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
This office action is responsive to the amendment filed on October 1, 2025. As directed by the amendment: claim(s) 1, 7, 12 and 24 have been amended, claim(s) 6 have been cancelled, and no claim(s) have been added. Thus, claims 1-5 and 7-30 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 11, filed October 1, 2025, with respect to the 35 U.S.C. 112(b) rejection of claims 6 and 7 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of claims 6 and 7 has been withdrawn.
Applicant's arguments filed October 1, 2025 have been fully considered but they are not persuasive. In regards to the 35 U.S.C. 101 rejection the applicant principally argues that the claims are not directed to a judicial exception because the contain recitations that cannot be practically performed in the human mind. The examiner respectfully disagrees. The applicant states “a human mind cannot, for example, “extract, from the physiological data, data of a set of physiological parameters, “adjust the derived measure for each physiological parameter from the set of physiological parameters based on a baseline measure for the corresponding physiological parameter from the set of physiological parameters.” This is simply untrue. The instant specification details “…the physiological parameters includes two or more of: heart rate, heart rate variability, skin temperature, respiration rate,…” These four parameters alone can be extracted from physiological data by the human mind. In fact, doctors often do this without pen and paper and merely using simple tools that aren’t even sensors. The use of a physical aid (e.g., pencil and paper or a slide rule) to help perform a mental step (e.g., a mathematical calculation) does not negate the mental nature of the limitation, but simply accounts for variations in memory capacity from one person to another. See MPEP 2106.04(a)(2)(III)(B).
Secondly, the applicant argues that the claims amount to significantly more than the judicial exception when the additional elements are considered both individually and in combination. The applicant states that the claimed invention improves the technical field of methods and system by incorporating multifaceted adjustments to data of physiological parameters and using a model to predict an infection risk. However, the adjustments to the data of physiological parameters is merely “more data or information” or “insignificant extra-solution activity” and utilized to make an informed decision and the courts have indicated as cited in MPEP 2106.05(a) “Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” and further in MPEP 2106.05(g) details how this is mere data gathering and selecting a particular data source or type of data to be manipulated. Therefore, the examiner is not convinced and the 35 U.S.C. 101 rejection of the claims is maintained and the new limitations addressed below.
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 1-5 and 7-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a process (claims 1-5 and 7-23) and machine (claims 24-30) (Step 1).
Claims 1-5 and 7-30 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.
In accordance with MPEP 2106.04, each of Claims 1-5 and 7-30 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 1-5 and 7-30 recites at least one step or instruction for processing data, which is grouped as a mental process in MPEP 2106.04(a)(2)(III).
Accordingly, each of Claims 1-5 and 7-30 recites an abstract idea.
Specifically, Claim 1 recites:
A method, comprising:
receiving, from one or more sensors, physiological data of a patient measured by the one or more sensors, the physiological data including movement data associated with the patient; (additional element)
identifying a resting time period during which the patient is at rest based on the movement data; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
extracting, from the physiological data, data of a set of physiological parameters during a portion of the resting time period; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
receiving at least one of demographic data or medical data of the patient; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
adjusting the data of the set of physiological parameters extracted during the portion of the resting time period based on the at least one of the demographic data of the medical data; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
determining, after adjusting the data of the set of physiological parameters, a derived measure for each physiological parameter from the set of physiological parameters based on the data of the set of physiological parameters extracted during the portion of the resting time period; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
adjusting the derived measure for each physiological parameter from the set of physiological parameters based on a baseline measure for the corresponding physiological parameter from the set of physiological parameters to produce a set of adjusted measures, the baseline measure associated with physiological data of the patient collected during a time period prior to the resting time period; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
inputting the set of adjusted measures into a model for predicting an infection risk of the patient to obtain a predictive value indicative of an infection level of the patient; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)) and
determining an infection state of the patient based on the predictive value (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)).
Similarly, Independent Claim 24 recites An apparatus, comprising:
a memory; (additional element) and
a processor operatively coupled to the memory and a set of sensors; the processor configured to execute instructions stored in the memory to: (additional element)
receive, from the set of sensors, physiological data of a patient measured by the set of sensors; (additional element)
extract, from the physiological data, data of a set of physiological parameters during a resting time period associated with the patient; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)).
determine a derived measure for each physiological parameter from the set of physiological parameters based on the data of the set of physiological parameters extracted during the resting time period; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)).
adjust the derived measure for each physiological parameter from the set of physiological parameters based on a baseline measure for the corresponding physiological parameter from the set of physiological parameters to produce a set of adjusted measures, the baseline measure associated with physiological data of the patient collected during a time period prior to the resting time period; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)).
determine a predictive value indicative of an infection level of the patient using a model for predicting an infection risk of the patient and the set of adjusted measures; and (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)).
determine whether the predictive value is greater than a predefined threshold value, wherein the predefined threshold value is adjustable to modify a sensitivity for determining an infection state of the patient; (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)).
Further, dependent Claims 2-5, 7-23 and 25-30 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1 and 24 (and their respective dependent Claims 2-5, 7-23 and 25-30) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1 and 24), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: memory, processor, and sensors are generically recited computer elements in independent Claim 1 and 24 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1 and 24 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g. processor and memory as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 24 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 24 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 1-5, and 7-30 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: memory, processor, and sensors.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, [0045] and [0048] describes the memory and processor with a high level of generality and as a commercially available product. Per applicant’s specification, in [0038] and [0044] describes sensors with a high level of generality and as a commercially available product (e.g. accelerometer, cardiac sensor, optical sensor, ECG sensor, and etc.).
Accordingly, in light of Applicant’s specification, the claimed term processor is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements 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 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1-5, and 7-30 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatuses and methods of Claims 1-5 and 7-30 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent 1 and 24 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1-5 and 6-30 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-5 and 6-30 are not patent eligible and rejected under 35 U.S.C. 101.
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).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jessandra Hough January 28, 2026
/J.F.H./Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796