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 Objections
Allowable Subject Matter
Claims 8-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 102
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 1-16, 18-35, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doelling et al. (US Pub No. 2011/0295083).
Regarding claim 1, Doelling teaches a method comprising:
establishing a positional sleep therapy alert range with reference to a positional sensor of a positional therapy device (See [0054] teaches a position sensor to sense a sleep position. [0057] and [0062]-[0064] teach monitoring the sensed sleep position against a preestablished benchmark and alarm output when sensed readings are outside of the benchmark), wherein the positional therapy device is integrated with a positive airway pressure (PAP) mask system (See [0052]);
during a sleep session of a user, wearing the PAP mask system, determining a sleep position of the user is within the positional sleep therapy alert range based on a state of the positional sensor (See [0052] teaches integration with a CPAP mask. See [0062]-[0064], & Fig. 10, 11, 16, and 18 which teach that the alarm is only output when the sensed conditions are outside of the benchmark.); and
after said determining, prompting the user to alter the sleep position (See [0068] and [0069]).
Regarding claim 2, Doelling teaches logging a plurality of observations regarding a current sleep position of the user and whether the current sleep position is within or outside of the positional sleep therapy alert range (See [0061] which teaches that the device maintains a record log for the sensed conditions.).
Regarding claim 3, Doelling teaches additionally logging one or more of a breathing rate of the user, a heart rate of the user, a snoring state of the user, existence or non-existence of a breathing interruption, and an oxygen saturation of blood of the user by performing repeated measurements over time of the positional sensor and one or more other sensors associated with the positional therapy device (See [0056] which teaches all of the sensed conditions).
Regarding claim 4, Doelling teaches determining involves one or more of: periodically monitoring the state of the positional sensor and reading the state of the positional sensor after detecting movement of the user (See [0064] which teaches continuous monitoring of sensors at all times including before and after movement.).
Regarding claim 5, Doelling teaches determining involves one or more of: periodically monitoring the state of the positional sensor and reading the state of the positional sensor after detecting movement of the user (See Fig. 11 shows a loop of constant alerting and collecting sensor data.).
Regarding claim 6, Doelling teaches the alert profile specifies one or more of: a volume of an audible notification, a rate of repetition of the audible notification with a set time duration in between, a time delay of a start of the audible notification, a dynamically calculated and manually set number of repetitions of the audible notification, a pattern of the audible notification, a duration of the audible notification, and a type of sound associated with the audible notification (See [0281]).
Regarding claim 7, Doelling teaches observing a subsequent sleep position of the user is outside of the positional sleep therapy alert range; and after said observing, discontinuing said repeating (See [0068]).
Regarding claim 11, Doelling teaches transmitting the state of the positional sensor from the positional therapy device to a smartphone or external processing device in communication with the positional therapy device via wireless communication; and wherein said determining is performed by an application running on the smartphone or the external processing device (See [0238]).
Regarding claim 12, Doelling teaches transmitting the state of the positional sensor from the positional therapy device to a smartphone or external processing device in communication with the positional therapy device via wireless communication; and wherein said determining is performed by an application running on the smartphone or the external processing device (See [0293]-[0295] teaches that processing is done on a microprocessor located on the bedside device.).
Regarding claim 13, Doelling teaches the positional sensor comprises one or more of an accelerometer, a gyroscope, an inertial measurement unit, and a magnetometer (See [0092]).
Regarding claim 14, Doelling teaches wherein the positional sleep therapy alert range represents: one or more undesired orientations of a head of the user in three-dimensional (3D) space; or one or more desired orientations of the head of the user in 3D space (See [0054]).
Regarding claim 15, Doelling teaches comprising logging time-series data during the sleep session, wherein a given record of the time-series data for a particular time interval includes a timestamp and one or more of: information regarding a sleep position determined during the particular time interval; a breathing rate of the user; an indication of whether a breathing interruption was detected during the particular time interval; an indication of whether snoring by the user was detected during the particular time interval; an indication of whether the sleep position determined during the particular time interval was within or outside of the positional sleep therapy alert range; information regarding Electroencephalograph (EEG) data including one or more of EEG signals, voltage measurements, electrode channels, and electrical waveforms; and information regarding Electrooculography (EOG) data including one or more of EOG signals, voltage measurements, electrode channels, and electrical waveforms (See [0122]).
Regarding claim 16, Doelling teaches comprising exporting a report or raw data in a data interchange format or a medical format based on the time-series data (See [0195]).
Regarding claim 18, Doelling teaches during the sleep session, detecting the user is snoring based on sound received via a microphone associated with the positional therapy device or via vibration detected by the positional sensor; and after said detecting, prompting the user to alter the sleep position (See [0233]).
Regarding claim 19, Doelling teaches a positional therapy device comprising:
a positional sensor including one or more of an accelerometer, a gyroscope, an inertial measurement unit, and a magnetometer (See [0092]);
a means for alerting a user of a positive airway pressure (PAP) mask system with which the positional therapy device is integrated (See [0157]);
one or more processors (See [0170]); and instructions that when executed cause the positional therapy device to:
establish a positional sleep therapy alert range with reference to a positional sensor of a positional therapy device (See [0054] teaches a position sensor to sense a sleep position. [0057] and [0062]-[0064] teach monitoring the sensed sleep position against a preestablished benchmark and alarm output when sensed readings are outside of the benchmark), wherein the positional therapy device is integrated with a positive airway pressure (PAP) mask system (See [0052]);
during a sleep session of a user, wearing the PAP mask system, determining a sleep position of the user is within the positional sleep therapy alert range based on a state of the positional sensor (See [0052] teaches integration with a CPAP mask. See [0062]-[0064], & Fig. 10, 11, 16, and 18 which teach that the alarm is only output when the sensed conditions are outside of the benchmark.); and
after said determining, prompting the user to alter the sleep position (See [0068] and [0069]).
Regarding claim 20, claim 20 is rejected with the same reasoning as claim 4.
Regarding claim 21, claim 21 is rejected with the same reasoning as claim 5.
Regarding claim 22, claim 22 is rejected with the same reasoning as claim 6.
Regarding claim 23, claim 23 is rejected with the same reasoning as claim 7.
Regarding claims 24 and 25, Doelling teaches the positional therapy device is integrated with straps of the PAP mask system permanently or semi-permanently (See [0052] which teaches integration with a CPAP mask.).
Regarding claim 26, claim 23 is rejected with the same reasoning as claim 15.
Regarding claim 27, Doelling teaches comprising one or more of: an oximeter; a set of one or more Electroencephalograph (EEG) electrodes/pads; and a set of one or more Electrooculography (EOG) electrodes/pads (See [0056]).
Regarding claim 28, Doelling teaches further comprising a microphone (See [0146]-[0147]).
Regarding claim 29, claim 29 is rejected with the same reasoning as claim 18.
Regarding claim 30, Doelling teaches a method comprising: logging, by a positional therapy device, a plurality of observations regarding existence or non-existence of an incident of breathing cessation and one or more of: an orientation in three-dimensional (3D) space of a head of a user of a positive airway pressure (PAP) mask system with which the positional therapy device is integrated, a breathing rate of the user, a heart rate of the user, a snoring state of the user, an oxygen saturation of blood of the user, Electroencephalograph (EEG) data for the user, and Electrooculography (EOG) data for the user (See [0056] which teaches all of the sensed conditions and [0061] which teaches that the devices maintains a record log for the sensed conditions.);
and wherein the logging is based on performance of repeated measurements over time of one or more sensors associated with the positional therapy device while the PAP mask system is worn by the user during a sleep session (See [0061] which teaches that the device maintains a record log for the sensed conditions. [0052] teaches integration with a CPAP mask.); and identifying the user as potentially having a sleep respiratory issue by evaluating the plurality of observations (See [0104], [0256]-[0257], and [0281]).
Regarding claim 31, Doelling teaches notifying the user to consult with a medical professional regarding potential existence of the sleep respiratory issue (See [0046] and [0291]).
Regarding claim 32, Doelling teaches one or more sensors comprise a positional sensor including one or more of an accelerometer, a gyroscope, an inertial measurement unit, and a magnetometer and wherein the method further comprises determining the orientation of the head of the user based on a state of the positional sensor (See [0092]).
Regarding claim 33, Doelling teaches measuring and logging the breathing rate based on positional data received from the positional sensor or based on breath sounds received by a microphone of the positional therapy device (See [0130]).
Regarding claim 34, Doelling teaches comprising measuring and logging the heart rate based on one or more of: positional data received from the positional sensor, an electrocardiogram, a pulse oximeter, and on heart sounds detected by a microphone of the positional therapy device (See [0130]).
Regarding claim 35, Doelling teaches facilitating diagnosis of the sleep respiratory issue by a medical professional by exporting a report or raw data based on the logging in a data interchange format or a medical format (See [0128] and [0195]).
Regarding claim 37, Doelling teaches measuring and logging EEG and EOG data based on data collected via one or more EEG and EOG electrodes (See [0056]).
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 17 is rejected under 35 U.S.C. 103 as being unpatentable over Doelling as applied to claim 1 above, and further in view of Su et al. (US Pub No. 2020/0383633).
Regarding claim 17, Doelling does not teach presenting to the user via an application associated with the positional therapy device a summary of the sleep session based on the time-series data.
Su teaches presenting to the user via an application associated with the positional therapy device a summary of the sleep session based on time-series data (See [0059]).
One of ordinary skill in the art at the time the invention was filed would have been motivated to modify Doelling’s device to include Su’s teachings in order to better help the user by providing “information that can help the user to maintain a healthy lifestyle” (Su, [0003]). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Doelling as applied to claim 1 above, and further in view of Goldstein et al. (US Pub No. 2019/0388024).
Regarding claim 36, Doelling does not teach measuring and logging oxygen saturation based on data received from one or more pulse oximeters of the one or more sensors.
Goldstein teaches measuring and logging oxygen saturation based on data received from one or more pulse oximeters of the one or more sensors (See [0158]).
One of ordinary skill in the art at the time the invention was filed would have been motivated to modify Doelling’s device to include Goldstein’s teachings in order “decrease or eliminate hypoxia, hypercapnia and the disturbance of cardiac and pulmonary hemodynamics, and give users of the apparatus a report of their critical sleep data each morning” (Goldstein, [0003]). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
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/THOMAS S MCCORMACK/ Primary Examiner, Art Unit 2686
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