DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03 February 2026 has been entered.
Status of Claims
Claim(s) 1-5 and 7-10 is/are currently amended. Claim(s) 1-10 is/are pending.
Objections and/or Rejections Withdrawn
Objections to the claims, rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 1 and claims dependent thereon, the limitations "wherein the SDPPG signal has multiple feature points of a feature point a, a feature point b, a feature point c, a feature point d and a feature point e corresponding to possible pulsatile waves of the human body for physiological parameter monitoring; and performing…a feature extraction operation on the TDPPG signal to impute multiple missing feature points out of the multiple feature points." It is unclear what "multiple…feature points" are "missing" as the claim expressly recites and/or encompasses the SDPPG having feature points a-e, and there is no indication any analysis of the SDPPG and/or TDPPG is performed to identify "missing" points.
The limitation "thereby improving an analysis reliability of the PPG signal to estimate health indicators of blood pressure, pulse wave velocity (PWV) or vascular age of the wearable sensing device in development" is further indefinite. First, it is unclear to what "in development" refers this context. Secondly, it is unclear what health indicators…of the wearable sensing device refers and/or how a wearable sensing device has/possesses indicators of blood pressure, PWV or vascular age. Lastly, it is unclear what additional steps, if any, the limitation requires. Does the method require actively analyzing the PPG signal to estimate health indicators, or is the above limitation merely reciting an intended result of performing the feature extraction operation?
Regarding claim 4 and claims dependent thereon, the limitation "taking the time of an initial zero-crossing point from the multiple zero-crossing points of the TDPPG signal as the time of the feature point a" is indefinite. It is unclear if the "initial zero-crossing point" refers to the initial zero-crossing point within the search interval, or the initial zero-crossing point of the TDPPG signal overall. For the purpose of this Office action, the above-noted limitation will be further discussed with the understanding it refers to the initial zero-crossing point within the search interval, consistent with, e.g., [0035] of the specification as filed.
Additionally, "the multiple extremums of the TDPPG signal in the interest interval" of the limitation "designating the multiple extremums of the TDPPG signal in the interest interval" lacks insufficient antecedent basis in the claims. While claim 3 recites determining "multiple extremums of the TDPPG signal," there is no indication the extrema determined in claim 3 are in the "interest interval." Additionally, it is unclear as or to what the regional extreme points are being designated.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 and claims dependent thereon, the limitations "wherein the SDPPG signal has multiple feature points of a feature point a, a feature point b, a feature point c, a feature point d and a feature point e corresponding to possible pulsatile waves of the human body for physiological parameter monitoring; and performing…a feature extraction operation on the TDPPG signal to impute multiple missing feature points out of the multiple feature points" are indefinite, as noted above. However, if it is Applicant's intention that the limitations are intended to indicate that any of the feature points a-e may be imputed in they are "missing," the full scope of this limitation lacks sufficient support in the application as filed. Specifically, Applicant fails to disclose any algorithm for "imputing" feature point a and/or feature point e. Rather, the only feature extraction operation or algorithm disclosed indicates particular zero-crossing points of the TDPPG signal within a search/cardiac interval are marked as feature points a and e and used in imputing feature points b, c, and d (e.g., [0033], Fig. 5).
Additionally, Applicant discloses a PPG signal may be obtained by a wearable sensing device ([0029]), and further discloses "the feature extraction method of the present invention can effectively improve the subsequent estimation of blood pressure, PWV, vascular age and other health indicators, and is helpful for the development of smart health wearable devices" ([0057]). However, being "helpful for the development of smart health wearable devices" does not clearly provide support for the wearable sensing device used to obtain the PPG signal being used to calculating the derivative signals and perform the feature extraction operation as required by claim 1. Accordingly, the limitations "calculating by the wearable sensing device…; and performing, by the wearable sensing device…" further lack sufficient support in the application as filed.
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
Claims 1-10 recite the steps of calculating, from an obtained PPG signal, a FDPPG signal, a SDPPG signal, and a TDPPG signal; performing a feature extraction operation on the TDPPG signal to impute missing feature points of the SDPPG signal; and performing a feature extraction operation on the SDPPG signal to impute a maximum slope feature point of the FDPPG signal.
The step of calculating the derivatives of the PPG signal is a mathematical calculation(s), and therefore falls within the mathematical concepts grouping of abstract ideas. Additionally, the steps of the extraction operation(s), as drafted, are a process that, under its broadest reasonable interpretation, covers performance of the steps in the mind. That is, nothing in the claim precludes the steps from practically being performed in the mind. For example, the various extraction operation steps encompass a user manually/mentally observing amplitudes of extrema in the TDPPG and/or SDPPG; assessing whether the amplitudes are positive or negative (and/or comparing said values to a threshold of 0), and assigning/marking points based on the result of said comparison. If claim limitations, under a BRI thereof, cover performance of the limitations in the mind, then it falls within the "mental processes" grouping of abstract ideas. Accordingly, claims 1-10 recite an abstract idea. See MPEP 2106.04(II)(B).
This judicial exception is not integrated into a practical application. The claims recite the additional elements of a step of obtaining a PPG signal of a human body from a PPG sensor of a wearable sensing device and a generic, presumably computer, component, i.e., "wearable sensing device," for implementing the abstract idea and/or data gathering steps. The PPG signal obtaining step is recited at a high level of generality, is directed to necessary data gathering, and is comparable to concepts identified by the courts as insignificant extrasolution activity (e.g., performing clinical tests on individuals to obtain input for an equation, see MPEP 2106.05(g)). The generic computer component is recited at a high-level of generality and performing generic computer functions of mathematical calculations and analyzing data, such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, the additional elements merely recite using a generic computer component as a tool to perform the abstract idea and add insignificant extra-solution activity to the judicial exception, and therefore do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea. See MPEP 2106.04(d).
The claims do 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 generic computer component to perform the abstract idea amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Further, as discussed above, the claim recites the additional element of obtaining the PPG signal, i.e., insignificant pre-solution activity. Applicant appears to acknowledge PPG as a low-cost optical device included in wearable devices (e.g., ¶ [0002]). Additionally, Tsai et al. provides further evidence that generically obtaining PPG signals was conventional (i.e., widely studied) (e.g., pg. 1. Introduction) and/or achievable with commercially-available sensors (e.g., 2.1. Signal Processing Flow). Accordingly, there is sufficient evidence of record to indicate generically obtaining a PPG signal is well-understood, routine and/or conventional in the field. The addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Therefore, claims 1-10 are not patent eligible.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant contends, "[Pursuing] accurate and reliable PPG signals of a human body should be an inventive approach on improving the practical application of healthcare devices. Although the step of calculating the derivatives of the PPG signal is related to mathematics, the steps of applying the mathematical calculations to improve the analysis reliability of the PPG signal to estimate health indicators of blood pressure, pulse wave velocity (PWV) or vascular age of the wearable sensing device in development may not be simply falling within the 'mental processes' grouping of abstract ideas" (Remarks, pg. 9).
It is unclear to what application of "the mathematical calculations to improve the analysis reliability of the PPG signal to estimate health indicators of blood pressure, pulse wave velocity (PWV) or vascular age" Applicant is referring. As discussed with respect to rejections under 35 U.S.C. 112(b) below, it is unclear what additional steps, if any, the "thereby" limitation of claim 1 requires. Since the method is directed to a "feature extraction method," to the best of the examiner's understanding, the "thereby" limitation is intended to recite an intended result of performing the feature extraction operation. That result is not further utilized and/or practically applied by the claims. Accordingly, the examiner is presuming Applicant is referring to the feature extraction operation (or the steps thereof). However, said operation (or the steps thereof) is itself an abstract idea. As noted with respect to rejections under 35 U.S.C. 101 above, the various recited extraction operation steps encompass a user manually/mentally observing amplitudes of extrema in the TDPPG and/or SDPPG; assessing whether the amplitudes are positive or negative (and/or comparing said values to a threshold of 0), and assigning/marking points based on the result of said comparison. As noted in MPEP 2106.04(d), "Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application." Accordingly, using the mathematical calculations in a(nother) judicial exception, such as performing the feature extraction operation, is insufficient to integrate the judicial exception(s) into a practical application.
Applicant further cites In re Thales Visionix Inc. v. United States (Fed. Cir. 2017) ("Thales") and In re CardioNet, LLC, BRAEMAR MANUFACTURING, LLC v. lnfoBionic, Inc. (Fed. Cir. 2020) ("CardioNet"), and concludes, "Accordingly, the claimed invention is not a mere abstract mathematical formula or a generic algorithm; instead, it is a specific application of mathematical tools to solve a concrete technical problem within the specialized field of physiological signal analysis" (Remarks, pg. 10).
The relevance of Thales and/or CardioNet to the claims of the present application is unclear, as Applicant fails to provide any indications as to how the fact patterns of Thales and/or CardioNet correlate to the claims of the present application. With respect to Applicant's conclusion, the examiner respectfully disagrees, for the reasons noted above. While performing the feature extraction operation arguably "applies mathematical tools" (e.g., employs the use of derivative signals), said feature extraction operation is a judicial exception, or mental process, and therefore cannot itself amount to a practical application of said mathematical tools.
Applicant further contends, "The claimed invention directly addresses a known technical challenge: imputing multiple missing feature points out of the multiple feature points from the TDPPG signal. PPG signals, especially in real-world scenarios (e.g., from wearable devices), are often noisy, incomplete, or ambiguous. This method provides a technical solution to enhance the integrity and utility of physiological data, enabling more reliable analysis for health monitoring" (Remarks, pgs. 10-11).
The examiner is unclear to what technical solution Applicant is referring. At least with respect to claim 1, the feature extraction operation of said claim only broadly requires imputing multiple missing feature points out of the multiple feature points from the TDPPG signal, i.e., merely repeating the alleged "technical challenge." Additionally, as discussed with respect to rejections under 35 U.S.C. 112, it is unclear what "multiple…feature points" are "missing" as claim 1 expressly recites and/or encompasses the SDPPG has feature points a-e, and there is no indication any analysis of the SDPPG and/or TDPPG is performed to identify "missing" and/or ambiguous points.
Applicant further contends, "Moreover, the present invention focuses on the critical capability of real-time processing within wearable devices, which enables us to instantly and effectively recognize and analyze features from physiological data. This real-time capability is crucial for the subsequent implementation of high-performance health monitoring on integrated circuits, as it provides valuable analytical results immediately, rather than just raw data" (Remarks, pg. 11).
The examiner is unable to locate any indication in the claims or the application as filed that the extraction method is performed in real-time or entirely by a wearable device. Similarly, there is no "subsequent implementation" of either the imputed points, or other any other features of the PPG signal(s), recited in the claims.
Applicant contends, "The claimed invention provides a concrete, non-conventional technical solution to a recognized problem in PPG signal analysis: reliably imputing missing feature points. This is a practical improvement over generic signal processing, where missing data can severely impact the accuracy and utility of the derived physiological parameters. While obtaining a PPG signal itself might be known, the subsequent specific and detailed steps for deriving and combining information from different orders of derivative signals to impute missing feature points, as elaborated in claim 1 and further detailed in dependent claims, constitute a non-routine and inventive approach. This is not simply applying a known algorithm in a generic way, but rather a specialized processing technique developed to address the unique challenges of PPG signal analysis.
Applicant appears to be contending that the method is patent eligible because the feature extraction operation is not disclosed by the prior art of record. However, "judicial exceptions need not be old or long-prevalent, and that even newly discovered or novel judicial exceptions are still exceptions" (MPEP 2106.04(I)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791