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 . 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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/02/2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 05/02/2025 (“Amendment”). Claims 8-21 are currently under consideration. The Office acknowledges the amendments to claims 8 and 16. Claims 1-7 remain withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
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.
Claim 8-21 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.
Regarding claims 8 and 16, there is insufficient antecedent basis for the recitations of “the user’s activity metrics.”
Claims 9-15 and 17-21 are rejected because they depend on rejected claims.
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.
Claims 8, 10, 11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2017/0055573 (“Utley”) in view of US Patent Application Publication 2019/0221297 (“Satake”), US Patent Application Publication 2019/0198150 (“Kang”), and non-patent publication Zavorsky, Gerald S., et al. "Increased carbon monoxide clearance during exercise in humans." Medicine & Science in Sports & Exercise 44.11 (2012): 2118-2124 (“Zavorsky”).
Regarding claim 8, Utley teaches [a] method of timing carbon monoxide dissipation in a user having a level of exhaled carbon monoxide which is above a predetermined threshold (see system 100 comprising device 102 shown in Fig. 1; “The system and methods described herein allow for a multi-phased approach to engaging individuals that smoke and quantifying their smoking behavior to better assist the individual to eventually achieve the goal of smoking cessation,” para. [0007] - also see Figs. 9, 21-24, etc., showing dissipation over time), comprising: receiving a sample breath from the user (“device 102 or 202 includes a detector unit and a communications unit ... For breath-based sensors, patient input may include blowing into a tube as part of the detector unit,” para. [0079]); determining the level of exhaled carbon monoxide from the sample breath as indicative of a carbon monoxide level within a body of the user (“The systems and methods non-invasively detect and quantify smoking behavior for a patient based on measuring one or more of the patient's carbon monoxide levels, exhaled carbon monoxide levels (eCO), carboxyhemoglobin (SpCO), oxyhemoglobin (SpO2),” para. [0057], where e.g. eCO is described as a way to measure CO levels in the patient’s blood); … and displaying the carbon monoxide level within the body along a scale which is delineated to provide a relative comparison of the carbon monoxide level of the user (indicator 124 of Figs. 22 and 23 displays the current value along a scale that provides a relative comparison).
Utley does not appear to explicitly teach initiating a first timer which is displayed to the user upon initiating for tracking a countdown time (although it does teach “the processor analyzes the received data to determine a recent smoking event. For example, an elevated SpCO level beyond a certain threshold may suggest that the patient has recently smoked a cigarette,” para. [0128]), wherein the countdown time corresponds to a first length of time until the carbon monoxide level within the body of the user is expected to dissipate from the carbon monoxide level within the body to below the predetermined threshold (although Fig. 22 does show an eCO goal of 5 PPM, and Fig. 23 shows a target level for non-smokers (¶ 0183)).
Satake teaches estimating eCO levels based on an attenuation function (¶ 0068 - also see Fig. 9, showing the attenuation). Satake also teaches presenting/displaying guidance information which includes smoking cessation therapy information to a user (Fig. 8, S812-S814, ¶¶s 0059, 0074, etc.).
Kang teaches estimating the time until a patient has achieved a recovery goal for the purpose of motivating the patient to stick to their goal (¶ 0068).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to initiate and display a countdown timer upon a determination that a user’s eCO level has risen above a threshold, indicating that they have smoked (Utley: ¶ 0128), the timer corresponding to a length of time until a carbon monoxide level is expected to dissipate from the current level to below the threshold (based on the attenuation function of Satake), for the purpose of motivating the user to achieve their goal (Utley: Fig. 22, ¶ 0182; Kang: ¶ 0068).
Utley-Satake-Kang does not appear to explicitly teach the countdown time being based upon a personalized half-life value which accounts for the user’s activity metrics.
Zavorsky teaches that exercise affects the half-life of CO elimination in a predictable manner (Abstract: Conclusions, Fig. 1, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to account for user activity metrics such as exercise in the combination as in Zavorsky, thereby personalizing the half-life value for the attenuation function, to improve accuracy of the determined amount of carbon monoxide in the body (Zavorsky: Fig. 1, with elimination significantly changing based on the amount of exercise), and for the purpose of accounting for a generally relevant factor (Zavorsky: Abstract).
Regarding claim 10, Utley-Satake-Kang-Zavorsky teaches all the features with respect to claim 8, as outlined above. Utley-Satake-Kang-Zavorsky further teaches wherein receiving the sample breath comprises receiving the sample breath through a collection opening located along a housing of a sampling unit and into contact with an electrochemical gas sensor positioned within the sampling unit (Utley: “device 102 or 202 includes a detector unit and a communications unit ... For breath-based sensors, patient input may include blowing into a tube as part of the detector unit,” para. [0079] - also see ¶ 0108, describing submitting breath samples to device 102 or 202, and Fig. 19 and ¶ 0166, showing the opening and describing the electrochemical gas sensor).
Regarding claim 11, Utley-Satake-Kang-Zavorsky teaches all the features with respect to claim 8, as outlined above. Utley-Satake-Kang-Zavorsky further teaches wherein determining the level of exhaled carbon monoxide further comprises visually displaying the level to the user (Utley: Fig. 22, panel 122).
Regarding claim 13, Utley-Satake-Kang-Zavorsky teaches all the features with respect to claim 8, as outlined above. Utley-Satake-Kang-Zavorsky further teaches adjusting the countdown timer upon receiving a subsequent sample breath having a second level of exhaled carbon monoxide which is higher than the level of exhaled carbon monoxide (Satake: Fig. 10 shows the attenuation change after smoking another cigarette (¶ 0071), it being obvious to adjust the countdown timer based on this for the purpose of providing an accurate timer).
Regarding claim 14, Utley-Satake-Kang-Zavorsky teaches all the features with respect to claim 8, as outlined above. Utley-Satake-Kang-Zavorsky further teaches wherein initiating the first timer further comprises determining the countdown time corresponding to a half-life value of the carbon monoxide level within the body of the user (Satake: ¶ 0068, the attenuation function based on a half-life).
Regarding claim 15, Utley-Satake-Kang-Zavorsky teaches all the features with respect to claim 8, as outlined above. Utley-Satake-Kang-Zavorsky further teaches wherein the predetermined threshold comprises a level of 6 PPM (Utley: ¶ 0164, 5.6 ppm, obvious to use since it indicates a healthy value).
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2017/0055573 (“Utley”) in view of US Patent Application Publication 2019/0221297 (“Satake”), US Patent Application Publication 2019/0198150 (“Kang”), non-patent publication Zavorsky, Gerald S., et al. "Increased carbon monoxide clearance during exercise in humans." Medicine & Science in Sports & Exercise 44.11 (2012): 2118-2124 (“Zavorsky”), and US Patent Application Publication 2019/0147139 (“Roy”).
Regarding claim 9, Utley-Satake-Kang-Zavorsky teaches all the features with respect to claim 8, as outlined above. Utley-Satake-Kang-Zavorsky does not appear to explicitly teach initiating a second timer for tracking a cumulative time upon a determination that the level of exhaled carbon monoxide is below the predetermined threshold, wherein the cumulative time corresponds to a second length of time in which subsequent sample breaths maintain the level of exhaled carbon monoxide below the predetermined threshold (although Kang does teach adapting display prompts (¶¶s 0066-0068, Figs. 1 and 2) to motivate a patient to stick to a plan and hold the patient accountable (¶ 0068)).
Roy teaches calculating a time-in-range measure indicative of a duration during which a physiological value was within a target range (claim 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to initiate a timer for tracking the cumulative time within the target range of Utley (e.g. below 5 PPM as in Fig. 22), as in Roy, for the purpose of encouraging the user to maintain a healthy state (Kang: ¶ 0068).
Regarding claim 12, Utley-Satake-Kang-Zavorsky-Roy teaches all the features with respect to claim 9, as outlined above. Utley-Satake-Kang-Zavorsky-Roy further teaches wherein initiating the second timer further comprises displaying the cumulative time to the user until at least one of the subsequent sample breaths result in exhaled carbon monoxide above the predetermined threshold (Kang: adapting display prompts (¶¶s 0066-0068, Figs. 1 and 2) to motivate a patient to stick to a plan and hold the patient accountable (¶ 0068). After eCO rises above the predetermined threshold, it would have been obvious to display the time to goal, instead of the time in goal).
Claims 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2017/0055573 (“Utley”) in view of US Patent Application Publication 2019/0147139 (“Roy”), US Patent Application Publication 2019/0198150 (“Kang”), US Patent Application Publication 2019/0221297 (“Satake”), and non-patent publication Zavorsky, Gerald S., et al. "Increased carbon monoxide clearance during exercise in humans." Medicine & Science in Sports & Exercise 44.11 (2012): 2118-2124 (“Zavorsky”).
Regarding claim 16, Utley teaches [a] method of timing carbon monoxide dissipation in a user having a level of exhaled carbon monoxide which rises above a predetermined threshold (see system 100 comprising device 102 shown in Fig. 1; “The system and methods described herein allow for a multi-phased approach to engaging individuals that smoke and quantifying their smoking behavior to better assist the individual to eventually achieve the goal of smoking cessation,” para. [0007] - also see Figs. 9, 21-24, etc., showing dissipation over time), comprising: receiving a sample breath from the user (“device 102 or 202 includes a detector unit and a communications unit ... For breath-based sensors, patient input may include blowing into a tube as part of the detector unit,” para. [0079]); determining a level of exhaled carbon monoxide from the sample breath as indicative of a carbon monoxide level within a body of the user (“The systems and methods non-invasively detect and quantify smoking behavior for a patient based on measuring one or more of the patient's carbon monoxide levels, exhaled carbon monoxide levels (eCO), carboxyhemoglobin (SpCO), oxyhemoglobin (SpO2),” para. [0057], where e.g. eCO is described as a way to measure CO levels in the patient’s blood); visually displaying the level of exhaled carbon monoxide to the user (Fig. 22, panel 122); … .
Utley does not appear to explicitly teach initiating a first timer which is displayed to the user upon initiation for tracking a cumulative time when the level of exhaled carbon monoxide is below the predetermined threshold (although ¶ 0142 describes determining goals for the patient and rewarding them when the goals are achieved - also see Fig. 22, an eCO goal of e.g. 5 PPM); displaying the cumulative time to the user, wherein the cumulative time corresponds to a first length of time in which subsequent sample breaths maintain the level of exhaled carbon monoxide below the predetermined threshold; displaying the carbon monoxide level within the body relative to a cohort carbon monoxide level (although Figs. 22 and 23 do show display of target levels, and well as display of an indicator 124 which includes a current value and its location on a scale).
Roy teaches calculating and displaying a time-in-range measure indicative of a duration during which a physiological value was within a target range (claim 1, Figs. 9A and 9B, etc.). Roy also teaches displaying this value relative to a cohort level (¶¶s 0064, 0084, 0085, etc., the target range is calculated from values of a cohort).
Kang teaches adapting display prompts (¶¶s 0066-0068, Figs. 1 and 2) to motivate a patient to stick to a plan and hold the patient accountable (¶ 0068).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to initiate a timer for tracking the cumulative time within the target range of Utley (e.g. below 5 PPM as in Fig. 22) and to calculate and display the cumulative time, as in Roy, for the purpose of encouraging the user to maintain a healthy state (Kang: ¶ 0068). It would have been obvious to display the carbon monoxide level in relation to a target/cohort level (as already contemplated by the indicator 124 of Fig. 22 of Utley), for the purpose of enabling the user to see how they compare to others (Roy: ¶ 0064), which can also encourage the user to maintain a healthy state (Kang: ¶ 0068).
Utley-Roy-Kang does not appear to explicitly teach initiating a second timer for tracking a countdown time when the level of exhaled carbon monoxide rises above the predetermined threshold (although Utley does teach “the processor analyzes the received data to determine a recent smoking event. For example, an elevated SpCO level beyond a certain threshold may suggest that the patient has recently smoked a cigarette,” para. [0128]); and displaying the countdown time to the user, wherein the countdown time corresponds to a second length of time until the carbon monoxide level within the body of the user is expected to dissipate from the carbon monoxide level within the body to below the predetermined threshold based upon a personalized half-life value which accounts for the user’s activity metrics (although Utley: Fig. 22 does show an eCO goal of 5 PPM, and Fig. 23 shows a target level for non-smokers (¶ 0183)).
Satake teaches estimating eCO levels based on an attenuation function (¶ 0068 - also see Fig. 9, showing the attenuation). Satake also teaches presenting guidance information which includes smoking cessation therapy information to a user (Fig. 8, S812-S814, ¶¶s 0059, 0074, etc.).
Kang teaches estimating the time until a patient has achieved a recovery goal for the purpose of motivating the patient to stick to their goal (¶ 0068). The time is delivered as e.g. a display prompt (¶¶s 0066-0068, Figs. 1 and 2).
Zavorsky teaches that exercise affects the half-life of CO elimination in a predictable manner (Abstract: Conclusions, Fig. 1, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to initiate a countdown timer when a user’s eCO level rises above a threshold, indicating that they have smoked (Utley: ¶ 0128), the timer corresponding to a length of time until a carbon monoxide level is expected to dissipate from the current level to below the threshold (based on the attenuation function of Satake), and to display the countdown time to the user (Kang: ¶ 0068), for the purpose of motivating the user to achieve their goal (Utley: Fig. 22, ¶ 0182; Kang: ¶ 0068). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to account for user activity metrics such as exercise in the attenuation function as in Zavorsky, thereby personalizing the half-life value for the attenuation function, to improve accuracy of the determined amount of carbon monoxide in the body (Zavorsky: Fig. 1, with elimination significantly changing based on the amount of exercise), and for the purpose of accounting for a generally relevant factor (Zavorsky: Abstract).
Regarding claim 17, Utley-Roy-Kang-Satake-Zavorsky teaches all the features with respect to claim 16, as outlined above. Utley-Roy-Kang-Satake-Zavorsky further teaches wherein receiving the sample breath comprises receiving the sample breath through a collection opening located along a housing of a sampling unit and into contact with an electrochemical gas sensor positioned within the sampling unit (Utley: “device 102 or 202 includes a detector unit and a communications unit ... For breath-based sensors, patient input may include blowing into a tube as part of the detector unit,” para. [0079] - also see ¶ 0108, describing submitting breath samples to device 102 or 202, and Fig. 19 and ¶ 0166, showing the opening and describing the electrochemical gas sensor).
Regarding claim 18, Utley-Roy-Kang-Satake-Zavorsky teaches all the features with respect to claim 16, as outlined above. Utley-Roy-Kang-Satake-Zavorsky further teaches wherein determining the level of exhaled carbon monoxide further comprises visually displaying the level to the user (Utley: Fig. 22, panel 122).
Regarding claim 19, Utley-Roy-Kang-Satake-Zavorsky teaches all the features with respect to claim 16, as outlined above. Utley-Roy-Kang-Satake-Zavorsky further teaches wherein initiating the first timer further comprises displaying the cumulative time to the user until at least one of the subsequent sample breaths result in exhaled carbon monoxide above the predetermined threshold (Kang: adapting display prompts (¶¶s 0066-0068, Figs. 1 and 2) to motivate a patient to stick to a plan and hold the patient accountable (¶ 0068). After eCO rises above the predetermined threshold, it would have been obvious to display the time to goal, instead of the time in goal).
Regarding claim 20, Utley-Roy-Kang-Satake-Zavorsky teaches all the features with respect to claim 16, as outlined above. Utley-Roy-Kang-Satake-Zavorsky further teaches adjusting the countdown timer upon receiving a subsequent sample breath having a second level of exhaled carbon monoxide which is higher than the level of exhaled carbon monoxide (Satake: Fig. 10 shows the attenuation change after smoking another cigarette (¶ 0071), it being obvious to adjust the countdown timer based on this for the purpose of providing an accurate timer).
Regarding claim 21, Utley-Roy-Kang-Satake-Zavorsky teaches all the features with respect to claim 16, as outlined above. Utley-Roy-Kang-Satake-Zavorsky further teaches wherein initiating the second timer further comprises determining a half-life value of the carbon monoxide level within the body of the user (Satake: ¶ 0068, the attenuation function based on a half-life).
Response to Arguments
In response to the amendments and arguments regarding the rejections under 35 USC 103, they are persuasive. Therefore, a new grounds of rejection is made in further view of Zavorsky, and all claims remain rejected in light of the prior art.
Conclusion
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791