Prosecution Insights
Last updated: October 02, 2026
Application No. 18/855,259

Assessment Of Respiratory Depression Risk from a Wearable Device

Final Rejection §101§103§112
Filed
Oct 08, 2024
Priority
Apr 29, 2022 — nonprovisional of PCTUS2022026935
Examiner
OKONAK, ELIZABETH LOUISE
Art Unit
3792
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Google LLC
OA Round
2 (Final)
17%
Grant Probability
At Risk
3-4
OA Rounds
1y 2m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants only 17% of cases
17%
Career Allowance Rate
1 granted / 6 resolved
-53.3% vs TC avg
Strong +83% interview lift
Without
With
+83.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
34 currently pending
Career history
32
Total Applications
across all art units

Statute-Specific Performance

§101
12.6%
-27.4% vs TC avg
§103
49.5%
+9.5% vs TC avg
§102
17.3%
-22.7% vs TC avg
§112
16.8%
-23.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 6 resolved cases

Office Action

§101 §103 §112
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 Applicant’s arguments, see pg. 8, filed 07/17/2026, with respect to the objection to the specification have been fully considered and are persuasive in light of amendments. The objection of the specification has been withdrawn. Applicant’s arguments, see pg. 8, with respect to the objection to claim 6 have been fully considered and are persuasive in light of amendments. The objection of claim 6 has been withdrawn. Applicant's arguments, see pg. 8-9, with respect to the 35 USC 101 rejection of claims 1-20 have been fully considered but they are not persuasive. Applicant argues that “by integrating this processing step into the wearable device, the claims provide a technical solution to a technical problem and amount to significantly more than any alleged abstract idea” (see pg. 9). The examiner respectfully disagrees. As stated in the non-final rejection filed 04/29/2026 (see pgs. 5-6), when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes groping unless the claim limitation cannot be practically performed in the mind. Amended claim 1 recites determining a respiration rate based on heart rate data, then further analyzing thresholds/percentages of the respiration rate to determine whether the user is at risk for respiratory depression. While the examiner acknowledges that these actions are claimed to be integrated into a wearable device, a person is still capable of performing these actions in their mind, under the broadest reasonable interpretation. Therefore, the 35 USC 101 rejection is maintained. See rejection below for further details. Applicant’s arguments, see pg. 9-11, with respect to Hite teaching/suggesting the limitation of claims 7/16 now incorporated into independent claims 1/12, have been fully considered but are not persuasive. As cited in the non-final rejection (pg. 17), Fig. 11B and [0518] of Hite disclose the limitation: “a percentage of a predetermined period of time spent with the respiration rate below a threshold value”. Applicant argues that Hite only discloses instantaneous threshold and rate-of-change escalation triggers. It is the examiner’s position that Hite also discloses the above limitation. When referring to a “medium” level of alarm (see early stage row of Fig. 11B), Hite [0518] states: “…device alarm logic 315 and alert logic 317 activate a “Medium” level series of alarms and alerts if motion-state sensors continue to show a no-motion or low-motion state, and RR is less than 8 breaths per minute…” As seen in the early stage row of Fig. 11B and in [0518], Hite discloses a detection of a respiration rate below 8 breaths/min from a time of 1-2 minutes. The limitation “a predetermined period of time” can be interpreted as time = 0-2 minutes. Therefore, Hite discloses that the respiration rate was below 8 breaths/min for 50% of the time from 0-2 minutes. See also Fig. 11C, [0519] of Hite (when detecting a medical event late stage, 100% of the time period of 4 minutes was spent with an RR < 8 breaths/min). As such, under the broadest reasonable interpretation of the claims, Hite teaches the limitation: “a percentage of a predetermined period of time spent with the respiration rate below a threshold value”. Applicant’s arguments, see pg. 9-11, with respect to the 35 USC 103 rejection of claims 1-20, have been fully considered. The amendments to independent claims 1 and 12 to include the added limitation of determining a number of segments with a significant decrease in respiration rate overcome the rejection detailed in the non-final filed 04/29/2026. Since independent claims 1 and 12 were amended to include new limitations, new grounds of rejection are warranted for independent claims 1 and 12 and dependent claims 2-6, 8-11, 13-15, and 17-20. See prior art rejections below. 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 1-6, 8-15, and 17-20 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. The term “significant” in claims 1 and 12 is a relative term which renders the claims indefinite. The examiner has interpreted a “significant” decrease in the respiration rate to mean a decrease of > 3 breaths per minute in a 5 minute window, as in the specification [0058]. 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 1-6, 8-15, and 17-20 are rejected under 35 U.S.C 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts grouping, without significantly more. The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception. Step (1) The claimed invention in claims 1-6, 8-15, and 17-20 are directed to a system and method, and thus, the claims all fall under one of the four patent eligible categories. Step (2a) Prong 1 (Judicial Exception) Regarding claims 1-6, 8-15, and 17-20, the recited steps are directed towards mental processes of performing concepts in a human mind or by a human using a pen and paper and utilizing mathematical concepts (See MPEP 2106.04(a)(2) subsections (I) and (III)). Independent claims 1 and 12 recite: determining, based at least in part on the heart rate data, a respiration rate; determining, based at least in part on the respiration rate, one or more metrics associated with the risk for respiratory depression, wherein the one or more metrics comprise a first metric comprising a percentage of a predetermined period of time spent with the respiration rate below a threshold value and a second metric comprising a number of segments where there is a significant decrease in the respiration rate over the predetermined period of time; and determining the overall respiration risk metric based, at least in part, on the respiration rate and the one or more metrics; determining, based at least in part on the overall respiration risk metric, whether the user is at risk for respiratory depression. Under the broadest reasonable interpretation, these limitations require determining a heart rate, respiration rate, period of time when the respiration rate was below a threshold, the number of times there was a significant decrease in the respiration rate, and a user’s risk for respiratory depression. These limitations are processes that, as drafted, cover that which can be wholly performed in a person’s mind via a series of mental observations and judgements and utilizing mathematical concepts. In particular, a person can observe a heart rate, then use the heart rate to calculate the respiration rate, further determining metrics to identify if the user is at risk for respiratory depression. These are data gathering and processing steps (determining) that reflect mental processes and mathematical concepts. Accordingly, claims 1-6, 8-15, and 17-20 are directed to a judicial exception including one or more abstract ideas, specifically mental processes. Independent claims 1, 12 recite the corresponding apparatus associated with the system/method, including a wearable computing device, processor, and heart rate sensor. Under the broadest reasonable interpretation, these claims also recite a judicial exception including one or more abstract ideas under the mental processes and mathematical concepts buckets. The additional limitations in claims 4-5 comprise additional abstract ideas and mathematical concepts and/or further limit the abstract ideas of claims 1, 12. Claim 4 recites determining respiratory sinus arrhythmia (RSA) based on heart rate data. Under the broadest reasonable interpretation, RSA can be observed by correlating inhalation periods with increased heart rate, and exhalation periods with decreased heart rate. A person could observe these increases/decreases in heart rate and associate them with RSA and therefore respiration.1 Claim 5 recites determining a power spectral density and a spectral peak. Under the broadest reasonable interpretation, a person can observe/calculate portions of the signal that have the most power/would be best for using for further analysis. The additional limitations in claims 2-3, 6, 8-11, 13-15, and 17-20 (sensor types, graphing, obtaining demographics) comprise additional abstract ideas and mathematical concepts and/or further limit the abstract ideas of claims 1, 12. Step (2a) Prong 2 (Integration into a Practical Application) This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d). For claims 1-6, 8-15, and 17-20, the judicial exception is not integrated into a practical application. Regarding claims 1, 3, 12, 14 the additional elements of a heart rate sensor/optical sensor amount to recitation of a generic optical heart rate sensor. Under the broadest reasonable interpretation, these elements are nothing more than the pre-solution activity of mere data gathering using generic components. Regarding claims 1, 12, the additional element of notifying a user amounts to recitation of a generic notification. Under the broadest reasonable interpretation, these elements are nothing more than the post-solution activity of providing results using generic components. Regarding claims 1, 12, the additional elements of a wearable computing device and a processor amounts to recitation of a generic processor/computer that can be worn. This additional element merely defines the field of user of the current claim. This additional element does not practically integrate the judicial exception because this element does not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Furthermore, when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mental processes grouping. Step (2b) (Inventive Concept) The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of a wearable computing device, processor, and heart rate sensor in the field of heart rate monitoring are well-understood, routine and conventional activities previously known in the industry as indicated in the following references: Annoni et al. (US Pre-Grant Publication 2019/0167176) teaches a wearable computing device (monitoring device 321, Fig. 3, [0099], monitoring device and control circuit are integrated), processor ([0068], processor), and heart rate sensor ([0112], PPG sensor). Hornick (US Pre-Grant Publication 2012/0238834) teaches a wearable computing device (respiratory monitor 200, Fig. 2), processor (processor 206, Fig. 1), and heart rate sensor (sensors 202, Fig. 2, [0135], can be photoplethysmography probes or heart rate sensors). Dependent claims 3, 14 recite an optical sensor, which are also recited at a high level of generality and are considered to be well-known, routine and conventional in the art as indicated in the following references: Annoni et al. (US Pre-Grant Publication 2019/0167176) teaches an optical sensor ([0112], PPG sensor). Hornick (US Pre-Grant Publication 2012/0238834) teaches an optical sensor (sensors 202, Fig. 2, [0135], can be photoplethysmography probes). Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 1-6, 8-15, and 17-20 are thus rejected under 35 USC 101 for reciting patent-ineligible subject matter- abstract ideas and mathematical concepts. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 1-3, 6, 8-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Batchelder et al. (US Pre-Grant Publication 2014/0275887), hereinafter ‘Batchelder’, in view of Annoni et al. (US Pre-Grant Publication 2019/0167176), hereinafter ‘Annoni’, further in view of Hite et al. (US Pre-Grant Publication 2024/0074701), hereinafter ‘Hite’, further in view of Takahashi (US Pre-Grant Publication 2017/0268796), hereinafter ‘Takahashi’. Regarding claim 1, Batchelder teaches a device for monitoring respiratory depression events (abstract), further comprising: one or more processors (processor 412, Fig. 4, [0064]), a heart rate sensor (oximeter 420, Fig. 4, [0078], provides PPG signal); a non-transitory computer-readable memory (RAM 54 and ROM 52, Fig. 2, [0040]), the non-transitory computer-readable memory configured to store instructions that, when executed by the one or more processors, cause the one or more processors to perform operations ([0065], memory used by processor), the operations comprising: obtaining, via the heart rate sensor, heart rate data ([0023], PPG signal indicates pulse rate); determining, based at least in part on the heart rate data, a respiration rate ([0067], determine respiration rate based on data corresponding to light received by detector 18, Fig. 1); determining, based at least in part on the respiration rate, an overall respiration risk metric associated with a user (step 906, identify morphological characteristic, Fig. 9), the overall respiration risk metric representing a likelihood that the user is at risk for respiratory depression ([0084], identification of morphological characteristic indicative of respiratory depression events), wherein determining the overall respiration risk metric comprises: determining, based at least in part on the respiration rate, at least one metric associated with the risk for respiratory depression ([0076], changes in peak morphology can be indicative of respiratory depression); determining, based at least in part on the overall respiration risk metric, whether the user is at risk for respiratory depression (step 910, generate respiratory condition signal, Fig. 9, [0084], breathing classified as normal or indicative of respiratory depression); and responsive to determining the user is at risk for respiratory depression, providing a notification (step 914, alarm on respiratory depression, Fig. 9) indicative of the user being at risk for respiratory depression ([0085], alarm triggered when respiratory depression event is detected). Batchelder teaches that the sensors are wearable ([0074], sensors/detectors are positioned on patient), but does not teach that the sensing and computing devices are integrated into one wearable device. Annoni teaches a system for monitoring respiratory distress in a patient (abstract), further comprising: a wearable computing device ([0099], monitoring device 321 and control circuit 322 are integrated into a single medical device, Fig. 3). It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Batchelder to incorporate the teachings of Annoni to include a wearable device with sensing and computing capabilities. Doing so would allow for the device to be wearable, as recognized by Annoni [0108]. Batchelder and Annoni do not specifically teach that the at least one metric comprises a percentage of time spent with the respiration rate below a threshold value. Hite teaches a wearable device that detects a respiratory emergency of a user (abstract), further comprising: a percentage of a predetermined period of time spent with the respiration rate below a threshold value ([0518-0519], Figs. 11B, 11C); determining the overall respiration risk metric based, at least in part, on the respiration rate and the one or more metrics ([0517], activate alarm based on RR threshold, Fig. 11B). It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Batchelder and Annoni to incorporate the teachings of Hite to include determining the risk metric based on time spent with a low respiration rate. Doing so would provide another method of detecting emergencies, as recognized by Hite [0518]. Batchelder, Annoni, and Hite do not specifically teach determining a number of segments with a significant decrease in respiration rate. Takahashi teaches a method for measuring a respiratory state of a user (see [0152]), further comprising: a second metric comprising a number of segments where there is a significant decrease in the respiration rate over the predetermined period of time (Fig. 12, [0159], counting the drops of the respiratory rate during a time period from t10-t11). It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Batchelder, Annoni, and Hite to incorporate the teachings of Takahashi to include determining a number of segments with a significant decrease in respiration rate. Doing so would help differentiate between healthy/normal behavior and a serious situation, as recognized by Takahashi [0159]. Regarding claim 12, see rejection of similarly worded claim 1. Batchelder teaches a method for monitoring respiratory depression events (abstract), further comprising a computer-implemented method for determining whether a user wearing device is at risk of respiratory depression (Fig. 9). Regarding claim 2, Batchelder, Annoni, Hite, and Takahashi teach the device according to claim 1. Batchelder teaches the device further comprising: comparing the overall respiration risk metric to a threshold value ([0084], respiratory condition signal may be a scale of 1-10, low numbers indicate normal breathing and high numbers indicate respiratory depression condition); and determining the user is at risk for respiratory depression when the overall respiration risk metric satisfies a threshold criteria ([0084], predict the likelihood of onset of respiratory depression). Regarding claim 3, Batchelder, Annoni, Hite, and Takahashi teach the device according to claim 1. Batchelder teaches the device further comprising: wherein the heart rate sensor comprises one or more optical sensors ([0023], light sensor). Regarding claim 6, Batchelder, Annoni, Hite, and Takahashi teach the device according to claim 1. Batchelder teaches the device further comprising: generating, based at least in part on the determined respiration rate, a graphical representation depicting the determined respiration rate over a duration of time (Fig. 8). Regarding claim 8, Batchelder, Annoni, Hite, and Takahashi teach the device according to claim 1. Batchelder teaches the device further comprising: obtaining, via user input (user inputs 56, Fig. 2), a plurality of demographic factors ([0042], determine information about the patient such as age, weight, height, etc.); determining the overall respiration risk metric based at least in part on at least one of the respiration rate, or one or more of the plurality of demographic factors ([0042], allows monitor to determine patient-specific threshold ranges). Regarding claim 9, Batchelder, Annoni, Hite, and Takahashi teach the device according to claim 1. Batchelder teaches the calculation of respiratory rate and tidal volume ([0080]), but does not explicitly teach the calculation of a minute ventilation value. Annoni teaches a system for monitoring respiratory distress in a patient (abstract), further comprising: wherein determining the overall respiration risk metric is based, at least in part, on at least one of the respiration rate or a determined minute ventilation value (Table 1, minute volume (MV), total volume of gas inhaled or exhaled in one minute). It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Batchelder to incorporate the teachings of Annoni to include the calculation of minute ventilation value. Doing so would allow for the detection of rapid breathing that indicates acute exacerbation, as recognized by Annoni (Table 1). Regarding claim 10, Batchelder, Annoni, Hite, and Takahashi teach the device according to claim 1. Batchelder teaches the device further comprising: wherein determining the overall respiration risk metric is based, at least in part, on at least one of the respiration rate or a determined tidal volume value ([0091], derivation of tidal volume). Regarding claim 11, Batchelder, Annoni, Hite, and Takahashi teach the device according to claim 10. Batchelder teaches the device further comprising: wherein the overall respiration risk metric is based, at least in part, on at least one of the respiration rate or a tidal volume variability value that is based at least in part on the determined tidal volume value ([0073], change in tidal volume used to identify/predict respiratory depression event). Regarding claim 13, Batchelder, Annoni, Hite, and Takahashi teach the method according to claim 12. Batchelder teaches the method further comprising: comparing the overall respiration risk metric to a threshold value ([0084], respiratory condition signal may be a scale of 1-10, low numbers indicate normal breathing and high numbers indicate respiratory depression condition); and determining the user is at risk for respiratory depression when the overall respiration risk metric satisfies a threshold criteria ([0084], predict the likelihood of onset of respiratory depression). Regarding claim 14, Batchelder, Annoni, Hite, and Takahashi teach the method according to claim 12. Batchelder teaches the method further comprising: wherein the heart rate sensor comprises one or more optical sensors ([0023], light sensor). Regarding claim 15, Batchelder, Annoni, Hite, and Takahashi teach the method according to claim 12. Batchelder teaches the method further comprising: generating, based at least in part on the determined respiration rate, a graphical representation of the determined respiration rate over a duration of time (Fig. 8). Regarding claim 17, Batchelder, Annoni, Hite, and Takahashi teach the method according to claim 12. Batchelder teaches the method further comprising: obtaining, via user input (user inputs 56, Fig. 2), a plurality of demographic factors ([0042], determine information about the patient such as age, weight, height, etc.); determining, based at least in part on a combination of the respiration rate and the plurality of demographic factors, the overall respiration risk metric ([0042], allows monitor to determine patient-specific threshold ranges that can enable additional algorithms). Regarding claim 18, Batchelder, Annoni, Hite, and Takahashi teach the method according to claim 12. Batchelder teaches the calculation of respiratory rate and tidal volume ([0080]), but does not explicitly teach the calculation of a minute ventilation value. Annoni teaches a system for monitoring respiratory distress in a patient (abstract), further comprising: wherein determining the overall respiration risk metric is based at least in part on a combination of the respiration rate and a determined minute ventilation value (Table 1, minute volume (MV), total volume of gas inhaled or exhaled in one minute, [0073], one or more patient signals can be indicative of the state of respiratory distress). It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Batchelder to incorporate the teachings of Annoni to include the calculation of minute ventilation value. Doing so would allow for the detection of rapid breathing that indicates acute exacerbation, as recognized by Annoni (Table 1). Regarding claim 19, Batchelder, Annoni, Hite, and Takahashi teach the method according to claim 12. Batchelder teaches the method further comprising: wherein determining the overall respiration risk metric is based at least in part on a combination of the respiration rate and a determined tidal volume value ([0091], derivation of tidal volume, step 1130, Fig. 11, derive multiple respiratory characteristics). Regarding claim 20, Batchelder, Annoni, Hite, and Takahashi teach the method according to claim 19. Batchelder teaches the method further comprising: wherein the overall respiration risk metric is based at least in part on a combination of the respiration rate and a tidal volume variability value based at least in part on the determined tidal volume value ([0073], change in tidal volume used to identify/predict respiratory depression event, step 1130, Fig. 11, derive multiple respiratory characteristics). Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Batchelder et al. (US Pre-Grant Publication 2014/0275887) in view of Annoni et al. (US Pre-Grant Publication 2019/0167176), further in view of Hite et al. (US Pre-Grant Publication 2024/0074701), further in view of Takahashi (US Pre-Grant Publication 2017/0268796), further in view of Shiau et al. (US Pre-Grant Publication 2017/0035304), hereinafter ‘Shiau’. Regarding claim 4, Batchelder, Annoni, Hite, and Takahashi teach the device according to claim 1. Batchelder teaches analyzing a PPG signal to extract a respiratory signal (Fig. 5, [0070]), but does not explicitly teach determining respiratory sinus arrhythmia (RSA) to further determine the respiration rate. The Examiner notes that RSA can be observed by correlating inhalation periods with increased heart rate, and exhalation periods with decreased heart rate2. Shiau teaches a system for respiration monitoring using a PPG signal (abstract), further comprising: determining respiratory sinus arrhythmia based at least in part on the heart rate data [0028], peaks/troughs occur at exhale/inhale points, Fig. 2); and determining, based at least in part on the respiratory sinus arrhythmia, the respiration rate ([0028], calculate local maxima/minima to determine the number of respiratory efforts during a time epoch). It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Batchelder, Annoni, Hite, and Takahashi to incorporate the teachings of Shiau to include the calculation of respiration rate based on RSA. Doing so would allow for the monitoring of various physiological parameters, as recognized by Shiau [0006-0007]. Regarding claim 5, Batchelder, Annoni, Hite, Takahashi, and Shiau teach the device according to claim 4. Batchelder teaches the device further comprising: obtaining, via the heart rate sensor, heart rate data associated with a specific epoch of time (Fig. 3d, time on x-axis); determining, based at least in part on the heart rate data associated with the specific epoch of time, a power spectral density (Fig. 3a, pulse band, [0056], pulse component of PPG produces a dominant band); determining, based at least in part on the power spectral density, a spectral peak (Fig. 3b, band maxima (ridge)); and determining, based at least in part on the spectral peak, the respiration rate (Fig. 3c, band/ridge b, [0072], respiratory signal determined by analyzing a ridge). 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /E.L.O./Examiner, Art Unit 3792 /SHIRLEY X JIAN/Primary Examiner, Art Unit 3792 September 4, 2026 1 See https://my.clevelandclinic.org/health/diseases/21666-sinus-arrhythmia: Respiratory sinus arrhythmia section. 2 See https://my.clevelandclinic.org/health/diseases/21666-sinus-arrhythmia: Respiratory sinus arrhythmia section.
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Prosecution Timeline

Oct 08, 2024
Application Filed
Apr 29, 2026
Non-Final Rejection mailed — §101, §103, §112
Jul 17, 2026
Response Filed
Sep 09, 2026
Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
17%
Grant Probability
99%
With Interview (+83.3%)
3y 1m (~1y 2m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 6 resolved cases by this examiner. Grant probability derived from career allowance rate.

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