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 .
Drawings
The drawings are objected to because of the following reasons:
In Fig. 2, the activity tracker (element 270) was labelled incorrectly as a user device (element 260).
In Fig. 2, the user device (element 260) was labelled incorrectly as an EEG sensor (element 240).
The element number 142 is mentioned in the description but not included in the drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0066] “form” should be changed to “from”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 6-7, the phrase “trigger event” renders the claims indefinite because it is unclear what defines a trigger event. For the purpose of continued examination, the examiner has interpreted a “trigger event” broadly as any event that generates data.
Regarding claim 5, the claim requires a "microphone" that detects one or more of light, time to fall asleep, and time asleep. There is insufficient antecedent basis for these limitations in the claim. It is unclear what type of microphone can detect light/time to fall asleep and time asleep, and the claim does not mention a device capable of performing this.
Regarding claim 6, the phrase “preventing” renders the claim indefinite because it is unclear whether noise data portions are actually not stored when the trigger event is not detected, or if the method simply attempts or “prevents” them from being stored. For the purpose of continued examination, the examiner has interpreted “preventing portions of the noise data from being stored” to encompass when the user is not being monitored/has not voluntarily put on the monitoring device when they go to sleep (see above rejection of “trigger event”).
Regarding claims 10 and 16, the phrase “non-therapy usage” renders the claims indefinite because it is unclear how this value is calculated. The non-therapy usage could be the time the user does not use the therapy in a sleep session, other sleep quality data not associated with the respiratory therapy device, etc. For the purposes of examination, the examiner has interpreted “non-therapy usage” to mean other sleep quality data not associated with the respiratory therapy device.
Regarding claim 10, the phrase “sleep score information is based on therapy usage” renders the claim indefinite because the claim has not defined or disclosed monitoring sleep during “therapy usage.” The claim does not mention how/when/what parameters are detected with respect to therapy.
Regarding claim 14, the phrase “therapy usage latency” renders the claim indefinite because it is unclear how this value is calculated. The therapy usage latency could be the time the user begins therapy after receiving instructions to do so, the time the user begins therapy after getting in bed, etc. For the purposes of examination, the examiner has interpreted “therapy usage latency” to mean the time the user begins therapy after getting in bed.
Regarding claims 15-16, the phrase “comparing the sleep score for the user to the user’s completion of the task” renders the claim indefinite because it is unclear what comparison is being made. The limitations of claim 16 suggest that the method compares sleep score (with therapy) with sleep score (without therapy), but it is unclear how the “completion of the task” relates to this comparison.
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 1-16 are rejected under 35 U.S.C 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes grouping, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step (1)
The claimed invention in claims 1-16 is directed to statutory subject matter as the claims recite a method for gathering data and adjusting parameters to calculate a sleep score, and thus, the claims all fall under one of the four patent eligible categories.
Step (2a) Prong 1 (Judicial Exception)
Regarding claims 1-16, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.04(a)(2) subsection (III)).
Independent claim 1 recites:
capturing… noise data associated with the user sleeping;
detecting, based on the noise data, a trigger event;
in response to detecting the trigger event, storing at least a portion of the noise data; and
calculating… based on the at least a portion of the noise data, the sleep score for the user.
Under the broadest reasonable interpretation, these limitations require detecting a trigger event based on noise data, storing a portion of the noise data, and calculating a sleep score. These limitations are processes that, as drafted, cover that which can be wholly performed in a person’s mind via a series of mental observations and judgements. In particular, a person could gather noise data and detect noise event by visually or mentally observing a sleeping person, and/or by reading a microphone; the person can then determine a sleep score based at least in part on the noise data by performing mental judgement or calculations. These are data gathering and processing steps (capturing, detecting, storing, processing) that reflect mental processes (e.g., storing and calculating parameters based on the noise data).
Accordingly, claim 1 is directed to a judicial exception including one or more abstract ideas, specifically mental processes.
Independent claim 1 recites the corresponding apparatus associated with the method, including a microphone and control system. Under the broadest reasonable interpretation, the claim also recites a judicial exception including one or more abstract ideas under the mental processes bucket.
The dependent claims recite additional limitations for detecting trigger events and calculating a sleep score, including additional types of data to be collected, data storage instructions, sleep score calculations, and therapy usage recommendations. These limitations also fall within the judicial exception of mental processes.
Step (2a) Prong 2 (Integration into a Practical Application)
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
For claims 1-16, the judicial exception is not integrated into a practical application.
Regarding claim 1, the additional element of a microphone for capturing noise data amounts to recitation of a generic microphone. Under the broadest reasonable interpretation, this element is nothing more than the pre-solution activity of mere data gathering using generic components.
Regarding claim 1, the additional element of a control system amounts to recitation of a generic controller. This additional element merely defines the field of user of the current claim. This additional element does not practically integrate the judicial exception because this element does not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Furthermore, when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mental processes grouping.
The additional elements in claims 3, 8, and 15 (microphone, respiratory device, movement sensor, mobile device) amounts to recitation of generic sensing components. Under the broadest reasonable interpretation, these elements are nothing more than the pre-solution activity of mere data gathering using generic components.
Step (2b) (Inventive Concept)
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of a microphone and control system in the field of sleep monitoring are well-understood, routine and conventional activities previously known in the industry as indicated in the following references:
Tiron et al. (US Pre-Grant Publication 2022/0007965) teaches a microphone (microphone or sound sensor 7302) and control system (central controller 4302).
Wren et al. (US Pre-Grant Publication 2022/0339380) teaches a microphone (microphone 140) and control system (control system 110).
Dependent claims 2, 4-7, 9-14, and 16 are further directed towards insignificant extra-solution activities (MPEP 2106.05(g)) and do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Dependent claims 3, 8, and 15 recite a respiratory therapy device, movement sensor, and mobile device, which are also recited at a high level of generality and are considered to be well-known, routine and conventional in the art as indicated in the following references:
Tiron et al. (US Pre-Grant Publication 2022/0007965) teaches a respiratory therapy device (RT device 4000), movement sensor (motion sensor 7010), and mobile device (mobile phone or processing device 7100, Fig. 7B-2).
Wren et al. (US Pre-Grant Publication 2022/0339380) teaches a respiratory therapy device (respiratory device 122), movement sensor (motion sensor 138), and mobile device ([0066], external device 170 can be mobile device).
Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 1-16 are thus rejected under 35 USC 101 for reciting patent-ineligible subject matter- abstract ideas.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9, 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tiron et al. (US Pre-Grant Publication 2022/0007965), hereinafter ‘Tiron’.
Regarding claim 1, Tiron teaches a method for calculating a sleep score for a user ([0242], providing sleep score, sleep score 8926, Fig. 8B), the method comprising:
capturing, via a microphone (microphone or sound sensor 7302, Fig. 7B-2), noise data associated with the user sleeping ([0172], audio analysis);
detecting, based on the noise data, a trigger event (feature extraction process/module 8914 determines outputs such as coughing, soring, wheezing, gasping, etc.);
in response to detecting the trigger event, storing (memory/data storage 7312, Fig. 7B-3) at least a portion of the noise data ([0136], data storage); and
calculating, by a control system (processing device 7100) based on the at least a portion of the noise data, the sleep score for the user ([0242], system provides sleep score).
Regarding claim 2, Tiron teaches the method according to claim 1, further comprising:
wherein the trigger event is the user snoring ([0383], monitor snore, snore classification module 8920, Fig. 8B)
Regarding claim 3, Tiron teaches the method according to claim 1, further comprising:
wherein the microphone is associated with one or more of a respiratory therapy device and a mobile device ([0061], processing device can include respiratory therapy device or smart devices, and microphone can be coupled to it)
Regarding claim 4, Tiron teaches the method according to claim 1, further comprising:
wherein the sleep score is calculated based on a number of disturbances detected in the at least a portion of the noise data ([0341], processor adjusts sleep score based on disruptions).
Regarding claim 5, Tiron teaches the method according to claim 4, further comprising:
wherein the disturbances include one or more of detection of light, detection of sound, detection of movement, a time to fall asleep, and a time asleep ([0055-0057], detecting coughing, [0481], detecting waking, Fig. 7B-2, process 7204).
Regarding claim 6, this claim is rejected under 35 USC 112(b), please refer to Examiner’s interpretation above. Tiron teaches a method for sleep score calculation according to claim 1, further comprising preventing portions of the noise data from being stored when the trigger event is not detected. (Since the claim does not explicitly define who or what performs the preventing, as such under BRI, the user in Tiron voluntarily placing the sensor for detecting sleep session performs said “preventing portions of the noise data from being stored when the trigger event is not detected” in this claim. Tiron [0139] teaches providing memory/data storage 312 for storing detected sensor data.)
Regarding claim 7, Tiron teaches the method according to claim 1, further comprising:
detecting, based on the noise data, a wake event ([0211], sleep/wake differentiation);
wherein the sleep score is calculated based on the at least a portion of the noise data between the detecting the trigger event and the detecting the wake event ([0481], system determines detected snoring is not from user since they are awake).
Regarding claim 8, Tiron teaches the method according to claim 1, further comprising:
detecting, via a movement sensor (motion sensor 7010, Fig. 7C-1), movement data for the user ([0142], bodily movement of patient);
wherein the calculating the sleep score for the user is further based on the movement data ([0467], movement/activity counts determined by 8912, Fig. 8B)
Regarding claim 9, Tiron teaches the method according to claim 1, further comprising:
comparing, by the control system, the sleep score for the user with historical sleep score information ([0392], using current cough score compared to personal baseline cough score, [0460], comparisons of various aspects of sleep related parameters).
Regarding claim 11, Tiron teaches the method according to claim 9, further comprising:
determining, by the control system based on the comparing the sleep score for the user with the historical sleep score information, a therapy usage recommendation for the user ([0058, 0228, 0366, 0501, 0747] discuss adjusting setting of a treatment device, or recommending different type of therapy based on sleep score or other sleep breathing events).
Regarding claim 12, Tiron teaches the method according to claim 11, further comprising:
the therapy usage recommendation for the user includes one or more of a recommended number of nights for therapy usage, recommended duration of therapy usage, and recommended frequency of therapy usage ([0440], patient offered various exercise regimes, treatments, changes, etc.).
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tiron et al. (US Pre-Grant Publication 2022/0007965) as applied to claim 9 above in view of Shouldice et al. (US Pre-Grant Publication 2025/0134451), hereinafter ‘Shouldice’.
Regarding claim 10, Tiron teaches the method according to claim 9, but does not explicitly teach comparing sleep scores of when a user uses therapy to when the user does not.
Shouldice teaches a system/method for facilitating insomnia therapy (abstract), further comprising:
the historical sleep score information is based on therapy usage ([0178-0180], sleep therapy plan score 528, Fig. 5) and the sleep score for the user is based on non-therapy usage ([0148], physiological sleep-related parameters).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tiron to incorporate the teachings of Shouldice to include comparing the user’s sleep score with their historical sleep scores. Doing so would allow the system to identify therapy parameters more likely than others to improve the user’s sleep, as recognized by Shouldice [0178].
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Tiron et al. (US Pre-Grant Publication 2022/0007965) in view of Wren et al. (US Pre-Grant Publication 2022/0339380), hereinafter ‘Wren’.
Regarding claim 13, Tiron teaches the method of claim 11, but does not teach analyzing therapy usage trends.
Wren teaches a system/method for determining sleep parameter for a user, the method further comprising:
analyzing, by the control system (control system 110), therapy usage trends ([0090], system compares reports to determine trends and provide recommendations)
wherein the therapy usage recommendation for the user is further based on the therapy usage trends ([0096], recommendations regarding use of therapy device 122).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tiron and Shouldice to incorporate the teachings of Wren to include different types of therapy usage recommendations. Doing so would aid in improving the quality of the sleep score, as recognized by Wren [0094].
Regarding claim 14, Tiron and Wren teach the method of claim 13. Wren teaches the method further comprising:
the therapy usage trends include a therapy usage latency for the user ([0138], enter bed and go to sleep times).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tiron and Shouldice to incorporate the teachings of Wren to include different types of therapy usage recommendations. Doing so would aid in improving the quality of the sleep score, as recognized by Wren [0094].
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tiron et al. (US Pre-Grant Publication 2022/0007965) as applied to claim 1 above, and in view of Dothie et al. (US Pre-Grant Publication 2011/0015495), hereinafter ‘Dothie’.
Regarding claim 15, Tiron teaches the method according to claim 1, but does not teach presenting a task to the user.
Dothie teaches a system and method for managing a user’s sleep (Fig. 1), the method further comprising:
presenting, to the user via a mobile device (Fig. 2), a task to complete (Figs. 11(a), 11(b)), cognitive task)
evaluating, by the control system (processing means 16, Fig. 3), the user's completion of the task ([0176], collect data on cognitive/psychomotor performance); and
comparing the sleep score for the user to the user's completion of the task ([0141], processing unit tracks changes in sleep quality and performance metrics).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tiron to incorporate the teachings of Dothie to include presenting the user with a task and comparing their performance to the sleep score. Doing so would allow the user to track how higher sleep quality may positively impact their cognitive performance and vice versa, as recognized by Dothie [0141].
Regarding claim 16, Tiron and Dothie teach the method according to claim 15. Dothie teaches the method further comprising:
wherein the user's completion of the task is evaluated over a period of time ([0152], tests carried out over different time periods);
wherein the comparing the sleep score for the user to the user's completion of the task indicates correlations between therapy usage and non-therapy usage for the completion of the task ([0147], establish correlations between objective data collected while user is asleep).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tiron to incorporate the teachings of Dothie to include presenting the user with a task and comparing their performance to the sleep score. Doing so would allow the user to track how higher sleep quality may positively impact their cognitive performance and vice versa, as recognized by Dothie [0141].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./
Examiner, Art Unit 3792
/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792