DETAILED ACTION
Applicant’s arguments, filed 05/26/2026, 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 1-17 and 19-22 are the current claims 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 1-17 and 19-22 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 and 11:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a computer implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a method. Claim 11 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Therefore, further consideration is necessary regarding claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 11 recite an abstract idea. In particular, the claims generally recite
the following:
generating a first respiration rate estimate using the motion information (claims 1 and 11);
generating a second respiration rate estimate using the PPG data (claims 1 and 11);
determining, based on the motion information, a physical activity level of a person wearing the ear-wearable electronic device (claims 1 and 11);
determining that an increase in the second respiration rate estimate is associated with an increase in the physical activity level of the person wearing the ear-wearable electronic device, or determining that a decrease in the second respiration rate estimate is associated with to a decrease in the physical activity level of the person wearing the ear-wearable electronic device (claims 1 and 11);
determining that the activity status test is negative when the physical activity level of the person wearing the ear-wearable electronic device is consistent with the second respiration rate (claims 1 and 11); and
producing a final respiration rate estimate using the first and second respiration rate estimates (claims 1 and 11).
These elements recited in claims 1 and 11 are drawn to an abstract idea since they are directed towards mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
“generating a first and second respiration rate estimate using the motion information and the PPG data” are 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 estimate the respiration of a user given the motion information and PPG data from their respective sensors. There is nothing to suggest an undue level of complexity in “generating a first and second respiration rate estimate using the motion information and the PPG data”.
“determining, based on the motion information, a physical activity level of a person wearing the ear-wearable electronic device” 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 motion information to determine a user’s physical activity level therefrom. There is nothing to suggest an undue level of complexity in “determining, based on the motion information, a physical activity level of a person wearing the ear-wearable electronic device”.
“determining that an increase in the second respiration rate estimate corresponds to an increase in the physical activity level of the person wearing the ear-wearable electronic device, or determining that a decrease in the second respiration rate estimate corresponds to a decrease in the physical activity level of the person wearing the ear-wearable electronic device” 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 motion information and physical activity level to determine if they correspond to each other. There is nothing to suggest an undue level of complexity in “determining that an increase in the second respiration rate estimate corresponds to an increase in the physical activity level of the person wearing the ear-wearable electronic device, or determining that a decrease in the second respiration rate estimate corresponds to a decrease in the physical activity level of the person wearing the ear-wearable electronic device”.
“determining that the activity status test is negative when the physical activity level of the person wearing the ear-wearable electronic device is consistent with the second respiration rate” 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 motion information and physical activity level to determine if they correspond to each other to determine a result. There is nothing to suggest an undue level of complexity in “determining that the activity status test is negative when the physical activity level of the person wearing the ear-wearable electronic device is consistent with the second respiration rate”.
“producing a final respiration rate estimate using the first and second respiration rate estimates” 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 calculate a respiration rate between two measured respiration rates. There is nothing to suggest an undue level of complexity in “producing a final respiration rate estimate using the first and second respiration rate estimates”.
Prong Two: Claims 1 and 11 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., "obtaining motion information from a motion sensor of the ear-wearable electronic device" (claim 1), "obtaining photoplethysmographic (PPG) data from a PPG sensor of the ear-wearable electronic device" (claim 1), “a motion sensor configured to generate motion information (claim 11), and “a photoplethysmographic sensor configured to generate PPG data” (claim 11)).
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 and 11 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, “a motion sensor” as disclosed in the Applicant’s specification on page 14, line 40 to page 15, line 2, “The motion sensor 106 can be or include an accelerometer (e.g., a 3-axis accelerometer), a gyroscope, an inertial measurement unit (IMU), a magnetometer or any combination of these motion sensing devices” or a “PPG sensor” as disclosed in the Applicant’s specification on page 16, lines 13-14, “The PPG sensor 108 may be implemented as a pulse oximeter or other form of sensor capable of optically obtaining a plethysmogram”.
As a further example, this arrangement of sensors is well-understood, routine, and conventional as disclosed by Ayers (US 2022/0096002), wherein a PPG sensor and an IMU sensor are disposed in an in-ear audio device (Paragraphs 0012-0013).
Further, "a processor", "a communication device", "an external electronic device", and "a cloud database" 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 dependent claims 2-10, 12-17, and 19-22:
Claims 4-5, 9, 14-15, 20, and 22 recite mental steps that may be performed in the human mind with the aid of pen and paper or a generic computer, which add to the abstract idea. The mental steps are identified as:
“selecting one of the first windows and one of the second windows for processing based on predefined spectral content criteria; wherein the predefined spectral content criteria comprises a highest peak in a spectral domain in the range of about 0.1 Hz to about 0.5 Hz” (claim 4);
“performing a test of motion sensor signal integrity; and performing a test of PPG sensor signal integrity” (claim 5);
“generating one or more of an early warning score, long term analyses, and respiration rate trending reports by one or both of the external electronic device or a cloud processor” (claim 9);
“a memory configured to capture the motion information in a plurality of temporally spaced first windows and to capture the PPG data in a plurality of temporally spaced second windows; wherein the processor is configured to select one of the first windows and one of the second windows for processing based on predefined spectral content criteria, and the predefined spectral content criteria comprises a highest peak in a spectral domain in the range of about 0.1 Hz to about 0.5 Hz” (claim 14);
“perform a test of motion sensor signal integrity; and perform a test of PPG sensor signal integrity” (claim 15);
“wherein the processor is configured to calculate the final respiration rate estimate of the wearer in response to successful signal integrity, activity, and validity tests” (claim 20); and
“wherein one or both of the external electronic device and a cloud processor are configured to generate one or more of an early warning score, long term analyses, and respiration rate trending reports” (claim 22).
Claims 2-3, 6-8, 12-13, 16-17, and 19 recite steps that are mathematical concepts, which add to the abstract idea. The mathematical concepts are identified as:
“filtering the motion information using a bandpass filter configured to pass frequencies in a frequency range consistent with human breathing; and applying a sinus fitting to the bandpass-filtered motion information to generate the first respiration rate estimate” (claim 2);
“filtering the PPG data using a high pass filter having a specified cutoff frequency; performing a time domain-to-frequency domain transform on the high pass-filtered PPG data; performing peak and local minimum detection on the transformed PPG data; and applying a sinus fitting to heights of peaks of the transformed PPG data to generate the second respiration rate estimate” (claim 3);
“wherein producing the final respiration rate estimate comprises processing the first and second respiration rate estimates using a fusion algorithm to produce the final respiration rate estimate” (claim 6);
“comparing the second respiration rate to a threshold” (claim 7);
“further comprising performing a validity test of the second respiration rate estimate by comparing the second respiration rate estimate to a threshold” (claim 8);
“bandpass filter configured to pass frequencies of the motion information in a frequency range consistent with human breathing; and motion sensing circuitry implementing a sinus fitting module configured to apply sinus fitting to the bandpass-filtered motion information to generate the first respiration rate estimate” (claim 12);
“a high pass filter having a specified cutoff frequency configured to filter the PPG data; a peak and local minimum detector configured to perform peak and local minimum detection on frequency transformed PPG data; and PPG sensing circuitry implementing a sinus fitting module configured to apply a sinus fitting to heights of peaks of the frequency transformed PPG data to generate the second respiration rate estimate” (claim 13);
“wherein the processor is configured to process the first and second respiration rate estimates using a fusion algorithm to produce the final respiration rate estimate” (claim 16);
“compare the second respiration rate to a threshold” (claim 17);
“wherein the processor is configured to perform a validity test of the second respiration rate estimate by comparing the second respiration rate estimate to a threshold” (claim 19);
Claims 4, 7, 9, 17, and 21 recite limitations in addition to the abstract idea: they merely:
Further describe the pre-solution activity (“capturing the motion information in a plurality of temporally spaced first windows; capturing the PPG data in a plurality of temporally spaced second windows” (claim 4)), and
Further describe the post-solution activity (“outputting the second respiration rate estimate in response to the second respiration rate exceeding the threshold; outputting the first respiration rate estimate in response to the second respiration rate failing to exceed the threshold” (claim 7), “comprising communicating respiration rate data alone or in combination with other physiologic data to one or both of an external electronic device and a cloud database” (claim 9), “output the second respiration rate estimate in response to the second respiration rate exceeding the threshold; and output the first respiration rate estimate in response to the second respiration rate failing to exceed the threshold” (claim 17), “wherein the processor is configured to communicate respiration rate data alone or in combination with other physiologic data to one or both of an external electronic device and a cloud database” (claim 21)).
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 differently.
Therefore, claims 1-17 and 19-22 are rejected as being directed to non-statutory subject matter.
Response to Arguments
Applicant’s arguments, see page 15, filed 05/26/2026, with respect to the 35 U.S.C. §112(b) rejection have been fully considered and are persuasive. Applicant has clarified the language of the second respiration rate is “influenced by” to “caused by” the physical activity of the person and “corresponds to” to “associated with”. Applicant has sufficiently argued that one of ordinary skill would recognize how to determine a respiration rate form motion information and PPG data. Therefore, the rejections are withdrawn.
Applicant’s arguments, see pages 9-14, filed 05/26/2026, with respect to the 35 U.S.C. §101 rejection have been fully considered but are not found persuasive.
Applicant argues that the independent claims are not merely directed to an abstract idea. Applicant asserts that the abstract idea is tied to physical sensors (i.e., the PPG and motion sensors), a processor, and a communication device, and that these elements are not merely nominal components performing the method. Examiner respectfully disagrees.
The abstract idea identified above of generating respiration rates from motion information and PPG data, determining a physical activity level, comparing a respiration rate with the physical activity level, determining consistency between the physical activity level and the respiration rate, and producing a final respiration rate are broad recitations of steps. The data collection steps (i.e., obtaining motion information and PPG data) are directed towards insignificant extra-solution activity; thus, the collection of the data is not the abstract idea. The data collections steps merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer.
The abstract idea steps identified above are mental steps that can be performed in the human mind, with the aid of pen and paper or a generic computer. One of ordinary skill in the art would be capable of performing these steps as they do not suggest any undue complexity in their respective calculations.
Further, the abstract idea is implemented on additional elements that are well-understood, routine, and conventional. For example, a “PPG sensor” and a “motion sensor” are well-understood, routine, and conventional sensors. Per Applicant’s specification, multiple types of motion and PPG sensors are disclosed on page 14, line 40 to page 15, line 2, “The motion sensor 106 can be or include an accelerometer (e.g., a 3-axis accelerometer), a gyroscope, an inertial measurement unit (IMU), a magnetometer or any combination of these motion sensing devices” and on page 16, lines 13-14, “The PPG sensor 108 may be implemented as a pulse oximeter or other form of sensor capable of optically obtaining a plethysmogram”. These lines are in the specification are directed to a broad swath of sensors capable of obtaining the motion information and PPG data. While the sensors may be integral to the claimed respiration rate determination technique, they are broadly recited as a “motion sensor” and “PPG sensor”. Per the example provided above, Ayers discloses a PPG sensor and IMU arrangement, implemented in an in-ear audio device. As such, this combination of sensors is well-understood, routine, and conventional. Therefore, the additional elements do not integrate the judicial exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea).
Applicant further asserts that the rejection does not properly address the claim elements as a whole – an ordered combination. While the ordered combination may be unique, the claimed ordered combination is still directed towards mental processes implemented on well-understood, routine, and conventional additional elements.
Lastly, Applicant argues that the dependent claims integrate the abstract idea into a practical application and/or amount to significantly more. Applicant specifically points to claims 2-3 and 12-13 as an example, wherein using a bandpass filter and applying a sinus fitting to the filtered motion is performed to generate the first respiration rate and wherein using a high-pass filter performing a transform, peak and local minimum and detection, and sinus fitting to the PPG data are directed to not mental processes. Further, Applicant asserts that the other dependent claims recite additional signal-processing and quality-control features that reinforce the claims are directed to a practical sensor-based physiological measurement technique. Examiner respectfully disagrees.
Examiner points to the updated rejection of the claims, wherein the dependent claims are further applied to the Alice/Mayo subject matter eligibility test. The dependent claims further recite mental steps, mathematical concepts, and/or merely add to the abstract idea, as described above. Therefore, the claims remain rejected.
Prior Art
The prior art of record, Ayers, Thorp, Burg, Jarchi, and Melker, teach analogous devices to the instant application.
Ayers (US 20220096002) teaches a method of determining a respiration rate using an ear-wearable device (Fig. 2) comprising PPG and motion sensors (Paragraph 0046 and Fig. 2, biosensors 212) and using these sensors to estimate respiration and a user activity (Paragraphs 0066-0074). However, Ayers fails to teach performing an activity status by comparing the user’s physical activity detected based on motion information to a respiration rate estimate detected based on PPG information.
Melker (US 20150105632) teaches a data fusion model for detecting respiratory parameters from accelerometers and PPG (Paragraph 0033). Thorp (US 20240197200) teaches a device for sensing acceleration changes indicative of respiration (Paragraphs 0045-0047). Burg (US 20190298183) teaches a device for measuring respiration rate using PPG and motion sensors (Paragraph 0010). Jarchi (US 20210000384) teaches estimating respiration rate from PPG and accelerations (Paragraphs 0012, 0045, and 0055). However, the prior art of record fails to teach performing an activity status test by comparing motion information and PPG information to determine if the user’s physical activity is consistent with the users estimated respiration rate.
Thus, the prior art of record, alone or in combination, fails to teach or provide an obviousness rationale to combine the prior art to read on the claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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