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 .
Remarks
This action is in response to the remarks filed 01/02/2026.
Claims 1, 5, 7, 8, 11, 13, and 14 are pending.
Response to Arguments
Applicant's arguments, see Remarks filed 01/02/2026, pages 13-20, regarding the rejection of claims 1, 3-5, 7, 8, 10, 11, 13, and 14 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Rejection of claims 1, 3-5, 7, 8, 10, 11, 13, and 14 under 35 U.S.C. 101
Independent claims 1, 8, and 14 have been amended to recite limitations from claims 3, 4, and 10, which have now been cancelled. Claims 1, 8, and 14 have been further amended to recite obtaining annotations of the raw input signals, a specific formula for the percentage change, collecting PPG signals and ground truth PPG signals, computing heart rate values from the PPG signals collected, and selecting only good PPG signals. Applicant argues that the amended claims are not directed towards an abstract idea, and further integrates the judicial exception into a practical application of applying or using a judicial exception to effect a particular treatment or prophylaxis for a medical condition.
The argument (see pages 14-18) that the claims integrate the judicial exception into a practical application with an improvement in the functioning of a computer or an improvement to other technology or technological field (pages 14-15 and 16-18) and by applying or using a judicial exception to effect a particular treatment or prophylaxis for a medical condition (page 15) is not found to be persuasive.
First, Applicant argues that classifying the PPG signals into good and bad signals in accordance with metrices as claimed provides an improvement in the functioning of a computer or an improvement to other technology or technological field. Then, Applicant argues that a mobile PPG application to collect PPG signals and ground truth signals and selecting only good PPG signals to avoid erroneous heart rate features applies or uses the judicial exception to effect a particular treatment or prophylaxis for a medical condition. Finally, Applicant argues that avoiding erroneous heart rate features by only selecting good PPG signals as classified by the PPG quality checker device implemented on medical devices improves the functioning of a computer.
These arguments are not persuasive. As recited, the claims require determining a quality of a PPG signal, comprising receiving raw data associated with a PPG signal, obtaining annotations of the raw input data, filtering the raw data using a filter, extracting heart frequency and breathing frequency components, determining a plurality of metrices, estimating a plurality of thresholds, determining a quality of input signals as a bad signal or good signal through filtering, extracting, and application of a formula, collecting PPG signals and ground truth PPG signals, computing heart rate values, and selecting only good PPG signals. These are limitations that are directed towards data collection and analysis. As best understood, the crux of the invention is the data processing performed to determine the quality of the input signals. Any improvement to a technology or technological field resides within the abstract idea itself. Further, the addition of the formula falls within the “Mathematical Concepts” grouping of abstract ideas. See MPEP 2106.04(a)(2)(I).
Next, Applicant argues that the claims recite significantly more by deploying the PPG quality checker in an edge computing scenario (pages 18-19) and points to XY, LLC v. Trans Ova Genetics. This is not found to be persuasive. While the claim recites an edge device, these edge devices are well known, conventional and routine. According to the instant specification at par. [0037], an edge device can be a “smartwatch, wearables or medical devices for deducing health parameters of patients”, and further can comprise “a wearable, several diagnostic/health monitoring tools used in an Intensive Care Unit (ICU), and a medical grade devices”. These devices are well known, as explained in the Non-Final Rejection of 09/28/2024, page 10 (e.g. Alam et al., US Patent Application Publication 2019/0133533, of record, Par. [0043]: system can be implemented in many devices such as a wearable device). Further, as explained above, the crux of the invention is the data processing performed to determine the quality of the input signals, which is an abstract idea of data processing.
Applicant is reminded that abstract ideas cannot provide a practical application or significantly more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the additional elements of the claims are merely generically recited computer elements used as tools for executing the abstract ideas or insignificant extra-solution activity. Further, references to XY, LLC v. Trans Ova Genetics (see page 18) are not applicable here due to distinct fact patterns. In the instant claims, specific mathematical formulas are claimed to perform parts of the data analysis, which is the abstract idea of mathematical concepts.
Therefore, there is no further description, in the claims or the specification, of any particular technology for performing the steps recited in the claim other than generic computer components used in their ordinary capacity as tools to apply the abstract idea. Nor does the claimed invention use a particular, or special, machine. In other words, the claims “are not tied to any particular novel machine or apparatus” capable of rescuing them from the realm of an abstract idea.
Therefore, the claims do not recite any additional elements that: (1) improve the functioning of a computer or other technology, (2) are applied with any particular machine, (3) effect a transformation of a particular article to a different state, and (4) are applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment or field of use. Please See MPEP § 2106.05(a)(c), (e)-(h). The rejection of the claims under 35 U.S.C. 101 is maintained.
Claim Objections
Claims 1, 8, and 14 are objected to because of the following informalities:
Claim 1, page 3, lines 13-14, “wherein the plurality of metrices facilitates to classify the filtered signals” is grammatically unclear.
Claim 1, page 4, end of the claim, “identified that the computed HR values collected from the mobile PPG application are mapped with the HR values computed from GT PPG facilitates to avoid erroneous HR features” is grammatically unclear.
Claims 8 and 14 recite the same language as above.
Appropriate correction is required.
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, 7, 8, 11, 13, and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method, system, and computer program product for determining quality of a photoplethysmogram (PPG) signal. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed towards a method, claim 8 is directed towards a system, and claim 14 is directed towards a computer program product, and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
The claims recite the abstract idea of both a “Mental Process” and “Mathematical Concepts”.
Claim 1 is directed towards a method, claim 8 is directed towards a system, and claim 14 is directed towards a computer program product for determining a quality of a PPG signal, comprising receiving raw data associated with a PPG signal, obtaining annotations of the raw input data, filtering the raw data using a filter, extracting heart frequency and breathing frequency components, determining a plurality of metrices, estimating a plurality of thresholds, determining a quality of input signals as a bad signal or good signal through filtering, extracting, and application of a formula, collecting PPG signals and ground truth PPG signals, computing heart rate values, and selecting only good PPG signals. The limitation of determining a quality of a PPG signal, as drafted in claims 1, 5, 7, 8, 11, 13, and 14, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or using pen and paper or a generic computing component.
For example, determining a quality of a PPG signal in the context of this claim encompasses a user acquiring PPG data, filtering the PPG data, extracting heart frequency and breathing frequency components, determining a plurality of metrices, estimating a plurality of thresholds, determining a quality of input signals as a bad signal or good signal through filtering, extracting, and application of a formula, collecting PPG signals and ground truth PPG signals, computing heart rate values, and selecting only good PPG signals.
The step of acquiring PPG data is considered to be a mere data gathering step (i.e. an insignificant extra-solution activity, see MPEP 2016.05(g)), and the steps filtering the PPG data, extracting heart frequency and breathing frequency components, determining a plurality of metrices, estimating a plurality of thresholds, determining a quality of input signals as a bad signal or good signal through filtering, extracting, and application of a formula, computing heart rate values, and selecting only good PPG signals are considered to be data analysis steps.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Further, claims 1, 8, and 14 recite the limitations of determining the percentage change by using a specific claimed formula and classifying the PPG signal by using a specific claimed formula. These limitations fall within the “Mathematical Concepts” grouping of abstract ideas. See MPEP 2106.04(a)(2)(I).
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
The additional elements of one or more hardware processors are recited at a high level of generality (i.e., as generic computing elements performing the steps of gathering and analyzing data) such that they amount to no more than mere instructions to apply the exception using a generic computer component. Further, the processors recited in the claim are generic, well-known processors (e.g. par. [0023] of the instant specification: “the one or more hardware processors 104 can be implemented as one or more microprocessors, microcomputers, microcontrollers, digital signal processors, central processing units, state machines, logic circuitries, and/or any devices that manipulate signals based on operational instructions”). Further, while the claim recites an edge device, these edge devices are well known, conventional and routine. As best understood, according to the instant specification at par. [0037], an edge device can be a “smartwatch, wearables or medical devices for deducing health parameters of patients”, and further can comprise “a wearable, several diagnostic/health monitoring tools used in an Intensive Care Unit (ICU), and a medical grade devices”. These devices are well known, as explained in the Non-Final Rejection of 09/28/2024, page 10 (e.g. Alam et al., US Patent Application Publication 2019/0133533, of record, Par. [0043]: system can be implemented in many devices such as a wearable device).
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination is not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of one or more hardware processors and an edge device to gather data and perform the data analysis amounts to no more than mere instructions to apply the exception using a generic data analysis model. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 5, 7, 11, and 13 depend on claims 1 and 8 and recite the same abstract idea as claims 1 and 8 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 5, 7, 11, and 13 (i.e. performing more analysis using the claimed filtering and extraction methods) are simply further data analysis steps. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provide a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
While there are no prior art rejections for claims 1, 5, 7, 8, 11, 13, and 14, they are not indicated as allowable due to the rejection of the claims under 35 U.S.C. 101, as explained above.
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 SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796