Prosecution Insights
Last updated: July 17, 2026
Application No. 17/132,581

BREATH SENSOR MEASUREMENT METHODS AND APPARATUS

Final Rejection §103§112
Filed
Dec 23, 2020
Priority
Dec 31, 2019 — provisional 62/955,561
Examiner
WEARE, MEREDITH H
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Carrot Inc.
OA Round
4 (Final)
50%
Grant Probability
Moderate
5-6
OA Rounds
0m
Est. Remaining
82%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allowance Rate
353 granted / 706 resolved
-20.0% vs TC avg
Strong +32% interview lift
Without
With
+32.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
44 currently pending
Career history
763
Total Applications
across all art units

Statute-Specific Performance

§101
11.3%
-28.7% vs TC avg
§103
63.4%
+23.4% vs TC avg
§102
2.1%
-37.9% vs TC avg
§112
16.2%
-23.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 706 resolved cases

Office Action

§103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA . Response to Amendment The amendment to the claims filed 23 February 2026 has been entered. Claim(s) 1, 4-5, 7, 9, 12-14, 16 and 18 is/are currently amended. Claim(s) 1-43 is/are pending, with claim(s) 19-43 withdrawn from consideration for being drawn to a non-elected invention and/or species. Rejections Withdrawn Rejections under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks. 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 pre-AIA 35 U.S.C. 112, 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. Claim(s) 10 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention. Regarding claim 10 and claims dependent thereon, the limitation "prompting the user with instructions to inhale through the sampling unit for a second predetermined period of time via the pressure sensor; measuring a second parameter of the sample breath over the second predetermined period of time" is indefinite. Firstly, it is unclear how the user is prompted "via the pressure sensor." Secondly, the sample breath (presumably the first sample breath) of claim 9, on which claim 10 depends, is a breath exhaled over a first period of time (e.g., claim 9, "prompting the user…to exhale a first sample breath into a sampling unit for a first predetermined period of time"). Claim 10 indicates the second predetermined period of time is a period during which the user is prompted to inhale. It is unclear how, or in what manner, a second parameter of "the sample breath" (i.e., an exhalation occurring during a first predetermined period of time) is measured "over the second predetermined period of time" during which the user, and/or is prompted to, inhale(s). For the purpose of this Office action, claim 10 will be discussed with the understanding that the user is prompted to inhale through the sampling unit, said inhalation being a "second breath sample," and a second parameter of the inhalation/second breath sample is measured, e.g., within the scope of, "prompting the user with instructions to inhale a second breath sample through the sampling unit for a second predetermined period of time; measuring a second parameter of the second sample breath over the second predetermined period of time…." Claim Rejections - 35 USC § 103 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: Determining the scope and contents of the prior art. Ascertaining the differences between the prior art and the claims at issue. Resolving the level of ordinary skill in the pertinent art. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 1, 3-12 and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0164373 A1 (previously cited, Davis) in view of US 2015/0347689 A1 (Neagle), "Breath Carbon Monoxide Output is Affected by Speed of Emptying the Lungs: Implications for Laboratory and Smoking Cessation Research" (Raiff), US 2011/0021940 A1 (previously cited, Chu) and US 2019/0261891 A1 (previously cited, Ahmad). Regarding claims 1, 3-5 and 7, Davis discloses and/or suggests an apparatus configured to measure pulmonary parameters of a user, comprising: a sampling unit (portable device 100) having a breath sampling port (flow chamber 200); at least one sensor located within the sampling unit and in communication with the breath sampling port (flow sensor 304-1 and/or pressure sensor 304-2 for measuring high and low flow rates); at least one gas sensor configured to detect an analyte of interest from a first sample breath exhaled by the user into the breath sampling port, wherein the at least one gas sensor is positioned in the sampling unit and in fluid communication with at least a portion of the first sample breath (sensors 304-3, 304-4, and 304-5 used to respectively monitor NO, CO, and O2 concentrations in exhaled breath); a processor in communication with the at least one pressure sensor and the at least one gas sensor (mobile device 118, or inherent processing means thereof, in communication with the above-noted sensors via microcontroller 110), wherein the processor is configured to: prompt a user with instructions to exhale the first sample breath for a first pre-determined period of time into the breath sampling port (¶ [0045] guide a breath maneuver for user 112 via the UI of mobile device 118; etc.); measure a parameter relating to a pressure level corresponding to an increase in the pressure level at a beginning of a receipt of a sample breath and a decrease in the pressure level at an end of the receipt of the sample breath via the at least one sensor (¶ [0054] data collected from sensors 304-1 and 304-2 to replicate a real-time collection of samples throughout a breathing maneuver); receive a measurement from the gas sensor(s) and correlate this measurement to the analyte of interest from the first sample breath (e.g., ¶ [0062] sensors 304-3, 304-4, and 304-5 output a measurable voltage from which concentration is determined, as described in ¶ [0055]); and calculate a pulmonologic parameter of the user based on the parameter (¶ [0057] FVC, FEV, FEV1 and/or a spirometry graph; ¶ [0072]; etc.), which is tracked by the processor as an indicator of health of the user (e.g., ¶ [0076] said parameters are monitored as an indicator(s) of lung function; ¶ [0052] lung function parameters are useful in describing the disease state in the lungs, assessing therapeutic intervention, and/or monitoring for adverse reactions to medication; etc.). Davis does not expressly disclose the pulmonologic parameter is obtained from the first sample breath. Rather, Davis discloses a first tidal breathing maneuver is performed during which the analyte(s) of interest are detected and a second spirometry breathing maneuver is performed during which the parameter is measured (¶ [0072]). Neagle discloses a comparable apparatus configured to measure an analyte of interest, such as CO, in a first sample breath and simultaneously measure a parameter relating to a pressure level of the first breath sample over a predetermined period of time (e.g., exhaled volume); measuring a second parameter of a second sample breath over a second predetermined period of time (e.g., inhaled volume); and determining a total volume of air corresponding to a lung capacity of the user based on the first and second parameters over the first and second predetermined periods of time (e.g., determine pulmonary capacity and function from the volume measurements), wherein the pulmonologic parameter is tracked as an indicator of health of the user by comparing the pulmonologic parameter against a subsequent pulmonologic parameter to estimate lung capacity of the user over time (e.g., changes in lung capacity and CO level) (¶¶ [0037]-[0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Davis with the apparatus detecting the analyte of interest, such as CO, in the first breath sample and measuring a parameter and pulmonologic parameter from the first breath sample as taught/suggested by Neagle in order to facilitate obtaining additional/alternate pulmonologic parameter(s) useful for monitoring, e.g., smoking cessation compliance, in a manner that significantly decreases an amount of time the patient spends in making measurements (Neagle, ¶¶ [0037]-[0039]), particularly if/when a full set of common spirometric measurements (e.g., FVC, FEV, FEV1 and/or a spirometry graph) is neither needed and/or desired. While Davis discloses the processed sensor signals can be used to generate visual feedback, and visual feedback provided to the user may comprise guiding a breath maneuver (e.g., ¶ [0045]), Davis as modified does not expressly disclose the processor is configured to correlate the parameter corresponding to a beginning of a receipt of the first sample breath and an end of the receipt of the first sample breath to a sufficiency of the first sample breath as determined by a comparison of an expected duration and intensity of the pressure level against a measured duration and intensity of the pressure level. Raiff discloses/suggests a maneuver/protocol for measuring CO in an exhaled first breath sample comprising: inhaling for a predetermined period of time; breath holding for at least 10 seconds, then exhaling the first breath sample for at least 6 to 12 seconds (pg. 834, to measure CO, smokers are typically instructed to take a deep breath and hold it for 15-20 s, after which they exhale into a CO monitor; pgs. 386-387, minimum exhalation speed of 10 seconds; etc.). Chu discloses/suggests a similar apparatus configured to measure pulmonary parameters of a user, the system comprising, inter alia: a sampling unit (pulmonary measurement machine 1000) having a breath sampling port (receiver 1100 for accepting pulmonary input, e.g., inhalation and/or exhalation, from a person, and/or input carrier 1150); at least one sensor located within the sampling unit and in communication with the breath sampling port (sensor 1200 exposed to the pulmonary input); a processor in communication with the at least one pressure sensor and the at least one gas sensor (processor 1250), wherein the processor is configured to: prompt a user with instructions to exhale a first sample breath for a first predetermined period of time into the breath sampling port (Fig. 7; ¶ [0041] providing audible instruction signals for complete exhalation and/or providing audible instruction signals for exhalation following maximal inhalation; etc.); and measure a parameter corresponding to a beginning of a receipt of the first sample breath and an end of the receipt of the first sample breath via the at least one sensor (¶¶ [0026]-[0028] sensor 1200 can be selected and/or configured to produce a voltage that varies in magnitude depending on the characteristic to be measured, such as spirometric flow, spirometric volume, etc.), and correlate this parameter to a sufficiency of the first sample breath (Fig. 7; determining if each step of a breathing maneuver meets predefined criteria (e.g., sufficiently stable, exhalation and/or inhalation is complete) exhalation is complete; ¶ [0028] responsive audible signals may also be selected on a combination of both a pulmonary input and some other non-pulmonary input factor, such as time; etc.). Ahmad similarly discloses an apparatus (e.g., Fig. 1, apparatus 4) comprising a sampling unit having a breath sampling port (¶ [0107] apparatus 4 comprises a housing, with a breath input portion in the form of a mouthpiece extending from an end of the housing); at least one sensor located within the sampling unit and in communication with the breath sampling port for measuring a parameter relating to a pressure level (¶ [0109] means are included for measuring flow characteristics as breath is inputted into and passes through the apparatus; ¶ [0268] volume measurement apparatus that may include a pressure transducer; etc.); and a processor (¶ [0118] apparatus 4 comprises a processor) configured to, inter alia, measure a parameter relating to a pressure level corresponding to an increase in the pressure level at a beginning of a receipt of a first sample breath and a decrease in the pressure level at an end of the receipt of the first sample breath via the at least one sensor and correlate this parameter to a sufficiency of the first sample breath as determined by a comparison of an expected duration and intensity of the pressure level against a measured duration and intensity of the pressure level (¶ [0195] breath analysis device may compare an exhalation to the user's stored breath profile to determine if the exhalation is proper or aberrant; ¶ [0133] breath profile includes certain characteristics, such as the duration and/or volume of the breath; etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Davis with the processor being configured to prompt to user with instructions for measuring the analyte of interest (e.g., prompting the inhale for a second predetermined period of time through the breath sampling port; prompting the user to hold their breath for at least 10 seconds; prompting the user to then exhale the first sample breath for at least 6 to 12 seconds) as taught/suggested by Raiff and Chu, and to correlate the parameter relating to a pressure level to a sufficiency of the first sample breath as determined by a comparison of an expected duration and intensity of the pressure level against a measured duration and intensity of the pressure level as taught and/or suggested by Chu and Ahmad in order to facilitate indicating to a user that the first sample breath meets established requirements for an acceptable sample and/or maneuver (Davis, ¶ [0072]; Ahmad, ¶ [0195]; etc.), e.g., is "sufficiently" complete and/or proper for analysis (Chu, ¶ [0041]; Ahmad, ¶ [0195]; etc.), which may enable signaling to the user that he/she may stop exhaling (or performing some other step of a breathing maneuver) without substantially affecting reliability of the test; to help determine if the user needs further instructions so as to streamline the measurement process (Ahmad, ¶ [0267]); etc. Regarding claim 6, Davis as modified discloses and/or suggests the processor is further configured to prompt the user to exhale for a third predetermined period of time into the breath sampling port (e.g., ¶ [0072] signaling the user to perform a second breath maneuver, i.e., a full spirometry breath maneuver, which includes instructing the user to exhale for at least 6 sec to obtain a suitable FVC alternate and an acceptable spirometry maneuver) to provide additional pulmonologic parameter(s) and/or a more complete lung function test. Regarding claim 8, Davis as modified discloses/suggests the gas sensor(s) is configured to sense a level of H2, CH4, CO2, O2, or C3H6O (¶ [0055] 304-5 used to monitor O2 concentration). Regarding claims 9-12, 14 and 17, Davis discloses and/or suggests a method of measuring pulmonary parameters of a user, the method comprising: prompting the user with instructions to exhale a first sample breath into a sampling unit for a first predetermined period of time (¶ [0045] guide a breath maneuver for user 112 via the UI of mobile device 118); measuring a first parameter relating to a pressure level of a sample breath over the first predetermined period of time via a sensor in communication with the sample breath (¶ [0054] data collected from sensors 304-1 and 304-2 to replicate a real-time collection of samples throughout a breathing maneuver); measuring a biological parameter from the first sample breath via at least one gas sensor in fluid communication with at least a portion of the first sample breath (¶ [0066] collecting data from chemical sensors); correlating a measurement of the biological parameter to an analyte of interest via a processor in communication with the at least one gas sensor (mobile device 118, or inherent processing means thereof, in communication with the above-noted sensors via microcontroller 110) (e.g., ¶ [0062] sensors 304-3, 304-4, and 304-5 output a measurable voltage from which concentration of respective analytes is determined, as described in ¶ [0055]); and calculating a pulmonologic parameter of the user via the processor based on the parameter (¶ [0057] FVC, FEV, FEV1 and/or a spirometry graph; ¶ [0072]; etc.), which is tracked as an indicator of health of the user (e.g., ¶ [0076] where said parameters are monitored as an indicator(s) of lung function; ¶ [0052] lung function parameters are useful in describing the disease state in the lungs, assessing therapeutic intervention, and/or monitoring for adverse reactions to medication; etc.). Davis does not expressly disclose the pulmonologic parameter is obtained from the first sample breath. Rather, Davis discloses a first tidal breathing maneuver is performed during which the analyte(s) of interest are detected and a second spirometry breathing maneuver (i.e., exhalation) is performed during which the parameter is measured (¶ [0072]). Neagle discloses a comparable apparatus configured to measure an analyte of interest, such as CO, in a first sample breath and simultaneously measure a parameter relating to a pressure level of the first breath sample over a predetermined period of time (e.g., exhaled volume); measuring a second parameter of a second sample breath over a second predetermined period of time (e.g., inhaled volume); and determining a total volume of air corresponding to a lung capacity of the user based on the first and second parameters over the first and second predetermined periods of time (e.g., determine pulmonary capacity and function from the volume measurements), wherein the pulmonologic parameter is tracked as an indicator of health of the user by comparing the pulmonologic parameter against a subsequent pulmonologic parameter to estimate lung capacity of the user over time (e.g., changes in lung capacity and CO level) (¶¶ [0037]-[0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Davis detecting the analyte of interest, such as CO, in the first breath sample; measuring the parameter/pulmonologic parameter from the first breath sample; measuring a second parameter of a second, inhaled sample breath over a second predetermined period of time; and determining, with the processor, a total volume of air corresponding to a lung capacity of the user based on the first and second parameters over the first and second predetermined periods of time as taught/suggested by Neagle in order to facilitate obtaining additional/alternate pulmonologic parameter(s) useful for monitoring, e.g., smoking cessation compliance, in a manner that significantly decreases an amount of time the patient spends in making measurements (Neagle, ¶¶ [0037]-[0039]), particularly if/when a full set of common spirometric measurements (e.g., FVC, FEV, FEV1 and/or a spirometry graph) is neither needed and/or desired. While Davis discloses the processor is in communication with the sensor (e.g., Fig. 1), and processed sensor signals can be used to generate visual feedback, wherein visual feedback provided to the user may comprise guiding a breath maneuver (e.g., ¶ [0045]), Davis as modified does not expressly disclose the method comprises correlating the first parameter to a sufficiency of the first sample breath as determined by a comparison of an expected duration and intensity of the pressure level against a measured duration and intensity of the pressure level via the processor. Raiff discloses/suggests a maneuver/protocol for measuring CO in an exhaled first breath sample comprising: inhaling for a predetermined period of time; breath holding for at least 10 seconds, then exhaling the first breath sample for at least 6 to 12 seconds (pg. 834, to measure CO, smokers are typically instructed to take a deep breath and hold it for 15-20 s, after which they exhale into a CO monitor; pgs. 386-387, minimum exhalation speed of 10 seconds; etc.). Chu discloses/suggests a similar an apparatus configured to measure pulmonary parameters of a user, the system comprising, inter alia: a sampling unit (pulmonary measurement machine 1000) having a breath sampling port (receiver 1100 for accepting pulmonary input, e.g., inhalation and/or exhalation, from a person, and/or input carrier 1150); at least one sensor located within the sampling unit and in communication with the breath sampling port (sensor 1200 exposed to the pulmonary input); a processor in communication with the at least one pressure sensor and the at least one gas sensor (processor 1250), wherein the processor is configured to: prompt a user with instructions to exhale a sample breath for a first predetermined period of time into the breath sampling port (Fig. 7; ¶ [0041] providing audible instruction signals for complete exhalation and/or providing audible instruction signals for exhalation following maximal inhalation; etc.); and measure a parameter corresponding to a beginning of a receipt of the sample breath and an end of the receipt of the sample breath via the at least one sensor (¶¶ [0026]-[0028] sensor 1200 can be selected and/or configured to produce a voltage that varies in magnitude depending on the characteristic to be measured, such as spirometric flow, spirometric volume, etc.), and correlate this parameter to a sufficiency of the sample breath (Fig. 7; determining if each step of a breathing maneuver meets predefined criteria (e.g., sufficiently stable, exhalation and/or inhalation is complete) exhalation is complete; ¶ [0028] responsive audible signals may also be selected on a combination of both a pulmonary input and some other non-pulmonary input factor, such as time; etc.). Ahmad discloses an apparatus (e.g., Fig. 1, apparatus 4) comprising a sampling unit having a breath sampling port (¶ [0107] apparatus 4 comprises a housing, with a breath input portion in the form of a mouthpiece extending from an end of the housing); at least one sensor located within the sampling unit and in communication with the breath sampling port for measuring a parameter relating to a pressure level (¶ [0109] means are included for measuring flow characteristics as breath is inputted into and passes through the apparatus; ¶ [0268] volume measurement apparatus that may include a pressure transducer; etc.); and a processor (¶ [0118] apparatus 4 comprises a processor) configured to, inter alia, measure a parameter relating to a pressure level corresponding to an increase in the pressure level at a beginning of a receipt of the sample breath and a decrease in the pressure level at an end of the receipt of the sample breath via the at least one sensor and correlate this parameter to a sufficiency of the sample breath as determined by a comparison of an expected duration and intensity of the pressure level against a measured duration and intensity of the pressure level (¶ [0195] breath analysis device may compare an exhalation to the user's stored breath profile to determine if the exhalation is proper or aberrant; ¶ [0133] breath profile includes certain characteristics, such as the duration and/or volume of the breath; etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Davis with prompting to user with instructions for measuring the analyte of interest (e.g., prompting the inhale for a second predetermined period of time through the breath sampling port; prompting the user to hold their breath for at least 10 seconds; prompting the user to then exhale the first sample breath for at least 6 to 12 seconds) as taught/suggested by Raiff and Chu, and correlating the first parameter to a sufficiency of the first sample breath as determined by a comparison of an expected duration and intensity of the pressure level against a measured duration and intensity of the pressure level via the processor as taught and/or suggested by Chu and Ahmad in order to facilitate indicating to a user that a provided first sample breath meets established requirements for an acceptable sample and/or maneuver (Davis, ¶ [0072]; Ahmad, ¶ [0195]; etc.), e.g., is "sufficiently" complete and/or proper for analysis (Chu, ¶ [0041]; Ahmad, ¶ [0195]; etc.), which may enable signaling to the user that he/she may stop exhaling (or performing some other step of a breathing maneuver) without substantially affecting reliability of the test; to help determine if the user needs further instructions so as to streamline the measurement process (Ahmad, ¶ [0267]); etc. Regarding claim 15, Davis as modified discloses/suggests further comprising prompting the user to exhale for a third predetermined period of time into the breath sampling port (e.g., ¶ [0072] signaling the user to perform a second breath maneuver, i.e., a full spirometry breath maneuver, which includes instructing the user to exhale for at least 6 sec to obtain a suitable FVC alternate and an acceptable spirometry maneuver) to provide additional pulmonologic parameter(s) and/or a more complete lung function test. Regarding claim 16, Davis as modified discloses and/or suggests measuring the biological parameter from the sample breath comprises venting a portion of the sample breath (¶ [0046] residual of the exhaled breath exits flow tube 202 from second open end 206). Alternatively/Additionally, Ahmad discloses measuring a biological parameter from a first sample breath comprises venting a portion of the first sample breath (e.g., ¶¶ [0143]-[0145]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Davis with venting a portion of the first sample breath as taught/suggested by Ahmad in order to ensure an alveolar breath sample is provided to the gas sensor for analysis (Ahmad, ¶¶ [0143]-[0144]). Regarding claim 18, Davis as modified discloses and/or suggests measuring the biological parameter comprises sensing a level of H2, CH4, CO2, O2, or C3H6O from the first sample breath (¶ [0055] 304-5 used to monitor O2 concentration). Claim(s) 2 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Neagle, Raiff, Chu and Ahmad as applied to claim(s) 1 and 9 above, and further in view of US 2021/0290101 A1 (previously cited, Douglas). Regarding claims 2 and 13, Davis as modified discloses/suggests the limitations of claims 1 and 9, as discussed above, but does not expressly disclose the processor is configured to prompt the user to exhale at a constant flow rate or constant pressure when exhaling the sample breath. Ahmad discloses some sensor designs may be sensitive to fluid flow perturbations, high or low flow rates, or the like, disclosing steady or linear flow rates are ideal for said sensors (e.g., ¶ [0159]). Douglas discloses an apparatus, which is configured to operate in multiple configurations, e.g., a first spirometry configuration and a second nitric oxide test configuration (e.g., ¶ [0018]). Douglas discloses each configuration requires different sample breath (i.e., exhalation) maneuvers to be performed by the user, wherein the user may be prompted to perform said maneuvers by the apparatus (e.g., ¶ [0307]; ¶ [0348], etc.), and wherein, in the nitric oxide test configuration, the user is required to exhale into the mouthpiece at a slow and constant flow rate for a predetermined duration (e.g., ¶ [0308]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus and method of Davis with the processor being further configured for prompting the user to exhale the first sample breath at a constant flow rate or constant pressure as taught/suggested by Ahmad and Douglas in order to enable utilizing the same apparatus for multiple diagnostic tests (Douglas, ¶ [0001]), such as a nitric oxide test and/or providing steady exhalation to a sensor sensitive to fluid flow perturbations, high or low flow rates, etc. (Ahmad, ¶ [0159]). Response to Arguments Applicant's arguments with respect the prior art rejection(s) have been considered but are moot because the new ground(s) of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant's remaining arguments have been fully considered but they are not persuasive. Applicant's arguments fail to address the rejection of claim 10 and claims dependent thereon under 35 U.S.C. 112(b) made of record in the previous Office action. Accordingly, said rejection has been maintained. 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 extension fee 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 date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. 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. /Meredith Weare/Primary Examiner, Art Unit 3791
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Prosecution Timeline

Show 1 earlier event
May 23, 2024
Non-Final Rejection mailed — §103, §112
Nov 20, 2024
Response Filed
Feb 18, 2025
Final Rejection mailed — §103, §112
Aug 15, 2025
Request for Continued Examination
Aug 20, 2025
Response after Non-Final Action
Sep 02, 2025
Non-Final Rejection mailed — §103, §112
Feb 23, 2026
Response Filed
Jun 03, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
50%
Grant Probability
82%
With Interview (+32.4%)
3y 10m (~0m remaining)
Median Time to Grant
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