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, 139-157 are pending.
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) 1, 139-157 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. [US 20170312117] in view of Mostov [US 20160022204].
As to claim 1 is rejected using the same prior arts and reasoning as to that of claim 148.
As to claims 139-147 are rejected using the same prior arts and reasoning as to that of claims 149-157, respectively.
As to claim 148. Shah discloses A system comprising:
a memory device having stored thereon machine-readable instructions, [0207]; and
a control system having one or more processors, [fig. 7A, 0155] microprocessor 740, the control system being coupled to the memory device such that the one or more processors are configured to execute the machine-readable instructions, [0155, 0207] to:
receive one or more signals representative of one or more parameters associated with a user, [0158], receive sensor data used for determining apnea, during application of pressurized air to an airway of the user, [0151] blowers apply pressure to an incoming air, the pressurized air applied from a flow path, [fig. 6A, 0148, 0151] blowers 445 increase the pressure of incoming air coming through a flow path 655, through a tube and a mouth piece connected to a respiratory device, [fig. 6A, 0148] pressurized air passes through tube located between the mouth guard 600 and the front housing holding blowers 645, during a sleep session of the user, [0140] during the use of the sleep apnea treatment device while sleeping, wherein the tube has one end connected to the respiratory device, [fig. 6A, 0148] the micro-blowers, and another end connected to the mouth piece, [fig. 6A] the tube connects the blower housing 610 and the mouth guard, and wherein the mouth piece is externally positionable over an area of a nose and/or mouth of the user, [fig. 6B, 9, 0171], 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. 6A, 0149];
process the one or more parameters to determine a sleep status of the user, [0116, 0199] determine sleep time, the sleep status being at least one of awake, asleep, or a sleep stage, sleep time measures the time the patient is asleep; and
calculate an apnea-hypopnea index for the user during the sleep session based, at least in part, on the sleep status, [0175] calculate AHI based on the sleep time determined.
Shah fails to disclose wherein the mouth piece is a mask connected to the device; wherein the calculated AHI is based in part 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.
Shah, in a separate embodiment, teaches that it is known in the art to have the device implemented as a mask, [0003].
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 Shah as nothing but a design choice for implementing the use of micro-blowers of Shah attached to the front of the mask for scenarios where the identified comfort is not a factor as masks and mouth guards are well known methods of providing pressurized air to a user.
Shah fails to disclose wherein the calculated AHI is based in part 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.
Mostov teaches an apparatus for monitoring of sleep apnea by determining the sleep/wake stages, [0146], and using a wake stage exclusion and AHI calculation unit to determine AHI by disregarding wake stage data, [0151].
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 Shah with that of Mostov so that the AHI index can be made accurate, as indicated in [0053, 0199] of Shah.
As to claim 149. Shah 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, [0175, 0199],
(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. Shah discloses The system of claim 148, wherein
(i) the sleep stage includes an indication of non-REM, N1 sleep, N2, sleep, N3 sleep, or REM sleep,
(ii) the one or more events are one or more apneas, one or more hypopneas, or a combination thereof, [0175, 0201]], or
(iii) a combination thereof.
As to claim 151. Shah 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, [0114-0116, 0174] receive data from wireless sensors.
As to claim 152. Shah 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, [0114-0116, 0174], 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. Shah 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, [0116] brain activity on sleep time, [0120] sleep information and other parameters over a period of time, [0199] sleep time.
As to claim 154. Shah fails to disclose 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.
Mostov teaches an apparatus for monitoring of sleep apnea by determining the sleep/wake stages, [0146], and using a wake stage exclusion and AHI calculation unit to determine AHI by disregarding wake stage data, [0151]; wherein the system uses a FFT unit in the calculation of the AHI, [fig. 20, 0082, 0192].
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 Shah with that of Mostov so that rhythmic processes can be determined.
As to claim 155. Shah 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, [0054] apneaic or hypopneaic events.
Shah fails to explicitly disclose wherein the system further 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.
Mostov teaches an apparatus for monitoring of sleep apnea by determining the sleep/wake stages, [0146], and using a wake stage exclusion and AHI calculation unit to determine AHI by disregarding wake stage data, [0151]; wherein the system excludes apnea events during wake stage, [0151].
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 Shah with that of Mostov so that the AHI index can be made accurate, as indicated in [0053, 0199] of Shah.
As to claim 156. Shah discloses The system of claim 148, wherein the processing is performed by a sleep staging classifier based on one or more of supervised machine learning, [0154] the algorithm learns from patterns, deep learning, a convolutional neural network, or a recurrent neural network.
As to claim 157. Shah 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, [0154],
(b) communicating the apnea-hypopnea index to an external device, [0154], or
(c) adjusting an operational setting of the respiratory device.
Response to Arguments
Applicant's arguments filed 03/23/2026 have been fully considered but they are not persuasive.
Argument 1: Shah specifically teaches away from using an external mask in conjunction with a respiratory therapy device.
Response 1: Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Shah does not teach away from the use of mask. Shah only provides an improvement from a use of a traditional mask for providing pressurized air. The claimed functionalities of the system using a tube to provide pressurized air from a respiratory device to a user is described in Shah as detailed in the rejection of claims 1, and 148 above. It is obvious for one of ordinary skill in the art to replace the mouth guard with a mask for scenarios where comfort is not a factor, without imparting from the use of a micro-blower attached to the mask to provide the pressurized air, as detained in Shah.
Argument 2: In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., mask worn externally on the face) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Response 2: The claimed limitation only specifies a mask “externally positionable over an area of a nose and/or mouth of the user”.
Argument 3: The pressurized air generated by the micro-blowers of Shah do not pass through a tube.
Response 3: [fig. 6A] of Shah illustrates a tube between the micro-blower and the mouth guard 600.
Argument 4: the combination of Shah and Mostov does not disclose the newly amended scope of the claims.
Response 4: The Office Action is amended to address the newly amended scope of the claims as detailed above.
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 BENYAM HAILE whose telephone number is (571)272-2080. The examiner can normally be reached 7:00 AM - 5:30 PM Mon. - Thur..
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/Benyam Haile/Primary Examiner, Art Unit 2688
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