DETAILED ACTION
Applicant’s arguments, filed 04/20/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1-20 are pending and hereby under examination.
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 .
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 1-20 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.
Analysis of independent claims 1, 18, and 20:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1 and 20 are directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 18 is directed to a computer implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a method. Therefore, further consideration is necessary regarding claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1, 18, and 20 recite an abstract idea. In particular, the claims generally recite
the following:
transform the at least two PPG signals from a time domain to a frequency domain or time-frequency domain (claims 1, 18, and 20);
extract harmonics based on the transformed at least two PPG signals and use the extracted harmonics as coordinates (claims 1, 18, and 20);
decompose the transformed at least two PPG signals according to the coordinates to obtain a set of characteristics of the harmonics (claims 1, 18, and 20); and
determine a hemoglobin concentration in the blood of the user based on the obtained set of characteristics and an information from a database (claims 1, 18, and 20).
These elements recited in claims 1, 18, and 20 are drawn to an abstract idea since they are directed towards mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I) and mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
“transform the at least two PPG signals from a time domain to a frequency domain or time-frequency domain” is directed towards a mathematical concept. A person of ordinary skill could reasonably transform (e.g., using a Fourier transform) the signal to a frequency or time-frequency domain.
“extract harmonics based on the transformed at least two PPG signals and use the extracted harmonics as coordinates” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably review a transformed signal to identify harmonics and take their coordinates. There is nothing to suggest an undue level of complexity in “extract harmonics based on the transformed at least two PPG signals and use the extracted harmonics as coordinates”.
“decompose the transformed at least two PPG signals according to the coordinates to obtain a set of characteristics of the harmonics” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably take harmonic coordinates are determine a set of characteristics therefrom. There is nothing to suggest an undue level of complexity in “decompose the transformed at least two PPG signals according to the coordinates to obtain a set of characteristics of the harmonics”.
“determine a hemoglobin concentration in the blood of the user based on the obtained set of characteristics and an information from a database” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably compare the set of characteristics to another set of characteristics from a database to determine hemoglobin concentration. There is nothing to suggest an undue level of complexity in “determine a hemoglobin concentration in the blood of the user based on the obtained set of characteristics and an information from a database”.
Prong Two: Claims 1, 18, and 20 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are "directed to" the abstract idea. The additional elements merely:
Add insignificant extra-solution activity (the pre-solution activity of: using generic data gathering components (e.g., "at least one photoplethysmographic (PPG) sensor configured to irradiate a tissue of the user with radiation of at least two different wavelengths and to detect at least two PPG signals at the at least two different wavelengths" (claim 1), "irradiating a tissue of the user with radiation of at least two different wavelengths; detecting at least two photoplethysmographic (PPG) signals from the tissue of a user in a time domain at the at least two different wavelengths" (claim 18), and “at least one photoplethysmographic (PPG) sensor configured to irradiate a tissue of the user with radiation of at least two different wavelengths and to detect at least two PPG signals at the at least two different wavelengths” (claim 20))).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. 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, 18, and 20 do 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 implementing the abstract ideas on generic processing components, the pre-solution activity of using generic data-gathering components, and generic post-solution activities, which merely facilitate the abstract idea.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “PPG sensor” as disclosed in the Applicant’s specification “the at least one PPG sensor of the wearable device includes at least one radiation source including two or more light-emitting diodes (LEDs)… the light-emitting diodes may be laser LEDs… the at least one PPG sensor of the wearable device includes at least one radiation detector being preferably a wide-bandwidth photodetector or a photodiode… one of said different wavelengths emitted by at least one PPG sensor of the wearable device is in the range of 495-570 nm, and preferably is 530 nm… the PPG signals provided by the wearable device are back-reflected and/or back-scattered from the user’s tissues” (Paragraphs 0066-0070).
“wearable device” as disclosed in Applicant’s specification “the wearable device 201 is configured in the form of a smartwatch that is adapted to be placed on a user’s wrist. In other embodiments of the disclosure, the wearable device 201 may be configured to be placed on other parts of user’s body, for example, on a hand finger” (Paragraph 0135).
Further, "cloud storage”, “remote server”, and “communication interface” do not qualify as significantly more because this limitation is simply appending well understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well understood, routine and conventional activity previously known in the industry (see Electric PowerGroup, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014); SAP Am. v. lnvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements include a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-17 and 19 depend from the independent claims. Dependent claims 2-17 and 19 merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“extract the harmonics from the reference signal and use the extracted harmonics as coordinates” (claims 2 and 19), “wherein the wearable device is configured to, when determining a hemoglobin concentration, compare the obtained set of characteristics with sets of characteristics from the database, each of which corresponds to a specific value of hemoglobin concentration” (claims 2 and 19), “the transformation of the at least two PPG signals from the time domain to the frequency domain comprises a Fourier transform or a Hilbert-Huang transform, and wherein the transformation from the time domain to the time-frequency domain comprises a wavelet transform” (claim 7), “wherein the extraction of the harmonics from the reference signal comprises: determining a coordinate of a fundamental harmonic; and calculating coordinates of other harmonics” (claim 9), “decomposing the transformed at least two PPG signals according to the coordinates to obtain the set of characteristics of the harmonics comprises measuring, for each harmonic, an amplitude, an area under curve, a peak width at half height and/or a signal-to-noise ratio to obtain the set of characteristics of the harmonics” (claim 10), “the comparison is based on a use of a numerical method or a prediction algorithm taking into account data from profiles of other users, the sets of characteristics from the database previously measured from the other users, and hemoglobin concentrations previously measured by a laboratory method” (claim 11), and “wherein the wearable device is further configured to determine an oxyhemoglobin concentration in the blood of the user” (claim 15)),
Further describe the pre-solution activity (“select the most significant signal from all the transformed at least two PPG signals and use it as a reference signal” (claims 2 and 19), “wherein the at least one PPG sensor comprises at least one radiation source comprising two or more light-emitting diodes” (claim 3), “wherein the at least one PPG sensor comprises at least one radiation detector, preferably being a wide-bandwidth photodetector” (claim 4), “wherein one of the at least two different wavelengths is in a range of 495-570 nm” (claim 5), “wherein the wearable device is further configured to filter out motion artifacts from the at least two PPG signals” (claim 6), “wherein the most significant signal is characterized by the best signal-to-noise ratio, the highest amplitude and/or the lowest noises” (claim 8), and “a memory configured to store the database” (claim 12), “wherein the wearable device is configured to be placed on a wrist” (claim 16), “wherein the wearable device is a smart device, and wherein the smart device is at least one of a smartwatch or a fitness bracelet” (claim 17)), and
Further describe the post-solution activity (“correlate the determined hemoglobin concentration using a hemoglobin concentration value measured by the laboratory method; update the database; and revise the prediction algorithm using a machine learning algorithm or a neural network” (claim 13) and “an input and output device configured to input a user profile data and display the determined hemoglobin concentration; and a communication module configured to communicate with a remote server and/or a cloud storage” (claim 14), etc.).
Taken alone or 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. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. 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. The result of the abstract idea does not cause the computing device and/or application to perform different.
Therefore, claims 1-20 are rejected as being directed to non-statutory subject matter.
Response to Arguments
Applicant’s arguments, see page 7, filed 4/20/2026, with respect to the claim objections have been fully considered and are persuasive. Applicant has amended claim 10 to overcome the objection. Applicant has amended claim 11 per the suggestion of the Examiner. The objection of the claims has been withdrawn.
Examiner acknowledges Applicant amending claim 20 with regards to the communication interface. Applicant has removed the “means for” language; thus, the “means for a communication interface” is no longer interpreted under 112(f) as laid out in the Office Action filed 01/30/2026.
Applicant’s arguments, see pages 7-8 , filed 04/20/2026, with respect to the 35 U.S.C. §112(b) rejections have been fully considered and are persuasive. Applicant has amended claims 2 and 10 to remove the recitations of a “set of amplitude phase characteristics”. Applicant removed the word “preferably” from claims 5 and 17. Applicant has corrected the lack of antecedent basis issue of the user profile in claim 14. The rejection of the claims has been withdrawn.
Applicant’s arguments, see pages 8-13, filed 04/20/2026, with respect to the 35 U.S.C. §102(a)(1) and 35 U.S.C. §103 rejections have been fully considered and are persuasive. Applicant has amended the claims to recite that harmonics are extracted from the at least two PPG signals, coordinates are obtained from the harmonics, and the at least two PPG signals are decomposed according to the coordinates to obtain a set of characteristics. Examiner agrees with Applicant’s arguments that Kulcke fails to teach these limitations. Additionally, Schweitzer, Baker, Newberry, and Li fail to teach or suggest these limitations, alone or in combination with Kulcke. The rejection of the claims has been withdrawn.
Prior Art
The closest prior art of record is identified below.
Kim (US 20240148282) teaches a method of estimating glycated hemoglobin or glucose (Abstract), wherein a signal collection unit 210 measures PPG signals of a user at multiple wavelengths (Paragraphs 0053-0054). The signal undergoes spectral analysis (Paragraphs 0058-0059) for determining hemoglobin concentration (Paragraph 0086). Kim fails to teach or suggest extracting harmonics from the data, decomposing the harmonics to obtain a set of characteristics from harmonic coordinates, and determining the hemoglobin concentration from the set of characteristics.
Vermeulen (US 20170127981) teaches a hemoglobin detection apparatus that irradiates a user at different wavelengths covering a spectral modulation interval (Abstract). The harmonic frequency components of the signals show the contribution of oxyhemoglobin and deoxyhemoglobin in the absorption signals (Paragraphs 0137-0143). However, Vermeulen fails to teach or suggest using the harmonic coordinates to determine a set of characteristics and using the set of characteristics to determine a hemoglobin concentration.
Kulcke (US 20190028662) teaches a PPG sensor (Paragraph 0099) configured to irradiate a subject with at least two wavelengths (Paragraphs 0119-0120). The signals are transformed to a frequency domain (Paragraph 0047) and the harmonics are extracted (Paragraphs 0047-0049). A hemoglobin concentration is calculated from the signals (Paragraph 0060). Kulcke fails to teach or suggest using the harmonics as coordinates to determine a set of characteristics, and determining the hemoglobin therefrom.
Strachan (US 20150105666) teaches a PPG analysis by calculating a harmonic of the heart rate (Abstract). The harmonic of the heart rate is used to determine characteristics of the heart rate, and it is then compared against a normal heart rate to determine a vascular condition (Paragraphs 0047-0053). Strachan fails to teach or suggest determining a hemoglobin concentration.
Thus, alone or in combination, the prior art of record fails to teach or suggest determining a hemoglobin concentration based on a set of characteristics determined from harmonic coordinates of at least two PPG signals.
Conclusion
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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