DETAILED ACTION
This action is pursuant to claims filed on 06/04/2026. Claims 1-21 are pending. An action on the merits of claims 1-21 is as follows.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/04/2026 has been entered.
Claim Objections
Claim 16 is objected to because of the following informalities:
In claim 16, line 2, “movement of the body of the user” should read “the movement of the body of the user”
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 4-5, 7-8, 11-13, and 20-21 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 claim 4, the claim recites the limitation “a vertical position, a seated position, or a horizontal position” in lines 2-3. It is unclear if any of these positions is the same as, related to, or different from the first or second position of claim 1. The relationship among these positions should be made clear. Claim 5 is also rejected due to its dependence on claim 4.
Regarding claim 7, the claim recites the limitation “at least one of the first position of the second position” in lines 2-3. It is unclear if this limitation is supposed to read as the first position or the second position, or the first position of the second position. If it is meant to read as the first position of the second position as currently written, it is unclear what the first position of the second position is, and how only one of them can be selected if they are related to teach other. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, this limitation is being interpreted as reading as “the first position or the second position”, and only one is required to be selected for display.
Regarding claim 8, the claim recites the limitation “at least one of the first position of the second position” in lines 2-3. It is unclear if this limitation is supposed to read as the first position or the second position, or the first position of the second position. If it is meant to read as the first position of the second position as currently written, it is unclear what the first position of the second position is, and how only one of them can be selected if they are related to teach other. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, this limitation is being interpreted as reading as “the first position or the second position”, and the time displayed with the animation is only required to be associated with one of the first position or the second position.
Regarding claim 11, the claim recites the limitation “the determination as to whether the user is in a vertical position, a seated position, or a horizontal position” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this claim is meant to depend on claim 4, which introduces this specific determination, or if this claim is meant to read as “a determination as to whether the user is in a vertical position, a seated position, or a horizontal position”. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as reading as “a determination as to whether the user is in a vertical position, a seated position, or a horizontal position”. Also, it is unclear if any of “a vertical position, a seated position, or a horizontal position” is the same as, related to, or different from the first or second position of claim 1. The relationship among these positions should be made clear. Claims 12-13 are also rejected due to their dependence on claim 11.
Regarding claim 20, the claim recites the limitation “a particular position” in line 24. It is unclear if this limitation is meant to refer to the first position, the second position, both, or a different position. If it is meant to refer to the first and/or second position, it needs to clearly refer back to it. If it is meant to refer to a different position, it needs to be distinguished from the previously introduced positions. For purposes of examination, it is being interpreted as referring to the first and/or second positions.
Regarding claim 21, the claim recites the limitation “a particular position” in line 21. It is unclear if this limitation is meant to refer to the first position, the second position, both, or a different position. If it is meant to refer to the first and/or second position, it needs to clearly refer back to it. If it is meant to refer to a different position, it needs to be distinguished from the previously introduced positions. For purposes of examination, it is being interpreted as referring to the first and/or second positions.
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 1-2, 6-10, and 14-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers (US 20210113099).
Regarding independent claim 1, Rogers teaches a system for monitoring a sleep of a user ([0002]: “Systems and methods are provided for mechano-acoustic electrophysiological sensing electronics derived from the body using a 3-axis high frequency accelerometer”), the system comprising:
one or more patches (Figs. 1 and 2), each patch from the one or more patches including an associated sensor from a plurality of sensors ([0136]: “FIG. 2 illustrates an example of a wearable (e.g., epidermally mounted) mechano-acoustic electrophysiological measurement device”; [0062]: “Differential measurement of separate areas of a patient’s body may also be useful in improving data collection and accuracy. In some cases a single device may measure two different areas by being positioned on a biological boundary, in some cases, multiple devices may be used.”);
a processor ([0013]: “The medical sensor may comprise a processor to provide a real-time metric”) configured to process positional data generated by the plurality of sensors when each patch from the one or more patches is positioned adjacent to a surface of a body of the user ([0126]: “the sensor systems of the inventor are wearable, tissue mounted or implantable or in mechanical communication or direct mechanical communication with tissue of a subject.”) at a predefined location from a plurality of predefined locations ([0243]: “FIG. 30A provides a schematic illustrating potential mounting locations (schematically shown by superimposed boxes) on a subject”), the positional data including orientation data and motion data ([0278]: “The device captures body orientation by measuring quasistatic gravity projection in device frame, which is associated to the core-body frame”; [0017]: “The electronic devices described herein may comprise a stretchable electrical interconnect, a microprocessor, an accelerometer, a stimulator, a resistor and a capacitor in electronic communication to provide sensing of vibration or motion by the accelerometer”); and
a data communication system configured to transmit the positional data to the processor ([0002]: “The devices are referred herein as soft, flexible, and wearable with advanced power conservation functions and wireless communication capabilities,”; [0013]: “The medical sensor may comprise a processor to provide a real-time metric. The processor may be on-board with the electronic device or is positioned in an external device that is located at a distance from the medical sensor and in wireless communication with the wireless communication system”);
the processing of the positional data including:
determining a first position of the body of the user at a first time; determining a first image based on the first position of the body of the user at the first time; detecting a change in position of the body of the user based on a measure function and a threshold value; in response to detecting the change in position of the body of the user: determining a second position of the body of the user at a second time subsequent to the first time, and determining a second image based on the second position of the body of the user at the second time; generating, based on the first image and the second image, an animation of a movement of the body from the first position of the body of the user at the first time to the second position of the body of the user at the second time ([0191]: “Another novel feature of this aspect of the invention is recapitulating sleep position and/or motion using the sensor across time. This allows using the accelerometer on the sensor to reconstruct movement and body position.”; [0027]: “The medical sensors described herein may be capable of reproducing an avatar or video representation of body position and movement of a subject across time”. The sensors are used to gather positional data and motion data and reconstruct a video with an avatar based on this data, therefore it is inherent that the system creates a first image based on the position of the body, then creates another image of the body using the data when a change of position is detected.); and
determining that a respiratory quality of the user degrades when the user is in at least one of the first position or the second position ([0191]: “In sleep, the sensor can detect a subject having altered vital signs (aberrant vital signs) that may include a combination of elevated or depressed heart rate, cessation of respiratory rate, decrease in pulse oximetry, or snoring (aberrant respiratory sounds). This then triggers a feedback mechanism such as a vibration, audio, visual, electrical, or thermal that causes the individual to shift position or become aware/awake”; [0194]: “Another novel feature of this aspect of the invention is recapitulating sleep position and/or motion using the sensor across time. This allows using the accelerometer on the sensor to reconstruct movement and body position. This may allow for direct video feedback to the user and the ability to tie body position with vital signs or respiratory sounds (e.g. snoring) visually. FIG. 41 provides example sensor data for use of multimodal sensors of the inventor for sleep therapy, for example, for determination of body position and correlation of body position with vital signs and/or respiratory sounds.”. The device ties the body position to the respiratory sounds such as snoring, which is a degraded respiratory quality.).
Regarding claim 2, Rogers teaches the system of claim 1, wherein at least one sensor from the plurality of sensors includes at least one of an accelerometer or a micro- electromechanical gyroscope ([0017]: “The electronic devices described herein may comprise a stretchable electrical interconnect, a microprocessor, an accelerometer”; [0045]: “The medical sensors described herein may comprise a gyroscope, for example, a 3-axis gyroscope”).
Regarding claim 6, Rogers teaches the system of claim 1, wherein each patch from the one or more patches further includes a pressure sensor for generating pressure data ([0050]: “The sensor system may comprise one or more sensors selected from the group consisting of a pressure sensor”), a sensor for generating data related to a respiratory effort ([0025]: “The medical device may be configured to be worn by a user and for use in a respiratory therapeutic device, wherein the output signal is for respiratory inspiration and/or expiration: effort”; [0186]: “the sensor can track both respiratory rate and swallowing behavior”; [0003]: “Mechano-acoustic signals are known to contain essential information for clinical diagnosis and healthcare applications. Specifically, mechanical waves that propagate through the tissues and fluids of the body as a result of natural physiological activity reveal characteristic signatures of individual events, such as the closure of heart valves, the contraction of skeletal muscles, the vibration of the vocal folds, the cycle of respiration, the movement and sound of scratching, and movement in the gastrointestinal tract”), and a pulse sensor for generating pulse data ([0147]: “Additional sensors within the platform may include but are not limited to the following: … pulse oximeter”).
Regarding claim 7, Rogers teaches the system of claim 1, wherein processing the positional data further includes causing display of the at least one of the first position of the second position ([0027]: “The medical sensors described herein may be capable of reproducing an avatar or video representation of body position and movement of a subject across time”. The avatar includes displaying the body position, which includes the first position and the second position.).
Regarding claim 8, Rogers teaches the system of claim 1, wherein the animation includes (1) the at least one of the first position or the second position ([0027]: “The medical sensors described herein may be capable of reproducing an avatar or video representation of body position and movement of a subject across time”. The avatar includes displaying the body position, which includes the first position and the second position.) and (2) a time associated with the at least one of the first position of the second position ([0176]: “labeling the activity to signal by time stamping the data at the time when the event occurs”; [0229]: “The system may use Bluetooth to communicate with the smartphone, although the smartphone largely serves as a visual display”; [0169]: “Communications to the user interface machine that displays, stores, and analyzes the data are generally known”. The data includes the timestamps, which is displayed to the user.).
Regarding claim 9, Rogers teaches the system of claim 1, wherein each patch from the one or more patches further includes an oximeter for generating blood oxygen level data ([0050]: “The sensor system may comprise one or more sensors selected from the group consisting of a pressure sensor, an electrophysiological sensor, a thermocouple, a heart rate sensor, a pulse oximetry sensor”. The pulse oximetry sensor generates blood oxygen level data.).
Regarding claim 10, Rogers teaches the system of claim 1, wherein each patch from the one or more patches further includes a temperature sensor for detecting a body temperature of the user ([0050]: “The sensor system may comprise one or more sensors selected from the group consisting of a pressure sensor, an electrophysiological sensor, a thermocouple, a heart rate sensor, a pulse oximetry sensor”).
Regarding claim 14, Rogers teaches the system of claim 1, wherein each patch from the one or more patches further includes one of an audio sensor, a nasal pressure sensor, or a vibrational sensor ([0186]: “the system is configured to provide a sensor that detects one or more parameters which are used as the basis of input for a feedback loop involving a signaling device component that provides one or more signals to a subject (e.g., patient), such as a vibrational signal (e.g. electromechanical motor), and electrical signal, a thermal signal (e.g. heater), a visual signal (either LED or a full graphical user interface), an audio signal”).
Regarding claim 15, Rogers teaches the system of claim 1, wherein the animation includes a representation of it least one of: pressure data, respiratory effort, pulse data, blood oxygen level data, temperature data, or a snoring condition of the user ([0191]: “the sensor can detect a subject having altered vital signs (aberrant vital signs) that may include a combination of elevated or depressed heart rate, cessation of respiratory rate, decrease in pulse oximetry, or snoring (aberrant respiratory sounds).”; [0191]: “Another novel feature of this aspect of the invention is recapitulating sleep position and/or motion using the sensor across time. This allows using the accelerometer on the sensor to reconstruct movement and body position. This may allow for direct video feedback to the user and the ability to tie body position with vital signs or respiratory sounds (e.g., snoring) visually. FIG. 41 provides example sensor data for use of multimodal sensors of the inventor for sleep therapy, for example, for determination of body position and correlation of body position with vital signs and/or respiratory sounds.”).
Regarding claim 16, Rogers teaches the system of claim 1, wherein the processor is configured to estimate a deep stage of the user based on movement of the body of the user ([0278]: “FIG. 47F shows the inference of the sleep stages from machine learning the accelerometer data in comparison with the clinical-inspected sleep stages”).
Regarding claim 17, Rogers teaches the system of claim 1, wherein the processor is further configured to detect a significant change in sensed data, the sensed data including one of pressure data, respiratory effort, pulse data, blood oxygen level data, temperature data, or snoring data, based on a predefined threshold ([0191]: “the sensor can detect a subject having altered vital signs (aberrant vital signs) that may include a combination of elevated or depressed heart rate, cessation of respiratory rate, decrease in pulse oximetry, or snoring (aberrant respiratory sounds); [0157]: “using histogram, or automatic threshold setting algorithm, certain activity can be determined and classified”. The automatic threshold setting algorithm can include a predetermined threshold used to classify the altered vital signs.).
Regarding claim 18, Rogers teaches the system of claim 1, further comprising a display, wherein the processor is further configured to present the animation via the display ([0229]: “The system may use Bluetooth to communicate with the smartphone, although the smartphone largely serves as a visual display”; [0169]: “Communications to the user interface machine that displays, stores, and analyzes the data are generally known”. The data includes the animation, which is displayed to the user.).
Regarding claim 19, Rogers teaches the system of claim 1, wherein the animation is an accelerated time-lapse animation ([0027]: “The medical sensors described herein may be capable of reproducing an avatar or video representation of body position and movement of a subject across time”. This video representation of the body position and movement of a subject over time can encompass any type of video, which can include an accelerated time-lapse animation.).
Regarding independent claim 20, Rogers teaches a method for monitoring a sleep of a user ([0002]: “ Systems and methods are provided for mechano-acoustic electrophysiological sensing electronics derived from the body using a 3-axis high frequency accelerometer.”), the method comprising:
positioning one or more patches adjacent to a surface of a body of the user ([0126]: “the sensor systems of the inventor are wearable, tissue mounted or implantable or in mechanical communication or direct mechanical communication with tissue of a subject.”), each patch from the one or more patches including an associated sensor from a plurality of sensors ([0136]: “FIG. 2 illustrates an example of a wearable (e.g., epidermally mounted) mechano-acoustic electrophysiological measurement device”; [0062]: “Differential measurement of separate areas of a patient’s body may also be useful in improving data collection and accuracy. In some cases a single device may measure two different areas by being positioned on a biological boundary, in some cases, multiple devices may be used.”),
causing positional data generated by the plurality of sensors to be transmitted to a processor ([0002]: “The devices are referred herein as soft, flexible, and wearable with advanced power conservation functions and wireless communication capabilities,”; [0013]: “The medical sensor may comprise a processor to provide a real-time metric. The processor may be on-board with the electronic device or is positioned in an external device that is located at a distance from the medical sensor and in wireless communication with the wireless communication system”), the positional data including orientation data and motion data ([0278]: “The device captures body orientation by measuring quasistatic gravity projection in device frame, which is associated to the core-body frame”; [0017]: “The electronic devices described herein may comprise a stretchable electrical interconnect, a microprocessor, an accelerometer, a stimulator, a resistor and a capacitor in electronic communication to provide sensing of vibration or motion by the accelerometer”); and
processing the positional data vi the processor by:
determining a first position of the body of the user at a first time; determining a first image based on the first position of the body of the user at the first time; detecting a change in position of the body of the user based on a measure function and a threshold value; in response to detecting the change in position of the body of the user, determining a second position of the body of the user at a second time subsequent to the first time, determining a second image based on the second position of the body of the user at the second time; generating, based on the first image and the second image, an animation of a movement of the body from the first position of the body of the user at the first time to the second position of the body of the user at the second time ([0191]: “Another novel feature of this aspect of the invention is recapitulating sleep position and/or motion using the sensor across time. This allows using the accelerometer on the sensor to reconstruct movement and body position.”; [0027]: “The medical sensors described herein may be capable of reproducing an avatar or video representation of body position and movement of a subject across time”. The sensors are used to gather positional data and motion data and reconstruct a video with an avatar based on this data, therefore it is inherent that the system creates a first image based on the position of the body, then creates another image of the body using the data when a change of position is detected.); and
determining that a respiratory quality of the user degrades when the user is in a particular position ([0191]: “In sleep, the sensor can detect a subject having altered vital signs (aberrant vital signs) that may include a combination of elevated or depressed heart rate, cessation of respiratory rate, decrease in pulse oximetry, or snoring (aberrant respiratory sounds). This then triggers a feedback mechanism such as a vibration, audio, visual, electrical, or thermal that causes the individual to shift position or become aware/awake”; [0194]: “Another novel feature of this aspect of the invention is recapitulating sleep position and/or motion using the sensor across time. This allows using the accelerometer on the sensor to reconstruct movement and body position. This may allow for direct video feedback to the user and the ability to tie body position with vital signs or respiratory sounds (e.g. snoring) visually. FIG. 41 provides example sensor data for use of multimodal sensors of the inventor for sleep therapy, for example, for determination of body position and correlation of body position with vital signs and/or respiratory sounds.”. The device ties the body position to the respiratory sounds such as snoring, which is a degraded respiratory quality.).
Regarding independent claim 21, Rogers teaches a non-transitory computer readable medium storing instructions that, when executed by a processor, cause the processor to perform operations ([0132]: “embodiment may include a machine-readable medium having stored thereon instructions which may be used to program a computer (or other electronic devices) to perform a process”) comprising:
positioning one or more patches adjacent to a surface of a body of the user ([0126]: “the sensor systems of the inventor are wearable, tissue mounted or implantable or in mechanical communication or direct mechanical communication with tissue of a subject.”), each patch from the one or more patches including an associated sensor from a plurality of sensors ([0136]: “FIG. 2 illustrates an example of a wearable (e.g., epidermally mounted) mechano-acoustic electrophysiological measurement device”; [0062]: “Differential measurement of separate areas of a patient’s body may also be useful in improving data collection and accuracy. In some cases a single device may measure two different areas by being positioned on a biological boundary, in some cases, multiple devices may be used.”),
determining a first position of a body of a user at a first time and based on a patch ([0126]: “the sensor systems of the inventor are wearable, tissue mounted or implantable or in mechanical communication or direct mechanical communication with tissue of a subject.”; [0136]: “FIG. 2 illustrates an example of a wearable (e.g., epidermally mounted) mechano-acoustic electrophysiological measurement device”; [0062]: “Differential measurement of separate areas of a patient’s body may also be useful in improving data collection and accuracy. In some cases a single device may measure two different areas by being positioned on a biological boundary, in some cases, multiple devices may be used.”);
determining a first image based on the first position of the body of the user at the first time; detecting a change in position of the body of the user based on a measure function and a threshold value; in response to detecting the change in position of the body of the user, determining a second position of the body of the user at a second time subsequent to the first time, determining a second image based on the second position of the body of the user at the second time; generating, based on the first image and the second image, an animation of a movement of the body from the first position of the body of the user at the first time to the second position of the body of the user at the second time ([0191]: “Another novel feature of this aspect of the invention is recapitulating sleep position and/or motion using the sensor across time. This allows using the accelerometer on the sensor to reconstruct movement and body position.”; [0027]: “The medical sensors described herein may be capable of reproducing an avatar or video representation of body position and movement of a subject across time”. The sensors are used to gather positional data and motion data and reconstruct a video with an avatar based on this data, therefore it is inherent that the system creates a first image based on the position of the body, then creates another image of the body using the data when a change of position is detected.); and
generating an output indicating that a respiratory quality of the user is modified when the user is in a particular position ([0191]: “In sleep, the sensor can detect a subject having altered vital signs (aberrant vital signs) that may include a combination of elevated or depressed heart rate, cessation of respiratory rate, decrease in pulse oximetry, or snoring (aberrant respiratory sounds). This then triggers a feedback mechanism such as a vibration, audio, visual, electrical, or thermal that causes the individual to shift position or become aware/awake”; [0194]: “Another novel feature of this aspect of the invention is recapitulating sleep position and/or motion using the sensor across time. This allows using the accelerometer on the sensor to reconstruct movement and body position. This may allow for direct video feedback to the user and the ability to tie body position with vital signs or respiratory sounds (e.g. snoring) visually. FIG. 41 provides example sensor data for use of multimodal sensors of the inventor for sleep therapy, for example, for determination of body position and correlation of body position with vital signs and/or respiratory sounds.”. The device ties the body position to the respiratory sounds such as snoring, which is a degraded respiratory quality.).
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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers as applied to claim 1 above, and further in view of Ren (US 20200281508).
Regarding claim 3, Rogers teaches the system of claim 1, wherein the animation includes a prefix video that shows a sleep parameter of the user ([0193]: “Another novel feature of this aspect of the invention is recapitulating sleep position and/or motion using the sensor across time. This allows using the accelerometer on the sensor to reconstruct movement and body position. This may allow for direct video feedback to the user and the ability to tie body position with vital signs or respiratory sounds (e.g. snoring) visually. FIG. 41 provides example sensor data for use of multimodal sensors of the inventor for sleep therapy, for example, for determination of body position and correlation of body position with vital signs and/or respiratory sounds.”).
However, Rogers does not teach the prefix video appearing in the animation before the movement of the body from the first position of the body of the user to the second position of the body of the user.
Ren discloses sensors used for motion analysis of a user. Specifically, Ren teaches the prefix video appearing in the animation before the movement of the body from the first position of the body of the user to the second position of the body of the user (Fig. 1, “display motion” and “display animation” references show the body motion (analogous to the prefix video) before the display animation, which contains the movement from the first position to the second position.). Rogers and Ren are analogous art as they are all related to systems that monitor a user’s motions and provides an analysis.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the video being shown before the animation from Ren into the system from the device from Rogers as it allows the user to see the sleep parameters before the animation, so they are aware of their information while viewing the animation of their movement.
Claims 4-5 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers as applied to claim 1 above, and further in view of Young (US 11504013).
Regarding claim 4, Rogers teaches the system of claim 1. However, Rogers does not disclose wherein the processor is further configured to determine whether the user is in a vertical position, a seated position, or a horizontal position.
Young teaches a wearable monitoring system that can measure a user’s health related parameters while in a certain state, such as a sleep state. Specifically, Young teaches wherein the processor is further configured to determine whether the user is in a vertical position, a seated position, or a horizontal position (Column 6, lines 1-3: “ the portable device 114 can include one or more motion sensors, such as an accelerometer, to determine the user's body movement, position, and/or posture of the user during sleep”. Since Young discloses determining the user’s position and posture, that includes a vertical, seated, or horizontal position). Rogers and Young are analogous art as they all disclose a wearable device used to measure health parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the determination of the user’s position as it allows for more information to be provided that can help the system determine whether the user is asleep or not. By knowing the position the user is sitting in, it can be easier for the system to determine the sleep state.
Regarding claim 5, the Rogers/Young combination teaches the system of claim 4.
However, the Rogers/Young combination does not teach wherein the processor is configured not to process positional data when the user is in the vertical position.
Young teaches wherein the processor is configured not to process the positional data when the user is in the vertical position (Column 15, lines 7-14: “the one or more first user parameters includes one or more of a body movement, a body position, and a body posture of the user, the determination of the state of the user includes generating body motion signals, body posture signals, or both, and the determination of whether the state of the user meets the one or more criteria includes determining whether the body motion signals, the body posture signals, or both meet one or more motion or posture thresholds”; Young, Column 8, lines 36-40: “The monitoring system can use the user's parameters to determine whether one or more criteria (e.g., sleep state) are met (step 258 of process 250). Once the one or more criteria are met, the monitoring system can measure the user's blood pressure (step 260 of process 250).”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the step of not processing positional data when the user is in a vertical position from Young into the Rogers/Young combination as it allows the combination to only perform the processing when the user is in a sleeping position, which ensures data is only processed when the user is in the state that is meant to be analyzed.
Regarding claim 11, Rogers teaches the system of claim 1.
However, Rogers does not disclose wherein the processor is further configured to determine whether the user is in a vertical position, a seated position, or a horizontal position.
Young teaches wherein the processor is configured to determine whether the user is sleeping based on (1) the determination as to whether the user is in a vertical position, a seated position, or a horizontal position (Young, Column 15, lines 7-14: “the one or more first user parameters includes one or more of a body movement, a body position, and a body posture of the user, the determination of the state of the user includes generating body motion signals, body posture signals, or both, and the determination of whether the state of the user meets the one or more criteria includes determining whether the body motion signals, the body posture signals, or both meet one or more motion or posture thresholds”) and wherein the processor is configured to determine whether the user is sleeping based on (2) at least one of respiratory effort or pulse data determined for a first predefined time period (Column 14, lines 63-67: “the one or more first user parameters include breathing intervals, breathing amplitudes, or both, the determination of the state of the user includes generating one or more respiratory rate signals, one or more heart rate variability signals, or both from the breathing intervals, the breathing amplitudes, or both, and the determination of whether the state of the user meets the one or more criteria includes determining whether the one or more respiratory rate signals, the one or more heart rate variability signals, or both meet one or more respiratory thresholds.”; Column 4, lines 7-11: “The sensors can include one or more functionalities such as measuring the user's respiration rate and/or heart rate to determine, alone or in combination with signals from other components, the user's state”; Column 1, line 43-49: “Disclosed herein is a monitoring system configured to take a cuff-based measurement of the user's blood pressure and/or other health metrics while the user is in a certain sleep state, or in other user states. The monitoring system can include one or more sensors configured to measure the user's parameter(s) while lying in bed and/or sleeping, or while in other user states or conditions”; Column 51-59: “Based on whether the user is in the certain state and/or one or more criteria being met, the monitoring system can perform a physiological measurement such as a blood pressure measurement. The monitoring system can be capable of dynamically adjusting the measurement parameters, criteria, and acquired information based one or more scalers such as the user's parameters. The criteria can be based on user states or conditions (e.g., the user's sleep state”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the determination of the user’s position and respiratory signals as it allows for more information to be provided that can help the system determine whether the user is asleep or not. By knowing the position the user is sitting in and their respiratory effort, it can be easier for the system to determine the sleep state.
Regarding claim 12, the Rogers /Young combination teaches the system of claim 11, wherein the processor is further configured to determine whether the user is sleeping further based on a change in respiratory effort or a change in pulse data during a second predefined period of time subsequent to the first predefined time period (Young, Column 14, lines 63-67: “the one or more first user parameters include breathing intervals, breathing amplitudes, or both, the determination of the state of the user includes generating one or more respiratory rate signals, one or more heart rate variability signals, or both from the breathing intervals, the breathing amplitudes, or both, and the determination of whether the state of the user meets the one or more criteria includes determining whether the one or more respiratory rate signals, the one or more heart rate variability signals, or both meet one or more respiratory thresholds.”; Column 4, lines 7-11: “The sensors can include one or more functionalities such as measuring the user's respiration rate and/or heart rate to determine, alone or in combination with signals from other components, the user's state”; Column 1, line 43-49: “Disclosed herein is a monitoring system configured to take a cuff-based measurement of the user's blood pressure and/or other health metrics while the user is in a certain sleep state, or in other user states. The monitoring system can include one or more sensors configured to measure the user's parameter(s) while lying in bed and/or sleeping, or while in other user states or conditions”; Column 51-59: “Based on whether the user is in the certain state and/or one or more criteria being met, the monitoring system can perform a physiological measurement such as a blood pressure measurement. The monitoring system can be capable of dynamically adjusting the measurement parameters, criteria, and acquired information based one or more scalers such as the user's parameters. The criteria can be based on user states or conditions (e.g., the user's sleep state”).
Regarding claim 13, the Rogers/Young combination teaches the system of claim 11.
However, the Rogers/Young combination does not teach wherein the processor is configured not to process positional data when the user is in the vertical position.
Young teaches wherein the processor is configured not to process positional data when the processor determines that the user is not sleeping (Column 8, lines 36-40: “The monitoring system can use the user's parameters to determine whether one or more criteria (e.g., sleep state) are met (step 258 of process 250). Once the one or more criteria are met, the monitoring system can measure the user's blood pressure (step 260 of process 250).”; Column 1, lines 50-62: “The user's parameter(s) can be used to determine whether the user is in a certain state. Based on whether the user is in the certain state and/or one or more criteria being met, the monitoring system can perform a physiological measurement such as a blood pressure measurement. The monitoring system can be capable of dynamically adjusting the measurement parameters, criteria, and acquired information based one or more scalers such as the user's parameters. The criteria can be based on user states or conditions (e.g., the user's sleep state, posture, the number of successful measurements, etc.) such that user disruptions such as sleep disruption can be reduced and the measurement accuracy and/or efficiency can be enhanced”; Column 3, lines 1-5: “detecting the health condition can be more accurate when the physiological measurement such as a blood pressure measurement is taken while the user is sleeping or in some other state or condition”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the step of not processing positional data when the user is not sleeping from Young into the Rogers/Young combination as it allows the combination to only perform the processing when the user is in a sleeping position, which ensures data is only processed when the user is in the state that is meant to be analyzed.
Response to Arguments
Applicant's arguments filed 06/04/2026 have been fully considered but they are not persuasive. Applicant states that the cited references do not teach the newly amended limitations, however as stated in the 103 rejection above, Rogers (US 20210113099 is the US counterpart of application WO 2019161277, the application used in the previous rejection) does discloses this limitation ([0191]: “In sleep, the sensor can detect a subject having altered vital signs (aberrant vital signs) that may include a combination of elevated or depressed heart rate, cessation of respiratory rate, decrease in pulse oximetry, or snoring (aberrant respiratory sounds). This then triggers a feedback mechanism such as a vibration, audio, visual, electrical, or thermal that causes the individual to shift position or become aware/awake”; [0194]: “Another novel feature of this aspect of the invention is recapitulating sleep position and/or motion using the sensor across time. This allows using the accelerometer on the sensor to reconstruct movement and body position. This may allow for direct video feedback to the user and the ability to tie body position with vital signs or respiratory sounds (e.g. snoring) visually. FIG. 41 provides example sensor data for use of multimodal sensors of the inventor for sleep therapy, for example, for determination of body position and correlation of body position with vital signs and/or respiratory sounds.”. The device ties the body position to the respiratory sounds such as snoring, which is a degraded respiratory quality.).
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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