 0046-0048, previous experiences of SDB can set an index used for future determination of SDB and adjustments to pressure delivery).
Regarding claim 57, the modified device of Farrugia discloses the device of claim 49.
Farrugia is silent regarding specifically wherein the generating the alarm is further based at least in part on a predicted remaining duration of the current sleep session.
However, Farrugia also teaches that the index is based on the number of apneas and hypopneas during a particular measured time, such as the duration of the sleep study (Paragraph 0015, 0034-0042; The AHI index can be based on the average across the sleep duration or on an average hourly AHI) and that the prescriptive therapeutic pressure increase is based on the AHI exceeding a previous AHI index (Paragraph 0015, 0034-0042).
Bertinetti also teaches generation of the alarm in response to the measure of apnea above a threshold (0071-0085).
Furthermore, it would be obvious to have excessive apneas/hypopneas exceeding a previous night’s AHI index after only a few hours trigger the threshold for the AHI index and to generate an alert. A patient can have variability between nights in the amount of apneas/hypopneas and if a patient has a particularly bad duration of sleep the AHI index will be surpassed despite a predicted remaining duration in sleep, or with a number of remaining number of expected hours of sleep based on the total duration of the first sleep session. In other words, the generation of the alert/alarm is obvious to generate if the current AHI has already surpassed the AHI index for a previous night after only a few hours, since the patient is experiencing a drastic increase in SDB that should be disrupted to reattempt regular sleep.
Regarding claim 58, the modified device of Farrugia discloses the device of claim 57.
Farrugia further discloses determining a likelihood that the user will experience an apnea event during the predicted remaining duration of the current sleep session (see rejection of claim 21 above and Paragraphs 0015, 0034-0042 of Farrugia; An increased frequency of apneas/hypopneas over a relatively small duration of time can be indicative to be in gross excess of previous AHI index to generate the alert; Thus, the generation of the alert is according to a high likelihood since the patient is experiencing SDB at a higher rate than the normal previous night).
Additionally, Bertinetti teaches wherein generating the alarm is based at least in part on the condition of the user interface indicating that the user interface is not securely engaged to the user (Paragraphs 0071-0085). Additionally, high apnea count can result from leaky mask seals since the pressure at the patient interface will be depressed or irregular and thereby can be considered cessation of breathing/SDB.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Farrugia to include generating the alarm based on the likelihood that the user will experience an apnea event during the predicted remaining duration and based on the user interface being not securely engaged, such as that taught by Farrugia and Bertinetti, in order to prompt the user to reseat the mask and re-attempt normal sleep after predicted excessive SDB (Paragraph 0015, 0034-0042 of Farrugia, 0071-0085 of Bertinetti).
Regarding claim 60, the modified device of Farrugia discloses the device of claim 49.
Bertinetti further teaches wherein the condition of the user interface indicates that the user interface is not currently engaging the user (Paragraphs 0071-0073, 0080-0081, 0091-0092; The detected condition can be a disconnect condition).
Farrugia further wherein the control system is further configured to execute the machine-readable instructions to: analyze the historical data to determine a historical sleep metric associated with the user, the historical sleep metric being indicative of how well the user has slept in the past, the historical sleep metric including an average number of times the one or more prior sleep sessions of the user are interrupted (Paragraph 0015, 0020-0021, 0031-0042; The sleep index may be based on historic sleep and the number of apneas/hypopneas the patient experiences over previous sleep sessions, which is indicative of how much disruption the user has experienced in the past and therefore also indicative of sleep quality; The index can be based on an average number of apneas/hypopneas) and wherein the sensed apnea condition is based on the historical sleep metric satisfying a threshold (see Paragraph 0015, 0020-0021 and 0031-0042; The index can be compared to a threshold).
Bertinetti also further teaches generating the alarm based on sleep disordered breathing satisfying a threshold (Paragraphs 0071-0073, 0080-0081, 0091-0092).
Regarding claim 70, the modified device of Farrugia discloses the device of claim 1.
Bertinetti further teaches wherein the condition of the user interface indicates that the user interface is not currently engaging the user (Paragraphs 0071-0073, 0080-0081, 0091-0092; The detected condition can be a disconnect condition).
Farrugia further teaches analyzing the historical data to determine a historical sleep metric associated with the user, the historical sleep metric being indicative of how well the user has slept in the past, the historical sleep metric including an average number of times the one or more prior sleep sessions of the user are interrupted (Paragraph 0015, 0020-0021, 0031-0042; The sleep index may be based on historic sleep and the number of apneas/hypopneas the patient experiences over previous sleep sessions, which is indicative of how much disruption the user has experienced in the past and therefore also indicative of sleep quality; The index can be based on an average number of apneas/hypopneas) and wherein the sensed apnea condition is based on the historical sleep metric satisfying a threshold (see Paragraph 0015, 0020-0021 and 0031-0042; The index can be compared to a threshold).
Bertinetti also further teaches generating the alarm based on sleep disordered breathing satisfying a threshold (Paragraphs 0071-0073, 0080-0081, 0091-0092).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Farrugia (U.S 2008/0053440 A1) in view of Bertinetti (U.S 2016/0158478 A1), as applied to claim 1, in further view of Yoon (U.S 2016/0217672 A1).
Regarding claim 15, the modified method of Farrugia discloses the method of claim 1.
Farrugia is silent regarding determining that the user has interacted with a mobile device after disengaging with the user interface, the determining that the user has interacted with the mobile device including detecting a use of a screen of the mobile device, detecting a change in position of the mobile device, or both, and wherein the generating the alarm includes sending a notification to the mobile device.
It is first noted that applicant has not defined a particular structure or any indication of what is performing the ‘determination’ or ‘detecting’ steps. Thus, the claims are significantly broader than applicant may intend. Yoon teaches determining that the user has interacted with a mobile device after disengaging with the user interface (Paragraph 0119; The system may detect use of a mobile device/portable terminal that is connected/can receive information from the apparatus; Alternatively, the mobile device can detect use of itself, or similarly a hospital employee may similarly detect such incidents), the determining that the user has interacted with the mobile device including detecting a use of a screen of the mobile device (Paragraph 0119, similarly, the mobile device/portable terminal itself may detect use of its screen), and wherein the generating the alarm includes sending a notification to the mobile device (Paragraph 0119; The portable terminal can receive alarms from the apparatus about the state of the patient, to include apnea states detected; also see Paragraphs 0111, 0107; also see Paragraph 0125 regarding terminal interface detecting another device such as the portable terminal).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Farrugia to have included detecting use of a screen of a mobile device after disengagement of the user interface and sending the alert to the mobile device, such as that taught by Yoon, in order to provide alerts to the state of the user and to allow monitoring of devices connected to the respiratory device (Paragraph 0119, 0111, 0107, 0125).
Claim 59 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Farrugia (U.S 2008/0053440 A1) in view of Bertinetti (U.S 2016/0158478 A1), as applied to claims 1 and 49, in further view of Räisänen (U.S 2021/0142894 A1).
Regarding claim 59, the device of Farrugia discloses the device of claim 49.
Farrugia is silent regarding specifically a secondary device configured to generate additional data associated with the user, the additional data being indicative of the user experiencing one or more events including central apneas, obstructive apneas, mixed apneas, hypopneas, snoring, periodic limb movement, restless leg syndrome, or any combination thereof.
However, Räisänen teaches use of secondary devices configured to generate additional data associated with the user, the additional data being indicative of the user experiencing one or more events including central apneas, obstructive apneas, mixed apneas, hypopneas, snoring, or any combination thereof (Paragraph 0005, 0014-0026, 0089; A smartphone running an application, small electronic devices in/on a mattress, or a wearable tracker may be worn to assess health information which can be inclusive of apneas; This information can be relayed to a server or other device for assessment).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Farrugia to have included a secondary device to generate additional data indicative of apneas, such as that taught by Räisänen, in order to provide additional monitoring modalities and to allow diagnosing of various health issues from the different sensors (Paragraph 0005-0006) and because such devices are known to also evaluate SDB (Paragraph 0005-0006).
Bertinetti further teaches generating the alarm based on the SDB and apnea data (Paragraph 0071-0073, 0080-0081, 0085, 0091-0092). Thus, any additional data provided by an additional sensor/device would equally be considered for generation of the alarm.
Regarding claim 69, the device of Farrugia discloses the device of claim 1.
Farrugia is silent regarding generating additional data associated with the user, the additional data being indicative of the user experiencing one or more events including central apneas, obstructive apneas, mixed apneas, hypopneas, snoring, periodic limb movement, restless leg syndrome, or any combination thereof, andwherein the generating the alarm is based at least in part on the generated additional data.
However, Räisänen teaches use of secondary devices configured to generate additional data associated with the user, the additional data being indicative of the user experiencing one or more events including central apneas, obstructive apneas, mixed apneas, hypopneas, snoring, or any combination thereof (Paragraph 0005, 0014-0026, 0089; A smartphone running an application, small electronic devices in/on a mattress, or a wearable tracker may be worn to assess health information which can be inclusive of apneas; This information can be relayed to a server or other device for assessment).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Farrugia to have included a secondary device to generate additional data indicative of apneas, such as that taught by Räisänen, in order to provide additional monitoring modalities and to allow diagnosing of various health issues from the different sensors (Paragraph 0005-0006) and because such devices are known to also evaluate SDB (Paragraph 0005-0006).
Bertinetti further teaches generating the alarm based on the SDB and apnea data (Paragraph 0071-0073, 0080-0081, 0085, 0091-0092). Thus, any additional data provided by an additional sensor/device would equally be considered for generation of the alarm.
Claims 61 and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Farrugia (U.S 2008/0053440 A1) in view of Bertinetti (U.S 2016/0158478 A1), as applied to claims 1 and 49, in further view of Kwok (U.S 2010/0180895 A1).
Regarding claim 61, the device of Farrugia discloses the device of claim 49.
Bertinetti further teaches wherein the control system is further configured to execute the machine-readable instructions to: determine that the condition of the user interface changed from the user interface not being securely engaged to the user to the user interface being securely engaged to the user; and responsive to the determination that the user interface is securely engaged to the user: stop the alarm (see Paragraph 0072, the control system can determine the condition of the user interface through leak and mask-off conditions and thus can determine when the mask is no longer off and pressures are normal; Additionally, the alarm is contingent on such mask-off conditions and thus won’t continue when the mask is reseated and the mask-off conditions stop).
Farrugia is silent regarding specifically causing the respiratory therapy device to provide the supplied pressurized air at a first pressure, the first pressure being relatively lower than a prescribed treatment pressure for the user; and ramp up the pressure of the supplied pressurized air from the first pressure to the prescribed treatment pressure over a predetermined time period.
However, Kwok teaches CPAP treatment for sleep disordered breathing wherein disruption of gas flow and excessive mask leak causes the respiratory therapy device to provide the supplied pressurized air at a first pressure, the first pressure being relatively lower than a prescribed treatment pressure for the user; and ramp up the pressure of the supplied pressurized air from the first pressure to the prescribed treatment pressure over a predetermined time period (Paragraphs 0029-0042, 0068-0077; The pressure applied may be reduced when excessive mask leak is detected and pressures at the patient interface are inadequate indicating leak/disconnection; Ramping pressures can occur to reassess quality of the mask seal, starting from a low pressure and ramping to the prescribed treatment pressure).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Farrugia to have included ramping up the pressure of supplied air from a first pressure to the prescribed treatment pressure after cessation of pressure and reconnection of the mask, such as that taught by Kwok, in order to prevent waste of generated air during leak, to reassess mask integrity, and recontinue the prescribed treatment (0029-0042, 0068-0077).
Regarding claim 71, the device of Farrugia discloses the device of claim 1.
Bertinetti further teaches wherein the control system is further configured to execute the machine-readable instructions to: determine that the condition of the user interface changed from the user interface not being securely engaged to the user to the user interface being securely engaged to the user; and responsive to the determination that the user interface is securely engaged to the user: stop the alarm (see Paragraph 0072, the control system can determine the condition of the user interface through leak and mask-off conditions and thus can determine when the mask is no longer off and pressures are normal; Additionally, the alarm is contingent on such mask-off conditions and thus won’t continue when the mask is reseated and the mask-off conditions stop).
Farrugia is silent regarding specifically causing the respiratory therapy device to provide the supplied pressurized air at a first pressure, the first pressure being relatively lower than a prescribed treatment pressure for the user; and ramp up the pressure of the supplied pressurized air from the first pressure to the prescribed treatment pressure over a predetermined time period.
However, Kwok teaches CPAP treatment for sleep disordered breathing wherein disruption of gas flow and excessive mask leak causes the respiratory therapy device to provide the supplied pressurized air at a first pressure, the first pressure being relatively lower than a prescribed treatment pressure for the user; and ramp up the pressure of the supplied pressurized air from the first pressure to the prescribed treatment pressure over a predetermined time period (Paragraphs 0029-0042, 0068-0077; The pressure applied may be reduced when excessive mask leak is detected and pressures at the patient interface are inadequate indicating leak/disconnection; Ramping pressures can occur to reassess quality of the mask seal, starting from a low pressure and ramping to the prescribed treatment pressure).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Farrugia to have included ramping up the pressure of supplied air from a first pressure to the prescribed treatment pressure after cessation of pressure and reconnection of the mask, such as that taught by Kwok, in order to prevent waste of generated air during leak, to reassess mask integrity, and recontinue the prescribed treatment (0029-0042, 0068-0077).
Allowable Subject Matter
Claims 6 and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 6, none of the prior art teaches or suggest a pulsing of air through the patient interface to emit a sound and constitute part of the alarm. It is noted that a ‘pulse’ of air is clearly understood to be a purposeful delivery of air with limited duration to cause such an emission of sound from the patient interface, as opposed to a constant delivery of air which may incidentally cause whistling during a disconnection or leak event. The prior art teaches general sensors located in the patient interface which can detect a leak/disconnection event to prompt the generation of an alarm, but do not teach anything about the alarm being generated at the patient interface through pulsation of the delivered air.
Similar arguments can be made for claim 24. The pulsing is understood to be purposeful and none of the prior art teaches such a discrete burst of air in order to evaluate the condition of the user interface as seated or with disconnection/leak.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS WILLIAM GREIG whose telephone number is (571)272-5378. The examiner can normally be reached Monday - Thursday: 7:30AM - 5:00PM.
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785