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 .
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.
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” and “causing” in the context of this claim encompasses the user manually calculating indices and notifying the user. 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 § 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 with out 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. 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]). 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, Heneghan discloses the one or more indications further include a recommendation to discontinue use of the respiratory therapy system ([¶74] 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 10/15/25 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that Heneghan does not disclose a first sleep session and a second sleep session where the user used the respiratory therapy system, Examiner respectfully disagrees. Heneghan specifically discloses a first session that is an initial or intake session where initial sleep targets are setup. The subsequent sessions are then used to determine the performance of the therapies and treatments. Heneghan discloses its use with a CPAP device but Armistead is now relied on to specifically teaches an initial session without the therapy device and subsequent sessions using the therapy device.
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.
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 W CHEN/Supervisory Patent Examiner, Art Unit 3791