DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on October 15, 2025 were received and fully considered. Claims 1, 10, and 19 were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Claim Rejections - 35 USC § 112B
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 35 U.S.C. 112 (pre-AIA ), 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.
Claims 1-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, and all dependent claims thereof, recites “the signal condition feature reflecting a coupling between different systems of a body that the tissue is from” in lines 5-6, which is unclear as it is not understood what is meant by “reflecting a coupling between different systems of a body that the tissue is from”. For purposes of prior are consideration, Examiner interprets that an association or relationship between waveform features from multiple measurement devices, sensors, etc. placed in different locations of a body equates to the limitation in condition.
Similar indefiniteness is exhibited in mirrored independent claims 10 and 19, and all dependent claims thereof.
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 1-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a respiration rate prediction method. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“determining a respiration rate estimate and a signal condition feature from the hemodynamic signal, the signal condition feature reflecting a coupling between different systems of a body that the tissue is from; determining a signal quality indicator from the signal condition feature; deciding whether to determine a respiration rate prediction with a machine learning algorithm based on the signal quality indicator; determining the respiration rate prediction and a confidence score for the respiration rate prediction, the confidence score based on the respiration rate estimate and the signal condition feature being inputs into the machine learning algorithm…”
These limitations describe a mathematical calculation. When given their broadest reasonable interpretation in light of the specification, the limitations identified above including the recited machine learning algorithm are mathematical calculations. Moreover, the plain meaning a machine learning algorithm is a series of mathematical calculations. See also 2024 AI SME Update, which held a similar claim construction was not patent eligible (see claim 2 of example 47, using a trained artificial neural network to analyze anomalies on input data was not patent eligible). The 2024 AI SME Update also sets forth that a trained machine learning model/engine amounts to a mental process (claim 2 of example 47). As such, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“…emitting light into tissue with a light emitter; detecting the light from the tissue with a photodetector as a hemodynamic signal… and outputting the respiration rate prediction from the machine learning algorithm based on the confidence score.”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, i.e., mere data gathering steps necessary to perform the identified judicial exception and outputting do not integrate a judicial exception into a practical application. See MPEP 2106.05g.
The additional limitations also do not add significantly more to the identified judicial exception because they pertain to widely known, routine, and conventional components in the art. Examiner takes official notice that utilizing a light emitter and photodetector in the manner recited is well-known in PPG monitoring systems.
Independent claims 10 and 19 are also not patent eligible for substantially similar reasons.
Dependent claims 2-9, 11-18, and 20-27 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1-27 are not patent eligible under 35 USC 101.
Response to Arguments
Applicant's arguments filed with respect to the 35 USC 101 rejections raised in the previous office action have been fully considered, but they are not persuasive. Applicant appears to argue that the claimed invention recites an improvement to RR detection technology, i.e. “improve accuracy of the respiration rate prediction” (see remarks, pg. 9). Examiner respectfully disagrees. The claims, as currently formulated, recite a judicial exception (mathematical calculation and/or mental process) that is (1) not integrated into a practical application; and (2) the addition limitations do not recite significantly more. Any purported improvement lies within the judicial exception itself1. However, an alleged better calculation is still a calculation nonetheless and would not be patent eligible. For at least these reasons, the 35 USC 101 rejections are maintained. Please see corresponding rejection heading above for more detailed analysis.
Applicant’s arguments filed with respect to the 35 USC 103 rejections raised in the previous office action were persuasive in view of the current amendment. Therefore, these rejections are withdrawn.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PG Pub. No. 2023/0309855 A1
Conclusion
No claim is allowed.
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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 “the judicial exception alone cannot provide the improvement.” See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981).