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
The Amendment filed March 16, 2026 has been entered. Claims 1-3, 5 and 7-11 remain pending in the application.
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 1-3, 5 and 7-11 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.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to “a device” which describes one of the four statutory categories of patentable subject matter, i.e. a machine or manufacture.
Claim 5 is directed to “a device” which describes one of the four statutory categories of patentable subject matter, i.e. a machine or manufacture.
Claim 9 is directed to “a device” which describes one of the four statutory categories of patentable subject matter, i.e. a machine or manufacture.
Claim 10 is directed to “a device” which describes one of the four statutory categories of patentable subject matter, i.e. a machine or manufacture.
Claim 11 is directed to “a device” which describes one of the four statutory categories of patentable subject matter, i.e. a machine or manufacture.
Each of Claims 1-3, 5 and 7-11 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claim 1 recites (“sets forth” or “describes”) the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows: “isolate and normalize R-wave information from the ECG data by filtering the ECG data to provide filtered ECG data, replacing negative values from the filtered ECG data with zero values, amplifying the positive filtered ECG data values, removing information not attributed to R-waves from the positive filtered ECG data to provide an amplified ECG signal, and reducing the amplified ECG signal to a one-dimensional data-set, isolate information associated with the cardiac rhythm from the isolated and normalized R- wave information to provide pulse waves, determine temporal characteristics of the pulse waves, convert and normalize the optical data in a wavelet time-frequency plane, and calculate pulse arrival time utilizing each of the temporal characteristics of the pulse waves and the converted and normalized optical data.”
In claim 1, the above recited steps are mathematical concepts, which is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. The Specification teaches that ecg and ppg signals are used to compute the PAT. Spec. [0060 – 0061], the specification teaches the different equations used as equations 1-5 see pages 12-26 discussing the mathematical equations, the filtering techniques and comparison calculations to calculate the pulse arrival time. Computing these encompasses the use of mathematical equations, which has been recognized as an abstract idea (i.e., a mathematical concept). Patent Eligibility Guidance, 84 Fed. Reg. at 52. In sum, we determine that Prong 1 recites a judicial exception, and proceed to Step 2A, Prong 2. Therefore, each of the above steps are grouped as mathematical concepts, hence an abstract idea.
Claim 5 recites (“sets forth” or “describes”) the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows: “isolate and normalize R-wave information from the ECG data, isolate information associated with the cardiac rhythm from the isolated and normalized R- wave information to provide pulse waves, determine temporal characteristics of the pulse waves, convert and normalize the optical data in a wavelet time-frequency plane, and calculate pulse arrival time utilizing each of the temporal characteristics of the pulse waves, the converted and normalized optical data, and a multi-resolution synchronization index, wherein the multi-resolution synchronization index attenuates points in time with low synchronization between the optical data and the ECG data while preserving points in time with high synchronization between the optical data and the ECG data.”
In claim 5, the above recited steps are mathematical concepts, which is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. The Specification teaches that ecg and ppg signals are used to compute the PAT. Spec. [0060 – 0061], the specification teaches the different equations used as equations 1-5 see pages 12-26 discussing the mathematical equations, the filtering techniques and comparison calculations to calculate the pulse arrival time. Computing these encompasses the use of mathematical equations, which has been recognized as an abstract idea (i.e., a mathematical concept). Patent Eligibility Guidance, 84 Fed. Reg. at 52. In sum, we determine that Prong 1 recites a judicial exception, and proceed to Step 2A, Prong 2. Therefore, each of the above steps are grouped as mathematical concepts, hence an abstract idea.
Claim 9 recites (“sets forth” or “describes”) the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows: “isolate and normalize R-wave information from the ECG data, creating a one-dimensional time series of heart rates associated with the ECG signal, superimposing the one-dimensional time series of heart rates onto a wavelet time- frequency plane, recording a plurality of maximum wavelength amplitudes of the wavelet time- frequency plane within a confidence interval at each point of the one- dimensional time series of heart rates, isolating amplitudes within the confidence interval from the plurality of maximum wavelength amplitudes, and normalizing the isolated amplitudes, isolate information associated with the cardiac rhythm from the isolated and normalized R- wave information to provide pulse waves, determine temporal characteristics of the pulse waves, convert and normalize the optical data in a wavelet time-frequency plane, and calculate pulse arrival time utilizing each of the temporal characteristics of the pulse waves and the converted and normalized optical data.”
In claim 9, the above recited steps are mathematical concepts, which is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. The Specification teaches that ecg and ppg signals are used to compute the PAT. Spec. [0060 – 0061], the specification teaches the different equations used as equations 1-5 see pages 12-26 discussing the mathematical equations, the filtering techniques and comparison calculations to calculate the pulse arrival time. Computing these encompasses the use of mathematical equations, which has been recognized as an abstract idea (i.e., a mathematical concept). Patent Eligibility Guidance, 84 Fed. Reg. at 52. In sum, we determine that Prong 1 recites a judicial exception, and proceed to Step 2A, Prong 2. Therefore, each of the above steps are grouped as mathematical concepts, hence an abstract idea.
Claim 10 recites (“sets forth” or “describes”) the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows: “isolate and normalize R-wave information from the ECG data; isolate information associated with the cardiac rhythm from the isolated and normalized R- wave information to provide pulse waves, determine temporal characteristics of the pulse waves through: creating a wavelet time-frequency plane using real components of wavelet coefficients of a binary ECG vector, and isolating a portion of the real component wavelet time-frequency plane related to cardiac rhythm, convert and normalize the optical data in a wavelet time-frequency plane, and calculate pulse arrival time utilizing each of the temporal characteristics of the pulse waves and the converted and normalized optical data.”
In claim 10, the above recited steps are mathematical concepts, which is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. The Specification teaches that ecg and ppg signals are used to compute the PAT. Spec. [0060 – 0061], the specification teaches the different equations used as equations 1-5 see pages 12-26 discussing the mathematical equations, the filtering techniques and comparison calculations to calculate the pulse arrival time. Computing these encompasses the use of mathematical equations, which has been recognized as an abstract idea (i.e., a mathematical concept). Patent Eligibility Guidance, 84 Fed. Reg. at 52. In sum, we determine that Prong 1 recites a judicial exception, and proceed to Step 2A, Prong 2. Therefore, each of the above steps are grouped as mathematical concepts, hence an abstract idea.
Claim 11 recites (“sets forth” or “describes”) the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows: “isolate and normalize R-wave information from the ECG data, isolate information associated with the cardiac rhythm from the isolated and normalized R- wave information to provide pulse waves, determine temporal characteristics of the pulse waves, convert and normalize the optical data in a wavelet time-frequency plane, and calculate pulse arrival time utilizing each of the temporal characteristics of the pulse waves and the converted and normalized optical data through: trimming time borders of wavelet time-frequency planes of each of the ECG signal and the optical signal by a trim time period, aligning the trimmed ECG time-frequency plane and the trimmed optical time- frequency plane, deriving a product-sum of the trimmed ECG time-frequency plane and the trimmed optical time-frequency plane, time shifting the trimmed optical time-frequency plane relative to the trimmed ECG time-frequency plane, deriving a product-sum series of the trimmed optical time-frequency plane and the trimmed ECG time-frequency plane until the trimmed optical signal is time- shifted by the trim time period, identifying a local maximum in the product-sum series within the period of the trim time period, and designating the identified local maximum as an average pulse arrival time.”
In claim 11, the above recited steps are mathematical concepts, which is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. The Specification teaches that ecg and ppg signals are used to compute the PAT. Spec. [0060 – 0061], the specification teaches the different equations used as equations 1-5 see pages 12-26 discussing the mathematical equations, the filtering techniques and comparison calculations to calculate the pulse arrival time. Computing these encompasses the use of mathematical equations, which has been recognized as an abstract idea (i.e., a mathematical concept). Patent Eligibility Guidance, 84 Fed. Reg. at 52. In sum, we determine that Prong 1 recites a judicial exception, and proceed to Step 2A, Prong 2. Therefore, each of the above steps are grouped as mathematical concepts, hence an abstract idea.
Prong Two: Claims 1, 5 and 9-11 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites (1) “a wearable housing coupled with a sensor configured to provide electrocardiogram (ECG) data from a user; an optical sensor configured to provide optical data from the user; and”
(2) “output PAT”.
(3) “a controller”.
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details).
The step in (2) represents merely notification outputting by a processor as a post-solution activity and is recited at a high level of generality.
The steps in (3) merely recite generic computer components used to implement the abstract idea on, as tools.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 5 and 9-11 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of (1) “a wearable housing coupled with a sensor configured to provide electrocardiogram (ECG) data from a user; an optical sensor configured to provide optical data from the user; and”
(2) “output PAT”.
(3) “a controller”.
These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality.
The ECG and PPG are obtained from ECG and PPG sensors. These additional limitations merely represent insignificant, conventional pre-solution activities well-understood in the industry of bio-information estimation, as the sensors recited are well understood, routine and conventional, as evidenced by Alghorani et al. (US 2022/0296169 A1) (“Alghorani”). [0012] discussing how the sensors are routine well understood, routine and conventional.
Note that the pulse transit time (PTT) and pulse arrival time (PAT) is known in the field of art as a mathematical variant of the pulse wave signal (or vibration waveforms), i.e., it can be derived from pulse wave signals via mathematical operations routinely practiced in the field of art. Accordingly, these additional steps and tools for measuring a pulse wave signal, and outputting a notification amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept.
The recited processors and computer-readable storage medium are generic computer elements (i.d. para. [0056 - 0060] describing generic computers).
Therefore, none of the Claims 1, 5 and 9-11 amounts to significantly more than the abstract idea itself.
Accordingly, Claims 1, 5 and 9-11 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
Claims 2-3 and 7-8 recitations further limits the abstract idea above, merely further defines the mental process or mathematical equations discussed above.
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed March 16, 2026 have been fully considered but they are not persuasive. With respect to the arguments regarding the section 101 rejections, the arguments are not persuasive. The arguments state that there is provided structure and controller functionality and are thus eligible, see page 10. Page 13 further argues that the recitation of the wearable housing coupled with the sensors is the structure and is not merely data gathering. However, para. [0056 – 0060] of the present specification describe the wearable housing as generic wearable electronic watches or fitness trackers and continue to describe the other computer components (controller) as generic computer components.
See MPEP 2106.05(g): This consideration is similar to factors used in past Office guidance (for example, the now superseded Bilski and Mayo analyses) that were described as mere data gathering in conjunction with a law of nature or abstract idea. When determining whether an additional element is insignificant extra-solution activity, examiners may consider the following:
(1) Whether the extra-solution limitation is well known. See Bilski v. Kappos, 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (2010) (well-known random analysis techniques to establish the inputs of an equation were token extra-solution activity); Flook, 437 U.S. at 593-95, 198 USPQ at 197 (a formula would not be patentable by only indicating that is could be usefully applied to existing surveying techniques); Intellectual Ventures I LLC v. Erie Indem. Co., 850 F.3d 1315, 1328-29, 121 USPQ2d 1928, 1937 (Fed. Cir. 2017) (the use of a well-known XML tag to form an index was deemed token extra-solution activity). Because this overlaps with the well-understood, routine, conventional consideration, it should not be considered in the Step 2A Prong Two extra-solution activity analysis.
(2) Whether the limitation is significant (i.e. it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention). See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715-16, 112 USPQ2d 1750, 1755 (Fed. Cir. 2014) (restricting public access to media was found to be insignificant extra-solution activity); Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1242, 120 USPQ2d 1844, 1855 (Fed. Cir. 2016) (in patents regarding electronic menus, features related to types of ordering were found to be insignificant extra-solution activity). This is considered in Step 2A Prong Two and Step 2B.
(3) Whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). This is considered in Step 2A Prong Two and Step 2B.
Below are examples of activities that the courts have found to be insignificant extra-solution activity:
• Mere Data Gathering:
i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989);
These additional limitations merely represent insignificant, conventional pre-solution activities well-understood in the industry of bio-information estimation, as the sensors recited are well understood, routine and conventional, as evidenced by Alghorani et al. (US 2022/0296169 A1) (“Alghorani”). [0012] discussing how the sensors are routine well understood, routine and conventional.
Note that the pulse transit time (PTT) and pulse arrival time (PAT) is known in the field of art as a mathematical variant of the pulse wave signal (or vibration waveforms), i.e., it can be derived from pulse wave signals via mathematical operations routinely practiced in the field of art. Accordingly, these additional steps and tools for measuring a pulse wave signal, and outputting a notification amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept.
The recited processors and computer-readable storage medium are generic computer elements (i.d. para. [0056 - 0060] describing generic computers).
Thus, the arguments are not persuasive.
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 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 date of this final action.
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/J.A.T./Examiner, Art Unit 3791
/TSE CHEN/ Supervisory Patent Examiner, Art Unit 3791
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