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 .
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/13/2026 has been entered.
Response to Arguments
2. Applicant's arguments filed 07/13/2026 regarding the U.S.C. 101 rejection have been fully considered but they are not persuasive.
The Applicant argues that the amendments to the claims would overcome the U.S.C. 101 mental process rejection. The Examiner respectfully disagrees. The new claim limitation "and the hardware processor is further configured to, based on the identified one of the plurality of sleep stages or the wake stage, provide a prediction of a disease of the user selected from a group consisting of hypertension and diabetes mellitus” is not considered an additional element that integrates the abstract ideas into a practical application thereof. Rather, this limitation is still a mental process and/or mathematical concept. For instance, a user could look at the sleep data and determine if there is an increase in the N1 sleep stage and then make a prediction that the patient could experience hypertension or diabetes mellitus.
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 limitation “based on the identified one of the plurality of sleep stages or the wake stage, provide a prediction of a disease of the user selected from a group consisting of hypertension and diabetes mellitus” is an abstract idea and not an additional element. The additional elements of claims, i.e., hardware processor, is merely a generically recited computer element used as a tool for executing the abstract ideas or insignificant extra-solution activity. See MPEP 2106.05(a), wherein “[i]t is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.”
If there was an actual treatment step (i.e., the data is being used to control/administer a treatment for hypertension/diabetes), then that would integrate the concept into practical application. The current amendment would not be enough to integrate the claims into practical application since there is not an actual step about administering treatment or controlling treatments based on the predicted diagnosis. The Examiner points to the MPEP 2106.04(d)(2).
Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.
Based on the bolded portion of the recited passage, the step of predicting a disease is not enough to integrate a judicial exception into practical application.
Regarding the argument directed to the HR sensor, the Examiner points to the last full paragraph on page 9 of the Applicant’s specification which discloses, “[f]or example, the input/output control interface unit 108 may be a heart rate detection means capable of detecting a heart rate signal, such as a pressure detection sensor or a vibration detection sensor.” The specification describes no structure, no special relationship with the processor or any specificity at all. This is an admission of well understood routine conventional activity. Despite this admission, Applicant makes no argument that the HR sensor is not known. Rather, Applicant argues that even if a HR sensor is "known," the collection of heart rate signal data is essential to the present invention. That’s not a persuasive argument because data gathering is extra-solution activity per MPEP 2106.05(g) and MPEP 2106.05(d).
Regarding the argument directed towards the data requirement, the claim does not specify an amount of data or an amount of time that would preclude mental storage. For example, there is currently no time limit or amount of data listed in the claims; therefore, a user can take in one night of sleep data and then has infinite time to make determinations. Even so, gathering or storing data is extra-solution activity per MPEP 2106.05(g) and MPEP 2106.05(d).
The U.S.C. 101 rejection still stands. Also, a U.S.C. 112a written description rejection has been added (see below).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
3. Claims 12, 13, 16-17, and 21-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to claims 12, 13, and 16, they have been amended to recite “and the hardware processor is further configured to, based on the identified one of the plurality of sleep stages or the wake stage, provide a prediction of a disease of the user selected from a group consisting of hypertension and diabetes mellitus”. It is unclear how exactly this prediction is done. There is not anything in the specification tying the Applicant’s processor to this prediction or disclosing the steps the processor would take in order to make this prediction. For instance, the specification teaches that there is a correlation between an increase in the N1 sleep stage and a patient having hypertension/diabetes mellitus, but the claims, nor the specification, do not state that the processor is making this determination that N1 is elevated, and thus the patient is experiencing hypertension/diabetes mellitus. There are no working examples, guidance, or steps as to how this function is achieved. It is ultimately unclear how the prediction is being made using the Applicant’s processor (i.e. how is this prediction performed with the algorithm/steps?). See also MPEP 2161.01.
As noted in the MPEP, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient).
It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement
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.
4. 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
5. 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached on Monday-Friday, 7:30-5:30 EST.
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/SLC/Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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