DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/26/26 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11, 14, 16, 21-22, 24, 27-30, 42-44, 46, 47 and 51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites determining a first set of sleep-rated parameters, determining a second set of sleep-related parameters, causing one or more indications associated with first sleep session or the second sleep session be communicated to the user and modifying the predetermined time range for a subsequent alarm for a subsequent sleep session of the user, wherein automatically modifying the predetermined time range includes comparing the sleep-wake signal and the second sleep-wake signal to determine a change, between the first sleep session in which the user did not use the respiratory therapy system and the second sleep session in which the user used the respiratory therapy system, in a timing of occurrence of the light sleep stage during a terminal portion of a sleep session, and setting a start time of the modified predetermined time range based on the determined change while maintaining the user-selected wake-up time as an end time of the modified predetermined time range, and wherein the subsequent alarm is configured to be generated via the user device during the modified predetermined time range when the user is closest to light sleep based on a subsequent sleep-wake signal associated with the subsequent sleep session.
The limitation of determining sleep-related parameters and causing one or more indications, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a processor”, the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor and therapy system, “determining” “causing” “modifying” and “setting” in the context of this claim encompasses the user manually calculating indices and notifying the user and adjusting the alarm window. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of one or more sensors and a respiratory therapy system. These sensor involve mere data gathering and amount to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the processor and respiratory therapy system are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. The respiratory device merely tries to link the abstract idea to a particular technological environment or field of use. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11, 14, 16, 21-22, 24, 27-30, 42-44, 46, 47 and 51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. It is unclear where in the specification there is support for determining the alarm for a subsequent sleep session and where the alarm is modified based on the change in the sleep wake signal from the first session and the second session. The specification discusses the alarm and its modification at ¶128-131 but this does not discuss anything related to the new limitations.
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) 1-11, 14, 16, 21-22, 24, 27-30, 42-44, 46, 47 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heneghan et al. US 2011/0178377 in view of Armistead et al. US 2011/0203588 and Shouldice et al. US 2016/0151603.
Regarding claim 1, 42 and 51, Heneghan discloses a method comprising:
receiving first data associated with a first sleep session of a user, the first data including (i) first respiration data associated with the user, (ii) first audio data reproducible as one or more sounds recorded during the first sleep session, or (iii) both (i) and (ii), wherein the user did not use a respiratory therapy system during the first sleep session ([FIG. 2 and 7a][¶18,31,36,39] not contact sensors can recorded sound and various physiological parameters while the user sleeps normally for an intake session);
determining a first set of sleep-related parameters associated with the first sleep session of the user based at least in part on the first data ([¶75,76] a sleep index is determined);
receiving second data associated with a second sleep session of the user, the second data including (i) second respiration data associated with the user, (ii) second audio data reproducible as one or more sounds recorded during the second sleep session, or (iii) both (i) and (ii), ([FIG7A] multiple sleep sessions are monitored and used to determine treatment effectiveness [¶47] one of those devices is a CPAP machine);
determining a second set of sleep-related parameters associated with the second sleep session of the user based at least in part on the second data ([FIG7A][¶75,76]); and
causing one or more indications associated with the first sleep session, the second sleep session, or both, to be communicated to the user, via a user device, subsequent to the second sleep session to aid in encouraging the user to use the respiratory therapy system ([¶30] the parameters of testing can be displayed to the user).
Heneghan discloses the use of a CPAP device and an initial monitoring and setup followed by treatment sessions but does not specifically disclose wherein the user used the respiratory therapy system during at least a portion of the second sleep session. Armistead teaches a similar sleep analysis and treatment system that teaches having an initial session without the therapy device and subsequent sessions use the therapy device ([¶64]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Heneghan with the teachings of Armistead in order to titrate the correct pressure of the therapy device ([¶64]) and as Heneghan discloses its device and method are useable with CPAP devices like Armistead.
Heneghan does not specifically disclose generating an alarm for the second sleep session, via a user device, the alarm set within a predetermined time range relative to a user-selected wake-up time when the user is closest to light sleep based on the second data associated with the second sleep session or automatically modifying the alarm time range.
Shouldice teaches a similar sleep monitoring system that has a smart alarm feature that sounds an alarm within a predetermined window or when sleep is the lightest ([¶350-354]). Shouldice further teaches automatically modifying, based at least in part on the first set of sleep-related parameters and the second set of sleep-related parameters, the predetermined time range for a subsequent alarm for a subsequent sleep session of the user ([¶210] the system can automatically amend system settings. [¶713-717] the system can modify wake up times and nap durations for future sleep sessions. Shouldice does not explicitly disclose changing the wake alarm window but it would have been obvious to one of ordinary skill in the art at the time of filing to use the teachings of adjusting sleep parameters like duration and wake to change the wake window specifically in light of avoiding triggering the alarm in deep sleep [¶351,364]), wherein automatically modifying the predetermined time range includes comparing the sleep-wake signal and the second sleep-wake signal to determine a change, between the first sleep session in which the user did not use the respiratory therapy system and the second sleep session in which the user used the respiratory therapy system, in a timing of occurrence of the light sleep stage during a terminal portion of a sleep session ([¶118,231,390] historical trend data for the sleep sessions is used in recommendations and changing settings. The trend data being change data), and setting a start time of the modified predetermined time range based on the determined change while maintaining the user-selected wake-up time as an end time of the modified predetermined time range ([¶93] the wake up time is the final alarm. [¶210] the system can automatically amend system settings), and wherein the subsequent alarm is configured to be generated via the user device during the modified predetermined time range when the user is closest to light sleep based on a subsequent sleep-wake signal associated with the subsequent sleep session ([¶713-717] the system can modify wake up times and nap durations for future sleep sessions). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Heneghan with the alarm of Shouldice in order to wake the patient at an optimal time to ensure the most restful sleep ([¶349]).
Regarding claim 2, Shouldice teaches causing one or more indications associated with the first sleep session, the second sleep session or both, to be communicated to the user, via the user device, subsequent to the second sleep session to aid in encouraging the user to use the respiratory therapy system ([¶75,78] therapy recommendations are made based on the data).
Regarding claim 3, Heneghan discloses the one or more indications include (i) an indication associated with at least a portion of the first set of sleep- related parameters, (ii) an indication associated with at least a portion of the second set of sleep- related parameters, or (iii) both (i) and (ii) ([¶30] the parameters of testing can displayed to the user).
Regarding claim 4, Heneghan discloses the first set of sleep-related parameters and the second set of sleep-related parameters includes an apnea- hypopnea index (AHI), an identification of one or more events experienced by the user, a number of events per hour, a pattern of events, a sleep score, a total sleep time, a total time in bed, a wake-up time, a rising time, a hypnogram, a total light sleep time, a total deep sleep time, a total REM sleep time, a number of awakenings, a sleep-onset latency, or any combination thereof ([¶35,57,64] a AHI is calculated [FIG6] events per hour are displayed).
Regarding claim 5, Heneghan discloses wherein the one or more indications include an indication of a first AHI for the first sleep session and an indication of a second AHI for the second sleep session ([¶30,75,76] the index is display after the sessions).
Regarding claim 6, Heneghan discloses the one or more events include snoring, apneas, central apneas, obstructive apneas, mixed apneas, hypopneas, a mask leak, a restless leg, a sleeping disorder, choking, labored breathing, an asthma attack, an epileptic episode, a seizure, or any combination thereof ([¶67,75,76] apnea can be determined).
Regarding claim 7, Heneghan discloses receiving, from the user, first subjective feedback associated with the first sleep session; and receiving, from the user, second subjective feedback associated with the second sleep session ([¶37,50] daily feedback is recorded).
Regarding claim 8, Heneghan discloses prompting the user to provide the first subjective feedback subsequent to the first sleep session and prior to the second sleep session; and prompting the user to provide the second subjective feedback subsequent to the second sleep session ([¶37,50] daily feedback is recorded).
Regarding claim 9, Heneghan discloses the first subjective feedback includes a subjective sleepiness level subsequent to the first sleep session, a subjective sleepiness level prior to the first sleep session, a subjective sleep satisfaction rating for the first sleep session, or any combination thereof ([¶50] sleepiness scores are entered after a session).
Regarding claim 10, Heneghan discloses the one or more indications include (i) an indication of at least a portion of the first subjective feedback for the first sleep session, (ii) an indication of at least a portion of the second subjective feedback for the second sleep session, or (iii) both (i) and (ii) ([¶64] system can display and report the subjective feedback).
Regarding claim 11, Heneghan discloses the first set of sleep-related parameters includes an identification of one or more events experienced by the user during the first sleep session, and wherein the method further comprises causing a portion of the first audio data that is associated with the one or more events experienced by the user during the first sleep session to be communicated to the user via a speaker subsequent to the first sleep session ([¶32,57-59] sleep awake events are determined).
Regarding claim 14, Heneghan discloses the first data, the second data, or both is generated by one or more sensors, the one or more sensors including an acoustic sensor, a microphone, a speaker, or any combination thereof ([¶10,31] a microphone is used).
Regarding claim 16, Heneghan discloses the one or more sensors includes (i) an acoustic sensor having a first microphone and a speaker and (ii) a second microphone, and wherein the first respiration data and the second respiration data are generated by the acoustic sensor and the first audio data and the second audio data are generated by the second microphone ([¶10,31,66] two microphones are used to record ambient sounds and respiratory sounds).
Regarding claim 21, Heneghan discloses the one or more indications include a comparison between a first one of the first set of sleep-related parameters for the first sleep session and a second one of the second set of sleep-related parameters for the second sleep session ([¶69,70,75,76] the index is compared across sessions and shown to the user).
Regarding claim 22, Heneghan discloses the first one of first one of the first set of sleep-related parameters is a first AHI and the second one of the second set of sleep- related parameters is a second AHI ([¶69,70,75,76] the index is compared across sessions and shown to the user).
Regarding claim 24, Heneghan discloses the one or more indications include a comparison between a portion of the first subjective feedback for the first sleep session and a portion of the second subjective feedback for the second sleep session, wherein the portion of the first subjective feedback includes a first subjective sleep satisfaction for the first sleep session and the portion of the second subjective feedback includes a second subjective sleep satisfaction for the second sleep session ([¶57,69,75] the subjective feedback from the sessions can be displayed and it is compared across sessions in determining the quality index).
Regarding claim 27, Heneghan discloses determining whether the user experienced co-morbid insomnia sleep apnea (i) during the first sleep session based at least in part on the first data, (ii) during the second sleep session based at least in part on the second data, or (iii) both (i) and (ii) ([¶16,67] the system determines apnea and if the user has other health conditions so it determines a comorbid apnea event).
Regarding claim 28, Heneghan discloses the first respiration data is indicative of a first respiration signal of the user during at least a portion of the first sleep session and the second respiration data is indicative of a second respiration signal of the user during at least a portion of the second sleep session ([¶18,39] respiratory signals can be determined by the sensors and the system).
Regarding claim 29, Heneghan discloses causing (i) a representation of at least a portion of the first respiration signal to be displayed on the display device subsequent to the first sleep session, (ii) a representation of at least a portion of the second respiration signal to be displayed on the display device subsequent to the second sleep session, or (iii) both (i) and (ii) ([FIG4,5][¶67] the respiration signals can be displayed).
Regarding claim 30, Heneghan discloses causing (i) an indication of one or more events experienced by the user during the first sleep session to be overlaid on the displayed representation of the first respiration signal, (ii) an indication of one or more events experienced by the user during the second sleep session to be overlaid on the displayed representation of the second respiration signal, or (iii) both (i) and (ii) ([FIG4,5][¶67] the respiration signals can be displayed along with events).
Regarding claim 43, Heneghan discloses the respiratory therapy system, wherein the respiratory therapy system includes: a respiratory device configured to supply pressurized air; and a user interface coupled to the respiratory device via a conduit, the user interface being configured to engage a user and aid in directing the supplied pressurized air to an airway of the user ([¶47] can use a CPAP which has a conduit and interface/mask)
Regarding claim 44, Heneghan discloses at least one of the one or more sensors is coupled to or integrated in the respiratory therapy system or (ii) the user device ([¶18,47] the sensors and components can be integrated into one device like a CPAP).
Regarding claim 46, Heneghan discloses the first data associated with the first sleep session is generated by a first sensor of the one or more sensors and the second data associated with the second sleep session is generated by a second sensor of the one or more sensors that is separate and distinct from the first sensor ([¶39-51] many different sensors can be used in the sleep monitoring across sessions).
Regarding claim 47, Heneghan discloses wherein the one or more sensors include a microphone, a speaker, an acoustic sensor, a pressure sensor, a flow rate sensor, or any combination thereof ([¶39-51]).
Response to Arguments
Applicant's arguments filed 5/26/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 101 rejection, Examiner respectfully disagrees. First, Applicant argues that the clinician can not mentally determine when the user is closest to light sleep from listening to respiration or audio data. This not required for the process to still be a mental concept. The clinician does not have to listen to audio data and make a determination from just that. The claims recite using respiration data or audio data or a combination and the clinician could observe a respiratory waveform and from signal that determine stages of sleep. Generating a sleep wake signal also does not have to be as specific as Applicant argues. A person could observe the data stream and split it into various stages and that can be marked to provide a sleep wake metric. Similarly, automatically adjusting an alarm, while performed by the device, is just the automation of something the clinician could do manually. Applicant argues that the claims recite a practical application but provides no argument other than saying that it is a practical application. Adjusting the alarm merely links the abstract idea to a particular field of use. The adjustment of the alarm is not a particular treatment or prophylaxis to any condition. Applicant argues that the claims recite a technological improvement but it is unclear how the adjustment of an alarm provides any particular improvement. It is not clear that this improves the user condition or treats any particular condition. As seen in the prior art, adjusting the alarm for a sleep monitoring system is already available, see ¶69 of Shouldice.
Regarding Applicant’s argument against Shouldice, Examiner respectfully disagrees. First, Shouldice at ¶717 does disclose changing parameters related to the duration, timing and wake up for the nap embodiments but, as shown in the rejection above, given Shouldice teaches automatically modifying settings and parameters based on historical data for other sleep uses of the device it would have been obvious to one of ordinary skill in the art to apply the nap adjustments to the regular sleep alarms. Second, Shouldice teaches modifying settings based on historical sleep trend data over multiple sessions. Applicant argues that Shouldice does not compare between therapy and non-therapy sleep sessions or analyze the effect of therapy on the sleep stages but this is not what is actually claimed. The claim just recites that the time range is modified based on the first session parameters and the second sessions parameters and a comparison of their change. There would be some indications related to how the therapy affected sleep, since one session uses therapy and the other does not, but there is no recitation of analysis or determination other than determining changes in the session parameters and Shouldice teaches comparing data and trends across past sleep sessions. Third, Applicant argues that the comparison of the occurrence of the light sleep stage during the terminal portion of a sleep session is a specific determination of how introducing respiratory therapy has shifted the alarm window. All of this is implied and not actually recited in the claim. There is no claimed analysis other than comparing the change in light sleep at the end of a session and Shouldice compares sleep stages and trends across sessions ([¶208,384-390]). Fourth, which ties back to the first point, Shouldice does not specifically disclose automatically adjusting the alarm window but Shouldice does teach changing parameters related to the duration, timing and wake up for the nap embodiments but, as shown in the rejection above, given Shouldice teaches automatically modifying settings and parameters based on historical data for other sleep uses of the device it would have been obvious to one of ordinary skill in the art to apply the nap adjustments to the regular sleep alarms.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791
/TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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