DETAILED ACTION
Applicant’s arguments, filed 02/17/2026, 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 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 (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. 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) and "obtaining photoplethysmographic (PPG) data from a PPG sensor of the ear-wearable electronic device" (claim 1)).
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 the dependent claims:
Claims 2-10, 12-17, and 19-22 depend from the independent claims. Dependent claims 2-10, 12-17, and 19-22 merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“applying a sinus fitting to the bandpass-filtered motion information to generate the first respiration rate estimate” (claim 2), “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), “wherein producing the final respiration rate estimate comprises: comparing the second respiration rate to a threshold; outputting the second respiration rate estimate in response to the second respiration rate exceeding the threshold; and outputting the first respiration rate estimate in response to the second respiration rate failing to exceed the threshold” (claim 7), “performing a validity test of the second respiration rate estimate by comparing the second respiration rate estimate to a threshold” (claim 8), “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), “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), “wherein the processor is configured to produce a final respiration rate by being configured to: compare the second respiration rate to a threshold; 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 perform a validity test of the second respiration rate estimate by comparing the second respiration rate estimate to a threshold” (claim 19), and “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)),
Further describe the pre-solution activity (“filtering the motion information using a bandpass filter configured to pass frequencies in a frequency range consistent with human breathing” (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” (claim 3), “capturing the motion information in a plurality of temporally spaced first windows; capturing the PPG data in a plurality of temporally spaced second windows; and 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), “a test of motion sensor signal integrity; and performing a test of PPG sensor signal integrity” (claim 5), “bandpass filter configured to pass frequencies of the motion information in a frequency range consistent with human breathing” (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” (claim 13), “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), and “herein the processor is configured to: perform a test of motion sensor signal integrity; and perform a test of PPG sensor signal integrity” (claim 15)), and
Further describe the post-solution activity (“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), “comprising 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 10), “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), 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)).
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 different. The result of the abstract idea does not cause output of the user-accessible output.
Therefore, claims 1-17 and 19-22 are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112
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 1-17 and 19-22 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.
Regarding claims 1 and 11, it is unclear as to how the first respiration rate is estimated using motion information from the motion sensor of the ear-wearable electronic device. What motion data is measured to calculate a respiration rate? How is the motion data used to calculate a respiration rate? For examination purposes, any disclosure of measuring a respiration rate from a motion sensor will be required to meet the claim. Claims 2-10, 12-17, and 19-22 are also rejected due to their dependence on claims 1 and 11.
Regarding claims 1 and 11, it is unclear as to how the second respiration rate is estimated using PPG data from the PPG sensor of the ear-wearable electronic device. It appears Applicant intends to claim the details of claim 3, wherein a sinus fitting is applied to the peaks of the PPG data to estimate the second respiration rate. For examination purposes, this is how the claim will be interpreted.
Regarding claims 1 and 11, the metes and bounds of the claim are unclear with regard to the second respiration rate being “influenced” by physical activity. How “influenced” does the second respiration rate estimate have to be by the physical activity to determine the result of the activity status test? Would any amount of physical activity necessarily influence a respiration rate estimate? For examination purposes, “influenced” will be interpreted as “caused by”.
Regarding claims 1 and 11, it is unclear how determining the respiration rate increase/decrease “corresponds to” an increase/decrease to the physical activity level of a person. How much of a change (increasing or decreasing) is required to determine that the estimates “correspond to” the physical activity level. Is there an algorithm or calculation to determine that the estimate and activity level correspond to each other, and, if so, is there a cutoff or a threshold for one or both? For examination purposes, any amount of increase (or decrease) in both the respiration rate estimate and physical activity level will result in the two values “corresponding to” each other.
Response to Arguments
Applicant’s arguments, see page 9, filed 10/28/2025, with respect to the 35 U.S.C. §112(b) rejection have been fully considered and are persuasive. Applicant has amended the claim for proper antecedent basis. The rejection of the claims has been withdrawn. However, new rejections have been added.
Upon further consideration of the claims, a new rejection under 35 U.S.C. §101 has been added.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record, Ayers, Thorp, Burg, Jarchi, and Melker, teach analogous devices to the instant application.
Ayers 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 teaches a data fusion model for detecting respiratory parameters from accelerometers and PPG (Paragraph 0033). Thorp teaches a device for sensing acceleration changes indicative of respiration (Paragraphs 0045-0047). Burg teaches a device for measuring respiration rate using PPG and motion sensors (Paragraph 0010). Jarchi 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
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
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791