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 .
Response to Amendment
Amendment received on 1/30/2026 is acknowledged and entered. Claims 12-13, 15-16, 19, 22-23, 26-27, 29-34 and 38-41 have been previously canceled. Claims 1, 3, 24-25, 35-36 and 42 have been amended. Claims 1-11, 14, 17-18, 20-21, 24-25, 28, 35-37 and 42-43 are currently pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/2025 is being 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 1-11, 14, 17-18, 20-21, 24-25, 28 and 35-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
In determining whether a claim falls within an excluded category, the Examiner is guided by the Court’s two-part framework, described in Mayo and Alice. Id. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)); Bilski v. Kappos, 561 U.S. 593, 611 (2010); 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019); the October 2019 Update of the 2019 Revised Guidance (Oct. 17, 2019); 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (July 17, 2024), and the USPTO’s Paten Subject Matter Eligibility Memorandums of August 4, 2025 and December 5, 2025.
Step 1
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 (i.e., laws of nature, natural phenomena, and abstract ideas). Alice Corp. v. CLS Bank Int'l, 573 U. S. ____ (2014). Claims 1 and 35 are directed to a statutory category, because a series of steps for calculating a total health score associated with a sleep session satisfies the requirements of a process (a series of acts). (Step 1: Yes).
Next, the claim is analyzed to determine whether it is directed to a judicial exception.
Step 2A – Prong 1
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more of calculating a total health score associated with a sleep session. The claim recites:
1. A method comprising:
causing one or more sensors to generate physiological data associated with a sleep session, the physiological data including first physiological data collected during the sleep session and second physiological data collected during a duration adjacent the sleep session, the one or more sensors including a flow rate sensor and/or a pressure sensor integrated in a respiratory therapy system;
receiving subjective feedback data associated with the sleep session;
generating a set of component scores based on the physiological data and the subjective feedback data;
calculating a total health score associated with the sleep session using the set of component scores;
adjusting a pressure setting associated with the respiratory therapy system based at least in part on the physiological data associated with the sleep session;
causing, via the respiratory therapy system, pressurized air to be supplied to a user using the adiusted pressure settings; and
presenting the total health score in a graphical user interface, the graphical user interface having a dashboard view,
wherein the dashboard view presents the total health score as a total health score indication having a numerical health score indication and a plurality of graphical health score component indications associated with the set of component scores, the plurality of graphical health score component indications provided as sub-areas of a total shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score contributing to the total health score.
The limitations of receiving physiological data; receiving feedback data; generating a set of scores; calculating a health score; adjusting a pressure setting; causing air to be supplied, and presenting the score, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind, which may be practically performed in the human mind using observation, evaluation, judgment, and opinion (MPEP 2106.04(a)(2), subsection III), and/or certain methods of organizing human activity but for the recitation of generic computer components. (Note: Examiner’s language (e.g. “receiving physiological data”; “receiving feedback data”; etc.) is an abbreviated reference to the detailed claim steps and is not an oversimplification of the claim language; the Examiner employing such shortcuts (that refer to more specific steps) when attempting to explain the rejection). For example, the physiological data of a patient can be received or observed by a physician during in person training session, during which the physician can evaluate or score patient’s performance, and adjust the pressure settings of the respiratory system himself/herself, or advise the patient to do it (“causing” limitation). Then the physician can discuss the results with the patient, and they may review those results in the contest of other patients’ records. Thus, other than reciting “by a processor,” nothing in the claim element precludes the step from practically being performed in the mind, and/or performed as organized human activity. Aside from the general technological environment (addressed below), it covers purely mental concepts and/or certain methods of organizing human activity processes, and the mere nominal recitation of a generic network appliance (e.g. an interface for inputting or outputting data, or generic network-based storage devices and displays) does not take the claim limitation out of the mental processes and/or certain methods of organizing human activity grouping.
Specifically, the utilizing statistical tools to process data and to output the estimated values - said functions could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., mental comparison regarding a sample or test subject to a control or target data in Ambry, Myriad CAFC, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) (Grams)). In Grams, the recited functions require obtaining data or patient information (from sensors), and analyze that data to ascertain the existence and identity of an abnormality or estimated responses, and possible causes thereof. While said functions are performed by a computer, they are in essence a mathematical algorithm, in that they represent "[a] procedure for solving a given type of mathematical problem." Gottschalk v. Benson, 409 U.S. 63, 65, 93 S.Ct. 253, 254, 34 L.Ed.2d 273 (1972). Moreover, the Federal Circuit has held, “without additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.” Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1351 (Fed. Cir. 2014). Further, “analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, [are] essentially mental processes within the abstract-idea category.” Elec. Power, 830 F.3d at 1354; see also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir. 2016). “[T]he fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.” Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012).
It is similar to other abstract ideas held to be non-statutory by the courts. See, also, Mayo Collaborative Svcs. v. Prometheus Labs. 566 U.S. __, 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012), - Optimizing drug therapeutic efficacy for treatment of immune-mediated gastrointestinal disorders; Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363 (Fed. Cir. 2015)—tailoring sales information presented to a user based on, e.g., user data and time data; TLI Communications LLC v. AV Automotive LLC 823 F.3d 607, 118 U.S.P.Q.2d 1744 (Fed. Cir. 2016) - recording, transmitting and administering digital images; DataTreasury Corp. v. Fidelity National Information Services 669 Fed. Appx. 572 (Fed. Cir. 2016) - remote image capture with centralized processing and storage; RecogniCorp LLC v. Nintendo Co. 855 F.3d 1322, 122 U.S.P.Q.2d 1377 (Fed Cir. 2017) - encoding and decoding image data; Intellectual Ventures I LLC v. Erie Indemnity Co. 850 F.3d 1315, 121 U.S.P.Q.2d 1928 (Fed Cir. 2017) - mobile interface for accessing remotely stored documents, and retrieving data from a database using an index of XML tags and metafiles.
As per receiving, storing and outputting data limitations, it has been held that “As many cases make clear, even if a process of collecting and analyzing information is ‘limited to particular content’ or a particular ‘source,’ that limitation does not make the collection and analysis other than abstract.” SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1168 (Fed. Cir. 2018) (citation omitted); see also In re Jobin, 811 F. App’x 633, 637 (Fed. Cir. 2020) (claims to collecting, organizing, grouping, and storing data using techniques such as conducting a survey or crowdsourcing recited a method of organizing human activity, which is a hallmark of abstract ideas).
All these cases describe the significant aspects of the claimed invention, albeit at another level of abstraction. See Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240-41 (Fed. Cir. 2016) ("An abstract idea can generally be described at different levels of abstraction. As the Board has done, the claimed abstract idea could be described as generating menus on a computer, or generating a second menu from a first menu and sending the second menu to another location. It could be described in other ways, including, as indicated in the specification, taking orders from restaurant customers on a computer.").
Therefore, if a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” and/or “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. (Step 2A – Prong 1: Yes).
Step 2A – Prong 2
In Prong Two, the Examiner determines whether claim 1, as a whole, recites additional elements that integrate the judicial exception into a practical application of the exception, i.e., whether the additional elements apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the judicial exception. See Guidance, 84 Fed. Reg. at 54-55. If the additional elements do not integrate the judicial exception into a practical application, then the claim is directed to the judicial exception. See id., 84 Fed. Reg. at 54. “An additional element [that] reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field” is indicative of integrating a judicial exception into a practical application. See Guidance, 84 Fed. Reg. at 55.
The Examiner determined that 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. In particular, the claim recites additional elements – using a processor to perform the steps of receiving physiological data; receiving feedback data; generating a set of scores; calculating a health score; adjusting a pressure setting; causing air to be supplied, and presenting the score. However, the processor in each step is recited (or implied) at a high level of generality, i.e., as a generic processor performing a generic computer functions of processing data, including receiving, storing, comparing, and outputting data. This generic processor limitation is nor more than mere instructions to apply the exception using a generic computer component. See MPEP 2106.05(f). The processor that performs the recited steps merely automates these steps which can be done mentally or manually. Thus, while the additional elements 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." The claim only manipulates abstract data elements into another form, and does not set forth improvements to another technological field or the functioning of the computer itself and, instead, uses computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above.
Further, 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 "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)).
The recited steps do not control or improve operation of a machine (MPEP 2106.05(a)), do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)), and do not apply the judicial exception with, or by use a particular machine (MPEP 2106.05(b)), but, instead, require receiving, comparing, storing and outputting data.
Furthermore, compare to Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018) (Vanda), claim 1 is directed to conventional health information collecting and processing routine, and outputting said information to a user. Contrary to Vanda, claim 1 as a whole does not identify a particular medical application and does not discover a particular treatment for a particular medical condition. Similar to Mayo, claim 1 as a whole is not directed to the application of a drug to treat a particular disease." (The Federal Circuit noted that while the "claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease." Id. at 1134). Accordingly, while claim 1 recites the steps of receiving physiological data; receiving feedback data; generating a set of scores; calculating a health score; adjusting a pressure setting; causing air to be supplied, and presenting the score, said steps are conducted without discovering or establishing a natural relationship between the drug or medicine and a human body for a particular medical condition. Thus, similar to Mayo, claim 1 is not a "method of treatment" claim that practically apply the natural relationship.
As per receiving, storing and/or outputting data limitations, these recitations amount to mere data gathering and/or outputting, is insignificant post-solution or extra-solution component and represents nominal recitation of technology. Insignificant "post-solution” or “extra-solution" activity means activity that is not central to the purpose of the method invented by the applicant. However, “(c) Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the execution of the claimed method steps. Use of a machine or apparatus that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would weigh against eligibility”. See Bilski, 138 S. Ct. at 3230 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, ___ (1978)). Thus, claim drafting strategies that attempt to circumvent the basic exceptions to § 101 using, for example, highly stylized language, hollow field-of-use limitations, or the recitation of token post-solution activity should not be credited. See Bilski, 130 S. Ct. at 3230.
Thus, the claim as a whole, outputs only data structure, - everything remains in the form of a code stored in the computer memory. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Therefore, the claim is directed to an abstract idea. (Step 2A – Prong 2: No).
Step 2B
If a claim has been determined to be directed to a judicial exception under revised Step 2A, examiners should then evaluate the additional elements individually and in combination under Step 2B to determine whether the provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself).
The Examiner determined that the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the steps of receiving physiological data; receiving feedback data; generating a set of scores; calculating a health score; adjusting a pressure setting; causing air to be supplied, and presenting the score amount to no more than mere instructions to apply the exception using a generic computer component. The claim is now re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field.
The claimed method would require a processor and memory in order to perform basic computer functions of receiving information, storing the information in a database, retrieving information from the database, comparing data, and outputting said information. These components are not explicitly recited and therefore must be construed at the highest level of generality. Based on the Specification, the invention utilizes existing, conventional sensors, communication networks, and generic processors, which can be found in mobile devices or desktop computers, conventional memory and display devices, and the functions performed by said generic computer elements are basic functions of a computer - performing a mathematical operation, receiving, storing, comparing and outputting data - have recognized by the courts as routine and conventional activity. Specifically, regarding the recited functions, MPEP 2106.05(d)(II) defines said functions as routine and conventional, or as insignificant extra-solution activity:
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) (“The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.”); collecting and comparing known information in Classen 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
iii. Electronic recordkeeping, Alice Corp., 134 S. Ct. at 2359, 110 USPQ2d at 1984 (creating and maintaining “shadow accounts”); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log);
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
v. Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
vi. A web browser’s back and forward button functionality, Internet Patent Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015).
Thus, the background of the current application does not provide any indication that the processor is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the recited steps are well-understood, routine, conventional activity is supported under Berkheimer Option 2. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Further, similar to Electric Power Group v Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016) (Power Group), claim’ invocation of computers, networks, and displays does not transform the claimed subject matter into patent-eligible applications. Claim 1 does not require any nonconventional computer, network, or display components, or even a “non-conventional and non-generic arrangement of known, conventional pieces,” but merely call for performance of the claimed information collection, analysis, and display functions on a set of generic computer components and display devices. Nothing in the claim, understood in light of the specification, requires anything other than off-the-shelf, conventional computer, network, and display technology for gathering, sending, and presenting the desired information. Analogous to Power Group, claim 1 does not even require a new source or type of information, or new techniques for analyzing it. As a result, the claim does not require an arguably inventive set of components or methods, such as measurement devices or techniques that would generate new data. The claim does not invoke any assertedly inventive programming. Merely requiring the selection and manipulation of information - to provide a “humanly comprehensible” amount of information useful for users - by itself does not transform the otherwise-abstract processes of information collection and analysis into patent eligible subject matter. Merely obtaining and selecting information, by content or source, for collection, analysis, and display does nothing significant to differentiate a process from ordinary mental processes, whose implicit exclusion from § 101 undergirds the information-based category of abstract ideas. Therefore, the recited steps represent implementing the abstract idea on a generic computer, or “reciting a commonplace business method aimed at processing business information despite being applied on a general purpose computer” Versata, p. 53; Ultramerical, pp. 11-12.
Furthermore, the recited functions do not improve the functioning of computers itself, including of the processor(s) or the network elements. There are no physical improvements in the claim, like a faster processor or more efficient memory, and there is no operational improvement, like mathematical computation that improve the functioning of the computer. Applicant did not invent a new type of computer; Applicant like everyone else programs their computer to perform functions. The Supreme Court in Alice indicated that an abstract claim might be statutory if it improved another technology or the computer processing itself. Using a (programmed) computer to implement a common business practice does neither. 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, storing, comparing and transmitting data—see the Specification 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). 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. “However, it is not apparent how appellant’s programmed digital computer can produce any synergistic result. Instead, the computer will simply do the job it is instructed to do. Where is there any surprising or unexpected result? The unlikelihood of any such result is merely one more reason why patents should not be granted in situations where the only novelty is in the programming of general purpose digital computers”. See Sakraida v. Ag. Pro, Inc., 425 U.S. 273 [ 96 S.Ct. 1532, 47 L.Ed.2d 784], 189 USPQ 449 (1976) and A P Tea Co. V. Supermarket Corp., 340 U.S. 147 [ 71 S.Ct. 127, 95 L.Ed. 162], 87 USPQ 303 (1950).
Moreover, there is no transformation recited in the claim as understood in view of 35 USC 101. The steps of receiving physiological data; receiving feedback data; generating a set of scores; calculating a health score; adjusting a pressure setting; causing air to be supplied, and presenting the score merely represent abstract ideas which cannot meet the transformation test because they are not physical objects or substances. Bilski, 545 F.3d at 963. Said steps are nothing more than mere manipulation or reorganization of data, which does not satisfy the transformation prong. It is further noted that the underlying idea of the recited steps could be performed via pen and paper or in a person's mind. Moreover, “We agree with the district court that the claimed process manipulates data to organize it in a logical way such that additional fraud tests may be performed. The mere manipulation or reorganization of data, however, does not satisfy the transformation prong.” and “Abele made clear that the basic character of a process claim drawn to an abstract idea is not changed by claiming only its performance by computers, or by claiming the process embodied in program instructions on a computer readable medium. Thus, merely claiming a software implementation of a purely mental process that could otherwise be performed without the use of a computer does not satisfy the machine prong of the machine-or-transformation test”. CyberSource, 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011)
Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception, because, when considered separately and in combination, the claim elements do not add significantly more to the exception. Considered separately and as an ordered combination, the claim elements do not provide an improvement to another technology or technical field; do not provide an improvement to the functioning of the computer itself; do not apply the judicial exception by use of a particular machine; do not effect a transformation or reduce a particular article to a different state or thing; and do not add a specific limitation other than what is well-understood, routine and conventional in the operation of a generic computer. None of the hardware recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). As per “a control system including one or more processors configured to execute the machine-readable instructions” recitations, as narrated in system claim 42, these limitations do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment, that is, implementation via computers." Id., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)). Limiting the claims to the particular technological environment is, without more, insufficient to transform the claim into patent-eligible applications of the abstract idea at their core.
Accordingly, claim 1 is not directed to significantly more than the exception itself, and is not eligible subject matter under § 101. (Step 2B: No).
So as independent method claim 35 recites similar limitations, claim 35 is rejected on the same grounds.
Further, although the Examiner takes the steps recited in the independent claim as exemplary, the Examiner points out that limitations recited in dependent claims 2-11, 14, 17-18, 20-21, 24-25, 28 and 36-37 further narrow the abstract idea but do not make the claims any less abstract. Dependent claims 2-11, 14, 17-18, 20-21, 24-25, 28 and 36-37 each merely add further details of the abstract steps recited in claims 1 and 35 without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. These claims "add nothing of practical significance to the underlying idea," and thus do not transform the claimed abstract idea into patentable subject matter. Ultramercial, 772 F.3d at 716. Therefore, dependent claims 2-11, 14, 17-18, 20-21, 24-25, 28 and 36-37 are also directed to non-statutory subject matter.
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 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.
Claims 1-10, 14, 17-20, 21, 28, 35-37 and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Dees et al. (US 2015/0112722 A1) (IDS of 01/24/2023) in view of Armitstead et al. (US 2017/0311879 A1) (IDS of 01/24/2023), further in view of Dawson et al. (US 2019/0355271 A1) (IDS of 01/24/2023) and further in view of Tarumi et al. (US 2019/0156956 A1).
Claims 1 and 42. Dees et al. (Dees) discloses a method comprising:
causing one or more sensors to generate physiological data associated with a sleep session, the physiological data including first physiological data collected during the sleep session and second physiological data collected during a duration adjacent the sleep session; (a trend; a real-time status) [0052]; [0053]; [0056]
While Dees discloses various examples of physiological data received, such as the patient's heart rate as measured by a heart rate sensor, the patient's oxygen levels as measured by an oxygen level sensor, and/or the like, Dees does not specifically teach the one or more sensors including a flow rate sensor and/or a pressure sensor integrated in a respiratory therapy system, which is disclosed in Armitstead et al. (Armitstead) [0067].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Armitstead, for the benefit of presenting a therapy quality indicator of a session, such as a number derived from contributions of a plurality of parameters for the session associated with the patient, as specifically stated in Armitstead. [0034]
Dees, as modified by Armitstead, further teaches:
receiving subjective feedback data associated with the sleep session; Dees, [0052]; [0056]
generating a set of component (events) scores based on the physiological data and the subjective feedback data; Dees, [0053]; [0056]; [0057]
calculating a total (evaluation or overall) health score associated with the sleep session using the set of component scores; Dees, [0057]
adjusting a pressure setting associated with the respiratory therapy system based at least in part on the physiological data associated with the sleep session; Armitstead, [0033]
causing, via the respiratory therapy system, pressurized air to be supplied to a user using the adiusted pressure settings; Armitstead, [0033], and
presenting the total health score. Dees, Fig. 5; [0057]
Further, Dawson et al. (Dawson) discloses presenting the total score. cl. 68; [0166]; [0251]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit of better engaging patients and improving of patients wellbeing, as specifically stated in Dawson. [0011]; [0229]
Dees, as modified by Dawson, further teaches:
presenting the total health score in a graphical user interface, the graphical user interface having a dashboard view, Dees; Fig. 5; [0053]; [0054]; Dawson; [0049];
wherein when selected on the graphical user interface, the dashboard view presents the total health score as a total health score indication having a plurality of graphical health score component indications associated with the set of component scores, Dees; [0087]; [0088]; Dawson; Figs. 1-99, 102
Further, Armitstead discloses a GUI configured to provide a numerical health score indication and a plurality of graphical health score component indications, the plurality of graphical health score component indications provided as sub-areas of a shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score. Figs. 9 and 10.
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit of presenting a therapy quality indicator of a session, such as a number derived from contributions of a plurality of parameters for the session associated with the patient, as specifically stated in Armitstead. [0034]
Further, Tarumi discloses displaying a plurality of graphical health score component indications provided as sub-areas of a total shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score contributing to the total health score. (a pie-shaped chart) Fig. 16B; [0136]
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Tarumi, because it would advantageously allow even uninformed readers to see a data comparison at a glance and to make an immediate analysis or to understand information quickly, and even without need to examine or measure underlying numbers.
Claims 2 and 43. The method of claim 1, wherein, for at least one of the set of component scores, the generating the component score includes: determining a measurement score associated with one or more measurements associated with a component being scored; determining a compliance score based on a number of measurement instances or a duration of measurement associated with the one or more measurements associated with the component being scored; and calculating the component score based on the measurement score and the compliance score. Dees; [0052]
Claim 3. The method of claim 1, further comprising causing the respiratory therapy system to generate medical device usage data, the medical device usage data being associated with usage of the respiratory therapy system during the sleep session, the generating the set of component scores being further based on the medical device usage data. Dees; [0052]; Armitstead; Figs. 1, 3, 7A-B.
Claim 4. The method of claim 3, wherein the presenting the total health score includes presenting a therapy of whether or not the respiratory therapy system was used during the sleep session, the therapy indication at least partially overlaid on the total health score indication. Dees discloses a report module that generates one or more reports for the patient based on a state of the patient's medical condition and a subjective feedback being received from a client device associated with the patient, wherein the report module 306 may report the patient's wellness status to the patient's doctor via an interface, electronic message, or the like. [0009]; [0010]; [0057]; [0076], thereby at least suggesting the recited limitations. Armitstead; Figs. 1, 3, 7A-B, 9 and 10.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as suggested in Dees, because it would advantageously allow the doctor to use the wellness status to determine a course of action for the patient, as specifically stated in Dees.
Claim 5. The method of claim 1, wherein each component score in the set of component scores is associated with a weighting value, and wherein the calculating the total health score includes, for each component score in the set of component scores, applying the weighting value to the component score. Dees; [0043]; [0062]; [0066]; [0088]
Claim 6. The method of claim 5, further comprising adjusting one or more of the weighting values based on a number of data sources used to generate the set of component scores. (changing weighting values based on historical data of patent’s reactions and other patients’ reaction on changes in environmental conditions) Dees; [0067]
Claim 7. The method of claim 5, further comprising adjusting one or more of the weighting values based on one or more historical component scores. (changing weighting values based on historical data of patent’s reactions on change in environmental conditions) Dees; [0067]
Claim 8. The method of claim 7, wherein the adjusting the one or more of the weighting values includes: identifying a component to be improved or maintained based on the one or more historical component scores, the component represented by one component score of the set of component scores; and modifying the one or more weighting values to increase a weighting value associated with the one of the set of component scores relative to one or more weighting values associated with other components of the set of component scores. Dees discloses changing weighting values based on historical data of a particular patent’s reactions on change in environmental conditions, and changing accordingly component scores to reflect a factor of importance for the patient, [0067]; [0043]; [0062]; [0066]; [0067]; [0088], thereby suggesting the recited limitations.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as suggested in Dees, because it would advantageously allow the doctor to use the received data to determine a course of action for the patient, as specifically stated in Dees.
Claim 9. While Dees discloses the use of a regression analysis, Dees does not explicitly teach applying the set of component scores to a machine learning algorithm, which is disclosed in Dawson. [0014]; [0153]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, because it would advantageously allow to readily identify an unexpected pattern in data stream, and to identify which data streams and types are tightly correlated and what the relationship might be, as specifically stated in Dawson. [0163]
Claim 10. The method of any one of claim 5, further comprising: receiving demographic information, medical history information, or family health information; and adjusting one or more of the weighting values based on the demographic information, the medical history information, the family health information, or any combination thereof. Dees; [0059]; [0060]; [0062]; [0066]
Claim 14. The method of any one of claims claim 1, wherein the set of component scores includes a blood pressure score based on the second physiological data, wherein the blood pressure score is based at least in part on (i) a blood pressure measurement score that is based at least in part on one or more blood pressure measurements taken during the duration adjacent to the sleep session, (ii) a blood pressure compliance score that is based at least in part on a number of times one or more blood pressure measurements were taken during the duration adjacent to the sleep session, or (iii) both (i) and (ii). Dees; [0050]; Dawson; [0041]; [0045]; [0150]; [0155]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit better engaging patients and improving of health reporting, as specifically stated in Dawson. [0009]
Claim 17. The method of claim 1, wherein the set of component scores includes an activity score based on the second physiological data. Dees; [0052]; [0053]; [0056]
Claim 18. The method of claim 17, wherein the activity score is based at least in part on (i) an activity measurement score that is based at least in part on a value associated with an amount of activity tracked during the duration adjacent to the sleep session, (ii) an activity compliance score that is based at least in part on a length of time activity was tracked during the duration adjacent to the sleep session, or (iii) both (i) and (ii). Dees; [0052]; [0053]; [0056]
Claim 20. The method of claims claim 1, wherein the set of component scores includes a sleep score based on the first physiological data. Dees; [0053]; [0056]; [0057] Same rationale as applied to claim 1.
Claim 21. The method of claim 20, wherein the sleep score is based at least in part on (i) a sleep measurement score that is based at least in part on a value associated with a quality of sleep during the sleep session, (ii) a sleep compliance score that is based at least in part on whether or not the first physiological data was collected during the sleep session, or (iii) both(i) and (ii). Dawson. [0086]; [0193] – [0195]; [0199]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit better engaging patients and improving of patients wellbeing, as specifically stated in Dawson. [0011]; [0229]
Claim 28. The method of claim 1, further comprising: (i) presenting, for at least one of the set of components scores, a target value associated with the component score,(ii) presenting, for each of the set of component scores, an indicator of an amount the component score contributed to the total health score; or (iii) both (i) and (ii). Dawson; cl. 68; [0166]; [0251].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit better engaging patients and improving of patients wellbeing, as specifically stated in Dawson. [0011]; [0229]
Claim 35. Dees discloses a method comprising:
receiving a set of existing component scores associated with a sleep session or a previous sleep session; (a trend; a real-time status) [0052]; [0053]; [0056]
receiving data associated with the sleep session, wherein receiving data associated with the sleep session comprises: receiving physiological data associated with the sleep session, the physiological data including first physiological data collected during the sleep session and second physiological data collected during a duration adjacent the sleep session; (a trend; a real-time status) [0052]; [0053]; [0056],
Dees does not specifically teach:
adjusting a pressure setting associated with the respiratory therapy system based at least in part on the physiological data associated with the sleep session;
causing, via the respiratory therapy system, pressurized air to be supplied to a user using the adiusted pressure settings; Armitstead, [0033]; [0067]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Armitstead, for the benefit of presenting a therapy quality indicator of a session, such as a number derived from contributions of a plurality of parameters for the session associated with the patient, as specifically stated in Armitstead. [0034]
Dees, as modified by Armitstead, further teaches:
generating a set of updated component (events) scores based on the set of existing component scores and the received data; [0053]; [0056]; [0057]
calculating a total health score associated with the sleep session using the set of updated component scores; [0057] and
presenting the total health score. Fig. 5; [0057]
Further, Dawson discloses presenting the total score. cl. 68; [0166]; [0251]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit better engaging patients and improving of patients wellbeing, as specifically stated in Dawson. [0011]; [0229]
Dees, as modified by Dawson, further teaches:
presenting the total health score in a graphical user interface, the graphical user interface having a dashboard view, Dees; Fig. 5; [0053]; [0054]; Dawson; [0049]
wherein the dashboard view presents the total health score as a total health score indication having a health score indication and a plurality of graphical health score component indications associated with the set of component scores, Dees; [0087]; [0088]; Dawson; Figs. 1-99, 102
Further, Armitstead discloses a GUI configured to provide a numerical health score indication and a plurality of graphical health score component indications, the plurality of graphical health score component indications provided as sub-areas of a shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score. Figs. 9 and 10.
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Dawson, for the benefit of presenting a therapy quality indicator of a session, such as a number derived from contributions of a plurality of parameters for the session associated with the patient, as specifically stated in Armitstead. [0034]
Dees, as modified by Dawson and Armitstead, further teaches:
wherein when selected on the graphical user interface, the displayed data indicates the total health score on a measurement indicator (e.g. for a selected day), and wherein the plurality of graphical health score component indications are dynamically sized. Dees; Fig. 5; [0055]; Dawson; Figs. 1-99; Armitstead; Figs. 9 and 10.
Further, Tarumi discloses displaying a plurality of graphical health score component indications provided as sub-areas of a total shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score contributing to the total health score. (a pie-shaped chart), wherein the plurality of graphical score component indications are dynamically sized. Fig. 16B; [0136]
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Tarumi, because it would advantageously allow even uninformed readers to see a data comparison at a glance and to make an immediate analysis or to understand information quickly, and even without need to examine or measure underlying numbers.
Claim 36. The method of claim 35, wherein the receiving the data associated with the sleep session further comprises: receiving subjective feedback data associated with the sleep session. (a trend; a real-time status) Dees; [0052]; [0053]; [0056]. Same rationale as applied to claim 35.
Claim 37. The method of claim 35, wherein the calculating the total health score comprises updating an existing total health score, and wherein the presenting the total health score comprises updating a presentation of an existing total health score using the total health score. Dees; [0052]; [0053]; [0056]
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Dees in view of Armitstead, further in view of Dawson, further in view of Tarumi, and further in view of KUSUKAME et al. (CN 106361270 A).
Claim 11. Dees does not specifically teach: wherein the set of component scores includes a sleepiness score, wherein the sleepiness score is based at least in part on (i) a sleepiness measurement score selected from a range based on the subjective feedback data, (ii) a sleepiness compliance score that is based on whether or not the subjective feedback data is provided, or (iii) both (i) and (ii), which is disclosed in KUSUKAME et al. (KUSUKAME). (Thus, in order to use the wakefulness degree of user to correct the drowsiness level 2 of wakefulness degree. The wakefulness degree drowsiness level 3 or the gradient of the straight line represented by a dotted line of FIG. 10 of the value, the processing part 13 may also perform feedback, the wakefulness degree of the user using the calculated as a sleepiness level 4 of time point detected by the bio-information of the user (such as blood pressure, heart rate) is judged.)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in KUSUKAME, for the benefit of analyzing sources of wakefulness, and decreasing the wakefulness degree of the user, in order to improve the user waking degree (awake) and, thereby, increase safety of a driver during driving, as specifically stated in KUSUKAME.
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Dees in view of Armitstead, further in view of Dawson, further in view of Tarumi, and further in view of Heneghan et al. (US 2016/0270718 A1).
Claim 24. The method of claim 20, further comprising receiving medical device usage data, the sleep score being calculated using the medical device usage data, wherein the calculating the sleep score comprises: determining at least one sub-score selected from the group consisting of: determining a usage score representing a duration of time a respiratory therapy system was used during the sleep session based on the medical device usage data, determining an interface score representing an effectiveness of a user interface seal of the respiratory therapy system during the sleep session based on the medical device usage data, and determining an interruption score representing a number and/or duration of times the user interface was removed during the sleep session based on the medical device usage data; and using the determined sub-score to calculate the sleep score. Armitstead; [0017]; [0065]; [0210]; [0255]; Heneghan et al. (Heneghan) [0119]; [0125]; [0198]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Dees to include the recited limitations, as disclosed in Heneghan, for the benefit of determining a severity of contributing factors to fatigue, such as poor sleep quality (e.g., due to family/recreational factors, stress, noise, respiratory disorders and other health issues), as specifically stated in Heneghan. [0020]; [0021]
Claim 25. The method of claim 24, wherein the calculating the sleep score further includes determining an event score representing a number of events that occurred during the sleep session based on the medical device usage data to calculate the sleep score, wherein the event score is further combined with one or more of the usage score, the interface score, and the interruption score to calculate the sleep score. Same rationale as applied to claims 24 and 20.
Response to Arguments
Applicant's arguments filed 1/30/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims, as currently amended, recite automatic adjustment of settings, and, as such, the current amendment obviates claim rejections under 35 USC 101.
Examiner respectfully points out that the “automatic adjustment” limitation is introduced only in system claims, and method claims do not have said “automatic” or “by a processor” limitation. Since the scope of the amended method claims is now broader than what was discussed during the interview of 1/28/2026, the rejection under 35 USC 101 is maintained.
Applicant argues that the cited references fail to disclose "displaying a plurality of graphical health score component indications provided as sub-areas of a total shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score contributing to the total health score", and "wherein at least two sub-areas are dynamically resized to maintain a same size of the total shaped area.
The Examiner respectfully points out that Dees discloses total health score as a total health score indication having a plurality of graphical health score component indications associated with the set of component scores, [0087]; [0088]; Dawson; Figs. 1-99, 102. Armitstead discloses a GUI configured to provide a numerical health score indication and a plurality of graphical health score component indications, the plurality of graphical health score component indications provided as sub-areas of a shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score. Figs. 9 and 10.
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Further, Tarumi discloses displaying a plurality of graphical health score component indications provided as sub-areas of a total shaped area with each respective graphical health score component indication sized proportionally to an amount associated with a respective component score contributing to the total health score. (a pie-shaped chart) Fig. 16B; [0136]
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Conclusion
The prior art search has been conducted, with no significant prior art found.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/IGOR N BORISSOV/Primary Examiner, Art Unit 3685 2/25/2026