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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 25, 2025 has been entered.
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 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-20 are directed to “a method” and “an apparatus” which describe one of the four statutory categories of patentable subject matter, i.e., a process and an apparatus (Step 1, Yes).
The claim limitations within claims 1,13 and 20 that set forth or describe the abstract idea is/are: “decomposing/decompose….the first set of physiological data of the user to generate one or more physiological parameters, each of the one or more physiological parameters corresponding to one or more respective physiological systems of the user”, “determining/determine…one or more uncertainty values indicating an accuracy of to the one or more physiological parameters”, “analyzing/analyze… the one or more physiological parameters and the one or more uncertainty values to output a period classification” and “determining/determine…, whether or not the period classification is indicative of an infection”. The reasons that the limitations is/are considered an abstract idea is/are the following: The limitations of “decomposing/decompose”, “determining/determine…parameters”, “analyzing/analyze”, and “determining/determine…infection” is a process that under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “by one or more processor applying a heart rate algorithm” (claims 1,13 and 20), “processor..configured to execute a set of computer-readable instructions” (claim 13) and “computer-readable storage medium having stored thereon a set of instructions executable by at least one processor” (claim 20) and “a user interface” (claims 1,13 and 20) nothing in the claim precludes the steps from practically being performed in the mind. For example the “decomposing/decompose” language in the context of the claim encompasses the user, within the aid of pen and paper, decomposing the physiological data to provide one or more physiological parameters, the “determine/determining…parameters” language in the context of the claim encompasses the user, within the aid of pen and paper, determining one or more uncertainty values indicating an accuracy of the one or more physiological parameters, the “analyzing/analyze” language in the context of the claim encompasses the user, within the aid of pen and paper, analyzing the physiological parameters and uncertainty values to determine/output a classification, and the “determining/determine…infection” language in the context of the claim encompasses the user, within the aid of pen and paper, comparing the classification to a threshold or baseline to determine whether the classification is indicative of infection. There is nothing to suggest an undue level of complexity in the steps of “decomposing/decompose”, “determining/determine…parameter”, “analyzing/analyze”, and “determining/determine…infection”. If a claim limitations, under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls with the “Mental Processes” grouping of abstract ideas. Accordingly the claims recite an abstract idea. Although not drawn to the same subject matter, the claimed limitation(s) is/are similar to the concepts that have been identified as abstract by the courts, such as: collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016), selecting certain information, analyzing it using mathematical techniques, and reporting or displaying the results of the analysis in SAP America Inc. v. Investpic, LLC, 890 F.3d 1016, 126 USPQ2d 1638 (Fed Cir. 2018). Thus, the claim(s) are directed to a judicial exception and fall squarely within the realm of "abstract ideas," which is a patent-ineligible concept (Step 2A: Prong One YES).
Analyzing the claim as whole, the claim does not include additional elements/steps that integrate the judicial exception into a practical application. Claims 1,13 and 20 do not include additional elements that integrate the mental process into a practical application. The additionally recited element(s) appended to the abstract idea include: “receiving/receive, from a wearable device of a user, a first set of physiological data of the user, wherein the first set of physiological data of the user comprises at least heart rate data during a first time period” (claims 1 and 13), “by one or more processor applying a heart rate algorithm” (claim 1), “a user interface” (claim 13), “wearable device of a user configured to…” (claim 13) “a memory…storing..heart rate algorithm” (claim 13), “a processor” (claim 13), “receiving/receive, from a wearable device of a user, a second set of physiological data of the user, wherein the second set of physiological data of the user comprises at least heart rate data during a second time period” (claims 1 and 13), “A non-transitory computer-readable storage medium having stored thereon a set of instructions, executable by at least one processor” (claim 20), “accessing a first set of physiological data of the user, wherein the first set of physiological data of the user comprises at least heart rate data during a first time period” (claim 20), “accessing a second set of physiological data of the user, wherein the second set of physiological data of the user comprises at least heart rate data during a second time period” (claim 20), “displaying, in a user interface, a warning to the user that indicates infection” (claims 1,13 and 20).
The additional elements reciting “receiving/receive, from a wearable device of a user, a first set of physiological data of the user, wherein the first set of physiological data of the user comprises at least heart rate data during a first time period” (claims 1 and 13), “wearable device of a user configured to…” (claim 13), “receiving/receive, from a wearable device of a user, a second set of physiological data of the user, wherein the second set of physiological data of the user comprises at least heart rate data during a second time period” (claims 1 and 13), “by applying the heart rate algorithm” (claims 13 and 20), “accessing a first set of physiological data of the user, wherein the first set of physiological data of the user comprises at least heart rate data during a first time period” (claim 20), and “accessing a second set of physiological data of the user, wherein the second set of physiological data of the user comprises at least heart rate data during a second time period” (claim 20) merely: add insignificant extra-solution activity and are recited at a high level of generality (i.e. as a general means of gathering signals) and are merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to mere data gathering, which is a form of insignificant extra-solution activity (pre-solution activity), all uses of the recited judicial exception require the pre-solution activity of data gathering. The additional elements reciting “displaying, in a user interface, a warning to the user that indicates infection” (claims 1,13 and 20) merely: add insignificant extra-solution activity and are recited at a high level of generality and is nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to mere displaying/presenting of results, which is a form of insignificant extra- solution activity (post-solution activity). As discussed above with respect to integration of abstract idea into a practical application, the additional element of “by one or more processor applying a heart rate algorithm” (claim 1), “by applying the heart rate algorithm” (claims 13 and 20), “a user interface” (claim 13), “a processor” (claim 13), “A non-transitory computer-readable storage medium having stored thereon a set of instructions, executable by at least one processor” (claim 20), amount to no more than mere instruction to apply the exception using generic computer components. The “user interface” , “processor”, “CRM” are purely general-purpose computer components recited as carrying out the general-purpose computer functions of processing data and displaying to enable the abstract process. The disclosed “user interface” , “processor”, “CRM” are recited at a high level of generality as a processor that is running a heart rate algorithm and a user interface displaying the results (see specification, para. [0113]). Further, the recitation of “by applying the heart rate algorithm” (claims 1, 13 and 20), also merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “by applying the heart rate algorithm” limits the identified judicial exceptions “decomposing” and “analyzing” by applying the heart rate algorithm, this type of limitation merely confines the use of the abstract idea to a particular technological environment (artificial intelligence based heart rate models) and thus fails to integrate the abstract idea into a practical application, see MPEP 2106.05(h). Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application (Step 2A, Prong Two, NO).
Analyzing the claim as whole for an inventive concept, the claim does not include additional elements/steps that are sufficient to amount to significantly more than the judicial exception. Claims 1,13 and 20 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. e.g., all elements are directed to insignificant extra-solution activity which merely facilitate the abstract idea and/or purely general-purpose computer components recited as carrying out the general-purpose computer function of processing data and displaying to enable the abstract process. The recited additional elements are well-understood, routine, conventional activity including receiving or transmitting data over a network, performing repetitive calculations and storing or retrieving information in memory, see MPEP 2106.05(d). Further, the use of a wearable device for capturing a first set of physiological data comprising at least heart rate data of the user during a first period, “a user interface” for displaying the results and “a processor” for analyzing the physiological parameters based on the physiological data are well-understood, routine, conventional activity, see US 2023/0210472 to Berckmans et al., see “processor” par. [0019], CRM storing a computer program, para. [0062]. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Similarly, when considered as an ordered combination, the additional components/steps of the claim(s) add nothing that is not already present when the steps are considered separately (Step 2B: NO). The claims are not patent eligible.
Claim(s) 2-12, 14-19 and 21 depend directly or indirectly from claim(s) 1 and 13. Therefore, the dependent claims rely upon the same abstract idea as the independent claim(s), as set forth above. Additionally, the dependent claims do nothing more than further limiting the abstract idea while failing to qualify as "significantly more", and the specificity of an abstract idea does not make it any "less abstract" as it is still directed to concepts relating to organizing or analyzing information in a way that can be performed mentally or is analogous to human mental work subject matter. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely a. further describe the abstract idea, physiological parameters include…(claims 2 and 14), determining a recovery time… (claims 4-5 and 16), removing sleep data…(claims 6 and 17), comparing to a baseline… (claims 8-9 and 19), physiological systems include…(claim 10), training…the heart rate algorithm (claim 11-12), wherein the one or more uncertainty values comprise… (claim 21) b. further describe the pre-solution activity (or the structure used for such activity), wherein the physiological data comprises…(claims 3,7,15 and 18) c. add insignificant extra-solution activity and/or merely indicate a field of use or technological environment to apply the judicial exception, see MPEP 2106.04(d)(2), rendering/rendering a selectable medical provider contact option… (claims 4-5 and 16), physiological systems comprise…(claim 10). Therefore, the dependent claim(s) are also not patent eligible for the reasons discussed above.
The instantly rejected claim(s) are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. In the interest of advancing prosecution, the examiner suggests: providing evidence, for example, delineating how the abstract idea and/or additional elements appended to the abstract idea results in an improvement to the technology/technical field, which can show eligibility and/or adding a practical application of the claimed method outside of the computer. See MPEP § 716.01(c) for examples of providing evidence supported by an appropriate affidavit or declaration. For additional guidance, applicant is directed generally to MPEP § 2106.
Response to Arguments
In view of the claim amendments, applicant’s arguments regarding the 103 rejections using Berckmans, see pgs. 11-12, filed 6/25/2025, with respect to claims 1-21 have been fully considered and are persuasive. The 103 rejections using Berckmans in view of Newberry of claims 1-21 have been withdrawn.
Regarding the 101 rejections, applicant's arguments have been fully considered but they are not persuasive.
Rejections under 35 USC 101
Applicant argues that that each of claims 1-20 are patent eligible under at least Step 2A, Prong Two. Specifically that the claims integrate any alleged abstract idea into a practical application under Step 2A, Prong Two because claim 1 recites an improvement to the field of infection detection and monitoring, see pgs. 10-11 of the response filed 6/25/2025, the examiner respectfully disagrees. MPEP 2106.04 recites relevant considerations for evaluating whether additional elements integrate a judicial exception into a practical application including: An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP § 2106.04(d)(1) and 2106.05(a). The claims do not include “additional elements” which integrate the judicial exception into a practical application. Applicant points to the “determining an uncertainty value” limitation and states that by determining and utilizing uncertainty values the present system more effectively and accurately detects infections, however the “determining an uncertainty value” and “analyzing…the one or more uncertainty values to output a period classification” steps are part of the abstract idea and not “additional elements”. The “(eligibility “cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.”).”, see MPEP 2106.04(II)(A)(2). Further, MPEP 2106.05(a) states “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. Therefore it is the additional elements which provide the improvement not the abstract idea itself. Additionally, when evaluating improvements to any other technology or technical field, MPEP 2106.05(a)(II) states “To show that the involvement of a computer assists in improving the technology, the claims must recite the details regarding how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology.” Regarding the limitations “by one or more processors applying a heart rate algorithm”, as stated within the rejection, the additional element of “by one or more processor applying a heart rate algorithm” (claim 1), “by applying the heart rate algorithm” (claims 13 and 20), “a processor” (claim 13), “A non-transitory computer-readable storage medium having stored thereon a set of instructions, executable by at least one processor” (claim 20), amount to no more than mere instruction to apply the exception using generic computer components. The “processor”, “CRM” are purely general-purpose computer components recited as carrying out the general-purpose computer functions of processing data and displaying to enable the abstract process. The disclosed “processor”, “CRM” are recited at a high level of generality as a processor that is running a heart rate algorithm and a user interface displaying the results (see specification, para. [0113]). The specification discloses that the heart rate algorithm is a trained artificial intelligence based model, see para. [0047]-[0048], [0050]-[0051], used to generally apply the abstract idea without placing any limits on how the trained artificial intelligence based model functions. These limitations only recite the outcome of the “decomposing”, “determining” and “analyzing” and do not include any details about how the “decomposing”, “determining” and “analyzing” are accomplished. See MPEP 2106.05(f). Further, the recitation of “one or more processor applying a heart rate algorithm” and “by applying a heart rate algorithm” in the “decomposing”, “determining” and “analyzing” limitation steps also merely indicate a field of use or technological environment in which the judicial exception is performed. Although the additional elements “one or more processor applying a heart rate algorithm” and “by applying a heart rate algorithm” limit the identified judicial exceptions “decomposing”, “determining” and “analyzing” this type of limitation merely confines the use of the abstract idea to a particular technological environment (artificial intelligence based heart rate models) and thus fails to integrate the abstract idea into a practical application. See MPEP 2106.05(h).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2017/0169180 to Hamann et al. which discloses situation-dependent blending method for predicting progression of disease.
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/JENNIFER L GHAND/Examiner, Art Unit 3796