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 Arguments
1. Applicant's arguments filed 10/02/2025 regarding the U.S.C. 101 rejection have been fully considered but they are not persuasive.
The Applicant argues that the amendments citing a wearable terminal comprising a heart rate sensor would overcome the current U.S.C. 101 mental process rejection. The Examiner respectfully disagrees. This wearable terminal with a heart rate sensor is merely insignificant extra-solution activity of data gathering. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The use of a wearable heart rate sensor to gather HR data is well known in the art as disclosed by the following references: US 20150190086 A1 and US 20160007868 Al. Well-understood, routine and conventional activity cannot be significantly more than the abstract idea itself. The Applicant has not cited any information or amended the claims in a way that would make this wearable device novel (for instance, is there are particular configuration or placement of this wearable terminal that would not make it routine and conventional?). The rejection still stands.
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.
2. Claims 12, 13, 16-17, and 21-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The independent claims 12, 13, and 16 recite a system/method for a sleep determination unit that comprises a “wearable terminal comprising a heart rate sensor… a memory storing Equations (1) to (5); an input/output controller; and a hardware processor which executes a stored program to control the sleep determination apparatus” wherein the processor can receive, store, and apply a filter to the heart rate signal data to obtain a filtered heart rate signal; and detect a peak interval signal from the filtered heart rate signal by calculating a power spectral density, and “obtaining, based on the filtered heart rate signal and the power spectral density, a very low frequency component (VLF), a ratio of a low frequency component (LF) to a high frequency component (HF), a mean heartbeat interval (RRI), and a standard deviation of each heartbeat interval (RRI) of the heart rate in the heart rate signal data, as heart rate variability parameters indicating a heart rate state; generating data indicating which one of a plurality of sleep stages or a wake stage (WK) the user is in, by processing to identify the one of the plurality of sleep stages or the wake stage using all of the heart rate variability parameters, the plurality of sleep stages including a REM sleep stage (REM), a lightest first non-REM sleep stage (N1), a second non-REM sleep stage (N2) deeper than the first non-REM sleep stage (N1), a third non-REM sleep stage (N3) deeper than the second non-REM sleep stage (N2), and a deepest non-REM sleep stage (N4); and outputting, to an output device via the input/output controller.”
The limitation of determining sleep states of a user, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, gathering and analyzing heart data (via filters and equations) related could simply by looking at the data on a printout or screen or could be accomplished mentally and determining a sleep state could be done in the mind of a physician given the data from the heart rate obtainer. 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.
Claim 12 in particular also contains mathematical equations (1)-(5) with associated variables and definitions used to determine the probability that a user is in a particular sleep stage. These equations and steps of using these formulas would be considered abstract mathematical concepts. Further, the step of calculating a power spectral density in claims 12, 13, and 16 would also be considered an abstract mathematical idea.
This judicial exception is not integrated into a practical application. The components are recited at a high-level of generality such that it amounts no more than any structure that can obtain heart rata data, filter the data, determine the sleep stage from this data, and then output the result. Further, the use of a wearable terminal, sensors, controllers, and processors as cited, are merely insignificant extra-solution activity of data gathering. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The additional elements, such as the wearable terminal comprising a sensor to gather HR data and the processor to receive data and filer it, while being mere structures for data gathering are also well-understood, routine, conventional activity that is widely prevalent or common use in the relevant industry. The use of wearable terminals having sensors to gather HR data and processors to receive and filter this data are well known in the art as disclosed by the following references: US 20150190086 A1 and US 20160007868 Al. Well-understood, routine and conventional activity cannot be significantly more than the abstract idea itself. The claims are not patent eligible.
Prior Art Rejections
3. There are currently no art rejections applied to claims 12, 13, 16-17, and 21-24. The claims contain subject matter that is not found in the art. Such subject matter includes the probability calculations (1)-(5) in claim 12 and “wherein: threshold values th1 to th4, each for distinguishing between the first non-REM sleep stage (N1) and the second non-REM sleep stage (N2), are set for all of the heart rate variability parameters of the very low frequency component (VLF) of heart rate variability, the ratio of the low frequency component (LF) to the high frequency component (HF), the mean heartbeat interval (RRI), and the standard deviation of each heartbeat interval (RRI), and the determining comprises determining that the user is in the first non-REM sleep stage (N1) in a case where respective values of the very low frequency component (VLF) of heart rate variability, the ratio of the low frequency component (LF) to the high frequency component (HF), and the standard deviation of each heartbeat interval (RRI) are larger than the set threshold values th1, th2, and th4, respectively, and (ii) determining that the user is in the first non-REM sleep stage (N1) in a case where the value of the mean heartbeat interval (RRI) is smaller than the set threshold value th3.” in claim 13. However, the U.S.C. 101 rejections still need to be addressed.
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.
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/SLC/Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792