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
This action is in reply to the application filed on 7/25/24.
Claims 1-20 are currently pending and have been examined.
Priority
Applicant’s claim to the benefit of and priority to US Provisional Application 63/516,361 is acknowledged. Accordingly, a priority date of 07/28/23 has been given to this application.
IDS
The information disclosure statement (IDS) submitted on 08/02/24 have been considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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.
Claims 1-20 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1-18 are drawn to a method, Claim 19 is drawn to a non-transitory computer readable medium computer program product, and Claim 20 is drawn to a system, each of which are within the four statutory categories. Claims 1-20 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claims 1, 19 and 20 recite implementing the steps of:
determining one or more first measures of wellbeing of a user with sleep disordered breathing during an off period when the user is not adhering to a respiratory pressure therapy;
determining one or more second measures of the wellbeing of the user during an on period when the user is at least partially adhering to the respiratory pressure therapy; and
presenting an indication to the user on how at least partially adhering to the respiratory pressure therapy improves the wellbeing of the user by comparing the one or more first measures to the one or more second measures.
The above limitations, under broadest reasonable interpretation, cover performance of the limitation in the mind or with a calculation aid such as pen and paper (Claim 1). The above limitations, under broadest reasonable interpretation, cover performance of the limitation in the mind or with a calculation aid such as pen and paper but for recitation of general purpose computing components in Claims 19-20. Fundamentally, the process is that of a person making a determination of one or more first measures of wellbeing of a user when the user is not adhering to a therapy program, making a determination of a different measure of wellbeing when the user is adhering to the therapy program, comparing the two measures, and presenting an indication regarding how adhering to the program improves the user’s wellbeing. The steps include observations, evaluations, judgements, and opinions. If a claim limitation, under its broadest reasonable interpretation, covers the performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “mental processes” grouping of abstract ideas.
Additionally, these limitations also amount to managing personal behavior or relationships or interactions between people and therefore recite certain methods of organizing human activity as they represent a series of personal behaviors that may be performed by a healthcare provider to determine measures of a user’s wellbeing when the user is and is not adhering to a therapy program and showing the user an indication of how adhering to the therapy program improves their wellbeing.
The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
The above claims are therefore directed to an abstract idea.
Step 2A Prong 2
Regarding Claim 1, this judicial exception is not integrated into a practical application because the claim does not recite any additional elements by which to integrate the judicial exception into practical application.
Regarding Claims 19-20, this judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
A non-transitory computer readable medium computer program product comprising instructions which, when executed by a computer, cause the computer to implement the steps of the abstract idea (Claim 19)
A system comprising: a memory that stores machine-readable instructions; and a control system that includes one or more processors, the one or more processors are configured to execute the machine-readable instructions to implement the steps of the abstract idea (Claim 20)
The broad recitation of general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools. Regarding the non-transitory CRM computer program product, no particulars are provided; therefore, these elements are given their broadest reasonable interpretation as general purpose computing components/devices functioning in their ordinary capacity to implement the steps of the abstract idea. The “computer” is understood to be a smartphone, desktop, laptop ([0088], [0139]) functioning in its ordinary capacity.
Regarding the system comprising a memory that stores machine-readable instructions; and a control system that includes one or more processors, the one or more processors are configured to execute the machine-readable instructions, these are understood to be general purpose computing components functioning in their ordinary capacity to implement the steps of the abstract idea (see paras. [0055]-[0056]).
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 19, 20 only recite the aforementioned computing elements as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f). As explained above with respect to Step 2A Prong 2, Claim 1 does not recite any additional elements.
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
Depending Claims
Claim 2 recites limitations pertaining to wherein the one or more first measures of wellbeing relate to sleep quality and are based on information obtained from one or more devices other than a sleep respiratory device providing the respiratory pressure therapy, and the one or more second measures of the wellbeing relate to sleep quality and are based on information obtained from sleep respiratory device providing the respiratory pressure therapy, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 3 recites limitations pertaining to wherein each type of first measure of the one or more first measures is normalized among its respective type of the first measure to compare the respective type of the first measure with the one or more first measures, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 4 recites limitations pertaining to wherein each type of second measure of the one or more second measures is normalized among its respective type of the second measure to compare the respective type of the second measure with the one or more second measures, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 5 recites limitations pertaining to wherein each type of first measure of the one or more first measures is normalized among its respective type of the first measure to compare the respective type of the first measure with the one or more second measures, and each type of second measure of the one or more second measures is normalized among its respective type of the second measure to compare the respective type of the second measure with the one or more first measures, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 6 recites limitations pertaining to wherein a format of the indication is based on a health history of the user, one or more current health issues of the user, a type of sleep disordered breathing, or a combination thereof, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 7 recites limitations pertaining to wherein the indication is presented on a respiratory therapy device the user uses for the respiratory pressure therapy or across multiple devices associated with the user, which only amounts to mere instructions to apply the abstract idea, e.g., using an electronic device to implement the step of presenting the indication. MPEP 2106.05(f). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 8 recites limitations pertaining to further comprising collecting information from one or more devices associated with the user separate from a respiratory therapy device that provides the positive airway pressure to the user, which amounts to insignificant extra-solution activity in the form of mere data gathering, e.g., it amounts to collecting the data necessary to perform the abstract idea. This also amounts to activity that is well-understood, routine and conventional in the form of receiving/transmitting data over a network. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 9 recites limitations pertaining to wherein the information is collected at least during the off period, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 10 recites limitations pertaining to wherein the one or more first measures, the one or more second measures, or a combination thereof are determined based on one or more common objective measures of the wellbeing of the user, wherein the one or more common objective measures include measures of consistency and/or punctuality in one or more daily routines, results of one or more cognitive tests, performance during one or more games, performance during one or more predefined routines, or a combination thereof, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 11 recites limitations pertaining to wherein the one or more daily routines include a daily routine of waking up and getting ready for work, including time to get out of bed, time to take a shower, and time to brush teeth, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 12 recites limitations pertaining to wherein the one or more cognitive tests include reaction time tests, reading time tests, and reading comprehension tests, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 13 recites limitations pertaining to wherein the one or more first measures, the one or more second measures, or a combination thereof are determined based on one or more subjective measures provided by the user, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 14 recites limitations pertaining to wherein the one or more first measures, the one or more second measures, or a combination thereof are determined based on health information associated with the user, which further narrows the scope of the abstract idea as set out above. Claim 14 also recites that the one or more first measures, the one or more second measures, or a combination are collected by one or more smart devices, which only amounts to insignificant extra-solution activity in the form of mere data gathering which is well understood, routine and conventional receiving or transmitting data. These limitations are not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 15 recites limitations pertaining to wherein the one or more second measures are determined based on health information associated with the user, which further narrows the scope of the abstract idea as set out above. Claim 15 further recites limitations pertaining to the one or second measures are collected by a respiratory therapy system used by the user for at least partially adhering to the respiratory pressure therapy, which only amounts to insignificant extra-solution activity in the form of mere data gathering which is well understood, routine and conventional receiving or transmitting data. These limitations are not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 16 recites limitations pertaining to wherein the one or more first measures of wellbeing and the one or more second measures of wellbeing relate to fatigue of the user, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
Claim 17 recites limitations pertaining to further comprising: determining one or more contributing factors that affect the wellbeing of the user during the off period, the on period, or a combination thereof, wherein the indication to the user correlates the one or more contributing factors with the one or more first measures of wellbeing, the one or more second measures of wellbeing, or a combination thereof, which can also be performed using human mental observation, evaluation, judgement and opinion, and therefore falls into the abstract grouping of a mental process.
Claim 18 recites limitations pertaining to wherein the one or more contributing factors include one or more environmental factors, which further narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more.
The dependent claims have been given the full two-part analysis including analyzing the additional limitations both individually and in combination. The dependent claims, when analyzed individually, and in combination, are also held to be patent ineligible under 35 U.S.C. 101 as they include all of the limitations of claim 1. The additional recited limitations of the dependent claims fail to establish that the claims do not recite an abstract idea because the additional recited limitations of the dependent claims merely further narrow the abstract idea. Beyond the limitations which recite the abstract idea, the claims recite additional elements which encompass adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f). There is no indication that a combination of additional elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Dependent claims 2-17, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
For the reasons stated, Claims 1-20 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
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.
Claim(s) 1, 2, 6-9, 13-15, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klee et. al. (US Publication 20180199882A1) in view of Halperin et. al. (US Publication 20130267791A1).
Regarding Claim 1, Klee discloses
determining one or more first measures of wellbeing of a user with sleep disordered breathing during [a first period of a respiratory pressure therapy] ([0002], teaching on treating COPD and obstructive sleep apnea (OSA) (“sleep disordered breathing”) with positive airway pressure (PAP) therapy; [0037], teaching on treating patients with OSA therapy; [0044] teaching on providing feedback information to a patient with the intention of increasing patients’ compliance with the therapy relating to upper airway disorder; feedback information encompasses information regarding the progress and effort of the therapy; [0045] teaches on the feedback information including statistical information about the time period the patient has used the underlying therapy and correlating of the same with vital sign information to reflect the benefit of the usage of the therapy relating to an upper airway disorder – vital sign information is interpreted as a measure of wellbeing of the user, where [0029] teaches on vital signs including glucose level, heart rate, blood pressure, sleep stage data – vital signs are interpreted as “measures of wellbeing of the user”; [0050]-[0052] teach on providing information regarding therapy progress as a “temporal progression”, e.g., feedback is provided with one time period of therapy relative to a “passed time period” – if therapy data is collected for two time periods, the “passed time period” is understood to include vital sign from the first/earlier time period);
determining one or more second measures of the wellbeing of the user during an on period when the user is at least partially adhering to the respiratory pressure therapy ([0002], teaching on treating COPD and obstructive sleep apnea (OSA) with positive airway pressure (PAP) therapy; [0044] teaching on providing feedback information to a patient with the intention of increasing patients’ compliance with the therapy relating to upper airway disorder; feedback information encompasses information regarding the progress and effort of the therapy; [0045] teaches on the feedback information including statistical information about the time period the patient has used the underlying therapy and correlating of the same with vital sign information to reflect the benefit of the usage of the therapy relating to an upper airway disorder – vital sign information is interpreted as a measure of wellbeing of the user, where [0029] teaches on vital signs including glucose level, heart rate, blood pressure, sleep stage data – vital signs are interpreted as “measures of wellbeing of the user”; [0050]-[0052] teach on providing information regarding therapy progress as a “temporal progression”, e.g., feedback is provided with one time period of therapy relative to a “passed time period” – if therapy data is collected for two time periods, the current time period is interpreted as being a period when the user is at least partially adhering to the respiratory therapy); and
presenting an indication to the user on how at least partially adhering to the respiratory pressure therapy improves the wellbeing of the user by comparing the one or more first measures to the one or more second measures ([0050] teaches on feedback information comprising information regarding the progress and effort of the therapy; [0051] teaches on information regarding progress and effort of the therapy being provided in conjunction with temporal progression of the monitored vital signs (measures of wellbeing); information regarding the progress and effort of the therapy may include changes in glucose level, heart rate changes, blood pressure changes, sleep state changes; [0052] teaches on providing feedback information wherein the patient is informed about the time period using the therapy in comparison to a passed time period; the patient may be informed about his progress regarding regular and/or prescribed use of the therapy (interpreted as ‘at least partially adhering to the respiratory pressure therapy); the feedback information may also comprise information in conjunction with vital signs and vital sign changes over time; the feedback may thus show the patient the beneficial effect of the therapy on the monitored vital sign (e.g., an indication of how at least partially adhering to the therapy improves the user’s wellbeing)).
Klee teaches on determining measures of wellness at different time points when a user is adhering to a respiratory pressure therapy to indicate how the user’s vital signs (wellbeing) improve over time, but does not explicitly teach on determining a measure of wellness during an off period when the user is not adhering to a respiratory pressure therapy
Halperin, which is directed to monitoring, predicting and treating clinical episodes, teaches:
determining a measure of wellness during an off period when the user is not adhering to a respiratory pressure therapy ([0623]-[0631] teaching on continuously monitoring at least one physiological parameter (measure of wellness) of a patient; the system determines a lack of compliance (interpreted as determining a “measure of wellness during an off period when the user is not adhering to a respiratory pressure therapy”) with a treatment protocol in order to provide feedback to the patient to improve compliance; the system determines and generates an output that is indicative of a correlation between the monitored physiological parameter and non-compliance by the patient with the treatment protocol).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Klee with these teachings of Halperin, to determine a measure of wellness during an off period when the user is not adhering to a respiratory pressure therapy to compare to the “on period” of Klee, rather than comparing two consecutive periods of therapy, with the motivation of encouraging the patient to use the CPAP device by showing them changes in a medical condition when the CPAP device is not used and how that increase the patient’s risk of undergoing a health deterioration (Halperin [0628]).
Regarding Claim 2, Klee/Halperin teach the limitations of Claim 1. Klee further discloses wherein the one or more first measures of wellbeing relate to sleep quality ([0029] teach on the vital signs (measures) including “sleep stage data”; where [0032] teaches on sleep stage data including time between sleep stages and/or duration of sleep stages as well as general information about sleep quality such as objective measurement from another person and/or subjective information from the patient) and are based on information obtained from one or more devices other than a sleep respiratory device providing the respiratory pressure therapy ([0097] teaches on the accelerometer being located on a different body part of the patient such as the wrist – interpreted as a device other than a sleep respiratory device providing the therapy), and the one or more second measures of the wellbeing relate to sleep quality ([0029] teach on the vital signs (measures) including “sleep stage data”; where [0032] teaches on sleep stage data including time between sleep stages and/or duration of sleep stages as well as general information about sleep quality such as objective measurement from another person and/or subjective information from the patient) and are based on information obtained from sleep respiratory device providing the respiratory pressure therapy ([0095] teaches on a sleep stage sensor which comprises an accelerometer for acquiring sleep stage data of the patient; [0095] teaches on the accelerometer being implemented in the therapy device).
Regarding Claim 6, Klee/Halperin teach the limitations of claim 1. Klee further discloses wherein a format of the indication is based on a health history of the user, one or more current health issues of the user, a type of sleep disordered breathing, or a combination thereof ([0029] teaches on a linkage between upper airway disorders and abnormal vital signs, such as glucose levels in patients suffering from Type 2 Diabetes; [0090] teaches on presenting a glucose indication, e.g., critical level, warning level, or acceptable glucose level – the format of showing varying glucose levels is understood to be based on a current health issue of diabetes of the user).
Regarding Claim 7, Klee/Halperin teach the limitations of claim 1. Klee further discloses wherein the indication is presented on a respiratory therapy device the user uses for the respiratory pressure therapy or across multiple devices associated with the user ([0090] teaching on glucose levels may be indicated on the CPAP mask or any other part of the therapy system).
Regarding 8, Klee/Halperin teach the limitations of claim 1. Klee further discloses further comprising collecting information from one or more devices associated with the user separate from a respiratory therapy device that provides the positive airway pressure to the user ([0070]-[0071] teaches on a therapy device for providing a pressurized flow of breathable gas to a patient such as nasal masks, oral masks, full face masks – interpreted as being the respiratory therapy device; [00[0083] teaches on using a “standalone glucometer” as the glucose sensor that analyzes the patient’s blood glucose level).
Regarding Claim 9, Klee/Halperin teach the limitations of Claim 8. Klee does not disclose, but Halperin further teaches wherein the information is collected at least during the off period ([00625] teaches on determining a treatment protocol has not been followed, interpreted as an “off period”, and analyzing physiological parameter received during that period).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify Klee/Halperin with these teachings of Halperin, to collect information during at least the off period, with the motivation of encouraging the patient to use the CPAP device by showing them changes in a medical condition when the CPAP device is not used and how that increase the patient’s risk of undergoing a health deterioration (Halperin [0628]).
Regarding Claim 13, Klee/Halperin teach the limitations of claim 1. Klee further discloses wherein the one or more first measures, the one or more second measures, or a combination thereof are determined based on one or more subjective measures provided by the user ([0029] teach on the vital signs (measures) including “sleep stage data”; where [0032] teaches on sleep stage data including general information about sleep quality such as subjective assessment by the patient).
Regarding Claim 14, Klee/Halperin teach the limitations of claim 14. Klee further discloses, wherein the one or more first measures, the one or more second measures, or a combination thereof are determined based on health information associated with the user and collected by one or more smart devices ([0066] teaches on a processing unit for processing therapy and vital sign data (first/second measures of wellbeing) such as glucose level data; the processing unit may be smartphone).
Regarding Claim 15, Klee/Halperin teach the limitations of claim 14. Klee further discloses wherein the one or more second measures are determined based on health information associated with the user and collected by a respiratory therapy system used by the user for at least partially adhering to the respiratory pressure therapy ([0097] teaches on sensors giving information on sleep stages and sleep quality, which can include respiratory sensors such as airflow sensors of CPAP devices – e.g., the respiratory therapy system; respiratory information can be useful for sleep staging – if sleep information is provided by airflow sensors of a CPAP device, it is necessarily understood that it is being obtained while ethe patient is at least partially adhering to the respiratory pressure therapy).
Regarding Claim 19, Klee/Halperin teach the limitations of Claim 1. Claim 19 recites the same or substantially similar limitations as Claim 1, and the discussion above with respect to Claim 1 is equally applicable to Claim 19. Claim 19 additionally recites the following which are also taught by Klee a non-transitory computer readable medium computer program product comprising instructions which, when executed by a computer, cause the computer to carry out ([0027], teaching on system architecture; [0066] teaching on a processing unit which may be comprised by a device such as a smartphone or tablet, interpreted as a computer).
Regarding Claim 20, Klee/Halperin teach the limitations of Claim 1. Claim 20 recites the same or substantially similar limitations as Claim 1, and the discussion above with respect to Claim 1 is equally applicable to Claim 20. Claim 20 additionally recites the following which are also taught by Klee a system comprising: a memory that stores machine-readable instructions; and a control system that includes one or more processors, the one or more processors are configured to execute the machine-readable instructions to ([0027], teaching on system architecture, [0066], teaching on a processing unit which may be in the form of a processor).
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klee et. al. (US Publication 20180199882A1) in view of Halperin et. al. (US Publication 20130267791A1) as applied to Claim 1 above, and further in view of Bugrim et. al. (US Publication 20090138251A1).
Regarding Claim 3, Klee/Halperin teach the limitations of Claim 1 but do not teach the following. Bugrim, which is directed to bioinformatics research and analysis systems, teaches wherein each type of first measure of the one or more first measures is normalized among its respective type of the first measure to compare the respective type of the first measure with the one or more first measures ([0033] teaches on normalization of data for the purpose of standardizing data so it can be used for comparing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Klee/Halperin with these teachings of Bugrim, to apply Bugrim’s data normalization to the first measures of wellness of Klee/Halperin, with the motivation of normalizing data contained in different scales so that data values can be compared on a common scale (Bugrim [0033]).
Regarding Claim 4, Klee/Halperin/Bugrim teach the limitations of Claim 3. Klee does not disclose but Bugrim further teaches, wherein each type of second measure of the one or more second measures is normalized among its respective type of the second measure to compare the respective type of the second measure with the one or more second measures ([0033] teaches on normalization of data for the purpose of standardizing data so it can be used for comparing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Klee/Halperin with these teachings of Bugrim, to apply Bugrim’s data normalization to the second measures of wellness of Klee/Halperin, with the motivation of normalizing data contained in different scales so that data values can be compared on a common scale (Bugrim [0033]).
Regarding Claim 5, Klee/Halperin/Bugrim teach the limitations of Claim 4. Klee does not disclose but Bugrim further teaches, wherein each type of first measure of the one or more first measures is normalized among its respective type of the first measure to compare the respective type of the first measure with the one or more second measures, and each type of second measure of the one or more second measures is normalized among its respective type of the second measure to compare the respective type of the second measure with the one or more first measures ([0033] teaches on normalization of data for the purpose of standardizing data so it can be used for comparing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Klee/Halperin with these teachings of Bugrim, to apply Bugrim’s data normalization to the first and second measures of wellness of Klee/Halperin to compare the first and second measures to each other, with the motivation of normalizing data contained in different scales so that data values can be compared on a common scale (Bugrim [0033]).
Claim(s) 10, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klee et. al. (US Publication 20180199882A1) in view of Halperin et. al. (US Publication 20130267791A1) as applied to Claim 1 above, and further in view of Stubna et. al. (US Publication 20130054215 A1).
Regarding Claim 10, Klee/Halperin teach the limitations of claim 1 but do not teach the following. Stubna, which is directed to systems and methods for apnea-adjusted neurobehavioral performance prediction and assessment, teaches: wherein the one or more first measures, the one or more second measures, or a combination thereof are determined based on one or more common objective measures of the wellbeing of the user ([0041] teaching on using objective reaction-time tests and cognitive tasks such as the Psychomotor Vigilance Task), wherein the one or more common objective measures include measures of consistency and/or punctuality in one or more daily routines, results of one or more cognitive tests ([0041] teaching on using objective reaction-time tests and cognitive tasks such as the Psychomotor Vigilance Task), performance during one or more games, performance during one or more predefined routines, or a combination thereof.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Klee/Halperin with these teachings of Stubna, to use results of one or more cognitive tests as the common objective measure of the user’s wellbeing, with the motivation of assessing neurobehavioral deficits of apnea-afflicted individuals that are related to fatigue (Stubna [0041]).
Regarding Claim 12 Klee/Halperin/Stubna teach the limitations of claim 10. Klee does not disclose, but Stubna further teaches wherein the one or more cognitive tests include reaction time tests, reading time tests, and reading comprehension tests ([0041] teaching on using objective reaction-time tests and cognitive tasks such as the Psychomotor Vigilance Task).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Klee/Halperin with these teachings of Stubna, to use results of one or more cognitive tests as the common objective measure of the user’s wellbeing, with the motivation of assessing neurobehavioral deficits of apnea-afflicted individuals that are related to fatigue (Stubna [0041]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klee et. al. (US Publication 20180199882A1) in view of Halperin et. al. (US Publication 20130267791A1) and further in view of Stubna et. al. (US Publication 20130054215 A1) as applied to Claim 10 above, and further in view of Lavi et. al. (US Publication 20170365182A1).
Regarding Claim 11, Klee/Halperin/Stubna teach the limitations of Claim 10 but do not teach the following. Lavi, which is directed to a bio-feedback health management system, teaches wherein the one or more daily routines include a daily routine of waking up and getting ready for work, including time to get out of bed, time to take a shower, and time to brush teeth ([0028] teaches on an individual’s daily routine including when the individual bathes (“time to take a shower”) and when the individual brushes their teeth).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Klee/Halperin/Stubna with the teachings of Lavi, to incorporate time to take a shower and brush teeth as one or more daily routines, with the motivation of identifying meaningful information about the user’s habits (Lavi [0034]). Examiner notes that per conditional limitation of parent Claim 10, only “results of one or more cognitive tests” is required to fulfill claim requirements and “one or more daily routines” is not required. For the sake of completion, Examiner has provided art for Claim 11.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klee et. al. (US Publication 20180199882A1) in view of Halperin et. al. (US Publication 20130267791A1) as applied to Claim 1 above, and further in view of Stahmann et. al. (US Publication 20050039745 A1).
Regarding Claim 16, Klee/Halperin teach the limitations of claim 1 but do not teach the following. Stahmann, which is directed to adaptive therapy for disordered breathing, teaches: wherein the one or more first measures of wellbeing and the one or more second measures of wellbeing relate to fatigue of the user ([0065] teaches on a patient reporting feeling tired after sleeping – interpreted as a measure of wellbeing “related to fatigue” of the user).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Klee/Halperin with these teachings of Stahmann, to incorporate a measure of wellbeing related to the fatigue of the user within the system of Klee/ Halperin, because feeling tired after sleeping could indicate the patient is having sleep disturbances (Stahmann [0065]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klee et. al. (US Publication 20180199882A1) in view of Halperin et. al. (US Publication 20130267791A1) as applied to Claim 1 above, and further in view of Singleton et. al. (US Publication 20230380776A1) .
Regarding Claim 17, Klee/Halperin teach the limitations of Claim 1 but do not teach the following. Singleton, which is directed to measuring impact of environmental factors on physiological data of a user, teaches: further comprising: determining one or more contributing factors that affect the wellbeing of the user during the off period, the on period, or a combination thereof, wherein the indication to the user correlates the one or more contributing factors with the one or more first measures of wellbeing, the one or more second measures of wellbeing, or a combination thereof ([0037] teaches on receiving environmental data associated with one or more characteristics of a user and feedback indicating a physical/physiological state of the user (interpreted as wellbeing of the user) while experiencing the one or more characteristics of the environment; environmental data/characteristics of environment is interpreted as a contributing factor affecting user’s wellbeing; [0040] teaches on the system determining a trend between air quality (environmental data, contributing factor) and user’s physiological data and displaying “an indication of the trend” to the user via a GUI).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Klee/Halperin with these teachings of Singleton, to determine one or more contributing factors which affect the user’s wellbeing during the on/off period of Klee/Halperin and displaying them to the user, with the motivation of detecting impacts of contributing factors such as environmental data on the user’s well-being and identifying relationships between contributing factors and user’s well-being (Singleton [0037], [0039]).
Regarding Claim 18, Klee/Halperin/Singleton teach the limitations of Claim 17. Singleton further teaches wherein the one or more contributing factors include one or more environmental factors ([0037] teaches on receiving environmental data associated with one or more characteristics of a user and feedback indicating a physical/physiological state of the user (interpreted as wellbeing of the user) while experiencing the one or more characteristics of the environment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Klee/Halperin with these teachings of Singleton, to include environmental factors as the contributing factors to a user’s wellbeing, with the motivation of identifying when a change over time periods associated with the environment could be associated with a physiological state of the user (Singleton [0100]).
Conclusion
In the interest of expediting prosecution, Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20200001031A1, teaching on system and method for increasing adherence to a pressure support therapy
US Publication 20220152406A1, teaching on systems and methods of monitoring wear compliance of a patient wearing an ambulatory medical device
US Patent 10318897B1, teaching on calculating a value of future adherence which is an expected cost of conversion from non-adherence to adherence of a patient to a healthcare regimen
US Publication 20170135629A1, teaching on determining a level of sleep of a user
US Publication 20230181105A1, teaching on sensor based therapy compliance of a patient to a treatment regimen
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682
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