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 .
This action is in response to the filing on 3/18/2026. Since the previous filing, claims 1 and 9 have been amended and no claims have been added or cancelled. Thus, claims 1-16 are pending in the application.
In regards to the previous 103 Rejections, in light of the Applicant’s arguments and for the purpose clarity and compact prosecution, the previous 103 Rejections have been withdrawn with new rejections entered below.
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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mulcahy (US 2009/0038616) in view of Delache (US 2005/0166920).
In regards to claim 1, Mulcahy discloses an apparatus for treating a respiratory disorder comprising (paragraph 2): a breathable gas pressure generating device (paragraph 4 line 4-5), and a controller, including at least one processor (paragraph 20 line 5-6 and paragraph 22 line 5), the controller configured to: collect a plurality of historic pre-sleep parameters concerning a patient initially falling asleep with the apparatus (device remembers and “learns” from data acquired over time to adjust initial settling time, paragraph 97 line 13-17); upon initiation of treatment, control, based on the historic pre-sleep parameters, operation of the breathable gas pressure generating device to provide breathable gas to the patient according to a pre-sleep limit and a pre-sleep profile wherein the pre-sleep limit is set based on at least one of the historic pre-sleep parameters (paragraph 97 line 13-22); the pre-sleep profile includes a plurality of sub-therapeutic pressures defined as a set of pressure amounts and corresponding time points over a duration spanning the pre-sleep limit (paragraph 94-96), and at least one sub-therapeutic pressure of the plurality of sub-therapeutic pressures is an amount of pressure determined based on at least one of the historic pre-sleep parameters (device may deliver ramping set of sub therapeutic pressure prior to patient falling asleep, paragraph 96 line 5-7); and control operation of the breathable gas pressure generating device to provide a plurality of ramping sub-therapeutic pressures based on the pre-sleep limit (paragraph 97 line 13-22); and wherein the controller is configures with a user interface to permit the patient of the apparatus to input to the controller, pre-sleep parameters comprising a pre-sleep pressure, for controlling the provision of the breathable gas to the patient according to the pre-sleep and the pre-seep profile (patient input information into device which results in adjustment of treatment, paragraph 133, claim 79 and 80).
While Mulcahy discloses wherein the processor controls operation of the breathable gas pressure generating device to provide a therapeutic pressure to the patient in response to detecting a sleep related event (paragraph 54 and 74-75), it does not explicitly disclose wherein this occurs within the pre-sleep limit. However, Mulcahy does not limit the processor’s ability to respond to sleep related events to any particular sleep stage, instead indicating that it applies this ability to the entire time during which the device is active (paragraph 74-75). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mulcahy wherein the processor controls operation of the breathable gas pressure generating device to provide a therapeutic pressure to the patient in response to detecting a sleep related event within the pre-sleep limit as taught by Mulcahy as this would allow the device to respond to a sleep related event occurring after the patient has fallen asleep but before the device has switched modes to ensure that the patient receives the support they need no matter the device mode.
In the alternative, if Mulcahy is deemed insufficient to teach the claimed limitations, Delache teaches an apparatus for treating a respiratory disorder (apparatus 1) having a period of subtherapeutic pressure wherein the device is controlled to provide a therapeutic pressure to the patient in response to detecting a sleep related event before the expiration of the subtherapeutic phase (if snoring is detected within ramp period then the device responds by accelerating ramp up to therapeutic pressure, paragraph 28, Fig 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mulcahy wherein the operation of the breathable gas pressure generating device is controlled to provide a therapeutic pressure to the patient in response to detecting a sleep related event as taught by Delache as this would ensure that the patient receives support when they require it.
In regards to claim 2, Mulcahy in view of Delache teaches the device of claim 1 and Mulcahy further discloses wherein the controller is configured to collect the historic pre-sleep parameters by: detecting, with one or more sensors, sleep onset of the patient during use of the breathable gas pressure generating device (sensor determines sleep stage of patient, paragraph 31 line 3-5, controller remembers and learns from input to “snooze” button by user, paragraph 97 line 13-17); and determining a length of time for the sleep onset of the patient (controller adjusts initial settling time based on acquired data, paragraph 97 line 13-17).
In regards to claim 3, Mulcahy in view of Delache teaches the device of claim 1 and Mulcahy further discloses wherein the controller is configured to collect the historic pre-sleep parameters by receiving a sleep onset time at a user input device (initial settling time preset, paragraph 95 line 1-4).
In regards to claim 4, Mulcahy in view of Delache teaches the device of claim 1 and Mulcahy further discloses wherein the controller is configured to collect the plurality of the historic pre-sleep parameters according to a window timeframe comprising a number of treatment sessions (controller remembers input to “snooze” button and adjusts future initial settling time based on data from multiple prior sessions, paragraph 97 line 13-22, paragraph 114 and 117).
In regards to claim 5, Mulcahy in view of Delache teaches the device of claim 4 and Mulcahy further discloses wherein the window timeframe is a rolling window timeframe (the controller is capable of storing and utilizing data collected over a series of treatment sessions counting up from the initial session, therefore the controller could be configured to count back from the current session, paragraph 114 and 117).
In regards to claim 6, Mulcahy in view of Delache teaches the device of clam 1 and Mulcahy further discloses wherein the controller is further configured to set a default pre-sleep limit in an absence of a sufficient collection of the historic pre-sleep parameters (initial setting time, paragraph 5 line 1-4).
In regards to claim 7, Mulcahy in view of Delache teaches the device of claim 1 and Mulcahy further discloses wherein the controller is further configured to: control a display to provide a prompt for input, the prompt for input including: one or both of (a) at least one of the historic pre-sleep parameters, and (b) at least one statistic concerning the historic pre-sleep parameters (user inputs answers to questions presented on display, paragraph 55 and 62); and determine the pre-sleep limit based on input received in response to the prompt (controller adjusts future treatments based on user input data, paragraph 63).
In regards to claim 8, Mulcahy in view of Delache teaches the device of claim 1 wherein the pre-sleep profile includes a first sub-therapeutic pressure and a minimum therapeutic pressure, the minimum therapeutic pressure being higher than the first sub-therapeutic pressure (pressure may ramp up during settling time, paragraph 96 line 3-7), the first sub-therapeutic pressure is to be delivered at a beginning of the pre-sleep limit, and the minimum therapeutic pressure is to be delivered at an end of the pre-sleep limit (paragraph 95).
In regards to claim 9, Mulcahy discloses a method for controlling a pressure treatment for a respiratory disorder (paragraph 2) comprising: collecting, by at least one controller, a plurality of historic pre-sleep parameters concerning a patient initially falling asleep with a pressure generating apparatus (paragraph 20 line 5-6, paragraph 97 line 13-17); upon initiation of treatment, controlling, by the at least one controller based on the historic pre-sleep parameters, operation of the pressure generating apparatus to generate a flow of breathable gas at a pressure above atmospheric pressure according to a pre-sleep limit and a pre-sleep profile (paragraph 4 line 4-5, paragraph 97 line 13-22), wherein the pre-sleep limit is set based on at least one of the historic pre-sleep parameters (paragraph 97 line 13-22), the pre-sleep profile includes a plurality of sub-therapeutic pressures defined as a set of pressure amounts versus time having a duration spanning the pre-sleep limit, and the pre-sleep profile comprises at least one sub-therapeutic pressure of the plurality of sub-therapeutic pressures having a pressure amount determined based on at least one of the historic pre-sleep parameters (paragraph 94-96); and control operation of the apparatus to provide a plurality of ramping sub-therapeutic pressures based on the pre-sleep limit (device may deliver ramping set of sub therapeutic pressures prior to patient falling asleep, paragraph 96 line 5-7); and wherein the controller is configures with a user interface to permit the patient of the apparatus to input to the controller, pre-sleep parameters comprising a pre-sleep pressure, for controlling the provision of the breathable gas to the patient according to the pre-sleep and the pre-seep profile (patient input information into device which results in adjustment of treatment, paragraph 133, claim 79 and 80).
While Mulcahy discloses wherein the processor controls operation of the breathable gas pressure generating device to provide a therapeutic pressure to the patient in response to detecting a sleep related event (paragraph 54 and 74-75), it does not explicitly disclose wherein this occurs within the pre-sleep limit. However, Mulcahy does not limit the processor’s ability to respond to sleep related events to any particular sleep stage, instead indicating that it applies this ability to the entire time during which the device is active (paragraph 74-75). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mulcahy wherein the processor controls operation of the breathable gas pressure generating device to provide a therapeutic pressure to the patient in response to detecting a sleep related event within the pre-sleep limit as taught by Mulcahy as this would allow the device to respond to a sleep related event occurring after the patient has fallen asleep but before the device has switched modes to ensure that the patient receives the support they need no matter the device mode.
In the alternative, if Mulcahy is deemed insufficient to teach the claimed limitations, Delache teaches an apparatus for treating a respiratory disorder (apparatus 1) having a period of subtherapeutic pressure wherein the device is controlled to provide a therapeutic pressure to the patient in response to detecting a sleep related event before the expiration of the subtherapeutic phase (if snoring is detected within ramp period then the device responds by accelerating ramp up to therapeutic pressure, paragraph 28, Fig 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mulcahy wherein the operation of the breathable gas pressure generating device is controlled to provide a therapeutic pressure to the patient in response to detecting a sleep related event as taught by Delache as this would ensure that the patient receives support when they require it.
In regards to claim 10, Mulcahy in view of Delache teaches the method of claim 9 and Mulcahy further discloses wherein the collecting the historic pre-sleep parameters comprises: detecting, with one or more sensors, sleep onset of the patient during use of the pressure generating apparatus (sensor determines sleep stage of patient, paragraph 31 line 3-5, controller remembers and learns from input to “snooze” button by user, paragraph 97 line 13-17); and determining a length of time for the sleep onset of the patient (controller adjusts initial settling time based on acquired data, paragraph 97 line 13-17).
In regards to claim 11, Mulcahy in view of Delache teaches the method of claim 9 and Mulcahy further discloses wherein the collecting the historic pre-sleep parameters comprises receiving a sleep onset time at a user input device (initial settling time preset, paragraph 95 line 1-4).
In regards to claim 12, Mulcahy in view of Delache teaches the method of claim 9 further comprising: collecting, by the at least one controller, the plurality of the historic pre-sleep parameters according to a window timeframe comprising a number of treatment sessions (controller remembers input to “snooze” button and adjusts future initial settling time based on data from multiple prior sessions, paragraph 97 line 13-22, paragraph 114 and 117).
In regards to claim 13, Mulcahy in view of Delache teaches the method of claim 12 and Mulcahy further discloses wherein the window timeframe is a rolling window timeframe (the controller is capable of storing and utilizing data collected over a series of treatment sessions counting up from the initial session, therefore the controller could be configured to count back from the current session, paragraph 114 and 117).
In regards to claim 14, Mulcahy in view of Delache teaches the method of claim 9 further comprising: setting, by the at least one controller, a default pre-sleep limit in an absence of collection of the historic pre-sleep parameters (initial settling time, paragraph 5 line 1-4).
In regards to claim 15, Mulcahy in view of Delache teaches the method of claim 9 further comprising: controlling, by the at least one controller, a display to provide a prompt for input, the prompt for input including: one or both of (a) at least one of the historic pre-sleep parameters, and (b) at least one statistic concerning the historic pre-sleep parameters (user inputs answers to questions presented on display, paragraph 55 and 62); and determining, by the at least one controller, the pre-sleep limit based on input received in response to the prompt (controller adjusts future treatments based on user input data, paragraph 63).
In regards to claim 16, Mulcahy in view of Delache teaches the method of claim 9 wherein the pre-sleep profile includes a first sub-therapeutic pressure to be delivered at a first time during the pre-sleep limit and minimum therapeutic pressure to be delivered at a second time during the pre-sleep limit, the minimum therapeutic pressure being higher than the first sub-therapeutic pressure (pressure may ramp up during settling time, paragraph 96 line 3-7), the first time being at a beginning of the pre-sleep limit, and the second time being at an end of the pre-sleep limit (paragraph 95).
Response to Arguments
In regards to the arguments concerning independent claims 1 and 9, while Examiner does not accede that Mulcahy fails entirely to teach the claimed limitations as outlined in the previous rejections and above, Examiner does accede that there is no explicit teaching of such limitations found in Mulcahy. The exemplary disclosure in Mulcahy does, as Applicant details, show detection of sleep events at later phases of the delivery and does not show detection at the initial pre-sleep stage. It is agreed that the primary focus of Mulcahy is providing a timed subtherapeutic phase or phases of pressure delivery for acclimatization purposes. However, Mulcahy is also intended to provide therapeutic pressures and to increase delivered pressure in response to the detection of a sleep event. The means and method of this detection is not expressly described in Mulcahy and Examiner maintains that there is no evidence that Mulcahy lacks the capability of detecting a sleep event throughout the activation of the device. However, for the purpose of clarity and compact prosecution, a new rejection using an alternative secondary reference is entered above to more specifically address the limitations at issue.
Arguments concerning dependent claims are in reference to their dependency from above argued claim 1 and claim 9 and are therefore addressed in the response above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached on (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARIELLE WOLFF/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights