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 .
Status of Claims
Amended claims 21-40, as presented in the 09/05/2025 claim set, are currently pending and under examination.
Priority
The instant application (filed on 05/02/2025) is a continuation of 18/514,837 (filed 11/20/2023) and 16/757,125 (filed 04/17/2020). Application 16/757,125 is a national stage of PCT/US2018/058558 (filed on 10/31/2018) which has domestic priority claims for 62/579794 (filed 10/21/2017) and 62/649448 (filed 03/28/2018). Instant claims 29-40 are adequately supported in 62/579794 to receive an effective filing data of 10/21/2017. However, neither of the provisional applications discusses the calendar interface in claims 21-28 (which are adequately supported in the PCT application). Therefore, instant claims 21-28 will receive an effective filing date of 10/31/2018.
Claim Objections
The following claims are objected to because of the following informalities:
• Claims 21 and 36: The underlined comma in “determining a signal using, the first selection, the second selection, the sensor data and at least one of baseline patient data or population data” appears unnecessary.
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 21-40 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.
Claims 21, 25, 28-29, 38, and 40: The following are interpreted as contingent method steps under MPEP 2111.04.(II) (“The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met”).
Claim 21:
• in response to receiving a selection of a first option corresponding to a particular date from the one or more selectable options, displaying a second user interface comprising a first set of selectable symptoms associated with an obstructive condition and a second set of selectable symptom levels associated with the obstructive condition
• in response to determining that the signal satisfies a defined alert threshold:
- determining a status of the obstructive condition using the signal; and
- displaying a summary interface indicating the status of the obstructive condition.
Claim 25
• in response to receiving a subsequent selection of the first option corresponding to the particular date from the one or more selectable options:
displaying the summary interface;
receiving an update to at least one of the first selection or the second selection; and
determining an updated signal based on the update to the at least one of the first selection or the second selection.
Claim 28
• in response to a user input to the graphical element, causing display of the first user interface.
Claim 29
• in response to determining that the first signal satisfies a defined alert threshold:
displaying a first user interface comprising a first set of selectable symptoms associated with an obstructive condition receiving a first selection from the first set of selectable symptoms;
displaying a second user interface comprising a second set of selectable symptom levels associated with the obstructive condition;
receiving a second selection from the second set of selectable symptom levels
Claim 38
• displaying the status of the obstructive condition in response to determining that the signal satisfies the defined alert threshold.
Claim 40
• outputting an alert in response to determining a change in the status of the obstructive condition.
While the identified steps can be interpreted as contingent limitations because the responses are not required to occur, the context of the claim and specification suggests a specific method including those responses in meant to be claimed (hence all the limitations are still considered in the prior art and 101 rejections, according to MPEP 2143.03(I)). However, removing the contingent statements would enhance the clarity of the claim and are necessary to give the identified limitations patentable weight.
Claim 24: The limitation “a risk score configured to indicate a risk of exacerbation of the obstructive condition based on a comparison of the signal to the at least one of the baseline patient data or the population data” is indefinite because it is unclear whether a second comparison is made to baseline or population data. The signal itself is already composed of baseline or population data in claim 21 with “determining a signal using, the first selection, the second selection, the sensor data and at least one of baseline patient data or population data,” so it is unclear what additional comparison with baseline or population data is being performed.
Dependent claims 22-23, 26-27, 30-37, and 39 are rejected for being dependent on rejected claims 21, 25, 28-29, 38, and 40.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental processes) without significantly more.
Step 1
The invention in claims 21-40 is to a statutory subject matter as the claims recite a method for monitoring physiologic conditions, which would belong to one of the four statutory categories.
Step 2A, Prong One
Independent claims 21, 29, and 36 recite abstract ideas in the form of mental processes that "can be performed in the human mind, or by a human using a pen and paper" (see MPEP 2106.04(a)(2) subsection (III)).
Regarding Claim 21, the following limitations could be performed by the human mind:
• “determining a signal using, the first selection, the second selection, the sensor data and
at least one of baseline patient data or population data”
• “determining a status of the obstructive condition using the signal”
Regarding Claim 29, the following limitations could be performed by the human mind:
• “determining a first signal using the sensor data and at least one of baseline patient data
or population data”
• “determining a second signal using, the first selection, the second selection, the sensor
data and the at least one of the baseline patient data or the population data”
• “determining a status of the obstructive condition using the second signal”
Regarding Claim 36, the following limitations could be performed by the human mind:
• “determining a signal using, the first selection, the second selection, the sensor data”
• “at least one of baseline patient data or population data; and determining a status of the obstructive condition using the signal”
Step 2A, Prong Two
For the claim 21 limitations from Step 2A Prong One, the claim does not recite additional elements that integrate the judicial exception into a practical application. Additional limitations include a first user interface, a second user interface, a calendar view, a first selection, a second selection, sensors, a display, and a summary interface. The interfaces, calendar view, and selections are related to generic computer functions which are performed by generic computer structures. The first and second interfaces (where data is entered), the sensors, display, and summary interface are insignificant extra-solution activity of data gathering and display.
Dependent claims 22-28 further describe making determinations, which could be mental processes, while monitoring physiological conditions.
For the claim 29 limitations from Step 2A Prong One, the claim does not recite additional elements that integrate the judicial exception into a practical application. Additional limitations include a first user interface, a second user interface, a first selection, a second selection, sensors, a display, and a summary interface. The interfaces and selections are related to generic computer functions which are performed by generic computer structures. The first and second interfaces (where data is entered), the sensors, display, and summary interface are insignificant extra-solution activity of data gathering and display.
Dependent claims 30-35 further describe making determinations, which could be mental processes, while monitoring physiological conditions.
For the claim 36 limitations from Step 2A Prong One, the claim does not recite additional elements that integrate the judicial exception into a practical application. Additional limitations include a first user interface, a second user interface, a first selection, a second selection, sensors, a display, and a summary interface. The interfaces and selections are related to generic computer functions which are performed by generic computer structures. The first and second interfaces (where data is entered), the sensors, display, and summary interface are insignificant extra-solution activity of data gathering and display.
Dependent claims 37-40 further describe making determinations, which could be mental processes, while monitoring physiological conditions.
Step 2B
For the claim 21, 29, and 36 limitations from Step 2A Prong One, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. The claimed invention is a monitoring device for a medical condition where sensor and user input data are used to determine the status of an obstructive condition and display the results to the user. The sensors are claimed generically and the user interface is a mechanism to display selectable symptoms, selectable symptom level, and condition summary information. There is nothing apparently unconventional about these functions or structures based on the claim language, where Westbrook (US 2013/0131464 A1) discusses the utility of collecting and analyzing sensor outputs, user inputs, and population/baseline data to arrive at more accurate diagnoses. The calendar view in claim 21 would be a conventional interface for entering daily symptoms in a similar manner to a generic electronic calendar on a computer which can have inputs entered for each day.
Therefore, claims 21-40 are directed to a judicial exception, as abstract ideas (mental processes), without significantly more.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 36 and 38-39 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Westbrook (US 2013/0131464 A1).
Regarding Claim 36, Westbrook discloses a method for monitoring physiological conditions of a user ([0002]), the method comprising:
• displaying a user interface comprising a first set of selectable symptoms associated with an obstructive condition and a second set of selectable symptom levels associated with the obstructive condition ([0098] – questionnaire presented as a computer interface, [0099] - symptoms and symptom levels reported related to obstructive conditions and sleep);
• receiving a first selection from the first set of selectable symptoms ([0099] – questionnaires present options for selecting “abnormal self-reported levels of depression, mood, anxiety, and sleepiness”);
• receiving a second selection from the second set of selectable symptom levels ([0099] – questionnaires present options for selecting “abnormal self-reported levels of depression, mood, anxiety, and sleepiness”);
• receiving sensor data from one or more sensors configured to measure at least one physiological parameter of the user and generate sensor data from the measured at least one physiological parameter ([0034] – a data acquisition system (DAU) 210 is worn above the forehead to collect physiologic data from the sensor strip 220 and nasal pneumotachometer 240; collected and analyzed in steps 120 ([0080]) and 130 ([0095]));
• determining a signal using, the first selection, the second selection, the sensor data ([0098] – step 150; [0099] – “a limited number of questionnaire responses can be selected and combined with the sleep quality measures to develop a patient profile”) and at least one of baseline patient data or population data ([0101] – “To improve the diagnostic accuracy of the sleep study results, the individual's data can be additionally compared to a database of values from healthy individuals and/or patients with chronic diseases (step 170)”); and
• determining a status of the obstructive condition using the signal ([0102] - integrates the findings of the questionnaire, sensor data, and comparison to population data into a study results report); and
• displaying the status of the obstructive condition ([0102] of study results report with descriptions of embodiments in [0104-0111] and a user interface for displaying the report in [0103]).
Regarding Claim 38, the method according to Claim 36 is anticipated by Westbrook, as indicated hereinabove. Westbrook identifies segments of data which would be classified as apneas or hypopnea events ([0081-0086]), which could be understood as a defined alert threshold because an obstructive condition is detected (“determining that the signal satisfies a defined alert threshold”). Westbrook discloses further comprising: displaying the status of the obstructive condition in response to determining that the signal satisfies the defined alert threshold ([0102] - integrates the findings of the questionnaire, sensor data, and comparison to population data into a study results report which describes the obstructive condition and treatment).
Regarding Claim 39, the method according to Claim 36 is anticipated by Westbrook, as indicated hereinabove. Westbrook further discloses comprising:
• receiving information related to one or more environmental conditions associated with a location of the user ([0088] – the microphone detects environmental noises in the location the patient is sleeping where Westbrook suggests “environmental conditions such as noise i.e., snoring bed partner, passing vehicles, etc. or sleeping away from home can contribute to delayed sleep onset, abnormal sleep architecture, and increased susceptibility to arousals” in [0007]); and
• updating the signal based on the one or more environmental conditions ([0089] – filtering out environmental noise not originating from patient snoring).
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 21-23 are rejected under U.S.C 103 as being unpatentable over Westbrook (US 2013/0131464 A1) in view of Allena (NPL, “An electronic diary on a palm device for headache monitoring: a preliminary experience”).
Regarding Claim 21, Westbrook discloses a method for monitoring physiological conditions of a user ([0002]), the method comprising:
• receiving a first selection from the first set of selectable symptoms ([0099] – questionnaires present options for selecting “abnormal self-reported levels of depression, mood, anxiety, and sleepiness”);
• receiving a second selection from the second set of selectable symptom levels ([0099] – questionnaires present options for selecting “abnormal self-reported levels of depression, mood, anxiety, and sleepiness”). Note the questionnaire makes use of “any number of conventional questionnaire instruments (e.g., Epworth Sleepiness Score, Beck Depression Index, State-Trait Anxiety Index, Pittsburgh Insomnia Rating Scale, Profile of Mood states, etc.) or any combination of questions that provide the appropriate information” ([0099]).
• receiving sensor data from one or more sensors configured to measure at least one physiological parameter of the user and generate the sensor data from the measured at least one physiological parameter ([0034] – a data acquisition system (DAU) 210 is worn above the forehead to collect physiologic data from the sensor strip 220 and nasal pneumotachometer 240; collected and analyzed in steps 120 ([0080]) and 130 ([0095]));
• determining a signal using the first selection, the second selection, the sensor data ([0098] – step 150; [0099] – “a limited number of questionnaire responses can be selected and combined with the sleep quality measures to develop a patient profile”) and at least one of baseline patient data or population data ([0101] – “To improve the diagnostic accuracy of the sleep study results, the individual's data can be additionally compared to a database of values from healthy individuals and/or patients with chronic diseases (step 170)”); and
• in response to determining that the signal satisfies a defined alert threshold ([0081-0086] – identification of segments of data which would be classified as apneas or hypopnea events):
determining a status of the obstructive condition using the signal ([0102] integrates the findings of the questionnaire, sensor data, and comparison to population data into a study results report); and
displaying a summary interface indicating the status of the obstructive condition ([0102] of study results report with descriptions of embodiments in [0104-0111] and a user interface for displaying the report in [0103]).
Westbrook further discusses substantial night-to-night variability when acquiring multiple night studies ([0030]). However, Westbrook does not disclose:
• displaying a first user interface comprising a calendar view having one or more selectable options each corresponding to a different date;
• in response to receiving a selection of a first option corresponding to a particular date from the one or more selectable options, displaying a second user interface comprising a first set of selectable symptoms associated with an obstructive condition and a second set of selectable symptom levels associated with the obstructive condition.
The user interface for headache symptom collection (Abstract) in Allena would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the monitoring device for obstructive respiratory conditions in the instant application because there is a common problem to be solved with respect to providing an interface for entering time-dependent symptom information. Allena teaches an electronic symptom diary with a calendar view where individual days can be selected from the calendar (Fig. 1, p.539 – describes the e-diary structured as days of a calendar view). Each day interface has a link for entering information regarding pain and sleep symptoms (Fig. 1, p.539 – “the patient is required to note, for each headache day, sleep time (hours), presence of aura symptoms, time of pain onset and features of pain (intensity, side, type, presence of associated symptoms)”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Westbrook’s system for the assessment of sleep quality using a patient questionnaire by incorporating the calendar view for the entry of symptom information on a daily basis in Allena. This would have been obvious because both Westbrook and Allena discuss a patient entering symptom information relevant to a medical condition. Allena provides an improvement of an interface where symptoms are entered on a day-by-day basis to account for the daily variability discussed in Westbrook. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook by incorporating the calendar view and daily symptom entry in Allena for the questionnaire symptoms and symptom levels in Westbrook.
Regarding Claim 22, the method according to Claim 21 is obvious over Westbrook in view of Allena, as indicated hereinabove. Westbrook does not disclose wherein the one or more selectable options are displayed as a month-view and each of the one or more selectable options correspond to a different day of the month-view.
As stated in claim 21, the proposed combination with Allena yields “the e-diary was structured as a calendar in which the dates were already printed. Diary recording periods consisted of 30 consecutive days, and the instrument offered the possibility of visualizing daily/weekly/monthly reports” (p.539) where a weekly view, as an example, is displayed in Fig. 2.
Regarding Claim 23, the method according to Claim 22 is obvious over Westbrook in view of Allena, as indicated hereinabove. Westbrook does not disclose wherein each day of the one or more selectable options comprises a visual indicator that is configured to indicate whether a corresponding day comprises symptom information or sensor data.
As stated in claim 21, the proposed combination with Allena yields “the e-diary was structured as a calendar in which the dates were already printed. Diary recording periods consisted of 30 consecutive days, and the instrument offered the possibility of visualizing daily/weekly/monthly reports” (p.539) where a weekly view, as an example, is displayed in Fig. 2. The weekly report in Fig. 2 contains markings associated with entries based on day and hour entries.
Claims 24-25 are rejected under U.S.C 103 as being unpatentable over Westbrook (US 2013/0131464 A1) in view of Allena (NPL, “An electronic diary on a palm device for headache monitoring: a preliminary experience”) and Gerard (US 2015/0379227 A1).
Regarding Claim 24, the method according to Claim 22 is obvious over Westbrook in view of Allena, as indicated hereinabove. Westbrook discloses “the results obtained prior and subsequent to a treatment intervention can allow the change in risk level based on the treatment efficacy to be determined and reported” ([0101]). However, Westbrook does not disclose wherein at least one of the one or more selectable options comprises a risk score configured to indicate a risk of exacerbation of the obstructive condition based on a comparison of the signal to the at least one of the baseline patient data or the population data.
As stated in claim 21, the proposed combination with Allena yields an electronic symptom diary with a calendar view where individual days can be selected from the calendar (Fig. 1, p.539 – describes the e-diary structured as days of a calendar view). Each day interface has a link for entering information regarding pain and sleep symptoms (Fig. 1, p.539) on a daily basis.
Gerard, in the same field of endeavor of monitoring a respiratory condition with self-reported and sensor data ([0038-0040]), teaches a periodic check-in phase, which can be daily, where the patient records the severity of symptoms associated with the chronic illness ([0048-0049]). After the check-in session is complete, the app shifts to an algorithm phase where an algorithm is applied to the new check-in data to calculate an exacerbation score ([0061]). The exacerbation score is part of a report detailing how the disease has changed from an established baseline during the course of the monitoring ([0059]). Gerard also states: “after a baseline score has been generated, a patient may then begin recording exacerbation severities for a plurality of symptoms 102, for example, on a regular basis” ([0043]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Westbrook’s system for the assessment of sleep quality using respiratory parameters by incorporating the updating of changes during the monitoring phase into a report as discussed in Gerard. This would have been obvious because both Westbrook and Gerard discuss assessing obstructive respiratory disorders with sensor and user inputs. Gerard provides an improvement by incorporating newly-entered data into an assessment to ensure that the patient’s condition reflects newly provided symptom information and current symptom severity. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook by incorporating the updating of changes during the monitoring phase into a report as discussed in Gerard.
Regarding Claim 25, the method according to Claim 21 is obvious over Westbrook in view of Allena, as indicated hereinabove. Westbrook discloses a combination of sensor, questionnaire, and population data to serve as a baseline comparison ([0098-0102]). A study results report based on the findings from the collected data ([0102]) is provided via a user interface ([0103]). Westbrook further discusses the substantial night-to-night variability when acquiring multiple night studies ([0030]).
However, Westbrook does not disclose comprising, in response to receiving a subsequent selection of the first option corresponding to the particular date from the one or more selectable options:
• displaying the summary interface;
• receiving an update to at least one of the first selection or the second selection; and
• determining an updated signal based on the update to the at least one of the first selection or the second selection.
As stated in claim 21, the proposed combination with Allena yields an electronic symptom diary with a calendar view where individual days can be selected from the calendar (Fig. 1, p.539 – describes the e-diary structured as days of a calendar view). Each day interface has a link for entering information regarding pain and sleep symptoms (Fig. 1, p.539) on a daily basis.
Gerard, in the same field of endeavor of monitoring a respiratory condition with self-reported and sensor data ([0038-0040]), teaches a periodic check-in phase, which can be daily, where the patient records the severity of symptoms associated with the chronic illness ([0048-0049]). After the check-in session is complete, the app shifts to an algorithm phase where an algorithm is applied to the new check-in data to calculate an exacerbation score ([0061]). The exacerbation score is part of a report detailing how the disease has changed from an established baseline during the course of the monitoring ([0059]). Gerard also states: “after a baseline score has been generated, a patient may then begin recording exacerbation severities for a plurality of symptoms 102, for example, on a regular basis” ([0043]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Westbrook’s system for the assessment of sleep quality using respiratory parameters by incorporating the updating of changes during the monitoring phase into a report as discussed in Gerard. This would have been obvious because both Westbrook and Gerard discuss assessing obstructive respiratory disorders with sensor and user inputs. Gerard provides an improvement by incorporating newly-entered data into an assessment to ensure that the patient’s condition reflects newly provided symptom information and current symptom severity. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook by incorporating the updating of changes during the monitoring phase into a report as discussed in Gerard.
Claims 26 is rejected under U.S.C 103 as being unpatentable over Westbrook (US 2013/0131464 A1) in view of Allena (NPL, “An electronic diary on a palm device for headache monitoring: a preliminary experience”) and Finkelstein (US 6,283,923 B1).
Regarding Claim 26, the method according to Claim 21 is obvious over Westbrook in view of Allena, as indicated hereinabove. Westbrook discloses a questionnaire presenting options for selecting “abnormal self-reported levels of depression, mood, anxiety, and sleepiness” ([0099]). Westbrook additionally discloses the detection of obstructive diseases, such as asthma ([0088] – “Detection of coughing, wheezing and similar respiratory breathing patterns are useful in providing a differential diagnosis between OSA and asthma or chronic obstructive pulmonary disease or a lack of response or use of steroid inhalers”; [0099] – assessment to differentiate these conditions using the questionnaire). However, Westbrook does not disclose the specific wherein:
• the first set of selectable symptoms includes multiple first selectable elements each corresponding to a different respiratory symptom; and
• the second set of selectable symptom levels includes multiple second selectable elements comprising a mild element, a moderate element and severe element.
Finkelstein, in the same field of endeavor of characterizing a respiratory condition with self-reported and sensor data (col 5, lines 12-28), teaches a patient GUI which allows a patient to enter data into a symptom diary (Fig. 2, col 5, lines 12-28) where symptom information as part of the test results is wirelessly forwarded to a processing facility (col 5, lines 53-65). Symptom diary questions are specifically presented as a selection among a list of symptoms where the severity of the symptom is scaled as none, mild, moderate, and severe (Fig. 3 – symptoms listed, col 8 , lines 54-60).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Westbrook’s system for the assessment of sleep quality using a patient questionnaire by incorporating the specific selectable respiratory symptoms and severity levels in Finkelstein. This would have been obvious because both Westbrook and Finkelstein discuss a patient entering symptom information, relevant to respiratory diseases, into a patient questionnaire. Finkelstein provides an improvement by permitting the user to separately identify and characterize the severity of individual respiratory symptoms, which provides enhanced self-reported symptom detail, beyond the levels of “depression, mood, anxiety, and sleepiness” in Westbrook. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook by incorporating the specific selectable respiratory symptoms and severity levels in Finkelstein.
Claim 27 is rejected under U.S.C 103 as being unpatentable over Westbrook (US 2013/0131464 A1) in view of Allena (NPL, “An electronic diary on a palm device for headache monitoring: a preliminary experience”), Finkelstein (US 6,283,923 B1), and Sachdev (US 2016/0029971 A1).
Regarding Claim 27, the method according to Claim 26 is obvious over Westbrook in view of Allena and Finkelstein, as indicated hereinabove. Westbrook discloses a combination of sensor, questionnaire, and population data to serve as a baseline comparison ([0098-0102], [0056]). A study results report based on the findings from the collected data ([0102]) is provided via a user interface ([0103]). Westbrook further discusses the substantial night-to-night variability when acquiring multiple night studies ([0030]).
However, Westbrook does not disclose wherein:
• determining the signal comprises adjusting a baseline value based on the first selection and the second selection; and
• determining that the signal satisfies the defined alert threshold comprises determining that the signal diverges from the baseline value by a defined deviation.
As stated in claim 21, the proposed combination with Allena yields an electronic symptom diary with a calendar view where individual days can be selected from the calendar (Fig. 1, p.539 – describes the e-diary structured as days of a calendar view). Each day interface has a link for entering information regarding pain and sleep symptoms (Fig. 1, p.539) on a daily basis.
Sachdev, in the same field of endeavor of monitoring a respiratory condition with self-reported and sensor data ([0015]; [0039] - questionnaire), teaches the calculation of a dynamic baseline as an aggregation of multiple preceding metric values, such as a four day moving average of baseline values where recent data may be weighted more ([0045-0046]). Sachdev further teaches a notification to a caregiver is triggered by a current metric value exceeding a threshold in comparison to the dynamic baseline ([0047]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Westbrook’s system for the assessment of sleep quality using respiratory metrics by incorporating the use of a patient-specific dynamic baseline in Sachdev.
This would have been obvious because both Westbrook and Sachdev discuss assessing obstructive respiratory disorders with sensor and questionnaire inputs. Sachdev provides an improvement by using a dynamic baseline which incorporates the changing status of a patient over the course of monitoring to determine whether current changes in patient metrics represent clinically meaningful deteriorations relative to the recent known condition of the patient. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook by incorporating the use of a patient-specific dynamic baseline in Sachdev.
Claims 28 is rejected under U.S.C 103 as being unpatentable over Westbrook (US 2013/0131464 A1) in view of Allena (NPL, “An electronic diary on a palm device for headache monitoring: a preliminary experience”) and Partovi (US 2012/0129139 A1).
Regarding Claim 28, the method according to Claim 21 is obvious over Westbrook in view of Allena, as indicated hereinabove. Westbrook does not disclose comprising: displaying a dashboard interface comprising a menu having a graphical element for displaying the calendar view; and in response to a user input to the graphical element, causing display of the first user interface.
As stated in claim 21, the proposed combination with Allena yields an electronic symptom diary with a calendar view where individual days can be selected from the calendar (Fig. 1, p.539 – describes the e-diary structured as days of a calendar view). Each day interface has a link for entering information regarding pain and sleep symptoms (Fig. 1, p.539) on a daily basis.
The personalized patient disease management system in Partovi would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the monitoring device for obstructive respiratory conditions in the instant application because there is a common problem to be solved with respect to providing a user-friendly interface for navigating between features on an application. Partovi teaches an interface with a dashboard tab where tabs can be selected to switch to a treatment view and calendar view (Fig. 5, [0103-0104]). Clicking on the calendar tab displayed on the graphical interface causes the calendar tab to be displayed ([0104]). The user is able to enter questionnaire information using this interface ([0082]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter the combination of Westbrook’s system for the assessment of sleep quality using a patient questionnaire and Allena’s calendar entry by incorporating the interface dashboard view with a selectable calendar tab in Partovi. This would have been obvious because both Westbrook and Partovi discuss a graphical interface for entering information and viewing reports. Partovi provides an improvement by using a convenient graphical navigation mechanism for accessing tracking health information with a calendar and symptom-entry functions. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook/Allena by incorporating the interface dashboard view with a selectable calendar tab in Partovi.
Claims 29 and 32-35 are rejected under U.S.C 103 as being unpatentable over Westbrook (US 2013/0131464 A1) in view of Cronin (WO 2017/089171 A1) and Finkelstein (US 6,283,923 B1).
Regarding Claim 29, Westbrook further discloses a method for monitoring physiological conditions of a user ([0002]), the method comprising:
• receiving sensor data from one or more sensors configured to measure at least one physiological parameter of the user and generate sensor data from the measured at least one physiological parameter ([0034] – a data acquisition system (DAU) 210 is worn above the forehead to collect physiologic data from the sensor strip 220 and nasal pneumotachometer 240; collected and analyzed in steps 120 ([0080]) and 130 ([0095]));
• determining a first signal using the sensor data and at least one of baseline patient data or population data ([0101] – “To improve the diagnostic accuracy of the sleep study results, the individual's data can be additionally compared to a database of values from healthy individuals and/or patients with chronic diseases (step 170)” where sensor data is included in the original data);
displaying a first user interface comprising a first set of selectable symptoms associated with an obstructive condition ([0098] – questionnaire presented as a computer interface);
receiving a first selection from the first set of selectable symptoms ([0099] – questionnaires present options for selecting “abnormal self-reported levels of depression, mood, anxiety, and sleepiness”);
receiving a second selection from the second set of selectable symptom levels ([0099] – questionnaires present options for selecting “abnormal self-reported levels of depression, mood, anxiety, and sleepiness”). Note the questionnaire makes use of “any number of conventional questionnaire instruments (e.g., Epworth Sleepiness Score, Beck Depression Index, State-Trait Anxiety Index, Pittsburgh Insonmia Rating Scale, Profile of Mood states, etc.) or any combination of questions that provide the appropriate information” ([0099]).
• determining a second signal using, the first selection, the second selection, the sensor data ([0101]) and the at least one of the baseline patient data or the population data ([0101] – “To improve the diagnostic accuracy of the sleep study results, the individual's data can be additionally compared to a database of values from healthy individuals and/or patients with chronic diseases (step 170)”);
• determining a status of the obstructive condition using the second signal ([0102] - integrates the findings of the questionnaire, sensor data, and comparison to population data into a study results report); and
• displaying a summary interface indicating the status of the obstructive condition ([0102] of study results report with descriptions of embodiments in [0104-0111] and a user interface for displaying the report in [0103]).
Westbrook does not disclose explicitly separate interfaces required in displaying a second user interface comprising a second set of selectable symptom levels associated with the obstructive condition.
Finkelstein, in the same field of endeavor of characterizing a respiratory condition with self-reported and sensor data (col 5, lines 12-28), teaches a patient GUI which allows a patient to enter data into a symptom diary (Fig. 2, col 5, lines 12-28) where symptom information as part of the test results is wirelessly forwarded to a processing facility (col 5, lines 53-65). Symptom diary questions are specifically presented as a selection among a list of symptoms where the severity of the symptom is scaled as none, mild, moderate, and severe (Fig. 3 – symptoms listed, col 8 , lines 54-60).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Westbrook’s system for the assessment of sleep quality using a patient questionnaire by incorporating the specific selectable respiratory symptoms and severity levels in Finkelstein. This would have been obvious because both Westbrook and Finkelstein discuss a patient entering symptom information, relevant to respiratory diseases, into a patient questionnaire. Finkelstein provides an improvement by permitting the user to separately identify and characterize the severity of individual respiratory symptoms, which provides enhanced self-reported symptom detail, beyond the levels of “depression, mood, anxiety, and sleepiness” in Westbrook. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook by incorporating the specific selectable respiratory symptoms and severity levels in Finkelstein.
While Westbrook discloses different signals made of various combinations of sensor, user-provided, and control data from other patient populations ([0098-0102]), Westbrook does not disclose the interfaces for the user-provided data being provided in response to determining that the first signal satisfies a defined alert threshold (where the first signal is the sensor and control data).
Cronin, in the same field of endeavor of characterizing a respiratory condition with self-reported and sensor data (Abstract), teaches “setting a threshold for at least one monitored pulse oximetry parameter; measuring at least one of blood oxygen saturation, pulse rate, and respiration rate via a pulse oximeter; displaying via a virtual assistant a questionnaire retrieved from the questions database when the threshold for the at least one monitored pulse oximetry parameter is exceeded” (page 3, lines 33-35 and page 4, lines 1-3). The questionnaire specifically selects questions to present which are relevant to the condition signified by the exceeded sensor threshold (page 7, lines 25-35 and page 8, lines 1-18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Westbrook’s system for the assessment of sleep quality using a patient questionnaire by incorporating the selection and display of a user questionnaire geared toward a condition indicated by an exceeded respiratory sensor threshold in Cronin. This would have been obvious because both Westbrook and Cronin discuss the interaction between sensor and questionnaire data as being relevant to respiratory diseases. Cronin provides an improvement where questionnaire information is specifically geared toward gathering user input to provide further context to a sensor with an exceeded threshold. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook by incorporating the selection of a user questionnaire geared toward a condition indicated by an exceeded respiratory sensor threshold in Cronin.
Regarding Claim 32, the method according to Claim 29 is obvious over Westbrook in view of Cronin and Finkelstein, as indicated hereinabove. Westbrook further discloses wherein:
• the summary interface comprises a selectable option configured to display an action plan for the obstructive condition ([0102] – recommendations for disease management are provided in the sleep study report based on data acquired, [0086] – respiratory parameters relevant to diagnosis and treatment are discussed); and
• the action plan comprises user-specific information related to the obstructive condition ([0109] – respiratory parameters used to determine disease states for report).
Regarding Claim 33, the method according to Claim 29 is obvious over Westbrook in view of Cronin and Finkelstein, as indicated hereinabove. Westbrook discloses a questionnaire presenting options for selecting “abnormal self-reported levels of depression, mood, anxiety, and sleepiness” ([0099]). Westbrook additionally discloses the detection of obstructive diseases, such as asthma ([0088] – “Detection of coughing, wheezing and similar respiratory breathing patterns are useful in providing a differential diagnosis between OSA and asthma or chronic obstructive pulmonary disease or a lack of response or use of steroid inhalers”; [0099] – assessment to differentiate these conditions using the questionnaire). However, Westbrook does not disclose the specific wherein:
• the first set of selectable symptoms includes multiple first selectable elements each corresponding to a different respiratory symptom; and
• the second set of selectable symptom levels includes multiple second selectable elements comprising a mild element, a moderate element and severe element.
As stated in claim 29, the proposed combination with Finkelstein yields a patient GUI which allows a patient to enter data into a symptom diary (Fig. 2, col 5, lines 12-28) where symptom information as part of the test results is wirelessly forwarded to a processing facility (col 5, lines 53-65). Symptom diary questions are specifically presented as a selection among a list of symptoms where the severity of the symptom is scaled as none, mild, moderate, and severe (Fig. 3 – symptoms listed, col 8 , lines 54-60).
Regarding Claim 34, the method according to Claim 29 is obvious over Westbrook in view of Cronin and Finkelstein, as indicated hereinabove. Westbrook further discloses wherein the at least one physiological parameter comprises at least one of a heart rate, a heart rate variability, and a respiratory rate ([0094] – measured parameters include heart rate, heart rate variability, and respiration).
Regarding Claim 35, the method according to Claim 29 is obvious over Westbrook in view of Cronin and Finkelstein, as indicated hereinabove. Westbrook further discloses wherein:
• the one or more sensors comprise a heart rate sensor ([0039] - ECG sensor) and a respiratory sensor ([0088] – breathing patterns assessed with a microphone and actigraphy, airflow, and oximetry, [0089] – accelerometer-based respiration signal);
• the baseline patient data or population data correspond to heart rate data and respiratory data associated with non-asthmatic conditions ([0101] – data compared to healthy populations); and
• the sensor data comprises at least one of a heart rate, a heart rate variability, a respiratory rate or a respiratory rate variability ([0094] – heart rate, heart rate variability, and respiration).
Claims 30-31 are rejected under U.S.C 103 as being unpatentable over Westbrook (US 2013/0131464 A1) in view of Cronin (WO 2017/089171 A1), Finkelstein (US 6,283,923 B1), and Douen (WO 2012/094718 A1).
Regarding Claim 30, the method according to Claim 29 is obvious over Westbrook in view of Cronin and Finkelstein, as indicated hereinabove. Westbrook discloses step 180 as generating a study results report that integrates data from the previous steps with disease management recommendations ([0102]) which are displayed in a computerized user interface “where the external computer system is implemented as a web portal, a web page or series of web pages can be provided that allow patients and/or clinicians to generate and view reports” ([0103]). However, Westbrook does not disclose comprising:
• selecting, from a set of modules, one or more modules related to the obstructive condition; and
• causing display of an interface comprising one or more selectable icons each corresponding to a module of the selected one or more modules.
The method of using a computer program for the presentation of medical information (Abstract) in Douen would be considered “reasonably pertinent” (see MPEP 2141.01(a)1) to the monitoring device for obstructive respiratory conditions in the instant application because there is a common problem to be solved with respect to providing an intuitive interface for educating a patient after a diagnosis. Douen teaches a non-practitioner can be directed to a patient specific detail page such as that shown in Fig. 17 (page 48). Douen further describes “in some implementations, the detail page 1700 may include selectable items (selected by clicking on the item, hovering over the item, etc.) to provide general information to the non-practitioner type user” where some of the accessible selectable items (which are interpreted as equivalent to modules) for a diagnosed disease are links to “definition and causes,” “symptoms.” “investigation and treatment,” “risk factors and prevention,” and “outcome” (pages 48-49).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Westbrook’s system study results report by incorporating the learning interface for the patient describing features of a diagnosed condition in Douen. This would have been obvious because both Westbrook and Douen discuss providing a report to the user regarding diagnostic information and treatment recommendations. Douen provides an improvement by displaying selectable modules of information about the diagnosis as part of a report to help the patient better understand the report and treatment options. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook by incorporating the learning interface for the patient describing features of a diagnosed condition in Douen.
Regarding Claim 31, the method according to Claim 30 is obvious over Westbrook in view of Cronin, Finkelstein, and Douen, as indicated hereinabove. Westbrook discloses step 180 as generating a study results report that integrates data from the previous steps with disease management recommendations ([0102]) which are displayed in a computerized user interface “where the external computer system is implemented as a web portal, a web page or series of web pages can be provided that allow patients and/or clinicians to generate and view reports” ([0103]). However, Westbrook does not disclose wherein the one or more modules are selected using the second signal.
As stated in claim 30, the proposed combination with Douen yields an interface where a non-practitioner can be directed to a patient specific detail page such as that shown in Fig. 17 (page 48). Douen further describes “in some implementations, the detail page 1700 may include selectable items (selected by clicking on the item, hovering over the item, etc.) to provide general information to the non-practitioner type user” where some of the accessible selectable items (which are interpreted as equivalent to modules) for a diagnosed disease are links to “definition and causes,” “symptoms.” “investigation and treatment,” “risk factors and prevention,” and “outcome” (pages 48-49). These learning modules would be provided to further describe the diagnosis and treatment recommendations to the patient in Westbrook.
Claims 37 is rejected under U.S.C 103 as being unpatentable over Westbrook (US 2013/0131464 A1) in view of Series (US 5,456,264).
Regarding Claim 37, the method according to Claim 36 is anticipated by Westbrook, as indicated hereinabove. Westbrook discloses obstructive conditions as being caused by characteristic reductions in respiratory flow, such as during inspiration ([0081-0083]). However, Westbrook does not disclose wherein determining the signal comprises determining an inspiratory-expiratory ratio using the sensor data.
Series, in the same field of endeavor of characterizing a respiratory condition (Abstract), teaches
the inspiratory/expiratory ratio as a practical and accurate method of identifying inspiratory flow limitations, a feature of upper airway obstructions, with higher specificity than simply measuring inspiration (col 2, lines 1-33).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Westbrook’s system for the assessment of sleep quality via respiratory parameters by incorporating inspiratory/expiratory ratio as a measured parameter in Series. This would have been obvious because both Westbrook and Series discuss the identification of metrics describing obstructed breathing. Series provides an improvement of an objective parameter describing inspiratory flow limitation to better facilitate identification of upper airway obstruction during sleep. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook by incorporating inspiratory/expiratory ratio as a measured parameter, as described in Series.
Claim 40 is rejected under U.S.C 103 as being unpatentable over Westbrook (US 2013/0131464 A1) in view of Arnold (US 2006/0189872).
Regarding Claim 40, the method according to Claim 36 is anticipated by Westbrook, as indicated hereinabove. Westbrook identifies segments of data which would be classified as apneas or hypopnea events ([0081-0086]), which could be understood as a defined alert threshold because an obstructive condition is detected. However, Westbrook does not disclose comprising outputting an alert in response to determining a change in the status of the obstructive condition.
Arnold, in the same field of endeavor of characterizing and monitoring respiratory conditions ([0002]), teaches the monitoring device is programmed to “recognize the significant increase in the output signal when the patient is suffering from obstructive apnea” via a parameter threshold value for indicating obstructive apnea or a sudden jump in a parameter value compared to an average ([0073]). When this occurs, “the monitoring device, or other connected devices, may be programmed to provide notification that the patient is at risk for or is experiencing obstructive apnea” ([0073]). Notifications are stated to include an alarm (such as audible or visible) or a condition-indicating system (such as a display) ([0069]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Westbrook’s system (which contains thresholds when identifying apnea events) by incorporating an alarm or indication on a display that an obstructive event has occurred in Arnold. This would have been obvious because both Westbrook and Arnold discuss the identification of obstructed breathing. Arnold provides an improvement of an obstructive event warning to the user with an alarm to get the user’s attention so the issue can be corrected. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Westbrook by incorporating the alarm or indication on a display that an obstructive event has occurred in Arnold.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
