DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1, 139-158 are pending.
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 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.
Claim(s) 1, 139-145, 147-155, 157 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mumford et al. [US 20070208269].
As to claim 1, is rejected using the same prior arts and reasoning as to that of claim 148.
As to claims 139-145, 147 are rejected using the same prior arts and reasoning as to that of claims 149-155, 157, respectively.
As to claim 148. Mumford discloses A system comprising:
a memory device having stored thereon machine-readable instructions, [figs. 1, 8, 15, 0099] memory unit 608 of a monitoring unit 16; and
a control system having one or more processors, [figs. 1, 8, 15, 0099] control unit 600 of a monitoring unit 16, the control system being coupled to the memory device such that the one or more processors are configured to execute the machine-readable instructions, [figs. 8, 15, 0099] to:
receive one or more signals representative of one or more parameters associated with a user, [0152] receive sensor data and extract biological data from sensors 1110, [fig. 11, 0118], during application of pressurized air to an airway of the user, [0222] sensor electrodes in the PAP mask are used for determining sleep stage data during airflow via the CPAP device, the pressurized air applied from a flow path, [figs. 1, 9, 0055, 0106] pressurized gas received gas supply tube 730/30, through a tube and a mask connected to a respiratory device, [figs. 1, 9, 0106] received through a gas supply tube, [fig. 1, 0055] connected to the CPAP device 14, during a sleep session of the user, [0104] CPAP device activated only when the patient falls asleep, wherein the tube has one end connected to the respiratory device and another end connected to the mask, [fig. 1, 0055] tube 30 connected to the CPAP device 14 and the mask 12, and wherein the mask is externally positionable over an area of a nose and/or mouth of the user, [fig. 1], at least some of the one or more of the parameters being detected by one or more sensors on or within the tube, on or within the mask, on or within the respiratory device, or a combination thereof, [fig. 1, 0058];
process the one or more parameters to determine a sleep status of the user, [0101], the sleep status being at least one of awake, asleep, an REM-sleep stage, or a non-REM sleep stage, [0101]; and
calculate an apnea-hypopnea index for the user during the sleep session, [fig. 21, 0240], based, at least in part, on the sleep status, [0240], by disregarding one or more events that affect the calculating of the apnea-hypopnea index of the user in response to the sleep status being determined as awake during the one or more events, [0104] CPAP device activated only when the patient falls asleep; wherein the calculating an apnea-hypopnea index includes calculating a first apnea-hypopnea index for a REM sleep stage and a second apnea-hypopnea index for a non-REM sleep stage, [0240] AHI calculated for specific sleep stages, each based on sleep time in the corresponding sleep stage, [0223, 0227] apnea or hypopnea events determined for a given sleep stage based on duration in a given sleep stage.
As to claim 149. Mumford discloses The system of claim 148, wherein the one or more parameters relate to
(i) duration, period, rate, frequency, intensity, or type of movement of the user, [0208, 0213],
(ii) heart rate, heart rate variability, cardiac output, or a combination thereof of the user,
(iii) audio associated with the tube, the mask, or a combination thereof connected to the respiratory device, or
(iv) a combination thereof.
As to claim 150. Mumford discloses The system of claim 148, wherein
(i) the sleep status includes N1 sleep, N2, sleep, or N3 sleep, [0101], and
(ii) the one or more events are one or more apneas, one or more hypopneas, or a combination thereof, [0101].
As to claim 151. Mumford discloses The system of claim 148, wherein at least one of the one or more parameters is measured based on at least one sensor of a device operable to connect to other devices or networks, [0058, 0098] receive data from wireless sensors.
As to claim 152. Mumford discloses The system of claim 151, wherein the device is one or more of
(1) a smart watch, a smart phone, an activity tracker, a smart mask, a smart garment, a smart mattress, a smart pillow, smart sheets, a smart ring, or a health monitor, [fig. 1, 0055] the monitoring unit 16, each one being in contact with the user,
(2) a smart phone, a smart speaker, a smart TV, a radar-based sensor, a sonar-based sensor, a LiDAR-based sensor, or other non-contact motion sensor, each one being in proximity of the user,
(3) or a combination thereof.
As to claim 153. Mumford discloses The system of claim 148, wherein the processing of the one or more parameters includes processing a signal representative of at least one parameter of the one or more parameters over time, [0232].
As to claim 154. Mumford discloses The system of claim 148, wherein the detecting of the one or more parameters is based on a cepstrum analysis, a spectral analysis, a fast Fourier transform, or a combination thereof of one or more flow signals, one or more audio signals, or a combination thereof, [0195].
As to claim 155. Mumford discloses The system of claim 148, wherein the control system further is configured to execute the machine-readable instructions to:
determine a plurality of events during the sleep session of the user that affect calculation of the apnea-hypopnea index of the user, [0221] apnea or hypopnea events, and
determine the one or more events from among the plurality of events based on the one or more events occurring during the sleep status being awake, [0221].
As to claim 157. Mumford discloses The system of claim 148, wherein the control system further is configured to execute the machine-readable instructions to: initiate an action based, at least in part, on the apnea-hypopnea index, the sleep status, or a combination thereof, wherein the action includes one or more of
(1) saving a record of the apnea-hypopnea index, [0238],
(b) communicating the apnea-hypopnea index to an external device, or
(c) adjusting an operational setting of the respiratory device, [0224].
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 146, 156, 158 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mumford in view of Shouldice et al. [US 20200383580].
As to claim 146, is rejected using the same prior arts and reasoning as to that of claim 156.
As to claim 156. Mumford fails to disclose The system of claim 148, wherein the processing is performed by a sleep staging classifier based on one or more of supervised machine learning, deep learning, a convolutional neural network, or a recurrent neural network.
Shouldice teaches a system and method for physiological sensing used to determine sleep apnea, [0119]; wherein the system uses a machine learning algorithm for classification purposes, [0137, 0146].
It would have been obvious for one of ordinary skill in the art at the time of the filing of the claimed invention to combine the teachings of Mumford with that of Shouldice so that the algorithm can be used to identify patterns that are not easily identifiable by an algorithm dependent on human defined criteria.
As to claim 158. Mumford fails to disclose The system of claim 148, wherein the one or more sensors include a microphone, and wherein the one or more parameters include movement of the user being detected by the microphone.
Shouldice teaches a system and method for physiological sensing used to determine sleep apnea, [0119]; wherein the system uses a microphone for evaluation of physiological movement signals, [0264].
It would have been obvious for one of ordinary skill in the art at the time of the filing of the claimed invention to combine the teachings of Mumford with that of Shouldice as the use of microphone can be used for multiple additional purposes, including detecting snoring, reducing implementation cost of the system.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 139-158 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/Benyam Haile/Primary Examiner, Art Unit 2688
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