DETAILED ACTION
This action is made in response to the request for continued examination filed on June 17, 2026. This action is made non-final.
Claims 1, 2, 4, 7-9, 11, 14, 15, 17-19, 21, 26-29, 40, 41, and 44-46 are pending. Claims 3, 5, 7, 10, 13, 16, 20, 22-25, 30-39, 42, and 43 have been previously cancelled. Claims 1, 26, and 46 have been amended. Claims 1, 26, and 46 are independent claims.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 17, 2026 has been entered.
Response to Arguments
In view of the Applicant’s amendments, the 101 rejection has been withdrawn. The claimed invention is subject matter eligible based on MPEP 2106.04(d) as it improves the functioning of another technology or technical field. However, as rejected below, the claim limitations appear to be directed to new matter.
With respect to the 112(a) rejection, Applicant argues the specification teaches “automatically causing, by a control system, a minimum pressure setting, a maximum pressure setting, or both, on the PAP system” and (2) providing the recommended therapy using the modified minimum pressure setting, the modified maximum pressure setting, or both, on the PAP system ... by delivering pressurized air". The 112(a) rejection is withdrawn with respect to “automatically causing, by a control system” in view of paragraphs [0095] and [0120]. However, the examiner respectfully disagrees the originally filed specification provides support for providing the recommended therapy using the modified minimum pressure setting, the modified maximum pressure setting, or both, on the PAP system ... by delivering pressurized air".
With respect to the “providing the recommended therapy using the modified minimum pressure setting, the modified maximum pressure setting, or both, on the PAP system ... by delivering pressurized air", Applicant relies on [0030] and [0037] and the as providing support. While [0030] and [0037] teach a respiratory system such as a positive airway system that delivers pressurized air, the recited paragraphs fail to teach providing the recommended therapy using the modified minimum pressure setting, the maximum pressure setting, or both on the PAP system…by delivering pressurized air. In other words, the specification, at best teaches modifying the settings and communicating the modifications, on a display, but is silent as to actually providing the PAP therapy to the user with the modified settings on the PAP device itself. As such, the previous 112(a) rejection is maintained.
With respect to the 103 rejection, Applicant argues the previously cited reference, Nolan is a feedback system that compares a patient’s profile data to those of other patients but does not teach “modifying the determined profile for the user based at least in part on the second physiological data and the second subjective feedback,”, where “the second physiological data is received from one or more sensors coupled to or integrated in the PAP system” and “wherein the control system is coupled to or positioned within a portion of the respiratory therapy device”. However, the examiner respectfully disagrees.
Nolan teaches a patient feedback system for providing feedback information to the patient as well as to a therapeutic device. Nolan further teaches the determining a personal profile data of the user based on the patient’s physiology or medical situation, wherein the system obtains patient data through various monitoring devices (e.g., see 21:9-18). Nolan further teaches updating a database will any new changes that contribute to device settings changes, updating the therapeutic device settings based on the data, and “automatically adapt the personal settings of the patient’s therapeutic device according to the reference device settings” using the control elements (e.g., see Figs. 1-3, 19:12-20:8, 21:5-6). Notably, Figs. 1-3 of Nolan illustrating a control element as part of the system is similar to at least Fig. 1 of Applicant’s originally filed specification and is consisted with reading upon the claim language “wherein the control system is coupled to or positioned within a portion of the respiratory therapy device”. As such, Nolan teaches “modifying the determined profile for the user based at least in part on the second physiological data”, where “the second physiological data is received from one or more sensors coupled to or integrated in the PAP system”, and “automatically causing, by the control system, a pressure setting to be modified based on the modified determined profile, wherein the control system is coupled to or positioned within a portion of the respiratory therapy device”. While previously, cited Scarberry was relied upon for teaching, among other things, “receiving subjective feedback” and Kayyali was relied upon for teaching the “minimum and maximum pressure settings”, Applicant makes no remarks as to the explicit limitations for which these references were relied upon and merely argues the references do not teach the features for which Nolan is cited as teaching, which has been addressed above. Accordingly, for at least the above stated reasons, and those below, the previous grounds of rejection are maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, 7-9, 11, 14, 15, 17-19, 21, 26-29, 40, 41, and 44-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to independent claims 1, 26, and 46, the claims recite, among other things “automatically causing, by a control system, a minimum pressure setting, a maximum pressure setting, or both, on the PAP system” and “providing the recommended therapy using the modified minimum pressure setting, the modified maximum pressure setting, or both, on the PAP system… by delivering pressurized air”. However, a review of the specification fails to teach or disclose the control system that automatically causes a pressure setting in the PAP system, nor does it disclose providing the therapy using those pressure settings by delivering pressurized air. Rather, the specification discloses a control system that can determine a recommended therapy and further discloses communicating the recommended therapy to the user (e.g., see [0005], [0121]). While [0023] states the control system can be used to actuate various components of the system and further suggests a recommended therapy can include the use of a respiratory system with the maximum and minimum settings of a user profile ([0119]), the originally filed specification is silent as to “automatically causing, by the control system, a minimum pressure setting, a maximum pressure setting, or both on the PAP system” and further fails to teach “providing the recommended therapy using the modified minimum pressure setting, the modified maximum pressure setting, or both, on the PAP system… by delivering pressurized air”.
Appropriate correction is required.
Dependent claims 2, 4, 7-9, 11, 14, 15, 17-19, 21, 27-29, 40, 41, and 44-45 Fail to resolve the 112 deficiency of their parent claims and are similarly rejected.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “providing the recommended therapy using the modified minimum pressure setting, the modified maximum pressure setting, or both, on the PAP system to treat the sleep- related or respiratory-related disorder of the user by delivering pressurized air via the user interface to aid in preventing the airway of the user from narrowing or collapsing during sleep, wherein the one or more recommended parameters include the minimum pressure setting and the maximum pressure setting, and wherein the PAP system is actuated to deliver pressurized air using the minimum pressure setting and the maximum pressure setting as bounds during the second sleep session” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1, 2, 4, 6, 9, 17, 18, 21, 26-29, 40, 44, and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nolan (WO 2015/062897; hereinafter Nolan) in further view of Scarberry (USPPN: 2019/0021654; hereinafter Scarberry) and Kayyali et al. (USPN: 8,545,416; hereinafter Kayyali).
As to claim 1, Nolan teaches A computer-implemented method (e.g., see Abstract, 3:20-25) comprising:
receiving, during at least a portion of an initial sleep session, first physiological data associated with a user suffering from a sleep-related or respiratory-related disorder (e.g., see 5:8-14, 6:14-16, 10:2-6, 14:4-8 wherein physiological data of a patient is received during at least a portion of their sleep, wherein the patient is being treated for a respiratory condition and/or sleep apnea);
receiving demographic information associated with the user (e.g., see 16:25-26 teaching receiving profile parameters of a patient including their sex, weight, height, size, age, etc.);
determining a profile for the user based at least in part on the first physiological data associated with the user, the demographic information associated with the user (e.g., see 19: 24-35 wherein a cohort (i.e., profile) matching the patient based on the patient data is identified),
performing, by a control system, a diagnosis that provides (i) a recommended therapy for the user and (ii) one or more recommended parameters for the recommended therapy based at least in part on a comparison between the determined profile for the user and other profiles associated with a plurality of other users to aid in identifying a most effective therapy for the user, the other profiles being determined based on respective physiological data, demographic information, and subjective feedback of the plurality of other users (e.g., see 5:15-23, 9:9-15, 17:11-16, 19:24-35, 20: 7-9 wherein a recommended therapy including one or more recommended parameters for the therapy are determined based on the patient profile and those of other patients with similar profiles including physiological data, demographic information, and their results).
receiving second physiological data associated with the user during at least a portion of a second sleep session involving the recommended therapy and the one or more recommended parameters, the recommended therapy including use of a positive airway pressure (PAP) system comprising a respiratory therapy device configured to generate pressurized air and a user interface configured to engage a portion of the user’s face and deliver the pressurized air to an airway of the user, wherein the second physiological data is received from one or more sensors coupled to or integrated in the PAP system (e.g., see Fig. 3, 5:10-11, 17:13-16, 21:9-19 teaching monitoring user physiological data using a sensor of the system, which includes the PAP device (i.e., coupled to), while they sleep and storing the profile parameters automatically, wherein the user is using the therapeutic device, such as a PAP machine which delivers pressurized air to the patient’s airway via a mask engaged to the user’s face);
modifying the determined profile for the user based at least in part on the second physiological data (e.g., see Fig. 3, 21:9-19 teaching automatically storing the profile parameters based on the measure physiological data); and
automatically causing, by the control system, a minimum pressure setting, a maximum pressure setting, or both, on the PAP system to be modified based on the modified determined profile to aid in increasing the efficacy of the therapy, wherein the control system is coupled to or positioned within a portion of the respiratory therapy device (e.g., see Figs. 1-3, 19:11-13, 21:3-8 wherein the device settings can be automatically adjusted in accordance with the reference device settings of the identified cohort, wherein each new contribution of profile data and device settings contributes to the database for identifying the cohorts and the control element is coupled to the therapy device).
While Nolan teaches receiving patient data, including physiological and demographic data and further teaches receiving feedback data (e.g., see 18:18-24), wherein a recommended therapy and its settings are provided based on the received data, Nolan fails to teach receiving subjective feedback associated with at least a portion of the initial sleep session from the user; determining a profile based at least in part on the subjective feedback for the initial sleep session; receiving second subjective feedback from the user subsequent to the second sleep session.
However, in the same field of endeavor of therapeutic devices, Scarberry teaches receiving subjective feedback associated with at least a portion of the initial sleep session from the user (e.g., see Abstract, [0018] wherein a user may provide subjective sleep quality information during an initial sleep test); and determining a profile based at least in part on the subjective feedback for the initial sleep session (e.g., see Abstract, Fig. 3, [0028]-[0031] teaching receiving subjective user feedback for the quality of their sleep (i.e., initial sleep session) wherein the subjective data is used to identify where a user fits a group for making various recommendations); receiving second subjective feedback from the user subsequent to the second sleep session (e.g., see Abstract, Fig. 3, [0018], [0033] wherein patient’s sleep quality is received on a second or subsequent sleep test).
Furthermore, while Nolan is relied upon as teaching receiving second physiological data, it is noted Scarberry additionally teaches receiving second physiological data associated with the user during at least a portion of a second sleep session involving the recommended therapy and the one or more recommended parameters, the recommended therapy including use of a respiratory therapy system (e.g., see Abstract, Fig. 3, [0033] wherein the efficacy of the treatment is determined by measuring sleep quality signals during a second (or successive) sleep test using the identified treatment, the identified treatment can include an airway treatment); modifying the determined profile for the user based at least in part on the second physiological data and the second subjective feedback (e.g., see Abstract, Fig. 3, [0034] wherein the user is kept in the same treatment or recommended to different treatment based on the measured sleep quality signals, wherein sleep quality can be described subjectively by the patient).
Accordingly, it would have been obvious to modify Nolan in view of Scarberry with a reasonable expectation of success. One would have been motivated to make the modification to provide sufficient information about the condition of a patient in order to optimize treatment (e.g., see [0003] of Scarberry).
Nolan-Scarberry teach providing the recommended therapy using the modified minimum pressure setting, the modified maximum pressure setting, or both, on the PAP system to treat the sleep-related or respiratory-related disorder of the user by delivering pressurized air via the user interface to aid in preventing the airway of the user from narrowing or collapsing during sleep, wherein the one or more recommended parameters includes the minimum pressure setting and the maximum pressure setting, and wherein the PAP system is actuated to deliver pressurized air using the minimum pressure setting and the maximum pressure setting as bounds during the second sleep session (Notably, “to treat the sleep-related or respiratory-related disorder of the user by delivering pressurized air via the user interface to aid in preventing the airway of the user from narrowing or collapsing during sleep” and “wherein the PAP system is actuated to deliver pressured air using the minimum pressure setting and maximum pressure setting as bounds during the second sleep session” is interpreted as being an intended use or result statements. Applicant is remined that, typically, no patentable distinction is made by an intended use or result unless some structural difference is imposed by the use or result on the structure or material recited in the claim, or some manipulative difference is imposed by the use or result on the action recited in the claim. An intended use generally does not impart a patentable distinction if it merely states an intention or is a description of how the claimed apparatus is to be used. An intended result is a description of what necessarily happens as a result of the structure or actions recited in the claims (See MPEP 2111.05. Nonetheless, Nolan-Scarberry teach providing the recommended therapy e.g., see Fig. 3, 1:14-2:3 of Nolan teaching the use of PAP devices that deliver pressurized air to keep patient airway open while sleeping in accordance with recommended therapy settings, wherein Scarberry teaches updating a recommended therapy). While Nolan-Scarberry teach providing the recommended therapy, wherein Nolan teaches the recommended therapy can be related to the flow rate or air pressure, Nolan-Scarberry fail to explicitly teach a wherein the one or more recommended parameters includes the minimum pressure setting and the maximum pressure setting
However, in the same field of endeavor of diagnosing and treating sleep-related conditions, Kayyali teaches wherein the one or more recommended parameters includes the minimum pressure setting and the maximum pressure setting (e.g., see 2:19-21, 51:39-52:3 wherein a recommended treatment therapy is provided in which the settings of the device are adjusted with a maximum and minimum pressure settings for the patient’s sleep cycle). Accordingly, it would have been obvious to modify Nolan-Scarberry in view of Kayyali with a reasonable expectation of success. One would have been motivated to make the modification in order to treat the patient using identified optimal pressure parameters to improve or treat the patient’s symptoms or sleep disorder (e.g., see 2:39-44 of Kayyali).
As to claim 4, the rejection of claim 2 is incorporated. Nolan further teaches wherein the one or more recommended parameters for the recommended therapy includes a recommended user interface for the respiratory therapy device, wherein the recommended user interface is a face mask, a nasal mask, a nasal pillow mask, or a mouthpiece (e.g., see 2:6, 17:17 wherein the therapy includes a face/mouth/nose mask).
As to claim 7, the rejection of claim 1 is incorporated. Nolan further teaches wherein the one or more recommended parameters for the recommended therapy include a recommended duration for the recommended therapy (e.g., see 6:7 wherein a recommendation includes operating hours (i.e., duration)).
As to claim 9, the rejection of claim 8 is incorporated. Nolan further teaches wherein the first physiological data is received from a first sensor and the second physiological data is received from a second sensor that is different than the first sensor (e.g., see 14:8-10 teaching the use of multiple sensors. While Nolan teaches the claimed limitation, it is noted Heneghan also teaches the use of multiple sensors, e.g., see also [0071] of Heneghan).
As to claim 17, the rejection of claim 11 is incorporated. Nolan further teaches wherein at least one of the initial sleep session or the second sleep session is a diagnostic sleep session (The claim limitation of “the initial/second sleep session is a diagnostic sleep session” is interpreted as being an intended use. Applicant is remined that, typically, no patentable distinction is made by an intended use or result unless some structural difference is imposed by the use or result on the structure or material recited in the claim, or some manipulative difference is imposed by the use or result on the action recited in the claim. An intended use generally does not impart a patentable distinction if it merely states an intention or is a description of how the claimed apparatus is to be used. (See MPEP 2111.05). In the present case the manner in which data from a sleep session is acquired does not impose any structural difference in the collection of said data, therefore, any type of “session” in which it is acquired meets the claimed limitation. Nonetheless, see 10:6, 18:8 teaching collecting the sleep data from a medical personal for procedures and/or studies).
As to claim 18, the rejection of claim 1 is incorporated. Nolan further teaches further comprising determining whether the user experienced one or more events during the initial sleep session based at least in part on the physiological data (e.g., see 21:9-15 teaching detecting an apnea related parameter based on monitoring devices).
As to claim 21, the rejection of claim 1 is incorporated. Nolan further teaches wherein the demographic information associated with the user includes an age of the user, a gender of the user, a weight of the user, a body mass index of the user, a height of the user, a race of the user, a family history of insomnia, an employment status of the user, an educational status of the user, a socioeconomic status of the user, one or more medical conditions associated with the user, medication usage by the user, or any combination thereof (e.g., see 9:30-31 wherein the demographic information includes sex, age, weight, height, medical history, medical devices used, etc. Notably, while the claims recite “any combination thereof” and is therefore taught by Nolan, it is noted Heneghan further teaches demographic information including socio-economic status, BMI, environmental factors, health issues, etc.).
As to claim 26, the claim is directed towards the system implementing the method of claim 1 and further claim an electronic interface, a memory, a control system (e.g., see Fig. 1, 18:15-20, 25:23-25) and is similarly rejected.
As to claim 27, the rejection of claim 26 is incorporated. Nolan further teaches a first sensor configured to generate the first physiological data (e.g., see 10:18-20 teaching a sensor for obtaining physiological data).
As to claim 29, the rejection of claim 26 is incorporated. Nolan further teaches a second sensor configured to generate the second physiological data, wherein the second sensor is physically coupled to or integrated to a user device or an activity tracker (e.g., see 14:8-10 teaching the use of multiple sensors directly or remotely connected to the system. While Nolan teaches the claimed limitation, it is noted Heneghan also teaches the use of multiple sensors physically coupled to a user device, e.g., see also [0076], [0086] of Heneghan).
As to claim 40, the rejection of claim 1 is incorporated. Nolan further teaches wherein the recommended therapy for the user is determined based on another therapy of the one or more of the plurality of other users, the another therapy being selected from other profiles that are most similar to the profile for the user (e.g., see 5:15-23, 9:9-15, 17:11-16, 19:24-35, 20: 7-9 wherein a recommended therapy including one or more recommended parameters for the therapy are determined based on the patient profile and those of other patients with similar profiles including physiological data, demographic information, and their results).
As to claim 44, the rejection of claim 1 is incorporated. Nolan further teaches wherein the profile for the user is determined based on one or more reported symptoms and test results (e.g., see 10:1-15 wherein the sleep data for generating the patient profile is collected from a medical personal of procedures and/or studies (i.e., symptoms/test results)).
As to claim 45, the rejection of claim 1 is incorporated. Nolan further teaches wherein the profile for the user is determined prior to the diagnosis of the recommended therapy or the one or more recommended parameters for the recommended therapy (e.g., see 16:1-7 wherein the patient profile is determined before recommended therapy and/or treatment).
As to claim 46, the claim is directed to the method of claim 1 and is similarly rejected.
Claim(s) 8, 11, 14, 15, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nolan, Scarberry, and Kayyali, as applied above, and in further view of Heneghan et al. (USPPN2016/0270718; hereinafter Heneghan).
As to claim 8, the rejection of claim 1 is incorporated. Nolan teaches receiving physiological data associated with the user (e.g., see Fig. 3, 21:9-19 teaching monitoring user physiological data);
modifying the determined profile for the user based at least in part on the physiological data (e.g., see Fig. 3, 21:9-19 teaching automatically storing the profile parameters based on the measure physiological data); and
modifying the recommended therapy, the one or more recommended parameters for the recommended therapy, or both based at least in part on the modified determined profile for the user (e.g., see 19:11-13, 21:3-8 wherein the device settings can be automatically adjusted in accordance with the reference device settings of the identified cohort, wherein each new contribution of profile data and device settings contributes to the database for identifying the cohorts).
Nolan fails to teach the physiological data being additional physiological data associated with the user subsequent to the initial sleep session and prior to the second sleep session.
However, in the same field of endeavor of therapeutic devices, Heneghan teaches receiving additional physiological data associated with the user subsequent to the initial sleep session and prior to the second sleep session (e.g., see [0048]-[0050]] teaching repetitive monitoring of patient activity, including those while the user is awake (i.e., subsequent to an initial sleep session and prior to a second sleep session)); modifying the determined profile for the user based at least in part on the second physiological data; and modifying the recommended therapy, the one or more recommended parameters for the recommended therapy, or both based at least in part on the modified determined profile for the user (e.g., see [0048], [0056], [0181], [0200], [0201] teaching modifying the patient profile based on the collected data, wherein the data is used to identify where a user fits within a population for making various recommendations).
Accordingly, it would have been obvious to modify Nolan in view of Heneghan with a reasonable expectation of success. One would have been motivated to make the modification to assist in the monitoring and management of fatigue in a more objective and personalisable way (e.g., see [0040] of Heneghan).
As to claim 11, the rejection of claim 1 is incorporated. Nolan fails to teach receiving third physiological data associated with the user during at least a portion of a second sleep session that is subsequent to the initial sleep session, wherein the recommended therapy is used during the second sleep session; and modifying the determined profile for the user based at least in part on the third physiological data.
However, in the same field of endeavor of therapeutic devices, Heneghan teaches receiving third physiological data associated with the user during at least a portion of a second sleep session that is subsequent to the initial sleep session, wherein the recommended therapy is used during the second sleep session (e.g., see [0048], [0049], [0173] teaching repetitive monitoring of objective patient sleep measures using various sensors and patient compliance with the recommended therapy); modifying the determined profile for the user based at least in part on the third physiological data (e.g., see [0048], [0056], [0181], [0200], [0201] teaching modifying the patient profile based on the collected data, wherein the data is used to identify where a user fits within a population for making various recommendations).
Accordingly, it would have been obvious to modify Nolan in view of Heneghan with a reasonable expectation of success. One would have been motivated to make the modification to assist in the monitoring and management of fatigue in a more objective and personalisable way (e.g., see [0040] of Heneghan).
As to claim 14, the rejection of claim 11 is incorporated. Nolan fails to teach wherein the modifying the one or more recommended parameters for the recommended therapy includes reducing a recommended duration for the recommended therapy.
However, in the same field of endeavor of therapeutic devices, Heneghan teaches wherein the modifying the one or more recommended parameters for the recommended therapy includes reducing a recommended duration for the recommended therapy (e.g., see [0056], [0173]-[0184] teaching one or more recommended therapies including increasing/reducing duration).
Accordingly, it would have been obvious to modify Nolan in view of Heneghan with a reasonable expectation of success. One would have been motivated to make the modification to assist in the monitoring and management of fatigue in a more objective and personalisable way (e.g., see [0040] of Heneghan).
As to claim 15, the rejection of claim 11 is incorporated. Nolan fails to explicitly teach determining a second recommended therapy for the user that is different than the recommended therapy based at least in part on the third physiological data, the second subjective feedback, or both.
However, in the same field of endeavor of therapeutic devices, Heneghan teaches determining a second recommended therapy for the user that is different than the recommended therapy based at least in part on the third physiological data, the second subjective feedback, or both (e.g., see [0048], [0056], [0118], [0181], [0200], [0201] teaching a repetitive process of modifying the patient profile based on the collected data over time, wherein the data, including subjective questionnaire data, is used to identify where a user fits within a population for making various recommendations).
Accordingly, it would have been obvious to modify Nolan in view of Heneghan with a reasonable expectation of success. One would have been motivated to make the modification to assist in the monitoring and management of fatigue in a more objective and personalisable way (e.g., see [0040] of Heneghan).
As to claim 28, the claim is directed towards the system implementing the method of claim 8 and is similarly rejected.
Claim(s) 19 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nolan, Scarberry, and Kayyali, as applied above, and in further view of Goff et al. (USPPN: 2019/0142625; hereinafter Goff).
As to claim 19, the rejection of claim 18 is incorporated. Nolan teach wherein the determining the profile for the user is based at least in part on the determined one or more events experienced by the user during the initial sleep session (e.g., see 10:1-15 of Nolan teaching identifying whether a user has obstructive sleep apnea based on one or more events indicating a sleep apnea event). However, Nolan-Heneghan fail to explicitly teach wherein the one or more events includes a positional sleep apnea
However, in the same field of endeavor of detecting sleep apnea, Goff teaches wherein the one or more events includes a positional sleep apnea (e.g., see [0017], [0044] wherein a user sleep profile includes their sleeping position such as on their back or side).
Accordingly, it would have been obvious to modify Nolan-Scarberry in view of Goff with a reasonable expectation of success. One would have been motivated to make the modification in order to provide better therapy and better understanding of efficacy of treatment based on a person’s sleeping position (e.g., see [0012]-[0016] of Goff).
As to claim 41, the rejection of claim 1 is incorporated. Nolan-Scarberry fail to teach wherein the profile for the user is further based on one or more body positions of the user during at least a portion of the initial sleep session, wherein the one or more body positions include one or more of a first position in which the user is laying generally on a user side, a second position in which the user is laying generally on a user back, a third position in which the user is laying generally face down, a fourth position in which the user is inclined, or a fifth position in which the user is declined.
However, in the same field of endeavor of detecting sleep apnea, Goff teaches wherein the profile for the user is further based on one or more body positions of the user during at least a portion of the initial sleep session, wherein the one or more body positions include one or more of a first position in which the user is laying generally on a user side, a second position in which the user is laying generally on a user back, a third position in which the user is laying generally face down, a fourth position in which the user is inclined, or a fifth position in which the user is declined (e.g., see [0017], [0044] wherein a user sleep profile includes their sleeping position such as on their back or side).
Accordingly, it would have been obvious to modify Nolan-Scarberry in view of Goff with a reasonable expectation of success. One would have been motivated to make the modification in order to provide better therapy and better understanding of efficacy of treatment based on a person’s sleeping position (e.g., see [0012]-[0016] of Goff).
Relevant Art not Cited
As a courtesy, the following prior art documents have been found during the course of examination and deemed relevant to applicant’s disclosure. Applicant is strongly encouraged to review the following references prior to any amendments/remarks:
Shugg et al. (USPPN: 2021/0007659): System and method for sleep disorders: screening, testing, and management
Klee et al. (WO 2016/0192941): System for increasing a patient’s compliance with a therapy relating to an upper airway disorder
It is noted that any citation to specific pages, columns, lines, or figures in the prior art references and any interpretation of the references should not be considered to be limiting in any way. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Further, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
Conclusion
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/STELLA HIGGS/ Primary Examiner, Art Unit 3686
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