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
Claim 7 and 17 objected to because of the following informalities: Claims 7 and 17 recite “a sleep breathing disorder notification” the second to last line, but instead should be --the sleep breathing disorder notification--. 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 10 and 20 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.
Claims 10 and 20 recite “considering a user’s previous sleep record” in lines 2-3, but is indefinite. Is the previous sleep record of the same user as in the independent claims or a separate user? It appears that the sleep record is of the same user recited in the independent claims and will be interpreted as such. Based on the intended interpretation, the limitation must be amended to provide clarity regarding the user. The same issue is seen line 5, “related to a user’s past sleep activity.”
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.
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.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tiron et al. (US 20220007965).
Regarding claims 1 and 11, Tiron teaches an electronic device comprising: a communication circuit; at least one sensor (¶[0032-33], sensors for generating active and passive signals are incorporated); and
at least one processor connected to the communication circuit and the at least one sensor, wherein the at least one processor is configured to: obtain biometric information of a user through the communication circuit or the at least one sensor during a user's sleep (¶[0033], respiratory signals, motion signals, etc., are obtained when the user is sleeping to determine sleeping disorders);
In separate embodiments, the device is configured to determine a reference condition for detecting a sleep breathing disorder event, based on underlying disease information of the user (¶[0055-56,0065,0097,0184,0234-38,0331-340,0359,0366,0377,0385,0396,0467] and figs. 8,15 and 34, “illustrating a risky sleeper assessment of SDB risk,” “developing a classifier (such as a logistic regression model classifier) to estimate an AHI from those features,” “The system can provide an estimate of AHI,” “The output of the system can be combined with other risks factors—age, BMI, race, income, comorbidities, alcohol intake—in order to calculate and overall “risky sleep” index. This may be input to and characterized by the classifier(s) described herein,” An AHI estimate is determined based on the features and factors that aid in providing a more complete picture to achieve an overall AHI (the output). ). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tiron, such that the reference condition for detecting a sleep breathing disorder event, is based on underlying disease information of the user, as taught by Tiron, to aid in calculating an inclusive AHI estimate of the user for sleep score determination (see. Fig 8 and ¶[0234-238]).
detect the sleep breathing disorder event, based on the biometric information and the reference condition (¶[0033,0039,0048,0321] and figs. 8A-8D, biometric information (active and passive signals) from sensors and AHI estimation in each embodiment); and
provide a user interface for the sleep breathing disorder event as the sleep breathing disorder event is detected (figs. 14-25).
Claims 2-3, 12-13, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Tiron, as applied to claims 1 and 11, and further in view of Bhat et al. (US 20170027527).
Regarding claims 2, 12, and 21, Tiron teaches identify whether or not the user has an underlying disease, based on the underlying disease information (¶[0013,0056, 0235,0358-59], the device is configured to also monitor coughing that can be associated with sleeping disorder, “chronic cough (which is more prevalent in women) can be the sole presenting symptom for patients with obstructive sleep apnea,” and users are categorized with an illness based on the cough); and adjust the reference condition from a preconfigured first condition to a second condition (¶[0238], “a clinical threshold of SDB events (e.g., AHI greater than a threshold such as 15). This threshold could be adjusted to 10 or 5, for example, or to be higher or lower as desired”), but fails to teach that the adjustment is based on whether or not the user has the underlying disease.
Bhat teaches a device and method for detecting an event using a variable threshold (abstract). The device is configured to combine a plurality of physiologic information into individual indexes or values, when the estimate of the physiologic information exceeds its index/value threshold an alert period can be initiated, and subsequently adjust the threshold for a different physiologic information estimate that is lower or higher to aid avoiding a series of short alert periods when an index value remains close to an onset threshold value (¶[0060-63,0075], “the event detection computes or receives one or more of a transthoracic impedance index, a fluid index, and apnea hypopnea index, or a decompensation index and compares the index to a threshold” “the physiologic data analyzer circuit 215 combines multiples types of physiologic information (e.g. two or more of transthoracic impedance, respiration, activity, hearts sounds, and posture, or any other physiologic information identified herein) into a composite index,” “When a trend of physiologic information such as an index exceeds a threshold, the physiologic data analyzer circuit 215 may declare the beginning of an alert period,” “The physiologic data analyzer circuit 215 may then continue to compare trended information against another, different threshold—e.g. a higher or lower threshold—and declare an end to the alert period when the trend falls below the threshold.” In a case where at least one of the plurality of physiological parameters is above the first threshold, can indicate the user has an underlying disease.).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tiron, such that the threshold of a reference condition is adjust based on whether or not the user has an underlying disease, as taught by Bhat, to aid in avoiding a series of short alert periods when an index value remains close to an onset threshold value. Thus, the device will have increased sensitivity when at least one physiologic parameter is high.
Regarding claims 3 and 13, Tiron-Bhat teaches wherein a case that the user has the underlying disease, an apnea-hypopnea index threshold value included in the reference condition is lowered from a first value to a second value (¶[0238] of Tiron, “a clinical threshold of SDB events (e.g., AHI greater than a threshold such as 15). This threshold could be adjusted to 10 or 5, for example, or to be higher or lower as desired”).
Regarding claims 22-23, Tiron teaches wherein the reference condition is an AHI threshold value and wherein the at least one sensor is configured to monitor biometric information of the user during a period of sleep, and wherein the processor is configured to assign an AHI value to the biometric information and to detect a sleep breathing disorder event in response to the AHI value exceeding the changed AHI threshold value (¶[0238], passive and active sensor signals are obtained to compute the AHI value and when it exceeds the threshold).
Claims 4-6, 10, 14-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tiron, as applied to claims 1 and 11, and further in view of Bhat et al. (US 20170027527).
Regarding claims 4 and 14, Tiron teaches wherein at least one processor is configured to:
determine a risk level of a sleep breathing disorder, based on the underlying disease information (¶[0238], “Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterized by events including occlusion or obstruction of the upper air passage during sleep” and “system performs an assessment of the SDB risk”), but fails to teach adjusting the reference condition from a preconfigured first condition to a second condition, based on the risk level.
An teaches a system and method for monitoring patients with multiple chronic diseases (abstract). The system is configured to adjust the reference condition threshold from a first threshold to a second threshold based on the risk of developing the disease associated with the threshold (¶[0074], “the alert threshold generator 310 may increase the alert threshold if the first or second risk indication indicates a low risk of developing the first or second disease, or decrease the alert threshold if the first or second risk indication indicates a high risk of developing the first or second disease”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tiron, such reference condition is adjusted based on the risk level, as taught by An, to aid in timely detection of worsening health conditions with lower false positive detections (¶[0030], “fewer false positive detections are provided, device battery life can be extended, fewer unnecessary drugs and procedures may be scheduled, prescribed, or provided, and an overall system cost savings may be realized”). Moreover, Tiron requires adjusting AHI threshold, but fails to provide details, and An teaches that thresholds of reference conditions can be adjust based on a risk level.
Regarding claims 5 and 15, Tiron-An teach lowing an AHI threshold value (¶[0238] of Tiron teaches adjusting the AHI in view of An (¶[0074]) as combined above) included in the reference condition from a first value to a third value, based on the risk level (¶[0074], the reference condition adjusted from a first value to higher or lower values (second/third));
and detect the sleep breathing disorder event, based on the case where the AHI value from the biometric information exceeds the third value (¶[0238,0337], “ The output risk probability of an apnea/hypopnea count being greater than a threshold” indicates that as long as the AHI is above any of the thresholds, a determination of a SDB event can be output).
Regarding claims 6 and 16, Tiron fails to teach wherein the at least one processor is configured to: adjust the reference condition as the underlying disease information is updated; and detect the sleep breathing disorder event, based on the adjusted reference condition.
An teaches that the adjusted reference condition thresholds for each disease is updated based on the progression and/or historical information that is input (therefore updated), and continue to detect the health disorder, based on the adjusted reference condition thresholds (¶[0058-59,0098]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tiron, such that the reference condition is adjusted based on updated underlying disease information and detecting a sleep disorder event based on the refence condition, as taught by An, to aid in timely detection of worsening health conditions with lower false positive detections.
Regarding claims 10 and 20, Tiron fails to teaches wherein the at least one processor is configured to detect the sleep breathing disorder event by further considering a user's previous sleep record, and wherein the previous sleep record comprises at least one piece of: first sleep data related to a user's past sleep activity repeated a specified number of times or more; second sleep data related to the user's past sleep activity during a recent predetermined period; and sleep breathing disorder analysis result data based on the first sleep data or the second sleep data.
An teaches “the risk stratifier circuit that may be configured to determine the first or second risk indication based on a medical history of the patient” (¶[0021]). The risk indications are “at least based on clinical indications or medical history of the patient, such as exacerbation of recent chronic disease, a previous medical procedure, a clinical lab test result, patient medication intake or other treatment undertaken, or other clinical information relevant to the patient risk of developing a future disease.” Therefore, An teaches that the historical information during a recent predetermined period (post-surgery, recent disease state determination) is important to account for due to higher and/or lower risk of a physiological event occurring (¶[0051,0058-59], “the impedance acquisition and analysis session may be programmed to exclude certain time periods, such as night time, or when the patient is asleep,” “The patient medical history may have time-varying effect on the patient risk of developing a future disease. For example, a more recent disease state or a surgery may put the patient at higher risk for developing a cardiac, pulmonary, or renal disease than a more remote historical disease in patient medical history”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tiron, such that the physiological event is detected by considering a user’s history during a recent predetermined period, as taught by An, to aid in timely detection of worsening health conditions with lower false positive detections.
Therefore, the combination arrives to claimed invention because the physiological event is the sleep breathing disorder event of Tiron (abstract) in view of processing the historical record of the user in An (¶0087] of An).
Claims 7-9 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tiron, as applied to claims 1 and 11 , and further in view of Patel et al. (US 20160249174).
Regarding claims 7 and 17, Tiron fails to teach wherein the at least one processor is configured to: determine whether or not to deactivate a sleep breathing disorder notification function, based on temporary state information of the user; and deactivate the sleep breathing disorder notification function, based on the determination whether or not to deactivate a sleep breathing disorder notification function.
Patel teaches an electronic monitoring device configured to deactivate/activate sensors and/or alarms of the device based on location sensing, to aid in conserving resources of the device, e.g. battery life (abstract and ¶[0140]). Therefore, the device is capable of deactivating notifications that are sent via audio, visual, or tactile means based on the determine location of the user (¶[-156-176]).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tiron, such that the notification function is deactivated/activated based on temporary state information of the user, as taught by Patel, to aid in conserving resources of the medical monitoring device. Additionally, the modification is merely using a known technique (deactivating/activating notification based on temporary user state) to improve similar device (medical monitoring devices) in the same way.
Regarding claims 8 and 18, Tiron fails to teach wherein the processor is configured to skip at least one of determining the reference condition, detecting the sleep breathing disorder event, or providing the user interface as the sleep breathing disorder notification function is deactivated.
However, Patel teaches wherein the processor is configured to skip detecting physiological events or providing notifications to the user interface when deactivating the components (¶[0055,0139-140,0202], “additional components for performing one or more additional sensor modalities, such as, but not limited to, heart rate measurements, electrical signal measurements (e.g., EKG, EMG, ECG), hydration level measurements, neural activity measurements, conductance measurements, and/or pressure measurements” and “the automatic determination of location, the wearable device 100 can change its operating mode, such as by enabling and/or disabling additional components of the wearable device.” The device would therefore not be able to display any of the information due to the deactivation of display and/or sensors for a particular metric.)
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tiron-Patel, such that detecting a physiological event or providing a notification of to the user interface, as taught by Patel, to aid in conserving resources of the medical monitoring device.
Regarding claims 9 and 19, Patel teaches wherein the temporary state information is of at least location (¶[0140]).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Tiron, as applied to claim 21, and further in view of Farrell et al. (US 20070161913).
Regarding claim 24, Tiron teaches wherein determining the underlying disease state includes identifying the user as one of an attention-required having symptoms of having a sleep breathing disorder or a general user excluding the symptoms of a sleep breathing disorder.
Farrell teaches monitoring and/or detecting sleep breathing disorder, SDB, (abstract). The system is configured to obtain inputs of a user including symptoms of SBD by providing a questionnaire that can be combined with AHI test (¶[0055-66], “Do you have a history of hypertension?”. The user’s response are tallied based on the positive responses to generate the SDB index, therefore, identification of a user having a symptom or not is executed (attention required or general user based on the tallies or amount of tallies) (¶[0055-66]).
As such, it would have been obvious to one of ordinary skill in the art at the time invention was effectively filed to have modified the device of Tiron, such that determining the underlying disease state includes identifying the user as one of having or one of not having symptoms of a sleep breathing disorder, as taught by Farrell, to aid in conducting a more detailed assessment of SDB, and providing an urgent notification to the patient with the higher likelihood of SDB based on the information gathered (¶[0055] of Farrell).
Regarding claim 25, Tiron fails to teach wherein the underlying disease state includes a user experiencing hypertension is the attention required user, but Farrell teaches that it can be user experiencing hypertension (¶[0065] of Farrell, “ Do you have a history of hypertension? ”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Tiron, such that the underlying disease state includes a user experiencing hypertension is the attention required user, as taught by Farrell, to aid in determining SDB (¶[0055] of Farrell).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hoffman teaches automatically activate recording of athletic activity data using the first sensor device, and automatically deactivate recording of athletic activity data using the second sensor device, otherwise, in response to determining that the user's athletic activity does include the change in physical location, automatically activate recording of athletic activity data using the second sensor device. US 20120116550
Wright teaches the invention discloses 20 as a threshold, by recording stroke indicators such as the AHI of many patients in a database and analyzing other data for the patients, the threshold may be adjusted to improve the accuracy of the threshold. US 20020185130
Gozal teaches demographic and clinical features of the dataset taking into account the proposed AHI cut-off thresholds for the disease. US 20180353126
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/MARTIN NATHAN ORTEGA/ Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791