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 .
Response to Amendment
Receipt is acknowledged of applicant's amendment filed on.3/4/26 Claims 8-14 are cancelled. Claims 21-27 are new. Claims 1-7 and 15-27 are currently pending and an action on the merits is as follows.
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 1-7 and 15-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the steps of generating a merged sleep session, estimating an estimated apnea hypopnea index and generating an indication of whether the user has sleep apnea.
The limitation of generating a merged sleep session, estimating an estimated apnea hypopnea index and generating an indication of whether the user has sleep apnea, as drafted, are processes that, under their broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a wearable device” and “a hardware 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, “estimating” and “generating” in the context of this claim encompasses the user manually merging the sleep session information and estimating the AHI. 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 a wearable device with implied SpO2 sensors. These devices involve mere data gathering and amount to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the processor and wearable device 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. 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 1-7 and 15-27 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. The claims recite wherein the machine learning model is trained to generate eAHI values based on training data including polysomnography data collected concurrently with SpO2 data during training sleep sessions but there is no support in the specification for this limitation. The specification at ¶63 discusses the machine learning but does not disclose the specifics of how the training data is collected just that it can be given sleep sessions and accompanying SpO2. It is not clear what the training data is at all and without any specific disclosure of the machine learning architecture its unclear what it is training with or what determinations or algorithms are used.
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) 1-7 and 15-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Russell et al. US 2022/0225929 in view of Grant et al. US 2005/0131283 in view of Remmers et al. US 2018/0078403.
Regarding claims 1, 8, 15 and 21, Grant discloses a method within and by a wearable device including a hardware processor, the method comprising:
continuously monitoring in real time, by the hardware processor, sensor signals including PPG signals generated by sensors of the wearable device including a PPG sensor to detect a plurality of sleep sessions occurring during a plurality of one or more sleep cycles ([¶24] an electronic device is worn by the patient while they sleep and collects physiological information);
for each sleep session of the plurality of sleep sessions, detecting, by the hardware processor ([¶65] the device has a SpO2 sensor);
generating, by the hardware processor, a merged sleep session by combining selected sleep sessions of the plurality of sleep sessions occurring in a same sleep cycle ([¶86-87] the physiological data which has been filtered for extreme values is combine with time data for the sleep determinations);
estimating, by the hardware processor, executing a machine learning model, an estimated apnea hypopnea index (eAHI) for each sleep cycle of the plurality of sleep cycles ([¶83-84,86-87] an overall sleep metric is determined including halted breathing); and
Russell does not specifically disclose that the SpO2 data is derived from the PPG signals by detecting that a minimum number of SpO2 values within a range defined by a lower SpO2 threshold and upper SpO2 threshold have been collected that cover a minimum duration of the sleep sessions and generating, by the hardware processor, an indication of whether the user has sleep apnea based on one or more of the eAHIs for the one or more sleep cycles. Grant teaches a similar sleep monitoring device that determines an AHI ([¶45-46]) and discarding each sleep sessions and corresponding data of the plurality of sleep cycles having invalid SpO2 data and merging the saturation data ([¶36] non valid readings are removed and the remaining data which counts as sleep sessions or cycles is merged into one). Grant also teaches the SpO2 data is derived from the PPG signals by detecting that a minimum number of SpO2 values within a range defined by a lower SpO2 threshold and upper SpO2 threshold ([¶36] non valid SpO2 signals are removed. Lower threshold 20% upper is physical limit of 100%) have been collected that cover a minimum duration of the sleep sessions ([¶87] The SpO2 readings must be within a certain range and sufficient amount must be collected). 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 Russell with the teachings of Grant in order to remove artifacts from the signal ([¶36]) and to provide a predictive model for determining OSA.
Russel does not specifically disclose merging sessions that are being within a predetermined time from another or the machine learning and training. Remmers teaches one of the selected sleep sessions begins within a predetermined amount of time of an end of another of the selected sleep sessions and each of the selected sleep sessions has valid SpO2 data ([¶87,88] [¶115,237,238] the amount of time for the sessions and the time gap between events can be adjusted based on meeting certain thresholds or criteria) or wherein the machine learning model is trained to generate eAHI values based on training data including polysomnography data collected concurrently with SpO2 data during training sleep sessions ([¶89]). 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 Russell with the teachings of Remmers in order to adjust the test or accuracy ([¶237,238]).
Regarding claims 2 and 22, Grant teaches the generating the indication comprises: for each of the one or more sleep cycles, comparing the eAHI associated with the sleep cycle with a threshold eAHI; and indicating that the user has sleep apnea in response to determining that the eAHI associated with at least one sleep cycle exceeds the threshold eAHI ([¶4,15] a threshold of 5-20 events an hour is used to determine apnea).
Regarding claims 3 and 23, Grant teaches merging the first sleep session and a second sleep sessions of the selected sleep sessions in response to detecting that each of the first and second sleep sessions is longer in duration than a minimum duration ([¶87] sessions are combined based on time and total duration of combined sessions).
Regarding claims 4, 17 and 24, Grant teaches the merged sleep session is formed of a first sleep session and a second sleep session, and wherein the estimating the eAHI comprises, for the merged sleep session: determining a first eAHI associated with the first sleep session based on a number of apneas during the first sleep session; determining a second eAHI associated with the second sleep session based on a number of apneas during the second sleep session; and generating an eAHI for the merged sleep session by combining the first eAHI and the second eAHI ([¶36] the non-artifact periods are combined over the night for an total AHI determination).
Regarding claims 5, 18 and 25, Russel discloses combining the first eAHI and the second eAHI using a weighted sum; and determining the weighted sum using weights determined based on a duration of the first sleep session and a duration of the second sleep session ([¶87] the weighting can be adjusted based on the previous sessions or total number of sessions and the length being a parameter of those sessions).
Regarding claim 6, 7, 26 and 27, Remmers teaches a SpO2 device that varies the amount of time between sleep sessions based on whether the first test or session did not meet parameters ([¶115,237,238] the amount of time for the sessions and the time gap between events can be adjusted based on meeting certain thresholds or criteria).
Response to Arguments
Applicant's arguments filed 3/4/26 have been fully considered but they are not persuasive.
Regarding Applicant’s argument against the 101 rejection Step 2A, Prong 1 analysis, Examiner respectfully disagrees. The claims recite the abstract idea of determining valid SpO2 data, generating a merged sleep sessions, discarding invalid SpO2 data and estimating an eAHI. All of these steps can be performed mental with the aid of pen and paper. A clinician could look at the sensor data and determine is the signals where with the correct thresholds and if the sleep sessions were of the appropriate length and merge data to get a combined session of appropriate duration or including sufficient valid data points. The PPG sensor and the real time monitoring are not considered mental processes but they are merely pre-solutional data collection necessary to perform the judicial exception. Similarly, the machine learning model, like the recitation of the processor, is a generically recited computer data structure that the abstract idea is performed on or with and does not integrate it into a particular machine or application. Applicant then argues Prong 2 analysis that the claims recite a technical improvement to the technology but it seems the improvement is merging data to get sufficient data which seems to have been performed in the prior art so it is unclear what the specific improvement is if the prior art performs all the same recited steps. Additionally, the machine learning model cannot provide a technological improvement as it is a generic computer structure and it serves to automate a process that could be performed mentally, much like executing the mental process on a computer processor.
Regarding Applicant arguments against the 102 and 103 rejections, Examiner respectfully disagrees. Russel and Grant do not disclose the new limitations, however, Remmers that was applied to the now cancelled claims teaches using machine learning that validity parameters and the merging parameters.
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 CHEN/Supervisory Patent Examiner, Art Unit 3791
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