DETAILED ACTION
This action is made in response to the amendments/remarks filed on February 6, 2026. This action is made final.
Claims 1, 2, 4, 6-9, 11, 12, 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 .
Response to Arguments
Applicant’s arguments with respect to the previous 101 rejection has been fully considered.
Upon reconsideration and in view of the Applicant’s amendments, the 101 rejection with respect to claims 26-29 (the system claims) are withdrawn.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 amendments appear to be directed to new matter.
As to the method claims 1, 2, 4, 6-9, 11, 12, 14, 15, 17-19, 21, 40, 41, and 44-46, Applicant is advised to amend the claims to recite a “computer-implemented method” to best overcome the previous 101 rejection. However, as rejected below, the claim amendments appear to be directed to new matter. The claims, as presently drafted being directed to a method rejected under 101 for reciting an abstract idea.
Applicant argues the claims recite a specific disease context and specific device-mediated course of treatment and therefore is integrated into a practical application.
Examiner respectfully disagrees. When considering if a particular treatment and prophylaxis is considered a practical application under Step 2A Prong Two, Examiner considered the factors presented in MPEP § 2106.04(d)(2)
(A). The particularity or generality of the treatment or prophylaxis. Here, the treatment plan determined from the abstract idea is not "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, a claim that recites an abstract idea and “administering a suitable medication to a patient” is not a particular administration step and is merely instructions to “apply” the exception in a generic way. Here, the treatment delivered is not specified. The only limitation regarding the type of treatment includes using a PAP system with a maximum and minimum pressure setting. While the claim recite that a therapy is provided to the patient, there is no particularity to the treatment; the claim does not state what the actual treatment/prophylaxis is, how often it is applied, the amount/concentration of treatment, the length of treatment, etc. Merely setting a maximum and minimum setting of pressurized air, without any specificity as to the maximum and minimum values, is not “particular”. Furthermore, the delivery of the treatment from a treatment device with appropriate settings may be manually programed by a human and not integrated into the computer system performing the abstract idea.
(B). Whether the limitations have more than a nominal or insignificant relationship to the exception. Here, the treatment limitation does not have a significant relationship to the judicial exception – that is it does not integrate the law of nature into a practical application. As stated above, because the delivered treatment is not defined, there is no correlation between some unknown treatment of unlimited range and the sleep/respiratory disorder. Insomuch as Applicant asserts the “automatically” setting of the PAP system disqualifies the limitation from being categorized as an abstract idea, the examiner, respectfully disagrees. Language such as concurrently, automatically, instantly, or simultaneously to describe the automation of a manual process is not enough to overcome a subject matter eligibility rejection (MPEP § 2106.05(a)(I) Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality (iii) mere automation of manual processes). Examiner also notes that language such as this is not restricted to computer processes, humans can automatically/instantly/simultaneously complete different tasks (see MPEP § 2106.04(a)(2)(III) stating that the mental processes may be completely by humans plural – not just a singular human mind).
(C). Whether the limitation(s) are merely extra-solution activity or a field of use. Here, the treatment or prophylaxis limitation does not impose meaningful limits on the judicial exception and is only extra-solution activity or a field-of-use (see MPEP § 2106.05(g))). The administering step of providing a cpap machine for sleep apnea is well known, nominally related to the concept of creating the treatment plan, and amount to outputting the result similar to that of In re Brown (see MPEP § 2106.05(g)). The step does not add a meaningful limitation to the process of determining a treatment plan for a patient.
Therefore, the claims do no recite a particular treatment/prophylaxis and the prophylactic step is recited as as a tool which only serves to as insignificant post solution activity (MPEP § 2106.05(g) - insignificant pre/post-solution activity) and is therefore not a practical application of the recited judicial exception.
Applicant’s argument with respect to the previous 103 rejection has been fully considered but is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Nolan teaches modifying a therapeutic device, such as a positive airway pressure (PAP) system, in accordance with a user profile data in which the settings can be automatically controlled by the system (e.g., see Abstract, 6:10-7:5, 21:2-6). Scarberry teaches monitoring the sleep quality of a patient over a series of sleep tests, in which the sleep quality can be measured objectively and subjectively from the patient (e.g., see Abstract, [0018]). Accordingly, it would have been obvious to modify the therapeutic device of Nolan after the subjective feedback received from 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). Furthermore, While Nolan and Scarberry teach the recommended therapy may include changes to the pressure of the device (e.g., see 17:11-15 of Nolan and [0032] of Scarberry), Nolan and Scarberry fail to explicitly teach a minimum and 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).
Accordingly, for at least the above stated reasons, the previous 103 rejection is 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, 6-9, 11, 12, 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, 6-9, 11, 12, 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.
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, 2, 4, 6-9, 11, 12, 14, 15, 17-19, 21, 40, 41, and 44-46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 2, 4, 6-9, 11, 12, 14, 15, 17-19, 21, 40, 42, and 44-46 recite a method of recommending a therapy, which is within the statutory category of a process.
Claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability. Alice Corp. v. CLS Bank Int'l, 573 U.S. ___ (2014). Claims 1, 2, 4, 6-9, 11, 12, 14, 15, 17-19, 21, 40, 41, and 44-46, each considered as a whole and as an ordered combination, are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
MPEP 2106 Step 2A – Prong 1:
The limitations of:
Claims 1 and 46 (claim 1 being representative)
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; receiving demographic information associated with the user; receiving subjective feedback associated with at least a portion of the initial sleep session from the user; 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, and the subjective feedback for the initial sleep session; performing 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; 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; receiving second subjective feedback from the user subsequent to the second sleep session; modifying the determined profile for the user based at least in part on the second physiological data and the second subjective feedback; automatically causing, by a 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; and providing the recommended therapy using the setting on the respiratory therapy system 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.
as presently drafted, under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. For example, but for the noted computer elements, the claim encompasses a person following rules or instructions to monitor user physiological data and subjective feedback and update the pressure settings of the PAP device in response to the assessed data in the manner described in the abstract idea. The examiner further notes that “methods of organizing human activity” includes a person’s interaction with a computer (see October 2019 Update: Subject Matter Eligibility at Pg. 5). If the claim limitation, under its broadest reasonable interpretation, covers managing persona behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
MPEP 2106 Step 2A – Prong 2:
This judicial exception is not integrated into a practical application because there are no meaningful limitations that transform the exception into a patent eligible application. The additional elements merely amount to instructions to apply the exception using generic computer components (“control system”—all recited at a high level of generality). Although they have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." (See MPEP 2106.04(d)(2) indicating mere instructions to apply an abstract idea does not amount to integrating the abstract idea into a practical application). Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea.
The claims only manipulate abstract data elements as part of performing the abstract idea. They do not set forth improvements to another technological field or the functioning of the computer itself and instead use computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. None of the additional elements recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
At the levels of abstraction described above, the claims do not readily lend themselves to a finding that they are directed to a nonabstract idea. Therefore, the analysis proceeds to step 2B. See BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349 (Fed. Cir. 2016) ("The Enfish claims, understood in light of their specific limitations, were unambiguously directed to an improvement in computer capabilities. Here, in contrast, the claims and their specific limitations do not readily lend themselves to a step-one finding that they are directed to a nonabstract idea. We therefore defer our consideration of the specific claim limitations’ narrowing effect for step two.") (citations omitted).
MPEP 2106 Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the same reasons as presented in Step 2A Prong 2. Moreover, the additional elements recited are known and conventional generic computing elements (“control system”—see Specification Fig. 1, [0023]-[0025], [0065] describing the various components as general purpose, common, standard, known to one of ordinary skill, and at a high level of generality, and in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy the statutory disclosure requirements). Therefore, these additional elements amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept that amounts to significantly more. See MPEP 2106.05(f).
The Federal Circuit has recognized that "an invocation of already-available computers that are not themselves plausibly asserted to be an advance, for use in carrying out improved mathematical calculations, amounts to a recitation of what is 'well-understood, routine, [and] conventional.'" SAP Am., Inc. v. InvestPic, LLC, 890 F.3d 1016, 1023 (Fed. Cir. 2018) (alteration in original) (citing Mayo v. Prometheus, 566 U.S. 66, 73 (2012)). Apart from the instructions to implement the abstract idea, they only serve to perform well-understood functions (e.g., receiving, translating, and displaying data—see Specification above as well as Alice Corp.; Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307 (Fed. Cir. 2016); and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) covering the well-known nature of these computer functions).
Dependent Claims
The limitations of dependent but for those addressed below merely set forth further refinements of the abstract idea without changing the analysis already presented. Claims 8, 10, 12, 14, 15, 17-19, 21, 28, 40, 41, 44, and 45 merely recite the type of data collected for determining the recommendation, which covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions).
Claims 2, 4, 6, and 7 further refine the abstract idea described in the independent claim and merely recite using a respiratory therapy system and/or its recommended parameters. Claims 9, 27 and 29 merely recite using sensors to collect data. These additional elements are considered to “apply it” under both the practical application and significantly more analysis, as detailed in the analysis above.
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 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 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 a 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 (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).
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 2, the rejection of claim 1 is incorporated. Nolan-Scarberry further teaches wherein the recommended therapy includes use of the respiratory therapy system during the sleep session (e.g., see Fig. 3, 14:30-35 of Nolan wherein the recommended therapy includes respiratory therapy. Notably, Scarberry additionally teaches the recommended therapy including respiratory therapy during the sleep session, see Fig. 4, [0032]).
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 system, 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 6, the rejection of claim 2 is incorporated. Nolan further teaches wherein the one or more recommended parameters for the recommended therapy include a minimum pressure setting for the respiratory therapy system, a maximum pressure setting for the respiratory therapy system, or both (e.g., see 6:4-7, 25:8-9, 20 wherein the recommended therapy includes pressure settings for a respiratory device, including ranges values thereof).
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 6 (inclusive of claim 1) and is similarly rejected.
Claim(s) 8, 11, 12, 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 12, the rejection of claim 11 is incorporated. Nolan fails to teach receiving second subjective feedback from the user subsequent to the second sleep session, wherein the modifying the determined profile is further based at least in part on the second subjective feedback.
However, in the same field of endeavor of therapeutic devices, Heneghan teaches receiving second subjective feedback from the user subsequent to the second sleep session, wherein the modifying the determined profile is further based at least in part on the second subjective feedback (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 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/STELLA HIGGS/ Primary Examiner, Art Unit 3686